Genta Incorporated (OTCBB: GNTA.OB) today announced financial results
for the quarter ended September 30, 2008. The Company recorded
significant milestones in the third quarter, including the following:
-
AGENDA Phase 3 trial of Genasense in melanoma passes futility
analysis; enrollment completion expected in First Quarter 2009
-
FDA targets December 3, 2008 for decision on Genasense®/CLL
NDA
-
Tesetaxel regulatory applications completed enabling clinical trials
"We are continuing our dialog with FDA on the
Genasense® NDA in CLL and look forward to news
regarding a decision later this quarter,” said
Dr. Raymond P. Warrell, Jr., Genta’s Chairman
and Chief Executive Officer. "Patient accrual
into AGENDA, our randomized Phase 3 trial of Genasense in advanced
melanoma, is proceeding well, and we anticipate completing enrollment in
the 1st quarter of 2009. The recent evaluation
of AGENDA by the independent Data Monitoring Committee for both safety
and futility has allowed the trial to progress to completion. For
tesetaxel, we have now completed the regulatory filings needed to resume
clinical trials. This new agent, which we believe is the leading oral
taxane currently in clinical development, may offer substantial benefit
to patients, along with significant revenue and partnering potential for
our Company. We remain focused on creating the financial structures that
will enable us to leverage these portfolio opportunities.”
Recent highlights include the following:
Genasense in Chronic Lymphocytic Leukemia (CLL): In July 2009,
the Food and Drug Administration (FDA) notified the Company that the
amendment to its New Drug Application (NDA) for the use of Genasense
plus chemotherapy in patients with relapsed/refractory CLL had been
accepted for review. This submission was based primarily on new
information from the Company's completed, randomized Phase 3 trial that
showed, among other findings, a significant increase in overall survival
for patients who achieved a complete or partial response when treated
with Genasense plus chemotherapy compared with patients treated with
chemotherapy alone. FDA has assigned a Prescription Drug User Fee Act
(PDUFA) goal date of December 3, 2008 to this application.
Genasense in Melanoma: Genta is currently enrolling patients with
advanced melanoma in a Phase 3 trial of Genasense plus chemotherapy,
known as AGENDA. AGENDA is a randomized, double-blind,
placebo-controlled trial that is intended to support global registration
of Genasense for patients with advanced melanoma. The study is designed
to confirm certain safety and efficacy results from Genta's prior
randomized trial of Genasense combined with dacarbazine in 300 patients
identified by a biomarker who have not previously received chemotherapy.
During the third quarter, an independent Data Monitoring Board reviewed
information from this study and communicated to the Company that the
trial passed a planned analysis for futility and enrollment should
continue to intended completion. The Company currently expects to
complete enrollment in the first quarter of 2009.
Tesetaxel: In recent regulatory activity, Genta has submitted
amendments to both the Investigational New Drug (IND) applications and
to the Drug Master File (DMF). Acceptance of these amendments should
allow the Company to resume clinical trials with tesetaxel. Tesetaxel, a
leading oral taxane, 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 completed Phase 2a studies have
demonstrated anticancer activity in patients with advanced gastric
cancer and advanced breast cancer. If further studies document efficacy
and safety, tesetaxel may offer substantial opportunities to improve
convenience, safety, and activity for patients who are currently
receiving conventional taxanes. The Company expects to announce its
clinical development plans and timelines for tesetaxel in the near
future.
Financial Information
In June 2008, the Company entered into a convertible note transaction
(described below). That transaction required that the Company seek
stockholder approval to increase the number of authorized shares of
common stock. While such approval was obtained in October 2008, for
prior periods, including the third-quarter results that are being
reported today, the Company has been required to mark-to-market the
liabilities for the conversion feature of its notes and a warrant issued
as part of the transaction. These liabilities change with the price of
Genta’s common stock, and these fluctuations
have caused us to report positive net income for the third quarter of
2008.
The Company reported net income of $212.6 million, or $5.78 per basic
share, and $0.10 per diluted share for the third quarter of 2008,
compared with a net loss of $7.7 million, or $(0.25) per share, for the
third quarter of 2007. The calculation of diluted earnings per share
includes the assumption that all outstanding instruments potentially
convertible into shares of common stock are converted, including the
impact of converting $20 million of convertible notes into 2 billion
shares of common stock and the warrant into 40 million shares of common
stock. For the nine months ended September 30, 2008, the Company
reported a net loss of $535.4 million, or $(14.97) per share, compared
with a net loss of $21.6 million, or $(0.74) per share, for the nine
months ended September 30, 2007.
Net product sales of Ganite for the third quarter and nine months ended
September 30, 2008 of $0.1 million and $0.4 million, respectively, were
virtually unchanged from the comparison periods one year ago.
Research and development expenses were $5.3 million for the third
quarter of 2008, compared with $4.8 million for third quarter of 2007.
This increase was primarily due to higher expenses from the AGENDA
clinical trial, partially offset by lower payroll costs, resulting from
lower headcount. The Company reduced its workforce to conserve cash in
both April 2008 and in May 2008. Research and development expenses were
$16.1 million for the nine months ended September 30, 2008, compared
with $12.2 million for the nine months ended September 30, 2007. This
increase was primarily due to the recognition in March 2008 of $2.5
million for license payments on tesetaxel and higher expenses from the
AGENDA clinical trial, partially offset by lower payroll costs.
Selling, general and administrative expenses for the three and nine
months ended September 30, 2008 were $2.3 million and $8.5 million,
respectively, compared with $4.1 million and $12.9 million for their
comparison periods. The reductions are primarily due to our efforts at
lowering administrative expenses, lower office rent and lower payroll
costs.
In May 2008, to reduce its ongoing expenses, the Company reduced its
office space. The Company’s landlord received
a termination payment of $1.3 million, comprised of security deposits,
and will receive a future payment of $2.0 million upon the earlier of
July 1, 2009 or Genta’s receipt of at least
$5.0 million from a business development transaction. This agreement
resulted in an incremental $3.3 million in expenses for the nine months
ended September 30, 2008.
In the fourth quarter of 2006, the Company recorded an expense of $5.3
million that provided for the issuance of 2.0 million shares of Genta
common stock, for a settlement in principle of class action litigation.
This liability was marked to market until the date that the settlement
became final, June 27, 2008. The fluctuation in the price of Genta’s
common stock resulted in income of $0.8 million in the third quarter of
2007, and income of $0.3 million for the nine months ended September 30,
2008, compared with $2.6 million for the nine months ended September 30,
2007.
On June 5, 2008, the Company entered into a securities purchase
agreement with certain institutional and accredited investors to place
up to $40.0 million of senior secured convertible notes. On June 9,
2008, the Company placed $20.0 million of such notes in the initial
closing. The notes bear interest at an annual rate of 15% payable at
quarterly intervals in stock or cash at the Company's option, and are
convertible into shares of Genta common stock at a conversion rate of
100,000 shares of common stock for every $1,000.00 of principal. The
Company incurred a financing fee of $1.2 million, and in addition,
issued a warrant to its financial advisor to purchase 40,000,000 shares
of common stock at an exercise price of $0.02 per share.
On the date that the convertible notes were issued, there were an
insufficient number of authorized shares of common stock in order to
permit exercise of all of the issued convertible notes. In accordance
with EITF 00-19 "Accounting for Derivative
Financial Instruments Indexed to, and Potentially Settled in, a Company’s
Own Stock” when there are insufficient
authorized shares, the conversion obligation for the convertible notes
is classified as a liability measured at fair value on the balance
sheet. On June 9, 2008, based on a Black-Scholes valuation model that
included a closing price of Genta’s common
stock of $0.20 per share, a fair value of the conversion feature of
$380.0 million was calculated, and that amount that exceeded the
proceeds of the $20.0 million initial closing, $360.0 million, was
expensed. The Company recorded an initial discount of $20.0 million
equal to the face value of the notes.
Similarly, the warrant was treated as a liability, and was recorded at a
fair value of $7.6 million based upon the Black-Scholes valuation model
and a closing price of Genta’s common stock
of $0.20 per share. The $20 million in initial discount on the
convertible note, the $7.6 million recorded upon the issuance of the
warrant and the $1.2 million financing fee are being amortized over the
two-year life of the note, resulting in amortization of deferred
financing costs of $3.6 million and $4.4 million, respectively, for the
three and nine months ended September 30, 2008.
On June 30, 2008, both the conversion feature liability and warrant
liability were valued based upon a Black-Scholes valuation model that
included a closing price of our common stock of $0.38 per share. On
September 30, 2008, the conversion feature liability and the warrant
liability were valued based on a Black-Scholes valuation model that
included a closing price of Genta’s common
stock of $0.27 per share, resulting in income of $220.0 million and $4.4
million, respectively, for the third quarter of 2008 and expense of
$500.0 million and $2.8 million, respectively, for the nine months ended
September 30, 2008.
The conversion feature liability and the warrant liability will be
re-measured and credited to permanent equity as of October 6, 2008, the
date on which the Company’s stockholders
approved an amendment to Genta’s Restated
Certificate of Incorporation, as amended, to increase the total number
of authorized shares of capital stock available for issuance.
Net other expense was $0.7 million and $0.8 million, respectively, for
the three and nine months ended September 30, 2008, compared to net
other income of $0.2 million and $0.7 million, respectively, for the
three and nine months ended September 30, 2007. This difference was due
to accrued interest on the recently issued convertible notes and from
lower investment income, resulting from lower investment balances.
At September 30, 2008, Genta had cash, cash equivalents and marketable
securities totaling $8.7 million compared with $7.8 million at December
31, 2007. During the first nine months of 2008, cash used in operating
activities was $22.0 million compared with $23.7 million for the same
period in 2007. The Company estimates that its average net cash outflow
will be less than $2.5 million per month for the remainder of 2008.
Conference Call and Webcast
Genta management will host a conference call and live audio webcast to
discuss these financial results and corporate activities on Thursday,
November 6, 2008, at 8:00 am EST. Participants can access the live call
by dialing (877) 634-8606 (U.S. and Canada) or (973) 200-3973
(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 70101499.
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: 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.
Such forward-looking statements include
those that express plan, anticipation, intent, contingency, goals,
targets, or future developments and/or otherwise are not statements of
historical fact.
The words "potentially”,
"anticipate”, "could”,
"calls for”, and
similar expressions also identify forward-looking statements.
The
Company does not undertake to update any forward-looking statements.
Factors
that could affect actual results include, without limitation,
risks
associated with:
-
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, the Company’s
ability to obtain sufficient financing to maintain the Company’s
planned operations, or the Company’s risk
of bankruptcy;
-
the adequacy of the Company’s patents
and proprietary rights;
-
the impact of litigation that has been brought against the Company;
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.
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.
|
Genta Incorporated
|
|
Selected Condensed Consolidated Statement of Operations
|
|
(In thousands, except per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
September 30
|
|
September 30
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Product sales - net
|
|
$
|
115
|
|
|
$
|
115
|
|
|
$
|
363
|
|
|
$
|
314
|
|
|
Cost of goods sold
|
|
|
26
|
|
|
|
20
|
|
|
|
79
|
|
|
|
68
|
|
|
Gross margin
|
|
|
89
|
|
|
|
95
|
|
|
|
284
|
|
|
|
246
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
5,255
|
|
|
|
4,763
|
|
|
|
16,146
|
|
|
|
12,244
|
|
|
Selling, general and administrative
|
|
|
2,308
|
|
|
|
4,083
|
|
|
|
8,534
|
|
|
|
12,870
|
|
|
Settlement of office lease obligation
|
|
|
-
|
|
|
|
-
|
|
|
|
3,307
|
|
|
|
-
|
|
|
Reduction in liability for settlement of litigation
|
|
|
-
|
|
|
|
(800
|
)
|
|
|
(340
|
)
|
|
|
(2,600
|
)
|
|
Total operating expenses
|
|
|
7,563
|
|
|
|
8,046
|
|
|
|
27,647
|
|
|
|
22,514
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred financing costs and debt discount
|
|
|
(3,600
|
)
|
|
|
-
|
|
|
|
(4,441
|
)
|
|
|
-
|
|
|
Fair value - conversion feature liability
|
|
|
220,000
|
|
|
|
-
|
|
|
|
(500,000
|
)
|
|
|
-
|
|
|
Fair value - warrant liability
|
|
|
4,400
|
|
|
|
-
|
|
|
|
(2,800
|
)
|
|
|
-
|
|
|
All other income/(expense), net
|
|
|
(713
|
)
|
|
|
219
|
|
|
|
(804
|
)
|
|
|
697
|
|
|
Net income/(loss)
|
|
$
|
212,613
|
|
|
$
|
(7,732
|
)
|
|
$
|
(535,408
|
)
|
|
$
|
(21,571
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) per basic share
|
|
$
|
5.78
|
|
|
$
|
(0.25
|
)
|
|
$
|
(14.97
|
)
|
|
$
|
(0.74
|
)
|
|
Net income/(loss) per diluted share
|
|
$
|
0.10
|
|
|
$
|
(0.25
|
)
|
|
$
|
(14.97
|
)
|
|
$
|
(0.74
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net income/(loss) per basic share
|
|
|
36,756
|
|
|
|
30,621
|
|
|
|
35,763
|
|
|
|
29,284
|
|
|
Shares used in computing net income/(loss) per diluted share
|
|
|
2,076,191
|
|
|
|
30,621
|
|
|
|
35,763
|
|
|
|
29,284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
|
|
|
|
|
|
|
2008
|
|
December 31
|
|
|
|
|
|
|
Unaudited
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
8,715
|
|
|
$
|
7,813
|
|
|
|
|
|
|
Working (deficit)/capital
|
|
|
(3,377
|
)
|
|
|
877
|
|
|
|
|
|
|
Total assets
|
|
|
35,113
|
|
|
|
29,293
|
|
|
|
|
|
|
Total stockholders' (deficit)/equity
|
|
|
(529,197
|
)
|
|
|
2,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes fair value of the conversion feature liability and the
warrant liability
|