SAN DIEGO, Nov. 10, 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 third quarter and nine months ended September 30, 2015.
Clinical Highlights and Upcoming Milestones:
- The Company recently announced the continued expansion of its
Resolaris clinical program in rare myopathies with an immune
component (RMICs) with the initiation of a Phase 1b/2 clinical
trial in patients with early onset facioscapulohumeral muscular
dystrophy (FSHD), a rare and severe genetic myopathy for which
there are currently no approved treatments.
- During the third quarter of 2015, the first patients were dosed
in the newly initiated long-term safety extension study of
Resolaris in FSHD. The open label study includes adult patients
enrolled in the Company's ongoing, double-blinded,
placebo-controlled, multiple ascending dose Phase 1b/2 trial of
Resolaris in adult patients with FSHD. Data from the adult FSHD
Phase 1b/2 study are expected in the first quarter of 2016, while
the extension study is expected to continue through the third
quarter of 2016.
- The Company further expanded its Resolaris clinical program in
RMICs during the third quarter by initiating a Phase 1b/2 clinical
trial in patients with limb girdle muscular dystrophy (LGMD) 2B and
adult patients with FSHD. Both LGMD2B and FSHD are progressive,
debilitating muscle diseases characterized by an immune component
in the affected skeletal muscles.
- Additionally, plans to expand clinical trials of Resolaris into
specific indications in interstitial lung disease, or ILD, are
currently being evaluated. The Company expects to initiate a Phase
1b/2 trial in the first half of 2016 in an ILD indication.
Additional Operational Highlights:
- In November, the Company announced the publication of research
on the discovery of a new Physiocrine pathway as a potential target
for the treatment of rare hereditary peripheral neuropathies. The
research was co-authored by Xiang-Lei
Yang, Ph.D., professor at The Scripps
Research Institute and co-founder of aTyr Pharma, and was
published in the October 29, 2015
issue of Nature.
- In October, the Company presented an overview of the
therapeutic potential of Resolaris in RMICs at the International
World Muscle Congress 2015 in Brighton,
UK, as well as a broader overview of the therapeutic
potential of Physiocrines at the 10th Annual International
Symposium on Aminoacyl-tRNA Synthetases in Barcelona.
- Melissa Ashlock, M.D., has been
promoted to Senior Vice President, Translational Medicine and
Therapeutics, from Vice President, Translational Medicine and
Therapeutics. Dr. Ashlock has been with aTyr since 2011 and
previously served as the Vice President of Drug Discovery for the
Cystic Fibrosis Foundation (CFF), where she was the program leader
for multiple CFF-funded collaborative drug discovery programs with
industry, including Kalydeco.
- Ashraf Amanullah, Ph.D., has
been appointed Vice President, Manufacturing. Dr. Amanullah most
recently served as Senior Director at Gilead Sciences, where he
oversaw the cell line development, drug substance, analytical
development, potency, stability, QC and formulation, drug product
and device development functions as well as external drug substance
and drug product manufacturing. Prior to joining Gilead, he was
Director of Process Development at Genentech, where he headed a
cross-functional department charged with process development of
early stage therapeutics, late stage and post-approval processes
and technology transfer, ultimately contributing to the development
of Avastin and Actemra. Prior to Genentech, he held various
positions at Merck & Co. Inc. over a nine-year tenure, with
responsibility for process development, cGMP manufacturing, and
technology transfer and commercialization of vaccines, including
Gardasil and Gardasil 9.
- John T. Blake, C.P.A., has been
promoted to Vice President, Finance. Mr. Blake had served as Senior
Director, Finance, and Controller of aTyr since March 2015. Prior to joining the Company, Mr.
Blake served as Director, Financial Planning and Analysis, of
Volcano Corporation, a global medical device company, through the
acquisition by Royal Philips NV.
Third Quarter Results
Research and development expenses were $7.7 million for the quarter ended September 30, 2015, as compared to $4.4 million for the same period in 2014. The
increase was primarily due to an additional $2.3 million related to manufacturing costs and
clinical development incurred in support of various activities for
Resolaris and an $0.8 million
increase related to compensation expenses resulting from increased
headcount in research and development functions, including
$0.3 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 expanding 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 $3.6 million and $1.8
million for the quarters ended September 30, 2015 and 2014, respectively.
The change of $1.8 million was
due primarily to a $0.7 million
increase in personnel costs resulting from increased headcount,
including $0.3 million in non-cash
stock-based compensation. Another $0.4
million was associated with increased public company costs
and intellectual property-related projects.
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.
Year-To-Date Results
Research and development expenses for the nine months ended
September 30, 2015 and 2014 were
$21.8 million and $12.4 million, respectively. The increase of
$9.4 million was due primarily to a
$5.2 million increase related to
manufacturing costs and clinical development incurred in support of
various activities for Resolaris; a $2.5
million increase related to compensation expenses, including
$1.0 million of non-cash stock-based
compensation expense; and a one-time $1.4
million non-cash expense for the assignment of certain
intellectual property rights.
General and administrative expenses were $9.3 million and $5.1 million for the nine months ended
September 30, 2015 and 2014,
respectively. The change of $4.2
million was due primarily to a $1.8
million increase in personnel costs resulting from increased
headcount, including $0.7 million in
stock-based compensation; a $1.4
million increase in public company costs and a $0.4 million increase in intellectual
property-related projects.
Net losses for the first nine months of 2015 were $31.5 million, as compared to $18.3 million for the same period in 2014.
As of September 30, 2015, the
number of shares outstanding was 23.6 million and the Company had
cash, cash equivalents and investments totaling $136.8 million.
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 RMICs. Resolaris is currently in a
Phase 1b/2 clinical trial in adult patients with FSHD; a Phase 1b/2
trial in adult patients with LGMD2B or FSHD; and a Phase 1b/2 trial
in patients with an early onset form of FSHD. An initial
trial is planned in rare pulmonary diseases with an immune
component (RPIC) in patients with 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. 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 of
1933 and Section 21E of the Securities Exchange Act of 1934,
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 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, 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 and of reporting results from our
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 Ended
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
7,739
|
|
$
4,410
|
|
$
21,834
|
|
$
12,436
|
General and
administrative
|
|
3,574
|
|
1,821
|
|
9,299
|
|
5,088
|
Total operating
expenses
|
|
11,313
|
|
6,231
|
|
31,133
|
|
17,524
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(11,313)
|
|
(6,231)
|
|
(31,133)
|
|
(17,524)
|
|
|
|
|
|
|
|
|
|
Other income
(expenses), net
|
|
(16)
|
|
(400)
|
|
(347)
|
|
(788)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
(11,329)
|
|
(6,631)
|
|
(31,480)
|
|
(18,312)
|
|
|
|
|
|
|
|
|
|
Accretion to
redemption value of redeemable convertible
preferred stock
|
|
-
|
|
(139)
|
|
(15)
|
|
(416)
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
(11,329)
|
|
$
(6,770)
|
|
$
(31,495)
|
|
$
(18,728)
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders,
basic and diluted
|
|
$
(0.48)
|
|
$
(8.02)
|
|
$
(2.38)
|
|
$
(22.73)
|
Weighted average
shares outstanding, basic and diluted
|
|
23,581,001
|
|
843,817
|
|
13,221,551
|
|
824,062
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ATYR PHARMA
INC.
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
136,813
|
|
$ 15,853
|
|
|
|
|
Other
assets
|
|
2,715
|
|
2,866
|
|
|
|
|
Property and
equipment, net
|
|
1,841
|
|
1,925
|
|
|
|
|
Total
assets
|
|
$
141,369
|
|
$ 20,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
6,265
|
|
$
5,759
|
|
|
|
|
Current portion of
commercial bank debt
|
|
3,307
|
|
3,134
|
|
|
|
|
Convertible
promissory note
|
|
—
|
|
2,000
|
|
|
|
|
Commercial bank debt,
net of current portion
|
|
2,640
|
|
5,142
|
|
|
|
|
Redeemable
convertible preferred stock
|
|
—
|
|
95,619
|
|
|
|
|
Stockholders'equity
(deficit)
|
|
129,157
|
|
(91,010)
|
|
|
|
|
Total liabilities and
stockholders'equity (deficit)
|
|
$
141,369
|
|
$ 20,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/atyr-pharma-announces-third-quarter-2015-operating-results-300176096.html
SOURCE aTyr Pharma, Inc.