- Initiation of Phase 1 clinical trial of iMod.Fc
on-track for this quarter -
aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged
in the discovery and development of immuno-modulatory protein
therapeutics to treat patients suffering from rare, severe,
immune-mediated diseases, as well as various cancers, today
announced operating results for the third quarter ended September
30, 2017.
“We look forward to initiating a Phase 1 study of iMod.Fc for
the treatment of interstitial lung diseases this quarter. This will
be our second therapeutic candidate in the clinic that applies our
understanding of Physiocrine biology to target the Resokine pathway
and its role in modulating the immune system to disrupt progression
of disease,” said Sanjay Shukla, M.D., M.S., President and CEO of
aTyr Pharma. “Earlier this month, I was honored to be appointed as
President and CEO, and I am thrilled by the opportunity to lead
aTyr. I am confident that our talented team is well-positioned,
with sufficient funding, to advance the development of our iMod.Fc
and ORCA programs.”
Program Highlights
- iMod.Fc – iMod.Fc is aTyr’s engineered
Physiocrine-based therapeutic candidate in development for the
potential treatment of interstitial lung diseases with an immune
component.○ Initiation of Phase 1 clinical trial expected in
4Q 2017.
- ORCA – ORCA is aTyr’s preclinical research
program that targets a novel, proprietary immuno-oncology pathway
using antibodies to enhance the immune response in tumor
settings.○ Selection of antibody as IND candidate expected in
4Q 2017.
- Resolaris – Resolaris is aTyr’s first
Physiocrine-based therapeutic candidate in development for the
potential treatment of rare myopathies with an immune component. In
October, aTyr presented clinical data from its phase 1b/2
early-onset facioscapulohumeral muscular dystrophy (003) trial at
the 22nd International Annual Congress of the World Muscle Society
in Saint Malo, France.○ Continued development expected
following a strategic partnership or collaboration.
Corporate Highlights
- Dr. Sanjay Shukla Appointed President and CEO
– In November, aTyr announced the appointment of Sanjay Shukla,
M.D., M.S. as President and Chief Executive Officer of aTyr Pharma.
Dr. Shukla joined aTyr as Chief Medical Officer in March 2016.
- $45.8M Equity Financing – In August, aTyr
announced the successful completion of a $45.8M financing, which
enables aTyr to advance the iMod.Fc and ORCA programs through key
development milestones.
Third Quarter 2017 Financial
Results
Research and development expenses were $7.1 million and $10.4
million for the three months ended September 30, 2017 and 2016,
respectively. The decrease of $3.3 million was due primarily
to a $2.2 million decrease related to manufacturing costs incurred
in support of Resolaris and a $1.8 million decrease as a result of
the completion of clinical trials related to Resolaris. The
decrease was partially offset by a $0.3 million increase related to
discovery research efforts, a $0.2 million increase in iMod.Fc
research and non-clinical development costs and $0.2 million
increase related to ORCA research activities.
General and administrative expenses remained relatively
consistent at $3.7 million versus $3.5 million for the three months
ended September 30, 2017 and 2016, respectively.
Year-to-Date 2017 Financial
Results
Research and development expenses were $24.8 million and $33.7
million for the nine months ended September 30, 2017 and 2016,
respectively. The decrease of $8.9 million was due primarily
to a $6.5 million decrease related to manufacturing costs incurred
in support of Resolaris, a $4.0 million decrease as a result of the
completion of clinical trials related to Resolaris, a $0.3 million
decrease in discovery projects, and a $0.3 million decrease in
non-cash stock based compensation. The decrease was partially
offset by a $1.1 million increase related to research and
non-clinical development costs incurred for iMod.Fc, and a $1.1
million increase related to ORCA research activities.
General and administrative expenses were $11.2 million and $11.7
million for the nine months ended September 30, 2017 and 2016,
respectively. The decrease of $0.5 million was primarily due to a
decrease in professional fees.
Financial Guidance
As of September 30, 2017, aTyr had $90.4
million in cash, cash equivalents and investments and 41.1
million shares of common stock outstanding on an if-converted basis
(includes 29.7 million shares of common stock and 11.4 million
shares of common stock if converted from Class X Preferred
stock).
aTyr expects that its cash, cash equivalents and investments
will be sufficient to fund its anticipated operations into the
middle of 2019.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and development of
innovative medicines for patients using its knowledge of
Physiocrine biology, a newly discovered set of immunological and
physiological pathways. To date, aTyr has generated three
innovative and unique development programs based on its knowledge
of the Resokine pathway to treat patients suffering from rare,
severe, immune-mediated diseases, as well as various cancers.
aTyr’s two lead programs, Resolaris and iMod.Fc, are agonists of
the Resokine pathway designed to temper immune engagement in
diseases characterized by excessive immune cell involvement. aTyr’s
third program, ORCA, represents a preclinical research program that
targets a novel, proprietary immuno-oncology pathway using
antibodies to enhance the immune response in tumor settings. aTyr
has built an intellectual property estate, to protect its pipeline,
comprising over 220 issued patents or allowed patent applications
that are owned or exclusively licensed, including over 300
potential Physiocrine-based protein compositions. 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 and potential therapeutic benefits of
Resolaris, iMod.Fc, or potential product candidates from our ORCA
program, the ability of the Company to successfully advance its
pipeline or product candidates, undertake certain development
activities (such as clinical trial enrollment and the conduct of
clinical trials) and accomplish certain development goals and the
timing of such activities and development goals, the timing of our
clinical trials and IND candidate selection, our ability to receive
regulatory approvals for, and commercialize, our product candidates
and of reporting results from our clinical trials, the scope and
strength of our intellectual property portfolio, and our 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, the risk that we may cease or
delay preclinical or clinical development activities for any of its
existing or future product candidates for a variety of reasons
(including difficulties or delays in patient enrollment in planned
clinical trials), and the risk that we may not be able to raise the
additional funding required for its business and product
development plans, as well as those set forth in our most recent
Annual Report on Form 10-K for the year ended December 31, 2016 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 |
|
(unaudited, in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
7,133 |
|
|
$ |
10,395 |
|
|
$ |
24,757 |
|
|
$ |
33,702 |
|
General
and administrative |
|
|
3,694 |
|
|
|
3,470 |
|
|
|
11,188 |
|
|
|
11,711 |
|
Total operating
expenses |
|
|
10,827 |
|
|
|
13,865 |
|
|
|
35,945 |
|
|
|
45,413 |
|
Loss from
operations |
|
|
(10,827 |
) |
|
|
(13,865 |
) |
|
|
(35,945 |
) |
|
|
(45,413 |
) |
Other
income (expense), net |
|
|
(363 |
) |
|
|
46 |
|
|
|
(788 |
) |
|
|
124 |
|
Net loss |
|
|
(11,190 |
) |
|
|
(13,819 |
) |
|
|
(36,733 |
) |
|
|
(45,289 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.50 |
) |
|
$ |
(1.91 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
25,818,008 |
|
|
|
23,696,511 |
|
|
|
24,462,835 |
|
|
|
23,669,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ATYR PHARMA INC. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents
and available-for-sale investments |
|
$ |
90,381 |
|
|
$ |
76,149 |
|
Other assets |
|
|
1,915 |
|
|
|
2,954 |
|
Property and equipment,
net |
|
|
2,191 |
|
|
|
1,421 |
|
Total
assets |
|
$ |
94,487 |
|
|
$ |
80,524 |
|
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities |
|
$ |
7,453 |
|
|
$ |
8,186 |
|
Term loans, net of debt
issuance costs |
|
|
14,746 |
|
|
|
9,537 |
|
Stockholders’
equity |
|
|
72,288 |
|
|
|
62,801 |
|
Total
liabilities and stockholders’ equity |
|
$ |
94,487 |
|
|
$ |
80,524 |
|
|
|
|
|
|
|
|
|
|
Contact:Mark JohnsonSr.
Director, Investor Relationsmjohnson@atyrpharma.com858-223-1163
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