THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical
company developing personalized immunotherapies for autoimmune disorders
including multiple sclerosis (MS) and neuromyelitis optica (NMO), today
reported financial results for the three months ended September 30, 2015
and provided an update on the Company’s recent corporate developments.
Recent highlights include:
Clinical and Operational Highlights
-
The Phase 2b clinical trial of Tcelna® (imilecleucel-T)
in secondary progressive multiple sclerosis (SPMS) (Abili-T trial)
continued to advance in the third quarter. Top line data is expected
in the second half of 2016. The two-year trial is fully enrolled and
to date, approximately 92% of the total patient visits have been
completed. The Abili-T clinical trial is a randomized, double-blind,
placebo-controlled study being conducted at approximately 35 leading
clinical sites in the U.S. and Canada.
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A preclinical bioactivity animal study conducted for Opexa’s
neuromyelitis optica (NMO) development program showed evidence that
T-cell immunotherapy with attenuated antigen-specific T-cells
significantly suppressed the T-cell response to Aquaporin-4 (AQP4) in
a dose-dependent manner, compared to vehicle control, as measured by
reduction in both Aquarporin-4 reactive T-cells (ARTC) proliferation
and associated cytokine activity. The results were statistically
significant.
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Opexa expanded its intellectual property portfolio with the issuance
of four additional key patents covering its broad T-cell immunotherapy
platform. The recent allowances bring the number of granted U.S. and
international patents in Opexa’s patent portfolio to 160, including
in-licensed patents. The expansion of Opexa’s intellectual property
portfolio further strengthens the patent estate surrounding Tcelna,
Opexa’s personalized T-cell immunotherapy in development for the
treatment of secondary progressive multiple sclerosis.
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At a recent and regularly scheduled meeting, the independent Data and
Safety Monitoring Board (DSMB) overseeing Opexa’s Abili-T trial
recommended the trial continue as planned based on the committee’s
review of safety data from the trial. Opexa has received Fast Track
designation from the U.S. Food and Drug Administration (FDA) for
Tcelna in SPMS.
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During the third quarter of 2015, Opexa continued with IND-enabling
activities to support OPX-212, Opexa’s preclinical development
candidate for NMO. The Company expects to submit an IND and be in a
position to initiate a Phase 1/2 proof-of-concept clinical trial in
the first half of 2016, assuming the availability of sufficient
resources.
Financial Highlights
-
In September 2015, Opexa entered into a stock purchase agreement with
investors to fund the Company’s NMO program, including its planned
Phase 1/2 trial, pursuant to which Opexa sold in tranche one of a
private placement 113,636 shares of common stock for a per share
purchase price of $4.40 and issued warrants to purchase a like number
of shares, for a total purchase price of $499,999. Opexa also agreed
to sell and the purchasers agreed to purchase an additional aggregate
of $4.5 million of common stock in four additional tranches upon
achievement of certain pre-specified milestones to further the
clinical development of OPX-212. Each subsequent tranche will include
the sale of common stock only (i.e., no additional warrants will be
issued), with such shares priced at 90% of the 10-day volume weighted
average price of Opexa’s common stock immediately preceding the
occurrence of the related milestone.
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Based on the current activities of the Company and projected burn,
Opexa believes it has sufficient liquidity to support its current
clinical activities for the Abili-T trial of Tcelna in SPMS, to
continue planned preclinical development activities for OPX-212 in
NMO, and for general operations to sustain the Company and support
such activities into the fourth quarter of 2016. Opexa expects
top-line data for the Abili-T trial to be available in the second half
of 2016, and thus believes it has sufficient resources to complete
such trial.
“The third quarter of 2015 progressed well with the focus remaining
clearly on the conduct of the Phase 2b Abili-T clinical study in
secondary progressive multiple sclerosis,” commented Neil K. Warma,
President and Chief Executive Officer of Opexa. “The trial continues to
move toward completion as we expect top-line results in the second half
of next year. With no treatments approved for patients with the
progressive form of MS, we remain committed in our efforts to advance
what, we believe, could be the first safe and effective treatment for
this patient population.”
“We are also pleased with the results of the bioactivity animal study we
have been running over the past several months, which support our
development candidate, OPX-212, in neuromyelitis optica. The results are
encouraging and show a dose-dependent reduction in Aquaporin-4 reactive
T-cells in the mouse model utilized. We believe this adds support to our
hypothesis around the mechanism of action for our therapy and we expect
to include the data as part of our IND submission for OPX-212 in NMO. We
are continuing with the preclinical development activities of OPX-212,
including completing the manufacturing runs and expect to submit the IND
to the U.S. FDA and be in a position to open a Phase 1/2 clinical study
in NMO patients in the first half of 2016, assuming the availability of
sufficient resources. The private financing that was secured in the
third quarter of 2015 is in support of the NMO program and could provide
Opexa with up to $5 million in tranched funding for the Phase 1/2
clinical trial, subject to hitting pre-determined milestones,” added Mr.
Warma.
Third Quarter Financial Results
Opexa reported revenue of $726,291 and $307,686 for the three months
ended September 30, 2015 and 2014, respectively. The revenue is related
to the recognized portion of the $5 million upfront payment received
from Merck Serono in conjunction with the Option and License Agreement
entered into between Opexa and Merck Serono during February 2013 and the
$3 million payment from Merck Serono in connection with the March 2015
amendment.
Research and development expenses were $2,420,220 for the three months
ended September 30, 2015, compared with $3,173,538 for the three months
ended September 30, 2014. The decrease in expenses is primarily due to a
decrease in the procurement and use of supplies for product
manufacturing and development, a decrease in the investigator costs
associated with the ongoing clinical trial of Tcelna in SPMS and lower
intellectual property legal fees.
General and administrative expenses for the three months ended September
30, 2015 were $1,023,848, compared with $917,335 for the three months
ended September 30, 2014. The increase in expense is primarily due to an
increase in legal costs and employee compensation and was partially
offset by lower consultant expenses.
Depreciation and amortization expenses for the three months ended
September 30, 2015 were $89,018, compared with $97,364 for the three
months ended September 30, 2014. The decrease in expense is due to some
assets being fully amortized and was partially offset by increases in
depreciation for laboratory, manufacturing and computer equipment
acquired during 2014 and 2015.
Interest income net of interest expense was $2,222 for the three months
ended September 30, 2015, compared to $2,498 for the three months ended
September 30, 2014.
Other income was $11,760 for the three months ended September 30, 2015,
compared to $0 in the three months ending September 30, 2014. This was
primarily driven by a gain on exchange rate, which was related to two
clinical sites located in Canada and the difference between the Canadian
dollar and the US dollar on payments to these clinical sites. Payments
to these sites began in December 2014.
Net loss reported for the three months ended September 30, 2015 was
approximately $2.8 million, or $0.42 loss per share (basic and diluted),
compared with a net loss of approximately $3.9 million, or $1.11 loss
per share (basic and diluted), for the three months ended September 30,
2014. The decreased net loss for the quarter is primarily related to the
increase in revenue due to the March 2015 amendment to our Option and
License Agreement with Merck Serono and a decrease in research and
development expenses, which was partially offset by the increase in
general and administrative expenses.
Cash and cash equivalents were $15,592,500 as of September 30, 2015,
compared to $9,906,373 as of December 31, 2014.
For additional information please see Opexa’s Quarterly Report on Form
10-Q filed today with the SEC.
Opexa Therapeutics to Webcast Analyst and Investor Event
Opexa will host an Analyst and Investor Event today where members of
Opexa’s senior management team will provide an R&D update and review of
the Company’s Abili-T clinical trial for Secondary Progressive Multiple
Sclerosis and the development program for Neuromyelitis Optica. The
Analyst and Investor Event will take place at the New York Hilton
Midtown.
A live webcast of the event will start at 5:15 p.m. Eastern Time and may
be accessed here,
or on the Investor Relations section of the Company’s website, www.opexatherapeutics.com.
The event should conclude by 7:00 p.m. An archived version of the
webcast will be available for 90 days after the event on the Company’s
website.
About Opexa
Opexa is a biopharmaceutical company developing a personalized
immunotherapy with the potential to treat major illnesses, including
multiple sclerosis (MS) as well as other autoimmune diseases such as
neuromyelitis optica (NMO). These therapies are based on Opexa’s
proprietary T-cell technology. The Company’s leading therapy candidate,
Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb
clinical development program (the Abili-T trial) for the treatment of
secondary progressive MS. Tcelna consists of myelin-reactive T-cells,
which are expanded ex vivo from the patient’s peripheral blood and
reintroduced into the patient in an attenuated form via subcutaneous
injections. This process triggers a potent immune response against
specific subsets of autoreactive T-cells known to attack myelin for each
individual patient.
For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com
or follow company news on Twitter
via @OpexaCEO.
Cautionary Statement Relating to Forward-Looking Information for the
Purpose of "Safe Harbor" Provisions of the Private Securities Litigation
Reform Act of 1995
Statements contained in this release, other than statements of
historical fact, constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. The
words "expects," "believes," "may," "intends," "potential" and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements do not constitute guarantees of future
performance. Investors are cautioned that forward-looking statements,
including without limitation statements regarding the safety, efficacy
and projected development timeline of drug candidates such as Tcelna®
and OPX-212 constitute forward-looking statements. These forward-looking
statements are based upon our current expectations and involve
assumptions that may never materialize or may prove to be incorrect.
Actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include without limitation our
ability to raise additional capital to continue our development
programs, our ability to successfully develop potential products such as
Tcelna and OPX-212, our ability to obtain, maintain and protect
intellectual property rights (including for Tcelna and OPX-212), as well
as other risks associated with the process of discovering, developing
and commercializing drug candidates that are safe and effective for use
as human therapeutics. These and other risks are described in detail in
our SEC filings, including our Annual Report on Form 10-K for the year
ended December 31, 2014 and our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2015. All forward-looking statements
contained in this release speak only as of the date on which they were
first made by us, and we undertake no obligation to update such
statements to reflect events that occur or circumstances that exist
after such date.
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OPEXA THERAPEUTICS, INC
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OPEXA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months
Ended September 30,
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Nine Months
Ended September 30,
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2015
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2014
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2015
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2014
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Revenue:
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Option revenue
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$
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726,291
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$
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307,686
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$
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1,830,036
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$
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964,209
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Expenses:
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Research and development
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2,420,220
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3,173,538
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7,853,076
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9,393,887
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General and administrative
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1,023,848
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917,335
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3,375,602
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2,987,582
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Loss on disposition of assets
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1,167
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-
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1,167
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Depreciation and amortization
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89,018
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97,364
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280,003
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291,608
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Operating loss
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(2,807,962
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(3,880,551
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)
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(9,679,812
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)
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(11,708,868
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)
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Interest income, net
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2,222
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2,498
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5,290
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11,982
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Other income, net
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11,760
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-
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32,781
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-
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Net loss
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$
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(2,793,980
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)
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$
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(3,878,053
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)
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$
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(9,641,741
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)
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$
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(11,696,886
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)
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Basic and diluted loss per share
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$
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(0.42
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$
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(1.11
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$
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(1.75
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$
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(3.38
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Weighted average shares outstanding - Basic and diluted
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6,709,251
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3,478,324
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5,498,228
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3,461,479
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Selected Balance Sheet Data:
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September 30,
2015
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December 31,
2014
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(unaudited)
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Cash and cash equivalents
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$
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15,592,500
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$
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9,906,373
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Subscription receivable
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232,934
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-
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Other current assets
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329,323
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758,943
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Fixed assets, net
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886,878
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1,098,104
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Other long term assets
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9,734
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38,939
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Total assets
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17,051,369
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11,802,359
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Total current liabilities
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4,964,564
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3,132,424
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Total long-term liabilities
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726,293
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1,230,748
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Total stockholders’ equity
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11,360,512
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7,439,187
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Total liabilities and stockholders’ equity
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$
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17,051,369
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$
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11,802,359
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View source version on businesswire.com: http://www.businesswire.com/news/home/20151110005331/en/
Source: Opexa Therapeutics, Inc.