SAN DIEGO, June 18, 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 first
quarter 2015. The Company successfully completed its initial public
offering following the end of the quarter on May 12, 2015, with estimated net proceeds of
$76.9 million. Total cash and
investments are expected to be approximately $145 million as of June
30, 2015.
Proceeds raised during the first half of 2015 will be used to
fund operations, including the ongoing Phase 1b/2 clinical trial of
Resolaris™, a first-in-class protein therapeutic in adult patients
with facioscapulohumeral muscular dystrophy (FSHD), as well as
expansion into other forms of muscular dystrophy. While estimates
of FSHD prevalence vary, we believe approximately 19,000 people
suffer from adult or juvenile forms of FSHD in the U.S. The Company
plans to initiate a Phase 1b/2 clinical trial in early onset FSHD
patients, expected to begin in the third quarter of 2015.
After evaluating a number of muscular dystrophies (MD),
including Duchenne muscular dystrophy and a broad class of MD
indications of more than 20 rare genetic conditions known as the
limb-girdle muscular dystrophies (LGMD), the Company has selected
LGMD 2B as its next expansion indication after early onset FSHD.
LGMD affects an estimated 16,000 patients in the U.S.,
approximately 3,000 of whom have LGMD 2B. The Company expects 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.
The Company expects to protect its expanding pipeline of
innovative therapeutics for patients with severe rare disease with
its growing patent estate. At the close of the first quarter 2015,
the Company solely owned or exclusively licensed 34 patents and has
since received additional allowances, increasing the total number
of granted or allowed patents to 45.
First Quarter Results
Research and development expenses were $6.6 million for the quarter ended March 31, 2015, as compared to $4.4 million in the same period one year ago. The
increase primarily relates to a one-time $1.4 million non-cash expense for the assignment
of certain intellectual property rights. Additional expenses are
associated with development of and clinical trials for Resolaris™
and preclinical research efforts targeting the potential
therapeutic application of other Physiocrines in additional rare
diseases.
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; 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 $2.3 million and $1.5
million for the quarters ended March
31, 2015 and 2014, respectively. The increases relate
primarily to employee-related costs including stock-based
compensation and benefits, intellectual property-related projects
and professional services and fees.
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.
Net losses for the first quarter of 2015 were $9.1 million, as compared to $6.1 million for the first quarter of 2014. The
number of shares outstanding was 23.6 million as of the close of
the initial public offering on May 12,
2015.
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 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 Statement
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, expected cash and investment balances 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 that was filed with the SEC
on May 7, 2015. 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 March 31,
|
|
|
2015
|
|
2014
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
$
6,593
|
|
$
4,388
|
|
General and
administrative
|
|
2,329
|
|
1,542
|
|
Total operating
expenses
|
|
8,922
|
|
5,930
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(8,922)
|
|
(5,930)
|
|
|
|
|
|
|
|
Other income
(expenses), net
|
|
(149)
|
|
(163)
|
|
|
|
|
|
|
|
Net loss
|
|
|
(9,071)
|
|
|
(6,093)
|
|
|
|
|
|
|
|
|
|
Accretion to
redemption value of redeemable convertible preferred
stock
|
|
|
-
|
|
|
(138)
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
|
(9,071)
|
|
$
|
(6,231)
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
|
$
|
(9.39)
|
|
$
|
(7.87)
|
|
Weighted average
shares outstanding, basic and diluted
|
|
|
966,322
|
|
|
791,283
|
|
|
|
|
ATYR PHARMA
INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
March 31,
|
|
December 31,
|
|
2015
|
2014
|
|
|
(unaudited)
|
|
|
|
Cash, cash
equivalents and investment securities
|
|
$
|
54,512
|
|
$
|
15,853
|
|
Other
assets
|
|
|
3,554
|
|
|
2,866
|
|
Property and
equipment, net
|
|
|
1,839
|
|
|
1,925
|
|
Total
assets
|
|
$
|
59,905
|
|
$
|
20,644
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
7,104
|
|
$
|
5,759
|
|
Current portion of
commercial bank debt
|
|
|
3,190
|
|
|
3,134
|
|
Convertible
promissory note
|
|
|
2,000
|
|
|
2,000
|
|
Commercial bank debt,
net of current portion
|
|
|
4,322
|
|
|
5,142
|
|
Redeemable
convertible preferred stock
|
|
|
141,295
|
|
|
95,619
|
|
Stockholders'
deficit
|
|
|
(98,006)
|
|
|
(91,010)
|
|
Total liabilities and
stockholders' deficit
|
|
$
|
59,905
|
|
$
|
20,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/atyr-pharma-announces-first-quarter-2015-operating-results-300101695.html
SOURCE aTyr Pharma, Inc.