aTyr Pharma(LIFE) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements The company's financial statements show increased assets, continued net losses, and sufficient liquidity, primarily from equity offerings Condensed Consolidated Balance Sheet Data (in thousands) | Balance Sheet Items | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $17,220 | $11,055 | | Total current assets | $87,492 | $81,954 | | Total assets | $101,534 | $96,830 | | Total current liabilities | $15,531 | $14,967 | | Total liabilities | $26,878 | $26,998 | | Total stockholders' equity | $74,656 | $69,832 | | Accumulated deficit | ($566,457) | ($532,046) | Condensed Consolidated Statements of Operations Data (in thousands, except per share data) | Income Statement Items | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $— | $— | $— | $235 | | Research and development | $15,384 | $13,973 | $27,198 | $27,337 | | General and administrative | $4,929 | $3,342 | $8,888 | $6,849 | | Loss from operations | ($20,313) | ($17,315) | ($36,086) | ($33,951) | | Net loss attributable to aTyr | ($19,531) | ($16,306) | ($34,411) | ($31,797) | | Net loss per share, basic and diluted | ($0.22) | ($0.23) | ($0.39) | ($0.46) | Condensed Consolidated Statements of Cash Flows Data (in thousands) | Cash Flow Items | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,314) | ($42,829) | | Net cash (used in) provided by investing activities | ($1,119) | $5,372 | | Net cash provided by financing activities | $36,525 | $21,130 | | Net change in cash, cash equivalents and restricted cash | $6,092 | ($16,327) | - The company has incurred net losses since its inception in 2005, with an accumulated deficit of $566.5 million as of June 30, 2025[26] - Management believes that existing cash, cash equivalents, restricted cash, and available-for-sale investments of $83.2 million as of June 30, 2025, will be sufficient to meet material cash requirements for at least one year from the filing date of this report[28] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage pipeline, financial performance, and funding strategies, with key updates on efzofitimod Overview aTyr Pharma is a clinical-stage biotech advancing efzofitimod for ILD, with Phase 3 data expected soon, and other preclinical candidates - The lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator for treating interstitial lung disease (ILD)[70] - The global pivotal Phase 3 EFZO-FIT study for pulmonary sarcoidosis completed enrollment of 268 subjects in July 2024 and the last patient visit was completed in July 2025, with topline data expected in mid-September 2025[74] - The Phase 2 EFZO-CONNECT study in patients with SSc-ILD is ongoing, with interim data in June 2025 showing clinically important improvement in skin scores for three of four efzofitimod-treated patients[76] - The collaboration with Kyorin for efzofitimod in Japan has generated $20.0 million in payments to date, with up to an additional $155.0 million in potential milestones, plus royalties[77] Liquidity and Capital Resources The company's liquidity, accumulated deficit, and funding sources are discussed, highlighting reliance on equity offerings and changes in cash flow from operations - As of June 30, 2025, the company had cash, cash equivalents, restricted cash, and available-for-sale investments of $83.2 million and an accumulated deficit of $566.5 million[82] - The company sold 8,771,725 shares of common stock for net proceeds of approximately $36.7 million under its ATM Offering Program during the six months ended June 30, 2025[85] Summary of Net Cash Flow (in thousands) | Period | Net Cash Used in Operating Activities | Net Cash (Used in)/Provided by Investing Activities | Net Cash Provided by Financing Activities | | :--- | :--- | :--- | :--- | | Six Months Ended June 30, 2025 | $(29,314) | $(1,119) | $36,525 | | Six Months Ended June 30, 2024 | $(42,829) | $5,372 | $21,130 | - The decrease in net cash used in operating activities in H1 2025 compared to H1 2024 was primarily due to the timing of certain upfront efzofitimod manufacturing payments made in 2024[87] Results of Operations Operating expenses increased in Q2 2025 due to higher R&D and G&A costs, with similar trends for the first six months, and further increases are anticipated Comparison of Operating Expenses for the Three Months Ended June 30 (in thousands) | Expense Category | 2025 | 2024 | Increase / (Decrease) | | :--- | :--- | :--- | :--- | | Total research and development expenses | $15,384 | $13,973 | $1,411 | | Total general and administrative expenses | $4,929 | $3,342 | $1,587 | - The $1.4 million increase in Q2 2025 R&D expenses was primarily due to a $1.0 million increase in manufacturing costs for a potential BLA filing for efzofitimod[107] - The $1.6 million increase in Q2 2025 G&A expenses was mainly due to a $1.2 million increase in personnel and pre-commercialization costs[108] Comparison of Operating Expenses for the Six Months Ended June 30 (in thousands) | Expense Category | 2025 | 2024 | Increase / (Decrease) | | :--- | :--- | :--- | :--- | | Total research and development expenses | $27,198 | $27,337 | ($139) | | Total general and administrative expenses | $8,888 | $6,849 | $2,039 | Quantitative and Qualitative Disclosures About Market Risk The company states that this item is not applicable - Not applicable[116] Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the quarter, with no material changes identified - Based on an evaluation as of the end of the quarter, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[118] - No changes in internal control over financial reporting were identified during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[119] PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings, though it may face routine claims in the ordinary course of business - aTyr Pharma is not a party to any material legal proceedings at this time[121] Risk Factors The company faces significant risks related to clinical trial success, manufacturing, capital requirements, third-party collaborations, and market volatility - The company may face substantial delays in clinical trials and may fail to demonstrate safety and efficacy, particularly for the EFZO-FIT study, as there is no established FDA regulatory pathway for approval of a drug in pulmonary sarcoidosis[123][133] - The company faces risks of manufacturing stoppages and challenges with its CDMOs, which could affect the clinical or commercial manufacture of its product candidates and regulatory activities required for a BLA submission[123][146] - The company has a history of significant losses and will need to raise additional capital to fund operations, which may not be available on favorable terms or at all[123][179] - The company depends on its collaboration with Kyorin for the development and commercialization of efzofitimod in Japan, and if this collaboration is not successful, the market potential may not be realized[126][191] - The market price of the company's common stock has been and is likely to continue to be highly volatile[126][295] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None[345] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[346] Mine Safety Disclosures This item is not applicable to the company - Not applicable[347] Other Information During the quarter, the Chief Financial Officer and General Counsel adopted Rule 10b5-1 trading plans for pre-arranged security sales Executive Trading Arrangements (Rule 10b5-1) | Name and Title | Action | Adoption Date | Total Shares to be Sold (Max) | Expiration Date | | :--- | :--- | :--- | :--- | :--- | | Jill M. Broadfoot, Chief Financial Officer | Adoption | 6/16/2025 | 252,514 | 6/16/2026 | | Nancy E. Denyes, General Counsel | Adoption | 6/13/2025 | 100,000 | 6/13/2026 | Exhibits This section provides an index of exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance and certification documents