Serpin Peptide 16

- Low early termination rate (4.3%) among the first 116 patients completing the study suggests Halneuron ® treatment to be well tolerated - ATLANTA, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has achieved over 50% of the planned enrollment in its ongoing HAL-CINP-203 Phase 2b chemotherapy induced neuropathic pain (“HALT-CINP”) trial. HALT-CINP remains on track for top line results to be available during the third quarter of 2026. “If the HALT-CINP study is successful, Halenuron ® would represent a new therapeutic agent for treating chemotherapy-induced neuropathic pain, a condition for which there are currently no approved therapies. There remains a great need for treatment options for the millions of patients suffering from chemotherapy-induced neuropathic pain and we continue to be encouraged by the rate of enrollment, interim outcomes and safety profile,” said Dogwood Therapeutics Chief Medical Officer R. Michael Gendreau, M.D., Ph.D., “Against a history of failed clinical trials, the ongoing Halneuron ® clinical trial has the potential to be the first statistically significant trial treating chemotherapy-induced neuropathic pain patients under FDA chronic pain study guidance.” In December 2025, Dogwood announced encouraging results from an interim analysis of 97 patients who had completed treatment in the HALT-CINP study. An independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron ® treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. This preliminary evidence of a Halneuron ® treatment effect is noteworthy as patients in the interim analysis population presented with an average duration of chemotherapy-induced neuropathic pain of 5 years. The overall study dropout rate of approximately 4.0% is far below rates typically observed in studies of other FDA approved chronic pain medicines. The study is designed to provide statistical power of approximately >80% to detect a Halneuron ® treatment difference versus placebo upon study unblinding in the third quarter of 2026. Halneuron ® CINP Phase 2b Trial Overview (NCT06848348) HALT-CINP is a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron ® vs placebo in cancer patients with established neuropathy due to a previous platinum or taxane-based chemotherapy regimen. Participants receive 8 sub-cutaneous doses of Halneuron ® or placebo over a 14-day period and are followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change in the weekly average of daily 24-hour recall pain intensity scores from baseline to week four. The study is being conducted at approximately 30 sites in the U.S. Secondary measures will assess Halneuron’s ® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health. Final HALT-CINP Phase 2b trial results are projected for the third quarter of 2026. About Dogwood Therapeutics: Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron ® and SP16 IV. Our lead product candidate, Halneuron ® , is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron ® has been granted fast track designation from the FDA for the treatment of chemotherapy induced neuropathic pain (“CINP”). Halneuron ® is a non-opioid, Na V 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron ® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy induced peripheral neuropathy trial is fully funded by the National Cancer Institute. Dogwood Therapeutic’s largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit . Forward-Looking Statements: Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2024, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law. Investor Relations: CORE IR (516) 222-2560 IR@dwtx.com

This board strengthens Serpin Pharma’s ability to advance innovative immune‑modulating therapeutics and expand our strategic partnerships in 2026 and beyond. SP16 is a clinically validated, collaborator‑endorsed asset with transformative platform combating inflammation. SP16 is a bio‑superior alternative to the A1ATD drug recently acquired by Sanofi.” — Dr. Alexander Fleming MANASSAS, VA, UNITED STATES, January 19, 2026 / EINPresswire.com / -- Serpin Pharma Inc. Announces Election of New Board of Directors Shareholders Approve Distinguished Leaders in Medicine, Biotechnology, and Strategic Finance Serpin Pharma Inc., a clinical‑stage biotechnology company developing immune‑modulating therapeutics, today announced that shareholders have elected a new Board of Directors at the Company’s Annual Meeting held on December 29, 2025. The newly elected board brings together internationally recognized experts in drug development, regulatory science, academic medicine, and financial strategy to support Serpin Pharma’s next phase of growth. “The election of this board marks a significant milestone for Serpin Pharma,” said Dr. Cohava Gelber, Founder, CEO, and Executive Chairperson. “Their collective expertise strengthens our ability to advance innovative therapies, expand strategic partnerships, and deliver meaningful impact for patients.” Newly Elected Directors Dr. Denise Barbut, MD, FRCP, FCPP A physician, scientist, and serial entrepreneur, Dr. Barbut has founded and led multiple medtech and biotech companies and raised more than $300 million to advance breakthrough therapies. A former Professor of Neurology at Weill‑Cornell Medical College and Chief of the Neurovascular Division, she holds approximately 300 issued patents and is widely recognized for her contributions to cerebral protection, therapeutics, and regenerative medicine. Dr. G. Alexander Fleming, MD Dr. Fleming is a globally respected regulatory expert and former senior official at the U.S. Food and Drug Administration. During his FDA tenure, he led approvals for metformin, the first statin, insulin analogs, PPAR‑agonists, and multiple growth hormone indications. He is Executive Chairman of Kinexum and President of the Kitalys Institute, and continues to shape international regulatory policy and clinical development standards. Dr. Lawrence Steinman, MD A leading physician‑scientist and Professor of Neurology and Neurological Sciences at Stanford University, Dr. Steinman is known for pioneering work in autoimmune and neuroinflammatory diseases. His discoveries contributed to therapies now used worldwide for multiple sclerosis and Crohn’s disease. He is an elected member of the National Academy of Sciences and the National Academy of Medicine and has co‑founded several biotechnology companies. William B. Johns, MBA Mr. Johns is a seasoned executive with deep experience in global finance, capital markets, and healthcare information technology. As former CEO of Healthcare Capital Corp., he led strategic transactions in the healthcare IT sector. He currently advises private investors and family offices through W. Johns Associates LLC, providing governance and investment strategy expertise. Dr. Cohava Gelber, PhD, MBA Founder, CEO, and Executive Chairperson of Serpin Pharma, Dr. Gelber brings more than 25 years of leadership in drug discovery, translational research, and biotechnology management. She has held senior roles at Duke University, ImmuLogic, ATCC, and MannKind Corporation, and has secured more than $500 million in grants and contracts. She continues to guide Serpin Pharma’s scientific and strategic direction. About Serpin Pharma Inc. Serpin Pharma Inc. is a clinical biotechnology company developing SP16, a powerful, first‑in‑class platform that activates the body’s own inflammation‑resolving pathways through precise LRP1 targeting, delivering potent efficacy without immune suppression. Its 300‑fold enhanced activity over AAT, exceptional safety profile, and broad clinical validation position it as a transformative engine for multiple high‑value inflammatory and autoimmune indications. The company is committed to advancing transformative treatments for inflammatory, autoimmune, and degenerative diseases through rigorous science, strategic collaboration, and patient‑focused innovation. DR. Cohava Gelber Serpin Pharma +1 703-343-3258 cgelber@serpinpharma.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.