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Genvec Expands TNFerade Phase II Pancreatic Cancer Study Into Phase II/III Trial |
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15 Mar 2006 |
Company Secures $30 Million Equity Facility To Help Fund Clinical Program
GAITHERSBURG, MD, USA | Mar 15, 2006 | GenVec, Inc. (Nasdaq:GNVC) today announced that it received clearance from the U.S. Food and Drug Administration (FDA) to expand its current Phase II clinical trial with TNFerade in locally advanced pancreatic cancer into a Phase II/III trial with a 12-month survival endpoint. Targeted enrollment will be expanded from 74 to 330 patients. The expanded Phase II/III trial will include additional study sites outside the United States.
“Working closely with the FDA has allowed us to expand the TNFerade study into a Phase II/III trial for U.S. product registration. Expanding the Phase II study in this manner will allow us to continue to enroll patients at current clinical sites, avoid the potential delays associated with starting a new trial and facilitate international registration and partnering efforts by including medical centers from outside the United States,” said Paul Fischer, Ph.D., GenVec’s president and CEO.
In order to support the expanded study, GenVec has entered into a $30 million Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited, an institutional investor, under which Kingsbridge will make available to GenVec up to $30 million in capital over a three-year period through the purchase of newly issued shares of GenVec’s common stock. Under the terms of the CEFF, GenVec will determine the exact timing, amount and price of any CEFF financings, subject to certain conditions summarized below. The CEFF allows GenVec to raise needed capital as required, at the time, price, and in amounts deemed suitable to the company, during a three-year period once a registration statement related to the resale of common stock issued pursuant to the CEFF is declared effective by the Securities and Exchange Commission.
Phase II/III Protocol
This expanded Phase II/III international multi-center trial will seek to enrol approximately 330 patients with locally advanced pancreatic cancer. Patients will be randomized two-to-one to receive chemotherapy (fluorouracil) and radiation therapy for five weeks, with or without a weekly intratumoral injection of TNFerade, followed by maintenance therapy (gemcitabine with or without Tarceva®). The primary endpoint of the study will be overall survival at 12 months. GenVec is actively recruiting new study sites in the United States, India and Israel in addition to the U.S. sites that have been participating in the ongoing Phase II trial.
Committed Equity Financing Facility
• For a period of three years, subject to the conditions of the CEFF, GenVec can access up to $30 million from Kingsbridge in exchange for newly issued shares of GenVec’s common stock. GenVec may access the capital after the Securities and Exchange Commission (SEC) declares effective the registration statement to be filed by GenVec covering the resale of the shares of common stock issuable in connection with the CEFF and the shares of common stock underlying the warrant discussed below.
• Capital may be accessed under the CEFF in tranches of up to the lesser of $5 million or 1.75% of GenVec’s market capitalization at the time of the draw down, subject to certain conditions. Each tranche will be priced over an eight-day pricing period. Kingsbridge will purchase shares of common stock pursuant to the CEFF at discounts ranging from 8% to 12% depending on the average market price of the common stock during the eight-day pricing period. The minimum acceptable purchase price for any shares to be issued to Kingsbridge during the eight-day pricing period will be equal to the higher of $1.25 or 75% of GenVec’s share price the day before commencement of each draw down.
• GenVec is only obligated to use $2 million of the $30 million available under the CEFF and there are no minimum use penalties. The CEFF agreement does not contain any restrictions on GenVec’s operating activities, automatic pricing resets or minimum market volume restrictions.
• The agreement does not prohibit GenVec from conducting additional debt or equity financings, other than financing that are substantially similar to the CEFF.
• Throughout the term of the agreement, Kingsbridge is restricted from engaging in any shorting transactions intended to reduce its economic risk of owning shares of GenVec common stock.
• In connection with the CEFF, GenVec issued a warrant to Kingsbridge to purchase up to 520,000 shares of GenVec common stock at an exercise price of $2.67 per share. This represents a 25% premium to the common stock’s average closing price over the five trading days preceding the date of the agreement. The exercise term of the warrant is five years beginning with the six-month anniversary of the date of the agreement.
The securities issuable in connection with the CEFF and upon the exercise of the warrant issued to Kingsbridge have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration under the Securities Act of 1933 and applicable state securities laws or available exemptions from registration requirements. GenVec has agreed to file a registration statement for the resale of the shares of common stock issuable in connection with the CEFF and the shares of common stock underlying the warrant within 60 days of the date of the agreement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.
Conference Call and Webcast
GenVec will host its year-end financial results conference call at 10:30 a.m. Eastern time (7:30 a.m. Pacific time) today. The conference call will be accessible live via GenVec’s website at www.genvec.com under Webcasts & Data or by telephone at 866-831-6270 (U.S. or Canada) or 617-213-8858 (international); access code 81712142. An archive of the conference call will be available on the GenVec website approximately one hour after the event for the duration of 30
days.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Additional information on GenVec and its portfolio of product candidates is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.
SOURCE: GenVec, Inc |
