Viracta Therapeutics Q2 2024 Financial Results and Business Update

Viracta Therapeutics, Inc., a precision oncology company specializing in virus-associated cancers, has announced significant developments in its clinical trials and corporate activities. The company's focus is on the treatment and prevention of Epstein-Barr virus (EBV) associated cancers through its leading therapeutic candidate, Nana-val—a combination of nanatinostat and valganciclovir. In the second quarter of 2024, Viracta reported positive outcomes from the Phase 2 NAVAL-1 trial, particularly in the relapsed or refractory (R/R) EBV-positive peripheral T-cell lymphoma (PTCL) cohort.

The NAVAL-1 trial demonstrated substantial antitumor activity and a generally well-tolerated safety profile for Nana-val. Among the 21 patients in Stages 1 and 2 of the R/R EBV-positive PTCL cohort, the overall response rate (ORR) was 33%, with a complete response rate (CRR) of 19% in the intent-to-treat (ITT) population. In the efficacy-evaluable (EE) population, these rates were 41% and 24%, respectively. Notably, in the second-line EBV-positive PTCL subpopulation, the ORR reached 60%, and the CRR was 30% in the ITT population, with even higher rates in the EE population.

Viracta has received positive feedback from the FDA, informing its updated clinical development plan for Nana-val in EBV-positive PTCL patients. The company plans to initiate a randomized controlled trial (RCT) in the second half of 2025, aiming for potential registration and accelerated approval based on interim analyses of the ongoing NAVAL-1 trial.

Several key milestones are anticipated in the near future. Viracta expects to determine the recommended Phase 2 dose for patients with advanced EBV-positive solid tumors by late 2024. Additional data from the NAVAL-1 trial's expansion phase for second-line EBV-positive PTCL patients are expected in the fourth quarter of 2024. Furthermore, the company plans to report Stage 1 data from patients with R/R EBV-positive diffuse large B-cell lymphoma (DLBCL) in the first half of 2025, meet with the FDA to finalize the RCT design, and initiate the RCT in the second half of 2025. Interim analysis outcomes from the NAVAL-1 trial are expected in 2026, with the goal of filing for accelerated approval based on these data.

On the business front, Viracta has appointed Michael Faerm as Chief Financial Officer. The company has also realigned its resources to prioritize the more advanced EBV-positive lymphoma programs, pausing its EBV-positive solid tumor program. This strategic shift has led to a reduction in workforce, impacting about 23% of employees.

Financially, Viracta reported a cash position of approximately $30 million as of June 30, 2024, which should fund operations into the first quarter of 2025. Research and development expenses were $6.5 million and $16.5 million for the three and six months ended June 30, 2024, respectively. General and administrative expenses were $3.0 million and $7.0 million for the same periods. The net loss for the quarter was $9.8 million, or $0.25 per share, and $19.0 million, or $0.48 per share, for the six months ended June 30, 2024.

Viracta's lead product, Nana-val, is being evaluated in ongoing clinical trials, including a potentially registrational, global Phase 2 trial for R/R EBV-positive lymphomas and a multinational Phase 1b/2 trial for recurrent or metastatic EBV-positive nasopharyngeal carcinoma and other advanced solid tumors. The company continues to explore its "Kick and Kill" approach for other virus-related cancers.

In summary, Viracta Therapeutics is making significant strides in the development of treatments for EBV-associated cancers, with promising clinical trial results and strategic business initiatives setting the stage for future advancements and potential regulatory approvals.