SEATTLE, WA today announced its financial results for the fourth
quarter and year ended December 31, 2007. The Company will hold a
conference call with analysts and investors to discuss its
financial and business results at 10:30 a.m. ET today.
For the fourth quarter of 2007, the Company reported a net loss
of $5.1 million, or $0.26 per common share, compared to net income
of $808,000, or $0.08 per common share for the fourth quarter of
2006. For the year ended December 31, 2007, the Company reported a
net loss of $16.1 million, or $0.98 per common share, compared to a
net loss of $34.0 million, or $3.47 per common share for the year
ended December 31, 2006. Per share results for 2007 reflect the
issuance of 2.2 million shares in January 2007 and 6.7 million
shares in June 2007.
Revenue for the fourth quarter of 2007 was $3.2 million,
compared to $4.0 million for the same quarter in the prior year and
was $10.3 million for the year ended December 31, 2007 compared to
$9.9 million for the year ended December 31, 2006. Revenue for both
the fourth quarter and the full year consists primarily of research
and development revenue earned under the Company's NIAID-funded
subcontract to develop adeno-associated viral (AAV)-based HIV/AIDS
vaccines. Fiscal year 2007 revenue results also include revenue
generated by the Company's heart failure collaboration with
Celladon Corporation and licensing revenue primarily from a
milestone payment. Revenue in 2006 consisted primarily of
development revenue earned under the Company's heart failure
collaboration, HIV/AIDS vaccine collaboration activity and $1.8
million in licensing revenue in the fourth quarter from a license
fee received from Amsterdam Molecular Therapeutics for a
non-exclusive license to certain of our AAV1 patent rights.
Research and development expenses for the fourth quarter of 2007
increased to $4.9 million from $4.0 million in the fourth quarter
of 2006 and increased to $17.7 million for the year ended December
31, 2007 from $14.5 million for the prior year. Increases for both
periods were due to higher development and vaccine candidate
manufacturing costs associated with the Company's NIAID-funded
HIV/AIDS vaccine subcontract, higher clinical costs to support more
subjects in the Company's Phase I/II clinical study of tgAAC94 to
treat inflammatory arthritis and increased research and development
activities and costs to support the Company's heart failure
collaboration with Celladon, which entered Phase I clinical trials
in the second quarter of 2007.
General and administrative expenses for the fourth quarter of
2007 were $2.2 million compared to $1.6 million for the fourth
quarter of 2006 and were $7.0 million and $6.4 million for the year
ended December 31, 2007 and 2006, respectively. The increases for
both periods over the prior year results were primarily related to
higher compensation costs, patent prosecution and issuance
activities and non-cash stock-based compensation expense.
The Company's cash balance was $16.4 million at December 31,
2007, as compared to $6.2 million at December 31, 2006. This
increase is primarily due to net proceeds of $26.0 million
resulting from two private equity financings completed in 2007.
"2007 has been a challenging, yet rewarding year. We are very
pleased with the advancement of our clinical development programs
in arthritis, heart failure and HIV/AIDS vaccines, and intend to
move our lead candidate, tgAAC94 for inflammatory arthritis, into
Phase II clinical studies later this year," said H. Stewart Parker,
president and chief executive officer of Targeted Genetics. "During
2008, we will continue to leverage our emerging RNAi platform, data
momentum and strong AAV manufacturing patent position to drive the
business forward."
Highlights for 2007
In 2007, we made progress in our development collaborations and
our product development programs and expanded and leveraged our
patent portfolio. More specifically:
-- In February 2007, the Company reported results from the complete Phase
I clinical trial of the investigational HIV/AIDS vaccine candidate
partnered with IAVI. The results of this study indicated a favorable safety
and tolerability profile consistent with the results observed in clinical
trials for this product candidate to date, and provided the rationale for
the ongoing Phase II study to evaluate the vaccine at higher doses and at
different dosing intervals. The results of these studies support further
evaluation of HIV/AIDS vaccines which will be done in conjunction with our
NIAID-funded vaccine program.
-- In May 2007, the first patient was dosed in the Phase I clinical trial
of MYDICAR(TM), heart failure product candidate under development through
the Company's collaboration with Celladon.
-- In May 2007, the University College London's Institute of
Ophthalmology and Moorefield's Eye Hospital initiated a Phase I/II clinical
trial to test the use of an AAV vector to deliver RPE65 to treat a form of
childhood blindness. The Company manufactured the vector (AAV-RPE65) used
in this trial, which is funded by the UK Department of Health.
-- In June 2007, the Company reported additional data from its ongoing
Phase I/II clinical trial of its tgAAC94 inflammatory arthritis product
candidate that demonstrated safety and a trend in a higher percentage of
subjects with a two-point reduction, on a three point severity scale, in
swelling in treated joints compared to placebo. Enrollment and initial
dosing in this trial was completed in May 2007. In July 2007, this trial
was placed on clinical hold when a patient participating in the clinical
trial experienced a serious adverse event, or SAE, and subsequently died.
In September 2007, the National Institutes of Health Recombinant DNA
Advisory Committee held a public hearing which reviewed the SAE. Evidence
presented at the hearing suggested that the subject died of an invasive
fungal infection.
-- In November 2007, the U.S. Food and Drug Administration, or FDA,
removed the hold on the Company's Phase I/II clinical trial of its tgAAC94
inflammatory arthritis product candidate after an in depth review of all
product and clinical data. Also in November 2007, the Company reported
additional data indicating that a higher percentage of subjects who
received the drug candidate showed improvement in function and pain
compared to results from the placebo injected group. These data also
indicated that tgAAC94 is well-tolerated at the highest dose tested in the
trial.
-- In September 2007, the Company received a milestone payment from
Amsterdam Molecular Therapeutics, or AMT, upon initiation of a clinical
trial for AMT-011, an AAV1-based therapy for lipoprotein lipase (LPL) Type
1 deficiency, a genetic disorder caused by the reduced or absent activity
of an enzyme called lipoprotein lipase, which results in accumulation of
lipids in the blood.
-- Additional patents the Company had applied for have issued,
strengthening our AAV vector patent portfolio and expanding the coverage of
potential applications of AAV-based gene delivery.
Conference Call and Webcast Information
The Company will host a conference call reviewing financial
results and its product development portfolio, including an update
on the tgAAC94 inflammatory arthritis program and other clinical
and business developments, today beginning at 10:30 a.m. Eastern
Time / 7:30 a.m. Pacific Time. You may access the live webcast via
the "Events" section found on the homepage of the Company's website
at www.targetedgenetics.com or via telephone at 800.240.4186
(domestic) or 303.262.2139 (international).
Replay Access
Webcast replay will be available for 90 days at
www.targetedgenetics.com; telephone replay will be available
following today's call at approximately 12:30 p.m. ET through 11:59
p.m. ET, Wednesday, June 25, 2008, by calling 800.405.2236
(domestic) or 303.590.3000 (international); passcode 11110469#.
About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company
committed to the development of innovative targeted molecular
therapies for the prevention and treatment of acquired and
inherited diseases with significant unmet medical need. Targeted
Genetics' proprietary Adeno-Associated Virus (AAV) technology
platform allows it to deliver genes that encode proteins to
increase gene function or RNAi to decrease or silence gene
function. Targeted Genetics' product development efforts target
inflammatory arthritis, AIDS prophylaxis, congestive heart failure
and Huntington's disease. To learn more about Targeted Genetics,
visit Targeted Genetics' website at www.targetedgenetics.com.
Safe Harbor Statement under the Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements regarding the
Company's liquidity and financial resources, its ability to fund
ongoing and future operations, its business strategy and product
development, including statements regarding the data collected in
the tgAAC94 program, the cause of the serious adverse event and the
impact, if any, on the timing, continuance or results of this
trial, establishment or determination of efficacy endpoints from
the data collected in the trial, the timely and complete accrual of
patients in the trial and our ability to commercialize tgAAC94, the
strength of our patent portfolio, and other statements about the
Company's plans, objectives, intentions and expectations. These
statements involve current expectations, forecasts of future events
and other statements that are not historical facts. Inaccurate
assumptions and known and unknown risks and uncertainties can
affect the accuracy of forward-looking statements. Factors that
could affect actual future events or results include, but are not
limited to, payments anticipated by the Company under product
development collaborations and contracts, the Company's actual
expenses, the Company's ability to raise capital when needed, the
timing, nature and results of the Company's clinical trials,
potential development of alternative technologies or more effective
products by competitors, the Company's ability to obtain and
maintain regulatory or institutional approvals, the Company's
ability to maintain its listing on the NASDAQ Capital Market and
the Company's ability to obtain, maintain and protect its
intellectual property, as well as other risk factors described in
"Item 1A. Risk Factors" in the Company's most recent annual report
on Form 10-K for the year ended December 31, 2006 filed with the
SEC. The Company anticipates updating the risk factors in its
annual report on Form 10-K for the year ended December 31, 2007, to
be filed with the SEC. You should not rely unduly on these
forward-looking statements, which apply only as of the date of this
release. The Company undertakes no duty to publicly announce or
report revisions to these statements as new information becomes
available that may change the Company's expectations.
TARGETED GENETICS CORPORATION
(in thousands, except per share information)
Quarter ended Year-to-date ended
December 31, December 31,
-------------------- --------------------
Statement of Operations
Information: 2007 2006 2007 2006
--------- --------- --------- ---------
(unaudited) (unaudited)
Revenue:
Collaborative agreements $ 3,120 $ 2,258 $ 9,732 $ 8,114
Licensing revenue 100 1,750 600 1,750
--------- --------- --------- ---------
Total revenue 3,220 4,008 10,332 9,864
Operating expenses:
Research & development 4,869 3,999 17,709 14,482
General & administrative 2,208 1,646 7,029 6,382
Restructure charges 1,339 188 2,148 2,006
Goodwill impairment charge - - - 23,723
--------- --------- --------- ---------
Total expenses 8,416 5,833 26,886 46,593
--------- --------- --------- ---------
Loss from operations (5,196) (1,825) (16,554) (36,729)
Investment income 123 99 428 567
Interest expense - (49) (1) (411)
Gain on debt restructure - 2,583 - 2,583
--------- --------- --------- ---------
Net income (loss) $ (5,073) $ 808 $ (16,127) $ (33,990)
========= ========= ========= =========
Net income (loss) per common
share $ (0.26) $ 0.08 $ (0.98) $ (3.47)
========= ========= ========= =========
Shares used in computation of
net income (loss) per
common share 19,814 10,502 16,504 9,788
========= ========= ========= =========
TARGETED GENETICS CORPORATION
(in thousands)
December 31, December 31,
Balance Sheet Information: 2007 2006
------------ ------------
(unaudited)
Cash and cash equivalents $ 16,442 $ 6,206
Other current assets 2,854 2,029
Property and equipment, net 1,052 1,100
Other assets 8,126 8,132
------------ ------------
Total assets $ 28,474 $ 17,467
============ ============
Current liabilities $ 4,657 $ 5,188
Long-term obligations and other liabilities 7,577 6,912
Shareholders' equity 16,240 5,367
------------ ------------
Total liabilities and shareholders' equity $ 28,474 $ 17,467
============ ============
Investor and Media Contact: Stacie D. Byars WeissComm Partners
for Targeted Genetics 415.946.1072 Email Contact
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