Earnings release
Page 1
Viracta | Investor Relations Viracta Therapeutics Reports First Quarter 2021 Financial Results and Provides Clinical and Corporate Updates NAVAL - 1 , a global pivotal trial for the treatment of relapsed / refractory EBV - positive lymphoma is on track to be initiated in Q2 2021 NAVAL - 1 trial design to be featured in a Key Opinion Leader webinar taking place on May 20 , 2021 Closed merger with Sunesis Pharmaceuticals and $ 65 million private placement Cash and cash equivalents of approximately $ 129.2 million as of March 31 , 2021 SAN DIEGO , May 12 , 2021 / PRNewswire / -- Viracta Therapeutics , Inc. ( Nasdaq : VIRX ) ( Viracta or the Company ) , a precision oncology company targeting virus - associated malignancies , today announced financial results for the first quarter of 2021 and provided a clinical and corporate update . " Viracta has emerged from our first quarter as a publicly traded company well - positioned to make a significant impact on patients and create meaningful value for our shareholders . We are on track to initiate our pivotal NAVAL - 1 trial as planned this quarter for the treatment of EBV - associated lymphoma , and we look forward to expanding into our second global clinical program in EBV - associated solid tumors in the second half of 2021 , " said Ivor Royston , M.D. , President and Chief Executive Officer of Viracta . Dr. Royston continued , " Today , we are excited to provide additional details of the NAVAL - 1 trial design , which has been reviewed by the United States Food and Drug Administration . We believe the innovative and adaptive design of this registration - enabling pivotal trial will allow us to simultaneously progress towards potential NDA filings in multiple lymphoma subtypes . " First Quarter 2021 and Recent Highlights Clinical • Announced design of NAVAL - 1 , a global pivotal trial in Epstein - Barr virus ( EBV ) -positive relapsed / refractory ( R / R ) lymphoma . NAVAL - 1 ( Nanatinostat in Combination with Valganciclovir ) is a multinational , multicenter , open - label Phase 2 basket trial . The trial , which will include multiple subtype- specific cohorts of R / R EBV - positive lymphoma patients , is designed to evaluate the anti - tumor activity of the combination treatment of nanatinostat with valganciclovir and is anticipated to enroll up to 140 patients . The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee . If successful , Viracta believes this trial could support multiple NDA filings across various EBV - positive lymphoma subtypes . Viracta remains on track to initiate NAVAL - 1 in Q2 2021 . • Completed enrollment in Phase 2 expansion cohort of its Phase 1b / 2 R / R EBV - positive lymphoma trial , with updated data expected in H2 2021. VT3996-201 , Viracta's Phase 1b / 2 open- label , dose escalation / expansion trial of nanatinostat - valganciclovir combination treatment in R / R EBV- positive lymphoma has generated promising efficacy and safety data to date , as presented at the 62nd American Society of Hematology Annual Meeting in December 2020 , including preliminary objective response and complete response rates ( ORR / CR ) of 80 % / 40 % ( n = 10 ) and 67 % / 33 % ( n = 6 ) in T / NK cell non- Hodgkin's lymphoma and diffuse large B - cell lymphoma , respectively . The median duration of response was 10.4 months . Corporate • Closed merger with Sunesis Pharmaceuticals , Inc. Shares of the combined company , Viracta Therapeutics , Inc. , commenced trading on the Nasdaq Global Select Market under the ticker symbol " VIRX " on February 25 , 2021 . • Completed a $ 65 million private placement . On February 24 , 2021 , Viracta closed a private financing featuring a premier investor syndicate of biotechnology - focused and institutional accredited investors . • Strengthened balance sheet through a multi - license milestone and royalty monetization transaction with XOMA . In March 2021 , Viracta announced that XOMA had purchased the potential future milestones and royalties associated with existing licenses relating to two clinical - stage drug candidates that Viracta obtained in the merger in exchange for an upfront payment of $ 13.5 million and up to $ 20 million in a pre - commercialization , event - based milestone . In the merger , Viracta also obtained exclusive and global rights to assets previously held by Sunesis including SNS - 510 , a PDK - 1 inhibitor , and vecabrutinib , a BTK inhibitor . Viracta is evaluating future development and collaboration opportunities for SNS - 510 and potential partnering opportunities for vecabrutinib . • Extended intellectual property protection around lead lymphoma program . In March 2021 , the U.S. Patent and Trademark Office ( USPTO ) granted patent 10,953,011 , which covers the anticipated dose regimen to be advanced in the NAVAL - 1 trial . The patent provides Viracta with intellectual property protection into at least 2040 .