Gary A. Reys, Chairman, President and CEO of CellCyte Genetics Corporation and Theresa A. Deisher, Vice President of Research and Development of the Bothell, Washington-based biotechnology firm recently gave their views about moving quickly into a global leadership position in the emerging field of regenerative medicine with the company's breakthrough stem cell-enabling therapeutic products and devices that are providing innovative solutions to critical barriers in stem cell organ repair in a Q & A interview published in The Wall Street Transcript.
In bringing perspectives to The Wall Street Transcript, an independent weekly investment publication for serious investors, Mr. Reys said CellCyte Genetics' focus since it was formed in 2003 has been "to acquire technologies that were already patented or had patents pending covering breakthrough technology discoveries that were far down the research and development pathway. This approach would mitigate many of the risks associated with startup companies and allow CellCyte to take these products to market at a much more rapid pace. We are focused on basically (adult) stem cell delivery, not embryonic stem cells."
Mr. Reys also noted, "CellCyte Genetics' business platform is now well understood by the investment communities as we are the first company in the stem cell sector to offer a true blockbuster product platform and revenue model. It is a very sound platform, one-of-a-kind in the world. We are the leader in non-invasive cell (stem-cell) delivery, with a true biologic product supplied in a vial; 'the pill in the bottle,'" he said.
In using a biologic to allow stem cells to be selectively and non-invasively delivered to organs, Dr. Deisher said, "This is the first ever delivery of stem cells through a patient's circulatory/vascular system. In other unique aspects about CellCyte Genetics, we are able to retain stem cells in the organs to which they are delivered, our device division is synergistic with our biologics for cell delivery, and we are re-developing a bioreactor, which dramatically expands cell numbers."
Dr. Deisher, an internationally renowned cardiovascular scientist with extensive biotechnology expertise, said the market potential for successful stem cell therapy is quite dramatic. "If you look just at the numbers in the U.S. for heart indications, which will be our first clinical target, there are over 1 million people who suffer a heart attack each year and those patients are all potential customers for our product. That customer base is only expected to increase over time, and actually the World Health Organization has predicted that within the next two decades, heart disease may well be the number one killer worldwide."
Looking back over the past year, Mr. Reys said CellCyte has accomplished its goals, having completed licensing negotiations and the acquisition of the assets of another biotechnology company, greatly expanded patent intellectual property platforms, hired key individuals, identified and executed a lease on a corporate and research facility, and funded CellCyte externally as a public company.
He also noted very strong financials. "We are debt free and we are sitting on roughly $6 million in the bank," he said. "We are extremely fiscally responsible when it come to our burn rate. We are about to begin a second private funding round primarily through investment bankers, which we expect to be completed within the next couple of months. We are renovating a 25,000 square foot corporate headquarters and research facility in Bothell, Washington, and we have invested in state-of-the-art nuclear imaging technology to advance our therapeutic pipeline."
Looking ahead, Mr. Reys said: "In the next six months we will have our cell expansion technology producing cells in-house. Within 12 to 24 months we plan to have our cell expansion technology available to the research and drug development sectors. On our therapeutic side, we are on target to file an IND (Initial New Drug application) and to begin Phase I clinical trials in 2008. Because of the unmet medical needs of heart attack patients and because of the anticipated safety profile of our product, we plan to ask for FDA fast-track designation after the appropriate IND filing." He said CellCyte is currently traded on the OTC markets and the company's Board is positioning CellCyte to move onto a more senior exchange at its earliest opportunity. CellCyte is also trading on the Frankfurt exchange, which has given it international exposure.