Regulus aims to develop important, novel oligonucleotide therapeutics that are designed to inhibit dysregulated microRNA targets for the benefit of patients with genetically based orphan diseases. We are focused on orphan kidney diseases where microRNA genetic drivers are implicated and there are clear unmet medical needs with an initial focus on orphan kidney diseases, including Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Beyond genetic kidney disease, we are excited about the potential applications of oligonucleotide inhibitors of microRNA for additional genetically defined diseases.
Our technology is based on our position as exclusive licensee of IP provided by Alnylam and Ionis, two leaders in oligonucleotide-based therapeutics, along with our continued novel discoveries since inception.
Jay HaganChief Executive Officer
Jay Hagan has served as our chief executive officer and principal executive officer since May 2017. Mr. Hagan previously served as our chief operating officer, principal financial officer and principal accounting officer from January 2016 to May 2017. From June 2011 through December 2015, Mr. Hagan served as the executive vice president, chief financial officer and chief business officer of Orexigen Therapeutics, Inc. (“Orexigen”). From May 2009 to June 2011, Mr. Hagan served as Orexigen’s senior vice president, corporate development, strategy and communications. From September 1998 to April 2008, Mr. Hagan served as managing director of Amgen Ventures. Prior to starting the Amgen Ventures Fund, Mr. Hagan served as head of corporate development for Amgen Inc. (“Amgen”). Before joining Amgen, Mr. Hagan spent 5 years in the bioengineering labs at Genzyme and Advanced Tissue Sciences. Mr. Hagan previously served on the board of Aurinia Pharmaceuticals, Inc., from February 2018 to July 2023, and previously served on the board of directors of Zosano Pharma Corp, a publicly-traded biotechnology company, from May 2015 to May 2022. He received an M.B.A. from Northeastern University and a B.S. in Physiology and Neuroscience from the University of California, San Diego.
Preston S. Klassen, M.D., M.H.S.President & Head of Research & Development
Preston S. Klassen, M.D., M.H.S.
Preston Klassen joined Regulus in 2023 and serves as president and head of research and development. He joined Regulus from Metacrine where he served as president and chief executive officer. From June 2016 to March 2017, he was chief medical officer of Laboratoris Sanifit S.L., and prior to that, was executive vice president, head of global development at Orexigen Therapeutics, Inc. Dr. Klassen also held several positions of increasing responsibility at Amgen Inc., including therapeutic area head for nephrology. Before joining Amgen, he was a faculty member in the Division of Nephrology at Duke University Medical Center. Dr. Klassen has previously served on the board of Conatus Pharmaceuticals, Corvidia Therapeutics and Chinook Therapeutics. He holds a B.S. in chemistry from Central University of Iowa. Dr. Klassen received his medical degree from the University of Nebraska College of Medicine and completed his residency in internal medicine, fellowship in nephrology, and Master of Health Sciences degree at Duke University.
Cris CalsadaChief Financial Officer
Cris joined Regulus in August 2019 and currently serves as chief financial officer. She joined Regulus from Sanifit where she served as chief financial officer. Before joining with Sanifit, Cris spent several years as a finance consultant to life sciences companies. From 2004 until 2015, she served in positions of increasing responsibility with Ambrx, culminating as chief operating officer and vice president of finance and guiding the company through its acquisition. Prior to Ambrx, she worked for Sony Online Entertainment as executive director of finance and controller. Earlier in her career, she practiced as a certified public accountant. Cris received a B.S. in business administration with an emphasis in accounting from San Diego State University and an MBA from the University of Southern California Marshall School of Business.
Christopher AkerSenior Vice President & General Counsel
Chris joined Regulus in February 2011 and serves as senior vice president and general counsel. Prior to joining Regulus, he served as the senior director, administration and senior corporate counsel for Phenomix Corporation, a privately held biopharmaceutical company, and was responsible for operational and legal oversight. Prior to Phenomix, Chris was senior corporate counsel at SUGEN, Inc., a wholly owned subsidiary of Pharmacia, until its acquisition by Pfizer. Prior to SUGEN, Mr. Aker was in private practice with various law firms. He received his B.A. in international relations from the University of California, Davis and his J.D. from the Santa Clara University.
Rekha Garg, M.D., M.S.Senior Vice President, Clinical Development & Regulatory
Rekha Garg, M.D., M.S.
Rekha joined Regulus in 2022 and is a physician executive with over 20 years of experience in leadership roles in the biopharma industry, across multiple therapeutic areas including kidney diseases. Before joining Regulus, she was Senior Vice President, Regulatory Affairs and Safety, at Sanifit Therapeutics. Prior to that, she was Vice President at Infinity Pharmaceuticals and served in multiple leadership roles in clinical development focused on regulatory affairs and risk management at Amgen and Eli Lilly. Prior to joining the pharmaceutical industry, she held a similar role the National Heart, Lung, and Blood Institute. Rekha received her BA in Biology from Oberlin College, her M.D. from the Medical College of Ohio and completed her residency at the University of Maryland School of Medicine where she also received an M.S. in Epidemiology.
Claire Padgett, Ph.D.Senior Vice President, Clinical Operations
Claire Padgett, Ph.D.
Claire brings to Regulus more than 25 years of experience in clinical and development operations, with experience in these functions accrued at multiple biotech companies including Sanifit Therapeutics, a company focused on the Phase 3 clinical development of SNF472 in chronic kidney disease. Previously she held similar roles at Mirati Therapeutics, Mast Therapeutics, and Cylene Pharmaceuticals. She earned an MBA from Seton Hall University and holds a Ph.D. in organizational management and leadership from Capella University.
Moh Ahmadian, Ph.D.Vice President, Chemistry & Pharmaceutical Development
Moh Ahmadian, Ph.D.
Moh Ahmadian is an organic/nucleic acid chemist with extended experience in oligonucleotide syntheses, RNAi technologies and drug delivery. He received his Ph.D. degree from the department of medicinal chemistry and molecular pharmacology at Purdue University and spent his post-doctoral years at Southern Research Institute. Afterwards he worked on developing PCR probes at what was then Epoch Biosciences. Shortly after the introduction of RNAi technology in early years of the 2000s, he moved to Nastech pharmaceuticals working on developing new platform for siRNA technology. Since 2008, Moh was technical lead in establishing synthesis and purification of oligonucleotides at various scales as well as delivery of siRNA exploring “liposomes” & “lipoplexes” [LNPs] for siRNA delivery. He also designed, modified, and tested siRNA sequences. The efforts resulted in two drug substances/products to go in clinical trials. In 2013, he moved to Kinovate Life Sciences leading to improve the “oligonucleotides solid support manufacturing company” in planning & manufacturing solid support for the company which now has become the undisputed leader in providing solid support for therapeutic oligonucleotide manufacturing.
Moh is “silent co-founder” of a therapeutic company, contributing author to two books, Modified Nucleosides in Biochemistry, Biotechnology and Medicine and Current protocols in Nucleic Acid Chemistry. In addition to over 10 published peer reviewed articles in various scientific journals he is a co-inventor in over 100 published U.S, and international patents and patent applications.
Brian K. Campion, Ph.D.Vice President, Business Development
Brian K. Campion, Ph.D.
Brian joined Regulus in July 2020 as Vice President, Business Development. His career includes corporate business development roles at Dermira Inc. (Eli Lilly), Bird Rock Bio and Ora Inc. While at Dermira he led technology in-licensing activities to expand Dermira’s product and technology portfolio. He was instrumental in securing a multi-target in-licensing partnership with Takeda Pharmaceuticals and the transformative in-licensing of global rights for Lebrikizumab from Roche. Dermira was acquired by Eli Lilly in January of 2020. Brian received his B.A. and Ph.D. degrees in chemistry from the University of California, San Diego and was a postdoctoral Fellow at UC Berkeley.
Edmund Lee, Ph.D.Vice President, Translational Medicine
Edmund Lee, Ph.D.
Edmund is Vice President, Translational Medicine at Regulus Therapeutics. Prior to joining Regulus, he was with Hoffmann-La Roche and Millennium Pharmaceuticals (now Takeda Oncology), where he participated in the discovery of the proteosome inhibitor ixazomib (MLN9708) for the treatment of multiple myeloma. Edmund has led numerous discovery and translational research programs, including most recently the first anti-miR-17 oligonucleotide (RGLS4326), as well as the next-generation anti-miR-17 (RGLS8429) for the potential treatment of ADPKD. Edmund received his B.Sc. (Honors) in biochemistry from Queen’s University in Ontario Canada, his Ph.D. in cell and molecular biology from the University of Notre Dame, and completed his postdoctoral training at the Fred Hutchinson Cancer Research Center.
Morgan Carlson, Ph.D.Vice President, Biology
Morgan Carlson, Ph.D.
Morgan joined Regulus Therapeutics in 2020, bringing 10 years of experience in drug discovery and leading translational research teams. He was previously a senior investigator at Novartis, where he established and led preclinical efforts in areas including post-myocardial infarction and heart failure, congenital heart disease, and cellular senescence. He also served as assistant professor of genetics and development biology at the University of Connecticut School of Medicine and Stem Cell Institute, where his research laboratory focused on biological aging and tissue regeneration to drive the discovery of novel mechanisms and therapeutics for treating musculoskeletal degenerative disease. Morgan earned his B.S. in biology from Elon University, an M.S. in comparative pathology/virology from University of California, Davis, a joint Ph.D. in bioengineering from University of California, San Francisco and Berkeley, and was a postdoctoral research fellow at Children’s Hospital of Oakland Research Institute and University of California, Berkeley.
Amin Kamel, Ph.D.Vice President, Drug Metabolism & Pharmacokinetics
Amin Kamel, Ph.D.
Amin joined Regulus in 2022 and is vice president, drug metabolism and pharmacokinetics. Prior to joining Regulus, he was the scientific director of Takeda, drug metabolism and pharmacokinetics, where he was responsible for project management, operations, and served as a scientific advisor. Prior to Takeda, he was principal investigator at Biogen, where he led project management and provided scientific expertise and support for small molecule drug discovery and early development. Previously, he worked as a research investigator for Novartis Institutes for BioMedical Research, and, prior to that, worked for a number of years as a research scientist at Pfizer Global Research and Development. Amin holds a Ph.D. in chemistry from the University of Rhode Island with collaboration with University of Delaware.
Curtis Monnig, Ph.D.Vice President, CMC
Curtis Monnig, Ph.D.
Curtis Monnig joined Regulus in 2023 and serves as vice president of CMC. He was previously vice president of CMC at January Therapeutics. Prior to that he worked at Currax Pharmaceuticals as senior director, global and technical development. From 2006-2016, he served in multiple roles at Allergan Inc, culminating in senior director, strategic planning and operations. Before that, he was senior director scientific affairs and operation excellence at Cardinal Health and before that he was at Amylin Pharmaceuticals as senior scientific investigator. Prior to joining the pharmaceutical industry, he was an assistant professor of chemistry at the University of California. Dr. Monnig earned his B.S. in biochemistry and M.S. in chemistry from the University of Missouri and his Ph.D. in chemistry from Indiana University.
Daniel PenksaVice President, Finance & Controller
Dan joined Regulus in June 2015, and currently serves as vice president of finance & controller, overseeing the Finance and Accounting functions at Regulus and providing strategic direction and leadership to the organization. Prior to joining Regulus, he served as a Senior Audit Associate at Grant Thornton, primarily focusing on publicly traded life sciences companies. Dan received a B.S. in finance, a B.S. in accounting, and an M.S. in accounting, all from the University of Nevada, Las Vegas, and is a certified public accountant.
Tate Owen, Ph.D.Senior Director, Drug Metabolism & Pharmacokinetics
Tate Owen, Ph.D.
Tate currently serves as senior director of drug metabolism and pharmacokinetics at Regulus Therapeutics. Prior to joining Regulus, he was with Genalyte, Inc. pushing the frontiers in genomics, sequencing, and autoimmune diagnostics. At Regulus, he has advised and enabled the DMPK component of several research programs in disease area’s ranging from ADPKD, to diabetes, to hepatitis. Tate received his B.S. in chemistry from UC Santa Cruz, his Ph.D. in chemistry from UC Santa Barbara, and postdoctoral training from the University of Washington’s bioengineering department.
Board of Directors.
Principal Executive Offices
4224 Campus Point Court, Suite 210,
San Diego, CA 92121
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