THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a biopharmaceutical
company developing personalized immunotherapies including multiple
sclerosis (MS) and neuromyelitis optica (NMO), today reported financial
results for the three months ended March 31, 2022 and provided an update
on the Company’s recent corporate developments.
Recent highlights include:
Financial Highlights
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In April 2015, Opexa completed a rights offering and raised
$13,804,140 in gross proceeds, before expenses, through subscriptions
for 25,098,437 units, including the exercise of over-subscription
privileges. Each unit consisted of one share of common stock and a
warrant to purchase an additional share of common stock. Net proceeds,
after deduction of fees and expenses, are expected to be approximately
$12 million.
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In March 2015, Opexa received a $3 million payment from Merck Serono
(a division of Merck, Darmstadt, Germany).
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The payment, which was made as part of an amendment to an existing
Option and License Agreement between the parties, provides support
for the ongoing Phase 2b Abili-T clinical study of Tcelna® (imilecleucel-T),
Opexa’s personalized immunotherapy in development for patients
with secondary progressive MS (SPMS), as well as the preparation
and planning of potential Phase 3 studies.
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Based on the current activities of the Company and projected burn,
Opexa believes it has sufficient liquidity into the fourth quarter of
2016. The Company expects this will support the completion and
reporting of top line results for the Phase 2b Abili-T study of Tcelna
in SPMS patients and the completion of the preclinical activities for
OPX-212 in NMO, as well as supporting general operations of the
Company.
Clinical Highlights
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As of April 30, 2022, approximately 75% of the patient visits have
been completed in the Abili-T study in SPMS patients. 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. The trial is fully enrolled with 190 total subjects
enrolled.
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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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Opexa was invited to present biomarker data on patients with
neuromyelitis optica (NMO) at a scientific session and poster
presentation at the 67th American Academy of Neurology
(AAN) Annual Meeting in April.
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Opexa continued IND enabling activities for OPX-212 (Opexa’s NMO
therapeutic candidate), including advancing a bio-activity study and
performing process development work. IND submission for OPX-212 is
expected in 2015.
“We are coming off a productive quarter, which was highlighted with the
announcement of a $3 million payment from Merck Serono to further
support the development of Tcelna,” said Neil K. Warma, Opexa’s
President and Chief Executive Officer. “We welcome Merck Serono’s
continued support as a vote of confidence in our ability to execute on
the Abili-T trial. We are pleased that the $15 million we raised in the
first four months of 2015 should enable us to fully fund the balance
required for our Phase 2b Abili-T trial of Tcelna in secondary
progressive MS patients through the release of top-line data. We expect
results from this trial in the second half of 2016.”
“Our second disease program in neuromyelitis optica (NMO) is moving
forward as we continue our preclinical and IND enabling studies. We
generated some interesting data last quarter and were invited to present
these data during the recent American Academy of Neurology annual
meeting. Our results showed that despite patients receiving B-cell
depleting therapy, there remained an underlying and persistent
inflammation due to the presence of activated T-cells. Our belief is
that treatment using Opexa’s novel immunotherapy drug development
candidate, OPX-212, could dampen both the T-cell and B-cell inflammatory
process, thereby attacking the root cause of the disease.”
Financial Results for the Three Months Ended March 31, 2022
Opexa reported total revenues of $377,543 and $348,837 for the three
months ended March 31, 2022 and 2014, respectively. Included in total
revenues is $307,686 and $348,837 which was recognized for the three
months ended March 31, 2022 and 2014, respectively, related to the
$5 million upfront payment received from Merck Serono in connection with
a February 2013 Option and License Agreement. In addition, revenues for
the three months ended March 31, 2022 include $69,767 related to the $3
million payment from Merck Serono made in connection with the March 2015
amendment to such 2013 Agreement.
Research and development expenses for the three months ended March 31,
2015 were $2,636,999, a decrease of 6.2% compared to the $2,811,139 for
the three months ended March 31, 2022. The decrease in expenses is
primarily due to a decrease in the costs in connection with the ongoing
clinical trial of Tcelna in SPMS, a decrease in the procurement and use
of supplies for product manufacturing and development, partially offset
by increases in employee compensation expense and facility costs.
General and administrative expenses for the three months ended March 31,
2015 were $1,006,130, a decrease of 8.8% compared to the $1,102,880 for
the three months ended March 31, 2022. The decrease in expense is due to
decreases in employee compensation and stock compensation expenses
partially offset by increases in business development expenses.
Depreciation and amortization expenses for the three months ended March
31, 2015 were $96,982 compared with $95,586 for the three months ended
March 31, 2022. The increase in expense is due to increases in
depreciation for laboratory, manufacturing and computer equipment
acquired during 2014 and 2015.
Opexa reported a net loss for the three months ended March 31, 2022 of
$3,350,880, or $.12 loss per share (basic and diluted), compared with a
net loss of $3,655,574, or $.13 loss per share (basic and diluted), for
the three months ended March 31, 2022. The decreased net loss is
primarily related to the decrease in research and development expenses
and the decrease in general and administrative expenses, and was
partially offset by the gain on exchange rate and by higher revenues for
the quarter ending March 31, 2022.
Cash and cash equivalents were $9,572,880 as of March 31, 2022, compared
to $9,906,373 as of December 31, 2021. The Company’s monthly burn rate
for the three months ending March 31, 2022 was approximately $1.1
million.
For additional information please see Opexa’s Annual Report on Form 10-Q
filed today with the SEC.
Conference Call and Webcast Details
Opexa will conduct a conference call and webcast to provide a corporate
update and discuss the financial results at 4:30 P.M. ET today. To
participate in the conference call, dial in approximately ten minutes
before the scheduled 4:30 P.M. ET time to 201-689-8040 or toll free at
877-407-8133. Please reference conference ID 13609081 or the Opexa
Therapeutics Earnings Call.
A live webcast of the call can also be accessed here or
via the webcast link on the Investor Relations page of Opexa's website (www.opexatherapeutics.com).
An archive of the webcast will be available on the Company's website
until August 12, 2015.
There will be a brief Question & Answer session following management
commentary.
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.
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, our ability to obtain, maintain and protect intellectual
property rights (including for Tcelna and future pipeline candidates
such as 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, 2021 and our Quarterly
Reports on Form 10-Q. 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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Statement of Operations Data:
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Three Months
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Ended March 31,
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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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377,453
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$
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348,837
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Research and development
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2,636,999
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2,811,139
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General and administrative
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1,006,130
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1,102,880
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Depreciation and amortization
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96,982
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95,586
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Operating loss
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(3,362,658
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(3,660,768
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Interest income
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1,478
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5,194
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Other income, net
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10,300
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-
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Net loss
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$
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(3,350,880
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$
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(3,655,574
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Basic and diluted loss per share
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$
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(0.12
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$
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(0.13
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Weighted average shares outstanding
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28,234,751
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27,584,615
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Selected Balance Sheet Data:
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March 31,
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December 31,
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2015
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2014
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Cash and cash equivalents
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$
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9,572,880
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$
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9,906,373
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Other current assets
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683,452
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758,943
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Property and equipment, net
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1,007,532
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1,098,104
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Other long term assets
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29,204
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38,939
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Total assets
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11,293,068
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11,802,359
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Total current liabilities
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5,330,355
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3,132,424
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Deferred revenue
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2,178,877
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1,230,748
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Total stockholders’ equity
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3,783,836
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7,439,187
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Source: Opexa Therapeutics, Inc.