-
New Phase 3 trial of Genasense® in melanoma opens to
global accrual
-
Clinical trial opened for G4544 treatment of bone
disease
-
Named-patient/compassionate-use program ships initial
supply
-
Appeal filed to review FDA decision on Genasense in
CLL
-
Brief high-dose IV infusions of Genasense
well-tolerated in new clinical trial
BERKELEY HEIGHTS, NJ - November 7, 2007
- Genta Incorporated (NASDAQ: GNTA) today reported financial
results for the third quarter ended September 30, 2007 and provided
an update on the significant progress made in its pipeline of
clinical development programs.
"The third quarter was noteworthy for a number of key initiatives,"
commented Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief
Executive Officer. "For Genasense, we initiated patient accrual
into our global Phase 3 trial in melanoma, known as AGENDA.
We secured FDA allowance of the G4544 oral gallium IND and
initiated its first clinical trial. We completed the filing
of our NDA appeal to FDA in CLL. We showed that brief
high-dose infusions of Genasense were well-tolerated, potentially
offering new treatment options and improved convenience for
patients. Finally, we recorded the first revenues for
Genasense from the named-patient program. These are major
accomplishments in ambitious programs that should significantly
enhance shareholder value."
AGENDA: A randomized Phase 3 trial of Genasense in
advanced melanoma
During the 3rd quarter, the first patients were randomized and
treated on the AGENDA trial. This trial seeks to confirm the
effectiveness and safety of the Genasense/chemotherapy combination
in patients who had the greatest benefit in a preceding randomized
trial. AGENDA will enroll patients using a biomarker that has
been confirmed as a powerful indicator of outcome. The trial
will enroll approximately 300 patients at sites in North America,
Europe and Australia. More information about AGENDA can be
accessed at:
http://www.genta.com/index.php?option=com_content&task=view&id=38&Itemid=55
.
Initial clinical trial for G4544 opens: a new oral
drug for bone disease
G4544 is a new tablet formulation using delivery technology
developed by Emisphere Technologies, Inc. that enables oral
absorption of the active ingredient contained in Ganite. This
compound is a highly potent inhibitor of bone loss. Diseases
associated with accelerated bone loss include hypercalcemia, bone
metastases, Paget's disease and osteoporosis. The first
clinical trial of G4544 began in normal volunteers during the 3rd
quarter. Genta currently intends to manage the clinical
development process of oncology indications for G4544 and to seek a
development and commercial partner for non-malignant metabolic bone
diseases.
FDA appeal filed for use of Genasense in chronic
lymphocytic leukemia (CLL)
Following FDA's established Dispute Resolution Process, Genta filed
a formal request that FDA's Center for Drug Evaluation and Research
review and overturn the previous non-approvable decision for
Genasense in patients with relapsed or refractory CLL.
An oral hearing on the matter has been scheduled for the 4th
quarter 2007.
"Named-Patient" Program Ships Initial Supplies of
Genasense®
In parallel with the AGENDA trial, Genta has established a program
that will provide Genasense on a named patient/compassionate-use
basis outside the U.S. Via collaboration with IDIS, a
U.K.-based company, Genta distributes drug upon request for
specific patients, and revenue from the first Genasense shipment
under this program was recorded. During the 3rd quarter, two
European-based physicians were hired to facilitate patient accrual
into AGENDA and to respond to physician requests for
information. The Company anticipates hiring additional
headcount to support these efforts.
Financial Information
The Company reported a net loss of $7.7 million or $0.25 per share
for the third quarter of 2007, compared to a net loss of $14.9
million or $0.66 per share for the third quarter of 2006. For the
nine months ended September 30, 2007, the Company reported a net
loss of $21.6 million, or $0.74 per share, compared to a net loss
of $39.5 million, or $1.83 per share, for the nine months ended
September 30, 2006. (All share and per share data have been
retroactively adjusted to account for the effect of a 1-for-6
reverse stock split on July 13, 2007.)
Net product sales of Ganite were $0.1 million for both the three
months ended September 30, 2007 and the comparable prior-year
period. Net product sales for the nine months ended September
30, 2007 of $0.3 million declined from the prior-year period of
$0.6 million as the prior-year period included the effects of a
reduction in the provision for sales returns of Ganite of $0.3
million. The initial product shipment of Genasense under the
named patient program resulted in gross revenue of $23,000.
Operating expenses for the three months and nine months ended
September 30, 2007 declined from their comparable prior-year
periods, as the prior year included a buildup of sales, marketing
and manufacturing expenses incurred in preparation for a possible
commercial launch of Genasense. In addition, lower expenses
in 2007 reflect the impact of a staff reduction in December 2006.
In the fourth quarter of 2006, the Company recorded an expense of
$5.3 million that provides for the issuance of 2 million shares of
Genta common stock, for a settlement in principle of class action
litigation. The expense was net of insurance recovery of
$18.0 million. At September 30, 2007, the revised estimated
value of the common shares portion of the litigation settlement is
$2.7 million based on a closing price of Genta's common stock of
$1.34 per share, resulting in a reduction in the provision of $0.8
million and $2.6 million for the three months and nine months ended
September 30, 2007, respectively. As of September 30, 2007,
Genta had no long-term debt, $0.1 million in short-term debt, and
had cash, cash equivalents and marketable securities of $15.5
million. At December 31, 2006, the Company had cash, cash
equivalents and marketable securities of $29.5 million. Net cash
used in operating activities through September 30, 2007 was $23.7
million.
Conference Call and Webcast
Genta management will host a conference call and live audio webcast
to discuss financial results and general corporate activities on
November 7, 2007 at 8:00 am EST.
Conference call information:
US/Canada call: 877-634-8606; conference code Genta
Incorporated
International call: 706-679-3140; conference code Genta
Incorporated
Webcast:
http://www.genta.com/investorrelation/events.html
The webcast will be archived for 30 days. Audio replay will be
available approximately two hours after completion of the call, and
will be archived for 30 days. Access numbers for this replay are:
(800) 642-1687 (U.S./Canada) and (706) 645-9291 (International);
conference ID number is 20277650.
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. Two major programs anchor the Company's research
platform: DNA/RNA-based Medicines and Small Molecules. Genasense®
(oblimersen sodium) Injection is the Company's lead compound from
its DNA/RNA Medicines program. Genta is currently recruiting
patients for a global Phase 3 trial of Genasense in patients with
advanced melanoma. The leading drug in Genta's Small Molecule
program is Ganite® (gallium nitrate injection), which the Company
is exclusively marketing in the U.S. for treatment of symptomatic
patients with cancer related hypercalcemia that is resistant to
hydration. The Company has developed an oral formulation of
the active ingredient in Ganite that is currently undergoing
initial clinical trials as a potential treatment for diseases
associated with accelerated bone loss. Ganite® and Genasense®
are available on a "named-patient" basis in countries outside the
United States. For more information about Genta, please visit
our website at: www.genta.com.
Safe Harbor
This press release may 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. Forward-looking
statements include, without limitation, statements about:
- the Company's ability to obtain necessary regulatory approval
for Genasense® from the U.S. Food and Drug Administration ("FDA")
or European Medicines Agency ("EMEA");
- the safety and efficacy of the Company's products or product
candidates;
- the Company's assessment of its clinical trials;
- the commencement and completion of clinical trials;
- the Company's ability to develop, manufacture, license and
sell its products or product candidates;
- the Company's ability to enter into and successfully execute
license and collaborative agreements, if any;
- the adequacy of the Company's capital resources and cash flow
projections, and the Company's ability to obtain sufficient
financing to maintain the Company's planned operations;
- the adequacy of the Company's patents and proprietary
rights;
- the impact of litigation that has been brought against the
Company and its officers and directors and any proposed
settlement of such litigation;
- the Company's ability to retain compliance with the NASDAQ's
listing qualifications; and
- the other risks described under Certain Risks and
Uncertainties Related to the Company's Business, as contained in
the Company's Annual Report on Form 10-K and Quarterly Report on
Form 10-Q.
The Company does not undertake to update any forward-looking
statements. 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 on Form 10-K for 2006 and its most recent
quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Brian Korb
The Trout Group
908-286-3980
