AVI BioPharma Reports Third Quarter Financial Results.PORTLAND, Ore. -- AVI BioPharma, Inc. (Nasdaq:AVII) today reported financial results for the three and nine months ended September 30, 2006. The net loss for the third quarter of 2006 was $6.8 million, or $0.13 per share, compared with a net loss for the third quarter of 2005 of $1.7 million, or $0.04 per share. Results for the third quarter of 2006 include stock-based compensation expenses of $1.0 million recognized in accordance with SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 123R. Results for the third quarter of 2005 do not include SFAS 123R compensation expenses since the adoption occurred beginning January 1, 2006. Revenues for the 2006 third quarter were $13,000, down from $3.3 million in the prior-year quarter, reflecting lower research contract revenues. Revenues for the 2005 third quarter were primarily due to the recognition of $3.2 million in research contract revenue from the receipt in 2005 of $3.4 million in government funding for work on viral disease research projects. Research and development (R&D) expenses for the quarter increased to $5.9 million from $4.1 million in the prior year, and general and administrative (G&A) expenses increased to $1.3 million from $1.1 million in the prior year. The increase in R&D expenses was due to an additional $690,000 in employee costs, including $645,000 related to SFAS 123R, and to higher clinical costs of $980,000 from the expansion of clinical programs in hepatitis C virus
abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ) and coronary artery bypass grafting (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ). The remaining increase in R&D expenses also reflects $120,000 in contracting costs for the production of GMP GMP (guanosine monophosphate): see guanine. subunits, which are used by 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. to manufacture compounds for future clinical trials. The increase in G&A expenses was due primarily to an additional $300,000 in employee costs, including $360,000 related to SFAS 123R, partially offset by decreases in employee costs of $125,000 from the transition of nine employees in AVI's Colorado facility to Cook Group Inc. in April 2006, subsequent to AVI's licensing transaction with Cook. For the nine months ended September 30, 2006, AVI BioPharma reported a net loss of $22.7 million, or $0.43 per share, compared with a net loss for the comparable period in 2005 of $12.1 million, or $0.28 per share. Results for the nine months ended September 30, 2006 include stock-based compensation expense of $3.9 million, of which $3.1 million is related to SFAS 123R and $830,000 is related to the acceleration of the vesting of certain stock options. Results for the nine months ended September 30, 2005 do not include SFAS 123R compensation expense. Revenues for the nine months ended September 30, 2006 were $98,000, down from $3.4 million in the prior-year period, reflecting lower research contract revenues. Revenues for the nine months ended September 30, 2005 were primarily due to the recognition of $3.2 million in research contract revenue from the receipt in 2005 of $3.4 million in government funding for work on viral disease research projects. R&D expenses for the nine months ended September 30, 2006 increased to $18.6 million from $12.2 million in the prior-year period, and G&A expenses increased to $5.7 million from $3.8 million. The increase in R&D expenses was due primarily to an additional $2.4 million in employee costs, including $1.8 million related to SFAS 123R, $430,000 related to the acceleration of the vesting of certain stock options, and to higher clinical costs of $1.9 million from the expansion of clinical programs in HCV and CABG. The increase in R&D expenses also reflects $500,000 in AVI common stock issued to Chiron Corporation as the first milestone payment under a license agreement granting AVI a nonexclusive license to Chiron's patents and patent applications for the research, development and commercialization of 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). therapeutics against HCV, and $1.1 million in contracting costs for the production of GMP subunits. The increase in G&A expenses was due primarily to an additional $1.8 million in employee costs, including $1.3 million related to SFAS 123R and $400,000 related to the acceleration of the vesting of certain stock options. AVI had cash, cash equivalents and short-term securities of $38.4 million as of September 30, 2006, a decrease of $8.6 million from December 31, 2005. This decrease was due primarily to $15.5 million used in operations and approximately $1.2 million used for purchases of property and equipment and patent-related costs, offset by the receipt of $5.0 million in 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). from a stock purchase agreement with Cook and $3.1 million from the exercise of warrants and options and sales under the company's employee stock purchase plan during the nine months ended September 30, 2006. In January 2006 AVI announced that the final version of the 2006 defense appropriations act had been approved, which included an allocation of $11.0 million to fund AVI's ongoing defense-related programs. AVI's NEUGENE([R]) technology will be used to continue developing therapeutic agents against Ebola, Marburg and dengue viruses, as well as to continue developing countermeasures for anthrax exposure and antidotes for ricin toxin. AVI continues to work with the government to define the scope of the work to be performed on these programs. This additional funding for 2006 has not been received and has not been reflected in AVI's 2006 third quarter financial statements. "As planned we have initiated our clinical program for the treatment of coronary vascular disease with AVI-5126, or Resten-CP[TM], which combines our third-generation antisense drug AVI-4126 with our proprietary CytoPorter[TM] delivery peptide," said Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., chief executive officer of AVI BioPharma. "We are taking a cost-effective and efficient approach to Resten-CP's clinical development. These studies are being conducted at clinical cardiovascular surgery cardiovascular surgery Heart surgery An operation for repairing structural defects of the cardiovascular system Examples CABG, repair of congenital heart defects, varicose veins, aortic aneurysms, ventricular remodeling, transmyocardial sites in the Ukraine and Poland as the first step in our program. Based on anticipated efficacy results from these studies, which are expected in late 2007, we expect to broaden our program with a goal to commercialize Resten-CP for CABG in all major global markets within five years. "We are actively enrolling patients in our modified HCV clinical trial with plans to discuss preliminary results in the first half of 2007, and continue making progress with activities to enter the clinic with our Exon Exon In split genes, a portion that is included in the ribonucleic acid (RNA) transcript of a gene and survives processing of the RNA in the cell nucleus to become part of a spliced messenger RNA (mRNA) or structural RNA in the cell cytoplasm. Skipping Pre-RNA Interference Technology, or ESPRIT, therapeutics in Duchenne muscular dystrophy Duchenne muscular dystrophy (DMD) The most severe form of muscular dystrophy, DMD usually affects young boys and causes progressive muscle weakness, usually beginning in the legs. . Based on strong preclinical data that indicate the ability of our NEUGENE compounds to target multiple strains of influenza and animal studies that are in progress, we plan to file an Investigational New Drug (IND) application for the treatment of avian influenza avian influenza: see influenza. ," added Dr. Burger. Product Pipeline Update Technology Overview AVI has developed proprietary third-generation NEUGENE antisense technology, which is characterized by a novel synthetic backbone. 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 believes that this chemistry allows NEUGENE antisense
agents to be more stable, specific, efficacious and safer than
second-generation antisense compounds in clinical development by others.AVI's clinical development is focused on two disease categories: cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. . In addition, AVI applies its technology to certain other clinical applications that it believes are particularly amenable to antisense drug development, namely genetic disorders, inflammatory diseases and oncology. In September 2005 the company announced a new application of its proprietary NEUGENE technology, called ESPRIT (Exon Skipping Pre-RNA Interference Technology). ESPRIT therapeutics allow for fine genetic surgery at the RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic processing level that enables the deletion of disease-causing genetic sequences or the skipping of functional sequences that are over-expressed or harmful in certain diseases. In February 2006 the company announced publication of an article in Nature Medicine indicating that AVI's ESPRIT technology may hold significant potential to bypass faulty dystrophin dys·tro·phin n. A structural protein found in small amounts in normal muscle but absent or present in abnormal amounts in individuals with muscular dystrophy. gene expression in patients with muscular dystrophy muscular dystrophy (dĭs`trōfē), any of several inherited diseases characterized by progressive wasting of the skeletal muscles. There are five main forms of the disease. . The company is applying the ESPRIT therapeutic approach in genetic disorders, including a potential collaborative program in muscular dystrophy, as well as to diseases with an immunologic component, such as diabetes and multiple sclerosis. Cardiovascular Disease Program Resten-NG([R]) (AVI-4126) is a NEUGENE antisense drug for treating cardiovascular restenosis, the re-narrowing of a coronary artery coronary artery n. 1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and following angioplasty. Resten-NG inhibits the expression of the c-myc gene, which plays a key role in the development of the pathology leading to restenosis. In a completed Phase II study, AVI demonstrated that Resten-NG prevented restenosis at the site of balloon angioplasty balloon angioplasty: see under angioplasty. as measured by angiography angiography or arteriography X-ray examination of arteries and veins with a contrast medium to differentiate them from surrounding organs. The contrast medium is introduced through a catheter to show the blood vessels and the structures they supply, including and intravascular ultrasound at six months. In March 2006 AVI announced a development and commercialization agreement with Cook Group Inc., in which Cook Group licensed AVI-4126 for the down-regulation of c-myc gene expression in vascular diseases vascular diseases, n.pl diseases of the peripheral circulatory system. . This agreement covers device-delivery of Resten-NG as well as Resten-MP[TM], the microparticle formulation of AVI-4126, for treating cardiovascular restenosis. As part of this agreement, Cook Group has assumed control of the ongoing APPRAISAL Phase II clinical study, in which Resten-MP is being evaluated in the prevention of restenosis when delivered intravenously in conjunction with the placement of one or more bare-metal stents. 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-MP was as effective in preventing restenosis as was AVI-4126 delivered by catheters or stents. In October 2006 AVI announced the initiation of a clinical program to assess the safety and effectiveness of Resten-CP for the treatment of coronary vascular disease. Resten-CP is a new-generation of AVI-4126 that incorporates the company's proprietary transporter tail CytoPorter to enhance delivery to the saphenous vein saphenous vein n. Either of two main superficial veins of the leg, one larger than the other, that begin at the foot. Saphenous vein A long vein in the thigh or calf commonly used for bypass grafts. ex vivo ex vivo /ex vi·vo/ (eks´ ve´vo) outside the living body; denoting removal of an organ (e.g., the kidney) for reparative surgery, after which it is returned to the original site. before use in bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). . The first step planned in this program is to assess the therapeutic benefit of exposing an excised saphenous vein to Resten-CP immediately before connecting it to the coronary artery circulation of patients undergoing CABG procedures. In October 2006 AVI also initiated pivotal studies in the Ukraine and Poland. Based on anticipated efficacy results from these trials expected in late 2007, AVI expects to initiate a worldwide clinical program to bring Resten-CP to all major markets within five years. Infectious Disease Program AVI's infectious disease program is extensive, encompasses research on more than 50 different viruses representing most viral families, and involves collaborations with investigators worldwide. Results from these studies have enhanced AVI's ability to design effective agents for emerging as well as for engineered pathogens. AVI's antiviral research program has produced antisense drugs shown to be active in preclinical studies against a wide range of RNA viruses, including HCV, influenza A virus, West Nile virus West Nile virus, microorganism and the infection resulting from it, which typically produces no symptoms or a flulike condition. The virus is a flavivirus and is related to a number of viruses that cause encephalitis. , dengue virus, SARS coronavirus, Ebola virus and Marburg virus. AVI has published confirmation through independent laboratories of NEUGENE antisense efficacy in preclinical experiments against multiple strains of influenza, including avian influenza strain H5N1, a potential worldwide public health threat. AVI plans to focus its antiviral drug development program on infectious diseases that represent large market opportunities. In June 2005 the company announced the acceptance by the U.S. Food and Drug Administration (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. ) of an IND application for the treatment of HCV using the company's NEUGENE compound AVI-4065. In September 2005 AVI announced the initiation of an HCV clinical trial to assess the safety, tolerability, pharmacokinetics and viral response to treatment with AVI-4065 in healthy volunteers and patients with chronic active HCV. The company reported favorable safety, tolerability and pharmacokinetic results in January 2006 from the first phase of its HCV program. Based on preliminary data in the second phase of the HCV study presented in May 2006, the clinical trial protocol A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in was modified to allow for extended treatment duration with AVI-4065 to enhance the pharmacokinetics and potentially enhance viral and clinical response in HCV patients. In July 2006 AVI began patient enrollment to fill an extended treatment cohort in this study. To potentially address the large seasonal influenza commercial market, AVI has developed NEUGENE antisense drug candidates that target genetic regions of the influenza A virus that are highly conserved between the six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century - the 1918 Spanish flu (H1N1), the 1957 Asian flu (H2N2) and the 1968 Hong Kong flu (H3N2) - and three subtypes of avian flu that have been reported to cause disease in humans (H5N1, H7N7 and H9N2). Collaborators have confirmed that a single NEUGENE drug was effective in preclinical studies against most influenza subtypes, including the emerging H5N1 avian strain. Based on animal studies in progress, AVI plans to file an IND application for its NEUGENE drug for avian flu that is also efficacious against the far more common influenza A viruses, which kill an average of 35,000 Americans every year. The company is collaborating with the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) in its dengue virus program, and expects dengue dengue or breakbone fever or dandy fever Infectious, disabling mosquito-borne fever. Other symptoms include extreme joint pain and stiffness, intense pain behind the eyes, a return of fever after brief pause, and a characteristic rash. fever/dengue hemorrhagic fever to be the next viral program to move into clinical development. Bio-Defense Program AVI has an active collaborative program with the Department of Defense in the area of bio-threats and emerging diseases. In 2005 and early 2006 AVI received $4.6 million for ongoing programs in drug development for the highly lethal Ebola and Marburg viruses, and countermeasures for ricin ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins. ri·cin n. and anthrax toxins. In January 2006 the final version of the 2006 defense appropriations act was approved, which included an allocation of $11.0 million to fund AVI's ongoing defense-related programs. AVI continues to work with the government to define the scope of the work to be performed on these programs. This additional funding has not been received and has not been reflected in AVI's 2006 third quarter financial statements. Conference Call AVI BioPharma has scheduled an investor conference call regarding this announcement, and the company's current and planned business activities, to be held November 15th beginning at 11:00 a.m. Eastern time. Individuals interested in listening to the conference call may do so by dialing (888) 803-8271 within the U.S. and Canada, or (706) 634-2467 for international callers. A telephone replay of the conference call will be available for 48 hours beginning within two hours of the conclusion of the call, by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation number 9155986. The live conference call also will be available to private investors via the Internet at www.avibio.com. A replay of the call will be available on the company's Web site for 14 days following the completion of the call. About AVI BioPharma AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer 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 targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, Ebola virus and influenza A virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at http://www.avibio.com. "Safe Harbor" 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. [TABLE OMITTED] |
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