Conference Call To Highlight Financial Strength,
Pipeline Progress and Developments
BERKELEY HEIGHTS, NJ November 7, 2002
-Genta Incorporated (Nasdaq: GNTA) today announced financial
results for the period ended September 30, 2002, including a strong
cash position of $126.9 million compared to $34.2 million for the
period ended 2001. Going forward, the Company's financial strength
will be further enhanced by reimbursements for costs incurred for
the development of GenasenseTM, Genta's lead anticancer drug.
Financial Strength and Aventis Reimbursement
Cash, cash equivalents, and short-term investments
totaled $126.9 million as of September 30, 2002, compared to $143.5
million at June 30, 2002. During the 2nd quarter, the Company
signed a collaborative agreement with Aventis Pharma related to
Genasense
TM
. Pursuant to cost-sharing provisions of the collaboration, the
Company has recorded a $6.7 million reimbursable expense in the 3rd
quarter as a receivable on the balance sheet. Of an additional $3.0
million recorded as prepaid expenses, $2.6 million represents
deposits for the purchase of Genasense drug substance, a
substantial portion of which is also expected to be reimbursed.
In the 3rd quarter, total operating expenses, net
of $6.7 million in reimbursements, increased by approximately $5.5
million relative to the comparable quarter in 2001. The increase in
expenses primarily reflects financial support of ongoing clinical
trials, including third party expenses, and costs of drug supply.
Year-to-date, total operating expenses increased by $17.0 million
compared with the comparable nine-month period in 2001.
The Company reported a net loss of $15.1 million,
or $(0.21) per share, for the quarter ended September 30, 2002,
compared to a net loss of $10.4 million, or $(0.19) per share, for
the comparable period in 2001. For the nine months ended September
30, 2002, the Company"s net loss was $44.8 million, or $(0.64) per
share, compared to a net loss of $28.8 million, or $(0.54) per
share, for the comparable period in 2001. Additional highlights of
the quarter include:
GenasenseTM Clinical Trials
Genta currently has four randomized clinical
studies evaluating Genasense in combination with chemotherapy
versus chemotherapy alone in patients with malignant melanoma,
multiple myeloma, chronic lymphocytic leukemia (CLL), and non-small
cell lung cancer. Assuming a positive clinical result is observed
is at least one of the first 3 trials, the Company believes it will
be able to submit a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) in the summer of 2003.
Earlier this week, Genta announced the initiation
of two additional non-randomized studies of Genasense in
combination with chemotherapy. These ongoing clinical programs
include combinations with more than 18 different anti-cancer
agents, such as Rituxan® (rituximab; Genentech/IDEC), Gleevec®
(imatinib mesylate; Novartis), Eloxatin. (oxaliplatin;
Sanofi-Synthelabo, Inc.), Thalomid.(thalidomide; Celgene),
Taxotere.(docetaxel; Aventis), Paraplatin. (carboplatin;
Bristol-Myers Squibb), and daunorubicin.
GaniteTM (gallium nitrate for injection)
Earlier this year, the Company filed an
Investigational New Drug (IND) exemption with the Oncology Division
at FDA. The Company subsequently initiated a Phase 2b trial of
Ganite in patients with relapsed non-Hodgkin's lymphoma (NHL).
During the 3rd quarter, the Company filed an Orphan Drug
Application for the use of Ganite in this indication. In addition
to certain tax benefits, designation as an Orphan Drug allows for 7
years of marketing exclusivity after regulatory approval has been
granted for the indication.
About Genasense
Genasense works by inhibiting the production of
Bcl-2, a protein made by cancer cells that is thought to block
chemotherapy-induced cell death. By reducing the amount of Bcl-2 in
cancer cells, Genasense may enhance the effectiveness of current
anticancer treatments. Genasense is currently in multiple
late-stage randomized clinical trials including malignant melanoma,
multiple myeloma, chronic lymphocytic leukemia (CLL) and non-small
cell lung cancer.
About Genta
Genta Incorporated is a biopharmaceutical company
with a diversified product portfolio that is focused on anticancer
therapy. The Company's research platform is anchored by
oligonucleotide chemistry, particularly applications of antisense
and decoy aptamer technology. GenasenseTM, the Company"s lead
compound, is being developed in collaboration with Aventis and is
currently undergoing late-stage, Phase 3 clinical testing in
several clinical indications. Genta's pipeline also comprises a
portfolio of small molecules, including gallium-containing
compounds and Androgenics compounds for prostate cancer. For more
information about Genta, please visit our website at:
http://www.genta.com/
.
The statements contained in this press release and the
related conference call that will take place today that are not
historical are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended,
including statements regarding the expectations, beliefs,
intentions or strategies regarding the future. Without limiting
the foregoing, the words ``anticipates,"" ``believes,""
``expects,"" ``intends,"" ``may"" and ``plans"" and similar
expressions are intended to identify forward-looking statements.
The Company intends that all forward-looking statements be
subject to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
reflect the Company"s views as of the date they are made with
respect to future events, but are subject to many risks and
uncertainties, which could cause the actual results of the
Company to differ materially from any future results expressed or
implied by such forward-looking statements. For example, the
results obtained in pre-clinical or clinical studies may not be
indicative of results that will be obtained in future clinical
trials, and delays in the initiation or completion of clinical
trials may occur as a result of many factors. Further examples of
such risks and uncertainties also include, but are not limited
to: the obtaining of sufficient financing to maintain the
Company"s planned operations; timely development, receipt of
necessary regulatory approvals, and acceptance of new products;
the successful application of the Company"s technology to produce
new products; the obtaining of proprietary protection for any
such technology and products; the impact of competitive products
and pricing and reimbursement policies; and changing market
conditions. The Company does not undertake to update
forward-looking statements. Although the Company believes that
the forward-looking statements contained herein are reasonable,
it can give no assurances that the Company"s expectations are
correct. All forward looking statements are expressly qualified
in their entirety by this cautionary statement and other factors
detailed in the Company"s reports filed with the Securities and
Exchange Commission.
SOURCE: Genta Incorporated
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