Group 1: Market Overview - U.S. stock futures were higher, with Dow futures gaining more than 50 points on Monday [1] - New Mountain Finance Corporation shares fell sharply in pre-market trading, dipping 4.4% to $10.01 after a downgrade from Buy to Underperform by B of A Securities analyst Derek Hewett, with a price target cut from $11.75 to $10 [1] Group 2: Notable Stock Movements - Kindly MD Inc shares tumbled 37.1% to $1.75 in pre-market trading after a 30% drop on Friday [3] - aTyr Pharma Inc shares fell 19.7% to $4.84 after gaining around 15% on Friday [3] - GlucoTrack, Inc. shares dipped 17.4% to $8.73 after a significant jump of 117% on Friday due to a purchase agreement announcement [3] - Hang Feng Technology Innovation Co., Ltd. shares declined 17.4% to $10.16 after a 209% gain on Friday following its IPO pricing [3] - Akso Health Group shares fell 16.4% to $1.60 after a more than 4% gain on Friday [3] - YD Bio Ltd shares declined 9.1% to $21.00 after a 13% gain on Friday [3] - Texas Instruments Incorporated shares declined 2.9% to $177.35 amid reports of an anti-dumping investigation by the Chinese Ministry of Commerce into American-made analog IC chips [3] - Analog Devices, Inc. shares fell 2.7% to $238.63, also related to the same anti-dumping investigation [3]

aTyr Pharma said on Monday its experimental drug had failed to meet the main goal in a late-stage study testing it in patients with a type of lung disease known as pulmonary sarcoidosis, a disease imp... ...

Core Insights - The Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint regarding the reduction in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefits were observed across multiple parameters [1][5][7] - A significant proportion of patients treated with efzofitimod achieved complete steroid withdrawal and showed improvement in the King's Sarcoidosis Questionnaire (KSQ)-Lung score compared to placebo [2][6][16] Study Results - The study involved 268 patients and compared the efficacy and safety of efzofitimod at doses of 3.0 mg/kg and 5.0 mg/kg against placebo over 48 weeks [4][9] - The mean daily OCS dose at week 48 was reduced to 2.79 mg for the 5.0 mg/kg efzofitimod group compared to 3.52 mg for placebo, with a p-value of 0.3313 [5][16] - Complete steroid withdrawal was achieved by 52.6% of patients on 5.0 mg/kg efzofitimod versus 40.2% on placebo (p=0.0919) [1][16] - Improvement in KSQ-Lung score was statistically significant for the efzofitimod group (p=0.0479), with 29.5% of patients achieving both complete steroid withdrawal and improved KSQ-Lung score compared to 14.4% in the placebo group (p=0.0199) [2][6][16] Safety and Tolerability - Efzofitimod was well-tolerated, maintaining a consistent safety profile across both tested doses [2][16] - The study demonstrated that lung function, as measured by forced vital capacity (FVC), was maintained with a change from baseline of -1.81 for efzofitimod versus -2.11 for placebo (p=0.7875) [6][16] Future Plans - The company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the results and determine the future path for efzofitimod in treating pulmonary sarcoidosis [3][7] - A conference call and webcast to discuss the study results is scheduled, indicating the company's commitment to transparency and stakeholder engagement [3][13] Context of Pulmonary Sarcoidosis - Pulmonary sarcoidosis affects approximately 200,000 Americans and is characterized by granuloma formation, leading to varying degrees of lung function impairment [14] - Current treatment options are limited and often associated with significant side effects, highlighting the need for safer and more effective therapies like efzofitimod [14][17]

Core Viewpoint - aTyr Pharma Inc. (NASDAQ:ATYR) is considered a promising multibagger stock, with a Buy rating and a price target of $16, driven by optimism surrounding the EFZO-FIT trial for efzofitimod as a treatment for pulmonary sarcoidosis [1][2]. Group 1: Trial Insights - Feedback from two key opinion leaders (KOLs) suggests efzofitimod could provide a safe, steroid-sparing treatment option if trial results are favorable [2]. - Anecdotal evidence of successful steroid tapering has increased confidence in the trial, despite its small size and blinded design [2][3]. - The KOLs emphasized the strength of patient selection and trial operations, which were designed to minimize placebo effects [2]. Group 2: Probability of Success - One KOL estimated the probability of success for the trial at 65-70%, slightly higher than the analyst's estimate of 60% [3]. - Despite the high-risk nature of the trial, the potential reward is seen as justifying the Buy rating due to efzofitimod's ability to address a significant unmet medical need [3]. Group 3: Company Overview - aTyr Pharma Inc. is a clinical-stage biotechnology company focused on leveraging evolutionary intelligence to develop new therapies targeting fibrosis and inflammation [3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 ...

Topline results expected in the third quarter of 2025. SAN DIEGO, July 22, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in- class medicines from its proprietary tRNA synthetase platform, today announced that the last patient has completed their last visit in the Company's Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis ...

Efzofitimod for Interstitial Lung Disease (ILD) - Efzofitimod is a first-in-class biologic immunomodulator in Phase 3 development for ILD, addressing a significant unmet medical need[10] - aTyr is advancing Efzofitimod as the standard-of-care for ILD, which encompasses over 200 types of rare lung diseases[11, 13] - The company's current focus is estimated at a $2-5 billion global market opportunity[13] - Efzofitimod is positioned to be the first approved product for sarcoidosis in over 60 years[31] Clinical Development and Trial Design - Phase 3 catalyst for multi-billion dollar indication in Q3 2025[6] - The Phase 3 EFZO-FIT study in pulmonary sarcoidosis is fully enrolled with 268 patients, and topline data is expected in Q3 2025[50] - Interim data from the Phase 2 EFZO-CONNECT study in SSc-ILD is expected in Q2 2025[70] - The addressable population for Efzofitimod in sarcoidosis is estimated to be 50-75% of all sarcoidosis patients[28] Financial Position and Pipeline - The company had approximately $68.9 million in cash, restricted cash, cash equivalents, and investments as of Q3 2024, with an additional $19.4 million raised subsequently[70] - The company's cash runway extends through the filing of a Biologics License Agreement (BLA) for efzofitimod in pulmonary sarcoidosis[70]

Group 1 - aTyr Pharma, Inc. is expected to be added to the Russell 2000 Index and the Russell 3000 Index effective after the U.S. market close on June 27, 2025, as part of the 2025 Russell U.S. Indexes annual reconstitution [1] - The Russell 3000 Index tracks the performance of the largest 3,000 publicly traded U.S. companies, while the Russell 2000 Index focuses on small-cap companies [2] - Membership in the Russell Indexes lasts for one year and results in automatic inclusion in appropriate growth and value style indexes, which are utilized by investment managers and institutional managers [2] Group 2 - aTyr is a clinical stage biotechnology company that focuses on developing first-in-class medicines from its proprietary tRNA synthetase platform [4] - The company's lead therapeutic candidate is efzofitimod, which is in clinical development for treating interstitial lung disease, a group of immune-mediated disorders [4]

Summary of aTyr Pharma (ATYR) 2025 Conference Call Company Overview - **Company**: aTyr Pharma (ATYR) - **Event**: 2025 Jefferies Global Healthcare Conference - **Focus**: Lead program for pulmonary sarcoidosis and updates on other indications Key Points on Pulmonary Sarcoidosis Program - **Phase Three Study**: Baseline demographics presented at ATS, showing expected characteristics in race, gender, and age of sarcoidosis patients [3][4] - **Steroid Dosage**: Average steroid dose at entry for the phase three trial was 10.5 mg, slightly lower than the 12-13 mg in phase two, aligning with treatment guidelines [4][6] - **Patient Management**: Patients on lower steroid doses are more sensitive to reductions, with a focus on managing flare-ups in the placebo group [12][13] - **FDA Feedback**: FDA recommended simplifying the statistical analysis plan to focus on the last four weeks of treatment, which increases the power to detect smaller differences [17][18] - **Power Assumptions**: The trial is powered to show a statistically significant absolute reduction of 3 mg in steroid use compared to placebo [22][23] - **Market Opportunity**: The target population for the therapy is larger than initially estimated, with 150,000 to 160,000 steroid-dependent patients in the U.S. [48][49] Other Indications and Updates - **Scleroderma-Related ILD Study**: Interim data showed promising results in skin improvement, particularly in diffuse scleroderma patients [60][62] - **Potential for Broader Applications**: Interest in expanding the use of epsofitimod to other forms of interstitial lung disease (ILD) and connective tissue disease ILD, with a potential market value exceeding $5 billion [70][71] Financial Position - **Cash Position**: The company has sufficient cash to support operations through the upcoming readouts and for at least another year beyond that [72] Conclusion - aTyr Pharma is positioned to potentially change treatment paradigms in pulmonary sarcoidosis and other ILDs, with significant market opportunities and a strong financial position to support ongoing and future trials.

Core Insights - The interim analysis of the Phase 2 EFZO-CONNECT™ study indicates that three out of four patients treated with efzofitimod showed clinically significant improvement in the modified Rodnan Skin Score (mRSS) at 12 weeks [1][3][7] - Efzofitimod is generally safe and well tolerated across all doses, with no serious adverse events reported [1][7] 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][9] - The lead therapeutic candidate, efzofitimod, is being investigated for the treatment of interstitial lung disease (ILD) related to systemic sclerosis (SSc) [8][9] Study Details - The EFZO-CONNECT™ study is a Phase 2 randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with limited or diffuse SSc-ILD [4] - The study involves 28 weeks of treatment with three parallel cohorts randomized to receive either 270 mg or 450 mg of efzofitimod or placebo, with a total of 25 patients expected to be enrolled [4] Key Findings - The interim analysis revealed stable or improved mRSS for all patients, with a notable improvement of 4 points or greater for three out of four efzofitimod-treated patients with diffuse SSc-ILD [7] - Preliminary signals of improvement were observed in inflammatory biomarkers such as interferon gamma (IFN-γ) and monocyte chemoattractant protein-1 (MCP-1) [7] Disease Context - Systemic sclerosis (SSc) is a chronic autoimmune disease that can lead to interstitial lung disease (SSc-ILD), affecting approximately 100,000 people in the U.S., with up to 80% potentially developing ILD [6] - Current treatment options for SSc-ILD are limited and primarily focus on slowing lung function decline, often with significant toxicity [6]