Genta Incorporated (NASDAQ: GNTA) today announced financial
results and progress for the quarter and year ended December 31,
2008. The Company noted significant recent milestones,
including:
- AGENDA: Phase 3
biomarker-directed trial nears completion in melanoma
- Tesetaxel, a leading Phase 2
oral taxane, prepares for pivotal trial in gastric cancer
- Genasense�
intermittent schedule enters trial in melanoma
- Decision on FDA appeal for
Genasense NDA in CLL expected this quarter
- New oral product for bone
loss, G4544, completes initial Phase 1 trial
�Genta has three exceptional, high-value, late-stage products in
our portfolio,� noted Dr. Raymond P. Warrell, Jr., Genta�s Chairman
and Chief Executive Officer. �We expect the Phase 3 AGENDA trial of
Genasense� in patients with advanced melanoma to complete accrual
later this quarter. Positive results from AGENDA should support
global regulatory applications. We have aggressively pursued the
clinical development of tesetaxel, a drug that we believe can be
the first oral taxane approved in oncology. Tesetaxel offers a
unique and exceptionally attractive market opportunity to reduce
side effects for patients and potentially expand the diseases that
may respond to this class of compounds. Lastly, we continue to
pursue development of G4544, which also offers a potential
early-to-market opportunity via a streamlined 505(b)(2) regulatory
strategy. Each drug in our portfolio offers significant partnering
opportunities that can accelerate their development.�
Highlights and updates of the Genta programs appear below.
GENASENSE�: CLINICAL AND REGULATORY
ACTIVITY
Phase 3/Melanoma: Genta will shortly conclude patient
accrual into its second Phase 3, randomized, controlled trial of
Genasense� in patients with advanced melanoma, known as AGENDA. The
study is designed to confirm certain safety and efficacy results
from our prior randomized trial of Genasense� combined with
dacarbazine (DTIC) 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.
These patients are characterized by low-normal levels of LDH
(lactate dehydrogenase), a tumor-derived enzyme that is readily
detected in blood. Analysis of those efficacy outcomes in the prior
study, which were observed in 274 patients, showed the following
results:
Endpoint
�
Genasense�/DTIC
�
DTIC
�
Hazard
Ratio
�
P
Overall response 20.8% 7.2% 0.002 Durable response 10.7% 2.4% 0.007
Progression-free survival, median 3.6 mos. 1.6 mos. 0.58 <
0.0001 Overall survival, median 12.3 mos. 9.9 mos. 0.64 0.0009
A scientific article that describes efficacy and safety results
from this study can be accessed at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1. AGENDA
has co-primary endpoints of progression-free survival and overall
survival. Genta currently expects the final analysis of
progression-free survival, and the first interim assessment of
overall survival, to be available in the Fall of 2009.
Phase 3/Chronic Lymphocytic Leukemia (CLL)/NDA Status:
Genta has appealed a prior �non-approvable� decision on the
Genasense� New Drug Application (NDA) for patients with
relapsed/refractory CLL. The appeal is now pending a decision by
FDA�s Center for Drug Evaluation and Research (CDER). The pivotal
randomized trial achieved its primary endpoint, which was to
significantly increase the proportion of patients who achieved
complete remission by adding Genasense� to standard chemotherapy
compared with patients treated with chemotherapy alone. With
5-years of follow up, all patients who achieved a major response
(either complete or partial remission) on the Genasense� treatment
arm achieved superior survival compared with responders treated
with chemotherapy alone. A decision from CDER is expected in the
current quarter.
TESETAXEL, THE LEADING ORAL TAXANE IN CLINICAL
DEVELOPMENT
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane
that is in the same class of drugs as paclitaxel and docetaxel.
However, both prototype agents suffer from serious safety issues,
particularly hypersensitivity reactions related to intravenous
infusions that are occasionally fatal and that require careful
premedication and observation. Other prominent side-effects of this
drug class include myelosuppression (low blood counts) and
peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed
to maintain the high antitumor activity of the taxane drug class
while eliminating infusion reactions, reducing neuropathy, and
increasing patient convenience. The oral route also enables
development of novel schedules that may expand dosing options when
tesetaxel is used alone or in combination with other anticancer
drugs. Preclinically, tesetaxel has demonstrated substantially
higher activity against cell lines that were resistant to
paclitaxel and docetaxel, since acquired resistance is not mediated
by the multidrug-resistant p-glycoprotein.
Tesetaxel has demonstrated anticancer activity in several
completed Phase 2 clinical trials, including patients with advanced
gastric cancer and advanced breast cancer. The drug has not been
associated with severe infusion reactions that are linked with
other taxanes. Moreover, unlike other oral taxanes, nerve damage
has not been a prominent side effect of tesetaxel. Thus, the drug
offers substantial opportunities to improve patient convenience,
safety, and anticancer activity.
More than 250 patients worldwide have been treated with oral
tesetaxel in Phase 1 and Phase 2 clinical trials. Genta is
currently running a U.S. clinical trial to examine the
pharmacokinetics of tesetaxel over a critical dosing range for
pivotal regulatory trials. Data from this trial should be available
at the annual meeting of the American Society of Clinical Oncology
held in Orland, FL May 29-June 2, 2009.
Tesetaxel received designation as an Orphan Drug by FDA for
treatment of patients with advanced gastric cancer and advanced
melanoma. Genta has submitted a proposal for a randomized
controlled trial of tesetaxel to FDA for Special Protocol
Assessment to support an efficacy claim for patients with advanced
gastric cancer who have progressed on first-line therapy.
G4544, A NEW ORAL DRUG FOR SKELETAL DISEASES
G4544 contains the active ingredient in Ganite�, a highly
effective intravenous drug that is approved in the U.S. and
marketed for treatment of patients with cancer-related
hypercalcemia that is resistant to hydration. Low doses of the
active ingredient have shown clinical activity in a range of
skeletal diseases, such as bone metastasis, Paget�s disease and
osteoporosis. Genta has completed an initial Phase 1 study of
G4544, a proprietary small molecule formulation of this active
ingredient.
The Company has sought and received FDA guidance on the initial
development of G4544. Genta believes that a 505(b)(2) regulatory
pathway may shorten development time and enable regulatory approval
by establishing bioequivalence to Ganite�. The 505(b)(2) approach
enables potential approval in the currently approved indication for
Ganite (cancer-related hypercalcemia) in parallel with development
in other indications.
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 the period from June 9, 2008 through October
6, 2008, the Company was 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 changed with the price
of Genta�s common stock, and these fluctuations resulted in net
income for the fourth quarter of 2008.
The Company reported net income of $29.6 million, or $0.26 per
basic share, and $0.02 per diluted share for the fourth quarter of
2008, compared with a net loss of $1.7 million, or $(0.06) per
share, for the fourth 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 $15.5 million of
convertible notes into 1.55 billion shares of common stock and the
warrant into 40 million shares of common stock. For the year ended
December 31, 2008, the Company reported a net loss of $505.8
million, or $(9.10) per share, compared with a net loss of $23.3
million, or $(0.79) per share, for the year ended December 31,
2007. Presently, the Company has approximately 950 million shares
outstanding.
Unexpected returns of Ganite� in the fourth quarter of 2008
resulted in no net reported sales during the fourth quarter and
$0.4 million for the year compared with sales of $0.3 million and
$0.6 million in their respective comparison periods.
Research and development expenses for the fourth quarter and
year ended December 31, 2008 were $3.8 million and $20.0 million,
respectively, compared with $1.2 million and $13.5 million for
their comparison periods. The annual increase in expenses in 2008
is primarily due to the recognition in March 2008 of $2.5 million
for license payments on tesetaxel, $1.0 million in accrued
milestone payments related to tesetaxel and higher expenses
resulting from the AGENDA clinical trial. These increases were
partially offset by lower compensation expense, as the Company
reduced its workforce to conserve cash in both April 2008 and in
May 2008.
Selling, general and administrative expenses for the fourth
quarter and year ended December 31, 2008 were $1.9 million and
$10.5 million, respectively, compared with $4.0 million and $16.9
million for their comparison periods. The reductions are primarily
due to our efforts at lowering administrative expenses, lower
office rent and lower compensation expense.
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 the
Company agreed to 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 year ended December
31, 2008. In January 2009, we entered into another amendment of our
agreement with our landlord whereby the future payment of $2.0
million is now payable on January 1, 2011. The Company will pay
6.0% interest in arrears to our landlord from July 1, 2009 through
the new payment date. The first interest payment of approximately
$30 thousand will be payable as of October 1, 2009.
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 $1.6 million in the fourth quarter of 2007, and income of $0.3
million for the year ended December 31, 2008, compared with $4.2
million for the year ended December 31, 2007.
In June 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 $6.8 million and $11.2
million, respectively, for the three months and year ended December
31, 2008.
On October 6, 2008, the date on which our 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, we re-measured the conversion
feature liability and warrant liability and credited them to
Stockholders� equity, resulting in income of $40.0 million and $0.8
million for the fourth quarter, respectively and total expense for
the year ended December 31, 2008 of $460.0 million and $2.0 million
for the year, respectively.
Net other expense was $0.6 million and $1.4 million,
respectively, for the fourth quarter and year ended December 31,
2008, compared to net other income of $0.1 million and $0.8
million, respectively, for the prior-year comparison periods. This
difference was due to accrued interest on the convertible notes and
from lower investment income, resulting from lower investment
balances.
At December 31, 2008, Genta had cash, cash equivalents and
marketable securities totaling $4.9 million compared with $7.8
million at December 31, 2007. During 2008, cash used in operating
activities was $25.7 million compared with $31.7 million for the
same period in 2007.
CONFERENCE CALL AND WEBCAST
Genta management will host a conference call and live audio
webcast to discuss financial results and corporate activities on
February 13, 2009 at 4:30 pm ET. 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 84733610.
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�);
- 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 � Twelve Months Ended December
31 December 31 2008 � 2007 2008 � 2007 Product sales - net $ - $
267 $ 363 $ 580 Cost of goods sold � 23 � � 22 � � 102 � � 90 �
Gross margin (23 ) 245 261 490 � Operating expenses: Research and
development 3,845 1,247 19,991 13,491 Selling, general and
administrative 1,918 3,995 10,452 16,865 Settlement of office lease
obligation - - 3,307 - Reduction in liability for settlement of
litigation � - � � (1,640 ) � (340 ) � (4,240 ) Total operating
expenses 5,763 3,602 33,410 26,116 � Amortization of deferred
financing costs and debt discount (6,789 ) - (11,229 ) - Fair value
- conversion feature liability 40,000 - (460,000 ) - Fair value -
warrant liability 800 - (2,000 ) - All other income/(expense), net
� (631 ) � 139 � � (1,435 ) � 836 � Income/(loss) before income
taxes 27,594 (3,218 ) (507,813 ) (24,790 ) � Income tax benefit �
1,975 � � 1,470 � � 1,975 � � 1,470 � Net income/(loss) $ 29,569 �
$ (1,748 ) $ (505,838 ) $ (23,320 ) � Net income/(loss) per basic
common share $ 0.26 � $ (0.06 ) $ (9.10 ) $ (0.79 ) Net
income/(loss) per diluted common share $ 0.02 � $ (0.06 ) $ (9.10 )
$ (0.79 ) � Shares used in computing net income/(loss) per basic
common share � 114,599 � � 30,621 � � 55,576 � � 29,621 � per
diluted common share � 1,670,074 � � 30,621 � � 55,576 � � 29,621 �
� �
Selected Condensed Consolidated Balance Sheet Data �
December 31 2008 December 31
Unaudited
2007
Cash, cash equivalents and
marketable securities
$ 4,908 $ 7,813 Working (deficit)/capital (5,220 ) 877 Total assets
12,693 29,293 Total stockholders' (deficit)/equity (4,864 ) 2,931
Genenta Science (NASDAQ:GNTA)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Genenta Science (NASDAQ:GNTA)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024