SAN DIEGO, Nov. 14, 2016 /PRNewswire/ -- aTyr Pharma,
Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the
discovery and development of Physiocrine-based therapeutics to
address severe, rare diseases, today announced operating results
for the third quarter ended September 30,
2016.
"During the third quarter, we continued to make significant
progress in our clinical development of Resolaris™ for the
treatment of patients with facioscapulohumeral muscular dystrophy
(FSHD), early onset FSHD, and limb-girdle muscular dystrophy 2B
(LGMD2B). We look forward to announcing data from our three ongoing
clinical trials in these indications next month," said John Mendlein, PhD, CEO of aTyr Pharma. "We
anticipate initiating clinical development for our iMod.Fc program
for rare pulmonopathies next year. Finally, we continue to advance
our understanding of the Resokine pathway to aid in therapeutically
intervening in homeostatic pathways in a fiscally prudent
manner."
Recent Highlights
- Fast Track Designation – In October, Resolaris was
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) for the treatment of FSHD, making it the first
known therapeutic candidate for the treatment of FSHD to receive
the designation.
- World Muscle Society Presentation on Resolaris for FSHD
– In October, aTyr presented clinical data from its adult FSHD
(002) trial at the 21st International Annual Congress of
the World Muscle Society in Granada, Spain. The presentation included detailed data
covering the safety, tolerability and pharmacokinetics of
Resolaris, and further detailed activity seen in the
patient-reported outcomes, known as the Individualized
Neuromuscular Quality of Life Assessment (INQoL), and the
physician-reported functional assessment of Manual Muscle Testing
(MMT).
- Early Onset FSHD Enrollment Completed – During the third
quarter, aTyr completed enrollment in Stage 1 of its early onset
FSHD (003) trial testing Resolaris in that indication.
- Research Expertise – In September, David J. King, Ph.D., joined aTyr Pharma as
Senior Vice President, Research. Dr. King's industry experience is
highlighted by his tenures at Medarex, Inc. (acquired by
Bristol-Myers Squibb in 2009) and Celltech Therapeutics Ltd.
(acquired by UCB in 2004). At Medarex, he led programs to identify
therapeutic antibodies and played a key role in programs targeting
novel biologics (including PD-1), and at Celltech, he directed the
protein biochemistry and antibody engineering activities that led
to the discovery and development of Cimzia®. Dr. King
also served as Chief Scientific Officer at AnaptysBio, Inc. where
he led research that developed a novel technology for generating
antibody therapeutics.
Upcoming Milestones
- Early Onset FSHD (003) Trial:
- Data from first four (of eight) patients enrolled in Stage 1
expected to be announced in December
2016.
- Results from all eight patients enrolled in Stage 1 expected to
be announced in first half of 2017.
- LGMD2B/FSHD (004) Trial: Top-line results expected to be
announced in December 2016.
- First Extension (005) Trial: Update from the rollover
patients expected to be announced in December 2016.
- Second Extension (006) Trial: Update from the rollover
patients expected to be announced in first half of 2017.
Third Quarter 2016 Financial Results
Research and development expenses were $10.4 million and $7.7
million for the quarters ended September 30, 2016 and 2015, respectively. The
increase of $2.7 million was due
primarily to a $0.9 million increase
related to cGMP manufacturing of Resolaris to support future
clinical trials, a $0.8 million
increase in clinical and non-clinical development costs for
Resolaris and a $0.6 million increase
in GMP manufacturing development costs for iMod.Fc. For Resolaris,
we have substantially completed our GMP manufacturing runs at
commercial scale and do not anticipate additional commercial scale
runs in 2017.
General and administrative expenses remained relatively flat at
$3.5 million compared to $3.6 million for the quarters ended September 30, 2016 and 2015, respectively.
Year-to-Date 2016 Financial Results
Research and development expenses were $33.7 million and $21.8
million for the nine months ended September 30, 2016 and 2015, respectively. The
increase of $11.9 million was due
primarily to a $5.7 million increase
related to cGMP manufacturing of Resolaris to support future
clinical trials, a $3.9 million
increase in clinical and non-clinical development costs for
Resolaris, a $1.7 million increase
related to compensation expenses resulting from increased headcount
in research and development functions, including $0.2 million of non-cash stock-based
compensation, a $1.3 million increase
in other pre-clinical development costs and a $0.8 million increase in GMP manufacturing
development costs for iMod.Fc. The increase was offset by a
decrease related to a one-time $1.4
million non-cash expense for the assignment of certain
intellectual property rights in the prior year period.
General and administrative expenses were $11.7 million and $9.3
million for the nine months ended September 30, 2016 and 2015, respectively. The
increase of $2.4 million was due
primarily to a $2.1 million increase
in personnel costs resulting from increased headcount, inclusive of
$1.2 million of non-cash stock-based
compensation.
Financial Guidance
As of September 30, 2016, we had $80.9 million in
cash, cash equivalents and investments and 23.7 million shares of
common stock outstanding.
aTyr continues to expect that its cash, cash equivalents and
investments will be sufficient to fund its anticipated operations
into 2018.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development
of innovative medicines for patients suffering from severe rare
diseases using its knowledge of Physiocrine biology, a newly
discovered set of physiological modulators. The Company's lead
candidate, Resolaris™, is a potential first-in-class intravenous
protein therapeutic for the treatment of rare myopathies with an
immune component. Resolaris is currently in a Phase 1b/2 trial in
adult patients with limb-girdle muscular dystrophy 2B (LGMD2B or
dysferlinopathies) or FSHD; and a Phase 1b/2 trial in patients with
an early onset form of FSHD. In addition, Resolaris is currently
being evaluated in two Phase 1b/2 long-term safety extension
studies, one in patients with adult FSHD and the other in patients
with adult FSHD, early onset FSHD, and LGMD2B. aTyr has built an
intellectual property estate, to protect its pipeline, comprising
over 80 issued or allowed patents and over 230 pending patent
applications that are owned or exclusively licensed by aTyr,
including over 300 potential Physiocrine-based protein
compositions. aTyr's key programs are currently focused on severe,
rare diseases characterized by immune dysregulation for which there
are currently limited or no treatment options. 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 of Resolaris™ or iMod.Fc, the ability of
the Company to undertake certain development activities (such as
clinical trial enrollment and the conduct of clinical trials) and
accomplish certain development goals, the timing of initiation of
additional clinical trials and of reporting results from our
clinical trials and 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, as well as those set forth in our most recent Annual
Report on Form 10-K for the year ended December 31, 2015 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.
Contact:
Mark Johnson
Sr.
Director, Investor Relations
mjohnson@atyrpharma.com
858-223-1163
ATYR PHARMA
INC.
Condensed Consolidated Statements of Operations (unaudited,
in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
10,395
|
|
$
|
7,739
|
|
$
|
33,702
|
|
$
|
21,834
|
|
General and
administrative
|
|
|
3,470
|
|
|
3,574
|
|
|
11,711
|
|
|
9,299
|
|
Total operating
expenses
|
|
|
13,865
|
|
|
11,313
|
|
|
45,413
|
|
|
31,133
|
|
Loss from
operations
|
|
|
(13,865)
|
|
|
(11,313)
|
|
|
(45,413)
|
|
|
(31,133)
|
|
Other income
(expenses), net
|
|
|
46
|
|
|
(16)
|
|
|
124
|
|
|
(347)
|
|
Net loss
|
|
|
(13,819)
|
|
|
(11,329)
|
|
|
(45,289)
|
|
|
(31,480)
|
|
Accretion to
redemption value of redeemable convertible preferred
stock
|
|
|
—
|
|
|
(15)
|
|
|
—
|
|
|
(15)
|
|
Net loss attributable
to common stockholders
|
|
|
(13,819)
|
|
|
(11,344)
|
|
|
(45,289)
|
|
|
(31,495)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
|
$
|
(0.58)
|
|
$
|
(0.48)
|
|
$
|
(1.91)
|
|
$
|
(2.38)
|
|
Weighted average
shares outstanding, basic and diluted
|
|
|
23,696,511
|
|
|
23,581,001
|
|
|
23,669,154
|
|
|
13,221,551
|
|
ATYR PHARMA
INC.
Condensed Consolidated Balance Sheets (in
thousands)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale investments
|
|
$
|
80,859
|
|
|
$
|
125,349
|
|
Other
assets
|
|
|
3,470
|
|
|
|
2,533
|
|
Property and
equipment, net
|
|
|
1,596
|
|
|
|
1,793
|
|
Total
assets
|
|
$
|
85,925
|
|
|
$
|
129,675
|
|
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
9,296
|
|
|
$
|
9,483
|
|
Total commercial bank
debt
|
|
|
2,640
|
|
|
|
5,142
|
|
Stockholders'
equity
|
|
|
73,989
|
|
|
|
115,050
|
|
Total liabilities and
stockholders' equity
|
|
$
|
85,925
|
|
|
$
|
129,675
|
|
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SOURCE aTyr Pharma, Inc.