Genta Announces 1st Quarter 2003 Financial Results and Highlights Conference Call To Update Financial Strength, Pipeline and Product Development
BERKELEY HEIGHTS, N.J., May 1, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA) today announced financial results for the period
ended March 31, 2003.
Financial Strength, Reimbursement and Line of Credit
Genta continues in a strong cash position with cash, cash equivalents, and
short-term investments totaling $103.3 million as of March 31, 2003, compared to
$113.7 million at December 31, 2002, and $33.5 million at March 31, 2002.
Pursuant to cost-sharing provisions of the Aventis collaboration for the
Company's lead anti-cancer drug, Genasense(TM) (oblimersen sodium), Genta
recorded $9.2 million of expense reimbursement in the first quarter as a
receivable.
During the first quarter, Genta signed an amendment to its collaboration
agreement with Aventis, which established a $40 million line of credit related
to commercialization of Genasense. In the first quarter, the Company drew down
$17.5 million in cash from that instrument.
In the first quarter, operating expenses decreased from $12.9 million in 2002 to
$11.2 in 2003, net of Aventis reimbursement. Total gross operating expenses,
before the $9.2 million of expense reimbursement, increased by approximately
$7.5 million relative to the comparable quarter in 2002. The increase in
expenses primarily reflects the costs of the Genasense Phase 3 clinical trials,
NDA preparation activities, and costs associated with Ganite(TM) pre-launch
activities. This increase was offset by reduced drug supply costs due to the
large amount of drug substance purchased in the fourth quarter of 2002.
For the quarter ended March 31, 2003, the Company reported a net loss of $9.6
million, or $(0.13) per share, compared to a net loss of $12.6 million, or
$(0.19) per share, for the comparable period in 2002.
Additional, product-related highlights of the first quarter included:
Genasense(TM)
* The Company completed target enrollment into the first three,
randomized, Phase 3 trials using Genasense combined with chemotherapy.
These trials include patients with malignant melanoma, multiple
myeloma, and chronic lymphocytic leukemia. In these trials, the
Company has sought to determine the incremental benefit of adding
Genasense to standard chemotherapy in order to improve overall outcomes
for patients. The Company believes that a positive result from at
least one of these trials will support a New Drug Application (NDA) to
FDA later this summer.
* Together with Aventis, the Company continues to enroll patients into a
4th randomized, controlled, clinical trial of Genasense plus
chemotherapy for patients with non-small cell lung cancer who have
failed or relapsed from first-line treatment. The standard agent in
this trial is docetaxel (Taxotere(R); Aventis).
* Genta, in collaboration with Aventis, is currently conducting 11 other,
non-randomized trials of Genasense plus standard chemotherapy treatment
in 10 distinct cancer indications. These studies are being sponsored
either directly by Genta or via collaboration with the U.S. National
Cancer Institute. These studies employ combinations with important
anticancer agents, some of which include Rituxan(R), Gleevec(R),
Taxotere(R), Thalomid(R), 5-FU, carboplatin, and Eloxatin(R). The
Company expects to initiate additional trials of this type throughout
the current year.
Ganite(TM)
* During the first quarter, the Company completed the filing of a
regulatory supplement related to the chemistry, manufacturing, and
controls portion of the Ganite NDA. Assuming there are no regulatory
delays, the Company believes that it can initiate marketing of Ganite
during the second-half of this year.
* The Company has continued to build its Sales and Marketing teams by
expanding its oncology-focused field force to effectively manage the
commercial goals and objectives for Ganite. Genta intends to retain all
commercial rights and to market Ganite exclusively in the U.S.
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 (DNA-based medicines) and small
molecules. Genasense(TM) (oblimersen sodium) is the Company's lead compound from
its oligonucleotide program, which 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 intends to launch
later this year for treatment of cancer-related hypercalcemia that is resistant
to hydration. For more information about Genta, please visit our website at:
www.genta.com. |
