Conference Call To Update Financial Strength and Product
Development
BERKELEY HEIGHTS, NJ - October 30, 2003
-Genta Incorporated (Nasdaq: GNTA) announced financial results for
the third quarter of 2003, a period that has been marked by
significant milestones in the Company's history. These achievements
included:
- Food and Drug Administration (FDA) approval and launch of
Ganite
TM
(gallium nitrate
injection), Genta's first commercial product
- Deployment of Genta's field-based oncology specialists to
promote Ganite
- Announcement of positive results from the Company's
Phase 3 trial with Genasense
TM
(oblimersen sodium) for the treatment of patients with advanced
malignant melanoma
- Initiation of a "rolling" New Drug Application (NDA)
submission to the FDA for Genasense in advanced malignant
melanoma
- Acquisition of Salus Therapeutics, a private company
specializing in DNA and RNA-based
therapeutics
"Any one of these milestones would be noteworthy for the
quarter, but accomplishing all five is testament to the exemplary
skills and experience of our organization," stated Dr. Raymond P.
Warrell, Jr., Genta's Chairman and Chief Executive Officer. "We
look forward to the completion of the Genasense NDA filing for
melanoma later this quarter."
Senior executives from Genta will discuss results of the quarter
on a conference call that will be webcast beginning at 8:30 a.m.
EST on October 30, 2003. The webcast can be accessed at:
http://www.genta.com/genta/InvestorRelation/events.html
Financial Strength and 3rd Quarter Results
Genta continues in a strong cash position with cash, cash
equivalents, and short-term investments totaling $87.4 million as
of September 30, 2003, compared to $113.7 million at December 31,
2002 and $126.8 million at September 30, 2002.
In the 3rd quarter of 2003, revenues totaled $1.3 million,
unchanged from the corresponding 2002 period. The revenues are
primarily comprised of amortization of payments made by Aventis
pursuant to the collaboration agreement for Genasense that was
signed during the 2nd quarter of 2002. Total 3rd quarter gross
operating expenses of $30.4 million, before the net Aventis expense
reimbursement, increased by approximately $6.8 million relative to
the comparable quarter in 2002. The 2003 increase in expenses was
associated with the Genasense Phase 3 clinical trials and NDA
preparation activities, and costs associated with the start-up of
the Genta sales force and Ganite launch activities.
Pursuant to cost-sharing provisions of the Aventis collaboration to
develop Genasense, Genta recorded $11.8 million of net expense
reimbursement in the 3rd quarter, which is recorded as a receivable
at September 30, 2003. In the 3rd quarter, operating expenses, net
of Aventis reimbursement, increased from $16.9 million in 2002 to
$18.6 million in 2003.
As a result of the factors described above, the Company reported
a net loss of $17.2 million, or $(0.23) per share, for the quarter
ended September 30, 2003, compared to a net loss of $15.1 million,
or $(0.21) per share, for the 3rd quarter of 2002.
Earlier this year Genta signed an amendment to its collaboration
agreement with Aventis, which established a $40 million secured
line of credit related to commercialization of Genasense. In the
first two quarters of 2003, Genta drew down $25 million of the line
of credit. There were no further draw downs in the 3rd quarter. A
potential of up to $15 million remains available to the Company
under the line of credit.
Business and Product Development Events in the Third
Quarter 2003
Genasense
TM
(oblimersen sodium)
- Genasense is being broadly tested in more than 20 randomized
and non-randomized trials for its ability to increase the
effectiveness of current types of anticancer therapy for a number
of diseases, including acute and chronic leukemias, multiple
myeloma, non-Hodgkin's lymphoma, and cancers of the breast,
colon, kidney, lung, liver, pancreas, and prostate.
- In September 2003, Genta and its partner Aventis released
positive results from their first randomized Phase 3 trial of
Genasense. In that study, 771 patients with advanced malignant
melanoma were randomly assigned to receive chemotherapy alone (a
standard drug known as
dacarbazine) or chemotherapy plus Genasense. Findings from the
study can be accessed at:
http://www.genta.com/Genta/InvestorRelation/2003/press_20030910_1.html
- The formal scientific presentation of results from the
melanoma clinical trial will take place on November 14, 2003 at
the 6th Perspectives in Melanoma Conference in Miami, FL.
- Based on these data, Genta and Aventis have begun submission
of a NDA to the FDA for the treatment of patients with advanced
malignant melanoma who received Genasense plus dacarbazine. The
application is being submitted on a "rolling" basis, based on the
drug's "Fast Track" designation. Completion of the submission is
expected within the 4th quarter of 2003.
- The Company has completed enrollment in two additional
randomized trials (multiple myeloma and chronic lymphocytic
leukemia). Assuming positive data from either of these trials,
the Company intends to submit additional, supplemental New Drug
Applications in a sequential manner after a decision has been
rendered on its application for melanoma.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA and DNA-based medicines) and small
molecules. Genasense
TM
(oblimersen sodium), the Company's lead compound from its
oligonucleotide program, is being developed with Aventis and is
currently undergoing late-stage, Phase 3 clinical testing. The
leading drug in Genta's small molecule program is Ganite
TM
(gallium nitrate injection), which the Company is exclusively
marketing in the U.S. for treatment of patients with cancerrelated
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
This press release and the conference call to follow contain
forward-looking statements with respect to business conducted by
Genta Incorporated. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to
events and depend on circumstances that will occur in the future.
There are a number of factors that could cause actual results and
developments to differ materially. For a discussion of those risks
and uncertainties, please see the Company's Annual
Report/Form 10-K
for 2002
.
SOURCE: Genta Incorporated
