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Viracta Therapeutics (VIRX) investor relations material

Viracta Therapeutics H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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H.C. Wainwright 26th Annual Global Investment Conference 2024 summary11 Sep, 2024

Key presentations and announcements

  • Vireacta Therapeutics presented NanoVal, an oral therapy targeting EBV-associated cancers, with a focus on PTCL, DLBCL, and PTLD lymphomas, as well as nasopharyngeal carcinoma and gastric cancer.

  • NanoVal demonstrated compelling overall response rates of 60–70% in second-line EBV-positive PTCL patients, with durable responses and manageable side effects.

  • A clear regulatory path was outlined, targeting an NDA filing in 2026, following FDA guidance to conduct a randomized controlled study alongside the ongoing pivotal Phase II trial.

  • The solid tumor program is paused pending additional financing or partnership, with dose-ranging work completed and a recommended Phase II dose expected in Q4 2024.

  • A 23% reduction in force was implemented in August to align resources with strategic priorities.

Industry analysis and market outlook

  • EBV-associated cancers represent about 2% of global cancer cases, with over 300,000 new patients annually, highlighting significant unmet medical need.

  • EBV-positive lymphomas have much poorer survival rates compared to EBV-negative cases, with rapid disease progression and limited treatment options.

  • NanoVal’s novel “kick and kill” mechanism offers a targeted approach, potentially setting a new standard of care for EBV-positive PTCL, especially in second-line treatment.

  • The company’s data compare favorably to other treatments that have received accelerated approval for PTCL, despite those not being EBV-specific.

  • Expansion into additional lymphoma subtypes and solid tumors is planned, contingent on future funding or partnerships.

Forward-looking statements and plans

  • Additional efficacy and safety data from the PTCL Stage 2 expansion cohort will be presented in Q4 2024 and H1 2025.

  • A randomized controlled study in second-line PTCL is set to begin enrollment in H2 2025, with interim analysis planned for 2026.

  • NDA submission for NanoVal in EBV-positive PTCL is targeted for 2026, aiming for accelerated approval.

  • Solid tumor program will resume once additional financing or partnerships are secured.

  • The company aims to expand NanoVal’s indications to other EBV-associated lymphomas and solid tumors in the future.

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Frequently asked questions

Viracta Therapeutics Inc. is a precision oncology company focused on developing treatments for virus-associated cancers. The company's leading product candidate, Nana-val, is an all-oral combination therapy comprising its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir. Beyond Nana-val, Viracta is exploring the "Kick and Kill" approach for other virus-related cancers, aiming to leverage its expertise in oncology to address the needs of patients with virus-associated malignancies globally. Headquartered in Cardiff-by-the-Sea, California, Viracta Therapeutics Inc.'s shares are listed on the Nasdaq.

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