EXHIBIT 99.1
[TITAN PHARMACEUTICALS, INC. LOGO]
Company: Media: Investors:
Alison R. Lehanski Mark Padgett Robert Ferris
Director, Corporate Communications GCI Group GCI Group
650-244-4993 212-537-8082 212-537-8025
FOR IMMEDIATE RELEASE
TITAN REPORTS FOURTH QUARTER AND YEAR END 2002 RESULTS
SOUTH SAN FRANCISCO, CA - MARCH 27, 2003 - Titan Pharmaceuticals, Inc. (ASE:
TTP) today announced financial results for the fourth quarter and fiscal year
ended December 31, 2002.
Revenues for fourth quarter 2002 were approximately $236,000, compared to
$589,000 for fourth quarter 2001. For fiscal year 2002, revenues were
approximately $2.9 million, compared to $4.6 million for fiscal year 2001. The
difference in revenue is primarily due to additional licensing fees for
iloperidone and SBIR grant revenue for Spheramine(R) received in 2001. Net loss
for fourth quarter 2002 was approximately $8.9 million, or $0.32 per share,
compared to $6.3 million, or $0.23 per share, for fourth quarter 2001. The
Company's net loss for fiscal year 2002 was approximately $28.2 million, or
$1.02 per share, compared to $17.5 million, or $0.63 per share, for fiscal year
2001.
Interest income, net of other expenses for fourth quarter 2002 was approximately
$233,000 compared to $1.6 million for fourth quarter 2001. For fiscal year 2002,
interest income, net of other expenses was approximately $3.8 million compared
to $6.7 million for fiscal year 2001, with the difference related to lower
interest rates and lower average cash balance. At December 31, 2002, the Company
had approximately $73.5 million in cash and marketable securities.
"Our operating financial results in the fourth quarter and in fiscal year 2002
reflect the development expenditures for completing a Phase III clinical trial,
as well as advancing numerous other clinical development programs," stated Dr.
Louis R. Bucalo, Chairman, President and CEO. "In 2003, our internal resources
are focused on four core product development programs, Spheramine, Pivanex(R),
gallium maltolate and Probuphine(TM). This focus is directed at accelerating
progress in key areas, and is also targeted to achieve an approximately 25
percent reduction in annual R&D expenditures, allowing us to maximize our cash
position."
"We look forward to directly advancing these core programs in new clinical
studies, while continuing to enhance the potential of our other clinical stage
programs with corporate, government and academic collaborations," stated Dr.
Bucalo.
CLINICAL STAGE DEVELOPMENT PROGRAMS
Titan has eight clinical stage products in various stages of development, and is
presently focused on advancing the following four product development programs.
SPHERAMINE
Significant progress was made in 2002 in advancing the development program for
Spheramine, Titan's novel cell therapy product for Parkinson's disease. Positive
one-year results from the Spheramine pilot study were presented at the American
Academy of Neurology annual meeting in April 2002 and at the International
Congress of Parkinson's Disease and Movement Disorders in November 2002. New
results from the pilot study continue to show promise two years post treatment.
These two-year data will be presented at the American Academy of Neurology
annual meeting next week. A randomized, controlled, blinded Phase IIb clinical
study of Spheramine in advanced Parkinson's disease was also initiated in
December 2002. Titan's corporate partner for the development of Spheramine,
Schering AG, Germany, is funding this study.
PIVANEX
Titan also made progress in 2002 in advancing Pivanex, a histone deacetylase
inhibitor with broad-spectrum anti-cancer activity. Pivanex has shown clinical
benefit as a single agent in a Phase II clinical study in non-small cell lung
cancer (NSCLC), the results of which were presented at the American Society of
Clinical Oncology annual meeting in May 2002. In addition, data were presented
at the American Association of Cancer Research (AACR) annual meeting in April
2002, demonstrating that Pivanex can be combined with current chemotherapeutic
agents, including docetaxel, to increase anti-cancer activity. Pivanex is
planned to enter a randomized Phase IIb clinical study in NSCLC in combination
with docetaxel in mid-2003. This study will initiate following the successful
completion of a dose escalation study being conducted to assess the safety of
Pivanex with docetaxel. Additional preclinical study results demonstrating that
Pivanex is synergistic with docetaxel in NSCLC will be presented at AACR in
April 2003.
GALLIUM MALTOLATE
In 2002, Titan continued to advance a Phase I/II clinical study of gallium
maltolate, a novel oral agent designed to inhibit cancer and bone disease
cellular processes. Titan is currently completing the Phase I portion of this
study and plans to initiate two Phase II clinical studies in the second half of
2003. One of these Phase II studies will examine the anti-cancer effects of
gallium maltolate in several cancers, and the second study will evaluate
treatment with gallium maltolate in metastatic bone disease. Preliminary results
from the Phase I portion of the study were presented at the European
Organization for the Research and Treatment of Cancer-National Cancer
Institute-American Association for Cancer Research (EORTC-NCI-AACR) meeting in
November 2002.
PROBUPHINE
Titan is initiating a Phase I clinical study of Probuphine, a novel long-term
treatment for opiate addiction, which utilizes the Company's proprietary
ProNeura drug delivery system. Patient enrollment is expected to begin in
mid-2003. Probuphine has been shown in preclinical studies to deliver targeted
therapeutic levels of buprenorphine, an approved treatment for opiate addiction,
for eight months with no adverse effects. Results from these studies were
presented at the International Conference on Pain and Chemical Dependency in
June 2002.
Additional Programs
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Titan is also currently engaged in clinical development of several additional
products which are primarily advanced through collaborations with corporate and
government partners. These programs are outlined below.
ILOPERIDONE
In 2002, Novartis Pharma AG, Titan's corporate partner for iloperidone,
completed a study evaluating the EKG profile of patients receiving iloperidone,
which showed that the change in QTc interval for iloperidone was roughly
comparable to that of ziprasidone, one of the approved agents in the study. The
FDA concurs with this assessment and has indicated that one additional
successful pivotal Phase III study is necessary to complete the efficacy data
package prior to NDA submission. The QTc profile may potentially limit the
opportunity of iloperidone as first line therapy for schizophrenia. Novartis is
currently evaluating the next steps for the iloperidone program, which may
include sublicensing the compound to another company, continuing iloperidone
development, or returning the rights to Titan.
IMMUNOTHERAPEUTICS
In December 2002, the results of a Phase III study of Titan's monoclonal
antibody CeaVac(R) in Dukes' D colorectal cancer were announced, demonstrating a
trend toward overall survival improvement of approximately 2 to 3 months in
patients receiving greater than 5 doses of CeaVac versus placebo (modified
intent-to-treat population) but failed to demonstrate a statistically
significant improvement in the primary endpoint of survival in the overall
efficacy evaluable population or intent-to-treat population. Additional product
development of CeaVac through potential external government collaborations is
currently under review.
Several government-sponsored national clinical cooperative groups are already
conducting clinical studies with CeaVac, and Titan's other monoclonal
antibodies, TriAb(R) and TriGem(TM). Studies in progress include two Phase II
studies of combination therapy with CeaVac and TriAb being funded by the
National Cancer Institute - one being conducted by the Radiation Therapy
Oncology Group for the treatment of non-small cell lung cancer and the other
being conducted by the Cancer and Leukemia Group B for the treatment of
colorectal cancer. In addition, the Southwest Oncology Group is initiating a
Phase II study of TriAb and TriGem in small cell lung cancer.
ABOUT TITAN PHARMACEUTICALS
Titan Pharmaceuticals, Inc. (ASE: TTP) is a biopharmaceutical company focused on
the development and commercialization of novel treatments for central nervous
system disorders, cancer and other serious and life-threatening diseases.
Titan's numerous products in development utilize novel technologies that have
the potential to significantly improve the treatment of these diseases. Titan
also establishes partnerships with multinational pharmaceutical companies and
government institutions for the development of its products.
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 DECEMBER 31, TWELVE MONTHS ENDED DECEMBER 31,
--------------------------------- ---------------------------------
2002 2001 2002 2001
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(UNAUDITED)
Contract and grant revenue $ 236 $ 489 $ 2,892 $ 1,972
License revenue -- 100 -- 2,600
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Total revenue 236 589 2,892 4,572
Operating expenses:
Research and development 8,212 7,243 29,819 23,339
General and administrative 1,161 1,276 5,076 5,383
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Total operating expenses 9,373 8,519 34,895 28,722
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Loss from operations (9,137) (7,930) (32,003) (24,150)
Interest income, net of other expenses 233 1,606 3,821 6,686
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Net loss $ (8,904) $ (6,324) $ (28,182) $ (17,464)
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Basic and diluted net loss per share $ (0.32) $ (0.23) $ (1.02) $ (0.63)
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Shares used in computing basic and
diluted net loss per share 27,642 27,649 27,642 27,595
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CONDENSED CONSOLIDATED BALANCE SHEETS
DECEMBER 31, DECEMBER 31,
2002 2001
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(Note A)
Assets
Cash, cash equivalents, and marketable securities $ 73,450 $ 105,051
Prepaid expenses, receivables, and other current assets 1,197 906
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Total current assets 74,647 105,957
Furniture and equipment, net 979 575
Investment in other companies 300 600
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$ 75,926 $ 107,132
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Liabilities and Stockholders' Equity
Current liabilities $ 3,945 $ 5,764
Minority interest - Series B preferred stock of Ingenex, Inc. 1,241 1,241
Stockholders' Equity 70,740 100,127
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$ 75,926 $ 107,132
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Note A: The balance sheets at December 31, 2002 and 2001 have been derived
from the audited financial statements at those dates but do not include all
of the information and footnotes required by generally accepted accounting
principles in the United States for complete financial statements
presentation.