aTyr Pharma Announces First Quarter 2019 Results and Provides Corporate Update
Phase 1b/2a proof-of-concept clinical trial of ATYR1923 in pulmonary sarcoidosis patients ongoing
Advanced lead position in Neuropilin-2 (NRP-2) biology with inaugural NRP-2 summit
Company to host conference call and webcast today at
“During the first quarter, we continued to execute on our Phase 1b/2a study of our lead therapeutic candidate, ATYR1923, a selective NRP-2 inhibitor, in patients with pulmonary sarcoidosis, and we look forward to reporting interim results in the fourth quarter of this year,” said Dr.
First Quarter 2019 and Subsequent Period Highlights
- Advanced its ongoing Phase 1b/2a clinical trial of ATYR1923 in pulmonary sarcoidosis patients, with interim data expected during the fourth quarter of this year.
- Hosted an inaugural Neuropilin-2 (NRP-2) Summit Meeting featuring key researchers from
the United Statesand Europeto discuss the most recent discoveries relating to the development of therapeutics directed to the NRP-2 co-receptor, and related signaling pathways.
- Closed a
$5 millionregistered direct investment led by Federated Kaufmann Small Cap Fund.
- Announced a research collaboration and option agreement with global biotherapeutics leader CSL Behring to accelerate development of product candidates derived from up to four tRNA synthetases from aTyr’s preclinical pipeline.
- Announced an upcoming poster presentation at the
American Thoracic Society2019 International Conference, which is being held May 19-22in Dallas. The poster will describe preclinical findings from a study of ATYR1923 in murine models of interstitial lung diseases (ILDs), including sclerodermatous chronic graft-versus-host disease (scl cGvHD), Saccharopolyspora rectivirgula-induced chronic hypersensitivity pneumonitis (CHP), propionibacterium acnes-induced pulmonary granulomatosis (sarcoidosis) and rheumatoid arthritis-associated interstitial lung disease (RA-ILD). ATYR1923 treatment significantly decreased both skin and lung fibrosis in the scl cGvHD model, and it also reduced lung protein levels of several fibrosis-related cytokines or chemokines in the highly inflammatory experimental CHP and sarcoidosis models.
- Presented a poster at the 2019
American Association for Cancer Research(AACR) summarizing recent data from the Company’s collaboration and ongoing pilot study with the University of Nebraska Medical Centeraimed at advancing NRP-2 biology and exploring potential therapeutic opportunities for ATYR1923. The pilot study was led by Dr. Kaustubh Datta, a recognized expert in the field of NRP-2 biology.
- Presented preclinical data at Keystone Symposia 2019 Conference in February 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.
First Quarter 2019 Financial Results and Cash Position
Research and development expenses were
Conference Call and Webcast Details
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
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.
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 current and 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 March 31,|
|Research and development||$||3,345||$||6,150|
|General and administrative||2,532||4,070|
|Total operating expenses||5,877||10,220|
|Loss from operations||(5,877||)||(10,220||)|
|Total other expense, net||(260||)||(447||)|
|Net loss per share attributable to common stock holders, basic and diluted||$||(0.18||)||$||(0.36||)|
|Weighted average common stock shares outstanding, basic and diluted||33,823,909||29,795,466|
|ATYR PHARMA INC.|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash, cash equivalents and available-for-sale investments||$||43,019||$||49,545|
|Property and equipment, net||1,692||1,853|
|Accounts payable, accrued expenses and other liabilities||$||2,703||$||3,066|
|Current portion of operating lease liability||681||—|
|Current portion of long-term debt, net of issuance costs and discount||7,791||7,767|
|Long-term operating lease liability, net of current portion||2,815||—|
|Long-term debt, net of current portion and issuance costs and discount||6,440||8,263|
|Total liabilities and stockholders’ equity||$||49,915||$||52,746|
Source: aTyr Pharma, Inc.