The ink is still drying on a $15 million deposit slip being prepared by AVI BioPharma Inc., which hurriedly raised the funds in a private placement Friday.
The Portland, Ore.-based company entered definitive agreements to sell 3 million common shares at $5 apiece to several unnamed institutional investors. The sale price represents about an 8 percent discount to Friday's closing price of $5.41, though about a 58 percent premium to the shares' value a month earlier, when AVI's stock opened April at $3.17. On Monday the stock (NASDAQ:AVII) closed at $5.52, up 11 cents.
"This was taking advantage of some positive movement in volume in the stock over the last few weeks," AVI CEO Denis Burger told BioWorld Today. "In fact, we had no plans to do this ahead of time, but on Friday after giving a report to our analyst who covers us at Rodman & Renshaw, we were presented by the bankers with this $15 million opportunity. We agreed to the discount from Friday's close, and worked all weekend to get it done and finished it early this morning."
Chicago-based Rodman & Renshaw Inc. acted as the placement agent in the transaction, in which the investors also received warrants to purchase 1.5 million common shares at $7 apiece. Prior to the sale, AVI had about 26 million shares outstanding.
Some of the recent stock surge is attributable to late April news surrounding two of AVI's Neugene antisense drugs. The company said it would begin clinical trials this summer to test AVI 4020 in targeting West Nile virus. AVI also said it would work with the Bethesda, Md.-based National Institutes of Health in its efforts to combat severe acute respiratory syndrome. AVI provided to the National Institute of Allergy and Infectious Diseases an experimental Neugene antisense drug targeted against the human coronavirus implicated in SARS.
AVI, which reported a year-end net loss of $29.4 million, closed 2002 with about $19.3 million in cash, cash equivalents and short-term securities. Burger said AVI's 2003 burn would total between $18 million and $20 million.
"This takes a financial risk off the table and allows us to concentrate on our clinical and preclinical programs without worrying about our burn rate in the next few months," Burger said. "This extra funding allows us to expand preclinical and clinical development to a broader group of the single-strand RNA viruses where we've been particularly effective."
AVI is banking on later-stage clinical trials sitting on its near-term horizon as well.
Burger said plans are on track for a fourth-quarter initiation of a pivotal Phase III trial of its Avicine cancer vaccine in pancreatic cancer patients. The study is expected to enroll between 500 and 600 patients and divide them into two arms - one group treated with gemcitabine (Gemzar, from Eli Lilly and Co.), and the other group treated with Avicine and gemcitabine, the only approved advanced pancreatic cancer treatment.
The trial is designed to measure two primary endpoints, median and one-year survival.
Nearly a year ago, AVI outlined plans to pursue an approval pathway in pancreatic cancer, with a Phase I/II trial of Avicine in colorectal cancer patients designed to bolster the drug's profile in the regulatory process. At the time AVI said approval could come quickest in the pancreatic cancer indication, given strong findings reported weeks later at the American Society of Clinical Oncology meeting in Orlando, Fla. (See BioWorld Today, May 3, 2002.)
Survival data from a Phase II study in pancreatic cancer patients showed that those treated with a combination of Avicine and gemcitabine increased the one-year survival rate to 30 percent - double the rate of gemcitabine alone. (See BioWorld Today, May 22, 2002.)
The colorectal cancer trial began in January 2001. Avicine's development to date has been partnered with Dublin, Calif.-based SuperGen Inc.
A Phase II study of another Neugene product, Resten-NG, recently was completed in high-risk cardiovascular restenosis patients. Interim data showed use of the antisense drug resulted in an 80 percent reduction in the rate of restenosis, Burger said, with final data expected to be released this quarter. He said AVI is planning to begin a pivotal study in Europe later this year.
The compound is designed to inhibit production of the transcription factor c-myc.
AVI has developed plans for a Phase II program of Resten-NG in polycystic kidney disease, with expectations of moving it forward in collaboration with an as-yet-determined partner. Two Phase I studies in drug metabolism have been completed, with an initial study using an oral formulation of the compound planned as well, Burger said.
"We have a busy clinical program going forward," he said.