ATYR

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Exhibit 99.1

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Second Quarter 2026 Results, Program Prioritization and Corporate Restructuring to Support Efzofitimod Program in ILD

Company awaiting comments from FDA by the end of August 2026 on protocol submitted for planned Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis.

Workforce reduction of approximately 60% and program prioritization conserves capital and aligns resources on efzofitimod program in ILD.

Enrollment completed in Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD; topline results expected in the first quarter of 2027.

Ended the second quarter 2026 with $58.9 million in cash, cash equivalents, restricted cash and investments; cash runway into late 2028 based on current operations.

SAN DIEGO – August 7, 2026 – 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 second quarter 2026 results and a corporate restructuring to prioritize its efzofitimod program in interstitial lung disease (ILD), including pulmonary sarcoidosis and systemic sclerosis (SSc)-related ILD (SSc-ILD).

The program prioritization aims to focus the Company’s resources on advancing its lead asset, efzofitimod, and targeted pipeline development to conserve capital in anticipation of receiving comments from the U.S. Food and Drug Administration (FDA) on the protocol for its planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, a major form of ILD. The Company submitted the protocol in June 2026 and is expecting feedback from the FDA by the end of August 2026.

“We are proactively taking decisive, necessary action to focus our resources on our lead therapeutic candidate, efzofitimod, as we await feedback from the FDA on the protocol we submitted for our planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease. This approach positions aTyr to advance this planned Phase 3 study efficiently and continue completing the Phase 2 EFZO-CONNECT™ study in SSc-ILD,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We remain confident in the potential of efzofitimod to become a meaningful therapy for patients with these forms of ILD, and these changes are essential to our ability to achieve that goal. We are deeply grateful to our dedicated team members for their

outstanding contributions, commitment, and perseverance, including those who have helped advance tRNA synthetase biology over the years.”

Program Prioritization and Corporate Restructuring

• Workforce reduction of approximately 60% will align organizational resources to support the efzofitimod program in ILD in anticipation of comments from the FDA on a protocol submitted for a planned Phase 3 study in pulmonary sarcoidosis and to complete the Phase 2 EFZO-CONNECT™ study in SSc-ILD.

• Jill Broadfoot, aTyr’s Chief Financial Officer (CFO), will step down as of September 30, 2026, and transition to serve as a consultant to the Company. Brandon Yaras, aTyr’s Vice President of Finance, will be appointed as CFO as of October 1, 2026.

• Nancy Denyes, aTyr’s General Counsel, will step down as of September 30, 2026, and transition to serve as a consultant to the Company.

• The Company expects that this restructuring and additional cost saving measures will reduce annualized operating expenses by approximately $13 million, beginning in the fourth quarter of 2026.

Second Quarter 2026 and Subsequent Period Highlights

• Protocol submitted to FDA in June 2026 for planned Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The Company is expecting feedback from the FDA by the end of August 2026. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in forced vital capacity (FVC) at week 48 and the key secondary endpoint will be change from baseline in the King’s Sarcoidosis Questionnaire-Lung score at week 48.

• Enrollment completed in the Phase 2 EFZO-CONNECT™ study to evaluate th

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Exhibit 99.1

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces First Quarter 2026 Results and Provides Corporate Update

Company to continue development of efzofitimod in pulmonary sarcoidosis following Type C meeting with the FDA.

Company plans to submit an IND in June 2026 for a Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as primary endpoint and KSQ-Lung as key secondary endpoint.

On track to complete enrollment in Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD in the first half of 2026.

Ended the first quarter 2026 with $68.3 million in cash, cash equivalents, restricted cash and investments.

SAN DIEGO – May 15, 2026 – 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 first quarter 2026 results and provided a corporate update.

“2026 is off to a productive start, as we now have a clear path forward for efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following our recent Type C meeting with the U.S. Food and Drug Administration (FDA),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Based on feedback from the FDA, we plan to file an investigational new drug (IND) application next month for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as a key secondary endpoint. We look forward to the continued advancement of efzofitimod in this form of ILD where there remains a high unmet medical need.”

First Quarter 2026 and Subsequent Period Highlights

• Announced plans to continue the development of efzofitimod in pulmonary sarcoidosis following a Type C meeting with the FDA to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis. The Company plans to file an IND in June 2026 for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as the primary endpoint of the study and the

KSQ-Lung score as the key secondary endpoint. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48.

• On track to complete enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD) in the first half of 2026. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025.

• Poster related to the Company's investigational new drug candidate, ATYR0101, accepted for presentation at the Extracellular Matrix Pharmacology Congress, which is scheduled to take place June 14 – 17, 2026 in Copenhagen, Denmark. The poster, which is titled, “Natural Asp-tRNA Synthetase Fragment Interacts with LTBP-1 on the ECM Promoting Myofibroblast Apoptosis and Reducing Fibrosis,” presents research indicating that AYTR0101 selectively induces myofibroblast apoptosis via modulation of focal adhesion kinase (FAK) signaling through a novel binding interaction with latent-transforming growth factor beta binding protein 1 (LTBP-1) and results in a significant reduction of fibrosis in lung and kidney models. The poster will be available on the Company’s website once presented.

First Quarter 2026 Financial Highlights and Cash Position

• Cash & I

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aTyr Pharma Advancing tRNA synthetase biology Efzofitimod in Pulmonary Sarcoidosis and Beyond May 11, 2026 © 2026 aTyr Pharma Exhibit 99.1

Forward-Looking Statements The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.  The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” “opportunity,” or “continue,” and other similar expressions are intended to identify forward-looking statements.  For example, all statements regarding: the potential therapeutic benefits of proteins derived from tRNA synthetase genes and our product candidates and development programs; the ability to successfully advance our product candidates and undertake certain development activities (such as the initiation of clinical trials, clinical trial enrollment, the conduct of clinical trials and announcement of clinical results) and accomplish certain development goals, and the timing of such events; the potential market opportunity for our product candidates; our ability to receive regulatory approvals for, and commercialize, our product candidates; our ability to identify and discover additional product candidates; potential activities and payments under collaboration agreements; and the ability of our intellectual property portfolio to provide protection are forward-looking statements. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. These risks, uncertainties and other factors are more fully described in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K, our subsequently filed Quarterly Reports on Form 10-Q, and in our other filings. The forward-looking statements in this presentation speak only as of the date of this presentation and neither we nor any other person assume responsibility for the accuracy and completeness of any forward-looking statement. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. We own various U.S. federal trademark applications and unregistered trademarks, including our company name. All other trademarks or trade names referred to in this presentation are the property of their respective owners. Solely for convenience, the trademarks and trade names in this presentation are referred to without the symbols ® and ™, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involved a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. | © 2026 aTyr Pharma

FDA Type C Meeting Informs Future Efzofitimod Development Background EFZO-FIT missed its primary endpoint but demonstrated a safety profile consistent with previous trials and durable benefit on multiple clinically meaningful, prespecified quality of life measures aTyr was granted a Type C meeting to discuss the EFZO-FIT data, clinical development plan and validation of KSQ-L as a fit-for-purpose endpoint for pulmonary sarcoidosis Discussion focused on: Endpoints (FVC; KSQ-L) Our rationale for FVC as endpoint in target patient population Dosing (Q3W) Safety monitoring Benefit / risk profile FDA Type C Meeting Meeting objective: align on the path forward for efzofitimod in pulmonary sarcoidosis Abbreviations: FDA, Food and Drug Administration; KSQ-L, King’s Sarcoidosis Questionnaire-Lung; FVC, forced vital capacity | © 2026 aTyr Pharma

FDA Type C Meeting Informs Future Efzofitimod Development FDA indicated support for FVC and KSQ-L as clinically meaningful endpoints in pulmonary sarcoidosis FDA indicated FVC to be a direct measure of how patients function FDA indicated KSQ-L to be a dir

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Exhibit 99.1

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Fourth Quarter and Full Year 2025 Results and Provides Corporate Update

Company scheduled to meet with the FDA in mid-April 2026 to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis.

Phase 2 EFZO-CONNECT™ study of efzofitimod in systemic sclerosis-related interstitial lung disease (SSc-ILD) on track to complete enrollment in the first half of 2026.

Ended 2025 with $80.9 million in cash, cash equivalents, restricted cash and investments.

SAN DIEGO – March 5, 2026 – 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 fourth quarter and full year 2025 results and provided a corporate update.

“In 2025 we announced results from our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD) where a significant proportion of patients develop chronic or progressive disease with debilitating symptoms despite current treatment options. This marked an important milestone, not only for the broader sarcoidosis community, but also for aTyr, as it was the Company’s largest and first Phase 3 study of a tRNA synthetase-derived therapy generated from our platform,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

“We are ready and look forward to engaging with the U.S. Food and Drug Administration (FDA) in mid-April to review the results of the study and determine the path forward for efzofitimod in pulmonary sarcoidosis. We plan to provide an update regarding the next steps for the program following the receipt of the official FDA meeting minutes.”

Fourth Quarter 2025 and Subsequent Period Highlights

• Announced the scheduling of a Type C meeting with the FDA in mid-April 2026 to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis. The Company expects to provide an update regarding the outcome of the meeting following the receipt of the official meeting minutes. EFZO-FIT™ was a Phase 3 study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo in 268 patients

with symptomatic pulmonary sarcoidosis. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. Clinical benefit for 5.0 mg/kg efzofitimod was observed across multiple pre-specified study efficacy parameters at week 48 compared to placebo, including the King’s Sarcoidosis Questionnaire (KSQ)-Lung score (p=0.0479), Fatigue Assessment Scale score (p=0.0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196). Additionally, treatment with efzofitimod maintained lung function as measured by forced vital capacity and was well-tolerated with a safety profile consistent with prior trials conducted to date.

• On track to complete enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD) in the first half of 2026. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025.

• Presented a poster related to its investigational new drug candidate, ATYR0101, at the Keystone Symposia on Fibrosis: Cross Organ Pathology and Pathways to Clinical Development. The poster demonstrated that subcutaneous delivery of ATYR0101 yielded a comparable pharmacokinetic and immunogenicity profile, which is favorable to other delivery methods, while reducing lung inflammation. The findings presented in the poster suggest the ability of ATYR0101 to potentially resolve the cycle of chronic inflammation and fibrosis utilizing a novel mechanism and further support a compelling therapeutic profile for patients suffering from fibrosis. The poster is available on the Company’s website.

• Published an article demonstrating the generation of a functional neuropilin-2 (NRP2)/plexinA1 (PLXNA1) bispecific antibody in the Journal of Biological Chemistry. The publication, entitled, “A bispecific antibody designed to act as a NRP2/PLXNA1 agonist mimics anticancer activity of SEMA3F,” demonstrates that the bispecific antibody selectively mimics the benef

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EX-99.1

Exhibit 99.1

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Third Quarter 2025 Results and Provides Corporate Update

Results reported for Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis.

Company plans to meet with the FDA to determine path forward for efzofitimod in pulmonary sarcoidosis in the first quarter of 2026.

Company expects to complete enrollment in Phase 2 EFZO-CONNECT™ study of efzofitimod in systemic sclerosis-related interstitial lung disease (SSc-ILD) in the first half of 2026.

Ended the third quarter 2025 with $92.9 million in cash, cash equivalents, restricted cash and investments.

SAN DIEGO – November 6, 2025 – 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 third quarter 2025 results and provided a corporate update.

“In September, we announced results from our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). While we did not meet the primary endpoint, efzofitimod is the first investigational therapy to exhibit improvements in quality of life across multiple disease-related health outcomes while also reducing steroid burden in patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Treatment options for pulmonary sarcoidosis are limited and can include a significant reliance on the use of oral corticosteroids, which often have significant side effects. There remains an urgent need for a new safe and effective treatment for patients with chronic, symptomatic disease.”

“Based on the findings from EFZO-FIT™, we believe there is drug activity for efzofitimod as evidenced by improvements across multiple clinically relevant efficacy measures. Based on this, coupled with the ongoing high unmet medical need in pulmonary sarcoidosis, we plan to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to review the results of the study and determine the path forward for efzofitimod in pulmonary sarcoidosis. We plan to provide an update regarding the next steps for the program following that meeting.”

Third Quarter 2025 and Subsequent Period Highlights

• Reported results from the global Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo in 268 patients with pulmonary sarcoidosis. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. Clinical benefit for 5.0 mg/kg efzofitimod was observed across multiple pre-specified study efficacy parameters at week 48 compared to placebo, including the King’s Sarcoidosis Questionnaire (KSQ)-Lung score, KSQ-General Health score, Fatigue Assessment Scale, and complete steroid withdrawal and improvement in KSQ-Lung score. Additionally, treatment with efzofitimod maintained lung function as a measure of forced vital capacity and was well-tolerated with a safety profile consistent with prior trials conducted to date. Based on these findings, the Company plans to meet with the FDA in the first quarter of 2026 to review the results and determine the path forward for efzofitimod in pulmonary sarcoidosis.

• Presented the results from the Phase 3 EFZO-FIT™ study in a late-breaking oral abstract at the European Respiratory Society Congress 2025, which took place September 27 – October 1, 2025, in Amsterdam, Netherlands. Daniel Culver, D.O., Chair of the Department of Pulmonary Medicine at the Cleveland Clinic and principal investigator of the study, delivered the presentation, titled “EFZO-FIT: The Largest Ever Interventional Trial in Pulmonary Sarcoidosis.”

• Enrollment is progressing in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025, and the Company expects to complete enrollment in the study in the first half of 2026.

• Presented at the Federation of European Biochemical Societies (FEBS) Special Meeting, “Expanding frontiers in aminoacyl-tRNA synthetase research,” which took place September 28 – October 3, 2025, in Dubrovnik, Croatia. Leslie Nangle, Ph.D., Vice President of Research at aTyr, delive

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EX-99.1

Exhibit 99.1

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Second Quarter 2025 Results and Provides Corporate Update

Last patient visit completed in Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis; topline results expected in mid-September 2025.

SAN DIEGO – August 7, 2025 – 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 second quarter 2025 results and provided a corporate update.

“With the recent completion of the last patient visit in our Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), we are on track to report topline data in mid-September,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This upcoming readout represents a major inflection point for aTyr, our clinical program for efzofitimod in ILD, and the broader sarcoidosis community, and we look forward to sharing the results.”

Second Quarter 2025 and Subsequent Period Highlights

• Completed the last patient visit in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. Topline data from the study are expected in mid-September 2025. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo administered intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis across 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction measured as the absolute change from baseline to week 48. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.

• Announced interim data from the ongoing Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously

monthly for a total of six doses. Enrollment in the study is ongoing, and the study intends to enroll up to 25 patients at multiple centers in the United States. The interim analysis evaluated skin assessments and serum biomarkers at baseline and week 12 for efzofitimod and placebo patients. Eight patients were evaluated, including five with diffuse and three with limited SSc-ILD. Key findings for efzofitimod-treated patients to date included:

o Stable or improved modified Rodnan Skin Score (mRSS), a key measure of skin fibrosis, for all patients and an improvement of 4 points or greater for three out of four efzofitimod-treated patients with diffuse SSc-ILD, where the minimal clinically important difference (MCID) is a 4 to 6 point improvement at 12 months

o Preliminary signals of improvement for inflammatory biomarkers including interferon gamma (IFN-γ) and monocyte chemoattractant protein-1 (MCP-1) and disease biomarkers Krebs von den Lungen-6 (KL-6) and surfactant protein-D (SP-D)

o Efzofitimod was generally safe and well tolerated at all doses, with no treatment related serious adverse events

• Advanced ATYR0101 to investigational new drug (IND) candidate stage for pulmonary fibrosis. ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce cell death of myofibroblasts, which are key cells responsible for driving the progression of fibrosis. The Company anticipates filing an IND application in the second half of 2026.

o Preclinical data generated to date demonstrating ATYR0101’s unique anti-fibrotic mechanism through LTBP-1 were presented in an oral presentation at the American Thoracic Society 2025 Respiratory Innovation Summit

• Announced that the Company was added to the Russell 2000® Index and broad market Russell 3000® Index. These additions were a part of the 2025 Russell U.S. Indexes annual reconstitution.

Second Quarter 2025 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of June 30, 2025, were $83.2 million. Subsequent to the end of the second qu

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Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces First Quarter 2025 Results and Provides Corporate Update

Topline data from Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis on track for the third quarter of 2025.

Blinded baseline demographics and disease characteristics from Phase 3 EFZO-FIT™ study and current U.S. epidemiology and treatment practices for pulmonary sarcoidosis to be presented at ATS 2025.

SAN DIEGO – May 7, 2025 – 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 first quarter 2025 results and provided a corporate update.

“Throughout the first quarter of 2025 we have maintained strong and steady progress with our clinical program for efzofitimod in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “The program’s cornerstone is our Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis, the most prevalent form of ILD for which no new treatments have been approved in more than 70 years. We look forward to reporting topline data from this study next quarter with the hopes of advancing standard of care beyond oral corticosteroids for sarcoidosis patients.”

First Quarter 2025 and Subsequent Period Highlights

• On track to announce topline data in the third quarter of 2025 from the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo administered intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction measured as the absolute change from baseline to week 48. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.

• Enrollment ongoing in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited and diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Patients who complete the study are eligible to participate in a 24-week open-label extension. Interim data from the study are expected in the second quarter of 2025 and will focus on skin assessments measured at baseline and week 12 in approximately eight patients, including patients in both the efzofitimod and placebo arms. The data will include skin histopathology, including immune biomarkers, and the modified Rodnan skin score.

• Appointed Dalia R. Rayes as Head of Commercial, Global Efzofitimod Franchise. Ms. Rayes has over 25 years of experience building and leading commercial organizations at biotechnology and pharmaceutical companies, including leading rare disease product launches. She will serve as a member of the Company’s executive leadership team, overseeing global commercial strategy and operations for the efzofitimod program in ILD, including its lead indication in pulmonary sarcoidosis.

• Posters for efzofitimod accepted for presentation at the upcoming American Thoracic Society (ATS) 2025 International Conference. The conference is scheduled to take place May 16 – 21, 2025, in San Francisco, CA.

• Poster 9320 – Real-World Treatment Patterns Among Pulmonary Sarcoidosis Patients with Parenchymal Involvement in the US on Sunday May 18, 2025, at 11:30 a.m. PDT.

• Poster 6808 – EFZO-FIT, Largest Placebo-Controlled Trial in Pulmonary Sarcoidosis – Trial Design and Patient Characteristics on Monday, May 19, 2025, at 11:30 a.m. PDT.

• Poster 9092 – Incidence, Prevalence, and Mortality of Pulmonary Sarcoidosis with Parenchymal Involvement in the US on Tuesday May 20, 2025, at 11:30 a.m. PDT.

• Presented preclinical data for its neuropilin-2-targeting antibody ATYR2810 at the American Association for Cancer Research (AACR) Annual Meeting 2025. The findings from the research, which was conducted in collaboration with Michael Lim, M.D., Chair of the Depart

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Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Sr. Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Fourth Quarter and Full Year 2024 Results and Provides Corporate Update

Topline data from Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis expected in the third quarter of 2025.

Fourth positive DSMB review for efzofitimod in Phase 3 EFZO-FIT™ study reinforces its favorable safety profile.

Publication in Science Translational Medicine validates efzofitimod’s mechanism of action.

Company to host conference call and webcast today, March 13th at 5:00 p.m. EDT / 2:00 p.m. PDT.

SAN DIEGO – March 13, 2025 – 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 fourth quarter and full year 2024 results and provided a corporate update.

“2024 was an important year for aTyr, as we completed enrollment in our global pivotal Phase 3 EFZO-FIT™ study, which is the largest interventional study ever to be conducted in pulmonary sarcoidosis, a disease where incidence and prevalence are rising yet there are still limited treatment options,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “The stage is set for 2025 to be a potential milestone year as we look toward reporting topline data for EFZO-FIT™ in the third quarter. Leading into this pivotal readout, we are very pleased with the execution of the study to date and the continued favorable safety profile demonstrated for efzofitimod, including our most recent positive DSMB review, which recommended the study continue as designed. Efzofitimod is poised to potentially become a safe and effective alternative to the current standard of care and improve patients’ lives.”

Fourth Quarter 2024 and Subsequent Period Highlights

• Enrollment complete in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in nine countries.

The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Topline data from the study are expected in the third quarter of 2025. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.

• Held a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the statistical analysis plan (SAP) for the Phase 3 EFZO-FIT™ study. The main objective of the meeting was to finalize the way in which the study endpoints are assessed from a statistical standpoint. Based on FDA feedback, steroid reduction will be measured as the absolute change from baseline to week 48.

• Announced the fourth positive data and safety monitoring board (DSMB) review for the Phase 3 EFZO-FIT™ study. The independent DSMB recommended that the study continue without modifications based on the pre-planned analysis.

• Enrollment ongoing in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited and diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Patients who complete the study are eligible to participate in a 24-week open-label extension. Interim data from the study are expected in the second quarter of 2025 and will focus on skin assessments measured at baseline and week 12 in approximately 8 patients, including patients on drug and placebo. The data will include skin histopathology, including immune biomarkers, and the modified Rodnan skin score.

• Manuscript demonstrating the immunomodulatory activity for efzofitimod in lung inflammation and fibrosis published in the peer-reviewed journal Science Translational Medicine. The publication describes efzofitimod’s unique anti-inflammatory effect on macrophages through neuropiln-2 (NRP2) and details the preclinical data supporting its development. The publication, which is entitled, “A human histidyl-tRNA synthetase spli

EX-99.1

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EX-99.1

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 corticosteroid relapse rate for efzofitimod.

SAN DIEGO – November 7, 2024 – 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 third quarter 2024 results and provided a corporate update.

“We achieved a significant milestone this quarter by completing enrollment in our global pivotal Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis and topline data is expected in the third quarter of 2025,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Additionally, our efzofitimod program was featured in this year’s Best of CHEST Journals session at the CHEST 2024 annual meeting and we recently published favorable steroid relapse data for efzofitimod in the European Respiratory Journal. These events have generated increased interest in efzofitimod and the potential promise it holds to be a transformative therapy for patients.”

Third Quarter 2024 and Subsequent Period Highlights

• Completed enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in nine countries, which exceeded the targeted enrollment. Topline data from the study are expected in the third quarter of 2025. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program (EAP).

• Continued enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the United States. Patients who complete the study and wish to receive ongoing treatment with efzofitimod are eligible to participate in a 24-week open-label extension (OLE). Interim data from the study are expected in the second quarter of 2025.

• Publication demonstrating the efficacy of efzofitimod in pulmonary sarcoidosis published in the European Respiratory Journal. Findings from a post hoc analysis of the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis demonstrated a statistically significant difference in time-to-first relapse for corticosteroid use and improvement in corticosteroid relapse rate in therapeutic (3.0 and 5.0 mg/kg efzofitimod) versus subtherapeutic (1.0 mg/kg efzofitimod and placebo) groups. The publication, entitled, “Therapeutic Doses of Efzofitimod Demonstrate Efficacy in Pulmonary Sarcoidosis,” is available on the Journal’s website and can be accessed at: https://openres.ersjournals.com/content/early/2024/07/18/23120541.00536-2024.

• Efzofitimod for pulmonary sarcoidosis featured in the Best of CHEST Journals session at the CHEST 2024 Annual Meeting. The session featured recent data and publications that generated significant interest and readership among the pulmonology community. Dr. Daniel A. Culver, Chair of the Department of Pulmonary Medicine at Cleveland Clinic, presented data from the Phase 1b/2a study published in CHEST, the post hoc analysis on corticosteroid steroid relapse published in the European Respiratory Journal with further elucidation on efzofitimod’s mechanism of action.

Third Quarter 2024 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, cash equivalents, restricted cash and investments as of September 30, 2024, were $68.9 million. Subsequent to the end of the third quarter 2024, the Company raised approximately $19.4 million in gross proceeds from its at-the-market (ATM) offering with Jefferies LLC, before deducting commission

EX-99.1

2 atyr-ex99_1.htm

EX-99.1

EX-99.1

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 – August 13, 2024 – 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 second quarter 2024 results and provided a corporate update.

“The second quarter of 2024 was a milestone quarter for aTyr, as we completed enrollment in our global pivotal Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This landmark study is the largest interventional study ever to be conducted in sarcoidosis and presents an opportunity to deliver a potentially transformative therapy to sarcoidosis patients who have been waiting more than 60 years for a new drug to be approved for this disease. We look forward to releasing topline data from this study in the third quarter of 2025.”

Second Quarter 2024 and Subsequent Period Highlights

• Completed enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in 9 countries, exceeding the targeted enrollment. Topline data from the study are expected in the third quarter of 2025. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program (EAP).

• Continued enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with systemic sclerosis (SSc, or scleroderma)-related

ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the U.S. Patients who complete the study and wish to receive ongoing treatment with efzofitimod are eligible to participate in a 24-week open-label extension (OLE), which was recently incorporated into the study protocol. Based on current enrollment projections, the Company expects to report interim data from the study in the second quarter of 2025.

• Presented a poster describing efzofitimod’s mechanism of action at the American Thoracic Society (ATS) 2024 International Conference. The findings further demonstrated that neuropilin-2 (NRP2), efzofitimod’s binding partner, is an important new immune target in ILD and that efzofitimod modulates myeloid cells to confer its anti-inflammatory benefit.

• Entered into a research agreement with Stanford Medicine to explore the role of the Company’s anti-NRP2 antibodies in glioblastoma multiforme (GBM). Michael Lim, M.D., Chair of the Department of Neurosurgery at Stanford Medicine, will serve as the principal investigator for the study, which aims to explore the role anti-NRP2 antibodies in combination with chemotherapy to evaluate their role in reversing immune evasion in GBM, the most common type of primary brain cancer.

• Appointed Jayant Aphale, Ph.D., as Vice President, Technical Operations. Dr. Aphale has more than 30 years of experience working in technical operations and manufacturing for novel therapeutic and vaccine products at biotechnology and pharmaceutical companies. Dr. Aphale will serve as a member of the Company’s executive leadership team, overseeing manufacturing activities at contract development and manufacturing organizations and implementing strategies related to the continuous improvement of commercial manufacturing, supply chain management, process development of new products and product life cycle management.

Second Quarter 2024 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, cash equivalents, restricted cash and investments as of June 30, 2024, were $81.4 million.

• R&D Expenses: Research an

EX-99.1

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EX-99.1

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 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 first quarter 2024 results and provided a corporate update.

“During the first quarter of 2024 we continued to execute on our two clinical studies for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We are pleased with the study conduct and quality to date for our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD with high unmet medical need, and we look forward to completing enrollment in this study, which is anticipated this quarter.”

First Quarter 2024 and Subsequent Period Highlights

• Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 patients with pulmonary sarcoidosis. The study is currently enrolling at more than 90 centers in 9 countries. Based on current enrollment projections, the Company anticipates completing enrollment in the study in the second quarter of 2024. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program (EAP).

• Continued enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly

for a total of 6 doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the U.S.

• Presented a poster on ATYR0750 at the Gordon Research Conference Fibroblast Growth Factors in Development and Disease. The poster demonstrated that the alanyl-tRNA synthetase fragment that forms ATYR0750 binds selectively to FGFR4 and induces morphological changes and downstream signaling in liver cells with functional similarities to FGF2.

• Poster for efzofitimod to be presented at the upcoming American Thoracic Society (ATS) 2024 International Conference. The conference is scheduled to take place May 17 – 22, 2024, in San Diego, CA.

• Poster 8837 – Efzofitimod is an Immunomodulator of Myeloid Cell Function and Novel Therapeutic Candidate for Interstitial Lung Diseases on Sunday, May 19, 2024, at 2:15 p.m. PDT.

First Quarter 2024 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, cash equivalents, restricted cash and investments as of March 31, 2024, were $87.7 million. Based on the Company’s current operational plans and existing cash, the Company maintains its prior guidance and believes its cash runway will be sufficient to fund the Company’s operations through the filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis.

• R&D Expenses: Research and development expenses were $13.4 million for the first quarter 2024, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT™ and Phase 2 EFZO-CONNECT™ studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.

• G&A Expenses: General and administrative expenses were $3.5 million for the first quarter 2024.

• Collaboration and License Revenue: Collaboration and license revenue related to the Kyorin Agreement was $0.2 million for the first quarter of 2024, which consisted of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT™ study.

About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derive

EX-99.1

2 life-ex99_1.htm

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EX-99.1

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

Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis anticipated to complete enrollment in the second quarter of 2024.

Company launches Individual Patient Expanded Access Program (EAP), allowing access to efzofitimod for patients who complete EFZO-FIT™.

Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD currently enrolling.

Ended 2023 with $101.7 million in cash, cash equivalents and investments.

Company to host conference call and webcast today, March 14th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

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 2023 results and provided a corporate update.

“Throughout 2023 we made meaningful progress with our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Our primary focus for 2024 is completing enrollment in our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, which is anticipated in the second quarter.”

“We ended 2023 with more than $100 million in cash, restricted cash, cash equivalents and investments. Based on our current cash position and operational plans, we believe our financial resources are sufficient to fund the Company’s operations through the filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis."

Fourth Quarter 2023 and Subsequent Period Highlights

• Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12

doses. The study intends to enroll up to 264 patients with pulmonary sarcoidosis. The study is currently enrolling at more than 90 centers in 9 countries. A positive data and safety monitoring board review assessed that the study could continue unmodified. Based on current enrollment projections, the Company anticipates completing enrollment in the study in the second quarter of 2024.

• Announced an Individual Patient Expanded Access Program (EAP) for efzofitimod for patients with pulmonary sarcoidosis. The EAP has been initiated based on blinded EFZO-FIT™ study investigator and patient participant feedback. The program is designed to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.

• Continued enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the U.S.

• Poster for efzofitimod accepted for presentation at the upcoming American Thoracic Society (ATS) 2024 International Conference. The conference is scheduled to take place May 17 – 22, 2024, in San Diego, CA.

o Poster 8837 – Efzofitimod is an Immunomodulator of Myeloid Cell Function and Novel Therapeutic Candidate for Interstitial Lung Diseases on Sunday, May 19, 2024, at 2:15 p.m. PDT.

• Presented two posters highlighting the importance of neuropilin-2 (NRP2) in immune regulation at the Keystone Symposia on Myeloid Cell Diversity. The findings further demonstrate that efzofitimod modulates myeloid cells via the NRP2 receptor to promote a unique anti-inflammatory mechanism and validates the role of NRP2 in the immune system by the activity of an NRP2 blocking antibody in preclinical models.

• Announced Wayne A. I. Frederick, M.D., President Emeritus of Howard University, as an advisor to the Company. Dr. Frederick is a distinguished physician executive with extensive knowledge on disparities in healthcare and will advise the Company on its efzofitimod program in ILD.

• Poster for ATYR0750 accepted for presentation at the upcoming Gordon Research Conference Fibroblast Growth Factors in Development and Disease. The conference is scheduled to take place March 24 – 29, 2024, in Galveston, TX.

EX-99.1

2 life-ex99_1.htm

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EX-99.1

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Third Quarter 2023 Results and Provides Corporate Update

Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis expected to complete enrollment early in the second quarter of 2024.

Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD initiated patient dosing.

Ended the third quarter of 2023 with $105.6 million in cash, cash equivalents and investments.

SAN DIEGO – November 9, 2023 – 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 third quarter 2023 results and provided a corporate update.

“During the third quarter we made meaningful progress with our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We had a positive data and safety monitoring board (DSMB) review for our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD with high unmet medical need. This study continues to enroll in the U.S., Europe and Japan and based on current projections, we expect to complete enrollment in this study early in the second quarter of 2024. Additionally, we dosed the first patient in our Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD), which is currently enrolling in the U.S.”

Third Quarter 2023 and Subsequent Period Highlights

• Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis. The study is open for enrollment at nearly all of the centers intended in the U.S., Europe and Japan and is expected to

1

expand to include centers in Brazil. Based on current enrollment projections, the Company expects to complete enrollment in the study early in the second quarter of 2024.

• Completed a positive DSMB review for the Phase 3 EFZO-FIT™ study. Data from the pre-planned, interim analysis of the safety and tolerability of efzofitimod in patients with pulmonary sarcoidosis, which included the evaluation of patients who completed treatment, was evaluated. There were no drug-related serious adverse events, consistent with prior studies. The DSMB assessed that the study could continue unmodified and that the drug does not pose any undue risk to the patient that warrants additional safety measures.

• Dosed the first patient in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll 25 patients at multiple centers in the U.S. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimod on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD.

• Peer-reviewed article for efzofitimod published in the journal Frontiers in Pharmacology. The publication, titled, “Exposure-response analyses of efzofitimod in patients with pulmonary sarcoidosis,” highlights a positive exposure response demonstrated by efzofitimod across multiple clinically relevant endpoints in the Phase 1b/2a study in patients with pulmonary sarcoidosis.

• Presented two posters for efzofitimod at the European Respiratory Society (ERS) International Congress 2023. The posters presented new data from a pooled, post hoc analysis from the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis that further demonstrates efficacy and findings that identify the expression of neuropilin-2 (NRP2), efzofitimod’s binding partner, in the skin of patients with SSc-ILD.

• Poster for efzofitimod accepted for presentation at the upcoming American College of Rheumatology (ACR) Convergence 2023. The conference is scheduled to take place November 10 – 15, 2023, in San Diego, CA. The poster presents new data demonstrating the effects of efzofitimod in preclinical models of rheumatoid arthritis (RA) and RA-associated lung fibrosis.

o Poster 1322 – Efzofitimod, a First-in-Class NRP2-targeting Immunomodulator, Amelior

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2 life-ex99_1.htm

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EX-99.1

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Public Affairs

adunston@atyrpharma.com

aTyr Pharma Announces Second Quarter 2023 Results and Provides Corporate Update

Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis currently enrolling in the U.S., Europe and Japan.

Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD expected to initiate in the third quarter of 2023.

Ended the second quarter of 2023 with $112.0 million in cash, cash equivalents and investments.

SAN DIEGO – August 9, 2023 – aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter 2023 results and provided a corporate update.

“Throughout the second quarter we have continued to progress and invest in our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, the most prevalent form of ILD, continues to enroll and our Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-associated ILD (SSc-ILD), is expected to enroll the first patient in the third quarter.”

Second Quarter 2023 and Subsequent Period Highlights

• Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis. The study is open for enrollment at nearly all of the centers intended in the U.S., Europe and Japan and is expected to expand to include centers in Brazil.

• Progressed plans to initiate the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study will be a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts

1

randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study is expected to enroll 25 patients at multiple centers in the U.S. The primary objective of the study will be to evaluate the efficacy of multiple doses of intravenous efzofitimod on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. The study is expected to initiate in the third quarter of 2023.

• Received European Commission orphan drug designation for efzofitimod for the treatment of SSc based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. The EMA grants orphan status to products intended for the treatment, prevention or diagnosis of a disease with a prevalence no more than five in 10,000 people in the EU that is life-threatening or chronically debilitating for which either no satisfactory method of diagnosis, prevention, or treatment exists, or if such a method exists, the medicine is of significant benefit to those affected by such condition. EMA orphan drug designation provides certain benefits, including the potential for up to 10 years of marketing exclusivity following regulatory approval in the EU, reduction in regulatory fees and a centralized EU approval process.

• Announced two posters for efzofitimod accepted for presentation at the upcoming European Respiratory Society (ERS) International Congress 2023. The conference is scheduled to take place September 9 – 13, 2023, in Milan, Italy. The Company will present new data from a pooled, post hoc analysis from the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis that further supports efficacy measures in these patients. Additionally, new mechanistic data supports the rationale for efzofitimod as a potential treatment for patients with SSc-ILD.

o Poster PA419 – Efzofitimod: A Novel Therapeutic Candidate for SSc-ILD on Sunday, September 10, 2023, from 8:00 a.m. to 9:30 a.m. CEST.

o Poster PA1744 – Therapeutic Doses of Efzofitimod Significantly Improve Multiple Pulmonary Sarcoidosis Efficacy Measures on Sunday, September 10, 2023, from 4:00 p.m. to 5:30 p.m. CEST.

Second Quarter 2023 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, restricted cash, cash equivalents and investments as of June 30, 2023, were $112.0 million. Based on the Company’s current operational plans and existing cash, the Company maintains its prior guidance and believes its cash runway will extend into 2026.

• R&

EX-99

2 life-ex99_1.htm

EX-99.1

EX-99

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

adunston@atyrpharma.com

aTyr Pharma Announces First Quarter 2023 Results and Provides Corporate Update

Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis currently enrolling in the U.S., Europe and Japan.

Phase 2 proof-of-concept study of efzofitimod in patients with SSc-ILD expected to initiate in the third quarter of 2023.

Company to host multiple presentations for efzofitimod at the upcoming American Thoracic Society (ATS) 2023 International Conference.

February follow-on common stock offering generated $48.1 million in net proceeds.

Ended the first quarter 2023 with $117.6 million in cash, cash equivalents and investments.

SAN DIEGO – May 9, 2023 – aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced first quarter 2023 results and provided a corporate update.

“We are pleased with the start to the year and the progress we have made with our efzofitimod clinical development program for interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, the most prevalent form of ILD, continues to enroll in the U.S., Europe and Japan, and we are on track with our plans to initiate a Phase 2 study in patients with systemic sclerosis (SSc, or scleroderma)-associated ILD (SSc-ILD), a major form of connective tissue disease-related ILD, in the third quarter of this year.”

“We finished the first quarter of 2023 with $117.6 million in cash, cash equivalents and investments. With our current cash position and the opportunity for additional milestone payments from our partner Kyorin Pharmaceutical Co., Ltd., we believe we are well capitalized to complete and read out our two efzofitimod clinical trials.”

First Quarter 2023 and Subsequent Period Highlights

• Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized,

1

double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis. Enrollment is in progress at centers in the U.S., Europe and Japan.

• Progressed plans to initiate a Phase 2 proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This study will be a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study is expected to enroll 25 patients at multiple centers in the U.S. The primary objective of the study will be to evaluate the efficacy of multiple doses of intravenous efzofitimod on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. The study is expected to initiate in the third quarter of 2023.

• Announced the publication of the first review article for efzofitimod in the peer-reviewed journal Sarcoidosis, Vasculitis and Diffuse Lung Diseases. In the article, titled, “Efzofitimod: a novel anti-inflammatory agent for sarcoidosis,” the authors, led by Robert P. Baughman, M.D., Professor of Medicine at the University of Cincinnati Medical Center, describe the mechanism for efzofitimod as it relates to the granulomatous inflammation central to the pathophysiology of sarcoidosis and review the preclinical and clinical data generated for efzofitimod that support its anti-inflammatory properties and the potential for it to be a novel therapeutic approach to immune-mediated fibrotic lung diseases such as pulmonary sarcoidosis.

• Announced multiple presentations for efzofitimod at the upcoming American Thoracic Society (ATS) 2023 International Conference. The conference is scheduled to take place May 19 – 24, 2023, in Washington, D.C.

o Respiratory Innovation Summit – Showcase Five: Fibrosis Innovators on Saturday, May 20, 2023, at 3:45 p.m.

o Mini Symposium 9209 – Efzofitimod, a Novel Immunomodulator for Pulmonary Sarcoidosis, Modulates Patient Inflammatory Responses Through Myeloid Cells on Monday, May22, 2023, at 3:15 p.m.

o Thematic Poster P645 – Exposure-Efficacy Analysis Supports Proof of Concept for Efzofitimod in Pulmonary Sarcoidosis on Tuesday, May 23, 2023, from 11:30 a.m. to 1:15 p.m.

o Industry Theater Presentation – Efzofitimod: An Emerging Treatment for Sarcoidosis? on Tuesday, May 23, 2023, at 1:30 p.m.

2

Fi

EX-99

2 life-ex99_1.htm

EX-99.1

EX-99

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

adunston@atyrpharma.com

aTyr Pharma Announces Fourth Quarter and Full Year 2022 Results and Provides Corporate Update

Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis enrolling in the U.S., Europe and Japan.

Phase 2 proof-of-concept study of efzofitimod in patients with SSc-ILD expected to begin in 2023.

February 2023 follow-on common stock offering of approximately $52.0 million in gross proceeds.

Company to host conference call and webcast today, March 9th, at 5:00 p.m. EST / 2:00 p.m. PST.

SAN DIEGO – March 9, 2023 – aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the "Company”), a biotherapeutics 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 2022 results and provided a corporate update.

“2022 was an important year for aTyr as we advanced our lead therapeutic candidate, efzofitimod, to a global pivotal Phase 3 study in patients with pulmonary sarcoidosis, the most prevalent form of interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This study, which is known as EFZO-FIT™, is expected to be the largest interventional study in sarcoidosis to date and is currently enrolling patients at multiple centers in the U.S., Europe and Japan.”

“We are also expanding the clinical development program for our novel immunomodulator efzofitimod with plans to initiate a Phase 2 proof-of-concept study in patients with systemic sclerosis (SSc, or scleroderma)-associated ILD (SSc-ILD) this year, which increases the potential market opportunity in these forms of ILD with high unmet medical need. As a result of program prioritization and proceeds from a recent public offering, we project that we will have sufficient cash to fund both of our efzofitimod clinical trials and the company's operations into 2026. We are very proud of our progress and look forward to the year ahead as we continue our pursuit to develop a new class of medicines.”

Fourth Quarter 2022 and Subsequent Period Highlights

• Continued enrollment in EFZO-FIT™, a global pivotal Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either

1

3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis and is currently enrolling at multiple centers in the U.S., Europe and Japan.

• Kyorin Pharmaceutical Co., Ltd. (Kyorin), aTyr’s partner for the development and commercialization of efzofitimod for ILD in Japan, dosed the first patient in Japan in EFZO-FIT™. This achievement triggered a $10.0 million milestone payment to aTyr in the fourth quarter. Under the collaboration and license agreement with Kyorin, aTyr has received $20.0 million in upfront and milestone payments to date and is eligible to receive up to an additional $155.0 million in the aggregate upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalties on any net sales in Japan. Kyorin has the exclusive rights to develop and commercialize efzofitimod in Japan for all forms of ILD.

• Announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This is expected to be a 28-week study with three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. It is expected that the study will enroll 25 patients with progressive disease who are currently receiving background mycophenolate therapy at multiple centers in the U.S. The primary objective of the study will be to evaluate the efficacy of multiple doses of intravenous efzofitimod on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. The Company plans to initiate this study in 2023.

• Received European Union (EU) orphan drug designation for efzofitimod for the treatment of sarcoidosis from the European Commission based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. To qualify for EMA orphan status, a product must, among other things, be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating for which either no satisfactory method of diagnosis, prevention or treatment exists, or if such method exists, the medic

EX-99.1

2 life-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

adunston@atyrpharma.com

aTyr Pharma Announces Third Quarter 2022 Results and Provides Corporate Update

First patient dosed in Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis; multiple centers in the U.S. are open for enrollment.

Company to prioritize resources towards largest value driver efzofitimod program.

Ended the third quarter 2022 with $79.6 million in cash, restricted cash, cash equivalents and investments.

Company to host conference call and webcast today, November 10th, at 5:00 p.m. EST / 2:00 p.m. PST.

SAN DIEGO – November 10, 2022 – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2022 results and provided a corporate update.

“The third quarter saw the initiation of EFZO-FIT™, a global pivotal Phase 3 study of our lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, the most prevalent form of interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Given current market conditions, we intend to focus our resources on the EFZO-FIT™ study, which is our largest value driver, to ensure a timely and successful completion of this study.”

“As part of this prioritization, we have made the strategic decision not to use internal resources to initiate a Phase 1 study of ATYR2810 this year. The data we have generated for ATYR2810 firmly support its therapeutic potential in rare aggressive tumors, thus we intend to pursue alternative non-dilutive funding avenues, including academic collaborations, to advance this program.”

Third Quarter 2022 and Subsequent Period Highlights

• Dosed the first patient in EFZO-FIT™, a global pivotal Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study is currently enrolling and intends to enroll up to 264 subjects with pulmonary sarcoidosis at multiple centers in the U.S., Europe and Japan.

1

• Announced the publication of results of the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis in the peer-reviewed medical journal CHEST. The study demonstrated that efzofitimod was safe and well-tolerated at all doses and exhibited a consistent dose response on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

• Received U.S. Food and Drug Administration (FDA) Fast Track designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma)-associated ILD. Fast Track designation helps facilitate development and expedite the review of drugs to treat serious or life-threatening diseases with unmet medical need. Fast Track designation provides certain benefits, including enhanced interactions with the FDA throughout the development program, as well as eligibility for accelerated approval, priority review and rolling review.

• Presented a poster at the European Respiratory Society International Congress 2022 on findings for an antibody for immunohistochemical detection of neuropilin-2 (NRP2) protein, efzofitimod’s binding partner, in patient tissue samples. The antibody may provide a useful tool for patient selection or stratification for sarcoidosis, other ILD, oncology or other indications where NRP2 is implicated.

• Completed IND-enabling activities and received a notice of allowance for a patent for ATYR2810, a fully humanized monoclonal antibody targeting NRP2, in preclinical development for cancer.

• Announced a research collaboration with Dualsystems Biotech AG, a company specializing in custom proteomics, aimed at accelerating drug discovery and generating new therapeutics based on aTyr’s extensive intellectual property portfolio. Under the collaboration, which is exclusive with respect to tRNA related molecules, Dualsystems will utilize their proprietary receptor screening technology and research expertise to attempt to identify and validate 10 new target receptors for tRNA synthetases by 2025. aTyr previously worked with Dualsystems to identify fibroblast growth factor 4 (FGFR4) as the target receptor for a fragment of alanyl-tRNA synthetase (AARS).

Third Quarter 2022 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, restricted cash, cash equivalents and investments as of September 30, 2022, were $79.6 million.

• R&D Expenses: Research and development expenses we

EX-99.1

2 life-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

adunston@atyrpharma.com

aTyr Pharma Announces Second Quarter 2022 Results and Provides Corporate Update

First sites initiated in Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis.

FDA granted Fast Track designation for efzofitimod for the treatment of pulmonary sarcoidosis.

Ended the second quarter 2022 with $89.3 million in cash, restricted cash, cash equivalents and investments.

Company to host conference call and webcast today, May 15th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

SAN DIEGO – August 15, 2022 – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter 2022 results and provided a corporate update.

“We are pleased with our second quarter progress as we announced our plans to initiate EFZO-FIT™, a Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This global pivotal study is a major milestone for the sarcoidosis community and is projected to be the largest interventional study for patients with sarcoidosis to date. We are on track to enroll the first patient in this study this quarter.”

Second Quarter 2022 and Subsequent Period Highlights

• In May 2022, announced plans to initiate the global pivotal EFZO-FIT™ study, a global pivotal Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll 264 subjects with pulmonary sarcoidosis at multiple centers in North America, Europe and Japan. The trial design will incorporate a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.

• Accomplished several operational milestones for the EFZO-FITTM study since its announcement in May 2022, including multiple interactions with regulatory authorities in the United States, European Union and Japan along with the submission of study protocol and clinical trial applications to regulatory authorities, ethics committees and institutional review boards. Site selection, qualification and initiations for several sites have occurred, as well as an investigator meeting for U.S. sites. The company is on track to enroll the first patient in the study in the third quarter of 2022.

• Received U.S. Food and Drug Administration (FDA) Fast Track designation for efzofitimod for the treatment of pulmonary sarcoidosis. Fast Track designation helps facilitate development and expedite the review of drugs to treat serious or life-threatening diseases with unmet medical need. Fast Track designation provides certain benefits, including more frequent interactions with the FDA throughout

1

the development program, as well as eligibility for accelerated approval, priority review and rolling review.

• Presented clinical data from the recently completed Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis at the American Thoracic Society (ATS) 2022 International Conference in San Francisco, California.

• Announced fibroblast growth receptor 4 (FGFR4) as the target receptor for a fragment of the Alanyl-tRNA Synthetase (AARS) in a poster presented at the Keystone Symposia on Tissue Fibrosis and Repair: Mechanisms, Human Disease and Therapeutics. FGFR4 is known to play a role in diseases related to inflammation and fibrosis, including conditions where unchecked fibrosis can precede the development of certain cancers. The company intends to interrogate the interaction between this fragment of AARS and FGFR4 and the implications for disease in order to explore this synthetase fragment as a potential pipeline candidate.

Second Quarter 2022 Financial Highlights and Cash Position

• Cash & Investment Position: Cash, restricted cash, cash equivalents and investments as of June 30, 2022, were $89.3 million.

• R&D Expenses: Research and development expenses were $9.1 million for the second quarter of 2022, which consisted of product development and manufacturing costs for the efzofitimod and ATYR2810 programs, as well as startup costs for the Phase 3 EFZO-FITTM study.

• G&A Expenses: General and administrative expenses were $3.4 million for the second quarter of 2022.

• Shares Outstanding: Common shares outstanding were 28,127,458 as of June 30, 2022.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its f

EX-99.1

2 life-ex991_6.htm

EX-99.1

life-ex991_6.htm

Exhibit 99.1

IMMEDIATE RELEASE

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

adunston@atyrpharma.com

aTyr Pharma Announces First Quarter 2022 Results and Provides Corporate Update

Company to present clinical data for efzofitimod (ATYR1923) in pulmonary sarcoidosis at upcoming American Thoracic Society International Conference in May.

Planned registrational study of efzofitimod in pulmonary sarcoidosis on track to initiate in the third quarter of 2022.

FDA granted orphan drug designation for efzofitimod for the treatment of systemic sclerosis; company to explore potential expansion of clinical program in other ILD.

Ended the first quarter 2022 with $98.7 million in cash, cash equivalents and investments.

Company to host conference call and webcast today, May 9th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

SAN DIEGO – May 9, 2022 – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology platform, today announced first quarter 2022 results and provided a corporate update.

“We are pleased with the start of 2022 and the continued progress throughout the first quarter for our efzofitimod clinical program in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “With the receipt of U.S. Food and Drug Administration (FDA) orphan drug designation and a positive End-of-Phase 2 meeting with the FDA, we are on track to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of this year.”

“The second quarter is shaping up to be an important period, as we prepare to present the clinical data for the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis at the upcoming American Thoracic Society (ATS) International Conference and anticipate the potential publication of a related manuscript. We are focused on preparation for the planned registrational study so that the balance of the year may center upon initiating the study in the U.S. and Europe and supporting our partner Kyorin Pharmaceutical with the anticipated launch of

1

the study in Japan.”

First Quarter 2022 and Subsequent Period Highlights

●

Announced posters accepted for presentation for efzofitimod in pulmonary sarcoidosis at the upcoming ATS 2022 International Conference. The posters will present clinical data from the recently completed Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for efzofitimod on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

●

Announced a company reception at the upcoming ATS 2022 International Conference in San Francisco, CA, on Monday, May 16, 2022. The event, which will convene sarcoidosis medical experts, principal investigators, advocacy organizations, analysts and investors, will review results from the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis and discuss an outlook for the planned registrational study that the company expects to initiate in the third quarter of 2022.

●

Received FDA orphan drug designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma), a chronic, progressive autoimmune disease in which many patients may develop associated ILD, known as SSc-ILD. Orphan drug designation is granted to support the development of medicines for patients with unmet needs for rare disorders affecting fewer than 200,000 people in the U.S. and provides certain benefits, including the potential for seven years of market exclusivity following regulatory approval. The company expects to explore the potential expansion of its efzofitimod clinical program into other forms of ILD with high unmet medical need.

●

Presented preclinical research in a poster at the American Association for Cancer Research Annual Meeting characterizing the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, in highly aggressive tumor subtypes, including triple-negative breast cancer. The findings suggest that ATYR2810 reduces metastasis and enhances chemosensitivity by downregulating key genes linked to these processes. The company expects to initiate a phase 1 study of ATYR2810 in cancer patients in the second half of 2022.

First Quarter 2022 Financial Highlights and Cash Position

●

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2022, were $98.7 million.

●

R&D Expenses: Research and development expenses were $8.9 million for the first quarter of 2022, which consisted primarily of product development and manufacturing costs for the efzofitimod

life-8k_20220412.htm

false 0001339970

0001339970

2022-04-12 2022-04-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 12, 2022

ATYR PHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-37378

20-3435077

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

3545 John Hopkins Court, Suite #250

San Diego, CA

92121

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (858) 731-8389

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

LIFE

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company     ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 8.01   Other Events.

On April 12, 2022, the U.S. Food and Drug Administration granted aTyr Pharma, Inc. orphan drug designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, also known as scleroderma).

2

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: April 13, 2022

3