Genta Reports Fourth Quarter and Year End 2002 Results and Progress
BERKELEY HEIGHTS, N.J., Feb 13, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA) today announced financial results for the fourth
quarter and year ended December 31, 2002, including a strong cash position of
$113.7 million, more than double the 2001 year-end level of $54.1 million.
Financial Strength
Cash, cash equivalents, and short-term investments totaled $113.7 million as of
December 31, 2002, compared to $126.9 million at the end of the 3rd quarter on
September 30, 2002. In the 4th quarter ended December 31, 2002, the Company's
net loss applicable to common shareholders was $29.7 million, or $(0.40) per
share, compared to a loss of $17.9 million, or $(0.28) per share for the same
period in 2001. For the year ended December 31, 2002, the Company reported a net
loss applicable to common shareholders of $74.5 million, or $(1.05) per common
share, compared to a net loss of $46.7 million, or $(0.84) per common share, for
the corresponding period in 2001.
In the 4th quarter, total operating expenses, net of $14.6 million in
reimbursements, were $31.3 million, which represented an increase of
approximately $12.6 million relative to the comparable quarter in 2001. The
increase in expenses primarily reflects costs of ongoing Genasense(TM) and
Ganite(TM) clinical trials, including payments to third parties and drug
supplies. For the year ending December 31, 2002, total operating expenses, net
of $28.5 million in reimbursements, increased by $29.6 million compared with the
comparable period in 2001.
Revenues in the 4th quarter totaled $1.3 million compared with $0.04 million in
the corresponding period for 2001. Revenues were primarily comprised of
amortization of payments made by Aventis pursuant to a collaboration agreement
for Genasense that was signed in the 2nd quarter. Pursuant to cost-sharing
provisions of that agreement, the Company recorded a $14.6 million credit to
expense in the 4th quarter, which appears as a receivable on the balance sheet.
For the year, these reimbursable expenses totaled $28.5 million; of which, Genta
received $13.9 in reimbursement payments.
A key expense in the 4th quarter related to drug substance purchases for ongoing
and new clinical trials. These purchases totaled $22.6 million in the 4th
quarter, compared with $7.0 million in the 3rd quarter of 2002. A substantial
portion of these 4th quarter expenses are expected to be reimbursed by Aventis
in future quarters.
Significant progress was made in the development of the Company's lead
anticancer compounds, Genasense and Ganite. Some highlights of the quarter and
year-end include:
Genasense(TM) (oblimersen sodium)
Collaboration
* In April 2002, Genta and Aventis signed an agreement to jointly
develop and market Genasense, which provides up to $477 million in
upfront cash, milestones and convertible debt, and exclusive of
additional royalty payments on future sales. In addition to these
funds, Aventis will fund 75% of all NDA-directed development costs in
the U.S. and 100% of all other development and marketing costs
worldwide. Full details of the agreement can be accessed at:
genta.com. From April through December
2002, the Company received approximately $146 million as a result of
this agreement, plus a pending reimbursement of $14.6 million for Q4
2002 activity.
Clinical Trials
* Randomized Phase 3 trials of Genasense in both multiple myeloma and
malignant melanoma achieved their target accrual at 200 patients and
750 patients, respectively. To date, the chronic lymphocytic leukemia
(CLL) trial has exceeded 85% of its 200-patient target. The Company is
currently studying Genasense in a randomized trial in patients with
non small cell lung cancer. Genta plans to initiate additional
randomized trials to test the utility of Genasense as a leading agent
to enhance the effectiveness of cancer chemotherapy.
* During 2002, Genta and the National Cancer Institute (NCI) jointly
approved approximately 20 clinical trials under their expanded
Cooperative Research and Development Agreement (CRADA). The expansion
of the CRADA allows the Company to explore a number of opportunities,
including:
-- the evaluation of Genasense in diseases that lie outside the
Company's priorities for initial development;
-- to quickly translate findings of preclinical studies showing
synergy with new drugs into clinical testing;
-- to expand the clinical safety and efficacy information base with a
larger number of chemotherapeutic agents;
-- to enable a considerably larger number of physicians to use the
drug in their clinical practices;
-- to use these trials as the basis for potential new randomized
trials.
* With NCI's collaboration, in 2002 Genta initiated new clinical trials
that explore the synergistic use of several new combinations,
including Genasense plus:
-- Eloxatin(R) (oxaliplatin; Sanofi)
-- Gleevec(R) (imatinib mesylate; Novartis)
-- Rituxan(R) (rituximab; Genentech, Idec)
-- Thalomid(R) (thalidomide; Celgene).
Manufacturing
* In December 2002, Genta signed a 5-year manufacturing and supply
agreement with Avecia, the world's largest manufacturer of
oligonucleotide-based drugs, for the production of Genasense drug
substance. This agreement provides for sufficient quantities of drug
product to accommodate both existing and new clinical trials, as well
as quantities of Genasense for world-wide commercial launch.
Ganite(TM) (gallium nitrate injection)
Ganite(TM) is the first compound to emerge from the Company's pipeline of
Gallium Products. Ganite has been approved by the U.S. Food and Drug
Administration (FDA) for intravenous treatment of patients with cancer-related
hypercalcemia, a life-threatening condition caused by excessive amounts of
calcium in the bloodstream. Published reports also suggest the drug may be
useful as a chemotherapeutic agent in diseases such as non-Hodgkin's lymphoma
(NHL), bladder cancer, and certain other conditions. Genta intends to work with
the FDA to execute a clinical development program that will seek expansion of
the regulatory label for Ganite to treat patients with NHL.
* In May, Genta initiated a Phase 2b trial of Ganite in NHL to support
earlier published work of the drug as an anti-cancer compound.
* In December, the first of a two-part submission was made to the
Metabolism and Endocrine Division of the FDA. The first submission
related to manufacturing methods; the second part, which is expected
to be filed by the end of the 1st quarter 2003, will address drug
product and methods validation. Genta has been advised by the
Division that these supplements will be subject to a 4-month review
period from the filing date.
* In the 2nd half of 2002, Genta submitted an Orphan Drug Application to
the FDA for Ganite as a treatment for patients with relapsed NHL.
Operations
During the year, the Company's senior team was significantly strengthened by the
appointments of key leaders, including:
* Mr. William Keane as Vice President, Finance, and Chief Financial
Officer;
* Dr. Bharat Mehta as Vice President, Manufacturing Operations;
* Ms. Jean O'Connor as Vice-President, Quality Assurance.
Two new members were elected to the Company's Board of Directors:
* Mr. Douglas Watson, former President and Chief Executive Officer,
Novartis Corporation;
* Dr. Jerome Groopman, Professor of Medicine at Harvard Medical School.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product
portfolio that is focused on anticancer therapy. The Company's research platform
is anchored by oligonucleotide chemistry, particularly applications of antisense
and decoy aptamer technology. Genasense(TM), the Company's lead compound, is
being developed in collaboration with Aventis and is currently undergoing
late-stage, Phase 3 clinical testing in several clinical indications. Genta's
pipeline also comprises a portfolio of small molecules, including
gallium-containing compounds and Androgenics compounds for prostate cancer, as
well as an anticancer series of DNA-based compounds called "decoy aptamers." For
more information about Genta, please visit our website at: genta.com.
This press release and the webcast to follow 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.
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/Form 10-K for 2001.
Genta Incorporated
Selected Condensed Consolidated Financial Data
(In thousands, except per share data)
Three Months Ended Years Ended
December 31, December 31,
2002 2001 2002 2001
Revenues $1,319 $41 $3,559 $146
Costs and expenses:
Research and development,
net 26,326 15,569 58,899 39,355
General and administrative,
net 4,696 2,633 19,347 8,215
Promega settlement -- -- -- 1,000
Compensation expense
related to stock options 300 494 1,016 1,074
Total cost and expenses 31,322 18,696 79,262 49,644
Loss from operations (30,003) (18,655) (75,703) (49,498)
Other income, principally
net interest income 466 724 1,359 2,785
Income taxes (184) -- (184)
Net loss applicable to
common shareholders $(29,721) $(17,931) $(74,528) $(46,713)
Net loss per common share $(0.40) $(0.28) $(1.05) $(0.84)
Shares used in computing
net loss per share 73,399 64,260 70,656 55,829
Condensed Consolidated Balance Sheet Data
December 31, December 31,
2002 2001
Cash, cash equivalents and
short-term investments $113,716 $54,086
Working capital 91,586 42,709
Total assets 136,419 60,630
Total stockholders' equity 46,703 48,310
SOURCE Genta Incorporated |
