Opexa Therapeutics (NASDAQ: OPXA)

 Research Report

Opexa Therapeutics, Inc. (NASDAQ:OPXA) is a publicly traded biotechnology company dedicated to the development of patient-specific immunotherapies for the treatment of multiple sclerosis. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive Multiple Sclerosis.

Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders.

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Investment HighlightsValue Proposition
Company Name Opexa Therapeutics
Market/Symbol NASDAQ: OPXA
Recent Price
Market Cap $6.36M
Avg. Daily Vol. (3m) 598,341
Price/Book N/A
Price/Cash Flow N/A
As of Dec. 8, 2016
*Source: QuoteMedia


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Recent Company Videos


Opexa Therapeutics: Developing Immunotherapies for Multiple Sclerosis

Nov. 16, 2015

Learn more at: http://www.redchip.com/company/healthcare/OPXA/194/healthcare Dave Gentry, host of "The RedChip Money Report," interviews Neil Warma, ...


Investment Highlights


  • Each patient receives a personalized T-cell therapy tailored to their individual disease profile on an annual basis
  • Novel proprietary platform, 50 patents have been issued (domestic and international)

  • Previous Phase IIb clinical trials in RRMS show 88% reduction in brain atrophy, a statistically significant improvement in disability (by EDSS), and a 55% reduction in the annualized relapse rate for patients treated with Tcelna vs. a placebo
  • 80% of patients with SPMS treated with Tcelna in Phase I//II study showed no further disease progression by EDSS at 2 years
  • Demonstrated superior safety profile compared to existing MS products
  • Limited treatment options currently available for SPMS

Potential SPMS market in North America alone could exceed $7 billion

Fast Track designation granted by FDA for Tcelna in SPMS

Tcelna has a single-cycle manufacturing process; annual course of treatment (5 doses) from one blood draw

Option Agreement with Merck Serono (up to $220 million in additional payments, 8-15% royalties); a strong potential commercial partner

Value Proposition


OPXA’s lead program, Tcelna, has the potential to treat Secondary Progressive Multiple Sclerosis (SPMS), a $7B+ market (North America only), for which treatment options are limited. Based on encouraging Tcelna data and the need for a viable treatment for SPMS, the FDA has granted a Fast Track designation for Tcelna. Tcelna possesses a unique mechanism of action that combats the demyelination of the nerve fibers in the central nervous system (the underlying cause of MS), and Phase IIb clinical trials in relapsing- remitting MS (RRMS) and clinically isolated syndrome (CIS) have demonstrated the therapy’s efficacy and safety. Tcelna’s single-cycle manufacturing process, with an annual course of treatment derived from one blood draw, indicates that the therapy should be economically feasible as well. Opexa secured partnership (option and license agreement) with Merck Serono for MS indications – Merck Serono to pay for all Phase III and commercial costs and provide Opexa with potential milestones of $220M and 8-15% royalties – if option exercised and program successful. Receptos, Inc. (NasdaqGS: RCPT), has a market cap of $945.4M, and its lead product to treat RRMS is in Phase II/III trial; OPXA has a market cap of only $51.8M, providing investors with an attractive entry point prior to the results of Tcelna’s Phase IIb clinical trial.

Opexa Therapeutics Latest News


Ask the CEO



Meet The Board of Directors

Gail J. Maderis

Director

Scott B. Seaman

Director

Michael S. Richman

Director

Neil K. Warma

President & CEO

Meet The Management Team

Neil K. Warma

President and Chief Executive Officer, Director

Karthik Radhakrishnan

Chief Financial Officer

Donna R. Rill

Chief Development Officer

Don Healey

Chief Scientific Officer

Kenny Frazier

Vice President of Clinical Development and Regulatory Affairs

OPXA Research

Since our last update on 9/9/2014, OPXA has made significant progress, receiving funding which allows it to complete its Phase IIb clinical trial in secondary-progressive multiple sclerosis… Read More

Sep. 08, 2015

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Historical SEC Filings

Date Form Title
Nov 25, 2016 8-K 8-K - Current report
Nov 14, 2016 8-K 8-K - Current report
Nov 14, 2016 10-Q 10-Q - Quarterly report [Sections 13 or 15(d)]
Nov 02, 2016 8-K 8-K - Current report
Oct 31, 2016 UPLOAD UPLOAD [Cover] - SEC-generated letter
Oct 28, 2016 8-K 8-K - Current report
Oct 26, 2016 CORRESP CORRESP [Cover] - Correspondence
Oct 18, 2016 UPLOAD UPLOAD [Cover] - SEC-generated letter
Oct 07, 2016 CORRESP CORRESP [Cover] - Correspondence
Sep 27, 2016 UPLOAD UPLOAD [Cover] - SEC-generated letter

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