SAN DIEGO - Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company, today announced positive results from the first stage of its Phase 2 NAVAL-1 trial, evaluating Nana-val, a combination of nanatinostat and valganciclovir, in treating relapsed or refractory Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL).
The data, presented at the Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan, highlighted that Nana-val achieved a 50% overall response rate and a 20% complete response rate in the intent-to-treat population.
The trial included 20 patients who had received at least one prior systemic therapy, with a median of two treatments. These patients were randomized to receive either nanatinostat monotherapy or Nana-val. Notably, patients in the Nana-val arm demonstrated substantially greater efficacy compared to those receiving monotherapy, with a manageable safety profile.
The most common treatment-related adverse events reported were thrombocytopenia, anemia, fatigue, decreased appetite, nausea, diarrhea, and weight loss, which were generally mild to moderate.
Hung Chang, M.D., the trial's principal investigator, remarked on the clinical response and the potential of Nana-val as a convenient all-oral treatment option. Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta, emphasized the lack of EBV-targeted treatments for patients with a poor prognosis and expressed optimism about the trial's validation of Nana-val's mechanism of action.
The company plans to engage with the FDA regarding an accelerated approval pathway and anticipates sharing further results from the NAVAL-1 trial later in the year.
This news is based on a press release statement from Viracta Therapeutics, Inc.
InvestingPro Insights
Amid the promising clinical trial outcomes for Viracta Therapeutics' Nana-val therapy, the financial health and market performance of the company also warrant attention. According to InvestingPro data, Viracta has a market capitalization of 45.16 million USD, reflecting its size within the biotech industry. Despite the enthusiasm around the trial results, the company's P/E ratio stands at -0.86, highlighting that it is not currently profitable. This is further underscored by a negative operating income of -50.69 million USD over the last twelve months as of Q4 2023, which aligns with analysts' expectations that the company will not be profitable this year.
However, looking at recent market performance, Viracta's stock has shown a strong return over the last three months, with an 80.32% price total return. This surge is consistent with the company's large price uptick over the last six months, which sits at 50.7%. These metrics suggest that investor sentiment may be positive in light of recent developments, despite the company's financial challenges.
Two InvestingPro Tips that could be particularly relevant for investors considering Viracta are: the company holds more cash than debt on its balance sheet, which could provide a buffer against financial instability; and the firm has been quickly burning through cash, which may raise concerns about long-term sustainability without additional funding or revenue streams. For investors looking to delve deeper into these aspects, there are 5 additional tips listed on InvestingPro that could provide further insights into Viracta's financial health and market potential.
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