CymaBay Therapeutics(US:CBAY)2023-03-23 20:06Financial Performance - As of December 31, 2022, the company has an accumulated deficit of $872.9 million, primarily due to research and development expenses, general and administrative expenses, and net interest expenses [323]. - Total operating expenses for the year ended December 31, 2022, were $93.1 million, an increase of $5.5 million compared to $87.6 million in 2021 [324]. - The net loss for the year ended December 31, 2022, was $106.0 million, compared to a net loss of $90.0 million in 2021, representing an increase in loss of $16.0 million [324]. - The company expects to continue incurring substantial losses from operations for the foreseeable future, with no assurance of generating sufficient revenue to achieve profitability [323]. - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $135.5 million, down from $194.6 million at the end of 2021 [334]. Research and Development - Research and development expenses for 2022 were $68.0 million, up from $64.5 million in 2021, reflecting an increase of $3.5 million [324]. - Research and development expenses increased by $3.5 million to $68.0 million in 2022 from $64.5 million in 2021, with expectations for further increases due to ongoing late-stage development of seladelpar in PBC [325]. - Internal research and development costs rose by $5.6 million to $26.4 million in 2022 from $20.8 million in 2021, driven by an increase in headcount for clinical studies [328]. - The RESPONSE trial for seladelpar, a treatment for primary biliary cholangitis, completed enrollment of 193 patients, with top-line data expected in Q3 2023 [303]. - The ASSURE trial is actively enrolling patients, with over 200 subjects currently enrolled and an expected total enrollment of over 300 patients [304]. - The company retains full commercial rights to MBX-2982, which is being evaluated in a Phase 2a study for Type 1 Diabetes, with potential applications in inflammatory diseases [306]. Expenses and Costs - General and administrative expenses rose to $25.1 million in 2022 from $23.0 million in 2021, an increase of $2.1 million [324]. - General and administrative expenses increased by $2.1 million to $25.1 million in 2022 from $23.0 million in 2021, primarily due to increased headcount in administrative personnel [329]. - Interest expense, net increased by $10.5 million to $12.9 million in 2022 from $2.4 million in 2021, mainly due to additional proceeds from the Financing Agreement and full-year interest accrual in 2022 [331]. - Total project costs decreased by $2.1 million to $41.6 million in 2022 from $43.7 million in 2021, primarily due to the completion of enrollment in the RESPONSE trial and lower spending in other clinical studies [328]. Future Outlook and Agreements - The company has significant potential payment obligations under the Financing Agreement, including fixed and variable success payments contingent upon regulatory approval and sales milestones for seladelpar [349]. - The company received ¥4.5 billion ($34.2 million) from Kaken Pharmaceutical in January 2023 as part of a Collaboration and License Agreement for seladelpar commercialization in Japan [337]. - The company sold 11,821,428 shares of common stock at $7.00 per share in January 2023, raising approximately $97.7 million in gross proceeds [338]. - The accumulated deficit reached $872.9 million as of December 31, 2022, with expectations to incur substantial expenses related to ongoing development activities [344]. COVID-19 Impact - The company has not experienced adverse impacts on financial reporting due to COVID-19, but future disruptions remain uncertain [308].