SAN FRANCISCO -- Titan Pharmaceuticals, Inc. (AMEX: TTP) today announced financial results for the second quarter ended June 30, 2006.
Net loss for the second quarter of 2006 was approximately $3.4 million, or $0.09 per share, compared to a net loss of approximately $5.7 million, or $0.18
Research and development expenses were approximately $2.4 million, compared to $4.5 million for the same period last year. General and administrative expenses for the second quarter 2006 were approximately $1.2 million, compared to $1.3 million for the same period last year.
At June 30, 2006, the Company had approximately $20.3 million in cash and marketable securities.
"Financial results for the second quarter were in line with expectations, and reflect the Company's efforts to manage operating costs, while preparing for launch of our Probuphine Phase III program." stated Dr. Louis R. Bucalo, Chairman, President and CEO.
Titan's Product Development Programs in Clinical Testing
Iloperidone
Iloperidone, is being evaluated in a randomized, double-blind, placebo-controlled Phase III clinical study in schizophrenia. The study is being conducted by Vanda Pharmaceuticals, Inc., and is designed to confirm the product's efficacy. Vanda has recently stated that the study is ahead of schedule, and that it expects to report top-line results in the first quarter of 2007. If the study is successful, Vanda plans to file a New Drug Application (NDA) with the FDA for iloperidone by the end of 2007. Vanda acquired iloperidone from Titan's sublicensee, Novartis, and Vanda is funding the ongoing iloperidone Phase III development program.
Probuphine(R)
Probuphine is our novel, proprietary product in development for the treatment of opiate dependence. Over the past several months, we have achieved substantial regulatory and manufacturing progress in preparation for the initiation of a registration directed, multinational Phase III clinical development program for the treatment of opiate addiction. If successful, this Phase III program is intended to lead to potential product approval and commercialization in the U.S. and Europe. The Company plans to initiate Phase III testing for Probuphine later this year.
Spheramine(R)
Spheramine is Titan's novel, cell-based therapeutic for the treatment of advanced Parkinson's disease. Spheramine is being evaluated in an ongoing, double-blind, placebo controlled Phase IIb clinical study that is funded by Schering AG, Germany, our corporate partner for the development of Spheramine. Results from this study are expected to be available in the second half of 2007. The Investigational New Drug application (IND) for Spheramine was transferred to Schering earlier this year, and Spheramine has been granted both Fast Track and Orphan Drug designations by the FDA.
DITPA
Titan has expanded the development of DITPA, our novel, proprietary analogue of thyroid hormone (T3), beyond the potential treatment of congestive heart failure (CHF), into the potential treatment of elevated cholesterol. In addition to the two ongoing, randomized, controlled Phase II clinical studies that are evaluating DITPA in the treatment of CHF, an investigator sponsored study of DITPA as a potential treatment for elevated cholesterol is being conducted at The Johns Hopkins medical institutions in Baltimore.
Gallium maltolate
Gallium maltolate is our novel, oral agent for the potential treatment of chronic bacterial infections, bone disease and cancer. Titan has developed a new formulation of gallium maltolate with potentially improved bioavailability, and plans to use this new formulation in future clinical development of gallium maltolate.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders, cardiovascular disease, chronic bacterial infections, bone disease and other disorders. Titan's products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with government institutions and other leading pharmaceutical development companies. For more information, please visit the Company's 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 Company's 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 Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional financing if necessary. Such statements are based on management's 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
------------------- -------------------
2006 2005 2006 2005
------------------- -------------------
(unaudited) (unaudited)
License revenue $1 $13 $2 $27
Operating expenses:
Research and development 2,378 4,523 6,065 9,722
General and administrative 1,237 1,338 2,370 2,600
--------- --------- --------- ---------
Total operating expenses 3,615 5,861 8,435 12,322
--------- --------- --------- ---------
Loss from operations (3,614) (5,848) (8,433) (12,295)
Interest income, net of
other expense 188 106 302 257
--------- --------- --------- ---------
Net loss $(3,426) $(5,742) $(8,131) $(12,038)
========= ========= ========= =========
Basic and diluted net loss
per share $(0.09) $(0.18) $(0.22) $(0.37)
========= ========= ========= =========
Weighted average shares used
in computing basic and
diluted net loss per share 38,874 32,361 37,407 32,350
========= ========= ========= =========
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, December 31,
2006 2005
------------ ------------
(unaudited) (Note A)
Assets
Cash, cash equivalents, and marketable
securities $20,261 $17,369
Prepaid expenses, receivables and other
current assets 496 1,216
------------ ------------
Total current assets 20,757 18,585
Furniture and equipment, net 574 788
Investment in other companies 150 150
Other assets 214 214
------------ ------------
$21,695 $19,737
============ ============
Liabilities and Stockholders' Equity
Current liabilities $2,999 $3,136
Minority interest - Series B preferred
stock of Ingenex, Inc. 1,241 1,241
Stockholders' Equity 17,455 15,360
------------ ------------
$21,695 $19,737
============ ============
Note A: The balance sheet has been derived from the audited
consolidated financial statements at that date but does not include
all of the information and footnotes required by U.S. generally
accepted accounting principles for complete financial statement
presentation.