On April 2, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that KEYTRUDA (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. This approval, which also covers KEYTRUDA SC [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU.

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"Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1-positive platinum-resistant ovarian cancer across Europe."

This approval is based on results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), in which KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the trial’s primary endpoint, and overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) compared to placebo plus paclitaxel, with or without bevacizumab. The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), received in February 2026.

"We’re proud to bring this KEYTRUDA-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer – giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally."

In the KEYNOTE-B96 trial, KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS, reducing the risk of disease progression or death by 28% (HR=0.72 [95% CI, 0.58-0.89]; p=0.0014) in patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) when compared to placebo plus paclitaxel, with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median PFS was 8.3 months (95% CI, 7.0-9.4) versus 7.2 months (95% CI, 6.2-8.1) for patients receiving the placebo regimen.

The KEYTRUDA-based regimen also demonstrated a statistically significant and clinically meaningful improvement in OS for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.61-0.94]; p=0.0053) compared to placebo plus paclitaxel with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median OS was 18.2 months (95% CI, 15.3-21.0) versus 14.0 months (95% CI, 12.5-16.1) for patients receiving the placebo regimen.

This approval authorizes marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In February 2026, KEYTRUDA plus paclitaxel, with or without bevacizumab, was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

About KEYNOTE-B96/ENGOT-ov65

KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel), with or without bevacizumab, compared to placebo plus chemotherapy with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel, with or without bevacizumab, or placebo plus paclitaxel, with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

Results from the final analysis of the KEYNOTE-B96 trial evaluating KEYTRUDA plus paclitaxel, with or without bevacizumab, including PFS and OS results for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status, were recently presented at the European Society of Gynaecological Oncology (ESGO) 2026 Congress.

About platinum-resistant ovarian cancer

Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, APR 2, 2026, View Source [SID1234664152])

On April 2, 2026 CellCarta, a global provider of precision medicine laboratory services for drug development, and Pillar Biosciences, a leader in NGS-based oncology molecular diagnostics, reported a global multi-year strategic partnership to broaden access to fast, operationally streamlined next-generation sequencing (NGS) tumor profiling for biopharma sponsors and clinical research partners worldwide.

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As oncology drug development becomes increasingly biomarker-driven, sponsors are under pressure to enroll faster while managing tighter budgets. At the same time, trial designs continue to fragment into smaller molecular subgroups, increasing screening volume, operational complexity, and the cost of delay. Testing strategies that rely on broad panels by default can add unnecessary time, expense, and friction when studies require a fit-for-purpose set of actionable markers.

This partnership is designed to remove that bottleneck by combining Pillar’s portfolio of oncoReveal NGS-based kitted panels with CellCarta’s global clinical trial testing execution. Together, the companies will help sponsors right-size molecular testing to each study objective, reduce avoidable operational steps, and deliver actionable results on timelines that support enrollment and decision-making.

The collaboration will focus on enabling indication-relevant tumor profiling with reduced hands-on complexity, consistent performance expectations, and faster sample-to-report execution compared to traditional, more operationally burdensome approaches.

The partnership will help address sponsor cost pressure with fit-for-purpose profiling aligned to indication and trial objectives when broad panels are unnecessary and will support increasingly complex, biomarker-driven trial designs where turnaround time and reliability directly impact screen-fail rates and timelines.

Robin Grimwood, SVP of Genomics at CellCarta"Biomarker-driven oncology trials demand testing strategies that are both operationally efficient and aligned with long-term development goals," said Robin Grimwood, SVP of Genomics at CellCarta. "Through our partnership with Pillar Biosciences, we combine their streamlined, rapid workflow with our global laboratory execution and deep CDx expertise to support faster enrollment and standardized implementation across regions. Importantly, this collaboration enables us to offer highly targeted, indication-specific panels for prospective testing, with the flexibility to develop custom panels aligned to sponsor programs — providing a consistent foundation for potential companion diagnostic alignment as assets advance."

(Press release, Pillar Biosciences, APR 2, 2026, View Source [SID1234664151])

On April 2, 2026 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported the pricing of an underwritten public offering of 12,500,000 shares of its common stock and accompanying Series A warrants to purchase up to 12,500,000 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.40 per share of common stock and Series B warrants to purchase up to 12,500,000 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.40 per share of common stock, at a combined public offering price of $1.40 per share of common stock and accompanying Series A and Series B warrants. All of the securities in the offering are being sold by INOVIO. The offering is expected to close on or about April 6, 2026, subject to the satisfaction of customary closing conditions. INOVIO also granted the underwriter an option for a period of 30 days to purchase up to 1,875,000 additional shares of the Company’s common stock and Series A warrants to purchase up to 1,875,000 additional shares of its common stock and Series B warrants to purchase up to 1,875,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by INOVIO, excluding any exercise of the underwriter’s option to purchase additional securities and assuming no exercise of the accompanying Series A and Series B warrants, are expected to be approximately $17.5 million.

Piper Sandler is acting as sole manager for the offering.

A shelf registration statement relating to the shares of common stock and accompanying Series A and Series B warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Inovio, APR 2, 2026, View Source [SID1234664149])

On April 2, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported annual financial results for the year ended December 31, 2025 and provided a corporate update. A summary of the consolidated financial statements is included below.

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Pascal Prigent, CEO of GENFIT commented: "Iqirvo’s performance in its first full year of sales, together with encouraging early results from both our oncology and ACLF assets, were very promising signs for GENFIT last year. 2026 could be even better and significantly accelerate the Company’s trajectory. Indeed, we expect to see continued strong performance from Iqirvo in PBC, while also anticipating a significant acceleration in our diagnostic business. On top of these growing businesses, there are also promising programs further down the pipeline. This summer, we expect to receive full results from our Phase 1b oncology trial, which could become a game changer. In 2027, we anticipate results from the Phase 2 proof‑of‑concept study evaluating NTZ in ACLF that we will start later this year. Looking further ahead, Ipsen’s ongoing development efforts in PSC also have the potential to represent a step change for the Company."

In 2025, GENFIT benefited from the strong commercial performance of Iqirvo1 in Primary Biliary Cholangitis (PBC), driven by Ipsen’s commercial execution. Performance will continue to be closely monitored, and current indicators suggest that Ipsen is on track to deliver results meaningfully above initial expectations. Beyond this existing business, several additional programs in our pipeline or with partners have the potential to generate additional significant value in the future on a scale comparable to, or exceeding, PBC royalties:

In metabolic dysfunction‑associated steatohepatitis (MASH), GENFIT’s diagnostic technology targets a very large and rapidly expanding market, supported by accelerating therapeutic development and deepening engagement from major industry players. In this context, our non-invasive technology is recognized as a critical component of this evolving ecosystem. We believe that the potential royalties deriving from our technology could be very significant. Key catalysts will be reimbursement status and industry partnerships, with multiple initiatives currently underway to drive broader deployment.
In oncology, new Phase 1b clinical data from the GNS561 combination in cholangiocarcinoma (CCA) are expected mid‑year and should provide important insights to inform further development and support progression toward Phase 2.
In Acute-on-Chronic Liver Failure (ACLF), a Phase 2 study evaluating NTZ is expected to start in the second half of this year, marking a significant step forward in this indication.
Finally, in PSC, a market comparable in size to PBC, Ipsen has initiated a Phase 3 study called ELASCOPE2 in February 2026, and currently is the sole company at this stage of development in PSC.
I. 2025 Highlights – including post-closing events

Commercial & partnership highlights

In 2025, GENFIT’s partners achieved significant progress, driving a number of important developments across key programs:

Ipsen’s Iqirvo (elafibranor) in PBC and PSC

PBC: Iqirvo’s net sales for the fourth quarter 2025 amounted to US$88 million, bringing full-year 2025 sales to US$208 million3, triggering the first US$20M commercial milestone payment to GENFIT one year ahead of schedule. This momentum also allowed GENFIT to activate, in January 2026, an additional €30 million tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility without shareholder dilution.
PSC: Ipsen initiated the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.
Following the mutual termination of GENFIT’s agreement with Terns in December 2025, Ipsen exercised its contractual opt‑in right to include Greater China in the existing Licensing Agreement, resulting in a worldwide elafibranor license for Ipsen under the same favorable financial terms.

Non-invasive diagnostic technology in MASH

The MASH therapeutics market accelerated in 2025, with near‑blockbuster performance (~US$1 billion in sales) achieved by the first approved therapy in its first year of commercialization, increasing the need for large‑scale, non‑invasive diagnostic, further reinforced by the entry of an additional major therapeutic player in August. Against this backdrop, pricing for NASHnext—developed by Labcorp as a Laboratory Development Test (LDT) under license from GENFIT and based on GENFIT’s proprietary non‑invasive diagnostic technology for identifying at‑risk patients in MASH (formerly NASH)—, was established by U.S. Medicare and Medicaid at the end of 2025. This represents an important step toward reimbursement.

R&D highlights

In 2025, GENFIT advanced its lead clinical programs in ACLF and CCA, reprioritized VS‑01, and continued to assess the potential of multiple mechanisms of action across its research portfolio.

Clinical developments

G1090N/NTZ (ACLF): Our lead program generated preliminary Phase 1 data showing a favorable safety profile and a robust anti-inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and from cirrhotic donors.
GNS561 (CCA): Encouraging preliminary data were generated from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers.
VS-01 (ACLF): GENFIT decided to discontinue this program in ACLF, following the emergence of a safety signal, prompting a precautionary reassessment of the benefit/risk ratio in this indication, and refocused development in Urea Cycle Disorder (UCD) where the disease biology, patient population and development framework materially differ.

Research developments

SRT–015 (ACLF): Although activity on the ASK1 target has been demonstrated in preclinical models, the in vivo data available to date do not confirm a sufficient benefit, and uncertainties remain regarding the expected effects in ACLF.
CLM–022 (ACLF): Alongside preclinical studies, GENFIT pursued the activities preliminary to clinical development, including pharmacokinetic and nonclinical safety characterization. While the NLRP3 target remains valid, developability challenges with CLM-022 have been identified and will be further assessed.
VS-02-HE (ACLF continuum): VS‑02‑HE is being optimized as an oral formulation designed to act at the colonic level, where ammonia is primarily produced, to minimize its systemic concentration while reducing glutamine levels in the brain. In the first quarter of 2026, regulatory toxicology studies were initiated.
EViv (ACLF): At the end of 2025, GENFIT initiated a research collaboration with EverZom aimed at evaluating the therapeutic potential of extracellular vesicles derived from human adipose‑derived mesenchymal stem cells (hAD‑MSC‑EVs) in Acute Decompensation (AD) and ACLF.
VS-01-HAC (UCD): VS01 was reprioritized to Urea Cycle Disorders (UCD) following the discontinuation of the ACLF program. Positive initial data from a pivotal juvenile toxicology study in Göttingen minipigs supported the tolerability of the compound. VS-01-HAC was granted Rare Pediatric Disease Designation by the FDA for UCD, potentially enabling eligibility for a Priority Review Voucher upon New Drug Application approval.

Other developments

In 2025, GENFIT contributed to positioning ACLF as a strategic focus within the Forum for Collaborative Research, an independent multi‑stakeholder initiative bringing together regulators, industry leaders, academics, clinicians, scientists and patient groups to help shape and accelerate drug development in areas of high unmet medical need.

Financial highlights

The Royalty Financing agreement signed in March 20254 has significantly extended GENFIT’s cash runway, beyond the end of 2028, enabling the Company to further develop its pipeline focused on ACLF and support general corporate purposes. See III. Financial results for further details.

Genfit recorded a revenue of €65.4 million in 2025. This consists of greater than expected royalty revenue of €21.8 million and two milestones totalling €43.6 million, both of which stem from positive market performance of Ipsen’s Iqirvo.

For the year ended December 31, 2025, the Company’s net loss amounted to €86.0 million compared with a net gain of €1.5 million for the year ended December 31, 2024.
Excluding certain one‑time non‑cash operating expenses of €49.1 million, and excluding an estimated €13.3 million in financial expenses arising from faster than expected repayment of the royalty financing, the 2025 net loss would be reduced to €23.6 million. These items are described in more detail below in section III. Financial Results.

Sustainability highlights

B Corp certification was granted at the end of 2025, providing an independent, internationally recognized mark of credibility. This certification underscores GENFIT’s engagement in social, societal, environmental and governance matters as the Company continues to execute its ESG roadmap on schedule.

Corporate governance updates

Mr. Tristan IMBERT was appointed as a director for a three-year term by the General Meeting of Shareholders held on June 17, 2025 and joined the Audit Committee and ESG Committee following his appointment. The terms of office of Mr. Eric BACLET and Ms. Katherine KALIN as directors were renewed for a period of three years. Mr. John BROZEK replaced Ms. Florence SÉJOURNÉ as permanent representative of Biotech Avenir SAS on the Company’s Board of Directors. Dr. Pejvack MOTLAGH replaced Dr. Carol ADDY as Chief Medical Officer and member of the Executive Committee in November 2025, following her retirement on June 30, 2025. Sakina SAYAH-JEANNE, formerly Executive Vice President of Research and Translational Science and member of the Executive Committee, replaced Dean HUM, Chief Scientific Officer following his retirement on September 30, 2025.

II. 2026 Outlook

Commercial and partnership outlook

Ipsen’s Iqirvo (elafibranor) in PBC and PSC

Ipsen is expected to publish its first‑quarter 2026 financial results on April 23, 2026. For further information on the development of Iqirvo in PBC and PSC, please refer to Ipsen’s news flow and financial calendar: View Source

Non-invasive diagnostic technology in MASH

Building on the therapeutic market momentum observed in 2025, and the expected evolution of the competitive landscape with the entry of additional large pharmaceutical players, the MASH diagnostics market is expected to further develop in 2026. Addressing this opportunity at scale will require reliable and scalable solutions to support patient identification, treatment decision‑making and longitudinal monitoring across care pathways. In this context, GENFIT’s technology is already referenced in international clinical guidance as the only fully blood‑based approach for identifying at‑risk MASH patients, recognized by the LITMUS and NIMBLE consortia and supported by a robust body of scientific literature. Looking ahead, further progress in 2026 will depend on a combination of factors, including reimbursement and payer adoption, demand generated through broad pharmaceutical programs, and advances toward an IVD‑labeled version to support wider clinical use.

R&D outlook

Clinical outlook

G1090N/NTZ (ACLF): GENFIT will engage with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF where systemic immune dysregulation is a critical driver of disease progression. Initiation remains targeted for the second half of 2026, with data expected in 2027. In March 2026, Orphan Drug Designation (ODD) was granted for NTZ for the treatment of ACLF.
GNS561 (CCA): Phase 1b dose escalation is progressing as planned, with additional cohort data expected in mid‑2026. The Phase 1 study is designed to assess safety, define the recommended Phase 2 doses for the combination, and evaluate preliminary signs of activity. Initiation of Phase 2 remains targeted for the second half of 2026. In parallel, GENFIT will investigate the biological rationale for autophagy inhibition in the emergence of resistance to standards of care. These studies will aim to assess the therapeutic potential of new combination strategies, associating GNS561 with other agents.
Research outlook

SRT-015 (ACLF): Current work focuses on finishing the preclinical activities to decide by the end of the first semester of 2026 if we move the program into a first‑in‑human clinical trial.
CLM-022 (ACLF): Ongoing work aims to strengthen the translational rationale for NLRP3 inhibition in the indications of AD and ACLF.
VS-02-HE (ACLF continuum): Pharmacological studies are ongoing, and the regulatory toxicology studies are expected to be completed by early 2027. Subject to confirmation, a first‑in‑human trial could be launched in the second half of 2027.
EViv (ACLF): GENFIT and EVerZom plan to conduct exploratory studies to evaluate the efficacy of EViv in ACLF, with a decision point targeted mid-2027 on whether to advance into clinical development.
VS-01-HAC (UCD): A plan of action is currently executed, aimed at securing the developability of VS‑01 in UCD, before potentially initiating a first clinical trial.

Other developments

In May 2026, ahead of its annual congress, the European Association for the Study of the Liver (EASL) will bring together leading international learned societies, spanning North America, Asia‑Pacific, Latin America and Africa, represented by AASLD5, APASL6, ALEH7 and SOLDA8, to jointly address ACLF. This pre‑congress program sends a strong signal for patients, healthcare providers and industrial stakeholders, underscoring growing alignment and momentum across the global hepatology community.

(Press release, Genfit, APR 2, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-full-year-2025-financial-results-and-provides [SID1234664148])

On April 2, 2026 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the fiscal year ended December 31, 2025, and provides a business update.

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2025 business and operational highlights

The Company remains focused on partnering its intellectual property and has progressed in the discussions with potential partners for selected out-licensing of its technologies;
The Company discontinued its R&D activities and sold its research facility for €3 million.
Full year 2025 financial review

As of December 31, 2025, the Company’s Treasury position amounts to €1.7 million.

The Company projects that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements into third quarter 2026. Hence, its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that the financial statements are issued.

Key financial figures for full-year 2025, compared with full-year 2024, are summarized below:

Selected key financial figures (€ millions) Full year 2025 Full year 2024
Revenue 0.02 0.2
Research and development expenses (3.4) (3.2)
General and administrative expenses (3.8) (3.2)
Other income/(expenses) 8.3 0.4
Operating profit/loss 0.9 (5.9)
Profit/loss for the period/year 0.8 (5.8)
Net cash used in operations (2.5) (2.8)
Treasury position (1) 1.7 4.2
(1) "Treasury position" is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS. Management’s purpose of this measure is to identify the level of cash available internally (excluding external sources of financing) within 12 months.

Research and Development (R&D) expenses were €3.4 million in 2025 as compared to €3.2 million in 2024, a year-over-year increase of €0.2 million. The increase in the Company’s R&D expenses is a consequence of the Company’s decision to discontinue its R&D activities and to restructure its organization accordingly and which has driven severance and other termination‑related costs incurred as part of the phased reduction of R&D operations.

General and Administrative (G&A) expenses were €3.8 million in 2025 as compared to €3.2 million in 2024, a increase of €0.6 million. General and administration expenses increased mainly due to higher employee expenses and share-based payments, mainly reflecting severance and other termination‑related costs incurred; these increases were partially offset by a decrease in consulting fees as reliance on external advisors declined in line with the scaled‑back corporate activities.

Until December 31, 2025, Management has determined that there has been no event (such as a firm sublicense or collaboration contract) that led to a change in fair value of the contingent consideration and other financial liabilities towards Dartmouth and Celdara.

The Company’s other income increased by €7.8 million mainly due to three elements:

• Grant income that resulted from the Company’s decision to stop several subsidized research contracts with the Walloon Region and to transfer the rights on the related research results to the Walloon Region;

• R&D tax credit: the current year income increases compared to December 31, 2024, due to the derecognition of the related liability as the conditions for recognizing the underlying grant income are fully fulfilled end of 2025;

• The gain on sale of property, plant and equipment in 2025 amounts to €2,3 million and relates to the Company’s divestment of its research facility in Mont‑Saint‑Guibert. Under the terms of an asset purchase agreement, the Company sold the research facility’s laboratory equipment and office furniture for a total consideration of €3 million.

Net profit for the year ending December 31, 2025, was €0.8 million, or €0.018 per share, compared to a net loss of €5.8 million, or 0.14€ per share, for the same period in 2024. The decrease in net loss between periods are primarily due to the elements explained here above.

Net cash used in operations for the year ending December 31, 2025, which excludes non-cash effects, amounted to €6.9 million, which is above the net cash used in operations of €5.7 million for the year ended December 31, 2024.

Alarm bell status

The net assets of the Company per 31 December 2025, on a BE-GAAP non-consolidated basis, having fallen below twenty-five percent of the Company’s capital, the board of directors will submit to the ordinary shareholders meeting on the 20th of May 2026 the proposal to continue the Company’s activities in accordance with article 7:228 of the Belgian Code for Companies and Associations. The board of directors will publish a special report in this respect, by the 17th of April 2026, together with the convening notice with proposed resolutions for the shareholders’ meeting.

Annual Report 2025

The Annual Report for the year ended December 31, 2025, will be published on April 02, 2026, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, BDO Réviseurs d’Entreprises SRL (or ‘BDO’), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements but that they will include in their audit opinion a paragraph referring to the existence of a material uncertainty about going concern. This was already the case last year and BDO also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.

Financial Calendar 2026

May 20th, 2026 Annual shareholders meeting
September 23th, 2026 First Half 2026 Interim Results
The financial calendar is communicated on an indicative basis and may be subject to change.

(Press release, Celyad, APR 2, 2026, View Source [SID1234664147])