=BioCryst Pharma (BCRX) reported earnings on Mon 27 Feb 17 (b/o)

BioCryst Pharma beats by $0.18, beats on revs; reports statistically significant and clinically meaningful reductions in attack frequency from an interim analysis of its ongoing APeX-1 clinical trial in patients with HAE :

Reports Q4 (Dec) loss of $0.06 per share, $0.18 better than the Capital IQ Consensus of ($0.24); revenues rose 95.7% year/year to $9 mln vs the $4.6 mln Capital IQ Consensus. This increase, compared to the fourth quarter of 2015, resulted from higher peramivir royalty revenue and inventory sales to Seqirus, and was slightly offset by lower collaborative revenue in the fourth quarter of 2016.

• 'Based upon development plans and our awarded government contracts, BioCryst expects its 2017 net operating cash use to be in the range of $30 to $50 million, and its 2017 operating expenses to be in the range of $53 to $73 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company's stock, as well as by vesting of the Company's outstanding performance-based stock options.

Co also reported statistically significant and clinically meaningful reductions in attack frequency from an interim analysis of its ongoing APeX-1 clinical trial in patients with HAE.

• Reduction of 63% in overall attack rate in HAE patients with severe disease (p=0.006).
• Twenty-eight subjects, randomized equally to receive BCX7353 350 mg QD or placebo for 28 days, were included in the interim analysis.
• The baseline attack rate was ~1/week, and average C1 inhibitor levels were less than 20% of the normal mean, indicating a severely affected patient population. Baseline characteristics were generally well balanced between the two groups with the exception of prior androgen use, which was more common in the BCX7353 group (11 of 14 compared with 6 of 14 on placebo).
• The pre-specified per-protocol (:PP) interim analysis included data on 24 subjects with confirmed Type 1 or Type 2 HAE completing 28 days of treatment (11 treated with BCX7353 and 13 with placebo).
• The mean rate of independently-adjudicated angioedema attacks for the pre-defined effective dosing period (weeks 2 through 4) in BCX7353-treated subjects was 0.34/week compared to 0.92/week for placebo, a reduction of 0.57/week (63%), p = 0.006.
• In the intent-to-treat (ITT) population of 28 subjects, the rates of attacks for the effective dosing period for BCX7353 and placebo groups were 0.44/week and 0.91/week, a reduction of 0.47/week (52%), p = 0.035.
• Daily oral dosing with BCX7353 strongly inhibited plasma kallikrein throughout the 24 hour dosing interval; the degree of inhibition was similar to that seen with this dose in the healthy subject Phase 1 trial.
• Oral BCX7353 350 mg once-daily for 28 days was generally safe and well tolerated in subjects with HAE.
• There were no serious adverse events (AEs) and no related severe AEs.
• No clinically significant changes in hematology parameters, renal function tests, electrolytes, or urinalysis were observed.