CellPro reports results for second fiscal quarter.SEATTLE--(BUSINESS WIRE)--Oct. 30, 1996--CellPro Inc. (Nasdaq: CPRO CPRO Columbia Pike Revitalization Organization CPRO Connecticut Peer Review Organization, Inc. ) today reported a net loss of $5.1 million, or $0.36 per share, for its second fiscal quarter ended Sept. 30, 1996. This compares with a net loss of $5.5 million, excluding non- recurring contract revenue of $6.0 million, or $0.39 per share for the quarter ended Sept. 30, 1995. Net income, including the $6.0 million of non-recurring revenue, was $0.5 million, or $0.03 per share, for the quarter ended Sept. 30, 1995. At Sept. 30, 1996, the company had approximately 14.4 million shares issued and outstanding. CellPro reported $1.9 million in product sales for the quarter ended Sept. 30, 1996. This represents a 54% increase from the $1.3 million reported for the quarter ended Sept. 30, 1995. Increased sales of the CEPRATE(r) SC Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Concentration System accounted for this improvement. The CEPRATE SC System is approved for use in the 18-member European Economic Area European Economic Area: see European Free Trade Association; European Union. and Canada and is commercially available in other European countries, Israel, Asia Pacific and Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. . In addition, the company is selling the CEPRATE SC System, on a limited basis, for investigational use in the United States under a cost recovery program. The CEPRATE(r) SC System is used to provide stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young to repopulate the bone marrow of patients being treated for diseases such as breast and ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , lymphoma, multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility and acute hematological malignancies. The company has been notified by 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. ) that its premarketing approval application is approvable, subject to final approval of product labeling, and completion of GMP GMP (guanosine monophosphate): see guanine. certification of its manufacturing facilities. The company also reported interest income totaling $1.1 million for the fiscal quarter ended Sept. 30, 1996. This was comparable to the $1.0 million earned in the quarter ended Sept. 30, 1995. At Sept. 30, 1996, the company's cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaled approximately $65 million. Research and development expense totaled $3.8 million for the quarter ended Sept. 30, 1996, unchanged from the $3.8 million for the quarter ended Sept. 30, 1995. The company has completed patient enrollment in a Phase III trial designed to demonstrate the CEPRATE SC System's ability to deplete de·plete v. 1. To use up something, such as a nutrient. 2. To empty something out, as the body of electrolytes. tumor cells from peripheral blood peripheral blood Cardiology Blood circulating in the system/body stem cell transplants in patients being treated for multiple myeloma. This clinical trial is in the post-treatment patient follow-up phase. Additionally, in October 1996, the company began a multicenter Phase I/II clinical trial utilizing the CEPRATE SC System together with a new second generation product, the CEPRATE TCD TCD Trinity College Dublin TCD Chad (ISO Country code) TCD Transcranial Doppler TCD Thermal Conductivity Detector TCD Traffic Control Device TCD Tropical Conservation and Development T-Cell Depletion System, for mismatched allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically transplantation in children with leukemia. Trial subjects are children who need stem cell transplants, but for whom no matched-donor can be found. These children typically do not have any viable alternative treatment option. The CEPRATE SC System is being used in numerous additional clinical trials, including applications in dose-intensified, multicycle chemotherapy to treat solid-tissue tumors and allogeneic matched- and mismatched-donor trials to treat leukemias. Further, the company is participating in various gene therapy trials in which the CEPRATE SC System is used to concentrate stem cells to enhance the efficiency of gene insertion to treat genetic disorders and diseases such as cancer and AIDS. The CEPRATE SC System is also being used to deplete T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. from stem cell products used to repopulate the marrow of patients receiving marrow-killing chemotherapy to treat multiple sclerosis. Selling, general and administrative expenses were $3.3 million for both of the quarters ended Sept. 30, 1996 and 1995. The company intends to increase sales and marketing activities in the United States in anticipation of FDA approval of the CEPRATE SC System. -0- This news release contains forward-looking statements. However, the company's business involves risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, those mentioned in CellPro's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended March 31, 1996, and CellPro's quarterly report on Form 10Q for the fiscal quarter ended June 30, 1996 under the heading "Investment Considerations" and in CellPro's other public filings. Particular attention should be given to the Investment Considerations labeled "Uncertainty of Product Acceptance" and "Legal Proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. " in CellPro's Annual Report on Form 10-K for the fiscal year ended March 31, 1996. -0- Located in Bothell, CellPro Inc. is a biotechnology company specializing in the development, manufacturing and marketing of proprietary continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. -0-
CELLPRO INC.
(a company in the development stage)
SELECTED FINANCIAL DATA
Statement of Operations Data:
(unaudited)
Three Months Ended Six Months Ended
Sept. 30, Sept. 30,
1996 1995 1996 1995
Product sales $1,923,263 $1,251,045 $3,921,223 $2,507,426
Related party revenue 6,000,000(a) 6,000,000(a)
Contract and other
revenue $5,961 13,814
Interest income $1,117,092 1,048,330 2,059,723 2,047,910
3,046,316 8,299,375 5,994,760 10,555,336
Costs and expenses:
Cost of sales 1,074,994 662,664 2,295,610 1,325,304
Research and
development 3,802,301 3,831,938 7,475,328 8,305,398
Selling, general and
administrative 3,267,079 3,285,138 5,916,270 6,319,837
Interest 12,857 19,757 26,660 53,272
Total costs and
expenses 8,157,231 7,799,497 15,713,868 16,003,811
Net income (loss) ($5,110,915) $499,878 ($9,719,108)($5,448,475)
Net income (loss)
per share ($0.36) $0.03 ($0.68) ($0.40)
Weighted average number
of shares outstanding 14,393,595 14,246,164 14,384,069 13,462,118
Sept. 30, March 31,
1996 1996
Balance Sheet Data: (unaudited)
Cash, cash equivalents and
marketable securities $65,254,211 $74,143,851
Total assets 88,136,014 97,941,349
Long-term debt, net of current
portion 1,397,689 208,001
Total stockholders' equity 82,997,517 92,213,233
(a) This is non-recurring revenue received for prior research and
development services rendered by CellPro as part of the termination
of business arrangements between CellPro and Corange International Ltd.
CONTACT: CellPro Inc. Joann Reiter, 206/485-7644 e-mail: invest@cellpro.com http://www.cellpro.com |
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