Cell Therapeutics Announces Third Quarter Results.SEATTLE--(BW HealthWire)--Nov. 13, 1997--Cell Therapeutics, Inc. (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 : CTIC CTIC Conservation Technology Information Center CTIC Chicago Title Insurance Company CTIC Centro Tecnológico de la Información y de la Comunicación (Spanish: Center for the Development of Information and Communication Technologies in Asturias) ) today reported financial results for the third quarter ended September 30, 1997. The net loss for the period was approximately $4.3 million, or $0.33 per share, compared to a net loss of approximately $5.1 million, or $1.03 per share, in the comparable period of 1996. A greater number of shares were outstanding during the 1997 quarter, reflecting the Company's initial public offering in March 1997 and the related conversion of all outstanding preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. . Cell Therapeutics, Inc. (cti) recorded approximately $3.6 million of revenues for the quarter ended September 30, 1997, for development cost reimbursements and a milestone payment of $1 million under its collaboration agreement with the R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and Ortho Biotech Inc., both Johnson & Johnson Companies (NYSE NYSE See: New York Stock Exchange : JNJ JNJ Johnson and Johnson (stock symbol) JNJ Journal of Nursing Jocularity ). Johnson & Johnson is cti's corporate partner for the development of lisofylline, the Company's lead drug candidate. Revenues for the comparable quarter in 1996 were $250,000. For the nine months ended September 30, 1997, revenues from collaboration agreements were approximately $8.9 million, compared with $3.3 million in the comparable period of 1996. Revenues for the first nine months of 1996 primarily resulted from a signing fee in connection with a terminated collaboration agreement. Cti's total 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. for the third quarter of 1997 increased to approximately $8.5 million from approximately $5.4 million for the same period in 1996. This increase in operating expenses was primarily due to increased research and development expenses, which rose to approximately $6.1 million from approximately $3.6 million in the third quarter of 1996. For the first nine months of 1997, total operating expenses increased to approximately $25.2 million from approximately $16.3 million in the comparable period of 1996, with research and development expenses increasing to approximately $18.7 million from approximately $11 million. For the nine months ended September 30, 1997, research and development expenses increased primarily due to expanded activities related to manufacturing and preclinical and clinical development. These activities included the ongoing funding of multiple Phase III clinical trials Noun 1. phase III clinical trial - 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 and the recruitment of additional personnel with respect to the development of lisofylline. As of September 30, 1997, cti had cash, cash equivalents, securities available-for-sale and collaboration agreement receivables totaling approximately $45.2 million, compared to approximately $31.0 million at December 31, 1996. This amount does not include the net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $34.3 million from cti's October follow-on offering Follow-On Offering An offering of additional shares after a company has had an initial public offering. Notes: This sometimes means the company is strapped for cash. So they need to issue more shares to pay bills or finance a new project. of 2.3 million shares of common stock at $16 per share. As a result of that offering, cti currently has approximately 15.4 million shares of common stock outstanding. The $1 million milestone payment recorded in the third quarter marks a significant expansion of the lisofylline collaboration. RWJPRI will now also fund 60% of development costs related to achieving additional marketing approval from 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. ) for the use of lisofylline in treating the side effects Side effects Effects of a proposed project on other parts of the firm. of induction chemotherapy induction chemotherapy Oncology The use of chemotherapy as a primary treatment for Pts presenting with advanced CA for which no alternative treatment exists. See Salvage treatment. in AML AML - A Manufacturing Language patients. Approximately 25,000 patients undergo BMT BMT bone marrow transplantation. BMT, n.pr See bone marrow transplant. BMT Bone marrow transplant, see there and approximately 75,000 patients receive high dose induction chemotherapy annually 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. . In July, the Company reported the results of its Phase II randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. double-blind, placebo-controlled trial of lisofylline among patients undergoing high dose induction chemotherapy to treat AML. In that trial, there was a 50 percent reduction in the incidence of serious neutropenic infections among lisofylline patients when compared to placebo recipients. In addition, fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. were seen in 14% of placebo recipients, whereas no patients (0%) receiving lisofylline developed a fungal infection fungal infection, infection caused by a fungus (see Fungi), some affecting animals, others plants. Fungal Infections of Human and Animals . The lisofylline collaboration, initiated in November 1996, focuses on the development and commercialization of cti's lead drug candidate, lisofylline. Lisofylline is being developed to reduce the incidence and severity of the side effects of high-dose chemotherapy high-dose chemotherapy Oncology The administration of chemotherapeutics in excess of BM toxicity; given the risk of aplastic anemia, HDC requires autologous BMT and use of 'rescue' factors such as G-CSF, GM-CSF, and erythropoietin. See Bone marrow transplantation. and/or radiation therapy. This news release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of lisofylline and related compounds includes risks associated with preclinical and clinical development in the biotechnology industry in general and of lisofylline and related compounds in particular (including, without limitation, the potential failure of lisofylline and related compounds to prove safe or effective for treatment of disease), determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling lisofylline and related compounds, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent Registrations on Forms 10-K, 8-K and Form 10-Q Form 10-Q See 10-Q. . Cell Therapeutics, Inc. focuses on the discovery, development, and commercialization of small molecule drugs that selectively regulate the metabolism of oxidized oxidized having been modified by the process of oxidation. oxidized cellulose see absorbable cellulose. lipids and phospholipids relevant to the treatment of cancer and inflammatory and immune diseases. http://www.businesswire.com/cnn/ctic.htm -0-
CELL THERAPEUTICS, INC.
(A Development Stage Company)
SELECTED FINANCIAL DATA
(Unaudited)
Statement of Operations Data:
-----------------------------
Three months Nine months
ended ended
Sep 30, Sep 30,
1997 1996 1997 1996
Revenues:
Collaboration
agreements $ 3,629,324 $ 250,000 $ 8,896,304 $ 3,250,000
Operating expenses:
Research and
development 6,099,485 3,583,362 18,726,776 10,980,238
General and
administrative 2,350,861 1,831,305 6,483,265 5,358,418
8,450,346 5,414,667 25,210,041 16,338,656
Loss from
operations (4,821,022) (5,164,667) (16,313,737) (13,088,656)
Other income
(expense):
Investment income 654,344 199,168 1,836,913 746,863
Interest expense (90,917) (128,526) (296,820) (387,785)
Net Loss $(4,257,595)$(5,094,025)$(14,773,644) $(12,729,578)
Net loss per
share,
historical(a) $ (0.33)$ (1.03)$ (1.41) $ (2.58)
Shares used in computation
of historical(a)
net loss per
share 13,031,064 4,943,021 10,454,081 4,938,161
Net loss per
share, pro forma(b) $ (0.33) $ (0.65) $ (1.23) $ (1.63)
Shares used in computation of
pro forma(b) net
loss per share 13,031,064 7,851,783 11,978,161 7,797,929
(a) Per share results on a historical basis assume no conversion of
the Company's outstanding preferred shares into common shares for all
periods which the convertible preferred shares were outstanding.
(b) Per share results on a pro forma basis assume conversion of all
of the Company's outstanding convertible preferred shares into common
shares for all periods presented.
Sep 30, Dec 31,
Balance Sheet Data: 1997 1996
-------------------
Cash, cash equivalents
and securities
available for sale $ 41,444,821 $ 30,986,564
Collaboration agreement
receivables 3,765,208 --
Prepaid expenses and other
current assets 317,638 256,892
Total current assets 45,527,667 31,243,456
Property and equipment, net 5,564,768 5,117,936
Other assets 553,363 640,301
Total assets $ 51,645,798 $ 37,001,693
Current liabilities $ 5,010,475 $ 4,943,398
Long-term obligations,
less current portion 1,061,551 2,004,575
Commitments -- --
Shareholders' equity 45,573,772 30,053,720
Total liabilities and
shareholders' equity $ 51,645,798 $ 37,001,693
CONTACT: Cell Therapeutics, Inc. Lee M. Parker, 800/664-CTIC 206/282-7100 invest@ctiseattle.com www.cticseattle.com |
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