EPRS

Grant from Bill & Melinda Gates Foundation MENLO PARK, Calif.--(BUSINESS WIRE)-- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced that it has received a research grant from the Bill & Melinda Gates Foundation to discover novel, boron containing small molecules for the treatment of tuberculosis and malaria. Funding from the Gates Foundation will support the discovery of novel inhibitors of aminoacyl-tRNA synthetases using AN2’s proprietary boron chemistry platform. AN2’s boron chemistry has the potential to address biological targets for tuberculosis and malaria that build on the scientific expertise of several AN2 scientists that were involved in discovering novel leucyl-tRNA synthetase inhibitors including epetraborole, tavaborole, as well as ganfeborole, which is currently in development for tuberculosis. AN2’s boron chemistry platform has demonstrated success against leucyl- tRNA synthetase, a target that has proven difficult to inhibit using traditional medicinal chemistry approaches. “Novel drugs that combat drug resistance and shorten therapy are urgently needed to reduce the impact of tuberculosis and malaria, diseases that are responsible for over 2 million deaths per year and disproportionately affect people in low- and middle-income countries,” said Eric Easom, Co-Founder, President and Chief Executive Officer of AN2 Therapeutics. “Our boron chemistry platform and team have a proven track record of delivering novel compounds targeting serious unmet needs in infectious diseases and global health that can be game-changers, and we are excited to engage in this important work. This grant underscores our commitment to address areas of high unmet need in global health and capture synergies with our existing research programs using non-dilutive funding.” About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at . 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 expressed or implied in this press release include, but are not limited to, statements regarding: the timing, progress, and anticipated results AN2's anticipated progress, business plans, business strategy and planned research efforts; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the continuing effects of the COVID-19 pandemic; macroeconomic conditions; early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidate; the significant uncertainty associated with AN2's product candidate ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in AN2's reports to be filed with the SEC, including AN2’s Report on Form 10-Q for the quarter ended June 30, 2023. These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at . Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

Conference hosted by the International Union of Biochemistry and Molecular Biology (IUBMB) to feature leading research in tRNA synthetase biology. Presentations showcase company’s progress in generating new therapeutics from tRNA synthetase platform. SAN DIEGO, June 06, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced multiple presentations at the International Union of Biochemistry and Molecular Biology’s 13th International Symposium of Aminoacyl-tRNA Synthetases (AARS 2023), which is scheduled to take place June 4 – 9 in Ontario, Canada. “As a leader in the field of tRNA biology, we look forward to highlighting some of the recent findings from our platform at AARS 2023,” said Leslie A. Nangle, Ph.D., Vice President, Research at aTyr. “In these presentations we describe the process from concept to clinical proof-of-concept for efzofitimod, our lead tRNA synthetase-derived candidate in development for interstitial lung disease, and how we have applied that same process to identify extracellular targets for two additional tRNA synthetase candidates from our platform. Furthermore, we present exciting findings that solidify a connection between patients with certain genetic conditions and lower circulating levels of the tRNA synthetase HARS, which forms the active portion of efzofitimod. As these patients exhibit dysregulated respiratory immune responses, this data provides rationale for a link between human extracellular HARS deficiency and diseases with respiratory symptoms.” Extracellular tRNA synthetases represent a class of proteins that may play important roles in regulating cellular responses to certain disease states, in particular, cellular stress and imbalances in tissue homeostasis. aTyr is focused on elucidating novel pathways mediated through extracellular tRNA synthetases and creating new biologics to modulate these pathways by developing protein therapies based on extracellular tRNA synthetase fragments. Details of the presentations appear below. The posters will be available on the aTyr website once presented. Title: Clinical Proof-of-Concept for a Novel Therapeutic Based on Histidyl-tRNA Synthetase for Treatment of Interstitial Lung DiseasesFormat: PresentationPresenter: Leslie A. Nangle, Ph.D.Date and Time: Tuesday, June 6, 2023, at 3:30 p.m. Title: Identification of Key Fibrotic Extracellular Targets for Alanyl- and Aspartyl-tRNA Synthetases Format: Poster PresentationDate and Time: Tuesday, June 6, 2023, at 8:10 p.m. Title: Circulating His-tRNA Synthetase is Reduced in Patients Harboring the Usher Syndrome Type 3B-Linked Mutation Y454SFormat: Poster PresentationDate and Time: Tuesday, June 6, 2023, at 8:10 p.m. Title: tRNA Biology Industry Panel Format: PanelPanelist: Leslie A. Nangle, Ph.D.Date and Time: Wednesday, June 7, 2023, at 11:40 a.m. About Efzofitimod aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr is currently conducting EFZO-FIT™, a global pivotal Phase 3 study of efzofitimod in pulmonary sarcoidosis. About aTyr aTyr is a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is efzofitimod, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to downregulate immune engagement in fibrotic lung disease. For more information, please visit http://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 “believes,” “expects,” “intends,” “may,” “plans,” “forward,” “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 potential therapeutic benefits and applications of efzofitimod and research and development activities related to future tRNA synthetase candidates. 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 or strategies 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 our product candidates, the risk that we or our partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates 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 Report on Form 10-Q and in our subsequent 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. Contact:Ashlee DunstonDirector, Investor Relations and Corporate Communicationsadunston@atyrpharma.com

First patient dosed in Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis; multiple centers in the U.S. are open for enrollment. Company to prioritize resources towards largest value driver efzofitimod program. Ended the third quarter 2022 with $79.6 million in cash, restricted cash, cash equivalents and investments. Company to host conference call and webcast today, November 10th, at 5:00 p.m. EST / 2:00 p.m. PST. SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2022 results and provided a corporate update. “The third quarter saw the initiation of EFZO-FIT™, a global pivotal Phase 3 study of our lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, the most prevalent form of interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Given current market conditions, we intend to focus our resources on the EFZO-FIT™ study, which is our largest value driver, to ensure a timely and successful completion of this study.” “As part of this prioritization, we have made the strategic decision not to use internal resources to initiate a Phase 1 study of ATYR2810 this year. The data we have generated for ATYR2810 firmly support its therapeutic potential in rare aggressive tumors, thus we intend to pursue alternative non-dilutive funding avenues, including academic collaborations, to advance this program.” Third Quarter 2022 and Subsequent Period Highlights Dosed the first patient in EFZO-FIT™, a global pivotal Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 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 once a month for a total of 12 doses. The study is currently enrolling and intends to enroll up to 264 subjects with pulmonary sarcoidosis at multiple centers in the U.S., Europe and Japan.Announced the publication of results of the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis in the peer-reviewed medical journal CHEST. The study demonstrated that efzofitimod was safe and well-tolerated at all doses and exhibited a consistent dose response on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.Received U.S. Food and Drug Administration (FDA) Fast Track designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma)-associated ILD. Fast Track designation helps facilitate development and expedite the review of drugs to treat serious or life-threatening diseases with unmet medical need. Fast Track designation provides certain benefits, including enhanced interactions with the FDA throughout the development program, as well as eligibility for accelerated approval, priority review and rolling review.Presented a poster at the European Respiratory Society International Congress 2022 on findings for an antibody for immunohistochemical detection of neuropilin-2 (NRP2) protein, efzofitimod’s binding partner, in patient tissue samples. The antibody may provide a useful tool for patient selection or stratification for sarcoidosis, other ILD, oncology or other indications where NRP2 is implicated.Completed IND-enabling activities and received a notice of allowance for a patent for ATYR2810, a fully humanized monoclonal antibody targeting NRP2, in preclinical development for cancer.Announced a research collaboration with Dualsystems Biotech AG, a company specializing in custom proteomics, aimed at accelerating drug discovery and generating new therapeutics based on aTyr’s extensive intellectual property portfolio. Under the collaboration, which is exclusive with respect to tRNA related molecules, Dualsystems will utilize their proprietary receptor screening technology and research expertise to attempt to identify and validate 10 new target receptors for tRNA synthetases by 2025. aTyr previously worked with Dualsystems to identify fibroblast growth factor 4 (FGFR4) as the target receptor for a fragment of alanyl-tRNA synthetase (AARS). Third Quarter 2022 Financial Highlights and Cash Position Cash & Investment Position: Cash, restricted cash, cash equivalents and investments as of September 30, 2022, were $79.6 million.R&D Expenses: Research and development expenses were $9.9 million for the third quarter of 2022, which consisted of product development and manufacturing costs for the efzofitimod and ATYR2810 programs, as well as startup costs for the Phase 3 EFZO-FIT™ study.G&A Expenses: General and administrative expenses were $3.6 million for the third quarter of 2022.Shares Outstanding: Common shares outstanding were 29,009,382 as of September 30, 2022. Conference Call and Webcast DetailsaTyr will host a conference call and webcast today at 5:00 p.m. EST / 2:00 p.m. PST 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: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event. About EfzofitimodaTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr is currently conducting EFZO-FIT™, a Phase 3 study of efzofitimod in pulmonary sarcoidosis event. About aTyraTyr is a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is efzofitimod, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to downregulate immune engagement in fibrotic lung disease. For more information, please visit www.atyrpharma.com. Forward-Looking StatementsThis 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 “believes,” “expects,” “intends,” “may,” “plans,” “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 statements regarding the expected number of patients to be enrolled in the EFZO-FIT™ study; the potential therapeutic benefits and applications of efzofitimod and our discovery programs; and timelines and plans with respect to certain development activities and development goals. 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 or strategies 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, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the COVID-19 pandemic, and geopolitical conflicts, including the risk of delays in our clinical trials, risks associated with the discovery, development and regulation of our product candidates, including 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the SEC on November 10, 2022 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. ATYR PHARMA INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) Operating expenses: Research and development$9,867 $5,138 $27,898 $17,309 General and administrative 3,625 2,590 10,556 8,066 Total operating expenses 13,492 7,728 38,454 25,375 Loss from operations (13,492) (7,728) (38,454) (25,375)Total other income (expense), net 247 59 634 159 Consolidated net loss (13,245) (7,669) (37,820) (25,216)Net loss attributable to noncontrolling interest in Pangu BioPharma Limited 1 2 3 7 Net loss attributable to aTyr Pharma, Inc.$(13,244) $(7,667) $(37,817) $(25,209)Net loss per share, basic and diluted$(0.46) $(0.42) $(1.34) $(1.56)Shares used in computing net loss per share, basic and diluted 28,663,047 18,159,231 28,184,698 16,145,351 ATYR PHARMA INC. Condensed Consolidated Balance Sheets (in thousands) September 30, December 31, 2022 2021 (unaudited) Cash, cash equivalents, restricted cash and available-for-sale investments$79,613 $107,911 Other receivables 873 435 Property and equipment, net 1,275 543 Operating lease, right-of-use assets 6,971 1,267 Financing lease, right-of-use assets 768 — Prepaid expenses and other assets 6,555 5,381 Total assets$96,055 $115,537 Accounts payable, accrued expenses and other liabilities$10,398 $5,033 Current portion of operating lease liability 657 980 Current portion of financing lease liability 158 — Long-term operating lease liability, net of current portion 7,218 398 Long-term financing lease liability, net of current portion 618 — Total stockholders’ equity 77,006 109,126 Total liabilities and stockholders’ equity$96,055 $115,537 Contact:Ashlee DunstonDirector, Investor Relations and Corporate Communicationsadunston@atyrpharma.com