Verastem(VSTM) - 2022 Q3 - Quarterly Report

Financial Performance - The company has an accumulated deficit of $720.7 million as of September 30, 2022[124]. - The net loss for the three months ended September 30, 2022, was $18.1 million, compared to $57.0 million for the same period in 2021[124]. - Total revenue for the three months ended September 30, 2022, was $0.0 million, a decrease of 100% compared to $2.0 million in the same period of 2021[134]. - Net loss for the three months ended September 30, 2022, was $18.1 million, a decrease of 21% compared to a net loss of $22.8 million in the same period of 2021[134]. - Total revenue for the nine months ended September 30, 2022, was $2.6 million, an increase of 72% from $1.5 million in the same period of 2021[146]. - Transition services revenue for the nine months ended September 30, 2022, was $0.0 million, a decrease of 100% from $0.6 million in the same period of 2021[149]. Expenses - Research and development expenses for the three months ended September 30, 2022, were $11.3 million, an increase of 21% from $9.3 million in the same period of 2021[135]. - Selling, general and administrative expenses for the three months ended September 30, 2022, were $6.4 million, up 16% from $5.5 million in the same period of 2021[141]. - Research and development expenses for the nine months ended September 30, 2022, were $39.8 million, a 42% increase from $28.0 million in the same period of 2021[150]. - Selling, general and administrative expenses were $18.9 million in 2022, up from $18.5 million in 2021, a 2.2% increase[2]. Cash and Investments - The company had cash, cash equivalents, and investments totaling $104.0 million as of September 30, 2022, expected to fund operations for at least 12 months[124]. - As of September 30, 2022, the company had $104.0 million in cash, cash equivalents, and investments[5]. - Cash provided by investing activities was $53.2 million in 2022, primarily from net maturities of investments[7]. - The company raised approximately $27.4 million from the sale of 23,573,403 shares under its at-the-market equity offering program in 2022[8]. Debt and Financing - The company expects to finance future development costs through existing cash, milestone payments, and potential strategic financing opportunities[125]. - The company entered into a Loan Agreement with Oxford for up to $150.0 million, with an initial term loan of $25.0 million funded at closing[9]. - Interest income for the nine months ended September 30, 2022, increased to $0.4 million, a 216% increase from $0.1 million in the same period of 2021[146]. - Interest expense for the nine months ended September 30, 2022, was $1.4 million, an 86% decrease from $10.0 million in the same period of 2021[146]. - Interest income increased to $0.4 million in 2022 from $0.1 million in 2021, a 300% increase driven by higher interest rates[3]. - Interest expense decreased significantly to $1.4 million in 2022 from $10.0 million in 2021, a reduction of 86% due to the conversion of 2020 Notes[4]. Clinical Trials and Research - The combination of avutometinib (VS-6766) and defactinib has received breakthrough designation from the FDA for treating recurrent low-grade serous ovarian cancer (LGSOC)[109]. - The ongoing FRAME study is evaluating the combination of avutometinib (VS-6766) and defactinib in patients with various cancers, including KRAS mutant NSCLC and LGSOC[112]. - The RAMP 201 trial is assessing the efficacy and safety of avutometinib (VS-6766) alone and in combination with defactinib in patients with recurrent LGSOC[113]. - The company received a $3.8 million Therapeutic Accelerator Award from the Pancreatic Cancer Network to support a Phase 1b/2 clinical trial of avutometinib (VS-6766) in combination with defactinib[120]. - The RAMP 202 trial did not meet criteria for continuation in the trial expansion phase for KRAS G12V NSCLC patients[116]. - The company has entered into clinical collaboration agreements with Amgen and Mirati Therapeutics to evaluate combinations of avutometinib (VS-6766) with their respective KRAS inhibitors[117][119]. Future Outlook - The company expects to continue incurring significant expenses and operating losses while funding obligations for at least the next twelve months[191]. - The company may finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing stockholders' interests[196].