aTYR PHARMA INC Files 8-K Report

TL;DR

ATYR files 8-K, check for updates on financials and other events.

AI Summary

On September 15, 2025, aTYR PHARMA INC filed an 8-K report. The filing indicates "Other Events" and "Financial Statements and Exhibits" as key items. The company is incorporated in Delaware and its principal executive offices are located at 10240 Sorrento Valley Road, Suite 300, San Diego, CA 92121.

Why It Matters

This 8-K filing signals that aTYR PHARMA INC has made a significant disclosure to the SEC, potentially impacting investors' understanding of the company's current status and future outlook.

Risk Assessment

Risk Level: low — This filing is a routine disclosure and does not inherently present new risks.

Key Players & Entities

• aTYR PHARMA INC (company) — Registrant
• September 15, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 10240 Sorrento Valley Road, Suite 300 (address) — Principal executive offices
• San Diego, CA 92121 (address) — Principal executive offices
• 001-37378 (company_id) — Commission File Number
• 20-3435077 (tax_id) — IRS Employer Identification No.

FAQ

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share ATYR The Nasdaq Capital M

Filing Documents

• atyr-20250915.htm (8-K) — 73KB
• atyr-ex99_1.htm (EX-99.1) — 14KB
• atyr-ex99_1s1.jpg (GRAPHIC) — 308KB
• atyr-ex99_1s2.jpg (GRAPHIC) — 792KB
• atyr-ex99_1s3.jpg (GRAPHIC) — 481KB
• atyr-ex99_1s4.jpg (GRAPHIC) — 424KB
• atyr-ex99_1s5.jpg (GRAPHIC) — 276KB
• atyr-ex99_1s6.jpg (GRAPHIC) — 319KB
• atyr-ex99_1s7.jpg (GRAPHIC) — 275KB
• atyr-ex99_1s8.jpg (GRAPHIC) — 311KB
• atyr-ex99_1s9.jpg (GRAPHIC) — 361KB
• atyr-ex99_1s10.jpg (GRAPHIC) — 228KB
• atyr-ex99_1s11.jpg (GRAPHIC) — 166KB
• 0001193125-25-202865.txt ( ) — 5627KB
• atyr-20250915.xsd (EX-101.SCH) — 25KB
• atyr-20250915_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On September 15, 2025, aTyr Pharma, Inc. (the "Company") announced topline results from its Phase 3 EFZO-FIT study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid ("OCS") dose at week 48. The change from baseline in mean daily OCS dose reduced to an average of 2.79 mg for 5.0 mg/kg efzofitimod vs 3.52 mg for placebo (p=0.3313). The study's statistical analysis plan was designed on a hierarchical assessment basis, as such since the primary endpoint was not met, all subsequent statistical testing is reported as nominal findings. The study demonstrated a clinical improvement in the King's Sarcoidosis Questionnaire ("KSQ")-Lung score at week 48 for 5.0 mg/kg efzofitimod compared to placebo (p=0.0479), with a responder analysis of patients who achieved complete steroid withdrawal at week 48 with an improved KSQ-Lung score also showing improvement in patients treated with 5.0 mg/kg efzofitimod compared to placebo (p=0.0199). Lung function as measured by forced vital capacity ("FVC") at week 48 was maintained. Based on these findings, which the Company believes indicate drug activity for efzofitimod as evidenced by improvements across multiple clinically relevant efficacy endpoints, the Company plans to engage with the U.S. Food and Drug Administration (FDA) to review the results and determine the path forward for efzofitimod in pulmonary sarcoidosis. EFZO-FIT was a global Phase 3 interventional study in 268 patients with pulmonary sarcoidosis that compared the efficacy and safety of efzofitimod at 3.0 mg/kg and 5.0 mg/kg doses versus placebo after 48 weeks of treatment, which included a protocol guided steroid taper in the first 12 weeks of the study, followed by continued taper or rescue until week 48. Presented below are the families of endpoints analyzed in the study. As the primary e

Forward-Looking Statements

Forward-Looking Statements Certain statements contained in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include, without limitation, statements regarding the potential therapeutic benefits and applications of efzofitimod; potential drug activity for efzofitimod; and plans to engage the FDA to determine a path forward for efzofitimod in pulmonary sarcoidosis as well as the Company's expectations with respect to the outcome of that meeting and next steps for the development of efzofitimod in pulmonary sarcoidosis. Words such as "believes," "plans," "will" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these results will be achieved. Actual results may differ materially from those set forth in this report due to the risks and uncertainties associated with research and development of pharmaceutical product candidates, as well as risks and uncertainties inherent in the Company's business. Additional factors that could cause actual results to differ materially from those stated in or implied by the Company's forward-looking statements are disclosed in its other filings with the U.S. Securities and Exchange Commission, including in the section captioned "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. All forward-looking statements are qualified in their entirety by this cautionary statement. Thi

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 aTyr Pharma, Inc. Corporate Presentation dated September 15, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ATYR PHARMA, INC. By: /s/ Jill M. Broadfoot Jill M. Broadfoot Chief Financial Officer Date: September 15, 2025 4

View Full Filing

View this 8-K filing on SEC EDGAR