This past year was an extraordinary time for our company. With your continued support, we've forged valuable relationships with important cancer centers and major pharmaceutical companies in our continuing quest to develop T-cell vaccines for the treatment of breast and ovarian cancer. We've also entered Phase II clinical studies for several of our unique cancer vaccine programs, working closely with our top-tier clinical partners. We are well on our way to becoming a leading immuno-oncology company.
Every day, doctors and scientists are harnessing the immune system to treat chronic infectious diseases and cancer. As you are well aware by now, TapImmune is leading the charge in this exciting new era of vaccine development.
Our energy at TapImmune comes from the great leadership we've been able to attract to the company. We strengthened our executive management team with the appointments of Dr. John Bonfiglio as President and Chief Operating Officer and Michael J. Loiacono as Chief Financial Officer, Chief Accounting Officer, and Corporate Secretary. Dr. Bonfiglio brings more than 27 years of pharmaceutical industry experience and has a background working with pharmaceutical companies during the development stage as well as companies with commercialized products.
We reached a major milestone in early November when the company was up-listed to the NASDAQ Capital Market (NASDAQ: TPIV). This expands our visibility, provides access to a broader investor base and enhances stock liquidity. This great news followed on the heels of entering into definitive agreements which resulted in successfully raising over $8.5 million from the exercising of outstanding warrants. The proceeds also helped remove in excess of $26 million of derivative liabilities from the company's balance sheet, which was recently reflected in our Form S-3 filing.
These achievements establish a strong foundation for our future growth in one of the most rapidly growing sectors of the oncology market. We believe we are poised for significant value inflection based on our numerous upcoming clinical catalysts.
Those of us who have experienced cancer diagnosis in our own families know how important it is to have hope—and TapImmune is hope in action.
There are approximately 30,000 ovarian cancer patients newly diagnosed every year. More than 14,000 will die from the disease.
Just as sobering, more than 41,000 people – men and women – will die this year from breast cancer in the U.S. alone. Our vaccines in development target these deadly diseases, and our unique, comprehensive approach gives us confidence in our clinical programs.
I'm proud to tell you about several other key milestones this year and how we executed on strategic goals set for the company.
Among the highpoints, the FDA granted its Fast Track Designation for our cancer vaccine TPIV 200 (the company's Folate Receptor Alpha cancer vaccine) for the treatment of platinum sensitive ovarian cancer. This important designation enables us to have more frequent interaction with the FDA regarding the clinical development of TPIV 200 and provides a pathway to accelerate the review of our New Drug Application once our clinical work is complete.
We've also made important progress with the initiation of multiple Phase II clinical trials to determine the safety and efficacy of our vaccines, including:
- A company-sponsored trial of TPIV 200 that is currently enrolling patients. By year-end we expect to have nine clinical sites open with three more opening in early 2017. In this trial, TPIV 200 is being evaluated for the treatment of triple negative breast cancer.
- A trial sponsored by Memorial Sloan Kettering, in collaboration with AstraZeneca, is treating patients with ovarian cancer who are platinum resistant (meaning they've failed chemo and have few options moving forward with therapy). This exciting study is testing a combination of TPIV 200 with AstraZeneca's checkpoint inhibitor, durvalumab. The combination of these two cancer immunotherapies could have a more significant effect on tumors than either drug alone.
- A Mayo Clinic-sponsored trial evaluating TPIV 200 as a standalone agent for patients with triple negative breast cancer is anticipated to begin in 2017. The study is expected to enroll 280 patients and is fully funded thanks to a $13.3 million grant from the U.S. Department of Defense.
We recently activated our first clinical site of a fourth Phase II clinical study of TPIV 200 in ovarian cancer patients (platinum-sensitive). We plan to have additional clinical sites open in early 2017.
We will initiate a Phase II trial for our TPIV 110 vaccine (targeting HER2/neu) in 2017 for HER2 breast cancer.
Looking ahead for our shareholders, 2017 is shaping up to be another landmark year.
We expect our solid clinical progress to be the primary value driver for TapImmune, and we are looking forward to several catalysts as we focus on advancing our clinical pipeline as efficiently as possible.
Another goal is to continue formalizing industry relationships, potentially giving us more commercial reach.
We are also excited about unveiling our newly revamped website at the beginning of the new year. It will showcase quick and easy access to essential information and features and will offer a more comprehensive understanding of the company's innovative approach for the treatment of cancer.
We encourage you to visit our website at https://tapimmune.com/. Once you're on the site, please register to receive our future shareholder updates and other useful notifications. In addition, if you or any of your loved ones would like more information on our ongoing clinical trials, please go to www.clinicaltrials.gov for more information.
Again, we thank you for your loyalty and ongoing support.
I wish you and all those near and dear a happy and healthy New Year.
Very truly yours,
Glynn Wilson, Ph.D.
Chairman and CEO
About TapImmune, Inc.
TapImmune, Inc. is an immuno-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients' killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities.
Please visit the Company's website at https://tapimmune.com/ for details.
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
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SOURCE TapImmune, Inc.