Clinical Development and Presentations - The company will present three posters for its lead therapeutic candidate, efzofitimod, at the American Thoracic Society (ATS) 2025 International Conference [1] - The posters include details on the EFZO-FIT trial design, real-world treatment patterns, and the incidence, prevalence, and mortality of pulmonary sarcoidosis in the US [2] - The EFZO-FIT trial is the largest placebo-controlled trial in pulmonary sarcoidosis, with topline data expected in Q3 2025 [1][2] About Efzofitimod - Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD) [3] - It selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent fibrosis progression [3] - The company is investigating efzofitimod in the global Phase 3 EFZO-FIT study for pulmonary sarcoidosis and the Phase 2 EFZO-CONNECT study for systemic sclerosis-related ILD [3] About aTyr - aTyr is a clinical-stage biotechnology company focused on translating tRNA synthetase biology into new therapies for fibrosis and inflammation [4] - The company's discovery platform leverages a proprietary library of domains derived from all 20 tRNA synthetases to uncover novel signaling pathways [4] - Efzofitimod is the lead therapeutic candidate, targeting immune-mediated disorders that cause inflammation and progressive fibrosis in the lungs [4]

SAN DIEGO, Dec. 17, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference, which is scheduled to take place January 13 – 16, 2025, in San Francisco, CA. Details of the presentation appear below: C ...

SAN DIEGO, Dec. 12, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the appointment of Eric Benevich to the Company’s Board of Directors, effective as of December 10, 2024. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc. (Neurocrine). “We are excited to welcome ...

SAN DIEGO, Nov. 15, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the Company will present two posters related to its tRNA synthetase candidate ATYR0101 at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution, which is scheduled to take place December 8 – 11, 2024, ...

Efzofitimod Clinical Development and Trials - The company's lead therapeutic candidate, efzofitimod, has shown positive results in a Phase 1b/2a clinical trial for pulmonary sarcoidosis, with consistent dose response and improvements in key efficacy endpoints compared to placebo[75][76] - The global pivotal Phase 3 EFZO-FIT study for efzofitimod in pulmonary sarcoidosis completed enrollment of 268 patients, exceeding the target of 264, with topline data expected in Q3 2025[77] - The company initiated an Individual Patient Expanded Access Program for efzofitimod, allowing patients who complete the Phase 3 EFZO-FIT study to receive treatment outside the clinical trial[78] - A Phase 2 proof-of-concept study (EFZO-CONNECT) for efzofitimod in SSc-ILD was amended to include a 24-week open-label extension, with interim data expected in Q2 2025[79] Collaboration and Licensing Agreements - The company has a collaboration with Kyorin Pharmaceutical for the development and commercialization of efzofitimod in Japan, generating $20 million in upfront and milestone payments, with potential for an additional $155 million and tiered royalties[80] - Kyorin Agreement milestone payment of $10.0 million triggered by the first patient dosing in Japan for the EFZO-FIT study, recorded as revenue in 2022 and received in February 2023[91] - Total upfront and milestone payments from Kyorin Agreement to date: $20.0 million, with potential for an additional $155.0 million upon achieving development, regulatory, and sales milestones[91] Pipeline and Therapeutic Candidates - The company has identified target receptors for domains of two additional tRNA synthetases, forming the basis of new pipeline candidates[83] - ATYR0101, a fusion protein derived from aspartyl-tRNA synthetase, shows potential for treating multiple fibrotic diseases by inducing apoptosis of myofibroblasts in a TGFβ-dependent manner[84] - ATYR0750, a fusion protein derived from alanyl-tRNA synthetase, is a novel ligand to FGFR4, with potential therapeutic benefits in diseases related to inflammation and fibrosis[85] Financial Performance and Cash Position - As of September 30, 2024, the company had $68.9 million in cash, cash equivalents, restricted cash, and available-for-sale investments, sufficient to meet material cash requirements for at least one year[87] - The company raised $48.1 million in a February 2023 public offering and $21.4 million through an at-the-market offering program in the first nine months of 2024[89][90] - Net cash used in operating activities for the nine months ended September 30, 2024: $56.0 million, primarily due to increased costs for EFZO-FIT and EFZO-CONNECT studies and BLA preparation[92] - Net cash provided by investing activities for the nine months ended September 30, 2024: $23.3 million, driven by timing differences in investment activities[93] - Net cash provided by financing activities for the nine months ended September 30, 2024: $21.0 million, primarily from the issuance of common stock[94] Expenses and Cost Analysis - Research and development expenses expected to increase, primarily driven by clinical development and manufacturing of efzofitimod[106] - Research and development expenses increased to $14.8 million in Q3 2024, up from $10.3 million in Q3 2023, primarily due to a $3.5 million increase in efzofitimod expenses[110] - Efzofitimod expenses rose to $11.9 million in Q3 2024, compared to $8.5 million in Q3 2023, driven by the advancement of the EFZO-FIT study and increased manufacturing efforts[110] - General and administrative expenses increased to $3.3 million in Q3 2024, up from $2.6 million in Q3 2023, mainly due to higher personnel-related costs[111] - Research and development expenses for the nine months ended September 30, 2024, were $42.1 million, up from $29.5 million in 2023, with a $12.5 million increase in efzofitimod expenses[114] - General and administrative expenses for the nine months ended September 30, 2024, were $10.2 million, compared to $9.8 million in 2023, due to higher personnel-related costs and professional fees[115] - Efzofitimod expenses for the nine months ended September 30, 2024, were $34.2 million, up from $21.7 million in 2023, driven by the EFZO-FIT study and manufacturing efforts[119] - Total research and development expenses for the nine months ended September 30, 2024, were $42.1 million, up from $29.5 million in 2023, with a $12.6 million increase[119] Revenue and Other Income - License and collaboration agreement revenues were $0.2 million for the nine months ended September 30, 2024, down from $0.4 million in the same period in 2023[113] - Other income, net decreased to $0.8 million in Q3 2024, down from $1.3 million in Q3 2023, primarily due to a lower cash balance[112] - Other income, net for the nine months ended September 30, 2024, was $3.0 million, slightly down from $3.3 million in 2023, due to a lower cash balance[116] Corporate Operations and Leasing - Corporate headquarters lease base rent: $5.75 per square foot per month for the first 12 months, with annual upward adjustments of approximately 3.0%[100] - Financing lease liabilities as of September 30, 2024: $1.6 million, with $2.2 million in cash collateral included in restricted cash[101] Accounting and Financial Policies - Critical accounting policies and estimates remain consistent with those disclosed in the 2023 Annual Report[109] - General and administrative expenses include salaries, stock-based compensation, and costs for legal, accounting, and patent maintenance[107]

Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces Third Quarter 2024 Results and Provides Corporate Update Enrollment completed in Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis; topline data expected in the third quarter of 2025. Publication in European Respiratory Journal demonstrated statistically significant difference in time-to-first relapse for corticosteroid use and improvement in cort ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37378 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction ...

Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces Second Quarter 2024 Results and Provides Corporate Update Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis enrollment completed with 268 patients; topline data from this 52-week study expected in the third quarter of 2025. Ended the second quarter 2024 with $81.4 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO – Augu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37378 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37378 | --- | --- | |------------------------------------------------------------------------------------------------------------------- ...