Summary of Atyre Pharma Conference Call Company Overview - Atyre Pharma is positioned as a leading company in the interstitial lung disease sector, focusing on the development of therapies for conditions such as pulmonary sarcoidosis with its lead program, esofitimod [4][5] Key Points and Arguments Upcoming Phase Three Catalyst - Atyre Pharma is anticipating a major phase three trial readout for esofitimod in pulmonary sarcoidosis, which could be the first new therapy for this condition in 70 years [4][5] - The company has transitioned esofitimod through various stages of development, culminating in a highly derisked asset ready for pivotal trials [5] Data-Driven Approach - Atyre emphasizes a data-driven methodology, showcasing significant preclinical and phase two data that supports the efficacy of esofitimod in modulating immune responses without the heavy immunosuppressive effects typical of existing treatments [6][7][9] - The company has published extensively, including in high-impact journals, to validate its findings and maintain transparency with investors [12][14][15] FDA Interaction and Endpoint Adjustments - Recent discussions with the FDA have led to a refined approach to analyzing steroid reduction as a primary endpoint, which is now expected to yield more favorable statistical outcomes [18][19][22] - The FDA's guidance has allowed Atyre to adjust its statistical model positively, potentially lowering the threshold for demonstrating statistical significance [19][22] Market Potential and Demographics - Atyre's updated epidemiological work indicates that the steroid-dependent population for sarcoidosis is larger than previously estimated, now believed to be around 75% of the 200,000 patients in the U.S. [44][45] - The potential market opportunity for esofitimod is now projected to be between $5 billion to $6 billion, significantly higher than earlier estimates [46] Clinical Trial Insights - The trial involves a diverse patient population across 90 centers in nine countries, with baseline demographics aligning closely with previous studies [30][31][34] - The company has taken steps to ensure data integrity and quality, which is crucial for the pivotal submission [39] Future Indications and Pipeline - Atyre is exploring additional indications for esofitimod, including scleroderma ILD, although the readouts from this trial are not expected to directly influence the sarcoidosis data [50][53] - The company has introduced a new IND program targeting myofibroblast apoptosis, which could have significant implications for treating idiopathic pulmonary fibrosis (IPF) [58][60] Other Important Content - The company has received positive feedback from the medical community regarding its innovative approach to treating sarcoidosis, with many expressing gratitude for the efforts to reduce steroid dependency [10][26] - Atyre's commitment to rigorous clinical trial design and data publication is highlighted as a key differentiator in the biotech space [12][15] This summary encapsulates the critical insights and developments discussed during the conference call, reflecting Atyre Pharma's strategic direction and market positioning.

Core Insights - aTyr Pharma, Inc. is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [1][2] - The company will present at several investor conferences in May and June 2025, including the RBC Capital Markets Global Healthcare Conference and the Jefferies Global Healthcare Conference [1] Group 1: Upcoming Conferences - aTyr Pharma's President and CEO, Sanjay S. Shukla, will present at the RBC Capital Markets Global Healthcare Conference on May 21, 2025, at 11:00am EDT in New York, NY [1] - The company will also participate in the Piper Sandler 3 Annual Virtual Lung Symposium on May 27, 2025, at 2:00pm EDT [1] - Additionally, aTyr will present at the Jefferies Global Healthcare Conference on June 5, 2025, at 2:00pm EDT in New York, NY [1] Group 2: Company Overview - aTyr leverages evolutionary intelligence to develop therapies targeting fibrosis and inflammation through its tRNA synthetase biology [2] - The company's lead therapeutic candidate, efzofitimod, is a first-in-class biologic immunomodulator in clinical development for interstitial lung disease [2]

Core Insights - The ongoing Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis has a balanced demographic and disease characteristic profile, representative of the target trial population [1][4] - Real-world evidence indicates that the target market for efzofitimod is larger than previously estimated, with increased morbidity among patients [1][3] - Approximately 75% of diagnosed pulmonary sarcoidosis patients in the U.S. require treatment with steroids, highlighting the reliance on corticosteroids despite their limited clinical evidence and side effects [1][3][6] Company Overview - aTyr Pharma, Inc. is a clinical-stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [2][10] - The lead therapeutic candidate, efzofitimod, is in clinical development for interstitial lung disease (ILD), specifically targeting pulmonary sarcoidosis and systemic sclerosis-related ILD [9][10] Clinical Study Details - The Phase 3 EFZO-FIT™ study has enrolled 268 patients, with 264 dosed and included in the analysis, focusing on a moderate to severe chronic symptomatic pulmonary sarcoidosis population [7][8] - The mean baseline oral corticosteroid dose among participants was 10.55 mg, with 38.3% on steroid-sparing immunosuppressants at baseline [7] Treatment Landscape - Glucocorticoids remain the most common treatment for pulmonary sarcoidosis, with higher usage rates than previously reported [6] - Treatment intensity escalates over time, with patients rapidly progressing to later-line therapies, and 10% of non-incident patients requiring high-cost, off-label biologics within three years [6] Epidemiological Insights - Approximately 158,900 individuals in the U.S. have pulmonary sarcoidosis with parenchymal involvement, with an estimated 30,000 new cases diagnosed annually [12] - The disease disproportionately affects women and Black individuals, with 1 in 8 patients hospitalized within three years, and an average hospital stay exceeding 5 days [12]

Core Insights - aTyr Pharma has advanced its investigational new drug candidate, ATYR0101, which will be presented at the ATS 2025 Respiratory Innovation Summit, highlighting its unique anti-fibrotic mechanism through interaction with LTBP-1 [2][4][5] Company Overview - aTyr Pharma is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [2][6] - The company’s lead therapeutic candidate is efzofitimod, which is in clinical development for interstitial lung disease [6] ATYR0101 Details - ATYR0101 is a fusion protein derived from the extracellular domain of aspartyl-tRNA synthetase (DARS) that induces apoptosis in myofibroblasts, which are crucial in the progression of fibrosis [3][5] - Preclinical data suggest that ATYR0101 may have the potential to reverse fibrosis, representing a significant advancement in treating pulmonary fibrosis [4][5] - The drug is currently undergoing IND-enabling studies, with an IND application anticipated to be filed in the second half of 2026 [4][5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37378 ATYR PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-3435077 (State or other jurisdiction ...

Clinical Trials - Topline data from the Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis is expected to be announced in the third quarter of 2025[1] - The Phase 3 EFZO-FIT™ study enrolled 268 patients across 85 centers in nine countries, with a primary endpoint focused on steroid reduction from baseline to week 48[4] - Interim data from the Phase 2 EFZO-CONNECT™ study is expected in the second quarter of 2025, focusing on skin assessments in approximately eight patients[6] Financial Performance - Cash, cash equivalents, restricted cash, and available-for-sale investments as of March 31, 2025, were $78.8 million, sufficient to fund operations for one year post-Phase 3 EFZO-FIT™ readout[5] - Research and development expenses for the first quarter of 2025 were $11.8 million, primarily for clinical trial costs related to the EFZO-FIT™ and EFZO-CONNECT™ studies[10] - General and administrative expenses for the first quarter of 2025 totaled $4.0 million[10] - The consolidated net loss for the first quarter of 2025 was $14.9 million, compared to a net loss of $15.5 million in the same period of 2024[13] - The total operating expenses for the first quarter of 2025 were $15.8 million, a decrease from $16.9 million in the first quarter of 2024[13] - Total assets as of March 31, 2025, were $97.2 million, with total stockholders' equity of $74.9 million[15] Leadership Changes - The company appointed Dalia R. Rayes as Head of Commercial for the Global Efzofitimod Franchise, bringing over 25 years of experience in biotechnology and pharmaceutical sectors[6]

Core Insights - aTyr Pharma is progressing with its clinical program for efzofitimod, a first-in-class biologic immunomodulator targeting pulmonary sarcoidosis, with topline data from the Phase 3 EFZO-FIT™ study expected in Q3 2025 [1][4][3] Company Updates - The first quarter of 2025 saw aTyr Pharma report a net loss of $14.88 million, compared to a loss of $15.49 million in the same period of 2024, with total revenues remaining at $0 [13] - Research and development expenses for Q1 2025 were $11.8 million, primarily for clinical trial costs related to the EFZO-FIT™ and EFZO-CONNECT™ studies [10][13] - The company appointed Dalia R. Rayes as Head of Commercial for the Global Efzofitimod Franchise, bringing over 25 years of experience in biotechnology and pharmaceutical commercial organizations [4] Clinical Trials - The Phase 3 EFZO-FIT™ study is a randomized, double-blind, placebo-controlled trial involving 268 patients across 85 centers in nine countries, focusing on steroid reduction as the primary endpoint [4][7] - The ongoing Phase 2 EFZO-CONNECT™ study aims to evaluate efzofitimod in patients with systemic sclerosis-related interstitial lung disease, with interim data expected in Q2 2025 [4][7] Financial Position - As of March 31, 2025, aTyr Pharma had cash and cash equivalents totaling $78.8 million, which is projected to fund operations for one year following the Phase 3 EFZO-FIT™ readout [10][15] - General and administrative expenses for Q1 2025 were reported at $4.0 million, slightly higher than the previous year's $3.5 million [10][13]

Core Insights - aTyr Pharma, Inc. is presenting preclinical data for ATYR2810, a monoclonal antibody targeting neuropilin-2 (NRP2), at the AACR Annual Meeting 2025, indicating progress in its clinical development [1][2] Group 1: Company Overview - aTyr Pharma is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform [1][4] - The company's lead therapeutic candidate is efzofitimod, which is in clinical development for treating interstitial lung disease [4] Group 2: Research Findings - ATYR2810 has shown potential in combating drug resistance mechanisms in aggressive cancers like glioblastoma multiforme (GBM) [2][3] - Preclinical research indicates that ATYR2810 enhances anti-tumor immunity and significantly increases overall survival when used as a single agent [3] - The combination of ATYR2810 with anti-PD-1 therapies further improves survival rates and reduces tumor size in GBM models [3]

SAN DIEGO, April 03, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will participate in two upcoming investor conferences scheduled to take place in April 2025. Details of the conferences appear below: Conference: Jones Healthcare and Technology Innovation Conference Date: April 8 – 9, 2025Location: Las Vegas, ...

Core Viewpoint - aTyr Pharma has appointed Dalia R. Rayes as Head of Commercial for the Global Efzofitimod Franchise, aiming to advance the commercialization of efzofitimod, a potential first treatment for pulmonary sarcoidosis in over 70 years [1][2]. Company Overview - aTyr Pharma is a clinical stage biotechnology company focused on developing first-in-class medicines from its proprietary tRNA synthetase platform, targeting therapies for fibrosis and inflammation [4]. - The lead therapeutic candidate, efzofitimod, is in clinical development for interstitial lung disease (ILD), which includes immune-mediated disorders causing lung inflammation and fibrosis [4]. Appointment Details - Dalia R. Rayes brings over 25 years of experience in biotechnology and pharmaceuticals, having led product launches in rare diseases [1][2]. - Ms. Rayes previously served as Senior Vice President at ChemoCentryx, where she developed the commercial strategy for TAVNEOS® prior to its acquisition by Amgen [2]. - She has also held significant roles at Actelion Pharmaceuticals, contributing to the launch of products like VALCHLOR® and OPSUMIT® [2]. Compensation Package - As part of her appointment, Ms. Rayes was granted an option to purchase 225,000 shares of aTyr's common stock at an exercise price of $3.49 per share, with a vesting schedule over four years [3].