SOUTH SAN FRANCISCO, Calif., March 14 /PRNewswire-FirstCall/ -- Titan Pharmaceuticals, Inc. today announced financial results for the fourth quarter and fiscal year ended December 31, 2005.
Net loss for fourth quarter 2005 was approximately $4.0 million, or $0.12 per share, compared to $7.8 million, or $0.24 per share, for fourth quarter 2004. The Company's net loss for fiscal year 2005 was approximately $22.5 million, or $0.69 per share, compared to $26.0 million, or $0.83 per share, for fiscal year 2004. The lower net losses for the fourth quarter and for fiscal year 2005 are related to the conclusion of certain clinical studies in 2004 and expense reduction strategies initiated in 2005. In 2004, we recorded a one-time acquired research and development expense of $759,000 in connection with the acquisition of the remaining minority shares of Titan's wholly owned subsidiary, ProNeura, Inc.
Revenues for fourth quarter 2005 were approximately $61,000, compared to $30,000 for fourth quarter 2004. For fiscal year 2005, revenues were approximately $89,000, compared to $31,000 for fiscal year 2004. Revenues during 2005 and 2004 were derived from fees received under various licensing agreements. Interest income, net of other expenses, for the fourth quarter 2005 was approximately $171,000 compared to $161,000 for the fourth quarter 2004. For fiscal year 2005, interest income, net of other expenses, was approximately $589,000 compared to $376,000 for fiscal year 2004, with the difference primarily related to higher interest rates in 2005 and higher one- time expenses in 2004.
At December 31, 2005, the Company had approximately $17.4 million in cash and marketable securities.
In September 2005, the Company established an equity financing agreement with Cornell Capital Partners LLP, from which there is currently available to the Company up to approximately $31 million, subject to shareholder approval requirements for certain amounts
"Titan made progress in several development programs during 2005, while reducing expenses and arranging for further financing to support our development programs," stated Dr. Louis R. Bucalo, Chairman, President and CEO.
Important product development milestones achieved by Titan in 2005 include the following:
We have scaled up Probuphine(R) manufacturing and produced our Probuphine product in preparation for planned Phase III clinical development activities. We are currently in the process of finalizing the Phase III development program with guidance from the U.S. Food and Drug Administration (FDA) and other regulatory agencies.
Phase III clinical testing of iloperidone was initiated by Vanda Pharmaceuticals, Inc. in November 2005. Vanda acquired iloperidone from Titan's sublicensee, Novartis Pharma AG in 2004. Vanda is funding the iloperidone Phase III development program, and all of our rights and economic interests in iloperidone, including royalties on sales of iloperidone, remain essentially unchanged under the Vanda and Novartis agreement.
Enrollment is continuing in the double-blind, placebo controlled Phase IIb clinical study of Spheramine(R) in the treatment of Parkinson's disease. In accordance with our agreement with Schering AG, Germany, our corporate partner for the development of Spheramine, the Investigational New Drug application (IND) held by Titan with the FDA was transferred to Schering, and Schering has assumed additional responsibilities for the management of the Spheramine development program. Accordingly, Titan has reduced staff at its New Jersey facility, and Dr. Richard Allen, Executive Vice President, Cell Therapy, has left the Company to pursue other interests, and will remain a consultant to the Company. The Spheramine program continues to be jointly managed by Titan and Schering through a previously established Joint Development Committee.
Enrollment has advanced in our Phase II, randomized, double blind clinical study of DITPA in congestive heart failure (CHF) patients with low serum T3 levels, and also in a second randomized, double blind study in CHF patients, funded by the Department of Veterans Affairs Cooperative Studies Program.
We are also developing DITPA as a potential treatment for elevated cholesterol levels and recently initiated a Phase II, randomized, double- blind, placebo-controlled study to evaluate DITPA in individuals receiving standard lipid-lowering therapy, whose LDL cholesterol levels are above National Cholesterol Education Program (NCEP) guidelines.
We have developed a new formulation of gallium maltolate, and subsequent clinical trials are planned to use this new formulation of gallium maltolate. Additional data were also generated this past year in preclinical testing, demonstrating the potential of gallium maltolate to improve the treatment of certain bacterial infections.
In addition to the above activities, we have advanced preclinical testing of additional products in development utilizing additional drugs and applications of our ProNeura drug delivery technology.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders, cardiovascular disease, 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 http://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 amount) Three Months Ended Twelve Months Ended December 31, December 31, 2005 2004 2005 2004 (Unaudited) (Unaudited) License and contract revenue $61 $30 $89 $31 Total revenue 61 30 89 31 Operating expenses: Research and development 3,047 5,846 17,770 20,415 Acquired research and development - 759 - 759 General and administrative 1,231 1,384 5,370 5,237 Total operating expenses 4,278 7,989 23,140 26,411 Loss from operations (4,217) (7,959) (23,051) (26,380) Interest income, net of other expense 171 161 589 376 Net loss $(4,046) $(7,798) $(22,462) $(26,004) Basic and diluted net loss per share $(0.12) $(0.24) $(0.69) $(0.83) Shares used in computing basic and diluted net loss per share 33,450 32,271 32,635 31,381 CONDENSED CONSOLIDATED BALANCE SHEETS December 31, December 31, 2005 2004 (Note A) (Note A) Assets Cash, cash equivalents, and marketable securities $17,369 $36,322 Prepaid expenses, receivables, and other current assets 1,216 1,110 Total current assets 18,585 37,432 Furniture and equipment, net 788 1,044 Investment in other companies 364 150 $19,737 $38,626 Liabilities and Stockholders' Equity Current liabilities $3,136 $3,672 Minority interest - Series B preferred stock of Ingenex, Inc. 1,241 1,241 Stockholders' Equity 15,360 33,713 $19,737 $38,626 Note A: The balance sheet has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles in the United States for complete financial statement presentation.
Titan Pharmaceuticals, Inc.CONTACT: Robert Farrell, Executive Vice President & CFO, +1-650244-4990;Media/Investors, Jonathan Fassberg, The Trout Group, +1-212-477-9007
Web site: http://www.titanpharm.com/
