Cemiplimab-RWLC

IMMUNOLIFE, a Phase 2 randomized exploratory study, will evaluate the potential of MaaT033 in combination with Cemiplimab versus Best Investigator Choice (i.e.: second line) in enhancing disease control rate in patients with Non-Small Cell Lung Cancer (NSCLC) who have received antibiotics The IMMUNOLIFE trial is sponsored by Gustave Roussy, a world-renowned center in cancer treatment and conducted within the IMMUNOLIFE consortium, which brings together leading experts in immuno-oncology including Lisa Derosa, MD, PhD This exploratory trial assesses the rationale for combining a full-ecosystem microbiotherapy with immune checkpoint inhibitors (ICIs) in patients presenting antibiotic-induced dysbiosis and improve clinical outcomes This collaboration will generate additional data to advance MaaT034 program in immuno-oncology and the Company’s microbiome-informed AI platform Lyon, France, January 20, 2026 – 6:30pm CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that the first patient has been randomized in the IMMUNOLIFE Phase 2 clinical trial, a randomized multicenter study evaluating the potential of an oral pooled fecal microbiotherapy (MaaT033) in combination with Regeneron’s Cemiplimab (CB) in enhancing disease control rate versus best investigator’s choice (BIC) in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis. The IMMUNOLIFE trial is evaluating MaaT033 in combination with CB vs BIC in 162 patients with advanced NSCLC who are refractory to immune checkpoint inhibitors (ICIs) and have received antibiotics. Patients are randomized (1:1) to receive either MaaT033 orally for one week prior to each cycle of CB (administered every 3 weeks for 6 months), followed by CB alone, or BIC. The primary objective is to assess whether the combination is associated with an improved disease control rate at 12 weeks compared to BIC. The study includes 14 centres in France, with patient enrolment of approximately 2 years and total CB treatment duration of 2 years. Primary results after 1-year follow-up post-treatment could be expected in late 2030. An interim futility analysis around H1 2027, after the 81st randomized patient. “Gut dysbiosis is increasingly recognized as a risk factor for immunoresistance to immunotherapy. MaaT033 is designed to restore microbiome balance and may help improve patients’ response to treatment,” said Lisa Derosa, MD, PhD at Gustave Roussy and coordinating investigator of the IMMUNOLIFE trial. “We have built substantial evidence in our hemato-oncology programs that complex donor-derived products restore immune homeostasis in the context of pre-existing dysbiosis. This study represents an opportunity to further explore these findings in immuno-oncology in a well-defined patient population expected to show antibiotic-mediated dysbiosis,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. This trial, sponsored by Gustave Roussy, is part of MaaT Pharma’s exploratory strategy launched in 2022, which also includes the PICASSO trial, a Phase 2a randomized controlled trial sponsored by AP-HP in Paris evaluating Xervyteg® (MaaT013) in combination with ICIs, ipilimumab (Yervoy®) and nivolumab (Opdivo®) for patients with metastatic melanoma. The Company has been informed by PICASSO’s academic sponsor that topline results could not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026. Overall, IMMUNOLIFE and PICASSO studies aim to contribute to the ongoing assessment of the Company’s research strategy, including indication, treatment line, and patient population. This will also inform on the clinical development of MaaT034, a co-cultured microbiome-based therapy and the Company’s next-generation drug candidate, designed to target large indications in solid tumors. In parallel, data already generated and to be generated during the IMMUNOLIFE consortium will also fuel the Company’s AI platform and support the development of all the Company’s microbiome-based drug candidates. The IMMUNOLIFE consortium includes leading academic institutions such as Gustave Roussy, INSERM, Paris Saclay University, INRAe, Hospital-University Institute (IHU) Méditerranée Infection and biotech companies. The consortium aims to address the challenge of primary resistance to ICI observed in advanced NSCLC patients following antibiotic exposure. The IMMUNOLIFE consortium receives funding from the French National Research Agency (“ANR-21-5 RHUS-0017 IMMUNOLIFE”). For more information on the IMMUNOLIFE (IMMUNOLIFE2) study: NCT07001618 About MaaT033 MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). About MaaT034 MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer. About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Reports positive early clinical experience from first and only clinically validated, extracellular protein degraders using Biohaven's proprietary MoDE™ and next-generation, highly selective TRAP™ degraders exclusively licensed from Yale University. Early clinical experience in patients demonstrates rapid removal of circulating disease-causing proteins, resulting in robust clinical improvement with a well-tolerated profile to date: IgA Nephropathy (IgAN) Program: First dosing of BHV-1400 TRAP degrader in IgAN patients achieved early observations of both biomarker and clinical responses including: selective lowering of only the disease-causing galactose-deficient IgA1 (Gd-IgA1) while sparing off-target effects on healthy antibodies (IgA, IgM, IgE, IgG), resolution of blood in the urine (hematuria), deep reductions in proteinuria, and improvement in fatigue and kidney function (eGFR) within weeks. Completed 4Q25 FDA meeting to align on pivotal IgAN study design; study to initiate in early 2026 Graves' Disease Program: First-in-patient clinical experience with BHV-1300, an IgG MoDE degrader, resulted in a complete suppression of disease-causing TSH receptor-stimulating antibodies with accompanying normalization of previously elevated thyroid hormones within weeks after dosing a patient with Graves' disease. BHV-1300 has shown the potential for best-in-class reductions of IgG, with maximum reductions of up to an 87% decrease from baseline within weeks of dosing. Biohaven is planning a pivotal study of BHV-1300 in Graves' disease in 2026. Advancement of Broad Degrader Portfolio: With clinical proof-of-concept now established, Biohaven is positioned to advance multiple next-generation degraders targeting high value immune-mediated disease indications and explore strategic partnerships to advance the breadth of this platform technology. Announces preliminary data with opakalim, a selective Kv7 channel activator, in an ongoing open-label extension (OLE) clinical study in focal epilepsy. Demonstrated clinically meaningful reductions in seizure frequency compared to pretreatment baseline. Specifically, the majority of participants treated with opakalim 75 mg once daily who completed at least 6 months of OLE treatment showed ≥50% reductions in seizure frequency compared to pretreatment baseline. Well-tolerated in the OLE with a low incidence of central nervous system adverse events, representing a potential paradigm-shift for patients with a highly favorable and differentiated safety profile compared to other approved or investigational antiseizure medicines. Pivotal results for opakalim in the treatment of focal epilepsy expected in 2026. Announces initiation of obesity Phase 2 study with Biohaven's myostatin-activin inhibitor targeting high quality weight loss. Dosing began in 4Q 2025 with topline results expected in 2026 Taldefgrobep alfa, an inhibitor of the myostatin-activin II receptor signaling pathways, directly targets: fat reduction, increased lean muscle mass and improves in bone density while avoiding intolerable adverse effects. Taldefgrobep-myostatin complexes also result in the inhibition of Activin E - ALK7 in adipocytes, thereby having a direct effect on reducing adipose tissue. Taldefgrobep has demonstrated a highly favorable safety and tolerability profile in >700 clinical trial participants studied to date. Highlights clinical progress with Biohaven's next generation antibody drug conjugates (ADCs) in oncology Phase 1/2 study evaluating BHV-1510 (Trop2 ADC) as monotherapy and in combination with Regeneron's anti-PD-1 monoclonal antibody cemiplimab shows continued clinical activity with confirmed responses and a differentiated safety profile in the ongoing study. Endometrial cancer expansion cohort has been initiated with the combination of BHV-1510 and cemiplimab. Initiated novel subcutaneous dosing with BHV-1510, first and only Trop2 ADC in clinic with potential subcutaneous route of administration. First-in-class FGFR3 directed ADC, BHV-1530, continues with dose escalation and no dose limiting toxicities to date. Advancements across portfolio of early clinical and next-generation future programs, including: Pivotal clinical trial continues to advance enrollment with Biohaven's brain-penetrant TYK2/JAK1 inhibitor, BHV-8000 to treat early Parkinson's disease. BHV-1955, a novel, long-acting intranasal formulation of oxytocin, for the central treatment of tinnitus. BHV-8100, a brain-penetrant activator of the M2 isoform of pyruvate kinase (PKM2) for neurodegenerative disorders and aging. NEW HAVEN, Conn., Jan. 12, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today highlighted its broad portfolio progress at the 44th Annual J.P. Morgan Healthcare Conference. A copy of the slide presentation is available on the Events and Presentations section of the Biohaven website. Continue Reading BHV-1400 Directly Targets the Disease-Driver of IgA Nephropathy BHV-1400 Early Disease Clinical Experience Complete Resolution of Hematuria Within Weeks of Dosing BHV-1400 Advanced Disease Patient Rapid Improvement in Proteinuria and Increase in eGFR Within Weeks of Dosing BHV-1400 Single Patient Data Highlights Rapid Proteinuria Reduction Where Competitor Requires Months. Biohaven IgG Degrader Targets the Root Cause of a Broad Autoimmune Disease To Treat and Prevent Multi-Organ Complications BHV-1300 First Graves’ Patient Dosed — Pathogenic Antibody Levels Undetectable and Thyroid Hormones Normalized Within First Month Opakalim Offers Potential Best-in-Clinic Kv7-Activator Profile