Opexa Therapeutics Inc : Opexa Therapeutics' CEO Letter to Shareholders
01/07/2014 | 11:34am US/EasternRecommend:
To Our Shareholders,
2013 has been an excellent year for Opexa. We reached several key milestones and executed on strategic goals set for the Company. We saw strong enrollment in the landmark Phase IIb Abili-Tclinical trial evaluating Tcelna®(imilecleucel-T) in Secondary Progressive Multiple Sclerosis (SPMS), achieving 70% enrollment in December 2013. We ended the year in a strong financial position with a clean balance sheet. Earlier this year we secured an option and license agreement for Tcelna with Merck Serono, one of the leading multinational companies focused on the treatment of multiple sclerosis (MS). If we are successful with the development of Tcelna and Merck Serono exercises its option, Opexa could be eligible to receive up to $220 million in milestone payments and, additionally, 8-15% in royalties. Importantly, Merck Serono would also be responsible for absorbing all future costs related to clinical development, including all Phase III trials, as well as pre-commercialization expenses. We feel this agreement provides further validation as to the potential of Tcelna and, if executed, could provide Opexa with a strong development and commercialization partner.
We continued to focus on building and maintaining a strong team of individuals with a broad range of expertise across numerous functions. We are currently a dedicated group of approximately 40 individuals covering a range of activities including manufacturing, quality control and quality assurance, shipping and logistics, clinical and regulatory affairs, research and development, business development, finance, accounting and compliance. Our focus as a group remains locked on working hard to deliver shareholder value and improve the quality of life for individuals with MS.
Should Tcelna prove to be safe and effective in the ongoing Abili-T SPMS clinical trial, Opexa will have differentiated itself significantly from other MS focused companies. Individuals suffering from SPMS have very few treatment options available to them. The estimated potential market for SPMS is over $7 billion in the United States alone, and we believe Tcelna has the potential to become a treatment of choice in this patient population. A significant milestone in evaluating Tcelna's potential comes in mid-2016, when top-line data from the Abili-T trial are expected.
We have built-up significant knowledge and expertise in the area of immunotherapy and continue the strengthening of our patent estate to protect our assets and technology. In 2013, we secured the 50th patent on our T-cell technology (US and international jurisdictions, collectively), and submitted an additional patent application in 2013 for our proprietary Epitope Screening Assay.
Opexa uses its proprietary manufacturing process, ImmPath®, to manufacture all Tcelna product. The process has proven robust over the past year enabling us to manufacture over 350 doses of Tcelna for patients in the Abili-T trial. This T-cell platform technology supports the ongoing and future clinical development manufacturing needs of Tcelna and, importantly, also has the potential to be leveraged for possible therapies against other disease indications.
In summary, we are pleased with the following objectives achieved this past year:
· Achieved enrollment of 70% of patients in the Abili-T clinical trial;
· Achieved initiation and activation of 33 clinical sites in the United States and Canada;
· Implemented what we believe is one of the most comprehensive Immune Monitoring/Biomarker Programs in MS as part of the Abili-T trial;
· Strengthened our financial position and cleaned-up the balance sheet through the elimination of debt;
· Unencumbered all intellectual property and physical assets pledged as collateral;
· Secured an option and license agreement with Merck Serono which, if exercised by Merck Serono, has the potential to bring in $220 million in milestone payments plus 8-15% royalties;
· Secured the 50th patent (US and international jurisdictions, collectively); and
· Laid the foundation to potentially diversify and expand off the T-cell platform.
We believe 2014 should be another strong year for Opexa. We look forward to reaching full enrollment in the Abili-T trial, which will be a key milestone for the Company and SPMS patients. The ongoing analysis of data generated from the Immune Monitoring program could also yield important developments.
We work closely with the MS Society, sponsoring and supporting important events for the community, including the MS Walk program and the MS 150. Interactions with the MS patient community are rewarding for all members of the Opexa team and remind us of the purpose of our work and, most importantly, what remains to be done.
We are grateful for the support of our shareholders and are committed to working hard to build value in the Company.
Sincerely,
Neil K. Warma
President and Chief Executive Officer