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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.
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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