Announcement • Jun 09
aTyr Pharma, Inc. Receives Additional Compliance Period from Nasdaq As previously disclosed, on December 4, 2025, aTyr Pharma, Inc. (the Company) received a deficiency notice (the Notice) from the listing qualifications staff (the Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that, for the last 30 consecutive business days preceding the date of the Notice, the bid price of the Company's common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The Notice had no immediate effect on the listing of the Company's common stock on The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had 180 calendar days, or until June 2, 2026 (the Initial Compliance Date), to regain compliance with the minimum bid price requirement by having shares of the Company's common stock maintain a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days before the Initial Compliance Date. On June 3, 2026, the Company received a letter from the Staff (the Letter) notifying the Company that the Company is eligible for an additional 180-day period, or until November 30, 2026 (the Compliance Date), to regain compliance, based on the Staff's determination of the Company meeting the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and the Company's written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. The Letter has no immediate impact on the listing of the Company's common stock on The Nasdaq Capital Market. If at any time during the second compliance period the closing bid price of the Company's common stock is at least $1.00 per share for a minimum of 10 consecutive business days (which may be extended to be a period of up to 20 consecutive business days in the discretion of the Staff), Nasdaq will provide the Company with written confirmation of compliance. If the Company does not regain compliance by the Compliance Date, the Staff will provide written notification that the Company's common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set in the applicable Nasdaq listing rules. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to actively monitor the closing bid price of its common stock between now and the Compliance Date and, as appropriate, will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price requirement. Announcement • May 12
aTyr Pharma, Inc. Provides Regulatory And Clinical Update For Efzofitimod In Pulmonary Sarcoidosis aTyr Pharma, Inc. had announced the path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following the receipt of the official meeting minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to review the results of the Phase 3 EFZO-FIT study and determine the next steps for the program in pulmonary sarcoidosis. Based on feedback from the FDA, the Company plans to continue the development of efzofitimod in pulmonary sarcoidosis in 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 the key secondary endpoint. The Company chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and the Company concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for the KSQ-Lung as recommended by the FDA. The Company plans to submit an investigational new drug (IND) application for this study in June 2026. Evidence from EFZO-FIT shows that patients with restrictive lung disease (defined as FVC percent predicted = 80%) experienced a clinically meaningful benefit for FVC when treated with efzofitimod compared to the observed decline in placebo. Furthermore, these more severe patients from EFZO-FIT also experienced positive trends of improvement across multiple patient-reported outcomes, including the KSQ-Lung score. As part of the discussion with the FDA regarding the benefit risk profile for efzofitimod, the Company plans to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial. Considering the consistent safety profile seen for efzofitimod in trials to date, the Company believes this strategy to increase drug exposure, coupled with additional risk mitigation strategies and safety surveillance, may enhance the effects of efzofitimod without incurring additional safety concerns. 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 (OCS) 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. Efzofitimod is a novel 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 derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes. 
