Earnings release
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Viracta | Investor Relations Viracta Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update Announced that final results of Phase 1b / 2 trial of nanatinostat and valganciclovir ( Nana - val ) in relapsed / refractory ( R / R ) Epstein - Barr virus - positive ( EBV + ) lymphoma were selected for an oral presentation at the 2021 American Society of Hematology ( ASH ) Annual Meeting Continued the global expansion of pivotal NAVAL - 1 trial of Nana - val in R / R EBV + lymphoma ; multiple U.S. and international sites now open for enrollment Initiated Phase 1b / 2 trial of Nana - val in patients with EBV + solid tumors ; preliminary data anticipated in 2022 Announced that preclinical data on vecabrutinib was selected for oral and poster presentations at ASH Secured expanded $ 50 million credit facility from Silicon Valley Bank and Oxford Finance Cash and cash equivalents of approximately $ 111.0 million as of September 30 , 2021 SAN DIEGO , Nov. 10 , 2021 / PRNewswire / -- Viracta Therapeutics , Inc. ( Nasdaq : VIRX ) , a precision oncology company targeting virus - associated malignancies , today announced financial results for the third quarter of 2021 and provided an update on recent corporate activities . " Over the past months we achieved key milestones that have furthered the development of Nana - val and positioned us to broaden our addressable patient population , " said Ivor Royston , M.D. , President and Chief Executive Officer of Viracta . " We expanded our clinical trial pipeline with the initiation of our EBV - positive solid tumor trial and reacquired all rights to Nana - val in China , a strategically important territory given the high prevalence of EBV - associated cancers in Asia . Looking ahead , we expect continued progress in our solid tumor trial , as well as continued global expansion of our pivotal NAVAL - 1 trial in EBV - positive lymphoma . In addition , we are excited about our multiple ASH presentations that will feature final results from our Phase 1b / 2 EBV - positive lymphoma trial and preclinical findings on vecabrutinib , our reversible inhibitor of Bruton's tyrosine kinase ( BTK ) and interleukin - 2 - inducible kinase ( ITK ) , which we are exploring for potential use in combination with CAR T - cell therapy . " Dan Chevallard , Chief Operating Officer and Chief Financial Officer of Viracta , added , " Viracta remains in a strong financial position as we move toward the end of year . We ended the third quarter with approximately $ 111.0 million in cash and have reiterated our plan to end the year with over $ 100.0 million in cash . Importantly , we have now secured access to significant additional and undrawn non - dilutive and available capital through our recently expanded credit facility . We believe our financial strength positions us well to deliver on our development and strategic objectives into 2024. " Third Quarter 2021 and Recent Highlights Clinical • Continued the global expansion of pivotal NAVAL - 1 trial ; multiple U.S. and international sites now open for enrollment . NAVAL - 1 ( Nanatinostat in Combination with Valganciclovir ) is a global , multicenter , open - label Phase 2 basket trial . The trial , which will include patients with multiple subtypes of R / R EBV + lymphoma , is designed to evaluate the anti - tumor activity of Nana - val and is designed to enroll approximately 140 patients . The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee . If successful , the Company believes this trial could potentially support multiple new drug application ( NDA ) filings across various EBV + lymphoma subtypes . The study employs a Simon two - stage design where a limited number of patients are enrolled into each cohort in Stage 1 and , if a pre - specified activity threshold is reached , additional patients will be enrolled in Stage 2. During Stage 2 , the Company anticipates discussing the preliminary results with the U.S. Food and Drug Administration ( FDA ) and may amend the protocol to include additional patients as necessary to enable registration . The Company anticipates providing an update on the initial cohort ( s ) that have expanded into Stage 2 in the second half of 2022 . • Initiated a Phase 1b / 2 trial of Nana - val in patients with EBV + recurrent or metastatic nasopharyngeal carcinoma ( RM - NPC ) and other EBV + solid tumors . This Phase 1b / 2 open - label multicenter trial is evaluating Nana - val alone and in combination with pembrolizumab in patients with advanced EBV + solid tumors . The Phase 1b dose escalation part will evaluate safety and determine the recommended Phase 2 dose ( RP2D ) of Nana - val in patients with EBV + RM - NPC . In Phase 2 , up to 60 patients with EBV + RM - NPC will be randomized to receive Nana - val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy . Additionally , patients with other EBV + solid tumors will be enrolled to receive Nana - val at the RP2D in a Phase 1b dose expansion cohort . The Company anticipates providing preliminary clinical data from the trial in 2022 . • Announced an upcoming oral presentation at the 2021 ASH Annual Meeting featuring final results from VT3996-201 , the Phase 1b / 2 trial of Nana - val in R / R EBV + lymphoma . Data indicate that Nana - val was well tolerated and shows promising efficacy in patients with R / R EBV + lymphoma . The presentation's corresponding abstract is currently available on the ASH website . Preclinical • Announced upcoming oral and poster presentations at the 2021 ASH Annual Meeting featuring preclinical data on vecabrutinib , a reversible inhibitor of BTK and ITK . Data to be featured in the oral