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Onxeo Interim / Quarterly Report 2025
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Interim / Quarterly Report
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Société anonyme au capital de 4.888.478,61 euros Siège social : 49, boulevard du général Martial Valin – 75015 Paris 410 910 095 R.C.S. Paris
2025 HALF-YEAR FINANCIAL REPORT
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SOMMAIRE
| 1. | PREAMBLE | 4 |
|---|---|---|
| 2. | SCOPE OF THE GROUP | 5 |
| 3. | BUSINESS DEVELOPMENTS AND SIGNIFICANT EVENTS DURING THE FIRSTHALF OF THE FISCAL YEAR | 5 |
| 3.1.Research and development5 | ||
| 3.2.Financing6 | ||
| 3.3.Governance6 | ||
| 3.4.Key corporate communications during the first half of 20257 | ||
| 4. | IMPACT ON THE FINANCIAL POSITION AND RESULTS | 8 |
| 4.1.Review of accounts and results8 | ||
| 4.2.Cash position9 | ||
| 5. | MAIN RISKS AND UNCERTAINTIES FOR THE NEXT SEMESTER | 9 |
| 5.1.Financial risks9 | ||
| 5.2.Business risks10 | ||
| 5.3.Legal and regulatory risks10 | ||
| 5.4.Insurance and risk coverage11 | ||
| 5.4.Litigation11 | ||
| 6. | EXPECTED DEVELOPMENT OF THE GROUP'S SITUATION AND OUTLOOK | 11 |
| 6.1.Main future investments and financing strategy12 | ||
| 6.2.Significant Events Since the End of the Period12 | ||
| 7. | RELATED PARTY TRANSACTIONS | 14 |
| 8. | CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OFJUNE 30, 2025 | 14 |
| Consolidated Statement of Financial Position15 | ||
| Consolidated Statement of Comprehensive Income16 | ||
| Consolidated Statement of Changes in Equity17 | ||
| Consolidated Statement of Cash Flows18 | ||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS19 | ||
| NOTE 1: BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS19 | ||
| NOTE 2: CONSOLIDATION SCOPE19 | ||
| NOTE 3 : REPORTING ON OPERATING SEGMENTS (IFRS 8)20 | ||
| NOTE 4 : INTANGIBLE ASSETS20 |
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| NOTE 5 : RIGHT-OF-USE ASSETS | 20 | ||
|---|---|---|---|
| NOTE 6 : CURRENT ASSETS | 21 | ||
| NOTE 7 : CASH AND CASH EQUIVALENTS | 21 | ||
| NOTE 8 : SHAREHOLDERS' EQUITY | 22 | ||
| NOTE 9 : NON-CURRENT LIABILITIES | 25 | ||
| NOTE 10 : CURRENT LIABILITIES | 26 | ||
| NOTE 11 : OPERATING INCOME AND EXPENSES | 27 | ||
| NOTE 12 : FINANCIAL RESULT | 28 | ||
| NOTE 13 : EARNINGS PER SHARE | 28 | ||
| NOTE 14 : RELATED PARTIES | 29 | ||
| NOTE 15 : SUBSEQUENT EVENTS | 29 | ||
| 9. | CERTIFICATION OF THE PERSON RESPONSIBLE FOR THE INTERIMFINANCIAL REPORT | 30 | |
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1. PREAMBLE
Valerio Therapeutics(formerly Onxeo) (the "Company") is a biotechnology company developing innovative drug candidates through its two proprietary platforms: the V-body platform, which generates singledomain therapeutic antibodies, and the integrated chemistry platform, designed to develop immunoconjugates. The Company aims to advance novel or breakthrough compounds from early translational research to clinical proof of concept — a key value inflection point that is highly attractive to potential partners.
Valerio Therapeutics is listed on the Euronext Growth market in Paris.
The Company's portfolio includes:
- platON: Valerio Therapeutics' proprietary chemical platform for DNA decoy therapies, which generates novel and innovative compounds and expands the Company's product pipeline. The development of this platform has currently been deprioritized to focus resources on integrating the other two platforms — V-body and integrated chemistry.
- DecoyTAC: the third-generation evolution of the platON™, platform, leveraging the unique mechanism of action of DNA decoy therapies combined with targeted protein degradation (PROTAC) technology. This advancement extends platON™,'s activity beyond DNA repair by targeting other proteins, such as transcription factors, in oncology as well as in non-oncology indications, including inflammatory and muscular diseases. In 2024, an initial proof of concept was achieved targeting the oncoprotein c-Myc. As mentioned above, development of the PlaTONTM platform has been deprioritized.
- V-body platform: the acquisition of Emglev Therapeutics (a subsidiary of Valour Bio, itself wholly owned by Valerio Therapeutics) enabled the use of phage display technology to produce singledomain antibodies, known as V-bodies, from proprietary synthetic libraries. These V-bodies differ from traditional antibodies by their significantly smaller size — approximately one-tenth that of conventional antibodies. This size advantage allows for faster tissue penetration and access to otherwise difficult-to-reach targets, while retaining the binding and/or neutralizing functions of a full-length antibody.
Moreover, Valour Bio's proprietary libraries are humanized or fully human, reducing the potential for immunogenicity and toxicity. This humanization process enhances compatibility with the human immune system, potentially improving their tolerability as therapeutic agents.
The versatility of V-bodies enables targeting oftargeting a broad range of antigens, expanding their therapeutic applicability. Single-domain antibodies (SdAbs) have demonstrated strong potential in multiple disease areas, including autoimmune, inflammatory, and oncologic disorders. Their ability to bind effectively to diverse targets makes them valuable tools in the development of antibodybased therapies for complex diseases.
V-bodies can be applied in several therapeutic formats, such as bispecific T-cell engagers (BiTEs), antibody-drug conjugates (ADCs), and chimeric antigen receptor T-cells (CAR-Ts). ADCs are particularly noteworthy, as they can deliver a variety of payloads, including radioisotopes, chemotherapeutic agents, small molecules, or oligonucleotides. This diversity broadens the potential therapeutic applications across different patient populations, making V-bodies a promising platform in biomedicine.
In addition, V-bodies can potentially be administered through multiple routes — subcutaneous, inhaled, oral, or intravenous — offering a significant advantage over traditional antibodies that generally require intravenous administration.
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Overall, Valour Bio's V-body approach represents a major advancement in antibody-based therapeutics, addressing key limitations of conventional antibodies and providing new therapeutic opportunities.
• Integrated chemistry platform:
Major challenges associated with oligonucleotide-based therapies, such as siRNAs, include their short half-life and non-specific delivery. Combining the V-body platform with the integrated chemistry platform aims to leverage both innovations by:
- o Extending half-life through a V-body anti-albumin conjugated to siRNA;
- o Increasing specificity using V-bodies targeting tissue-specific receptors for delivery and conjugated to siRNA.
The Company strongly believes in the significant therapeutic potential and disruptive innovation of these technologies, which could pave the way for a new treatment paradigm in oncology, rare diseases, and inflammatory and autoimmune disorders.
2. SCOPE OF THE GROUP
The Group comprises the Company, which carries out the majority of its operations, and its subsidiaries, most of which have limited activity:
- Topotarget UK (company liquidated during 2024),
- Topotarget Switzerland,
- Valerio Therapeutics Inc.,
- Valour Bio,
- Emglev Therapeutics
3. BUSINESS DEVELOPMENTS AND SIGNIFICANT EVENTS DURING THE FIRST HALF OF THE FISCAL YEAR
3.1. RESEARCH AND DEVELOPMENT
3.1.1 VIO-01
The clinical development of VIO-01 was discontinued in early 2025 in order to redirect research and development efforts toward next-generation drug candidates derived from the Company's V-body and integrated chemistry platforms.
3.1.2 THIRD-GENERATION platONTM PLATFORM
Valerio Therapeutics has ceased optimization of the platON™, platform to concentrate on developing assets generated from its other two platforms — V-body and integrated chemistry.
3.1.3 NEW V-BODY PLATFORM
The Valour Bio platform will enable the diversification and expansion of the Company's portfolio toward additional oncology targets as well as non-oncology indications, including autoimmune, inflammatory, and rare genetic diseases.
Assets generated through the integrated chemistry platform, the V-body platform (including bispecifics,
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ADCs, and CAR-Ts), or through combined conjugates (V-body–oligonucleotide), are expected to transform the Company's therapeutic approach to these diseases and create significant value by attracting new investors and facilitating future fundraising activities.
During the fourth quarter of 2024, the Company successfully internalized the expertise and technologies associated with this new platform and conducted initial proof-of-concept experiments. Valerio Therapeutics has since continued to optimize both platforms and generate additional proof-of-concept data to validate its technologies and begin identifying lead drug candidates to enrich the new pipeline.
3.1.4 EVOLUTION OF THE R&D PORTFOLIO
Changes compared to the portfolio presented in the 2024 Annual Report are as follows:
- The Phase 1/2 clinical trial of VIO-01 in the United States was closed in January 2025 to refocus the Company's resources on optimizing the new platforms;
- Initial proof-of-concept results were obtained with both new platforms;
- Ongoing optimization of the V-body and integrated chemistry platforms.
As of the date of this report, the Company's R&D portfolio is as follows:
3.2. FINANCING
In 2025, following the announcement on February 3, 2025, regarding the termination of clinical activities and the strategic refocus on preclinical R&D, the Company entered into discussions with its main stakeholders.
On June 12, 2025, the Company announced that it had obtained current account advances from its main shareholders, Artal International SCA and Financière de la Montagne, totaling €5.5 million, part of which was converted into equity in July 2025. The Company also negotiated amendments to its bank debt, as well as payment extensions and reductions with certain suppliers.
These measures have secured the Company's financial trajectory and cash position at least through the end of 2025.
3.3. GOVERNANCE
As of the date of this report, the Board of Directors is composed of five members, including one independent director.
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| Name and Title | IndependentDirector | FirstAppointment | Termexpiry | AuditCommittee | Compensation &NominationCommittee | ScientificCommittee |
|---|---|---|---|---|---|---|
| M. Antoine Barouky,Deputy CEO | No | 2025 | 2028 | Member | ||
| M. Julien Miara,representing ArtalInternational SCA (InvusGroup), CEO | No | 2022 | 2028 | Member | ||
| Financière de laMontagne, representedby Mr. Nicolas Trebouta | No | 2011 | 2026 | Member | ||
| M. Bryan Giraudo | Yes | 2021 | 2026 | Chair | Chair | |
| M. Jacques Mallet,Chairman of the Board | No | 2021 | 2028 | Member | Chair |
3.4. KEY CORPORATE COMMUNICATIONS DURING THE FIRST HALF OF 2025
February 3, 2025 – Strategic Refocus Announcement
The Company announced its strategic decision to discontinue all clinical trials and related activities, including the ongoing VIO-01 trial. This decision, approved by the Board of Directors, followed challenges in securing sufficient funding.
The discontinuation of clinical programs will allow the Company to concentrate exclusively on earlystage drug development, ensuring efficient use of available capital while maintaining a strong focus on innovation.
As part of this transition, the Company will terminate its oncology clinical operations and close its U.S. office in Lexington, MA.
February 27, 2025 – Termination of the Liquidity Contract
The Company announced the termination of the liquidity contract concluded on October 29, 2018, with Kepler Cheuvreux, effective February 19, 2025.
This termination was part of the cost-saving measures implemented in light of the Company's cash position. The Company does not intend to enter into a new liquidity contract at this stage.
May 5, 2025 – Delay in the Publication of the 2024 Annual Financial Report
The Company announced the postponement of the publication of its 2024 Annual Financial Report, initially scheduled for April 30, 2025, as well as the finalization and approval of its statutory and consolidated financial statements, due to significant difficulties in accessing accounting information from its U.S. subsidiary, Valerio Therapeutics Inc.
Although the assets of this subsidiary have been fully impaired in the Company's statutory accounts and operations ceased at the end of 2024, this delay in the accounting treatment of Valerio Therapeutics Inc. prevents the Company from finalizing both its standalone and consolidated financial statements.
Consequently, the approval and publication of the Company's 2024 statutory and consolidated financial statements could not occur before the end of July 2025, with shareholders' approval of the 2024 accounts expected in September 2025.
June 12, 2025 – Update on Financial Situation
The Company announced the finalization of an agreement to extend the maturity of its bank debt and
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to reduce or reschedule payables with its main suppliers.
The Company's principal shareholders, Artal International SCA and Financière de la Montagne, provided advances amounting to €5.5 million, part of which has already been used to settle certain debts, and which are expected to be converted into equity to support short-term needs and fund operations at least through year-end 2025.
The Company's financial position remains fragile, and a sustainable long-term financing solution continues to be actively pursued.
June 24, 2025 – Temporary Suspension of Trading
The Company announced that Euronext had temporarily suspended trading of its shares as of June 17, 2025, following the delay in the publication of its annual financial report for the fiscal year ended December 31, 2024.
The Company reminded shareholders that the delay was due to significant accounting access issues at its U.S. subsidiary, Valerio Therapeutics Inc.
July 10, 2025 – Resumption of Trading
The Company announced the resumption of trading of its shares as of market opening on July 10, 2025. Following Euronext's approval, trading resumed after the publication of the Company's Annual Financial Report for the fiscal year ended December 31, 2024, which was released on July 9, 2025.
4. IMPACT ON THE FINANCIAL POSITION AND RESULTS
Operating expenses decreased in the first quarter of 2025, following the discontinuation of clinical activities and the closure of the U.S. subsidiary in January 2025.
Expenses increased over the remainder of the semester due to the refocus on preclinical research as part of the strategic review of the R&D portfolio, as well as the development of partnership agreements requiring additional operating expenditures.
No changes to the debt structure are planned for the period.
Revenue projections anticipate cash inflows between August and November 2025, estimated at approximately €1.2 million, primarily derived from partnership agreements and research tax credits (CIR – Crédit d'Impôt Recherche).
4.1. REVIEW OF ACCOUNTS AND RESULTS
The Group recorded consolidated revenue of €126 thousand for the period endedending June 30, 2025, corresponding to the payment received under a partnership agreement.
Personnel expenses amounted to €1.111 million, compared to €4.3 million as of June 30, 2024. External expenses totaled €869 thousand as of June 30, 2025, versus €4.6 million for the same period in 2024.
Financial income for the first half of 2025 showed a loss of €285 thousand, compared with a loss of €33 thousand as of June 30, 2024, partly reflecting increased current account interest expenses related to the shareholder advances from Artal International SCA and Financière de la Montagne.
As a result of the changes in activity reflected in the revenues and expenses described above, the net loss as of June 30, 2025, amounted to €208 thousand, compared to a net loss of €11 million as of June 30, 2024.
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4.2. CASH POSITION
The Group's cash balance as of June 30, 2025, was €2.6 million, compared to €1.178 million as of December 31, 2024.
The change in cash position primarily reflects the shareholder loans received from Artal International SCA and Financière de la Montagne during the second quarter of 2025.
The available cash as of June 30, 2025 — combined with the expected receipt of the Research Tax Credit (Crédit d'Impôt Recherche), the execution of partnership agreements, the service agreement with Valour Bio, and the optimization of operating expenses — provides financial visibility for Valerio Therapeutics through the end of 2025.
5. MAIN RISKS AND UNCERTAINTIES FOR THE NEXT SEMESTER
Important Note on Health, Geopolitical, Economic and Regulatory Context
Its exposure to risks related to COVID-19 (or any other pandemic) and to the Russia–Ukraine and Israel– Palestine conflicts to be limited, given its current activities now refocused on preclinical R&D.
However, the Company does not rule out that government restrictions, new economic sanctions, trade tensions, or logistical disruptions could affect certain outsourced operations, including the manufacturing and shipment of experimental batches.
On the regulatory front, several ongoing European reforms — such as the revision of pharmaceutical legislation ("Pharma Package"), the implementation of the European Health Data Space (EHDS), and the proposed "Biotech Act" — could eventually alter authorization procedures, health data management, and market access timelines. While some measures may simplify administrative processes and enhance competitiveness, their exact scope and operational impact remain to be clarified.
In the United States, any future FDA regulatory changes related to foreign clinical trials or the potential introduction of additional tariffs on raw materials, biological samples, or imported equipment could increase the costs and timelines of certain international collaborations.
Finally, persistent inflation and financial market volatility may significantly increase operating expenses and funding needs. The combined effect of these factors could weigh on the Company's ability to raise capital under favorable conditions, despite the reaffirmed support of its main shareholders during the first half of 2025.
Aside from these considerations, no new risk factors have been identified for the second half of 2025, other than those inherent to the Company's business model, structure, and strategy, as described in the 2024 Annual Financial Report — notably those related to the development of innovative drugs and regulatory constraints regarding safety, tolerability, and efficacy.
5.1. FINANCIAL RISKS
The Company's financial risks remain primarily linked to cash flow management, as it continues to operate without generating significant revenue relative to its R&D expenditures.
As of June 30, 2025, available cash amounted to €2.6 million, including shareholder advances totaling €5.5 million received in June 2025 from Artal International SCA and Financière de la Montagne, part of which was converted into equity in July 2025, as well as cost savings from operational streamlining following the strategic refocus. The Company also expects to receive, during the second half of 2025, a Research Tax Credit (Crédit d'Impôt Recherche) of €954 thousand.
In addition, one partnership agreement was signed during the first half of 2025, and two others were in final negotiation as of the date of this report. These agreements are expected to generate additional revenue of approximately €287,947.50 in the second half of the year, contributing to the funding of R&D programs.
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These elements, combined with the bank debt restructuring and agreements with certain suppliers (payment extensions and reductions), provide financial visibility through year-end 2025. However, as mentioned in Section 6, the Group's ability to continue as a going concern beyond this period will depend on the successful execution of ongoing partnership negotiations, the signing of new licensing agreements, and the obtaining of non-dilutive and/or additional equity financing in the short to medium term.
Factors such as delays or failures in partnership or licensing agreements, insufficient progress in preclinical programs, inability to access non-dilutive or equity funding under acceptable terms, or increased development costs due to regulatory or intellectual property requirements, could increase funding needs and affect financing conditions.
5.2. BUSINESS RISKS
The Company's operational risks primarily relate to the development of its product candidates up to the achievement of significant clinical milestones (proof of mechanism or proof of concept in humans) necessary to initiate partnership discussions.
The Company's development portfolio is largely composed of early-stage programs, and there is a significant risk that some or all of its drug candidates cannot be developed, formulated, or manufactured under economically viable conditions, may be discontinued, fail to attract partnership or licensing agreements, not receive regulatory approval, or never reach commercialization.
The risk of failure or significant delay exists at all stages of drug development — particularly during clinical trials — even though the Company leverages its translational research expertise to identify factors predicting drug activity in humans.
Additionally, regulatory review timelines for clinical trial applications may vary, especially if additional information requests are made by authorities. The Company also faces significant competitive risk across all its development programs.
From a structural and strategic perspective, the most significant risks stem from the Company's resources and size. The Company must continue to attract and retain key personnel while relying on outsourcing and subcontracting for production activities.
5.3. LEGAL AND REGULATORY RISKS
The Company's ability to successfully commercialize its products depends on its capacity to obtain, maintain, and protect its intellectual property (IP) rights.
It is essential for the success of its business that the Company can freely operate its products without infringing on the patents or IP rights of third parties, and conversely, that its own IP rights and those of its partners or licensors are not infringed upon. As of the date of this report, the Company holds rights to 110 published patents or patent applications, of which 93 (approximately 85%) have been granted in major jurisdictions, including the United States, Europe, China, and Japan.
Patent law in the pharmaceutical sector (legislation, implementing regulations, case law, etc.) continues to evolve and remains uncertain. In particular, no globally uniform policy has yet emerged concerning patent scope or allowable claims in biotechnology. As a result, patents may be granted with differing scopes depending on the jurisdiction.
Although the Company implements a proactive intellectual property strategy, closely aligned with its R&D projects — including systematic invention disclosure, patent portfolio strengthening, and competitive intelligence on third-party filings — it cannot fully eliminate legal risk.
The Company conducts its activities in compliance with applicable laws and regulations, with the support of its in-house legal team and external law firms. However, legal proceedings could be initiated against the Company by competitors, partners, subcontractors, or other third parties in the course of its business.
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As of the date of this report, there are no governmental, judicial, or arbitration proceedings, including any of which the Company is aware, that are pending or threatened (except for a dispute with a counterparty over a contested invoice) and that are likely to have, or have had in the past 12 months, a material impact on the Group's financial position or profitability.
Nevertheless, the possibility of future litigation cannot be excluded. The Company's liability could be engaged due to negligent or wrongful acts committed by its employees, collaborators, service providers, subcontractors, or partners.
The Company maintains civil liability insurance coverage, including for clinical activities. However, if litigation costs or damages exceed insurance limits, the Company could be required to bear part or all of such expenses directly. Significant legal expenses or damages could adversely impact the Company's business operations. If the Company or its partners, licensees, or subcontractors were held liable, or if adequate insurance coverage could not be obtained or maintained at an acceptable cost, it could materially affect product commercialization and more broadly the Company's business, financial position, and development prospects.
5.4. INSURANCE AND RISK COVERAGE
The Company believes it has appropriate insurance coverage for its activities, including the mandatory coverage required for clinical trials.
Following the discontinuation of clinical activities in the first half of 2025, insurance coverage has been adjusted to align with the Company's current preclinical R&D focus.
Valerio Therapeutics does not anticipate any particular difficulty in maintaining adequate insurance levels in the future and will remain vigilant to adapt its policies in the event of a resumption of clinical activities or an expansion of its operational scope.
5.4. LITIGATION
As of the date of this report, the Company is not aware of any governmental, judicial, or arbitration proceedings, either ongoing or threatened, that could have a material impact on its financial position, operations, or results.
6. EXPECTED DEVELOPMENT OF THE GROUP'S SITUATION AND OUTLOOK
In 2025, following the strategic review conducted in February, Valerio Therapeutics completed a full refocus of its activities on the development of preclinical (early-stage) R&D programs, discontinuing all clinical studies, including the development of VIO-01 (formerly OX425) and AsiDNA™. This repositioning is intended to concentrate resources and investments on two differentiated platforms:
- V-Body: production of humanized single-domain antibodies (sdAbs) serving as biological vectors.
- Integrated chemistry platform: a transversal backbone enabling the chemical synthesis of multiple therapeutic modalities (oligonucleotides, small molecules), bioconjugation, stabilization, and formulation of products generated by the other two platforms.
The subsidiary Valour Bio, created in 2024 and strengthened by the acquisition of Emglev Therapeutics, constitutes a strategic hub for the development and valorization of the V-Body platform, with the objective of generating differentiated preclinical data, notably in rare, autoimmune, and inflammatory diseases. The Valerio Therapeutics team provides Valour Bio with administrative, scientific, and technical support for its priority programs.
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In parallel, the Company is evaluating and optimizing new candidates emerging from its technology platforms and remains actively engaged in pursuing strategic partnerships and licensing agreements to maximize asset value prior to clinical proof-of-concept. These initiatives form part of a financing plan that combines industrial partnerships, non-dilutive funding, and targeted equity raises to support the development of key programs.
6.1. MAIN FUTURE INVESTMENTS AND FINANCING STRATEGY
Following the strategic review conducted in February 2025, Valerio Therapeutics decided to terminate all of its clinical trials, including the VIO-01 study, in order to focus exclusively on preclinical (early-stage) R&D programs.
This refocus enables the Company to allocate its available resources to the Group's two differentiated technological platforms:
- the V-Body platform, dedicated to single-domain antibodies (sdAbs) and their applications (radioconjugates, bispecifics, blocking and binding antibodies, and CAR-Ts), and
- the integrated chemistry platform, designed to generate V-body–siRNA immunoconjugates.
The Company also intends to leverage synergies between its platforms and develop targeted strategic partnerships, notably through co-development and licensing agreements, in order to maximize the value of its assets prior to clinical proof of concept.
In addition, the Company's financial structure was strengthened in June 2025 through shareholder advances totaling €5.5 million, part of which was converted into equity in July 2025, along with agreements to reschedule and reduce certain debts with banks and suppliers.
These measures, combined with the expected receipt of €954 thousand under the Research Tax Credit (Crédit d'Impôt Recherche) and the execution of a partnership agreement (with two others nearing completion), ensure financial visibility for the Company through the end of 2025, with a cash position of €2.5 million as of June 30, 2025.
Finally, the Company reserves the right to further strengthen its financial resources through additional nondilutive financing or equity fundraising, in parallel with ongoing efforts to secure new licensing and partnership agreements.
6.2. SIGNIFICANT EVENTS SINCE THE END OF THE PERIOD
In May 16, 2025, Euronext Growth imposed a sanction on Valerio Therapeutics, transferring it to the Penalty Bench as of May 16, due to the delay in publishing its 2024 Annual Report. This measure was subsequently reinforced on June 17, 2025, by a temporary suspension of trading, following difficulties in accessing the accounting records of its U.S. subsidiary, which delayed the finalization and certification of Valerio Therapeutics' financial statements.
The sanction was, however, quickly lifted: the 2024 Annual Financial Report was published on July 9, 2025, followed by the resumption of trading on July 10, 2025, after Euronext's approval.
On July 22, 2025, the Company announced the completion of several capital transactions aimed at restructuring part of its liabilities. At its meeting held on July 21, 2025, the Board of Directors adopted the following resolutions:
- Capital reduction to offset losses through nominal value reduction
Under the authorization granted by the Shareholders' Meeting of July 17, 2025, the Board of Directors decided to carry out a capital reduction to offset part of the accumulated losses, in the amount of €20,067,355.47.
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This reduction was implemented by decreasing the nominal value of the Company's shares from €0.14 to €0.01, without affecting the number of shares in circulation.
Following this transaction, the Company's share capital amounted to €1,543,642.73, divided into 154,364,273 ordinary shares with a nominal value of €0.01 each.
- Conversion of convertible bonds held by Financière de la Montagne
As a reminder, under the authorization granted by the Shareholders' Meeting of June 10, 2021 (13th resolution), the Board of Directors decided on April 6, 2022, to issue a convertible bond loan with a nominal amount of €4,000,000, through the issuance of 4,000,000 convertible bonds ("OC") with a nominal value of €1 each, of which €1,500,000 was subscribed by Financière de la Montagne.
The Convertible Bond Agreement was executed between the Company and Financière de la Montagne on April 20, 2022.
In accordance with the agreement, the Company sent a conversion notice to Financière de la Montagne for the conversion of 1,500,000 convertible bonds into 27,777,777 ordinary shares with a nominal value of €0.01 each (following the aforementioned capital reduction), at a conversion price of €0.054, calculated based on the volume-weighted average price (VWAP) of the three last trading sessions preceding the conversion, rounded to three decimal places.
Using the authorization granted by the Shareholders' Meeting, the Board of Directors on July 21, 2025, acknowledged the conversion by Financière de la Montagne of 1,500,000 convertible bonds into 27,777,777 ordinary shares, resulting in a capital increase of €277,777.77 in favor of Financière de la Montagne. Following this transaction, the Company's share capital amounted to €1,821,420.50, divided into 182,142,050 ordinary shares with a nominal value of €0.01 each.
- Capital increase through debt-to-equity conversion
Under the authorization granted by the Shareholders' Meeting of July 17, 2025, the Board of Directors decided on July 21, 2025, to carry out a capital increase of €1,683,658.93 through debt-to-equity conversion, by issuing 168,365,893 new ordinary shares with a nominal value of €0.01 each, with preemptive subscription rights waived in favor of specific categories of investors.
The subscription price for the new shares was set at €0.046 per share, including a €0.036 share premium, corresponding to the volume-weighted average price (VWAP) of the three last trading sessions on Euronext Growth Paris (July 16, 17, and 18, 2025 — €0.054), reduced by a 15% discount, in compliance with the shareholder authorization. This represented a total subscription amount, including share premium, of €7,744,831.08.
The capital increase was fully subscribed through debt compensation, primarily by Artal International SCA, Financière de la Montagne, and SCP Esperanza 2019.
Following these transactions, the Company's share capital amounted to €3,505,079.43, divided into 350,507,943 ordinary shares with a nominal value of €0.01 each.
On October 15, 2025, Valerio Therapeutics completed a capital increase of €6,363,636.20, through the issuance of 138,339,918 new shares at €0.046 per share, with preemptive subscription rights waived.
The operation, fully subscribed, comprised €3,499,999.99 in cash and €2,863,636.20 through debt conversion, primarily from Artal International SCA, Fidat Ventures, Esperanza 2019, and Saint James Ventures 2. Following this transaction, the Company's share capital now amounts to €4,888,478.61, divided into 488,847,861 ordinary shares with a nominal value of €0.01 each, with the new shares representing 28% of the total share capital. This transaction further strengthens the Company's financial structure, supporting both the development of its technology platforms and the ongoing debt restructuring efforts.
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7. RELATED PARTY TRANSACTIONS
Related party transactions, as defined under paragraph 9 of IAS 24, concern exclusively entities included within the consolidation scope.
In June 2025, the Company's main shareholders, Artal International SCA and Financière de la Montagne, entered into a shareholder current account agreement totaling €5.5 million, part of which was converted into equity in July 2025.
This transaction formed part of a comprehensive financial restructuring plan, which also included extensions and amendments of bank debt, as well as settlement agreements with certain suppliers involving reductions and/or rescheduling of payables.
These measures have contributed to securing the Company's cash position through the end of 2025.
8. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF JUNE 30, 2025
The interim financial statements as of June 30, 2025, prepared in accordance with IFRS standards and approved by the Board of Directors on October 20, 2025, have neither been audited nor reviewed. The interim financial statements for the period from January 1 to June 30, 2025, were prepared on a going concern basis.
This preparation is based on an assessment of liquidity risk relative to the 2025–2026 cash flow forecasts, and on the assumption that ongoing projects and partnership agreements will be successfully executed, allowing the Group to maintain sufficient financing to meet its estimated cash requirements over the next 12 months.
However, the Group's ability to continue as a going concern remains uncertain, as it depends on its capacity to secure short- to medium-term financing and renegotiate certain debts with its principal creditors.
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CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| ASSETS (in € thousands) | 30/06/2025 | 31/12/2024 | Note |
|---|---|---|---|
| Non-current assetsIntangible assetsProperty, plant and equipmentRight-of-use assetsOther financial assets | 11 96761543177 | 11 967607565220 | 45 |
| Total non-current assets | 13 090 | 13 360 | |
| Current assetsTrade receivables and related accountsOther current receivablesCash and cash equivalents | 2 7541 9602 638 | 1 7241 6671 178 | 6.16.2 |
| Total current assets | 7 353 | 4 569 | |
| TOTAL ASSETS | 20 443 | 17 929 |
| LIABILITIES AND EQUITY (in € thousands) | 30/06/2025 | 31/12/2024 | Note |
|---|---|---|---|
| Equity | |||
| Share capital | 21 611 | 21 611 | 8.1 |
| Less: treasury shares | -36 | 8.2 | |
| Share premium | 15 692 | 15 692 | 8.3 |
| Reserves | -46 212 | -22 278 | |
| Net income (loss) for the period | -208 | -23 919 | |
| Equity attributable to owners of the Company | -9 117 | -8 930 | |
| Non-controlling interests | 666 | 665 | |
| Total equity | -8 451 | -8 265 | |
| Non-current liabilities | |||
| Non-current provisions | 307 | 305 | 9.1 |
| Deferred tax liabilities | 0 | 0 | |
| Non-current financial liabilities | 7 160 | 5 630 | 9.2 |
| Non-current lease liabilities | 163 | 182 | 9.2 |
| Other non-current liabilities | 0 | 1 740 | 9.3 |
| Total non-current liabilities | 7 639 | 7 858 | |
| Current liabilities | |||
| Current provisions | 0 | 0 | 9.1.2 |
| Short-term borrowings and financial liabilities | 11 027 | 7 298 | 10.1 |
| Current lease liabilities | 222 | 325 | |
| Trade payables and related accounts | 4 087 | 5 247 | 10.2 |
| Other current liabilities | 5 928 | 5 467 | 10.3 |
| Total current liabilities | 21 265 | 18 337 | |
| TOTAL LIABILITIES | 20 443 | 17 929 |
{15}------------------------------------------------
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
| In € thousands | 30/06/2025 | 30/06/2024 | Note |
|---|---|---|---|
| Recurring revenue from license agreements | |||
| Non-recurring revenue from license agreements | |||
| Total revenue | 126 | 89 | 11.1 |
| Purchases consumed | -394 | -163 | |
| Personnel expenses | -1 111 | -4 345 | 11.2 |
| External expenses | -869 | -4 627 | 11.3 |
| Taxes and duties | -23 | -5 | |
| Net depreciation, amortization and provisions | -268 | -1 680 | |
| Other current operating expenses | -203 | - 108 | |
| Total operating expenses | -2 867 | -10 928 | |
| Other current operating income | 1 049 | 2 | |
| Operating income (loss) | -1 692 | -10 837 | |
| Other operating income | 1 785 | ||
| Other operating expenses | -15 | -88 | |
| Share of profit (loss) from associates | |||
| Operating result after share of profit (loss) of associates | 78 | -10 925 | |
| Net cost of financial debt | -98 | ||
| Other financial income | 13 | 27 | |
| Other financial expenses | -201 | -60 | |
| Financial result | -285 | -33 | 12 |
| Profit (loss) before tax | -208 | -10 958 | |
| Income tax | |||
| (including deferred tax) | |||
| Net income (loss) for the period | -208 | -10 958 | |
| Basic earnings per share (€) | -0,00 | -0,07 | 13 |
| Diluted earnings per share (€) | -0,00 | -0,07 |
| In € thousands | 30/06/2025 | 30/06/2024 Note |
|---|---|---|
| Net income (loss) for the period | -208 | -10 958 |
| Translation differences | -149 | 176 |
| Other recyclable comprehensive income (loss) | -149 | 176 |
| Actuarial gains and losses | 11 | |
| Other non-recyclable comprehensive income (loss) | 11 | |
| Total other comprehensive income (net of tax) | -139 | 176 |
| Total comprehensive income (loss) for the period | -347 | -10 782 |
| •Attributable to owners of the parent•Attributable to non-controlling interests | -347 | -10 782 |
{16}------------------------------------------------
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
Changes in Reserves and Retained Earnings
| In € thousands | Share Capital | Treasury SharesShare Premium | CurrencyTranslationReserves | Gains andLossesRecognised inEquity | ConsolidatedReserves andRetainedEarnings | Total Changes | Total Group | Non-controllingInterests | Total Equity | |
|---|---|---|---|---|---|---|---|---|---|---|
| Equity at June 30, 2023 | 38 591 | 97 | 28 991 | 365 | -38 | -44 636 | -44 310 | 23 176 | 23 176 | |
| Total comprehensive income for the periodCapital increase / (reduction) | 38 | 60 | 8 700 | 8 602 | -8 602 | -8 602 | ||||
| Treasury sharesOther movements | 37 | -40 | -40 | 3 | 3 | |||||
| Share-based payments | 244 | 244 | 244 | 244 | ||||||
| Equity at December31, 2023 | 38 591 | -60 | 28 991 | 403 | 22 | -53 142 | -52 716 | -8 441 | -8 441 | |
| Total comprehensive income for the period | 176 | -10 958 | -10 782 | -10 782 | -10782 | |||||
| Capital increase / (reduction) | -16 980 | 16 980 | 16 980 | |||||||
| Treasury shares | 1 | |||||||||
| Other movements | -1 | 96 | -96 | 1 | ||||||
| Share-based payments | ||||||||||
| Equity at30/06/2024 | 21 611 | -61 | 28 991 | 675 | 22 | -47 216 | -46 519 | 4 022 | 4 022 | |
| Total comprehensive income for the period | -337 | 108 | -12 973 | -13 202 | -13 202 | -13 | -13 215 | |||
| Capital increase / (reduction) | ||||||||||
| Treasury shares | 24 | |||||||||
| Changes in scope of consolidation | -123 | -123 | -123 | 678 | 555 | |||||
| Other movements | -13 299 | -35 | 13 315 | 13 280 | -19 | -19 | ||||
| Share-based payments | 390 | 390 | 390 | 390 | ||||||
| Equity at31/12/2024 | 21 611 | -36 | 15 692 | 180 | 130 | -46 484 | -46 173 | -8931 | 666 | -8265 |
| Total comprehensive income for the periodCapital increase / (reduction) | -149 | 11 | -208 | -347 | -347 | -347 | ||||
| Treasury shares | ||||||||||
| Changes in scope of consolidation | 36 | 36 | 36 | |||||||
| Other movements | ||||||||||
| Share-based payments | 53 | 53 | 53 | 53 | ||||||
| 72 | 72 | 72 | 72 | |||||||
| Equity at 30/06/2025 | 21 611 | 0 | 15 692 | 963 | 140 | -46 567 | -46 395 | -9 117 | 666 | -8 451 |
{17}------------------------------------------------
CONSOLIDATED STATEMENT OF CASH FLOWS
| In € thousands | Note | 30/06/2025 31/12/2024 30/06/2024 | ||
|---|---|---|---|---|
| Consolidated net income | -208 | -23 931 | -10 958 | |
| +/- Net depreciation, amortisation and provisions (excluding | 4, 5, | |||
| current assets) | 9.1 | 282 | 11 314 | 1 680 |
| -/+ Unrealised gains and losses from fair value changes | ||||
| +/- Share-based payment expenses | 8.4 | 72 | 195 | |
| -/+ Other non-cash income and expenses | 390 | |||
| -/+ Gains and losses on disposals | 15 | -787 | 88 | |
| -/+ Gains and losses of dilution | ||||
| +/- Share of profit (loss) of associates | ||||
| +/- Other non-cash items | 13 | |||
| Cash flows from operating activities after net financial expense | ||||
| and taxes | 162 | -13 015 | -8 982 | |
| + Gross financial expense | 12 | -98 | 178 | |
| +/- Income tax expense (including deferred tax) | 377 | |||
| Cash flows from operating activities before net financial expense | 259 | -12 460 | -8 982 | |
| and taxes | ||||
| - Income tax paid | ||||
| +/- Change in working capital requirements (including employee | -3 861 | 4 091 | 2 149 | |
| benefits obligations) | ||||
| Net cash flows from operating activities | -3 602 | -8 369 | -6 833 | |
| Net cash flows from operating activities | -107 | -319 | -40 | |
| - Purchases of property, plant and equipment and intangible assets | ||||
| + Proceeds from disposals of property, plant and equipment and | ||||
| intangible assets | ||||
| - Purchases of financial assets (non-consolidated) | 145 | 9 | 4 | |
| + Proceeds from disposals of financial assets (non-consolidated) | -1 080 | |||
| +/- Impact of changes in consolidation scope | ||||
| + Dividends received (associates, non-consolidated shares) | ||||
| +/- Change in loans granted | ||||
| + Investment grants received | ||||
| Net cash flows from investing activities | 38 | -1 389 | -36 | |
| + Amounts received from shareholders under capital increases | ||||
| . Paid by shareholders of the parent company | 8.1 | |||
| . Paid by minority shareholders of consolidated companies | ||||
| + Amounts received from exercise of share options | ||||
| -/+ Net purchase/sale of treasury shares | 8.2 | 42 | 24 | |
| + Proceeds from new borrowings | 5 392 | 5 542 | 5 000 | |
| - Loan repayments (including lease liabilities) | 9.2, | -405 | -1 356 | -812 |
| 10.1 | ||||
| of which lease liability repayments (IFRS 16) | -177 | -357 | -172 | |
| +/- Other cash flows related to financing activities | ||||
| Net cash flows from financing activities | 5 029 | 4 210 | 4 188 | |
| +/- Effect of exchange rate changes | -2 | -115 | -154 | |
| Net change in cash and cash equivalents | 1 462 | -5 663 | -2 835 | |
| Cash and cash equivalents at beginning of period | 1 151 | 6 814 | 6 814 | |
| Cash and cash equivalents at end of period | 2 614 | 1 151 | 3 979 |
{18}------------------------------------------------
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Valerio Therapeutics is a clinical-stage biotechnology company developing novel cancer therapeutics that target tumor DNA functions through unique mechanisms of action in the field of DNA Damage Response (DDR).
NOTE 1: BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
The condensed consolidated interim financial statements of Valerio Therapeutics as of June 30, 2025, were approved by the Board of Directors on October 20, 2025.
They have been prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the European Union, specifically IAS 34 – Interim Financial Reporting, which allows the presentation of selected explanatory notes.
Accordingly, these condensed financial statements should be read in conjunction with the consolidated annual financial statements for the year ended December 31, 2024, as included in the 2024 Annual Financial Report published on July 9, 2025.
The accounting principles applied as of January 1, 2025, are identical to those detailed in the notes to the consolidated financial statements published as of December 31, 2024.
Furthermore, the Group has elected not to early adopt any new standards, amendments or interpretations whose mandatory application date is subsequent to June 30, 2025, whether or not they have been endorsed by the European Union. The potential impacts of these new standards and amendments are currently under review.
Use of estimates
As of June 30, 2025, the Group used estimates and assumptions in preparing its financial statements, particularly with respect to:
- the fair value of R&D programs acquired through business combinations (see Note 4),
- share-based payment plans (see Note 8.3),
- retirement benefit obligations and provisions (see Note 9.1.1),
- trade payables accrued at period-end related to ongoing clinical trials.
Going concern
The interim financial statements for the period from January 1 to June 30, 2025, have been prepared on a going-concern basis. This assumption relies on an assessment of liquidity risk based on cash-flow forecasts for 2025–2026 and on the expectation that ongoing projects will progress satisfactorily and that partnership agreements will be implemented, allowing the Group to maintain sufficient financial resources to meet its estimated cash requirements over the next 12 months.
However, the Group's ability to continue its operations beyond the next 12 months remains dependent on its capacity to raise additional funds in the short and medium term.
NOTE 2: CONSOLIDATION SCOPE
The Group comprises Valerio Therapeutics SA, which conducts the majority of its operations in Paris, as well as the following subsidiaries:
{19}------------------------------------------------
- Valerio Therapeutics Inc.
- Topotarget Switzerland
- Valour Bio SAS
- Emglev Therapeutics
All subsidiaries are 100% owned and fully consolidated as of June 30, 2025.
NOTE 3: REPORTING ON OPERATING SEGMENTS (IFRS 8)
The Group operates as a single operating segment. In accordance with paragraphs 32 and 33 of IFRS 8, information on the geographical breakdown of revenue is provided in Note 11.1. Consistent with this standard, the Group's property, plant and equipment and intangible assets are primarily located in France.
NOTE 4: INTANGIBLE ASSETS
| In € thousands | December 31, 2023 | Increase | Decrease | December 31, 2024 | Increase | Decrease | June 30,2025 |
|---|---|---|---|---|---|---|---|
| AsiDNA™ R&D Assets | 2 472 | 787 | 3 259 | 3 259 | |||
| Goodwill | 20 059 | 1 932 | 21 991 | 21 991 | |||
| OtherIntangible assets | 511 | 1 004 | 1 515 | 1 | 1 516 | ||
| Total gross value | 23 042 | 3 723 | 26 765 | 1 | 26 766 | ||
| Accumulated amortization | -511 | -4 263 | -4 774 | -1 | -4 775 | ||
| Total amortization | -511 | -4 263 | - 4 774 | -1 | -4 775 | ||
| Impairment of goodwill | -2 000 | - 8 023 | -10 023 | -10 023 | |||
| Total impairment | -2 000 | -8 023 | -10 023 | -10 023 | |||
| TOTAL | 20 531 | -8 563 | 787 | 11 968 | 11 968 |
Assessment of Impairment Indicators and Impairment Testing
The R&D assets acquired in connection with the acquisition of DNA Therapeutics, namely AsiDNA™, as well as goodwill, are subject to an impairment test at least once a year in accordance with IAS 36.
No impairment indicators have been identified with respect to the R&D assets related to AsiDNA, therefore, no impairment testing was performed and no impairment loss was recognized as of June 30, 2025.
Similarly, no impairment indicators were identified for goodwill. As the Company's market capitalization as of June 30, 2025—representing the fair value of goodwill—exceeded the consolidated net book value at that date, no impairment testing was performed and no impairment loss was recognized.
NOTE 5 : RIGHT-OF-USE ASSETS
| In € thousands | 31/12/2023 | Increase | Dicrease | 31/12/2024 | Increase | Dicrease | 30/06/2025 |
|---|---|---|---|---|---|---|---|
| Right-of-use assets | 2 896 | 220 | -100 | 3 015 | 54 | -215 | 2 854 |
| Accumulated amortization of right-of-use assets | -2 169 | -381 | 100 | -2 450 | -188 | 215 | -2 423 |
| Net book value of right-of-use assets | 727 | -161 | 565 | -135 | 431 |
{20}------------------------------------------------
The right-of-use assets mainly relate to the lease of the Company's headquarters, as well as to the rental of laboratory equipment and vehicles. These right-of-use assets are depreciated over the remaining term of the respective lease agreements.
NOTE 6 : CURRENT ASSETS
6.1. Trade receivables and related accounts
| In thousands of € | June 30,2025 | < 1 year | > 1 year | December31, 2024 |
|---|---|---|---|---|
| Trade receivables and related accounts | 2,754 | 2,754 | 1,724 |
As of June 30, 2025, trade receivables mainly correspond to amounts due from the partner Biogen, relating to royalties receivable on sales under a license agreement. This receivable was collected during the first half of 2025.
6.2. Other receivables
| In thousands of € | June 30, 2025 | < 1 year | > 1 year | December 31, 2024 |
|---|---|---|---|---|
| Suppliers – Advances and prepayments | ||||
| Staff and related accounts | 3 | 3 | 4 | |
| Research Tax Credit (Crédit d'Impôt Recherche) | 1,340 | 1,340 | 874 | |
| Other tax receivables | 622 | 622 | 668 | |
| Other receivables | 4 | 4 | ||
| Prepaid expenses | -9 | -9 | 117 | |
| Net value of other receivables | 1,960 | 1,960 | 1,667 |
The "Research Tax Credit" item includes a French R&D tax credit for 2024 in the amount of €954 thousand, which had not yet been reimbursed as of June 30, 2025, as well as the tax credit for the first half of 2025, amounting to €477 thousand.
In accordance with IAS 20, this credit has been deducted from the corresponding expense items by nature, as follows:
| In thousands of € | June 30, 2025 | December 31,2024 | June 30, 2024 |
|---|---|---|---|
| Personnel expenses | 221 | 443 | 105 |
| External expenses | 241 | 482 | 595 |
| Depreciation and amortization | 15 | 30 | |
| Total | 477 | 954 | 700 |
Other tax receivables mainly relate to deductible VAT and a VAT credit of €250 thousand, for which the Company has requested reimbursement.
NOTE 7 : CASH AND CASH EQUIVALENTS
| In thousands of € | Net value as ofJune 30, 2025 | Net value as ofDecember 31,2024 | Change incash position |
|---|---|---|---|
| Cash | 2,638 | 1,178 | 4,316 |
| Cash equivalents | – | – | |
| Total net cash position | 2,638 | 1,178 | 4,316 |
{21}------------------------------------------------
The change in net cash position is mainly attributable to operating expenses (€2,867 million), primarily related to research and development activities, repayments of debts to third parties**,** and supplier debt repayments**.** These outflows were offset by cash advances from the main shareholders — €4.5 million from Artal International SCA and €0.5 million from Financière de la Montagne — received during the first half of 2025 (in April, May, and June).
NOTE 8 : SHAREHOLDERS' EQUITY
8.1. Share capital
As of June 30, 2025, the share capital amounted to €21,610,998.20, divided into 154,364,273 ordinary shares with a nominal value of €0.14 each, all of the same class and fully paid up.
During the period, the share capital evolved as follows:
| Nominal value (€) Number of shares | Amount € | ||
|---|---|---|---|
| Fully paid shares as of December 31, 2024 | 0,14 | 154 364 273 | 21 610 998,20 |
| Capital reduction | |||
| Fully paid shares as of June 30, 2025 | 0,14 | 154 364 273 | 21 610 99820 |
8.2. Treasury shares
The liquidity agreement with Kepler Cheuvreux was terminated during the first half of 2025. As of June 30, 2025, the Company no longer held any treasury shares.
Gains and/or losses from share buybacks as of June 30, 2025, amounting to €5,857, were recorded under reserves in accordance with applicable accounting standards.
8.3. Share-based payments
Full details of stock options and share warrants granted by the Group are provided below.
During the first half of the year, no stock options or share warrants were granted.
{22}------------------------------------------------
8.3.1. Summary of Share Warrants (BSA) as of June 30, 2025
| Туре | Date of authorization | AuthorizedBSAs | Grant date | Granted BSAs | SubscribedBSAs | Beneficiaries | OutstandingBSAs as of06/30/2025(adjusted 1 ) | ExercisableBSAs as of06/30/2025(adjusted 1 ) | Subscription price per share (€) (adjusted ¹) | Expiry date |
|---|---|---|---|---|---|---|---|---|---|---|
| Membres du CA | ||||||||||
| BSA 2015 | May 20 2015 – | 405,000 | Oct 27 2015 | 80,000 | 65,000 | non-salariés et | 65,000 | 65,000 | 3.61 | Oct 27 2025 |
| BSA 2015-2 | Resolution 18 | .00,000 | Jan 23 2016 | 90,000 | 90,000 | non dirigeants | 90,000 | 90,000 | 3.33 | Jan 23 2026 |
| BSA 2016 | Jul 28 2016 | 260,000 | 190,000 | non umgeunts | 160,000 | 160,000 | 3.16 | Jul 28 2026 | ||
| BSA 2016-2 | Apr 6 2016 –Resolution 23 | 405,520 | Oct 25 2016 | 30,000 | 30,000 | Key consultants of the Company | 30,000 | 30,000 | 2.61 | Oct 25 2026 |
| BSA 2016-3 | Dec 21 2016 | 70,000 | 70,000 | 52,500 | 52,500 | 2.43 | Dec 21 2026 | |||
| BSA 2017 | May 24 2017 –Resolution 29 | 470,440 | Jul 28 2017 | 340,000 | 30,000 | 300,000 | 300,000 | 4.00 | Jul 28 2027 | |
| BSA 2018 | Jun 19 2018 – | 200,000 | Jul 27 2018 | 359,500 | 274,500 | Non-executiveBoard members | 274,500 | 274,500 | 1.187 | Jul 27 2028 |
| BSA 2018-2 | Resolution 28 | 360,000 | Oct 25 2018 | 85,000 | 85,000 | board members | 85,000 | 85,000 | 1.017 | Oct 25 2028 |
| BSA 2020 | Sep 17 2020 | 500,000 | 350,000 | 350,000 | 350,000 | 0.684 | Sep 17 2030 | |||
| BSA 2021 | Resolution 31 | 500,000 | Apr 28 2021 | 150,000 | 150,000 | Key consultantsof the Company(1) | 150,000 | 150,000 | 0.723 | Apr 28 2031 |
| BSA 2021-2 | Jun 11 2021 | 100,000 | 100,000 | Non-executiveBoard members | 100,000 | 100,000 | 0.662 | Jun 11 2031 | ||
| BSA 2021-3 | Jul 29 2021 | 300,000 | 125,000 | 125,000 | 125,000 | 0.620 | Jul 29 2031 | |||
| BSA 2021-4 | Jun 10 2021 – | 700,000 | Oct 6 2021 | 150,000 | 75,000 | 75,000 | 75,000 | 0.560 | Oct 6 2031 | |
| BSA 2022 | Resolution 19 | Feb 2 2022 | 150,000 | 150,000 | Chairwoman of the Board | 150,000 | 150,000 | 0.420 | Feb 2 2032 | |
| BSA 2022-2 | Feb 2 2022 | 75,000 | 75,000 | Non-executiveBoard members | 75,000 | 75,000 | 0.420 | Feb 2 2032 | ||
| TOTAL BSA | 2 082 000 | 2 082 000 |
{23}------------------------------------------------
8.3.2. Summary of Stock Subscription Options (SO) as of June 30, 2025
| Plan designation | Authorization date | Authorized options | Grant date | Granted options | Beneficiaries | Outstanding options as of 06/30/2025 (adjusted 1) | Exercisable options as of 06/30/2025 (adjusted 1) | Adjusted exercise price per share (€) 1 | Expiry date |
|---|---|---|---|---|---|---|---|---|---|
| Employees SO 2018 | Jun 19 2018 – | 070.000 | Jul 27 2018 | 758,604 | Employees | 53,655 | 53,655 | 1.187 | Jul 27 2028 |
| Executives SO 2018 | Resolution 27 | 970,000 | Jul 27 2018 | 150,723 | Executives | 0 | 0 | 1.187 | Jul 27 2028 |
| TOTAL SO 2018 | 970,000 | 909,327 | 53,655 | 53,655 | |||||
| Employees SO 2020 | Jun 19 2020 – | 1,200,000 | Sep 17 2020 | 1,030,000 | Employees | 120,000 | 120,000 | 0.684 | Sep 17 2030 |
| Executives SO 2020 | Resolution 30 | 1,200,000 | Sep 17 2020 | 170,000 | Executives | 0 | 0 | 0.684 | Sep 17 2030 |
| TOTAL SO 2020 | 1,200,000 | 1,200,000 | 120,000 | 120,000 | |||||
| Employees SO 2021 | Jul 29 2021 | 281,000 | Employees | 49,000 | 49,000 | 0.62 | Jul 29 2031 | ||
| Executives SO 2021 | Jun 10 2021 –Resolution 30 | 1,500,000 | Jul 29 2021 | 60,000 | Executives | 0 | 0 | 0.62 | Jul 29 2031 |
| SO 2021-2 | Resolution 50 | Jul 29 2021 | 429,194 | Employees & Executives | 8,665 | 8,665 | 0.62 | Jul 29 2031 | |
| TOTAL SO 2021 | 1,500,000 | 770,194 | 57,665 | 57,665 | |||||
| SO 2022 | Jun 10 2021 –Resolution 18 | 1,500,000 | Feb 2 2022 | 250,000 | Executives | 250,000 | 250,000 | 0.42 | Feb 2 2032 |
| SO 2022-2 | Apr 19 2022 - | May 4 2022 | 2,030,000 | Employees | 922,500 | 922,500 | 0.40 | May 4 2032 | |
| SO 2022-3 | Resolution 4 | 7,350,000 | May 4 2022 | 3,810,285 | Executives | 3,066,905 | 3,066,905 | 0.40 | May 4 2032 |
| SO 2022-4 | Sep 13 2022 | 240,000 | Employees | 90,000 | 90,000 | 0.33 | Sep 13 2032 | ||
| TOTAL SO 2022 | 8,850,000 | 7,050,285 | 4,329,405 | 4,329,405 | |||||
| SO 2022-5 | 720,000 | Apr 21 2023 | 720,000 | Employees | 173,750 | 173,750 | 0.32 | Apr 21 2033 | |
| SO 2023-1 | Jun 6 2023 –Resolution 10 | 7,350,000 | Jun 29 2023 | 645,000 | Employees | 31,250 | 31,250 | 0.26 | Jun 29 2033 |
| SO 2023-2 | Jun 29 2023 | 1,714,500 | Executives | 428,625 | 428,625 | 0.26 | Jun 29 2033 | ||
| TOTAL SO 2023 | 7,350,000 | 2,359,500 | 633,625 | 633,625 | |||||
| TOTAL SO | 5,194,350 | 5,194,350 |
(1) Adjustment of the number and subscription price of options following capital increases in July 2011, July 2013, and December 2014, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' resolutions of July 28 2011, November 14 2013, and January 22 2014).
{24}------------------------------------------------
NOTE 9 : NON-CURRENT LIABILITIES
9.1. Non-current provisions
| In thousands of € | Dec. 31, 2024 | Additions | Reversals | Actuarialvariance | June 30, 2025 |
|---|---|---|---|---|---|
| Retirement benefit obligations | 34 | 13 | -11 | 36 | |
| Other provisions | 271 | 271 | |||
| Total non-current provisions | 305 | 13 | -11 | 307 |
9.1.1. Retirement benefit obligations
Provisions for retirement benefits amounted to €35,651 as of June 30, 2025, compared with €33,673 as of December 31, 2024.
This change breaks down into an addition of €12,531 and an actuarial variance of €10,553.
The actuarial assumptions used were as follows:
| June 30, 2025 | Dec. 31, 2024 | |||||
|---|---|---|---|---|---|---|
| Collective agreement | National Collective Agreement of the Pharmaceutical Industry | |||||
| Retirement Age | Between 65 and 67 years, in accordance with the French pensionreform law of April 14 | |||||
| Valuation date | June 30, 2025 | Dec. 31, 2024 | ||||
| Mortality table | INSEE 2024 | INSEE 2024 | ||||
| Discount rate | 3,45% | 3,35% | ||||
| Salary increase rate | 3% | 3% | ||||
| Turnover rate | By age group:– 0% from 16–24 years– 1.12% from 25–34 years– 6.74% from 35–44 years– 2.25% from 45–54 years– 0% above 55 years | By age group:– 0% from 16–24 years– 1.12% from 25–34 years– 6.74% from 35–44 years– 2.25% from 45–54 years– 0% above 55 years | ||||
| Social contribution rate | 40% |
9.1.2. Provisions
The provisions consist of a restoration provision recognized in accordance with IFRS 16, amounting to €271 thousand.
9.2. Non-current financial liabilities
| Variation | |||||
|---|---|---|---|---|---|
| In thousands of € | 30/06/2025 | 31/12/2024 | Total | Cash impact | Non-cash impact |
| Government-backloans (PGE) | 3,102 | 1,548 | 1,554 | 1 554 | |
| Convertible bond loan | 4,000 | 4,000 | |||
| Repayable advances | 58 | 83 | -25 | -25 | |
| Shareholder loans | |||||
| Subtotal | 7,160 | 5,630 | 1,530 | 1 530 | |
| Lease liabilities | 163 | 182 | -19 | -19 |
{25}------------------------------------------------
TOTAL 7,323 5,813 1,511 1,554 -44
The Government backed loans (PGE) were granted in February 2021 by Bpifrance and the Group's commercial banks. Valerio Therapeutics chose to repay these loans over a 5-year period starting in February 2022, with the first year being a grace period during which only interest was payable.
These loans bear interest rates between 0.69% and 2.25% over the repayment period. Given these relatively low rates, the loans could give rise to the recognition of a government grant in accordance with IAS 20.
However, considering the purpose and terms of the PGEs, the value of such a grant is linked to the duration of the loan and should be recognized in profit or loss symmetrically with the interest expense. Therefore, recognizing a grant would have no practical impact on the income statement or presentation compared with recognizing the PGE at its contractual rate. For this reason, the Group has chosen to recognize them at the amount of cash received, net of transaction costs.
The convertible bonds were issued in April 2022 and subscribed by Invus Public Equities LP and Financière de la Montagne for €2.5 million and €1.5 million, respectively.
The maturity date is April 6, 2027. The convertible bonds are non-interest-bearing and may be converted into ordinary shares at the Company's discretion between the issue date and maturity date. Each bond entitles its holder, upon conversion, to a number of ordinary shares equal to the nominal value of one bond divided by X, where X is the lower of:
- (a) €0.410, or
- (b) the volume-weighted average price (VWAP) over the three trading days preceding the conversion request, without any discount.
It should be noted that Financière de la Montagne converted €1.5 million of convertible bonds into shares in July 2025.
Repayable advances were granted by Bpifrance and the Île-de-France Region, notably under the Innov'Up Leader PIA program, to finance the Company's R&D programs AsiDNA™ and PlatON™. These advances are non-interest-bearing. They have been due since the end of 2023 and are now considered current financial liabilities.
Lease liabilities are recognized in accordance with IFRS 16, in counterpart of right-of-use assets for buildings and equipment leased by the Group.
The following table provides a maturity analysis of non-current liabilities:
| In thousands of € | 30/06/2025 | 1 to 5 years | Over 5 years |
|---|---|---|---|
| Government backed-loans | 3,102 | 3,102 | |
| Convertible bond loan | 4,000 | 4,000 | |
| Repayable advances | 58 | 58 | |
| Lease liabilities | 163 | 163 | |
| TOTAL | 7,323 | 7,323 |
9.3. Others non-current financial liabilities
Other non-current liabilities previously included the debt owed to SpePharm, related to the settlement agreement signed by the Group on February 11, 2020, for an initial amount of €4.048 million.
This liability has been reclassified as a current liability following the rescheduling of repayments over 2025 and 2026, thereby providing improved visibility and greater flexibility in the management of the Group's cash flows.
NOTE 10 : CURRENT LIABILITIES
10.1. Current provisions
Current provisions are estimated at €61 thousand. They mainly relate to provisions for social security liabilities.
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10.2. Short-term borrowings and financial liabilities
| Variation | |||||||
|---|---|---|---|---|---|---|---|
| In thousands of € | 30/06/2025 | 31/12/2024 | Total | Cash impact | Non-cashimpact | ||
| Governmenntbacked-loans(PGE) | 253 | 1,854 | -1,601 | -47 | -1,554 | ||
| Repayable advances | 33 | 33 | |||||
| Accrued interest and fees | 2 | 11 | -9 | -9 | |||
| Other | 10,739 | 5,399 | 5,340 | 5,340 | |||
| Subtotal | 11,027 | 7,297 | 3,730 | 5,293 | -1,563 | ||
| Lease liabilities | 222 | 325 | -103 | -103 | |||
| TOTAL | 11,249 | 7,622 | 3,627 | 5,293 | -1,666 |
10.3. Trade payables
| In thousands of € | 30/06/2025 | 31/12/2024 |
|---|---|---|
| Trade payables and related accounts | 4,088 | 5,247 |
The change in trade payables is mainly due to the repayment of outstanding supplier debts.
10.4. Other current liabilities
| In thousands of € | 30/06/2025 | 31/12/2024 |
|---|---|---|
| Social liabilities | 1,211 | 1,713 |
| Tax liabilities | 461 | 627 |
| Other liabilities | 4,256 | 3,126 |
| Total | 5,928 | 5,467 |
The decrease in social liabilities mainly results from the termination of clinical trials, which led to the closure of the U.S. subsidiary and the departure of its employees.
The increase in other liabilities is primarily due to the reclassification of the SpePharm debt as current liabilities, amounting to €1.25 million as of June 30, 2025, with final maturity scheduled for April 2026.
NOTE 11: OPERATING INCOME AND EXPENSES
11.1. Revenue
| In thousands of € | 30/06/2025 | 30/06/2024 |
|---|---|---|
| Recurring revenue from licensing agreements | 0 | 0 |
| Non-recurring revenue from licensing agreements | 126 | 88 |
| Total revenue | 126 | 88 |
11.2. Staff costs
Staff costs are broken down as follows:
| In thousands of € | 30/06/2025 | 30/06/2024 |
|---|---|---|
| Salaries | 852 | 3,442 |
| Social security contributions | 405 | 800 |
| Employee benefits (IFRS 2) | 72 | 195 |
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| Research tax credit deduction | -221 | -105 |
|---|---|---|
| Other staff expenses | 2 | 13 |
| Total | 1,111 | 4,345 |
The total headcount (employees and corporate officers) was 25 people as of June 30, 2025, compared with 38 people as of June 30, 2024.
11.3. External expenses
External expenses are composed as follows:
| In thousands of € | 30/06/2025 | 30/06/2024 |
|---|---|---|
| R&D expenses | 395 | 4,360 |
| Research tax credit deduction | -241 | -595 |
| General and administrative expenses | 715 | 862 |
| Total | 869 | 4,627 |
The decrease in R&D expenses compared with 2024 mainly reflects the termination of clinical trials and the closure of the U.S. subsidiary in January 2025, as part of the refocusing of resources on the new R&D strategy implemented in 2025.
NOTE 12 : FINANCIAL RESULT
| In thousands of € | 30/06/2025 | Cash impact | Non-cashimpact | 30/06/2024 |
|---|---|---|---|---|
| Income from cash and cash equivalents | ||||
| Cost of financial debt | -98 | -98 | ||
| Net cost of financial debt | -98 | -98 | ||
| Other financial income | 13 | 13 | 27 | |
| Other financial expenses | -201 | -201 | -60 | |
| Financial result | -285 | -98 | -188 | -33 |
NOTE 13 : EARNINGS PER SHARE
| 30/06/2025 | 30/06/2024 | |
|---|---|---|
| Net income attributable to ordinary shareholders (€) | -207 738 | -10 958 202 |
| Number of shares issued | 154 364 273 | 154 364 273 |
| Treasury shares | 0 | 392 365 |
| Number of shares outstanding (excluding treasury shares) | 154 364 273 | 153 971 808 |
| Stock options | 5 194 350 | 7 775 344 |
| Warrants (BSA) | 2 082 000 | 2 186 886 |
| Total potential and issued shares (excluding treasury shares) | 161 640 623 | 163 934 138 |
| Weighted average number of shares outstanding (excluding treasuryshares) | 161 640 623 | 163 934 138 |
| Basic earnings per share (€) | -0,00 | -0,07 |
| Diluted earnings per share (€) | -0,00 |
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The impact of dilution is not presented for 2024 and 2025, as it would be anti-dilutive due to the negative result.
NOTE 14 : RELATED PARTIES
Transactions with related parties, as defined in paragraph 9 of IAS 24, relate exclusively to companies included within the scope of consolidation.
In May 2025, the Company entered into shareholder loan agreements with Artal International SCA and Financière de la Montagne, for €5 million and €500,000 respectively.
NOTE 15 : SUBSEQUENT EVENTS
See Section 6.2 of the 2025 Interim Financial Report.
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9. CERTIFICATION OF THE PERSON RESPONSIBLE FOR THE INTERIM FINANCIAL REPORT
I hereby certify that, to the best of my knowledge, the condensed interim consolidated financial statements have been prepared in accordance with the applicable accounting standards and give a true and fair view of the assets, financial position, and results of the Company and of all entities included in the consolidation. I further certify that the interim management report (presented in Chapter 4 of this report) gives a fair description of the significant events that occurred during the first six months of the year, their impact on the financial statements, the main related-party transactions, and a description of the principal risks and uncertainties for the remaining six months of the year.
Paris, October 24, 2025
Mr. Julien Miara Chief Executive Officer