DepoTech Reports First Quarter 1998 Financial Results; NDA Supplement for DepoCyt Filed With FDA.SAN DIEGO--(BUSINESS WIRE)--April 24, 1998--DepoTech Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DEPO DEPO Delegated Episcopal Pastoral Oversight DEPO Devils Postpile National Monument (US National Park Service) DEPO Defence Export Promotion Organization (Pakistan) DEPO Double Even Pass Odd ) today reported financial results for the first quarter ended March 31, 1998. For the quarter, the company reported operating revenue operating revenue Revenue from any regular source. Revenue from sales is adjusted for discounts and returns when calculating operating revenue. Compare other revenue. of $1.2 million and operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. of $6.7 million, compared to operating revenue of $1.2 million and operating expenses of $5.3 million in 1997. Net loss for the period was $5.5 million, or 38 cents per share Cents per share The amount of a mutual fund's dividend or capital gains distributions that a shareholder will receive for each share owned. , compared to net loss of $3.9 million or 30 cents per share in 1997. The 1998 financial results reflect expanded efforts in clinical trials and manufacturing scale-up of DepoCyt(TM) and DepoMorphine(TM). In February 1998, the company reduced its workforce aimed at lessening operating expenses and focusing resources on the company's lead product, DepoCyt, as well as DepoMorphine and partnered funded feasibility programs. During the first quarter of 1998, the company recorded a one-time charge of approximately $0.4 million relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc severance and out placement expenses associated with this reduction in workforce. The company also announced that it has filed an amendment to its New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for DepoCyt, an anticancer drug anticancer drug see antineoplastic. anticancer drug Chemotherapeutic, see there for the treatment of neoplastic meningitis The infiltration of the subarachnoid space with cancer cells. The cancer cells can be metastatic or from a primary brain tumor like medulloblastoma. (NM) from solid tumors, with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Submission of the amendment extends the time period available to the FDA to review the NDA under the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. by three months, to July 28, 1998. The NDA amendment provides interim data from 30 patients from a phase IV clinical trial Noun 1. phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier of NM from solid tumors. Submission of the data from the phase IV study approximately doubled the number of patients treated with DepoCyt in the phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial previously submitted in connection with the company's NDA. In addition, the filing includes interim data from 28 patients from a phase III study of NM from lymphomas. DepoCyt is a sustained-release formulation of the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, cytarabine, being developed for patients with NM from solid tumors, lymphomas and leukemia leukemia (l  kē`mēə), cancerous disorder of the blood-forming tissues (bone marrow, lymphatics, liver, spleen) characterized by excessive production of immature or mature . In December 1997, the
Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic ConferenceODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) to the FDA declined to recommend approval of DepoCyt for use in patients with NM from solid tumors. In March 1998, DepoTech announced that following discussions with the FDA and a representative of ODAC, the company reached agreement for further review of DepoCyt for the treatment of solid tumors whereby DepoTech would submit the amendment to the NDA. DepoTech is a drug delivery company dedicated to the development and manufacture of innovative, sustained-release therapeutic products based on DepoFoam(TM) technology. Products are being developed to satisfy medical needs in cancer, pain management and other fields. -0-
DEPOTECH CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
March 31,
1998 1997
------------------------------
(unaudited)
Contract revenue $ 1,214,733 $ 1,171,810
Total revenue 1,214,733 1,171,810
Costs and expenses:
Research and development 5,411,138 4,382,903
General and administrative 1,260,783 933,595
Total costs and expenses 6,671,921 5,316,498
Loss from operations (5,457,188) (4,144,688)
Interest income 360,078 453,793
Interest expense (359,481) (219,949)
Net loss $ (5,456,591) $ (3,910,844)
Basic and diluted
net loss per share $ (0.38) $ (0.30)
Shares used in computing
basic and diluted
net loss per share 14,363,523 13,032,336
CONDENSED BALANCE SHEETS
March 31, Dec. 31,
1998 1997
--------- ------------
(Unaudited) (Unaudited)
Cash, cash equivalents
and short-term investments $21,213,782 $27,360,555
Accounts receivable
from collaborations 1,474,496 1,361,837
Other current assets 1,180,586 1,141,210
Total current assets 23,868,864 29,863,602
Property and equipment, net 27,445,146 26,948,328
Other assets, net 921,983 857,756
Total assets $52,235,993 $57,669,686
Current liabilities $ 8,318,364 $ 7,797,343
Non-current liabilities 11,237,824 11,799,552
Shareholders' equity 32,679,805 38,072,791
Total liabilities and
shareholders' equity $52,235,993 $57,669,686
-0- This press release may contain forward-looking statements regarding DepoCyt, the company and the company's results of operations or financial condition. Actual results could differ materially from those described in this press release as a result of a number of factors, including, but not limited to the following: Uncertainties involved in obtaining regulatory approval for DepoCyt or any of the company's potential products in the U.S. and other markets, including timing of approval, if at all, and other uncertainties related to regulatory matters, and uncertainties involved in commercialization of DepoCyt or any of the company's potential products. The company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this release. Additional written materials and recent releases regarding DepoTech are available on the World Wide Web at http://www.depotech.com DepoFoam is a trademark of DepoTech Corp. CONTACT: DepoTech Corp. Dana S. McGowan, 619/625-2424 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion