aTYR PHARMA INC Q3 FY2021 earnings call

• Third quarter was a major inflection point with clinical proof of concept for ATYR1923 in sarcoidosis, showing safety, tolerability, and efficacy in reducing steroid burden, improving lung function, and symptom measures.
• Announced positive preclinical research on ATYR2810 at the 2021 Society for Immunotherapy in Cancer Annual Meeting, advancing understanding of its mechanism of action.
• Appointed Dr. Robert Ashworth as Vice President of Regulatory Affairs.
• Raised $80.6 million through a public offering in September 2021.
• Details on the Phase Ib/IIa study of ATYR1923 in pulmonary sarcoidosis, including safety, tolerability, steroid sparing effects, lung function improvement, and symptom improvements.
• Plans to advance ATYR1923 to a registrational trial in pulmonary sarcoidosis next year and meet with regulators.
• Discussion on NRP2 as a target for ATYR2810 and other antibodies, with preclinical data supporting its potential in cancer.
• Emphasis on the tRNA synthetase biology platform and its potential for new medicines.

No product segment breakdown by absolute revenue and contribution % provided in the transcript. Financials noted: Cash, cash equivalents and investments as of September 30, 2021, were $116.4 million. Research and development expenses were $5.1 million for Q3 2021. General and administrative expenses were $2.6 million for Q3 2021.

• Plan to initiate a registrational trial for ATYR1923 in pulmonary sarcoidosis next year.
• Working closely with regulators, including the FDA, to discuss data and clinical development path.
• Kyorin Pharmaceutical is ready to join the trial immediately, no delays.
• Finalizing indication selection for ATYR2810's Phase I study in cancer next year, with data from SITC informing development.

• Forward-looking statements involve risks and uncertainties as per the safe harbor provision.
• Risks related to clinical trial outcomes, regulatory approvals, and market acceptance.

Q: Thoughts on partnering ATYR1923 and registrational endpoints?

A: Data is generating interest, partnering not commented on yet, endpoints include steroid reduction, FVC, and symptoms.

Q: Timing of Phase III study with Kyorin and IND for ATYR2810?

A: No delays with Kyorin, IND for ATYR2810 is on track, working on indication selection.

Q: Trial design endpoints and development for other ILDs?

A: Preference for symptom improvement, ready to move into other ILDs after sarcoidosis trial.

Q: Potential for partnering ATYR1923 and timeline for meeting with FDA?

A: Capable of marketing alone, meeting with FDA soon.

Q: Biomarkers for ATYR1923 and trial size/duration?

A: Biomarkers consistent, trial size around 200 patients, duration 9-12 months.

Q: Milestones with Kyorin and CMC for ATYR2810?

A: Milestones tied to development, CMC for ATYR2810 on track with Lonza.