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Pliant Therapeutics Appoints S. Mishima Gerhart as Chief Regulatory Officer

2023-10-16

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SOUTH SAN FRANCISCO, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced the appointment of Ms. S. Mishima Gerhart as Chief Regulatory Officer. Ms. Gerhart will lead the Company’s regulatory and quality strategies and activities. “Mishima brings a dynamic set of drug development experiences including the design and execution of global regulatory strategies in support of preclinical to commercial-stage programs,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer at Pliant. “Mishima’s successful track record, having achieved results in a variety of diverse, global regulatory and quality settings, will be an invaluable asset to Pliant as we enter late-stage development with our expanding portfolio of novel drug candidates.” Ms. Gerhart is a recognized leader in the biotechnology and pharmaceutical industries who brings over 20 years of global regulatory expertise and experience leading cross-functional teams across multiple therapeutic areas. Ms. Gerhart previously held the role of Chief Regulatory Officer and Head of Quality at Taysha Gene Therapies where she established and grew the regulatory and quality organizations and was responsible for all US and Ex-US regulatory interactions. Prior to Taysha, Ms. Gerhart held senior regulatory roles at Sanofi, serving as Vice President and Head of North America and Global Labeling where she led teams across multiple therapeutic areas including rare diseases, oncology, diabetes, cardiovascular and vaccines. Ms. Gerhart also held the position of Vice President and Head of Regulatory Affairs, China, and Emerging Markets where she managed a 500+ person organization and was responsible for all pre-commercial and commercial-stage products across numerous therapeutic areas and geographies. Prior to this, Ms. Gerhart was Head of Regulatory at Genzyme and held regulatory positions of increasing seniority at AbbVie, Reata Pharmaceuticals, Pfizer/ Wyeth, AstraZeneca, and Wyeth. Ms. Gerhart received a M.S. in Quality Assurance and Regulatory Affairs from Temple University and a B.S. from Kutztown University majoring in biology and minoring in chemistry. Ms. Gerhart added, “I am excited to join Pliant at this important time and draw on my years of regulatory experience in support of a portfolio focused on addressing areas unmet needs. I look forward to working with the outstanding leadership team to further execute on the company’s mission of improving the lives of patients with fibrotic diseases.” About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, a Phase 2b trial of bexotegrast in IPF. Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 integrin for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant has initiated a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition to clinical-stage programs, Pliant currently has a preclinical program targeting muscular dystrophies. For additional information, please visit: . Follow us on social media Twitter, LinkedIn, Facebook and YouTube. Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) In connection with the commencement of Ms. Gerhart’s employment with the Company on October 16, 2023 (the “Grant Date”), the Company plans to grant her non-statutory stock options to purchase an aggregate of 150,000 shares of Company common stock (the “Inducement Grant”). The Inducement Grant has been granted outside of the Company’s 2020 Equity Incentive Plan (the “Plan”) but remains subject to the terms and conditions of the Plan. The Inducement Grant was granted as an inducement material to Ms. Gerhart entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grant has an exercise price per share that is equal to the closing price of the Company’s common stock on the Grant Date. The Inducement Grant will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of Ms. Gerhart’s start date, and thereafter the remainder of the shares vest in 36 equal monthly installments, subject to Ms. Gerhart’s continued employment with the Company through the applicable vesting dates. Investor and Media Contact: Christopher Keenan Vice President, Investor Relations and Corporate Communications Pliant Therapeutics, Inc. ir@pliantrx.com