aTyr Pharma (ATYR) Q4 2024 earnings summary

Executive summary

• Completed enrollment in the global phase III EFZO-FIT study for efzofitimod in pulmonary sarcoidosis, the largest interventional study in this indication to date.

• Four positive DSMB reviews for EFZO-FIT with no safety concerns; study continues as designed and topline data expected in Q3 2025.

• Initiated an Expanded Access Program (EAP) for patients completing EFZO-FIT, reflecting strong investigator and patient interest.

• Advanced phase II EFZO-CONNECT study in systemic sclerosis-associated ILD, with interim skin assessment data expected in Q2 2025.

• Published a peer-reviewed manuscript in Science Translational Medicine validating efzofitimod’s mechanism of action.

Financial highlights

• Ended 2024 with $75.1 million in cash, restricted cash, cash equivalents, and investments.

• Raised $18.8 million in gross proceeds post-Q4 via at-the-market offering.

• Research and development expenses totaled $54.4 million; general and administrative expenses were $13.8 million for 2024.

• Collaboration and license revenue from Kyorin agreement was $0.2 million for 2024; over $20 million received to date, with up to $155 million in potential milestones.

• Net loss attributable to aTyr Pharma for 2024 was $64.0 million, with net loss per share of $(0.86).

Outlook and guidance

• Cash runway expected to fund operations for at least one year following phase III EFZO-FIT topline readout, including potential BLA filing.

• Interim EFZO-CONNECT data in Q2 2025 and EFZO-FIT top-line data in Q3 2025.

• Commercial readiness activities underway, including board appointment of an experienced commercial leader.