Titan Reports First Quarter 2002 Results.Business Editors & Health/Medical Writers BIOWIRE2K SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--May 14, 2002 Titan Pharmaceuticals, 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 announced financial results for the first quarter 2002. Revenues for first quarter 2002 were approximately $2.3 million, compared to $600,000 for first quarter 2001. The increase in revenue was primarily due to a milestone payment Titan received from Schering AG for Spheramine(R), Titan's product in development 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. . Net loss for first quarter 2002 was approximately $5.0 million, or $0.18 per share, compared to $4.5 million, or $0.16 per share, for the same period last year. The increase is related to additional activity and progress in the Company's product development programs. "Our financial performance in the first quarter was in line with expectations and reflects the continued advancement of our clinical programs, with the milestone payment from Schering marking the successful completion of the Phase I/II Spheramine study," said 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. "We anticipate advancing Spheramine into 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 testing later this year, as well as completing additional clinical studies of iloperidone and a number of cancer therapeutics in development." Interest income for first quarter 2002 was approximately $1.4 million compared to $1.5 million for first quarter 2001. At March 31, 2002, the Company had approximately $96 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 . Development Programs Titan has 10 products under development including seven in clinical testing, two of which are in Phase III trials. The Company is focused on developing novel products to treat disorders of the central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ), cancer and other serious and life-threatening diseases. Recent highlights from progress made in Titan's development programs are described below. CNS Therapeutic Products in Development Last month at the American Academy of Neurology The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 by A.B. Baker of the University of Minnesota to advance the art and science of neurology, and thereby promote the best , Titan reported that treatment with its novel cell therapy product, Spheramine produced significant improvement in motor function and quality of life in patients with advanced Parkinson's disease in a completed, 12 month Phase I/II study. Titan and its corporate development partner for Spheramine, Schering AG, are now preparing to initiate a randomized clinical study of Spheramine in the treatment of late-stage Parkinson's disease. This trial is targeted to begin during the second half of 2002. Spheramine is Titan's first product in development using the Company's proprietary cell-coated microcarrier (CCM CCM Contemporary Christian Music CCM Critical Care Medicine CCM County College of Morris (New Jersey) CCM Chama Cha Mapinduzi (political party, Tanzania) CCM CORBA Component Model (TM)) technology. Pre-clinical data demonstrating the efficacy of CCM technology in other disease models will be presented at the International Society for Cellular Therapy in Barcelona this month. As previously outlined, Novartis Pharma AG, Titan's corporate partner for iloperidone, is conducting additional Phase III studies to more fully profile iloperidone, an investigational treatment for schizophrenia. Results from a safety study evaluating the EKG EKG: see electrocardiography. profile of patients receiving iloperidone are expected mid-year 2002. Preliminary Phase III data support the overall favorable therapeutic profile of iloperidone. Additional safety and efficacy results with iloperidone will be presented by Novartis at the Collegium col·le·gi·um n. pl. col·le·gi·a or col·le·gi·ums 1. An executive council or committee of equally empowered members, especially one supervising an industry, commissariat, or other organization in the Soviet Union. Internationale Neuro-Psychopharmacologicum in Montreal in June. Probuphine(TM), Titan's treatment for opiate opiate /opi·ate/ (o´pe-it) 1. any drug derived from opium. 2. hypnotic (2). o·pi·ate n. 1. addiction which utilizes the Company's novel long-term drug delivery system, is advancing toward clinical testing. Results from pre-clinical testing have demonstrated the ability of Probuphine to deliver targeted therapeutic levels of buprenorphine with no adverse effects, and will be presented at the International Conference on Pain and Chemical Dependency chemical dependency n. A physical and psychological habituation to a mood- or mind-altering drug, such as alcohol or cocaine. chemical dependency in June. Titan plans to initiate clinical testing of Probuphine in the second half of 2002. Oncology Therapeutic Products in Development Titan further advanced its cancer programs with the initiation of an additional clinical study of its novel monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing products. This Phase II study with CeaVac(R) and TriAB(R) for the treatment of resected 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. is being conducted by the Cancer and Leukemia Group B Cancer and Leukemia Group B (CALGB) is a cancer research cooperative group in the United States. CALGB research is focused on seven major disease areas: leukemia, lymphoma, breast cancer, lung cancer, gastrointestinal malignancies, genito-urinary malignancies, and melanoma. and funded by the National Cancer Institute. A separate ongoing Phase II study of CeaVac and TriAb in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. is being conducted by the Radiation Therapy Oncology Group and also funded by the NCI See Liberate. . In addition, a Phase III study of CeaVac for the treatment of Dukes' D colorectal cancer is progressing with a final analysis to be performed in the fourth quarter. An additional Phase III study of CeaVac in Dukes' C colorectal cancer, which will be conducted by the American College of Surgeons Oncology Group The American College of Surgeons Oncology Group (ACOSOG) is a clinical trial cooperative group supported publicly by the National Cancer Institute (NCI). Established during the 1990s, ACOSOG has a different mission when compared to other cooperative groups. , also funded by the NCI, is expected to begin in the second half of 2002. Results from the recently completed Phase II clinical study in the treatment of lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. of Titan's novel drug Pivanex(TM) will be presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. in May. New pre-clinical data were recently presented at the American Association of Cancer Research annual meeting in April, demonstrating that Pivanex can be combined with current chemotherapeutic agents to increase anti-cancer activity. Based upon these results, Titan plans to initiate additional clinical testing of Pivanex in lung cancer. Gallium maltolate, Titan's orally delivered form of gallium, is progressing in a Phase I/II study in numerous cancer types including 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 , 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. , metastatic bladder cancer and refractory lymphoma. Activity of gallium in this group of cancers has been previously demonstrated using intravenous formulations of gallium. Phase I clinical testing with gallium maltolate indicates that potentially therapeutic blood levels of gallium can be achieved with gallium maltolate. Titan also plans to initiate an additional clinical study of gallium maltolate in the fourth quarter of 2002. 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) 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. 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 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 CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amount)
Three Months Ended March 31,
2002 2001
(unaudited)
Contract and grant revenue 2,347 580
Operating expenses:
Research and development 7,486 4,999
General and administrative 1,210 1,584
------------ -----------
Total operating expenses 8,696 6,583
------------ -----------
Loss from operations (6,349) (6,003)
Other income, net 1,399 1,484
------------ -----------
Net loss $ (4,950) $ (4,519)
============ ===========
Basic and diluted net loss per share $ (0.18) $ (0.16)
============ ===========
Shares used in computing basic and
diluted net loss per share 27,642 27,468
============ ===========
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, December 31,
2002 2001
------------ -----------
(unaudited) (Note A)
Assets
Cash, cash equivalents, and
marketable securities $ 96,013 $105,051
Prepaid expenses, receivables
and other current assets 1,579 906
------------ -----------
Total current assets 97,592 105,957
Furniture and equipment, net 690 575
Investment in other companies 600 600
------------ -----------
$ 98,882 $107,132
============ ===========
Liabilities and Stockholders' Equity
Current liabilities $ 3,473 $ 5,764
Minority interest - Series B
preferred stock of Ingenex, Inc. 1,241 1,241
Stockholders' Equity 94,168 100,127
------------ -----------
$ 98,882 $107,132
============ ===========
Note A: The balance sheet at December 31, 2001 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.
|
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion