Rinvecalinase alfa

Leading Maternal-Fetal Medicine Experts to Discuss FGR Disease State, the Clinical Rationale for DM199 (Rinvecalinase Alfa) Early Safety and Trial Findings from First Cohort of Phase 2 Early-Onset FGR Trial to Be Presented MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today announced that it will host a virtual key opinion leader (KOL) event on October 23, 2026 at 8:00am Eastern Time to discuss fetal growth restriction (FGR), the therapeutic rationale for evaluating DM199 (rinvecalinase alfa) as a potential treatment for FGR and preliminary, interim topline results from the first cohort of an investigator-sponsored Phase 2 early-onset FGR trial. The webinar will feature Professor Catherine Cluver, MD, PhD (Stellenbosch University), Professor Stephen Tong, MBBS, PhD (The University of Melbourne), Professor Susan Walker, AO, MBBS, MD (The University of Melbourne), and Professor Andrew Shennan, OBE, MBBS, MD (King’s College London). The experts will discuss the FGR disease state and current treatment landscape, the role of placental insufficiency and impaired uteroplacental blood flow, the clinical rationale for DM199 as a potential treatment option for FGR, and interim safety and clinical findings from the first six participants treated in the Phase 2 early-onset FGR trial. Dr. Cluver, the trial Principal Investigator, will review the trial design and present safety, tolerability and preliminary first-cohort results. The panel will discuss the clinical relevance of key measures being evaluated in the trial, and the interim findings in the context of early-onset FGR. Enrollment in the first of three planned FGR cohorts has been completed, consisting of six participants treated at the 5 µg/kg dose level. Dosing has also begun in the second cohort at the 10 µg/kg dose level. This is the first time DM199 has been used to treat patients with early-onset fetal growth restriction. A live question-and-answer session will follow the formal presentations. Event Details Date Friday, October 23, 2026 Time 8:00 AM EDT / 7:00 AM CDT Registration About Professor Catherine Cluver Professor Catherine Cluver is a maternal-fetal medicine specialist who founded and leads the Preeclampsia Research Unit at Tygerberg Hospital, Stellenbosch University, South Africa. Dr. Cluver has completed multiple preeclampsia treatment trials assessing novel therapies and curates one of the largest preeclampsia biobanks. She has published extensively in maternal-fetal medicine, including work in The Lancet and BMJ. Dr. Cluver is the Principal Investigator of the ongoing investigator-sponsored Phase 2 trial evaluating DM199 in preeclampsia and fetal growth restriction at Tygerberg Hospital. About Professor Stephen Tong Professor Stephen Tong is an obstetrician-scientist at the University of Melbourne and Mercy Hospital for Women with a strong focus on translational research and the development of therapeutics for major pregnancy complications. He has played a leading role in advancing multiple therapeutic concepts from laboratory research into Phase 1 through Phase 3 clinical trials. Professor Tong has authored more than 300 scientific publications, including more than 100 on preeclampsia, with research published in journals including Nature, The Lancet, BMJ and Nature Communications. About Professor Susan Walker Professor Susan Walker is the Sheila Handbury Chair of Maternal Fetal Medicine, Head of the Department of Obstetrics, Gynaecology and Newborn Health at the University of Melbourne, and Divisional Chair of Perinatal Medicine at Mercy Hospital for Women. Her clinical and research program focuses on improving the detection and treatment of fetal growth restriction and preeclampsia. Professor Walker has authored more than 290 publications, including work in The Lancet, New England Journal of Medicine and BMJ. About Professor Andrew Shennan Andrew Shennan is Professor of Obstetrics at King’s College London, based at St. Thomas’ Hospital and specializes in clinical trials and the management of high-risk pregnancy. His research focuses on the prediction and prevention of preterm birth and preeclampsia, as well as reducing maternal and perinatal mortality. Professor Shennan has published more than 700 peer-reviewed research reports and has held leadership roles including Chair of the FIGO Preterm Birth Committee and Chair of Action on Pre-eclampsia UK. He also maintains an active clinical practice, including management of high-risk obstetric patients and a specialist preterm birth surveillance clinic. About the Phase 2 Investigator-Sponsored Fetal Growth Restriction Trial The Phase 2 study is the third part of an open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored trial of DM199 for the treatment of pregnancy complications currently being conducted at the Tygerberg Hospital in Cape Town, South Africa. This part of the trial is evaluating repeated SC dosing in up to 30 early-onset FGR subjects until delivery, using up to three dose levels initially based on Part 1a data; enrollment commenced in June 2026, and the first cohort of 6 participants has been enrolled. Dosing levels are at 5, 10 and up to 15 µg/kg. The dose for the third cohort will be between 1 and 15 µg/kg based on results from the first two cohorts. About Fetal Growth Restriction Fetal growth restriction (FGR) occurs when a fetus fails to reach its genetically determined growth potential in the womb, most commonly due to placental insufficiency. FGR affects an estimated 10% of pregnancies worldwide and is associated with significantly increased risks of stillbirth, preterm birth, and neonatal morbidity, as well as long-term neurodevelopmental, cardiovascular, and metabolic complications. In severe, early-onset cases, FGR often necessitates delivery before 32 weeks of gestation, when the risks of prematurity must be weighed against the dangers of continued growth restriction in utero. For further details, see the recently released white paper, “ The Potential of DM199 to Treat Fetal Growth Restriction ”. About DM199 (rinvecalinase alfa) DM199 is a recombinant form of human tissue kallikrein-1 (rhKLK1). KLK1 is a serine protease enzyme that plays an important role in vascular regulation through the kallikrein-kinin system, activating downstream pathways that increase the production and release of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” or “would,” the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the timing, nature and requirements for clinical trials, regulatory applications and approvals, anticipated dose levels for pending and future trials; the presentation and interpretation of preliminary, interim topline results from the Phase 2 early-onset FGR trial; expectations regarding the potential of pregnancy prolongation and changes in uterine and umbilical artery Doppler measures to characterize biological and potential clinical effects of DM199; continued ReMEDy2 trial enrollment and timing of the interim analysis; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. The preliminary, interim results discussed herein are based on a limited number of participants and may not be indicative of results from the completed trial or future trials. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing and outcomes of non-clinical studies; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction, and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia, fetal growth restriction, and acute ischemic stroke; and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including our most recent quarterly report on Form 10-Q. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws. Contacts Scott Kellen Chief Financial Officer Phone: (763) 496-5118 skellen@diamedica.com For Investor Inquiries: Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 mmoyer@lifesciadvisors.com Media Contact: Madelin Hawtin LifeSci Communications mhawtin@lifescicomms.com