– Resolaris Demonstrated Favorable Safety Profile
in Rare Muscular Dystrophy Patients in Extension Studies –– iMod.Fc
Program for Interstitial Lung Disease (ILD) on Track to Commence
Phase 1 Clinical Trial –– Project ORCA: Leverages a New
Immuno-Oncology Antibody Target Based on Physiocrine Biology –
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 ended June 30, 2017.
“During the first half of 2017, our team advanced three
innovative, first-in-class biologics that harness Physiocrine
biology in immunology,” said John Mendlein, Ph.D., CEO of aTyr
Pharma. “For our Resolaris program, we report favorable safety data
from two extension studies in patients with rare muscular
dystrophies underscoring the potential for improved clinical
outcomes over time based on stabilizing or improving muscle
function. In addition, we plan to initiate our first-in-human
clinical trial for our iMod.Fc program for ILD. Our third program,
ORCA targets a novel, proprietary immuno-oncology pathway using
antibodies to change levels of Resokine in tumor settings. We
believe tumors utilize Resokine to evade immune system responses.
Our Resolaris, iMod.Fc and ORCA programs demonstrate the power and
leverage arising from our new insights in immunology and novel
therapeutic modalities targeting homeostatic pathways.”
Resolaris Program – First Resokine Therapeutic Candidate
Based on a Protein Secreted by Muscle
• Safety Extension Study Results (005 and 006)
– aTyr recently completed two extension studies in patients with
limb-girdle muscular dystrophy 2B (LGMD2B), adult
facioscapulohumeral muscular dystrophy (FSHD), and early onset
FSHD. Per protocol patients received 3.0 mg/kg of Resolaris weekly
in these extension studies.
- No significant adverse events or observed signs of general
immunosuppression in either study.
- Across both studies, 12 patients received at least six months
of Resolaris in each study with no significant trends of worsening
in either manual muscle testing (MMT) or individualized
neuromuscular quality of life assessment (INQoL) scores:-- 5 of 10
patients remained stable or improved their MMT score at 24 weeks; 3
of 6 patients remained stable or improved their MMT score at 36
weeks.
- In the 006 trial, which commenced July 2016, 4 patients had
early-onset FSHD, 2 patients had adult FSHD and 2 patients had
LGMD2B.-- All 8 patients remained Jo-1 antibody negative throughout
the study; 2 patients experienced transient Jo-1 antibody levels
above the protocol-defined cut off for continuation in the
study.
- In the 005 trial, which commenced August 2015, 9 patients with
adult FSHD enrolled.-- All 9 patients remained Jo-1 antibody
negative throughout the study; 3 patients experienced transient
Jo-1 antibody levels above the protocol-defined cut off for
continuation in the study; 3 patients experienced transient,
mild-to-moderate infusion related reactions and were discontinued
per protocol.
- 44 patients, across all of our trials (002, 003, 004, 005, and
006), have now received Resolaris for a total drug exposure of 204
patient months.
• Promising Clinical Results for Resolaris in Early
Onset FSHD – During the quarter, aTyr announced top-line
results from its Phase 1b/2 trial (003) of Resolaris in patients
with early onset FSHD. Overall, 63% of patients (5/8) showed an
increase from baseline in their MMT score, with a mean change from
baseline of +3.8%. Resolaris was generally well-tolerated at doses
up to 3.0 mg/kg once weekly in this younger patient population
(patients in the trial were between the ages of 16 and 20) with no
observed signs of general immunosuppression.
• AAN Presentation – During the quarter, Dr.
John Vissing, M.D., Ph.D., Professor of Neurology, University of
Copenhagen, presented a poster titled “Results of a Phase 1b/2
Study of ATYR1940 in Adult Patients with Limb Girdle Muscular
Dystrophy Type 2B (LGMD2B) and Facioscapulohumeral Muscular
Dystrophy (FSHD) (ATYR-C-004)” at the American Academy of Neurology
(AAN) Annual Meeting on April 25, 2017 in Boston, MA.
• Clinical Development Plan – Initiation of a
randomized placebo-controlled trial with Resolaris is contingent
upon the identification of a PD assay and execution of a
partnership related to one of our pipeline programs.
iMod.Fc Program – First Fc Fusion Based Therapeutic
Candidate for Lung Diseases
• Clinical Development – aTyr Pharma plans to
commence a Phase 1 clinical program for the iMod.Fc program later
this year. This randomized, double-blind, placebo-controlled study
will investigate the safety, tolerability, immunogenicity,
pharmacokinetics and pharmacodynamics (PD) of intravenous iMod.Fc
in healthy volunteers.
• American Thoracic Society (ATS) Presentations
– During the quarter, aTyr Pharma presented two posters on
the iMod.Fc program at the ATS International Conference May 19 -
24, 2017 in Washington, D.C.:
- “Resokine Modulates Immune Cell Infiltration into the Lung and
Provides Therapeutic Activity in a Bleomycin-Induced Lung Fibrosis
Model”.
- “The Resokine Pathway is Implicated in the Pathology of
Interstitial Lung Disease”.
In conjunction with the ATS presentations, aTyr Pharma hosted an
educational webinar featuring Dr. Steven D. Nathan, M.D., FCCP,
Director of the Advanced Lung Disease Program and Lung Transplant
Program at Inova Fairfax Hospital, to provide disease education on
interstitial lung diseases that are characterized by an immune
component, such as idiopathic pulmonary fibrosis (IPF),
sarcoidosis, and chronic hypersensitivity pneumonitis (CHP). The
webinar is available on the aTyr Pharma investor website.
Project ORCA – First Antibody Antagonist to a
Physiocrine Immunology Pathway
• New Target in Immuno-Oncology – ORCA involves
a novel and proprietary target that aTyr believes is active across
multiple tumor types.
• Timeline – aTyr plans to select an antibody
as a potential IND candidate in 2017.
Second Quarter 2017 Financial
Results
Research and development expenses were $8.4 million and $11.3
million for the quarters ended June 30, 2017 and 2016,
respectively. The decrease of $2.9 million was due primarily
to a $2.2 million decrease related to Resolaris clinical trials
costs and $0.6 million decrease related to manufacturing costs
incurred in support of Resolaris.
General and administrative expenses were $3.5 million and
$4.1 million for the quarters ended June 30, 2017 and 2016,
respectively. The decrease of $0.6 million was due primarily to a
$0.4 million reduction in professional fees.
First Half 2017 Financial Results
Research and development expenses were $17.6 million and $23.3
million for the six months ended June 30, 2017 and 2016,
respectively. The decrease of $5.7 million was due primarily
to $4.2 million decrease related to manufacturing costs incurred in
support of Resolaris and $2.3 million decrease related to Resolaris
clinical trials costs. The decrease was partially offset by an
increase of $1.0 million related to research and non-clinical
development costs incurred for iMod.Fc.
General and administrative expenses were $7.5 million and $8.2
million for the six months ended June 30, 2017 and 2016,
respectively. The decrease of $0.7 million was due primarily to a
$0.4 million decrease in professional fees.
Financial Guidance
As of June 30, 2017, aTyr had $57.2 million in
cash, cash equivalents and investments and 23.8 million shares of
common stock outstanding.
aTyr expects that its cash, cash equivalents and investments
will be sufficient to fund its anticipated operations into the
third quarter of 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 immunological and physiological pathways. To
date, the Company has generated three innovative therapeutic
programs based on its knowledge of Physiocrine biology in three
different therapeutic areas and three different biologic
modalities. 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. aTyr's key programs are currently focused on severe
diseases characterized by immune imbalance 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 and potential therapeutic benefits of
Resolaris™, iMod.Fc, or potential product candidates from Project
ORCA, 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
initiation of additional clinical trials, the scope and strength of
our intellectual property portfolio, our ability to receive
regulatory approvals for, and commercialize, our product candidates
and of reporting results from our clinical trials, 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, 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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
8,420 |
|
|
$ |
11,307 |
|
|
$ |
17,624 |
|
|
$ |
23,307 |
|
General
and administrative |
|
|
3,487 |
|
|
|
4,126 |
|
|
|
7,494 |
|
|
|
8,241 |
|
Total operating
expenses |
|
|
11,907 |
|
|
|
15,433 |
|
|
|
25,118 |
|
|
|
31,548 |
|
Loss from
operations |
|
|
(11,907 |
) |
|
|
(15,433 |
) |
|
|
(25,118 |
) |
|
|
(31,548 |
) |
Other
income (expense), net |
|
|
(231 |
) |
|
|
50 |
|
|
|
(425 |
) |
|
|
78 |
|
Net loss |
|
|
(12,138 |
) |
|
|
(15,383 |
) |
|
|
(25,543 |
) |
|
|
(31,470 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.07 |
) |
|
$ |
(1.33 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
23,810,112 |
|
|
|
23,672,527 |
|
|
|
23,774,736 |
|
|
|
23,655,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ATYR PHARMA INC. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents
and available-for-sale investments |
|
$ |
57,221 |
|
|
$ |
76,149 |
|
Other assets |
|
|
2,248 |
|
|
|
2,954 |
|
Property and equipment,
net |
|
|
2,003 |
|
|
|
1,421 |
|
Total
assets |
|
$ |
61,472 |
|
|
$ |
80,524 |
|
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities |
|
$ |
6,863 |
|
|
$ |
8,186 |
|
Term loans, net of debt
issuance costs |
|
|
14,578 |
|
|
|
9,537 |
|
Stockholders’
equity |
|
|
40,031 |
|
|
|
62,801 |
|
Total
liabilities and stockholders’ equity |
|
$ |
61,472 |
|
|
$ |
80,524 |
|
Contact:
Mark Johnson
Sr. Director, Investor Relations
mjohnson@atyrpharma.com
858-223-1163
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