Regulus Therapeutics Announces Appointments of Industry Veterans, Drs. Rekha Garg and Claire Padgett, to Lead Clinical Development, Regulatory and Clinical Operations

Additional Preclinical Promotions Round Out Scientific Leadership

SAN DIEGO, Nov. 29, 2022 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the appointments of Rekha Garg, M.D., M.S., to Senior Vice President, Clinical Development and Regulatory, and Claire Padgett, Ph.D. to Senior Vice President, Clinical Operations. The company also announced the promotion of Morgan Carlson, Ph.D., to Vice President, Biology and Edmund Lee, Ph.D., to Vice President, Translational Medicine. Lastly, the Company announced, Denis Drygin, Ph.D., has stepped down from his role as Chief Scientific Officer to pursue other opportunities.

"We are very pleased to announce the appointment of these two industry veterans to focus on advancing RGLS8429 through clinical trials for the benefit of patients with ADPKD," said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics. "Both Drs. Garg and Padgett have been working with the Company as consultants moving the Phase 1 ADPKD program forward and we are happy to welcome them as employees to the Regulus team.  Additionally, the promotions of Dr. Lee and Dr. Carlson to the newly created roles of Vice President, Translational Medicine and Vice President, Biology are in recognition of their accomplishments in the development of our biomarker strategy for our ADPKD program as well as the effective leadership of our earlier stage research efforts. We would also like to express our gratitude to Denis, thank him for his many contributions and wish him the best in the next phase of his career."

Dr. Garg 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. Dr. Garg 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.

Dr. Padgett has 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.

Dr. Lee joined Regulus in 2013 from 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 at Regulus, 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 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.

Dr. Carlson joined Regulus in 2020. He was previously a senior investigator at Novartis, and before that, an assistant professor of genetics and developmental 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.  Dr. Carlson earned 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.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in San Diego, CA.

Forward-Looking Statements

Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the Company's RGLS8429 program, including the expected timing and future occurrence of other preclinical and clinical activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and the risk additional toxicology data may be negative. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These and other risks are described in additional detail in Regulus' filings with the Securities and Exchange Commission, including under the "Risk Factors" heading of Regulus most recently quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Regulus Therapeutics Inc.