On April 30, 2026 Bristol-Myers Squibb reported first quarter 2026 financial results.

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(Presentation, Bristol-Myers Squibb, APR 30, 2026, View Source [SID1234664998])

On April 30, 2026 AstraZeneca reported that The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit risk profile of AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation, based on the SERENA-6 Phase III trial. The Committee voted 3 to 6.

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In July 2025, the FDA accepted the New Drug Application (NDA) for camizestrant in combination with a CDK4/6 inhibitor based on positive results from the pivotal SERENA-6 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1 The FDA granted Breakthrough Therapy Designation (BTD) for the camizestrant combination in this setting in May 2025.

The FDA is not bound by the Committee’s guidance but takes its advice into consideration. AstraZeneca will continue to work with the FDA as it completes its review of the application.

Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical Oncology, Winship Cancer Institute of Emory University and investigator for the trial, said: "Patients with this specific form of breast cancer are in urgent need of new treatments that delay disease progression. Today’s recommendation by the ODAC is disappointing, as new options and innovative treatment strategies which address emerging resistance ahead of disease progression and deterioration in quality of life are needed in the 1st-line setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "New innovations and novel treatment strategies that provide benefit to patients are required to drive advances in this 1st-line setting, and so we are disappointed with the mixed outcome of today’s ODAC meeting. We strongly believe in the results of the SERENA-6 trial, and are encouraged that the Committee saw camizestrant as a safe and effective potential new medicine. We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity, and are committed to challenging the status quo in the pursuit of innovation that optimises outcomes for patients."

Results from a planned interim analysis of the SERENA-6 Phase III trial showed a highly statistically significant and clinically meaningful 56% reduction in the risk of disease progression or death with the camizestrant combination versus standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001).1 Median PFS was 16.0 months for patients who switched to the camizestrant combination versus 9.2 months for the comparator arm, and nearly one third (29.7%) of patients in the camizestrant arm showed sustained disease control at 24 months of treatment, versus 5.4% patients in the AI arm.1

Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis, however a subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months in favour of the camizestrant combination (HR: 0.63; 95% CI: 0.46, 0.86; p = 0.00373) and OS continued to mature in favour of the camizestrant combination (HR: 0.87, CI: 0.57-1.30). The trial will continue to assess OS as a key secondary endpoint. Additional analyses of patient reported outcome (PRO) measures published in Annals of Oncology showed that the camizestrant combination demonstrated consistent benefit in delaying time to deterioration (TTD) in quality of life and reduced the risk of deterioration in patient-reported cancer symptoms and functioning, where the camizestrant combination reduced the risk of deterioration in global health status and quality of life by 46% compared with the AI combination (HR 0.54; 95% CI, 0.34-0.84; nominal p<0.001).2

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms.

SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

Regulatory applications for camizestrant in this setting are also under review in the EU, Japan and several other countries.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.3 In the US, breast cancer is the most common cancer in women, with more than 300,000 new cases of the disease diagnosed annually, and more than 42,000 deaths.4 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.5

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.5 Estrogen receptor (ERs) often drive the growth of HR-positive breast cancer cells.6

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 In the US, approximately 37,000 patients with HR-positive metastatic breast cancer are treated with these therapies in the 1st-line setting.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.5,9

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap, the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

(Press release, AstraZeneca, APR 30, 2026, View Source [SID1234664997])

On April 30, 2026 Pliant Therapeutics (Nasdaq: PLRX) reported the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins αvβ8 and αvβ1.

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"We are pleased to announce this milestone for the FORTIFY trial and the expansion into solid tumor cohorts that we believe are supported by PLN-101095’s mechanism of action," said Bernard Coulie, M.D., Ph.D.., Chief Executive Officer of Pliant. "As a leader in integrin drug development, we look forward to exploring the full potential of this novel drug candidate."

FORTIFY – Phase 1b Clinical Trial Design

The primary objective of this trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of PLN-101095 when administered orally in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors. The expansion trial is enrolling three cohorts of patients with NSCLC, clear cell renal cell carcinoma, or one of a subset of tumors with high tumor mutational burden. Patients will be treated for 14 days with PLN-101095 as monotherapy dosed at 1,000 mg twice daily, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

PLN-101095 for the Treatment of Checkpoint Resistant Tumors

PLN-101095 is an oral, small molecule inhibitor of integrins αvβ8 and αvβ1. Activated transforming growth factor-β (TGF-β) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has been shown to prevent the activation of TGF-β and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 PLN-101095 is currently being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT 06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration.

(Press release, Pliant Therapeutics, APR 30, 2026, View Source [SID1234664996])

On April 30, 2026 EnGeneIC Limited reported that the first patient has been dosed in its clinical trial evaluating EnGeneIC’s investigational EGFR-targeted EDV (EnGeneIC Dream Vector) therapy in patients with recurrent glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer.The trial is being led by Principal Investigator Dr. Mark Wong, Medical Oncologist at Westmead Hospital, one of Australia’s leading comprehensive cancer centres. Additional Australian recruitment sites will include the Kinghorn Cancer Centre, with further expansion planned to clinical sites in Singapore.

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"This first patient dosed milestone is a critical step forward for patients with recurrent glioblastoma, who typically have very limited treatment options once standard therapies have failed," said Dr. Mark Wong. "We look forward to assessing the safety and potential clinical benefit of this investigational therapy in a patient population with significant unmet medical need."

The investigational treatment consists of EGFR-targeted EnGeneIC Dream Vectors (EDVs) — bacterially derived, nanocell-based particles engineered to selectively bind to epidermal growth factor receptor (EGFR), which is frequently over-expressed in glioblastoma. The EDVs are loaded with the chemotherapeutic agent doxorubicin and the immune-modulating adjuvant α-galactosyl ceramide (α-GalCer).

This dual-payload design is intended to directly kill EGFR-expressing tumour cells while simultaneously activating a broad anti-tumour immune response, potentially converting an immunologically "cold" tumour into one capable of sustained immune recognition and attack.

In the clinical context, recurrent GBM remains highly resistant to conventional chemotherapy and immunotherapy, and EGFR-targeted EDVs offer a novel approach by combining targeted intracellular drug delivery with immune activation in a disease where both effective tumour penetration and immune engagement have historically been major challenges.

Dr. Jennifer MacDiarmid, Joint CEO and Director of EnGeneIC, commented "This clinical trial builds on spectacular overall survival outcomes currently observed in Compassionate Case Study patients with recurrent glioblastoma who had exhausted all available treatment options. Those results provided the strong clinical rationale to advance this EGFR-targeted EDV therapy into a formal clinical trial, allowing us to rigorously evaluate both its anti-cancer and immune-stimulating potential."

Patient recruitment is expected to continue across Australian and Singaporean sites in accordance with the trial protocol and applicable regulatory approvals.

About Glioblastoma

Glioblastoma multiforme is the most common and aggressive primary brain cancer in adults. Despite treatment with surgery, radiation and chemotherapy, recurrence is common and survival outcomes remain poor, highlighting the urgent need for new therapeutic approaches.

(Press release, EnGeneIC, APR 30, 2026, View Source [SID1234664995])

On April 30, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (the "Company"), reported its full year 2025 unaudited consolidated financial results, as approved by the Board of Directors on April 29, 2026. Audit procedures by the Company’s statutory auditors on the Company’s 2025 consolidated financial statements are still ongoing.

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Full Year 2025 Consolidated Financial Results (IFRS, unaudited)

In million euros 2024 2025
Revenues 69.9 2.6
Other income 13.6 0.1
Operating income 83.4 2.7
Research and development expenses (30.4) (33.9)
General and administrative expenses (6.5) (8.8)
Share-based payments non-cash expenses (2.7) (1.9)
Other operating items - 4.4
Operating profit (loss) 43.7 (37.5)
Financial income (loss) (3.9) 0.1
Net income (loss) 37.4 (37.7)
EPS (in € per share) 1.71 (1.69)
Net cash flows from operating activities 48.4 (34.0)
Net cash flows from investment activities (46.9) 41.4
Net cash flows from financing activities (3.5) (6.5)
Net cash flows (1.9) 0.8
Cash and cash equivalents at closing 16.7 17.6
Total Cash Position at closing (incl. long-term deposits) 64.2 22.7

Operating income in 2025 amounted to €2.7 million, primarily reflecting revenues generated by Tedopi’s supply of early access program in France for €1.4 million, and the deferred recognition of a portion of the $48 million upfront payment from the AbbVie licensing agreement on OSE-230 signed in April 2024 for €0.8 million. In comparison, operating income in 2024 totaled €83.4 million, mainly driven by the immediate booking of the majority of the AbbVie upfront payment for €42.2 million, €25.3 million from the amendment to the agreement with Boehringer Ingelheim on BI 765063 (OSE-172), and €13.5 million from the asset purchase by Boehringer Ingelheim related to the "cis-targeting" anti-PD1/cytokine platform.

Research and development expenses increased by 11.5% over the period, amounting to €33.9 million in 2025, compared to €30.4 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 pivotal trial of Tedopi – Artemia – actively recruiting, as well as a lower amount of Research Tax Credit (CIR) amounting to €4.6 million in 2025, compared to €5.3 million in 2024.

General and administrative expenses increased by 34.0% over the period, amounting to €8.8 million in 2025, compared to €6.5 million in 2024. This significant increase primarily reflects legal fees incurred in connection with the exceptional context surrounding the Annual General Meeting held on September 30, 2025, which led to a complete renewal of the Company’s governance, as well as legal proceedings initiated against certain minority shareholders. These non-recurring expenses were partially offset by a reduction in personnel costs, following the partial deferral of compensation from 2023 to 2024 for certain key executives. Excluding these non-recurring expenses, general and administrative expenses represented €7.8m, increasing by 19.5% year-on-year.

Share-based payments non-cash expenses amounted to €1.9 million in 2025, compared to €2.7 million a year earlier. These expenses are mainly comprised of calculated non-cash expenses in application of IFRS2, amounting to €1.5 million and €2.1 million in 2025 and 2024, respectively. The decrease in 2025 notably reflects a reversal of expenses due to the cancellation of 219,970 free shares granted in 2024 to former CEO Nicolas Poirier, following a negative vote by shareholders on the "Say-on-Pay" ex post provision at the Annual General Meeting held on September 30, 2025.

Other operating items amounted to €4.4 million in 2025, representing a partial waiver of debt related to conditional advances paid by Bpifrance for the EFFICLIN project after it was terminated by the Company.

Operating loss amounted to €(37.5) million in 2025, compared to a profit of €43.7 million a year earlier, essentially reflecting an exceptional income in 2024 related to the AbbVie licensing agreement on OSE-230 and the amendment on the BI 765063 (OSE-172) agreement as well as the asset purchase agreement from the "cis-targeting" anti-PD1/cytokine platform by Boehringer Ingelheim.

Financial income amounted to €0.1 million in 2025, compared to a loss of €(3.9) million a year earlier. This variation is mainly related to calculated non-cash expenses reflecting the change in fair value of the warrant passive derivative in the European Investment Bank (EIB) finance contract.

Net loss amounted to €(37.7) million in 2025, compared to a profit of €37.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from operating activities amounted to €(34.0) million in 2025, reflecting our development programs moving forward, notably the ongoing Phase 3 trial of Tedopi – Artemia – actively recruiting, compared to €48.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from investment activities amounted to €41.4 million in 2025, compared to €(46.9) million a year earlier, essentially reflecting cash management in various term deposit instruments.

Net cash flows from financing activities amounted to €(6.5) million in 2025, compared to €(3.5) million a year earlier. This variation mainly reflects an early repayment of the EIB loan for €3.0 million in January 2025.

Cash and cash equivalents totaled €17.6 million as of December 31, 2025, compared to €16.7 million a year earlier. Including fixed-term deposits classified as current and non-current financial assets, total cash position amounted to €22.7 million and €64.2 million as of December 31, 2025 and 2024, respectively.

Cash Runway and Financing

The Company’s cash and cash equivalents totaled €17.0 million as of March 31, 2026, compared to €22.7 million as of December 31, 2025.

Based on its current plans, assumptions and available financial resources, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations until the beginning of fourth quarter 2026, as previously guided. This cash runway does not include any potential exercise of warrants issued to the benefit of Vester Finance, as the contract was fully terminated in April 2026, nor any potential future milestone payments from existing partnerships.

To extend its runway beyond the beginning of the fourth quarter of 2026, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, equity financing, restructuring of its existing debt, and potential milestone payments from current partnerships.

Although the Company is confident in its ability to meet its short-term financing objectives, there is no guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions to finance all of its activities on a 12-month horizon.

Pending the potential completion of such above-mentioned transactions, the Company has deferred the publication of its audited consolidated financial statements and its Universal Registration Document for the fiscal year 2025 to May 28, 2026, at the latest. Certification of the 2025 consolidated financial statements by the Company’s auditors will take place before the filing of the Universal Registration Document with the French financial markets authority (Autorité des Marchés Financiers) (the "AMF"), no later than May 28, 2026. Should no sufficient financing transaction be completed in due time, the statutory auditors are expected to include a going concern qualification in their certification report.

(Press release, OSE Immunotherapeutics, APR 30, 2026, View Source [SID1234664994])