Mineralys Therapeutics, Inc., a private, clinical-stage biopharmaceutical company founded by Catalys Pacific, announced today that the Company completed a $40 million Series A funding round. The financing was led by HBM Healthcare Investments and Samsara BioCapital with founding investment firm Catalys Pacific and Adam Street Partners participating in the round. The company also announced that the U.S. Food and Drug Administration (FDA) has accepted their Investigational New Drug Application (IND) for an investigational compound MLS-101, an aldosterone synthase inhibitor, for the treatment of hypertension. The financing will enable Mineralys to complete its Phase 2 proof-of-concept study for MLS-101, as well as preparatory work for its pivotal trial development program.
Aldosterone has been implicated as an underlying cause of hypertension in upwards of 30 percent of all hypertension patients and as such represents an ideal target for therapeutic intervention in these patients. In a Phase 1 study in healthy volunteers, MLS-101 demonstrated a safe and tolerable profile while selectively reducing aldosterone.
“We are delighted that this group of esteemed investors has confidence in our mission and supports our belief that MLS-101 has the potential to change the hypertension treatment landscape,” said Jon Congleton, chief executive officer (CEO), Mineralys Therapeutics. “Mineralys was established around our goal to develop a novel, potentially paradigm-shifting therapy for the treatment of hypertension, a condition with relatively low industry innovation but with significant unmet need. We are encouraged by the results of the Phase 1 study which demonstrated the promise of MLS-101 and the acceptance by the FDA of our IND. We are committed to advancing a targeted approach for the management of hypertension.”
“We founded Mineralys to combine ground-breaking science in endocrinology with excellent drug discovery from Japan,” said BT Slingsby, M.D., Ph.D., M.P.H., founder and executive chairman of Mineralys and managing partner, Catalys Pacific. “MLS-101 holds significant potential for patients worldwide and we are confident in the deep expertise and proven track record of Mr. Congleton and the growing executive team to develop MLS-101 and deliver on that promise.”
Joining BT Slingsby and Takeshi Takahashi on the board of directors are Alexander Asam, M.D., M.B.A., investment advisor of HBM Healthcare Investments and Srinivas “Srini” Akkaraju, M.D., Ph.D., Managing General Partner and Founder, Samsara BioCapital.
Management Team Appointments
Jon Congleton joined Mineralys as CEO in 2020. Mr. Congleton has over 30 years of experience in biopharmaceutical company leadership including pipeline development, commercial strategy and general management. He has worked in cardiovascular, gastroenterology and central nervous system (CNS) companies with a focus on providing solutions for patients and their caregivers. Most recently he was president and CEO of Impel NeuroPharma, where he was integral in the development of compounds for the treatment of CNS disorders. Prior to Impel, Congleton served as president and CEO of Nivalis Therapeutics, where he successfully executed the company’s initial public offerings and clinical programs.
Joining Mr. Congleton as chief medical officer (CMO) is David Rodman, M.D.. Dr. Rodman is an experienced industry and academic leader with over 15 years of leadership experience in the pharmaceutical and biotechnology industries, preceded by 15 years of academic medical experience. Dr. Rodman’s experience will provide strategic direction that will be valuable as Mineralys moves through the investigational process for MLS-101. Rodman has served as an executive leader at multiple companies including miRagen, Vertex Pharmaceuticals Inc., Novartis Institutes for Biomedical Research, as well as being a tenured professor of medicine, physiology and biophysics and a senior investigator in the Cardiovascular-Pulmonary Research Laboratory at the University of Colorado.