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 June 30, 2015 and
provided an update on the Company’s recent corporate developments.
Recent highlights include:
Clinical and Operational Highlights
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The Phase 2b clinical trial of Tcelna® (imilecleucel-T)
in Secondary Progressive Multiple Sclerosis (SPMS) (Abili-T trial)
continued to advance in the second quarter. Top line data is expected
in the second half of 2016. The two year trial is fully enrolled and
to date, approximately 86% 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.
-
Opexa continued to advance the Company’s second therapy candidate
toward the clinic. OPX-212 is being developed for the treatment of
Neuromyelitis Optica (NMO). During the second quarter of 2015, Opexa
continued with IND-enabling activities as well as process development
and manufacturing activities to support OPX-212 preclinical
development. An IND is expected to be filed by the end of 2015.
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Opexa was invited to present novel biomarker data in two poster
presentations at the American Academy of Neurology (AAN) 2015 annual
meeting, which included support for the proposed mechanism of action
of OPX-212 in NMO.
Financial Highlights
-
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, were approximately $12 million.
-
Based on the current activities of the Company and projected burn,
Opexa believes it has sufficient liquidity to continue its current
operations 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.
“The second quarter of 2015 progressed well as we advanced closer toward
our key Phase 2b clinical trial milestone and raised significant capital
to support the trial,” said Neil Warma, President and Chief Executive
Officer of Opexa. “The Phase 2b clinical study in Secondary Progressive
MS is expected to deliver top line results in the second half of 2016,
and we have now completed 86% of all patient visits. There are very
limited treatment options for patients with SPMS and we remain focused
on completing this trial as Tcelna would, if successful, mark a
significant contribution for patients with the progressive form of MS.
Importantly, with the completion of a significant rights offering in
April, Opexa is now fully funded to data for the Abili-T Phase 2b
clinical trial. This was an important milestone for the Company. With
the exercise of over-subscription rights, we managed to secure over 85%
subscription in the rights offering, which was encouraging. We were
especially pleased with the $3 million payment we received at the end of
the first quarter from Merck-Serono, our potential partner in MS. This
payment was outside the original agreement that was signed in 2013, and
supports Tcelna and the on-going Abili-T clinical trial.”
“Progress was made in our orphan program, OPX-212 in NMO during the
second quarter. We are continuing with IND-enabling studies and process
development steps that should prepare us for the submission of our IND
by the end of this year. As a result of our R & D studies, which showed
evidence of persistent inflammation in NMO patients despite receiving
B-cell depleting therapy, we were invited to present our data at this
year’s AAN Annual Meeting. Both programs progressed during the second
quarter and we remain committed to maintaining a leadership position in
the development of personalized T-cell immunotherapies in autoimmune
diseases,” added Mr. Warma.
Second Quarter Financial Results
Opexa reported revenue of $726,292 and $307,686 for the three months
ended June 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 $2,795,858 for the three months
ended June 30, 2015, compared with $3,409,210 for the three months ended
June 30, 2014. The decrease in expenses is primarily due to a decrease
in the investigator costs associated 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
intellectual property legal fees and employee compensation expense.
General and administrative expenses for the three months ended June 30,
2015 were $1,345,624, compared with $967,367 for the three months ended
June 30, 2014. The increase in expense is due to the expensing of
$238,154 of previously deferred costs related to financing agreements
with Lincoln Park and increases in employee cash compensation partially
offset by decreased stock compensation expense.
Depreciation and amortization expenses for the three months ended June
30, 2015 were $94,002, compared with $98,658 for the three months ended
June 30, 2014. The decrease in expense is due to some assets being fully
amortized which 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 $2,337 for the three months
ended June 30, 2015, compared to $4,290 for the three months ended June
30, 2014.
Other income was $9,974 for the three months ended June 30, 2015,
compared to $0 in the three months ending June 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 June 30, 2015 was
approximately $3.5 million, or $0.07 loss per share (basic and diluted),
compared with a net loss of approximately $4.2 million, or $0.15 loss
per share (basic and diluted), for the three months ended June 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 $18,283,560 as of June 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.
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. ET 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 13614871 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 November 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
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 Reports on Form 10-Q for the
quarter ended June 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.
OPEXA THERAPEUTICS, INC.
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OPEXA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months
Ended June 30,
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Six Months
Ended June 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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726,292
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$
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307,686
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$
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1,103,745
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$
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656,523
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Research and development
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2,795,858
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3,409,210
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5,432,857
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6,220,349
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General and administrative
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1,345,624
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967,367
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2,351,754
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2,070,247
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Depreciation and amortization
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94,002
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98,658
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190,984
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194,244
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Operating loss
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(3,509,192
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)
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(4,167,549
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)
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(6,871,850
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)
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(7,828,317
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)
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Interest income, net
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2,337
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4,290
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3,068
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9,484
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Other income, net
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9,974
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-
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21,021
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-
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Net loss
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$
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(3,496,881
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)
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$
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(4,163,259
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)
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$
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(6,847,761
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)
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$
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(7,818,833
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)
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Basic and diluted loss per share
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$
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(0.07
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)
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$
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(0.15
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)
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$
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(0.18
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)
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$
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(0.28
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)
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Weighted average shares outstanding - Basic and diluted
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49,769,294
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27,661,675
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39,061,510
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27,623,358
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Selected Balance Sheet Data:
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June 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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|
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$
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18,283,560
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$
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9,906,373
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Other current assets
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403,634
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758,943
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Fixed assets, net
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918,899
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1,098,104
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Other long term assets
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19,469
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38,939
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Total assets
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19,625,562
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11,802,359
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Total current liabilities
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4,954,385
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3,132,424
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Total long-term liabilities
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1,452,584
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1,230,748
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Total stockholders’ equity
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13,218,593
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7,439,187
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View source version on businesswire.com: http://www.businesswire.com/news/home/20150812006014/en/
Source: Opexa Therapeutics, Inc.