NUMBERS ARE ONLY PART OF THE STORY
Numbers are important. They can be compared against others and tell us how far we have come and how far we have to go. Numbers help us measure our goals and aspirations, and show the world how we intend to reach them. They estimate odds and probabilities and they calculate results. They are necessarily impartial, rational and dispassionate.
But numbers only tell half the story.
They will never be able to put a value on the loss of a loved one, or convey the appreciation for every battle that is won against cancer. However, the largest number would still be too small to measure an empty space in a family photograph.
FROM BENCH TO BEDSIDE
At OncoSec, our dedication to research and development is underpinned by the belief that behind every statistic is a life, and behind every estimate, hope. These principles have guided our work – from a product based clinical development plan and enhancing our capacity to strengthening the scope and depth of our team.
We are committed to improving the quality of life for patients living with deadly skin cancers by providing them with safer and more effective approaches to treating these terrible diseases. The patient is our focus and our path has never been clearer as we move closer than ever to making our commitment a reality.
In less than one year, OncoSec not only initiated and completed the formation of the Company, but also committed to three Phase II clinical studies in rare and deadly skin cancers with significant unmet medical needs. This important milestone was the pinnacle of a number of accomplishments made throughout 2011 that advanced OncoSec from a start-up to a clinical-stage company.
2011 IN REVIEW
The formation of OncoSec in 2011 occurred through the acquisition of certain non-DNA vaccine technologies and intellectual property assets relating to the Company’s OMS ElectroOncology therapies for treating solid tumor cancers. With seed capital secured, the Company quickly moved to attract and acquire an experienced and respected management team and scientific and clinical advisory board.
The Company then established a robust clinical development plan based on its novel, first-in-class OMS ElectroImmunotherapy platform for the treatment of rare and deadly skin cancers, including (1) metastatic melanoma; (2) Merkel cell carcinoma; and (3) cutaneous T-cell lymphoma. OMS ElectroImmunotherapy uses electroporation to deliver, directly into the patient’s own cells, a gene, which expresses interleukin-12, a potent, naturally occurring protein that is central to the regulation of the body’s anti-cancer immune function. Preclinical and Phase I studies have shown that the therapy is safe, without toxic side effects, and has resulted in immune responses that produced both a local and systemic response against cancerous lesions. Positive clinical data of DNA-based IL-12, the first-ever to demonstrate electroporation-mediated delivery of a DNA plasmid designed to express a therapeutic protein in humans, was presented at the 2011 Annual Meeting of the American Society of Clinical Oncology. In the Phase I human study, 15% of patients demonstrated 100% clearance of distant, untreated metastatic melanoma (stage III/IV) tumors; in retrospect only 0.25% would be expected to spontaneous resolve on their own if left untreated. If OncoSec’s Phase II trials further validate this evidence, the DNA-based IL-12 ElectroImmunotherapy platform would represent an important advancement in the treatment of both local and metastatic cancers. All three Phase II studies will be physician-sponsored clinical trials.
This past year also demonstrated the Company’s ability to continue to create value from its advanced-stage OMS ElectroChemotherapy program for the treatment of primary and recurrent localized solid tumors. Since the acquisition of a clinical data set of over 400 patients, OncoSec has compiled, reviewed, and analyzed the data and presented preliminary results from previous Phase IV European head & neck cancer trials and a Phase I/II breast cancer trial. The preliminary data sets from the completed Phase III recurrent head and neck cancer studies carried out in the U.S. and a comprehensive review of the Phase IV European trials in recurrent and primary skin cancers and head & neck cancer are now being analyzed. The Company expects to share this information with potential partners for the continued development of this program.
ON THE FUTURE, PATIENTS – AND NUMBERS
While the near-term outlook for OncoSec is exciting, the long-term outlook may be even brighter. Our platform technology is novel and unique, and data from our OMS ElectroOncology therapies are first-in-class. Over the next 12 months we expect to have interim clinical data from all three of our Phase II trials. We have successfully made the transition to a clinical development company and are well positioned to capitalize on the opportunities for growth ahead of us.
The Company will continue to build product value through next generation devices and drugs and generate additional intellectual property organically or through other in-licensing opportunities. In 2011, OncoSec established in-house capabilities to build, maintain and develop its own devices. In 2012, the Company expects to boost its capabilities by meeting additional stringent quality assurance standards and increasing manufacturing capabilities for its ongoing and future clinical trials through additional efficiencies and ability to scale up production as needed to support potential partners.
At OncoSec, we believe 2012 will continue the momentum gained in 2011: by maintaining a lean enterprise through outsourcing and cash flow management, while remaining flexible enough to respond to emerging opportunities; by collaborating with partners such as the University of California San Francisco, the University of Washington and the Fred Hutchinson Cancer Center in order to strengthen our treatment platforms; by creating value from our late-stage OMS ElectroChemotherapy program through potential partnering deals with regional or global partners; and by focusing on the health of the patient.
With our clinical studies off the ground, we look forward to treating the first patient with DNA-based IL-12 and moving ever closer to being able to improve lives with a potentially revolutionary treatment that could offer greater efficacy and safety than existing therapies. That we have advanced so far towards our goal underscores the hard work of the entire OncoSec team, scientific advisors, the Board of Directors, and the tremendous support of our investors. We are dedicated to bringing the entirety of our resources and expertise to try and meet the expectations of our shareholders and patients around the world.
February 3, 2012
President & CEO
This letter contains certain forward-looking statements relating to our plans to develop our OMS ElectroOncology therapies. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that Phase I clinical results referenced in this letter may not be indicative of results achievable from testing in Phase II clinical trials) and the other factors set forth in detail in our Annual Report on Form 10-K for the year ended July 31, 2011 and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products. We encourage our shareholders to carefully review the section entitled “Risk Factors” in the Annual Report with which this letter is provided.