BioCryst receives HHS contract to complete peramivir Phase 3 study in patients with influenza

January 03, 2016

Changing the primary efficacy analysis of the study to focus on a subset of approximately 160 patients not treated with neuraminidase inhibitors as SOC, in order to provide the greatest opportunity to demonstrate a statistically significant peramivir treatment effect Increasing the total study target enrollment up to 600 subjects from the current target of 445 subjects Adding at least 45 more clinical site locations in additional countries

The actual time to reach completion of enrollment will depend on the prevalence and severity of influenza, as well as the ability of the more than 265 investigator sites to successfully enroll patients. Further details regarding this Phase 3 study is available at: clinicaltrials/ct2/show/NCT00958776

Resulting Adjustment to 2010 Financial Results

In connection with the contract modification, HHS and BioCryst agreed to settle on final indirect rates for years 2007, 2008 and 2009. As a result, BioCryst will receive a $4.9 million cash payment from HHS related to the difference between the actual indirect costs incurred against the contract and the indirect costs that were invoiced at a provisional billing rate during those years. In order to reach agreement regarding the modification, the Company agreed to reductions of approximately $1.1 million of indirect costs relating to 2008 and 2009. As this subsequent event occurred after BioCryst's release of fourth quarter and full year 2010 financial results but prior to issuance of its annual financial statements to be included in Form 10-K, the Company will adjust the financial results previously reported in its February 10, 2011 press release. Accordingly, collaborative and other research and development revenues for the three and twelve months ended December 31, 2010 will be reduced to $17.4 million and $62.1 million, respectively. Net loss and loss per share for the three months ended December 31, 2010 will increase to $10.2 million and $0.23 per share. Net loss and loss per share for the twelve months ended December 31, 2010 will increase to $33.9 million and $0.76 per share. Receivables from collaborations, total assets, and stockholders' equity as of December 31, 2010 will be reduced to $30.2 million, $109.4 million and $65.5 million, respectively. Accumulated deficit as of December 31, 2010 will increase to $296.6 million. An adjusted financial table is available at: investor.shareholder/biocryst/releases.cfm

Source: BioCryst Pharmaceuticals, Inc