Titan Pharmaceuticals Announces Third Quarter 2008 Financial Results
Monday, November 10, 2008 2:13:01 PM ET
Titan Pharmaceuticals, Inc. (AMEX:TTP) today reported financial results
for the third quarter ended September 30, 2008.
Total operating expenses for the third quarter of 2008 were $6.0
million, compared with $4.6 million for the third quarter of 2007. Net
loss for the third quarter of 2008 was $5.9 million or $0.10 per share,
compared with a net loss of $4.3 million or $0.10 per share for the
third quarter of 2007. The year-over-year increase in expenses resulted
primarily from the increased research and development (R&D) expense
related to the completion of the first Phase 3 study and the continued
late stage development of Probuphine(R), and a
slight increase in general and administrative (G&A) expense.
At September 30, 2008, the Company had cash and cash equivalents of
$12.2 million, which it believes is sufficient to sustain its planned
operations through January 2009. However, if the Company is unable in
the immediate future to obtain a corporate partner or otherwise raise
the funding necessary to continue development and commercialization of
Probuphine it will be forced, in light of its known and contingent
financial obligations, to consider various alternatives prior to year
end, including the possible sale of assets, the discontinuance of
product development programs and/or the winding up of the business.
"We have continued to streamline our expenses
and focus our resources on the Phase 3 clinical development of Probuphine(R),"
said Marc Rubin, M.D., President and CEO of Titan Pharmaceuticals. "During
the third quarter, we have engaged in discussions with several potential
partners both in the U.S. and Europe and we are continuing these efforts
as we evaluate strategic alternatives for the Company. We continue to
receive strong support from key opinion leaders as well as the addiction
community at large for Probuphine and its potential to provide a safe
and effective treatment option for patients with opioid addiction."
Third Quarter 2008 Additional Financial Results
R&D expenses for the third quarter of 2008 were approximately $4.2
million, compared with approximately $3.1 million in the third quarter
of 2007. The increase in R&D expenses during the third quarter of 2008
primarily reflects the costs associated with the completion of the first
Phase 3 study and the continuation of planned Phase 3 clinical trials
for the Companys Probuphine product.
G&A expenses for the third quarter of 2008 were $1.8 million, compared
with $1.5 million in the third quarter of 2007. The increase in general
and administrative expenses is primarily related to the increased
non-cash stock compensation costs and market research costs associated
with Probuphine for the treatment of opiate addiction and chronic pain.
Probuphine: Recent and Upcoming Events
Probuphine is a novel formulation of buprenorphine designed to provide
six months of continuous drug delivery with a single administration. It
is in Phase 3 development by Titan for the treatment of opioid addiction
and the Company is currently pursuing potential partnerships for the
worldwide development and commercialization of Probuphine.
In July 2008, Titan announced positive results from the first Phase 3
randomized, double-blind, placebo-controlled, multi-center clinical
study (PRO-805) for the treatment of opioid addiction. In the study,
Probuphine reached both key primary and secondary endpoints as agreed
to with the U.S. Food & Drug Administration (FDA). Results of the
study showed that Probuphine was an effective treatment for opioid
addiction over a six-month period following a single administration.
Following the completion of the PRO-805 clinical study, 80% of
eligible patients that completed the trial signed informed consent to
enter the Companys follow-on open-label
retreatment study (PRO-807). To date, the PRO-807 study has enrolled
On October 29, 2008, the Company received an Office Action from the
U.S. Patent and Trademark Office (PTO) rejecting the claims in the
Companys method-of-use patent application
for the use of Probuphine in the treatment of opioid addiction and
chronic pain. Titan is preparing a response to be submitted to the PTO.
The Company will report the detailed clinical results of the first
Phase 3 Probuphine study at the Annual Meeting of the International
Society of Addiction Medicine (ISAM) on November 19th.
The conference will take place November 16-20, 2008 in Cape Town,
Conference Call Tomorrow
Titan management will host a live call and webcast tomorrow, Tuesday,
November 11, 2008, at 10:00 a.m. EST to discuss the Companys
third quarter 2008 results and current corporate developments. The live
webcast may be accessed by visiting the investor relations section of
the Companys website at www.titanpharm.com.
The call can also be accessed by dialing 1-866-356-4281 (domestic) or
1-617-597-5395 (international) five minutes prior to the start time and
providing the passcode 11261265. A replay of the call will be available
on the Titan website approximately two hours after completion of the
call and will be archived for two weeks.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is focused primarily on the
late-stage development and commercialization of innovative treatments
for central nervous system disorders. Probuphine, which utilizes Titans
proprietary ProNeura long term drug delivery technology, has
demonstrated positive results in Phase III testing for treatment of
opiate addiction, and the Company is planning to develop this validated
sustained drug delivery technology for other potential treatment
applications in which conventional treatment is limited by variability
in blood drug levels and poor patient compliance. Products based on
ProNeura technology can provide controlled drug release on an outpatient
basis over extended periods of up to 6-12 months. Titan also has two
other products, gallium maltolate and DITPA, in earlier stages of
development. For more information, please visit the Companys website at www.titanpharm.com.
The press release may contain "forward-looking
statements" within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Such statements include, but are not limited to, any
statements relating to the Companys
development program and any other statements that are not historical
facts. Such statements involve risks and uncertainties, including, but
not limited to, those risks and uncertainties relating to difficulties
or delays in development, testing, regulatory approval, production and
marketing of the Companys drug candidates,
adverse side effects or inadequate therapeutic efficacy of the Companys
drug candidates that could slow or prevent product development or
commercialization, the uncertainty of patent protection for the Companys
intellectual property or trade secrets, and the Companys
ability to obtain additional financing or a corporate partner to
continue its product development efforts. Such statements are based on
managements current expectations, but actual
results may differ materially due to various factors, including those
risks and uncertainties mentioned or referred to in this press release.
TITAN PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(in thousands, except per share
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
License revenue $ - $ - $ 73 $ 12
Research and development 4,190 3,093 12,810 7,782
General and administrative 1,828 1,467 7,086 4,296
Total operating expenses 6,018 4,560 19,896 12,078
Loss from operations (6,018 ) (4,560 ) (19,823 ) (12,066 )
Interest income, net of other expense 118 236 516 635
Net loss $ (5,900 ) $ (4,324 ) $ (19,307 ) $ (11,431 )
Basic and diluted net loss per share $ (0.10 ) $ (0.10 ) $ (0.33 ) $ (0.27 )
Weighted average shares used in computing basic and diluted net loss
58,288 44,478 58,284 41,901
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
(unaudited) (Note A)
Cash, cash equivalents, and marketable securities $ 12,204 $ 30,016
Prepaid expenses, receivables and other current assets 966 440
Total current assets 13,170 30,456
Furniture and equipment, net 326 388
$ 13,496 $ 30,844
Liabilities and Stockholders Equity
Current liabilities $ 4,438 $ 4,256
Other liabilities 117 -
Minority interest - Series B preferred stock of Ingenex, Inc. 1,241 1,241
Stockholders Equity 7,700 25,347
$ 13,496 $ 30,844
Note A: The December 31, 2007 condensed consolidated balance sheet
data was derived from the audited financial statements included in
the Companys 2007 Annual Report on Form
10-K, but does not include all disclosures required by accounting
principles generally accepted in the United States of America.
SOURCE: Titan Pharmaceuticals, Inc.
Titan Pharmaceuticals, Inc.
Robert Farrell, Executive Vice President & CFO
Jennifer Beugelmans, 646-596-7473