aTyr Pharma Announces Second Quarter 2023 Results and Provides Corporate Update
August 09 2023 - 4:00PM
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 second quarter 2023 results and provided
a corporate update.
“Throughout the second quarter we have continued
to progress and invest in 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. “Our global pivotal Phase 3
EFZO-FIT™ study in patients with pulmonary sarcoidosis, the most
prevalent form of ILD, continues to enroll and our Phase 2
EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or
scleroderma)-associated ILD (SSc-ILD), is expected to enroll the
first patient in the third quarter.”
Second Quarter 2023 and Subsequent
Period Highlights
- Continued
enrollment in the global pivotal Phase 3
EFZO-FIT™ study to evaluate the
efficacy and safety of efzofitimod in patients with pulmonary
sarcoidosis. This is a randomized, double-blind,
placebo-controlled, 52-week study consisting of three parallel
cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of
efzofitimod or placebo dosed intravenously monthly for a total of
12 doses. The study intends to enroll up to 264 subjects with
pulmonary sarcoidosis. The study is open for enrollment at nearly
all of the centers intended in the U.S., Europe and Japan and is
expected to expand to include centers in Brazil.
- Progressed
plans to initiate the Phase 2
EFZO-CONNECT™ study to evaluate
the efficacy, safety and tolerability of efzofitimod in patients
with SSc-ILD. This proof-of-concept study will be a
randomized, double-blind, placebo-controlled, 28-week study
consisting of three parallel cohorts randomized 2:2:1 to either 270
mg or 450 mg of efzofitimod or placebo dosed intravenously monthly
for a total of 6 doses. The study is expected to enroll 25 patients
at multiple centers in the U.S. The primary objective of the study
will be to evaluate the efficacy of multiple doses of intravenous
efzofitimod on pulmonary, cutaneous and systemic manifestations in
patients with SSc-ILD. The study is expected to initiate in the
third quarter of 2023.
- Received
European Commission orphan drug designation for efzofitimod for the
treatment of SSc based on the opinion of the European Medicines
Agency (EMA) Committee for Orphan Medicinal Products. The
EMA grants orphan status to products intended for the treatment,
prevention or diagnosis of a disease with a prevalence no more than
five in 10,000 people in the EU that is life-threatening or
chronically debilitating for which either no satisfactory method of
diagnosis, prevention, or treatment exists, or if such a method
exists, the medicine is of significant benefit to those affected by
such condition. EMA orphan drug designation provides certain
benefits, including the potential for up to 10 years of marketing
exclusivity following regulatory approval in the EU, reduction in
regulatory fees and a centralized EU approval process.
- Announced
two posters for efzofitimod accepted for presentation at the
upcoming European Respiratory Society (ERS) International Congress
2023. The conference is scheduled to take place September
9 – 13, 2023, in Milan, Italy. The Company will present new data
from a pooled, post hoc analysis from the Phase 1b/2a study of
efzofitimod in patients with pulmonary sarcoidosis that further
supports efficacy measures in these patients. Additionally, new
mechanistic data supports the rationale for efzofitimod as a
potential treatment for patients with SSc-ILD.
- Poster
PA419 – Efzofitimod: A Novel Therapeutic Candidate for
SSc-ILD on Sunday, September 10, 2023, from 8:00 a.m. to 9:30 a.m.
CEST.
- Poster
PA1744 – Therapeutic Doses of Efzofitimod Significantly
Improve Multiple Pulmonary Sarcoidosis Efficacy Measures on Sunday,
September 10, 2023, from 4:00 p.m. to 5:30 p.m. CEST.
Second Quarter 2023 Financial Highlights
and Cash Position
- Cash &
Investment Position: Cash, restricted cash, cash
equivalents and investments as of June 30, 2023, were $112.0
million. Based on the Company’s current operational plans and
existing cash, the Company maintains its prior guidance and
believes its cash runway will extend into 2026.
- R&D
Expenses: Research and development expenses were $9.8
million for the second quarter of 2023, which consisted primarily
of clinical trial costs for the Phase 3 EFZO-FIT™ study,
manufacturing costs for the efzofitimod program and research and
development costs for the efzofitimod and discovery programs.
- G&A
Expenses: General and administrative expenses were $3.7
million for the second quarter of 2023.
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
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,” “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
include statements regarding our belief that we will have
sufficient cash runway to fund both of our efzofitimod clinical
trials and the Company’s operations into 2026; the expected size
of, and number and nationality of patients to be enrolled in, the
EFZO-FIT™ and EFZO-CONNECT™ studies; certain potential benefits of
EMA orphan drug designation; 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
initiate in the third quarter of 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 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 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. |
|
Consolidated Statements of Operations |
|
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,840 |
|
|
$ |
9,135 |
|
|
$ |
19,219 |
|
|
$ |
18,031 |
|
General and administrative |
|
|
3,718 |
|
|
|
3,449 |
|
|
|
7,126 |
|
|
|
6,931 |
|
Total operating expenses |
|
|
13,558 |
|
|
|
12,584 |
|
|
|
26,345 |
|
|
|
24,962 |
|
Loss from operations |
|
|
(13,558 |
) |
|
|
(12,584 |
) |
|
|
(26,345 |
) |
|
|
(24,962 |
) |
Total other income (expense), net |
|
|
1,216 |
|
|
|
163 |
|
|
|
2,051 |
|
|
|
387 |
|
Consolidated net loss |
|
|
(12,342 |
) |
|
|
(12,421 |
) |
|
|
(24,294 |
) |
|
|
(24,575 |
) |
Net loss attributable to
noncontrolling interest in Pangu BioPharma Limited |
|
|
4 |
|
|
|
1 |
|
|
|
5 |
|
|
|
2 |
|
Net loss attributable to aTyr
Pharma, Inc. |
|
$ |
(12,338 |
) |
|
$ |
(12,420 |
) |
|
$ |
(24,289 |
) |
|
$ |
(24,573 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.88 |
) |
Shares used in computing net
loss per share, basic and diluted |
|
|
55,143,805 |
|
|
|
28,063,387 |
|
|
|
48,557,347 |
|
|
|
27,941,560 |
|
ATYR PHARMA INC. |
|
Condensed Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
|
Cash, cash equivalents, restricted cash and available-for-sale
investments |
|
$ |
112,000 |
|
|
$ |
69,311 |
|
Other receivables |
|
|
1,287 |
|
|
|
11,775 |
|
Property and equipment,
net |
|
|
5,812 |
|
|
|
3,059 |
|
Operating lease, right-of-use
assets |
|
|
7,119 |
|
|
|
7,250 |
|
Financing lease, right-of-use
assets |
|
|
1,894 |
|
|
|
1,248 |
|
Prepaid expenses and other
assets |
|
|
4,635 |
|
|
|
3,143 |
|
Total assets |
|
$ |
132,747 |
|
|
$ |
95,786 |
|
|
|
|
|
|
|
|
Accounts payable, accrued
expenses and other liabilities |
|
$ |
11,304 |
|
|
$ |
12,968 |
|
Current portion of operating
lease liability |
|
|
621 |
|
|
|
630 |
|
Current portion of financing
lease liability |
|
|
443 |
|
|
|
264 |
|
Long-term operating lease
liability, net of current portion |
|
|
12,802 |
|
|
|
9,633 |
|
Long-term financing lease
liability, net of current portion |
|
|
1,525 |
|
|
|
1,007 |
|
Total stockholders’
equity |
|
|
106,052 |
|
|
|
71,284 |
|
Total liabilities and stockholders’ equity |
|
$ |
132,747 |
|
|
$ |
95,786 |
|
Contact: |
Ashlee Dunston |
Director, Investor Relations and
Public Affairs |
adunston@atyrpharma.com |
|
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