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 third quarter ended September 30,
2014 and provided an overview of the Company’s recent corporate
developments.
Recent highlights include:
Operational Highlights:
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Opexa announced it had initiated early development in a second
autoimmune disease, Neuromyelitis Optica (NMO), a rare neurological
disease; preclinical development is on-going; and an IND for OPX-212,
Opexa’s product candidate in NMO, is expected to be submitted by
mid-2015;
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Opexa highlighted its NMO development plan and progress during an
analyst event at the 2014 Joint ACTRIMS/ECTRIMS meeting in Boston;
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Opexa announced the issuance of its 98th patent (US and
international) covering its T-cell technology;
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Opexa held an R&D update for analysts and investors in New York
highlighting progress on its pipeline candidates including the Phase
IIb Abili-T trial currently on-going in Secondary Progressive Multiple
Sclerosis (SPMS) and the preclinical development program for OPX-212
in NMO;
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Opexa was selected to present at the 12th Annual Cleveland
Clinic Medical Innovation Summit; and
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At a recent and regularly scheduled meeting of the Data Safety and
Monitoring Board (DSMB), the independent board overseeing Opexa’s
Phase IIb Abili-T trial, the DSMB recommended the trial be continued
as planned.
Financial Highlights
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Reported cash and cash equivalents of $13,637,419 as of September 30,
2014.
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Based on the current activities, Opexa believes it has sufficient
capital to support its clinical activities for the Abili-T trial, as
well as preclinical development activities for OPX-212 in NMO (with an
expected IND submission by mid-2015) and general operations of the
Company, into the fourth quarter of 2015.
“Opexa is coming off a productive quarter,” said Neil K. Warma, Opexa’s
President and Chief Executive Officer. “Importantly, our Phase IIb
clinical trial in Secondary Progressive MS, Abili-T, is advancing on
schedule, and on October 8th, the DSMB recommended continuing
the study as planned. The trial is fully enrolled and we expect top-line
data in the second half of 2016. Merck Serono, one of the leaders in MS,
secured the option to license the MS program in 2013 and we continue to
interact with them through the Joint Steering Committee that was first
convened in July of this year.”
“We were especially pleased to report on the launch of the second
disease off our proprietary T-cell platform. In September, we announced
the initiation of early development activities for Neuromyelitis Optica,
a rare disease that attacks the optic nerve and spinal cord. NMO is a
rare or orphan disease for which there is no approved treatment, giving
rise to a significant unmet medical need,” said Mr. Warma. “With this
announcement, we believe we have demonstrated our ability to leverage
our platform to be able to generate additional drug candidates,
including those for orphan diseases. Our target for NMO is to submit an
IND by the middle of next year and move into clinical development
thereafter, once the FDA has reviewed and accepted the submission and
once we have raised the necessary capital.”
As of September 30, 2014, Opexa’s cash and cash equivalents totaled
approximately $13,637,419 and the Company’s monthly burn rate for the
nine months ending September 2014 was approximately $1.1 million. Based
on the current activities, Opexa believes it has sufficient liquidity to
support its clinical activities for the Abili-T trial as well as
preclinical development activities for OPX-212 in NMO (with an expected
IND submission by mid-2015) and general operations of the Company into
the fourth quarter of 2015.
Third Quarter Financial Results
Opexa reported revenue of $307,686 for the three months ended September
30, 2014, compared to $348,837 for the three months ended September 30,
2013. 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.
Research and development expenses were $3,173,538 for the three months
ended September 30, 2014, compared with $2,494,463 for the three months
ended September 30, 2013. The increase in expenses is primarily due to
an increase in the costs in connection with the increased enrollment of
patients for the ongoing clinical trial of Tcelna in SPMS, an increase
in the procurement and use of supplies for product manufacturing and
development, and increases in the number of employees to support the
ongoing clinical trial, employee compensation expense and stock
compensation expense.
General and administrative expenses for the three months ended September
30, 2014 were $917,335 compared with $626,668 for the three months ended
September 30, 2022. The increase in expense is due to increases in
capital financing expenses which was brought about by the reversal of
accrued banker’s fees for $118,000 in the third quarter of 2013 due to a
settlement and increases in stock compensation expenses, and was
partially offset by decreases in legal fees.
Depreciation and amortization expenses for the three months
ended September 30, 2014 were $97,364, compared with $90,935 for the
three months ended September 30, 2013. The increase in expense is due to
increases in depreciation for laboratory, manufacturing and computer
equipment acquired during 2013 and 2014 and leasehold improvements
during 2013 and 2014 to support increased development activities.
Opexa reported a net loss for the three months ended September 30,
2014 of $3,878,053, or $0.14 loss per share (basic and diluted),
compared with a net loss of $5,723,932 or $0.39 loss per share (basic
and diluted) for the three months ended September 30, 2013. The
decreased net loss is primarily related to the recording of a $2.5
million loss on extinguishment of debt in 2013 and interest expense
related to promissory notes in 2013 partially offset by a decrease in
revenue, an increase in research and development expenses, higher
general and administrative expenses and higher depreciation expenses for
the quarter ending September 30, 2022.
Cash and cash equivalents were $13,637,419 as of September 30, 2014,
compared to $20,172,485 as of September 30, 2013.
For additional information please see Opexa’s Quarterly 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 5:00 p.m. Eastern
Time today. To participate in the conference call, dial in approximately
ten minutes before the scheduled 5:00 p.m. time to 201-689-8040 or toll
free at 877-407-8133. Please reference conference ID 13594378 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).
About Opexa
Opexa is a biopharmaceutical company developing personalized
immunotherapies 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 is derived from T-cells
isolated from the patient’s peripheral blood, expanded ex vivo,
and reintroduced into the patients via subcutaneous injections. This
process triggers a potent immune response against specific subsets of
autoreactive T-cells known to attack myelin. Opexa’s mission is to lead
the field of Precision Immunotherapy® by aligning the
interests of patients, employees and shareholders.
About Tcelna
Tcelna® is a potential personalized therapy that is under development to
be specifically tailored to each patient's disease profile. Tcelna is
manufactured using ImmPath®, Opexa's proprietary method for the
production of a patient-specific T-cell immunotherapy, which encompasses
the collection of blood from the MS patient, isolation of peripheral
blood mononuclear cells, generation of an autologous pool of
myelin-reactive T-cells (MRTCs) raised against selected peptides from
myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG)
and proteolipid protein (PLP), and the return of these expanded,
irradiated T-cells back to the patient. These attenuated T-cells are
reintroduced into the patient via subcutaneous injection to trigger a
therapeutic immune system response.
Opexa is currently conducting a Phase IIb study of Tcelna. Named
“Abili-T,” the trial is a randomized, double-blind, placebo-controlled
clinical study in patients who demonstrate evidence of disease
progression with or without associated relapses. The trial is being
conducted at approximately 35 leading clinical sites in the U.S.
and Canada with each patient receiving two annual courses of Tcelna
treatment consisting of five subcutaneous injections per year. The
trial’s primary efficacy outcome is the percentage of brain volume
change (atrophy) at 24 months. Study investigators will also measure
several important secondary outcomes commonly associated with MS,
including disease progression as measured by the Expanded Disability
Status Scale (EDSS), annualized relapse rate and changes in disability
as measured by EDSS and the MS Functional Composite.
About Neuromyelitis Optica (NMO)
NMO is a rare autoimmune disorder in which immune system cells and
antibodies mistakenly attack and destroy myelin cells in the optic
nerves and the spinal cord. The damage to the optic nerves produces
swelling and inflammation that cause pain and loss of vision; the damage
to the spinal cord causes weakness or paralysis in the legs or arms,
loss of sensation, and problems with bladder and bowel function. NMO
affects approximately 4,800 people in the U.S. and the worldwide
estimated prevalence is 1-2 people per 100,000 population. There is no
cure for NMO and there are no FDA-approved therapies, other than to
treat an attack while it is happening, to reduce symptoms and to prevent
relapses.
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
Ended September 30,
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Nine Months
Ended September 30,
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2014
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2013
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2014
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2013
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Revenue:
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Option revenue
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$307,686
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$348,837
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$964,209
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$917,774
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Research and development
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3,173,538
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2,494,463
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9,393,887
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6,338,859
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General and administrative
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917,335
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626,668
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2,987,582
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2,479,708
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Depreciation and amortization
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97,364
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90,935
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291,608
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258,144
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Operating loss
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(3,880,551)
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(2,863,229)
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(11,708,868)
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(8,158,937)
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Interest income
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3,456
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4,448
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12,940
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9,388
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Other income, net
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-
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37,910
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(Loss) on extinguishment of debt
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-
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(2,518,912)
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-
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(2,518,912)
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Interest expense
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(958)
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(346,239)
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(958)
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(2,267,293)
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Net loss
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$(3,878,053)
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$(5,723,932)
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$(11,696,886)
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$(12,897,844)
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Basic and diluted loss per share
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$(0.14)
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$(0.39)
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$(0.42)
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$(1.29)
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Weighted average shares outstanding - Basic and diluted
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27,826,615
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14,721,474
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27,691,855
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10,011,453
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Selected Balance Sheet Data:
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September 30, 2014
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December 31, 2013
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(unaudited)
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Cash and cash equivalents
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$
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13,637,419
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$
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23,644,542
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Other current assets
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727,830
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1,122,576
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Fixed assets, net
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1,152,603
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1,295,024
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Other long term assets
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48,674
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177,666
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Total assets
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15,566,526
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26,239,808
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Total current liabilities
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3,457,228
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3,324,493
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Deferred revenue
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1,538,434
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2,338,041
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Total stockholders’ equity
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10,570,864
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20,577,274
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Source: Opexa Therapeutics, Inc.