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

August 10, 2016

Date of Report (Date of earliest event reported)

 

 

ATYR PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

(858) 731-8389

 (Registrant’s telephone number, including area code)

 

 

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:

 

 

 

 

 

 

 

 

---

 

Item 2.02                                           Results of Operations and Financial Condition.

 

On August 10, 2016, aTyr Pharma, Inc. (the “Company”) announced financial results for the quarter ended June 30, 2016 in the earnings release attached hereto as Exhibit 99.1.

 

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 (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d) Exhibits.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

---

 

 

INDEX TO EXHIBITS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 

Exhibit 99.1

 

 

 

aTyr Pharma Announces Second Quarter 2016 Operating Results

 

SAN DIEGO – August 10, 2016 – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced operating results for the second quarter ended June 30, 2016.

“We continue to execute on our vision to bring innovative therapeutics to patients severely afflicted by rare diseases. During this last quarter, we made considerable progress toward that goal on three fronts: first, we advanced Resolaris in three distinct opportunities to help patients with rare myopathies with an immune component (RMIC),” said John Mendlein, PhD, Chief Executive Officer of aTyr Pharma. “Second, we further elucidated the mechanism of the Resokine pathway which includes affecting T-cell activation; and finally, we have advanced our second program, iMod.Fc, to cGMP manufacturing for GLP safety studies and are on track to have that candidate enter the clinic in 2017. We also want to thank the 35 facioscapulohumeral muscular dystrophy (FSHD) and 10 limb-girdle muscular dystrophy 2B (LGMD2B) patients that have participated or are participating in our clinical trials, as well as the physicians and investigators that make these studies possible across 14 global sites.”      

Recent Highlights and Upcoming Milestones

Following the encouraging results from our previously announced Phase 1b/2 trial of Resolaris in patients diagnosed with adult FSHD, our 002 trial, we continued to enroll patients across three ongoing clinical studies for three different types of rare myopathies with an immune component. The primary objectives of these studies are to establish a safety and tolerability database and to explore and establish activity signals, such as various functional endpoints and biomarkers, which will best inform our clinical development path forward, including endpoints for a Biologics License Application (BLA).

Highlights from our ongoing Resolaris program include:

1

---

Our scientists, clinical operations professionals, and clinicians continued to advance our science, protein manufacturing, and programs with recent highlights, including:

2

---

Second Quarter 2016 Financial Results  

Research and development expenses were $11.3 million and $7.5 million for the quarters ended June 30, 2016 and 2015, respectively. The increase of $3.8 million was due primarily to a $1.9 million increase in clinical and non-clinical development costs for Resolaris, a $0.8 million increase related to compensation expenses resulting from increased headcount in research and development functions, including $0.1 million in non-cash stock-based compensation, a $0.7 million increase related to cGMP manufacturing of Resolaris to support future clinical trials, and a $0.4 million increase in other pre-clinical development costs.

Sequentially, there was a $2.4 million decrease related to the cGMP manufacturing of Resolaris in the second quarter of 2016 versus the first quarter of 2016, as much of the investment required to supply future clinical trials was spent in the first quarter of 2016, partially offset by a $1.2 million increase in clinical and non-clinical development costs for Resolaris.  

General and administrative expenses were $4.1 million and $3.4 million for the quarters ended June 30, 2016 and 2015, respectively. The increase of $0.7 million was due primarily to a $0.5 million increase in non-cash stock-based compensation and a $0.2 million increase in costs associated with being a public company.

First Half 2016 Financial Results

Research and development expenses were $23.3 million and $14.1 million for the six months ended June 30, 2016 and 2015, respectively. The increase of $9.2 million was due primarily to a $4.7 million increase related to cGMP manufacturing of Resolaris to support future clinical trials, a $3.5 million increase in clinical and non-clinical development costs for Resolaris, a $1.6 million increase related to compensation expenses resulting from increased headcount in research and development functions, including $0.3 million of non-cash stock-based compensation, and $0.7 million in other pre-clinical development costs.  The increase was offset by a decrease related to a one-time $1.4 million non-cash expense for the assignment of certain intellectual property rights in the prior year period.

General and administrative expenses were $8.2 million and $5.7 million for the six months ended June 30, 2016 and 2015, respectively. The increase of $2.5 million was due primarily to a $1.8 million increase in personnel costs resulting from increased headcount inclusive of $1.0 million of non-cash stock-based compensation and a $0.6 million increase in costs associated with being a public company.

Financial Guidance

As of June 30, 2016, we had $96.6 million in cash, cash equivalents and investments and 23.7 million shares of common stock outstanding. 

We currently expect that our cash, cash equivalents and investments will be sufficient to fund our anticipated operations into 2018.

3

---

About Physiocrines

Physiocrines comprise naturally occurring proteins that aTyr believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state. Physiocrines are extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis. aTyr is currently focused on Physiocrines that act as endogenous modulators of the immune system. Physiocrines offer the opportunity for modulating biological pathways through newly discovered, naturally occurring mechanisms, many of which provide advantages over engineered immune-modulatory therapeutics, including the potential for improved patient outcomes and reduced side effect profiles.

About Resolaris™

aTyr Pharma is developing Resolaris as a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris is derived from a naturally occurring protein released in vitro by human skeletal muscle cells. aTyr believes Resolaris has the potential to provide therapeutic benefit to patients with rare myopathies with an immune component characterized by excessive immune cell involvement.

About FSHD

Facioscapulohumeral muscular dystrophy (FSHD) is a rare genetic myopathy affecting an estimated 19,000 people in the United States for which there are no approved treatments. The primary clinical phenotype of FSHD is debilitating skeletal muscle deterioration and weakness. The symptoms of FSHD often appear early in the face, shoulder blades, upper arms, lower legs and trunk, and can affect certain muscles while adjacent muscles remain healthy. In addition to muscle weakness, FSHD patients often experience debilitating fatigue and chronic pain. The disease is typically diagnosed by the presence of a characteristic pattern of muscle weakness and other clinical symptoms, as well as through genetic testing. Early onset FSHD occurs in individuals who experience symptoms of progressive muscle involvement as juveniles, and some of these patients suffer from a particularly severe form of the disease.  To learn more about FSHD please visit www.fshsociety.org.        

About LGMD2B

Limb girdle muscular dystrophy (LGMD) refers to a group of rare genetic myopathies, of which there are more than 20 different subtypes, none with approved therapies. LGMD affects an estimated 16,000 patients in the U.S., approximately 3,000 of whom have LGMD2B. LGMD2B is a recessive genetic disease caused by mutations in the dysferlin gene.  Patients experience debilitating muscle weakness and atrophy as well as immune cell invasion in the skeletal muscle.  Patients are primarily assessed for clinical symptoms to assess skeletal muscle health.  To learn more about LGMD2 please visit www.jain-foundation.org.

4

---

About aTyr Pharma

aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company's lead candidate, Resolaris™, is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris is currently in a Phase 1b/2 clinical trial in adult patients with facioscapulohumeral muscular dystrophy (FSHD); a Phase 1b/2 trial in adult patients with limb-girdle muscular dystrophy 2B (LGMD2B or dysferlinopathies) or FSHD; and a Phase 1b/2 trial in patients with an early onset form of FSHD. To protect this pipeline, aTyr has built an intellectual property estate comprising over 80 issued or allowed patents and over 230 pending patent applications that are owned or exclusively licensed by aTyr, including over 300 potential Physiocrine-based protein compositions. aTyr's key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. 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 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 of Resolaris™ or iMod.Fc, the ability of the Company to undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals, the timing of initiation of additional clinical trials and of reporting results from our clinical trials and 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 Physiocrine-based product candidates, as well as those set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2015 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.

 

5

---

 

 

ATYR PHARMA INC.

Condensed Consolidated Statements of Operations

(unaudited, in thousands, except share and per share data)

 

 

ATYR PHARMA INC.

Condensed Consolidated Balance Sheets

(in thousands)

 

 

# # #

6