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BioCryst 2010 third quarter revenue increases from $10.5 million to $12.0 million

October 19, 2017

During the August 2010 quarterly update, we projected 2010 cash use to be within, but at the high end of its previous guidance range of $25 to $30 million. Initiation of the modified Phase 3 program for peramivir will lead to a ramp up in development expenses during the fourth quarter of 2010. This creates a timing effect on our 2010 cash use, as these expenses will be reimbursed by HHS during the first quarter of 2011. As a result, we now expect our cash use for 2010 to be approximately $33 million.

Clinical Development Update & Outlook

The Phase 2 study to evaluate the efficacy and safety of BCX4208 alone and in combination with allopurinol in gout patients met its primary endpoint related to sUA reduction. A dose-response was demonstrated for both BCX4208 and allopurinol, and the combination of BCX4208 and allopurinol was shown to be superior to either drug alone in sUA reduction. In five of these nine combination groups, 80 percent or more of the patients achieved a sUA concentration of less than 6 mg/dL. Combinations of lower doses of BCX4208 with allopurinol showed synergistic effects in sUA reduction. The doses of BCX4208 alone and in combination with allopurinol evaluated in the study were generally safe and well-tolerated. In the pivotal Phase 2 study of 200 mg once-daily forodesine in the treatment of CTCL, eleven percent of late-stage patients (Stage IIB to IVA) achieved a partial cutaneous response. An interim analysis of the ongoing exploratory Phase 2 study evaluating 200 mg of forodesine twice-daily in 25 patients with CLL showed that three patients demonstrated a confirmed partial response to forodesine. Final results from this study are expected later in 2010, and the Company plans to present these results at an upcoming medical meeting. BioCryst is exploring the interest level of potential partners as a possible path forward for the future development of forodesine in the U.S. BioCryst has submitted a contract modification to HHS/Biomedical Advanced Research and Development Authority (BARDA), to include an additional efficacy study and Government funding to complete the Phase 3 development of i.v. peramivir. Start-up activities for the upcoming flu season have been approved by HHS/BARDA under the existing contract and are underway. BioCryst has recently presented new clinical safety and influenza B virologic data for i.v. peramivir at two medical meetings, ICAAC and IDSA. BioCryst is finalizing plans for a 12 week, randomized, controlled study of BCX4208 as add-on therapy in gout patients who have failed to adequately respond to allopurinol. The 200+ subject study is expected to begin enrollment in early 2011. The Company also plans to initiate a long-term safety study in 2011. During BioCryst's Investor Day event in September, the Company announced plans to conduct additional pre-clinical development activities to support the advancement of BCX4161 as a potential novel plasma kallikrein inhibitor for the treatment of hereditary angioedema.

Source: BioCryst Pharmaceuticals, Inc.