BioCryst Q2 Results and Upcoming Key Milestones

 —2Q 2021 revenue of $50.0 million—

—ORLADEYO® (berotralstat) net revenue of $28.5 million—

“The ORLADEYO launch is off to an excellent start because HAE patients want a safe and effective oral medicine to control their attacks and reduce their burden of therapy, and switching to ORLADEYO meets these needs for them,” said Charlie Gayer, chief commercial officer of BioCryst.

On June 15, 2021, the company announced the designs for REDEEM-1 and REDEEM-2, two upcoming pivotal trials with its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 (500 mg bid) monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor. REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 (500 mg bid) as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy. The primary endpoint for both trials is the change from baseline in hemoglobin, assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2. Trial site start-up activities are now underway at sites around the world and both pivotal trials are expected to begin enrolling patients in the second half of 2021.

In the second half of 2021, the company also plans to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. The trial will be a basket study including cohorts of patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9886913. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9886913.

https://www.globenewswire.com/news-release/2021/08/05/2275438/29446/en/BioCryst-Reports-Second-Quarter-2021-Financial-Results-and-Upcoming-Key-Milestones.html