Applied Therapeutics Appoints Reena Thomas Colacot as Vice President and Head of Quality

Rhea-AI Summary

Applied Therapeutics (NASDAQ: APLT) has appointed Reena Thomas Colacot as Vice President and Head of Quality in a newly created role. She brings over 25 years of quality leadership experience in the biopharmaceutical and medical device industries. Colacot will report to the executive leadership team and Executive Chairman, overseeing all quality matters including Good Manufacturing, Laboratory, and Clinical Practices.

Prior to joining Applied Therapeutics, Colacot led quality and compliance functions at Bellus Health, Inc., continuing through its acquisition by GSK plc in 2023. Her experience includes leadership roles at Quotient Sciences, International AIDS Vaccine Initiative, Antares Pharma, McNeil Consumer Healthcare, and Laureate Pharma/Purdue Biopharma. She holds M.S. degrees in Quality Assurance and Regulatory Affairs from Temple University and Biomedical Engineering from the University of Alabama at Birmingham.

Positive

• Appointment of experienced quality leadership with 25+ years in the industry
• Creation of new executive position focusing on quality oversight
• Strengthening of regulatory compliance capabilities

Negative

• None.

Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries

NEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Reena Thomas Colacot as Vice President and Head of Quality. Ms. Colacot joins Applied with over 25 years of quality leadership experience across the biopharmaceutical and medical device industries. In this newly created role, she will report directly to the executive leadership team and Executive Chairman, and will be responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices.

“We are pleased to welcome Reena to Applied and are confident that her wealth of experience as a leader across quality functions will support our mission of meeting the unmet needs of patients with rare diseases,” said John H. Johnson, Executive Chairman of Applied Therapeutics.

“I am excited to join Applied and work alongside this talented management team. They share my commitment to the highest standards of quality and my dedication to improving the lives of patients,” said Ms. Colacot.

Ms. Colacot brings over 25 years of leadership experience across quality roles, most recently at Bellus Health, Inc., where she built and led the quality and compliance functions. Following the acquisition of Bellus Health by GSK plc in 2023, Ms. Colacot continued to provide quality oversight in support of the successful integration and knowledge transfer of Bellus Health’s primary asset to GSK. Throughout her career, Ms. Colacot has led quality functions across clinical, research and development, commercial, and regulatory teams. Prior to Bellus Health, she served as Executive Director, Quality Assurance at Quotient Sciences and previously held leadership roles in quality assurance at the International AIDS Vaccine Initiative (IAVI), Antares Pharma Inc., McNeil Consumer Healthcare, and Laureate Pharma Inc/Purdue Biopharma. Ms. Colacot holds an M.S. in Quality Assurance and Regulatory Affairs from the Temple University School of Pharmacy and an M.S. in Biomedical Engineering from the University of Alabama at Birmingham.

About Applied Therapeutics

Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and PMM2-congenital disorder glycosylation (CDG).

To learn more, please visit www.appliedtherapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.

Such risks and uncertainties include, without limitation, (i) our plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating to our competitors and our industry, (xviii) our ability to achieve the anticipated benefits from the agreements entered into in connection with our partnership with Advanz Pharma and (xiv) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investors:
Maeve Conneighton / Andrew Vulis
(212) 600-1902 or
appliedtherapeutics@argotpartners.com

Media:
media@appliedtherapeutics.com

FAQ

What role did Reena Thomas Colacot take at Applied Therapeutics (APLT)?

Reena Thomas Colacot was appointed as Vice President and Head of Quality at Applied Therapeutics, a newly created role where she will oversee all quality matters including Good Manufacturing, Laboratory, and Clinical Practices.

What is Reena Thomas Colacot's experience before joining APLT?

She has over 25 years of quality leadership experience, most recently at Bellus Health, Inc., and previously held leadership roles at Quotient Sciences, IAVI, Antares Pharma, McNeil Consumer Healthcare, and Laureate Pharma/Purdue Biopharma.

What will be Colacot's responsibilities at Applied Therapeutics (APLT)?

She will report to the executive leadership team and Executive Chairman, overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices.

What is Reena Thomas Colacot's educational background?

She holds an M.S. in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy and an M.S. in Biomedical Engineering from the University of Alabama at Birmingham.