BERKELEY HEIGHTS, NJ - May 8, 2008
- Genta Incorporated (OTCBB: GNTA) today announced financial
results for the quarter ended March 31, 2008. From the
beginning of the year, the Company has recorded significant
milestones including the following:
- AGENDA Phase 3 trial passes initial DSMB
- Oral G4544 for bone disease completes single dose-trial in
505(b)(2) strategy
- Tesetaxel in-licensed -- leading oral taxane and new
clinical-stage product
- FDA provides regulatory guidance for Genasense in CLL
- Company restructures to conserve cash
- Genta will seek buyer for Ganite and terminates c-myb
antisense program
"Genta has successfully diversified with three high-value
clinical-stage products in our portfolio," noted Dr. Raymond P.
Warrell, Jr., Genta's Chairman and Chief Executive Officer.
"The Phase 3 trial of Genasense in melanoma has now enrolled more
than 25% of its target, we expect accrual completion this year, and
positive results should enable worldwide regulatory filings in
2009. During the quarter, FDA provided substantial guidance
on the development of each of our compounds. With G4544, an
internally developed compound for skeletal diseases, we have the
opportunity to submit a NDA for a product via a streamlined
505(b)(2) regulatory strategy. Our in-licensing of worldwide
rights to tesetaxel has provided us with a leading oral taxane that
addresses a very large and well-characterized market. This
portfolio includes unique compounds that offer significant
partnering opportunities to accelerate their development."
Highlights and updates of the Genta programs appear below.
GENASENSE: THE LEADING ANTISENSE DRUG IN CLINICAL
DEVELOPMENT
Genasense in Melanoma:
Genta is currently enrolling patients with advanced melanoma
in a randomized Phase 3 trial of Genasense plus chemotherapy, known
as AGENDA. The study is designed to confirm certain safety
and efficacy results from a preceding randomized trial of Genasense
combined with dacarbazine in patients who have not previously
received chemotherapy. AGENDA employs a biomarker to define
those patients who derived maximum clinical benefit during the
preceding study.
Genasense in Chronic Lymphocytic Leukemia (CLL):
With guidance from the Food and Drug Administration's (FDA)
Center for Drug Evaluation and Research, the Company is collecting
survival and progression data from its completed Phase 3 trial of
Genasense plus chemotherapy in patients with relapsed/refractory
CLL. Genta has also submitted a proposed confirmatory Phase 3
protocol of Genasense in CLL to the FDA for Special Protocol
Assessment (SPA) and to the European Medicines Agency (EMEA) for
Scientific Advice.
G4544: A NEW ORAL DRUG FOR SKELETAL DISEASES
G4544 is the Company's proprietary small molecule that is
intended to treat diseases associated with accelerated bone
loss. G4544 contains the active ingredient in Ganite®.
Genta has completed a Phase 1 single-dose study of G4544, whose
results will be presented at the 2008 ASCO meeting. The
Company had a teleconference with FDA's Endocrinology and
Metabolism Division that clarified regulatory steps needed to begin
more extensive clinical testing. At present, Genta intends to
seek approval of G4544 by a 505(b)(2) regulatory pathway, which may
shorten development time by allowing use of bioequivalence studies,
rather than trials to demonstrate efficacy and safety.
TESETAXEL: A LEADING ORAL TAXANE WITH ANTICANCER
ACTIVITY
Tesetaxel is the latest addition to the Genta oncology
portfolio. This agent was developed to avoid serious effects
associated with other taxanes (such as paclitaxel [Taxol®; Bristol
Myers Squibb] and docetaxel [Taxotere®; sanofi aventis]), including
severe infusion reactions, peripheral nerve damage, and drug
resistance. More than 250 patients have received tesetaxel,
and the drug has demonstrated anticancer activity in several
clinical trials. Due to the occurrence of several fatalities
related to neutropenia, the drug is currently on clinical hold in
the U.S. Based upon guidance from FDA, Genta has developed a
strategy that is intended to lift the clinical hold, thereby
enabling clinical testing to resume. If further studies
document efficacy and safety, tesetaxel offers substantial
opportunities to improve convenience, safety, and activity for
patients who are currently receiving conventional taxanes.
FINANCIAL INFORMATION
The Company reported a net loss of $9.7 million, or $0.29 per
share, for the first quarter of 2008, compared with a net loss of
$5.6 million, or $0.21 per share, for the first quarter of
2007. (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.)
Research and development expenses were $6.4 million for the
three months ended March 31, 2008, compared with $3.4 million for
the three months ended March 31, 2007. This increase was
primarily due to the recognition in March 2008 of $2.5 million for
license payments on tesetaxel, as well as expenses from the AGENDA
clinical trial. Selling, general and administrative expenses
were $3.6 million for the three months ended March 31, 2008,
compared with $4.1 million for the three months ended March 31,
2007. Share-based compensation expenses recognized under
Statement of Financial Accounting Standards No. 123 (revised 2004),
Share-Based Payment, (''SFAS 123R'') declined $0.3
million.
In the fourth quarter of 2006, the Company recorded an expense
of $5.3 million that provides for the issuance of 2.0 million
shares of Genta common stock, for a settlement in principle of
certain class action litigation. At March 31, 2007, the
revised estimated value of the common shares portion of the
litigation settlement was $3.7 million, based on a closing price of
Genta's common stock of $1.86 per share, resulting in a reduction
in the provision of $1.6 million, recognized in the first quarter
of 2007. At March 31, 2008, the revised estimated value of
the common stock portion of the litigation settlement was $0.8
million, based on a closing price of Genta's common stock of $0.39
per share, resulting in a reduction in the provision of $0.3
million, recognized in the first quarter of 2008. The larger
net loss in 2008 is primarily due to recognition of the tesetaxel
license payments of $2.5 million, the lower reduction in provision
for settlement of litigation of $1.3 million, and higher expenses
resulting from the AGENDA clinical trial.
At March 31, 2008, Genta had cash, cash equivalents and
marketable securities totaling $4.1 million compared with $7.8
million at December 31, 2007. In February 2008, the Company issued
6.1 million shares of its common stock at a price of $0.50 per
share, raising approximately $3.1 million, before estimated fees
and expenses. During the first three months of 2008, cash used in
operating activities was $6.2 million compared with $9.8 million
for the same period in 2007. Lower cash used in operating
activities was primarily due to the timing of payments in the two
respective periods.
In April 2008, the Company reduced its workforce by
approximately 30% in order to conserve cash. Genta also
announced that it would seek a buyer for its sole marketed product,
Ganite®. In a recent action, the Company has also terminated
its license to c-myb antisense due to diminishing patent life.
The Company will maintain an appropriate level of spending over
the upcoming fiscal year, given the uncertainties inherent in its
business and its current liquidity position. However, absent
additional funding, Genta will run out of funds in the second
quarter of 2008. If the Company is unable to raise additional
funds, it could be required to reduce its spending plans, reduce
its workforce, license or sell assets or products it would
otherwise seek to commercialize on its own, or file for
bankruptcy. There can be no assurance that the Company can
obtain financing, if at all, on acceptable terms. Due to the
Company's inability to demonstrate sustained compliance with the
minimum stockholders' equity requirement for continued listing on
The NASDAQ Capital Markets, the Company's common stock was recently
transferred to the Over-the-Counter Bulletin Board (OTCBB)
maintained by FINRA (formerly, the NASD).
CONFERENCE CALL AND WEBCAST
Genta management will host a conference call and live audio
webcast to discuss financial results and recent corporate
activities on May 8, 2008 at 8:00 am EST. Participants can
access the live call by dialing (877) 634-8606 (U.S. and Canada) or
(706) 679-3140 (International). The access code for the live call
is Genta Incorporated. The call will also be webcast live at
http://www.genta.com/investorrelation/events.html. For
investors unable to participate in the live call, a replay will be
available approximately two hours after the completion of the call,
and will be archived for 30 days. Access numbers for this replay
are: (800) 642-1687 (U.S. and Canada) and (706) 645-9291
(International); conference ID number is: 44823128.
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 to the
AGENDA
Trial
, 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
G4544
, an oral formulation of the active ingredient in Ganite, that has
recently entered clinical trials as a potential treatment for
diseases associated with accelerated bone loss. The Company
is also developing
tesetaxel
, a novel, orally absorbed, semi-synthetic taxane that is in the
same class of drugs as paclitaxel and docetaxel. 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 2007 and its most recent
quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
908-286-3980
info@genta.com
