Viracta(VIRX) - 2024 Q2 - Quarterly Results

Clinical Trial Results - Reported positive combined Stage 1 and Stage 2 results from the NAVAL-1 trial, showing an overall response rate (ORR) of 33% and a complete response rate (CRR) of 19% in the intent-to-treat population[3] - In the second-line EBV-positive PTCL subgroup, the ORR was 60% and the CRR was 30% in the intent-to-treat population, indicating a robust clinical response[4] - Additional data from the NAVAL-1 trial's expansion phase is expected to be reported in Q4 2024[5] - Viracta plans to initiate a randomized controlled trial in the second half of 2025 to support potential registration of Nana-val[4] - The company aims to file a New Drug Application (NDA) for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial data[5] Financial Performance - Net loss for Q2 2024 was approximately $9.8 million, or $0.25 per share, compared to a net loss of $12.5 million, or $0.32 per share, for the same period in 2023[7] - The net loss for the three months ended June 30, 2024, was $9,830,000, compared to a net loss of $12,484,000 in the same period of 2023, indicating an improvement of approximately 21%[17] - The net loss per share for the three months ended June 30, 2024, was $(0.25), an improvement from $(0.32) in the same period of 2023[17] - Comprehensive loss for the three months ended June 30, 2024, was $9,829,000, compared to $12,512,000 in the same period of 2023, reflecting a decrease of about 21%[17] - Total other income for the six months ended June 30, 2024, was $4,494,000, a significant increase compared to an expense of $(36,000) in the same period of 2023[17] Cash and Assets - Cash position as of June 30, 2024, was approximately $30.0 million, expected to fund operations into the first quarter of 2025[7] - As of June 30, 2024, cash, cash equivalents, and short-term investments decreased to $30,005,000 from $53,691,000 on December 31, 2023, representing a decline of approximately 44%[16] - Total assets decreased to $31,322,000 as of June 30, 2024, down from $56,692,000 at the end of 2023, indicating a reduction of about 45%[16] - Total liabilities decreased to $28,651,000 as of June 30, 2024, compared to $38,373,000 on December 31, 2023, reflecting a decrease of approximately 25%[16] Expenses - Research and development expenses for Q2 2024 were approximately $6.5 million, a decrease from $8.2 million in Q2 2023, driven by reduced costs in clinical development programs[7] - Research and development expenses for the three months ended June 30, 2024, were $6,548,000, down from $8,197,000 in the same period of 2023, a reduction of about 20%[17] - General and administrative expenses decreased to $3,041,000 for the three months ended June 30, 2024, from $4,253,000 in the prior year, a decline of approximately 29%[17] - Total operating expenses for the three months ended June 30, 2024, were $9,589,000, down from $12,450,000 in the same period of 2023, representing a decrease of about 23%[17] Management Changes - Appointed Michael Faerm as Chief Financial Officer, bringing over 25 years of experience in life sciences[6] - Viracta will pause its EBV-positive solid tumor program and focus resources on the more advanced EBV-positive lymphoma program, resulting in a reduction of approximately 23% of its workforce[6]