Titan Pharmaceuticals, Inc.
EXHIBIT 99.1
Company: Media: Investors:
Robert Farrell Mark Padgett Dawn Lauer
Executive Vice President & CFO GCI Group GCI Group
650-244-4990 212-537-8082 212-537-8088
TITAN REPORTS SECOND QUARTER 2003 RESULTS
SOUTH SAN FRANCISCO, CA - AUGUST 11, 2003 - Titan Pharmaceuticals, Inc. (ASE:
TTP) today announced financial results for the second quarter ended June 30,
2003.
Operating expenses for the second quarter of 2003 were approximately $7.0
million compared with operating expenses of $8.3 million for the second quarter
of 2002. For the first six months of 2003, operating expenses were approximately
$14.0 million, a reduction of approximately $3.0 million compared with operating
expenses of $17.0 million for the first six months of 2002.
Net loss for second quarter 2003 was approximately $6.7 million, or $0.24 per
share, compared to a net loss of $7.0 million, or $0.25 per share, for the
second quarter in 2002. For the first 6 months of 2003, net loss was $13.2
million or $0.48 per share, compared to a net loss of $12.0 million or $0.43 per
share, for the same six-month period in 2002.
Revenues for the first six months of 2003 were approximately $28,000, compared
to $2.5 million for the same six-month period in 2002. The difference in revenue
is primarily the result of a milestone payment Titan received from Schering AG
for Spheramine(R) in the first quarter of 2002.
Interest income, net of other expenses, for second quarter 2003 was
approximately $309,000 compared to $1.1 million for second quarter 2002,
primarily reflecting a decline in interest rates, and a lower balance of cash
and marketable securities. For the first six months of 2003, interest income,
net of other expenses, was $776,000 compared to $2.5 million for the same
six-month period in 2002. At June 30, 2003, the Company had approximately $59.6
million in cash, cash equivalents and marketable securities.
"Our operating results indicate that we continue to achieve significant
quarter-over-quarter reductions in operating expenditures," stated Dr. Louis R.
Bucalo, Chairman, President and CEO. "These reductions were made while
significantly advancing our four core product programs in clinical testing. We
look forward to further advancing these core programs during the second half of
the year."
Following is an update on the status and progress of Titan's core development
programs:
SPHERAMINE
Enrollment in a randomized, controlled, blinded, multi-center Phase IIb clinical
study of Spheramine in advanced Parkinson's disease is proceeding on schedule,
and the first cohort of twelve patients has been enrolled. Schering AG, Germany,
Titan's corporate partner for the development of Spheramine, is funding and
co-managing the study. In the second quarter, results from a pilot clinical
study of Spheramine, demonstrating an average 41 percent improvement in
patients' motor function 2 years post treatment, were presented at the American
Academy of Neurology.
PIVANEX
A randomized, controlled, multi-center Phase IIb clinical study of Pivanex in
combination with docetaxel in the treatment of non-small cell lung cancer
(NSCLC) was initiated in June. Pivanex is being administered at the same dose
level at which it demonstrated encouraging tumor response and survival data in a
previous Phase II clinical study, in which Pivanex was administered as a single
agent. In related development activities, additional laboratory study results
demonstrating that Pivanex is synergistic with docetaxel against NSCLC were
presented at the meeting of the American Association for Cancer Research in
July. Pivanex is a histone deacetylase inhibitor with potential activity in a
wide range of cancers.
GALLIUM MALTOLATE
Titan is completing the Phase I portion of a Phase I/II clinical study of
gallium maltolate in several cancers. There have been no significant adverse
events, and the maximum tolerated dose level has not yet been reached.
Accordingly, additional patient cohorts are being enrolled at higher doses.
Preclinical testing of gallium maltolate in other disease settings is also
ongoing. Gallium maltolate is a novel oral agent for the treatment of cancer and
bone disease.
PROBUPHINE
Titan is advancing a pilot clinical study of Probuphine, a novel long-term
treatment for opiate addiction that utilizes Titan's proprietary ProNeura drug
delivery system. The first cohort of six patients has been enrolled at the first
dose level being studied, with no adverse effects seen to date. Probuphine has
been shown in preclinical studies to deliver targeted therapeutic levels of
buprenorphine, an approved agent for the treatment for opiate addiction, for
eight months with no adverse effects. Results from these preclinical studies
were presented at the Meeting of the Controlled Release Society held in Glasgow,
Scotland in July 2003.
Conference Call Information:
Titan will hold a conference call today at 2:00 PM Eastern Daylight Time to
discuss the Company's financial results for the second quarter and first six
months of the year. The conference call will be broadcast live over the Internet
at www.titanpharm.com. Webcast listeners should log on at least 10 minutes prior
to the scheduled start time of the call to register and download or install any
required audio software.
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 (CNS) 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 JUNE 30, SIX MONTHS ENDED JUNE 30,
--------------------------- ---------------------------
2003 2002 2003 2002
------------ ------------ ------------ ------------
(UNAUDITED)
License and contract revenue $ 2 $ 151 $ 28 $ 2,498
------------ ------------ ------------ ------------
Total revenue 2 151 28 2,498
Operating expenses:
Research and development 5,735 6,919 11,377 14,405
General and administrative 1,257 1,391 2,638 2,601
------------ ------------ ------------ ------------
Total operating expenses 6,992 8,310 14,015 17,006
------------ ------------ ------------ ------------
Loss from operations (6,990) (8,159) (13,987) (14,508)
Interest income, net of other expense 309 1,127 776 2,526
------------ ------------ ------------ ------------
Net loss $ (6,681) $ (7,032) $ (13,211) $ (11,982)
============ ============ ============ ============
Basic and diluted net loss per share $ (0.24) $ (0.25) $ (0.48) $ (0.43)
============ ============ ============ ============
Shares used in computing basic and
diluted net loss per share 27,643 27,642 27,643 27,642
============ ============ ============ ============
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
2003 2002
------------ ------------
(unaudited) (Note A)
Assets
Cash, cash equivalents, and marketable securities $ 59,641 $ 73,450
Prepaid expenses, receivables, and other current assets 1,859 1,197
------------ ------------
Total current assets 61,500 74,647
Furniture and equipment, net 930 979
Investment in other companies 300 300
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$ 62,730 $ 75,926
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Liabilities and Stockholders' Equity
Current liabilities $ 3,991 $ 3,945
Minority interest - Series B preferred stock of Ingenex, Inc. 1,241 1,241
Stockholders' Equity 57,498 70,740
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$ 62,730 $ 75,926
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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.