aTyr Pharma, Inc. Q1 FY2022 earnings call

Sanjay Shukla highlighted key points: Efzofitimod clinical program made progress with FDA orphan drug designations for sarcoidosis and systemic sclerosis, positive Endo Phase II meeting with FDA, on track to initiate registrational study in pulmonary sarcoidosis in Q3 2022. Posters for Efzofitimod at ATS and preclinical data for 2810 at AACR were presented. Jill Broadfoot noted the company had a strong cash position of nearly $100 million, clean balance sheet, and support from high-quality investors, positioning the company well for upcoming catalysts.

At the end of the first quarter of 2022, aTyr Pharma had $98.7 million in cash, cash equivalents, and investments. Research and development expenses for the first quarter were $8.9 million, primarily related to product development and manufacturing costs for Efzofitimod and the 2810 programs. General and administrative expenses were $3.5 million. Common shares outstanding were approximately 28.1 million, and fully diluted shares were $29.2 million as of March 31st, 2022.

Plans to initiate a planned registrational study in pulmonary sarcoidosis in the third quarter of 2022. Anticipates presenting clinical data from the Phase 1b/2a study of Efzofitimod at ATS next week and potential publication of a related manuscript. Intends to start a Phase One study of 2810 in cancer patients in the second half of 2022.

Forward-looking statements involve risks and uncertainties as actual results may differ materially. Risks include those related to clinical trial outcomes, regulatory approvals, market acceptance of products, and potential challenges in manufacturing and supply chain management.

Q: Hartaj Singh asked about aspects of Efzofitimod data relevant to unmet need in pulmonary sarcoidosis, protocol design for the registrational trial, and 2810 Phase 1 plans.

A: Sanjay stated details would be outlined at ATS next week, emphasized Efzofitimod's unique effects in steroid reduction and endpoint improvements, and mentioned 2810 plan is being refined.

Q: Zegbeh Jallah inquired about investigator excitement for Efzofitimod, clinical execution, and 2810 manufacturing and combination plans.

A: Sanjay noted fast clinical execution despite COVID, ATS as key for outlining details, and 2810 manufacturing not rate-limited due to early investment, with ongoing work on combinations.

Q: Yale Jen asked about gating factors for scleroderma and FDA impact on 2810 study design.

A: Sanjay said the focus is on the sarcoidosis trial now, but scleroderma is a potential area, and the company is monitoring FDA oncology design trends