BERKELEY HEIGHTS, NJ - November 07, 2006-
Genta Incorporated (NASDAQ: GNTA) today announced financial results
and progress for the quarter ended September 30, 2006. The Company
has recently achieved significant milestones, including:
GENASENSE CLINICAL AND REGULATORY ACTIVITY
Chronic Lymphocytic Leukemia
On October 29, 2006, Genta was notified that the Food and Drug
Administration (FDA) had extended the regulatory review period of
the Company's pending New Drug Application (NDA) for Genasense®
(oblimersen sodium) Injection from October 29, 2006 to January 29,
2007. The NDA proposes the use of Genasense plus chemotherapy for
treatment of patients with relapsed or refractory chronic
lymphocytic leukemia (CLL). On September 6, 2006, the NDA was
presented before FDA's Oncologic Drugs Advisory Committee (ODAC)
and did not receive a majority vote to recommend approval. In
October, following discussion with FDA, the Company submitted new
data analyses that comprised a major amendment to the pending
NDA.
On October 6, 2006, Genta announced that its proposed trial of
Genasense plus fludarabine and rituximab (Rituxan®; Genentech,
Inc.) in previously untreated patients with CLL had completed
Special Protocol Assessment (SPA) by FDA. The Company has indicated
that a decision regarding initiation of this trial will not be made
until FDA has completed its review of the pending NDA. While the
NDA remains under active review, Genta will provide Genasense at no
cost to CLL patients in response to single-patient, "compassionate
use" requests.
Melanoma
Genta has filed a Marketing Authorization Application (MAA) that
is currently under review by the European Medicines Agency (EMEA)
for the use of Genasense plus dacarbazine for treatment of patients
with advanced melanoma. As part of that review, the Company
received a consolidated list of questions from the EMEA on June 1,
2006, and - after meeting with representatives from both rapporteur
countries - Genta has now filed its complete response. While
timelines cannot be stated with certainty, the Company currently
expects that an opinion from the Committee for Medicinal Products
for Human Use (CHMP) regarding the status of its application will
be available during the first quarter of 2007.
Genasense was designated an Orphan Drug for treatment of
patients with Stage IV melanoma by the Therapeutic Goods
Administration (TGA), the regulatory authority in Australia. Orphan
Drug designation may facilitate the development of drugs that
address significant unmet medical needs, and it provides 7 years of
market exclusivity after approval, grants and tax credits for
research and development, and reduced filing fees for marketing
applications. Genta has retained an agent in Australia to act on
its behalf for regulatory affairs.
Preliminary results of a collaborative study between Genta and
the Melanoma Group of the European Organization for the Research
and Treatment of Cancer (EORTC) were presented at a scientific
meeting in September 2006. This analysis confirmed the strong
relationship between multiple outcomes (including overall survival,
progression-free survival, overall response, and durable response)
and a blood biomarker, lactate dehydrogenase (LDH). This biomarker
was prospectively specified by stratification prior to
randomization in Genta's Phase 3 trial of Genasense in advanced
melanoma. Results of the Phase 3 trial were published in the
October 10, 2006 issue of
The Journal of Clinical Oncology
, accompanied by an editorial that discusses the trial's results in
the context of current options for melanoma treatment. The article
can be accessed at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
Acute Myeloid Leukemia
In October 2006, the Company announced that target patient
accrual had been completed into a randomized Phase 3 trial of
Genasense plus chemotherapy in previously untreated patients with
acute myeloid leukemia (AML). The trial was conducted by the Cancer
and Leukemia Group B (CALGB), the largest U.S. oncology cooperative
group, and was sponsored by the National Cancer Institute (NCI). In
this trial, more than 500 previously untreated patients were
randomly assigned to receive standard induction and consolidation
chemotherapy with or without Genasense. Data from this trial are
expected to be available during 2007. The Company believes a
positive result from this trial may be sufficiently robust to
support worldwide regulatory applications for Genasense in AML
NEW PIPELINE DRUG BEGINS CLINICAL TRIALS
In October, Genta announced initiation of a Phase 1 trial of a
new anticancer drug from the company's DNA/RNA Medicines program.
The new compound, known as G4460, uses antisense technology to
target a key regulatory proto-oncogene known as
c-myb
. Using an accelerated dosing schedule, this study will evaluate
dosing regimens, safety, biologic activity, and down-regulation of
c-myb
in patients with advanced hematologic cancers. The clinical trial
will be conducted using the General Clinical Research Center at the
University of Pennsylvania, Philadelphia, PA. Genta has applied for
and received Orphan Drug designation from FDA for the use of G4460
as treatment for patients with chronic myelocytic leukemia
(CML).
FINANCIAL INFORMATION
For the third quarter of 2006, the Company reported a net loss
of $14.9 million, or $0.11 per share, compared to a net loss of
$7.9 million, or $0.07 per share, for the third quarter of 2005. In
the third quarter of 2006, total operating expenses were $15.5
million, compared to $8.1 million in the prior-year period. The
increase was primarily due to higher research and manufacturing
expenses, and the planned expansion of our sales and marketing
activities in anticipation of a possible commercial approval and
launch of Genasense, as well as $0.9 million in stock optionrelated
expense recognized as a result of the adoption of Statement of
Financial Accounting Standards No. 123R, "Share-Based Payment", on
January 1, 2006.
As of September 30, 2006, Genta had no long-term debt, $0.1
million in short-term debt, and cash, cash equivalents, and
marketable securities of $40.1 million, compared to $21.3 million
as of December 31, 2005. On September 25, 2006, the Company sold 20
million shares of its common stock at a price of $0.79 per share
for gross proceeds of $15.8 million, before fees and expenses. Net
cash used in operating activities through September 30, 2006 was
$33.5 million, which represents an average monthly outflow of $3.7
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, 2006 at 8:00 am EDT.
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
3540311
.
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
Company has submitted a New Drug Application (NDA) to the Food and
Drug Administration for the use of Genasense plus fludarabine and
cyclophosphamide for treatment of patients with relapsed or
refractory chronic lymphocytic leukemia (CLL). Genta has also
completed a Marketing Authorization Application to the European
Medicines Agency (EMEA) for use of Genasense plus dacarbazine for
treatment of 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. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
Safe Harbor
This press release and the conference call to follow 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;
-
the Company's ability to regain 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 2005 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACTS:
Investor Relations
Tara Spiess/Andrea Romstad
TS Communications Group, LLC
info@genta.com
(908) 286-3980
Genta Incorporated
Selected Condensed Consolidated Statements of Operation
(In thousands, except per share data) (Unaudited)
| |
Three Months Ended
|
Nine Months Ended
|
| |
September 30
|
September 30
|
| |
2006
|
2005
|
2006
|
2005
|
|
Revenues:
|
|
|
|
|
| License fees / Development Funding |
$
-
|
$
-
|
$
-
|
$
26,229
|
| Product sales - net |
145
|
86
|
591
|
259
|
|
Total revenues
|
145
|
86
|
591
|
26,488
|
| |
|
|
|
|
| Cost of goods sold |
41
|
22
|
79
|
35
|
| |
|
|
|
|
|
Operating expenses:
|
|
|
|
|
| Research and development |
8,514
|
4,619
|
21,900
|
14,040
|
| Selling, general and administrative |
6,939 |
3,495 |
19,112 |
12,116 |
| Loss on disposition of property and equipment |
- |
1 |
- |
4 |
|
Total operating expenses - gross
|
15,453
|
8,115
|
41,012
|
26,160
|
| sanofi-aventis reimbursement |
-
|
-
|
-
|
(6,090)
|
|
Total operating expenses - net
|
15,453
|
8,115
|
41,012
|
20,070
|
| |
|
|
|
|
| Gain on forgiveness of debt |
-
|
-
|
-
|
1,297
|
| Other income, net |
409
|
147
|
1,023
|
361
|
|
Net (loss) / income
|
$ (14,940)
|
$ (7,904)
|
$ (39,477)
|
$ 8,041
|
|
Net (loss) / income per basic and diluted
share
|
$ (0.11)
|
$ (0.07)
|
$ (0.31)
|
$ 0.08
|
|
Shares used in computing basic net (loss) /
income per share
|
135,587
|
105,629
|
129,116
|
98,820
|
| |
|
|
|
|
|
Shares used in computing diluted net (loss) /
income per share
|
135,587
|
105,629
|
129,116
|
99,015
|
| |
|
|
|
|
| |
|
|
|
|
Selected Condensed Consolidated Balance Sheet Data
(Unaudited)
| |
September 30
|
December 31
|
| |
2006
|
2005
|
| Cash, cash equivalents and marketable securities |
$ 40,117
|
$ 21,282
|
| Working capital |
28,005
|
11,703
|
| Total assets |
44,560
|
27,386
|
| Total stockholders' equity |
31,259
|
15,697
|