AVI BioPharma Announces 1999 Third Quarter and Nine Month Financial Results
AVI Additionally Announces a $5 Million Equity Commitment
From a Strategic Partner
PORTLAND, Ore., Nov. 11 /PRNewswire/ -- AVI BioPharma Inc. ("AVI")
(Nasdaq: AVII, AVIIW) today reported financial results for the third quarter
and nine months ended September 30, 1999.
For the third quarter ended September 30, 1999, the company's net loss was
$2.2 million, or $0.17 per share compared with a net loss of $21.3 million, or
$1.84 per share for the third quarter 1998. The company's net loss and per
share figures for the 1998 third quarter include a one-time charge of
$19.5 million, or $1.69 per share, for acquired in-process research and
development, reflecting the acquisition of ImmunoTherapy Corporation (ITC).
The net loss for the nine month period ending September 30, 1999 was
$5.9 million, or $0.45 per share compared with a net loss of $24.3 million, or
$2.16 per share for the same period in 1998. The company's net loss and per
share figures for the 1998 nine month period include a one-time charge of
$19.5 million, or $1.69 per share, for acquired in-process research and
development, reflecting the acquisition of ITC.
Research and development expenses in the third quarter of 1999 increased
to $1.7 million from $1.5 million in 1998. For the nine months ended
September 30 1999, research and development expenses increased to $4.7 million
compared with $4.1 million from the comparable period in 1998.
Operating expenses for the third quarter and nine month period of
1999 were $2.2 million and $6.1 million respectively, compared with operating
expenses for the third quarter and nine month period of 1998 of $21.4 million
and $24.8 million respectively. The company's operating expenses for the
1998 third quarter and nine month period include a one-time charge of
$19.5 million for acquired in-process research and development, reflecting the
acquisition of ITC. These expenses resulted principally from increased
research and development staffing and increased expenses associated with
outside collaborations and pre-clinical testing of AVI's technologies.
Commenting on the quarter, Denis Burger, Ph.D., President and CEO of
AVI BioPharma, stated, "During the quarter we have furthered our research in
our technology platforms -- cancer immunotherapy and gene-targeted drugs -- in
several ways.
"In August, the first patient was treated in AVI's Phase II trial of
Avicine(TM) in pancreatic cancer at Georgetown University. This is the first
trial in which the vaccine, using our newly modified Avicine formulation, is
being administered with a chemotherapeutic agent, Eli Lilly & Co.'s
(NYSE: LLY) gemcitabine (Gemzar). We look forward to continued enrollment in
this clinical trial.
"In September, our Senior Vice President of Research and Development
Patrick Iversen, Ph.D., presented promising data at the 21st Congress of the
European Society of Cardiology held in Barcelona, Spain. The data showed that
our antisense compound, Resten-NG(TM), inhibited excessive cell growth in
blood vessel linings following coronary angioplasty, demonstrating the
tremendous therapeutic promise of this compound. Resten-NG is an important
component of our antisense development program that is exploring use of our
proprietary antisense technology in a variety of other life threatening
diseases."
Dr. Burger concluded, "This research, and other study results being
published, illustrate the progress we continue to make this year toward our
milestone goals of initiating a Phase III licensing trial of Avicine, and
filing an Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA). The IND will be the first step toward initiating
our clinical trials of Resten-NG."
AVI also announced today that it had received a commitment for an equity
investment of $5 million in cash and securities at a premium of approximately
20 percent to recent market. The payment represents the first stage of a
co-development and license agreement for the Company's therapeutic cancer
vaccine, Avicine. Under terms of this arrangement, the undisclosed industry
partner is granted an exclusive period to finalize the second stage of the
agreement under defined terms.
Commenting on this announcement, Dr. Burger stated: "This is a significant
milestone in the Company's aggressive clinical development strategy for
Avicine. It sets the stage for the parties to this agreement to move into the
final stages of clinical development of Avicine in a timely manner."
AVI BioPharma Inc. is dedicated to the development and commercialization
of products for the treatment of life-threatening diseases using two
technology platforms: gene-targeted drugs and immunotherapy for cancer. Its
lead clinical agent, Avicine(TM), an essentially non-toxic cancer vaccine,
will soon enter a Phase II trial in prostate cancer, as well as a Phase III
licensing trial in colorectal cancer. AVI's patented class of gene-targeted
drugs, called NeuGenes(R), show promise in the treatment of a wide range of
human diseases including cardiovascular restenosis and cancer. The company
expects to file the IND application for Resten-NG in the treatment of
restenosis, later this year.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act
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.
AVI BioPharma, Inc.
(A Development Stage Company)
Statements of Operations
Three Months Ended Nine Months Ended
September 30, September 30,
1999 1998 1999 1998
Revenues, from
grant and
research contracts $3,558 $4,977 $7,783 16,780
Operating expenses:
Research and
development 1,739,728 1,549,133 4,709,856 4,147,572
General and
administrative 504,607 366,637 1,341,099 1,178,587
Acquired
in-process
research and
development -- 19,476,091 61,337 19,476,091
2,244,335 21,391,861 6,112,292 24,802,250
Other income:
Interest income,
net 35,696 128,927 162,784 443,191
Net loss $(2,205,081) $(21,257,957) $(5,941,725) $(24,342,279)
Net loss per
share-basic
and diluted $(0.17) $(1.84) $(0.45) $(2.16)
Shares used in
per share
calculations 13,351,206 11,539,885 13,350,597 11,286,190)
Balance Sheet Highlights
September 30, Decembeber 31,
1999 1998
Cash and cash
equivalents $2,444,140 $8,510,020
Total current assets 2,475,382 9,019,448
Total assets 3,756,552 10,192,083
Total current
liabilities 677,593 1,186,399
Total shareholders'
equity $3,078,959 $9,005,684
SOURCE AVI BioPharma, Inc.
-0- 11/11/1999
/CONTACT: Denis R. Burger, Ph.D., President & CEO, or Alan P. Timmins,
COO & CFO, both of AVI BioPharma, Inc., 503-227-0554; or Ellen Berg of
Young & Roehr Group, media, 503-222-0626, or eberg@young-roehr.com; or
Judy Brenna of Noonan-Russo Communications, Investor Relations, 212-696-4455,
both for AVI BioPharma/
(AVI AVIIW)
CO: AVI BioPharma, Inc.
ST: Oregon
IN: FIN MTC
SU: ERN
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