Independent data and safety monitoring board (DSMB) recommends continuation of study without any modifications. Findings further support favorable safety profile of efzofitimod. SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE) (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 an independent data and safety monitoring board (DSMB) r ...

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 ...

Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces First Quarter 2024 Results and Provides Corporate Update Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis expected to complete enrollment in the second quarter of 2024. Ended the first quarter 2024 with $87.7 million in cash, cash equivalents, restricted cash and investments. SAN DIEGO – May 2, 2024 – aTyr Pharma, Inc. (Nasdaq: LIFE) ("aTyr" or t ...

Call Start: 17:00 January 1, 0000 5:43 PM ET aTyr Pharma, Inc. (NASDAQ:LIFE) Q4 2023 Earnings Conference Call March 14, 2024, 17:00 ET Company Participants Ashlee Dunston - Director, IR & Corporate Communications Sanjay Shukla - President, CEO & Director Jill Broadfoot - CFO Conference Call Participants Gregory Renza - RBC Capital Markets Joe Pantginis - H.C. Wainwright & Co. Yale Jen - Laidlaw & Company Robert LeBoyer - Noble Capital Markets Operator Good afternoon, ladies and gentlemen, and welcome to the ...

Clinical Development - Efzofitimod is a first-in-class biologic immunomodulator in clinical development for interstitial lung disease (ILD), with orphan drug designations from the FDA for sarcoidosis and systemic sclerosis (SSc) [21] - The Phase 1b/2a clinical trial for efzofitimod demonstrated safety and tolerability across all doses (1.0, 3.0, and 5.0 mg/kg) in 37 patients, with no serious drug-related adverse events [22] - The ongoing EFZO-FIT Phase 3 study aims to enroll up to 264 subjects with pulmonary sarcoidosis, evaluating the efficacy and safety of efzofitimod over 52 weeks [23] - The EFZO-CONNECT study, initiated in Q3 2023, targets SSc-ILD with a planned enrollment of 25 patients, assessing the efficacy of efzofitimod at doses of 270 mg and 450 mg [26] - The DSMB has approved the continuation of the EFZO-FIT study without modifications, with expected enrollment completion in Q2 2024 [24] - The ongoing Phase 3 EFZO-FIT study aims to enroll up to 264 patients with symptomatic pulmonary sarcoidosis, evaluating the efficacy and safety of efzofitimod at doses of 3.0 mg/kg and 5.0 mg/kg [54] - The Phase 1b/2a clinical trial demonstrated that efzofitimod was safe and well-tolerated across all doses, with no serious adverse events reported [62] - In the Phase 1b/2a trial, efzofitimod showed consistent dose response on key efficacy endpoints, including steroid reduction and improvements in lung function [62] - The EFZO-FIT study incorporates a forced steroid taper, aiming to reduce the need for oral corticosteroids in patients [54] - The first patient in the EFZO-FIT study was dosed in September 2022, with enrollment expected to complete by the second quarter of 2024 [56] - The Individual Patient EAP has been initiated to provide access to efzofitimod for patients completing the Phase 3 study [57] - Efzofitimod demonstrated a 58% overall reduction in steroid usage from baseline and a 22% relative reduction compared to placebo in the 5.0 mg/kg treatment group [64] - 33% of patients in the 5.0 mg/kg treatment group achieved and maintained complete steroid taper to 0 mg, while no patients in other groups achieved this [64] - The absolute improvement in FVC at week 24 was 3.3% in the 5.0 mg/kg treatment group compared to placebo, with an improvement of >2.5% considered clinically meaningful [64] - The Phase 2 clinical trial for efzofitimod in COVID-19 patients showed that a single IV dose was generally safe and well-tolerated [66] - The company is currently enrolling subjects in the EZFO-FIT study across the United States, Europe, Brazil, and Japan [184] - The company has established clinical proof-of-concept for efzofitimod in a Phase 1b/2a trial for pulmonary sarcoidosis, but further validation is needed [182] Financial Aspects - The Kyorin Agreement has generated $20 million in upfront and milestone payments, with potential for an additional $155 million upon achieving certain milestones in Japan [27] - The company anticipates continued significant losses as a pre-commercial biotherapeutics entity, relying on collaborations for product development [24] - The global market opportunity for pulmonary sarcoidosis and SSc-ILD is estimated to be between $2 billion and $3 billion [82] - As of December 31, 2023, the company's cash, cash equivalents, restricted cash, and available-for-sale investments totaled approximately $101.7 million, expected to meet material cash requirements for at least one year [213] - The company may need to raise additional capital or enter strategic partnerships to fund operations, with future funding requirements being difficult to forecast [213] - The company anticipates fluctuations in research and development expenses due to the high costs associated with developing therapeutic product candidates [213] Regulatory Considerations - The strategy includes expediting efzofitimod's regulatory approval for pulmonary sarcoidosis based on positive Phase 1b/2a results [31] - The FDA requires a Biologics License Application (BLA) submission that includes comprehensive data from preclinical and clinical studies, including both positive and negative results [115] - The FDA may issue an approval letter or a Complete Response Letter (CRL) after evaluating a BLA, with a CRL indicating that the application is not ready for approval [118] - The company may seek expedited review and accelerated approval programs, such as Fast Track designation, which allows for more frequent interactions with the FDA [120] - Orphan drug designation can be granted for drugs treating rare diseases, providing financial incentives and potential exclusivity for seven years if the product is the first approved for that indication [129] - The company has received orphan drug designation for efzofitimod for the treatment of sarcoidosis and systemic sclerosis in the US and EU, but this may not confer marketing exclusivity in other jurisdictions [201] - Regulatory approvals may be subject to limitations on approved uses and conditions, potentially requiring costly post-marketing studies [208] - The approval process in other jurisdictions may differ significantly from the FDA process, potentially leading to longer timelines for regulatory approval [134] - The company must obtain necessary approvals from foreign regulatory authorities before commencing clinical trials or marketing products in those countries [135] - The FDA may not accept data from clinical trials conducted outside the U.S., which could delay development plans [185] Manufacturing and Supply Chain - The company currently relies on contract development and manufacturing organizations (CDMOs) for the manufacturing and testing of product candidates, including efzofitimod [86] - The CDMO engaged in late 2021 completed its first and second full commercial-scale bulk drug substance GMP runs in 2023, meeting all release specifications [89] - Manufacturing of product candidates must comply with cGMP regulations, and any failure could impact clinical trial supplies [192] - The company is producing efzofitimod in E. coli, which may require complex manufacturing processes not easily adaptable to other candidates [195] - The company relies on third parties for the production of clinical and commercial quantities, which may face compliance issues during FDA inspections [126] Competitive Landscape - The biotechnology and pharmaceutical industries face intense competition, with potential challenges from companies with greater resources [77] - Clinical trial delays could shorten exclusive commercialization rights and allow competitors to bring products to market sooner, adversely affecting the company's business prospects [177] - The company is focusing its R&D efforts on extracellular functions of tRNA synthetase biology, with product candidates like efzofitimod and others derived from DARS and AARS proteins [178] Employee and Operational Considerations - As of December 31, 2023, the company had 59 employees, with 56 being full-time, including 36 in research and development roles [150] - The company operates in a highly competitive biotechnology industry, emphasizing the importance of attracting and retaining talented employees [151] - The company has a Code of Business Conduct and Ethics to ensure core values are upheld throughout its operations [152] - The company emphasizes the importance of employee health and safety, maintaining low occupational injury rates [153] Market and Economic Factors - The company may face significant uncertainty regarding coverage and reimbursement for its products from third-party payors, affecting sales potential [137] - The U.S. government has shown interest in implementing cost containment programs that could reduce the profitability of drug products [139] - The Inflation Reduction Act of 2022 includes provisions that may impact drug pricing and reimbursement, with negotiations for certain high-expenditure drugs starting in fiscal year 2023 [141] - Financial markets experienced volatility due to the Ukraine-Russia conflict, impacting trade and pricing stability globally [219] - The conflict has led to rapidly rising costs of living in Europe, primarily driven by higher energy prices [219] - Ongoing sanctions against Russia may disrupt supply chain continuity and credit availability in Europe and globally [219] - The situation has introduced significant uncertainty into global markets, affecting business operations [219] - The conflict in the Middle East has also resulted in trade disruptions and increased supply chain costs [219] - A weak or declining economy could strain suppliers and manufacturers, potentially disrupting production [219] - The company’s operations may be adversely affected if the Ukraine-Russia conflict escalates further [219] Challenges and Risks - The company faces challenges in patient enrollment due to the limited number of patients with the diseases being studied, which could delay clinical development [172] - The EFZO-FIT study lacks an established FDA regulatory pathway for approval, which may hinder the ability to support FDA approval even if the study is successful [165] - The company has expended significant resources on the discovery and development of product candidates but has not yet completed any human clinical trials demonstrating efficacy to the FDA's satisfaction [164] - Delays in clinical trials could result from various factors, including patient dropout, adverse events, and geopolitical tensions, which may compromise data integrity [163] - The company may need to conduct additional clinical trials if initial results are perceived as negative or inconclusive, delaying marketing approval [161] - The FDA has substantial discretion in the approval process and may require additional trials, which could significantly delay potential regulatory approval [166] - The company may face increased costs and delays in product development if it cannot enroll a sufficient number of eligible patients for clinical trials [176] - Undesirable side effects from product candidates could delay or prevent regulatory approval, impacting market acceptance [187] - The company is subject to ongoing regulatory scrutiny even after obtaining product approvals, which includes compliance with manufacturing and labeling requirements [206] - Any government investigation of alleged violations could require significant resources and negatively impact the company's ability to commercialize products [212]

Exhibit 99.1 IMMEDIATE RELEASE Contact: Ashlee Dunston Director, Investor Relations and Public Affairs adunston@atyrpharma.com aTyr Pharma Announces Fourth Quarter and Full Year 2023 Results and Provides Corporate Update SAN DIEGO – March 14, 2024 – aTyr Pharma, Inc. (Nasdaq: LIFE) ("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 fourth quarter and full year 20 ...

Financial Position - As of September 30, 2023, the company reported an accumulated deficit of $453.3 million and expects to continue incurring net losses for the foreseeable future[78]. - The company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling $105.6 million as of September 30, 2023[78]. - As of September 30, 2023, financing lease liabilities totaled $1.9 million, with $2.7 million in cash collateral included in restricted cash[92]. Revenue and Income - The company has not generated any revenues from product sales to date and anticipates increased expenses related to ongoing clinical development and commercialization efforts[87]. - License and collaboration agreement revenues for Q3 2023 were $0.4 million, unchanged from Q3 2022, consisting of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study[102]. - For the nine months ended September 30, 2023, license and collaboration agreement revenues remained at $0.4 million, consistent with the same period in 2022[105]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2023, was $22.2 million, a decrease from $31.5 million in 2022, primarily due to a $10.0 million milestone payment received from Kyorin[84]. - Net cash used in investing activities for the nine months ended September 30, 2023, was $(37.9) million, compared to $45.2 million in 2022, influenced by timing differences in investment transactions[85]. - Net cash provided by financing activities for the nine months ended September 30, 2023, was $60.2 million, significantly higher than $4.5 million in 2022, mainly from a $48.1 million follow-on public offering[86]. - Total cash and cash equivalents increased by $92,000 as of September 30, 2023, compared to a $18.3 million increase in 2022[84]. - Other income (expense), net rose to $1.2 million in Q3 2023 from $0.2 million in Q3 2022, attributed to higher cash balances and increased interest rates[104]. - Other income (expense), net for the nine months ended September 30, 2023, increased to $3.3 million from $0.6 million in 2022, reflecting higher cash balances and interest rates[106]. Clinical Development - The company received a $10.0 million milestone payment from Kyorin Pharmaceutical in February 2023, following the dosing of the first patient in Japan for the EFZO-FIT study[83]. - The EFZO-FIT study is a 52-week clinical trial enrolling 264 subjects with pulmonary sarcoidosis, with the primary endpoint being steroid reduction[70]. - The company initiated the EFZO-CONNECT study in October 2023, targeting patients with systemic sclerosis-associated interstitial lung disease, with a total of 25 patients to be enrolled[71]. - Research and development expenses are expected to increase as the company advances clinical trials for efzofitimod and other potential therapies[96]. - Research and development expenses increased to $10.3 million in Q3 2023 from $9.9 million in Q3 2022, primarily due to a $1.1 million rise in manufacturing costs and a $0.6 million increase in clinical trial costs[103]. - Research and development expenses for the nine months ended September 30, 2023, were $29.5 million, up from $27.9 million in 2022, driven by a $5.0 million increase in clinical trial costs[106]. General and Administrative Expenses - General and administrative expenses decreased to $2.6 million in Q3 2023 from $3.6 million in Q3 2022, mainly due to a $0.7 million reduction in personnel-related expenses[103]. - General and administrative expenses for the nine months ended September 30, 2023, decreased to $9.8 million from $10.6 million in 2022, primarily due to a $0.8 million reduction in personnel-related expenses[106]. Strategic Focus - The company is actively monitoring the impact of geopolitical and macroeconomic conditions on its operations, including inflation and rising interest rates[74]. - The company is focused on advancing its discovery pipeline for tRNA synthetase-derived therapies, leveraging collaborations and internal research efforts[73]. - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates, necessitating substantial additional funding[89]. Capital Expenditures - The company has incurred $5.6 million in tenant improvement costs for its new corporate headquarters, with an allowance of up to $5.5 million for such improvements[91].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q Washington, D.C. 20549 (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, 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 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-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, 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 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) (Registrant's telephone number, including area c ...

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, 2022 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction of incorporation or organization) 10240 Sorrento Valley Road, Suite 300, San ...