AVI BioPharma Announces 2001 Fourth Quarter and Full Year Financial Results.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--March 12, 2002 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, AVIIW, AVIIZ), a biopharmaceutical company that develops products based on 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). drug development and cancer immunotherapy, today reported financial results for the three and 12 months ended December 31, 2001. For the fourth quarter of 2001, the company reported a net loss of $4.6 million, or $0.20 per share, compared with a net loss of $3.0 million, or $0.14 per share, for the fourth quarter of 2000. Research and development expenses during the fourth quarter of 2001 increased to $4.2 million from $2.7 million for the comparable quarter last year, and general and administrative expenses increased to $806,544 from $786,143 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 preclinical and clinical testing of the company's products. For the year 2001, the company recorded a net loss of $26.9 million, or $1.20 per share, compared with a net loss of $9.2 million, or $0.49 per share, reported in 2000. The 2001 net loss included a $12.5 million one time, non-cash write-down of securities in accordance with SEC accounting rules. The 2001 net loss excluding this write-down was $14.4 million, or $0.64 per share. Revenues for the year 2001 were $706,102, compared with $1.3 million in 2000, which included a $1 million payment for expansion of a license for diagnostic applications. Research and development expenses during 2001 were $12.8 million, compared with $9.3 million in 2000, and general and administrative expenses were $3.4 million, compared with $2.3 million 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 preclinical and clinical testing of the company's products. The company had cash, cash equivalents and short-term securities of $25.6 million as of December 31, 2001, a decrease of $6.5 million from December 31, 2000. This decrease was due primarily to $12.6 million used in operations and $4.9 million used for capital expenditures and patent-related costs. This decrease was net of proceeds of $10 million from the stock purchase agreement with Medtronic, Inc., $0.8 million from the exercise of options and warrants, and a net $0.2 million increase in the value of the company's short-term securities. For 2001, AVI's operations were led by a growing investment in R&D, construction of a Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ) facility to produce antisense drugs for clinical trials, and continued expansion of the company's clinical development and regulatory affairs efforts. For 2002, the company expects higher operating costs as a result of a growing investment in R&D and expanded clinical trials, with an anticipated burn rate for the year of approximately $20 million. "The year was outstanding 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. because we achieved several major milestones with our NEUGENE(R) and AVICINE(R) platform technologies," said Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., chief executive officer of AVI. "Among the many highlights, we started the year by initiating a Phase III pivotal trial with AVICINE for 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. . In April, we announced a strategic alliance with Exelixis Inc. to apply its expertise in genetic model systems to discover, validate and screen novel targets suitable for inhibition by our antisense therapeutics. The following month, we signed a licensing agreement with Medtronic to use NEUGENES to coat stents for coronary restenosis. As a result, Medtronic has undertaken an aggressive development and regulatory program to bring coated stents to market both in the United States and in Europe. "Our momentum continued into the fourth quarter," said Dr. Burger. "In November, we announced results of an initial Phase I metabolic redirection study with NEUGENE, which showed no drug-related toxicity or safety issues, and we are completing a Phase Ib trial to determine whether NEUGENE improves the pharmacokinetic profile of a test drug. In December, we announced positive results of our Phase II AVICINE trial for 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. , which demonstrated a significant improvement in the one-year survival of patients who received AVICINE in combination with Eli Lilly's drug gemcitabine (Gemzar). In addition, in December, we entered a Phase I/II study with NEUGENE for polycystic kidney disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. (PKD Noun 1. PKD - kidney disease characterized by enlarged kidneys containing many cysts; often leads to kidney failure polycystic kidney disease kidney disease, nephropathy, renal disorder, nephrosis - a disease affecting the kidneys )." Dr. Burger said, "Among our milestones in the current year with NEUGENE, we intend to complete the Phase I/II Oncomyc-NG trial in cancer, complete the Phase I/II PKD trial and complete the Phase Ib metabolic redirection trial. With AVICINE, we anticipate continued progress on all fronts, including presentation of our pancreatic cancer Phase II results 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 in the spring." Product Update 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(TM) Resten-NG is a NEUGENE compound for treating cardiovascular restenosis, or the reclogging of an artery following balloon angioplasty balloon angioplasty: see under angioplasty. . Resten-NG targets a transcription factor, and upon entering arterial cells, it blocks the underlying cause of the disease: smooth muscle cell activation and proliferation. AVI has demonstrated in preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. Resten-NG significantly reduced coronary restenosis. A global license has been granted to Medtronic for AVI's antisense compounds deployed on stents or other devices for treating restenosis. Cancer AVI is conducting a Phase I/II clinical study with its NEUGENE antisense technology in patients with solid tumors. This study is expected to be completed around the end of 2002. Previous studies have shown that this antiproliferative antisense drug is both safe and effective at shutting down cell division, a hallmark of cancer progression. 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. In August 2001, AVI announced the initiation of a study in prostate cancer, funded by the Department of Defense. AVI presented preclinical study results at the Annual CaP Cure prostate cancer conference in September showing that AVI's antisense compounds inhibit cancer cell growth and cause cell death in prostate tumors. In December 2001, AVI was awarded a Department of Defense Prostate Cancer Research Program grant to pursue development of therapeutics to fight both the initial stages and the incurable metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. forms of prostate cancer using AVI's NEUGENES. Also in December, AVI presented preclinical study results at the 10th International Conference on Gene Therapy of Cancer demonstrating that a combination of two proprietary NEUGENE drugs had a synergistic effect Synergistic effect A violation of value-additivity in that the value of a combination is greater than the sum of the individual values. in halting cell growth of refractory cancer refractory cancer Oncology Cancer that is unresponsive to treatment. See Radioinsensitive. cells in prostate cancer. AVI plans to initiate a human clinical trial in prostate cancer later this year. Metabolic Redirection In November 2001, AVI successfully completed a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to collect safety and pharmacokinetic data of its antisense technology in modifying the function of a liver enzyme that is critical to the body's processing of many drugs. The study is based on the results of preclinical studies using AVI's NEUGENE antisense technology targeting liver cytochrome cytochrome (sī`təkrōm'), protein containing heme (see coenzyme) that participates in the phase of biochemical respiration called oxidative phosphorylation. enzymes, which control metabolism of most drugs. AVI hopes to show improved pharmacokinetics of existing FDA-approved drugs by down-regulating liver cytochrome enzymes. The company has completed the second part of the metabolic redirection study, which will evaluate whether AVI's antisense drug improves the pharmacokinetic profile of a test drug. Data from this trial will be presented at upcoming scientific forums later this year. Polycystic Kidney Disease AVI initiated a Phase I/II clinical study in patients with polycystic kidney disease in December 2001. Preclinical studies have demonstrated that AVI-4126 is effective in preventing some of the clinical manifestations of PKD. The study will evaluate the safety and pharmacokinetics of three doses of AVI-4126 in patients with PKD and varying degrees of compromised kidney function. 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 The company is in a Phase III pivotal trial with AVICINE for the treatment of colorectal cancer. This study was initiated in January 2001 and 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. The trial design is based on an analysis of data from five completed clinical trials, including a multicenter 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. . Pancreatic Cancer In December 2001, AVI reported that AVICINE provided substantial survival benefit to patients with pancreatic cancer as a result of a completed Phase II clinical study. In this study, patients were treated with AVICINE alone, or with AVICINE in combination with Gemzar. Those treated with AVICINE reported one-year survival data similar to historical results for those treated with Gemzar, without the vaccine-related side effects Side effects Effects of a proposed project on other parts of the firm. often associated with Gemzar. A one-year survival rate of 30 percent was reported for patients treated with AVICINE plus Gemzar, which is approximately double the survival rates for either treatment alone. AVI BioPharma has scheduled an investor conference call regarding this announcement to be held today, March 12 beginning at 11 a.m. Eastern Time. Those who want to participate in the live call via telephone may call (800) 252-8302. A telephone replay will be available until 10 a.m. Eastern Time March 14, by dialing (800) 633-8284, and entering reservation number 20209039. Those interested in listening to the conference call live via the Internet may do so by visiting the company's Web site at http://www.avibio.com/. A replay will be available on the site for 14 days. About AVI BioPharma AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NEUGENE antisense drugs and cancer immunotherapy. Its lead cancer agent, AVICINE a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and 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 and in Phase I/II trials for cancer and polycystic kidney disease. More information about AVI is available on the Company's Web site at http://www.avibio.com/. "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 preclinical 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
December 31, December 31,
(unaudited)
------------------- --------------------
2001 2000 2001 2000
---- ---- ---- ----
Revenues from license
fees, grants & research
contracts $295,309 $25,000 $706,102 $1,297,338
Operating expenses:
Research and development 4,220,640 2,692,377 12,750,901 9,268,330
General and
administrative 806,544 786,143 3,357,817 2,270,302
------------------- --------------------
5,027,184 3,478,520 16,108,718 11,538,632
Other income (loss):
Interest income, net 127,620 445,963 1,000,530 1,001,338
Write-down of short-term
securities --
available-for-sale -- -- (12,523,088) --
------------------- --------------------
Net loss $(4,604,255) $(3,007,557) $(26,925,174)$(9,239,956)
============ ============ ============ ============
Net loss per share, basic
and diluted $ (0.20) $ (0.14) $ (1.20) $ (0.49)
========== ========== ========== ==========
Shares used in per share
calculations 23,186,945 21,477,556 22,399,001 18,724,533
========== ========== ========== ==========
BALANCE SHEET HIGHLIGHTS
December 31, December 31,
2001 2000
------------------- ------------------
Cash, cash equivalents and
short-term securities $ 25,597,121 $ 32,112,099
Total current assets 27,511,076 33,131,265
Total assets 33,815,113 35,088,393
Total current liabilities 3,281,066 1,722,792
Total shareholders' equity $ 30,534,047 $ 33,365,601
|
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion