On November 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported third quarter 2021 results and provided a corporate update (Press release, aTyr Pharma, NOV 10, 2021, View Source [SID1234595274]).
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"The third quarter was a major inflection point for aTyr; we demonstrated, via clinical proof-of-concept data for ATYR1923, that our novel tRNA synthetase biology platform has the potential to treat serious diseases," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The positive results reported from our Phase 1b/2a study of ATYR1923 in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, suggest that ATYR1923 could be a transformative therapy for patients by reducing steroid burden while improving lung function and measures of sarcoidosis symptoms. We look forward to advancing ATYR1923 to a registrational trial in pulmonary sarcoidosis next year, which will bring us one step closer to delivering a potential new treatment to sarcoidosis patients with clinically meaningful outcomes."
Third Quarter 2021 and Subsequent Period Highlights
Reported positive results from a Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. 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. Based on the results of the study, the company expects to initiate a registrational trial in pulmonary sarcoidosis next year. Furthermore, the data support the expansion of the development of ATYR1923 in other forms of ILD, such as connective tissue disease-related ILD and chronic hypersensitivity pneumonitis.
Announced the presentation of preclinical research demonstrating the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, on tumor associated macrophages at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Treatment of human triple-negative breast cancer cells with ATYR2810 was shown to modulate key immune cells suppressing T-cell mediated anti-tumor responses in the tumor microenvironment and decrease ZEB1 gene expression, a master transcription factor regulating epithelial-mesenchymal transition, a process that is of great importance in regulating tumor growth, progression and metastatic cascade. These data advance the understanding of ATYR2810’s mechanism of action and the process by which it may inhibit tumor progression and disrupt immune invasion and will support clinical development for ATYR2810, including a planned Phase 1 study in cancer next year.
Appointed Robert W. Ashworth, PhD, as Vice President of Regulatory Affairs. Dr. Ashworth is an industry veteran with more than 35 years of regulatory and drug development experience, including a track record of contributing to the FDA approval of more than 12 new drugs. Dr. Ashworth will serve as a member of the company’s executive leadership team, overseeing regulatory affairs functions and strategies.
Raised net proceeds of $80.6 million through the issuance of 10,781,250 shares of common stock in September 2021 from a public offering.
Third Quarter 2021 Financial Highlights
Cash & Investment Position: Cash, cash equivalents and investments as of September 30, 2021 were $116.4 million.
R&D Expenses: Research and development expenses were $5.1 million for the third quarter of 2021, which consisted primarily of product development costs for ATYR1923 and ATYR2810 programs.
G&A Expenses: General and administrative expenses were $2.6 million for the third quarter of 2021.
Shares Outstanding: Commons shares outstanding were 27,790,677 as of September 30, 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 9134928. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source 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 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.