LAS VEGAS, April 24 /PRNewswire-FirstCall/ -- CardioVascular BioTherapeutics, Inc. (OTC Bulletin Board: CVBTE) has entered into an agreement with Mr. Phillip Frey Jr. to form Cardio Derma Clinical Partners (CDCP), an R&D Partnership. Mr. Frey, as sponsor and general partner, will fund a minimum of $1,000,000 and up to $5,000,000 of the clinical development of CVBT's wound healing drug candidate.
"R&D Partnerships have been successfully used in the past by some of today's biggest names in biotechnology to fund drug development. Many investors in these R&D Partnerships realized income tax advantages and have earned outstanding returns on their investments," said Mr. Phillip Frey Jr. He continued, "CVBT and Cardio Derma Clinical Partners are going back to these basics in an effort to advance this drug candidate."
CDCP will engage CVBT in a development agreement to conduct its wound healing clinical trial. CVBT will pay a royalty to CDCP of 10% of revenues or other moneys received from the commercialization of the drug candidate up to a maximum of ten times (10x) the funded amount of the development agreement in return for the intellectual property created. Additionally, CDCP will acquire warrants, the number of which is dependent upon the funded amount of the development agreement, to purchase CVBT common shares at an exercise price of $1.00 per share with a term of five years. Daniel C. Montano, CVBT's President and CEO, has agreed to personally provide the individual partners of CDCP a Put to Mr. Montano for their interest in CDCP equal to 200% of their investment in CDCP less distributions paid from CDCP commencing 36 months and ending 60 months after their investment in CDCP.
CVBT's pipeline includes drug candidates for the treatment of various cardiovascular diseases, including severe coronary heart disease, diabetic wounds, peripheral arterial disease, chronic back pain and bone repair. "We anticipate knowing whether we will meet the endpoints of the Phase II coronary heart disease and wound healing trials in approximately 12 to 18 months," said Mr. Montano. He continued, "Conducting FDA clinical trials is expensive and requires timely access to capital. The disruptions in the financial market over the last six months have made access to capital more difficult. Given the current market, we believe that structuring R&D Partnerships tailored to the circumstances of individual drug candidates and partnerships provides a sensible financing alternative for funding our clinical trials."
According to Mickael A. Flaa, CVBT's Chief Financial Officer, "The ability to attract capital in this form is a major milestone in the financial growth and maturity of CVBT." Mr. Flaa continued, "This financing vehicle is very attractive to both the Company and its shareholders due to assumption of risk of loss by the R&D Partnership and the modest dilution resulting from the financing. The R&D Partnership concept is the type of financing alternative that CVBT will focus on for other drug candidates in the pipeline until the financial markets are receptive to timely, cost effective access to capital for CVBT common stock."
About Mr. Phillip Frey Jr.
Mr. Phillip Frey Jr. is the retired Chairman, CEO, and President of Microsemi Corporation (MSCC). He was Chairman of Microsemi's Board of Directors from 1986 through 2002 and a member of the Board of Directors since 1973. He also served as its President and CEO from 1971 to December 2000. Microsemi Corporation designs, manufactures, and markets analog and mixed-signal integrated circuits (ICs) and semiconductors. Since retiring from Microsemi Corporation, Mr. Frey has focused his business endeavors in real estate investments and has been a major angel investor in numerous new ventures in the medical and electronics areas.
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing human FGF-1 for cardiovascular diseases characterized by inadequate blood flow to a tissue or organ. In addition to the Phase II trial it is conducting in patients with severe coronary heart disease, the company has two FDA-authorized clinical trials in the areas of impaired wound healing seen in diabetes and in patients suffering from peripheral artery disease of the legs. An additional proof-of-concept study is being conducted in patients with chronic back pain who may have perfusion defects to their spine. For more information please visit http://www.cvbt.com.
This news release contains forward-looking statements that involve
risks and uncertainties. Actual results and outcomes may differ materially
from those discussed or anticipated. For example, statements regarding
expectations for new research, progress with clinical trials or future
business initiatives are forward looking statements. Factors that might
affect actual outcomes include, but are not limited to, FDA approval of
CVBT drug candidates, market acceptance of CVBT products by customers, new
developments in the industry, future revenues, future expenses, future
margins, cash usage and financial performance. For a more detailed
discussion of these and associated risks, see the company's most recent
documents filed with the Securities and Exchange Commission.
CardioVascular BioTherapeutics, Inc.
|SOURCE CardioVascular BioTherapeutics, Inc.|
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