AVI BioPharma Announces 1999 Second Quarter and Six Month Financial Results.PORTLAND, Ore.--(BW HealthWire)--Aug. 11, 1999-- AVI BioPharma AVI BioPharma Inc. is a medical research and drug development company with corporate offices in Portland, Oregon, United States, and laboratories in Corvallis, Oregon. It was incorporated in 1980. ("AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. ")(Nasdaq: AVII, AVIIW), today reported financial results for the second quarter and six months ended June 30, 1999. For the second quarter ended June 30, 1998, the company's net loss was $1,997,185 or $0.15 per share compared with a net loss of $1,659,463 or $0.15 per share for the second quarter 1998. The net loss for the six month period ending June 30, 1999 was $3,736,644 or $0.28 per share compared with a net loss of $3,084,322 or $0.28 per share for the same period in 1998. Research and development expenses in the second quarter of 1999 increased to $1,627,478 from $1,304,174 in 1998. For the six months ended June 30 1999, research and development expenses increased to $2,970,128 compared with $2,598,439 from the comparable period in 1998. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. increased to $2,047,844 in the second quarter of 1999 from $1,809,159 in the second quarter of 1998 and to $3,867,957 for the six months ended June 30, 1999 from $3,410,389 for the comparable period of 1998. These expenses resulted principally from increased research and development staffing and increased expenses associated with outside collaborations and pre-clinical testing of AVI's technologies. Denis Denis, king of Portugal: see Diniz. Burger, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of AVI BioPharma, stated, "During the quarter, AVI reached two important development milestones, the announcement of additional clinical data from the company's Phase II trial of Avicine(TM) in colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. and the initiation of a multicenter Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of Avicine(TM) in pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. . "The additional clinical data gathered from our completed Phase II trial of AVICINE in 77 advanced colorectal cancer patients, suggest that patients who responded to both targets (epitopes) of the hCG peptide (CTP-37) experience a median survival of approximately 65 weeks, compared to the 39 week survival in patients treated with Pharmacia-Upjohn's FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved drug, Camptosar(R). Given this intriguing data, we have reformulated the vaccine to include an additional peptide, which we believe may increase a patient's ability to develop a strong and balanced antibody response. "In June, AVI initiated a multicenter Phase II clinical trial of Avicine(TM), in pancreatic cancer. This is the first trial in which the vaccine will be administered with a chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, , Eli Lilly & Co.'s (NYSE NYSE See: New York Stock Exchange : LLY) gemcitabine (Gemzar(TM)) as well as contain our newly modified Avicine formulation. Working closely with our Principal Investigator, John Marshall, M.D., of Georgetown University, we look forward to continuing enrollment into this important trial." Dr. Burger concluded, "These two significant events are tangible examples of the progress we made this year, as we continue to push ahead with the development of our lead product candidate. During the remainder of 1999, we expect to achieve additional key milestones that will enhance our ability to reach our long-term goals Long-term goals Financial goals expected to be accomplished in five years or longer. ." The company additionally announced that it assisted a placement of nearly 1,000,000 shares of AVI common stock, owned by James E. Summerton, Ph.D., founder of AVI and formerly Chairman of the Board, who resigned in 1998. As part of the transaction, Dr. Summerton's remaining shares are subject to a two-year lock-up agreement Lock-Up Agreement A legally binding contract between the underwriters and insiders of a company prohibiting these individuals from selling any shares of stock for a specified period of time. . He currently holds less than ten percent of the outstanding shares of the company. AVICINE, a therapeutic cancer vaccine, is AVI BioPharma's lead product candidate. AVICINE elicits a highly specific immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. to the human hormone and growth factor hCG, a cancer-associated oncofetal protein. AVICINE is essentially a non-toxic immunotherapy and has been evaluated in five clinical trials. To date, 174 patients have been treated. Early studies have provided evidence of objective tumor responses and apparent survival benefits in patients who have failed conventional therapy. AVI BioPharma Inc. is dedicated to the development and commercialization of products for the AVI BioPharma Inc. is dedicated to the development and commercialization of products for the treatment of life-threatening diseases using three platform technologies: vaccines, gene-targeted drugs, and drug delivery. Its lead product candidate, AVICINE(TM), an essentially non-toxic cancer vaccine, is about to enter a Phase III licensing trial in colorectal cancer, a Phase II trial in pancreatic cancer and a Phase II trial in prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . The company has also developed a patented class of gene-targeted drugs, called NEUGENES(R), which may be useful in the treatment of a wide range of human diseases including cardiovascular restenosis and cancer. Further, AVI has developed a drug delivery technology, called CYTOPORTER(TM), which has been successful in penetrating cell membranes and, as a result, may be useful in improving delivery of many FDA-approved drugs and drugs in development. "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings. -0-
ANTIVIRALS INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
Three Months Ended Six Month Ended
June 30, June 30,
1999 1998 1999 1998
Revenues, from
grant and
research
contracts $ 110 $ 6,153 $ 4,225 $ 11,803
Operating
expenses:
Research and
development 1,627,478 1,304,174 2,970,128 2,598,439
General and
administrative 418,868 504,985 836,492 811,950
Acquired
in-process
research and
development 1,498 -- 61,337 --
2,047,844 1,809,159 3,867,957 3,410,389
Other income:
Interest
income, net 50,549 143,543 127,088 314,264
Net loss $ (1,997,185) $ (1,659,463) $ (3,736,644) $ (3,084,322)
Net loss per
share - basic
and diluted $ (0.15) $ (0.15) $ (0.28) $ (0.28)
Shares used in
per share
calculations 13,351,206 11,166,536 13,350,287 11,157,240
BALANCE SHEET HIGHLIGHTS
June 30, December 31,
1999 1998
Cash and cash equivalents $ 4,385,598 $ 8,510,020
Total current assets 4,423,870 9,019,448
Total assets 5,697,966 10,192,083
Total current liabilities 413,926 1,186,399
Total shareholders' equity $ 5,284,040 $ 9,005,684
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