ChromaVision Reports Third Quarter; Nine-Month Results.SAN JUAN CAPISTRANO San Juan Capistrano (săn wän kăpĭsträ`nō), city (1990 pop. 26,183), Orange co., S Calif.; inc. 1961. San Juan Capistrano has some manufactures, including aircraft parts, medical apparatus, and boats, but the economy is , Calif.--(BW HealthWire)--Oct. 28, 1998-- ChromaVision Medical Systems Inc. (Nasdaq NM: CVSN), a leading cellular imaging diagnostics company and manufacturer of the Automated Cellular Imaging System (ACIS(TM)), Wednesday announced financial results for its third quarter and nine months ended Sept. 30, 1998. For this year's third quarter, the company reported a net loss of $1.9 million, or $0.11 loss per basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, compared with a net loss of $1.5 million, or $0.11 loss per basic and diluted share for the comparable period in 1997. For the first nine months of this year, the company reported a net loss of $5.9 million, or $0.35 loss per basic and diluted share, as compared with a net loss of $4.9 million, or $0.40 loss per basic and diluted share for the same period last year. The increase in net loss for both periods was due primarily to legal and licensing costs, an increase in research and development expenses related to clinical trials, and the addition of technical personnel to support commercialization activities. These costs were partially offset by an increase in net interest income from the investment of the company's public offering proceeds. "The company has continued to focus on applications development and our progress remains on track," said ChromaVision Chief Executive Officer, Douglas Harrington, M.D. "Our efforts during the past quarter have accelerated the commercialization of our Cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems. (CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) ) and HER2neu (Breast Cancer) applications, which partially offset the estimated delay in the Downs application." Dr. Harrington also commented, "Our recently announced co-development and cooperative sales and marketing agreement with DAKO Corporation is aimed at using the ACIS to enhance the objectivity in identifying appropriate patients for the recently developed breast cancer therapeutic, Herceptin(R), developed by Genentech (NYSE NYSE See: New York Stock Exchange : GNE GNE Gateway Network Element (data communications) GNE Game Neverending (MMORPG) GNE Gross National Expenditure GNE Game Networking Engine GNE Graphical Network Editor (Nortel) ). The HER2neu application is being rapidly driven by the availability of this drug therapy, which requires detection and quantification quan·ti·fy tr.v. quan·ti·fied, quan·ti·fy·ing, quan·ti·fies 1. To determine or express the quantity of. 2. of the HER2 protein." Dr. Michael Press, a leading cancer researcher at the Kenneth Norris, Jr. Comprehensive Cancer Center at the University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission , will oversee development of the ACIS in conjunction with DAKO Corp.'s HercepTest(R) kit to measure the overexpression of the HER2 protein in patients with breast cancer. The use of the ACIS with the DAKO test can provide pathologists a tool to quantify Quantify - A performance analysis tool from Pure Software. the amount of the HER2 protein expression in an objective and reproducible manner, replacing subjective interpretation. The company estimates commercial availability of this application by the end of the first quarter of 1999. ChromaVision expects to file its second 510(k) application with the 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. in mid-November. The filing seeks clearance of the ACIS for use with immunohistochemistry (IHC IHC Immunohistochemistry IHC Intermountain Health Care IHC Inner Hair Cells IHC International Harvester Company IHC Internet Healthcare Coalition IHC Indian Head Cent IHC Interactive Health Communication IHC International Hurricane Center ) reagents. The clearance would potentially enable a number of applications to be added to the ACIS platform. ChromaVision's clinical trial evaluating its method of screening maternal blood for Down syndrome Down syndrome, congenital disorder characterized by mild to severe mental retardation, slow physical development, and characteristic physical features. Down syndrome affects about 1 in every 730 live births and occurs in all populations equally. is continuing in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Europe. Data from the international clinical trials has been compiled at the primary research facility at Cambridge University Cambridge University, at Cambridge, England, one of the oldest English-language universities in the world. Originating in the early 12th cent. (legend places its origin even earlier than that of Oxford Univ. in England. This preliminary data is encouraging; however, additional Downs-affected specimens are necessary to validate the initial findings. The company estimates commercial availability of its Down syndrome application by the third quarter of 1999. About ChromaVision Medical Systems ChromaVision Medical Systems manufactures and markets an advanced cellular imaging system designed to advance the detection, diagnosis, and treatment of cellular disease. The Automated Cellular Imaging System (ACIS) combines a proprietary, color-based imaging technology with automated microscopy microscopy /mi·cros·co·py/ (mi-kros´kah-pe) examination under or observation by means of the microscope. mi·cros·co·py n. 1. The study of microscopes. 2. to bring unprecedented sensitivity, accuracy and reproducibility to cancer, infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and genetic cell-based diagnostics. ChromaVision currently markets its products to research centers, university medical centers and commercial laboratories throughout the world. ChromaVision Medical Systems was formed by XL Vision Inc., and is a Safeguard Scientifics Inc. (NYSE: SFE See Sydney Futures Exchange. ) partnership company. The statements contained herein regarding ChromaVision Medical Systems Inc. contain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve risks and uncertainty. Future events and the company's actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainty of success in developing any new diagnostic test, failure to obtain FDA clearance or approval for particular applications and dependence on third parties for clinical testing. ACIS is a trademark of ChromaVision Medical Systems Inc.
Chromavision Medical Systems Inc.
(A Development Stage Enterprise)
Summary Statements of Operations
(unaudited)
Period
from April 1,
1993
Three Months Ended Nine Months Ended (inception)
Sept. 30, Sept. 30, Through
Sept. 30,
1998 1997 1998 1997 1998
Revenues: $7,194 $0 $7,194 $0 $1,247,580
Cost of revenue 4,523 0 4,523 0 547,262
Expenses:
Selling, general
and
adminis-
trative 974,060 623,967 2,985,509 2,440,171 11,173,450
Research and
development 1,176,330 1,022,138 3,427,820 2,524,608 11,892,314
Legal
settlement 0 0 300,000 0 300,000
Loss from
Opera-
tions $(2,147,719)$(1,646,105)$(6,710,658)$(4,964,779)$(22,665,446)
Other income 225,080 124,793 772,241 48,030 1,577,082
Net loss $(1,922,639)$(1,521,312)$(5,938,417)$(4,916,749)$(21,088,364)
Net loss per
common share:
Basic and
diluted ($0.11) ($0.11) ($0.35) ($0.40)
Weighted avg.
number of
common shares
outstanding 17,257,745 14,334,512 17,221,604 12,208,180
ChromaVision Medical Systems Inc.
(A Development Stage Enterprise)
Summary Balance Sheets
Sept. 30, Dec. 31,
1998 1997
(Unaudited)
Cash and cash equivalents $ 4,951,081 $12,926,398
Marketable securities and
other investments 3,882,627 2,406,078
Note receivable 5,000,000 5,000,000
All other assets, net 3,018,708 1,916,540
Total assets $16,852,416 $22,249,016
Total current liabilities $ 1,332,788 $ 878,720
Stockholders' equity 15,519,628 21,370,296
Total current liabilities and
stockholders' equity $16,852,416 $22,249,016
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