aTyr Pharma Announces Appointment of Jayant Aphale, PhD, as Vice President of Technical Operations

Rhea-AI Summary

aTyr Pharma (Nasdaq: ATYR) has appointed Jayant Aphale, PhD, as Vice President of Technical Operations. Dr. Aphale will oversee manufacturing activities and implement strategies for commercial manufacturing, supply chain management, and process development. This appointment comes as aTyr prepares for the potential commercialization of its lead candidate, efzofitimod, for pulmonary sarcoidosis.

Key points:

• Pivotal Phase 3 data for efzofitimod expected in Q3 2025
• Commercial manufacturing process validation to begin later this year
• Dr. Aphale brings over 30 years of pharmaceutical industry experience
• He previously worked at Sarepta Therapeutics, GSK Vaccines, and other major companies
• Dr. Aphale received a stock option grant for 150,000 shares as part of his employment package

Positive

• Appointment of experienced executive Dr. Jayant Aphale to oversee critical manufacturing operations
• On track to begin commercial manufacturing process validation later this year
• Pivotal Phase 3 data for lead candidate efzofitimod expected in Q3 2025
• Preparation for potential Biologics License Application (BLA) submission and commercialization

Negative

• None.

SAN DIEGO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or “the Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the appointment of Jayant Aphale, Ph.D., as Vice President, Technical Operations. Dr. Aphale will serve as a member of the Company’s executive leadership team, overseeing manufacturing activities at contract development and manufacturing organizations and implementing strategies related to the continuous improvement of commercial manufacturing, supply chain management, process development of new products and product life cycle management.

“We are pleased to welcome Dr. Aphale, whose extensive experience in successfully implementing technical strategies for innovative therapeutic products at both biotechnology and pharmaceutical companies will be a valuable addition to aTyr,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “As we look towards releasing pivotal Phase 3 data for our lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis in the third quarter of 2025, we are focused on our ongoing preparation for the potential submission of a Biologics License Application (BLA) and subsequent commercialization, including manufacturing efzofitimod at commercial scale. Commercial manufacturing process validation, a critical component of a BLA submission, is on track to begin later this year, and we expect Dr. Aphale to play an instrumental role in helping to ensure the successful delivery of a potential new treatment option to patients in need.”

“I am excited to join aTyr at such an important time for the company as it heads towards the potential commercialization of efzofitimod,” said Dr. Aphale. “I look forward to supporting the company through this next inflection point and playing an integral role in helping to advance the first tRNA synthetase-derived product to market.”

Dr. Aphale has had a long-standing career in the pharmaceutical industry, with more than 30 years of experience encompassing several senior level roles in process development, manufacturing, technical operations and project management functions at both large pharmaceutical and clinical and commercial stage biotechnology companies as well as participation in several successful commercial product launches across multiple modalities. Prior to joining aTyr, Dr. Aphale was Vice President, RNA Manufacturing & Process Development for Sarepta Therapeutics, Inc., where he designed the manufacturing processes and supply chains used to launch and commercialize three rare disease related novel therapies, including EXONDYS™, AMONDYS™ and VYONDYS™, and also focused on clinical and commercial manufacturing. Dr. Aphale has also previously worked at GSK Vaccines, Enobia Pharma, Acambis, Wyeth Vaccines, Diosynth RTP and Roche Diagnostics, among other companies. Dr. Aphale earned a Ph.D. in Microbiology from The Ohio State University and an M.B.A. from the University of North Carolina, Chapel Hill.

In connection with Dr. Aphale’s appointment, the Compensation Committee of aTyr’s Board of Directors granted Dr. Aphale an option to purchase 150,000 shares of aTyr’s common stock with an exercise price of $1.88 per share, which is equal to the closing price per share of aTyr’s common stock as reported on the Nasdaq Capital Market as of August 5, 2024, the effective date of the grant and the start date of Dr. Aphale’s employment. The option is a non-qualified stock option and vests over a period of four years, with 25% vesting on the one year anniversary of the grant date and the remaining 75% vesting on a monthly basis over three years, subject to Dr. Aphale’s continuous employment through each vesting date. This award was granted as an inducement material to Dr. Aphale’s entering into employment with aTyr in accordance with Nasdaq Stock Market Rule 5635(c)(4).

About aTyr

aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as "anticipate," “believes,” “designed,” “can,” “expects,” “intends,” “may,” “plans,” “potential,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding potential therapeutic benefits and applications of efzofitimod; timelines and plans with respect to certain development activities (including the further development and commercialization of efzofitimod, the potential BLA submission, the timing of clinical trials and data releases including the EFZO-FIT™ study, and the timing of commercial manufacturing process validation); the roles we expect Dr. Aphale to perform and his potential impact; and certain development goals. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of efzofitimod, risks associated with clinical trials and their resulting data generally, the risk that we or our partners may cease or delay preclinical or clinical development activities for efzofitimod for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Ashlee Dunston
Director, Investor Relations and Public Affairs
adunston@atyrpharma.com 

FAQ

Who is the new Vice President of Technical Operations at aTyr Pharma (ATYR)?

Dr. Jayant Aphale has been appointed as the new Vice President of Technical Operations at aTyr Pharma (ATYR).

What is Dr. Jayant Aphale's role at aTyr Pharma (ATYR)?

Dr. Aphale will oversee manufacturing activities, implement strategies for commercial manufacturing, supply chain management, and process development as Vice President of Technical Operations at aTyr Pharma (ATYR).

When is aTyr Pharma (ATYR) expecting Phase 3 data for efzofitimod?

aTyr Pharma (ATYR) is expecting to release pivotal Phase 3 data for efzofitimod in pulmonary sarcoidosis in the third quarter of 2025.

What is the status of commercial manufacturing process validation for aTyr Pharma (ATYR)?

Commercial manufacturing process validation for aTyr Pharma (ATYR) is on track to begin later in 2024, which is a critical component of a Biologics License Application (BLA) submission.