false 0001339970 0001339970 2022-05-09 2022-05-09

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

  

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 9, 2022

 

ATYR PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-37378		20-3435077
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)
3545 John Hopkins Court, Suite #250 San Diego, CA				92121
(Address of Principal Executive Offices)				(Zip Code)

 Registrant’s telephone number, including area code: (858) 731-8389

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	LIFE	The Nasdaq Capital Market

 

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 May 9, 2022, aTyr Pharma, Inc. issued a press release announcing financial results for the three months ended March 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.		Description
99.1		Press Release, dated May 9, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

2

---

 

 

 

 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.

 

	ATYR PHARMA, INC.
	By:	/s/ Jill M. Broadfoot
		Jill M. Broadfoot
		Chief Financial Officer
Date: May 9, 2022

 

 

3

 

Exhibit 99.1

 

aTyr Pharma Announces First Quarter 2022 Results and Provides Corporate Update

 

Company to present clinical data for efzofitimod (ATYR1923) in pulmonary sarcoidosis at upcoming American Thoracic Society International Conference in May.

Planned registrational study of efzofitimod in pulmonary sarcoidosis on track to initiate in the third quarter of 2022.

FDA granted orphan drug designation for efzofitimod for the treatment of systemic sclerosis; company to explore potential expansion of clinical program in other ILD.

Ended the first quarter 2022 with $98.7 million in cash, cash equivalents and investments.

Company to host conference call and webcast today, May 9^th, at 5:00 p.m. EDT / 2:00 p.m. PDT.

SAN DIEGO – May 9, 2022 – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology platform, today announced first quarter 2022 results and provided a corporate update.

“We are pleased with the start of 2022 and the continued progress throughout the first quarter for our efzofitimod clinical program in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “With the receipt of U.S. Food and Drug Administration (FDA) orphan drug designation and a positive End-of-Phase 2 meeting with the FDA, we are on track to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of this year.”

“The second quarter is shaping up to be an important period, as we prepare to present the clinical data for the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis at the upcoming American Thoracic Society (ATS) International Conference and anticipate the potential publication of a related manuscript. We are focused on preparation for the planned registrational study so that the balance of the year may center upon initiating the study in the U.S. and Europe and supporting our partner Kyorin Pharmaceutical with the anticipated launch of

1

---

the study in Japan.”

First Quarter 2022 and Subsequent Period Highlights

First Quarter 2022 Financial Highlights and Cash Position

2

---

 

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the U.S., or 209-905-5951 internationally and using conference ID 9273437. 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 and adaptive immune response 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 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 intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.    

About aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology 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 http://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 “anticipates,” “believes,” “expects,” “intends,” “may,” “plans,” “will,” and variations of such words or similar expressions. We

3

---

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 the potential therapeutic benefits and applications of efzofitimod, ATYR2810 and our discovery programs; timelines and plans with respect to certain development activities (including the further development of efzofitimod and ATYR2810 and the timing and design of future clinical trials) and certain development goals. 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, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the COVID-19 pandemic, including 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.

 

4

---

 

 

 

 

5