aTyr Pharma Announces Fourth Quarter and Year-End 2017 Operating Results and Provides Corporate Update
“We achieved several key milestones in 2017 that will enable the continued development of our ORCA and ATYR1923 programs, and allows us to actively pursue our mission to develop and deliver innovative therapeutics based on our knowledge of novel immunological pathways,” said
Program Highlights
- In
November 2017 , aTyr initiated a Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, immunogenicity and pharmacokinetics of intravenous ATYR1923 in healthy volunteers.- aTyr expects to announce top-line results from this study in the second quarter of 2018.
- In
December 2017 , aTyr selected a panel of antibodies for continued preclinical development and initiated CMC activities from its ORCA program.- aTyr expects to initiate patient trials as early as 2019.
- In
January 2018 , aTyr presented data from its ORCA program highlighting the potential importance of Resokine in immuno-oncology at theAmerican Society of Clinical Oncology –Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium inSan Francisco .- Identification of Novel Liquid Biopsy Biomarker for Monitoring the
Immune Set Point in Both Solid Tumor and Hematological Malignancy Patients
- Identification of Novel Liquid Biopsy Biomarker for Monitoring the
- In
April 2018 , aTyr will present additional data on its ORCA program at the upcomingAmerican Association for Cancer Research (AACR) Annual Meeting inChicago :April 16, 2018 : Circulating levels of Resokine, a soluble modulator of the immune system, are upregulated in both experimental cancer models and in patients across multiple tumor typesApril 17, 2018 : Antibodies targeting Resokine, a soluble immune modulator, inhibit tumor growth in syngeneic mouse models
Corporate Highlights
- In
November 2017 , aTyr appointedSanjay Shukla , M.D., M.S., as President and Chief Executive Officer. - In
February 2018 , aTyr promotedDavid J. King , Ph.D. to Chief Scientific Officer andAshraf Amanullah , Ph.D. to Senior Vice President,Biologics Development and Manufacturing.
Fourth Quarter 2017 Financial Results
Research and development expenses were
General and administrative expenses were
Full Year 2017 Financial Results
Research and development expenses were
General and administrative expenses were
Financial Guidance
As of
aTyr expects that its cash, cash equivalents and investments will be sufficient to fund its anticipated operations into the third quarter of 2019.
Conference Call and Webcast Details
About
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 the potential therapeutic benefits of ATYR1923 or potential product candidates from our ORCA program, the ability of the Company to successfully advance its pipeline or product candidates, undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals and the timing of such activities and development goals, the timing of our clinical trials, our ability to receive regulatory approvals for, and commercialize, our product candidates and of reporting results from our clinical trials, the scope and strength of our intellectual property portfolio and our projected cash expenditures 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 those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the 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 its 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 its business and product development plans, as well as those 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, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 5,310 | $ | 9,144 | $ | 30,067 | $ | 42,846 | ||||||||
General and administrative | 5,890 | 3,383 | 17,078 | 15,094 | ||||||||||||
Total operating expenses | 11,200 | 12,527 | 47,145 | 57,940 | ||||||||||||
Loss from operations | (11,200 | ) | (12,527 | ) | (47,145 | ) | (57,940 | ) | ||||||||
Other income (expense), net | (274 | ) | (59 | ) | (1,062 | ) | 65 | |||||||||
Loss on extinguishment of debt | — | (29 | ) | — | (29 | ) | ||||||||||
Other income (expense) | (274 | ) | (88 | ) | (1,062 | ) | 36 | |||||||||
Loss before income taxes | (11,474 | ) | (12,615 | ) | (48,207 | ) | (57,904 | ) | ||||||||
Income tax benefit | — | 49 | — | 49 | ||||||||||||
Net loss | $ | (11,474 | ) | $ | (12,566 | ) | $ | (48,207 | ) | $ | (57,855 | ) | ||||
Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (0.53 | ) | $ | (1.87 | ) | $ | (2.44 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 29,768,259 | 23,716,904 | 25,799,853 | 23,681,019 | ||||||||||||
ATYR PHARMA INC. | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
December 31, | December 31, | ||||||||
2017 | 2016 | ||||||||
Cash, cash equivalents and available-for-sale investments | $ | 85,119 | $ | 76,149 | |||||
Other assets | 1,956 | 2,954 | |||||||
Property and equipment, net | 2,280 | 1,421 | |||||||
Total assets | $ | 89,355 | $ | 80,524 | |||||
Accounts payable, accrued expenses and other liabilities | $ | 5,379 | $ | 8,186 | |||||
Current portion of long-term loans, net of debt issuance costs and discount | 5,012 | 339 | |||||||
Term loans, net of current portion and debt issuance costs and discount | 14,719 | 9,198 | |||||||
Stockholders’ equity | 64,245 | 62,801 | |||||||
Total liabilities and stockholders’ equity | $ | 89,355 | $ | 80,524 | |||||
Contact:
Sr. Director, Investor Relations
mjohnson@atyrpharma.com
858-223-1163
Source: aTyr Pharma, Inc.