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Opexa Strengthens Patent Portfolio with Expansion Into B-cell Diseases and Announces Allowance of 98th T-cell Patent

09/29/2014

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 announced the expansion of its intellectual property portfolio. Opexa’s intellectual property portfolio has grown to reach 98 issued and validated patents worldwide. Additionally, Opexa is expanding its IP protection to cover B-cell mediated diseases in connection with its recently announced development program in Neuromyelitis Optica.

Opexa recently received a Notice of Allowance for Canadian patent No. 2,459,969, entitled, “Autologous T-Cell Vaccines Materials and Methods,” which broadly covers the Company’s core T-cell technology platform for the development of patient-specific immunotherapies. Once issued, this will bring the number of granted and validated patents (U.S. and international) in the Company’s IP portfolio to 98, including in-licensed patents. This group of patents mainly covers T-cell mediated autoimmune diseases, including multiple sclerosis.

Additionally, Opexa recently filed a U.S. provisional patent application in conjunction with the expansion of its innovative technology into B-cell mediated autoimmune disorders, including for diseases with significant unmet needs, such as NMO. Additional pending provisional applications are directed toward Opexa’s proprietary protocols for testing the potency of therapeutic T-cell vaccines and its proprietary screening assay, important for its personalized approach.

“Over the past several years, Opexa has built a significant IP estate around autoimmune diseases that are primarily T-cell mediated diseases, such as multiple sclerosis,” said Neil K. Warma, Opexa’s President and Chief Executive Officer. “This portfolio now includes almost 100 issued patents in the U.S. and internationally. With our recent move into NMO, which is a B-cell mediated disease, we are now pursuing patent coverage that may extend our IP protection across a much broader range of autoimmune disorders, i.e., both T-cell and B-cell disorders. This should enhance our position as a leader in the treatment of autoimmune disorders using personalized immunotherapies.”

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.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Forward-Looking Statements

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, 2013 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2014. 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.

Source: Opexa Therapeutics, Inc.

Company Contact:

Opexa Therapeutics, Inc.

Karthik Radhakrishnan, 281-775-0600

Chief Financial Officer

or

Investor Relations:

The Trout Group

Adam Cutler, 646-378-2936

opexa@troutgroup.com