Update of Genasense® Clinical Trials and Timelines
BERKELEY HEIGHTS, NJ - August 3, 2004
- Genta Incorporated (NASDAQ: GNTA) today announced financial
results for the 2nd quarter ended June 30, 2004. The Company
reported revenues of $1.6 million for the quarter, and a net loss
of $29.2 million or $0.37 per share. The net loss was largely
driven by special items, including expenses related to the resizing
of the Company and inventory that was expensed due to the
commercialization delay of Genasense® (oblimersen sodium)
Injection. At the end of the quarter, the Company had cash, cash
equivalents and marketable securities totaling $50.2 million.
"The major news of the quarter focused on the May 3 review by the
FDA's Oncology Drug Advisory Committee (ODAC) of the Genasense New
Drug Application (NDA) in melanoma," noted Dr. Raymond P. Warrell,
Jr., Genta's Chief Executive Officer. "While a majority of
committee members voted that the significant increase in response
rate provided evidence of clinical activity, the committee also
indicated that the overall evidence was insufficient to recommend
approval. Subsequent to that action, the Company withdrew the NDA
and implemented a major reduction in workforce in order to focus
resources on the late-stage Genasense development program."
"The Company remains committed to the further development of
Genasense. We expect to analyze and release final results from two
additional Phase 3 trials in the 4th quarter of this year. These
trials include a total of 465 patients with either multiple myeloma
or chronic lymphocytic leukemia. If the data from at least one of
these trials are positive, and with FDA agreement, we plan to
initiate submission of another Genasense NDA before year-end."
Financial Information
The Company reported revenues of $1.6 million for the 2nd quarter,
an 18% increase compared to the 2nd quarter of 2003. This increase
was due to sales of Ganiteâ (gallium nitrate injection), which
totaled $0.3 million for the quarter.
Second quarter gross expenses were $39.2 million, before
reimbursements pursuant to our commercialization agreement with
Aventis. This amount represented an increase of $14.8 million over
the comparable period in 2003. Several special items drove the
increase in 2004 expenses. Due to the delay in the commercial
launch of Genasense, $7.0 million of vialed drug product that we
expected to sell upon commercialization is now anticipated to be
used for clinical trials and has been expensed. Also, in accordance
with accounting practice, $11.7 million of Genasense bulk drug
substance has been expensed. This material can be used to produce
commercial supplies of Genasense drug product should one of the
pending clinical trials be positive and form the basis for a
Genasense NDA submission. In additio n, $1.9 million in expenses
related to severance costs and anticipated legal costs were
incurred during the quarter. Excluding these $20.6 million of
expenses, 2nd quarter gross expenses were $18.6 million, a $5.8
million or 24% decrease compared to the 2nd quarter of 2003.
Second quarter net expenses, after the Aventis expense
reimbursement of $8.5 million, increased from $5.0 million in the
2nd quarter of 2003 to $30.7 million in the 2nd quarter of 2004.
The aforementioned $20.6 million of expenses, increased selling,
general and administrative expenses associated with the marketing
of Ganite and costs of the sales force, plus a lower Aventis
reimbursement, drove the increase in net expenses. The lower level
of Aventis reimbursement in the 2nd quarter 2004 was primarily due
to the higher level of Genasense drug shipments to Aventis in the
2nd quarter of 2003. The Company reported a net loss for the 2004
2nd quarter of $29.2 million or $0.37 per share, compared with a
net loss of $3.4 million or $0.05 per share for the 2nd quarter of
2003.
Genta had cash, cash equivalents and marketable securities of $50.2
million as of June 30, 2004. This compares to $67.5 million as of
March 31, 2004 and $97.2 million as of June 30, 2003. In addition
to the net loss, a key factor in the cash used during the 2nd
quarter was $5.2 million in Genasense drug substance purchases.
We expect our recent re-sizing of the Company to reduce our cash
use for ongoing activities to an estimated $3 million per month.
Based on this lower rate, anticipated drug purchases, and other
items, the Company projects that it should have sufficient cash to
maintain operations at current levels through mid-2005. It is
likely that the Company will seek additional external financing
before that time.
Product Update
Genasense
Genasense is currently being studied in a number of clinical
trials. Together with Aventis and the National Cancer Institute
(NCI), the Company and its collaborators have completed or are
currently running randomized clinical trials in 6 different cancer
indications. Highlights of the randomized trials sponsored directly
by the Company appear below.
-
Myeloma
: The Phase 3 trial in multiple myeloma was closed to enrollment
in the 2nd quarter, 2003. A total of 224 patients were enrolled,
and a minimum of one-year of follow-up from time of randomization
is now available for all patients. In this trial, eligible
patients received high-dose dexamethasone and were randomly
assigned to receive Genasense or no additional therapy. The
primary end-point of the study is to increase time-to-disease
progression; secondary end-points include overall response,
response duration, survival, and safety.
-
Chronic lymphocytic leukemia (CLL)
: The Phase 3 trial in CLL completed enrollment late in the 2nd
quarter, 2003. A total of 241 patients were enrolled, and a
minimum of one-year of follow-up for randomization is now
available in all patients. In this trial, eligible patients
received fludarabine and cyclophosphamide and were randomly
assigned to receive Genasense or no additional therapy. The
primary end-point of the study is to demonstrate an increase in
the proportion of patients who achieve complete or "nodular
partial" remissions.
-
Non small cell lung cancer
: The Company announced that enrollment in its randomized trial
in non small cell lung cancer was completed in the 2nd quarter,
2004. A total of 298 patients enrolled in this trial that
targeted patients who had progressed on front- line chemotherapy.
Patients received docetaxel (Taxotere®; Aventis) with or without
Genasense. The primary end-point of the study is to improve
overall survival; key secondary end-points include
time-to-progression and antitumor response. Follow-up for the
survival end-point is expected to be complete in the 2nd half of
2005.
-
Acute myeloid leukemia
: This trial tests the addition of Genasense to daunorubicin plus
cytarabine in patients greater than or equal to 60
years of age who have not previously received chemotherapy.
Approximately 500 patients may be accrued to this study. The
primary end-point is overall survival; key secondary end-points
include complete remission rate, remission duration, and safety.
As yet, the CALGB has not released expectations for enrollment
completion.
-
Prostate cancer
: This trial evaluates the addition of Genasense to docetaxel in
patients with hormone-refractory prostate cancer who have not
previously received chemotherapy. Approximately 100 patients are
expected to enroll. Key end-points include response and
progression- free survival.
-
Small cell lung cancer
: This trial tests the combination of Genasense plus carboplatin
and etoposide in patients with extensive-stage disease who have
not previously received chemotherapy. The primary end-point of
the trial is to compare proportional survival at 12 months after
randomization. Approximately 55 patients will be enrolled.
Accrual to this trial is expected to conclude in the 2nd half of
2004.
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Chronic myeloid leukemia
- Waldenstrom's macroglobulinemia
- Breast cancer
- Colon cancer
- Liver cancer
- Kidney cancer
- Stomach cancer
- Pancreas cancer
- Pediatric solid tumors
Ganite
With the reduction in workforce previously announced, the Company
also suspended field sales and marketing support for Ganite.
Certain, previously initiated, clinical trials of Ganite are
continuing, and the Company has agreed to continue to supply the
drug to selected clinical investigators at no cost in order to
continue those clinical trials. The Company is currently reviewing
its strategic options for the product.
Corporate Highlights
Subsequent to the ODAC vote, the Company elected to withdraw its
NDA for the use of Genasense in combination with dacarbazine for
the treatment of patients with advanced melanoma. Genta and Aventis
also discontinued their previously announced Expanded Access
Program for patients with advanced melanoma.
Subsequent to the ODAC vote, Genta also implemented a reduction of
approximately 50% of its workforce and closed its laboratory and
office facility in Salt Lake City, UT. While all areas of the
Company were affected by these actions, the reductions concentrated
on corporate and field sales force and laboratory-based research
personnel. The Company plans to focus resources conserved by these
actions on the development of Genasense.
As a consequence of the negative outcome of the ODAC meeting and
the resulting drop in the share price of Genta common stock, a
number of class action and shareholder derivative lawsuits were
filed against the Company and certain of its Officers and
Directors. The Company believes these litigations are without merit
and will vigorously defend against these suits.
Conference Call and Webcast
Genta Incorporated will host a conference call and live audio
webcast of its second quarter financial results this morning,
Tuesday, August 3, 2004. Dr. Raymond P. Warrell, Jr., Genta's Chief
Executive Officer, and William Keane, Genta's Chief Financial
Officer, will host the call and webcast at 8:30 AM EDT.
The conference call can be accessed live at 8:30 AM EDT this
morning as follows:
U.S./Canada: Dial (877) 634-8606, reference Genta Incorporated.
International: Dial (706) 679-3140, reference Genta Incorporated.
The webcast will be available in the Investor Relations section of
the Company's website at:
http://www.genta.com/genta/InvestorRelation/events.html
and will be archived for 30 days.
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 2003.
SOURCE: Genta Incorporated
