Vienna, VA / CRWEPRESSRELEASE / January 8, 2016 -- The following letter is being released by CEL-SCI Corporation (NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholders:
As CEL-SCI shareholders most of you have been following the progress in our Phase 3 head and neck cancer trial, the largest of its kind in the world. We are proud of what we have achieved in 2015. Before summarizing our accomplishments during the year, I want to first thank each of you for choosing to support us in an enormous and ambitious undertaking. We believe that we can bring the promise of immunotherapy to treating newly diagnosed cancer patients when they can benefit from it most, before their immune systems are compromised by the existing cancer standard of care treatments.
For decades most cancers have been treated with the standard of care treatments which typically include surgery, radiation and/or chemotherapy. Now there is talk that immunotherapy represents "the future of cancer treatments." We were fervent advocates of cancer immunotherapy when few believed it would be useful. We are now investigating in our global Phase 3 clinical study what we believe is the logical next step in immunotherapy development. Based on the results of our Phase 2 studies we believe that immunotherapy should be administered as an initial therapy before a patient's immune system has been debilitated by surgery, radiation and chemotherapy. Data from our Phase 2 studies demonstrated that when Multikine* was administered for only 3 weeks immediately after diagnosis, the treatment reduced and in some cases eliminated all signs of a tumor before surgery, radiation and/or chemotherapy for head and neck cancer patients were administered.
CEL-SCI is the first, and to our knowledge the only company, to advance an investigational cancer immunotherapy into Phase 3 studies where it is actually administered as a first-line treatment immediately after diagnosis in the three week window before any standard of care treatments. Most other cancer immunotherapy treatment regimens must be administered over longer periods of time and cannot be given in the brief three week period before the current standard of care (surgery and/or radiation and chemotherapy) must be administered.
Other investigational cancer treatments and immunotherapies are usually tested as a last resort on patients who have already undergone and failed standard of care treatments. This is done so as not to delay the treatment of patients with the current standard of care. Also, if a therapy which is used as a last resort shows some efficacy, the primary endpoint for the clinical trial for that drug will be reached in a fairly short period. That is because patients in the end-stage of disease have a shorter life expectancy.
Our path to regulatory approval is longer than it would be if the patients in our Phase 3 trial had end stage disease. The reason for this is that the overall survival rate of our patients (the primary endpoint of our study) cannot be calculated until a certain number of patients have died. Since the patients in our Phase 3 trial are newly diagnosed cancer patients, they generally live longer than patients who have failed existing therapies and are in the end stage of disease. Yet the benefits to patients and rewards to shareholders will far outweigh the longer time lines if we are proven to be right. We hope that by administering Multikine prior to standard of care therapies we can extend the survival of head and neck and possibly other cancer patients.
If our study is successful we will have reduced the number of cancer recurrences and increased the overall survival of the patients who were treated with the Multikine regimen. From head and neck cancer, already a large market, we can then potentially develop Multikine for many other solid tumors. Our hope is that someday Multikine will be administered as the first treatment right after initial cancer diagnosis for many different types of cancers.
We chose to attack head and neck cancer first because it is a large unmet medical need. It represents approximately 6% of all cancer cases worldwide, about 650,000 new cases per year. It was about half a century ago when the last new therapy was approved by the FDA for the treatment of advanced primary (not yet treated) head and neck cancer, the same patient population that is being treated in our global Phase 3 study. We are conducting this study because we believe that our investigational immunotherapy should result in improving the clinical outcome and provide a new and better treatment option for these patients.
Our Phase 3 study is currently being conducted in 24 countries, including the U.S., with 668 patients enrolled at the end of December 2015. We have invested about $100 million dollars in the manufacturing of Multikine and have built a full scale manufacturing facility in Maryland. This facility is a key component in the FDA approval process for a biological product, such as Multikine, at the time a Biological Product License Application (BLA) is submitted. We are very proud of our highly regarded research partners including the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Navy. Our science is strong and has been published in leading peer reviewed scientific journals. We have also received multiple patents for Multikine from the respective patent offices in the U.S., Europe, Japan and China, including an additional patent in late 2015 from the European patent office.
We are very proud of all we have accomplished. We are honored to have you, our shareholders, share this ambitious vision and journey with us.
In 2015 we:
- Raised approximately $27.5 million to finance our expanding Phase 3 trial
- Added 7 countries to our Phase 3 study
- Enrolled 340 patients in the Phase 3 study
- Increased enrollment by 75% over 2014 enrollment
- Exceeded study enrollment of all 4 prior years combined
- Received an additional $2 million in non-dilutive funding for our Phase 3 trial from our clinical research organization (CRO) Ergomed, resulting in a total investment of $12 million from Ergomed in the trial
- Expanded our Phase 1 study of Multikine in the treatment of anal warts in HIV/HPV co-infected patients by adding another clinical site and a world renowned key opinion leader in the field as a Principal Investigator
- Granted additional support from the NIH for our LEAPS rheumatoid arthritis vaccine
- Fortified our $50 million arbitration suit against the former CRO whom we dismissed in 2013 by securing $5 million in non-dilutive funding for litigation expenses
Phase 3 Head & Neck Cancer Trial
Numerous factors indicate that our Phase 3 trial is proceeding quite well. We are now enrolling patients at a rate of more than one per day. This is a brisk enrollment rate that many companies wish they could achieve. We believe that doctors would not enroll new patients into the study unless they believed that their patients were benefiting from the Multikine treatment regimen.
In October 2015 Ergomed, the new CRO managing our Phase 3 trial, increased its investment into the Phase 3 trial from $10 million to $12 million. We do not think Ergomed would increase its investment in Multikine unless they too believed that Multikine could be successful. Ergomed is risking its own money in this trial, as they will only receive their money back if Multikine is licensed or approved. With 668 patients already enrolled, we expect to complete the currently planned enrollment goal of 880 patients in 2016.
Phase 1 Anal Warts Study in HIV/HPV Patients
Multikine is an immune therapy that has the potential to help the body fight not just head and neck cancer but other diseases too, potentially even viruses. We believe the immune system is a key factor in how the body fights anal warts in HIV/HPV co-infected men and women. Our ongoing Phase 1 study in this indication is being conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy at the San Diego Naval Medical Center. Ergomed has invested $6 million in co-development agreements to develop Multikine as a treatment for HIV/HPV co-infected patients, in addition to the $12 million committed to the head and neck cancer program. In July 2015, we announced expansion of this clinical trial with the addition of the University of California, San Francisco (UCSF) as a second clinical site. Dr. Joel Palefsky, a world renowned key opinion leader in the field has joined the study as the Principal Investigator at this site. We look forward to announcing data from this Phase 1 trial in 2016.
LEAPS Preclinical Program
The current focus for the LEAPS technology is to develop a vaccine for rheumatoid arthritis. This program has produced good results. The LEAPS rheumatoid arthritis vaccine has been shown to prevent the development and lessen the severity of rheumatoid arthritis in preclinical studies. In recognition of these results the program has received a $225,000 SBIR grant from the NIH's National Institute of Allergy and Musculoskeletal Skin Diseases (NIAMS) and was selected by the NIH as a recipient of a new technology commercialization program.
$50 Million Arbitration Suit
We believe that the current success with enrollment in our Phase 3 trial further validates the claims in our arbitration suit filed against the CRO that was previously running that same Phase 3 trial. The final hearing ("trial") date is currently being scheduled. Our position has been dramatically strengthened by accepting a $5 million litigation funding offer from Lake Whillans, a firm that specializes in litigation funding. This means our arbitration is now fully funded and will cost us nothing going forward. Lake Whillans, an expert in the field, conducted extensive due diligence on our case prior to extending the non-dilutive $5 million offer to us. They will only be repaid if we win the arbitration, by retaining a percentage of the proceeds.
In the year ahead we anticipate a series of positive developments in our Phase 3 trial. Aside from the Phase 3 trial, a near term upcoming event is our arbitration hearing. Should we win that hearing, and we believe we have a very strong case, then our balance sheet will be significantly fortified to support our Phase 3 head and neck cancer study. Other Multikine clinical trials and LEAPS research could be expanded as well. We look forward to a strong and positive year for the Company in 2016.
Geert Kersten Maximilian de Clara
Chief Executive Officer President
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2015. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
*Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy have not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is currently in progress.
Investor Relations Contact
Gavin de Windt
Phone: +1 703-506-9460
Source: CEL-SCI Corporation