THE WOODLANDS, TX -- (Marketwired) -- 08/11/16 --
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, including Tcelna® for multiple sclerosis (MS) and OPX-212 for neuromyelitis optica (NMO), today reported financial results for the quarter ended June 30, 2016, and provided an update on the Company's clinical development and corporate activities.
"During the second quarter we continued to advance our Phase 2b Abili-T trial in secondary progressive multiple sclerosis towards completion and we are excited to approach this significant milestone in the development of our personalized immunotherapy, Tcelna," stated Neil K. Warma, President and Chief Executive Officer of Opexa. "There are only a few scheduled patient visits remaining in the study and top-line results are expected early in the fourth quarter of this year. The entire Company is working diligently to complete the remaining activities and close out the study. We believe the Abili-T trial results could significantly impact the lives of those suffering with multiple sclerosis. Secondary progressive MS is a serious disease for which currently, there are no treatment options. We believe Tcelna has the potential to become the first safe and effective treatment for secondary progressive MS patients."
"If Tcelna is proven safe and effective, we believe it could become the therapy of choice for patients with the progressive form of multiple sclerosis and, possibly, enable us to enter what we estimate to be a roughly $7 billion overall market," continued Warma. "Additionally, with positive results in the Abili-T study, we could be positioned for a streamlined path to a Phase III pivotal trial in secondary progressive MS. This would involve working closely with Merck Serono, our potential partner for Tcelna. In 2013, we signed an option and license agreement with Merck Serono, one of the top MS companies in the world. With positive Phase II data, we believe Merck Serono would exercise their option and advance Tcelna into a Phase III trial and through clinical development in MS."
Financial Results for the Quarter Ended June 30, 2016
For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC.
Conference Call and Webcast Details
The Company will host a conference call and webcast today at 4:30 p.m. ET to provide an update on the Company and discuss second quarter 2016 financial results. To access the conference call, please dial 201-689-8040 or toll free 877-407-8133 five minutes prior to the start time. The conference ID number is 13642247.
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 11, 2016.
There will be a brief Question & Answer session following management commentary.
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 2b 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. Top-line results from the Abili-T trial are expected in early 4th quarter of 2016.
For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn.
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 as well as the sufficiency of our resources, 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), the ability of any of our potential products (such as Tcelna), assuming approval by applicable regulatory authorities (such as the Food and Drug Administration), to achieve commercial success, 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, 2015 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.
Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
Source: Opexa Therapeutics, Inc.