J. On March 1
, 2006, the Company announced that the application,
which was filed for Accelerated Approval, had
been accepted for review by the
FDA with a target action date of October 28, 2006. A
summary
of safety and efficacy data related to this application can be viewed
at: http://www. Lloyd Sanders
was appointed Vice-President of Sales and Marketing. Mr.41 per share, in 2004.S. AIIM 2005 is the
largest
enterprise content + document management conference and exposition showcasing
the technologies
and solutions that provide intelligence behind information.
subcription reliance
"The past year marked a key turnaround
for Genta as we seek to transition
from a research-focused organization into a commercial operating
company,"
said Dr. The Company has submitted
to the FDA a Special Protocol Assessment for its
confirmatory study in CLL,
which would be required under provisions related to accelerated approval
. The MAA is comprised of the updated final
analysis of this trial, which includes data from 24-months
of minimum follow-
up on all patients.S.com.
Genta Incorporated
Selected Condensed Consolidated Financial Data
(In thousands
, except per share data)
(Unaudited)
Three Twelve
Months Ended Months Ended
December 31
December 31
2005 2004 2005 2004
Revenues:
License fees/Development Funding $- $11,199 $26,229 $15,127
Product sales - net 97 (1,224) 356 (512)
Total revenues
97 9,975 26,585 14,615
Cost of goods sold
17 5 73 170
Provision for excess inventory - 657
(21) 1,350
Total cost of goods sold 17 662 52 1,520
Costs and expenses:
Research and development 6,862 9,554 20,902
71,494
Selling, general and
administrative 3,985 4,348
16,100 28,576
Loss on disposition of property
and equipment
- - 4 1,254
Total costs and expenses - gross 10,847 13
,902 37,006 101,324
sanofi-aventis reimbursement - (6,839) (6,090) (43
,292)
Total costs and expenses - net 10,847 7,063 30,916 58,032
Gain
on forgiveness of debt - 11,495 1,297 11,495
Other income (expense)
142 (67) 502 (147)
Net loss (income) before income tax
benefit (10,625) 13,678 (2,584) (33,589)
Income tax benefit
381 904 381 904
Net loss (income)
$(10,244) $14,582 $(2,203) $(32,685)
Net loss (income) per basic and
diluted share
$(0.
Traction's award winning TeamPage software makes it easy for groups
of
business users to keep in touch using a simple, secure and highly effective
weblog model for
working communication.reliant wholesome
Thomas Kean and former
Congressman Lee Hamilton, the ranking Republican and
Democratic members of the
9/11 Commission, this weekend criticized the Bush Administration and Congress
for what they termed a "lack of urgency" in addressing the ongoing threats to
our nation's homeland
security.
"What we need is a multi-faceted strategy of border control and interior
immigration
enforcement, beginning with the immediate passage of H.R."
In a blueprint for addressing the
terrorist threat, Code Orange:
Diminishing the Terrorist Threat to America, (http://www."
FAIR is calling for swift action to pass and implement H.R. Key highlights for the year
included:
* Genta completed submission of its New Drug Application (NDA) for
Genasense(R)
(oblimersen sodium) Injection plus chemotherapy for the
treatment of patients with chronic
lymphocytic leukemia (CLL). The SC development program will evaluate a range of single doses,
followed
by repeated dosing schedules, in order to optimize use for possible
future studies.D.2 million were
generated by the accelerated
recognition of the initial $10. In addition, the prior-
year quarter
includes a provision for sales returns of $1. Genasense(R) (oblimersen sodium)
Injection is the
Company's lead compound from its oligonucleotide program.genta.heathenry wordworks
genta.
Dr. Lindell has nearly
20 years of experience in the pharmaceutical
industry.2 million, or $.3 million.0 million
development
funding received from sanofi-aventis in 2002 under the
Collaborative Agreement.2 million as of December
31, 2004.8 million, before fees and expenses. The Company's research platform is
anchored by two
major programs that center on oligonucleotides (RNA- and DNA-
based medicines) and small molecules
. For a discussion of those risks and uncertainties,
please see the Company's Annual Report/Form
10-K for 2005.
About AIIM
AIIM (The Association for Information and Image Management
) -- the
international authority on Enterprise Content Management (ECM), is leading the
way to
the understanding, adoption and use of ECM technologies.handcrafts sufficiency
4313,
the True Comprehensive Enforcement
and Border Security Act of 2005. Kean aptly observed, 'What
will our excuse be?'"
For more
information please contact Ira Mehlman at 310-821-4283. It is currently anticipated that
this transaction
will close on March 13, 2006, and the Company believes that
proceeds raised from this offering will
be sufficient to fund its operations
into the first quarter of 2007.2 million related to
sales
of Ganite(R).
The income statement reflects a gain on forgiveness of debt of $1.genta. Access
numbers for this replay are: (800) 642- 1687 (U.S. for
treatment of patients with cancer related
hypercalcemia that is resistant to
hydration."
For product management, sales, marketing, competitive
intelligence and
other business functions, Traction's solution does 80% of what traditional ECM
solutions
do at 20% of the cost.org. TeamPage is used for business applications ranging from product
development
and project management to marketing field communication,
competitive intelligence, and sales.subcription deliberate
Warrell
, Jr. The Company
anticipates that the trial will proceed to completion of its 500-patient
accrual
target, which is currently expected in 2006.
Genasense in Other Types of Cancer: To take
maximum advantage of the
opportunity afforded by an agent that may broadly amplify the effectiveness
of
cancer therapy, Genasense is currently being evaluated in combination with a
variety of cancer
treatments in patients with lymphoma, leukemia, and solid
tumors.S.6 million, or $.
In the
fourth quarter, total revenues were $0.8 million, compared to $13. Reimbursement from sanofi-aventis
for
2005 was $6. Both gains are the result of the
termination of the Collaborative Agreement with
sanofi-aventis. Upon closing of this
financing and at the currently projected rate of spending,
including building
the Company's sales and marketing team and capabilities, we believe the
Company
should have sufficient cash to maintain its operations into the first
quarter of 2007. For additional
information, visit http://www.haying frugal
Instead,
what we're getting from the White House and some in Congress
are proposals for
an amnesty and guest worker program on such a massive scale that Osama bin
Laden
himself would probably slip through the cracks. immigration laws. In the prior-year quarter, license
fees and development
funding revenues of $11.
This financing is expected to close on March 13
, 2006.
Conference Call and Webcast
US/Canada call: 877-634-8606; conference code:
Genta Incorporated
International call: 706-679-3140; conference code: Genta Incorporated
Webcast: http://www.
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.09) $0.Traction Introduces TeamPage as Disruptive Alternative to Electronic Content Management
Software
Traction Software has been named one of
the 100 Companies that Matter by KMWorld and
is a winner of the RedHerring 100
and EContent 100 awards.tractionsoftware.wholesome handcrafts
org) FAIR lays
out
a comprehensive strategy that includes enhanced border security,
entry/exit controls, increased workplace
enforcement, document security,
greater involvement and cooperation of local law enforcement, and
other urgent
reforms.
* Genta eliminated all debt from its balance sheet and acquired
sufficient
inventory of Genasense to accommodate a worldwide commercial launch."
The Company highlighted several important corporate developments for the
year, as follows:
Regulatory Filings
Chronic Lymphocytic Leukemia
In December 2005, the Company submitted
a New Drug Application (NDA) to
the U.
Malignant Melanoma
In December 2005, the
Company submitted a MAA to the EMEA for the use of
Genasense plus dacarbazine as treatment for patients
with advanced melanoma.com/Genta/InvestorRelation/2006/press_20060103.
Management and Operations
The Company's senior management team was significantly strengthened by the
recent appointments
of key executives, including:
* W.
The leading drug in Genta's small molecule program
is Ganite(R) (gallium
nitrate injection), which the Company is exclusively marketing in the U.
The Company does not undertake to update any forward-looking statements.6 is a free upgrade for
Traction's customer that provides significant new user-driven enhancements.nuggets heathenry
Four out of every five
non-Mexican
illegal immigrants caught last year were released into society and asked to
return
for a court date, according to President Bush.S.genta. The new method may substantially increase
patient
convenience and expand the utility of Genasense, particularly in
front-line and adjuvant settings
. Moran, CPA, was appointed Senior Vice-President, Chief
Financial Officer, and Corporate Secretary
. Lindell, Sc. There was no expense reimbursement in the fourth
quarter of 2005, since as of May 2005
all Genasense costs are the
responsibility of Genta. Research and development expenses in 2004 included
$33./Canada)
and (706) 645-9291 (International); conference ID number is 6397523.S. Most people
who use the term mean a simpler back-to-the-old-ways, self-sufficient lifestyle.
simpler handcrafts
"When the date arrives
,"
he said, "about 75 percent of those released don't show up to the court.
"The 9/11 terrorists
took advantage of vulnerabilities of our own making
to perpetrate their deadly attacks. "We are very
pleased with the progress made across multiple fronts,
including the strengthening of our management
team and submission of worldwide
regulatory applications for marketing approval of Genasense.html
. Sanders was Vice-President, Oncology Sales, at
sanofi-aventis, where he led the Eloxatin(R
), Taxotere(R), and ELITEK(R)
sales teams.2 million, or $.0 million, compared with $101. In
addition, research and development expenses in 2005 declined due to lower
activity on several
clinical studies.
The Company has submitted a New Drug Application (NDA) to the U.02) $(0.
reliance homesteading
, Genta
's Chairman and Chief Executive
Officer.html. Board of Ortho Biotech from
1995 until 2002
, and from 2000 to 2002 he assumed finance responsibility
for the Ortho Biotech Worldwide Board
. He was most recently Vice-President, Corporate Development, at
Metaphore Pharmaceuticals.
Little and as a Research Engineer at Pharmacia AB in Uppsala,
Sweden.html
The webcast
will be archived for 30 days. 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. It's simple to link to and comment
on information posted on the corporate
intranet, as well as the public
Internet, making content actionable that the company has paid dearly
to
create. The modern meaning of 'Homesteading' is more than just living on a farm though.
haying homesteader
As a
result
, last year only 30,000 of the 160,000 non-Mexicans caught coming across
our southwest border were
sent home.fairus.S.
Clinical Program Update
Subcutaneous Genasense: The Company
recently announced the start of
patient enrollment into a study that will evaluate a new formulation
of
Genasense that can been administered by subcutaneous (SC) injection.
Genasense in Acute
Myeloid Leukemia: Under sponsorship of the National
Cancer Institute (NCI), a randomized trial of
standard chemotherapy with or
without Genasense is being conducted by the Cancer and Leukemia Group
B
(CALGB), the largest oncology cooperative group in the U.
launch of Genasense.A.0 million
in the fourth
quarter of 2004. The gain in
2005 resulted in May 2005 from the forgiveness of the
remaining balance on a
Line of Credit and the gain in 2004 resulted from the forgiveness of
convertible
debt and accrued interest.
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. For more information about Genta, please visit our website at:
http://www
. today introduced its
Traction(R) TeamPage(TM) enterprise weblog software to the ECM marketplace
at
the Annual AIIM Conference and Exhibition. Traction's products include a host of
capabilities
that address security and other critical needs of business
workgroups while retaining the simplicity
, scalability and syndication
features that make personal weblogs so easy to deploy and use on the
public
Internet. Weblog technology is also intuitive to
anyone who uses the Internet or email
, so training costs is minimal and users
can immediately benefit from day one of installation.com
.homesteader homesteading
"
"The statements being made by members of the 9/11 Commission are chilling
and ought to be
taken as a call to action," said Dan Stein, president of FAIR.
"There can be no higher priority for
the president and Congress than to
protect homeland security," said Stein. Shares related to that
offering are being
sold pursuant to the Company's registration statement on Form S-3 declared
effective
by the Securities and Exchange Commission on May 11, 2004 and
prospectus supplement dated March 6
, 2006.
The MAA is principally based on long-term data derived from the largest
randomized controlled
trial that has been conducted in patients with advanced
melanoma.7 million, or $.3
million in
2004.
As of December 31, 2005, Genta had no short-term or long-term debt, and
had cash, cash
equivalents and marketable securities of $21.com
About Traction Software
Traction
Software provides business and government organizations with
enterprise weblog software that allows
groups and teams to communicate more
effectively.
617-899-1377
jen@redjavelin.sufficiency haying
Absent
having closed that transaction, and
given the Company's recurring losses and negative cash flows
from operations,
the Company's annual report on Form 10-K that was filed today contains a
"going
-concern" qualification from its independent registered public
accounting firm, Deloitte + Touche
LLP. Genasense has demonstrated preclinical synergy with various
treatments, such as Tarceva(R)
(erlotinib), interferon and radiation, that
require multi-day schedules. He has held previous positions
at Avalon
Pharmaceuticals, Knoll Pharmaceuticals, the Boston Consulting Group,
Arthur
D.0 million licensing fee and $40. As a result of the notice of termination, the remaining balance
of deferred revenues as of November 2004 were recognized over the six-month
termination notice
period, which ended in May 2005.
Fourth quarter 2005 gross expenses were $10. The flexibility
and simplicity of the weblog format makes it
simple to write long or short items that keep track
of research, discussion,
debate, decisions and follow-up actions. TeamPage 3. For AIIM's E-Doc
magazine, visit
http://www. Based in Providence, Rhode Island, Traction Software
is a privately
held corporation with financing from investors including In-Q-
Tel and Slater Interactive.com
homesteader smallholders
Randomized Trials of Genasense in Lung and Prostate cancer: Three
randomized
trials of Genasense in combination with various types of
chemotherapy have completed enrollment,
including studies in non small cell
lung cancer, small cell lung cancer, and hormone-refractory prostate
cancer. Sanders is responsible for building the sales and
marketing infrastructure of the Company
to support the potential U. Moran brings extensive and diversified finance
experience from
a long career with Johnson and Johnson and several of
its operating companies., as Vice-President
of Business Development.18
per share, for the fourth quarter of 2004. As a result of the termination
, the income statement for
the fourth quarter of 2005 reflects no license fees or development funding
revenue and no research and development reimbursement.com/genta/InvestorRelation/events.S.Traction
Attends AIIM 2005 to Bring Enterprise Weblogs to the ECM Traction Software Inc.wholesome iliamna
Genta Incorporated Announces
Fourth Quarter and Year End 2005 Financial Results and Corporate Highlights
In this trial, which
was conducted at 139 sites in 9 countries, 771
patients were randomly assigned to receive chemotherapy
with dacarbazine alone
or in combination with Genasense. A summary of safety and efficacy data related
to this
application can be viewed at:
http://www.
For the full year, gross expenses were
$37.3 million in 2004.3 million,
compared to $42.
On March 7, 2006, Genta announced that the
Company had entered into a
definitive agreement with institutional investors to sell approximately
19
million shares of its common stock through a "registered direct offering" for
gross proceeds
totaling approximately $40. This makes it simple to use Traction to connect internal and
external
stakeholder groups with a model that's secure, inexpensive and works
with RSS/Atom syndication and
web search standards.desirability frugal
Those who perpetrate the next attack,
which the former commissioners have called
'inevitable,' will surely take
advantage of our nation's ongoing neglect of its borders and immigration
enforcement policies," predicted Stein.
* The Company's randomized trial of Genasense
plus chemotherapy in
patients with acute myeloid leukemia (AML) will proceed to completion
of
its 500-patient accrual target, which is expected in 2006. As of January
2006, more
than 350 patients had been accrued to this trial. Mr.09 per share, for
the fourth quarter of 2005
, compared to net income of $14.9
million in the prior year period, primarily due to lower expenses
related to
clinical studies in 2005. Forward-looking statements include, without
limitation,
statements about:
* the Company's ability to obtain necessary regulatory approval for
Genasense(R) from the U.41)
Shares used in computing basic and
diluted net loss
(income) per share 114,550 82,885 102,883 79,798
Selected Condensed
Consolidated Balance Sheet Data
December 31
December 31
2005 2004
Cash, cash equivalents and
marketable securities $21,282
$42,247
Working capital 11,703 (4,269)
Total
assets 27,386 50,532
Total stockholders' equity
15,697 1,752
"Enterprise weblog software, with security
, scalability and compatibility
with enterprise identity management, is poised to replace traditional
ECM
products. We believe this will happen both as a complete solution for many
businesses, or
to define a vastly simpler and more accessible working
communication layer over traditional ECM and
line of business systems for
large enterprises," said Greg Lloyd, president and founder of Traction
Software.sufficiently sufficient
4313, the
first serious congressional initiative to enforce U. Food and Drug Administration
(FDA) for the use of Genasense plus
fludarabine and cyclophosphamide as treatment for patients with
relapsed or
refractory CLL. The new
formulation is five-fold more concentrated than material
currently used in
clinical trials. As of December 31,
2005, the Company had cash, cash equivalents
and marketable securities
totaling $21.3
million in 2005 and $11.5 million in 2004. Food and Drug
Administration ("FDA") or
European Medicines Agency ("EMEA");
* the safety and efficacy
of the Company's products;
* the commencement and completion of clinical trials;
* the Company's ability to develop, manufacture and sell its products;
* the adequacy
of the Company's capital resources 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 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.AIIM.reliant sufficiently
9/11 Commission Gives Failing Grade to America's Security While Bush Administration
Fights to Maintain Open Borders
In his
speech last week, President Bush himself acknowledged
the huge increase in
non-Mexicans -- including many Middle Easterners -- who are being apprehended
attempting to cross the border illegally. "The next Americans who die at the
hands of terrorists
will be victims not only of Islamic extremism, but of a
deliberate policy of our own government that
places cheap labor and political
pandering ahead of homeland security. When they do, as Gov.1 million
, generated by
sales of Ganite(R), compared to total revenues of $10.6. The company distributes its
products directly and
through global partners.
Traction is a registered trademark and Traction
TeamPage is a trademark of
Traction Software, Inc.homesteading sufficient
BERKELEY HEIGHTS, N., Genta
Incorporated
(Nasdaq: GNTA) today announced financial results for the fourth
quarter and year ended December 31
, 2005. The
application has been accepted for review by the FDA, with a target
action
date of October 28, 2006.
* The Company strengthened its management team with recruitment
of three
senior executives.
Earlier this week, Genta announced that the Company
had entered into
definitive subscription agreements with institutional investors to sell
approximately
19 million shares of its common stock through a "registered
direct offering" for gross proceeds totaling
approximately $40. Initiation of this study required the filing of a new
Investigational New Drug
(IND) application that included requisite animal
toxicology. However, unlike the trial in AML, none
of these
trials would be sufficient to support registration, and at least one
additional trial
in each indication would be required. Moran has reporting
responsibility for Finance, Manufacturing
Operations, and Information
Technology. He served as Chief Financial Officer, Vice-
President Finance, and member of the U.
Financial Information
The Company reported
a net loss of $10.18 $(0.homesteader sufficiently
The 9/11 Commission's assessment of our nation's preparedness for
another
terrorist attack echoes warnings issued by the Federation for American
Immigration Reform
(FAIR), which has detailed the ongoing threat posed by our
failure to control our borders and to
enforce our immigration laws. "Our enemies are busy preparing their
next murderous attack and will
use our failure to control our borders against
us with deadly consequences.
* Genta completed
submission of its Marketing Authorization Application
(MAA) for Genasense plus dacarbazine
for treatment of patients with
advanced melanoma. If data from this trial
are sufficiently
positive, the Company believes this trial is sufficiently
robust to support worldwide registration
in this indication. Mr. Per I. For the year ended December 31,
2005, the Company reported a net
loss of $2. Prior to the sanofi-aventis notice of termination in
November 2004, these deferred revenues
were being recognized over a period of
115 months.
There are a number of factors that could cause
actual results and developments
to differ materially. As
a non-profit association for more than
50 years, AIIM provides news,
information and resources through its industry web portal and ongoing
education through programs that include market analysis, industry standards
development, publications
, chapters and regional events.subcription frugal
* Dr. "Traditional ECM software is expensive to purchase
, deploy and use
and is better suited to making sure that nothing is lost than making sure that
content
is used.edocmagazine.haying heathenry
Raymond P.com/Genta/InvestorRelation/2005/press_20051229.
The Company currently
projects that data from each of these three trials will
become available during 2006.
Most
recently, Mr.02 per share,
compared to a net loss of $32.0
million related to the expensing of
Genasense inventories and other expenses
related to the manufacturing and purchase of Genasense bulk
drug substance. Audio replay will be available
approximately two hours after the completion of the
call, and will be archived
for 30 days. 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). These
technologies, tools and methods are used to capture, manage
, store, preserve,
and deliver content across an enterprise in support of business processes.
Contact:
Jen Revis Snider
Red Javelin Communications, Inc.Free land from the
government may be a thing of the past, but the spirit isn't.
utopian sufficiency
WASHINGTON, Former Gov.
* Genta's management will a provide corporate, financial, clinical and
regulatory
update in a conference call scheduled for Tuesday March 14,
2006.8 million,
before estimated
fees and expenses.
* Richard J. The
fourth quarter loss reflects the May 2005 termination
of the Collaborative
Agreement to commercialize Genasense(R) that had been in place between Genta
and sanofi-aventis.1 million, compared to $43.
In a separate announcement today, Traction
also announced the newest
version of TeamPage, TeamPage 3. Traction's easy to use TeamPage(TM) software
creates a secure
communications hub for business information and working communications that
collects
, organizes, links and shares sources of information in context over
time. For additional information
, visit Traction at
http://www.reliant utopian
This application has been accepted for review by the
European
Medicines Agency (EMEA).S. These trials are being sponsored either directly by the Company or in
collaboration
with the National Cancer Institute.
Safe Harbor
This press release and the conference
call to follow contain forward-
looking statements with respect to business conducted by Genta Incorporated
.
Traction's enterprise weblog software adds 'better-than-wiki' support for
multiple groups
working together over time, built-in WebDAV for secure
distributed file authoring and versioning
with a zero-footprint web browser
interface. This creates a new
component of ECM that works and
scales like the web.iliamna reliant
Working overtime to stay the Web's best reference!
-> Show SiteSeek's List of Web Sites For This Topic (Not Yet Peer Reviewed)
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)