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.
SAN DIEGO, Ca, June 15, 2011 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage ElectroOncology therapies to treat solid tumor cancers, today reported financial results for the quarter ended April 30, 2011.
Total operating expenses for the three and nine months ended April 30, 2011, were $496,000 and $503,000 as compared to $3,000 and $15,000 for the three and nine months ended April 30, 2010.
The net loss attributable to common stockholders for the three and nine months ended April 30, 2011, was $499,000, or $0.01 per share, and $506,000, or $0.01 per share, as compared with a net loss attributable to common stockholders of $3,000, or $0.00 per share, and $15,000, or $0.00 per share, for the three and nine months ended April 30, 2010.
Research and development expenses for the three and nine months ended April 30, 2011, were $217,000 and $217,000 as compared to $0 for both the three and nine months ended April 30, 2010. The increase in research and development expenses for the comparable three month and nine month periods was due to our shift in focus from the online inventory services industry to the biomedical industry, which occurred in conjunction with the previously announced closing on March 24, 2011 of the asset purchase agreement with Inovio Pharmaceuticals, Inc. (Inovio) to acquire certain technology and related assets. The technology and related assets embodied in the asset purchase agreement relate to the use of drug-medical device combination products for the treatment of different cancers.
General and administrative expenses for the three and nine months ended April 30, 2011, were $280,000 and $287,000 as compared to $3,000 and $15,000 for the three and nine months ended April 30, 2010. The increase for the comparable three and nine month periods was due to an increase in salary, legal and other expenses associated with the increase in operations stemming from our shift in focus to the biomedical industry.
The $491,000 increase in net loss attributable to common stockholders for the nine months ended April 30, 2011, compared with the same period in 2010, resulted from our shift in focus to be a biomedical company concentrated on developing cancer therapeutic products.
As of April 30, 2011, our cash balance was $543,000, compared to $237 as of July 31, 2010. This change primarily resulted from an increase in cash resulting from proceeds of $1,092,000 we received in connection with a private placement of common stock announced on March 18, 2011. This was offset by the initial scheduled payment of $250,000 made to Inovio during March 2011, in accordance with the Asset Purchase Agreement, and operating expenses incurred during the nine month period ended April 30, 2011. With this private placement, we issued 1,456,000 units at a purchase price of $0.75 per unit for gross proceeds of $1,092,000. Each unit consisted of one share of common stock and one share purchase warrant entitling the holder to acquire one share of common stock at a price of $1.00 per share for a period of five years from the closing of the private placement.
As of April 30, 2011, we had a stockholder’s equity balance of $556,000 compared to a deficit balance of $30,000 at July 31, 2010, and also had 52,656,000 and 68,480,000 shares of common stock issued and outstanding for the same respective periods.
In this quarter, OncoSec purchased certain non-DNA vaccine technology and intellectual property from Inovio relating to electroporation delivery of chemotherapeutic agents and nucleic acids encoding cytokines for the treatment of solid tumors. Pursuant to the agreement, OncoSec made an upfront payment of $250,000 and will pay up to an additional amount of $2.75 M by March 24, 2013, based on achievement of milestones. OncoSec will also pay Inovio royalties based on commercial product sales.
OncoSec announced that it will initiate three Phase II clinical trials to evaluate its lead ElectroImmunotherapy technology, DNA IL-12 locally delivered using electroporation, in patients with melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. The company is building on positive Phase I dose-escalation trial results in 24 patients with metastatic melanoma. This previous study demonstrated that treatment with DNA IL-12 in conjunction with electroporation was safe and well tolerated, and suggested a systemic objective response in more than half of the subjects, 15% of patients showing 100% clearance of distant, untreated tumors. Each respective trial will be run under a physician-sponsored IND. These studies are expected to start before the end of 2011.
Oncosec Medical (OTCBB: ONCS) develops novel ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapies have achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials. More information is available at www.oncosec.com.
SAN DIEGO, Ca., Mar. 31, 2011 — OncoSec Medical Inc. (OTC BB: ONCS), a developer of innovative medical approaches to treat solid tumor cancers, announced today that it has raised more than $1 million of new capital through the issuance of units to three institutional investors. OncoSec issued 1,456,000 units at a price of $0.75 per unit for gross proceeds of $1,092,000. Each unit consisted of one share of common stock and one share purchase warrant entitling the warrant holder to purchase an additional share of common stock at a price of $1.00 per share for a period of five years from closing. These shares, and shares underlying the warrants, were issued in a private placement under Regulation S and/or Section 4(2) of the Securities Act of 1933, as amended, and are restricted securities under such Act.
OncoSec intends to use proceeds from the financing to acquire intellectual property from Inovio Pharmaceuticals, Inc., to advance its clinical development pipeline, and for working capital purposes.
OncoSec (OTC BB: ONCS) designs, develops and commercializes innovative medical approaches to treat solid tumor cancers for which currently approved therapies are inadequate based on their efficacy level or side effect profile. The company’s therapies are based on the use of electroporation delivery in combination with an approved cancer drug or a gene-based cytokine. More information is available at www.oncosec.com.