aTyr Pharma, Inc. Q3 FY2022 earnings call

Sanjay Shukla provided updates including the initiation of EFZO-FIT, a global pivotal Phase 3 study of efzofitimod in pulmonary sarcoidosis with the first patient dosed in September. Highlights also included publication of Phase 1b/2a study results in CHEST, a poster presentation at ERS on NRP2 antibody, FDA Fast Track designation for efzofitimod in systemic sclerosis-related ILD, a research collaboration with Dualsystems Biotech AG, and receipt of a notice of allowance for anti-neuropilin-2 monoclonal antibodies patent. EFZO-FIT study progress was discussed with regulatory approvals in multiple countries and Kyorin's submission in Japan. For preclinical and discovery programs, ATYR2810 was advanced to Phase 1 ready but a strategic decision was made not to initiate Phase 1 study of 2810 this year, exploring non-dilutive avenues.

Focus resources on EFZO-FIT to ensure timely completion. Have a financial and strategic plan to fund operations to EFZO-FIT data readout, utilizing current cash, Kyorin milestones, and equity vehicles.

Forward-looking statements involve risks and uncertainties. Market conditions and potential delays in clinical trial enrollment or execution pose risks.

Q: Concerns about Phase 3 trial site activation, enrollment cadence A: Sanjay stated a fast start expected, with quick regulatory approvals and patient enrollment. Early signs are encouraging Q: Development strategy in scleroderma ILD A: Focus on sarcoidosis initially, looking at neuropilin expression in scleroderma patients Q: EFZO-FIT site activation, patient screening A: Protocol tweaks for easier entry, using HRCT instead of PET scan Q: NRP2 platform utilization A: Pausing 2810 Phase 1 study, partnering with academic centers for rare cancers to progress 2810 Q: Value and pricing of efzofitimod A: Pricing could be similar to IPF drugs, with efzofitimod improving lung function, symptoms, and reducing steroid burden Q: Platform utility and partnerships A: Platform validated, potential partnerships for new targets identified through collaboration with Dualsystems Biotech AG Q: Preclinical study funding A: No contraction in discovery, different strategy for 2810 to save costs and time Q: Japan clinical study details A: ~10% of patients expected from Japan, trial powered appropriately Q: Phase 3 trial statistical plan, timing A: Powered trial, timing estimate around May '24 to early '25, focus on EFZO-FIT Q: Cash runway, 2810 impact A: Cash plan for EFZO-FIT, saving on 2810 clinical costs and time Q: Phase 3 trial site onboard, dropout rate A: Good site uptake, 7-8 patients per arm dropout cushion allowed in power calculations