AVI BioPharma, Inc. Reports 1999 Fourth Quarter and Year-End Financial Results.Business Editors PORTLAND, Ore.--(BUSINESS WIRE)--Feb. 29, 2000 AVI BIOPHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:AVII)(Nasdaq:AVIIW)(Nasdaq:AVIIZ) today reported financial results for the fourth quarter and year ended December 31, 1999. The net loss for the fourth quarter of 1999 was $2.3 million, or $0.17 per common share, compared with a net loss of $2.4 million, or $0.18 per share, for the same period in 1998. For the year ended December 31, 1999, the Company recorded a net loss of $8.3 million, or $0.62 per share, compared with a net loss of $26.7 million, or $2.27 per share, reported for the same period in 1998. The company's net loss, operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. and per share figures for the year ended December 31, 1998 include a one-time charge of $19.5 million, or $1.65 per share, for acquired in-process research and development, reflecting the acquisition of ImmunoTherapy Corporation. Excluding the one-time charge, the net loss for the year ended December 31, 1998 was $7.3 million, or $0.62 per share. 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 three month period ended December 31, 1999 were $2.4 million, versus $2.6 million in the fourth quarter of 1998. The decrease was primarily due to reduced expenses associated with outside collaborations and pre-clinical testing of the company's technologies, offset by heightened research and development activities. Operating expenses for the twelve month period ended December 31, 1999 were $8.5 million, compared with $27.4 million for the comparable period in 1998. These decreases are due primarily to the aforementioned one-time charge for acquired research and development. Excluding the one-time charge, operating expenses were $7.9 million for the year ended December 31, 1998. The increase in 1999 operating expenses is attributable to the continuation of the Company's research & development activities of approximately $6.7 million, versus $6.3 million as reported in 1998, and general and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. of $1.7 million, versus $1.6 million reported in the same period last year. Denis Denis, king of Portugal: see Diniz. Burger, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of AVI BioPharma, stated, "We have had an incredibly productive year at AVI BioPharma. In 1999, we announced two strategic alliances; one with Abgenix, Inc. in human monoclonal antibodies for cancer, and a second with 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, Ltd. in Neu-Gene therapeutics for Hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic and Hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. . Additionally, we entered into an exclusive negotiating arrangement with SuperGen, Inc. for US marketing and sales rights to Avicine, our therapeutic cancer vaccine. Originally anticipated to be completed in February, this arrangement has been extended through mid-March due to prior commitments by both parties. In the fourth quarter, we completed an $11.5 million financing, which included a private placement with institutional investors and an equity purchase by SuperGen. "Throughout the year 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. accelerated development of our platform technologies, moving from the laboratory into clinical trials. Midyear we initiated a multicenter 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 of Avicine 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. , which is progressing according to plan. We anticipate that the Phase III trial for Avicine in 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. will get underway sometime later this year. "In November, we filed our first IND application 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. for clinical development of our core NeuGene 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). technology. We initiated human clinical trials just a month later. This represents the first time that third generation antisense compounds have entered clinical development. Resten-NG is now completing Phase I studies and will enter Phase II trials for cardiovascular restenosis approximately mid 2000. "I would also like to point out that in 1999 we raised the profile of AVI as a leader in the biotech arena by presenting clinical and preclinical data at ten prestigious conferences as well as publishing a number of key articles in peer reviewed medical and scientific journals. "The first two months of 2000 have been equally productive. We have begun preclinical development of two human monoclonal antibodies for cancer applying technology licensed from Abgenix. We have selected Lenox Hill Hospital Lenox Hill Hospital, on Manhattan's Upper East Side, is a 652-bed, acute care hospital and a major teaching affiliate of NYU Medical Center. Founded in 1857 as the German Dispensary, today's 10-building Lenox Hill Hospital complex has occupied its present site since 1868 when it in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of as the clinical trials coordinator for our Resten-NG restenosis Phase II study. In addition we recently announced the launch of our NeuBiotic program using our NeuGene technology to produce a platform of novel antibiotics focusing first on antibiotic resistant organisms. We expect to enter the clinical phase with our first NeuGene antibiotic later this year. Also earlier this year, Cruttenden-Roth (now Roth Capital Partners Roth Capital Partners, LLC, is a full service Investment Banking firm, specializing in the small and micro cap markets. Roth’s focus, according to its official website, "has been, is, and will continue to be providing the full spectrum of investment banking services, ) initiated coverage on AVI with a strong buy recommendation. "I believe we are now positioned to make the coming year the most productive and rewarding in AVI's history," concluded Burger. 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, is in a Phase II trial in pancreatic cancer, and will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in prostate cancer. AVI has begun clinical trials on Resten-NG in cardiovascular restenosis, the first application of its novel third generation NeuGene antisense technology. 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. AVI has begun clinical development of NeuBiotics applying its antisense technology to develop novel antibiotics to treat infectious diseases, with an emphasis on antibiotic resistant organisms. More information about AVI is available at its website, www.avibio.com. 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. (tables to follow)
AVI BIOPHARMA, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
Three Months Ended Year Ended
Dec. 31 Dec. 31
1999 1998 1999 1998
Revenues, from grant and
research contracts $ 9,241 $ 103,571 $ 17,024 $ 120,351
Operating expenses:
Research and
development 1,962,171 2,159,288 6,672,027 6,306,860
General and
administrative 404,392 442,794 1,745,491 1,621,381
Acquired in-process
research and
development 10,537 (2,937) 71,874 19,473,154
----------- ------------ ----------- -----------
2,377,100 2,599,145 8,489,392 27,401,395
Other income
Interest income, net 31,143 103,890 193,927 547,081
Net loss $(2,336,716)$(2,391,684)$(8,278,441)$(26,733,963)
Net loss per share -
basic and diluted $ (0.17)$ (0.18)$ (0.62)$ (2.27)
Shares used in per
share calculations 13,713,993 13,331,225 13,440,205 11,801,453
BALANCE SHEET HIGHLIGHTS
Dec. 31, Dec. 31,
1999 1998
Cash and cash equivalents $ 8,683,005 $ 8,510,020
Total current assets 11,651,747 9,019,448
Total assets 12,929,628 10,192,083
Total current liabilities 1,040,154 1,186,399
Total shareholders' equity $ 11,889,474 $ 9,005,684
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