aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel immunological pathways, today announced second quarter
results and provided a corporate update.
“While the advent of the global COVID-19
pandemic impacted our Phase 1b/2a clinical trial of ATYR1923 in
pulmonary sarcoidosis, hindering patient enrollment during the
second quarter, I am pleased that the majority of our sites are now
continuing enrollment. Due to the strong scientific rationale of
ATYR1923’s mechanism of action and its overlap with COVID-19
disease pathology, including inflammatory lung injury, during the
second quarter we also initiated a Phase 2 trial of ATYR1923 in
COVID-19 patients with severe respiratory complications,” said Dr.
Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer
of aTyr.
“Additionally, we continue to drive value and
build momentum with our pipeline. The preclinical data resulting
from our Neuropilin-2 (NRP2) antibody program in oncology
demonstrates tumor inhibitory effects and we expect to declare an
Investigational New Drug (IND) candidate later this year. We also
expect to complete the first phase of our tRNA synthetase research
collaboration with CSL Behring early in the fourth quarter.”
Second Quarter 2020 and Subsequent
Period Highlights
- Progressed our ongoing Phase 1b/2a clinical trial of ATYR1923
in patients with pulmonary sarcoidosis. The majority of sites have
now resumed clinical trial activities and we continue to work with
each site to ensure the completion of the trial.
- Initiated enrollment of a Phase 2 randomized, double blind,
placebo-controlled study of ATYR1923 in COVID-19 patients with
severe respiratory complications. An independent data and safety
monitoring board conducted a pre-planned, blinded interim safety
analysis of the initial five patients dosed, which resulted in a
positive outcome recommending the trial continue unmodified.
Enrollment is ongoing and we expect to report data from this study
in the fourth quarter.
- Published two abstracts in the American Journal of Respiratory
and Critical Care Medicine that were also presented as posters at
the 2020 American Thoracic Society International Conference Virtual
Meeting. These findings characterize ATYR1923’s immunomodulatory
properties and confirm that it selectively binds to NRP2, a unique
target expressed on key immune cells in inflammatory conditions.
Further, the research demonstrates that NRP2 is expressed in
sarcoid granulomas, reinforcing its status as a key target in the
treatment of immune-mediated diseases.
- Presented preclinical data in a poster at the American
Association for Cancer Research Virtual Annual Meeting II from our
NRP2 antibody program demonstrating that one of these antibodies
blocked VEGF-C binding to NRP2, showing tumor inhibitory effects
and increased sensitivity to chemotherapy in preclinical models of
triple-negative breast cancer. We expect to declare an IND
candidate later this year from our NRP2 antibody program.
- Provided an update on our collaboration and license agreement
with Kyorin Pharmaceutical, Co., Ltd., for the development and
commercialization of ATYR1923 for interstitial lung diseases in
Japan (the Kyorin Agreement). Kyorin received a Clinical Trial
Notification from Japan’s Pharmaceutical and Medical Devices agency
which approves the initiation of a Phase 1 study to evaluate the
safety, pharmacokinetics and immunogenicity of ATYR1923 (also known
as KRP-R120) in Japanese healthy volunteers.
- Announced an amendment to the tRNA synthetase research
collaboration and option agreement with CSL Behring (the CSL
Agreement) that extends the work on the first phase of the research
program through September 30, 2020. As a result of the extension,
CSL has provided additional funding for research and development
activities.
Second Quarter 2020 Financial Results
Total revenues were $0.2 million and $0.1
million for the three months ended June 30, 2020 and 2019,
respectively. Revenues for the three months ended June 30, 2020
consisted of $0.1 million of license revenue under the Kyorin
Agreement and $0.1 million of license revenue under the CSL
Agreement while revenues for the three months ended June 30, 2019
consisted $0.1 million of license revenue under the CSL Agreement.
Research and development expenses were $4.4 million and $3.3
million for the three months ended June 30, 2020 and 2019,
respectively. The increase for research and development expenses
was due primarily to ATYR1923 clinical activities.
Total revenues were $8.3 million and $0.1
million for the six months ended June 30, 2020 and 2019,
respectively. Revenues for the six months ended June 30, 2020
consisted of $8.0 million from license revenue under the Kyorin
Agreement and $0.3 million from license revenue under the CSL
Agreement while revenues for the six months ended June 30, 2019
consisted of $0.1 million from license revenue under the CSL
Agreement. Research and development expenses were $8.0 million and
$6.7 million for the six months ended June 30, 2020 and 2019,
respectively. The increase for research and development expenses
was due primarily to ATYR1923 clinical activities. General and
administrative expenses were $4.7 million and $5.0 million for the
six months ended June 30, 2020 and 2019, respectively. The decrease
was due primarily to a reduction in professional fees.
As of June 30, 2020, aTyr had $41.4 million in
cash, cash equivalents and investments.
Conference Call and Webcast
Details
aTyr Pharma 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 5176802. 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 diseases. 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 is currently enrolling 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 recently initiated a Phase 2
clinical trial with ATYR1923 in COVID-19 patients with severe
respiratory complications. This Phase 2 study is a randomized,
double blind, placebo-controlled study that has been 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
immunological 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 and our NRP2 antibody program; timelines
and plans with respect to certain development activities (including
the further development of ATYR9123 and our NRP2 antibody program);
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 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 |
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(in thousands,
except share and per share data) |
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Three Months Ended
June 30, |
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Six Months
Ended June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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(unaudited) |
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Revenues: |
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|
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|
|
|
|
|
License revenues |
|
$ |
189 |
|
|
$ |
94 |
|
|
$ |
8,254 |
|
|
$ |
94 |
|
Total revenues |
|
|
189 |
|
|
|
94 |
|
|
|
8,254 |
|
|
|
94 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
4,361 |
|
|
|
3,314 |
|
|
|
7,977 |
|
|
|
6,659 |
|
General and administrative |
|
|
2,146 |
|
|
|
2,421 |
|
|
|
4,736 |
|
|
|
4,953 |
|
Total operating expenses |
|
|
6,507 |
|
|
|
5,735 |
|
|
|
12,713 |
|
|
|
11,612 |
|
Loss from operations |
|
|
(6,318 |
) |
|
|
(5,641 |
) |
|
|
(4,459 |
) |
|
|
(11,518 |
) |
Total other expense, net |
|
|
(129 |
) |
|
|
(207 |
) |
|
|
(236 |
) |
|
|
(467 |
) |
Consolidated net loss |
|
$ |
(6,447 |
) |
|
$ |
(5,848 |
) |
|
$ |
(4,695 |
) |
|
$ |
(11,985 |
) |
Net loss attributable to noncontrolling interest in Pangu
BioPharma Limited |
|
|
1 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
Net loss attributable to aTyr Pharma, Inc. |
|
$ |
(6,446 |
) |
|
$ |
(5,848 |
) |
|
$ |
(4,693 |
) |
|
$ |
(11,985 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(1.80 |
) |
|
$ |
(0.58 |
) |
|
$ |
(4.23 |
) |
Shares used in computing net loss per share, basic and
diluted |
|
|
9,357,432 |
|
|
|
3,244,920 |
|
|
|
8,119,612 |
|
|
|
2,834,079 |
|
ATYR PHARMA
INC. |
|
Condensed
Consolidated Balance Sheets |
|
(in thousands) |
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June 30, |
|
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December 31, |
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2020 |
|
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2019 |
|
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(unaudited) |
|
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Cash, cash equivalents and
available-for-sale investments |
|
$ |
41,434 |
|
|
$ |
31,144 |
|
Other receivables |
|
|
831 |
|
|
|
100 |
|
Prepaid expenses and other assets |
|
|
1,700 |
|
|
|
853 |
|
Property and equipment, net |
|
|
1,136 |
|
|
|
1,270 |
|
Right-of-use assets |
|
|
2,461 |
|
|
|
2,821 |
|
Total assets |
|
$ |
47,562 |
|
|
$ |
36,188 |
|
|
|
|
|
|
|
|
|
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Accounts payable, accrued
expenses and other liabilities |
|
$ |
4,016 |
|
|
$ |
3,431 |
|
Current portion of operating lease liability |
|
|
807 |
|
|
|
755 |
|
Term loans, net of issuance costs and discount |
|
|
4,976 |
|
|
|
8,737 |
|
Long-term operating lease liability, net of current
portion |
|
|
1,825 |
|
|
|
2,239 |
|
Total stockholders’ equity |
|
|
35,938 |
|
|
|
21,026 |
|
Total liabilities and stockholders’ equity |
|
$ |
47,562 |
|
|
$ |
36,188 |
|
|
|
Contact: |
|
Ashlee Dunston |
|
Investor Relations, aTyr Pharma |
|
adunston@atyrpharma.com |
|
|
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