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Friday, June 17, 2016 10:06:11 PM
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 develop Multikine for 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 816 patients enrolled at the end of May 2016. On the manufacturing of Multikine alone, 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 sound 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 very significant arbitration suit against the former CRO whom we dismissed in 2013 by securing $5 million in non-dilutive funding for litigation expenses In 2016 we: • Enrolled 148 patients in the Phase 3 study • A total of 816 patients have been enrolled as of May 31, 2016 • Raised another $5 million to finance Phase 3 trial
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, the new CRO managing our Phase 3 trial, Ergomed, 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 over 800 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 two 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 scheduled to start in the end of summer 2016. 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 closing, we look forward to a strong and positive future for the Company. Sincerely, Geert Kersten Maximilian de Clara Chief Executive Officer President
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