Carlsmed, Inc. Appoints Jennifer Kamocsay as Chief Legal Officer and Secretary




Carlsmed, Inc. Appoints Jennifer Kamocsay as Chief Legal Officer and Secretary

CARLSBAD, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the appointment of Jenifer Kamocsay as Chief Legal Officer and Secretary, effective immediately. Ms. Kamocsay will serve as legal counsel for the Company and oversee compliance and corporate governance.

Ms. Kamocsay brings more than two decades of corporate legal experience as in-house counsel across life science and technology sectors at Akoya Biosicences, Rubius Therapeutics, Inc. and Progress Software Corporation.

“We are pleased to welcome Jennifer to the Carlsmed leadership team as we strengthen our organization and strategically expand our leadership team following our IPO,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “Her deep expertise in corporate governance, securities law and broader legal strategy will be instrumental as we continue to scale our business and prepare for our cervical commercial launch.”

Prior to Akoya, Ms. Kamocsay served as General Counsel and Corporate Secretary of Rubius Therapeutics, Inc., where she was responsible for overseeing and managing all of the company’s legal affairs. Before Rubius, she served as Associate General Counsel and Assistant Secretary at Progress Software Corporation, where she managed the company’s corporate, securities law, and M&A initiatives. Ms. Kamocsay began her career at Skadden, Arps, Slate, Meagher & Flom LLP, where she provided counsel to public and private company clients in the biotechnology and pharmaceutical industries on M&A, securities law, and corporate governance matters. Ms. Kamocsay holds a B.A. in History from the University of California, Los Angeles and a J.D. from Northeastern University School of Law.

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects, including statements about the Carlsmed’s ability to scale the impact of its aprevo technology platform and advance its personalized spine surgery platform to transform patient outcomes and drive long-term growth, Carlsmed’s current expectation of launching aprevo cervical in the United States in 2026, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in the Carlsmed’s Registration Statement on Form S-1 on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
Caroline Corner, PhD
IR@Carlsmed.com

Media
LeAnn Burton
Senior Director Brand Marketing
LBurton@Carlsmed.com

Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer




Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer

REDWOOD CITY, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the appointment of Alan Sandler, M.D. into the newly created role of chief development officer, as well as the appointment of regional general managers in the U.S. and Europe.

“I am delighted to welcome Alan as our chief development officer as we pursue our bold vision to develop new global standards of care for patients with RAS-addicted cancers,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “As a physician-scientist, Alan is recognized as a leader in the field of lung cancer and has established a track record of excellence in oncology drug development. He brings valuable additional leadership to our organization as the scope and maturity of our development activities grow in support of advancing our compelling pipeline of distinguished clinical-stage RAS(ON) inhibitors on behalf of patients.”

Dr. Sandler joins Revolution Medicines from ALX Oncology, where he most recently served as chief medical officer. Prior to joining ALX Oncology, he was executive vice president and chief medical officer at Mirati Therapeutics through its acquisition by Bristol Myers Squibb. Previously, he served as president and head of global development, Oncology at Zai Lab Limited, and earlier held senior leadership roles at Genentech, a member of the Roche Group, where he drove multiple oncology development programs. Alan has also held academic leadership roles as division chief of Hematology/Oncology at Oregon Health and Science University, medical director of Thoracic Oncology at Vanderbilt University, and medical director of the Thoracic Oncology Program at Indiana University.

As a further step in building global commercial capabilities, Revolution Medicines has also appointed two key regional leaders: Alicia Gardner as senior vice president, general manager for the U.S. region, and Gerwin Winter as senior vice president, general manager for the European region. Alicia and Gerwin will play important leadership roles as the company prepares for the potential approvals and commercial launches of daraxonrasib in patients with cancers driven by RAS, including pancreatic ductal adenocarcinoma, as well as other innovative targeted medicines for patients living with RAS-addicted cancers.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline, its vision to develop new global standards of care and the potential approval and commercial launch of the company’s product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 6, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com

Revagenix, Inc. Announces Changes to Its Board of Directors




Revagenix, Inc. Announces Changes to Its Board of Directors

• J. Kevin Judice joins the Board of Directors
• Andrew McCandlish (Founder and Chief Operating Officer) steps down from the Board of Directors
• Revagenix, Inc. is advancing a focused pipeline of antibiotic programs designed to treat infections caused by multidrug-resistant organisms

SAN FRANCISCO, Sept. 29, 2025 (GLOBE NEWSWIRE) — Revagenix, Inc., a biopharmaceutical company dedicated to the discovery and development of novel antibiotics, today announced the appointment of J. Kevin Judice, PhD to its board of directors.

“Kevin brings with him a wealth of experience in drug development and successful exits,” said Ryan Cirz, PhD, Chief Executive Officer and Director of Revagenix. “His early experience in the antimicrobial space, including leading the discovery of telavancin and helming Achaogen through its formative years—with the foresight to focus on what became the Gram-negative resistance crisis—are critical elements to understanding our mission. Just as importantly, his later successes outside of the antibacterial space—most notably at DICE Therapeutics—equip him with the perspective needed to ensure Revagenix delivers both on the science and the business of bringing meaningful cures to patients in an incredibly challenging environment.”

In conjunction with Dr. Judice’s appointment, Founder and Chief Operating Officer Andrew McCandlish, PhD has resigned his role on the board. “Andy, along with the other founders, has served the Revagenix Board exceptionally well as we gradually built our internal leadership team and searched for additional Directors that could help us achieve our long-term vision,” continued Dr. Cirz. “Dr. McCandlish continues in his same critical capacity within the business, and his board resignation simply reflects our success in finding the next key addition to our Board.” Revagenix’s executive team is rounded out by Vice President of Pharmaceutical Development Mick Hurrey, PhD, and Vice President of Development Daniel Cloutier, PharmD.

Tina Marriott, Chair of the Revagenix Board of Directors, added: “We are thrilled to welcome Kevin to the Board. As a successful founder, CEO, and scientific leader, he brings invaluable experience translating cutting-edge research into medicines that matter—expertise that will be instrumental as we advance our multiple therapeutic candidates into the clinic.”

Dr. Judice commented: “The need for novel antibiotics has never been greater, and Revagenix is taking a disciplined and innovative approach to advancing next-generation antimicrobial agents that address unmet medical needs in commercially attractive settings. I look forward to contributing my experience to support the team as it works to deliver transformative therapies for patients facing multidrug-resistant infections.”

About Revagenix
Revagenix is dedicated to creating life-changing antibiotics, providing urgently needed anti-infective medicines to patients globally. We are advancing a focused pipeline designed to treat infections caused by multidrug-resistant organisms. The team—composed of seasoned industry experts, and augmented by a world-class network of strategic collaborators, partners, investors, and advisors— leverages extensive experience in anti-infective research, development, and commercialization. Together, we are developing the next generation of antibiotics to address the critical need for new treatments in the face of increasing antibiotic resistance. Learn more about our mission and work at www.revagenix.com.

Contact:
Arthur Culang
Director of Operations
info@revagenix.com

Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025




Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025

– Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, with greatest improvements observed in those with elevated baseline levels of key type 2 inflammatory markers –

– Significant reduction in annualized exacerbations observed in patients with one or more elevated type 2 inflammatory markers at baseline –

– Data supports ongoing Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in 1H26 –

SAN DIEGO, Sept. 29, 2025 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today presented data supporting rademikibart, the Company’s investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually.

“We are excited to share additional analyses from our Phase 2b asthma study at ERS. These data continue to expand our data package for rademikibart and reinforce its potential to deliver best-in-class efficacy for patients with moderate to severe asthma and COPD,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “These data build on previously reported Phase 2b study outcomes demonstrating rapid and sustained lung function improvements, with the greatest outcomes being observed in patients with elevated levels of key type 2 inflammatory biomarkers. In addition, these analyses have helped to refine our clinical development plans and clinical site strategies for our ongoing Seabreeze STAT asthma and COPD studies. We look forward to reporting topline data from both in the first half of 2026.”

Abstract Title: Rapid and Sustained FEV₁ Improvements with Rademikibart in Type 2 Asthma: Impact of Eosinophils and FeNO

• Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were evaluated in a post-hoc analysis to investigate the efficacy of rademikibart in subgroups of patients with asthma based on baseline levels of type 2 inflammatory biomarkers, indicated by blood eosinophil counts (EOS) of <300 or ≥300 cells/μL and fractional exhaled nitric oxide (FeNO) levels of <25 or ≥25 ppb.
• Rademikibart treatment led to rapid and sustained improvement in lung function and asthma control in subgroups with elevated baseline markers of Type 2 inflammation, with greatest improvements observed in patients with both high EOS and high FeNO.
• At Week 24, treatment with rademikibart improved prebronchodilator FEV₁ by 507 mL in patients with high EOS and high FeNO, 284 mL in patients with low EOS and high FeNO, 209 mL in patients with high EOS and low FeNO, and 108 mL in patients with low EOS and low FeNO.
• In addition to lung function and asthma control, a reduction in asthma exacerbations was observed in subgroups with at least one high type 2 inflammatory biomarker at baseline, with a 63% reduction in patients with high EOS and a 69% reduction in patients with high FeNO.
• These results highlight rademikibart’s potential to improve lung function and reduce asthma exacerbations, particularly in patients with elevated markers of Type 2 inflammation.

Abstract Title: Rademikibart in Moderate-to-Severe Asthma: Impact of Eosinophils and Regional Differences on Response

• A post-hoc analysis of the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma investigated the prespecified primary endpoint, absolute change in prebronchodilator FEV₁ at Week 12, in subgroups of patients enrolled in Poland and in the Rest of the World (ROW).
• Rademikibart rapidly and significantly improved lung function in adults with asthma, with greater benefit observed in patients with higher baseline EOS, in both the overall trial population and ROW subgroup.
• In Poland, placebo response was greater and rademikibart response was less than in the ROW subgroup and overall trial population. Four patients in the placebo group demonstrated unusually large improvements in lung function, potentially related to baseline factors, such as EOS <150 cells/μL, high FEV₁, and/or daily use of inhalers.
• In Poland, rademikibart-treated patients also had milder disease compared to the ROW subgroup, increased percent predicted FEV₁, and despite similar FeNO levels, this baseline imbalance may have impacted treatment effects.
• These results underscore the importance of rigorous trial conduct and comprehensive patient guidance and have informed the Company’s ongoing Phase 2 Seabreeze STAT clinical site strategy.

The presentations will be available on Connect’s website under the publications and presentations section.

About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma.

About Connect Biopharma
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect also has an exclusive license and collaboration agreement for rademikibart with Simcere in China.

For more information visit www.connectbiopharma.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.

Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “look forward to,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.

This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the National Medical Products Administration, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.

Investor Relations Contact:
Alex Lobo
Precision AQ
Alex.Lobo@precisionaq.com
(212) 698-8802

Media Contact:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604

Cue Biopharma Announces Strategic Transition in Leadership to Further Enable Next Stage of Growth with Disruptive Autoimmune Therapeutic Candidates




Cue Biopharma Announces Strategic Transition in Leadership to Further Enable Next Stage of Growth with Disruptive Autoimmune Therapeutic Candidates

• Usman Azam, M.D., is appointed President and Chief Executive Officer of Cue Biopharma, effective September 29, 2025
• Daniel Passeri, Chief Executive Officer of Cue Biopharma, transitions to Strategic Advisor to provide ongoing support to the Company
• Cue Biopharma prioritizes autoimmune disease for next stage of growth with focus on advancing first-in-class tolerogenic biologic CUE-401 into the clinic

BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) — — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today announced that Usman “Oz” Azam, M.D., has been appointed President and Chief Executive Officer (CEO) of Cue Biopharma, effective September 29, 2025. Daniel Passeri will transition from his current role as CEO to one of Strategic Advisor, effective as of the same date.  

“This strategic transition in leadership is a timely and important step forward, enhancing the Company’s next stage of corporate development with a prioritized focus on autoimmune disease,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Dr. Azam‘s significant experience across the entire drug development value-chain, including clinical trial design and execution, as well as product launches is invaluable for advancing the Company’s first-in-class tolerogenic drug candidate CUE-401 for autoimmune diseases, our partnered program CUE-501 and for securing strategic partners for our clinical-stage CUE-100 series assets.”

Dr. Azam brings over 25 years of drug discovery and development leadership as well as operating expertise to Cue Biopharma. Most recently, Dr. Azam served as CEO of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs. Prior to Inspirna, Dr. Azam served as CEO of Empyrean Neuroscience, a genetic engineering company, advancing a pipeline of neuroactive compounds targeting disorders of the central nervous system. As President and CEO of Tmunity Therapeutics, he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer. He served as Global Head of the Cell and Gene Therapies unit at Novartis where he helped deliver and launch the first-ever FDA approval for a CAR-T cell therapy in hematologic cancers. Dr. Azam is well-respected in the industry for his extensive experience in leadership roles across both innovative biotechnology and large pharmaceutical companies, namely Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK). The learnings across these roles and his in-depth experience with T cell therapeutics make him well-suited to foster the Company’s next stage of growth.

“I am very pleased to be taking on the role of CEO and working closely with the Cue Biopharma team at this important stage of the Company’s development,” said Dr. Azam. “What has me most excited about joining the Company is CUE-401, a molecule designed to restore immune homeostasis and tolerance, with the potential to disrupt the standard of care in autoimmune disease. I look forward to effectively driving CUE-401 through clinical development, creating value by addressing significant unmet medical need.”

Pasha Sarraf, M.D., Ph.D., chairman of the board of Cue Biopharma stated, “Cue’s board is pleased to welcome Oz as our new President and CEO. As the Company focuses on autoimmunity, we believe CUE-401’s tolerogenic mechanism has the potential to become the ‘Keytruda’ for autoimmune disease, enabling deep and durable remissions to free patients from lifelong therapies and chronic disease. The Board is energized to partner with Oz to bring this vision to life. Additionally, we extend our deep gratitude and sincere appreciation to Dan for his leadership and forward-looking vision navigating the company through the many challenges that have faced the biotech industry over the years. He has provided us with the foundation for continued success and growth.”

From the Cue Biopharma Team
We look forward to continuing to work with Dan in his new role as Strategic Advisor and thank him for his dedication and commitment to the development of novel therapeutics for patients suffering from life-threatening diseases.

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically as a master switch for regulatory T cell (Treg) differentiation and tolerance induction. It is a highly innovative bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin (IL-2) mutein in a single injectable biologic.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the executive transitions and the dates thereof; the company’s beliefs regarding the potential benefits and applications of its drug candidates and programs, including CUE-401’s potential to disrupt the standard of care in autoimmune disease; the company’s plans to secure strategic partners for its clinical-stage CUE-100 series assets; and the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to shift its focus to its autoimmune assets; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact
Marie Campinell 
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com

Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com

RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy




RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy

RAPT on track to initiate trial this year

SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with food allergy. The planned Phase 2b trial in food allergy is a randomized double-blind placebo-controlled study designed to evaluate the safety and efficacy of RPT904 dosed every 8 weeks (Q8W) and every 12 weeks (Q12W).

“Clearance of our IND application, which included data from our Chinese partner Jeyou, is an important and meaningful step for the program,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT. “We are excited to advance clinical development of RPT904, our next-generation, half-life extended anti-IgE molecule with a differentiated product profile. We are on track to initiate our Phase 2b clinical trial by the end of the year, taking us closer to our objective of delivering a best-in-class therapeutic option to patients in the large and underserved food allergy community. Furthermore, we look forward to data from Jeyou’s Phase 2 trials in chronic spontaneous urticaria and asthma, which we also expect by the end of the year.”

About the RPT904-01 (prestIgE) Phase 2b Trial
The Phase 2b trial, named “prestIgE”, is designed to assess the efficacy and safety of RPT904 monotherapy in participants with IgE-mediated food allergy. The two-part, multi-center, randomized, double-blind, placebo-controlled study will compare two dosing regimens of RPT904 (administered subcutaneously every 8 weeks or every 12 weeks, including a loading dose at Week 2) to placebo in a 2:2:1 ratio. In Part 1, approximately 100 participants with at least one food allergy (peanut, milk, egg, walnut or cashew) will be treated for 24 weeks. The primary endpoint for the trial is the proportion of participants who achieve a prespecified target threshold at a double-blind, placebo-controlled, oral food challenge (DBPCFC) at Week 24. In Part 2, the participants in the RPT904 treatment arms will continue treatment for another 24 weeks, while participants on placebo will be re-randomized 1:1 to receive RPT904 either every 8 weeks or every 12 weeks (with a loading dose at Week 26) through Week 48 and all participants will undergo a DBPCFC at Week 48. Participants will also be followed for an additional 16 weeks in a safety follow-up period.

About RPT904
RPT904 is a novel, half-life extended anti-IgE bio-better monoclonal antibody (mAb) targeting the same epitope as omalizumab for the treatment of patients with food allergies, chronic spontaneous urticaria and other allergic inflammatory diseases. RPT904 is designed to inhibit free and cell-bound human immunoglobulin E (IgE), a key driver of allergic diseases, and in early clinical studies has demonstrated extended pharmacokinetics and pharmacodynamic properties compared to omalizumab, a first generation anti-IgE mAb.

About RAPT Therapeutics, Inc.
RAPT is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases. Utilizing our deep and proprietary expertise in immunology, we develop novel therapies that are designed to modulate the critical immune responses underlying these diseases.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimates,” “expects,” “look forward,” “on track,” “planned,” “potential” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the development of RPT904, regulatory interactions, the therapeutic and commercial potential of RPT904, the design and timing of clinical trials and the availability of data therefrom, and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, our reliance on our partners and other third parties, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission (SEC) on August 7, 2025, and subsequent filings made by RAPT with the SEC. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements, except as required by law.

RAPT Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com

RAPT Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com

Inventiva reports its unaudited 2025 first-half financial results and provides a corporate update  




Inventiva reports its unaudited 2025 first-half financial results and provides a corporate update  

• Cash and cash equivalents at €146.7 million including €24.6 million in short-term deposits¹ as of June 30, 2025
• Receipt of the gross proceeds of €115.6 million from the second tranche of the structured financing of up to €348 million², following in particular the completion in April 2025 of enrolment of the Phase 3 clinical trial NATiV3 evaluating lanifibranor in patients with MASH
• Cash runway currently planned until the end of the third quarter of 2026
• Revenues of €4.5 million recorded in the first half of 2025
• Topline results of NATiV3 are expected in the second half of 2026

Daix (France), New York City (New York, United States), September 29, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial results for the six months ended June 30, 2025, and provided a corporate update.

Frédéric Cren, Chief Executive Officer and cofounder of Inventiva, stated: “The first half of 2025 has been a defining period for Inventiva, with decisive progress across both our clinical program and our financial position. As we advance into the final stretch of our Phase 3 clinical trial in MASH, we are reinforcing our organization to prepare for the upcoming data readouts and potential regulatory submissions. Financially, we reinforced our position with the closing of the €116 million second tranche of the structured financing announced in October 2024, unlocked by the randomization of the last patient in the main cohort of the NATiV3 study, a critical milestone in our journey. Inventiva has entered the second half of the year with confidence and undiminished ambition: to turn the hope of millions of patients living with MASH into therapeutic reality.”

Key financial results for the first half of 2025

The revenues for the first half of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024.

The revenues recorded by the Company in the first half of 2025 consist mainly of the $10 million (net proceeds of €8.5 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the settlement in May 2025 of the second tranche of the structured financing of up to €348 million³ (the “Structured Financing”). The receipt of the above-mentioned milestone payment from CTTQ in July 2025 will impact the cash flow of the second half of 2025.

Other income amounted to €1.2 million for the first half of 2025, as compared to €2.7 million for the first half of 2024. The decrease is mainly due to a more selective R&D tax credit eligibility for the R&D costs, the clinical development progressing, and to a lesser extent the first effects of the pipeline prioritization plan initiated in the first half of 2025.

R&D expenses for the first half of 2025 amounted to €44.9 million, mainly driven by the development of lanifibranor in MASH, and were down 4% compared to the €46.8 million for the first half of 2024. The evolution of the lanifibranor development costs was in line with expectations, while expenses related to the discontinued preclinical programs started to decrease compared to the same period in 2024.

Marketing and business development expenses stood at €0.7 million for the first half of 2025 compared to €0.6 million for the same period in 2024.

General and administrative expenses (G&A) amounted to €14.7 million in the first half of 2025, compared to €7.7 million in the first half of 2024, mainly due to the increase of personnel costs of €5.7 million related to share-based compensation plans non-cash expenses for €4.7 million.

Net financial income (loss) amounted to (€113.2) million in the first half of 2025, compared to €3.5 million for the same period in 2024. The net financial loss in the first half of 2025 is mainly due to (i) non-cash IFRS treatment of the accounting at the fair value, including (€84.7) million related to derivative instruments in connection with the second tranche of the Structured Financing and (€17.9) million from warrants previously issued to the EIB, and ii) (€9.7) million, mainly non-cash, in loans and royalty certificates interests expenses.

The Company’s net loss stood at (€175.9) million as of June 30, 2025, compared to (€49.0) million as of June 30, 2024.

As of June 30, 2025, the Company’s cash and cash equivalents amounted to €122.1 million and €24.6 million of short-term deposits⁴, compared to cash and cash equivalents at €96.6 million and no short-term deposits as of December 31, 2024.

Net cash used in operating activities amounted to (€53.7) million in the first half of 2025, compared to (€48.3) million for the same period in 2024, while the R&D expenses for the first half of 2025 were slightly lower at (€44.9) million, compared to the first half of 2024. The increase in net cash used in operating activities is mainly due to working capital evolution and the net cash impact of the Company’s pipeline prioritization plan during the first half of 2025.

Net cash used in investing activities for the first half of 2025 amounted to (€24.8) million, compared to €8.9 million generated in the first half of 2024. The change is mostly due to the new subscription of deposits during the period.

Net cash generated from financing activities for the first half of 2025 amounted to €104.8 million, compared to €22.6 million in the first half of 2024. The net cash generated from financing activities primarily comes from the receipt of the gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche⁵ of the Structured Financing.

Over the first half of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.7) million, compared to a positive effect of €0.1 million for the first half of 2024, due to the evolution of EUR/USD exchange rate.

Considering its current cost structure and forecasted expenditures, the Company estimates that its cash and cash equivalents and short-term deposits, combined with the $10 million (gross proceeds) milestone payment received from CTTQ on July 7, 2025, and the anticipated completion of the Company’s pipeline prioritization plan, should allow it to fund its operations as currently planned until the end of the third quarter of 2026⁶.

The Company will need to raise additional funds to achieve its long-term objectives for the development and potential commercialization of lanifibranor through other potential public offerings or private placements and potential strategic options such as business development partnerships, merger and acquisition transactions and/or licensing agreements.

Main areas of progress in the R&D portfolio and corporate update

• Ms. Lucy Lu resigned as a member of the Board of Directors of the Company, effective May 21, 2025. At the general meeting of shareholders, the shareholders of the Company appointed Ms. Renée Aguiar-Lucander as a director of the Company, effective May 22, 2025.
• On July 9, 2025, Inventiva announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development (“R&D”) and Chief Medical Officer (“CMO”) succeeding Pierre Broqua and Martine Zimmermann, PharmD, as Executive Vice President (“EVP”) of Regulatory Affairs and Quality Assurance. Prior to taking on this position, Ms. Zimmermann resigned as a member of the Company’s board of directors effective August 17, 2025.
• On May 19, 2025, the Company received authorization from the French labour authorities (DREETS) to implement the pipeline prioritization plan and reorganization presented to the workers council in February 2025. The related reduction in workforce started to take effect on May 23, 2025.
• On May 7, 2025, the Company settled the second tranche of its Structured Financing for an amount of €115.6 million (gross proceeds).
• On April 1, 2025, the Company announced the completion of enrollment of its pivotal Phase 3 clinical trial, NATiV3, evaluating lanifibranor in patients with MASH.
• On February 20, 2025, Inventiva and Hepalys Pharma, Inc., announced the initiation of the clinical development program of lanifibranor in Japan with the dosing of the first participant in a Phase 1 trial.
• On February 10, 2025, Inventiva announced that it has informed the representatives of its workers council of its plan to focus exclusively on the development of lanifibranor. The plan presented includes reducing the Company’s current workforce by approximately 50%.

Recent scientific publications

• On July 2, 2025, Inventiva announced the publication in the peer-reviewed scientific Journal of Hepatology Reports, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease (“MASLD”) and MASH.
• On April 24, 2025, the Company announced the publication of a collaboration with Dr. Jérôme Boursier in the peer-reviewed medical journal Clinical Gastroenterology and Hepatology, of an analysis on new non-invasive biomarker signatures predictive of histology response following treatment with lanifibranor in patients with MASH and fibrosis.
• On February 26, 2025, the Company announced the publication of a grant-supported collaboration with Ghent University Hospital researchers in Biomedicine & Pharmacotherapy of the results from a preclinical study showing improvement of portal hypertension with lanifibranor treatment.
• On January 29, 2025, Inventiva announced the publication in Journal of Hepatology of the results of the investigator-initiated proof-of-concept clinical trial led by Dr. Kenneth Cusi, demonstrating improvement of hepatic, muscle and adipose tissue insulin resistance in patients with MASLD and T2D treated with lanifibranor.

Next key milestones expected

• Topline results of NATiV3 – expected in the second half of 2026

Upcoming investor conference participation

• Stifel 2025 Virtual Cardiometabolic Forum – September 30, 2025 – Virtual
• European MIDCAP Event 2025 – September 30 – October 1, 2025 – Paris, France
• H.C. Wainwright Liver Disease Virtual Conference – October 21-22, 2025
• LifesciCapital/Sofinnova Growth & Innovation Summit – November 17, 2025 – London
• Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025 – New York, NY
• Stifel 2025 Healthcare Conference, November 11-13, 2025 – New York, NY
• UBS Global Healthcare Conference, November 12, 2025 – Palm Beach, Florida

Upcoming scientific conference participation

• MOSAIC – October 23-24, 2025 – Washington, DC
• AASLD The Liver Meeting – November 7-11, 2025 – Washington, DC

Next financial results publication

• Financial Results for the third quarter of 2025: November 21, 2025 (after U.S. market close)

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. 

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com

Contacts

Important Notice

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial results for Inventiva’s six months ended June 30, 2025, forecasts and estimates with respect to Inventiva’s cash resources and expenses, including expectations and assumptions in connection with Inventiva’s estimated cash runway, Inventiva’s ability to raise additional funds, the implementation and potential benefit of the pipeline prioritization plan and related workforce reduction, forecasts and estimates with respect to Inventiva’s clinical trials, including the NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including duration, timing and costs, and the results and timing thereof and regulatory matters with respect thereto, the information, insights and impacts that may be gathered from clinical trials, clinical trial data releases and publications, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, and Inventiva’s pipeline development plan and future activities, expectations, plans, growth and prospects of Inventiva, and the absence of material adverse events. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the completion of financial closing procedures, final adjustments and other developments that may arise that could cause the preliminary financial results for the first half of 2025 to differ from the financial results that will be reflected in Inventiva’s reviewed consolidated financial statements for the first half of 2025,  that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s ability to satisfy, on the expected timing or at all, and whether, when and to what extent the pre-funded warrants, the warrants issued in the Structured Financing and other dilutive instruments may be exercised, and by which holders, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners’ business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors” and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.

All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

¹ Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available.
² Cf. press release date October 14, 2024.

³ Cf. press release date October 14, 2024.
⁴ Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available
⁵ Cf. press release date May 5, 2025.

⁶ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any potential further proceeds from the Structured Financing, and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated

Attachment

• Inventiva – PR – 1H2025 Financial Report – EN – 09 29 2025

Pooled data presented at ERS: nerandomilast monotherapy linked to nominally significant reduction in risk of death in IPF and PPF




Pooled data presented at ERS: nerandomilast monotherapy linked to nominally significant reduction in risk of death in IPF and PPF

• A new pooled analysis of the FIBRONEER™-IPF and FIBRONEER™-ILD trials resulted in a nominally significant reduction in the risk of death by 59% in patients who received 18mg nerandomilast without background therapy versus placebo.¹

• Both FIBRONEER™ phase III trials, had met their primary endpoint (reduction of lung function decline measured in forced vital capacity) but did not meet their key secondary endpoint (risk of acute exacerbation, hospitalization for respiratory cause, or death).^1-3

• Nerandomilast had a favorable safety and tolerability profile, with a similar rate of discontinuation due to adverse events as placebo.^1-3

• Findings presented at ERS support previous clinical trial data on the safety and efficacy of nerandomilast in IPF and PPF as monotherapy and in combination with currently approved medications.¹

Boehringer Ingelheim today announced new data from the global Phase III FIBRONEER™ program on nerandomilast, an investigational oral preferential PDE4B inhibitor, which is currently not approved for use. The new pooled analyses, the first to demonstrate a nominally significant reduction in risk of death across IPF and PPF, was presented in a poster at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. Nominal significance means that the trial results showed a clear trend that suggests a possible benefit; however, the evidence does not meet the strict criteria to declare it statistically significant.

Both phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, had met their primary endpoint, demonstrating that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo.^2,3 Although both trials did not meet the key secondary endpoint (time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over duration of trial),^2,3 the pooled analysis resulted in a nominally significant reduction in risk of death across IPF and PPF for the 18mg nerandomilast dose vs placebo in monotherapy and with background nintedanib.¹ The trend was more pronounced in monotherapy.¹

“The new pooled data zoom in on nerandomilast’s potential as monotherapy, pairing efficacy with a nominally significant reduction in the risk of death.  While the findings are exploratory, they add to the growing body of evidence and may impact future research directions in pulmonary fibrosis,” said Marlies Wijsenbeek, Erasmus MC University Medical Centre. “The new findings go hand-in-hand with nerandomilast’s favorable safety and tolerability profile in previous studies. In a disease area with many patients discontinuing treatment,⁴ mostly related to limited tolerability of current therapies, this could really improve outcomes for patients.”    

Findings of the pooled analysis

In both FIBRONEER™ trials, patients (FIBRONEER™-IPF, n=1177; FIBRONEER™-ILD, n=1176) were randomized to receive nerandomilast 9mg twice per day, 18mg twice per day, or placebo.^2,3 The data was pooled and changes in FVC over 76 weeks and clinically relevant outcomes (acute exacerbations, respiratory hospitalization, and death) were analyzed. The analyses included the overall population and subgroups of patients by use of background therapy at baseline.¹

In the overall trial population, a nominally significant reduction in the risk of death by 43% was observed in patients who received 18mg (HR 0.57 [CI: 0.41-0.78)].¹  A nominally significant reduction in the risk of death, by 59%, was observed in patients who received 18mg nerandomilast without background therapy (HR 0.41 [CI: 0.24-0.70)].¹ This downward trend was also seen in patients taking background nintedanib with a nominally significant reduction in the risk of death by 41% (HR 0.59 [CI: 0.37-0.94)].¹

“For people living with pulmonary fibrosis, mortality remains unacceptably high, with every second person dying within 5 years of diagnosis,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “As the first Phase III trial program to demonstrate a nominally significant reduction in the risk of death in progressive pulmonary fibrosis, FIBRONEER heralds a significant advance for this group of patients, who face a devastating diagnosis and very limited treatment options.”

In the pooled analysis, nerandomilast showed a favorable safety and tolerability profile, with a similar rate of discontinuation due to adverse events as placebo, consistent with the prior phase III results.¹ The most frequent adverse event in the nerandomilast group without background therapy was diarrhea, reported in 14.6% in the placebo group, 17.5% in the nerandomilast 9 mg group, and 27.4% in the nerandomilast 18 mg group.¹ Patients receiving either background nintedanib or pirfenidone reported diarrhea in 27.1% in the placebo group, in 41.9% in the 9mg nerandomilast group and in 47.7% in the 18mg nerandomilast group. In all patients, serious adverse events occurred in 44.7%, 39%, and 40.5% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively.¹

These latest FIBRONEER™ findings reinforce nerandomilast’s potential as a new treatment for IPF and PPF.¹

About nerandomilast
Nerandomilast (BI 1015550) is an investigational orally administered preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF and PPF.^2,3 Its efficacy and safety has not been established.

Nerandomilast was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF in February 2022 and for the treatment of PPF in April 2025.^7,8 The FDA recently granted priority review to the New Drug Application (NDA) for nerandomilast in IPF, with an anticipated action date in Q4 2025. An NDA for nerandomilast in PPF has also been filed. Regulatory submissions are under review in China, the UK, and the EU, with filings in other geographies to follow.⁸

About IPF and PPF
Idiopathic pulmonary fibrosis (IPF) is one of the more common progressive fibrosing interstitial lung diseases (ILDs), primarily affecting people over 50 and more men than women.⁹ It is associated with breathlessness, persistent cough, fatigue, and reduced survival. With approximately half of patients dying within five years of diagnosis,^5,6 IPF is deadlier than many forms of cancer.^10,11

Patients with other types of fibrosing ILD can also develop a progressive phenotype, termed progressive pulmonary fibrosis (PPF). PPF is defined by worsening respiratory symptoms, physiological and radiological progression, despite management of the underlying cause.¹²

Globally, up to 3.6 million people may be affected by IPF and up to 5.6 million by PPF.^12,13

About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at http://www.boehringer-ingelheim.com/uk (UK) or www.boehringer-ingelheim.com (rest of world).

References

1. Oldham J, et al. (2025) Efficacy, safety and tolerability of nerandomilast in patients with pulmonary fibrosis: pooled data from the FIBRONEER-IPF and FIBRONEER-ILD trials. Poster, ERS 2025.
2. Maher T et al. (2025) Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2203-2214. DOI: 10.1056/NEJMoa2503643.
3. Richeldi L, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. DOI: 10.1056/NEJMoa2414108.
4. Levra S et al. Long-term safety of antifibrotic drugs in IPF: a real-world experience. Biomedicines. 2022;10(12):3229. doi:10.3390/biomedicines10123229.
5. Zheng Q et al. The global burden and temporal trends of interstitial lung disease: a systematic analysis from the Global Burden of Disease Study 2019. ERJ Open Res. 2022;8(1):00591-2021. DOI: 10.1183/23120541.00591‑2021.
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