Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the fourth quarter and year ended December 31, 2011.
Targacept reported a net loss of $9.8 million for the fourth quarter of 2011, compared to a net loss of $2.2 million for the fourth quarter of 2010. For the year ended December 31, 2011, Targacept reported a net loss of $8.5 million, compared to net income of $10.9 million for 2010. As of December 31, 2011, cash and investments in marketable securities totaled $249.3 million.
“We are continuing to execute on a business plan designed to advance the development of our robust pipeline of pharmacologically diverse NNR Therapeutics in therapeutic areas where there is a high unmet need and significant commercial opportunity,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “As the RENAISSANCE Program for TC-5214 nears completion, we remain focused on strategic prioritization and the optimal deployment of our cash resources to exploit our innovative science and pipeline.”
Recent Highlights and Program Updates:TC-5214 (co-development with AstraZeneca)
- Expect to report top-line results from two fixed dose trials (RENAISSANCE 4 and RENAISSANCE 5) and a long term study designed primarily to evaluate safety (RENAISSANCE 7) in the first half of 2012 in support of a potential second half of 2012 filing of a new drug application with the FDA as an adjunct to antidepressant therapy for major depressive disorder (MDD);
- Reported top-line results from two flexible dose clinical trials (RENAISSANCE 2 and RENAISSANCE 3) that did not meet the primary endpoint, change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo;
- Recruitment continuing for the Phase 2b “switch” monotherapy study (known as the EXPLORER study) for patients with MDD who do not respond adequately to initial antidepressant therapy;
- Initiated a Phase 2b study as a treatment for negative symptoms and cognitive dysfunction in schizophrenia; study planned to enroll approximately 450 patients with stable schizophrenia at U.S. and Eastern European sites, with a target of 80% tobacco users;
- Initiated a Phase 2 study in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHDi) that is now planned to enroll approximately 152 patients at sites in the United States with top-line results expected in the second half of 2012;
- Completed enrollment in Phase 2 studies in asthma and type 2 diabetes that are planned to guide the selection of indications for which this product candidate is best suited for later-stage development; expect to report top-line data from both studies in the first half of 2012;
- Recruitment continuing in a Phase 2b potential registration study of AZD3480 head-to-head against donepezil in mild to moderate Alzheimer’s disease at sites predominantly in Eastern Europe and also in the United States; the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog) and the Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC-(+)) are co-primary endpoints of the study, with the Alzheimer’s Disease Cooperative Study ― Activities of Daily Living Inventory (ADCS-ADL) replacing CIBIC-(+) as a co-primary endpoint for European regulatory purposes;
- Announced that Targacept was informed of AstraZeneca’s plans to progress the development of AZD1446 as a treatment for Alzheimer’s disease, with the next study expected to be a Phase 2 study as an adjunct treatment to donepezil; and
- Remained at the forefront of NNR research, with the following publication authored by Targacept scientists:
- Bencherif M, Stachowiak MK, Kucinski AJ, Lippiello PM. Alpha7 Nicotinic Cholinergic Neuromodulation May Reconcile Multiple Neurotransmitter Hypotheses of Schizophrenia. Med Hypotheses (in press).