LOS ANGELES--(BUSINESS WIRE)-- ImmunoCellular Therapeutics (OTCBB: IMUC) issued the following Letter to Shareholders today:
Dear Shareholders,
As the summer comes to a close, I wanted to update you on the Company’s accomplishments this year, which set the stage for an exciting fall. The first eight months of the year have been very successful, with the Company attaining many of its goals, despite a very difficult economic environment, which has created challenges for many small biotechnology companies. Today, IMUC is in its best financial position ever and well positioned to validate the success it achieved in a Phase I trial for ICT-107, its dendritic cell-based cancer vaccine product candidate. We expect to begin a Phase II study prior to the end of the year, which will be the broadest and most comprehensive study of the ICT-107 vaccine to date. Some of the recent corporate highlights include:
- Strengthened balance sheet. We raised $8.5 million earlier this year and have continued to be conservative in our cash burn rate while increasing our research and development expenses as we prepare for a larger Phase II trial. Our business model of focusing on product development without building our own infrastructure to do basic research and relying on outsourcing to the best-of-breed specialty service providers, has proven to be extremely capital efficient and a source of strategic strength in hard economic times. We finished Q2, 2010 with a cash balance of over $7.7 million. IMUC is in its strongest financial position ever, and we believe we have sufficient capital on hand to take ICT-107 through a significant portion of the planned Phase II study.
- Favorable clinical results for ICT-107. Results for Phase I clinical trial of the vaccine demonstrated a one year survival of 100% and a two year survival of 80% when ICT-107 was combined with surgery, radiation and chemotherapy. This compares favorably with historical 61.1% one-year and 26.5% two-year survival based on the standard of care alone. The median overall survival has not yet been reached at the 26.4 months analysis point. The 12-month disease-free survival from the time of surgery was 75% with ICT-107, compared with the historical control of 26.9%, and the 18-month disease-free survival with ICT-107 was 49.2%, compared with 18.4% historically. This past June the Company presented the results at the prestigious 2010 American Society of Clinical Oncology Annual Meeting in Chicago, which was very well received by participating neurosurgeons and neuro-oncologists. The results obtained so far have been superior to any other published clinical trial in glioblastoma over the last 30 years, and we believe this creates a new hope for this disease if Phase II data continues to show similar results. In addition, ICT-107 was granted orphan drug status by the U.S. Food and Drug Administration which would give us market exclusivity once the product is launched.
- Planning for Phase II for ICT-107. We have finalized a contract with a clinical research organization and plan on issuing a press release with details of the ICT-107 Phase II trial design very soon. The Phase II trial will be conducted as a double blinded randomized controlled trial so as to provide clear efficacy data, which should aid in our goal of forming partnerships with major pharmaceutical companies for development and commercialization of this vaccine.
- Monoclonal Antibody Programs. While we were disappointed to recently be advised that Roche has decided to discontinue development of our monoclonal antibody ICT-69 and not exercise its option to license this antibody, it does not in any way impact our ability to move ICT-107 into the Phase II trial. Roche’s decision was as a result of the unexpected binding of ICT-69 to T-cells, which could result in an immunosuppressive effect that could be undesirable for treating the indication it was pursuing, multiple myeloma. On the positive side, this effect could be a potential therapy for auto-immune diseases in which an immune-suppressive effect is desirable. We are in the process of researching potential development in this area.
- New and improved website. We recently launched a new website to better serve shareholders, researchers, clinicians, patients and partners who are interested in learning more about the company. The new website now provides easy access to key financial information and SEC filings, scientific publications, investor presentations, and a number of other helpful resources for learning more about our pipeline, technologies, and groundbreaking cancer stem cell research.
We are also opportunistically looking into other product candidates to be developed with our peptide-based vaccine approach for other cancer indications, such as ovarian cancer, and have plans to expand our business in other indications beyond glioblastoma in the next year. Our mission continues to be centered on using state-of-the-art science and technology to become a leading cancer immunotherapy company. We believe that ICT-107 has the potential to change the way glioblastoma and other cancers are treated, and we believe that we are entering a period of potentially great value creation for shareholders as we initiate this Phase II study.
We look forward to sharing these, and other corporate developments with our shareholders in the coming months.
| Best Regards, |
| Manish Singh, Ph.D. |
| President and CEO |
Forward-Looking Statements
This letter contains certain forward-looking statements that are subject to a number of risks and uncertainties, including without limitation the need for substantial additional capital to fund development of product candidates beyond their initial clinical or pre-clinical stages; the risk that the safety and efficacy results obtained in the Phase I trial for the dendritic cell-based vaccine will not be confirmed in subsequent trials; the risk that IMUC will not be able to secure a partner company for development or commercialization of ICT-107; the need to satisfy performance milestones to maintain the vaccine technology licenses with Cedars-Sinai; the risks associated with obtaining FDA clearance to commence clinical trials of the cancer stem cell vaccine on a timely basis or at all, including the need to successfully complete required animal toxicity studies; the risks associated with adhering to projected preclinical or clinical timelines and the uncertainties of outcomes of development work for product candidates, including those based on destroying cancer stem cells as a potentially safe and effective treatment for various cancers; the risk of obtaining patent coverage for the dendritic cell-based vaccine or cancer stem cell vaccine or that any patents covering those vaccines or IMUC’s monoclonal antibodies will provide commercially significant protection for these technologies; the risk that IMUC will be unable to secure complementary technologies or partners or licensees for its monoclonal antibodies on attractive terms or at all. Additional risks and uncertainties are described in IMUC’s most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
CEOcast, Inc. for ImmunoCellular Therapeutics, Ltd.
Gary Nash, 212-732-4300
Investor Relations
[email protected]
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical
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