Applied Molecular Transport Appoints Industry Veteran Carolyn Finkle as Senior Vice President, Head of Regulatory Affairs
Applied Molecular Transport Inc. (Nasdaq: AMTI) has appointed Carolyn Finkle as the senior vice president and head of regulatory affairs, a key position in the company's leadership team. With over 30 years of regulatory experience, her role will be crucial as AMT anticipates top-line data from four Phase 2 clinical trials of its oral biologic AMT-101 in 2022. The appointment aligns with AMT's strategy to enhance regulatory interactions as it develops products aimed at major markets in mucosal immunology.
- Carolyn Finkle's appointment strengthens AMT's regulatory expertise.
- Finkle has extensive experience that will support AMT's clinical objectives.
- Expectations for top-line data from four Phase 2 trials may attract investor interest.
- Potential concerns about continuity in leadership as the company transitions.
- Regulatory challenges could arise affecting the progress of AMT-101 trials.
Company continues to strengthen key functions and corporate leadership
Company on track to announce top-line data from four ongoing oral AMT-101 Phase 2 trials in 2022
SOUTH SAN FRANCISCO, Calif., March 14, 2022 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the appointment of Carolyn Finkle as senior vice president, head of regulatory affairs. She becomes a member of the AMT executive leadership team, reporting to chief executive officer and co-founder of AMT, Tahir Mahmood, Ph.D.
“We are thrilled to welcome Carolyn as the newest member of the executive leadership team at AMT,” said Dr. Mahmood. “Carolyn’s extensive regulatory experience dovetails with AMT’s focus to develop novel oral biologic products, targeting multi-billion dollar markets, within the areas of mucosal immunology. Her contributions will be instrumental for the company as we anticipate further interactions with global regulatory agencies following our four oral AMT-101 Phase 2 top-line data readouts expected this year.”
Ms. Finkle joins with more than thirty years of experience leading regulatory strategy, product development and product approvals for global biotechnology organizations. Most recently, Ms. Finkle served as chief operating officer and head of regulatory affairs at Medicago. Prior to her role at Medicago, she was the vice president of regulatory affairs at Karyopharm, head of U.S. commercialization and global client partnerships at Kinapse, and senior vice president of regulatory and pharmacovigilance at inVentiv Health. Ms. Finkle also previously held leadership roles in regulatory affairs and product development for Catalent, MedImmune, PAREXEL and Celsion.
Ms. Finkle holds a BSc in Chemistry from the University of Ottawa and an MSc from the University of Toronto. She currently serves as an adjunct lecturer at Georgetown University Graduate School and course co-director for the Pharmaceutical Education and Research Institute (PERI).
“I am excited to be joining AMT, whose breakthroughs in epithelial biology have led to the development of a proprietary active transport technology platform and robust multi-product pipeline,” said Ms. Finkle. “I look forward to contributing to this next phase of growth as AMT works to bring novel oral biologics to patients in need.”
About AMT-101
AMT-101 is a novel GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, currently in development in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelial (IE) barrier with limited entry into the bloodstream, thereby focusing IL-10 at the primary site of inflammation in UC, along the intestinal tissue lamina propria, potentially avoiding the side effects observed with systemic administration.
About Applied Molecular Transport Inc.
AMT is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT’s proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that uses the cell’s own machinery to transport materials across the IE barrier. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local intestinal tissue or enter systemic circulation to precisely address the relevant pathophysiology of disease.
AMT’s headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT’s plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT’s technology platform and the extent to which it may enable the development of new products and AMT’s internal manufacturing capabilities, statements regarding scaling our organization, statements regarding the potential size of the markets for our product candidates, growth of clinical activities, or pipeline expansion, statements regarding the optimization or expansion of our product development plans or the design of future clinical trials, statements regarding the potential of AMT-101, AMT-126, AMT’s respiratory carrier technology or regarding AMT-101 and AMT-126 clinical trials, including the timing of data readouts from such trials, advancing product candidates to future phases of development, and program updates, milestones for such trials, and our ability to replicate past clinical development strategies, statements regarding the potential for AMT’s product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and assumptions regarding the biological mode of action of our product candidates and the potential to avoid side effects with our product candidates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will,” “expect,” “enable,” “likely” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual events, trends or results could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements based on various factors. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in AMT’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission (the “SEC”), and AMT’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Investor Relations Contact:
Andrew Chang
Head, Investor Relations & Corporate Communications
achang@appliedmt.com
Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
FAQ
Who is the new senior vice president at Applied Molecular Transport Inc.?
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