AVI BioPharma Announces Fourth Quarter and Full Year Financial Results.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--Feb. 28, 2001 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. Inc. (Nasdaq:AVII) (Nasdaq:AVIIW) (Nasdaq:AVIIZ), a biopharmaceutical company developing products based on cancer immunotherapy and antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). technologies, today reported financial results for the three and 12 months ended Dec. 31, 2000. For the fourth quarter of 2000, the company reported a net loss of $3.0 million, or $0.14 per share, compared with a net loss of $2.3 million, or $0.17 per share, for the fourth quarter of 1999. Research and development expenses during the fourth quarter of 2000 increased 37 percent to $2.7 million from $2.0 million for the comparable quarter last year, while general and administrative expenses increased to $786,143 from $404,392 last year. These increases were primarily due to additional expenses associated with outside collaborations, and to pre-clinical and clinical testing of the company's products. For the year 2000, the company recorded a net loss of $9.2 million, or $0.49 per share, compared with a net loss of $8.3 million, or $0.62 per share, reported for in 1999. Revenues increased to $1.3 million from $17,000 last year, largely due to licensing fees for expansion of an existing diagnostic arrangement. Research and development expenses for the year 2000 increased 39 percent to $9.3 million, compared with $6.7 million in 1999. General and administrative expenses were $2.3 million and $1.7 million for 2000 and 1999, respectively. These increased expenses are due primarily to requirements associated with a growing product development pipeline, as discussed below. The company had cash and cash equivalents of $32.1 million as of Dec. 31, 2000, an increase of $20.5 million from Dec. 31, 1999. This increase is largely due to the completion of a $20 million follow-on offering Follow-On Offering An offering of additional shares after a company has had an initial public offering. Notes: This sometimes means the company is strapped for cash. So they need to issue more shares to pay bills or finance a new project. of common stock completed in August 2000. For 2001, the company expects higher 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. led by a growing investment in R&D and construction of a Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ) facility to produce large enough quantities of antisense drugs for clinical trials. The company anticipates a burn rate of approximately $12-14 million. "Last year was a landmark year for 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. , culminating in our January 4, 2001 announcement of the initiation of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with our AVICINE(TM) vaccine for the treatment of 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. ," commented Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., chief executive officer of AVI. "Our 2001 plans for additional work with AVICINE include completing our Phase II study 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. . We anticipate that early clinical data on this application will be available around mid-year." "We are proud of our scientific and clinical progress with our third-generation antisense products," he added. "Our most advanced NeuGene(R) application is Resten-NG(TM) for cardiovascular restenosis, with a study currently in Phase II. "We are also excited about our upcoming plans to study NeuGenes in a variety of diseases including cancer, polycystic kidney disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. and inflammation. Additionally, we are working on a new class of antibiotics, NeuBiotics(TM), with plans to complete preclinical development in the second half of 2001." Burger continued, "In tandem with our clinical progress, we have had an active year on the business development front best demonstrated by our alliance with SuperGen for AVICINE. "During the year 2000, we continued to strengthen our management ranks," continued Burger. "Alan Timmins, previously our chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. and chief financial officer, was named president and chief operating officer, while Mark Webber took over responsibilities as chief financial officer and chief information officer. "A key external hire was David Mason, Jr., M.D., who brings a wide range of experience to the new position of senior vice president of Clinical Development and Regulatory Affairs. We also added a pharmaceutical industry veteran, John Fara, Ph.D., to our board of directors. "Our capital structure is strong," noted Burger. "In March, we received $1 million to expand an existing license arrangement for the in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. diagnostic applications of our proprietary third-generation NeuGene technology. In August, we completed a secondary public offering with net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). to the Company of approximately $20 million." Burger concluded, "Overall, we had a very productive year in many arenas. As we enter 2001 with our management and finances in place as well as a solid foundation in business development, we look forward to further progress in our growing and maturing product development pipeline." Product Update Cancer Immunotherapy AVICINE AVICINE is a therapeutic cancer vaccine designed to elicit an 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 a well-characterized tumor-associated antigen tumor-associated antigen Immunology, oncology A molecule–eg, CA 15.3, 19-9, CA-125, that may be associated with specific tumors–eg, lymphomas, carcinomas, sarcomas, melanomas; TAAs may elicit cellular and/or humoral immune responses against the tumor, , human chorionic gonadotropin human chorionic gonadotropin (HCG): see gonadotropic hormone. (hCG). The hCG hormone is naturally produced during pregnancy, and is believed to stimulate growth and shield the embryo from immune attack. The hCG hormone is expressed by a wide range of cancers as a membrane-associated tumor marker tumor marker n. A substance, released into the circulation by tumor tissue, whose detection in the serum indicates the presence of a specific type of tumor. , and is believed to promote tumor growth and vascularization vascularization /vas·cu·lar·iza·tion/ (vas?ku-ler-i-za´shun) 1. the process of becoming vascular. 2. angiogenesis. 3. the surgically induced development of vessels in a tissue. and to render patients immunologically unresponsive to the tumor. The role of hCG in cancer and pregnancy is widely believed to be analogous. Thus, AVICINE stimulates the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to mount an attack against cancer cells expressing this hormone. Colorectal cancer The initiation of a Phase III pivotal trial is based on a complete analysis of the data from five completed clinical trials, including a multi-center Phase II study in advanced colorectal cancer, and following discussions with the 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. . The pivotal study involves first-line therapy for 800 patients randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. in two arms: AVICINE in combination with chemotherapy, and chemotherapy alone. Pancreatic cancer AVI is conducting a 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 in patients with pancreatic cancer in which patients were treated with AVICINE alone, or with AVICINE in combination with gemcitabine (Gemzar), an Eli Lilly & Co. product. Patient enrollment has been completed for this trial and clinical data is expected this year. Antisense NeuGene Antisense compounds are designed to bind specific disease-causing gene sequences to disable or inactivate in·ac·ti·vate v. 1. To render nonfunctional. 2. To make quiescent. in·ac  ti·va the disease process. AVI has
developed proprietary third-generation antisense compounds called
NeuGenes, which are characterized by a synthetic backbone instead of the
natural or modified backbone of competing antisense or gene-targeting
technologies.
This chemistry allows NeuGene antisense agents to be more stable, specific, efficacious, and safer than second-generation antisense compounds in clinical development by others. Resten-NG Resten-NG is a NeuGene compound for cardiovascular restenosis. It targets a transcription factor and when it enters arterial cells it blocks the underlying cause of the disease, smooth muscle cell proliferation. AVI is currently in Phase II clinical trials with Resten-NG. NeuBiotics AVI is applying its third-generation antisense technology to create a new class of antibiotics, NeuBiotics. Preclinical development should be completed in 2001. Other indications AVI expects to enter additional clinical trials in 2001 with NeuGene agents directed against cancer, polycystic kidney disease and a liver enzyme for pharmacokinetic improvement of approved drugs. Investor Information AVI BioPharma has scheduled an investor conference call regarding this announcement to be held today, beginning at 11:00 a.m. (ET). To participate in the live call via telephone, call 800/633-8520. A telephone replay will be available until 10:00 a.m. (ET) March 2, 2001 by dialing 800/633-8284, and entering reservation number 17700855. Individuals interested in listening to the conference call via the Internet may do so by visiting the company's Web site at www.avibio.com. A replay will be available on the Web site for 90 days. AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, AVICINE, a therapeutic cancer vaccine, has completed enrollment in a Phase II trial in pancreatic cancer and is in a Phase III pivotal trial in colorectal cancer. The first application of its NeuGene compounds, Resten-NG, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene oncogene Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells. c-myc. It is currently in Phase II trials for restenosis. More information about AVI is available on the company's Web site at http://www.avibio.com. 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 news 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.
AVI BioPharma Inc.
(A Development-Stage Company)
STATEMENTS OF OPERATIONS
Three Months Ended Year Ended
Dec. 31, Dec. 31,
(unaudited)
2000 1999 2000 1999
Revenues from license
fees, grants & research
contracts $ 25,000 $ 9,241 $ 1,297,338 $ 17,024
Operating expenses:
Research and
development 2,692,377 1,962,171 9,268,330 6,672,027
General and
administrative 786,143 404,392 2,270,302 1,745,491
Acquired in-process
Research and development -- 10,537 -- 71,874
3,478,520 2,377,100 11,538,632 8,489,392
Other income:
Interest income, net 445,963 31,143 1,001,338 193,927
Net loss $(3,007,557)$(2,336,716) $(9,239,956)$(8,278,441)
Net loss per share, basic
and diluted $ (0.14) $ (0.17) $ (0.49) $ (0.62)
Shares used in per
share calculations 21,477,556 13,713,993 18,724,533 13,440,205
BALANCE SHEET HIGHLIGHTS
Dec. 31, Dec. 31,
2000 1999
Cash and cash equivalents $ 32,112,099 $ 11,620,505
Total current assets 33,131,265 11,651,747
Total assets 35,088,393 12,929,628
Total current liabilities 1,722,792 1,040,154
Total shareholders' equity $ 33,365,601 $ 11,889,474
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