CED Member Tranzyme Pharma (Nasdaq:TZYM), a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, first-in-class small molecule therapeutics for the treatment of acute (hospital‑based) and chronic gastrointestinal (GI) motility disorders today announced its financial results for the fourth quarter and fiscal year ended December 31, 2011.
"We made significant progress in 2011 advancing our two key development programs through late-stage clinical testing in patients with GI motility disorders. We are very pleased that patient enrollment is complete in both of our Phase 3 pivotal trials and we look forward to announcing data from these trials in the first half of this year," said Vipin K. Garg, Ph.D., President and CEO of Tranzyme. "In addition, patient enrollment in our Phase 2b trial for TZP-102 for diabetic gastroparesis is on track to be completed in the second half of 2012 and we plan to announce top-line data by year-end."
Recent Highlights and Developments
Ulimorelin Phase 3 Trial Completion
- Patient enrollment in the ULISES 007 and 008 Phase 3 pivotal trials of ulimorelin for the acceleration of gastrointestinal recovery in patients undergoing abdominal surgery is complete. Ulimorelin is an intravenous ghrelin agonist discovered by Tranzyme using its proprietary drug discovery technology.
Debt Financing
- On January 31, 2012, Tranzyme received an additional net $9.3 million in term loan proceeds through an amendment and restatement of its existing debt financing facility. This financing extends the Company's cash runway into Q4 2013.
Select Fourth Quarter 2011 Financial Results
Total revenue for the fourth quarter of 2011 was $2.2 million compared to $2.9 million in the same period last year. Research and development expenses were $7.7 million in the fourth quarter 2011 as compared to $2.4 million for the same period in 2010. The increase during the period reflects costs associated with the two Phase 3 pivotal trials for ulimorelin and the Phase 2b clinical trial for TZP-102. General and administrative expenses were $2.1 million in the fourth quarter 2011 versus $1.0 million in the same period last year, reflecting increased expenses relating to pre-commercialization and corporate governance activities. The Company reported a consolidated net loss of $8.0 million compared to $1.1 million for the fourth quarter of 2010.
Select Fiscal Year 2011 Financial Results
Total revenue for fiscal year 2011 was $10.2 million compared to $8.5 million in 2010. Total operating expenses in 2011 were $30.9 million compared to $14.0 million in 2010. Research and development expenses were $24.9 million compared to $10.1 million in 2010. The increase during the period reflects costs associated with the two Phase 3 pivotal trials for ulimorelin and the Phase 2b clinical trial for TZP-102. General and administrative expenses were $6.0 million compared to $3.9 million in 2010, reflecting increased expenses relating to pre-commercialization and corporate governance activities. Net loss in fiscal year 2011 was $22.2 million compared to $7.3 million in 2010. Cash and cash equivalents were $40.9 million at December 31, 2011.
About Tranzyme Pharma
Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 20 percent of adults worldwide are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options. Tranzyme is developing an intravenous drug, ulimorelin, for patients in acute (hospital-based) settings, as well as an oral drug, TZP-102, for chronic conditions. Top-line data from the recently completed Phase 3 trials of ulimorelin are expected in the first half of 2012, and enrollment in a Phase 2b trial of TZP-102 is ongoing. Together these product candidates target a significant underserved market. By leveraging its proprietary drug discovery technology, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs.
For a full press release, including financial information, view the Tranzyme Investor Relations webpage.
For a full press release, including financial information, view the Tranzyme Investor Relations webpage.
