ATYR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-07

• Our lead therapeutic candidate is efzofitimod, 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 der…

• In September 2025, we announced top-line data from a global Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis (the EFZO-FIT study). The EFZO-FIT study was a 52-week study in 268 patients with …

• Our Phase 2 proof-of-concept clinical trial of efzofitimod (the EFZO-CONNECT study) is a 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 a 28-week study with three parallel cohorts r…

• Using efzofitimod as a model, we have developed a process to advance novel tRNA synthetase domains from a concept to therapeutic candidate. This process leverages our early discovery work as well as current scientific understanding of tRNA synthetase

• evolution, protein structure, gene splicing and tissue-specific regulation to identify potentially active protein domains. Screening approaches are employed to identify target cells and extracellular receptors for these tRNA synthetase-derived proteins. These cellular systems can then be used in mec…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• Our lead therapeutic candidate is efzofitimod, 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 der…

• treatment of pulmonary sarcoidosis and for the treatment of SSc-ILD. The European Commission has granted efzofitimod orphan drug designations for the treatment of sarcoidosis and for the treatment of SSc, based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Prod…

• We believe efzofitimod has potential applications in the treatment of other ILDs, such as chronic hypersensitivity pneumonitis (CHP) and connective tissue disease related ILD (CTD-ILD), including SSc-ILD and rheumatoid arthritis-associated ILD. As such, we designed a focused Phase 2 proof-of-concept…

• patients at multiple centers in the United States. The objective of the study is to evaluate the efficacy of multiple doses of IV efzofitimod on pulmonary, cutaneous (limited or diffuse) and systemic manifestations in patients with SSc-ILD. The primary endpoint is reduction in FVC. Secondary endpoin…

• In January 2020, we entered into a collaboration and license agreement (Kyorin Agreement) with Kyorin for the development and commercialization of efzofitimod for the treatment of ILD in Japan. Under the terms of the Kyorin Agreement, Kyorin received exclusive rights to develop and commercialize efz…

Text added vs the prior filing · source: 10-Q · 2026-08-07

• As required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the

• design and operation of our disclosure controls and procedures as of the end of the quarter covered by this Quarterly Report. Based on this evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonab…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• As required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure contro…

Text added vs the prior filing · source: 10-Q · 2026-08-07

• successfully complete development and obtain regulatory approval for a product candidate. Even if we obtain regulatory approval to market a product candidate, our future revenues will depend, in part, upon the size of any markets in which our product candidates have received approval, and our abilit…

• To date, we have expended significant time, resources and effort on the discovery and development of product candidates related to the extracellular proteins derived from the histidyl tRNA synthetase (HARS) family, including conducting preclinical studies and clinical trials. We have not yet success…

• necessary regulatory approvals from the FDA in the United States and from similar regulatory authorities in other jurisdictions, obtain adequate clinical and commercial manufacturing supplies, build commercial capabilities, which may include entering into a marketing collaboration with a third party…

• is an additional risk that the FDA could determine that the study design or protocol for a non-U.S. clinical trial was inadequate, which would likely require us to conduct additional clinical trials, in which case our development plans will be delayed, which could materially harm our business.

• are not applicable across the entire class. For example, fusion proteins, such as efzofitimod, include an additional antibody domain to improve PK characteristics, and may therefore require a more complex and time-consuming manufacturing process than other tRNA synthetase-based therapeutic candidate…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• significant amount of additional time and resources to support approval. In addition, it will require us to obtain additional capital through equity offerings or partnering to conduct such studies.

• To date, we have expended significant time, resources and effort on the discovery and development of product candidates related to the extracellular proteins derived from the histidyl tRNA synthetase (HARS) family, including conducting preclinical studies and clinical trials. We have not yet success…

• for one of our product candidates may not be readily adaptable to other product candidates that we develop, and we may need to engage multiple third-party manufacturers to produce our product candidates.

• government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, including executive and congressional priorities, the impacts of which are inherently fluid and unpredictable.

• and other factors, healthcare providers and payors may decide that the benefits of any therapeutic candidates for which we receive regulatory approval do not or will not outweigh its costs. Any inability to successfully develop commercially viable drugs would have an adverse impact on our business, …

Text added vs the prior filing · source: 10-Q · 2026-08-07

• On August 7, 2026, our board of directors approved the implementation of a corporate restructuring and program prioritization plan (the Restructuring Plan) to streamline our operations and conserve capital prior to the potential initiation of the Planned Phase 3 Study. In connection with the Restruc…

• Chief Financial Officer and General Counsel Separation and Consulting Agreements

• On August 7, 2026, in connection with the Restructuring Plan, our board of directors approved the separation of employment of Jill M. Broadfoot as our Chief Financial Officer and Nancy E. Denyes as our General Counsel, expected to be effective September 30, 2026 (the actual date of such separation o…

• Separation Agreements in connection with the separation of their employment (the Separation Agreements). Additionally, in connection with the transition support that Ms. Broadfoot and Ms. Denyes have agreed to provide, we, Ms. Broadfoot and Ms. Denyes will enter into Consulting Agreements expected t…

• The Separation Agreements generally provide that, subject to Ms. Broadfoot’s and Ms. Denyes's execution of a general release and waiver of claims, we will provide Ms. Broadfoot and Ms. Denyes the following severance benefits in connection with the separation of their employment, consistent with our …

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• On May 12, 2026, we received notice of termination of the Kyorin Agreement with Kyorin. Kyorin elected to terminate the Kyorin Agreement without cause in accordance with the terms of the Kyorin Agreement, and the termination will become effective 90 days after the date of receipt of the notice of te…

• In order to achieve a more equal balance of membership among the three classes of directors on our Board of Directors (the Board), the Board determined that one of its members should be reclassified from Class II (with a term expiring at our 2029 Annual Meeting of Stockholders) to Class I (with a te…

• Accordingly, on May 11, 2026, Timothy P. Coughlin agreed to resign from the Board and his position as a Class II director subject to, and contingent upon, his immediate reappointment as a Class I director. Effective immediately following Mr. Coughlin’s resignation, the Board reappointed him as a Cla…

• Amendment to 2015 Stock Option and Incentive Plan, as amended

• As reported under the caption “Submission of Matters to a Vote of Security Holders” below, at our 2026 Annual Meeting of Stockholders held on May 11, 2026 (the Annual Meeting), our stockholders, upon the recommendation of the Board, approved an amendment to our 2015 Stock Option and Incentive Plan, …