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aTyr Pharma, Inc. (LIFE)

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  • GlobeNewswire

    aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Doses First Subjects in Phase 1 Trial of ATYR1923 in Japan

    Study will evaluate the safety, pharmacokinetics and immunogenicity of ATYR1923 in Japanese healthy volunteersSAN DIEGO, Sept. 15, 2020 (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 its partner Kyorin Pharmaceutical Co., Ltd., or Kyorin, a wholly owned subsidiary of Kyorin Holdings, Inc., has dosed the first subjects in a Phase 1 trial of aTyr’s lead therapeutic candidate ATYR1923 (known as KRP-R120 in Japan). The Phase 1 trial, which is being conducted by Kyorin, is a placebo-controlled study to evaluate the safety, pharmacokinetics and immunogenicity of ATYR1923 in 32 healthy Japanese male volunteers. Assuming successful completion of the study, Kyorin would then be able to initiate patient trials in interstitial lung diseases (ILDs) in Japan.  “ATYR1923 is a potential first-in-class immunomodulator and may present a promising new approach to treating ILDs,” said Dr. Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “To date, ATYR1923 has had a favorable safety profile in trials conducted in the U.S. and Australia. We look forward to the outcome of this study in a Japanese population as we continue to advance our ILD program globally.”  “We are pleased to initiate clinical development of ATYR1923 in Japan by dosing the first healthy volunteers in this study,” said Yutaka Ogihara, President and Chief Executive Officer of Kyorin Holdings, Inc. “This trial is an important step towards offering a potential new treatment to ILD patients in Japan.”Kyorin is aTyr’s partner for the development and commercialization of ATYR1923 for ILDs in Japan. As per the agreement, aTyr previously received an $8 million upfront payment and is eligible to receive up to $167 million in the aggregate upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalties on the net sales in Japan. Kyorin has the exclusive rights to commercialize ATYR1923 in Japan for ILDs.About ATYR1923aTyr is developing ATYR1923 as a potential therapeutic for patients with 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 the innate and adaptive immune response in inflammatory disease states. aTyr is currently enrolling a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis, a form of interstitial lung disease. 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. In response to the COVID-19 pandemic, aTyr recently initiated a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study is a randomized, double blind, placebo-controlled study that has been designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923. About aTyraTyr 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. About Kyorin Trusted among patients and professionals in the medical industry, Kyorin Pharmaceutical Co., Ltd. strives to be a company that contributes to public health and is recognized as one with social significance by improving its presence in specific therapeutic areas and through global discovery of novel drugs. Kyorin Pharmaceutical Co., Ltd. uses a franchise customer strategy where its marketing efforts are focused on respiratory, otolaryngology and urology. In drug discovery, it is deploying 'selection and concentration' and promoting activities aimed at first-in-class drug discovery, such as actively searching for and introducing external drug discovery themes as well as multi-tiered program development. For more information, please visit http://www.kyorin-pharm.co.jp.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 “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; timelines and plans with respect to certain development activities (such as the scope and timelines of clinical trials), potential benefits of collaborations 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 Investor Relations and Corporate Communications adunston@atyrpharma.com

  • GlobeNewswire

    Virtual Conference for Life Sciences Companies Broadcast Live September 17th, 2020

    Company executives will share corporate vision and answer audience questions at LifeSciencesInvestorForum.com NEW YORK, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Life Sciences Investor Forum today announced the agenda for its quarterly event for public and private companies, investors and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.Individual investors, institutional investors, advisors and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, September 17th with the first live webcast at 9:30 AM ET.REGISTER NOW AT: https://bit.ly/3m5MTfYIt is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.Agenda and presenting companies:Eastern Time (ET)Company NameTicker(s) 9:30 AMStarpharma Holdings Ltd.OTCQX: SPHRY | ASX: SPL 10:00 AMVolitionRx LimitedNYSE AMERICAN: VNRX 10:30 AMKemPharm, Inc.OTCQB: KMPH 11:00 AMAssure Holdings Corp.OTCQB: ARHH | TSX-V: IOM 11:30 AMaTyr Pharma, Inc.Nasdaq: LIFE 12:00 PMSWK Holdings, IncNasdaq: SWKH 12:30 PMCardiol Therapeutics Inc.OTCQX: CRTPF | TSX: CRDL 1:00 PMXPhyto Therapeutics Corp.OTCQB: XPHYF | CSE: XPHY | FSE: 4XT 1:30 PMNuvo Pharmaceuticals Inc.OTCQX: NRIFF | TSX: NRI 2:00 PMSalarius Pharmaceuticals, Inc.Nasdaq: SLRX 2:30 PMWillow Biosciences Inc.OTCQB: CANSF | TSX: WLLW 3:00 PMOrexo ABOTCQX: ORXOY | Nasdaq STO: ORX 3:30 PMCaladrius Biosciences, Inc.Nasdaq: CLBS 4:00 PMKineta, IncPrivate Company 4:30 PMSixth Wave Innovations Inc.OTCQB: ATURF | CSE: SIXW | FSE: AHUH To facilitate investor relations scheduling and for more information about the program, please visit www.lifesciencesinvestorforum.com.About Life Sciences Investor Forum
 Life Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors.A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network. CONTACT: CONTACT Life Sciences Investor Forum John M. Viglotti SVP Corporate Services, Investor Access (212) 220-2221 johnv@lifesciencesinvestorforum.com

  • GlobeNewswire

    aTyr Pharma Announces $20 Million Common Stock Purchase Agreement with Aspire Capital Fund, LLC

    Aspire Capital commits to purchase up to $20 Million of Common Stock over a period of up to 30 months.SAN DIEGO, Sept. 14, 2020 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, today announced that it has entered into a Common Stock Purchase Agreement (the “Agreement”) providing for the sale of up to $20 million of common stock to Aspire Capital Fund, LLC, (Aspire Capital), a Chicago-based institutional investor and shareholder of aTyr.      Under the terms of the Agreement, Aspire Capital has committed to purchase up to $20 million of aTyr’s common stock over a period of up to 30 months at prices based on the market price at the time of each sale, subject to certain terms and conditions. aTyr will control the timing and amount of any shares of common stock sold to Aspire Capital. There are no warrants, options, financing swaps, derivatives or other securities associated with this Agreement. aTyr retains the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.“We are excited to enter into this agreement with Aspire Capital, a valued shareholder and strong supporter of our scientific platform,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This transaction provides an opportunity for aTyr to access capital in an efficient and flexible manner, allowing us to further support the advancement of our clinical program for ATYR1923, including our trials in pulmonary sarcoidosis and COVID-19 severe respiratory complications, and our preclinical programs in Neuropilin-2 (NRP2) antibody development and tRNA synthetase biology.”“We are very pleased to expand our investment in aTyr, a company dedicated to developing new therapies for patients who have diseases with a high unmet medical need,” said Steven G. Martin, Managing Member of Aspire Capital. “This equity vehicle enhances aTyr’s ability to leverage its broad portfolio of intellectual property and provides Aspire Capital the opportunity to invest in an emerging life science company. We look forward to developing a long-term relationship with aTyr and providing ongoing support as they work towards achieving several notable milestones in the remainder of 2020 and throughout the next two and a half years.”“We are impressed with aTyr’s thoughtful approach to drug discovery and development, including its NRP2 antibody program and the high-quality engineering of the antibodies,” said Michael Burrows, Ph.D., Vice President of Life Sciences at Aspire Capital. “The preclinical data generated in oncology that was presented at the American Association for Cancer Research Annual Meeting in June is a nice first step in demonstrating initial efficacy at blocking NRP2 and showing tumor inhibitory effects. We look forward to subsequent data from this program.”There are no limitations on the use of proceeds, financial or business covenants, or restrictions on future financings.Additional details regarding the Agreement are set forth in aTyr’s Current Report on Form 8-K, filed today with the U.S. Securities and Exchange Commission.This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sales 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 aTyraTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological 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.About Aspire Capital Fund, LLCAspire Capital Fund, LLC is a Chicago-based, long-only investment fund focused on making open market and direct equity investments in publicly traded companies. Aspire Capital Fund, LLC is managed by Aspire Capital Partners, LLC. Aspire Capital invests in a broad range of industries with emphasis in healthcare and technology.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 “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 and our NRP2 antibody program; timelines and plans with respect to certain development activities (including the further development of ATYR9123 and our NRP2 antibody program); potential sales of common stock and proceeds under the Agreement; 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 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, whether we are able to satisfy conditions required to sell shares of our common stock to Aspire Capital under the Agreement, 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 Investor Relations and Corporate Communications adunston@atyrpharma.com