aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel biological pathways, today announced third quarter results
and provided a corporate update.
“Throughout the third quarter, we remained
focused on our clinical program for our lead therapeutic candidate,
ATYR1923. We now have three active clinical trials as part of this
program. Most notably, we have completed enrollment in our Phase 2
trial in COVID-19 patients with severe respiratory complications.
We expect to report topline data from this study around the turn of
the calendar year. In addition, amidst the ongoing pandemic, our
pulmonary sarcoidosis trial sites have been reactivated to screen
and dose patients and finish enrollment of the third and final
cohort of our Phase 1b/2a study. Finally, our partner Kyorin
Pharmaceutical is currently enrolling a Phase 1 study in healthy
volunteers in Japan,” said Sanjay S. Shukla, M.D., M.S., President
and Chief Executive Officer of aTyr.
“While our clinical operations have expanded, so
too has our pipeline. We have selected an Investigational New Drug
(IND) candidate from our Neuropilin-2 (NRP2) antibody program,
ATYR2810. This antibody, which has generated compelling data in
pre-clinical cancer models, will be evaluated for the potential
treatment of certain aggressive tumors where NRP2 is
implicated.”
Third Quarter 2020 and Subsequent Period
Highlights
- Completed
enrollment in its Phase 2 randomized, double blind,
placebo-controlled study of ATYR1923 in COVID-19 patients with
severe respiratory complications. The study enrolled a total of 32
patients at hospitals in the U.S. and Puerto Rico, exceeding the
target enrollment of 30 patients. Topline data is expected at the
turn of the calendar year.
- Continued
enrollment in the third and final cohort of its ongoing Phase 1b/2a
multiple-ascending dose, placebo-controlled study of ATYR1923 in 36
patients with pulmonary sarcoidosis. The majority of sites have
reactivated and are screening and dosing patients.
- Kyorin
Pharmaceutical, Co., Ltd., aTyr’s partner in the development and
commercialization of ATYR1923 for interstitial lung diseases in
Japan, initiated and continues to enroll a Phase 1 study to
evaluate the safety, pharmacokinetics and immunogenicity of
ATYR1923 (known as KRP-R120 in Japan) in 32 Japanese healthy
volunteers.
- Declared an IND
candidate in oncology from its NRP2 antibody program, ATYR2810.
This fully humanized monoclonal antibody will be evaluated for the
potential treatment of certain aggressive tumors where NRP2 is
implicated. NRP2 expression is associated with worsened patient
outcomes in many cancers.
- Entered into a
research collaboration with the Medical University of South
Carolina (MUSC) to support the company’s NRP2 antibody program in
oncology. Dr. Robert Gemmill, the former Melvyn Berlinksy Chair of
Cancer Research and Professor of Medicine Emeritus in the Division
of Hematology/Oncology at MUSC, will serve as the principal
investigator for the collaboration, which aims to accelerate the
development of therapeutic antibodies that selectively target
specific NRP2 isoforms and validate their potential use in the
treatment of lung cancer.
- Published a
paper in the peer-reviewed journal mAbs titled, “Isolation of
monoclonal antibodies from anti-synthetase syndrome patients and
affinity maturation by recombination of independent somatic
variants,” which highlighted novel technological advances to
isolate, characterize and engineer high-affinity therapeutic
antibodies.
Third Quarter 2020 Financial Results
Total revenues were $0.1 million and $0.2
million for the three months ended September 30, 2020 and 2019,
respectively, consisting of license revenue. Research and
development expenses were $4.6 million and $3.8 million for the
three months ended September 30, 2020 and 2019, respectively. The
increase was due primarily to the progression of ATYR1923 clinical
activities. General and administrative expenses were consistent
between the periods at $2.0 million and $1.9 million for the three
months ended September 30, 2020 and 2019, respectively.
Total revenues were $8.4 million and $0.3
million for the nine months ended September 30, 2020 and 2019,
respectively. Revenues for the nine months ended September 30, 2020
included $8.0 million from license revenue under the collaboration
agreement with Kyorin. Research and development expenses were $12.6
million and $10.5 million for the nine months ended September 30,
2020 and 2019, respectively. The increase was due primarily to the
progression of ATYR1923 clinical activities. General and
administrative expenses were consistent between the periods at $6.8
million for each of the nine months ended September 30, 2020 and
2019.
As of September 30, 2020, aTyr had $36.1 million
in cash, cash equivalents and investments. As of September 30,
2020, aTyr had $3.1 million of term loans. On November 3, 2020,
aTyr fully repaid its term loans and retired its debt.
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 4549288. 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 is conducting 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
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 NRP2 antibody program;
timelines and plans with respect to certain development activities
(including the further development of ATYR9123, ATYR2810 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.
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ATYR PHARMA INC. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenues |
$ |
148 |
|
|
$ |
184 |
|
|
$ |
8,402 |
|
|
$ |
278 |
|
Total revenues |
|
148 |
|
|
|
184 |
|
|
|
8,402 |
|
|
|
278 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
4,616 |
|
|
|
3,799 |
|
|
|
12,593 |
|
|
|
10,458 |
|
General and administrative |
|
2,044 |
|
|
|
1,883 |
|
|
|
6,780 |
|
|
|
6,836 |
|
Total operating expenses |
|
6,660 |
|
|
|
5,682 |
|
|
|
19,373 |
|
|
|
17,294 |
|
Loss from operations |
|
(6,512 |
) |
|
|
(5,498 |
) |
|
|
(10,971 |
) |
|
|
(17,016 |
) |
Total other expense, net |
|
(88 |
) |
|
|
(147 |
) |
|
|
(324 |
) |
|
|
(614 |
) |
Consolidated net loss |
$ |
(6,600 |
) |
|
$ |
(5,645 |
) |
|
$ |
(11,295 |
) |
|
$ |
(17,630 |
) |
Net loss attributable to
noncontrolling interest in Pangu BioPharma Limited |
|
1 |
|
|
|
— |
|
|
|
3 |
|
|
|
— |
|
Net loss attributable to aTyr
Pharma, Inc. |
$ |
(6,599 |
) |
|
$ |
(5,645 |
) |
|
$ |
(11,292 |
) |
|
$ |
(17,630 |
) |
Net loss per share, basic and
diluted |
$ |
(0.68 |
) |
|
$ |
(1.47 |
) |
|
$ |
(1.31 |
) |
|
$ |
(5.55 |
) |
Shares used in computing net
loss per share, basic and diluted |
|
9,648,534 |
|
|
|
3,846,249 |
|
|
|
8,632,972 |
|
|
|
3,175,177 |
|
|
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ATYR PHARMA INC. |
|
Condensed Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents and
available-for-sale investments |
$ |
36,146 |
|
|
$ |
31,144 |
|
Other receivables |
|
245 |
|
|
|
100 |
|
Property and equipment,
net |
|
1,004 |
|
|
|
1,270 |
|
Right-of-use assets |
|
2,274 |
|
|
|
2,821 |
|
Prepaid expenses and other
assets |
|
1,967 |
|
|
|
853 |
|
Total assets |
$ |
41,636 |
|
|
$ |
36,188 |
|
|
|
|
|
|
|
|
|
Accounts payable, accrued
expenses and other liabilities |
$ |
4,138 |
|
|
$ |
3,431 |
|
Current portion of operating
lease liability |
|
834 |
|
|
|
755 |
|
Term loans, net of debt
issuance costs and discount |
|
3,061 |
|
|
|
8,737 |
|
Long-term operating lease
liability, net of current portion |
|
1,605 |
|
|
|
2,239 |
|
Total Stockholders’
equity |
|
31,998 |
|
|
|
21,026 |
|
Total liabilities and stockholders’ equity |
$ |
41,636 |
|
|
$ |
36,188 |
|
|
Contact: |
Ashlee
Dunston |
Director, Investor Relations and Corporate
Communications |
adunston@atyrpharma.com |
|
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