aTyr Pharma Announces Fourth Quarter and Full Year 2018 Results and Provides Corporate Update
Phase 1b/2a proof-of-concept clinical trial of ATYR1923 in pulmonary sarcoidosis patients initiated in
First tRNA synthetase partnership announced in
“We continue to execute our clinical development plan for our lead therapeutic candidate, ATYR1923, while also entering into meaningful collaborations with both academic institutions and global drug development partners that leverage our novel tRNA synthetase biology,” said Dr.
Fourth Quarter and Subsequent Period Clinical Highlights and Upcoming Milestones
- Initiated its Phase 1b/2a study of ATYR1923 in patients with pulmonary sarcoidosis in collaboration with the
Foundation for Sarcoidosis Research (FSR)- Interim results expected during the fourth quarter of this year
- Announced an expansion of its successful pilot study and entered into a research collaboration with the
University of Nebraska Medical Center (UNMC) to advance neuropilin-2 (NRP-2) biology and explore potential therapeutic opportunities for ATYR1923. Data from the pilot study has provided further evidence that ATYR1923 modulates immune cell biology and a poster will be presented at the 2019 AACR Annual Meeting onApril 3, 2019 .
Research Highlights
- Entered into a research collaboration and option agreement with CSL Behring (CSL) for the development of product candidates derived from up to four tRNA synthetases from aTyr’s preclinical pipeline. Under the terms of the collaboration, CSL will fund all research and development activities, and aTyr is eligible to receive up to
$17 million in option fees ($4.25 million per synthetase program). aTyr will grant CSL the option to negotiate licenses for worldwide rights to each IND candidate that emerges from this collaboration. - Presented preclinical data at Keystone Symposia 2019: Myeloid Cells demonstrating, for the first time, ATYR1923’s ability to bind to NRP-2 and down-regulate myeloid cells, specifically neutrophils, during lung inflammation. These findings help support aTyr’s belief in the mechanism of action of ATYR1923 to suppress immune engagement in pulmonary sarcoidosis as well as other interstitial lung diseases.
Fourth Quarter 2018 Financial Results and Cash Position
Research and development expenses were
General and administrative expenses were
Year Ended
Research and development expenses were
General and administrative expenses were
As of
Conference Call and Webcast Details
About ATYR1923
aTyr is developing ATYR1923 as a potential therapeutic for patients with interstitial lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase (HARS) 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 initiated a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis in the fourth quarter of 2018. 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 (PK) profile of multiple doses of ATYR1923. For the Phase 1b/2a trial, aTyr is collaborating with the
About aTyr
aTyr 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 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. aTyr is focused on the therapeutic translation of the Resokine pathway, comprised of extracellular proteins derived from the histidyl tRNA synthetase gene family. ATYR1923 is a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in interstitial lung diseases and other immune-mediated 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 Litigation Reform Act. 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, including statements regarding our projected cash expenditures, the potential therapeutic benefits and applications of our product candidates; our ability to successfully advance our product candidates, undertake certain development activities (such as the initiation of clinical trials, clinical trial enrollment, the conduct of clinical trials and the announcement of top-line results) and accomplish certain development goals, and the timing of such events; and the scope and strength of our intellectual property portfolio. 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 associated with the discovery, development and regulation of our product candidates, 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 (including difficulties or delays in patient enrollment in planned clinical trials), 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
| ATYR PHARMA INC. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Years Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,549 | $ | 5,310 | $ | 20,385 | $ | 30,067 | ||||||||
| General and administrative | 2,414 | 5,890 | 12,435 | 17,078 | ||||||||||||
| Total operating expenses | 5,963 | 11,200 | 32,820 | 47,145 | ||||||||||||
| Loss from operations | (5,963 | ) | (11,200 | ) | (32,820 | ) | (47,145 | ) | ||||||||
| Total other expense, net | (359 | ) | (274 | ) | (1,695 | ) | (1,062 | ) | ||||||||
| Net loss | $ | (6,322 | ) | $ | (11,474 | ) | $ | (34,515 | ) | $ | (48,207 | ) | ||||
| Net loss per share attributable to common stock holders, basic and diluted | $ | (0.21 | ) | $ | (0.39 | ) | $ | (1.15 | ) | $ | (1.87 | ) | ||||
| Weighted average common stock shares outstanding, basic and diluted | 30,327,072 | 29,768,259 | 29,957,102 | 25,799,853 | ||||||||||||
| ATYR PHARMA INC. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| December 31, | ||||||||
| 2018 | 2017 | |||||||
| Cash, cash equivalents and available-for-sale investments | $ | 49,545 | $ | 85,119 | ||||
| Other assets | 1,348 | 1,956 | ||||||
| Property and equipment, net | 1,853 | 2,280 | ||||||
| Total assets | $ | 52,746 | $ | 89,355 | ||||
| Accounts payable and accrued expenses | $ | 3,066 | $ | 5,379 | ||||
| Current portion of long-term loans, net of debt issuance costs and discount | 7,767 | 5,012 | ||||||
| Term loans, net of current portion and debt issuance costs and discount | 8,263 | 14,719 | ||||||
| Stockholders’ equity | 33,650 | 64,245 | ||||||
| Total liabilities and stockholders’ equity | $ | 52,746 | $ | 89,355 | ||||
Contact:
Managing Director,
jallaire@lifesciadvisors.com
Source: aTyr Pharma, Inc.