SAN DIEGO, Aug. 12, 2015 /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 second quarter and first half of 2015.
Resolaris™, a first-in-class protein therapeutic in adult
patients with facioscapulohumeral muscular dystrophy (FSHD), is
currently in an ongoing Phase 1b/2 clinical trial, with initial
results expected in late 2015 or early 2016. The Company is
on track to initiate a Phase 1b/2 clinical trial in early onset
FSHD patients in the third quarter of 2015.
In addition to indications in FSHD, the Company has selected a
specific form of limb-girdle muscular dystrophy, referred to as
LGMD 2B, as its next expansion indication and is expected to move
forward with a Phase 1b/2 clinical trial of Resolaris™ in LGMD 2B
beginning in the fourth quarter of 2015.
Additionally, plans to expand clinical trials of Resolaris™ into
specific indications in interstitial lung disease, or ILD, are
currently being evaluated to identify those most appropriate for
initial clinical assessment, with a Phase 1b/2 trial expected to
begin in the first half of 2016.
Second Quarter Results
Research and development expenses were $7.5 million for the quarter ended June 30, 2015, as compared to $3.6 million for the same period in 2014. The
increase was primarily due to an additional $2.7 million in clinical development and
manufacturing costs associated with Resolaris™ franchise
activities, and $0.9 million in
expenses resulting from increased headcount, including $0.4 million in non-cash stock-based
compensation.
The Company expects its research and development expense to
continue to increase with its Resolaris™ franchise expansion
activities, including the clinical development of Resolaris™, the
first protein therapeutic from the Resokine Pathway; advancements
in the development of a second program leveraging the Resokine
pathway using an iMod.Fc protein therapeutic, as well as other
therapeutic modalities to harness the power of the pathway in
muscle or lung disease; and continued engagement in additional
research and development activities relating to the therapeutic
applications of Physiocrines beyond the Resokine pathway.
General and administrative expenses were $3.4 million and $1.7
million for the quarters ended June
30, 2015 and 2014, respectively. The increase of
$1.7 million related primarily to
employee-related costs resulting from increased headcount,
including $0.3 million in stock-based
compensation, intellectual property-related projects and costs
associated with being a public company.
The Company expects general and administrative expenses to
increase substantially to support the continued development of its
product candidates and the costs associated with operating as a
public company, which include supporting regulatory and listing
requirements, insurance and investor relations. These
increases will also include the cost of additional personnel and
fees to outside consultants, among other expenses.
First Half Results
Research and development expenses for the six months ended
June 30, 2015 and 2014 were
$14.1 million and $8.0 million, respectively. The increase was
due primarily to an additional $2.9
million in clinical development and manufacturing costs to
support various Resolaris™ franchise activities; a $1.7 million increase in compensation expenses
resulting from increased headcount, including $0.4 million in stock-based compensation, and a
one-time $1.4 million non-cash
expense for the assignment of certain intellectual property
rights.
General and administrative expenses were $5.7 million and $3.3 million for the six months ended
June 30, 2015 and 2014, respectively.
The change of $2.5 million was
due primarily to an increase in headcount, including $0.7 million in stock-based compensation,
intellectual property-related projects and costs associated with
being a public company.
Net losses for the first six months of 2015 were $20.2 million, as compared to $11.7 million for the same period in 2014.
As of June 30, 2015, the number of
shares outstanding was 23.6 million and the Company had cash and
cash equivalents of $147.7 million, including $75.9 million in net proceeds resulting from the
IPO and related transactions.
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
first-in-class intravenous protein therapeutic for the treatment of
rare myopathies with an immune component. Resolaris™ is currently
in a Phase 1b/2 clinical trial in adult patients with
facioscapulohumeral muscular dystrophy (FSHD). Trials are planned
in additional indications, including early onset FSHD and
limb-girdle muscular dystrophy (LGMD) 2B. Trials are also planned
for indications in interstitial lung disease (ILD). To protect this
pipeline, aTyr built an intellectual property estate currently
comprising 45 issued or allowed patents and over 240 pending patent
applications that are solely owned or exclusively licensed by aTyr.
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. The Company was founded by
Professors Paul Schimmel, Ph.D., and
Xiang-Lei Yang, Ph.D., two leading
aminoacyl tRNA synthetase scientists at The Scripps Research Institute.
For more information, please
visit http://www.atyrpharma.com.
Forward-Looking Statements
Statements we make in this
press release may include statements which are not historical facts
and are considered forward-looking within the meaning of
Section 27A of the Securities Act and Section 21E of the
Securities Exchange Act, which 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 the safe
harbor provisions for forward-looking statements contained in
Section 27A of the Securities Act and Section 21E of the
Securities Exchange Act 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, 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, and the timing of initiation of additional
clinical trials 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
the prospectus for our recent offering of common stock and our most
recent Quarterly Report on Form 10-Q. 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
|
|
Six
Months
|
Ended June 30,
|
Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
7,502
|
|
$ 3,638
|
|
$
14,095
|
|
$ 8,026
|
General and
administrative
|
|
3,396
|
|
1,725
|
|
5,725
|
|
3,267
|
Total operating
expenses
|
|
10,898
|
|
5,363
|
|
19,820
|
|
11,293
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(10,898)
|
|
(5,363)
|
|
(19,820)
|
|
(11,293)
|
|
|
|
|
|
|
|
|
|
Other income
(expenses), net
|
|
(182)
|
|
(225)
|
|
(331)
|
|
(388)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(11,080)
|
|
|
(5,588)
|
|
|
(20,151)
|
|
|
(11,681)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion to
redemption value of redeemable convertible preferred
stock
|
|
|
(15)
|
|
|
(139)
|
|
|
(15)
|
|
|
(277)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
|
(11,095)
|
|
$
|
(5,727)
|
|
$
|
(20,166)
|
|
$
|
(11,958)
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
|
$
|
(0.74)
|
|
$
|
(6.85)
|
|
$
|
(2.53)
|
|
$
|
(14.69)
|
Weighted average
shares outstanding, basic and diluted
|
|
|
14,901,473
|
|
|
836,533
|
|
|
7,955,973
|
|
|
814,030
|
ATYR PHARMA
INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December 31,
|
|
2015
|
2014
|
|
|
(unaudited)
|
|
|
|
Cash, cash
equivalents and investment securities
|
|
$
|
147,695
|
|
$
|
15,853
|
|
Other
assets
|
|
|
3,364
|
|
|
2,866
|
|
Property and
equipment, net
|
|
|
2,022
|
|
|
1,925
|
|
Total
assets
|
|
$
|
153,081
|
|
$
|
20,644
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
7,003
|
|
$
|
5,759
|
|
Current portion of
commercial bank debt
|
|
|
3,248
|
|
|
3,134
|
|
Convertible
promissory note
|
|
|
-
|
|
|
2,000
|
|
Commercial bank debt,
net of current portion
|
|
|
3,489
|
|
|
5,142
|
|
Redeemable
convertible preferred stock
|
|
|
-
|
|
|
95,619
|
|
Stockholders' equity
(deficit)
|
|
|
139,341
|
|
|
(91,010)
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
|
153,081
|
|
$
|
20,644
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/atyr-pharma-announces-second-quarter-2015-operating-results-300127708.html
SOURCE aTyr Pharma, Inc.