AVI BioPharma Announces First-Quarter Financial Results.Business & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--May 8, 2001 AVI BioPharma 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 months ended March 31, 2001. For the first quarter of 2001, the company reported a net loss of $3.2 million, or $0.15 per share, compared with a net loss of $1.1 million, or $0.07 per share, for the first quarter of 2000. Research and development expenses during the first three months of 2001 increased to $2.6 million from $1.9 million for the comparable quarter last year, while general and administrative expenses increased to $964,000 from $436,000 last year. These increases were primarily due to additional expenses associated with outside collaborations, expansion of the company's clinical development and regulatory affairs efforts, and additional pre-clinical and clinical testing of the company's products. The company had cash, cash equivalents and short-term securities of $26.6 million as of March 31, 2001, a decrease of $5.5 million from Dec. 31, 2000. This decrease was due primarily to $2.8 million used in operations and $1.1 million used for investing activities, which consist primarily of leasehold improvements, purchases of property and equipment, and patent-related costs. The remaining $1.6 million decrease was due a decline in the value of the company's short-term securities. 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 growing investment in R&D, construction of a Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ) facility to produce sufficient quantities of antisense drugs for clinical trials, and continued expansion of the company's clinical development and regulatory affairs efforts. The company anticipates the 2001 burn rate to be approximately $12 million to $14 million. "During the first quarter, we demonstrated the breadth and depth of our third-generation antisense technology at a wide range of scientific gatherings. At the National Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Symposium, we presented findings that demonstrate that our NeuGene(R) antisense technology regulates stem cell proliferation and differentiation. At the American Association of Cancer Research annual meeting, we showed that based upon our pre-clincal research in mice, our technology might be a potent anti-cancer agent," commented Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., chief executive officer of AVI BioPharma. "At the American Society for Toxicology meeting, NeuGene antisense compounds were shown to alter drug metabolism Drug Metabolism/Interactions Definition Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. Precautions Drugs can interact with other drugs, foods, and beverages. . Additionally, at the American Chemical Society The American Chemical Society (ACS) is a learned society (professional association) based in the United States that supports scientific inquiry in the field of chemistry. Founded in 1876 at New York University, the ACS currently has over 160,000 members at all degree-levels and in meeting, we discussed the underlying chemistry that makes our technology safer, more stable and more efficacious than prior generations of antisense technology." Burger continued: "In addition to our growing scientific presence, we established an important strategic alliance with Exelixis Inc. (Nasdaq:EXEL). This agreement demonstrates yet another application for our technology, and serves as the first example of applying our antisense drug development technology in the area of functional genomics." Product Update Cancer Immunotherapy Avicine(TM) 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 in most, if not all, 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 was based upon 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 (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. currently 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 are 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 are expected to be presented at the upcoming American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) meeting this year. Antisense NeuGene(TM) 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 fully synthetic backbone, instead
of the natural or modified backbone of competing 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(TM) 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. Pre-clinical 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 Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. 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 a.m. Eastern Time. To participate in the live call via telephone, call 888/882-0115. A telephone replay will be available until 10 a.m. Pacific Time, May 10, 2001, by dialing 800/633-8284, and entering reservation number 18694642. 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 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 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
March 31,
2001 2000
Revenues from license fees, grants and
research contracts $ 15,980 $ 1,131,873
Operating expenses:
Research and development 2,592,615 1,936,473
General and administrative 964,131 436,063
3,556,746 2,372,536
Other income:
Interest income, net 362,056 100,781
Net loss $(3,178,710) $(1,139,882)
Net loss per share - basic and diluted $ (0.15) $ (0.07)
Shares used in per share calculations 21,529,674 16,359,671
BALANCE SHEET HIGHLIGHTS
March 31, Dec. 31,
2001 (a) 2000 (b)
Cash, cash equivalents and
short-term securities $26,619,942 $32,112,099
Total current assets 27,478,134 33,131,265
Total assets 30,456,128 35,088,393
Total current liabilities 1,617,801 1,722,792
Total shareholders' equity $28,838,327 $33,365,601
(a) Unaudited
(b) Derived from audited statements
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