On May 10, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the first quarter of 2022 and provided an update on recent corporate progress (Press release, Sunesis, MAY 10, 2022, View Source [SID1234614086]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have made encouraging progress in both clinical programs with our all-oral drug product candidate, Nana-val, which are advancing towards potential key catalysts in the second half of the year," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Since the first patient was dosed in January, our Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors has proceeded nicely and we anticipate reporting preliminary safety and efficacy data later this year. In addition, we are pleased to have expanded the clinical reach of NAVAL-1 beyond North America into Europe as well as Asia, and anticipate having an update on cohorts advancing into Stage 2 of the trial later this year."
First Quarter 2022 and Recent Highlights
Clinical
Continued global expansion and enrollment into NAVAL-1, the pivotal trial of Nana-val (nanatinostat and valganciclovir) for the treatment of patients with relapsed/refractory EBV+ lymphoma. NAVAL-1 employs a Simon two-stage design where patients are initially enrolled into six cohorts based on lymphoma subtype in Stage 1. If a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. Lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded. If successful, the Company believes NAVAL-1 could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. Clinical sites are open across the globe, including in the U.S., Canada, Europe, and Asia. The Company anticipates providing an update on the initial cohort(s) that may advance into Stage 2 of the trial in the second half of the year.
Dosed first patient in the Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other EBV+ solid tumors. Enrollment continues in the Phase 1b dose escalation part of the study, which is designed to evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to 60 patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. Viracta anticipates reporting preliminary Phase 1b safety and efficacy data from the trial in the second half of 2022.
Corporate
Hosted key opinion leader webinar on Nana-val for the treatment of advanced EBV+ solid tumors. The webinar featured presentations from key opinion leader Ezra Cohen, MD, FRCPSC, FASCO (University of California, San Diego) and members of the Viracta management team. Topics discussed included the current treatment landscape and unmet medical need in NPC, the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors, and preclinical data supporting the trial. A replay of the webinar is available here.
Anticipated 2022 Milestones
Provide preliminary Phase 1b safety and efficacy data from the Phase 1b/2 trial in advanced EBV+ solid tumors: 2H 2022
Update on NAVAL-1 cohort(s) that may progress from Stage 1 to Stage 2: 2H 2022
First Quarter 2022 Financial Results
Cash Position – Cash and cash equivalents totaled approximately $92.2 million as of March 31, 2022, which Viracta expects will be sufficient to fund its operations into mid-2024, excluding any borrowing under its previously announced $50.0 million credit facility from Silicon Valley Bank and Oxford Finance.
Research and development expenses – Research and development expenses were approximately $6.1 million for the three months ended March 31, 2022, compared to $4.0 million for the same period in 2021. The increase in research and development expenses for the three months ended March 31, 2022, was primarily due to increases in costs incurred to support the initiation of the NAVAL-1 and solid tumor trials as well as an increase in headcount and non-cash share-based compensation.
Acquired in-process research and development – For the three months ended March 31, 2021, the acquired in-process research and development included non-cash and non-recurring cost of $84.5 million associated with the estimated fair value of the in-process research and development projects acquired in the Sunesis asset acquisition with no alternative future use, which was charged to expense on the Sunesis merger date.
General and administrative expenses – General and administrative expenses were approximately $4.3 million for the three months ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase was largely due to incremental costs associated with being a publicly traded company including directors and officers’ insurance costs, and non-cash share-based compensation.
Gain on Royalty Purchase Agreement – For the three months ended March 31, 2021, the gain was associated with upfront proceeds of $13.5 million recorded in connection with the multi-license milestone and royalty monetization transaction with XOMA (US) LLC.
Adjusted loss from operations – There was not a comparative adjustment to loss from operations for the quarter ended March 31, 2022. Adjusted income from operations for the quarter ended March 31, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $5.6 million, compared to an unadjusted loss from operations of $78.8 million.
Net loss – Net loss was approximately $10.5 million, or $0.28 per share (basic and diluted) for the quarter ended March 31, 2022, compared to a net loss of $79.2 million or $5.22 per share for the same period in 2021.
About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.
About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.