Titan Reports Second Quarter 2001 Results.Business Editors SOUTH SAN FRANSISCO, Ca.--(BUSINESS WIRE)--Aug. 15, 2001 Titan Pharmaceuticals The introduction to this article provides insufficient context for those unfamiliar with the subject matter. Please help [ improve the introduction] to meet Wikipedia's layout standards. You can discuss the issue on the talk page. Titan Pharmaceuticals, Inc. , Inc. (ASE (Adaptive Server Enterprise) A relational DBMS from Sybase that runs on Windows NT/2000, Linux and a variety of Unix platforms. ASE is a comprehensive and robust data management product with a long history dating back to the late 1980s. : TTP TTP (thymidine triphosphate): see thymine. ) today reported financial results for the second quarter and first six months of 2001. Revenues for the second quarter of 2001 were approximately $2.9 million, compared to $281,000 for the same quarter in 2000. For the first six months of 2001, revenues were $3.5 million, compared to $616,000 for the same six-month period in 2000. The increase in revenue was primarily due to a license fee received from Novartis Pharma AG for the development and commercialization of iloperidone in Japan, and higher SBIR SBIR Small Business Innovation Research (program/grant) SBIR Space Based Infra-Red SBIR Speaker-Boundary Interference SBIR Site Backsurface-referenced Ideal Plane/Range (silicon wafers) grant revenues from the National Institutes of Health in support of the development of Spheramine(R), our novel treatment for Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. . Interest income for the second quarter 2001 was $1.9 million compared to $1.3 million for the same quarter in 2000. For the first six months of 2001, interest income was $3.4 million compared to $2.2 million for the same six-month period in 2000. The increase in interest income was a result of our significantly larger cash position. At June 30, 2001, the Company had $113.1 million in cash 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 . Titan's net loss for the second quarter 2001 was $1.8 million, or $0.07 per share, compared to $2.4 million, or $0.09 per share, for the same quarter in 2000. For the first six months of 2001, our net loss was $6.4 million, or $0.23 per share, compared to $6.1 million, or $0.24 per share, for the same six-month period in 2000. Commenting on the Company's operating results, Dr. Louis R. Bucalo, Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Titan, stated, "During the second quarter, Titan made important progress in a number of areas, including completion of enrollment in our 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 study of CeaVac(R) in Dukes' D colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. , positive preliminary results in initial Phase I/II clinical testing of Spheramine in Parkinson's disease, and expansion of our license agreement with Novartis to include development of iloperidone in Japan." In July, Titan and Novartis announced that additional studies will be incorporated into the iloperidone Phase III development program, and that analysis of data obtained from completed studies suggests that iloperidone is efficacious, with a favorable safety and tolerability profile, overall low incidence of extra-pyramidal symptoms and cardiovascular effects, little weight gain and low sedation Sedation Definition Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm. Purpose The process of sedation has two primary intentions. , which frequently affect patient compliance with agents in this class. In addition, Titan recently reported progress in several of its other product development programs. Titan's novel Spheramine product for the treatment of Parkinson's disease established an important milestone with the demonstration of positive Phase I/II safety and efficacy data in patients with late stage Parkinson's disease. At the International Congress on Parkinson's Disease in Helsinki, Finland in July, Titan presented data further demonstrating improvement in motor function and activities of daily living for Parkinson's patients treated with Spheramine. These encouraging results establish the basis for initiating 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. clinical studies. In June, Titan completed patient enrollment in its Phase III study of CeaVac for the treatment of Dukes' D colorectal cancer. Over 630 patients have been enrolled in the study, which is being conducted at over 50 sites in the U.S. and Europe. CeaVac is among the more advanced immunotherapy products in development for colorectal cancer, with data from previous studies demonstrating the ability of CeaVac to generate robust and sustained anti-cancer immune responses, with a relative lack of significant side effects Side effects Effects of a proposed project on other parts of the firm. . Titan also announced several other product development achievements during the second quarter, including positive results from a Phase II clinical study of TriGem(R) for the treatment of stage III melanoma, and the initiation of two additional clinical studies: a Phase I/II clinical trial of Pivanex(R), Titan's novel differentiating agent, for the treatment of liver tumors; and a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of gallium gallium (găl`ēəm), metallic chemical element; symbol Ga; at. no. 31; at. wt. 69.72; m.p. 29.78°C;; b.p. 2,403°C;; sp. gr. 5.904 at 29.6°C; (solid), 6.095 at 29.8°C; (liquid); valence +2 or +3. maltolate for the treatment of metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. and refractory 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 . In addition, Titan announced important progress with two products in pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. . Titan's RB94 cancer therapy demonstrated effectiveness in an animal model of head and neck cancer, utilizing novel mechanisms suggesting synergy with chemotherapy and radiation therapy. The potential effectiveness of Titan's long-term drug delivery system was also demonstrated in an animal model showing long-term delivery of buprenorphine for the potential treatment of opiate opiate /opi·ate/ (o´pe-it) 1. any drug derived from opium. 2. hypnotic (2). o·pi·ate n. 1. dependence. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. (ASE: TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) disorders, cancer and other serious and life-threatening diseases. Titan has assembled a deep pipeline of products utilizing novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes important partnerships with multinational pharmaceutical companies and government institutions for the development of its products. Iloperidone, Titan's novel drug for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. , is being developed through a corporate partnership agreement with Novartis Pharma AG. Titan has also entered into a corporate partnership with Schering AG to develop and commercialize Spheramine, a novel treatment for Parkinson's disease. In addition, several clinical programs in cancer therapy are supported by large oncology cooperative groups that are funded by the National Cancer Institute. For additional information about Titan Pharmaceuticals, please view our web site at HTTP HTTP in full HyperText Transfer Protocol Standard application-level protocol used for exchanging files on the World Wide Web. HTTP runs on top of the TCP/IP protocol. ://WWW.TITANPHARM.COM (1) (Computer Output Microfilm) Creating microfilm or microfiche from the computer. A COM machine receives print-image output from the computer either online or via tape or disk and creates a film image of each page. . The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.
TITAN PHARMACEUTICALS, INC.
CONDENSED CONSOILIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amount)
Three Months Six Months
Ended Ended
June 30, June 30,
2001 2000 2001 2000
(unaudited)
Contract and grant revenue $373 $281 $953 $616
License revenue 2,500 - 2,500 -
------ ------ -------- -----
Total revenue 2,873 281 3,453 616
Operating expenses:
Research and development 5,341 3,266 10,340 7,311
General and administrative 1,211 704 2,795 1,561
------- ------- -------- -------
Total operating expenses 6,552 3,970 13,135 8,872
Loss from operations (3,679) (3,689) (9,682) (8,256)
Interest and other income, net 1,845 1,266 3,329 2,185
------ ------- -------- --------
Net loss $(1,834)$(2,423) $(6,353) $(6,071)
======== ======= ======== ========
Basic and diluted net loss
per share $(0.07) $(0.09) $(0.23) $(0.24)
======= ======= ======== ========
Shares used in computing basic and
diluted net loss per share 27,619 25,769 27,544 24,821
====== ====== ======= =======
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, December 31,
2001 2000
(unaudited) (Note A)
Assets
Cash, cash equivalents, and marketable
securities $113,122 $117,523
Prepaid expenses, receivables, and
other current assets 763 326
-------- --------
Total current assets 113,885 117,849
Furniture and equipment, net 588 593
--------- --------
$114,473 $118,442
========= =========
Liabilities and Stockholders' Equity
Current liabilities $2,914 $2,463
Minority interest - Series B preferred
stock of Ingenex, Inc. 1,241 1,241
Stockholders' Equity 110,318 114,738
-------- ---------
$114,473 $118,442
======== =========
Note A: The balance sheet at December 31, 2000 has been derived
from the audited financial statements at that date but does not
include all of the information and footnotes required by generally
accepted accounting principles in the United States for complete
financial statements presentation.
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