AVI BioPharma Announces Second Quarter Results.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--Aug. 7, 2001 AVI BioPharma Inc. ("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) (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 six months ended June 30, 2001. For the second quarter of 2001, the company reported a net loss of $3.5 million, or $0.16 per share, compared with a net loss of $2.8 million, or $0.17 per share, for the second quarter of 2000. Revenues from license fees, grants and research contracts for the second quarter of 2001 were $87,264, compared with revenues of $18,250 reported in the second quarter of 2000. 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. for the 2001 second quarter were $3.9 million, compared with operating expenses for the 2000 second quarter of $3.0 million. Research and development expenses in the second quarter of 2001 increased to $3.2 million from $2.5 million in 2000, while general and administrative expenses increased to $709,527 from $490,185 in 2000. "The second quarter of 2001 highlighted the `year antisense technology begins to change the worlds of medicine, functional genomics and toxicology,' according to the June issue of the journal Current Opinion in Molecular Therapeutics," commented Denis Denis, king of Portugal: see Diniz. Burger, Ph.D., chairman and chief executive officer of AVI BioPharma. "Nowhere is that more evident than with the recent developments at AVI BioPharma, including the exclusive worldwide agreement with Medtronic to license a family of antisense compounds, including Resten-NG(TM), which Medtronic expects to load on medical devices, such as stents. "In addition, the recent initiation of a Phase I/II clinical study of the company's third-generation NeuGene(R) antisense compound in patients with cancer marks a significant step forward in our gene-targeted drug program. In both completed and ongoing human clinical trials, we have shown that our NeuGene technology is both safe and effective at shutting down cell division, the principle hallmark of cancer progression," he added. "Furthermore, data from the company's Phase II clinical study for the treatment of 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. with our AVICINE(TM) therapeutic cancer vaccine provided support for previous observations that AVICINE is an effective cancer-fighting agent. The study also showed that patients treated with the vaccine experienced no significant side effects Side effects Effects of a proposed project on other parts of the firm. ," Dr. Burger concluded. For the six months ended June 30, 2001, AVI BioPharma reported a net loss of $6.7 million, or $0.31 per share, compared with a net loss of $4.0 million, or $0.24 per share, for the comparable period in 2000. First-half 2001 revenues decreased to $103,244 from $1.2 million in the first half of 2000, which included receipt of a $1 million fee for expansion of a license for diagnostic applications. Operating expenses for the six months ended June 30, 2001 were $7.4 million, compared with operating expenses for the comparable period of 2000 of $5.3 million. Research and development expenses for the first half of 2001 increased to $5.8 million, compared with $4.4 million for the first half of 2000. For the six months ended June 30, 2001, general and administrative expenses increased to $1.7 million from $926,248 for the first six months of 2000. 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 $34.7 million as of June 30, 2001, an increase of $2.6 million from Dec. 31, 2000. This increase was due primarily to 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). of $10 million from a license and development agreement with Medtronic Inc. relating to the company's antisense compounds, and $272,325 from the exercise of options and warrants, offset by $6.3 million used in operations and $1.8 million used for investing activities, which consist primarily of purchases of property and equipment and patent-related costs. The remaining $382,891 increase was due to unrealized gains in the value of the company's short-term securities. For 2001, the company expects higher operating expenses led by a 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 that the full-year 2001 burn rate will approximate $14 million to $16 million. 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 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 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. The initiation of a Phase III pivotal trial in January 2001 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 currently is completing 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 interim clinical data was recently presented at the 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. Antisense NeuGene Antisense compounds are designed to bind to to contract; as, to bind one's self to a wife s>. See also: 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 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 a Phase II clinical trials with Resten-NG for treating restenosis, or the re-clogging of a previously opened artery. A global license was granted to Medtronic Inc. for loading the company's antisense compounds on medical devices; initially, Medtronic will be placing Resten-NG on their stents for treating restenosis. Cancer AVI recently initiated a Phase I/II clinical study with its NeuGene antisense technology in patients with lung, breast, colon or 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. . Previous studies have shown that this anti-proliferative antisense drug is both safe and effective at shutting down cell division, a hallmark of cancer progression. Polycystic Kidney Disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. AVI has completed preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. including GMP-manufacturing and plans to institute a Phase I/II clinical trial in patients with polycystic kidney disease later this year. Metabolic Redirection AVI has completed preclinical studies using its NeuGene antisense technology targeting liver cytochrome P450 enzymes that control metabolism of most drugs. By down regulating liver cytochrome enzymes, AVI plans to show improved pharmacokinetics of existing FDA approved drugs. AVI plans to initiate Phase I/II clinical trials later this year. AVI BioPharma Inc. has scheduled an investor conference call regarding this announcement to be held today, beginning at 11:00 a.m. Eastern Time. To participate in the live call via telephone, call 800/895-1075. A telephone replay will be available until 10:00 a.m. Pacific Time Aug. 9, 2001 by dialing 800/633-8284, and entering reservation number 19356327. Individuals interested in listening to the conference call live 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 14 days. AVI BioPharma Inc. 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. -0-
AVI BioPharma Inc.
(A Development-Stage Company)
STATEMENTS OF OPERATIONS
Three Months Ended Six Months Ended
June 30, June 30,
2001(a) 2000(a) 2001(a) 2000(a)
Revenues, from license
fees, grants &
research contracts $ 87,264 $ 18, 250 $ 103,244 $1,150,123
Operating expenses:
Research and
development 3,162,667 2,483,942 5,755,282 4,420,415
General and
administrative 709,527 490,185 1,673,658 926,248
3,872,194 2,974,127 7,428,940 5,346,663
Other income:
Interest income, net 238,915 115,464 600,971 216,245
Net loss $(3,546,015) $(2,840,413)$(6,724,725) $(3,980,295)
Net loss per
share -- basic
and diluted $ (0.16) $ (0.17) $ (0.31) $ (0.24)
Shares used in per
share calculations 21,785,140 16,710,194 21,658,113 16,534,932
BALANCE SHEET HIGHLIGHTS
June 30, Dec. 31,
2001(a) 2000(b)
Cash and cash equivalents $ 34,728,842 $ 32,112,099
Total current assets 35,859,956 33,131,265
Total assets 39,372,503 35,088,393
Total current liabilities 1,614,158 1,722,792
Total shareholders' equity 37,758,345 33,365,601
Note (a): Unaudited
Note (b): Derived from audited statements
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