aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel biological pathways, today announced first quarter 2021
results and provided a corporate update.
“During the first quarter, we remained focused
on advancing our lead therapeutic candidate, ATYR1923. We are
tracking towards the readout from our Phase 1b/2a proof-of-concept
study in pulmonary sarcoidosis, our initial interstitial lung
disease (ILD) indication, which is expected in the third quarter of
this year,” said Sanjay S. Shukla, M.D., M.S., President and Chief
Executive Officer of aTyr. “We have key mechanistic insights
regarding ATYR1923’s anti-inflammatory effects in patients from our
Phase 2 study in COVID-19 related respiratory complications. This
clinical data is consistent with what we have seen preclinically
for key anti-inflammatory cytokines that are implicated in
sarcoidosis and other ILD.”
“Furthermore, we generated additional
preclinical data for ATYR2810, our lead anti-Neuropilin-2 (NRP2)
antibody and IND candidate, including research presented at the
American Academy of Cancer Research (AACR) Annual Meeting
demonstrating tumor inhibitory effects in triple-negative breast
cancer (TNBC) and non-small cell lung cancer (NSCLC), as both a
single agent and in combination with chemotherapy and the targeted
agent bevacizumab. Our manufacturing agreement with Lonza for the
production of this antibody reflects our commitment to this
program. We are off to a strong start in 2021 and look forward to
building upon this progress throughout the year.”
First Quarter 2021 and Subsequent Period
Highlights
- Progressed its Phase 1b/2a
multiple-ascending dose, placebo-controlled study of ATYR1923 in 37
patients with pulmonary sarcoidosis. Data is expected in the third
quarter of this year.
- Reported positive results from its
Phase 2 study of ATYR1923 in COVID-19 patients with severe
respiratory complications, which provided proof-of-mechanism for
ATYR1923. The study met its primary safety endpoint and
demonstrated signals of clinical activity. Biomarker data showed
that ATYR1923 reduced levels of several inflammatory cytokines and
chemokines, including those that are implicated in sarcoidosis and
other ILD, which is consistent with findings from animal
models.
- Appointed leading sarcoidosis
advocate Andrea Wilson as a patient advisor to the company. Ms.
Wilson, Co-Founder and former member of the Board of Directors for
the Foundation for Sarcoidosis Research (FSR), will advise the
company on patient strategies related to its clinical program for
ATYR1923 in pulmonary sarcoidosis.
- Participated in a Virtual Town Hall
on Steroids and Sarcoidosis in collaboration with the FSR to
discuss the burden of steroid treatment for patients with
sarcoidosis and the need for new treatments.
- Presented two posters at the AACR
Annual Meeting related to preclinical research for ATYR2810 in
conjunction with the company’s scientific advisor Dr. Arthur
Mercurio and his lab at the Department of Molecular, Cell and
Cancer Biology at the University of Massachusetts Medical School.
In models of TNBC, ATYR2810 administered in combination with widely
used anti-cancer therapeutics, including chemotherapy or the
targeted VEGF antibody bevacizumab, increased the anti-tumor
effects of each agent. ATYR2810 also down-regulated
epithelial-mesenchymal transition genes, which may be a mechanism
that mediates its anti-tumor effects. In animal models of NSCLC,
ATYR2810 inhibited tumor growth when administered both as a single
agent and in combination with chemotherapy.
- Entered into an agreement with
Lonza, a leading contract development and manufacturing
organization, for the manufacture of ATYR2810 to support the
progression of ATYR2810 to clinical stage development.
- Pangu BioPharma, the company’s Hong
Kong subsidiary, together with the Hong Kong University of Science
and Technology, achieved the milestones of the first year of a
two-year project funded in part by the Hong Kong Government’s
Innovation and Technology Commission to develop a high-throughput
platform for the development of bispecific antibodies targeting
NRP2.
- Promoted Leslie Nangle, Ph.D., to
Vice President, Research. Dr. Nangle will serve as a member of the
company’s executive leadership team, managing research and
scientific operations.
First Quarter 2021 Financial Results
Total revenues were $0 and $8.1 million for the
three months ended March 31, 2021 and 2020, respectively. Revenues
for the three months ended March 31, 2020 consisted primarily of
license and collaboration agreement revenues under company’s
license agreement with Kyorin. Research and development expenses
were $4.5 million and $3.6 million for the three months ended March
31, 2021 and 2020, respectively. The increase was due primarily to
manufacturing costs related to ATYR1923, increased research and
development expenses related to ATYR2810 and increased expenses
related to the research program between Pangu BioPharma, Hong Kong
University and the Government of the Hong Kong Special
Administration Region. General and administrative expenses were
consistent between periods at $2.7 million and $2.6 million for the
three months ended March 31, 2021 and 2020, respectively.
During the first quarter of 2021, the company
raised gross proceeds of $9.9 million through its at-the-market
offering program with H.C. Wainwright & Co., LLC and $15.3
million through its common stock purchase agreement with Aspire
Capital Fund, LLC. As of March 31, 2021, aTyr had $50.6 million in
cash, cash equivalents and investments.
The company expects its expenses to continue to
increase in 2021 as research and development of ATYR1923 and
ATYR2810 progress.
Conference Call and Webcast
Details
aTyr will host a conference call and webcast
today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time 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 US, or 209-905-5951 internationally and using conference ID
6867948. 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 ATYR1923
aTyr is developing ATYR1923 as a potential
therapeutic for patients with inflammatory lung disease. ATYR1923,
a fusion protein comprised of the immuno-modulatory domain of
histidyl tRNA synthetase fused to the FC region of a human
antibody, is a selective modulator of Neuropilin-2 that
downregulates the innate and adaptive immune response in
inflammatory disease states. aTyr recently completed enrollment in
a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in
patients with pulmonary sarcoidosis. This Phase 1b/2a study is a
multi-ascending dose, placebo-controlled, first-in-patient study of
ATYR1923 that has been designed to evaluate the safety,
tolerability, steroid sparing effect, immunogenicity and
pharmacokinetics profile of multiple doses of ATYR1923. In response
to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial
with ATYR1923 in COVID-19 patients with severe respiratory
complications. This Phase 2 study was a randomized, double blind,
placebo-controlled study that was designed to evaluate the safety
and preliminary efficacy of a single dose of ATYR1923.
About aTyr
aTyr is a biotherapeutics company engaged in the
discovery and development of innovative medicines based on novel
biological pathways. 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 ATYR1923, a clinical-stage product
candidate which binds to the Neuropilin-2 receptor and is designed
to down-regulate immune engagement in inflammatory lung diseases.
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,”
“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
include statements regarding the potential therapeutic benefits and
applications of ATYR1923, ATYR2810 and our discovery programs;
timelines and plans with respect to certain development activities
(including the further development of ATYR9123, ATYR2810 and our
discovery programs) and value to be derived therefrom; expected
activities under our collaboration agreements 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 enrollment 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.
|
|
ATYR PHARMA INC. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share data) |
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
(unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
License and collaboration
agreement revenues |
$ |
— |
|
|
$ |
8,065 |
|
Total revenues |
|
— |
|
|
|
8,065 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
4,516 |
|
|
|
3,616 |
|
General and administrative |
|
2,686 |
|
|
|
2,590 |
|
Total operating expenses |
|
7,202 |
|
|
|
6,206 |
|
Income (loss) from
operations |
|
(7,202 |
) |
|
|
1,859 |
|
Total other income (expense), net |
|
47 |
|
|
|
(107 |
) |
Consolidated net income
(loss) |
$ |
(7,155 |
) |
|
$ |
1,752 |
|
Net loss attributable to
noncontrolling interest in Pangu BioPharma Limited |
|
4 |
|
|
|
1 |
|
Net income (loss) attributable
to aTyr Pharma, Inc. |
$ |
(7,151 |
) |
|
$ |
1,753 |
|
Basic, net income (loss) per
share |
$ |
(0.51 |
) |
|
$ |
0.25 |
|
Shares used in computing basic
net income (loss) per share |
|
14,103,783 |
|
|
|
6,881,791 |
|
Diluted net income (loss) per
share |
$ |
(0.51 |
) |
|
$ |
0.25 |
|
Shares used in computing
diluted net income (loss) per share |
|
14,103,783 |
|
|
|
6,884,797 |
|
|
|
ATYR PHARMA INC. |
|
Condensed Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents and
available-for-sale investments |
$ |
50,637 |
|
|
$ |
31,689 |
|
Other receivables |
|
89 |
|
|
|
2,039 |
|
Property and equipment,
net |
|
874 |
|
|
|
899 |
|
Right-of-use assets |
|
1,886 |
|
|
|
2,083 |
|
Prepaid expenses and other
assets |
|
1,642 |
|
|
|
2,016 |
|
Total assets |
$ |
55,128 |
|
|
$ |
38,726 |
|
|
|
|
|
|
|
|
|
Accounts payable, accrued
expenses and other liabilities |
$ |
3,561 |
|
|
$ |
5,003 |
|
Current portion of operating
lease liability |
|
890 |
|
|
|
861 |
|
Long-term operating lease
liability, net of current portion |
|
1,145 |
|
|
|
1,378 |
|
Total stockholders’
equity |
|
49,532 |
|
|
|
31,484 |
|
Total liabilities and stockholders’ equity |
$ |
55,128 |
|
|
$ |
38,726 |
|
|
Contact:Ashlee DunstonDirector, Investor
Relations and Corporate Communicationsadunston@atyrpharma.com
aTyr Pharma (NASDAQ:LIFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
aTyr Pharma (NASDAQ:LIFE)
Historical Stock Chart
From Apr 2023 to Apr 2024