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0001144204-08-044468.txt : 20080807
0001144204-08-044468.hdr.sgml : 20080807
20080807131420
ACCESSION NUMBER: 0001144204-08-044468
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 3
CONFORMED PERIOD OF REPORT: 20080806
ITEM INFORMATION: Results of Operations and Financial Condition
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20080807
DATE AS OF CHANGE: 20080807
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: TARGETED GENETICS CORP /WA/
CENTRAL INDEX KEY: 0000921114
STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
IRS NUMBER: 911549568
STATE OF INCORPORATION: WA
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-23930
FILM NUMBER: 08997650
BUSINESS ADDRESS:
STREET 1: 1100 OLIVE WAY
STREET 2: STE 100
CITY: SEATTLE
STATE: WA
ZIP: 98101
BUSINESS PHONE: 2066237612
MAIL ADDRESS:
STREET 1: 1100 OLIVE WAY
STREET 2: STE 100
CITY: SEATTLE
STATE: WA
ZIP: 98101
8-K
1
v122232_8k.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of Report (Date of earliest event reported)
|
August
6, 2008
|
Targeted
Genetics Corporation
|
(Exact
name of registrant as specified in its
charter)
|
Washington
|
0-23930
|
91-1549568
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
1100
Olive Way, Suite 100, Seattle, Washington
|
98101
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant's
telephone number, including area code
|
(206)
623-7612
|
Not
Applicable
|
(Former
name or former address if changed since last
report)
|
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
¨ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
¨ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
¨ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
|
¨ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
|
Item
2.02. Results of Operations and Financial
Condition.
On
August
6, 2008, Targeted Genetics Corporation announced financial results for the
quarter ended June 30, 2008. A copy of the press release related to this
announcement is attached as Exhibit 99.1 and is incorporated into this current
report by reference.
Item
9.01. Financial Statements and
Exhibits.
Exhibits.
99.1 |
Press
Release of Targeted Genetics Corporation dated August 6,
2008
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
Targeted Genetics Corporation
|
|
|
|
Dated:
August 6, 2008
|
By:
|
/s/
David J. Poston
|
|
|
David
J. Poston
|
|
|
Vice President Finance and
|
|
|
Chief Financial Officer
|
INDEX
TO EXHIBITS
Exhibit Number
|
|
Description
|
|
|
|
99.1
|
|
Press
Release of Targeted Genetics Corporation dated August 6,
2008
|
EX-99.1
2
v122232_ex99-1.htm
Unassociated Document
TARGETED
GENETICS REPORTS SECOND QUARTER 2008 FINANCIAL RESULTS
Conference
Call Today at 10:30 a.m. ET
SEATTLE,
Wash., August 6, 2008 –
Targeted Genetics Corporation (NASDAQ: TGEN) today announced its financial
results for the second quarter ended June 30, 2008. 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
quarter ended June 30, 2008, the Company reported a net loss of $3.8 million,
or
$0.19 per common share, compared to net loss of $4.2 million, or $0.31 per
common share, for the second quarter of 2007.
Revenue
for the second quarter of 2008 was $2.2 million, compared to $3.0 million for
the same quarter in 2007. The decrease in revenue for the second quarter of
2008
primarily reflects a decrease in research and development and manufacturing
activities under the NIAID-funded HIV/AIDS vaccine program and partially offset
by higher research and development activities under the Company’s collaboration
with Celladon. Revenue for the six months ended June 30, 2008 was $4.7 million,
even with revenue for the same period in 2007 as increases in 2008 Celladon
product development efforts were offset by lower 2008 HIV/AIDS vaccine program
activities.
Based
on
completion of planned development activities for funded projects and licensed
technology, the Company expects revenue from collaborative partners of
approximately $8.0 million to $9.0 million for the year ending December 31,
2008, compared to $10.3 million in 2007. The revenue plan for 2008 includes
the
expectation that Targeted Genetics, and its partners, achieve their respective
2008 product development work plans.
Research
and development expenses for the second quarter of 2008 decreased to $4.2
million, compared to $5.3 million in the same quarter of 2007. Research and
development expenses decreased to $8.1 million for the six months ended June
30,
2008 compared to $9.0 million for the same period in 2007. The decreases in
both
periods reflect lower clinical trial costs as the Company’s Phase 1/2
inflammatory arthritis clinical trial reaches completion. The R&D expense
decreases in both periods were partially offset by increased activity related
to
the partnered heart failure product candidate.
General
and administrative expenses for the three months ended June 20, 2008 were $1.8
million, compared to $1.6 million for the same period in 2007. General and
administrative expense increased to $3.6 million for the six months ended June
30, 2008, compared to $3.1 million for the same period in 2007. The increases
in
both periods reflect higher intellectual property charges related to patent
costs and higher legal fees as compared to the first half of 2007.
The
Company's cash balance was $12.7 million at June 30, 2008, compared to $16.4
million at December 31, 2007. The Company’s guidance for its estimated burn rate
for 2008 remains at a range of $12 to $14 million, and, based on its current
cash balances, the Company expects its cash horizon to extend into the first
quarter of 2009.
"This
was
a quarter of solid product development progress for the Company and its
collaborative partners,” said H. Stewart Parker, president and chief executive
officer of Targeted Genetics. “We were excited to be recommended for government
funding for a project targeting Amyotrophic Lateral Sclerosis, or ALS, more
widely known as Lou Gehrig’s disease, a devastating disease with significant
unmet need, potentially adding up to $2.4 million to fund the project’s
preclinical development costs. Also, research from two of our partnered programs
was presented and published this quarter. Dr. Robin Ali's team at University
College of London reported promising results in an early stage AAV-based
clinical trial in Leber’s Congenital Amaurosis (LCA), an inherited eye disease
that impairs vision and eventually causes blindness and was published in the
New
England Journal of Medicine. Dr. Beverly Davidson, at University of Iowa, was
recognized in PNAS for advances in delivery of small interfering RNA to the
brain, and represents a significant advance in addressing this treatment method
in Huntington's disease."
In
April,
the Company reported data showing proof of principle and early clinical benefit
from its Phase 1/2 clinical study in LCA. The study treated three young adults
between the ages of 17 and 23 years of age with early-onset severe retinal
dystrophy utilizing an Adeno-Associated Virus (AAV) vector containing the RPE
65
coding sequence, resulting in consistent improvement in visual function as
measured by visual field tests and improvement in subjective tests of visual
mobility. There were no adverse events. Targeted Genetics, a leader in the
development and manufacture of AAV-based product candidates, manufactures the
vector that is being used in this trial.
“Additional
studies are underway in order to assess this approach fully, but these initial
results suggest that AAV-based delivery of genes in the eye can be accomplished
safely and with promise,” added Parker.
The
Company also announced during the quarter, the publication of preclinical data
characterizing the novel use of Adeno-Associated Viral (AAV) vectors to deliver
small interfering RNA (siRNA) for the treatment of Huntington’s disease in the
Proceedings of the National Academy of Sciences (PNAS). The goal of this
research is to assess the use of interfering RNA to silence the mutant
huntingtin gene and thus, reduce the level of the defective protein.
The
paper
reported on findings that AAV-RNAi vectors efficiently abrogate disease in
mouse
models of Huntington’s disease and that they support a new approach to RNAi
delivery that has the potential to effectively overcome delivery limitations
of
RNAi related to off target effects and resulting non-specific toxicity. “These
new AAV-RNAi vectors, embedded in synthetic micro-RNA structures, retain the
efficiency of delivery and biologic efficacy, while having a greatly enhanced
safety profile,” said Barrie J. Carter, Ph.D., Executive Vice President and
Chief Scientific Officer of the Company.
“We
believe this new design concept is of great importance to the entire RNA
therapeutic field and that the use of AAV vectors for the delivery of expressed
RNAi has proven advantages over alternative RNAi delivery approaches due to
AAV’s long-term expression capabilities, stability and safety profile,” said
Parker. “These results in Huntington’s and in LCA continue to support our
beliefs that AAV delivery holds great promise in the creation of a broad new
class of innovative medicines and that Targeted Genetics is well positioned
to
participate in this opportunity.”
"We
continue to work diligently with our product development partners to move our
programs forward and are keenly focused on initiatives to extend our cash
horizon. We anticipate reporting data from our Phase 1/2 trial of tgAAC94 for
the treatment of inflammatory arthritis at the American College of Rheumatology
conference in October and Phase 1 data from our partnered heart failure program
at the American Heart Association Scientific Sessions 2008 conference in
November."
Conference
Call and Webcast Information
The
Company will host a conference call reviewing financial results, its product
development portfolio and other 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
303.275.2170 (international).
Replay
Access
Webcast
replay will be available for approximately 30 days at www.targetedgenetics.com
;
telephone replay will be available following Wednesday's call at approximately
9:30 a.m. PT through 11:59 p.m. PT, Saturday, September 6, 2008, by calling
800.405.2236 (domestic) or 303.590.3000 (international); pass code 11117734#.
About
Targeted Genetics Corporation
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, Leber's congenital
amaurosis, 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
and
its business strategy and product development, including statements regarding
the timing, nature and results of the Company's research and development
programs, and the potential impact of the results of such programs on the
Company’s operations, the Company’s revenue plan, the extent of the Company’s
cash horizon, the Company's ability to raise capital when needed, the Company’s
ability to obtain grant funding for the ALS research program 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 and cause actual results to differ materially from those expected
or
implied by the forward-looking statements. Factors that could affect actual
future events or results include, but are not limited to, the risk that the
Company will run out of cash earlier than expected, the risk that the Company
will not be able to raise capital when expected or at all, the risk that the
Company’s research and development programs are not successful or are delayed or
terminated, the risk that payments anticipated by the Company under product
development collaborations and contracts are not earned or received when
expected or at all, the risk that the Company will not obtain grant funding
for
the ALS research program in the amount expected or at all or that, even if
obtained, such funding is delayed, and the risk that the Company will not be
able to maintain its listing on the NASDAQ Capital Market as well as other
risk
factors described in "Item 1A. Risk Factors" in the Company's most recent
quarterly report on Form 10-Q for the period ended June 30, 2008 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.
#
#
#
Investor
and Media Contact:
Stacie
D.
Byars, WeissComm Partners
on
behalf
of
Targeted
Genetics Corporation
Phone:
206.660.2588
sdbyars@wcpglobal.com
SOURCE:
Targeted Genetics
TARGETED
GENETICS CORPORATION
(in
thousands, except per share information)
|
|
Quarter ended
|
|
Year-to-date ended
|
|
|
|
June 30,
|
|
June 30,
|
|
Statement of Operations Information:
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Collaborative
agreements
|
|
$
|
2,237
|
|
$
|
3,008
|
|
$
|
4,736
|
|
$
|
4,669
|
|
Total
revenue
|
|
|
2,237
|
|
|
3,008
|
|
|
4,736
|
|
|
4,669
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& development
|
|
|
4,156
|
|
|
5,270
|
|
|
8,102
|
|
|
8,966
|
|
General
& administrative
|
|
|
1,752
|
|
|
1,575
|
|
|
3,641
|
|
|
3,127
|
|
Restructure
charges
|
|
|
199
|
|
|
442
|
|
|
401
|
|
|
626
|
|
Total
expenses
|
|
|
6,107
|
|
|
7,287
|
|
|
12,144
|
|
|
12,719
|
|
Loss
from operations
|
|
|
(3,870
|
)
|
|
(4,279
|
)
|
|
(7,408
|
)
|
|
(8,050
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment
income
|
|
|
73
|
|
|
93
|
|
|
198
|
|
|
28
|
|
Interest
expense
|
|
|
-
|
|
|
(1
|
)
|
|
-
|
|
|
(1
|
)
|
Net
loss
|
|
$
|
(3,797
|
)
|
$
|
(4,187
|
)
|
$
|
(7,210
|
)
|
$
|
(8,023
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share
|
|
$
|
(0.19
|
)
|
$
|
(0.31
|
)
|
$
|
(0.36
|
)
|
$
|
(0.61
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in computation of net loss per common share
|
|
|
19,902
|
|
|
13,408
|
|
|
19,858
|
|
|
13,138
|
|
TARGETED
GENETICS CORPORATION
(in
thousands)
|
|
June 30,
|
|
December 31,
|
|
Balance
Sheet Information:
|
|
2008
|
|
2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
12,701
|
|
$
|
16,442
|
|
Other
current assets
|
|
|
582
|
|
|
2,854
|
|
Property
and equipment, net
|
|
|
1,304
|
|
|
1,052
|
|
Other
assets
|
|
|
8,126
|
|
|
8,126
|
|
Total
assets
|
|
$
|
22,713
|
|
$
|
28,474
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
$
|
5,983
|
|
$
|
4,657
|
|
Long-term
obligations and other liabilities
|
|
|
7,265
|
|
|
7,577
|
|
Shareholders'
equity
|
|
|
9,465
|
|
|
16,240
|
|
Total
liabilities and shareholders' equity
|
|
$
|
22,713
|
|
$
|
28,474
|
|
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end
-----END PRIVACY-ENHANCED MESSAGE-----