Syndax(US:SNDX)2024-05-08 11:04Financial Performance - For the three months ended March 31, 2024, the net loss was $72.4 million, compared to a net loss of $41.1 million for the same period in 2023, representing a 76% increase in losses[59]. - The company has not generated any product revenues to date, with no revenue recognized under the Incyte Agreements for the three months ended March 31, 2024[66]. - The company has an accumulated deficit of $974.8 million as of March 31, 2024, and anticipates continued significant losses in the coming years[96]. Research and Development - Research and development expenses increased by 66% to $56.5 million for the three months ended March 31, 2024, compared to $34.1 million in the same period in 2023[80]. - Total research and development expenses for Q1 2024 increased by $22.4 million, or 66%, to $56.5 million compared to Q1 2023[81]. - Revumenib-related costs rose by $16.5 million, primarily due to increased clinical trial expenses and pre-commercial manufacturing activities[81]. - Enrollment in the pivotal AUGMENT-101 trial for revumenib has been completed, with topline data expected in Q4 2024[61]. - The company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine by year-end 2024[61]. Expenses - Selling, general and administrative expenses rose by 92% to $23.0 million for the three months ended March 31, 2024, compared to $12.0 million in the same period in 2023[80]. - Selling, general and administrative expenses increased by $11.1 million, or 92%, to $23.0 million in Q1 2024 compared to Q1 2023[84]. Cash and Investments - As of March 31, 2024, the company had cash, cash equivalents, and investments totaling $522.0 million, sufficient to fund operations for at least the next 12 months[89]. - As of March 31, 2024, the company had cash and cash equivalents of $114.6 million and short and long-term investments totaling $407.4 million[105]. - Net cash used in operating activities for Q1 2024 was $83.5 million, compared to $39.2 million in Q1 2023, reflecting increased clinical trial activities[98]. - Net cash used in investing activities for Q1 2024 was $99.4 million, primarily due to the purchase of $167.4 million in available-for-sale securities[101]. Income and Interest - Interest income increased by 43% to $7.3 million for the three months ended March 31, 2024, compared to $5.1 million in the same period in 2023[80]. - Interest income for Q1 2024 increased by $2.2 million, or 43%, due to higher interest rates and increased average balances on cash equivalents and investments[85]. Regulatory Developments - The FDA granted Priority Review for the New Drug Application (NDA) for revumenib, with a target action date of September 26, 2024[61]. - The Biologics License Application (BLA) for axatilimab was accepted by the FDA, with a PDUFA action date of August 28, 2024[68]. Market Risk and Economic Factors - The primary exposure to market risk is interest rate sensitivity, which is influenced by changes in U.S. interest rates[105]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of cash equivalents and investments due to their short-term maturities and low risk profile[105]. - The company does not believe that inflation and changing prices significantly impacted its results of operations for the periods presented[106]. Other Financial Activities - The company entered into a sales agreement for an at-the-market offering program with potential proceeds of up to $200.0 million[90]. - Total other income (expense), net decreased in Q1 2024 primarily due to a reduction in foreign currency losses on investments[87]. - The company has established guidelines for approved investments and maturities to maintain safety and liquidity[105].