SeeThruEquity Initiates Coverage on Opexa Therapeutics, Inc. (NASDAQ: OPXA) with a Price Target of $3.06
NEW YORK, NY / CRWEPRESSRELEASE / August 27, 2015 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has initiated coverage of Opexa Therapeutics, Inc. (NASDAQ: OPXA) with a Price Target of $3.06.
The report is available here: OPXA Initiation Report. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
Headquartered in The Woodlands, TX, Opexa is an innovative biopharmaceutical company focused on developing precision immunotherapy initially targeting secondary progressive multiple sclerosis (SPMS) and neuromyelitis optica (NMO). The company’s lead drug candidate, Tcelna (R), is being developed as a potential therapy of choice in SPMS, a $7Bn+ annual market with limited competition. Tcelna (R) received fast track designation from the FDA and has attracted support from a strong potential partner in Merck-Serono. Beyond Tcelna (R), Opexa is also developing OPX-212, a preclinical compound intended for neuromyelitis optica (NMO), an orphan indication with no approved therapies. Longer term, we believe the company is focused on leveraging its proprietary technology and broad intellectual property (IP) portfolio to develop a personalized T-cell immunotherapy platform that can be leveraged for treatment of a number of autoimmune diseases, with the potential to yield multiple candidates tailored to each patient’s disease profile.
“We see the next twelve months as potentially game-changing for Opexa, as the company is nearing completion of a high profile Phase 2b clinical trial for its lead personalized immunotherapy candidate, Tcelna (R) for SPMS. We have high hopes for Tcelna (R) in what Opexa has dubbed the Abili-T Phase 2b clinical trial, which is designed to determine whether Tcelna (R) could improve clinical outcomes of SPMS patients. Opexa has designed Tcelna (R) to be a first line treatment for the $7Bn+ annual market for SPMS by taking a differentiated, personalized approach to treating MS, with the treatment specifically tailored to each patient’s immune response profile to myelin. Tcelna (R) received fast track designation from the FDA for SPMS, and demonstrated encouraging results in earlier Phase I/II trials – with 80% of patients showing no disease progression after two years of treatment. The candidate has also attracted the interest of major pharmaceutical companies, signing an option and license agreement with Merck-Serono in 2013 that could be worth up to $220mn in future license and milestone fees, in addition to royalties,” stated Ajay Tandon, CEO of SeeThruEquity. “We are initiating coverage with a 12-month price target of $3.06 per share.”
Additional highlights from the report are as follows:
Abili-T Phase 2b trial top line results on the horizon
We have high hopes for Tcelna (R) in Opexa’s “Abili-T” Phase 2b clinical trial, which is designed to determine whether Tcelna (R) could improve clinical outcomes of SPMS patients. According to management, patient visits in the two-year, double blind, placebo controlled, Abili-T study were over 85% complete, with completion and top line results expected in the second half of 2016E. Opexa completed a rights offering in April with net proceeds of $12mn, giving the company a clear runway to complete the trial.
Large market opportunity attracting Big Pharma interest
MS is a chronic, inflammatory condition of the central nervous system that affects approximately 2.5mn people globally and 450,000 people in North America, according to the National MS Society. Tcelna (R) received a fast track designation from the FDA for potential treatment of SPMS, and demonstrated encouraging results in earlier Phase I/II trials – with 80% of patients showing no disease progression after two years of treatment. Opexa aims for Tcelna (R) to be a first-to-market, personalized T-cell therapy for MS patients, which assuming 150,000 patients with SPMS in North America, could represent a potential market greater than $7Bn per year. If approved, Opexa looks to face limited competition in this large market from FDA-approved SPMS treatments, presenting an opportunity for Tcelna (R) to emerge as a blockbuster drug assuming its efficacy is supported by Phase 2b results.
Potential licensing deal with Merck-Serono enhances opportunity
Tcelna (R) has also attracted the interest of major pharmaceutical companies, with Opexa signing a global option and license agreement with Merck-Serono in 2013 that could be worth up to $220mn in future license and milestone fees and an attractive potential royalty rate of 8% – 15% depending on sales levels. If it exercises the option to license Tcelna (R), Merck-Serono would also fund Phase 3 clinical trials and commercialization costs. Merck-Serono has until the release of the Abili-T results to exercise the option to license Tcelna (R), adding to the importance of strong efficacy data from the Phase 2b trial. Clearly a potential partnership with Merck-Serono would be a significant catalyst and potentially transformative development for Opexa.
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About Opexa Therapeutics, Inc.
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 (R), 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.
For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.
SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. The company does not conduct any investment banking or commission based business. SeeThruEquity is approved to contribute its research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks, and distribute its research to its database of opt-in investors. The company also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
For more information visit www.seethruequity.com.