UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 9, 2023, aTyr Pharma, Inc. issued a press release announcing financial results for the year ended December 31, 2022. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information under this Item 2.02, including Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ATYR PHARMA, INC. |
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By: |
/s/ Jill M. Broadfoot |
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Jill M. Broadfoot |
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Chief Financial Officer |
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Date: March 9, 2023 |
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Exhibit 99.1
IMMEDIATE RELEASE |
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Contact: |
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Ashlee Dunston |
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Director, Investor Relations and Corporate Communications |
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adunston@atyrpharma.com |
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aTyr Pharma Announces Fourth Quarter and Full Year 2022 Results and Provides Corporate Update
Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis enrolling in the U.S., Europe and Japan.
Phase 2 proof-of-concept study of efzofitimod in patients with SSc-ILD expected to begin in 2023.
February 2023 follow-on common stock offering of approximately $52.0 million in gross proceeds.
Company to host conference call and webcast today, March 9th, at 5:00 p.m. EST / 2:00 p.m. PST.
SAN DIEGO – March 9, 2023 – aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the "Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2022 results and provided a corporate update.
“2022 was an important year for aTyr as we advanced our lead therapeutic candidate, efzofitimod, to a global pivotal Phase 3 study in patients with pulmonary sarcoidosis, the most prevalent form of interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “This study, which is known as EFZO-FIT™, is expected to be the largest interventional study in sarcoidosis to date and is currently enrolling patients at multiple centers in the U.S., Europe and Japan.”
“We are also expanding the clinical development program for our novel immunomodulator efzofitimod with plans to initiate a Phase 2 proof-of-concept study in patients with systemic sclerosis (SSc, or scleroderma)-associated ILD (SSc-ILD) this year, which increases the potential market opportunity in these forms of ILD with high unmet medical need. As a result of program prioritization and proceeds from a recent public offering, we project that we will have sufficient cash to fund both of our efzofitimod clinical trials and the company's operations into 2026. We are very proud of our progress and look forward to the year ahead as we continue our pursuit to develop a new class of medicines.”
Fourth Quarter 2022 and Subsequent Period Highlights
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Year Ended 2022 Financial Highlights and Cash Position
Conference Call and Webcast Details
aTyr will host a conference call and webcast today at 5:00 p.m. EST / 2:00 p.m. PST to discuss its financial results and provide a corporate update. Interested parties may access the call by registering here in order to obtain a dial in, personalized passcode and webcast information. Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event.
About Efzofitimod
aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate immune responses in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which
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demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr is currently conducting EFZO-FIT™, a Phase 3 study of efzofitimod in pulmonary sarcoidosis patients.
About aTyr
aTyr is a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform. 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 efzofitimod, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to downregulate immune engagement in fibrotic lung disease. For more information, please visit www.atyrpharma.com.
Forward-Looking Statements
This 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 “believes,” “expects,” “intends,” “may,” “plans,” “project,” “will,” "would," 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 our belief that we will have sufficient cash to fund both of our efzofitimod clinical trials and the company’s operations into 2026; the expected size of, and number of patients to be enrolled in, the EFZO-FIT™ study; our expectations regarding the size of the EFOZ-FIT™ study being the largest interventional study in sarcoidosis to date; the potential therapeutic benefits and applications of efzofitimod and our discovery programs; and timelines and plans with respect to certain development activities and development goals, including our expectation that our Phase 2 proof-of-concept study of efzofitimod in patients with SSc-ILD will begin in 2023. 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, our assumptions and expectations underlying our belief that we will have sufficient cash runway into 2026 may not be accurate, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the COVID-19 pandemic, and geopolitical conflicts, including the
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risk of delays 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, 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 Quarterly on Form 10-Q for the quarter ended September 30, 2022 filed with the SEC on November 14, 2022 and in our subsequent 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.
ATYR PHARMA INC. |
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Consolidated Statements of Operations |
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(in thousands, except share and per share data) |
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Three Months Ended |
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Years Ended |
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December 31, |
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December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenues: |
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License and collaboration agreement revenues |
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$ |
10,386 |
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$ |
— |
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$ |
10,386 |
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$ |
— |
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Total revenues |
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10,386 |
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— |
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10,386 |
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— |
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Operating expenses: |
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Research and development |
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$ |
14,910 |
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$ |
5,955 |
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$ |
42,808 |
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$ |
23,264 |
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General and administrative |
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3,426 |
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2,685 |
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13,982 |
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10,751 |
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Total operating expenses |
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18,336 |
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8,640 |
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56,790 |
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34,015 |
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Loss from operations |
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(7,950 |
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(8,640 |
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(46,404 |
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(34,015 |
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Total other income (expense), net |
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427 |
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79 |
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1,061 |
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238 |
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Consolidated net loss |
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(7,523 |
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(8,561 |
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(45,343 |
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(33,777 |
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Net loss attributable to noncontrolling interest in Pangu BioPharma Limited |
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2 |
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2 |
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5 |
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9 |
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Net loss attributable to aTyr Pharma, Inc. |
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$ |
(7,521 |
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$ |
(8,559 |
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$ |
(45,338 |
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$ |
(33,768 |
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Net loss per share, basic and diluted |
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$ |
(0.26 |
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$ |
(0.31 |
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$ |
(1.60 |
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$ |
(1.77 |
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Shares used in computing net loss per share, basic and diluted |
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29,116,524 |
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27,791,737 |
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28,419,569 |
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19,080,878 |
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ATYR PHARMA INC. |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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December 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents, restricted cash and available-for-sale investments |
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$ |
69,311 |
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$ |
107,911 |
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Other receivables |
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11,775 |
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435 |
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Property and equipment, net |
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3,059 |
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543 |
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Operating lease, right-of-use assets |
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7,250 |
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1,267 |
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Financing lease, right-of-use assets |
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1,248 |
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— |
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Prepaid expenses and other assets |
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3,143 |
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5,381 |
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Total assets |
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$ |
95,786 |
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$ |
115,537 |
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Accounts payable, accrued expenses and other liabilities |
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$ |
12,968 |
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$ |
5,033 |
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Current portion of operating lease liability |
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630 |
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980 |
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Current portion of financing lease liability |
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264 |
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— |
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Long-term operating lease liability, net of current portion |
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9,633 |
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398 |
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Long-term financing lease liability, net of current portion |
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1,007 |
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— |
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Total stockholders’ equity |
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71,284 |
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109,126 |
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Total liabilities and stockholders’ equity |
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$ |
95,786 |
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$ |
115,537 |
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