Sarcoidosis, Pulmonary

Molecure achieved key milestones in the development of its innovative therapies in 2024 and plans to accelerate research and development in its most advanced clinical programs: OATD-01 and OATD-02. A summary of the most important events of 2024: Initiation of Phase II clinical trial (KITE) for OATD-01 in the treatment of pulmonary sarcoidosis at centers in the USA and Europe. Randomization and administration of OATD-01 or placebo to several patients with pulmonary sarcoidosis have been completed.Efforts to initiate clinical development in MASH (Metabolism Associated Steatohepatitis) driven by strong preclinical results, independent research and projected growth of the MASH market to over $25 billion by 2032. Clinical development of OATD-01 for MASH treatment will be carried out in partnership.Progress in the first-in-human study of OATD-02, a key oncology program in Phase I, where no dose-limiting toxicity (DLT) has been observed in patients who have received the drug (during dose escalation). Positive recommendation from the Safety Review Committee (SRC) to continue recruitment and to include additional patients at the 20 mg daily dose level. In early 2025, after another positive recommendation from the SRC, Molecure decided to modify the first-in-human study protocol and submitted a request to the relevant authorities and ethics committees to move to higher doses than initially planned for new patients.Progress in the mRNA-targeted drug platform – two therapeutic targets validated (proof-of-concept in vitro), with a plan to select lead compounds. Molecure plans to enter into a collaboration or partnering agreement for these programs.Collaboration with Avicenna Biosciences in the USP7 program (deubiquitinase inhibitor in immuno-oncology) to optimize lead compounds using gen-AI tools. Molecure plans to select a preclinical candidate and accelerate partnering discussions to advance the program.Success of the stock issuance – raising approximately PLN 30 million (approximately $7.72 million as of March 27, 2025) and securing funding for the development of key projects until the first half of 2026.New roles on the Management Board – Dr. Piotr Iwanowski assumed the position of Chief Medical Officer and Member of the Management Board.Optimization of the organizational structure and reduction of discovery-phase programs from five to three, enabling the concentration of resources on the most promising clinical assets. Warsaw, March 28, 2025 – Molecure S.A. (“Molecure”, GPW ticker: MOC), a biotechnology company discovering and developing drugs to the clinical stage, utilizing unique worldwide expertise in medicinal chemistry and biology to search for and develop first-in-class small molecule drugs that directly modulate protein activity and mRNA functions for the treatment of many incurable diseases, published its annual report for 2024. The report is available at: https://molecure.com/pl/informacje-dla-inwestorow/ Comment by Marcin Szumowski, CEO of Molecure S.A. “The past year was a period of intense work, strategic decisions, and key progress in our clinical projects. We are consistently pursuing our vision of creating innovative therapies that address unmet medical needs for patients worldwide. One of the major achievements in 2024 was the initiation and progress of the international KITE clinical trial for OATD-01, which includes patients with pulmonary sarcoidosis. Several patients have already been randomized in the KITE trial, and the recruitment pace is accelerating. We are currently recruiting at five centers in the USA, with additional sites opening soon in Europe. To speed up recruitment, we have strengthened our cooperation with the Foundation for Sarcoidosis Research and are conducting educational activities aimed at doctors and patients. OATD-01 was also a key focus of partnering discussions. In 2024, we had several dozen meetings with potential partners, and we are now in advanced discussions with a number of them. The KITE trial not only evaluates the efficacy and safety of OATD-01 but also provides crucial data on the CHIT1 protein – a biological target whose role may be significant in the pathogenesis of other diseases, including MASH (Metabolism Associated Steatohepatitis). According to forecasts, the MASH market is expected to exceed $25 billion by 2032, making this area extremely attractive for potential therapeutic applications of OATD-01. At the same time, we are advancing our second key clinical candidate – OATD-02. Currently, dose escalation continues to determine the pharmacologically active dose (PAD) and maximum tolerated dose (MTD) of the drug. The primary goal of this phase of the trial is to assess the drug's safety, pharmacokinetics, and pharmacodynamics. So far, no dose-limiting toxicity has been observed in any of the 14 patients who received the drug, allowing for the continuation of the trial and dose escalation. Financially, 2024 was a positive year for Molecure. Despite the challenging market situation, we raised about PLN 30 million from a stock issuance (approximately $7.72 million as of March 27, 2025). This investor support will allow us to execute the next stages of our trials, including accelerating recruitment for the KITE trial and conducting an interim analysis in the second half of 2025. We also prioritized our pipeline and optimized the organizational structure, leading to measurable savings and an extended cash runway. We believe that 2025 will bring crucial milestones in our research programs that will strengthen Molecure’s position. Our priority is to enter into a partnering agreement for OATD-01, which will allow for further research in MASH and strengthen our financial position.” Webinar with the Management Board of Molecure On April 2, 2025, at 1:00 PM, a meeting will be held in Polish (with translation to English) to present the progress of the ongoing research programs, especially clinical trials, as well as development plans for the coming quarters and an overview of the operational and financial situation of the Company for 2024. The meeting will be held online, at the following link: https://livingmedia.com.pl/live/molecure/2024-en Development of Molecure's Preclinical Programs In the USP7 project, in collaboration with Avicenna Biosciences, lead compound optimization continues, leveraging advanced computational methods and AI driven approaches. New classes of compounds with more favorable pharmacological properties have also been identified. Currently, non-GLP toxicology studies are underway, and positive results will allow the official preclinical development of a selected molecule for oncology applications. Identifying a candidate for preclinical development will intensify partnering discussions. In the mRNA program, Molecure is on track to select lead compounds for two mRNA targets, having reached the in vitro proof-of-concept stage, confirming the ability of small molecules to bind to mRNA fragments and inhibit the translation of pathogenic proteins. Plans for 2025 include selecting two lead compounds and further developing expertise in modern biophysical techniques, as well as entering into service collaboration or partnering agreements. Business Development Activities In 2024, representatives of the Company participated in three major industry conferences: In March, at BIO Europe Spring in Barcelona, management held 38 meetings with representatives from the biotechnology and pharmaceutical industries, mainly with potential partners, investors, and global pharmaceutical companies. The key discussion topics were around OATD-01), OATD-02, and the RNA platform;In June, at the BIO International Convention in San Diego, management held a record 42 meetings, with 28 focusing on OATD-01, indicating growing and more specific interest in the preclinical and clinical research results for lung diseases as well as metabolic diseases such as MASH. There was also interest in the RNA platform (6 meetings) and the OATD-02 program (8 meetings). Some of the meetings at BIO International Convention in San Diego concerned more than one program, reflecting a positive reception and interest in the Company's entire pipeline. In November, BIO Europe in Stockholm, where the Company held 25 meetings with potential partners, primarily regarding OATD-01. In March 2025, Company representatives attended the BIO-Europe Spring conference in Milan (March 17-19), where they held 30 meetings, including 22 focused on OATD-01, 4 on OATD-02, and 4 on other programs – USP7 and mRNA. Most of the meetings were with mid-sized pharmaceutical companies and large biotech companies. Some meetings were a continuation of previous interactions at BIO conferences.Additionally, in the past year, Company representatives participated in scientific and medical conferences such as "Immunometabolism in Health and Disease" at Bryant University in Smithfield, the European Congress of Life Sciences EUROBIOTECH in Krakow, the International Conference on Medicinal Chemistry in France, PHASE2024 in Warsaw, the European Respiratory Society (ERS) Congress in Vienna, the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) in India, the IPF Summit in the USA, and many others.In 2025, Company representatives will attend several more industry conferences, including major global events such as Bio Europe (fall edition), BIO International, as well as WASOG, ERS, and the European Association for the Study of the Liver. Summary of Financial Data for 2024 (Comparative 2023 data was restated) Operating revenues amounted to PLN 2.9 million, compared to PLN 3.7 million in 2023.Operating costs amounted to PLN 35.2 million (including PLN 4.0 million in costs related to the incentive program) compared to PLN 35.8 million in 2023. The slight reduction in operating costs was due to lower external service costs (including consulting services) and employee benefits. The net loss amounted to PLN 31.3 million, compared to PLN 28.4 million in 2023.Cash position: PLN 18 million as of December 31, 2024. Additionally, in Q4 2024, the Company raised funds from a stock issuance amounting to approximately PLN 30 million (capital increase registration took place in December 2024, and the funds were received by the Company in early January 2025)The Company has secured financing from grants for the upcoming years amounting to approximately PLN 30 million and plans to secure additional funding for projects within its expanding pipeline of clinical and preclinical programs. *** About Molecure S.A. Molecure S.A. is a biotechnology company discovering and developing drugs to the clinical stage, utilizing its unique expertise in medicinal chemistry and biology to search for and develop first-in-class small molecule drugs that can directly modulate unexplored protein and RNA targets for the treatment of many incurable diseases. Molecure has created a diversified portfolio of seven distinct programs with the support of leading academic institutions worldwide, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan, Trinity College Dublin (TCD), and the International Institute of Molecular and Cellular Biology in Warsaw (MIBMiK). The most advanced drug candidate developed by Molecure is OATD-01, the first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, as well as MASH, which is in Phase II clinical trials. The second drug candidate is OATD-02, an oral, selective, first-in-class dual arginase (ARG1 and ARG2) inhibitor for the treatment of cancer, whose Phase I clinical trial began with the first patient dose in Q1 2023. Molecure’s headquarters and laboratories are located in Warsaw and Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC). For more detailed information, please visit: https://molecure.com/pl/ LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA For further information, please contact: Molecure S.A. (PR & IR) Marta Borkowska Email: m.borkowska@molecure.com +(48) 728 728 143

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 (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 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 splice variant therapeutic targets NRP2 to resolve lung inflammation and fibrosis,” is available on the journal’s website and at: https://www-science-org.sutd.idm.oclc.org/doi/10.1126/scitranslmed.adp4754. 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 research demonstrating anti-fibrotic effects of ATYR0101 in lung and kidney fibrosis in two posters at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution. The findings demonstrated that ATYR0101 interacts with LTBP-1 to induce myofibroblast apoptosis through a novel anti-fibrotic mechanism and suggest that ATYR0101 has the potential to be a next generation anti-fibrotic drug for lung and kidney fibrosis. Appointed Eric Benevich to the Company’s Board of Directors. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc., where he is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio. 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. Year Ended 2024 Financial Highlights and Cash Position Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of December 31, 2024, were $75.1 million. Subsequent to the end of the fourth quarter 2024, the Company raised approximately $18.8 million in gross proceeds from its at-the-market (ATM) offering with Jefferies LLC. Financial Guidance: The Company updated its prior guidance and believes its cash runway will be sufficient to fund its operations for a period of one year following the Phase 3 EFZO-FIT™ readout, which includes the potential filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis. R&D Expenses: Research and development expenses were $54.4 million for the year ended 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 $13.8 million for the year ended 2024. Collaboration and License Revenue: Collaboration and license revenue related to the Kyorin Agreement was $0.2 million for the year ended 2024, which consisted of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT™ study. 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 financial results and provide a corporate update. Interested parties may access the call by registering here in order to obtain a dial in, personalized passcode and webcast information. Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: https://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event. 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 derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related 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. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “aims” “anticipates,” “believes,” “can,” “designed,” “expects,” “intends,” “look toward,” “may,” “plans,” “potential,” “project,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding interactions with the FDA relating to the SAP for the Phase 3 EFZO-FIT™ study, including the measurement of steroid reduction; the expected size of, and number of patients to be enrolled in, the EFZO-CONNECT™ study; the skin assessments and expected number of patients to be included in the interim data for the EFZO-CONNECT™ study; the potential therapeutic benefits and applications of efzofitimod; expectations regarding our financial guidance and the sufficiency of our cash runway; and timelines and plans with respect to certain development activities and development goals, including the potential filing of a BLA for efzofitimod in pulmonary sarcoidosis and our expectation that our Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis will report topline data in the third quarter of 2025 and expectation that our Phase 2 EFZO-CONNECT™ study will report interim data in the second quarter of 2025. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks related to our reliance on third-party partners and the potential that such partners may not perform as anticipated, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the ultimate long-term impact of evolving macroeconomic and geopolitical conditions, the risk of delays in our clinical trials, risks associated with the discovery, development and regulation of our product candidates, including the uncertainty of related costs and regulatory filings and the risk that results from clinical trials or other studies may not support further development, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons, the fact that our collaboration agreements are subject to early termination, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Source: aTyr Pharma, Inc.

Peer-reviewed publication validates efzofitimod’s unique anti-inflammatory mechanism of action on macrophages through neuropilin-2 (NRP2) receptor. Scientific insights further strengthen the rationale for clinical program for efzofitimod in interstitial lung disease (ILD). SAN DIEGO, March 12, 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 a publication demonstrating the mechanism of action for its lead therapeutic candidate, efzofitimod, in the journal Science Translational Medicine. The publication, entitled, “A human histidyl-tRNA synthetase splice variant therapeutic targets NRP2 to resolve lung inflammation and fibrosis,” is available on the journal’s website and at: https://www-science-org.sutd.idm.oclc.org/doi/10.1126/scitranslmed.adp4754. “We are pleased to publish this extensive manuscript detailing the preclinical data supporting the development of efzofitimod, which includes all of the data generated for this novel drug candidate from concept to clinic,” said Leslie A. Nangle, Ph.D., Vice President, Research at aTyr. “This peer-reviewed publication in a highly regarded journal such as Science Translational Medicine validates the immunomodulatory activity and extracellularly mediated mechanism of efzofitimod in reducing inflammation and fibrosis. Furthermore, this validation considerably expands the basis for the application of efzofitimod in chronic inflammatory conditions, as well as encourages the potential development of other tRNA synthetase-based therapeutics for disease intervention.” The publication presents the foundational science, detailed preclinical studies and discovery work behind efzofitimod, a first-in-class immunomodulator derived from a splice variant of histidyl-tRNA synthetase (HARS), which is enriched in human lung and is upregulated by inflammatory cytokines in lung and immune cells. The article also describes the specific and selective binding for efzofitimod to neuropilin-2 (NRP2), a cellular receptor highly expressed by myeloid cells in active sites of inflammation. Through this binding, efzofitimod inhibits the expression of pro-inflammatory receptor and cytokines, thereby downregulating inflammatory pathways in macrophages. This mechanism can subsequently disrupt the cycle of chronic inflammation and fibrosis. “This publication is a culmination of our innovative drug discovery process and serves as a testament to the overwhelming amount of preclinical work that provides evidence for the immunomodulatory activity for efzofitimod,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This scientific work along with the compelling clinical proof-of-concept generated for efzofitimod in pulmonary sarcoidosis supports the ongoing clinical development program in interstitial lung disease (ILD) and further strengthens the rationale to target ILD in their inflammatory stages using this novel therapeutic agent.” Efzofitimod is currently being investigated in the global pivotal Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis, a major form of ILD, and the Phase 2 EFZO-CONNECT™ study in systemic sclerosis (SSc, or scleroderma-related ILD). Efzofitimod has received orphan drug designation in the U.S., E.U. and Japan for sarcoidosis and Fast Track designation in the U.S. for pulmonary sarcoidosis and orphan drug designation in the U.S. and E.U. for SSc and Fast Track designation in the U.S. for SSc-ILD. 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 derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related 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. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as "anticipate," “believes,” “designed,” “could,” “can,” “expects,” “intends,” “may,” “plans,” “potential,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding the clinical development for efzofitimod, including the immunomodulatory activity and unique anti-inflammatory mechanism of action on macrophages through NRP2, the ability of efzofitimod to resolve lung inflammation and fibrosis, and the potential for the ongoing clinical program for efzofitimod in ILD, including pulmonary sarcoidosis and SSc-ILD. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of efzofitimod, the risk that we or our partners may cease or delay preclinical or clinical development activities for efzofitimod for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Source: aTyr Pharma, Inc.