aTyr Pharma(LIFE) - 2024 Q3 - Quarterly Results

Corporate Update and Highlights aTyr Pharma completed Phase 3 EFZO-FIT™ study enrollment and advanced its Phase 2 EFZO-CONNECT™ study, with efzofitimod gaining recognition - Completed enrollment in the global pivotal Phase 3 EFZO-FIT™ study for pulmonary sarcoidosis, with topline data expected in Q3 2025[1][4][5] - Enrollment is ongoing for the Phase 2 EFZO-CONNECT™ study for SSc-ILD, with interim data expected in Q2 2025[6] - A publication in the European Respiratory Journal highlighted efzofitimod's statistically significant difference in time-to-first corticosteroid relapse and improved relapse rate in pulmonary sarcoidosis patients[2][6] - The efzofitimod program was featured in the Best of CHEST Journals session at the CHEST 2024 Annual Meeting, increasing pulmonology community interest[4][6] Third Quarter 2024 Financial Highlights and Cash Position aTyr Pharma reported $68.9 million cash in Q3 2024, raised $19.4 million post-quarter, projecting cash sufficiency through BLA filing - Cash, cash equivalents, restricted cash, and investments totaled $68.9 million as of September 30, 2024[7] - Subsequent to quarter-end, the company raised approximately $19.4 million in gross proceeds from its at-the-market (ATM) offering[7] - The company projects its cash runway is sufficient to fund operations through the filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis[7] Q3 2024 Operating Expenses | Expense Category | Amount (USD) | | :------------------------ | :------------ | | Research & Development | $14.8 million | | General & Administrative | $3.3 million | Financial Statements This section presents aTyr Pharma's unaudited condensed consolidated financial statements, detailing operations and balance sheet Condensed Consolidated Statements of Operations Q3 2024 reported no license revenue, with net loss increasing to $17.3 million from $11.3 million year-over-year due to R&D Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Total Revenues | $0 | $353 | | Research and Development | $14,807 | $10,319 | | General and Administrative | $3,336 | $2,649 | | Loss from Operations | $(18,143) | $(12,615) | | Net Loss Attributable to aTyr | $(17,259) | $(11,340) | | Net Loss Per Share | $(0.23) | $(0.20) | Condensed Consolidated Balance Sheets Total assets decreased to $91.6 million from $120.7 million as of September 30, 2024, with stockholders' equity at $65.1 million Balance Sheet Highlights (in thousands) | Metric | September 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, restricted cash and investments | $68,913 | $101,650 | | Total Assets | $91,616 | $120,653 | | Total Liabilities | $26,477 | $30,183 | | Total Stockholders' Equity | $65,139 | $90,470 | Company and Product Overview aTyr Pharma is a clinical-stage biotech company developing therapies for fibrosis and inflammation using its tRNA synthetase platform, with efzofitimod as its lead ILD candidate About Efzofitimod Efzofitimod is a first-in-class biologic immunomodulator for ILDs, modulating myeloid cells via NRP2 to resolve inflammation and prevent fibrosis - Efzofitimod is a first-in-class biologic immunomodulator for treating interstitial lung disease (ILD)[8] - It selectively modulates activated myeloid cells via neuropilin-2 to resolve inflammation without general immune suppression and potentially prevent fibrosis[8] - Currently under investigation in the global Phase 3 EFZO-FIT™ study for pulmonary sarcoidosis and the Phase 2 EFZO-CONNECT™ study for SSc-ILD[8] About aTyr Pharma aTyr is a clinical-stage biotech company leveraging tRNA synthetase biology and a proprietary discovery platform for fibrosis and inflammation therapies - aTyr is a clinical-stage biotech company that translates tRNA synthetase biology into new therapies for fibrosis and inflammation[9] - The company's discovery platform uses a proprietary library of domains from all 20 tRNA synthetases to uncover novel therapeutic intervention points[9] Forward-Looking Statements This section contains forward-looking statements regarding clinical timelines, efzofitimod's potential, and financial runway, subject to inherent risks - The press release contains forward-looking statements about clinical trial timelines, efzofitimod's potential benefits, and the sufficiency of the company's cash runway[10] - These statements are based on management's current beliefs and assumptions, which are inherently uncertain[10][11] - Actual results may differ due to risks including reliance on third parties, clinical trial delays, regulatory uncertainties, and the need for additional funding[11]