aTyr Pharma, Inc.
0.9366-0.03 (-3.32%)
Oct 30, 12:26:15 PM EDT · NasdaqCM · ATYR · USD
Key Stats
Market Cap
91.77MP/E (TTM)
-Basic EPS (TTM)
-0.79Dividend Yield
0%Recent Filings
8-K
Phase 3 misses primary endpoint
aTyr Pharma announced topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis on September 15, 2025, missing the primary endpoint of reducing mean daily oral corticosteroid dose to 2.79 mg versus 3.52 mg for placebo (p=0.3313). Yet, the 5.0 mg/kg dose showed clinical improvement in KSQ-Lung scores (p=0.0479) and higher complete steroid withdrawal with lung function improvement (29.5% vs 14.4%, p=0.0199). The drug proved well-tolerated. aTyr plans FDA engagement to chart next steps, while risks hinge on regulatory feedback.
10-Q
Q2 FY2025 results
aTyr Pharma posted a Q2 net loss of $19.5M, up 20% y/y from $16.3M, driven by higher R&D spend on efzofitimod manufacturing and G&A costs for pre-commercial prep, while other income dipped to $0.8M from $1.0M. YTD, the net loss narrowed to $34.4M from $31.8M, with R&D flat at $27.2M as EFZO-FIT trial costs eased post-enrollment and last patient visit in July 2025, offset by preclinical advances; diluted EPS improved to $(0.39) from $(0.46) on 88.3M shares (derived). Cash and investments swelled to $83.2M from $72.1M at year-end, fueled by $36.7M from ATM offerings, with net operating cash burn slowing to $29.3M from $42.8M; free cash flow not disclosed in the 10-Q. No debt beyond leases, and liquidity covers at least a year. Yet regulatory hurdles loom for efzofitimod's novel pathway in pulmonary sarcoidosis.
8-K
Phase 3 efzofitimod study completes
aTyr Pharma wrapped up the last patient visit in its Phase 3 EFZO-FIT™ study of efzofitimod for pulmonary sarcoidosis, with topline results due mid-September 2025. This milestone advances the lead candidate in interstitial lung disease, while interim Phase 2 data from EFZO-CONNECT™ in scleroderma-related ILD showed stable skin scores and biomarker improvements in eight patients. Cash stood at $83.2 million as of June 30, bolstered by $30.7 million from an ATM offering. Topline data will shape efzofitimod's path forward.
8-K
aTyr Q1 results advance efzofitimod
aTyr Pharma reported Q1 2025 net loss of $14.9 million, with R&D expenses at $11.8 million driving clinical progress on efzofitimod for pulmonary sarcoidosis, where no new treatments have emerged in over 70 years. Topline data from the Phase 3 EFZO-FIT study remains on track for Q3 2025 readout. Cash stood at $78.8 million, funding operations through that milestone. Interim Phase 2 data in scleroderma-ILD arrives Q2.
10-Q
Q1 FY2025 results
aTyr Pharma narrowed its Q1 net loss to $14.9M from $15.5M a year earlier, thanks to a 12% drop in R&D spending to $11.8M as efzofitimod's Phase 3 EFZO-FIT trial wrapped enrollment at 268 patients, with topline data due Q3. Operating expenses fell 6% to $15.8M, while other income dipped to $0.9M on lower cash balances; diluted EPS improved to $(0.17) from $(0.23) on 86.5M shares. Cash and investments stood at $78.8M, bolstered by $18.8M from ATM stock sales, funding operations through at least one year. No revenue hit the books this quarter, unlike $0.2M last year from Kyorin. Yet clinical momentum builds. Enrollment exceeded targets. Regulatory hurdles loom large in uncharted sarcoidosis approvals.
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