Conference Call To Update Financial Strength, Pipeline and
Product Development
BERKELEY HEIGHTS, NJ - July 31, 2003 -
Genta Incorporated (Nasdaq: GNTA) today
announced financial results for the period ended June 30, 2003.
Financial Strength and 2nd Quarter Results
Genta continues in a strong cash position with cash, cash
equivalents, and short-term investments totaling $97.2 million as
of June 30, 2003, compared to $113.7 million at December 31, 2002
and $143.5 million at June 30, 2002. Pursuant to cost-sharing
provisions of the Aventis collaboration to develop GenasenseTM
(oblimersen sodium), the Company's lead anti-cancer drug, Genta
recorded $19.4 million of net expense reimbursement in the 2nd
quarter, which is recorded as a receivable at June 30, 2003.
In the 2nd quarter of 2003, revenues totaled $1.3 million
compared with $0.9 million in the corresponding 2002 period. The
2003 revenues were primarily comprised of amortization of payments
made by Aventis pursuant to a collaboration agreement for Genasense
that was signed
during the 2nd quarter of 2002.
Total 2nd quarter gross operating expenses of $24.4 million,
before the net Aventis expense reimbursement, decreased by
approximately $1.0 million relative to the comparable quarter in
2002. Higher levels of drug substance purchases in 2002 and
expenses associated with the 2nd quarter 2002 closing of the
Aventis collaboration offset the 2003 increase in expenses
associated with the Genasense Phase 3 clinical trials and NDA
preparation activities, and costs associated with Ganite
TM
(gallium nitrate injection) pre- launch activities.
In the 2nd quarter, operating expenses, net of Aventis
reimbursement, decreased from $18.2 million in 2002 to $4.9 million
in 2003. A key factor driving the lower net expenses in 2003 was
$8.1 million of drug substance and product shipped to Aventis for
planned process validation and clinical activities.
As a result of the factors described above, the Company reported
a net loss of $3.4 million, or $(0.05) per share, for the quarter
ended June 30, 2003, compared to a net loss of $17.1 million, or
$(0.25) per share, for the 2nd 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
1st quarter, the Company drew down $17.5 million in cash from that
instrument. In the 2nd quarter Genta drew down a further $7.5
million. A potential of $15 million remains available to the
Company under the line of credit.
The second quarter was highlighted by the following clinical
presentations, Genasense trial initiations, regulatory hallmarks,
and personnel growth in anticipation of product
commercialization:
Genasense
TM
(oblimersen sodium)
Presentations at Scientific Conferences
Ninth International Workshop on Multiple Myeloma
- Preliminary results were presented from a Phase 1-2 clinical
trial of 17 heavily pretreated patients with multiple myeloma who
were treated with Genasense, Thalomid® (thalidomide; Celgene) and
high-dose dexamethasone. All patients had previously received
dexamethasone, half had previously received thalidomide, and 15
of the 17 (88%) had progressed despite high-dose chemotherapy and
stem cell transplantation. Of 15 evaluable patients, 3 patients
(20%) achieved a complete or near complete response, and 5
patients (33%) achieved a partial response, for an overall major
response rate of 53%. Four other patients (27%) achieved a minor
response.
- In a second preliminary study, patients with multiple myeloma
who were refractory to prior chemotherapy received Genasense plus
"VAD" (vincristine, doxorubicin, and dexamethasone). Of the 9
patients evaluable for response (8 of whom had received prior
dexamethasone, 5 of whom had received prior thalidomide, and 6 of
whom had undergone a prior transplant), 4 (44%) achieved a
partial response.
American Society of Clinical Oncology (ASCO)
- In an oral presentation, data from 25 patients with mantle
cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, were
presented. This study was designed to evaluate the effects of
Genasense used without chemotherapy. A maximum of 6 cycles of
Genasense could be given in the absence of disease progression.
If the disease progressed, patients who had not received chemo
therapy then received a combination of Genasense plus R-CHOP (a
standard regimen consisting of Rituxan®, cyclophosphamide,
doxorubicin, vincristine, and prednisone). Patients who had
failed chemotherapy were removed from the study. Thirty-seven
patients were enrolled into this trial; 25 patients were
evaluable for response at the time of presentation. Across all
treatment groups, 10 of the 25 patients (40%) remained stable
without progression during all 6 Genasense treatment cycles.
These included 4 of 9 newly diagnosed patients (44%) and 6 of 16
previously treated patients (38%). Seven newly diagnosed patients
crossed over to receive Genasense plus R-CHOP. Two of these
patients achieved a complete response (29%), 2 achieved a partial
response (29%), and 3 were too early to evaluate (42%). Of
the 16 previously treated patients (who received a median of 2
prior regimens), 1 patient (6%) achieved a complete response, and
6 patients (38%) achieved stable disease when receiving Genasense
alone.
- Data from a Phase 2 clinical trial of 29 evaluable patients
with hormone-refractory prostate cancer who received Genasense
plus Taxotere® (docetaxel; Aventis) were presented. Fourteen of
the 29 patients (48%) achieved greater than 50% reduction in
blood levels of PSA (prostate specific antigen); and 4 of 13
patients (31%) who had measurable disease achieved an objective
partial response.
- Genasense clinical data were also presented from a Phase 2
trial of patients with small cell lung cancer who had not
previously been treated with chemotherapy. In this trial,
patients were treated with Genasense plus carboplatin and
etoposide, two commonly administered chemotherapeutic agents. Of
14 evaluable patients, 12 achieved a partial response (86%) and
the remaining 2 patients exhibited stable disease.
American Association of Cancer Research (AACR)
- Data from several Genasense preclinical studies were
presented or published in the Proceedings of the annual meeting
that further support Genasense synergy when administered as a
pretreatment to chemotherapy.
New Clinical Trials with Genasense
- Seven clinical trials with Genasense were announced
during the quarter in a variety of patients with solid tumors and
hematologic malignancies, including 2 randomized studies and 5
non-randomized studies. These trials include:
A Phase 2 randomized trial sponsored by the CALGB for
patients with small cell lung cancer who will receive
carboplatin and etoposide with or without Genasense;
A Phase 2 randomized trial sponsored by the EORTC for
patients with hormone refractory prostate cancer who will
receive Taxotere with or without Genasense;
A Phase 2 trial for patients with breast cancer who will
receive Genasense in combination with docetaxel and
doxorubicin;
A Phase 2 trial for patients with advanced kidney disease
who will receive Genasense plus interferon-alpha (IFN-a);
A Phase 2 trial for patients with Waldenstrom's
macroglobulinemia (an aggressive from of lymphoma) who will
receive Genasense alone;
A Phase 1-2 trial for patients with advanced solid tumors,
focusing on patients with pancreatic cancer, who will receive
Genasense with gemcitabine (Gemzar®; Eli Lilly, Inc.);
A Phase 2 trial for patients with non-Hodgkin's lymphoma who
will be treated with Genasense plus R-CHOP.
Ongoing Clinical Trials with Genasense
- Genasense is currently the subject of 20 clinical trials
including randomized trials in patients with, prostate and
non-small cell lung cancer. Additionally, non-randomized trials
are ongoing for patients with myeloma, NHL, acute myeloid
leukemia and mantle cell lymphoma. In addition, Genasense is
being evaluated in the following nonrandomized NCI-sponsored
clinical studies:
Phase 1 Study of Genasense in Combination with Daunorubicin,
Cytarabine and GCSF in Elderly Patients with Previously
Untreated Acute Myeloid Leukemia
Phase 1 Study of Genasense, Carboplatin, Paclitaxel in
Patients with Advanced Solid Tumors
Phase 1 Study of Genasense and Cytotoxic Chemotherapy in
Relapsed Childhood Solid Tumors
Phase 1-2 Study of Genasense in Combination with Doxorubicin
in Patients with Advanced or Recurrent Hepatocellular
Carcinoma
Phase 1-2 Study of Genasense, Oxaliplatin and 5-FU/LV
(FOLFOX) in Patients with Colorectal Carcinoma
Phase 2 Study of Genasense plus Rituxan in Patients with
Recurrent Non- Hodgkin's Lymphoma
Phase 2 Study of Genasense in Combination with Thalidomide
and Dexamethasone in Relapsed and Refractory Multiple
Myeloma
Phase 2 Study of Genasense and Gleevec in Patients with
Chronic Myeloid Leukemia
The rationale for the initiation of such
non-randomized studies, include: the ability to evaluate
Genasense in diseases that lie outside the Company's priorities
for initial development; to quickly translate findings of
preclinical studies showing synergy with new drugs into clinical
testing; to expand the clinical safety and efficacy information
base with a larger number of chemotherapeutic agents; to enable a
considerably larger number of physicians to use the drug in their
clinical practices; and to use these trials as the basis for
potential new randomized trials.
Regulatory Milestones - Genasense and Ganite
- The Company received Fast Track designation for Genasense
for the treatment of chronic lymphocytic leukemia (CLL) from
the Food and Drug Administration (FDA). This notice completed
Fast Track designation in each of the fully enrolled Genasense
registration trials (CLL, melanoma, and multiple myeloma). Fast
Track designation is intended to expedite the regulatory review
of new drugs that are intended to treat serious or life
threatening conditions, which demonstrate the potential to
address unmet medical needs. This designation enables Genta to
submit a New Drug Application to the FDA in separate
sections.
- The Company filed its completed supplemental New Drug
Application (sNDA) to the FDA for Ganite (gallium nitrate
injection). The sNDA was submitted to the FDA's Metabolism and
Endocrine Division for the treatment of cancer-related
hypercalcemia that has not responded to hydration, a
life-threatening elevation of blood calcium that can occur in
up to 50% of patients with advanced cancer.
Preparation for Commercialization
- The Company has completed its initial sales force hiring
objectives with 18 field-based representatives throughout the
U.S, who will manage the launch of Ganite expected during the
second half of 2003. 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
molecule s. Genasense
TM
(oblimersen sodium) is the Company' s lead compound from its
oligonucleotide program, which is currently undergoing latestage,
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:
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' Annual
Report/Form 10-K
for 2002
.
SOURCE: Genta Incorporated
Financial Table to Follow:
