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

Company mission and lead asset

• Focused on treating and preventing virus-associated cancers, especially EBV-associated cancers, with a lead late-stage asset, Nana-val.

• Nana-val is an all-oral combination therapy targeting EBV cancer cells with a novel mechanism of action applicable to multiple cancer types.

• EBV-associated cancers represent a high unmet medical need, with worse outcomes than EBV-negative cancers.

• Approximately 2% of cancers worldwide are EBV-associated, affecting over 300,000 patients annually.

Clinical trial design and results

• Ongoing pivotal phase II basket trial in relapsed/refractory EBV-positive lymphomas, focusing on PTCL, DLBCL, and PTLD.

• PTCL cohort has passed both stage one and two, now enrolling in post stage two expansion.

• In 21 PTCL patients, observed 33% ORR (intent-to-treat), 41% ORR (efficacy-evaluable), and higher response rates in second-line patients (up to 67% ORR).

• Responses were prompt and durable, with median duration not yet reached and several patients ongoing at data cutoff.

• Nana-val was generally well-tolerated, with manageable adverse events; only one grade five event among over 150 treated.

Regulatory and development strategy

• Recent FDA meeting clarified requirements for accelerated approval: compelling ORR and a randomized control study.

• Interim analysis planned at 40 second-line patients; randomized control study of 120 patients to be initiated.

• NDA submission targeted for 2026, with additional data presentations planned for Q4 2024 and H1 2025.

• Solid tumor program paused after phase 2 dose determination, pending additional financing or partnership.

• Workforce reduced by 23% in August to focus resources on lymphoma program.