Mineralys Therapeutics reported full Phase 2 Explore-CKD results for lorundrostat in patients with uncontrolled hypertension and chronic kidney disease. The drug cut systolic blood pressure and albuminuria by statistically significant margins on top of background therapy. The patients were already heavily treated with multiple blood pressure drugs. The company's next catalyst is progress toward a new drug application (NDA) filing. On October 27, Mineralys signed a termination agreement with Tanabe. It now owns the lorundrostat intellectual property it previously licensed, while keeping its commercial milestone obligations and Tanabe's Japan right of first negotiation. Lorundrostat is not yet approved, and Mineralys still reports losses. Its current loss is $349.6 million.

Mineralys Therapeutics has added Kristine Peterson and Lonnel Coats to its board of directors, the biopharmaceutical company announced on October 19, 2026. The Radnor, Pennsylvania-based company is preparing for the potential approval and commercial launch of lorundrostat, a treatment for uncontrolled or resistant hypertension. Peterson was most recently chief executive officer of Valeritas. She also spent 20 years at Bristol-Myers Squibb and held senior roles at Johnson & Johnson and Biovail. Coats was most recently chief executive officer of Lexicon Pharmaceuticals. He previously led Eisai's North American business and spent eight years at Janssen Pharmaceuticals. Chief executive officer Jon Congleton said their commercial experience will help as Mineralys becomes a commercial-stage company.

Mineralys Therapeutics expands its Board of Directors with the appointments of Kristine Peterson and Lonnel Coats. The addition of Ms. Peterson and Mr. Coats brings additional commercial and product launch experience to Mineralys ahead of the December 22 PDUFA target action date for lorundrostat. RADNOR, Pa., Oct. 19, 2026 (GLOBE NEWSWIRE) - Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced that Kristine Peterson and Lonnel Coats have been appointed to the Company's Board of Directors. "We are delighted to welcome Kris and Lonnel to our Board of Directors as we prepare for the potential approval and commercial launch of lorundrostat for the treatment of uncontrolled or resistant hypertension," stated Jon Congleton, Chief Executive Officer of Mineralys. "As seasoned leaders who have each built and led commercial organizations, Kris and Lonnel bring deep experience launching and commercializing new therapies across multiple therapeutic areas, including cardiovascular and metabolic disease. We believe their track records of commercial execution, operational leadership and public company board service will make them valuable directors and resources as Mineralys transitions to a commercial-stage organization." "I am honored to join the Mineralys Board of Directors at such a pivotal time for the Company," stated Ms. Peterson. "Having spent much of my career launching new medicines, including in cardiovascular disease, I appreciate the significant unmet need among patients whose hypertension is not controlled with currently available therapies. I look forward to working with the Company's executive team and fellow Board members as Mineralys prepares for the potential commercial launch of lorundrostat." "I am pleased to join the Mineralys Board of Directors," stated Mr. Coats. "Hypertension remains a leading driver of cardiovascular risk, and too many patients are unable to reach their blood pressure goals with currently available treatments. Lorundrostat has significant potential to offer a targeted treatment approach for hypertension driven by dysregulated aldosterone, and I look forward to contributing as the Company advances toward this next chapter." Ms. Peterson is a biopharmaceutical executive with more than three decades of experience in commercial, operational and general management leadership, including launching numerous products across multiple therapeutic areas. She most recently served as Chief Executive Officer of Valeritas, Inc., a commercial-stage medical technology company. Prior to Valeritas, Ms. Peterson served as Company Group Chair of the Biotechnology Group and Executive Vice President of Pharmaceutical Group Strategic Marketing at Johnson & Johnson, where she led commercial, research and development, and biologics manufacturing in oncology, immunology and cell therapy. Prior to Johnson & Johnson, Ms. Peterson served as Senior Vice President, Commercial Operations, of Biovail Corporation and President of Biovail Pharmaceuticals. Earlier in her career, Ms. Peterson spent 20 years at Bristol-Myers Squibb Company in a variety of senior roles in sales, marketing and general management, including leading its cardiovascular and metabolic disease business unit. Ms. Peterson currently serves as a member of the Board of Directors at ArriVent BioPharma, Inc., Enanta Pharmaceuticals, Inc. and Immunocore Holdings plc. Ms. Peterson also previously served as a member of the board of directors of the Biotechnology Innovation Organization (BIO). Ms. Peterson received her B.S. in Marketing and her M.B.A. from the University of Illinois. Mr. Coats is a biopharmaceutical executive with more than three decades of experience in building and leading commercial pharmaceutical organizations. He most recently served as Chief Executive Officer of Lexicon Pharmaceuticals, Inc. Prior to joining Lexicon, Mr. Coats served in a series of leadership positions, including Chief Executive Officer of North America, at Eisai Inc. and Eisai Corporation of North America, where he oversaw the commercialization of Eisai products in the therapeutic areas of oncology, neurology, gastrointestinal disorders, epilepsy and metabolic disorders. Prior to Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of management and sales positions. Mr. Coats currently serves as a member of the Board of Directors of Relay Therapeutics, Inc. Mr. Coats received his B.S. in Public Administration from Oakland University. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, X and Bluesky. Forward-Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on Mineralys' current beliefs and expectations and include, but are not limited to, statements regarding the anticipated timing of the Food and Drug Administration's (FDA) review of Mineralys' accepted NDA and the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys' business, including, without limitation: any delays in the FDA's review of Mineralys' accepted new drug application (NDA), including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys' clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA's review of Mineralys' NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys' future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys' dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys' ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys' reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys' filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Media Relations Melyssa Weible Elixir Health Public Relations Email: [email protected]