- New Phase 3 trial of Genasense® seeks to confirm benefit in
melanoma
- New IND filed for clinical-stage product to treat bone
disease
- Company regains compliance for NASDAQ Global Markets listing;
Genta common stock to resume trading under "GNTA" symbol in
August 2007
- Named-patient/compassionate-use program for Genasense will
continue during Phase 3 trial
- Appeal of FDA decision on Genasense NDA in CLL pending
BERKELEY HEIGHTS, NJ - August 7, 2007
- Genta Incorporated (NASDAQ: GNTAD) today announced financial
results and corporate highlights for the second quarter ended June
30, 2007.
"Over the past several months, we critically examined our
development programs and have concluded that our assets and
employees represent a significant value opportunity for
shareholders," commented Dr. Raymond P. Warrell, Jr., Genta's
Chairman and Chief Executive Officer. "Our lead compound,
Genasense®, has demonstrated improved outcomes for patients with
CLL and melanoma, and we plan to pursue plans that will seek global
regulatory approvals of this drug. In addition to developing dosing
schedules of Genasense that may simplify its administration, we
have added a new clinical-stage compound with the announcement of
an IND filing for an orally available gallium product to treat
accelerated bone loss. We plan to continue ongoing efforts to
further diversify the Company's portfolio and leverage our
expertise in clinical research."
New Randomized Phase 3 Trial of Genasense plus
Dacarbazine in Advanced Melanoma
The Company has announced plans to initiate a new Phase 3 trial,
now known as AGENDA: "
A
Randomized Controlled Trial of
Gen
asense plus
Da
carbazine Compared with Dacarbazine Alone in Patients with Advanced
Melanoma". This trial will seek to evaluate the effectiveness of
the Genasense/dacarbazine combination in patients identified in the
preceding randomized trial of dacarbazine with or without Genasense
(known as GM301) as having derived greatest benefit. AGENDA seeks
to enroll patients using a readily available biomarker that
multiple studies have confirmed as the most powerful indicator of
prognosis. The trial will enroll approximately 300 patients and
will be conducted at sites in North America, Europe and Australia.
In July 2007, the Company announced that the European Medicines
Agency indicated that approval of Genasense in melanoma will
require the conduct of another clinical study, and the new trial is
intended to address this requirement.
Chronic Lymphocytic Leukemia (CLL)
The Company announced that it will request review of the
non-approvable decision by the Food and Drug Administration (FDA)
for the New Drug Application (NDA) for Genasense in patients with
relapsed or refractory chronic lymphocytic leukemia (CLL).
Following FDA's established Dispute Resolution Process, Genta will
submit its request to Dr. Steven Galson, Director of FDA's Center
for Drug Evaluation and Research (CDER), and the Company
anticipates a decision from CDER in the second half of 2007.
"Named-Patient" Distribution Will Provide Patient Access
to Genasense® and Ganite®
While the AGENDA trial is ongoing, Genta has elected to continue
to provide both Genasense (oblimersen sodium) and Ganite® (gallium
nitrate injection) on a compassionate-use/named patient basis.
Genta established this program via a collaboration with IDIS, a
U.K.-based company that will distribute the drug in territories
outside the United States upon physician request for a specific
patient. Going forward, the Company will levy a charge and record
revenue for the provision of both agents under this program.
IND Filed with FDA to Enable Clinical Testing of New Oral
Drug for Bone Disease
In August 2007, the Company filed an Investigational New Drug
Exemption (IND) with the FDA's Division of Endocrinologic and
Metabolic Drugs for a newly formulated compound, known as G4544.
Developed out of a joint collaboration with Emisphere Technologies,
Inc., G4544 is a new tablet formulation that enables oral
absorption of the active ingredient contained in Ganite. This
compound is a highly potent inhibitor of calcium release from bone.
Diseases associated with accelerated bone loss include
hypercalcemia, bone metastases, Paget's disease and osteoporosis.
Genta currently intends to manage the clinical development process
of oncology indications and to seek a development and commercial
partner for non-malignant metabolic bone diseases. Assuming
regulatory concurrence with the IND plan to establish
bioequivalence with the FDA-approved parenteral product, Genta
expects to initiate the initial clinical trial of G4544 in the
second half of 2007.
Stock Trading and Capital Structure
In July, Genta was notified by NASDAQ that the Company has
demonstrated compliance with all NASDAQ Marketplace rules. As a
consequence, the NASDAQ Listings Qualifications Panel determined
that Genta's common stock will continue to be listed on the NASDAQ
Global Market. As part of the plan to establish compliance, Genta
stockholders approved a one-for-six reverse split of the Company's
shares of common stock, which reduced the number of outstanding
shares to approximately 31 million. The Company's common stock
temporarily trades under the symbol "GNTAD". On or about August 10,
2007, the Company expects that the common stock will resume trading
under its former symbol, "GNTA".
Financial Information
All share and per share data included in this press release have
been retroactively adjusted to account for the effect of the
1-for-6 reverse stock split on July 13, 2007. The Company reported
a net loss of $8.2 million, or $0.27 per share, for the second
quarter of 2007, compared to a net loss of $14.6 million, or $0.66
per share, for the second quarter of 2006. For the six months ended
June 30, 2007, the Company reported a net loss of $13.8 million, or
$0.48 per share, compared to a net loss of $24.5 million, or $1.17
per share, for the comparable period in 2006.
Net product sales of Ganite in the second quarter and first six
months of 2007 of $0.1 million and $0.2 million, respectively,
declined from the prior-year periods of $0.4 million and $0.4
million, respectively. The second quarter of 2006 included the
effects of a reduction in the provision for Ganite sales returns of
$0.3 million. Excluding this adjustment, sales slightly increased
in the second quarter and first six months of 2007. Operating
expenses declined in the second quarter and first six months of
2007, 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 is net of insurance recovery of
$18.0 million. At June 30, 2007, the revised estimated value of the
common shares portion of the litigation settlement is $3.5 million,
based on a closing price of Genta's common stock of $1.74 per
share, resulting in a reduction in the provision of $0.2 million in
the second quarter and a reduction of $1.8 million for the first
six months of 2007.
As of June 30, 2007, Genta had no long-term debt, $0.2 million
in short-term debt, and had cash, cash equivalents and marketable
securities of $22.4 million, compared to $29.5 million as of
December 31, 2006. During the first six months of 2007, net cash
used in operating activities was $16.8 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 August 7, 2007 at 8:00 am EDT.
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/genta/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 11209530.
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® (oblimersen sodium) Injection is the
Company's lead compound from its oligonucleotide program. 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. Genta is partnered
with IDIS (
http://www.idispharma.com/
) on a program whereby both 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:
http://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.
CONTACT:
Tara Spiess
TS Communications Group LLC
info@genta.com
(908) 286-3980
