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Opexa Announces Granting of New T-cell Patents Covering Tcelna®; Patent Estate Increases to 160 Issued Patents

10/06/2022

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 issuance of four additional key patents covering its broad T-cell immunotherapy platform. The recent allowances bring the number of granted U.S. and international patents in Opexa’s patent portfolio to 160, including in-licensed patents. The expansion of Opexa’s intellectual property portfolio further strengthens the patent estate surrounding Tcelna®, Opexa’s personalized T-cell immunotherapy in development for the treatment of secondary progressive multiple sclerosis.

Recently-granted European Patent Nos. 1546719, 2016414 and 2420833 are directed to Opexa’s proprietary methods for preparing individualized T-cell vaccines, while European Patent No. 2363710 is directed to the autologous T-cell vaccine compositions themselves. The claims cover the use of particular immunodominant epitopes found in myelin basic protein, proteolipid protein and myelin oligodendrocyte protein in the preparation of such T-cell vaccines, as well as the identification and use of specific antigenic epitopes that are disease-relevant for individual patients from these and other polypeptide antigens.

“We are very pleased with the issuance of the new European patents and the continued growth of our intellectual property portfolio,” stated Neil K. Warma, President and Chief Executive Officer of Opexa. “This family of patents is key to protecting and strengthening our intellectual property position surrounding our personalized T-cell immunotherapy for the treatment of autoimmune diseases. We continue to be aggressive in the strengthening of our patent estate and have also recently submitted new patent applications related to our proprietary epitope screening assay and potency assay.”

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, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. 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.

Opexa Therapeutics, Inc.

Karthik Radhakrishnan, 281-775-0600

Chief Financial Officer