GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) reported its financial results for the fourth quarter and fiscal year ended January 3, 2010. The total net loss for the fourth quarter was $1.7 million, or $0.09 per share, compared with $6.2 million, or $0.60 per share, for the fourth quarter of 2008. The total net loss for 2009 was $27.9 million, or $2.18 per share, compared to $22.7 million, or $2.31 per share, for 2008.
Cash Position
Cash at January 3, 2010 totaled $3.8 million, a $7.8 million decrease compared to $11.6 million at December 28, 2008. Last month, GTC obtained an aggregate of $7 million of new funding from LFB Biotechnologies (LFB) in the form of a 4%, 36-month term loan with a single payment of principal and interest at maturity. With this new funding from LFB and anticipated receipts from existing partnering agreements, GTC projects that its cash resources will be sufficient to support its operations to the end of the second quarter of 2010, exclusive of future cash proceeds from potential new partnering agreements.
Significant product development events for 2009 and outlook for 2010
Factor VIIa
GTC, together with its collaboration partner LFB, has established the transgenic rabbit production system for its rhFVIIa program and initiated the production of clinical lots to support the IND filing and subsequent clinical program. Following discussions with the FDA, GTC plans to file an IND in April, with the objective of initiating a Phase I study in the 2nd quarter of 2010. This is planned to be a safety, pharmacokinetic and pharmacodynamic study in comparison with NovoSeven, in normal healthy volunteers. On the basis of current plans, GTC expects to have results from this study in the fourth quarter of 2010.
Alpha-Fetoprotein (AFP)
GTC in-licensed the AFP program in the middle of 2009. GTC has established a herd of transgenic goats that produce this product in significant quantities. Animal model tests are currently being conducted that are considered to be predictive for efficacy in autoimmune diseases such as myasthenia gravis and multiple sclerosis. GTC’s plan is to initiate a Phase II study in myasthenia gravis in the second half of 2010 once a partnering arrangement has been obtained.
ATryn
Following approval of ATryn by the FDA, Lundbeck, Inc. (Lundbeck), formerly Ovation Pharmaceuticals, Inc., launched ATryn in the USA in May 2009. Lundbeck continues its commercialization of ATryn in the hereditary deficiency indication. In addition, GTC is collaborating with Lundbeck to develop a protocol for a pivotal study of patients with acquired antithrombin deficiency who are undergoing cardiac surgery. GTC aims to initiate a clinical trial in this indication in the second half of 2010.
In Europe, GTC is seeking to establish an alternative partnering arrangement for the commercialization and further development of ATryn following the termination of GTC’s contract with LEO Pharma (LEO). At this time there is no final decision in the LEO arbitration proceedings which GTC initiated with the International Chamber of Commerce.
Monoclonal Antibodies and Follow-on Biologics
GTC, together with its collaboration partner LFB, has established transgenic goat production systems for the production of TG20, a monoclonal antibody that targets CD20. TG20, which is not identical to Rituximab (Rituxan), has demonstrated in in-vitro studies that it has an approximately 10-fold greater antibody dependent cell-mediated cytotoxicity (ADCC) than Rituximab. This may translate into improved efficacy or reduced dosage in hematologic malignancies. GTC is seeking a partner to support its share of the commercialization and clinical development of TG20.
GTC has established production animals which express Trastuzumab (Herceptin) in their milk, and this protein is currently being characterized. GTC is also developing transgenic animals for the production of Adalimumab (Humira), and, together with our collaboration partner AgResearch in New Zealand, transgenic animals for the production of Cetuximab (Erbitux). For each of these products we will be seeking partners to support further clinical development and commercialization.
This portfolio of product candidates addresses markets with total annual sales currently in excess of $16 billion. For our product candidates addressing oncology indications, the natural glycosylation of the transgenic production system may provide advantages in ADCC. GTC plans to characterize each of these proteins as they become available and to initiate non-clinical studies in support of future partnering activities.
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