Genta Announces 3rd Quarter 2002 Financial Results and Highlights Conference Call to Highlight Financial Strength, Pipeline Progress And Developments
BERKELEY HEIGHTS, N.J., Nov 7, 2002 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated ( ) today announced financial results for the period ended September 30, 2002, including a strong cash position of $126.9 million compared to $34.2 million for the period ended 2001. Going forward, the Company's financial strength will be further enhanced by reimbursements for costs incurred for the development of Genasense(TM), Genta's lead anticancer drug.
Financial Strength and Aventis Reimbursement
Cash, cash equivalents, and short-term investments totaled $126.9 million as of September 30, 2002, compared to $143.5 million at June 30, 2002. During the 2nd quarter, the Company signed a collaborative agreement with Aventis Pharma related to Genasense(TM). Pursuant to cost-sharing provisions of the collaboration, the Company has recorded a $6.7 million reimbursable expense in the 3rd quarter as a receivable on the balance sheet. Of an additional $3.0 million recorded as prepaid expenses, $2.6 million represents deposits for the purchase of Genasense drug substance, a substantial portion of which is also expected to be reimbursed.
In the 3rd quarter, total operating expenses, net of $6.7 million in reimbursements, increased by approximately $5.5 million relative to the comparable quarter in 2001. The increase in expenses primarily reflects financial support of ongoing clinical trials, including third party expenses, and costs of drug supply. Year-to-date, total operating expenses increased by $17.0 million compared with the comparable nine-month period in 2001.
The Company reported a net loss of $15.1 million, or $(0.21) per share, for the quarter ended September 30, 2002, compared to a net loss of $10.4 million, or $(0.19) per share, for the comparable period in 2001. For the nine months ended September 30, 2002, the Company's net loss was $44.8 million, or $(0.64) per share, compared to a net loss of $28.8 million, or $(0.54) per share, for the comparable period in 2001. Additional highlights of the quarter include:
Genasense(TM) Clinical Trials
Genta currently has four randomized clinical studies evaluating Genasense in combination with chemotherapy versus chemotherapy alone in patients with malignant melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL), and non-small cell lung cancer. Assuming a positive clinical result is observed is at least one of the first 3 trials, the Company believes it will be able to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the summer of 2003.
Earlier this week, Genta announced the initiation of two additional non-randomized studies of Genasense in combination with chemotherapy. These ongoing clinical programs include combinations with more than 18 different anti-cancer agents, such as Rituxan(R) (rituximab; Genentech/IDEC), Gleevec(R) (imatinib mesylate; Novartis), Eloxatin(R) (oxaliplatin; Sanofi-Synthelabo, Inc.), Thalomid(R)(thalidomide; Celgene), Taxotere(R)(docetaxel; Aventis), Paraplatin(R) (carboplatin; Bristol-Myers Squibb), and daunorubicin.
Ganite(TM) (gallium nitrate for injection)
Earlier this year, the Company filed an Investigational New Drug (IND) exemption with the Oncology Division at FDA. The Company subsequently initiated a Phase 2b trial of Ganite in patients with relapsed non-Hodgkin's lymphoma (NHL). During the 3rd quarter, the Company filed an Orphan Drug Application for the use of Ganite in this indication. In addition to certain tax benefits, designation as an Orphan Drug allows for 7 years of marketing exclusivity after regulatory approval has been granted for the indication.
About Genasense
Genasense works by inhibiting the production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatments. Genasense is currently in multiple late-stage randomized clinical trials including malignant melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL) and non-small cell lung cancer.
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. For more information about Genta, please visit our website at: genta.
The statements contained in this press release and the related conference call that will take place today that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words "anticipates," "believes," "expects," "intends," "may" and "plans" and similar expressions are intended to identify forward-looking statements. The Company intends that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward- looking statements. For example, the results obtained in pre-clinical or clinical studies may not be indicative of results that will be obtained in future clinical trials, and delays in the initiation or completion of clinical trials may occur as a result of many factors. Further examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Company's planned operations; timely development, receipt of necessary regulatory approvals, and acceptance of new products; the successful application of the Company's technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; and changing market conditions. The Company does not undertake to update forward-looking statements. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurances that the Company's expectations are correct. All forward looking statements are expressly qualified in their entirety by this cautionary statement and other factors detailed in the Company's reports filed with the Securities and Exchange Commission.
Genta Incorporated Selected Condensed Consolidated Financial Data (In thousands, except per share data)
Three Months Ended Nine Months Ended September 30, September 30, 2002 2001 2002 2001
Revenues $1,325 $23 $2,240 $105
Costs and expenses: Research and development, net 13,044 9,150 32,574 23,786 General and administrative, net 3,602 2,060 14,651 5,582 Promega settlement -- -- -- 1,000 Compensation expense related to stock options 239 186 716 580 Total cost and expenses 16,885 11,396 47,941 30,948
Loss from operations (15,560) (11,373) (45,701) (30,843)
Interest income and other expense, net 448 953 893 2,061 Net loss applicable to common shareholders $(15,112) $(10,420) $(44,808) $(28,782)
Net loss per common share $(0.21) $(0.19) $(0.64) $(0.54)
Shares used in computing net loss per share 73,410 54,735 69,732 52,988
Condensed Consolidated Balance Sheet Data
September 30, December 31, 2002 2001 Cash, cash equivalents and short-term investments $126,757 $54,086 Working capital 121,719 42,709 Total assets 143,227 60,630 Total stockholders' equity 75,398 48,310 |
