GeNeuro SA – 2023 Universal Registration Document

GENERAL OBSERVATIONS

Unless otherwise indicated, in this universal registration document (the "Universal Registration Document") the

terms "Company" or "GeNeuro" mean GeNeuro SA and the term "Group" means the Company and its subsidiaries

GeNeuro Innovation SAS ("GeNeuro Innovation"), in France.

This Universal Registration Document was prepared pursuant to Annex 1 and Annex 2 of the delegated regulation

(EU) 2019/980 of the Commission of 14 March 2019 which complements Regulation (EU) 2017/2019 of the

European Parliament and Counsel and, pursuant to article 19 of the Regulation (EU) 2017/1129, incorporates by

reference (i) the Company's consolidated financial statements for the year ended December 31, 2022, prepared in

accordance with IFRS, and the auditors' report related thereto presented in section 18.3 of the Universal

Registration Document filed with the AMF on 28 April 2023 and (ii) the Company's consolidated financial statements

for the year ended December 31, 2021, prepared in accordance with IFRS, and the auditors' report related thereto

presented in section 18.3 of the Universal Registration Document filed with the AMF on 27 April 2022.

This Universal Registration Document contains statements about the Group's objectives. These statements are

sometimes identified by the use of the future tense, the conditional tense, and expressions with forward-looking

character, such as "think," "has as an objective," "expects," "intends," "should," "with the ambition of," "consider,"

"believe," "wish," "could," etc. This information is based on data, assumptions, and estimates considered reasonable

by the Company. They may change or be changed because of uncertainties related to any business as well as to

the economic, financial, competitive and regulatory environment.

Furthermore, the achievement of the Group's objectives assumes the success of its strategy, which is set forth in

Section 5.1.2 of the Universal Registration Document. The Company can make no commitment or give any

assurance that the objectives set forth in this Universal Registration Document will be achieved.

Investors are urged to give consideration to the risk factors set forth in Chapter 3 "Risk Factors" of this Universal

Registration Document before making their investment decision. The occurrence of such risks could have a negative

effect on the Group's business, financial condition, results of operations, or prospects. Furthermore, other risks, not

presently identified or not considered material by the Company, could have the same negative effect, and investors

could lose all or part of their investment.

This Universal Registration Document also contains information about the markets in which the Group competes,

some of which information was obtained from sources external to the Company. Unless otherwise indicated, the

information relating to the markets in which the Group competes or its competitive position contained in this

Universal Registration Document comes from the Company's internal estimates. These internal estimates are

based on reports of analysts, specialized studies, industry publications, any and all information published by market

survey companies, and public and governmental sources, as well as internal knowledge of the market by the

Company. Even though such information is considered reliable, it has not been independently verified by the

Company. Furthermore, in light of the very rapid changes occurring in France, in the world, and in the industry in

which the Group competes, it is possible that such information may prove erroneous or not be up to date. The

Group's business, accordingly, could evolve in a different way from the one described in this Universal Registration

Document. The Company has not committed or agreed to publish any update of the information contained herein,

except in connection with any legal or regulatory obligation that may apply to it.

A glossary that contains definitions of certain technical terms used in this Universal Registration Document, as well

as an index of abbreviations used, are set forth in Appendix of this Universal Registration Document.

A reconciliation table with the Annual Financial Report is located at the end of this Universal Registration Document.

This Universal Registration Document has been prepared on the basis of the Company's annual consolidated

financial statements for the financial years ending December 31, 2022 and 2023.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 1.

PERSONS RESPONSIBLE FOR THIS UNIVERSAL REGISTRATION DOCUMENT

1.1 Person Responsible For The Universal Registration Document

Mr. Jesús Martin-Garcia, Chairman of the Board of Directors and Chief Executive Officer of GeNeuro.

1.2 Certificate Of The Person Responsible For The Universal Registration Document

I certify that, to my knowledge, the information contained in this Universal Registration Document is in accordance

with the facts and contains no omission likely to affect its import.

I certify that, to my knowledge, the financial statements of GeNeuro have been prepared in accordance with

applicable accounting standards and give a fair view of the assets, liabilities, financial position and results of the

Company and all the subsidiaries included in the scope of consolidation, and that the management report of the

board of directors, as referenced in the cross reference list included on page 241 gives a true and fair view of the

business trends, results and financial position of the Company and its subsidiaries included in the scope of

consolidation and describes the main risks and uncertainties with which they have to contend.

Mr. Jesús Martin-Garcia, Chairman of the Board of Directors and Chief Executive Officer of GeNeuro.

1.3 Information From Third Parties, Experts' Statements or Reports

Certain market information set forth in CHAPTER 5, "Description of the Group's Business" of this Universal

Registration Document, come from third-party sources. The Company certifies that such information has been

faithfully reproduced and that, to the Company's knowledge, on the basis of data published or provided by such

sources, no fact has been omitted that would make the information reproduced inaccurate or misleading.

1.4 Declaration relating to the registration document

Not applicable.

1.5 Person Responsible For The Financial Information

Mr. Miguel Payró

Group Chief Financial Officer

3 chemin du Pré-Fleuri, CH-1228 Plan-les-Ouates, Switzerland

Telephone:

+41 22 552 4800

info@geneuro.com

www.geneuro.com

1.6 Indicative Timetable for Financial Communication

April 30, 2024

2023 annual results

April 30, 2024

Q1 2024 cash position

June 12, 2024

Annual general meeting of shareholders

July 23, 2024

Q2 2024 cash position

September 30, 2024

1H 2024 results

October 25, 2024

Q3 2024 cash position

* This timetable is indicative and the Company reserves the right to amend the above-mentioned dates should it

deem it necessary to do so.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 3.

RISK FACTORS

The Company operates in a changing environment that involves risks, some of which are out of its control.

Investors are advised to take into consideration all the information contained in this Universal Registration

Document, including the risk factors set forth in this chapter. Pursuant to Article 16 of Regulation (EU)

2017/1129 and of Delegated Regulation (EU) 209/980, this chapter only presents the risks that the Company

believes, as of the date of filing of this Universal Registration Document, in the event they should occur,

might have a material adverse effect on the Group's business and operations, its results of operations, its

financial position, earnings, prospects or ability to hit its targets.

In order to identify and assess such risks, the Company has mapped the risks associated to its activity and

has grouped them into five categories below, it being stipulated that within each category and sub-

category, risk factors are presented by order of decreasing importance with an evaluation of their

probability (high, medium, low), negative impact (high, medium, low), and the net level of criticality,

estimated by combining for each risk its probability of occurrence and its negative impact, as assessed by

the Company as at the date on which the Registration Document was filed, together with taking into account

the potential actions and preventive measures undertaken by the Company at that date. The occurrence of

new events, both internal and external to the Company, may however alter this order of importance in the

future.

Sec-

tion

Risks Factors

Proba- Negative

bility

impact

Net level of

criticality

3.1

Risks Related To The Development and Potential Future

Commercialization of the Group's Product Candidates

3.1.1 GeNeuro has developed a new approach, the therapeutic benefit of which

has not yet been demonstrated, that is not based on confirmed pathways

such as the immunomodulation and immunosuppression approaches

used by existing therapies for the treatment of autoimmune diseases.

High

3.1.2 The Company's products, including its most advanced product candidate,

temelimab, may never be approved for marketing due to regulatory

reasons

High

3.1.3 The Company's product candidates may never be approved for

marketing due to operational reasons.

High

3.1.4 The Company may not be competitive in its market.

High

3.1.5 The Company has limited visibility on its future prospects and financial

results.

Medium

High

3.1.6 The uncertainty about reimbursement rates and measures to reform

healthcare systems could delay or compromise acceptance of products

by the market.

Medium

High

Medium

3.1.7 Other clinical applications of temelimab for conditions such as Post-

COVID are based solely on pre-clinical work, and the Company may

never succeed in developing and marketing effective treatments based

on such technology.

High

3.2

Risks Related To The Company's Financial Situation and Capital

Needs

3.2.1 The Company does not have sufficient funds needed to continue its

clinical development for the next twelve months..

High

3.2.2 The Company should continue to sustain operating losses in relation to

its research and development activities.

High

3.2.3 The Group benefits from Research Tax Credits from the French Medium Medium

government which regime may be challenged or modified in the future.

Medium

3.2.4 The Company could be unable to carry tax losses forward.

Medium

Low

3.2.5 Full exercise of all securities carrying the right to acquire shares granted

and outstanding would result in a dilution of existing shareholders.

Medium

Low

3.2.6 Exchange Rate Risk.

Medium

Low

3.3 Risks Related To The Company, Its Operations and Organization

3.3.1 The Company is dependent on its key employees and, as such, could

fail to continue attracting and retaining its key employees and scientific

advisors.

Medium

High

Medium

3.3.2 The Company faces the risk of liability linked to its products or operations

and it may not be able to obtain adequate insurance coverage at an

acceptable cost.

Medium

High

Medium

3.3.3 Shareholders might be unable to achieve a control premium in the event

of a change of control of the Company based on the fact that French and

Low

GeNeuro SA – 2023 Universal Registration Document

Sec-

tion

Risks Factors

Proba- Negative

bility

impact

Net level of

criticality

Swiss regulations concerning mandatory public takeover offers are not

applicable.

3.4

Risks Related To The Company's Dependency on Third Parties

3.4.1 The Company does not have manufacturing capabilities and is exposed

to the risks associated with relying on third party party raw material

providers and manufacturers for its most advanced product candidate

temelimab and its other products.

Medium

High

Medium

3.4.2 The Company does not have experience in the areas of sales, marketing

and distribution and may be required to rely on third parties and/or

mobilize new internal resources for this purpose.

High

Medium

3.4.3 The Company relies on external scientific collaborators.

Medium Medium

Medium

3.5

Risks Relating To The Company's Intellectual Property Rights

3.5.1 If the Company is unable to maintain or protect its intellectual property

rights, it could lose its competitive advantage and be unable to operate

profitably.

Medium

High

Medium

3.5.2 The Company's products and technologies could infringe or be claimed

to infringe patents and patent applications held or controlled by third

parties.

Medium

High

Medium

3.5.3 If the Company does not comply with its obligations under the license

agreement with bioMérieux, it could lose rights that are very important

for its business.

Medium

High

Medium

3.5.4 The Company's business could be affected if it is unable to protect the

confidentiality of its information and know-how.

Medium

High

Medium

3.1 Risks Related To The Development and Potential Future Commercialization of The

Group's Product Candidates

3.1.1 GeNeuro has developed a new approach, the therapeutic benefit of which has not yet been demonstrated,

that is not based on confirmed pathways such as the immunomodulation and immunosuppression approaches

used by existing therapies for the treatment of autoimmune diseases.

The Company is presently pursuing the development of its lead drug candidate, temelimab, in two indications:

Multiple sclerosis ("MS") and neuropsychiatric syndromes affecting Post-COVID patients ("Long-COVID", "Post-

COVID" or PASC - Post Acute Sequelae of COVID-19). In MS, the Company has developed a new treatment

approach that differentiates itself from therapies being sold on the date hereof. The same treatment approach is

being tested in Post-COVID, which is a new indication for which there is at present no approved therapy.

The Company is exploring a new medical path that involves Human Endogenous Retrovirus ("HERV") genes that

constitute approximately 8% of the human genome. The capacity for the abnormal expression of various elements

of a HERV of the W family ("HERV-W") has been detected in chronic diseases like MS as well as in acute COVID-

19 and Post-COVID. The Company seeks to develop, on the basis of this finding, a treatment designed to block the

deleterious properties of a protein, W-ENV, which is encoded by genes of the HERV-W family. Recent publications

have demonstrated that W-ENV may directly inhibit remyelination and that axonal injury in MS can be significantly

driven by W-ENV through activation of microglia and that this contributes to neurodegeneration, particularly in

progressive forms of MS. The primary analysis of ProTEct-MS, the Company's Phase 2 clinical trial in MS conducted

at the Karolinska Institutet in Stockholm, Sweden, that was completed in Q1 2022, have showed that the primary

endpoint of the study was met, with results confirming the excellent safety profile and tolerability of higher doses of

temelimab administered concomitantly with a high-efficacy anti-inflammatory drug; in addition, efficacy data,

obtained in this patient group already effectively treated against inflammation, showed that temelimab, an antibody

that neutralizes W-ENV, has a favorable impact on key MRI measures of neurodegeneration; the observed effect

sizes in this new patient population were consistent with the ones shown in the previous CHANGE-MS and ANGEL-

MS studies.

The Company's Phase IIb clinical trials in the MS indication have shown that temelimab has only modest effects on

neuroinflammation in the "active inflammatory patients" population as a monotherapy, but also that temelimab has

positive impacts on key MRI measures and soluble biomarkers associated with disability progression; as a result,

GeNeuro is now focusing on neurodegeneration and disability progression, most likely with temelimab as a

combination therapy together with marketed immunomodulatory drugs addressing neuroinflammation, rather than

as a monotherapy for "non-active" progressive patients. Whilst the Company's ProTEct-MS clinical trial enrolled

"non-active" progressive patients, it is important to note that neurodegeneration, and disability progression as a

biological feature, are present from the onset of disease, i.e. before patients are categorized as being in progressive

MS. This means that the indication of temelimab is not restricted to the latter stage of disease, but may include all

forms of MS.

GeNeuro SA – 2023 Universal Registration Document

In Post-COVID, publications show that SARS-CoV-2 infection triggers the expression of W-ENV,

and that W-ENV is found in hospitalized patients and associated with disease severity. In the aftermath of COVID-

19, the analysis of preliminary data from patients with Post-COVID depressive and/or cognitive disorders has also

shown the persistence of W-ENV in the blood in significant numbers of patients, suggesting that the

neuropsychiatric symptomatology seen in "Post-COVID" patients may be due to activation of W-ENV expression by

SARS-CoV-2 in these individuals, and to its persistence long after the acute COVID phase. GeNeuro initiated in the

fall of 2020 prospective collections of samples with Academic Institutes testing patients who suffered from

neurological and psychiatric syndromes post COVID, leading to a recent publication made available on MedRxiv

that has shown that W-ENV was observed in more than 25% of patients with persistent syndromes after having had

COVID.

At the end of 2022, GeNeuro launched a precision medicine, biomarker-based, Phase 2 trial, called GNC-501, that

is evaluating the clinical efficacy of a six-month treatment with temelimab, the anti-W-ENV antibody developed by

GeNeuro, on the improvement of fatigue, cognitive impairment and self-reported neuropsychiatric symptoms,

covering cognition, fatigue, anxiety, depression, and Quality Of Life in Post-COVID patients who are positive for the

presence of W-ENV protein in their blood. This study is now fully recruited, with 203 randomized patients; in the

course of this trial, 1'092 patients severely affected by neuropsychiatric symptoms (severe fatigue, cognition

problems) signed an informed consent and were tested for W-ENV in their blood, with 36% of them testing positive

for W-ENV. This opens the door to a personalized medicine approach that could, if the current clinical trial is

successful, offer a therapeutic solution to a well identified subset of the millions of patients affected by Post-COVID.

The results for this trial are expected in June 2024.

As of the filing date of this Universal Registration Document, there is no treatment that targets endogenous retroviral

genes approved for sale by the competent authorities, and such a treatment intended to block a protein expressed

by a HERV is, therefore, unproven.

Accordingly, the prospects for the development and profitability of the Company's most advanced product

candidate, temelimab, for Post-COVID or MS, or other indications, its safety, its effectiveness, and its acceptance

by patients, prescribers, and paying agencies, are uncertain. The positive results observed for temelimab for MS in

connection with Phase I, on the one hand, and successive Phases II, on the other hand, and more generally, those

relating to existing or future products in the Company's portfolio or based on its technology at the time of the

research or preclinical phase, may not be confirmed by future trial phases. Such a situation could have a very

material adverse impact on the Company's business, results, financial situation, and prospects.

3.1.2 The Company's products, including its most advanced product candidate, temelimab, may never be

approved for marketing due to regulatory reasons.

The Company is subject to regulations that are numerous and evolving and it may not be able to obtain the

necessary approvals to market and sell its products, including its product candidate at the most advanced stage of

development, temelimab. To obtain a product license for its candidate products, the Company must show, through

long, numerous and very expensive clinical trials with uncertain outcomes, that the use of the candidate products

is without danger and is effective in humans. Clinical trials are subject to supervision by regulatory authorities as

well as by ethics committees, in order to protect the persons participating in the medical research. If the Company

does not meet its development calendar (please see Section 5 of this Universal Registration Document), or if it is

unable to conduct the expected clinical trials successfully within applicable time limits, its business and operations

could be materially and adversely affected.

The Company's ability to obtain product licenses for its products will depend on several factors, including, but not

limited to:

•

the possibility of pursuing the development of those of its products presently in early clinical trials, or presently

in pre-clinical development to a clinical stage;

•

its ability, or that of its partners, to conduct clinical trials successfully and within relevant time periods without

having to devote significantly greater resources than initially expected;

•

its clinical trials showing the efficacy and safety of its products;

•

its products being approved for the indication they are intended to treat, or for any indication of any kind; and

•

an announcement by its competitors of more promising clinical results with their own products, which makes

the Company's economic equation unfavorable.

Traditionally in the biotechnology and pharmaceutical industries, it often happens that favorable results of pre-

clinical studies and Phase I/II clinical trials are not confirmed in later stages of clinical development. Regulatory

authorities in various countries in which the Company intends to market its products could block initiation of clinical

GeNeuro SA – 2023 Universal Registration Document

trials, or the pursuit of clinical developments, if the proposed clinical trials do not meet applicable regulatory

standards. Such authorities could likewise interpret results differently from the Company and, in any event, request

additional tests, on a discretionary basis (relating, among other things, to the study protocols, the characteristics

and number of patients, the length of treatment, the analytical methods, the preclinical safety, and post-treatment

follow-up), or impose additional or unexpected requirements at the time of such trials. Furthermore, the Company

might decide, or might be required by regulatory agencies, to suspend or terminate clinical trials, if new evidence

suggests that patients are exposed to unexpected risks. Deaths or other adverse events could occur during a clinical

trial, because of medical problems both linked and not linked to the treatments administered, forcing the Company

to delay or interrupt the trial. Also, on the basis of the trial's results, the Company could decide to abandon

development projects that were initially identified as promising. Finally, products already approved could turn out to

be unsafe and then be withdrawn from the market, or they could produce different effects from those initially

expected, which could, in turn, limit or prevent them having any commercial use. The occurrence of all or some of

these events could have material adverse effects on the Company's business, results, and prospects.

As of the date hereof, none of the Company's products, including its most advanced product candidate, temelimab,

has received a marketing authorization from any regulatory authority. The Company cannot be sure that it will

receive the necessary approvals to market and sell any of its products. The products may be subject to very stringent

laws, and regulatory requirements that are uncertain and subject to change and Universal Registration Document

(for a summary presentation of such laws and regulations in the United States and Europe, please see Chapter 9

"Regulatory Environment") of this Universal Registration Document). The U.S. Food and Drug Administration

("FDA") and the European Medicines Agency (the "EMA") as well as their counterparts in other countries regulate,

among other things, research and development, pre-clinical tests, clinical trials, manufacturing, safety, efficacy,

records retention, labeling, and the marketing, sale, and distribution of therapeutic products. In particular, without

the FDA's approval, it would be impossible for the Company to access the U.S. market, which is the largest

pharmaceutical market in the world, particularly for the therapeutic areas targeted by the Company (MS, Post-

COVID, Amyotrophic Lateral Sclerosis ("ALS"), etc.).

These regulatory steps are costly; they may take several years; and their outcomes are unpredictable. The data

from pre-clinical and clinical developments may give rise to different interpretations, which could delay obtaining or

restrict the scope of regulatory approval. The requirements of the regulatory process vary greatly from one country

to another, so that the Company or its strategic partners may not be able to obtain approval on a timely basis in

each relevant country. Since the Company's products are based on new, constantly changing technologies and

have not been tested on an in-depth basis in humans, the applicable regulatory requirements remain uncertain and

could be subject to significant differences of interpretation and changes. Changes in laws and regulations during

the development of a product and its regulatory review could cause delays in or the denial of approval.

In the United States, in Europe, and in other countries, applicable laws and regulations and changes to them could:

•

delay and/or significantly increase the cost of developing, testing, manufacturing, and marketing the

Company's products;

•

limit the indications for which it might be authorized to market and sell its products;

•

impose new, stricter requirements, suspend approval of the Company's products, or require the Company to

stop the clinical trials it is conducting or stop the marketing and sales of the products (for example, if

unexpected results are obtained during clinical trials by other researchers of products similar to those of the

Company); or

•

impose restrictive labeling.

If the Company does not comply with the laws and regulations applicable to its business and operations, it could

incur sanctions or penalties, which could include refusals to authorize pending applications, product recalls,

restrictions on sales, or the temporary or permanent suspension of its operations as well as civil and criminal

proceedings.

The Company has already completed for temelimab, its product candidate at the most advanced stage of

development, three clinical Phase I trials¹to define the pharmacological, immunogenic, and safe use on healthy

volunteers. The results of these trials have been published in scientific journals (Hartung et al.; MSJ2021) and are

considered positive regarding temelimab's safety, tolerability and efficacy.

The Company has also completed four Phase II trials on a patient population having MS and one Phase II trial on

a patient population having Type 1 Diabetes ("T1D"):

¹"Preclinical" and "clinical" phases are defined in the Appendix.

GeNeuro SA – 2023 Universal Registration Document

•

a Phase IIa clinical trial for MS², intended principally to show temelimab's tolerance over a period of one year

by the injection of potentially therapeutic doses and, secondarily, to take initial measurements on the clinical

evolution of treated patients; and

•

a 1-year Phase IIb clinical trial (CHANGE-MS³) for MS in patients with the remitting relapsing form of MS

(RRMS), with a primary endpoint evaluating the efficacy of repeated doses of temelimab versus placebo in

patients based on the cumulative number of Gadolinium-enhancing ("Gd+") T1 lesions on brain MRIs and

with secondary endpoints to evaluate measures of MRI markers associated with neuroprotection, notably

brain atrophy, hypointense T1 lesions ("black holes") and magnetization transfer ratio ("MTR"), considered to

be an indirect measure of the integrity of myelin; and

•

a 1-year Phase II extension study of CHANGE-MS (ANGEL-MS⁴) of the above Phase IIb clinical trial, which

allowed patients who took part in the Phase IIb study to benefit from two additional years of treatment;

following the decision from the Company's former development partner, in September 2018, not to exercise

its option for a license on temelimab, this extension study underwent an early termination and topline results

were presented on March 12, 2019; and

•

a Phase IIa clinical trial (ProTEct-MS) for MS in patients treated with rituximab and in whom disability was

worsening in the absence of relapses. This 1-year clinical trial enrolled patients with confirmed disability

progression without relapses, following previous treatment with the anti-CD20 drug rituximab, a highly potent

and efficacious drug against acute disease activity (relapses and brain lesion formation). All patients in the

trial received rituximab in the eight weeks preceding their enrollment in ProTEct-MS. The primary endpoint

for the study was safety of temelimab in combination with rituximab, and secondary and exploratory endpoints

were designed to assess efficacy measures based on the latest imaging and biofluid markers associated with

disease progression. The primary analysis of ProTEct-MS was presented at the European Committee for

Treatment and Research in Multiple Sclerosis (ECTRIMS 2022) Congress in Amsterdam, Netherlands and

showed that the primary endpoint of the ProTEct-MS study was met, with results confirming the excellent

safety profile and tolerability of higher doses of temelimab administered concomitantly with a high-efficacy

anti-inflammatory drug; in addition, efficacy data, obtained in this patient group already effectively treated

against inflammation, showed that temelimab has a favorable impact on key MRI measures of

neurodegeneration; the observed effect sizes in this new patient population were consistent with the ones

shown in the previous CHANGE-MS and ANGEL-MS studies; New exploratory data on soluble biomarkers

also showed favorable impact on measures of neurodegeneration at one year: the study showed a reduction

of GFAP biomarkers in cerebrospinal fluid (CSF). GFAP is a biomarker for astrocytic activation associated

with diffuse neuroaxonal damage leading to MS disease progression. The results on these CSF biomarkers

confirm the synergistic potential to treat neurodegeneration with temelimab in addition to a high-efficacy anti-

inflammatory therapy in MS. The analysis of the data now also allows GeNeuro to determine the optimal dose

for future temelimab trials in MS, in conjunction with potential partners.

•

In addition, the Company has completed a Phase IIa clinical trial for T1D in adult patients, which has met its

primary endpoint of safety at six months, and whose full 12-month results were announced in May 2019.

At the end of 2022, GeNeuro launched a Phase 2 trial, called GNC-501, that is evaluating the clinical efficacy of a

six-month treatment with temelimab on the improvement of cognitive impairment and/or fatigue in 203 Post-COVID

patients who are positive for the presence of W-ENV protein in their blood. Results are expected in June 2024.

The use of temelimab for MS or Post-COVID requires additional clinical development to be completed, including

Phase III clinical trials (in Post-COVID, even in the case where an emergency marketing authorization were

granted). Accordingly, if the Company does not receive approval of temelimab for the treatment of MS or Post-

COVID, its financial condition, results of operations, and prospects will be significantly and adversely affected.

3.1.3 The Company's product candidates may never be approved for marketing due to operational reasons.

The Company's clinical trials, especially for its leading product candidate, temelimab, could be delayed or not occur

in a satisfactory manner.

The Company's ability to conduct clinical trials successfully depends on many factors, especially on the pace of

patient recruitment, the size of the eligible patient population, the type of clinical protocol, the proximity of patients

to clinical sites, eligibility criteria, possible secondary effects, and competition with other clinical trials conducted on

product candidates developed by competing companies with, among other things, financial resources that may be

greater than the Company's.

In general, the Company could encounter difficulties in recruiting and retaining patients to participate in future clinical

trials of its products, in particular for temelimab, its most advanced product candidate for MS and Post-COVID. The

²Source: Derfuss T et al Mult Scler. 2015 Jun;21(7):885-93.

³Source: Hartung et al., Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension

study, Multiple Sclerosis Journal, July 2021

⁴Source: Hartung et al. ibid

GeNeuro SA – 2023 Universal Registration Document

strict criteria for inclusion in the trials could also make recruitment of patients difficult, notably for Post-COVID where

patients must test positive for the presence of W-ENV protein in their blood. Once recruited, the patients

participating in such trials could suspend or terminate their participation at any time without cause, or might be

unable to continue participating in a trial if medical, or other, emergencies lead governments to impose quarantines

or enforced isolation or require existing medical human resources or medical amenities to be solely dedicated to

the treatment of such emergencies. Delays in patient recruitment could also increase the costs, delay, or even

cause the cancellation of clinical trials (including in relation to the potential need to adjust existing protocols and

have such adjustments be agreed by the regulators). Finally, if too many patients terminate their participation in a

clinical trial, the analysis of the results of such trial could lack sufficient statistical significance.

Furthermore, large-scale clinical trials could lead to complexity in the management and supply of inventories of the

product candidate temelimab. Logistical difficulties and errors in storing and shipping products, and/or poor

management of inventories and their supply could cause delays in the completion of the trials.

Likewise, clinical trials designed and coordinated by the Company are conducted by medical and hospital centers

and companies that specialize in the organization of trials (a contract research organization or "CRO") and the

quality of their work (the selection of populations, base-line measurements, compliance with protocols, doses, the

number of administrations, intermediate delays and the collection of data) is determinant in the analysis and

precision of results. In addition, because Phase II and Phase III clinical trials are typically conducted in numerous

centers located in multiple countries, the Company cannot rule out heterogeneity and errors in the performance of

such centers, which could impact the precision of the results.

Furthermore, the Company has limited experience in conducting clinical trials at multiple centers and has turned or

will turn, now and in the future, to third parties to assist it in supervising and monitoring its trials. A breach or failure

by one of such third parties or CROs in performing their task or their failure to comply with applicable regulatory

standards could cause delays or even the premature termination of the trials.

3.1.4 The Company may not be competitive in its market

The market for MS treatments for which temelimab is intended, as well as the markets for which its other products

are intended, are characterized by rapid technological change, the predominance of protected products, and intense

competition. Many organizations, including pharmaceutical and biotechnology companies, academic institutions,

and other research entities, are actively engaged in the discovery, research, development, and marketing and sale

of products intended to treat MS. If the Company were to obtain a marketing license for temelimab, it might compete

with other presently prescribed therapies and/or those under development. Whilst there are today in MS no

approved drugs that address disease progression (as opposed to reducing the number of inflammatory relapses,

which is the area for which the existing immunotherapies such as immunomodulators and immunosuppressors

drugs have been approved), it is possible that new drugs under development could prove effective against

neurodegeneration and disease progression and thus be direct and strong competitors to temelimab.

A great number of companies developing immunomodulators or immuno-suppressors for MS, when compared with

GeNeuro, have much greater resources and experience in management, manufacturing, marketing and sales, and

research. In particular, major pharmaceutical companies like Bayer, Biogen, Bristol-Myers Squibb, Johnson &

Johnson, Merck KGaA, Novartis, Roche, Sanofi and Teva, which market and sell medications for MS, have much

greater experience than GeNeuro in conducting clinical trials and obtaining regulatory approvals. All such

companies could also compete with the Company to acquire rights to promising antibodies as well as other

complementary technologies.

The Company can give no assurance that its products:

•

will be granted regulatory approval, protected by patents, or marketed sooner than those of its competitors;

•

will remain competitive against other products developed by its competitors that are safer, more effective, or

less costly;

•

will be competitive against products of companies that might be more efficient in their production, marketing

and sales;

•

will be a commercial success; or

•

will not be made obsolete or unprofitable by technological progress or other therapies developed by its

competitors.

If the Company succeeds in obtaining regulatory approval to introduce products based on its technology, it will also

need time to gain the support of the medical community, including healthcare providers, patients, and third-party

payors. The degree of acceptance by the market will depend on many factors, including:

•

the safety and efficacy of its therapeutic products, as demonstrated during clinical trials;

•

the existence of undesirable side effects;

GeNeuro SA – 2023 Universal Registration Document

•

ease of administration;

•

the success of its marketing, sales, and public relations strategy;

•

the availability of alternative treatments;

•

pricing;

•

the reimbursement policies of governments and other third parties;

•

the effective adoption and implementation of a publication strategy; and

•

obtaining the support of recognized external opinion leaders.

Even if temelimab for MS or Post-COVID is approved for marketing, the market targeted by the Company could

turn out to be less significant than previously thought. The revenues that the Company may receive in connection

with the marketing and sale of temelimab may be limited by the number of patients with MS or Post-COVID, by the

categories of patients who respond well to treatment, by the perception of health providers as to the therapeutic

benefit, by its ability to achieve appropriate pricing and reimbursement levels, and by the impact of competition.

If the Company does not market and sell temelimab successfully, its revenues could not materialize and / or

decrease as a result, and it could find itself unable to finance the development and marketing of other products for

other indications.

3.1.5 The Company has limited visibility on its future prospects and financial results.

GeNeuro has a limited operating history, which does not allow it to estimate its prospects and future revenues. The

Company's operations have been so far limited to developing a humanized monoclonal antibody technology aimed

at a pathogenic protein expressed by a HERV and, on the basis of such technology, to conduct, with the assistance

of CROs, pre-clinical and clinical trials for the purpose of developing, marketing and selling therapeutic solutions.

Notwithstanding the experience and abilities of its management and scientific team, the Company has not yet shown

an ability to overcome the high number of risks and uncertainties that are frequently encountered by

biopharmaceutical companies in a rapidly evolving, highly uncertain and speculative industry. The Company's ability

to evaluate its future results or commercial prospects with precision, similarly, is more limited than if it had a long

operating history or products that had already received marketing approval.

As a result, the likelihood of the Company's success must be evaluated in light of the numerous potential challenges

and contingencies that are faced, at an early stage, by a company operating in the business of developing

medications, most of which are beyond its control. Considering its development schedule and, assuming the receipt

of relevant regulatory authorizations and the commercialization and marketing of its product candidate, GeNeuro

estimates as of the date of this Universal Registration Document that the potential sale of its most advanced product

candidate, temelimab, could commence between 2025 and 2027 for MS and/or Post-COVID. This timing is however

dependent on the success of the Phase III trial, or possibly of a Phase II trial that could be registration enabling

subject to its results, the absence of any event or setback delaying the proper conduct of the trials, and the absence

of other events which the Company is currently unable to identify or anticipate.

3.1.6 The uncertainty about reimbursement rates and measures to reform healthcare systems could delay or

compromise acceptance of products by the market.

The uncertainty about reimbursement rates and measures to reform healthcare systems could delay or compromise

acceptance of products by the market.

If the Company succeeds in marketing and selling the products developed in collaboration with partners, or by itself,

their acceptance in the market will depend, in part, on the rate at which government health funds and private insurers

reimburse them. Primary insurance health funds and other third-party payors often attempt to limit the cost of care

by restricting or refusing to cover costly products and therapies. At present there are several immunomodulating

products for the treatment of MS, but none specifically targets a causal factor or the progression of the illness, so

that there is little or no experience relating to potential payments for such a treatment by insurance providers. As

for Post-COVID, due to the recent occurrence of this disease and the absence of approved disease-modifying

therapies, there is no experience with reimbursement rates and measures.

In some foreign markets, the price of prescription pharmaceuticals is subject to control by the government. The

Company's ability to market and sell its products successfully will depend, in part, on the establishment by

governmental authorities, private insurers, and other agencies in the United States and Europe of a sufficient

reimbursement rate for its products and related treatments. In addition, the determination of the price and the

reimbursement rate for the Company's products could be influenced by an announcement by competitors of more

promising clinical results than those of the Company's products. Such a situation could have an adverse effect on

GeNeuro SA – 2023 Universal Registration Document

the conditions for setting the price and the reimbursement rate of products that could lose their competitive

advantage over other competing products. Third-party payors are questioning the price of therapeutic products and

medical services more and more frequently. Cost control measures that healthcare service providers and

reimbursement agencies adopt and healthcare system reforms could adversely affect the Company's operating

results. Also, as a result of the COVID-19 Pandemic, it may be expected that healthcare will be an important public

policy subject of focus and that associated increase of healthcare spending will be more carefully monitored. The

Company could thus fail to obtain satisfactory reimbursement for its products, which could impede their acceptance

by the market, in which case the Company would be unable to earn a sufficient return on its research and

development investments.

The Company's relations with clients and third-party payors are subject to U.S. anti-corruption (anti-kickback), anti-

fraud, and anti-abuse laws or other laws and regulations relating to healthcare which could expose it to civil penalties

and sanctions, damages, and interest, injury to its reputation, and diminution of its profits and future income.

Healthcare professionals, doctors, and third-party payors play a key part in the recommendation and prescription

of any product for which the Company may obtain a product license. Its future agreements with third-party payors

and customers could expose it more broadly to U.S. anti-fraud and anti-abuse laws and regulations, or other laws

and regulations relating to healthcare that may restrict business or financial agreements as well as relationships on

the basis of which the Company markets, sells, and distributes any product for which it may hold a product license.

Restrictions in accordance with U.S. federal anti-kickback, anti-fraud, and anti-abuse or other laws relating to

healthcare are as follows:

•

the U.S. federal anti-kickback statute prohibits people from, among other things, deliberately and knowingly

soliciting, offering, receiving, or supplying compensation, directly or indirectly, in cash or in kind, to induce or

compensate a business connection, or from purchasing, ordering, or recommending any product or service

payment which could be made in connection with a healthcare program in the United States, such as

Medicare and Medicaid;

•

U.S. federal law intended to prevent fraud by companies that are parties to public contracts (the "U.S. False

Claims Act") provides, among other things, for civil and criminal sanctions against individuals or companies

that knowingly present false or fraudulent requests for payment to the U.S. federal government, or make false

statements to avoid, reduce, or hide an obligation to pay money to the U.S. government. Such specific actions

are open to whistleblowers or any other entity (qui tam actions);

•

under the U.S. Health Insurance Portability and Accountability Act of 1996 ("HIPAA") a perpetrator of actions

intended to defraud any program for providing healthcare services or who makes false statements relating to

healthcare problems may be held civilly or criminally liable;

•

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and

regulations thereunder, also imposes obligations, including mandatory contractual language, to protect the

confidentiality, security, and transmission of personally identifiable health information;

•

U.S. federal law requires that manufacturers of medications report payments and other transfers of value to

doctors and university hospitals; and

•

analogous laws and regulations of U.S. or foreign states, such as anti-kickback laws, and those prohibiting

false claims, could apply to sales or commercial agreements as well as to claims about health products or

services reimbursed by non-governmental third-party payors, including private insurers.

If the Company's operations are deemed to be contrary to applicable U.S. law and regulations, the Company could

be liable for significant sanctions and penalties, including fines, damages, imprisonment, civil and criminal

prosecution, or exclusion of its products from governmental healthcare programs, such as Medicare or Medicaid,

or even the restructuring of its business. Any doctor, healthcare professional, or company involved in commercial

activities found to violate applicable laws and regulations could be exposed to civil or criminal actions or

administrative sanctions, including exclusion from government healthcare programs.

3.1.7 Other clinical applications of temelimab for conditions such as Post-COVID are based solely on pre-clinical

work, and the Company may never succeed in developing and marketing effective treatments based on such

technology.

Temelimab has been tested pre-clinically for its effect on chronic inflammatory demyelinating

polyradiculoneuropathy (CIDP), for which temelimab has received Orphan Drug Designation from the U.S. Food

and Drug Administration (the "FDA") in February 2018. Temelimab has also been tested in a Phase IIa trial for T1D

in adult patients, which has met its primary endpoint of safety at six months, and whose full 12-month results were

announced in May 2019⁵. Published research data has also opened the potential of temelimab as a therapeutic

candidate in Post-COVID (or PASC, Post Acute Sequelae of SARS-CoV-2 infection) patients, i.e., COVID-19

patients who develop long-term neurological and psychiatric Post-COVID ("neuropsychiatric") symptoms.

⁵Source: Curtin et al Diabetes Obesity and Metabolism, submitted 2019

GeNeuro SA – 2023 Universal Registration Document

On December 13, 2021, the Company announced it had been selected as one of the four projects retained by the

Swiss Federal Office of Public Health ("FOPH") within the framework of the CHF 50 million "Federal Funding

Programme for COVID-19 Medicines" incentive, and that it would receive a grant of 6.7 million Swiss francs (€6.4

million) to co-fund (up to 50%) a Phase II clinical trial to treat patients with long-standing COVID who exhibit

neurological and psychiatric ("neuropsychiatric") symptoms. In March 2023, GeNeuro announced it had entered

into a EUR 25 million credit line with the European Investment Bank ("EIB"), backed by InvestEU, to support clinical

developments against Post-COVID. These two funding programs have helped finance the Company's GNC-501

study in Post-COVID.

The Company is also using the technology it has developed in the area of endogenous retroviruses to develop new

approaches through pre-clinical programs that target, for example, ALS. In 2017, the Company entered into a

research agreement with the U.S. National Institutes of Health ("NIH") for developing new approaches against

pathogenic HERV-K Env protein as a target in the treatment of ALS, following which the Company has signed in

October 2018 an exclusive worldwide license with the National Institute of Neurological Disorders and Stroke

("NINDS"), part of the NIH. The agreement covers the development of an antibody program to block the activity of

HERV-K ENV (pathogenic envelope protein of the HERV-K family of Human Endogenous Retroviruses), a potential

key factor in the development of ALS. In August 2022, GeNeuro and NINDS announced the publications in the

leading scientific journal "Annals of Neurology" of the results of their collaboration on two publications describing

the novel pathogenic mechanism of HERV-K in sporadic ALS and confirming the rationale for the therapeutic

relevance of GeNeuro's antibody to neutralize this neurotoxic protein.

If the Company wishes to complete the development of its products and sell them for such indications, it will have

to devote significant research effort and undertake numerous tests and clinical trials, obtain regulatory approvals,

and make significant financial investments. In developing and marketing products based on its technology, the

Company is confronted with a high degree of risk and uncertainty that could slow or even suspend its efforts to

develop its products and have a material adverse effect on its business and operations. Even if the Company were

in a position to obtain and maintain regulatory approvals for marketing its products, it is possible that:

•

it may not obtain the regulatory approvals required for it to conduct clinical trials for such indications;

•

it may neither develop nor obtain a marketing approval for its products quickly enough to ensure a competitive

position in the target markets;

•

it may not be in a position to manufacture and market its future products successfully at a price,

reimbursement rate, or scale that allow them to be profitable;

•

its future products may not be accepted by medical centers, hospitals, practitioners, and patients, nor be

preferred to existing treatments at the time they are introduced, nor, more generally, meet with the expected

commercial success;

•

its future products may lose their competitive advantage and may become obsolete by the development of

new competing products; or

•

its future products may not be marketable because of third-party property rights.

If the Company is not successful in developing and marketing other products resulting from its technologies, its

revenues will continue to be limited, and its operating results could be significantly affected.

3.2 Risks Related To The Company's Financial Situation and Capital Needs

3.2.1 The Company does not have sufficient funds needed to continue its clinical development for the next

twelve month periods.

All of the Company's products are currently in the pre-clinical or clinical trial phase. The Company is currently

running a pivotal Phase 2 clinical trial in Post-COVID, called GNC-501, which is now fully recruited and for which

top-line results are planned for June 2024. Taking into account the net proceeds from the €5 million capital increase

completed in February 2024, the Company has enough financial resources to allow it to complete the GNC-501

clinical trial but its net working capital is insufficient to meet its obligations, including funding its operations, for a

period of twelve months from the date of this Universal Registration Document, as its financial runway will only

extend to the next five months from the date of this Universal Registration Document.

Attention is drawn to the fact that the Company is over-indebted as such term is defined under Article 725b of the

Swiss Code of Obligations (CO), as of December 31st, 2023. In order to meet its obligations for a period of twelve

months from the date of this Universal Registration Document, the Company estimates that its additional net

working capital requirement amounts to €3.5 million, excluding any costs in connection with the preparation of a

Phase 3 study or marketing authorization in Post-COVID but taking into account the last payment of €1.4 million

expected from the Swiss Federal Office of Public Health (FOPH), which is conditional upon submitting to

Swissmedic a marketing authorization application and submitting to the FOPH the preliminary final material &

financial report. Without the FOPH payment, the additional net working capital requirement amounts to €5 million.

GeNeuro SA – 2023 Universal Registration Document

Failure to raise additional financing to remedy such insufficient net working capital would force the Company to

declare itself insolvent and to request a debt-restructuring moratorium, which could lead the Company to initiate

bankruptcy proceedings in case the moratorium does not allow to find additional financing. The Company continues

to be engaged in discussions with investors, suppliers and lenders, including ongoing negotiations with the EIB,

with the objective to secure further additional financing to provide sufficient financial runway until Q1 2025.

Assuming positive results from the GNC-501 clinical trial, the Company will need to finance manufacturing of

additional batches of temelimab to allow further clinical studies, including a Phase III trial including in the United

States, as well as prepare large scale manufacturing to allow distribution of temelimab following the securing of

marketing approvals, as well as work with Bio-Techne, the supplier of the digital automated Western-Blot capillary

detection system used for the detection of W-ENV in patients' serum, in order to industrialize the test through the

development of kits that could be used by specialized decentralized labs for phase III.

In addition, further clinical

studies will be necessary for the development of temelimab for MS or other indications until the Company may

eventually apply for and receive a marketing authorization. The amount of €3.5 million of additional net working

capital requirement mentioned above does not take into account any of these costs.

Since its incorporation, the Company has mainly financed its growth by capital increases, including notably the

capital increase completed at the time of its initial public offering and listing on the regulated market of Euronext

Paris and four subsequent capital increases, the latest being in February 2024, as well as the FOPH subsidy and

EIB financing for its Post-COVID program, which expose it to liquidity risk resulting from indebtedness. The

Company will be required to seek additional funding to continue its development in MS, Post-COVID or ALS, which

may include, without limitation, revenues from new partnership agreements, funds from capital increases or other

funding, such as subsidies, grants, or other forms of financing.

As of December 31, 2023, cash and cash equivalents of the Company amounted to €1.8 million; in addition, the

Company received in January 2024 €1 million from a non-recourse bank pre-financing of its €1.3 million French

Research Tax Credit for 2022, and completed a €5 million capital increase in February 2024.

The Company has performed a specific review of its liquidity risk as of the filing date of this Universal Registration

Document. Taking into account the net proceeds of the capital increase completed on February 7, 2024, the

Company considers that, on the filing date of this Universal Registration Document, its financial resources are

sufficient to complete the GNC-501 pivotal clinical trial, with results expected in June 2024, and to extend its financial

visibility until the end of the third quarter of 2024 taking into account the last payment of €1.4 million expected from

the FOPH, which is conditional upon submitting to Swissmedic a marketing authorization application and submitting

to the FOPH the preliminary final material & financial report. Without the FOPH payment, the net working capital is

sufficient until mid-August 2024. The Company continues to be engaged in discussions with investors, suppliers

and lenders, including ongoing negotiations with the EIB, with the objective to secure further additional financing

required to extend its financial visibility until the second quarter of 2025.

In March 2023, the Company entered into a €25 million credit line with the EIB, backed by InvestEU, to support its

clinical developments against Post-COVID. This €25 million credit line comprised a first tranche of €7 million, which

was drawn down in March 2023, and two additional tranches of €10 million and €8 million being intended for the

preparation and launch of Phase 3 respectively, subject to certain conditions, including the need to raise, for each

additional tranche, €30 million in cash, in the form of equity, license revenues or customer advances. The Company

is renegotiating the terms of the credit line with the EIB, with the objective of securing an early draw-down of part

of the second tranche but cannot presume the outcome of such negotiations.

The Company's cash burn was €10.1 million during 2023, compared to €13.1 million during 2022. The lower cash

burn in 2023 is due to the favorable change in working capital of €3.9 million, compared to a negative amount of

€1.9 million in 2022, which offset the increase of €2.9 million in cash outflow from activities resulting from the higher

R&D expenses in 2023 for the completion of patient recruitment and conduct of the Post-COVID program. Not

taking into account the possible strategic and operational implications of the GNC-501 clinical trial results, the

Company expects that its cash burn for 2024 will be significantly lower than in 2023 due to the completion of the

GNC-501 trial in June 2024 and its limited current research and development programs. For 2024, the Company's

actual cash burn will depend largely upon its ability and decision to launch further Phase III trials in Post-COVID

and to launch additional manufacturing batches of temelimab and prepare technology transfers to large-scale

antibody manufacturers to allow eventual commercialization of temelimab in the Post-COVID indication should a

marketing, or temporary use, authorization be granted to the Company. However, neither the 2024 cash burn nor

the 2025 cash burn are necessarily indicative of future cash burn that will largely depend on future R&D and,

possibly, commercialization programs actually undertaken.

Although management continues to pursue its plans to finance the development of its products, there is no

assurance that the Company will be successful in obtaining sufficient funding in the future, when needed or at all,

on terms acceptable to the Company to fund its continuing operations.

The Company will have to bear, if it obtains approval from a country's authorities to test its product candidate in

humans in that territory, the significant cost of development of temelimab. Assuming positive results from the GNC-

GeNeuro SA – 2023 Universal Registration Document

501 clinical trial in Post-COVID, the Company considers that it will need to launch a Phase III clinical trial including

the United States and other countries to allow broad market access to temelimab in this indication; based on the

costs of the GNC-501 clinical trial and assuming a Phase III study would be several times larger than the Phase II

GNC-501, such costs would exceed €50 million, whereas such costs would likely exceed €100 million for a Phase

III study in MS.

In order to finance the continued clinical development of temelimab in MS, where the Company considers that the

most likely development pathway is a combination therapy approach with efficacious anti-inflammatory compounds

targeting inflammatory relapses, the Company is seeking to enter into licensing and distribution, or other

agreements with pharmaceutical companies which will be expected to have sufficient capability for conducting the

Phase III trials, manufacturing on an industrial scale, and distributing, marketing and selling the product. GeNeuro

is engaged in these partnering discussions but there is no certainty that these discussions may result in a new

partnership.

The Company also believes that the negative cash flow from its operations may increase significantly during future

years because of the need for conducting additional clinical trials, manufacturing its products, and extending its

research and development programs. It will need considerable funding to pursue its research and development

programs, conduct other pre-clinical and clinical trials of its products, and extend its manufacturing, quality control

capabilities, and regulatory and administrative capabilities.

The Company's future capital needs will depend on many factors, such as, among others:

•

the progress of its research and development programs;

•

the scale of such programs;

•

the extent of the costs and results of pre-clinical and clinical trials;

•

the time and costs necessary for obtaining regulatory approvals, including the time to prepare the application

files for regulatory bodies;

•

the marketing and sale of product, especially temelimab for MS or for Post-COVID;

•

the Company's ability to establish and maintain collaboration agreements with new partners;

•

the cost of improving its manufacturing and marketing capabilities; and/or

•

its need to acquire additional technologies or products, as the case may be.

The Company's level of financing needs and their scheduling over time also depends on matters that are largely

beyond the Company's control, including:

•

costs associated with possible requests or requirements (for example if trials are interrupted by emergencies

such as the COVID-19 epidemic) to change studies, or to include a greater number of patients;

•

costs of preparing, filing, defending, and maintaining its patents and other intellectual property rights;

•

competing technological developments; and/or

•

higher costs and longer lead times than those anticipated to obtain regulatory approvals for the marketing of

its products and access to reimbursement.

Finally, if the necessary funds should not be available or not available on a timely basis, the Company may be

forced to:

•

delay, reduce, or eliminate the number and scope of its pre-clinical and clinical trials;

•

grant licenses to technologies to partners or third parties;

•

enter into new collaboration agreements on terms and conditions less favorable to it than those that it might

have been able to obtain in different circumstances;

•

obtain funds through alliance, collaboration or partnering agreements that could force the Company to give

up rights to certain of its technologies or its products, rights which it would not have given up in different

circumstances; and/or

•

delay, reduce, or even cancel research and development programs, and reduce the number of its employees;

The occurrence of one or more of the risks mentioned above could have a material adverse effect on the Group's

business, financial condition, results, development, and prospects.

GeNeuro SA – 2023 Universal Registration Document

3.2.2 The Company should continue to sustain operating losses in relation to its research and development

activities.

The Company has sustained operating losses since its formation, except for the 2014 financial year. Such losses,

which amounted to €14.8 million for the 2023 financial year and €12.2 million for the 2022 financial year reflect both

the significance of the expenses incurred in research and development and the absence of revenues. The Company

foresees that such losses will continue over the next few years, at least until the potential marketing and sale of its

products, because of the significant investments required for research, development, manufacture, quality control,

and distribution of its products, pre-clinical and clinical trials, administrative activities, and activities linked to the

development of intellectual property, as well as license agreements for new products and for the acquisition of new

technologies that may become necessary, as the case may be.

The Company expects that its operating losses will increase in the near future, particularly when:

•

some of its products move beyond the stage of pre-clinical development to clinical development;

•

it is confronted with increased regulatory requirements for manufacturing, and trials for its product candidates

(including temelimab for MS or Post-COVID, which is its only product in an advanced stage of development);

•

it begins to pay fees in connection with applications for product licenses from regulatory bodies;

•

it increases its portfolio of products by adding new products for future development;

•

it makes milestone payments to third parties (such as bioMérieux) which have already licensed their

technologies to it;

•

it develops its research and development activities and buys new technologies, products or licenses, as the

case may be;

•

it develops its business worldwide; and

•

it has to finance structural expenses consistent with the growth of its business.

The amount of net losses and the time needed to reach sustained profitability are difficult to estimate and will depend

on several factors, including:

•

the degree of advancement of the Company's research and development activities, particularly pre-clinical

developments and clinical trials;

•

the calendar of regulatory procedures in connection with the preparation, review, and protection of patents

and intellectual property rights;

•

changes in collaboration arrangements made by the Company; and

•

other factors, a great number of which are beyond the Company's control.

Given the development stage of its most advanced product, the Company has not yet received any revenue from

product sales and the Company's operating revenue and operating profit (or loss) have fluctuated in the past and

could continue to do so in the future. Accordingly, its revenues for a given period are not a reliable indicator of its

future performance and the Company may never market or sell any products and, as a result, may never become

profitable. The Company expects that its main sources of revenue and funds until the potential marketing and sale

of its first product candidate, temelimab for MS or post-COVID, will be:

•

payments that may be made by future partners of the Company, if the Company enters into one or more

agreements with future partners relating to the development and/or marketing and sale of temelimab for MS

or post-COVID or other revenue of the Company;

•

public and private subsidies, including the remaining CHF 1.3 million balance from the Swiss FOPH subsidy

and other public funding it is continuing to seek;

•

debt financing, such as the €25 million credit facility recently established with the EIB, from which the

Company has already drawn a first tranche of €7 million in March 2023, and is currently negotiating to draw

down an additional amount through an early availability of part of the second tranche;

•

potential net proceeds of funds raised by the Company through capital markets transactions.

Any interruption of such financing sources could have a material impact on the operating revenue and operating

profit (loss) of the Company.

3.2.3 The Group benefits from Research Tax Credits from the French government which regime may be

challenged or modified in the future.

The Company's subsidiary GeNeuro Innovation, a French company, benefits from the French Research Tax Credit

(Crédit Impôt Recherche, "CIR") that provides a tax incentive to support the scientific and technical research efforts

of French companies. The research expenses that are eligible for the CIR include, under certain conditions, the

salaries and compensation of researchers and research technicians, the amortization of fixed assets dedicated to

research, services subcontracted to approved research entities (public or private), and expenses for maintaining

patents.

GeNeuro SA – 2023 Universal Registration Document

The amounts received by GeNeuro Innovation in respect of the CIR are as follows:

•

payment of the CIR for financial years 2011 to 2020 of €6,719 K, all of which was received;

•

payment of the CIR for financial year 2021 of €1,007 K, received in September 2022.

Companies must provide evidence to the French tax authorities, upon request, of the outstanding amount of the

CIR and the eligibility of the operations taken into account to benefit from this aid.

For the financial year 2022, the Company has accrued a CIR amount of €1,316 K. Whereas until 2022 GeNeuro

Innovation benefited from the early payment of the CIR (i.e., immediately, rather than three years following

application), this is no longer applicable as of 2023 onwards, which means that the Company must either wait the

statutory three-year period before being reimbursed, or must seek prefinancing alternatives, with the attending

financial cost. The Company has put in place a bank pre-financing from which it has received €990 K, net of up-

fronted interest charges, during January 2024; an amount of €132 K remains collectible in 2026 subject to the full

payment by the French tax authorities of the amount claimed.

If in the future the Company should no longer receive amounts under the CIR, or its status or calculations should

be questioned, this could have a material adverse effect on the Group's business, prospects, ability to achieve its

objectives, financial condition, cash position or operating profit (loss).

3.2.4 The Company could be unable to carry tax losses forward.

As of December 31, 2023, the Company had carried-forward tax losses of € 51,607K (CHF 50,394K converted at

the 2023 average rate). In Switzerland, tax carryforwards may be used within seven years of incurrence and are as

follows:

•

€ 9,610.2 originated in 2023 and expiring in 2031

•

€ 9,673.4 originated in 2022 and expiring in 2030

•

€ 7,783.8 originated in 2021 and expiring in 2029

•

€ 10,827.7originated in 2020 and expiring in 2028

•

€ 4,318.9 originated in 2019 and expiring in 2027

•

€ 5,478.8 originated in 2018 and expiring in 2026

•

€ 3,913.8 originated in 2017 and expiring in 2025

At the 2023 annual shareholders' meeting of GeNeuro SA, shareholders approved the resolution to apply EUR 30

million of additional paid-in capital to carried-forward losses, which reduced the amount of carried-forward losses

applicable for taxes. If the Company continues to apply additional paid-in capital to reduce its carried-forward losses,

it may reduce the amount of carried forward tax losses.

It is possible that future changes to Swiss tax law could alter such provisions by limiting or eliminating the

possibilities for attributing the tax loss carryforwards, which could have a material adverse effect on the Group's

business, prospects, ability to achieve its objectives, financial condition, cash position, or operating profit (loss).

3.2.5 Dilution Risk

Since its formation, the Company has granted stock options to its management and employees. In March 2024, the

Board of Directors awarded a total of 1,885,118 stock options to employees, directors and executive managers of

the Company, of which 1,021,000 were in "conversion" of cancelled cash bonuses and 774,118 were in "conversion"

of waived cash compensation by directors and the Company's Chief Executive Officer and Chief Financial Officer.

Accordingly, as of the filing date of this Universal Registration Document and taking into account the expiration of

unexercised stock options, the cancelation of unvested stock options for departing employees and the warrants

issued to the EIB in connection with its € 7 million Venture Debt financing of March 2023, full exercise of all securities

carrying the right to acquire shares granted and outstanding as of the date hereof would lead to the issuance of

3,380,323 shares, resulting in a potential dilution of 10.2% (such options are described in sections 13.1.3 and 19.1.5

of this Universal Registration Document). The weighted average exercise price of all such securities is €2.56,

compared to the market closing price for the Company's shares on Euronext Paris of €1.42 on April 15, 2024.

In connection with its incentive strategy for motivating its executives and employees and to attract additional skills,

the Company could issue or award shares or new equity securities carrying the right to acquire shares in the future,

which could cause further dilution, potentially material, for present and future shareholders of the Company. Dilution

could cause a drop in the price of the Company's shares.

3.2.6 Exchange Rate Risk

The Company is exposed to exchange rate risks relating to changes in the exchange rate between the euro ("EUR")

and the Swiss franc ("CHF") because a portion of the Company's operating expenses is incurred in the latter

currency.

GeNeuro SA – 2023 Universal Registration Document

If the Company succeeds in marketing and selling its products in the United States, it could earn a portion of its

revenue in U.S. dollars and, therefore, would be exposed to an exchange rate risk relating to changes in the

exchange rate between the U.S. dollar and the euro.

The Company will follow changes in its exposure to exchange rate risks on the basis of changes in its situation. If

the Company does not manage to take effective hedging steps in the future, its results of operations could be

negatively impacted.

3.3 Risks Related To The Company, Its Operations and Organization

3.3.1 The Company is dependent on its key employees and, as such, could fail to continue attracting and

retaining its key employees and scientific advisors.

The Company's success depends largely on the work and experience of its executive management and its key

scientific personnel, especially its Chairman and Chief Executive Officer (Président Directeur Général), Mr. Jesús

Martin-Garcia; its Chief Scientific Officer, Dr. Hervé Perron; its Chief Financial Officer, Mr. Miguel Payró; and its

Chief Development Officer, Dr Alois B Lang. The Company's previous Chief Medical Officer, Dr. David Leppert, has

retired effective December 31, 2023 and will remain a consultant to the Company; he has been replaced effective

January 1, 2024 by Dr. Anke Post, MD, PhD, who has in-depth academic and medical knowledge and training in

the field of neurosciences, psychiatry and neurology as well as broad pharmaceutical industry experience after

holding positions as senior physician and leader with more than 25 years of academic and Pharmaceutical R&D

activity in three major multinational pharmaceutical organizations as wells as in biotech and medical device

companies. The loss of their expertise could alter the Company's ability to reach its objectives. Furthermore, the

Company will need to recruit new qualified executives and scientific staff as it expands in areas that require

additional abilities, such as marketing, manufacturing, clinical trials, and regulatory affairs. The Company competes

with other companies, research organizations, and academic institutions to recruit and retain highly qualified

scientific, technical, and management staff. To the extent such competition is very intense, the Company could be

unable to attract or retain such key staff on terms and conditions that are acceptable from an economic point of

view. Its inability to attract and retain such key personnel could prevent it from reaching its overall objectives.

3.3.2 The Company faces the risk of liability linked to its products or operations and it may not be able to obtain

adequate insurance coverage at an acceptable cost.

The Company is exposed to the risk of liability, particularly product liability, arising in connection with the

manufacture and sale of therapeutic products for use in humans. Liability against the Company may also result

from clinical trials in connection with the testing of therapeutic products or unexpected adverse side effects resulting

from the administration of such products. Complaints or legal proceedings could be filed or brought against the

Company by patients, regulatory authorities, biotechnology and biopharmaceutical companies, and other third

parties using or selling its products. Such actions could include complaints resulting from actions by its partners,

licensees, and subcontractors over which it has little or no control. The Company can give no assurance that its

present insurance coverage will suffice to respond to liability actions that could be brought against it. If its partners,

licensees, and subcontractors or the Company itself are not in a position to obtain and maintain appropriate

insurance coverage at an acceptable cost or protect themselves in some way against product liability actions, they

could be held significantly liable, which could have the consequence of seriously affecting marketing and sale of

the Company's products and, more generally, harm its business.

The Company is also subject to environmental protection and health and safety laws and regulations that could

expose it to liability and restrict its operations. In its research and development programs and pre-clinical tests, the

Company uses hazardous substances and biological materials such as human cell lines. Accordingly, in countries

in which the Company operates, it is subject to environmental protection and safety laws and regulations governing

the use, storage, manipulation, production, and disposal of hazardous substances, including chemical and

biological products. The Company is also subject to laws and regulations relating to the use and manipulation of

genetically modified organisms under French, European, and U.S. laws and regulations.

In the event of a failure to comply with applicable laws and regulations, the Company could be subject to fines and

might have to suspend part or all of its operations. To comply with environmental, and health and safety laws and

regulations, the Company would incur additional costs and it could, in the future, incur significant expenses in doing

so in the relevant jurisdictions in which it operates. In complying with environmental, health and safety laws and

regulations, the Company may have to acquire equipment, modify facilities, and more generally, incur other material

expenses. In the event of accidental contamination, injuries, or any kind of damage, the Company could be held

liable for damages, which might not be paid by or covered under its insurance policies and which could harm the

Company's business.

GeNeuro SA – 2023 Universal Registration Document

3.3.3 Shareholders might be unable to achieve a control premium in the event of a change of control of the

Company based on the fact that French and Swiss regulations concerning mandatory public takeover offers

are not applicable.

In so far as the Company's registered office is in Switzerland whilst its shares are listed only on Euronext Paris's

regulated market, neither French regulations on mandatory public tender offers and buyouts, nor Swiss regulations

on public takeover offers (purchase or exchange offer) are applicable to public tender offers concerning the

Company's shares.

Under these conditions, a person might acquire shares in the Company to an extent representing a controlling stake

as defined under Swiss or French law without a legally enforceable obligation to file a public tender offer to all the

shareholders.

Similarly, because of the unenforceability of French and Swiss law on compulsory public tender offers, a person

could issue a public tender offer to some, but not all, shareholders.

3.4 Risks Related To The Company's Dependency on Third Parties

3.4.1 The Company does not have manufacturing capabilities and is exposed to the risks associated with relying

on third party raw materials providers and manufacturers for its most advanced product candidate temelimab

and its other products.

The Company has chosen to outsource the manufacturing of its products. Its dependence on third parties to

manufacture and assemble certain of its products and its lack of experience in manufacturing other products on an

industrial scale could affect its ability to develop and sell its products within a reasonable timeframe and on a

competitive basis. In particular, the Company depends on third parties to produce its most advanced product

candidate, temelimab for MS. In this respect, it has entered into an agreement with the contract manufacturing

organization ("CMO") Polymun Scientific GmbH ("Polymun"), to manufacture its antibody on the basis of good

manufacturing practices ("GMP"), for determined quantities of product at a pre-determined cost, without future

royalties. The Company will also depend on subcontracting agreements for the fill and finish of its products, both

for future clinical trials and for subsequent stages of sales and marketing.

The Company could also be unable to enter into subcontracting agreements for the future commercial supply of

temelimab, or to do so on acceptable terms and conditions. If it is unable to enter into acceptable subcontracting

agreements, the Company may be unable to market and sell temelimab successfully.

In the current post-COVID-19 pandemic and geopolitical situation, supply of culture media for antibody

manufacturing and other products continues to face considerable strain and competition for deliveries, which may

lead to delays in the manufacturing of future batches of temelimab.

Furthermore, dependency on third-party manufacturers involves additional risks to which the Company might not

be exposed if it manufactured temelimab itself, such as:

•

non-compliance of such third parties with regulatory and quality control standards;

•

the violation of such agreements by such third parties;

•

the termination or non-renewal of such agreements for reasons beyond its control; and

•

the insolvency of such third parties.

If the products manufactured by such third-party suppliers do not comply with regulatory standards, sanctions and

penalties could be imposed. Such sanctions could include fines; court orders; civil penalties; refusal of regulatory

authorities to grant product licenses; delays, suspension or withdrawal of approvals; revocation of product licenses;

product recalls or seizures; operating restrictions and criminal prosecutions, all of which are measures that could

have a material adverse effect on the Company's business, operations, its financial position and its financial results.

If the Company is unable to maintain its collaboration agreements with its existing partners, including the CMO

Polymun, or enter into new agreements on acceptable terms and conditions, it will have to develop and sell its

products at its own expense, or it will have to turn to other partners. This could increase its capital needs and limit

its growth and marketing and sales efforts to other areas. In addition, even if the Company, in connection with its

agreements, has included provisions designed to impose strict compliance by its partners with their commitments,

it cannot control either the extent or the timing of the resources that its existing and future partners will devote to

the development or sale of the Company's products. Such partners might also not meet their obligations as set out

in the contracts that the Company has, or may have, with them or under the terms it is expecting. In such cases,

the Company could be confronted with significant delays and not achieve success in obtaining the support of third

GeNeuro SA – 2023 Universal Registration Document

parties for the Company's new technology based on the neutralization of W-ENV, or support for the introduction of

the Company's products in various markets.

Even though the Company tries to include non-competition clauses in its collaboration agreements, no assurance

can be given that such restrictions will ensure sufficient protection to the Company. The Company's partners could

develop technologies alone or together with others, including its competitors.

Impact of the Russian-Ukrainian and Israeli-Palestinian conflicts

Current wars in Ukraine and the Middle East could further aggravate the global economic situation, which continues

to be impacted by the various crises and geopolitical tensions. Although the Company is not directly impacted by

these conflicts, as it has no commercial, development or clinical activities planned or underway in Russia, Ukraine,

Israel, the Palestinian territories or in the Middle East, it is possible that the stalemate, intensification or globalization

of these conflicts may lead to disruptions that could have a significant unfavorable effect on its business and clinical

trials, notably:

Delays in the production and receipt by clinical sites of supplies and equipment required for the Company's

clinical trials;

Delays in obtaining the authorizations required to launch potential future clinical trials by the Company

from the relevant administrative authorities;

Changes in local regulations due to conflict-related measures, which could force the Company to modify

the terms of its clinical trials, thereby incurring unforeseen costs or even interrupting them;

Disruption of global air and sea trade, which could affect the transportation of raw materials required for

the production of clinical trial materials;

Slow-down or Interruption of key clinical trial activities, such as clinical trial site monitoring, due to travel

restrictions imposed or recommended by federal or state authorities, employers or others;

Potential Increase in the costs associated with the clinical trials entrusted to CROs as a result of the

conflicts (although, as of the date of this Registration Document, the Company has not however observed

an increase in costs due to this conflict). and

Delays or delays induced by increased cybersecurity risks leading the Company to curtail its activity in

order to preserve the integrity of its data.

3.4.2 The Company relies on external scientific collaborators.

The Company relies on external scientific collaborators, including researchers attached to CROs or universities, to

successfully conduct relevant research activities, including in connection with development programs for products,

such as the conduct of clinical trials. The competition to maintain such networks is intense, and it may not be

possible to maintain them on acceptable conditions. In general, such external collaborators may terminate their

commitments at any time. Accordingly, the Company can control their activities only within certain limits and cannot

prevent them from devoting a portion of their time to research on and development of other products. Furthermore,

such scientific collaborators may be subject to intellectual property rights agreements, or other rights in relation to

the results of tests or research and development conducted jointly. Furthermore, they may not wish to grant a

license to such intellectual property rights on acceptable terms.

3.4.3 The Company does not have experience in the areas of sales, marketing and distribution and may be

required to rely on third parties and/or mobilize new internal resources for this purpose.

The Company also lacks experience in the areas of sales, marketing and distribution. If it secures a marketing

authorization for its products, it will therefore have to develop its own marketing and sales capabilities either alone,

or with strategic partners. In connection with its strategy, it could, therefore, be led to search for partners for the

sale, marketing, and distribution of some of its products. In the event of the direct marketing and sale of temelimab

by the Company, it will have to develop its own sales and marketing infrastructure, which would involve incurring

additional expenses, mobilizing management resources, organizing new skills and taking the time needed to create

the appropriate organization and structure to support the product in accordance with applicable law and, more

generally, optimizing its marketing and sales efforts. The Company is evaluating the strategic and financial

advantages of an alliance with one or several partners for the marketing and sale of temelimab for MS in worldwide

markets, if the opportunity should arise. It is possible that the Company may not succeed in entering into an alliance

for the marketing and sale of temelimab or any of its products on economically reasonable terms and conditions or

maintaining such alliances or marketing and selling its products itself.

The Company expects growth in all areas of its business while it develops and, subject to obtaining required

regulatory approvals, markets and sells its products, directly or through potential partners. It will therefore need to

recruit staff and expand its capabilities, which could significantly increase its managerial, operating, financing, and

other resources. To remain competitive and control its growth, the Company would have to:

•

train, motivate, and retain a growing number of employees;

GeNeuro SA – 2023 Universal Registration Document

•

forecast with precision the demand for its products and the revenue that they may be capable of generating;

and

•

increase the size of its existing operating, computer, and financial and management systems.

The inability to manage its growth effectively could harm the Company's business and prospects.

3.5 Risks Relating To The Company's Intellectual Property Rights

3.5.1 If the Company is unable to maintain or protect its intellectual property rights, it could lose its competitive

advantage and be unable to operate profitably.

The Company's rights under existing agreements, some of which give it access to future products and proprietary

processes belonging to third parties (such as its rights to various patents targeting the W-ENV envelope protein

under its agreement with bioMérieux-INSERM) or jointly owned with third parties (such as its rights to the HERV-K

patent targeting the -K Env envelope protein under its agreement with the NINDS/NIH) could expire or be

terminated. In addition, it might not be able to obtain licenses to other rights which it might need. If it is unable to

secure such rights or licenses, or to preserve them, it will have to search for other alternatives or develop the

necessary products itself so as to avoid infringing patents or technology rights belonging to third parties. It is possible

that such alternatives would not exist or that this could cause a significant increase in costs as well as development

time for its products.

It is important to the success of its business that the Company, as well as the licensor and any future licensees, be

able to obtain, maintain, and enforce its patent and other intellectual property rights in Europe, the United States,

and other countries. It cannot be ruled out that:

•

the Company may fail to develop new inventions that are patentable;

•

patent applications that are being reviewed, including certain important patents in several jurisdictions, are

not granted;

•

the patents granted or licenses to its partners or itself are contested or held to be invalid, or the Company

may be unable to enforce them;

•

the scope of protection granted by a patent is not sufficient to protect the Company from competition; or

•

third parties may claim proprietary rights to the patents or other intellectual property rights that the Company

owns outright or to which it holds a license.

The grant of a patent does not guarantee its validity or scope, and third parties may challenge both aspects. The

validity and scope of a patent in the area of biotechnology are highly uncertain and raise complex legal and scientific

questions. Until now, no uniform policy has emerged at a worldwide level in terms of the content of patents granted

in the area of biotechnology and the scope of individual claims. Legal action may be necessary to enforce the

Company's intellectual property rights, protect its trade secrets, or determine the validity and scope of its intellectual

property rights. Any dispute could entail considerable expense, reduce profits, and not provide the protection

sought. The Company's competitors could successfully challenge in court or through other proceedings the patents

the Company has been granted or has had licensed to it, which could have the consequence of reducing the scope

of its patents. In addition, such patents could be infringed or successfully avoided as a result of innovations.

3.5.2 The Company's products and technologies could infringe or be claimed to infringe patents and patent

applications held or controlled by third parties.

The Company's products and technologies could infringe or be claimed to infringe patents and patent applications

held or controlled by third parties. The Company's success depends on its ability to avoid the infringement or misuse

of patents or other intellectual property rights of third parties. The growth of biotechnology and the increase in the

number of patents granted in the field increase the risk that third parties will take the position that the Company's

products and technologies, including its processes, infringe their patents. In general, a patent application is not

published until 18 months after the priority date of the application. In the United States, some patent applications

are not published prior to issuance of the patent itself and may be granted on the basis of the date of invention,

which does not always result in the issuance of a patent to the party that was the first to file the application.

Discoveries or patent applications are made sometimes only months or often even years after the discovery. For

this reason, the Company cannot be certain that third parties have not been the first to invent products or file patent

applications for inventions covered by its own patent applications or those of its partners. In such cases, the

Company could need to obtain licenses to such third-party patents (licenses which it might not be able to obtain on

reasonable terms and conditions, if at all), terminate the production and sale of certain product lines, or develop

alternative technologies.

GeNeuro SA – 2023 Universal Registration Document

In addition, the Company uses antibodies and cells that are available on the market to manufacture certain products,

and the use of such antibodies and cells could infringe third-party rights, in which case the Company could be

obligated to acquire a license to such rights (a license that it may not be able to obtain on reasonable terms and

conditions, if at all), become involved in costly litigation, or stop using such antibodies or cells.

Any litigation or claim brought against the Company, regardless of the outcome, could involve substantial costs and

compromise its reputation. Some of the Company's competitors have greater resources than the Company and

could be in a better position to bear the cost of complex proceedings. Any dispute of this type could seriously affect

the Company's ability to continue in business. More specifically, intellectual property disputes could force the

Company to:

•

stop selling or using one or more of its products that depend on the challenged intellectual property rights,

which could reduce revenue;

•

obtain a license from the holder of intellectual property rights deemed infringed, a license that it may not be

able to obtain on reasonable terms and conditions, if at all; and

•

redesign or, in the event of claims relating to trademarks, rename its products to avoid violating intellectual

property rights of third parties. This may not prove to be possible or, in any event, given the time and financial

resources that would have to be dedicated to doing so, it may prove to be too costly and, as a result, it could

disrupt the Company's sales and marketing efforts.

3.5.3 If the Company does not comply with its obligations under the license agreements with bioMérieux or the

NINDS/NIH, it could lose rights that are very important for its business.

If the Company does not comply with its obligations under the license agreement with bioMérieux or under the

license agreement with the NINDS/NIH, it could lose rights that are very important for its business. The Company's

business depends on a license agreement to use various significant patents relating to temelimab that was granted

to the Company by bioMérieux and INSERM, and on a license agreement to use the first HERV-K patent that was

granted to the Company by the NINDS/NIH. The patent licenses granted to the Company may be revoked if the

Company does not comply with various terms and conditions set forth therein (in particular, milestone and other

payments). To comply with such conditions, the Company could be required to increase the resources dedicated

to development projects contemplated by such licenses. Such license agreements also include provisions with

which the licensor must comply. Among other things, the Company is counting on its licensor to prosecute any

infringement of the licensed patents by third parties. The Company can, however, give no assurance that its licensor

is or will be willing to undertake such proceedings.

3.5.4 The Company's business could be affected if it is unable to protect the confidentiality of its information and

know-how.

The Company's business could also be affected if it is unable to protect the confidentiality of its information and

know-how. The Company provides information and materials from time to time to researchers at academic

institutions as well as other public or private entities (including CMO manufacturers) with which it seeks to have

various tests or clinical trials conducted.

In both cases, the Company relies on the execution of confidentiality agreements. Its business also depends on

non-patented proprietary technology, processes, know-how, and data that it treats as trade secrets and that it

protects, in part, through confidentiality agreements with its employees, consultants, and various subcontractors.

These agreements and other means of protecting trade secrets may not provide the protection sought or may be

violated, the Company may not have effective recourse against such violations, or its trade secrets may be disclosed

to its competitors or developed independently by them.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 4.

INFORMATION ABOUT THE COMPANY AND THE GROUP

4.1 History And Development Of The Company And The Group

4.1.1 Legal and commercial name of the Company

Company legal name:

GeNeuro SA

Company commercial name:

GeNeuro

4.1.2 Place and number of registration and legal identity identifier (LEI)

The Company is registered at the Registre du commerce (commercial register) of Geneva, Switzerland, under

number CHE-112.754,833. The legal entity identifier (LEI) of GeNeuro is 213800FUJCKXO9LK3444.

4.1.3 Date of incorporation and length of life

The Company was incorporated on February 6, 2006 for an indefinite term.

4.1.4 Registered/principal office, legal form and applicable law

Registered/principal office:

3 chemin du Pré-Fleuri, CH-1228 Plan-les-Ouates, Switzerland

Telephone:

+41 22 552 4800

Electronic address:

contact@geneuro.com

Web page:

www.geneuro.com

The Company is a société anonyme (company limited by shares) organized under Swiss law and governed by its

Articles of Association and, in particular, Title XXVI of the Swiss Code of Obligations.

4.1.5 Major events in the development of the Company's and the Group's business

2024

On March 18, 20124, GeNeuro held an extraordinary shareholders' meeting at which two new directors

were elected and at which the capital band and conditional capital were increased to give the Company

additional funding flexibility following the February 2024 capital increase.

On February 2, 2024, GeNeuro announced the successful completion of a €5 million capital increase with

cancellation of the preferential subscription rights through an international private placement reserved for

specialized or strategic investors of (the "Private Placement") 4,666,901 new ordinary bearer shares of

GeNeuro and through a public offering for retail investors in France via the PrimaryBid platform (the

"PrimaryBid Offer", and together with the Private Placement, the "Offering") of 95,004 new ordinary bearer

shares of GeNeuro. All new ordinary shares have a par value of CHF 0.05 each (the "New Shares").

The New Shares have been offered at a price of €1.05 each, including nominal value and issue premium

(the "Subscription Price"). In connection with the Private Placement, GNEH SAS ("GNEH"), a subsidiary

of Institut Mérieux and Servier ("Servier"), which are existing shareholders of GeNeuro, have subscribed

to 2,087,451 and 1,135,070 New Shares, respectively, in cash. In accordance with applicable Swiss laws

and regulations, the GNEH representative on the Board of directors of the Company did not vote on board

of directors' decisions relating to the Offering. As a result, following the Offering, GNEH owns 40.2% of the

share capital and 40.5% of the voting rights of the Company on a non-diluted basis and Servier owns 8.4%

of the share capital and 8.5% of the voting rights of the Company on a non-diluted basis.

The proceeds of the Offering, combined with the Company's existing cash, are intended primarily to

complete the financing for the ongoing Phase 2 trial in Post-COVID, with results expected in June 2024,

and extend the company's runway into mid third quarter 2024. The funds would also be used to finance

the Company's general corporate needs. In parallel to the post-COVID program, GeNeuro continues its

discussions in the multiple sclerosis area with potential partners to define the best development path for

combining an effective anti-inflammatory treatment, to treat relapses, with temelimab, to address

neurodegeneration and disability progression.

The New Shares issued represent 19% of the Company's share capital prior to the Offering on a non-

diluted basis and 16% of the Company's share capital after the Offering.

GeNeuro SA – 2023 Universal Registration Document

The Subscription Price of €1.05 per New Share represented a discount of 16.7% on the closing market

price of the Company's shares on Euronext Paris on the last trading day preceding the closing date of the

Offering, i.e. €1.26 on January 31, 2024.

Based on the information available to the Company, the breakdown of the Company's share capital and

voting rights before and after the Offering is as follows:

Ownership and voting rights

before the Offering

after the Offering

Number of

shares and

voting rights

% of the share

capital and

voting rights

Number of

shares and

voting rights

% of share

capital and

voting rights

GNEH SAS ⁽¹⁾

9,886,195

39.55%

11,973,646

40.23%

Eclosion2 & Cie SCPC

6,228,041

24.91%

6,228,041

20.93%

Citigroup Global Markets

Limited

2,139,917

8.56%

2,139,917

7.19%

Servier International BV

1,365,659

5.46%

2,500,729

8.40%

Total institutional investors

19,619,812

78.48%

22,842,333

76.75%

Total employees and

directors

149,000

0.60%

149,000

0.50%

Treasury shares⁽²⁾

164,739

0.66%

164,739

0.55%

Free Float

5,065,477

20.26%

6,604,861

22.19%

TOTAL

24,999,028

100.00%

29,760,933

100%

(1) A subsidiary of Institut Mérieux

(2) Shares held in treasury have their voting rights suspended in accordance with Swiss law

On January 5, 2024, the Company announced the appointment of Anke Post, MD, PhD as Chief Medical

Officer, effective immediately, as David Leppert, MD, took retirement.

2023

On December 11, 2023, the Company announced that, based on the planned interim analysis of efficacy

and safety data, which included an analysis for futility, the Independent Data Monitoring Committee Board

IDMC recommended to "continue the trial without any modifications. The IDMC was established to perform

independent, periodic assessments of safety data generated during the conduct of the GNC-501 Trial.

On November 28, 2023, the Company announced that it had completed the recruitment of the GNC-501

Trial, with a total of 203 patients being randomized, and confirmed the timeline for topline results for the

end of June 2024.

On October 19, 2023, the Company announced a collaboration with Verily, an Alphabet precision health

technology company, to investigate biomarkers related to activation of the proinflammatory HERV-W

envelope protein (W-ENV) in SARS-CoV-2 infection.

On September 29, 2023, the Company reported its half-year financial results for the period ended June

30, 2023 and provided a corporate update.

On September 27, 2023, the Company announced the publication in the journal "Proceedings of the

National Academy of Sciences of the United States of America" (PNAS) of a study

resulting from a

collaboration between the Heinrich-Heine University in Düsseldorf, research teams from the Universities

of Zürich and Bern with GeNeuro, which confirms that the expression of the HERV-W Env protein (W-Env)

causes a neurodegenerative environment, through the fostering of demyelination and the reduction of

remyelination, which may explain the long-term neurodegeneration suffered by MS patients.

On June 15, 2023, the Company announced that its shareholders have approved all resolutions proposed

at its Annual General Meeting (AGM) of June 14, 2023.

On May 3, 2023, the Company announced the publication in the leading open science journal iScience

from "Cell Press" of the new results from the collaboration between GeNeuro and the CIRI, Centre

GeNeuro SA – 2023 Universal Registration Document

International de Recherche en Infectiologie, in Lyon, France, on the link between SARS-CoV-2 and the

pathogenic HERV-W proinflammatory envelope protein (W-ENV).

On April 15, 2023, the Company reported its full-year results for the year ended December 31, 2022, and

provided a corporate update in which it updated the expected timeline for the first results from the Post-

COVID study to be available between 1Q and 2Q 2024.

On March 7, 2023, GeNeuro announced the signature of a credit agreement for a total amount of up to

€25 million with the European Investment Bank ("EIB"), supported by the InvestEU programme, from which

a first Tranche A of €7 million was drawn immediately.

2022

On November 16, 2022, GeNeuro announced the recruitment of first patients in its Phase 2 trial evaluating

temelimab against Post-COVID at the Geneva University Hospitals post-COVID clinic (lead centre), as

well as in all the other Swiss clinical centres participating to the study, i.e., Inselspital in Bern, REHAB

Basel, Kantonsspital Graubünden in Chur and the Centre Hospitalier du Valais Romand in Sion.

On October 28, 2022, the primary analysis of the Phase 2 ProTEct-MS study was presented at the

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2022) Congress in

Amsterdam, Netherlands, by Dr. Fredrik Piehl, Professor of Neurology at the Department of Clinical

Neurosciences of the Karolinska Institutet, head of research at the MS clinic of the Academic Specialist

Center (ASC), and Principal Investigator of the study.

On October 11-14, 2022, GeNeuro unveiled new data further documenting the presence of W-ENV in

cohorts of post-COVID patients at the 18th Symposium of the International Society of Neuro Virology

(ISNV).

On August 30, 2022, GeNeuro announced the joint publications in the leading scientific journal "Annals of

Neurology" of the results of the collaboration between GeNeuro and the National Institute of Neurological

Disorders and Stroke (NINDS). NINDS is part of the National Institutes of Health (NIH) of the United States.

The two publications describe the novel pathogenic mechanism of HERV-K in sporadic ALS and confirm

the rationale for the therapeutic relevance of GeNeuro's antibody to neutralize this neurotoxic protein.

On May 2022, GeNeuro announced the successful completion of a €7.7 million capital increase with

cancellation of the preferential subscription rights through an international private placement only to certain

qualified and institutional investors of 2,678,251 new ordinary bearer shares of GeNeuro with a par value

of CHF 0.05 each.

On May 11, 2022, GeNeuro announced it had received the authorization by the Swiss Health Authority

(Swissmedic) to initiate a Phase II study evaluating temelimab in patients with severe neuropsychiatric

post-COVID syndromes.

On April 13, 2022, GeNeuro announced the first results of its collaboration with FondaMental Foundation

for the development of diagnostic and therapeutic options for patients with Post-COVID neuropsychiatric

syndromes. The study showed a strong correlation between SARS-CoV-2 infection, W-ENV protein and

markers of innate immunity, in patients with psychiatric disorders, confirming the interest of treating Post-

COVID neuropsychiatric syndromes by neutralizing the W-ENV protein with the temelimab antibody.

GeNeuro is preparing to launch a phase 2 clinical trial in 200 patients with Post-COVID syndromes and

positive for W-ENV.

On March 21, 2022, GeNeuro presented the top-line results from its ProTEct-MS clinical trial, which

showed that the primary endpoint of the study was met, with results confirming the excellent safety profile

and tolerability of higher doses of temelimab administered concomitantly with a high-efficacy anti-

inflammatory drug. In addition, efficacy data, obtained in patients already effectively treated against

inflammation, showed that temelimab had a favorable impact on key MRI parameters measuring

neurodegeneration.

On January 27, 2022, GeNeuro announced that it had completed its ProTEct-MS clinical trial and

confirmed that results from this study would be available by the end of March 2022. The Company also

reported its cash position as of December 31, 2021, and provided a business update.

2021

On December 13, 2021, GeNeuro announced that it was one of the four projects selected by the Swiss

Federal Office of Public Health (FOPH) FOPH to benefit from the "Federal Funding Programme for COVID-

19 Medicines" and that it would receive for a grant of 6.7 million Swiss francs (€6.4 million) to co-fund a

Phase II2 clinical trial to treat patients with long-standing COVID who exhibit neurological and psychiatric

("neuropsychiatric") symptoms.

GeNeuro SA – 2023 Universal Registration Document

On September 24, 2021, GeNeuro announced it had entered into a research collaboration with

Northwestern University, Chicago, Illinois, USA, to confirm evidence of the expression of human

endogenous retrovirus W envelope protein (W-ENV or W-ENV) in long-haul COVID patients, and identify

affected patients who may benefit from a treatment with GeNeuro's temelimab.

On July 13, 2021, GeNeuro announced a successful €6.0 million capital increase through an international

private placement only to certain qualified and institutional investors (the "2021 Offering").

On July 5, 2021, GeNeuro presented data supporting the pathogenic role of the endogenous retroviral

protein W-ENV in Post-COVID neuropsychiatric syndromes, and announced collaborations with the

FondaMental Foundation to accelerate the development of diagnostic and therapeutic options for Post-

COVID patients.

On June 24, 2021, GeNeuro announced it had renewed its collaboration agreement with the CIRI with an

expanded focus to Post-COVID syndromes.

On April 15, 2021, the Company announced recent research data on the detection of W-ENV in COVID-

19 patients and linking its expression to disease severity. A publication in the Lancet's EBioMedicine by

researchers from the "Tor Vergata" University of Rome, Italy, has shown that the pathogenic envelope

protein of the human endogenous retrovirus W (W-ENV) is found on lymphocytes of hospitalized patients

with COVID-19, and that its level of expression is associated with disease severity.

W-ENV's pro-

inflammatory properties are thought to act as an "accelerant" of the activation of the innate immune system,

fueling the severity of COVID-19 evolution and impacting long term recovery. In addition, through the

parallel effort supported by the ANR, preliminary data generated by GeNeuro and the CIRI in Lyon

(International Center for Research in Infectious Diseases), made available on Research Square, also

shows W-ENV expression in lymphocytes following in vitro exposure to SARS-CoV-2 in about 20% of

healthy blood donors, suggesting individual susceptibility. With W-ENV as a possible aggravating agent of

COVID-19, GeNeuro's temelimab, an anti-W-ENV monoclonal antibody already in a Phase II clinical trials

with an excellent tolerability and safety, could, without any prejudice to its existing programs, start tests

against COVID-19 as early as this summer.

On February 18, 2021, the Company announced the completed patient recruitment in its Phase 2 ProTEct-

MS trial of temelimab in MS patients, conducted at the Karolinska Institutet's Academic Specialist Center

(ASC), in Stockholm (Sweden).

On January 26, 2021, GeNeuro announced it had received an award from the French national research

agency, ANR (Agence Nationale de Recherche), for its COVERI project focused on understanding the role

of human endogenous retrovirus (HERV) proteins in the abnormal immune-inflammation or the

neurological damages suffered by important subsets of COVID-19 patients.

2020

On September 14, 2020, GeNeuro presented the rationale and outline of its Phase 2 ProTEct-MS clinical

study of temelimab at MSVirtual2020 (8th Joint ACTRIMS-ECTRIMS Meeting).

On July 20, 2020, GeNeuro announced the publication in Science Advances of data establishing a clear

link between human endogenous retroviral proteins and psychotic disorders.

On June 25, 2020, the Company announced the recruitment of the first patient in its Phase 2 trial of

temelimab in MS at the Karolinska Institutet's Academic Specialist Center (ASC), in Stockholm, Sweden.

On April 21, 2020, the Company announced the nomination, effective May 1, 2020, of its new Chief Medical

Officer, Dr. David Leppert, who is a highly experienced medical and industry professional.

On March 19, 2020, the Company announced that it was postponing the launch of its Karolinska Trial to

prioritize healthcare resources behind the fight of COVID-19 and to reduce the risk for MS patients.

On January 31, 2020, the Company announced that it had completed a €17.5 million capital increase

through a share offering to certain qualified and institutional investors. Its shareholder GNEH SAS

participated for €7.5 million in this offering and paid for its new shares by way of set-off with the €7.5 million

loan it had granted to the Company in 2019.

2019

On November 25, 2019, GeNeuro announced an agreement with the Karolinska Institutet / Academic

Specialist Center (ASC) of Stockholm to launch a new single center, Phase II clinical study of temelimab

in multiple sclerosis. The trial, to be conducted at the Center for Neurology of ASC (which, with

approximately 2,400 patients, is the largest MS center in Sweden), will be a one-year study that will enroll,

initially, 40 patients whose disability progresses without relapses, and will document the safety and

tolerability of temelimab following higher doses, as well as measures of efficacy based on the latest

biomarkers associated with disease progression. The study aimed to start enrolling patients in Q1 2020

GeNeuro SA – 2023 Universal Registration Document

with last patient out and top line results expected in H2 2021; however, due to the COVID-19 crisis, the

Company announced on March 19, 2020, that it was temporarily postponing this trial to prioritize healthcare

resources behind the fight of COVID-19 and to reduce the risk for MS patients. Assuming recruitement can

be completed by the end of 2020, the Company expects that results would still be communicated in H2

2021.

On September 16, 2019, GeNeuro presented at the European Committee for Treatment and Research in

Multiple Sclerosis (ECTRIMS 2019) Congress in Stockholm, Sweden the full results of the Phase II

CHANGE-MS trial and ANGEL-MS extension trial in relapsing-remitting MS (RRMS), which confirmed that

the neuroprotective effects of temelimab in MS patients extend to 96 weeks and that temelimab is safe to

use and well tolerated for a prolonged period.

In June 2019, GeNeuro announced that data supporting the mode of action of its lead product (temelimab)

in treating MS was published in the Proceedings of the National Academy of Sciences (PNAS). Temelimab

is a monoclonal antibody designed to neutralize a pathogenic, viral envelope protein, W-ENV, which plays

a causal role in the development of MS. The PNAS paper, entitled "W-ENVelope protein fuels microglial

cell-dependent damage of myelinated axons in multiple sclerosis", demonstrates that axonal injury in MS

can be significantly driven by W-ENV through activation of microglia and this contributes to

neurodegeneration, particularly in progressive forms of MS. In addition to the already published data

demonstrating that W-ENV may directly inhibit remyelination, these data provide additional neurobiological

rationale for the results from recently completed CHANGE-MS and ANGEL-MS Phase IIb trials. In these

studies, performed in patients with relapsing remitting MS, temelimab showed consistent neuroprotective

effects on MRI measures known to be associated with disability progression in MS, through neutralization

of W-ENV.

On May 7, 2019, the Company announced that a six-month extension of its Phase IIa study of temelimab

(GNbAC1) in T1D confirmed all previously-observed positive observations in the trial, meeting its primary

objective. GeNeuro believes these data open the door to further development in early-onset T1D pediatric

patient population.

On March 12, 2019, the Company announced positive results from the ANGEL-MS study of its lead

product, temelimab (GNbAC1), in MS. The ANGEL-MS data confirmed that treatment with temelimab for

2 years (96 weeks) had a continued, positive impact on key MRI measures of disease progression in

multiple sclerosis patients, confirming and extending the data reported at Week 48 in the CHANGE-MS

Phase IIb study. This includes reductions in brain atrophy, particularly in the cortex and thalamus, and

maintenance in myelin integrity, as measured by magnetization transfer ratio (MTR) imaging. Importantly,

for the first time, encouraging dose-dependent effects were seen on clinical measures of disease

progression. This has been evidenced by a lower proportion of patients with 12-week confirmed EDSS

progression, or with 20% worsening in 25-foot timed walk.

In January 2019, GeNeuro announced positive safety and tolerability results from a Phase 1 study

assessing the administration of high doses of temelimab (GNbAC1) to treat MS and other auto-immune

diseases. These results suggest that higher dose regimens or a front-loading could be evaluated in a future

next clinical study of temelimab in MS and other potential therapeutic indications.

2018

In December 2018, the Company signed a financing agreement with GNEH SAS, a subsidiary of Institut

Mérieux, to establish a €7.5 million credit line, allowing it to extend the Company's runway with all ongoing

programs until Q3 2020.

On October 17, the Company announced that following a successful collaboration in preclinical

amyotrophic lateral sclerosis (ALS) models, GeNeuro has signed an exclusive worldwide license with the

National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of

Health (NIH). The agreement covers the development of an antibody program to block the activity of

pHERV-K Env (pathogenic envelope protein of the HERV-K family of Human Endogenous Retroviruses),

a potential key factor in the development of ALS.

On October 11, the Company presented at ECTRIMS 2018 in Berlin the results from its 48-week CHANGE-

MS Phase IIb clinical trial in the MS indication, confirming a robust and coherent impact on the key MRI

markers associated with disease progression. Moreover, the benefits have also been observed in patients

with lower inflammatory burden, which are not served by existing anti-inflammatory treatments.

On September 26, the Company released the six-month results from the RAINBOW-T1D Phase IIa clinical

trial of temelimab in the T1D indication. The data showed that the study met the primary endpoint, with

temelimab showing an excellent safety and tolerability profile in T1D patients; some encouraging signals

were observed, such as a 32% reduction in the total number of hypoglycemic episodes in the treated group

versus placebo (p<0.0001), and a 21% decrease of anti-insulin antibodies in the treatment group, versus

an increase of 23% in the placebo group (p<0.01). But given the low occurrence of events in this well-

controlled population and the small size of the Phase IIa cohort, these signals require confirmation at Week

48, as well as through investigation in larger populations with a more recent onset.

GeNeuro SA – 2023 Universal Registration Document

On September 17, Servier, based on R&D strategic reasons and its international development priorities,

decided to decline the option to license temelimab in MS and to return worldwide rights ex US and Japan

for temelimab in MS. Should Servier have had exercised its option, it would have had to finance the global

development of temelimab, including in the USA and Japan. As a result, GeNeuro engaged in new

partnership discussions for its lead MS program. Following this notification by Servier, the ANGEL-MS two-

year extension study, undertaken at Servier's request and with Servier's funding, was terminated one year

before its expected end, with Servier bearing the study's closure costs. This early termination allowed to

generate 48-week results for ANGEL-MS, which were presented on March 12, 2019.

In March, the Company released the full results from its 48-week CHANGE-MS Phase IIb clinical trial in

the MS indication. The 12-month data of this 270-patient study, conducted in 12 European countries,

confirmed that there was a modest effect on most MRI measures of neuroinflammation, with no significant

separation between treatment groups. Full study results however showed robust and coherent impact at

the highest dose of 18 mg/kg on the key MRI markers associated with disease progression. Moreover, the

benefits are also observed in patients with lower inflammatory burden, which are not served by present

anti-inflammatory treatments. Safety of temelimab is confirmed.

In February, the Company's temelimab drug received the Orphan Drug Designation from the US FDA for

the chronic inflammatory demyelinating polyradiculoneuropathy ("CIDP") indication.

2017

Publication of the six-month results from the 48-week CHANGE-MS Phase IIb clinical trial on temelimab.

The data showed that temelimab is well tolerated and that there is no statistical difference at 6 months

between temelimab and placebo in the study's primary endpoint of reducing the number of cerebral Gad-

enhancing lesions as measured by MRI, nor on the other MRI measures of neuroinflammation. Post hoc

analyses of 6-month data however showed an anti-inflammatory effect in active patients at the highest (18

mg/kg) of the three doses tested at Week 24. In addition, at the same dose, a promising effect on

remyelination was observed at 24 weeks.

Launch of a Phase IIa clinical trial with temelimab in the Type 1 diabetes indication, with 60 recently

diagnosed adult patients, in over 10 centers in Australia. The primary endpoint will be the safety of

temelimab in this new patient population.

The Company entered into a research agreement with the US NIH for developing new approaches against

pHERV-K (K-ENV) protein as a target in the treatment of Amyotrophic Lateral Sclerosis (ALS).

2016

At the end of December 2016, completion of the recruitment of the 260 patients of the CHANGE-MS Phase

IIb clinical trial on temelimab, 4 months ahead of planning. A Data Safety Monitoring Board reviewed the

3-month data for the first 30 patients and confirmed the very good tolerance profile of temelimab.

Servier decides to finance a new ANGEL study which will allow patients having taken part in the Phase IIb

study to benefit from two additional years of treatment.

In April 2016, Initial Public Offering on Euronext's regulated market in Paris, coupled with a capital

increase, allowing the Company to raise gross proceeds of €33 million.

Launch of the CHANGE-MS Phase IIb clinical trial on temelimab, contemplating the recruitment of 260

patients initially through 69 clinical centers in 13 European countries. The trial's main endpoint is the

cumulative number of brain lesions evidenced by MRI at 6 months, then 12 months together with patients'

clinical evaluation.

2015

Servier International B.V. (owned 100% by Servier) acquires 8.6% of GeNeuro's outstanding shares

through a sale by Eclosion2 for €15 million on December 11, 2015. Servier exercises its first option under

the Collaboration Agreement to finance the Phase IIb trial of temelimab and makes a milestone payment

of €17.5 million to GeNeuro.

GeNeuro conducts a pharmacological study controlled against placebo to confirm the safety and

penetration in the central nervous system of high doses of the immunoglobulin temelimab on healthy

volunteers in preparation for launching a Phase IIb study.

2014

A Collaboration Agreement is signed by GeNeuro, Servier and Institut de recherches internationales

Servier for the development of a drug targeting a suspected causal factor of multiple sclerosis.

Completion of the one-year Phase IIa trial on 10 patients with good results in safety as well as

pharmacodynamic effects and the first signs of therapeutic responses in patients.

2011

GeNeuro announces the completion of the Phase I clinical trial of temelimab, showing that the product is

well tolerated.

2010

GeNeuro obtains a favorable opinion from the German committee for scientific regulation, the Paul Ehrlich

Institute, on the pre-clinical file for the temelimab monoclonal antibody to treat MS.

2009

GeNeuro Innovation, the subsidiary of the Company, is organized in Lyon, France.

2008

A capital increase of CHF 12 million is underwritten by Eclosion and Institut Mérieux to broaden GeNeuro's

operations and develop its medicines portfolio through clinical trials.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 5.

DESCRIPTION OF THE GROUP'S BUSINESS

5.1 General Presentation

GeNeuro is a clinical-stage biopharmaceutical company focused on understanding and stopping causal factors

driving the progression of neurodegenerative and autoimmune diseases. GeNeuro's most advanced therapeutic

candidate, temelimab, is a humanized monoclonal antibody that neutralizes a pathogenic protein of the HERV-W

family ("W-ENV") that has been identified as a potential causal factor in MS and has already completed Phase II

clinical trials in this indication with an excellent tolerability and safety profile; in addition, efficacy data, obtained both

in naïve patients and in patients already effectively treated against inflammation, showed that temelimab has a

favorable impact on key MRI parameters measuring neurodegeneration, indicating a positive effect of temelimab in

preserving neocortical anatomy and myelin integrity. The effect sizes in patients treated with highly effective anti-

inflammatory treatments were of comparable magnitude to those previously observed in the CHANGE-MS and

ANGEL-MS trials in patients without treatment. Furthermore, new exploratory data on soluble biomarkers also

showed favorable impact on measures of neurodegeneration, as the study showed a reduction of GFAP biomarkers

in cerebrospinal fluid (CSF) at one year. GFAP is a biomarker for astrocytic activation associated with diffuse

neuroaxonal damage leading to MS disease progression. The results on CSF biomarkers confirm the synergistic

potential to treat neurodegeneration with temelimab in addition to a high-efficacy anti-inflammatory therapy in MS.

GeNeuro has also initiated a program with temelimab in Post-COVID for patients with persistent neuropsychiatric

syndromes and launched at the end of 2022 a Phase 2 trial, called GNC-501, that is evaluating the clinical efficacy

of a six-month treatment with temelimab on the improvement of cognitive impairment and/or fatigue in Post-COVID

patients who are positive for the presence of W-ENV protein in their blood. In observational cohorts, the W-ENV

protein was observed in more than 25% of patients with persistent syndromes after having had COVID, as

evidenced in a recent publication made available on MedRxiv⁶, whereas real world experience from the GNC-501

trial shows that 36% of all patients who were screened in the study were positive for the presence of W-ENV. This

personalized medicine approach could, if the current clinical trial is successful, offer a therapeutic solution to a large

and well identified subset of the millions of patients affected by Post-COVID.

GeNeuro's program against Post-COVID is based on the initial discovery by academic collaborators that W-ENV

was found on lymphocytes of hospitalized patients with COVID-19, with a level of expression correlated with disease

severity. W-ENV's pro-inflammatory properties are thought to act as an "accelerant" of the activation of the innate

immune system, fueling the severity of COVID-19 evolution and impacting long term recovery. Published data also

shows the expression of W-ENV in lymphocytes following in vitro exposure to SARS-CoV-2 in about 20% of healthy

blood donors, suggesting individual susceptibility⁷. Furthermore, data presented in July 2021⁸showed that the

neuropsychiatric symptomatology seen in Post-COVID patients may be due to the continued presence of W-ENV

expression in these individuals , which may extend long after the acute COVID phase. These data provide a biologic

rationale explaining why so many COVID-19 patients develop long-term neurological and psychiatric symptoms

long after the initial infection, and open the door for a therapeutic intervention with temelimab targeting W-ENV.

According to recent large-scale studies, more than 10% of people infected by SARS-CoV-2 fail to fully recover

and/or develop new symptoms, with a high proportion of neurological and/or psychiatric affections. A recent study

published in Nature Reviews Microbiology states that at least 65 million individuals worldwide are estimated to have

long COVID, with cases increasing daily⁹. Of note, in more than 90% of the cases the original COVID-19 symptoms

were not severe enough to warrant hospitalization. With close to 500 million confirmed COVID-19 cases worldwide,

of which more than 225 million in the USA, Canada and Western Europe, Post-COVID is recognized as a major

public health emergency affecting millions of persons.

More broadly, GeNeuro is leveraging the potential of HERVs through research and academic partnerships to

develop new treatments for poorly understood autoimmune and neurodegenerative diseases, such as the

Cooperative Research and Development Agreement ("CRADA") signed in 2017 with the NINDS, part of the NIH,

to develop novel therapeutic antibodies for the treatment of ALS. In addition, W-ENV has been identified as a

potential causal factor in Type 1 Diabetes, CIDP, a rare autoimmune disorder of the peripheral nervous system and

Inflammatory Psychosis, although none of these indications is being pursued presently.

⁶Source: Charvet et al., April 2023, MedRxiv - https://doi.org/10.1101/2023.03.31.23288003

⁷Source: Charvet et al., April 2023, Cell Press - SARS-CoV-2 awakens ancient retroviral genes and the expression

of proinflammatory HERV-W envelope protein in COVID-19 patients.

⁸Source: Neuro Sciences Psychiatry and Neurology Days held in Paris, France, on July 1-2, 2021

⁹Source: Davis et al., Nature Reviews Microbiology, January 2023.

GeNeuro SA – 2023 Universal Registration Document

GeNeuro's novel approach against HERVs

The immune system is a complex set of defense mechanisms that seek to protect the body by identifying and

destroying potential threats, including infectious agents. Autoimmune diseases are defined as conditions where the

immune system of the patient is activated without known cause, and attacks and damages its own tissues. There

are many autoimmune diseases, affecting many organ classes, such as rheumatoid arthritis, juvenile (type 1)

diabetes, psoriasis, and multiple sclerosis. Since there is no known cause for autoimmune diseases, treatments in

these indications target the immune system of the patient to reduce the damage caused by the immune attack

and/or provide relief for the damage inflicted to an organ.

GeNeuro is developing a novel approach against autoimmune and neurodegenerative diseases by trying to block

potential causal factors of these disorders. This novel approach is the result of more than 25 years of research on

human endogenous retroviruses ("HERV"), 15 of which at Institut Mérieux and INSERM before the creation of

GeNeuro in 2006.

HERV DNA, which represents up to 8% of the human genome (see Figure 1 below), has originated from infections

by viruses whose DNA was integrated into the human germline during evolution. Since HERV DNA is normally

silent, HERVs are generally not expressed. In certain disease settings, however, such as MS, HERV genes can be

reactivated, which leads to significant levels of some HERV proteins in affected tissues.¹⁰In Post-COVID, the

International Center for Infectiology Research in Lyon, France (CIRI) has shown that when human peripheral blood

mononuclear cells from healthy donors were cultured and exposed to SARS-CoV-2, about 20% of donors

responded by expressing W-ENV in lymphocytes, cells in which the virus did not replicate. This expression was

triggered specifically by the spike protein of SARS-CoV-2, independently from cytokine release.

These proteins, considered as "self" by the body as encoded by its own cells, may retain some of their original viral

properties, which could explain in some disease settings the triggering of the immune system and local toxicity.

Figure 1 : DNA breakdown of the human genome

As detailed below, GeNeuro and some leading academic centers have developed and published strong evidence

suggesting that the envelope (ENV) protein of the HERV-W family could play a causal role in MS and Post-COVID,

as well as in other indications such as Inflammatory Psychosis or T1D. The NINDS, part of the NIH, has also

published the potential causal role of the ENV protein of the HERV-K family in ALS, and has confirmed in

publications made in Annals of Neurology¹¹in pre-clinical models of ALS the neurotoxic properties of HERV-K ENV

and the therapeutic potential of GeNeuro's antibody developed to neutralize HERV-K ENV.

And the amount of evidence for the involvement of HERV proteins in poorly understood diseases keeps building

up. If these proteins do indeed play a causal role in these pathologies, neutralizing them through therapeutic

molecules could, for the first time, allow medicine to have a direct impact on the onset and progression of these

diseases. GeNeuro leads the effort of leveraging these promising discoveries into novel and effective treatments

for patients, with its research and clinical work currently focused on a number of key indications shown below.

Source: Engel & Hiebert, Nature Med. 2010, May; 16(5): 517-8.

Source: Steiner et al, Annals of Neurology July 2022; Garcia-Montojo et al., Annals of Neurology – July 2022

GeNeuro SA – 2023 Universal Registration Document

Figure 2 : GeNeuro development pipeline

Multiple Sclerosis

MS is a long-term, degenerative disease that affects the central nervous system (consisting of the brain and spinal

cord) in which the immune system attacks the myelin sheath that protects nerve fibers and is characterized by

neuroinflammation and neurodegeneration. Without the protection of myelin, nerves lose functionality, become

damaged and are ultimately destroyed, which leads to the formation of scar tissue (sclerosis). In 85% of the cases

at the original diagnosis, MS presents itself in a form called relapsing-remitting MS (RRMS), which will usually

degenerate over time into a more aggressive form of the disease: the secondary progressive form (SPMS) during

which the loss of neuronal function increases. Approximately 15%¹²of patients present from the outset with a

progressive form of the disease called primary progressive MS (PPMS). There is currently no cure for MS, and no

treatment presently available has shown a determining impact on the progression of long-term disability resulting

from the disease. Present treatments work by reducing the number of relapses, speeding recovery from attacks,

and managing the symptoms of the disease, and are approved for the relapsing-remitting forms of MS (which

include the "active secondary progressive" form, which the FDA¹³has defined as one of the relapsing forms of MS).

In fact, based on the recent definition by the FDA¹⁴, it is even possible to split MS patients in two broad categories:

patients with inflammatory relapses (or "active inflammatory" patients), and patients with progression of their

disability without inflammatory relapses ("non-active progressive" patients).

Sales of medications for the treatment of MS in 2022 have been estimated at USD 20.5 billion¹⁵. All presently

approved medications target the adaptive immune system of the patient by altering or suppressing the functions of

the patient's adaptive immune system in order to reduce the number of relapses. The reduction in the number of

relapses in the RRMS form, however, has shown to have little or no long-term impact on the progression of

disability¹⁶. Treating all forms of MS with safe and effective medications able to stop the chronic neurodegeneration

leading to the build-up of disability remains a huge unmet medical need in MS.

In MS, W-ENV has been identified as a potential key factor fueling the inflammatory and neurodegenerative

components of the disease in all its forms, most recently in a publication in the Proceedings of the National Academy

of Science¹⁷. The Company believes that temelimab is the first treatment against a suspected causal factor of

neurodegeneration in MS, and, as such, temelimab has the potential to offer a safe and effective treatment which

could slow or even stop disability progression in all major forms of MS.

GeNeuro initiated in early 2016 a 48-week, multicentric Phase IIb double-blind placebo-controlled study called

"CHANGE-MS" to test its temelimab drug candidate in 270 patients in 50 clinical centers and 12 countries in Europe.

Source: United States National MS society

FDA Press release on Siponimod approval, March 26, 2019

ibid

Source: 2022 annual reports of companies active in this field

Source: Ebers et al.: study of 730 patents over a period of 28 years

Source: Kremer, Gruchot et al., PNAS, May 2019

NINDS: National Institute of Neurological Disorders and Stroke, part of the United States National Institutes of Health

IND : Investigational New Drug

HERV : Human endogenous retroviruses

GeNeuro SA – 2023 Universal Registration Document

Three doses were tested: 6 mg/kg, 12 mg/kg and 18 mg/kg, via intravenous injections every 4 weeks. The Company

presented 24-week results (including the study's primary endpoint) in August and October 2017, as well as full 48-

week results in March 2018.

Whilst the CHANGE-MS study confirmed the safety profile of temelimab, the primary outcome at 24 weeks, which

measured inflammation through the reduction of the cumulative number of Gd+ lesions¹⁸, did not reach statistical

significance. This could be due to the mode of action of the drug, which neutralizes a pathogenic factor but does

not have an immediate impact on active adaptive immunity cells. However, at CHANGE-MS completion at 48

weeks, data showed that temelimab administration had a significant, consistent positive impact on key

neuroprotection markers known to be linked to disability progression, such as reduction of brain atrophy, reduction

of the number of chronic black holes (permanent tissue damage) and stabilization of MTR values (a measure of

myelin integrity). At the ECTRIMS congress in Berlin in October 2018, the Company presented further analysis of

the CHANGE-MS 48-week results that showed that the neuroprotective effects of temelimab were comparable in

the active and inactive subpopulations, i.e., with or without new inflammatory lesions, suggesting a mode of action

specific to neurodegeneration.

The patients who had completed CHANGE-MS were offered to continue treatment with temelimab in an extension

study called ANGEL-MS. 95% of these patients chose to continue treatment, or a total of 219 patients. At the time

the study was interrupted, when Servier stepped out of its former partnership with GeNeuro, 154 patients had

already completed 96 weeks of treatment (including the 48 weeks of CHANGE-MS), and over 90% had over 86

weeks of treatment, providing a solid basis for evaluating the effect of longer treatment with temelimab.

The topline results of ANGEL-MS after a total of 96-weeks¹⁹of treatment were presented on March 12, 2019. These

results showed a continued, positive impact on key MRI measures of neurodegeneration in multiple sclerosis

patients, confirming and extending the data reported at Week 48 in the CHANGE-MS Phase IIb study. This includes

reductions in brain atrophy, particularly in the cortex and thalamus, and maintenance of myelin integrity, as

measured by magnetization transfer ratio ("MTR") imaging, a surrogate measure of remyelination. Importantly, for

the first time, encouraging dose-dependent effects were seen on clinical measures of disease progression. This

has been evidenced by a lower proportion of patients with 12-week confirmed EDSS progression, or with 20%

worsening in 25-foot timed walk. At the same time, ANGEL-MS confirmed that temelimab had only a modest effect

on neuroinflammation, as evidenced by a non-significant reduction in the number of T2 lesions. As a result, the

positive results observed suggest that the effect of temelimab is not mediated by inflammation but rather by a

specific effect reducing neurodegeneration, which is highly encouraging as temelimab which is the clear unmet

need in MS. The CHANGE-MS and ANGEL-MS results also provide the first evidence of the effect from neutralizing

a pathogenic HERV protein in an autoimmune disease, opening the way to multiple applications in other

autoimmune and neurodegenerative diseases. For a more detailed review of the results, please refer to sections

5.2.1.2 and 5.2.2.1 of the Universal Registration Document.

In 2020, GeNeuro launched a new single center Phase II clinical study of temelimab in multiple sclerosis at the

Karolinska Institutet / Academic Specialist Center (ASC) of Stockholm, which, with approximately 2,400 patients, is

the largest MS center in Sweden. The one-year trial enrolled 41 patients whose disability progressed without

relapses as they were previously treated with an anti-CD20 antibody, a high efficacy anti-inflammatory drug. On

October 27, 2022, GeNeuro presented the primary analysis of the Phase 2 ProTEct-MS study at the European

Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2022) Congress in Amsterdam,

Netherlands:

•

The primary endpoint of the ProTEct-MS study was met, with results confirming the excellent safety profile

and tolerability of higher doses of temelimab administered concomitantly with an anti-CD20 treatment. The

drug was well tolerated with no treatment related discontinuations, no serious or severe treatment emergent

adverse events, and no differences in overall clinical or laboratory safety findings, which meets the primary

endpoint of the study.

•

Efficacy data, obtained in this patient group already effectively treated against inflammation, showed that

temelimab has a favorable impact on key MRI parameters measuring neurodegeneration, as temelimab

showed a positive effect in preserving neocortical anatomy and myelin integrity. The effect sizes were of

comparable magnitude to those previously observed in the prior CHANGE-MS and ANGEL-MS trials in

patients without an anti-inflammatory treatment.

•

New exploratory data on soluble biomarkers also showed favorable impact on measures of

neurodegeneration at one year: the study showed a reduction of GFAP biomarkers in cerebrospinal fluid

(CSF). GFAP is a biomarker for astrocytic activation associated with diffuse neuroaxonal damage leading to

MS disease progression. The results on these CSF biomarkers confirm the synergistic potential to treat

neurodegeneration with temelimab in addition to a high-efficacy anti-inflammatory therapy in MS.

•

The analysis of the data also allows GeNeuro to determine the optimal dose for future temelimab trials in MS,

in conjunction with potential partners.

Gd+: gadolinium-enhancing lesions, as measured by MRI

48 weeks of CHANGE-MS + 48 weeks of ANGEL-MS

GeNeuro SA – 2023 Universal Registration Document

Based on the results of CHANGE-MS, ANGEL-MS and ProTEct-MS showing the impact of temelimab on MRI

measures and soluble biomarkers associated with disease progression, the Company has defined its development

path forward for temelimab in MS as targeting the key unmet medical need in MS: curbing the progression of

disability.

GeNeuro is therefore focusing on neurodegeneration and disease progression, which could be as a monotherapy

for "non-active"²⁰progressive patients, or, more likely, as an adjunctive therapy for remitting patients in combination

with existing immunomodulatory drugs addressing neuroinflammation, such paths being non-exclusive.

Following the announcement of the Karolinska Trial's results, GeNeuro has resumed discussions with potential

partners to define the best development path combining temelimab and anti-inflammatory treatments to treat

relapses and disability progression, the key unmet medical need in MS. Given the high costs of the international

clinical trials necessary to confirm efficacy and register a product in MS with both the FDA and the EMA, which the

Company estimates would exceed €100 million, continued development in MS requires a partnership.

Post-COVID

COVID-19 was the most severe global pandemic since the influenza pandemic of 1918. As of April 19, 2023,

according to the World Health Organization (WHO) there have been more than 750 million confirmed cases and

almost 7 million global deaths from COVID-19. Three years after the onset of this pandemic, although the majority

of patients infected with SARS-CoV-2 recover within a few weeks, "Post-COVID" is estimated to occur in 10–20%

of cases and affects people of all ages, including children, with most cases occurring in patients with mild acute

illness²¹. The consequence is widespread global harm to people's health, wellbeing, and livelihoods—an estimated

one in ten people who develop long COVID stop working, resulting in an extensive social and economic burden.

Current knowledge about this condition, known as post-COVID-19, PASC (Post Acute Sequelae of COVID-19), or

"Post-COVID", as well as about COVID-19 itself, is as recent as these conditions and continues to evolve daily.

Post-COVID collectively refers to the constellation of perduring symptoms that some patients experience after

contracting COVID-19. To estimate the prevalence and burden of this syndrome, Santé publique France conducted

an initial study on a large sample of the general adult population, the results of which showed that 30% of people

who had been infected with SARS-CoV-2 subsequently presented the criteria for "long COVID". On the scale of the

French population, the "post-COVID-19 condition" would thus concern 2 million people over the age of 18. In

parallel, large-scale academic studies indicate that up to 10% of people infected with SARS-CoV-2 do not fully

recover and/or develop new symptoms, with a high proportion of neurological and/or psychiatric disorders. A

January 2023 publication in Nature Reviews Microbiology²²thus estimates that at least 65 million people worldwide

now suffer from Post-COVID.

In 2021, results published in the Lancet journal EBioMedicine²³showed the presence of the W-ENV protein on

lymphocytes of hospitalized patients with COVID-19. These same results indicate a correlation between the level

of expression of the protein and the severity of the disease. In addition, recent data showed that SARS-CoV-2 was

able to induce in vitro expression of W-ENV in human blood cells from approximately 20% of healthy volunteers²⁴.

The expression of the pathogenic W-ENV protein triggered by SARS-CoV-2 infection can continue long after the

resolution of the acute phase and may play a major role in the persistence of neurological and psychiatric

syndromes in many Post-COVID patients.

Studies conducted on cohorts of several hundred European and American Post-COVID patients have detected the

presence of the W-ENV protein in over 25% of these patients²⁵, whereas in the GNC-501 clinical trial 36% of the

patients presenting long-COVID syndromes who were screened were positive to the presence of W-ENV in their

blood.

W-ENV is found in specific disease situations, and its presence is always tied to negative disease outcomes for the

patient. The pro-inflammatory effects of W-ENV are mediated through the activation of the TLR4 innate immune

receptor, a pathway closely associated with some of the key features of COVID-19, such as hyper-activation of

innate immunity, endothelial cell activation, vasculitis as well as coagulopathy. W-ENV has mostly been studied in

neurodegenerative diseases, with widely observed pathogenic effects on peripheral and central nervous system

cells. After the primary SARS-CoV-2 infection is over, if W-ENV has reached a self-fueling expression level, it could

²⁰Defined as MS patients experiencing progression of disability independent of the relapse activity

²¹Source: The Lancet, March 2023 - https://doi.org/10.1016/S0140-6736(23)00493-2

²²Source: Davis et al., Nature Reviews Microbiology, January 2023.

²³Source: Balestrieri et al., Lancet eBioMedicine, April 2021

²⁴Source: Charvet et al., April 2023, Cell Press - SARS-CoV-2 awakens ancient retroviral genes and the expression of

proinflammatory HERV-W envelope protein in COVID-19 patients.

Source: Charvet, Koralnik, Perron et al.: Blood biomarkers-defined subgroups show heterogeneity in post-acute COVID-19

syndrome: a rationale for precision medicine - https://doi.org/10.1101/2023.03.31.23288003

GeNeuro SA – 2023 Universal Registration Document

cause persistent damage to endothelial cells in blood vessels and also to cells from the peripheral and central

nervous system, which could explain many of the long-term neurological and psychiatric symptoms experienced by

patients long after SARS-CoV-2 infection.

GeNeuro is at the forefront of addressing this issue with the first personalized medicine clinical trial against Post-

COVID, evaluating temelimab as a disease-modifying therapy in Post-COVID patients who are positive for the

pathogenic protein W-ENV in their blood.

Temelimab has already been approved in Switzerland, Italy, Spain and the United Kingdom to conduct Phase 2

clinical trials to evaluate the efficacy and safety of this treatment in patients with cognitive impairment ("brain fog")

and severe fatigue and in whom the presence of W-ENV protein in the blood can be confirmed by a serum test.

The GNC-501 study, entitled "Temelimab as a Disease Modifying Therapy in Patients with Neurological,

Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19 (PASC)

Syndrome", has now enrolled 203 patients from Italian, Spanish and Swiss clinical centers. The study has enrolled

only those patients who also test positive for the pathogenic protein W-ENV, as the basis of a personalized medicine

approach. Topline results are planned for June 2024.

ALS

The scientific corpus supporting the involvement of HERVs in poorly understood diseases is growing, and GeNeuro

is working with leading research centers in the United States and Europe to apply this technology to the treatment

of other human diseases where HERVs could also be playing a key role and which are still incurable, such as

amyotrophic lateral sclerosis ("ALS"), which is a motor neuron disease. "Sporadic" or non-inherited ALS, accounts

for roughly 90% percent of cases, and 10% of cases are due to known genetic mutations²⁶. The sporadic form

affects approximately 10,000 new patients per year in the US and EU, with a poor prognosis of survival. GeNeuro

entered into a Cooperative Research And Development Agreement with the US National Institutes of Health in

February 2017 to advance research in the link between HERVs and ALS. This collaboration resulted in joint-

intellectual property on a novel antibody able to neutralize the pathogenic effects on the pathogenic envelope protein

in of the HERV-K family, which has been shown to be present in the CSF of sporadic ALS patients and cause the

death of motor neurons. GeNeuro signed in October 2018 an exclusive worldwide license with the National Institute

of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH) on the jointly

owned intellectual property. The agreement covers the development of an antibody program to block the activity of

the pathogenic envelope protein of the K family of Human Endogenous Retroviruses (HERV-K ENV, simplified as

"K-ENV").

In August 2022, GeNeuro and the National Institute of Neurological Disorders and Stroke (NINDS), part of the

National Institutes of Health (NIH) of the United States, announced the joint publication in the leading scientific

journal "Annals of Neurology" of the results of their collaboration. The two publications²⁷

describe the novel

pathogenic mechanism of HERV-K in sporadic ALS and confirm the rationale for the therapeutic relevance of

GeNeuro's antibody to neutralize this neurotoxic protein.

GeNeuro continues to work with NINDS to define the optimal path for the clinical development of the antibody.

GeNeuro has completed the characterization and selection of humanized antibody now identified as GNK301. The

first non-GMP batches of the antibody have been produced, and are now used in preclinical studies to ascertain

the route of administration for clinical trials., The Company continues to seek partnerships to fund this development.

Possible commercialization and marketing timelines

GeNeuro estimates that the potential sale of its lead product candidate, temelimab for MS or Post-COVID, could,

considering its development schedule, the receipt of regulatory authorizations and the commercialization and

marketing of its product candidate, commence between 2025 and 2027, subject to the success of one or several

Phase III trials, the absence of any event delaying the proper conduct of the trials, and the absence of other events

that the Company is currently unable to identify or anticipate.

5.1.1 Competitive Advantages

GeNeuro's competitive strengths are rooted in its novel approach against autoimmune and neurodegenerative

diseases, supported by strong IP and an experienced executive team with a strong track record.

²⁶Source : NIH Amyotrophic Lateral Sclerosis (ALS) Fact Sheet.

²⁷Source: Human Endogenous Retrovirus K Envelope in Spinal Fluid of Amyotrophic Lateral Sclerosis Is Toxic, J. Steiner et al.,

Annals of Neurology, July 2022

²⁸Source: Antibody response to HML-2 may be protective in Amyotrophic Lateral Sclerosis, M. Garcia-Montojo et al., Annals of

Neurology, July 2022

GeNeuro SA – 2023 Universal Registration Document

•

Temelimab has demonstrated its potential to offer a therapeutic option of great value for patients

suffering from MS. No presently available treatment has demonstrated a major impact on the progression of

long-term disability for any form of MS. By blocking upstream a potential key factor present in all types of MS

that fuels neurodegeneration, temelimab may provide a safe and effective treatment to serve the key unmet

medical need of disability progression which is common to all major forms of the disease in combination with

available high-efficacy anti-inflammatory drugs. This would best address the need of MS patients, which need

treatment against inflammation and against neurodegeneration.

•

Recent findings on the link between W-ENV and Post-COVID open the avenue to a new, large and highly

underserved market. Studies conducted on cohorts of several hundred European and American Post-COVID

patients have detected the presence of the W-ENV protein in over 25% of these patients, whilst the GNC-501

clinical trial patient recruitment screening process has shown that the W-ENV protein was detected in over 36%

of the screened patients. With the number of affected persons estimated to exceed several millions, GeNeuro

has launched the first personalized medicine trial, a pivotal Phase 2 trial in Switzerland, Italy and Spain, to

evaluate the efficacy and safety of temelimab in patients with severe fatigue and cognitive impairment ("brain

fog") and in whom the presence of W-ENV protein in the blood can be confirmed by a serum test. The GNC-

501 study, entitled "Temelimab as a Disease Modifying Therapy in Patients with Neurological,

Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19

(PASC) Syndrome", has now completed patient recruitment with the enrollment of 203 patients from European

and Swiss clinical centers. The study has only enrolled those patients who also test positive for the pathogenic

protein W-ENV, as the basis of a precision medicine approach. Topline results are expected in June 2024.

•

GeNeuro has full worldwide rights to temelimab. GeNeuro has full worldwide ownership of all rights to

temelimab and has all options open for geographic and/or indication-specific partnerships to develop its lead

compound worldwide, as a single agent for patients with progressive forms of MS, or in combination with existing

therapies for relapsing forms of the disease.

•

GeNeuro has demonstrated the efficacy of the W-ENV detection. With the GNC-501 trial offering real-world

conditions, the diagnostic test developed by GeNeuro with the support of INSERM has demonstrated its ability

to detect the presence of W-ENV in the serum of patients (in the case of the GNC-501 trial, 1'092 patients were

screened patients, of whom 36% were shown to be positive to W-ENV) thus opening the way to a biomarker-

based precision medicine approach to serve severely affected patients in the absence of any disease modifying

treatment to date.

•

Broad and strong intellectual property supports GeNeuro's first mover advantage in the HERV space.

GeNeuro's leadership position in the HERV space is supported by its acknowledged expertise in the field and a

portfolio of 17 patent families that cover Europe, the United States, and other major markets. These patents

(owned or under exclusive license from bioMérieux-Inserm, or with the NIH for HERV-K) cover antibodies

targeting W-ENV in the treatment of a wide range of therapeutic indications including MS, Post-COVID or

Inflammatory Psychosis and targeting HERV-K ENV in the treatment of ALS. GeNeuro believes that the scope

and quality of its patent portfolio give it a strong competitive position in the area of W-ENV and contribute to

protecting GeNeuro's first-mover advantage as a leader in HERV-mediated diseases.

•

GeNeuro has an experienced and highly synergistic management team assisted by internationally

renowned scientific and medical advisors. GeNeuro has assembled a talented team of professionals with

complementary skills who have demonstrated during the last ten years their ability to move research from the

laboratory to the clinic. The Company's management is supported by a team of internationally renowned experts

who assist on scientific and strategic matters. As key opinion leaders ("KOLs") in their respective fields, they

help to promote temelimab in the scientific, medical, and patient communities.

5.1.2 Company Strategy and Objectives

GeNeuro's strategy is to continue the development of temelimab to make it available as soon as possible to patients

affected with post-COVID and MS, to complete its GNC-501 clinical trial in post-COVID-19 during the first half of

2024 and, subject to funding, to continue the pre-clinical development of its anti-HERV-K antibody in ALS to reach

an IND and then launch a clinical trial in this orphan indication.

Large-scale academic studies indicate that more than 10% of people infected with SARS-CoV-2 do not fully recover

and/or develop new symptoms, with a high proportion of neurological and/or psychiatric disorders. This post-COVID

problem is now recognized as a major public health emergency, as it is affecting millions of people.

In Post-COVID, GeNeuro has launched a Phase 2 trial, called GNC-501, that is evaluating the clinical efficacy of a

six-month treatment with temelimab, the anti-W-ENV antibody developed by GeNeuro, on the improvement of

fatigue and/or cognitive impairment in Post-COVID patients who are positive for the presence of W-ENV protein in

their blood. This trial is running in 14 sites in Switzerland, Spain and Italy, and is now fully recruited, with the W-

ENV protein having been detected in more than 36% of screened patients suffering from persistent syndromes after

having had COVID which confirms the potential to identify and treat a well-defined sub-population within the huge

numbers of patients affected by Post-COVID.

GeNeuro SA – 2023 Universal Registration Document

Given the six-month treatment duration, topline results are expected by the end of June 2024. This personalized

medicine approach could, if the current clinical trial is successful, offer a therapeutic solution to a well identified

subset of the millions of patients affected by Post-COVID.

Subject to positive results, the Company intends to file

for an emergency marketing authorization or temporary use authorization.

GeNeuro's Post-COVID program is supported both by the Swiss Federal Office of Public Health (FOPH), which

selected GeNeuro to receive a grant of 6.7 million Swiss francs (€6.7 million), and by the European Investment

Bank (EIB), with which GeNeuro entered into a credit agreement for a total amount of up to €25 million, supported

by the InvestEU program, of which a first tranche of €7 million was immediately available and was drawn down in

March 2023; the Company is currently negotiating with the EIB for an early draw-down of part of the second tranche

of €10 million.

In MS, GeNeuro's assessment of its Phase 2 MS trials, in discussions with potential partners and key medical

opinion leaders, made clear that the impact of temelimab on MRI markers and soluble biomarkers associated with

disease progression indicates a very high potential against the key unmet medical need in MS: curbing the

progression of disability. GeNeuro has therefore decided to focus on neurodegeneration and disease progression,

which could be either as a monotherapy for "non-active" progressive patients, or, more likely, as an adjunctive

therapy for remitting patients in combination with existing immunomodulatory drugs addressing neuroinflammation,

such paths being non-exclusive. The results of the Karolinska Trial, presented at ECTRIMS 2022 in Amsterdam,

the Netherlands, in October 2022, have confirmed the safety of higher doses of temelimab and its synergistic

potential to address neurodegeneration on top of anti-inflammatory treatment in multiple sclerosis, with efficacy

data, obtained in patients already effectively treated against inflammation, showing that temelimab has a favorable

impact on key MRI parameters measuring neurodegeneration. Given the high costs of the international clinical trials

necessary to confirm efficacy and register a product in MS with both the FDA and the EMA, which the Company

estimates to exceed €100 million, continued development in MS requires a partnership and, following the results

from the ProTEct-MS trial, the Company has reactivated partnership discussions for the MS indication.

5.2 Temelimab: Clinical Development as of the Date Hereof

To date, ten clinical studies of temelimab have been or are being conducted on humans, which are summarized in

Table 1:

Table 1: Summary of clinical studies²⁹

Clinical Study

N°

Design

Subjects

Temelimab dose,

regimen, route of

administration

Formu-

lation

Placebo

compara

tor

Key results

GNC-001

Clinicaltrials.gov

identifier:

NCT01699555

Randomized

placebo-controlled

first-in-human study

with temelimab

33 healthy

male

subjects

(cohorts 0.1

5 to 6.00

mg/kg were

analyzed for

PK)

Single doses,

0.0025 mg/kg

0.025 mg/kg

0.15 mg/kg

0.60 mg/kg

2.00 mg/kg

6.00 mg/kg

intravenous

Liquid

Placebo

Well

tolerated

with all adverse

events mild or

moderate

GNC-002

Clinicaltrials.gov

identifier:

NCT01639300

Randomized

placebo-controlled

first-in-human study

with temelimab

Repeated dose

phase

Open label

10 MS

patients

(cohorts 2

and 6

mg/kg)

Single doses,

2 mg/kg

6 mg/kg

Intravenous

Open label:

repeated doses

2 mg/kg,

6 mg/kg

intravenous

Liquid

Placebo

in open

label

phase:

phase

tolerated,

Single

dose

phase:

well

tolerated, linear

PK and t½:17 –

49 days

Repeated dose

well

AR:

~3.0,

overall

stability of MRI

GNC-001B

Clinicaltrials.gov

identifier:

NCT02452996

Randomized

placebo-controlled

pharmacology study

with temelimab

21 healthy

male

subjects

Single doses,

6 mg/kg

18 mg/kg

36 mg/kg

Intravenous

Liquid

Placebo

Well tolerated

with all adverse

events mild or

moderate

GNC-003

CHANGE-MS

Phase IIb,

randomized,

placebo-controlled,

parallel-group,

270 RRMS

patients

Period 1: 4

cohorts in,

receiving either

placebo or

Liquid

Placebo

Well

tolerated

with all adverse

events mild or

moderate.

Source: GeNeuro.

GeNeuro SA – 2023 Universal Registration Document

Clinical Study

N°

Design

Subjects

Temelimab dose,

regimen, route of

administration

Formu-

lation

Placebo

compara

tor

Key results

24-week and 48

week completed

NCT02782858

multicenter study

with two treatment

periods in RRMS

patients: Period 1

(Day 1 to Day 169)

and Period 2 (Day

169 to Day 337).

Period 2 is

dose-blind with all

placebo patients

re-randomized to 1

of the temelimab

dose cohorts

temelimab i.v

every 4 weeks for

24 weeks with

69 subjects in the

placebo group and

67 subjects in

each of the

following

temelimab groups:

6 mg/kg, 12

mg/kg, and

18 mg/kg

Period 2: 3 cohorts

receiving

temelimab (same

doses as in Period

i.v.

every

4 weeks

for

24 weeks

Significant and

consistent

positive impact

key

neuroprotection

markers known

to be linked to

disease

progression.

GNC-004

ANGEL -MS

extension study

48 weeks

completed

NCT03239860

Two-year open-label

extension study to

GNC-003 in RRMS

patients; early

termination in

October 2018.

219 RRMS

patients

3 cohorts

receiving

temelimab at 6

mg/kg, 12 mg/kg

and 18 mg/kg i.v.

over 2 hours every

4 weeks until

optimal dose is

decided based on

GNC-003 results;

then all patients to

be shifted to this

dose

Liquid

none

Well

tolerated

with all adverse

events mild or

moderate.

Continued

positive impact

key

MRI

measures

disease

progression in

patients,

with

encouraging

dose-dependent

effects

clinical

measures

disease

progression.

GNC-301

RAINBOW

24-week,

extended to 48-

week,

completed

NCT03179423

Randomized

placebo-controlled

first-in-human

multicenter study

with temelimab in

T1D.

The first part of the

trial is double-blind

and the second part

is open-label with all

participants

receiving the active

treatment.

60 T1D

adult

patients

Period 1: 2

cohorts, receiving

either placebo or

temelimab i.v

every 4 weeks for

24 weeks with 20

subjects in the

placebo group and

40 subjects

temelimab 6

mg/kg group.

Period 2: open-

label with all

with

participants

receiving the

active treatment

Liquid

Placebo

Safety demon-

strated in

T1D

patients,

posi-

tive pharmaco-

dynamic signs

with decrease in

hypoglycaemia

frequencies and

anti-insulin

antibody levels

in patients treat-

temelimab

GNC-006

completed

Randomized

placebo-controlled

high-dose

pharmacology study

24 healthy

male

subjects

Single doses, 36

mg/kg, 60 mg/kg,

85 mg/kg, 110

mg/kg intravenous

Liquid

Placebo

Well

tolerated

with all adverse

events mild or

moderate

GNC-401

ProTEct-MS

48-week,

completed

NCT04480307

Phase IIa,

randomized, double-

blind, placebo-

controlled, parallel-

group, single center

study in RRMS

patients following

treatment with

rituximab

41 MS

patients

4 cohorts,

receiving either

placebo or

temelimab i.v

every 4 weeks for

48 weeks with

10 subjects in the

placebo group and

10 subjects in

each of the

following

Liquid

Placebo

Primary

endpoint was

met: results

confirm the

excellent safety

profile and

tolerability of

higher doses of

temelimab

administered

GeNeuro SA – 2023 Universal Registration Document

Clinical Study

N°

Design

Subjects

Temelimab dose,

regimen, route of

administration

Formu-

lation

Placebo

compara

tor

Key results

temelimab groups:

18 mg/kg, 36

mg/kg, and

54 mg/kg

concomitantly

with rituximab.

Efficacy data

showed that

temelimab has a

favorable impact

on key MRI

parameters

measuring

neurodegene-

ration.

GNC-402

extension study

of GNC-401,

closed

Phase IIa,

randomized, double-

blind, active

treatment, parallel-

group, single center

study in RRMS

patients following

treatment with

rituximab

33 MS

patients

Temelimab 18, 36

and 54 mg/kg

groups.

Patients from the

placebo arm of the

GNC-401 study

were re-

randomised in a

1:1:1 ratio to the

temelimab 18, 36

and 54 mg/kg

groups.

Liquid

None

None. The

GNC-402 study

was terminated

early because

the IMP

(temelimab) was

not available for

clinical supply,

following the

worldwide

shortage of

culture media

and supplies

due to the

COVID-19

pandemic

GNC-501

24-week,

on-going

NCT05497089

Phase 2,

randomized,

placebo-controlled,

double-blind,

multicenter study in

patients

experiencing

neuropsychiatric

symptoms and

functional

impairment in the

course of PASC –

Post-COVID

203 MS

patients

2 cohorts,

receiving either

placebo or

54 mg/kg

temelimab i.v

every 4 weeks for

24 weeks

Liquid

Placebo

Pending

A full description of the trials, excluding GNC-501, is available in the 2021 Universal Registration Document.

5.2.1 CHANGE-MS

5.2.1.1 Study design and objectives

GeNeuro conducted a double-blind placebo-controlled study, called CHANGE-MS, in patients with RRMS. The

study based the efficacy evaluation of the drug on MRI brain imaging. The primary objective was to assess the

efficacy of repeated doses of temelimab versus placebo in patients based on the cumulative number of Gadolinium-

enhanced T1 lesions on brain MRIs — a study end-point recommended by regulatory authorities for this

development phase of MS.³⁰The study also assessed pre-determined secondary objectives, among which:

(i) efficacy on other brain MRI end points; (ii) effect on the relapse rate; (iii) safety and tolerability of repeated doses

of temelimab; (iv)

pharmacokinetics of repeated doses of temelimab in a subgroup of patients; (v) identify an

optimal dose for Phase III studies based on efficacy and safety findings; (vi) study the pharmacodynamic response

on biomarkers, including W-ENV markers; (vii) assess the immunogenicity of temelimab; and (viii) assess the

health-related quality of life.

The study enrolled a total of 270 patients (please see the illustration below). Patients inclusion criteria were:

(i) RRMS according to the 2010 revised McDonald criteria; (ii) age between 18 and 55 years; (iii) present disease

activity characterized by at least one documented relapse within one year or one Gd-enhancing T1 lesion at

screening or evidenced within the last three months; and (iv) EDSS score less than 6.0. No other MS treatments

were provided during the study other than corticosteroids and symptomatic treatments such as fampridin.

The study was performed over two periods:

Source: EMA 2015.

GeNeuro SA – 2023 Universal Registration Document

Figure 3: Design of CHANGE-MS Study³¹

- Period 1 (weeks 1–24): a double-blind randomized,

placebo-controlled study with the following groups:

temelimab 6 mg/kg, 12 mg/kg or 18 mg/kg; or placebo

with a randomization ratio (1:1:1:1).

- Period 2 (weeks 25–48): extension where all

patients receive only active treatment. In Period 2,

patients from the placebo group were re-randomized

to temelimab 6 mg/kg, 12 mg/kg or 18 mg/kg

(randomization 1:1:1).

Temelimab was administered intravenously over a 2-

hour infusion in a glucose 5% solution bag at ~2

mL/min.

Centers located in the following countries participate

in the study: Bulgaria, Croatia, the Czech Republic,

Estonia, Germany, Hungary, Italy, Poland, Russia,

Serbia, Spain, and Ukraine. Fifty centers, mainly

university hospital centers, participated in the study.

The final 48-week results were announced in March

2018.

5.2.1.2 CHANGE-MS results

On August 28, 2017, GeNeuro announced the first results of CHANGE-MS as they became available. The first

output was the excellent safety profile of temelimab as can be seen in Table 2 below.

Table 2: CHANGE-MS safety results at 24 weeks

There was a very good balance in terms of frequencies of serious adverse events or events leading to

discontinuation among the different treatment groups and there was no evidence of more frequent or more severe

adverse events with higher doses of temelimab, comforting favorable safety results observed so far in the

development of temelimab.

Primary endpoint at 24 weeks: results on inflammatory end-points

The primary endpoint was not met and is presented in table below. Although the total number of lesions was reduced

by approximately 50% in the 18 mg/kg treatment group compared to placebo, after accounting for Baseline

imbalances, there were no statistically significant differences in the number of gadolinium enhancing T1 lesions

compared to placebo at 24 weeks for any active dose group.

Source: GeNeuro.

GeNeuro SA – 2023 Universal Registration Document

Table 3: main CHANGE-MS endpoints at 24 weeks

CHANGE-MS neuroprotection and remyelination endpoints at 48 weeks.

At 48 weeks, pre-specified, key secondary endpoints were assessed. For the second 24-week period, the group of

patients originally randomized to placebo and then (at week 24) re-randomized into the three active treatment arms

was used as the Control Group in the 48-week analyses.

Brain volume changes were analyzed for the whole brain and several cerebral structures. Benefits of temelimab

were seen, with less atrophy in the cerebral cortex and thalamus, with relative reductions of 31% and 72%

respectively between the 18 mg/kg (the highest dose studied) and Control Group, with a statistically significant

dose-relationship across treatment groups assessed by the Spearman correlation coefficient (p=0.045 for cortex

atrophy and p=0.014 for thalamic atrophy). For whole brain atrophy, there was a 29% relative reduction in brain

volume loss over 12 months for the 18 mg/kg group versus the Control Group. The Spearman correlation analysis

showed a trend for a dose-relationship (p=0.079).

Figure 4: CHANGE-MS brain volume changes

Importantly, the benefits observed were not dependent on

reducing inflammatory activity. As illustrated in the figure

below, the reductions in atrophy were at least as robust in

"non-active" patients (patients with no inflammatory

activity at baseline). This is evidence that the effect of

temelimab is mediated through its target cells (OPC and

microglia) and not through the modulation or suppression

of adaptive immunity. This is particularly important as the

critical unmet medical need in MS is to treat non-active

progressive patients, either because they progress while

taking existing, highly effective immunomodulatory DMTs,

or because they have reached the stage where adaptive

GeNeuro SA – 2023 Universal Registration Document

inflammation has a much lower influence on the course of

the disease (i.e. "non-active progressive MS").

The number of T1 hypointense lesions, or black holes,

was a key secondary measure of the study. The number

of new T1 black holes of at least 14mm3 volume (3mm

in diameter) was reduced by 63% at 48 weeks in the

18mg/kg versus the Control Group (pairwise

comparison p= 0.014). Reductions compared to the

Control Group were also observed at lower temelimab

doses. The figure below shows the average number of

black holes by treatment group at 48 weeks. These data

were supported by analyses of changes in T1 black hole

volume, which were smaller in the groups having

received temelimab throughout the 48 weeks of

CHANGE-MS compared to the Control Group with a

statistically significant dose-response effect (Spearman

correlation coefficient p = 0.030).

Magnetization

transfer

imaging

involves

the

measurement of the transfer of magnetization between

the free and bound proton pools in tissue. Images during

two sequences are subtracted leading to

magnetization transfer ratio (MTR) image, which is

proposed as a measure of myelin. Remyelination

following treatment with temelimab was measured by

MRI with magnetization transfer ratio (MTR) analyses

performed in the normal appearing white matter

(NAWM) and cerebral cortex of patients.

Recent studies have observed that there is a reduction in MTR signal in NAWM and cerebral cortex in patients with

MS versus controls, with a pathological gradient of MTR signal loss, as illustrated in the figure above. A decrease

of the MTR signal in the NAWM is associated with clinical disability³². Despite the variability inherent in a 50-center

MTR study, the Baseline data reproduced the pathological gradients observed in prior studies.

A benefit in Magnetization Transfer Ratio (MTR) signal for 18mg/kg dose group was observed in comparison with

the Control Group at 48 weeks, in both normal appearing white matter and cerebral cortex, consistent with a

potential benefit on myelin integrity. The table below presents the distributions and medians for MTR signal values

by treatment group at 24 and 48 weeks for normal appearing white matter (periventricular bands 1 to 3), showing

positive median changes in the 18 mg group (meaning that ≥ 50% of patients had an absolute increase in MTR

signal), while all other groups had a decrease in MTR signal, as would be expected in an MS patient population.

The results were consistent across all six normal appearing white matter and cerebral cortical bands.

Table 4: CHANGE-MS MTR results

Source: Traboulsee A, Dehmeshki J, Peters Kr et al. Disability in multiple sclerosis is related to normal appearing brain

tissue MTR histogram abnormalities Mult Scler 2003;9:566-73

GeNeuro SA – 2023 Universal Registration Document

For secondary endpoints related to MRI measures of neuroinflammation, patients in all treatment groups

improved from Week 24 to Week 48, however there was no significant separation between treatment groups. The

effect of temelimab on adaptive immune-mediated inflammation is not clinically relevant, and any reduction in

inflammatory activity does not appear to be responsible for the effects seen on neurodegenerative endpoints.

In terms of safety at 48 weeks, there were no organ-class specific toxicities and no dose dependent adverse events

were observed. As shown in Table 5 below, serious adverse events in general and those potentially related to the

treatment were infrequent and well balanced across treatment groups.

Table 5: CHANGE-MS safety results

Temelimab continued to show an excellent tolerability profile throughout the second part of the CHANGE-MS study.

5.2.2 ANGEL-MS Extension

ANGEL-MS (Assessing the W-ENV ANtagonist temelimab for Evaluation in an open label Long-term Safety Study

in Patients with MS) is an international long-term extension study of the Phase IIb Study GNC-003 (CHANGE-MS)

in patients with Relapsing Remitting Multiple Sclerosis (RRMS) with the primary objective of demonstrating the long-

term safety of monthly repeated doses of temelimab. The study was planned to last 96 weeks and patients

continued their temelimab treatment dose from GNC-003 (i.e. 6 mg/kg, 12 mg/kg or 18 mg/kg, administered

intravenously, with 4-week administration intervals). The primary endpoint is the long-term safety of temelimab,

based notably on adverse events (AEs) and clinical safety laboratory. The secondary objective is long-term efficacy

based on brain MRI markers, annualized relapse rate, disability, disease activity, EDSS and MSFC Scores.

5.2.2.1 ANGEL-MS Results

The study started on June 6th, 2017 and 219 patients in total enrolled, representing 94% of all patients who

completed the CHANGE-MS study. ANGEL-MS was fully funded by Servier and had an early termination due to

Servier's decision to end its partnership with GeNeuro, with all patients being offered end-of-study visits. Across

the two studies (CHANGE-MS and ANGEL-MS), a total of 154 patients received temelimab treatment for 96 weeks

or more. For patients not having completed 96 weeks, the end-of-study visit results were used in the analysis (last

observation carried forward). As there was no longer an administration of placebo during ANGEL-MS, to ensure

consistency, analyses of efficacy endpoints in ANGEL-MS were based on comparing the original groups in the

CHANGE-MS study: temelimab (18mg/kg, 12mg/kg, 6mg/kg) and Control Group (i.e. patients originally randomized

to placebo for 6 months in CHANGE-MS and re-randomized into the three active treatment arms for the last 6

months of CHANGE-MS).

Brain volume changes were analyzed on the whole brain and different anatomical locations, atrophy of the brain

and more specifically of certain of its parts such as the thalamus being often considered as a predictor of the

progression of disability. Benefits of temelimab were seen in a lower cortical and thalamic atrophy rate, with relative

volume loss reductions of 42% and 43% respectively between the highest dose of 18 mg/kg and the Control group,

with a dose-effect across treatment groups assessed by linear regression showing a trend value of p=0.058 for

cortical atrophy and a statistically significant value of p=0.038 for thalamic atrophy). Table 6 below presents the

evolution of median thalamic atrophy by time and by treatment groups since the original baseline of CHANGE-MS.

In terms of safety at 96 weeks (CHANGE-MS + ANGEL-MS), there were no organ-class specific toxicities and no

dose dependent adverse events observed. As shown in Table 6 below, serious adverse events in general and those

potentially related to the treatment were infrequent and well balanced across treatment groups. Temelimab

continued to show an excellent tolerability profile throughout the second part of the study.

GeNeuro SA – 2023 Universal Registration Document

Table 6: ANGEL-MS safety results

In order to ensure consistency, analyses of efficacy endpoints in ANGEL-MS were based on comparing the original

randomized groups from the CHANGE-MS study: temelimab (18mg/kg, 12mg/kg, 6mg/kg) and Control Group (i.e.

patients originally randomized to placebo for 6 months in CHANGE-MS and re-randomized into the three active

treatment arms for the last 6 months of CHANGE-MS).

Further, in order to examine the robustness of the efficacy analyses, several sensitivity analyses were performed.

First by dose groups, i.e. by the randomized dose received in ANGEL-MS, irrespective of time treated. Then by

absolute dose received, separating the total dose of temelimab into quartiles, irrespective of body weight or

randomized dose group. And finally separating the patients having received 18mg/kg during 96 weeks against all

other treatments. No corrections were performed for multiple testing.

Overall, the ANGEL-MS data confirmed that treatment with temelimab for 2 years had a continued, positive impact

on key MRI-based paraclinical measures, associated with disease progression in multiple sclerosis, extending the

data reported at Week 48 in the CHANGE-MS study. These include reductions in brain atrophy (notably in the

cerebral cortex and thalamus) and maintenance of myelin integrity, as measured by magnetization transfer ratio

(MTR) imaging. Importantly, for the first time, encouraging dose-dependent effects were seen on clinical measures

of disease progression.

In terms of MRI measures of neuroinflammation, all groups improved with treatment, however no significant

separation between treatment groups was observable. The effects of temelimab are unlikely to be driven by an anti-

inflammatory effect.

Effects of temelimab on brain atrophy measures observed in CHANGE-MS were confirmed in ANGEL-MS after

96 weeks of total treatment. As illustrated in Figure 5 and Figure 6 below, this was notable in the cerebral cortex

and thalamus, with relative reductions in volume loss of 42% and 43%, respectively, between the 18 mg/kg (highest

dose studied) and Control Group, with a trend for a dose-response across treatment groups for cortical atrophy

(p=0.058) and a statistically significant dose-response for thalamic atrophy (p=0.038).

GeNeuro SA – 2023 Universal Registration Document

Importantly, and for the first time, encouraging, dose-dependent effects were seen on clinical measures of

disease progression. This was as measured by a lower proportion of patients with 12-week confirmed EDSS

progression, or with 20% worsening in Timed 25-Foot Walk from Baseline of CHANGE-MS to week 96 (or end-of-

study) in ANGEL-MS.

A lower probability of 12-week confirmed disability progression in the 18 mg/kg group versus all other groups is

illustrated in Figure 10 below.

Figure 10: ANGEL-MS probability of disease progression

When pooling all groups against the 18mg/kg group, the result nearly reaches statistical significance. However, the

cohort of patients is small, as the study was not designed to examine disability progression, and the number of

events recorded is also very low. Therefore, although encouraging, these results are not conclusive.

Also encouraging, and consistent with the EDSS data, is the proportion of patients with a worsening of > 20% or

more in the Timed 25-Foot Walk Test when comparing CHANGE-MS Baseline to the end of ANGEL-MS, as may

be seen in Table 7 below.

Table 7: ANGEL-MS proportion of patients with worsening >20% of Timed 25-foot walk

Fifteen patients with extreme walking disability removed from analysis –for whom the test was

almost impossible to perform – excluded patients distributed equally across treatment groups

** Fisher exact test

At 96 weeks of treatment, a lower proportion of patients in the 18mg/kg group experienced a clinically relevant

worsening, than in any other group, with statistical significance of p=0.03. All of the sensitivity analyses performed

confirmed the results, as illustrated in Table 8 below.

Table 8: ANGEL-MS – sensitivity analysis of proportion of patients with worsening >20% of Timed 25-foot walk

Fifteen patients with extreme walking disability removed from analysis –for whom the test was almost impossible to

perform – excluded patients distributed equally across treatment groups

** Fisher exact test

GeNeuro SA – 2023 Universal Registration Document

The same caution as above holds true, but these results at 96 weeks appear to indicate that the positive effect

observed in MRI measures may translate into a clinical benefit.

Overall at 96 weeks of temelimab treatment, there was a consistent and sustained benefit with temelimab at the

dose of 18mg/kg on key independent markers of neurodegeneration, such as thalamic, cortex and whole brain

volumes, as well as MTR in cortical and normal appearing white matter. These markers are linked to long term

disease progression and worsening of disability in MS. Importantly, for the first time, encouraging dose-dependent

effects were seen on clinical measures of disease progression. This has been evidenced by a lower proportion of

patients with 12-week confirmed EDSS progression, or with 20% worsening in 25-foot timed walk. Moreover,

temelimab appeared safe during the whole duration of the trial.

These results are coherent with the pre-clinical knowledge to date on the mechanisms of action of W-ENV and of

temelimab.

5.2.3 GNC-401 (ProTEct-MS) Study: confirmation of safety of higher doses of temelimab and synergistic

potential to address neurodegeneration on top of anti-inflammatory treatment

Temelimab was used as a monotherapy in the one-year CHANGE-MS trial and its one-year ANGEL-MS extension.

The primary endpoint of CHANGE-MS at 6 months was not met (reduction of cumulative number of gadolinium

(Gd)-enhancing T1 lesions from week 12-24 in temelimab groups (6, 12, and 18mg/kg) compared with placebo).

However, at one year already, patients originally randomized to temelimab 18mg/kg in CHANGE-MS showed

evidence for relative improvements in MRI-measured neurodegenerative outcomes such as brain volumes, MTR

and blackholes during CHANGE-MS, compared to all other groups. The ANGEL-MS one-year extension confirmed

and enlarged the observed relative improvements in MRI-measured neurodegenerative outcomes. It also

demonstrated that temelimab is safe to use and well tolerated for a prolonged period. These data suggested a

possible neuroprotective effect of temelimab and supported further clinical development towards a treatment for

progression of MS-disability.

The key questions left open by the CHANGE-MS and ANGEL-MS trials were related to the MS population treated

and to the dose used:

•

In the earlier trials, temelimab was used as a monotherapy in an active RRMS population. However, today

the majority of patients in developed countries receive an effective therapy against inflammation and, while

approved anti-inflammatory therapies only have a modest impact on long-term disability progression, a

treatment against neurodegeneration could only be administered on top of existing therapies, in order to tackle

both inflammation and neurodegeneration.

The question was therefore whether temelimab's effect would still be visible and coherent with

previous results in combination with a potent anti-inflammatory drug and in a population whose

disability progresses.

•

In the earlier trials, 18mg/kg was the dose providing robust results, while the lower doses had little or no

impact on the above-described measures. As temelimab is well tolerated and could be used at higher doses,

there was uncertainly whether GeNeuro had found the "maximally effective minimal dose", which is a key

requirement before launching a Phase III.

The question was therefore whether a higher dose of temelimab would be confirmed as safe in a

treated population and provide additional efficacy signals.

The ProTEct-MS study was designed to answer these two questions. As described by Prof. Fredrik Piehl, Professor

of neurology, Karolinska Institutet in Stockholm, Sweden, and Principal Investigator of the study, at MS Virtual 2020,

"Because temelimab has no significant anti-inflammatory effect, combination with a highly effective DMT, such as

an anti-CD20-antibody, to protect against new focal neuroradiological disease activity is likely needed to properly

explore temelimab's tissue protective, anti-neurodegenerative effect: This represents the rationale for the ProTEct-

MS study."

This study was a Phase IIa, single-center, randomized, double-blind, placebo-controlled, parallel-group, study in 41

RRMS patients following treatment with rituximab.

Four cohorts of patients received (following treatment with rituximab) either placebo or temelimab i.v every 4 weeks

for 48 weeks with 10 subjects in the placebo group and 10 subjects in each of the following temelimab groups: 18

mg/kg, 36 mg/kg, and 54 mg/kg.

Figure 11: ProTEct-MS design

GeNeuro SA – 2023 Universal Registration Document

5.2.3.1 ProTEct-MS Results

On October 27, 2022, GeNeuro presented the primary analysis of the Phase 2 ProTEct-MS study at the European

Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2022) Congress in Amsterdam,

Netherlands. This study was performed in Stockholm, Sweden, at the Karolinska Institutet's Academic Specialist

Center in Stockholm under the leadership of Prof. Fredrik Piehl:

•

The primary endpoint of the ProTEct-MS study was met, with results confirming the excellent safety profile

and tolerability of higher doses of temelimab administered concomitantly with an anti-CD20 treatment, a high-

efficacy anti-inflammatory drug. The drug was well tolerated with no treatment related discontinuations, no

serious or severe treatment emergent adverse events, and no differences in overall clinical or laboratory

safety findings, which meets the primary endpoint of the study.

•

Efficacy data, obtained in this patient group already effectively treated against inflammation, showed that

temelimab has a favorable impact on key MRI parameters measuring neurodegeneration, which showed a

positive impact of temelimab in preserving neocortical anatomy and myelin integrity. The effect sizes were of

comparable magnitude to those previously observed in the prior CHANGE-MS and ANGEL-MS trials in

patients without an anti-inflammatory treatment.

•

New exploratory data on soluble biomarkers also showed favorable impact on measures of

neurodegeneration at one year: the study showed a reduction of GFAP biomarkers in cerebrospinal fluid

(CSF). GFAP is a biomarker for astrocytic activation associated with diffuse neuroaxonal damage leading to

MS disease progression. The results on these CSF biomarkers confirm the synergistic potential to treat

neurodegeneration with temelimab in addition to a high-efficacy anti-inflammatory therapy in MS.

•

The analysis of the data now also allows GeNeuro to determine the optimal dose for future temelimab trials

in MS, in conjunction with potential partners.

The analyses of efficacy endpoints showed a favorable impact of temelimab in preserving neocortical anatomy and

myelin integrity. The effect sizes were of comparable magnitude to those previously observed in the CHANGE-MS

and ANGEL-MS trials. The combined treatment of temelimab and rituximab protected against loss of cortical

thickness by more than 50% relative to rituximab alone. Furthermore, cortical tissue integrity, as measured by

magnetization transfer saturation, was improved with temelimab, potentially reflecting remyelination.

GeNeuro SA – 2023 Universal Registration Document

Figure 12: Impact on measures of cortical atrophy and myelin integrity

Benefits were also seen in soluble biomarkers of damage to nervous system cells

Figure 13: Biomarkers of damage to nervous system cells

The observed trends on MRI measures of neurodegeneration were consistent with CHANGE-MS and ANGEL-MS

results, but this time in a population of patients already treated with a highly effective anti-inflammatory drug. There

were favorable treatment effects on top of rituximab in all volume measures. The results in MTSat were also

favorable in Cortex, but not in NAWM. As expected, there were no relevant clinical signal given the size of the

patient cohorts and the one-year treatment duration.

The observed effect sizes are relevant (20-50%) in arms treated with temelimab versus rituximab alone, which

provides the expectation of yielding a clinical benefit in larger and longer trials. PK analysis and other are still

pending to define optimal fixed dose for future temelimab trials in MS. Since there was no clear advantage of higher

doses than 18mg/kg, and all doses were very well tolerated, the analysis of the data now also allows GeNeuro to

determine the optimal dose for future temelimab trials in MS, in conjunction with potential partners.

The ProTEct-MS trial provides an important step forward for temelimab in its path to treat MS patients in whom

disability progresses despite effective control of inflammation and relapses. Despite progresses made, the need to

address neurodegeneration and its associated disease progression remains a huge opportunity in MS.

ProTEct-MS has shown that temelimab could bring additional benefits on key markers of neurodegeneration in a

population of MS patients already treated with a highly effective anti-inflammatory drug. The data show the

synergistic potential of targeting neurodegeneration with temelimab on top of inflammation, by seeking to boost

myelin repair mechanisms and to block damaging mechanisms. This opens the path for future combination

treatments addressing both relapses and disability progression, a novelty in MS.

During ProTEct-MS, GeNeuro had initiated an extension study aimed at providing treatment to patients having

completed their treatment duration, until the results of the trial were available. The study was closed at the end of

April 2022.

GeNeuro SA – 2023 Universal Registration Document

5.3 Continued Clinical Development in MS

The 48-week results of the CHANGE-MS study and the 96-week results of the ANGEL-MS extension trial (resulting

from the addition of the 48-week CHANGE-MS study and the 48-week of the ANGEL-MS study) both showed that

the 18 mg/kg dose induced a positive response for neuroprotection markers such as brain volumes, black holes

and MTR, and showed encouraging dose-dependent effects on clinical measures of disease progression. In

addition, the safety profile over 96 weeks of temelimab at all tested doses appeared very favorable. The positive

results of the ProTEct-MS trial show that temelimab's pathway is synergistic with anti-inflammatory treatments and

opens the way towards combination treatments for MS patients in whom disability progresses despite effective

control of inflammation and relapses. Based on these results, temelimab may provide a safe treatment option

enhancing neuroprotection in all forms of the disease, that could result in the reduction of the disability progression,

which is the key unmet medical need in MS. Accordingly, GeNeuro has resumed discussions with potential partners

to define the best development path combining temelimab and anti-neuroinflammatory treatments to bring the

synergistic benefits of temelimab to patients.

Regulatory authorities, such as the FDA, and the MS community have clearly identified "progression without

relapses" as the urgent medical need in MS. GeNeuro's temelimab results indicate a true potential in this area

where there is no medication available, and thus has a wide number of options on how to continue development in

MS. Yet developing a drug against progressive forms of MS is a complex endeavor, as patients' condition evolves

slowly over time, and clinical trials require large cohorts treated for long periods of time.

Inclusion criteria for such

trials aiming at having homogenous patient populations are a key success factor.

Given the high costs of the international clinical trials necessary to confirm efficacy and register a product in MS

with both the FDA and the EMA, which the Company estimates to exceed €100 million, continued development in

MS requires a partnership and, following the results from the ProTEct-MS trial, the Company has reactivated

partnership discussions for the MS indications.

5.4 Post-COVID

GeNeuro is not pursuing development in acute COVID-19, where a broad range of vaccines, anti-viral drugs

and other treatments are not available to prevent and treat patients, but if focusing its efforts on Post-

COVID, also called Long-COVID or PASC (Post Acute Sequelae of COVID-19).

Origin and prevalence

COVID-19 was the most severe global pandemic since the influenza pandemic of 1918. As of January 2024,

according to the World Health Organization (WHO) there have been more than 770 million confirmed cases and

almost 7 million global deaths from COVID-19. Almost four years after the onset of this pandemic, although the

majority of patients infected with SARS-CoV-2 recover within a few weeks, post-COVID is estimated to occur in as

many as 10% of COVID-19 cases and affects people of all ages, including children, with most cases occurring in

patients with mild acute illness. The consequence is widespread global harm to people's health, wellbeing, and

livelihoods—an estimated one in ten people who develop long COVID stop working, resulting in extensive economic

losses.

Current knowledge about post-COVID-19, PASC (Post Acute Sequelae of COVID-19), or "Post-COVID", as well as

about COVID-19 itself, is as recent as these conditions and continues to evolve almost on a daily basis.

Post-COVID collectively refers to the constellation of long-term symptoms that some people experience after

contracting COVID-19. A January 2023 publication in Nature Reviews Microbiology estimated that at least 65 million

people worldwide now suffer from post-COVID. According to WHO Europe (the European Regional Office of the

World Health Organization), 36 million patients in the European Union (8% of the total EU population and 13% of

the confirmed COVID-19 cases in the EU) are affected by Post-COVID/PASC. In France alone, according to a

December 2023 report from the National Academy of Medicine , around 2 million people are thought to be affected

by post-COVID in France, out of a total number of SARS-Cov-2 infections in excess of 40 million.

ii)

Major findings

The onset and time course of symptoms differ across individuals and by symptom type. Neurological symptoms

often have a delayed onset of weeks to months: among participants with cognitive symptoms, 43% reported a

delayed onset of cognitive symptoms at least 1 month after COVID-19, with the delay associated with younger age

. Several neurocognitive symptoms worsen over time and tend to persist longer, whereas gastrointestinal and

respiratory symptoms are more likely to resolve.

Few people with long COVID demonstrate full recovery, with one study finding that 85% of patients who had

symptoms 2 months after the initial infection reported symptoms 1 year after symptom onset. Future prognosis is

uncertain, although diagnoses of ME/CFS and dysautonomia are generally lifelong.

GeNeuro SA – 2023 Universal Registration Document

The scientific community has emitted several hypothesized mechanisms for Post-COVID pathogenesis, including:

immune dysregulation,

microbiota disruption,

autoimmunity,

clotting and endothelial abnormality,

and dysfunctional neurological signaling.

GeNeuro's approach is based on the hypothesis of immune dysregulation: in 2021, results published in the Lancet

journal EBioMedicine

showed the presence of the W-ENV protein on lymphocytes of hospitalized patients with

COVID-19. These same results indicate a correlation between the level of expression of the protein and the severity

of the disease. In addition, recent data showed that SARS-CoV-2 was able to induce in vitro expression of W-ENV

in human blood cells from approximately 20% of healthy volunteers .

The expression of the pathogenic W-ENV protein triggered by SARS-CoV-2 infection can continue long after the

resolution of the acute phase and may play a major role in the persistence of neurological and psychiatric

syndromes in many post-COVID patients.

Studies conducted on cohorts of several hundred European and American post-COVID patients have detected the

presence of the W-ENV protein in over 25% of these patients .

W-ENV is found in specific disease situations, and its presence is always tied to negative disease outcomes for the

patient. The pro-inflammatory effects of W-ENV are mediated through the activation of the TLR4 innate immune

receptor, a pathway closely associated with some of the key features of COVID-19, such as hyper-activation of

immune functions, endothelial cell activation, vasculitis as well as coagulopathy. W-ENV has mostly been studied

in neurodegenerative diseases, with widely observed pathogenic effects on peripheral and central nervous system

cells. After the primary SARS-CoV-2 infection is over, if W-ENV has reached a self-fueling expression level, it could

cause persistent damage to endothelial cells in blood vessels and also to cells from the peripheral and central

nervous system, which could explain many of the long-term neurological symptoms experienced by patients long

after SARS-CoV-2 infection.

iii)

Current treatments

There are currently no specifically approved or broadly effective treatments for post-COVID, but treatments for

certain components have shown some efficacy for subsets of populations.

GeNeuro is at the forefront of addressing this issue with the first personalized medicine clinical trial against post-

COVID, evaluating temelimab as a disease-modifying therapy in post-COVID patients presenting severe

neuropsychiatric symptoms hampering their pursuit of daily living and professional activities and who are positive

for the pathogenic protein W-ENV in their blood.

Temelimab has already been approved in Spain, Italy and Switzerland to conduct Phase 2 clinical trials to evaluate

the efficacy and safety of this treatment in patients with cognitive impairment ("brain fog") and severe fatigue and

in whom the presence of W-ENV protein in the blood can be confirmed by a serum test.

The GNC-501 study, entitled "Temelimab as a Disease Modifying Therapy in Patients with Neurological,

Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19 (PASC)

Syndrome", has enrolled 203 patients from European and Swiss clinical centers. The ongoing study has enrolled

only those patients who also test positive for the pathogenic protein W-ENV, to have a personalized medicine

approach. From the 1'092 patients who were screened to participate in the study, 36% were positive to W-ENV.

Participants will receive intravenous (IV) temelimab at a dose of 54 mg/kg every 4 weeks for 6 months, or placebo,

both in addition to standard-of-care treatment. The study's primary endpoint is the occurrence of an improvement

in fatigue, measured by a decrease of ≥3 points in the Patient-Reported Outcomes Measurement Information

System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) score, at Week 24 as compared to baseline endpoint.

Secondary endpoints aim to evaluate the efficacy of treatment with temelimab plus local Standard of Care (SoC)

treatment versus local SoC alone over 6 months on measures of cognition, fatigue, anxiety, depression, functional

impairment/disability, and quality of life in PASC patients, and other safety and W-ENV biomarkers. The study

incorporates a built-in interim analysis for safety, futility, or overwhelming efficacy; in December 2023, the

Independent Data Monitoring Committee (IDMC) met to review the unblinded safety and efficacy data of the first 90

patients after three months of treatment and, based on the planned interim analysis of efficacy and safety data,

which included an analysis for futility, the IDMC recommended to "continue the trial without any modifications.

Recruitment started at the end of 2022 and was completed at the end of November 2023, and results are now

expected by the end of June 2024.

GeNeuro SA – 2023 Universal Registration Document

5.5 The HERV Platform in other indications

Recent biomedical research is showing that most chronic conditions affecting human beings are the consequence

of a combination of factors that include genetic, hormonal, and environmental triggers. HERVs belong to this modern

view of disease, acting through the combination of genetic predisposition and external factors to become reactivated

and acting directly as causal agents for disease.

Over 26 families of HERVs have been identified and GeNeuro believes that they represent factors for chronic,

multifactorial diseases with an autoimmune component. Developing the knowledge of the role played by HERV

proteins in such diseases makes it possible to envision the development of therapies for many diseases for which

there are currently no satisfactory treatments.

GeNeuro has focused its research on the HERV proteins W-ENV and HERV-K ENV and has established

relationships with third-party research groups studying this protein and other HERV proteins in different diseases.

5.5.1 Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis ("ALS") is a devastating motor neuron disease that occurs most often as a sporadic

disease with no known cause or inheritance pattern. It was first described by the French neurologist Jean-Martin

Charcot. The name ALS reflects both the degeneration of corticospinal motor neurons, the descending axons of

which show altered structure in the lateral spinal cord (lateral sclerosis) and the demise of spinal motor neurons,

with secondary denervation associated with muscle wasting (amyotrophy). ALS is a rapidly progressive and

ultimately fatal neurodegenerative disease resulting from motor neurons degeneration in the cerebral motor cortex,

the brainstem and spinal. ALS can affect people of any age, but usually starts around the age of 60 and in inherited

cases around the age of 50. The average survival from onset to death is three to five years. According to research

by the ALS Association, a little over 5,000 people in the U.S. are diagnosed with ALS each year, as many as 20,000

Americans have the disease at any given time and as many as 150'000 worldwide³³. About 10% of ALS cases

appear to be genetically transmitted in families (hereditary ALS) in association with specific genomic mutations

whereas 90% are sporadic³⁴. ALS is also considered a multisystem neurodegenerative disorder that can include

cognitive and behavioral changes in addition to muscle weakness.

Today, there is no cure for ALS. There are three current approved medications that may extend life by a few months

but do not strop the process of motor neuron death and do little to treat the underlying cause of ALS. Costs

associated with ALS are greater than that of other neurological diseases, indicating a continued need for medical

advances and financial support for patients and families. Most patients with ALS condition die from respiratory

failure.

Increased reverse transcriptase (RT) activity was found in the serum of ALS patients, which led to the speculation

that RT activity may derive from inherited active human endogenous retroviruses (HERVs). HERVs represent 8%

of the human genome

and the HERV-K family comprises recently integrated copies in the human genome.

Sequencing studies revealed that HERV-K sequences are more frequently expressed in patients with ALS

compared to controls³⁵. HERV-K gag- pol and env RNA have significantly elevated expression in brains from ALS

patients compared to controls.

Dr. Nath, Clinical Director of the National Institute of Neurological Disorders and Stroke ("NINDS"), part of the U.S.

National Institutes of Health ("NIH"), and his research group have discovered the expression and the pathogenic

effects of the envelope protein from HERV-K in ALS³⁶. Their research has evidenced that:

pathogenic HERV-K ENV proteins are expressed in the brains of ALS patients, and observed in the

anterior horn of the spinal cord, the site of lower motor neurons that degenerate in ALS³⁷.

HERV-K RT expression correlates with TDP-43 (TAR - transactivation responsive- DNA binding protein

43) deposits which are thought to be critical in motor neuron degeneration and are considered the final

hallmark of ALS³⁸

HERV-K ENV induces toxicity in human motor neurons in vitro. Transgenic mice expressing the HERV-K

ENV gene developed an ALS-like motor neuron dysfunction and develop profound weakness of the limbs

and spinal muscles, including those for respiration, resulting in 50% mortality by 10 months. These signs

of motor dysfunction observed in transgenic mice expressing HERV-K ENV support the pathophysiological

role of HERV-K ENV in this disorder³⁹

33 Sources: alsa.org, arsla.org

34 Source : NIH Amyotrophic Lateral Sclerosis (ALS) Fact Sheet.

35 Source: Douville, Liu et al. 2011, Douville and Nath 2014

36 Source: Li W, Lee MH, Henderson L, et al. Human endogenous retrovirus-K contributes to motor neuron disease. Sci Transl

Med. 2015 Sep

37 Source: Douville R et al. Ann Neurol. 2011; Alfahad et al. Antiviral Res. 2013; Li et al. ibid; Dolei A et al. Int J Mol Sci. 2019

38 Source: Manghera M et al. Neurobiol Dis, 2016; Li et al. ibid; Krug et al. PLoS Genet. 2017; Chang et al. Curr Biol. 2019

39 Source : Li et al, ibid

GeNeuro SA – 2023 Universal Registration Document

HERV-K ENV expression appears to be specific to ALS, since it could not be found in patients with MS,

Parkinson's or Alzheimer's disease⁴⁰.

The possibility that HERV-K plays a crucial role in the pathophysiology of ALS could explain why several

researchers have detected RT in ALS brain and blood samples, but have not been able to demonstrate human-to-

animal or human-to-human transmission of the disease, because HERVs arise from the genome and not from the

environment. Further, it may also explain the anatomical spread of the illness through paracrine activation of

permissive autologous cells, which generally starts in one region of the body and then spreads along an anatomical

pathway⁴¹.

Taken together, these findings suggest that endogenous retroviral elements and HERV-K in particular are involved

in the pathophysiology of ALS and could be the missing link between TDP43 and ALS⁴². Thus, HERV-K ENV protein

expression within neurons of patients with ALS may contribute to neurodegeneration and disease pathogenesis.

In February 2017, GeNeuro signed a Cooperative Research and Development Agreement ("CRADA") with the

NINDS to develop novel therapeutic antibodies for the treatment of amyotrophic lateral sclerosis. The research has

evaluated the ability of these antibodies to neutralize a potential causal factor of ALS, the envelope protein of HERV-

K (a family of Human Endogenous Retroviruses, HERVs). Under the terms of the agreement, GeNeuro provided

antibodies designed to block the activity of HERV-K Envelope protein. These candidate antibodies were tested in

cellular and animal models of HERV-K associated ALS by the NINDS, and have achieved preclinical proof-of-

concept of this novel therapeutic avenue addressing ALS pathogenesis.

Following the positive results of this pre-clinical work, GeNeuro has in October 2018 entered into an agreement

with the NIH granting GeNeuro an exclusive license on the jointly owned HERV-K patent. Based on this, the

Company has now launched a preclinical development program for its GNK301 HERV-K ENV antibody, a high

quality preclinical humanized mAb that is now ready for GMP production. In October and December 2021, the

NINDS and GeNeuro presented novel pre-clinical results of their joint ALS preclinical research program. These

results:

•

confirm that HERV-K ENV is present in the cerebro-spinal fluid of sporadic ALS patients;

•

elucidate the pathogenic effect of HERV-K ENV on motor neurons; and

•

show in preclinical models the therapeutic potential of GeNeuro's specific anti-HERV-K ENV antibody.

This joint NINDS/GeNeuro study has unveiled and characterized new pathogenic mechanism and has shown the

specific and efficient inhibition of HERV-K ENV neurotoxic effects from the extracellular medium in vitro and in vivo,

using GeNeuro's anti HERV-K K01 monoclonal antibody. This novel preclinical data holds promises that neutralizing

HERV-K ENV with GeNeuro's antibody could become a treatment option for patients with sporadic ALS and

GeNeuro's preclinical development program has enabled its anti-HERV-K ENV antibody to now be humanized and

ready to enter GMP manufacturing. Subject to funding, the program could start clinical trials as early as 2023. Based

on its current resources, the Company has decided to open active partnership discussions for this program.

40 Source: Li et al, ibid.; Arru et al. Eur J Neurol. 2018; Douville et al. ibid

41 Source: Kury, Nath, et al. 2018

42 Source: Alfahad et al, ibid

GeNeuro SA – 2023 Universal Registration Document

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Frontiers in Genetics July 2019

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Retroviruses in Neurological Diseases". Trends in Molecular Medicine In Press

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focus on the interferon-gamma inducible chemokines and their receptor". Curr Pharm Des 17:3202-16.

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GeNeuro SA – 2023 Universal Registration Document

5.6 Research And Development and Intellectual Property

The Company engages in research and development activities to develop:

•

new therapeutic products, especially monoclonal antibodies, for the treatment of diseases associated with

the expression of HERVs;

•

diagnostic products to act as companions for the therapeutic products; and

•

novel solutions for the study and treatment of HERV diseases.

GeNeuro files patent applications to protect its product candidates, technical processes and the processes used to

prepare its product candidates, the compounds or molecules contained in these product candidates and medical

treatment methods. GeNeuro also licenses rights to patents owned by third parties or jointly owned with third parties.

By 2006, the Mérieux group and INSERM had accumulated 15 years of work on HERVs, which led to a broad

intellectual property portfolio. GeNeuro has taken exclusive licenses to and/or holds 17 patent families offering

strong coverage of the W-ENV field, ranging from DNA sequences to products and their therapeutic applications,

plus one patent in the HERV-K field. GeNeuro's portfolio of patents is divided into four broad categories:

•

the "SEP 16" patent family covers W-ENV sequences necessary for the preparation of an antibody,

particularly an antibody targeting the identified sequences. Patents in this category have been granted in all

major markets and are owned by bioMérieux and INSERM. GeNeuro holds an exclusive license to such

intellectual property for therapeutic uses. These patents include HERV-W fusion, SEP 6, SEP 12, SEP 13,

SEP 15, SEP 16, SEP 18, SEP 19, SEP 20, SEP 21, and the INTERECO families described below;

•

the "TLR4" patent family broadly covers the use of any antibody targeting W-ENV in MS and other

neurological indications. This patent, described below, was granted in all principal markets and is owned by

bioMérieux and INSERM. GeNeuro has an exclusive license to such intellectual property for therapeutic uses;

•

the "MSRV ligand" patent family covers specific epitopes and antibodies against such epitopes (including

GeNeuro's first product candidate) and their use in a broad spectrum of therapeutic indications, including MS,

CIDP, and T1D. The basic patent, dating from 2009, was granted in the United States and is still pending in

Europe. GeNeuro has filed several patents thereafter on its products, the most recent dating from 2014.

GeNeuro owns these patents. These patents cover the MSRV ligand, and the endogenous antiviral,

remyelination, and the anti-TM family of antibodies described below;

•

the "antipsychotic treatment" patent covers an anti-HERV-W envelope protein antibody for use in the

treatment of psychotic diseases, and

•

the "HERV-K" patent, which covers the anti-HERV-K Envelope antibody and uses thereof.

Based on more than 25 years of work in the field and a systematic effort to optimize and develop intellectual

property, GeNeuro believes that its portfolio of intellectual property and its constant efforts to protect new

discoveries put the Company in a strong competitive position.

The term of individual patents depends upon the legal term of patents in the countries in which they are obtained.

In most countries, including the United States, the patent term is 20 years from the earliest claimed filing date of a

non-provisional patent application or its foreign equivalent in the applicable country. In the United States, a patent's

term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for

administrative delays by the USPTO in examining and granting a patent, or may be shortened if a patent is terminally

disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration

date. In the United States, a patent may also be eligible for limited patent term extension under the Drug Price

Competition and Patent Term Restoration Act of 1984 (see Section 9.1.9 of this Universal Registration Document).

For information on the accounting for costs related to research and development activities, please refer to section

7.2.1.2 "Operating Expenses by Function", as well as to notes 2, 10, 12 and 14 of the consolidated financial

statements for the year ended December 31, 2023 in Chapter 18 of this Universal Registration Document.

GeNeuro SA – 2023 Universal Registration Document

5.6.1 Intellectual Property

The table below summarizes the patent families to which the Company has obtained or has rights.

Table 9: Patent families

Patent Family

Name

Owners/Holder(s)

Family 1

MSRV Ligand

GeNeuro

Family 2

Endogenous antiretroviral

GeNeuro

Family 3

Remyelination

GeNeuro

Family 4

SEP 16

bioMérieux

Family 5

TLR4

bioMérieux & INSERM

Family 6

SEP 12

bioMérieux

Family 7

SEP 15

bioMérieux

Family 8

SEP 18

INSERM

Family 9

INTERECO

bioMérieux

Family 10

AntiTM antibody

GeNeuro

Family 11

HERV-W fusion

bioMérieux & INSERM

Family 12

SEP 6

bioMérieux

Family 13

SEP 13

bioMérieux

Family 14

SEP 19

bioMérieux

Family 15

SEP 20

bioMérieux

Family 16

SEP 21

bioMérieux

Family 17

Antipsychotic Treatment

GeNeuro

Family 18

HERV-K antibody in ALS

GeNeuro and the NIH, with exclusive license

to GeNeuro on jointly owned IP

5.6.1.1 Summary of Patent Families by Products

Antibodies directed against SU region of the ENV envelope protein of MSRV

The Company holds intellectual property rights to the monoclonal antibody being developed at the clinical stage:

•

the use of an anti-ENV-SU antibody capable of binding specifically to the soluble fraction of the Env protein

of MSRV (Family 5);

•

ligands, more specifically an antibody, including sequences corresponding to specific CDRs of the Env

envelope protein for MSRV (Family 1);

•

the use of such ligands in the treatment of MS, schizophrenia, CIDP, epilepsy, psoriasis, cancer, inflammatory

pancreatitis and, diabetes, in particular T1D (Family 1);

•

the use of an antibody against the envelope protein of HERV-W/MSRV, its fragment, and its derivatives as a

global antiretroviral agent (Family 2); and

•

the use of an antibody directed against HERV-W/W-ENV for its use in the prevention of a blockage of the

capacity for repairing myelin (Family 3), particularly in pathologies such as RRMS, chronic progressive MS,

CIDP, and schizophrenia or bipolar disorders.

MSRV Genetic Sequences

The Company is licensed under several patent families that cover genetic sequences of MSRV, including:

•

the Env gene sequence of MSRV (Family 4), as well as the Env gene sequence of the endogenous retrovirus

HERV-7q. (Family 8); and

•

the gag and pol gene sequences of MSRV (Family 6).

Therapeutic product

The Company holds a license to a patent family that covers a compound that consists of a therapeutic agent capable

of inhibiting superantigenic activity and the use of such compound for prophylaxis and/or treatment of a disease,

particularly an autoimmune disease such as MS (Family 16).

Diagnostic method

The Company holds a license to two patent families that cover methods for detecting the expression of an envelope

protein of an endogenous retrovirus (Family 11) and to detecting the MSRV-1 retrovirus (Family 15).

GeNeuro SA – 2023 Universal Registration Document

The Company also holds a license to a patent family that covers a composition of two pathogenic agents and/or

infectants associated with MS and which are useful in diagnostic or treatment methods, particularly for MS (Family

12).

The Company holds a license to a patent family that covers nucleic material capable of being used in a diagnostic

method, a prophylaxis method, or a method for treating MS or rheumatoid polyarthritis (Family 13).

The Company also holds a license to a patent family that covers an endogenous nucleic fragment that includes at

least a part of the gag gene of an endogenous retrovirus and which is useful for detecting autoimmune diseases,

particularly MS, or monitoring a pregnancy (Family 14).

The Company holds a license that covers an anti-HERV-W envelope protein antibody for use in the treatment of

psychotic diseases.

The Company also holds a license that covers an antibody directed against the HERV-K Envelope protein, and

uses thereof.

5.6.1.2 Patents and Patent Applications

Below is a description of the patents which GeNeuro holds or for which GeNeuro holds a license from a third party

or for which an application has been made, with a special reference to the PCT, European, and United States and

PCT patents, to which should be added the patents obtained or applied for in certain other countries which are not

included below.

Family 1: MSRV Ligand

Family 1 involves ligands including sequences corresponding to specific CDRs of the envelope protein EnSv of

MSRV.

In particular, it covers humanized antibodies directed against the envelope protein Env of MSRV.

This family covers, in a particular way, humanized antibodies directed against the epitope of the SU region of the

envelope protein Env of MSRV necessary for the activation of TLR4.

It thus covers the antibody presently being tested in MS. It also covers the use of such a humanized antibody in the

treatment of MS, schizophrenia, CIDP, epilepsy, psoriasis, cancer, inflammatory pancreatitis and diabetes,

particularly T1D.

Family 1 is wholly owned by the Company.

FAMILY 1: MSRV LIGAND

Owner

GeNeuro

Title

Therapeutic use of particular ligands in diseases associated with the MSRV retrovirus

PCT Extension & Engagements in National and/or Regional Phases

Theoretical Expiration Date⁴³: July 8, 2029

Claims subject matters

A: GNbAC1 (Temelimab) Antibody

B: Pharmaceutical composition comprising the GNbAC1 (Temelimab)

antibody

C: Method

of treatment of a MSRV-associated disease using the

GNbAC1 (Temelimab) antibody, in particular treatment of multiple

sclerosis, progressive multiple sclerosis, relapsing remitting multiple

sclerosis

D: Method of treating multiple sclerosis using the GNbAC1

(Temelimab) antibody

E: Method of treating MSRV-associated diabetes using the GNbAC1

(Temelimab) antibody

F: Method of binding an MSRV-ENV protein using the murine parental

version of GNbAC1 (Temelimab) antibody

G: Method of detection of the anti-ligand of the GNbAC1 (Temelimab)

antibody in a sample using the murine parental version of GNbAC1

H: Immunoassay kit for the detection of an anti-ligand comprising the

murine parental version of GNbAC1 (Temelimab) antibody

Combinations of claims

1 = A + B + C

2 = A + H

3 = A + B + C + D + E

4 = A + B + C + G + H

5 = A + B + G + H

6 = A + B + H

7 = A + C+ G + H

8 = A + G+ H

9 = D + F

Priority date

date

Country

Country / N° of

priority

Filing Date

N° of

Applicatio

Issue

N° of Patent

Expiry Date

Status

Claims

Subject to the due and punctual payment of applicable maintenance fees. This date does not take into consideration the

possibility of obtaining an additional protection certificate.

GeNeuro SA – 2023 Universal Registration Document

PCT

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

EP2009/0

58663

08/01/2011

Engaged

Australia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20092680

13.11.

2014

2009268025

08/07/2029

Granted

Brazil

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

0915667-4

25.05.

2021

PI0915667-4

08.07.2029

Granted

Canada

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

2,729,869

13.02.

2018

2,729,869

08/07/2029

Granted

China

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20098013

31.12.

4828.3

2014

ZL 200980134828.3

08/07/2029

Granted

Hong Kong

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

25/11/2011

11112831.

16.10.

2015

1158232

08/07/2029

Granted

South Africa

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

2011/0044 25.01.

2012

2011/00446

08/07/2029

Granted

USA

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

12/997

486

06.05.

2014

8,715,656

09/08/2030

Granted

USA

(Division)

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

14/221

963

24.01.

2017

9,550,824

25/08/2029

Granted

USA

Continuation

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

15/367

864

14.11.

2017

9,815,888

08/07/2029

Granted

USA

Continuation

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

26/10/2017

15/794

541

28.08.

2018

10,059,758

08/07/2029

Granted

India

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

336/KOLN 24.12.

P/2011

2018

304912

08/07/2029

Granted

Israel

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

210204

01.07.

2015

210204

08/07/2029

Granted

Japan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

2011-

517153

16.12.

2016

6058264

08/07/2029

Granted

Japan

(Division)

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

2015-

048795

17.03.

2017

6109869

08/07/2029

Granted

Japan

(Division)

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

2017-

043877

15.03.

2019

6495361

08/07/2029

Granted

Mexico

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

MX/A/201 21.11.

0/014319 2013

315557

08/07/2029

Granted

New-Zealand 13/03/2009

15/05/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

590515

30.04.

2013

590515

08/07/2029

Granted

Republic of

Korea

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

10-2011-

28.11.

7002937

2016

10-1682040

08/07/2029

Granted

Ukraine

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

a2011014 26.05.

2014

105495

08/07/2029

Granted

Eurasia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

31.10.

2016

24655

08/07/2029

Granted

Armenia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Azerbaijan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Belarus

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Russia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Kazakhstan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Kirghizstan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Moldavia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

GeNeuro SA – 2023 Universal Registration Document

Tajikistan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Turkmeni-

stan

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

20110016

01.11.

2016

24655

08/07/2029

Granted

same as

Eurasia

Europe

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029

Validated

Germany

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Austria

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Belgium

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Bulgaria

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Cyprus

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Croatia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Denmark

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Spain

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Estonia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Finland

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

France

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

United

Kingdom

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Greece

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Hungary

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Ireland

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Iceland

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Italy

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Latvia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Lithuania

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Luxembourg

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Macedonia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Malta

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Monaco

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Norway

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Netherlands

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

GeNeuro SA – 2023 Universal Registration Document

Poland

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Portugal

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Czech

republic

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Romania

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

San Marino

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Slovakia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Slovenia

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Sweden

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Swiss

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

Turkey

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

09780311.

26.04.

2017

2315777

08/07/2029 Validation

same as

Europe

(Division)

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

08/07/2009

17159699.

17.03.

2021

3211005

08/07/2029

Validated

Hong Kong

15/05/2009

13/03/2009

08/07/2008

US 61/213 189

US 61/202 581

US 61/129 613

28/02/2018

18102934.

03.09.

2021

1243436B

08/07/2029

Granted

C+D

*: As provided under the "Patent Term Adjustment" mechanism, the U.S. Patent and Trademark Office granted an additional term of protection for

this patent of 397 days

**: As provided under the "Patent Term Adjustment" mechanism, the U.S. Patent and Trademark Office granted an additional term of protection for

this patent of 48 days

Family 2: Endogenous Antiretroviral

Family 2 involves the use of an antibody directed against the envelope protein HERV-W/MSRV, its fragments, and

its derivatives as a global antiretroviral agent.

This family also covers the use of the combination of such an antibody, its fragments, or derivatives, with a classic

antiretroviral. The Company has also considered the synergistic effect of such a combination.

Family 2 is wholly owned by GENEURO.

Claims subject matters

A = Composition or combined preparation comprising the antibody GNbAC1 (temelimab) and

a retroviral reverse-transcriptase inhibitory drug

B = Combination of the antibody GNbAC1 (temelimab) with a retroviral reverse-transcriptase

inhibitory drug for treating multiple sclerosis

FAMILY 2: ENDOGENOUS ANTIRETROVIRAL

Owner/Holder

GeNeuro

Title

Antiretroviral drug targeting human endogenous retrovirus

Country

date

Priority Country / N°

of priority

Filing

date Application

N° of

Issue

date

N° of Patent

Expiratio

n date

Status

Claim

PCT

28/05/2014

27/05/

14305806.3

2015

EP2015/061691

28/11/2016

Engaged

Australia

28/05/2014

14305806.3

27/05/

2015

2015265936

12.11.2020

2015265936

27/05/2035

Granted

Brazil

28/05/2014

27/05/ 11 2016 027671

14305806.3

2015

27/05/2035

Pending

Canada

28/05/2014

27/05/

14305806.3

2015

2 949 884

27/05/2035

Pending

GeNeuro SA – 2023 Universal Registration Document

China

28/05/2014

14305806.3

27/05/ 201580027652.

2015

27/05/2035

Pending

Hong-Kong

28/05/2014

27/05/

14305806.3

2015

17109624.6

27/05/2035

Pending

Eurasia

28/05/2014

14305806.3

27/05/

2015

201692471

27.02.2020

0 34612

27/05/2035

Granted

Belarus

28/05/2014

14305806.3

27/05/

2015

201692471

27.02.2020

0 34612

27/05/2035 Validation

as in

Eurasia

Russia

28/05/2014

14305806.3

27/05/

2015

201692471

27.02.2020

0 34612

27/05/2035 Validation

as in

Eurasia

Kazakhstan

28/05/2014

14305806.3

27/05/

2015

201692471

27.02.2020

0 34612

27/05/2035 Validation

as in

Eurasia

Europa

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035

Granted

Germany

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27/05/2035 Validation

as in

Europe

Austria

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27/05/2035 Validation

as in

Europe

Belgium

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Denmark

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Spain

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Finland

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

France

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Great Britain

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Greece

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Hungary

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Ireland

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Italia

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Luxembourg

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Norway

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Netherlands

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Poland

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Portugal

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Czech

Republic

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Romania

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Sweden

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Switzerland

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Turkey

28/05/2014

14305806.3

27/05/

2015

15725326.1

31.07.2019

3148582

27.05.2035 Validation

as in

Europe

Israel

28/05/2014

14305806.3

27/05/

2015

249040

31.05.2020

249040

27/05/2035

Granted

India

28/05/2014

27/05/

14305806.3

2015

201617043958

27/05/2035

Pending

Mexico

28/05/2014

14305806.3

27/05/ MX/A/2016/0155

2015

11.08.2020

374177

27/05/2035

Granted

Russia

28/05/2014

14305806.3

27/05/

2015

2016151471

27.05.2019

2,689,326

27/05/2035

Granted

GeNeuro SA – 2023 Universal Registration Document

Ukraine

28/05/2014

14305806.3

27/05/

2015

a201613240

11.11.2019

120274

27/05/2035

Granted

USA

(Continuation)

28/05/2014

14305806.3

22.03.

2019

16/362 193

19.01.2021

10,894,820

27.05.2035

Granted

South of Africa

28/05/2014

14305806.3

27/05/

2015

2016/08050

27.05.2020

2016/08050

27/05/2035

Granted

Family 3: Remyelination

This application covers compounds and compositions for the prevention and/or treatment of a mechanism that

blocks the endogenous myelin repair capability of the adult nervous system in disorders associated with the

expression of the envelope protein W-ENV, particularly its subtype, MSRV.

This family also covers the use of an antibody directed against W-ENV for use in the prevention of the blockage of

the endogenous myelin repair capability, particularly in disorders such as RRMS, chronic progressive MS, CIDP,

and schizophrenia or bipolar disorders.

Family 3 is wholly owned by GENEURO.

FAMILY 3: REMYELINATION

Owner/Holder

GeNeuro

Title

Compound for treatment of inhibition of remyelination in diseases and disorders associated with expression

of the envelope protein HERV-W

PCT Extension & Engagements in National and/or Regional Phases

Theoretical Expiration Date⁴⁴: October 1, 2033

Claims subject matters

Composition comprising the antibody GNbAC1 (temelimab) and a nitric oxide inhibitory drug or Combined composition (kit) comprising the

antibody GNbAC1 (temelimab) and a nitric oxide inhibitory drug

Method for preventing or treating diseases associated with W-ENV using the antibody GNbAC1 (temelimab), in particular multiple sclerosis,

progressive multiple sclerosis, relapsing remitting multiple sclerosis

Method for preventing or treating diseases associated with HERV-W EN using the antibody GNbAC1 (temelimab) and a nitric oxide inhibitory

drug or using a composition comprising the antibody GNbAC1 (temelimab) and a nitric oxide inhibitory drug, in particular multiple sclerosis,

progressive multiple sclerosis, relapsing remitting multiple sclerosis

Method for preventing or treating progressive multiple sclerosis using the antibody GNbAC1(temelimab)

Country

date

Priority Country / N°

of priority

Filing date

N° of

Application

Issue date

N° of Patent

Expiration

date

Status

Claims

PCT

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

EP2013/070452

02/04/2015 Engaged

Saudi Arabia

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

515360207

18.09.2018

6097

01/10/2033

Granted

Australia

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

2013326552

06.09.2018

2013326552

01/10/2033

Granted

Australia

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

2018217328

02.01.2020

2018217328

01/10/2033

Granted

Brazil

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

122020015957-0

Pending

Canada

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

2 882 781

15.06.2021

2,882,781

01/10/2033

Granted

China

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

201380051713.4

19.06.2018

01/10/2033

Granted

China

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201610152679.5

05.06.2020

01/10/2033

Granted

Hong Kong

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/08/2016

16109172.3

22.01.2021

1221399B

01/10/2033

Granted

Colombia

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

15-095895

01.10.2013

33485

01/10/2033

Granted

United Arab

28/12/2012

Emirates

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

P431/15

01/10/2033

Pending

USA

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

14/429 199

12.12.2017

9,840,550

01/10/2033

Granted

44 Subject to the due and punctual payment of applicable maintenance fees. This date does not take into consideration the

possibility of obtaining an additional protection certificate.

GeNeuro SA – 2023 Universal Registration Document

USA (Division)

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

15/812 745

25.08.2020

10,752,675

01/10/2033

Granted

Eurasia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

Armenia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Azerbaijan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Belarus

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Russia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Kazakhstan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Kirghizistan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Tadjikistan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

Turkmenistan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

31.10.2017

028245

01/10/2033

Granted

as in

Eurasia

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201791525

26.02.2021

37253

01/10/2033

Granted

Armenia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Azerbaijan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Belarus

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01.10.2033 Granted

as in

Eurasia

Russia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Kazakhstan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Kirghizstan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Tajikistan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Turkmenistan

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

201590678

26.02.2021

028245

01/10/2033

Granted

as in

Eurasia

Israël

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01.10.2013

264382

31.05.2020

264382

01/10/2033

Granted

Israël

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01.10.2013

274047

01.03.2021

274047

01/10/2033

Granted

Japan

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

2015-533633

10.08.2018

6379331

01/10/2033

Granted

Japan

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

2017-214696

14.06.2019

6538138

01/10/2033

Granted

Malaisia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

PI 2015700643

15.11.2019

MY-172209-A 01/10/2033

Granted

Mexico

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013 MX/A/2015/003572 26.07.2019

366846

01/10/2033

Granted

Mexico

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013 MX/A/2019/008916 02.08.2021

385,003

01/10/2033

Granted

Singapore

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

11201501274V

06.04.2017 11201501274V

01/10/2033

Granted

Thailand

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

1501001128

01/10/2033

Pending

GeNeuro SA – 2023 Universal Registration Document

South of Africa

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

2015/01491

27.01.2016

2015/01491

01/10/2033

Granted

Europe

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033

Granted

Albania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Germany

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Austria

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Belgium

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Bulgaria

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Cyprus

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Croatia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Denmark

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Spain

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Estonia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Finland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

France

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

United

28/12/2012

Kingdom

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Greece

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Hungary

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Ireland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Iceland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Italia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Latvia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Lithuania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Luxembourg

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Macedonia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Malta

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Monaco

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Norway

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Netherlands

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

GeNeuro SA – 2023 Universal Registration Document

Poland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Portugal

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Czech Republic

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Romania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

San Marino

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Serbia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Slovakia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Slovenia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Sweden

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Switzerland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

Turkey

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

13770926.7

21.11.2018

2904009

01/10/2033 Validation

as in

Europe

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033

Granted

Albania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Germany

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Austria

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Belgium

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Bulgaria

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Cyprus

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Croatia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Denmark

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Spain

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Estonia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Finland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

France

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

United

28/12/2012

Kingdom

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Greece

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Hungary

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Ireland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

GeNeuro SA – 2023 Universal Registration Document

Iceland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Italia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Latvia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Lithuania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Luxembourg

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Macedonia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Malta

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Monaco

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Norway

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Netherlands

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Poland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Portugal

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Czech Republic

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Romania

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Serbia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Slovakia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Slovenia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Sweden

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Switzerland

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Turkey

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

18198309.9

3447070

01/10/2033 Validation

as in

Europe

Russia

28/12/2012

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

2015116149

3447070

01/10/2033

Granted

New Zealand

(Division) 02/10/2012

28/12/2012

US 61/746

792

61/708 779

US 01/10/2013

740726

03.11.2020

740726

01/10/2033

Granted

Republic of

28/12/2012

Korea

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

10-2015-7011152

01.04.2020

10-2098033

01/10/2033

Granted

Ukraine

28/12/2012

02/10/2012

61/708 779

US 61/746

792

US 01/10/2013

a201504292

25.04.2019

119032

01/10/2033

Granted

Ukraine

28/12/2012

(Division)

02/10/2012

US 61/746

792

61/708 779

US 01/10/2013

a201809345

02.11.2022

126558

01/10/2033

Granted

GeNeuro SA – 2023 Universal Registration Document

Family 4: SEP 16

Patent family 4 covers the sequence of the env gene.

This family covers the sequence necessary for the development of humanized antibodies directed against the

epitope of the envelope protein Env of MSRV necessary for the activation of TLR4.

Family 4 is wholly owned by bioMérieux.

FAMILY 4: SEP 16

Owner/Holder

bioMérieux

Title

Retroviral nucleic material and nucleotide fragments, in particular associated with multiple sclerosis and/or rheumatoid

arthritis, for diagnostic, prophylactic and therapeutic uses

Extensions

Theoretical Expiration Date⁴⁵: July 7, 2018

Country

Filing date and number

Publication

and number

date

Issue date and

number

Status

Canada

CA 2 295 935

July 7, 1998

CA 2 295 935

Sep. 9, 2014

Patent issued

Europe

EP 98936467.4

July 7, 1998

EP 0 996 731

May 3, 2000

EP 0 996 731

Aug. 31, 2005

Patent issued and confirmed in FR, SP, IT, GB,

GER, SW

Europe (division)

EP 05017735.1

July 7, 1998

EP 1 612 270

Jan. 4, 2006

EP 1 612 270

Sep. 2, 2009

Patent issued and confirmed in FR, SP, IT, GB,

GER, SW

Japan

JP 11-508255

July 7, 1998

JP 2002-509437

March 26, 2002

JP 4 272 264

March 6, 2009

Patent issued

United States

US 09/319 156

July 7, 1998

US 7 771 927

Aug. 10, 2010

Patent issued

United

States

(division)

US 12/776 893

July 7, 1998

US 8 088 910

Jan. 3, 2012

Patent issued

Family 5: TLR4

This patent family covers the use of an anti env-SU antibody capable of binding itself to the soluble fraction of the

Env protein of MSRV for preparation of a medication intended to treat MS or schizophrenia by inhibiting the pro-

inflammatory cascade involving the soluble fraction of Env of MSRV and such receptor.

This patent family, therefore, broadly covers an antibody directed against Env-SU of MSRV for use in the treatment

of MS or schizophrenia.

Family 5 is owned by bioMérieux and INSERM.

FAMILY 5: TLR4

Owner/Holder

bioMérieux and INSERM

Title

Composition for treating pathology associated with MSRV/HERV-W

Priority

Country

Filing date and number

Publication

date Issue

and number

date

and

number

Status

France

FR 04 00675

Jan. 23, 2004

FR 2 865 403

June 1, 2005

FR 04 00675

June 12, 2009

Patent issued

PCT Extension & Engagements in National and/or Regional Phases

Theoretical Expiration Date: ⁴⁶January 24, 2025

PCT

PCT/FR2005/00156

Jan. 24, 2005

WO2005/080437

Sep. 1, 2005

Application engaged

Canada

CA 2 554 263

Jan. 24, 2005

CA 2 554 263

Aug. 5,2014

Patent issued

China

CN 20058006462.3

Jan. 24, 2005

CN 1926153 A

March 7, 2007

ZL200580006462.3

May 4, 2011

Patent issued

Europe

EP 05717480.7

Jan. 24, 2005

EP 1 709 082

Oct. 11, 2006

EP 1 709 082

March 12, 2014

Patent issued and confirmed in SW, GER, SP,

FR, GB, IT, AU, BE, BG, CY, DK, EE, FI, GR,

HU, IE, IS, LT, LU, MC, NL, PL, PT, CZ, RO,

SI, SK, SE, TR

Europe

(division)

EP 10183899.3

Jan. 24, 2005

EP 2 365 002

Sep. 14, 2011

Examination pending

India

IN 3065/CHENP/2006

Jan. 24, 2005

IN 241 921

July 30, 2010

Patent issued

Japan

JP 2006-550240

Jan. 24, 2005

JP 2008-505847

Feb. 28, 2008

JP 4 991 314

May 11, 2012

Patent issued

United States

US 10/586 742

Jan. 24, 2005

US-2008-0038279

Feb. 14, 2008

US 7 666 420

Feb. 23, 2010

Patent issued*.

*: As provided under the "Patent Term Adjustment" mechanism, the U.S. Patent and Trademark Office granted an additional term of protection for

this patent of 103 days.

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 6: SEP 12

This patent family covers the gag and pol sequences of MSRV. Family 6 is wholly owned by bioMérieux.

FAMILY 6: SEP 12

Owner/Holder

bioMérieux

Title

Viral material and nucleotide fragments associated with multiple sclerosis useful for diagnostic, preventive and therapeutic

purposes

PCT Extensions & Engagements in National and/or Regional Phases

Theoretical Expiration Date⁴⁷: August 2, 2016

Country

Filing date and number

Publication

date

and number

Issue date and number

Status

PCT

PCT/FR1996/01244

Aug. 2, 1996

WO1997/06260

Feb. 20, 1997

Application engaged

Canada

CA 2 201 282

Aug. 2, 1996

CA 2 201 282

01 April 2013

Patent issued

Europe

EP 96420265.9

Aug. 2, 1996

EP 0 789 077

Aug. 13, 1997

EP 0 789 077

Sep. 26, 2007

Patent issued and confirmed in FR, GER, IT,

SP, SW, GB

Europe

(division)

EP 07018564.0

Aug. 2, 1996

EP 1 916 304

April 30, 2008

EP 1 916 304

Jan. 18, 2012

Patent issued and confirmed in FR, GER, IT,

SP, SW, GB

Japan

JP 9-508179

Aug. 2, 1996

JP 4 444 372

Jan. 22, 2010

Patent issued

Japan

(division)

JP 2009-265658

Aug. 2, 1996

JP 5 143 814

Nov. 30, 2012

Patent issued

United States

US 08/691 563

Aug. 2, 1996

US 6 001 987

Dec. 14, 1999

Patent issued

United States

(division)

US 09/374 766

Aug. 2, 1996

US 6 579 526

June 17, 2003

Patent issued

United States

(division)

US 11/463 109

Aug. 2, 1996

US 7 932 350

May 24, 2007

Patent issued."

*: As provided under the "Patent Term Adjustment" mechanism, the U.S. Patent and Trademark Office granted an additional term of protection for

this patent of 1133 days.

Family 7: SEP 15

This patent family covers a particular sequence that is expressed in the placenta.

Family 7 is wholly owned by bioMérieux.

FAMILY 7: SEP 15

Owner/Holder

bioMérieux

Title

Endogenic retroviral sequences associated with autoimmune diseases or with pregnancy disorders

PCT Extension & Engagements in National and/or Regional Phases

Theoretical Expiration Date^48:July 6, 2018

Country

Filing date and number

Publication date and

number

Issue date and number

Status

PCT

PCT/FR1998/01442

July 6, 1998

WO1999/02696

Jan. 21, 1999

Application engaged

Canada

CA 2 298 834

July 6 1998

CA 2 298 834

March 23, 2015

Patent issued

Europe

EP 98935106.9

July 6,

1998

EP 1 000 158

May 17, 2000

EP 1 000 158

Nov. 22, 2006

Patent issued and confirmed

Abandoned in confirmed countries

Japan

JP 11-508244

July 6, 1998

JP 2002-512530

April 23, 2002

JP 4 249 269

Jan. 23, 2009

Patent issued

Family 8: SEP 18

This patent family covers the env gene of the HERV-7q endogenous retrovirus.

Family 8 is wholly owned by INSERM.

FAMILY 8: SEP 18

Owner/Holder

INSERM

Title

Nucleic sequence and deduced protein sequence family with human endogenous retroviral motifs, and their uses

Priority

Country

Filing number and date

Publication

number

and date

Issue number and date

Status

France

FR 98 07920

June 23, 1998

FR 2 780 069

Dec. 24, 1999

FR 98 07920

June 28, 2002

Patent issued

Extensions

Theoretical Expiration Date^49:June 23, 2019

Canada

CA 2 331 923

23 June 23, 1999

CA 2 331 923

Feb. 18, 2014

Patent issued

Europe

EP 99926538.2

June 23,

1999

EP 1 090 122

April 11, 2001

EP 1 090 122

July 16, 2008

Patent issued and confirmed in GER, FR,

NL, GB

United States

US 09/719 554

June 23, 1999

US 6 919 438

July 16, 2005

Patent issued

United States

(division)

US 11/028 539

June 23, 1999

US 2005-0118573

June 2, 2005

US 7 534 439

May 19, 2009

Patent issued. *

*: As provided under the "Patent Term Adjustment" mechanism, the U.S. Patent and Trademark Office granted an additional term of protection for

this patent of 235 days.

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 9: INTERECO

This patent family covers the peptide domain required for interaction between the envelope of a virus pertaining to

the HERV-W interference group and an hASCT receptor. This area plays a part in the transmission of information

and the merger of cells.

Family 9 is wholly owned by bioMérieux.

FAMILY 9: INTERECO

Owner/Holder

bioMérieux

Title

Peptide domain required for interaction between the envelope of a virus pertaining to the HERV-W interference group

and an HASCT receptor

Priority

Country

Filing date and number

Publication date and

number

Issue date and number

Status

France

FR 06 50468

Feb. 9, 2006

FR 2 897 062

Aug. 10, 2007

FR 06 50465

Nov. 4, 2011

Patent issued

PCT Extension & Engagements in National and/or Regional Phases

Theoretical Expiration Date⁵⁰: February 9, 2027

PCT

PCT/FR2007/000236

Feb. 9, 2007

WO2007/090967

Aug. 16, 2007

Application engaged

Australia

AU 2007213591

Feb. 9, 2007

AU 2007213591

Feb. 19, 2012

Patent issued

Canada

CA 2 640 793

Feb. 9, 2007

CA 2 640 793

Patent issued

Awaiting official deed

China

CN 200780004699.7

Feb. 9, 2007

CN 101379079 A

March 4, 2009

ZL200780004699.7

Nov. 14, 2012

Patent issued

Europe

EP 07730950.8

Feb. 9, 2007

EP 1 981 904

Oct. 22, 2008

Examination pending

India

4129/CHENP/2008

Feb. 9, 2007

Examination pending

Israel

IL 193 353

Feb. 9, 2007

Examination pending

Japan

JP 2008-553798

Feb. 9, 2007

JP 2009-525741

July 16, 2009

Examination pending

Japan

(division)

JP 2015-200607

Feb. 9, 2007

Examination pending

United States

US 14/847 941

Feb. 9, 2007

Examination pending

Family 10: Ac AntiTM

This patent family covers a humanized antibody directed against the W-ENVelope protein, in particular the C-

terminal extremity of the SU region of the envelope protein of HERV-W, to the exclusion of any antibody specifically

directed against the liaison site of such Env protein and the hASCT1 or hASCT2 receptor. Such antibodies can be

advantageous for monitoring pathological pregnancies.

Family 10 is wholly owned by GENEURO.

FAMILY 10: Ac ANTITM

Owner/Holder

GeNeuro

Title

Pharmaceutical composition containing antibodies directed against the W-ENVelope

Priority

Country

Filing number and date

Publication

number

and date

Issue number and date

Status

France

FR 07 00952

Feb. 9, 2007

FR 2 912 314

Aug. 15, 2008

FR 07 00952

Aug. 3, 2012

Patent issued

–

theoretical

expiration date51: February 9,

2027

PCT Extension & Engagements in National and/or Regional Phases

PCT

PCT/FR2008/000166

Feb. 11, 2008

WO2008/113916

Sep. 25, 2008

Application engaged

Europe

EP 08761866.6

Feb. 11, 2008

EP 2 117 594

Nov. 18, 2009

Application abandoned

United States of

America

US 12/449,327

Feb. 11, 2008

US 2010-0074894

March 25, 2010

Application abandoned

The extensions of the patent filed subsequently were abandoned, because the MSRV ligand patent, providing

broader protection, was filed in the meantime; such extensions, therefore, were no longer of interest.

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 11: HERV-W fusion

This patent family covers a process for detecting the expression of the envelope protein of a HERV based on the

detection of the fusogenic power of such protein in a cellular tissue or of a cellular culture, by showing the formation

of syncytia.

Family 11 is owned by bioMérieux and INSERM.

FAMILY 11: HERV-W FUSION

Owner/Holder

bioMérieux and INSERM

Title

Method for detecting the expression of an envelope protein of a human endogenous retrovirus and uses of a gene

coding for said protein

PCT Extension & Engagements in National and/or Regional Phases theoretical expiration date⁵²

September 1, 2020

Country

Filing number and date

Publication

number

and date

Grant number and date

Status

PCT

PCT/FR00/02429

Sep. 1, 2000

WO01/16171

Sep. 8, 2011

Application engaged

Europe

EP 00960783.9

Sep. 1, 2000

EP 1 212 359

June 12, 2002

EP 1 212 359

Nov. 12, 2011

Patent granted

Europe

EP 10 183 612.0

Sep. 1, 2000

EP 2 385 058

Nov. 9, 2011

EP 2 385 058

Nov. 6, 2013

Patent granted

Japan

JP 2001-519732

Sep. 1, 2000

JP 2003-510032

March 18, 2003

JP 4 283 475

March 27, 2009

Patent granted

Japan

JP 2008-244988

Sep. 1, 2000

JP 2009-72194

April 9, 2009

JP 4 824 731

Sep. 16, 2011

Patent granted

Canada

CA 2 383 877

Sep. 1, 2000

CAK 2 383 877

April 15, 2014

Patent granted

United States of

America

US 10/069,883

Feb. 11, 2008

US 2010-0074894

March 25, 2010

7 442 550

Oct. 28, 2008

Patent granted

Family 12: SEP 6

This patent family covers a composition that consists of two pathogenic agents and/or infectants associated with

MS.

These agents are, respectively:

a first agent being a human virus possessing reverse transcriptase activity and which is related to a family

of endogenous retroviral elements or a variant of such virus, and

a second agent or variant of such agent.

Both of these pathogenic and/or infectant agents come from the same viral source chosen from the sources called,

respectively, POL-2.

This composition may be used in a diagnostic method, a prophylaxis method, or as a treatment method, particularly

for MS. Family 12 is wholly owned by bioMérieux.

FAMILY 12: SEP 6

Owner/Holder

bioMérieux

Title

MMSRV1 virus linked to multiple sclerosis, its nucleic components and their applications

PCT Extension & Engagements in National Phase

Country

Filing number and date

Publication number and

date

Grant number and date

Status

PCT

PCT/FR95/00142

Feb. 6, l995

WO95/21256

Aug. 10, 1995

Application engaged

United States

US 08/384 137

Feb. 6, 1995

US 5 871 996

Feb. 6, 1999

Patent granted

United States

US 08/470 006

Feb. 6, 1995

US 5 962 217

Jan. 5, 1999

Patent granted

United States

US 09/133 411

Feb. 6, 1995

US 6 342 383

Jan. 29, 2002

Patent granted

United States

US 08/471 969

Feb. 6, 1995

US 5 871 745

Feb. 16, 1999

Patent granted

United States

US 09/200 990

Feb. 6, 1995

US 6 184 025 B1

Feb. 6, 2001

Patent granted

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 13: SEP 13

This patent family relates to nucleic medicine capable of being used in a diagnostic mode, a method for prophylaxis,

or as a method for treating MS or rheumatoid polyarthritis.

Family 13 is wholly owned by bioMérieux.

FAMILY 13:SEP 13

Owner/Holder

bioMérieux

Title

Viral material and nucleotide fragments associated with multiple sclerosis, for diagnostic, prophylactic and therapeutic

purposes

PCT Extension & Engagements in National and/or Regional Phases theoretical expiration date⁵³: November 26, 2017

Country

Filing number and

date

Publication number

and date

Grant number and

date

Status

PCT

PCT/IB97/01482

Nov. 26, 1997

WO98/23755

June 4, 1998

Application engaged

Europe

EP 97 911 411.3

Nov. 26, 1997

EP 0 942 987

Sep. 22, 1999

EP 0 942 987

Aug. 19, 2009

Patent granted

Canada

CA 2 272 845

Nov. 26, 1997

CA 2 272 845

Jan. 12, 2010

Patent granted

Japan

JP 10-524475

Nov. 26, 1997

JP 2001-505768

May 8, 2001

JP 4 226 657

Dec. 5, 2008

Patent granted

United States

US 08/979 847

Nov. 26, 1997

US 6 582 703

June 24, 2003

Patent granted

United States

US 11/581 030

Nov. 26, 1997

US 2007-0031452

Feb. 8, 2007

US 7 674 888

Nov. 26, 1997

Patent granted

Family 14: SEP 19

This patent family relates to endogenous nucleotide fragments having at least one part of the gag gene of an

endogenous retrovirus associated with an autoimmune disorder or a failed pregnancy or pregnancy disorders.

This family also covers the use of such a fragment to detect, in a biological sample, susceptibility to an autoimmune

disease, especially MS, or for monitoring or following a pregnancy.

Family 14 is wholly owned by bioMérieux.

FAMILY 14: SEP 19

Owner/Holder

bioMérieux

Title

Process for the detection of an endogenous nucleic acid fragment associated with an autoimmune disease

PCT Extension & Engagements in National and/or Regional Phases theoretical expiration date⁵⁴: January 21, 2020

Country

Filing number and date

Publication

number

and date

Grant number and date

Status

PCT

PCT/FR00/00144

July 21, 2000

WO00/043521

July 27, 2000

Application engaged

Europe

EP 00 900 645.3

Jan. 21, 2000

EP 1 147 187

Oct. 24, 2001

EP 1 147 187

June 27, 2012

Patent granted

United States

US 10/632 793

Jan. 21, 2000

US 2004-0048298

March 11, 2004

US 7 632 931

Dec. 15, 2009

Patent granted

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 15: SEP 20

This family relates to a nucleic fragment of the LTR-RU5 region. This patent family also covers probes and methods

capable of hybridation with such fragment, the protein it encodes, an antibody directed against such protein, and a

protein for detecting the MSRV-1 retrovirus though such probe or the antibodies described in the invention.

Family 15 is wholly owned by bioMérieux.

FAMILY 15: SEP 20

Owner/Holder

bioMérieux

Title

The LTR region of MSRV-1 and the proteins it encodes, and probes and methods for detecting the MSRV-1 retrovirus

PCT Extension & Engagements in Regional Phase theoretical expiration date⁵⁵: February 15, 2020

Country

Filing number and date

Publication

number

and date

Grant number and date

Status

PCT

PCT/IB00/00159

Feb. 15, 2000

WO00/47745

Aug. 17, 2000

Application engaged

Europe

EP 00 902 825.9

Feb. 15, 2000

EP 1 151 108

Nov. 7, 2001

EP 1 151 108

Nov. 30, 2005

Patent granted

Family 16: SEP 21

This invention covers, in particular, a method for detecting superantigenic activity in a biological sample, including

demonstration of a majority expansion of lymphocytes.

This application also covers a composition consisting of a therapeutic agent capable of inhibiting superantigen

activity and the use of such composition for prophylactic steps and/or the treatment of a disease, particularly an

autoimmune disease, such as MS.

Family 16 is wholly owned by bioMérieux.

FAMILY 16: SEP 21

Owner/Holder

bioMérieux

Title

Method for detecting MSRV-1 induced superantigen activity in a biological sample

PCT Extension & Engagements in Regional Phase theoretical expiration date⁵⁶: March 20, 2020

Country

Filing number and date

Publication

number

and date

Grant number and date

Status

PCT

PCT/FR00/00691

March 20, 2000

WO00/57185

Sep. 28, 2000

Application engaged

Europe

EP 00 912 720.0

March 20, 2000

EP 1 163 522

Sep. 28, 2000

EP 1 163 522

Nov. 22, 2006

Patent granted

Family 17: Antipsychotic Treatment

This invention covers an anti-HERV-W envelope protein antibody for use in the treatment of psychotic diseases.

Family 17 is wholly owned by GeNeuro.

Claims subject matters

A = Antibody GN_mAb_Env-K01 defined by CDRs

B = Method of treatment of ALS with antibody GN_mAb_Env-K01

Priority

Country

Country / N° of

priority

date

Filing date

N° of Application

Issue date

date

N° of Patent

Expiration

Status

Claims

PCT

28.05.2020 EP20305561.1

28.05.2021 EP2021/064364

Engaged

Australia

28.05.2020 EP20305561.1

28.05.2021

2021281054

Pending

Canada

28.05.2020 EP20305561.1

28.05.2021

3,185,024

Pending

China

28.05.2020 EP20305561.1

28.05.2021

Pending

Eurasia

28.05.2020 EP20305561.1

28.05.2021

202293499

Pending

Europe

28.05.2020 EP20305561.1

28.05.2021

21727188.1

Pending

Israel

28.05.2020 EP20305561.1

28.05.2021

298594

Pending

Japon

28.05.2020 EP20305561.1

28.05.2021

2022-573646

Pending

Republic of

Korea

28.05.2020 EP20305561.1

28.05.2021

10-2022-7046045

Pending

South Africa

28.05.2020 EP20305561.1

28.05.2021

2022/13084

Pending

USA 28.05.2020 EP20305561.1

28.05.2021

17/927 764

Pending

Subject to the due and punctual payment of applicable maintenance fees.

GeNeuro SA – 2023 Universal Registration Document

Family 18: HERV-K"

This invention covers an antibody directed against the HERV-K Envelope protein, and uses thereof.

Family 18 is jointly owned by GeNeuro and the NIH; the NIH has entered into an exclusive license of its rights to

GeNeuro.

FAMILY 17: HERV-K

Owner/Holder

GeNeuro and the NIH

Title

Pharmaceutical composition containing antibodies directed against the HERV-K Envelope

Country

Priority

date

Country / N° of

priority

Filing date

N° of Application

Issue

date

N° of

Patent

Expiry date

Status

Europe

20/01/2017

17305062.6

20/01/2037

Pending

Argentine

20/01/2017

EP 17305062.6

19/01/2018

20180100129

19/01/2038

Pending

Taiwan

20/01/2017

EP 17305062.6

22/01/2018

107102219

22/01/2038

Pending

PCT

20/01/2017

EP 17305062.6

19/01/2018

US2018/014489

20/07/2019

Engaged

South

Africa

20/01/2017

EP 17305062.6

19/01/2018

2019/04587

19/01/2038

Pending

Australia

20/01/2017

EP 17305062.6

19/01/2018

2018210388

19/01/2038

Pending

Brazil

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

Canada

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

China

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

Eurasia

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

Japan

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

Korea

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

Ukraine

20/01/2017

EP 17305062.6

19/01/2018

not yet allocated

19/01/2038

Pending

20/01/2017

EP 17305062.6

19/01/2018

16/478 576

19/01/2038

Pending

Europe

20/01/2017

EP 17305062.6

19/01/2018

18713060.4

19/01/2038

Pending

India

20/01/2017

EP 17305062.6

19/01/2018

201917027958

19/01/2038

Pending

Israel

20/01/2017

EP 17305062.6

19/01/2018

267955

19/01/2038

Pending

Mexico

20/01/2017

EP 17305062.6

19/01/2018

MX/A/2019/00864

19/01/2038

Pending

New

Zealand

20/01/2017

EP 17305062.6

19/01/2018

755432

19/01/2038

Pending

5.7 Organization of the Company

5.7.1 Operating Organization Chart

GeNeuro is managed by its management under the supervision of its Board of Directors, which is composed of

internationally known persons. The Company also has a scientific committee that contributes significant expertise

in MS.

Detailed biographies of the members of the Board of Directors and management are set forth in CHAPTER 14,

"Corporate Governance, Administration, Management and Supervisory and General Management Bodies" of this

Universal Registration Document.

Present Organization

The Company is led by Jesús Martin-Garcia, CEO, to whom report:

•

Dr. Anke Post, Chief Medical Officer (since January 1, 2024

•

Dr. Hervé Perron, Chief Scientific Officer;

•

Dr. Alois B Lang, Chief Development Officer; and

•

Mr. Miguel Payró, Chief Financial Officer, also in charge of human resources.

Mr. Martin-Garcia, Dr. Post, Dr. Lang, Mr. Payró and Dr. Perron are part of GeNeuro's Executive Committee.

5.7.2 Product and Manufacturing

GeNeuro SA has substantial experience in the development of biopharmaceutical products such as therapeutic

monoclonal antibodies. This experience includes a broad scientific background, which incorporates the application

of analytical and bioanalytical technologies in the quality control of therapeutic antibodies, in the technical

assessment of the immunogenicity of such products, and in the humanization of therapeutic monoclonal antibodies

and its optimized manufacturability. Experience in the development of antibody-based technologies led to strong

interest from third parties.

GeNeuro SA – 2023 Universal Registration Document

GeNeuro has a mix of in-house expertise and working with highly qualified CMOs. Dr. Alois B. Lang is a

biopharmaceutical product development specialist, with particular expertise in the development of therapeutic

monoclonal antibody-based products. He has long-term industrial experience and successfully led the development

of several antibody-based products from the pre-clinical phase to the clinical trial phase.

GeNeuro's temelimab is manufactured by Polymun. Polymun developed both cell culture and downstream

purification processes suitable for the manufacture of the antibody in accordance with GMP and with clinical-grade

quality. The production and purification of temelimab uses established production protocols. The manufacturing

process is typical for a monoclonal antibody.

The Company believes that Polymun has sufficient capacity in terms of net fermentation volume as well as matching

capacity in downstream processing for the manufacturing of GeNeuro's antibody temelimab up to a Phase III clinical

trial or marketing application. Polymun has been successfully audited by the FDA. The process is optimized and

well characterized and was successfully presented by GeNeuro to relevant regulatory authorities, such as the Paul

Ehrlich Institute and Swissmedic. Polymun is already manufacturing other biopharmaceuticals for Phase III clinical

studies or for drugs which are already on the market and thus has the experience and know-how for related

procedures such as process validation and documentation for all stages of clinical development and applications

for market approval with the relevant authorities.

Since the COVID-19 pandemic, supply of culture media for antibody manufacturing and other products is facing

considerable strain and competition for deliveries. While the Company and its suppliers have been able to manage

this situation without any disruptions, tense supply conditions may lead to delays in the manufacturing of future

batches of temelimab and may have consequences on the timing of clinical trials.

5.7.3 Clinical Development Expertise

The clinical development team includes several experts, including one senior physician and a senior clinical

operations director who have long experience in clinical research and development and in obtaining product

licenses for medications and biological products. In particular, they have participated directly in the development

and/or registration of three products indicated for MS: ocrelizumab (Ocrevus©), siponimod (Mayzent ©) and

ofatumumab (Kesimpta ©).

As for clinical trials, the Company has already completed three Phase I clinical trials, three Phase IIa trials, one

Phase IIb trial and a Phase IIb extension trial, all in different countries in Europe and Australia, as described

elsewhere in this Universal Registration Document. These trials were the subject of several publications and

communications in international congresses and conferences in Europe and the United States as well as several

scientific articles⁵⁷published in international medical literature.

The clinical team also receives high-quality expertise on a consultative basis from Dr. Gordon S. Francis, who has

more than 30 years' experience in industrial development and who has played an important role in the registration

of three of the most important reference treatments for MS: beta interferon (Rebif©); natalizumab (Tysabri©); and

fingolimod (Gilenya©).

Academic experts recognized in related pharmacological or biostatistical areas are also regularly sought by the

Company for specific issues linked to clinical development.

5.7.4 Regulatory Expertise

GeNeuro has one senior consultant in regulatory affairs with extensive experience in regulatory matters. She has

substantial knowledge of regulatory development for pharmaceutical products, which is reflected in the regulatory

activities of the Company. GeNeuro focuses its regulatory activities on strategic planning and decisions, and uses

57 Sources: Curtin F, Lang AB, Perron H, Laumonier M, Vidal V, Porchet HC, Hartung HP. "Temelimab, a Humanized Monoclonal

Antibody Against the Envelope Protein of Multiple Sclerosis-Associated Endogenous Retrovirus: A First-in-Humans

Randomized Clinical Study". Clin Ther 2012, 34:2268-78.

Derfuss T, Curtin F, Guebelin C, Bridel C, Rasenack M, Matthey A, Du Pasquier R, Schluep M, Desmeules J, Lang AB,

Perron H, Faucard R, Porchet H, Hartung HP, Kappos L, Lalive PH. "A phase IIa randomized clinical study testing

Temelimab, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous

retrovirus in multiple sclerosis patients — a twelve month follow-up". J Neuroimmunol. 2015 Aug. 15; 285:68-70.

Derfuss T, Curtin F, Guebelin C, Bridel C, Rasenack M, Matthey A, Du Pasquier R, Schluep M, Desmeules J, Lang AB,

Perron H, Faucard R, Porchet H, Hartung HP, Kappos L, Lalive PH. "A phase IIa randomised clinical study of Temelimab,

a humanised monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus in

multiple sclerosis patients". Mult Scler. 2015 Jun; 21(7):885-93.

Curtin F, Vidal V, Bernard C, Lang AB, Porchet H. "Serum and Cerebrospinal Fluid Pharmacokinetics of the new IgG4

Monoclonal Antibody Temelimab to treat multiple sclerosis: a Phase I Study". MAbs. 2016 Jul; 8(5): 854–860.

GeNeuro SA – 2023 Universal Registration Document

highly regarded industry consultants as required to assist it. Some of the regulatory matters successfully conducted

by the Company include:

•

Organization of scientific advice meetings/requests with the following Health Authorities: Paul-Ehrlich Institute

(PEI) Germany

in 2010

and in 2014 (with respect to Quality, Non-Clinical and Clinical aspects); and

Swissmedic in 2012 (with respect to Non Clinical and Clinical aspects) and the European Medicines Agency

(EMA), London, UK in 2013. The scientific advice sought from PEI and Swissmedic concerned development

of temelimab in MS and from EMA relating to quality, non-clinical and clinical issues with respect to another

intended indication (chronic inflammatory demyelinating polyneuropathy).

•

SME status with the EMA: GeNeuro Innovation SAS, a subsidiary of GeNeuro SA, has obtained SME status

from the EMA (EMA SME number: EMA/SME/080/10/R3).

•

Approval by the EMA of the Pediatric Investigation Plan for temelimab in MS in 2017

•

Orphan Drug Designation for temelimab for CIDP by the FDA in 2018.

5.8 Material Events having an Impact on the Information set forth in Sections 5.1 to 5.3

None.

5.9 Degree of the Company's Dependence on Patents, Licenses, Manufacturing and

Commercial or Financial Agreements or new Manufacturing Processes

For a description of the risk factors relating to manufacturing agreements with CROs and CMOs, and patent licenses

with bioMérieux and INSERM, please see Section 3.4, "Risks Related To The Company's Dependency on Third

Parties Risks" and Section 3.5, "Risks Relating To The Company's Intellectual Property Rights of this Universal

Registration Document.

5.10 Factual Basis for any Statement by the Company about its Competitive Position

Except for estimates made by the Group as of the date of this Universal Registration Document, the facts on which

statements about the Group's competitive position are derived come principally from the following sources:

Atlas Multiple Sclerosis 2013; UK Multiple Sclerosis Trust; US National MS Society

Sorensen S. "New Management Algorithms in Multiple Sclerosis", Current Opinion Neurology 2014

www.clinicaltrials.gov

Scientific publications about clinical trial results

Annual reports of companies active in the field; and

BioMed tracker.

5.11 Investments

5.11.1 Historical Investments

Investments in tangible fixed assets have historically been limited to specific laboratory equipment as well as

information technology equipment. The first-time application of IFRS 16 as of January 1, 2019 using the modified

retrospective approach resulted in a € 913 thousand increase in the Company's financial liabilities and an increase

in property, plant and equipment for the same amount Intangible property investments include the cost of exclusive

licenses to bioMérieux patents in 2006 and the 2016 milestone payment, the cost of the exclusive license to NIH

for the jointly owned patent in 2018 as well as the acquisition costs of various software programs. Please see Notes

3 and 4 to the consolidated financial statements for the year ended 31 December 2021 set forth in CHAPTER 18

of this Universal Registration Document.

5.11.2 Pending Investments

None.

5.11.3 Future Investments

The Group does not expect at this stage to have to undertake investments over €250 thousand, to keep its computer

equipment and its laboratories in line with its growth and development.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 7.

ANALYSIS OF FINANCIAL CONDITION AND RESULTS

Readers are urged to read the following information and comments relating to the financial condition and results of

the Company and of its subsidiaries together with this entire Universal Registration Document and especially the

Group's consolidated financial statements and the notes thereto prepared in accordance with IFRS for the years

ended December 31, 2023 and 2022, reproduced with the notes thereto in CHAPTER 18 of this Universal

Registration Document.

The discussion of the financial statements set forth in this CHAPTER 7, "Analysis of Financial Condition and

Results" and CHAPTER 8, "Cash and Equity" of this Universal Registration Document has been prepared solely on

the basis of the consolidated financial statements prepared in accordance with IFRS, as issued

by the IASB,

included in CHAPTER 18, "Information Regarding the Company's Assets, Financial Situation and Results" of this

Universal Registration Document.

7.1 Financial Condition

7.1.1 General Discussion

GeNeuro is a clinical-stage biopharmaceutical company focused on the development of novel treatments of Human

Endogenous Retroviruses (or HERV)-mediated diseases, including diseases or disorders of the central nervous

system and other diseases induced by HERVs. Since its formation, GeNeuro has devoted its resources primarily

to the development of novel treatments for MS. GeNeuro's most advanced candidate, temelimab, is a humanized

monoclonal antibody that neutralizes a HERV protein called W-ENV which has been identified as a potential key

factor fueling the inflammatory and neurodegenerative components of MS. The Company believes that temelimab

is the first treatment against a suspected causal factor of MS and, as such, temelimab has the potential to offer a

safe and effective treatment that does not affect the patient's immune system, and which could slow or even stop

disease progression in all major forms of MS. In addition, W-ENV has been found at high levels in the blood of

about a third of patients suffering from severe neuropsychiatric consequences of COVID-19, (PASC, post-COVID

or Post-COVID. W-ENV is known to have a direct pathogenic effect on nervous system cells, translating into

neuropsychological (impaired cognitive functions), psychiatric (depression, anxiety) and neurological symptoms

(dysautonomia, sleep disorders), often observed in Post-COVID patients more than three months after the acute

phase Post-COVID has become a major public-health concern worldwide, affecting millions of individuals. While

most patients recover over time, there is a part of the population whose symptoms remain severe and are deeply

affected in their quality of life and ability to work.

The Company was formed on February 6, 2006 and, in 2009, formed a French subsidiary, GeNeuro Innovation, to

pursue research, then in 2016 formed an Australian subsidiary, GeNeuro Australia Pty Ltd, to conduct a clinical trial

in that country starting in 2017. Following completion of trial activities in Australia, this latter subsidiary was

liquidated during 2021.

At this stage, research and development has absorbed the majority of the resources of the Group, which has

devoted approximately 81% of its financial resources in 2023, and 75% in 2022, to research and development.

Since its formation, the Group has been financed primarily by successive capital increases, including the €33 million

capital increase completed in 2016 in connection with the Company's initial public offering (IPO) on Euronext's

regulated market in Paris, the €17.5 million capital increase completed in January 2020 through a private placement,

the €6.0 million capital increase completed in July 2021 through a private placement, the €7.7 million capital

increase completed in May 2022 through a private placement and the €5 million capital increase completed in

February 2024 through a private placement and a public offering via the PrimaryBid platform. The Group has also

received limited research subsidies, particularly from Bpifrance and the European Union in connection with the

Psych-Aid program, as well as research tax credits for work conducted by its French and Australian subsidiaries.

Finally, the Group has been selected as one of the four projects retained by the Swiss FOPH within the framework

of the CHF 50 million "Federal Funding Programme for COVID-19 Medicines" incentive to receive a grant of 6.7

million Swiss francs (€6.4 million) to co-fund (up to 50%) a Phase II clinical trial to treat patients with long-standing

COVID who exhibit neuropsychiatric symptoms, and has in March 2023 entered into a credit agreement for a total

amount of up to EUR 25 million with the European Investment Bank ("EIB"), supported by the InvestEU programme,

including a first tranche of €7 million, which was drawn in March 2023 and is intended to support the Phase 2 clinical

trial in Post-COVID.

Since the Group is active only in research and development, its operations during the various periods discussed

are organized under a single segment, "Research and Development of Pharmaceutical Products."

GeNeuro SA – 2023 Universal Registration Document

7.1.2 Principal Factors Having an Impact on the Group's Business and Profit (Loss)

In light of the Group's stage of development, historical results principally reflect the research and development

expenses of its product, temelimab.

The principal factors having an impact on the Group's business and operations, financial condition, profit and loss,

growth and development, and prospects are:

•

the scale of the Group's research and development programs, adherence to their development schedule,

and opportunities for developing new indications;

•

the generation of new pre-clinical and clinical data making it possible to confirm the therapeutic potential of

treatments based on the neutralization of HERVs;

•

the ability of the Group to finance its operations, including by equity increases and research subsidies.

7.1.3 Summary of Key Accounting Principles and Methods

The Group's financial statements for the financial years ended December 31, 2023 and 2022, which are reproduced

with the notes thereto in CHAPTER 18, "Information Regarding the Company's Assets, Financial Situation and

Results" of this Universal Registration Document, have been prepared in accordance with IFRS, as issued

by the

IASB. Such financial statements have been prepared in accordance with historical cost convention, except for

certain financial instruments which are measured at fair value and the plan assets included in the calculation of the

defined benefit pension plan liability, which are also measured at fair value.

In connection with the preparation of the Group's financial statements in accordance with IFRS, the Company has

exercised judgments and made estimates that could influence the amounts presented in respect of assets and

liabilities on the date of preparation of the financial statements and of revenue and expense for the period. Such

estimates have been made by the Company on a going concern basis in accordance with information available at

the time when such judgments and estimates were made. Such estimates are continuously evaluated and are

based on past experience as well as various other factors that have been deemed reasonable and that constitute

the basis for analyzing the book value of assets and liabilities. These estimates may be revised, if the circumstances

on the basis of which they were made change, or if new information becomes available. The Company's actual

results of operations may differ significantly from such estimates if the assumptions or conditions should change.

The Company believes that the most significant estimates or judgments involved in the preparation of the financial

statements are described below. For a more detailed description of the accounting principles and methods applied

by the Group, please see Note 2 of the consolidated financial statements included in CHAPTER 18 of this Universal

Registration Document.

Recognition of Revenue from Collaborative Agreements

There were no revenues from Collaborative Agreements recognized in 2023 or 2022.

Intangible Assets

Research and development expenses

Research and development costs are recognized as expenses when they are incurred. Costs incurred on

development projects are recognized as intangible assets when the following criteria are fulfilled:

•

it is technically feasible to complete the intangible asset so that it will be available for use or sale;

•

management intends to complete the intangible asset and use it or sell it;

•

there is an ability to use or sell the intangible asset;

•

it can be demonstrated how the intangible asset will generate probable future economic benefits;

•

adequate technical, financial, and other resources necessary to complete the development and to use or sell

the intangible asset are available; and

•

the expenditure attributable to the intangible asset during its development can be reliably measured.

In the opinion of management, due to uncertainties inherent in the development of the Group's products, the criteria

for development costs to be recognized as an asset, as prescribed by IAS 38, "Intangible Assets," are not met.

As a result, internal development expenses incurred (mainly consisting of the cost of pre-clinical experiments,

clinical trials, and the production cost of temelimab) are recognized under "research and development expenses"

when they are incurred.

Licenses

GeNeuro SA – 2023 Universal Registration Document

Licenses acquired by the Company to access intellectual property are recognized under intangible assets. The

amortization of such licenses over their useful lives shall start upon marketing approval of the related products

(please see Notes 19.3 and 19.4 of the Notes to the Group's consolidated financial statements set forth in

CHAPTER 18, "Information Regarding the Company's Assets, Financial Situation and Results" of the Universal

Registration Document).

Subsidies and Grants

Grants received from public entities to subsidize certain types of expenditure are recognized when there is

reasonable assurance that the entity will comply with the conditions attached to obtaining the grants. They are

recognized as a reduction in the related expenditure, in this case research and development ("R&D") expenses.

Contributions received from academic institutions are recognized as a reduction in R&D expenses, in a constant

proportion to the corresponding expenditure so as to maintain the principle of matching income with related

expenses.

Research Tax Credits

The Group receives certain specific project-related research tax credits ("RTC") that are granted to companies

incorporated in France as an incentive for technical and scientific research. Companies with expenses that meet

the eligibility criteria receive a tax credit that (i) can offset against corporate income tax due in the year in which it

is granted, as well as in the following three financial years, or, (ii) under certain circumstances, can be paid to the

Company.

Until 2019, the Group has also benefited from research tax credits for its activities in Australia for the research of

new treatments against Type 1 diabetes linked to endogenous retroviruses. This research tax credit scheme

provided a tax credit of 43.5% of admissible research expenses.

The Group considers the research tax credits received from French and Australian tax authorities as government

grants as the tax credits are received independently from tax payments of the Group. The Group recognizes these

credits in the consolidated statement of financial position within other current receivables given the expected time

of collection, and in the consolidated income statement under research and development subsidies. The credits are

recognized in the year in which the eligible expenses giving rise to the tax credit are incurred.

Bpifrance repayable advance

A repayable advance was granted to the Company's subsidiary, GeNeuro Innovation, by Bpifrance in September

2011 to provide financial support to the Group in conducting a clinical trial and developing a diagnostic test for CIDP

subject to a 70% waiver in case of failure of the program. In January 2023, Bpifrance acceded to GeNeuro

Innovation's request to consider the program a failure and confirmed the debt waiver of the 70% balance,

representing a gross amount of € 140K. Accordingly, the Bpifrance advance was presented as a non-current liability

at December 31, 2022 for €139K. The advance is described in Note 10.1 of the Notes to the Group's consolidated

financial statements set forth in CHAPTER 18 of the Universal Registration Document.

Forgivable loan

On December 13, 2021, GeNeuro entered into a subsidy contract with the FOPH for the financing of its Post-COVID

project testing temelimab in Post-COVID (or "Post-COVID") patients with neuro-psychiatric symptoms. Pursuant to

this contract, GeNeuro issued an invoice to the FOPH of CHF 3,090K (€ 2,991K) for the first instalment payment,

which amount is included within the "Other" receivables as of December 31, 2021 (see Note 6). The subsidy contract

allows the FOPH, in case of success of the project leading to a marketing authorization for the Company's drug in

Post-COVID, to apply the amount of the subsidy to the purchase price, at market levels, of temelimab for the Post-

COVID indication. Due to this component of the contract, GeNeuro considers that it has received a forgivable

conditional loan from the FOPH, as defined in IAS 20, and that it has accordingly benefitted from a government

loan at a below-market rate and the amount to be received as of Dec. 31, 2021 was therefore considered as a

liability. Under IAS 20, since the conditional loan does not bear annual interest, it is treated as an interest-free loan

for the Company (i.e. under conditions more favorable than market rates), and the difference between the amount

of the advance at historical cost and the advance discounted at market rates is considered as a public grant, in an

amount of €

467.8K for 2021. The first instalment payment was received in January 2022; in addition, a second

instalment payment of CHF 2,289.7K (€ 2,325.3K) was received in September 2022.

Evaluation of Purchase Options Granted to Employees, Executives, and Outside Service Providers

The determination of the fair value of payments made to employees, executives, and outside service providers

based on shares is based on the Black & Scholes option valuation model which makes assumptions about complex

and subjective variables. Such variables include notably the value of the Company's shares, the expected volatility

in the share price over the lifetime of the instrument, and the present and future behavior of the holders of those

instruments. There is a high, inherent risk of subjectivity when using an option valuation model to measure the fair

value of share-based payments in accordance with IFRS 2.

GeNeuro SA – 2023 Universal Registration Document

The fair value of the options is thus measured by taking into consideration the following valuation assumptions,

which are set forth in Note 9 of the consolidated financial statements:

•

the price of the underlying shares is deemed to be equal to the investor's subscription price, or is calculated

by reference to internal valuations;

•

the risk-free rate is selected by reference to on the average lifetime of the instruments; and

•

volatility is estimated by reference to a sample of listed companies in the biotechnology sector, at the date

when instruments are granted and over a period equivalent to the lifetime of the option.

The table below sets forth the assumptions used to calculate the fair value of the share purchase options in

accordance with IFRS 2 for the financial years ended December 31, 2023 and 2022:

Grants

Number

options

issued

Exercise

price

and

currency

Exercise

period

Volatility

Non-

risk

rate

Fair value

on the date

of grant in

accordance

with IFRS 2

(Black

&Scholes)

in EUR

Stock Purchase Options 04/2010 (1)

123,000 CHF 4.00

5 years

50.5%

1.11%

1.46

Stock Purchase Options 04/2013 (1)

3,000

CHF 4.00

5 years

50.3%

0.05%

1.41

Ordinary C shares granted to directors 11/2015

(2)

45,000

N/A

27.99

Performance Share Option Units (PSOU)

624,282

06/2016

€ 13.00

5 years

58.8%

-1.09%

2.29

Performance Share Option Units (PSOU)

35,000

01/2017

€ 13.00

5 years

53.6%

-0.86%

2.48

Performance Share Option Units (PSOU)

15,000

02/2017

€ 13.00

5 years

53.6%

-0.87%

1.74

Performance Share Option Units (PSOU)

20,000

02/2018

€ 13.00

5 years

50.0%

-0.77%

0.14

Stock-Options 02/2017

42,500

€ 13.00

5 years

53.6%

-0.94%

2.50

Stock-Options 02/2017 (plan 2)

7,500

€ 13.00

5 years

53.60%

-0.94%

2.35

Stock-Options 02/2018

22,500

€ 13.00

5 years

50.0%

-0.75%

0.80

Stock-Options 09/2018

158,540

€ 2.73

10 years

50.0%

0.00%

1.74

Stock-Options 03/2020

151,500

€ 3.34

10 years

49.4%

-0.58%

0.97 (2)

Stock-Options 12/2020

30,000

€ 2.95

10 years

53.6%

-0.71%

1.09 (2)

Stock-Options 02/2021

184,800

€ 3.19

10 years

63.0%

-0.57%

1.19 (2)

Stock-Options 03/2022

203,627

€ 3.48

10 years

56.0%

-0.23%

1.64 (2)

Stock-Options 04/2023

237,694

€ 2.86

10 years

63.0%

0.65%

0.82 (2)

(1) Reflects the number of PSOUs granted originally; the actual number of stock options granted in February 2019, at the end of the PSOU Plan,

is 602,335 for the 2016 Plan, 36,400 and 15,000, respectively, for the 2017 Plans and 18,500 for the 2018 Plan.

(2) Average fair value.

Stock options are valued on the basis of management assumptions on the likely exercise horizons for each option,

which are in certain cases split in two parts (1 and 2), with different volatility and risk-free rates used to value the

stock options using the Black & Scholes model.

7.1.4 Presentation of Principal Items of Consolidated Profit and Loss Statement

7.1.4.1 Revenue and Operating Profit and Loss

Given the stage of clinical development of its most advanced product, the Group has not earned any revenue from

product sales as of the date hereof.

The Group's research and development activities, given the significant financial resources involved, have generated

operating losses and have not generated operating revenue other than that resulting from the execution of

partnering and licensing agreements providing for lump-sum payments and royalties.

7.1.4.2 Research and Development

The Company conducts research and development on therapies associated with the presence of HERVs with first

indications for MS and for neuropsychiatric symptoms of Post-COVID.

GeNeuro SA – 2023 Universal Registration Document

During the years under review, the Company has devoted a significant part of its resources to the development of

such therapies. Research and development expenses are set forth in Note 14 of the annual financial statements,

which are reproduced set forth in CHAPTER 18 of the Universal Registration Document.

In accordance with IAS 38, development expenses may be recorded as intangible assets only if the Company can

show that the six criteria (described in Section 7.1.3 of the Universal Registration Document) for recording an asset

have been met. The Company has determined that these criteria are not met at this stage. Accordingly, internal

development expenses, consisting principally of expenses for pre-clinical and clinical studies, are recorded as

expenses in the line item Research and Development, when incurred.

Principal research and development expenses are:

•

the cost of research and conducting pre-clinical and clinical studies on temelimab for MS and Post-COVID;

•

the cost of developing and manufacturing the monoclonal antibody temelimab in accordance with GMP;

•

personnel expenses for members of the research and development team; and

•

expenses for protection of intellectual property.

Product candidates at advanced stages of clinical development generally have higher development costs than those

in the initial stages of clinical development, principally because of the increase in the size and duration of such

clinical trials. The Company expects that its research and development expense will continue to increase inasmuch

as it intends to initiate clinical trials for various product candidates while pursuing the later stages of clinical

development for temelimab for MS and Post-COVID.

7.1.4.3 General and Administrative Expenses

General and administrative expenses consist principally of:

•

compensation for administrative staff;

•

the fees of outside advisors; and

•

overhead costs for the rental of office space and the general expenses of the management of the Company,

including travel expense.

The Company applies a strict policy for incurring expenses, particularly for general and administrative expense,

so that it can devote its resources primarily to pre-clinical and clinical development.

7.1.4.4 Financial Income and Expenses

Net financial income and expenses consist essentially of:

•

interest on time deposits; and

•

currency exchange gains and losses in connection with payments made to foreign service providers in local

currencies.

7.2 Comparison Of The Financial Statements For The Two Years Ended December 31, 2023

and 2022

7.2.1 Constitution of Operating Loss and Net Loss

SIMPLIFIED INCOME STATEMENT

(in thousands of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Income

Research and development expenses

(12,492.1)

(9,833.2)

Subsidies

1,143.4

1,825.8

General and administrative expenses

(3,008.6)

(3,221.8)

Operating expenses

(14,357.3)

(11,229.2)

Operating loss

(14,357.3)

(11,229.2)

Net loss

(14,757.0)

(12,199.8)

GeNeuro SA – 2023 Universal Registration Document

7.2.1.1 Revenue

Given that its product is still at an early stage of development, the Company did not earn any revenue from product

sales during the financial years ended December 31, 2023 and 2022.

INCOME

(in K of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Income

Total Income

There was no revenue in 2023 or 2022.

7.2.1.2 Operating Expenses by Function

Research and development expenses

Research and development expenses during the financial years presented were as follows:

RESEARCH AND DEVELOPMENT

(in thousands of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Studies and research

(9,622.8)

(6,984.3)

Intellectual property

(305.2)

(267.1)

Travel and assignments expenses

(64.0)

(64.5)

Raw materials and consumables

(28.1)

(29.0)

Rental expenses

(46.6)

(41.5)

Professional fees

(146.3)

(178.5)

Payroll expense

(2,032.4)

(1,992.1)

Amortization and depreciation

(186.7)

(157.9)

Share based payment expense

(57.3)

(60.7)

Other

(2.7)

(57.6)

Research and Development expenses

(12,492.1)

(9,833.2)

Research tax credit

555.9

1,316.4

Other subsidies

587.5

509.4

Subsidies

1,143.4

1,825.8

Net research and development expense

(11,348.7)

(8,007.4)

Research and development expenses increased by €2.7 million in 2023 compared to 2022, due to the expenses

incurred in connection with the Post-COVID program, which led to an increase of €2.6 million in studies and research

in connection with the GNC-501 clinical trial.

Research & development payroll expense increased by €0.1 million, as the Company increased its clinical team to

manage the Post-COVID trial.

Other costs remained broadly in line with the levels observed in 2022.

Despite the higher level of studies and research expenses, subsidies (under the form of research tax credits linked

to R&D activities) decreased by €0.8 million in 2023 over 2022 as the bulk of the Company's GNC-501 Phase 2

clinical trial activities are conducted out of the Swiss parent and are therefore not eligible for French Research Tax

Credit; other subsidies increased from K€ 509 to K€ 588; these other subsidies include K€ 140 of debt cancellation

from Bpifrance in connection with the K€ 200 reimbursable advance that had been granted to GeNeuro Innovation

SAS in 2011, K€ 182 from the European Union HERVCOV grant and K€ 265 of subsidies accounted for in

connection with the Swiss FOPH grant.

GeNeuro SA – 2023 Universal Registration Document

General and administrative expenses

General and administrative expenses during the financial years presented were as follows:

GENERAL AND ADMINISTRATIVE

EXPENSES

(in thousands of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Travel and assignments expenses

(199.1)

(146.2)

Office expenses

(40.4)

(36.7)

Rental expenses

(36.1)

(39.3)

Professional fees

(864.0)

(876.8)

Payroll expense

(1,482.2)

(1,702.3)

Tax expense

(1.5)

(12.7)

Insurance expense

(69.1)

(69.2)

Postal and telecom expenses

(29.5)

(27.4)

Amortization and depreciation

(107.1)

(130.6)

Share based payment expense

(188.1)

(174.5)

Other

8.5

(6.1)

General and administrative expenses

(3,008.6)

(3,221.8)

In 2023, general and administrative expenses decreased by €0.2 million, as GeNeuro cancelled the cash bonuses

for all and management, resulting in a reduction of payroll expense by €0.2 million in 2023 compared to 2022.

7.2.1.3 Financial Income (Expenses)

FINANCIAL INCOME (EXPENSES), NET

(Amounts in thousands of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Change in fair value of derivatives

806.9

Other financial income

75.8

7.6

Share based expense related to capital increase

at discount to market

(589.2)

Other financial expenses

(952.6)

(269.3)

Foreign exchange gains (losses)

(325.6)

(117.6)

Financial income (expenses), net

(395.5)

(968.5)

In 2023, in connection with drawdown of the first €7 million tranche from the EIB Credit Facility, the Company issued

to the EIB a total of 642,031 share purchase warrants at an exercise price of €2.58 per share and an initial aggregate

valuation of K€ 1,106. Due to the decrease at December 31, 2023 of the Company's share price compared to the

exercise price, these warrants were valued at December 31, 2023 at K€ 299, leading to the above K€ 807 change

in fair value of the derivatives.

Other financial expenses increased due to the drawdown of the first €7 million tranche from the EIB Credit Facility,

which carries interest of 9% p.a. (of which 2% p.a. payable in cash and 7% p.a. to be capitalized until maturity).

In 2022, the share-based expense is related to the capital increases completed in May 2022 and July 2021 through

private placements. Because both capital increases were not open to all existing shareholders but were restricted

to certain selected institutional investors, pursuant to IFRS 2 the discount between the share price prior to the capital

increase and the actual issue price (€3.75 vs €3.48 for the 2021 capital increase, and €3.08 per share vs €2.86 per

share for the 2022 capital increase) is considered a share based payment, resulting in a charge of € 467K for 2021

and € 589K for 2022, accounted within financial expenses, with a corresponding amount added to reserves within

shareholders' equity.

The Group's financial income derives essentially from interest earned on its euro cash balances.

7.2.1.4 Income Tax

INCOME TAX (EXPENSE) / INCOME

(Amounts in K of EUR)

31 Dec. 2023

Audited

12 months

31 Dec. 2022

Audited

12 months

Deferred tax

Withholding tax

Income tax (expense) / income

GeNeuro SA – 2023 Universal Registration Document

Deferred tax assets are recorded when it is probable that the Company will have future taxable earnings against

which cumulative tax loss carryforwards may be used. In application of this principle, in light of the Group's earnings

prospects, no deferred tax assets were recorded as of December 31, 2023 or 2022. The amount of € 4.2K in tax

expense shown in the income statement is a Swiss tax on capital and is therefore excluded from the table above

which relates to taxes on income.

7.2.1.5 Earnings Per Share

RESULT PER SHARE

31 Dec. 2023

Audited

31 Dec. 2022

Audited

12 months

Weighted average number of outstanding shares

24,843.4

23,898.3

Net result for the period (in K of EUR)

(14,757.0)

(12,198.8)

Basic losses per share (EUR/share)

(0.59)

(0.51)

Diluted losses per share (EUR/share)

(0.59)

(0.51)

During the 2022 financial year, the Group recorded an increase of €5.4 million in its net loss, resulting primarily from

a €4.8 million increase in its operating loss, and from a €0.5 million increase in its financial expenses.

Losses per share were also impacted by the increase in the weighted average number of shares due to the capital

increase completed in May 2022.

7.2.2 Analysis of Statement of Financial Position

7.2.2.1 Non-currents Assets

NON-CURRENT ASSETS

(in thousands of EUR)

31 Dec. 2023

Audited

31 Dec. 2022

Audited

Intangible assets

1,152.3

1,139.8

Property, plant and equipment

742.1

992.9

Non-current financial assets

260.8

249.5

Non-current receivables

1,872.3

Total non-current assets

4,027.5

2,382.2

Intangible assets consist essentially of license rights acquired from bioMérieux in 2006, upon the formation of the

Company, and of milestone payments related thereto and due at the time of launching clinical trials.

Property, plant and equipment consist principally of laboratory equipment specific to the Group's research

operations and reflects the application of IFRS 16 as of January 1, 2019.

Non-current financial assets include the cash reserve related to the liquidity contract (described in Note 8 of the

financial statements for the year ended 31 December 2023) and security deposits related to the leases of the

Company's premises.

Non-current receivables consist of the French research tax credit receivables (€1.3 million

with respect to 2022 and €0.6 million with respect to 2023); the 2022 French research tax credit receivable was pre-

financed through a bank financing of €1 million in January 2024.

7.2.2.2 Current Assets

CURRENT ASSETS

(in thousands of EUR)

31 Dec. 2023

Audited

31 Dec. 2022

Audited

Other current assets

507.0

3,495.0

Cash and cash equivalents

1,827.4

5,593.3

Total current assets

2,334.4

9,088.3

Other current assets in 2022 consisted essentially of the French research tax credit receivables of €1.3 million, of

advance payments comprise payments made to service providers involved with the Company's clinical trials (€1.3

million at December 31, 2022).

Cash and cash equivalents consist of excess cash in bank accounts.

GeNeuro SA – 2023 Universal Registration Document

7.2.2.3 Equity

EQUITY

(in thousands of EUR)

31 Dec. 2023

Audited

31 Dec. 2022

Audited

Capital

1,100.2

Additional paid-in capital

33.6

27,157.0

Cumulative translation adjustments

202.2

Accumulated comprehensive income (loss)

(100.0)

628.7

Treasury shares

(796.1)

(794.7)

Accumulated deficit attributable to owners of the parent

(14,217.9)

(26,829.7)

Equity attributable to owners of the parent

(13,778.0)

1,463.7

Total Equity

(13,778.0)

1,463.7

The Company's capital as of December 31, 2023 was CHF 1,249,951.40 (€ 1,100K) divided into 24,999,028 fully

paid shares each with a nominal value of CHF 0.05 (unchanged from December 31, 2022). At the 14 June 2023

Annual General Meeting of Shareholders, shareholders decided to allocate €30 million from the additional paid-in

capital to "other reserves", included within accumulated deficit attributable to owners of the parent.

Net changes in the Group's net equity during the dates presented result principally from the annual losses for the

periods under review, reflecting research and development expenses incurred by the Group.

7.2.2.4 Non-current Liabilities

NON-CURRENT LIABILITIES

(in thousands of EUR)

31 Dec. 2023

Audited

31 Dec. 2022

Audited

Employee benefit obligations

928.3

153.8

Non-current financial liabilities

12,509.3

6,517.9

Non-current derivative liabilities

299.4

Other non-current liabilities

42.6

26.0

Total non-current liabilities

13,779.6

6,697.7

Obligations to employees include a provision for retirement obligations for GeNeuro's employees located in

Switzerland as well as retirement indemnities for employees of its French subsidiary, GeNeuro Innovation (please

see CHAPTER 18 of the Universal Registration Document). Employee benefit obligations increased in 2023 largely

due to actuarial changes in financial assumptions resulting from the change in market conditions, which led to an

increase of gross employee benefit obligations of €0.8 million compared to December 31, 2022.

Non-current financial liabilities include, at December 31, 2022, a repayable advance granted by Bpifrance to

GeNeuro Innovation, the balance of which was forgiven in January 2023. In addition, they include:

the long-term portion of a three-year non-secured bank loan for €0.5 million at December 31, 2022 and

€0.2 million at December 31, 2023;

the long-term portion of the lease liabilities pursuant to IFRS 16 for €0.7 million at December 31, 2022 and

€0.5 million at December 31, 2023;

the EIB Venture Debt loan, for € 6,319K at December 31, 2023 (IFRS value of a gross €7 million amount);

this loan was drawn in March 2023;

for € 5,630K at December 31, 2023 and € 5,136K at 31 December 2022, the FOPH subsidy deemed to be

a forgivable loan from FOPH for the financing of its Long-COVID project. The subsidy contract allows the

FOPH, in case of success of the project leading to a marketing authorization for the Company's drug in

Post-COVID, to apply the amount of the subsidy to the purchase price, at market levels, of temelimab for

the Long-COVID indication. Due to this component of the contract, GeNeuro considers that it has received

a forgivable conditional loan from the FOPH, as defined in IAS 20, and that it has accordingly benefitted

from a government loan at a below-market rate and the amount to be received as of Dec. 31, 2021 was

therefore considered as a liability. Under IAS 20, since the conditional loan does not bear annual interest,

it is treated as an interest-free loan for the Company (i.e. under conditions more favorable than market

rates), and the difference between the amount of the advance at historical cost and the advance

discounted at market rates is considered as a public grant, in an amount of € 115K and € 148K, respectively

for 2022 and 2023. The first instalment payment was received in January 2022; in addition, a second

instalment payment of CHF 2,289.7K (€ 2,325.3K) was received in September 2022. Refer to Section

8.1.4, "Funding Through Repayable Advances and Subsidies" of the Universal Registration Document.

GeNeuro SA – 2023 Universal Registration Document

CHAPTER 8.

CASH AND EQUITY

Readers are urged to review Notes 6, 7, 8 and 10 of the Notes to the Group's consolidated financial statements

prepared in accordance with IFRS for the financial years ended December 31, 2023 and 2022 set forth in CHAPTER

18 of this Universal Registration Document.

8.1 Information About Equity, Liquidity, And Sources Of Funds

As of December 31, 2023 and 2022, the net amount of cash and cash equivalents owned or held by the Group

(consisting of excess cash assets) as well as liquid investments (in the form of short-term deposits) was €5.6 million

and €5.5 million, respectively.

CASH AND LIQUID INVESTMENTS

(in thousands of EUR)

31 Dec. 2023

Audited

31 Dec. 2022

Audited

Cash and cash equivalents

1,827.4

5,593.3

Total cash and liquid investments

1,827.4

5,593.3

Since its formation, the Group has been financed primarily by successive capital increases. Please see Section

3.2.1 for further details of the Company's cash strategy, its financing and funding strategy, and its exposure to risks

linked to financial instruments and securities.

The Group has also received research subsidies, particularly from Bpifrance and the European Union in connection

with the Psych-Aid program, as well as research tax credits for work conducted by its French subsidiary. In addition,

the Group has been selected as one of the four projects retained by the Swiss FOPH within the framework of the

CHF 50 million "Federal Funding Programme for COVID-19 Medicines" incentive to receive a grant of 6.7 million

Swiss francs (€6.4 million) to co-fund (up to 50%) a Phase II clinical trial to treat patients with long-standing COVID

who exhibit neuropsychiatric symptoms (refer to sub-section 8.1.4) and in March 2023 has entered into a credit

agreement for a total amount of up to EUR 25 million with the European Investment Bank ("EIB"), supported by the

InvestEU programme, including a first tranche of €7 million, available immediately, which is intended to support the

Phase 2 clinical trial in Post-COVID.

8.1.1 Financing by Equity Capital

Until 2015, the Group had raised, by contributions from the founders and successive capital increases, a total of

CHF 28.7 million (€23.4 million at the applicable historical exchange rates between 2006 and 2014). Capital

increases from 2008 to 2015 have been fully subscribed by the Group's two historical shareholders, Eclosion2 &

Cie SCPC and Institut Mérieux. In 2016, in the context of its initial public offering on Euronext's regulated market in

Paris, the Group completed a new capital increase of €33 million, increasing the total amount of funds raised from

capital increases to €56.4 million.

On February 4, 2020, the Group completed a €17.5 million capital increase through an international private

placement open only to certain qualified and institutional investors (the "2020 Offering") at an issue price of €2.95

per share, determined through a book-building process. After deduction of the loan set-off (see below) and issuance

expenses and taxes, the net amount raised by the Company was € 9 million.

On July 13, 2021, the Group completed a €6.0 million capital increase through an international private placement

open only to certain qualified and institutional investors (the "Offering") at an issue price of €3.48 per share,

determined through a book-building process. After deduction of issuance expenses and taxes, the net amount

raised by the Company was € 5.4 million.

On May 13, 2022, the Group completed a €7.7 million capital increase through an international private placement

open only to certain qualified and institutional investors (the "Offering") at an issue price of €2.86 per share,

determined through a book-building process. After deduction of issuance expenses and taxes, the net amount

raised by the Company was € 7.0 million.

On February 2, 2024, GeNeuro completed a €5 million capital increase with cancellation of the preferential

subscription rights through an international private placement reserved for specialized or strategic investors of (the

"Private Placement") 4,666,901 new ordinary bearer shares of GeNeuro and through a public offering for retail

investors in France via the PrimaryBid platform (the "PrimaryBid Offer", and together with the Private Placement,

the "Offering") of 95,004 new ordinary bearer shares of GeNeuro. After deduction of issuance expenses and taxes,

the net amount raised by the Company was € 4.5 million.

GeNeuro SA – 2023 Universal Registration Document

8.1.2 Debt Financing

At December 31, 2023, the Company had the following debt financings:

An unsecured bank loan of €0.5 million, repayable over three years until June 2025;

An unsecured Venture Debt loan from the EIB, for a gross amount of €7 million, issued with warrants,

repayable at maturity in 2028;

The FOPH "forgivable loan" resulting from the IFRS treatment of the FOPH subsidy.

Refer to Section 8.1.4, "Funding Through Repayable Advances and Subsidies" of the Universal Registration

Document..

8.1.3 Financing by Leases

The first-time application of IFRS 16 as of January 1, 2019 using the modified retrospective approach resulted in a

€ 913 increase in the Company's financial liabilities and an increase in property, plant and equipment for the same

amount (see Note 7 and Note 4, respectively). The weighted average incremental borrowing rate applied by the

Company to lease liabilities recognized in the consolidated financial statements as of January 1, 2019 was between

1.5% to 2% for property leases and 5% for the other leases

8.1.4 Funding Through Repayable Advances and Subsidies

Bpifrance Repayable Advance

A repayable advance was made to the Company's subsidiary, GeNeuro Innovation, by Bpifrance on September 16,

2011 to support the Group financially in conducting a clinical trial and for development of a diagnostic test for CIDP.

The following table shows the changes in such repayable advance during the periods discussed.

(in thousands of EUR)

Bpifrance

reimbursable advance

At 31 December 2021

149.8

Reimbursement

(12.5)

Financial expenses

1.8

At 31 December 2022

139.1

Subsidies

(140.0)

Financial expenses

0.9

At 31 December 2023

On January 13, 2023, Bpifrance acceded to GeNeuro Innovation's request to consider the program a failure and

confirmed the debt waiver of the 70% balance, representing a gross amount of € 140K. Accordingly, the Bpifrance

advance is presented as a non-current liability at December 31, 2022. Refer to Note 10.1 of the Notes to the Group's

consolidated financial statements prepared in accordance with IFRS for the year ended 31 December 2023 set

forth in CHAPTER 18 of this Universal Registration Document.

FOPH Forgivable loan