BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that in response to recent events and an assessment of its assets, the Company is restructuring and implementing a focused strategy to advance its hereditary angioedema (HAE) and antiviral programs. The restructuring is intended to significantly reduce BioCryst’s cost structure and scale the organization appropriately for its current portfolio. The Company plans to direct its cash and other resources primarily to enable the achievement of important near-term milestones for the BCX4161 HAE, BCX4430 broad spectrum antiviral and BCX5191 hepatitis C (HCV) programs. “The strategic focus and restructuring announced today is based on an evaluation of our programs and operations, following the setbacks in our peramivir and BCX5191 programs, as well as the delay in our BCX4161 program,” said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. “The restructuring is a necessary but difficult measure that impacts many talented and dedicated BioCryst employees who will be leaving the company. We are grateful for their meaningful contributions and commitment over the years.” Mr. Stonehouse continued, “We have determined the best path forward and remain committed to advancing our HAE and antiviral programs to rebuild shareholder value. To succeed, we must significantly decrease our operating costs and carefully manage cash, while efficiently advancing our three priority programs. Therefore, we are implementing a substantial corporate restructuring to decrease our annual cash utilization and thereby extend our cash runway. The restructuring provides additional cash runway to reach value inflection points for these programs.” BioCryst’s corporate restructuring includes a workforce reduction of 50 percent of the Company’s headcount, or 38 positions. Excluding restructuring and deal charges, cash savings of $15 to $18 million are expected in 2013, as compared to an approximate $40 million cash use expected in 2012. The Company expects to record a restructuring charge of $2 to $4 million in the fourth quarter of 2012. For 2013, preliminary cash utilization guidance is in the range of $22 to $25 million, excluding restructuring and deal related costs. Detailed financial guidance for 2013 will be provided with the fiscal 2012 results announcement in February 2013.
Program Updates & Milestones
- BioCryst is conducting a study to characterize the efficacy of low doses of BCX5191 in chronically HCV infected chimpanzees, with the goal of demonstrating meaningful antiviral activity at low doses. Results from the study are expected in early 2013.
- By the end of January 2013, BioCryst plans to complete analysis of the peramivir Phase 3 trial results and to review the conclusions with HHS/BARDA. After reviewing the totality of peramivir clinical safety and efficacy data, a decision will be made regarding peramivir’s future.
- The BCX4161 Phase 1 program is expected to start around the end of the first quarter 2013. The goal of this program is to demonstrate safety, adequate drug exposure via oral administration and pharmacodynamic effect on kallikrein inhibition.
- A manuscript describing the activity of BCX4430 against certain filoviruses has recently been submitted to a journal for consideration. In addition, BioCryst has submitted a proposal to seek additional government funding for the development of BCX4430 under the animal rule.
- The Company’s strategy for the ulodesine gout program remains unchanged. BioCryst intends to secure a partner to take over the ulodesine Phase 3 development and to commercialize the product.