AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs,
today reported financial results for the three and nine months
ending September 30, 2008.
Revenues for the 2008 third quarter were $5.2 million, up from
$2.9 million in the prior-year quarter, reflecting increases in
research contracts revenues of $2.3 million. Revenues for the nine
months ended September 30, 2008 were $15.8 million, up from $5.8
million for the comparable period in 2007, primarily reflecting
increases in research contracts revenues of $10.0 million.
The net loss for the third quarter of 2008 was $6.0 million, or
$0.08 per share, compared with a net loss for the third quarter of
2007 of $7.0 million, or $0.13 per share. For the nine months ended
September 30, 2008, AVI BioPharma reported a net loss of $22.8
million, or $0.33 per share, compared with a net loss for the
comparable period in 2007 of $23.0 million, or $0.43 per share.
Research and development (R&D) expenses for the third
quarter of 2008 decreased to $7.9 million from $9.9 million during
the third quarter of 2007. The decrease in R&D expenses was due
primarily to decreases in contracting costs for the production of
GMP subunits. R&D expenses for the first nine months of 2008
decreased to $23.6 million from $25.4 million in the prior-year
period. This decrease was due primarily to decreases in contracting
costs for the production of GMP subunits and a decrease in
government research contract expenses partially offset by increases
in net clinical expenses, compensation costs and professional
consultants. During this period the Company completed an asset
acquisition of Ercole Biotechnology, Inc ("Ercole"), resulting in
additional expenses of $9.9 million relating to acquired in-process
research and development.
General and administrative (G&A) expenses for the third
quarter of 2008 increased to $3.2 million from $1.5 million for the
third quarter of 2007. The increase in G&A expenses was due
primarily to an increase in compensation costs, including
severance, for the Company's former President and Chief Operating
Officer who resigned during the quarter. G&A expenses for the
nine months ended September 30, 2008 decreased to $6.9 million from
$7.9 million in the prior-year period. The decrease in G&A
expenses for the nine-month period was due primarily to a decrease
in compensation costs. This decrease in compensation reflects year
2007 expenses related to the Separation and Release Agreement with
the Company's former Chief Executive Officer.
AVI had cash, cash equivalents and short-term securities of
$14.4 million as of September 30, 2008, a decrease of $10.7 million
from December 31, 2007. This decrease was due primarily to $9.9
million used in operations and $783,000 used for purchases of
property and equipment and patent-related costs.
"AVI's continued advancement as an RNA-based drug discovery and
development company is reflected in the progress of our programs,
our leadership and the effective management of our resources," said
Leslie Hudson, Ph.D., President and Chief Executive Officer of AVI
BioPharma. "We look forward to continued progress in our clinical
programs, such as today's milestone with our partner Cook Medical
to start the first clinical study of a drug eluting stent utilizing
AVI-5126, our RNA-based therapeutic agent."
Third Quarter and Recent Corporate Highlights:
-- Announced that partner Global Therapeutics, a Cook Medical company,
has initiated the world's first clinical trial of a drug eluting stent that
uses an antisense RNA therapeutic agent (AVI-5126) aimed at silencing one
of the genes (c-myc) responsible for causing arteries to reclose after
stenting (restenosis). AVI-5126 is an enhanced translation suppressing
oligomer (TSO) that targets c-myc a key regulatory gene involved in
cardiovascular restenosis, silencing the gene before the biochemical events
leading to restenosis can be triggered. The enhanced antisense compound
has increased potency compared with its predecessors, allowing for a DES
system with less drug and excipient.
-- Announced that the European Medicines Agency (EMEA) Committee for
Orphan Medicinal Products (COMP) adopted a positive opinion recommending
orphan medicinal product designation for AVI-4658 to treat Duchenne
muscular dystrophy (DMD). Additionally, the Company received notification
from the Gene Therapy Advisory Committee (GTAC) in the UK granting
provisional approval for the Company's planned clinical trial for systemic
delivery of AVI-4658 to treat DMD.
-- Co-hosted, along with The Foundation to Eradicate Duchenne, the
CureDuchenne Foundation, and Prosensa, a conference on 'Oligonucleotide-
directed splicing: Therapeutic Strategies for Duchenne muscular dystrophy
(DMD)' at the prestigious Cold Spring Harbor Laboratories. Invited
participants were drawn from all over the world and from all areas of
research, clinical development, regulatory affairs and key DMD disease
foundations to review the advances in oligonucleotides for the treatment of
DMD. Members of AVI's senior management, as well as several of the
Company's key collaborators, presented original research and development
findings.
-- J. David Boyle II joined the Company as Senior Vice President and
Chief Financial Officer. Mr. Boyle has previously held senior positions in
biotechnology and specialty pharmaceutical companies including XOMA Ltd., a
California-based leader in the discovery and development of therapeutic
antibodies, Salix Pharmaceuticals, Ltd. in the U.S. and at Ares Serono
Group both in the U.S. and Switzerland.
-- Hosted, a meeting for analysts, brokers, investors and the Company's
shareholders on September 10, 2008 at the Harvard Club in NYC. AVI's senior
management team and collaborators provided an update on the latest advances
in its third-generation antisense technology, status of the Company's
clinical programs including those for Duchenne Muscular Dystrophy,
cardiovascular restenosis and AVI's biodefense collaboration with USAMRIID
targeting Ebola, Marburg and other pathogens.
Conference Call
AVI management will hold a conference call to report third
quarter 2008 financial results on Monday, November 10, 2008, at
9:30 a.m. Eastern time (6:30 a.m. Pacific time).
Individuals interested in listening to the live conference call
may do so by dialing 866-550-6338 toll free within the United
States and Canada, or 347-284-6930 for international callers.
A replay of the call will be available by dialing 888-203-1112
toll free within the U.S. and Canada, or 719-457-0820. The passcode
for the replay is 4948533. In addition, a recording of the call
will be available within approximately 24 hours at
www.avibio.com.
About AVI BioPharma
AVI BioPharma is focused on the discovery and development of
RNA-based drugs utilizing proprietary derivatives of its antisense
chemistry (morpholino-modified phosphorodiamidate oligomers or
PMOs) that can be applied to a wide range of diseases and genetic
disorders through several distinct mechanisms of action. Unlike
other RNA therapeutic approaches, AVI's antisense technology has
been used to directly target both messenger RNA (mRNA) and its
precursor (pre-mRNA), allowing for both up- and down-regulation of
targeted genes and proteins. AVI's RNA-based drug programs are
being evaluated for the treatment of Duchenne muscular dystrophy as
well as for the treatment of cardiovascular restenosis through our
partner Global Therapeutics, a Cook Group Company. AVI's antiviral
programs have demonstrated promising outcomes in Ebola Zaire and
Marburg Musoke virus infections and may prove applicable to other
viral targets such as HCV or Dengue viruses. For more information,
visit www.avibio.com.
"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
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.
[Tables to Follow]
AVI BIOPHARMA, INC.
(A Development-Stage Company)
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------- --------------------------
2008 2007 2008 2007
----------- ----------- ------------ ------------
Revenues, from
license fees, grants
and research
contracts $ 5,170,663 $ 2,911,406 $ 15,778,243 $ 5,798,872
Operating expenses:
Research and
development 7,934,886 9,880,480 23,572,395 25,358,937
General and
administrative 3,173,942 1,544,512 6,853,417 7,879,193
Acquired in-process
Research and
development - - 9,916,271 -
----------- ----------- ------------ ------------
11,108,828 11,424,992 40,342,083 33,238,130
Other income:
Interest income,
net 60,147 182,320 307,949 848,397
Gain (loss)
on warrant
liability (168,975) 1,296,322 1,443,800 3,550,330
----------- ----------- ------------ ------------
Net loss $(6,046,993) $(7,034,944) $(22,812,091) $(23,040,531)
=========== =========== ============ ============
Net loss per
share -- basic
and diluted $ (0.08) $ (0.13) $ (0.33) $ (0.43)
=========== =========== ============ ============
Shares used in per
share calculations 71,150,972 53,693,693 69,160,118 53,500,250
=========== =========== ============ ============
BALANCE SHEET HIGHLIGHTS
(unaudited)
September 30, December 31,
2008 2007
----------- -----------
Cash, cash equivalents and short-term
securities $14,360,741 $25,074,413
Total current assets 19,659,981 28,711,451
Total assets 29,514,946 38,637,930
Total current liabilities 10,666,058 9,752,329
Total shareholders' equity $16,338,762 $26,381,748
AVI Press and Investor Contact: Julie Rathbun Investor Relations
(541) 224-2575 Investorrelations@avibio.com
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