SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 14, 2000--Titan Pharmaceuticals, Inc. (AMEX: TTP - news) today announced financial results for the third quarter and nine month period ended September 30, 2000.
Revenue for the third quarter and for the first nine months of 2000 were approximately $700,000 and $1.3 million, respectively. During the same periods last year, the Company had revenue of approximately $50,000 and $100,000, respectively. This increase in revenue is principally related to our corporate partnership with Schering AG, Titan's partner in the development of Spheramine(TM) for the treatment of Parkinson's disease, and certain additional licensing fees.
Other income for the third quarter and the first nine months of 2000 were approximately $1.4 million and $3.6 million, respectively, compared to approximately $100,000 and $400,000 for the same periods in 1999. These increases were related primarily to interest income and are a result of a greater cash and short-term investments position.
Net loss for the third quarter of 2000 was $0.14 per share, or $3.7 million, excluding the effect of a one-time charge for the acquisition of a new product platform, gallium maltolate. Net loss for the same quarter in 1999 was $0.16 per share, or $2.4 million. The one-time effect of the acquisition was an additional loss of $0.20 per share, or $5.0 million. For the nine months ended September 30, 2000, net loss including the one-time charge was $0.59 per share, or $14.8 million, compared to $0.55 per share, or $8.4 million, for the same period in 1999.
Research and development expenses for the third quarter and the first nine months of 2000 were approximately $4.6 million and $11.9 million, respectively, compared to approximately $1.7 million and $6.6 million for the same periods in 1999. This planned increase in research and development expense was a result of the expansion of Titan's randomized, placebo-controlled Phase III clinical study of CeaVac® in Dukes D colorectal cancer, commencement of the Phase I/II clinical trial of Spheramine, and increased manufacturing and development activity for CeaVac and for our other anti-cancer therapeutic monoclonal antibodies, TriAb® and TriGem(TM), to support the initiation of additional clinical efficacy studies over the next several months. These additional studies will be conducted by various government sponsored cooperative groups and funded largely by the National Cancer Institute.
General and administrative expenses for the third quarter and the first nine months of 2000 were approximately $1.2 million and $2.8 million, respectively, compared to approximately $800,000 and $2.2 million for the same periods in 1999.
At September 30, 2000 the Company had cash and cash equivalents of approximately $79.8 million.
Commenting on these results, Dr. Louis R. Bucalo, Chairman, President and CEO of Titan Pharmaceuticals stated, ``Titan's financial results for the third quarter and first nine months of this year were in line with expectations, and reflect our ability to expand our development programs in an efficient and cost-effective manner.''
``The Zomaril(TM) Phase III program in schizophrenia continues to make excellent progress. The second placebo controlled efficacy study of Zomaril demonstrated positive results, and confirmed prior data regarding Zomaril's excellent safety profile. The third placebo controlled study is proceeding very well, and the entire Phase III program is on track to be completed on schedule in the first quarter of next year. A depot formulation targeted to provide one month of treatment is also progressing in clinical testing.''
``Our Phase I/II study with Spheramine in Parkinson's disease is proceeding well, with the first cohort of three patients having received treatment, and an additional three patients planned for treatment this year.''
``In addition, we are pleased to announce that we have just been awarded an SBIR Phase II grant of over $1.1 million in support of this important program. We believe Spheramine has the potential to provide significant therapeutic benefit to patients with this wide-spread and disabling disease, and are excited about our progress and this additional support for the Spheramine program.''
In the validated MPTP primate model of Parkinson's disease, Spheramine recently demonstrated continued statistically significant efficacy for the 12 month study period after a single treatment, with a robust, greater than 60% improvement in disability as assessed by the modified Unified Parkinson's Disease Rating Scale. Additional studies demonstrated that Spheramine's therapeutic cells remained viable and active at the end of the 12 month study period. Based upon the excellent progress in the Company's Parkinson's disease program, Titan is initiating additional preclinical studies delivering a number of therapeutic factors for the potential treatment of glioma, Alzheimer's disease and other disorders.
``We believe our CCM(TM) technology represents an advantageous, platform approach for the delivery of therapeutic cells, proteins, and genes to the central nervous system,'' stated Dr. Bucalo.
``Further important progress was also made with our long term drug delivery system for the treatment of substance abuse. Clinical studies continue to show the benefit and cost effectiveness of medical therapy for people with opiate addiction and alcohol abuse. However, optimal systems for drug delivery and ensuring compliance have yet to be established. We believe that Titan's long term drug delivery system may represent an important solution to these needs, and are progressing toward initial clinical testing in patients with opiate addiction and alcohol abuse next year. We are developing a targeted formulation to provide 6 months of continuous treatment, and believe these products may have important advantages in this therapeutic setting.''
Continuing, Dr. Bucalo stated, ``We have also made significant progress in our cancer therapeutic programs. Our Phase III study with CeaVac for treatment of Dukes D colorectal cancer is on target to complete patient accrual soon. Additionally, our entire portfolio of anti-cancer monoclonal antibodies is continuing to gather momentum and support from a number of government sponsored cooperative groups with funding from the National Cancer Institute. The American College of Surgeons Oncology Group plans to launch a multi-center, randomized, 1400 patient, Phase III study with CeaVac in Dukes C colorectal cancer by year-end, and the Radiation Therapy Oncology Group will initiate a Phase II study with CeaVac and TriAb in non-small cell lung cancer in the first quarter 2001. A number of additional cooperative group studies are also planned for initiation next quarter.''
Recently, exciting new data has emerged with the Company's TriGem product in the treatment of stage three melanoma, suggesting that TriGem may enhance the benefit of high dose interferon alpha, which is currently a treatment of choice for patients with this stage of the disease. Phase III clinical studies are now being planned in conjunction with major academic centers to further evaluate TriGem's potential benefit in this setting. Dr. Kenneth Foon, Director of the Barrett Center for Cancer Prevention and Research at the University of Cincinnati Medical Center, commented, ``Recent preliminary Phase II clinical data suggest that TriGem may improve disease free survival and overall survival when given in conjunction with high-dose interferon a2b, the current standard of care for stage three melanoma. These encouraging Phase II data provide a strong basis for definitive Phase III testing of TriGem in this patient group. The potential for an agent such as TriGem with minimal toxicity to improve patient survival is an important new direction in cancer therapy.''
Titan is also making significant progress with other cancer therapeutics in development. Recent preclinical studies with Pivanex® have demonstrated effectiveness in models of head and neck cancer, and potential synergistic antitumor activity with gemcitabine and doxorubicin in lung cancer. Completion of the current Phase II clinical study in lung cancer is anticipated in the near future, and Titan will be evaluating additional potential applications of this agent upon completion of these studies.
In addition, recently completed preclinical studies of RB94, the company's novel anticancer gene, have demonstrated that the gene acts at a highly susceptible point in the cancer cell cycle, which may confer significant synergy with radiation therapy and chemotherapy. These laboratory studies have further confirmed the antitumor activity of RB94, and clinical studies are targeted for initiation next year.
Dr. Bucalo concluded, ``In addition to these important programs, we will soon be launching Phase II studies of gallium maltolate in patients with lymphoma, multiple myeloma, and HIV, targeting significant additional opportunities for important progress.''
Titan Pharmaceuticals, Inc. is a biopharmaceutical company developing proprietary therapeutics for the treatment of central nervous system disorders, cancer, and other serious and life threatening diseases. |
