LIFE aTyr Pharma Inc.

10.31
+0.05  (+0%)
Previous Close 10.26
Open 9.85
52 Week Low 2.93
52 Week High 12.97
Market Cap $174,443,880
Shares 16,919,872
Float 14,670,697
Enterprise Value $131,361,886
Volume 8,665,318
Av. Daily Volume 6,143,146
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Drug Pipeline

Drug Stage Notes
ATYR1923
Pulmonary sarcoidosis
Phase 1/2
Phase 1/2
Phase 1b/2a trial met primary endpoint September 13, 2021.
ATYR1923
COVID-19
Phase 2
Phase 2
Phase 2 data released January 4, 2021. Primary safety endpoint met. Median time to recovery of 5.5 days compared to 6 days in the placebo group. Biomarker data released March 15, 2021.

Latest News

  1. SAN DIEGO, Sept. 16, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, which is being held from September 20 – 23, 2021.

    The presentation will take place on Wednesday, September 22, 2021, at 3:45 p.m. ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conference.

    Following the event, a replay of the…

    SAN DIEGO, Sept. 16, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, which is being held from September 20 – 23, 2021.

    The presentation will take place on Wednesday, September 22, 2021, at 3:45 p.m. ET.

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conference.

    Following the event, a replay of the live presentations will be available on the Investor's section of the company's website at www.atyrpharma.com.

    About aTyr

    aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. 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 ATYR1923, a clinical-stage product candidate which binds to the Neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. For more information, please visit http://www.atyrpharma.com.

    Contact:
    Ashlee Dunston
    Director, Investor Relations and Corporate Communications
    adunston@atyrpharma.com


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  2. SAN DIEGO, Sept. 16, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced the pricing of an underwritten public offering of 9,375,000 shares of its common stock at a public offering price of $8.00 per share. The gross proceeds to aTyr from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $75.0 million. In addition, aTyr has granted the underwriters a 30-day option to purchase up to an additional 1,406,250 shares of its common stock. All of the shares to be sold in the offering are to…

    SAN DIEGO, Sept. 16, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced the pricing of an underwritten public offering of 9,375,000 shares of its common stock at a public offering price of $8.00 per share. The gross proceeds to aTyr from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $75.0 million. In addition, aTyr has granted the underwriters a 30-day option to purchase up to an additional 1,406,250 shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is expected to close on or about September 20, 2021, subject to customary closing conditions.

    Piper Sandler and RBC Capital Markets are acting as joint book-running managers for the offering. Laidlaw & Company (UK) Ltd. is acting as the lead manager for the offering. Roth Capital Partners LLC is acting as financial advisor.

    The offering is being made pursuant effective registration statements, filed by aTyr with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement on Form S-3. An electronic copy of the final prospectus supplement, when available, and accompanying prospectus relating to the offering will be available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at prospectus@psc.com; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at equityprospectus@rbccm.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About aTyr

    aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. 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 ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases.

    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 "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "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 timing and completion of the proposed public offering. 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, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the offering, 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.

    Contact:

    Ashlee Dunston

    Director, Investor Relations and Corporate Communications

    adunston@atyrpharma.com



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  3. SAN DIEGO, Sept. 15, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Piper Sandler and RBC Capital Markets are acting as joint…

    SAN DIEGO, Sept. 15, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Piper Sandler and RBC Capital Markets are acting as joint book-running managers for the offering.

    The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by aTyr that was declared effective by the Securities and Exchange Commission ("SEC") on August 23, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at prospectus@psc.com; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at equityprospectus@rbccm.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About aTyr

    aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. 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 ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung disease.

    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 "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "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 timing, terms and completion of the proposed public offering. 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 and uncertainties associated with market conditions, unanticipated demand on our capital resources and the satisfaction of customary closing conditions related to the offering, 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.

    Contact:

    Ashlee Dunston

    Director, Investor Relations and Corporate Communications

    adunston@atyrpharma.com



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  4. Trial met primary endpoint, ATYR1923 was safe and well-tolerated.

    Efficacy observed in key endpoints including steroid reduction of 58% in the 5.0 mg/kg treatment group with 33% of patients in the group able to taper completely off of steroids.

    Clinically meaningful improvements in forced vital capacity (FVC) of 3.3% and all sarcoidosis symptom measures, including shortness of breath, cough, and fatigue, observed in the 5.0 mg/kg treatment group.

    Management to host conference call and webcast today, September 13th at 8:30am ET/5:30am PT

    SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel…

    Trial met primary endpoint, ATYR1923 was safe and well-tolerated.

    Efficacy observed in key endpoints including steroid reduction of 58% in the 5.0 mg/kg treatment group with 33% of patients in the group able to taper completely off of steroids.

    Clinically meaningful improvements in forced vital capacity (FVC) of 3.3% and all sarcoidosis symptom measures, including shortness of breath, cough, and fatigue, observed in the 5.0 mg/kg treatment group.

    Management to host conference call and webcast today, September 13th at 8:30am ET/5:30am PT

    SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced positive results from its Phase 1b/2a double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR1923, in 37 patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

    "We are delighted by the results of this study, which provide the first clinical proof-of-concept for ATYR1923, as well as validation for our tRNA synthetase biology platform and Neuropilin-2 as a target. The consistency in dose response and clinically meaningful benefit observed, along with ATYR1923's favorable safety and tolerability profile, give us great confidence that ATYR1923 could be a transformative, disease modifying therapy for pulmonary sarcoidosis patients," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Based on the results of this study, we plan to meet with the U.S. Food and Drug Administration to present these data and our plans for subsequent clinical development and path to registration for ATYR1923 for pulmonary sarcoidosis, and we expect to initiate a registrational trial next year."

    "I am very impressed by this study, which is one of the best that I have seen conducted in sarcoidosis, a patient population that is highly underserved by current treatment options," said Robert Baughman, M.D., Professor of Medicine and Pulmonologist at the University of Cincinnati Medical Center. "The dose response and consistent response seen across multiple efficacy measures, without added toxicity, in this patient population with advanced disease is notable. Importantly, ATYR1923 demonstrated an improvement in several indicators of quality of life, a high priority for patients, by a much larger margin than I would expect in a trial of this size and duration."

    "The dose response and consistent results across almost every endpoint are remarkable findings, and as good as could be expected in this small study. The ability to taper patients off steroids while controlling disease symptoms in the ATYR1923 treatment groups is particularly compelling and supports advancement of ATYR1923 into the next phase of development," said Daniel Culver, D.O., Chair of the Department of Pulmonary Medicine and Director of Diffuse Parenchymal Lung Disease at The Cleveland Clinic.

    Key Safety and Clinical Efficacy Findings for ATYR1923

    • Safe and well-tolerated at all doses
      • No dose-relationship with most common adverse events associated with underlying disease
      • No drug-related serious adverse events
      • No signal of immunogenicity
    • Dose response and consistent positive findings across key efficacy endpoints
      • Steroid reduction of 58% overall from baseline and 22% relative reduction compared to placebo in steroid usage post taper in the 5.0 mg/kg treatment group
      • Complete steroid taper to 0 mg achieved and maintained for 33% of patients in the 5.0 mg/kg treatment group compared to no patients in any other group
      • Absolute improvement in forced vital capacity (FVC) as a measure of lung function at week 24 of 3.3% in the 5.0 mg/kg treatment group compared to placebo, with an improvement in FVC of > 2.5% considered clinically meaningful
      • Clinically meaningful improvement over placebo observed for dyspnea (shortness of breath), cough, fatigue and the King's Sarcoidosis Scores for Lung and General Health in 5.0 mg/kg treatment group
      • Dose dependent trends of improvement in key inflammatory biomarkers compared to placebo including IL-6, MCP-1, IFN-γ, IP-10 and TNFa as well as key sarcoidosis markers including ACE, IL-2Ra and SAA with tightest control in the 5.0 mg/kg treatment group
      • FDG-PET-CT was not evaluable due to incomplete data primarily caused by operational issues related to the COVID-19 pandemic

    Phase 1b/2a Clinical Trial in Patients with Pulmonary Sarcoidosis

    The Phase 1b/2a study was a randomized, double-blind, placebo-controlled, multiple-ascending dose clinical trial in 37 patients with pulmonary sarcoidosis. The trial consisted of three cohorts testing doses of 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg of ATYR1923 or placebo, dosed intravenously every month for six months. The primary objective of the study was to evaluate the safety, tolerability, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923 compared to placebo. Secondary objectives included the potential steroid-sparing effects of ATYR1923, in addition to other exploratory assessments of efficacy, such as lung function.

    Conference Call and Webcast

    aTyr Pharma will host a conference call and webcast to discuss the results today, September 13th at 8:30am ET/5:30am PT. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 1957829. Links to a live webcast and replay may be accessed on the aTyr website events page at: http://investors.atyrpharma.com/events-and-webcasts. A replay will be available for at least 90 days following the event.

    About Pulmonary Sarcoidosis and Other ILD

    Pulmonary sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Approximately 200,000 Americans live with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects that many patients cannot tolerate long-term.

    Pulmonary sarcoidosis is a major form of ILD, which is an umbrella term used for a large group of diseases that cause scarring (fibrosis) of the lung. The scarring causes stiffness in the lungs which makes it difficult to breathe and get oxygen to the bloodstream. Lung damage from ILD is often irreversible and gets worse over time. Other major forms of ILD include connective-tissue disease related ILD (e.g., scleroderma-related ILD), chronic hypersensitivity pneumonitis and idiopathic pulmonary fibrosis (IPF).

    About ATYR1923

    aTyr is developing ATYR1923 as a potential therapeutic for patients with severe inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory 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 ATYR1923 is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for ATYR1923 was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of ATYR1923 compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers.



    About aTyr

    aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. 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 ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. 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 "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "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 potential therapeutic benefits and applications of ATYR1923; timelines and plans with respect to certain development activities (such as the timing of additional clinical trials and planned interactions with regulatory authorities); and certain 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, uncertainty regarding the COVID-19 pandemic, 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 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.

    Contact:
    Ashlee Dunston
    Director, Investor Relations and Corporate Communications
    adunston@atyrpharma.com


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  5. Data from Phase 1b/2a clinical trial of ATYR1923 in pulmonary sarcoidosis expected in mid-September 2021.

    Company to host conference call and webcast today, August 10th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

    SAN DIEGO, Aug. 10, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced second quarter 2021 results and provided a corporate update.

    "We recently completed the last subject visit in our Phase 1b/2a proof-of-concept study of our lead therapeutic candidate, ATYR1923, in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication. We expect to report results from this important…

    Data from Phase 1b/2a clinical trial of ATYR1923 in pulmonary sarcoidosis expected in mid-September 2021.

    Company to host conference call and webcast today, August 10th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

    SAN DIEGO, Aug. 10, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced second quarter 2021 results and provided a corporate update.

    "We recently completed the last subject visit in our Phase 1b/2a proof-of-concept study of our lead therapeutic candidate, ATYR1923, in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication. We expect to report results from this important study in mid-September 2021," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This is a significant milestone for aTyr and the sarcoidosis community, and the upcoming readout represents a key inflection point for our ATYR1923 clinical program and tRNA synthetase biology platform."

    "The clinical proof-of-mechanism for ATYR1923 established in our Phase 2 study in COVID-19 patients and the favorable clinical safety profile demonstrated to date, along with the pre-clinical efficacy observed in multiple translational ILD models, support the potential for ATYR1923 as a new therapeutic approach for patients with pulmonary sarcoidosis and possibly other forms of ILD. We believe ATYR1923 could potentially offer an alternative to current treatments such as steroids with improved efficacy and fewer side effects."

    Second Quarter 2021 and Subsequent Period Highlights

    • Completed the last patient visit in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data from this study is expected in mid-September 2021.
    • Hosted a key opinion leader event featuring Daniel Culver, D.O., Chair of Pulmonary Medicine and Director of Diffuse Parenchymal Lung Disease at the Cleveland Clinic, who discussed limitations with the current standard of care and unmet medical need for treating patients with pulmonary sarcoidosis, including the toxicity burden of chronic steroid use and the need for better steroid sparing agents.
    • Kyorin Pharmaceutical, Co., Ltd., aTyr's partner in the development and commercialization of ATYR1923 for ILD in Japan, completed a Phase 1 study to evaluate the safety, pharmacokinetics (PK) and immunogenicity of ATYR1923 (known as KRP-R120 in Japan) in 32 healthy Japanese volunteers. ATYR1923 was observed to be generally safe and well-tolerated with no drug-related serious adverse events and PK findings were consistent with previous studies of ATYR1923.
    • Announced that two abstracts for ATYR1923 were accepted for presentation at the 2021 European Respiratory Society (ERS) International Congress to be held virtually September 5 – 8. The abstracts present research demonstrating the ability of a splice variant of histidyl-tRNA synthetase, the active portion of ATYR1923, to disrupt sarcoid granuloma formation in vitro and findings that ATYR1923 treatment reduces biomarkers in COVID-19 pneumonia patients.
    • Expanded its research collaboration with The Ohio State University (OSU) to deepen the understanding of the immune mechanisms of sarcoid granuloma formation and identify potential biomarkers of efficacy for ATYR1923 for pulmonary sarcoidosis. Dr. Elliott Crouser, Professor of Pulmonology, Critical Care and Sleep Medicine at OSU, will serve as principal investigator. The collaboration builds upon the successful pilot proof-of-concept study conducted with Dr. Crouser, including findings that were accepted for presentation at ERS.
    • Received a patent grant from the U.S. Patent and Trademark Office covering methods for the use of histidyl-tRNA synthetase Fc fusion proteins for reducing inflammatory response in the lung. The patent, U.S. Patent No. 11,072,787 entitled, "Histidyl-tRNA synthetase-FC conjugates," covers the use of the company's lead therapeutic candidate, ATYR1923, for reducing inflammatory response in the lung.
    • Strengthened its board of directors with the appointment of Sara Zaknoen, M.D., a highly accomplished drug development and clinical research executive. Dr. Zaknoen is a hematologist/oncologist who has previously held Chief Medical Officer positions at several biotech companies.
    • Presented preclinical research in a poster at the Keystone Symposia Cancer Stem Cells: Advances in Biology and Clinical Translation highlighting mechanistic insights into the tumor inhibitory effects of ATYR2810, the company's lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate. ATYR2810 selectively blocks the NRP2/VEGFR signaling axis and was shown to sensitize triple-negative breast cancer models to chemotherapy and downregulate several key epithelial-mesenchymal transition regulatory genes.
    • Presented preclinical research in a poster at the Antibody Engineering & Therapeutics Europe Virtual conference demonstrating the selective blocking ability of aNRP2-14 to Semaphorin 3F/NRP2 signaling.

    Second Quarter 2021 Financial Highlights

    • Cash & Investment Position: Cash, cash equivalents and investments as of June 30, 2021 were $44.1 million.
    • R&D Expenses: Research and Development expenses were $7.7 million for the second quarter of 2021, which consisted primarily of ATYR1923 and ATYR2810 program costs.
    • G&A Expenses: General and administrative expenses were $2.8 million for the second quarter of 2021.
    • Shares Outstanding: Commons shares outstanding were 16,919,872 as of August 9, 2021.

    Conference Call and Webcast Details

    aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 4692110. 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 ATYR1923

    aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung disease. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr has completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. Proof-of-mechanism for ATYR1923 was established in a Phase 2 clinical trial in COVID-19 patients with severe respiratory complications, which demonstrated that ATYR1923 reduced inflammatory cytokine levels in patients consistent with preclinical models, including cytokines that are implicated in sarcoidosis and other forms of interstitial lung disease.



    About aTyr

    aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. 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 ATYR1923, a clinical-stage product candidate which binds to the Neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. 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 "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "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 potential therapeutic benefits and applications of ATYR1923, ATYR2810 and our discovery programs; timelines and plans with respect to certain development activities (including the further development of ATYR9123, ATYR2810 and our discovery programs and the timing of data from clinical trials) and value to be derived therefrom; expected activities under our collaboration agreements and certain 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, including the risk of delays in enrollment 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 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.

    ATYR PHARMA INC. 
    Condensed Consolidated Statements of Operations 
    (in thousands, except share and per share data) 
           
      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2021  2020  2021  2020 
        
      (unaudited) 
    Revenues:                
    License and collaboration agreement revenues $  $189  $  $8,254 
    Total revenues     189      8,254 
    Operating expenses:                
    Research and development  7,655   4,361   12,171   7,977 
    General and administrative  2,790   2,146   5,476   4,736 
    Total operating expenses  10,445   6,507   17,647   12,713 
    Loss from operations  (10,445)  (6,318)  (17,647)  (4,459)
    Total other income (expense), net  53   (129)  100   (236)
    Consolidated net loss $(10,392) $(6,447) $(17,547) $(4,695)
    Net loss attributable to noncontrolling interest in Pangu BioPharma Limited  1   1   5   2 
    Net loss attributable to aTyr Pharma, Inc. $(10,391) $(6,446) $(17,542) $(4,693)
    Net loss per share, basic and diluted $(0.64) $(0.69) $(1.16) $(0.58)
    Shares used in computing basic net loss per share, basic and diluted  16,128,473   9,357,432   15,121,721   8,119,612 



    ATYR PHARMA INC. 
    Condensed Consolidated Balance Sheets 
    (in thousands) 
             
      June 30,  December 31, 
      2021  2020 
      (unaudited)     
    Cash, cash equivalents and available-for-sale investments, short-term $44,061  $31,689 
    Other receivables  90   2,039 
    Property and equipment, net  751   899 
    Right-of-use assets  1,685   2,083 
    Prepaid expenses and other assets  2,408   2,016 
    Total assets $48,995  $38,726 
             
    Accounts payable, accrued expenses and other liabilities $6,365  $5,003 
    Current portion of operating lease liability  919   861 
    Long-term operating lease liability, net of current portion  906   1,378 
    Total stockholders' equity  40,805   31,484 
    Total liabilities and stockholders' equity $48,995  $38,726 
             



    Contact:
    Ashlee Dunston
    Director, Investor Relations and Corporate Communications
    adunston@atyrpharma.com


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