Incendia Therapeutics, Inc.

Initial Phase 1 data suggest PRTH-101 contributes to disease control in recurrent/metastatic thymic epithelial carcinoma (TEC) with median progression-free survival (mPFS) of 7.9 months and 1 partial response (PR) observed Pivotal Phase 2 trial for the treatment of recurrent/metastatic TEC to compare PRTH-101 in combination with pembrolizumab to pembrolizumab alone, planned for 2026 CAMBRIDGE, Mass., Oct. 02, 2025 (GLOBE NEWSWIRE) -- Incendia Therapeutics, a biotechnology company focused on disrupting the tumor microenvironment (TME) to improve cancer outcomes, today announced that it will present two posters at the International Thymic Malignancy Interest Group Annual Meeting to be held in Milan, Italy, October 2-4, 2025. Both posters disclose clinical results with PRTH-101, a first-in-class discoidin domain receptor 1 (DDR1)-targeted antibody therapy, in patients with recurrent/metastatic thymic epithelial carcinoma (TEC). “PRTH-101 has shown encouraging anti-tumor activity in TEC patients, particularly in those with high DDR1 expression,” said Wendye R. Robbins, M.D., president and CEO of Incendia Therapeutics. “Traditionally, elevated tumor DDR1 has been associated with worsened outcomes. These results support the potential of DDR1 inhibition to overcome immune exclusion and improve outcomes in difficult-to-treat cancers, especially those with no approved therapies such as recurrent/metastatic TEC. Based on the promising Phase 1 findings, we look forward to advancing PRTH-101 into Phase 2 studies and exploring its benefit in advanced thymic malignancies.” Susan Macdonald, Ph.D., SVP Nonclinical Development and Strategy at Incendia Therapeutics added, “The data we have generated to-date demonstrate that PRTH-101 is engaging its target and delivering meaningful clinical benefit. By attacking the structural and biochemical underpinnings of the TME, PRTH-101 can enable host immune cells to penetrate the tumor core and allow immunotherapies to act on the tumor, offering a potentially transformative treatment for patients with TEC and other immune excluded and fibrotic tumors.” Presentation Details Title: A Phase 1 trial of PRTH-101, a monoclonal antibody targeting discoidin domain receptor 1 (DDR1), alone or in combination with pembrolizumab, for the treatment of thymic malignancies.​Abstract ID: AB10Presenter: Susan Macdonald, PhDDate and Time: Thursday, October 2, 3:45-4:15 pm CEST PRTH-101 is being evaluated in an ongoing Phase 1 trial as a monotherapy (Phase 1a), in combination with pembrolizumab (KEYTRUDA®) (Phase 1b), and alone or in combination with pembrolizumab in tumor-specific expansion cohorts (Phase 1c). Key clinical data include: Two confirmed PRs, multiple patients with minor RECIST and quality of life improvements across tumor types, and multiple with prolonged stable disease beyond published expectationsCorrelation between DDR1 expression and PFS with PRTH-101 treatment, when dosed with and without pembrolizumabCorrelation of tumor responses to PRTH-101 and pembrolizumab to expression of their respective targetsAmong all TEC patients (n=18 as of September 4, 2025), mPFS of 7.9 months (ongoing) vs. literature reports 4.2 months Title: A pivotal Phase 2 trial to compare PRTH-101, a monoclonal antibody targeting discoidin domain receptor 1 (DDR1), in combination with an immune checkpoint inhibitor (ICI) to ICI alone, for the treatment of recurrent or metastatic thymic epithelial carcinoma (TEC)Abstract ID: AB13Presenter: Irena Webster, MPHDate and Time: Thursday, October 2, 11:00-11:30 am CEST Pivotal Phase 2 study protocol highlights: Global registrational trial planned for 2026 in patients ≥12 years old with recurrent or metastatic TECOpen-label two-cohort trial design (immune checkpoint inhibitor [ICI]-refractory and ICI-naïve) will evaluate PRTH-101 in combination with pembrolizumab versus pembrolizumab alonePrimary and secondary endpoints to include overall response rate, PFS, and safety, with exploratory assessments including advanced tumor imaging assessments, DDR1 and PD-L1 biomarker expression, and quality-of-life assessmentsTrial design discussed with the FDA The posters will be available on the Incendia website October 2, 2025. About PRTH-101 PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By blocking collagen binding to DDR1, PRTH-101 disrupts tumor-associated collagen alignment to permit immune cell access into the tumor core. In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer. Currently, there are no approved drugs targeting DDR1. About the Phase 1 Trial The Phase 1 trial (NCT05753722) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment. About Incendia Therapeutics Incendia Therapeutics is a clinical-stage biotechnology company focused on disrupting the tumor microenvironment (TME) to improve cancer outcomes. The company’s approach targets immune-excluded solid tumors, an identifiable, prevalent tumor phenotype with high treatment relapse rates. By breaking down barriers in the TME, immune cells can reach tumors and improve treatment outcomes in solid cancers. The Company’s most advanced investigational therapeutic, PRTH-101, is in a Phase 1c clinical trial for the treatment of patients with advanced solid tumors. The Company is targeting initiation of Phase 2 in 2H2026. For more information visit incendia.com and LinkedIn. Forward-Looking Statements Statements in this press release that are not historical in nature are forward-looking statements. These statements reflect the Company’s expectations based on currently available information and involve risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to a variety of factors, including the risks inherent in the development of biopharmaceutical products such as ours. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement and Incendia Therapeutics undertakes no obligation to revise or otherwise update this press release to reflect events or circumstances after the date hereof. Contacts Michael Blashmichael.blash@incendiatx.com

SAN FRANCISCO, June 09, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Dr. Michael Kauffman to its Board of Directors effective June 4, 2025. “Michael is a well-recognized biotech industry veteran, who brings a wealth of biotech leadership experience to our board,” said James Schoeneck, chairman of the board of directors of FibroGen. “His expertise spanning all stages of drug development will be invaluable as FibroGen progresses its pipeline. Michael’s deep understanding of oncology will help the company through anticipated near-term clinical milestones and potential value-drivers.” “FibroGen has differentiated potential first-in-class assets and the company is positioning itself for a significant turnaround over the next several years,” said Dr. Kauffman. “It is an honor to join the board at this exciting time for the company, and I look forward to contributing to the company’s future success.” Michael Kauffman, M.D., Ph.D. Michael G. Kauffman, M.D., Ph.D. has about 30 years of experience in the life sciences industry, particularly in oncology therapeutic products, including expertise in preclinical research, clinical development, regulatory strategy and global approvals. He currently serves as chief executive officer (CEO), president, and board member of Nereid Therapeutics Inc. and is the Lead Director on the board of Verastem Oncology. In addition to Verastem Oncology and Nereid, he is a board member for FoRx Therapeutics, Kezar Life Sciences, Incendia Therapeutics, and BiVictriX Therapeutics. Previously, Dr Kauffman served as the co-founder and CEO of Karyopharm, where he guided the Company's transition from a discovery stage biotechnology company to a commercial stage organization and the global approvals of XPOVIO®. Prior to joining Karyopharm, Dr Kauffman was CMO of Onyx Pharma, where he led the development of Kyprolis® following the Onyx acquisition of Proteolix Inc., where he served as board member and then CMO. Previously, Dr. Kauffman was President and Chief Executive officer of EPIX Pharmaceuticals, Inc. (previously Predix Pharmaceuticals, Inc.). Before that, he was the leader of the Velcade® development program at Millennium Pharmaceuticals and has also held a number of senior positions at Millennium Predictive Medicine and Biogen. Dr Kauffman received his MD and PhD from Johns Hopkins Medical School, trained in Internal Medicine at Beth Israel (Deaconess) Medical Center and in Rheumatology at Massachusetts General Hospital, and is board certified in Internal Medicine. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer ir@fibrogen.com Source: FibroGen, Inc.

Bolstered management team with hires of Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experience Announced selection of IL15-superagonist as first payload to be delivered into tumors with Calidi’s first lead candidate using its systemic antitumor virotherapy platform, Redtail; IND filing expected in the second half of 2026 IND cleared by FDA for CLD-201 clinical trial SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the potential to deliver genetic payloads, today reported its first quarter 2025 operating and financial results and reviewed recent business highlights. “We are extremely excited about the progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We believe our systemic antitumor virotherapy platform, Redtail, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic proteins to metastatic sites, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi’s strong platforms.” First Quarter 2025 and Recent Corporate Developments CEO transition to Eric Poma, PhD. Dr. Poma brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development. Prior to joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), where he raised over $250 million in equity financing and secured over $150 million in strategic capital through agreements with Takeda, Vertex and BMS. Dr. Poma received a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, an M.B.A. from the Leonard N. Stern School of Business and a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill. Appointed Guy Travis Clifton, MD, as Chief Medical Officer, Consultant and Advisor. Dr. Clifton is a practicing surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy. Since 2013, he has served as a practicing surgical oncologist in the US Army. He also served as the Chief Medical Officer and co-founder of Parthenon Therapeutics / Incendia Therapeutics from October 2020 to August 2024. Dr. Clifton received his Bachelor of Science in Chemistry from the United States Military Academy, West Point, and Doctor of Medicine from Vanderbilt University; completed his residency in General Surgery from the Brooke Army Medical Center; and fellowship in General Surgical Oncology at the University of Texas, MD Anderson Cancer Center. New preclinical data surrounding Calidi’s systemic antitumor virotherapy, Redtail, presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025, in Chicago, IL., including IL15 superagonist as the first payload to be delivered into tumors. IL15 superagonist is a potent cytokine capable of generating robust and durable immune responses against tumors. The enveloped vaccinia virus is engineered for immune evasion and tumor targeting. Once within the tumor, these viruses exert a multimodal mechanism of action, including direct killing of tumor cells, induction of antitumor immunity, and delivery of transient, non-integrating genetic payload. The systemic administration of the enveloped virus allows Calidi to target metastatic disease patients with high unmet need. The U.S. Food and Drug Administration (FDA) cleared Calidi’s Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma. With non-dilutive funding support from the California Institute of Regenerative Medicine (CIRM), the IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. CLD-201 is a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus, demonstrating Calidi’s manufacturing know-how. First Quarter 2025 Financial Results The company reported a net loss attributable to common stockholders of $5.0 million, or $0.18 per share, for the three months ended March 31, 2025, compared to a net loss attributable to common stockholders of $7.2 million, or $2.03 per share, for the same period in 2024. Research and development expenses were $2.4 million for the three months ended March 31, 2025, compared to $2.7 million for the comparable period in 2024. General and administrative expenses were $2.6 million for the three months ended March 31, 2025, compared to $4.0 million for the comparable period in 2024. The company had approximately $10.6 million in cash and $0.2 million in restricted cash as of March 31, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024. About Calidi Biotherapeutics Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development a new generation of targeted immunotherapies. The company's proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations. The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com. Forward-Looking Statements This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC Form 10-K filed on March 31, 2025. These reports may be amended or supplemented by other reports we file with the SEC from time to time. Contacts: For Investors and Media: Dave Gentry, CEO RedChip Companies, Inc. 1-407-644-4256 CLDI@redchip.com