Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced financial results for its fiscal 2012 fourth quarter and year ended September 30, 2012.
"Arrowhead made progress on several fronts during the fourth quarter and the entire fiscal year that make us a stronger company," said Dr. Christopher Anzalone, President and Chief Executive Officer. "We advanced our clinical candidates, ARC-520, Adipotide, and CALAA-01, we continued to make improvements to our platform technologies, and have begun to make good progress on our business development goals."
Fiscal 2012 Fourth Quarter and Recent Company Highlights
- Program and Pipeline Highlights
- Submitted a pre-IND data package and subsequently completed a pre-IND meeting with the FDA on hepatitis B candidate ARC-520;
- Advanced ARC-520 into final IND-enabling steps, with IND filing expected in Q2 2013;
- Presented data on new DPC subcutaneous formulation showing 99% target gene knockdown in non-human primates without toxicity;
- Published studies in the journal Nucleic Acid Therapeutics demonstrating high levels of knockdown in non-human primates using cholesterol-conjugated siRNA, DPCs, and a novel co-injection strategy;
- Received additional patents on the DPC siRNA delivery system;
- Established a Clinical Advisory Board for hepatitis B including prominent hepatologist Dr. Robert G. Gish;
- Began dosing patients with anti-obesity treatment Adipotide ® in a phase 1 clinical trial;
- Completed patient dosing in a phase 1b trial of CALAA-01;
- Enrollment of a randomized phase 2 clinical study of partnered candidate CRLX101 (formerly IT-101) in non-small cell lung cancer completed by licensee Cerulean Pharma, with overall survival data expected in early 2013.
- Business Development Highlights
- Entered into a Collaboration and License Agreement with Shire for peptide-targeted therapeutics;
- Entered into an Evaluation Agreement with Merck for a monoclonal antibody candidate.
- Financial Highlights
- Strengthened the balance sheet through equity financings with gross proceeds of $10.5 million.
Selected Fiscal 2012 Fourth Quarter Financial ResultsTotal operating expenses for the quarter ended September 30, 2012 were $5.4 million, compared to $2.9 million during the quarter ended September 30, 2011.