BioCryst Pharmaceuticals, Inc. (BCRX) Reports In-Line Q1 Loss; Offers Update

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) reported Q1 EPS of ($0.17), in-line with the analyst estimate of ($0.17).

Clinical Development Update & Outlook

-- BioCryst recently completed enrollment in OPuS-1 (Oral ProphylaxiS-1), a Phase 2a trial of orally-administered BCX4161 in patients with hereditary angioedema. The Company expects to report results during the second quarter 2014. The OPuS-1 clinical trial is testing 400 mg of BCX4161 administered three times daily for 28 days in up to 25 HAE patients who have a high frequency of attacks (≥ 1 per week), in a randomized, placebo-controlled, two-period cross-over design.
-- Nonclinical development of our two second-generation plasma kallikrein inhibitors continues to progress as planned. The most advanced compound has completed additional nonclinical dosing studies, with results that continue to support a profile of once-daily dosing for HAE in the clinic.
-- Earlier this year, the NDA for i.v. peramivir was accepted with a PDUFA date of December 23, 2014. Following the issuance of a Warning Letter and a recent re-inspection by FDA, our contract manufacturer for peramivir drug product received a Form 483, which contained a number of observations that need to be addressed. It is unclear how these findings may impact the peramivir NDA or supply of peramivir drug product. BioCryst and its contract manufacturer are working with the FDA to meet the requirements for approval of the peramivir NDA.
-- In March, BioCryst announced the publication in the journal Nature of compelling BCX4430 efficacy results in animal models of infection with Marburg virus and Ebola virus, two highly virulent pathogens responsible for viral hemorrhagic fever diseases. The Nature online publication, "Protection against filovirus diseases by a novel broad-spectrum nucleoside analog BCX4430," represents the first report of protection of non-human primates from filovirus disease by a small molecule drug. This research was chosen for oral presentation at the 6th International Symposium on Filoviruses in Galveston, TX, on April 2 and also at The 27th International Conference on Antiviral Research (ICAR) in Raleigh, NC on May 14.
-- During the first quarter 2014, BioCryst's research team started small molecule drug discovery programs addressing two rare disease targets. These programs are intended to refill the clinical development pipeline in the timeframe our HAE assets come to market.

Financial Outlook for 2014

Based upon current trends, assumptions, and development plans, BioCryst expects its 2014 net operating cash use to be in the range of $35 to $43 million, and its operating expenses to be in the range of $48 to $59 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in projecting this expense, as it is impacted by the volatility and price of the Company's stock, as well as by the vesting of the Company's outstanding performance-based stock options.

For earnings history and earnings-related data on BioCryst Pharmaceuticals, Inc. (BCRX) click here.

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