AVI BioPharma Announces Second Quarter Results.Business/Health Editors PORTLAND, Ore.--(BW HealthWire)--Aug. 7, 2000 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 developing products based on cancer immunotherapy Cancer immunotherapy is the use of the immune system to reject cancer. The main premise is stimulating the patient's immune system to attack the malignant tumor cells that are responsible for the disease. 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, 2000. For the second quarter of 2000, the Company reported a net loss of $2,840,413, or $0.17 per share, compared with a net loss of $1,997,185, or $0.15 per share, for the second quarter 1999. Second quarter 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 $2,974,127 from $2,047,844 last year, primarily due to a 53% increase in research and development expenses to $2,483,942. The increase in R&D expenditures was attributable to ongoing pre-clinical and clinical efforts to support the Company's core technologies, including increases in staffing and expenses associated with outside collaborations and the development of large-scale manufacturing capabilities. For the six months ended June 30, 2000, AVI BioPharma reported a net loss of $3,980,295, or $0.24 per share, compared with a net loss of $3,736,644, or $0.28 per share, for the same period in 1999. First-half 2000 revenues increased to $1,150,123, compared with $4,225 for the first half of 1999. This increase was primarily due to the receipt of a $1,000,000 fee received from Gene Tools, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control for expansion of a license for diagnostic applications. At June 30, 2000 the Company had cash and cash equivalents of $6,949,190. On August 2, 2000 AVI BioPharma completed a 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 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 $20,000,000, with potential for an additional $3,000,000 should the over-allotment option be exercised in full. Additionally, the Company anticipates in early August the formal closing of its arrangement with SuperGen, Inc. wherein the company will receive $20 million in cash and SuperGen stock as part of the agreement. "This has been a very productive quarter for us from clinical, scientific and financial perspectives," commented Denis Denis, king of Portugal: see Diniz. Burger, Ph.D., chairman and chief executive officer of AVI BioPharma. "The closing of our financing in August coupled the pending closing of our agreement with SuperGen for AVICINE(TM) provide us with the financial resources to advance our AVICINE cancer immunotherapy and NEUGENE(R) antisense technology platforms. We also were awarded two grants totaling in excess of $850,000 to conduct studies utilizing NEUGENES in cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and polycystic kidney disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. . "In addition to improving our capital position," he continued, "we strengthened our management ranks by appointing Alan Timmins president and 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. , by promoting Mark Webber to chief financial officer, and by naming John Fara, Ph.D. to our Board of Directors." Dr. Burger noted that recent clinical advances included the initiation of Phase II studies with the Company's proprietary antisense compound, Resten-NG, for the treatment of cardiovascular restenosis. AVI BioPharma also commenced Phase I testing to evaluate the pharmacological action of oral delivery of Resten-NG. Resten-NG is part of the Company's third-generation NEUGENE antisense technology platform, and these studies are applicable to both the cardiovascular and anti-cancer formulations of the drug. "Our clinical progress will continue as AVICINE enters Phase III studies 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. around the end of the year," he noted. "We were pleased to report in July on the publication of an article authored by our scientists in the journal Antisense & Nucleic Acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. Drug Development, noting that NEUGENE decreased cell proliferation. The study was designed to evaluate the effectiveness of several morpholine Morpholine is an organic chemical compound having the chemical formula O(CH2CH2)2NH. This heterocycle, pictured at right, features both amine and ether functional groups. oligomers against a variety of growth and cell cycle-related genes. Our scientists found that oligomers directed against the c-myc gene, which is involved in cell proliferation disorders such as cancer and cardiovascular disease, were the most effective in halting cell growth. "Also, our scientists presented data at an international pharmaceutical conference held in London on using cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine to develop therapeutic antibodies, and published research in the Journal of Hematotherapy and 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. Research on the cancer therapeutic promise of a telomere-inhibiting compound that we licensed. Study results demonstrate that the compound, called TAG-6, will reach therapeutic levels without causing severe side effects Side effects Effects of a proposed project on other parts of the firm. ," according to Dr. Burger. "In addition to existing collaborations with Abgenix and XTL XTL Crystal XTL Xpress Train Limited XTL Anything-To-Liquids (synthetic fuels) XTL XML Template Language XTL Xml Transformation Language XTL Extensible Transformation Language XTL Executable Temporal Language Biopharmaceuticals, we are pleased to have added new relationships with DepoMed to investigate controlled oral delivery of our NEUGENE antisense agents, and with Lorus Therapeutics for antisense drug therapies for cancer and infectious diseases. These relationships further enhance our scientific portfolio and our business prospects," he concluded. AVI BioPharma has scheduled an investor conference call regarding this announcement to be held Tuesday, August 15th beginning at 11:00 a.m. Eastern Time. Individual investors are invited to listen to the conference call over the Internet through Vcall, a service of the Investor Broadcast Network, at www.vcall.com. To listen to the live call, please go to the Web site at least 15 minutes prior to the start of the call to register, download and install any necessary audio software. A replay will begin shortly after the call has ended and will be available for 90 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, is in a Phase II trial 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. and will soon enter a Phase III pivotal trial in colorectal 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. . AVI BioPharma has begun Phase II clinical trials of Resten-NG in cardiovascular restenosis, the first application of its novel third-generation NEUGENE antisense technology. Resten-NG is designed to treat cardiovascular restenosis, cancer, 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. More information about the Company is available at http://www.avibio.com. 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 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. 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
------------------------
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------ ------------------------
2000 1999 2000 1999
---- ---- ---- ----
Revenues from license
fees, grants &
research contracts $ 18,250 $ 110 $ 1,150,123 $ 4,225
Operating expenses:
Research and
development 2,483,942 1,627,478 4,420,415 2,970,128
General and
administrative 490,185 418,868 926,248 836,492
Acquired in-process
research and
development - 1,498 - 61,337
----------- ----------- ----------- -----------
2,974,127 2,047,844 5,346,663 3,867,957
Other income:
Interest income, net 115,464 50,549 216,245 127,088
----------- ----------- ----------- -----------
----------------
Net loss $(2,840,413) $(1,997,185) $(3,980,295) $(3,736,644)
=========== =========== =========== ===========
Net loss per share,
basic and diluted $ (0.17) $ (0.15) $ (0.24) $ (0.28)
=========== =========== =========== ===========
Shares used in per
share calculations 16,710,194 13,351,206 16,534,932 13,350,287
=========== =========== =========== ===========
BALANCE SHEET HIGHLIGHTS
------------------------
(unaudited)
June 30, December 31,
2000 1999
------------ ------------
Cash and cash equivalents $ 6,949,190 $ 8,683,005
Total current assets 10,597,332 11,651,747
Total assets 12,426,765 12,929,628
Total current liabilities 1,104,596 1,040,154
Total shareholders' equity $ 11,322,169 $ 11,889,474
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