UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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 November 9, 2023, aTyr Pharma, Inc. issued a press release announcing financial results for the quarter ended September 30, 2023. 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: November 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 Public Affairs |
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adunston@atyrpharma.com |
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aTyr Pharma Announces Third Quarter 2023 Results and Provides Corporate Update
Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis expected to complete enrollment early in the second quarter of 2024.
Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD initiated patient dosing.
Ended the third quarter of 2023 with $105.6 million in cash, cash equivalents and investments.
SAN DIEGO – November 9, 2023 – aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2023 results and provided a corporate update.
“During the third quarter we made meaningful progress with our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We had a positive data and safety monitoring board (DSMB) review for our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD with high unmet medical need. This study continues to enroll in the U.S., Europe and Japan and based on current projections, we expect to complete enrollment in this study early in the second quarter of 2024. Additionally, we dosed the first patient in our Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD), which is currently enrolling in the U.S.”
Third Quarter 2023 and Subsequent Period Highlights
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Third Quarter 2023 Financial Highlights and Cash Position
About Efzofitimod
Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
About aTyr
aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.
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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,” “potential,” “will,” “project,” 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 runway to fund the Company’s operations through the filing of a BLA for efzofitimod for pulmonary sarcoidosis; the expected size of, and number and nationality of patients to be enrolled in, the EFZO-FIT™ and EFZO-CONNECT™ studies; the potential therapeutic benefits and applications of efzofitimod; and timelines and plans with respect to certain development activities and development goals, including our expectation that our Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis will complete enrollment early in the second quarter of 2024. 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 to fund the Company’s operations through the filing of a BLA for efzofitimod for pulmonary sarcoidosis may not be accurate, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the ultimate long-term impact of evolving macroeconomic and geopolitical conditions, the 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 most recent Annual Report on Form 10-K, Quarterly Reports on form 10-Q and in our other 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.
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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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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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(unaudited) |
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Revenues: |
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License and collaboration agreement revenues |
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$ |
353 |
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$ |
— |
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$ |
353 |
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$ |
— |
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Total revenues |
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353 |
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— |
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353 |
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— |
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Operating expenses: |
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Research and development |
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$ |
10,319 |
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$ |
9,867 |
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$ |
29,538 |
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$ |
27,898 |
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General and administrative |
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2,649 |
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3,625 |
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9,775 |
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10,556 |
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Total operating expenses |
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12,968 |
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13,492 |
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39,313 |
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38,454 |
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Loss from operations |
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(12,615 |
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(13,492 |
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(38,960 |
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(38,454 |
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Total other income (expense), net |
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1,273 |
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247 |
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3,324 |
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634 |
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Consolidated net loss |
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(11,342 |
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(13,245 |
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(35,636 |
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(37,820 |
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Net loss attributable to noncontrolling interest in Pangu BioPharma Limited |
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2 |
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1 |
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7 |
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3 |
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Net loss attributable to aTyr Pharma, Inc. |
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$ |
(11,340 |
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$ |
(13,244 |
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$ |
(35,629 |
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$ |
(37,817 |
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Net loss per share, basic and diluted |
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$ |
(0.20 |
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$ |
(0.46 |
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$ |
(0.69 |
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$ |
(1.34 |
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Shares used in computing net loss per share, basic and diluted |
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57,885,393 |
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28,663,047 |
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51,700,864 |
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28,184,698 |
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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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September 30, |
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December 31, |
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2023 |
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2022 |
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(unaudited) |
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Cash, cash equivalents, restricted cash and available-for-sale investments |
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$ |
105,582 |
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$ |
69,311 |
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Other receivables |
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2,087 |
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11,775 |
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Property and equipment, net |
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5,644 |
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3,059 |
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Operating lease, right-of-use assets |
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6,812 |
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7,250 |
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Financing lease, right-of-use assets |
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1,791 |
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1,248 |
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Prepaid expenses and other assets |
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3,153 |
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3,143 |
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Total assets |
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$ |
125,069 |
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$ |
95,786 |
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Accounts payable, accrued expenses and other liabilities |
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$ |
11,648 |
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$ |
12,968 |
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Current portion of operating lease liability |
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774 |
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630 |
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Current portion of financing lease liability |
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459 |
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264 |
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Long-term operating lease liability, net of current portion |
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12,548 |
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9,633 |
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Long-term financing lease liability, net of current portion |
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1,437 |
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1,007 |
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Total stockholders’ equity |
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98,203 |
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71,284 |
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Total liabilities and stockholders’ equity |
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$ |
125,069 |
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$ |
95,786 |
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5