Viracta(VIRX) - 2022 Q4 - Annual Report

Financial Performance - The company incurred a net loss of approximately $35.5 million for the year ended December 31, 2022, compared to a net loss of $18.9 million for the year ended December 31, 2021 [513]. - As of December 31, 2022, the company had an accumulated deficit of approximately $214.9 million and expects to continue incurring net losses for at least the next several years [509]. - The company raised approximately $22.5 million from financing activities for the year ended December 31, 2022, compared to $62.4 million in 2021 [516]. - The company had cash, cash equivalents, and short-term investments of $91.0 million as of December 31, 2022, with working capital of $83.7 million [509]. - The company expects to incur additional expenses and increase operating losses for at least the next several years [512]. Research and Development - Research and development expenses for the year ended December 31, 2022, increased by approximately $2.4 million to $26.3 million compared to $23.9 million in 2021, primarily due to costs associated with clinical development programs [504]. - Viracta's lead product candidate, Nana-val, is currently being investigated in multiple clinical trials, including the NAVAL-1 trial for relapsed/refractory EBV+ lymphoma [484]. - The NAVAL-1 trial employs a Simon two-stage design, with the first stage focusing on a limited number of patients and potential expansion based on pre-specified activity thresholds [485]. - The median duration of response in the Phase 1b/2 trial for EBV+ R/R lymphoma was reported at 10.4 months, indicating promising activity [486]. - The Phase 1b/2 trial for EBV+ recurrent or metastatic nasopharyngeal carcinoma (NPC) is designed to evaluate the safety and efficacy of Nana-val, with the Phase 2 portion expected to initiate in the second half of 2023 [489]. - Viracta has received Fast Track Designation from the FDA for the treatment of R/R EBV+ lymphoid malignancies, along with orphan drug designations for several specific lymphoma types [487]. General and Administrative Expenses - General and administrative expenses rose to $24.3 million in 2022 from $15.4 million in 2021, reflecting an increase of $8.9 million [504]. - General and administrative expenses increased by approximately $8.9 million for the year ended December 31, 2022, largely due to non-cash share-based compensation [506]. - The company anticipates that general and administrative expenses will continue to increase as it prepares for potential commercialization of Nana-val [495]. Impact of COVID-19 - The COVID-19 pandemic has impacted clinical trial timelines and operations, with ongoing evaluations to mitigate these effects [490]. Investment Activities - Net cash used in investing activities was $53.9 million for the year ended December 31, 2022, primarily due to short-term investments initiated in June 2022 [515]. - The company received an upfront payment of $13.5 million from the Royalty Purchase Agreement with XOMA (US) LLC [507]. - The company has access to a $50.0 million credit facility, of which $20.0 million was drawn down as of December 29, 2022 [511]. Future Plans - The company plans to continue funding development activities and pre-commercialization activities for its lead product candidate [512].