Verastem(US:VSTM)2021-11-04 20:24Financial Performance - The company reported an accumulated deficit of $647.2 million as of September 30, 2021[145]. - The net loss for the three months ended September 30, 2021, was $22.8 million, compared to a net loss of $54.7 million for the same period in 2020[145]. - Total revenue for the three months ended September 30, 2021, was $2,000, a decrease of $78,645, or 100%, compared to $78,647 for the same period in 2020[1]. - Product revenue, net for the three months ended September 30, 2021, was $0.0 million, a decrease of $5,829, or 100%, compared to $5.8 million for the same period in 2020[1]. - Total revenue for the nine months ended September 30, 2021, was $1.5 million, a decrease of $86.5 million, or 98%, compared to $88.0 million for the same period in 2020[1]. - Sale of COPIKTRA license and related assets revenue for the nine months ended September 30, 2021, was $0.9 million, a decrease of $69.1 million, or 99%, compared to $70.0 million for the same period in 2020[1]. - Net loss for the nine months ended September 30, 2021, was $(54.7) million, compared to a net loss of $(47.9) million for the same period in 2020, representing an increase in loss of $6.9 million, or 14%[1]. Research and Development - The overall response rate (ORR) in the FRAME study for KRAS-G12 mutant low-grade serous ovarian cancer (LGSOC) was 52% among evaluable patients[136]. - The median progression-free survival across all patients in the FRAME study was 23.0 months[137]. - The combination of VS-6766 and defactinib received breakthrough designation from the FDA for recurrent LGSOC treatment[134]. - The FRAME study was expanded to include new cohorts in pancreatic cancer and KRAS-G12V mutant NSCLC[136]. - The company has commenced registration-directed trials for VS-6766 as a monotherapy and in combination with defactinib[138]. - The company expects to incur significant expenses and operating losses due to ongoing research and development of VS-6766 and defactinib[145]. Expenses - Research and development expenses for the three months ended September 30, 2021, were $9.3 million, a decrease of $1.6 million, or 15%, compared to $10.9 million for the same period in 2020[1]. - Selling, general and administrative expenses for the three months ended September 30, 2021, were $5.5 million, a decrease of $15.1 million, or 73%, compared to $20.6 million for the same period in 2020[1]. - Research and development expenses for the nine months ended September 30, 2021, were $28.0 million, a decrease of $3.2 million, or 10%, compared to $31.2 million for the same period in 2020[1]. - Selling, general and administrative expenses for the nine months ended September 30, 2021, were $18.5 million, a decrease of $37.2 million, or 67%, compared to $55.7 million for the same period in 2020[1]. Cash and Financing - The company had cash, cash equivalents, and investments totaling $103.4 million as of September 30, 2021[145]. - Net cash used in operating activities for the 2021 Period was $(43,569) thousand, compared to $(11,803) thousand in the 2020 Period, reflecting increased net losses[187]. - Cash provided by financing activities in the 2021 Period was $80 thousand, significantly lower than $106,236 thousand in the 2020 Period[187]. - The company sold 0 shares under the 2017 ATM in the 2021 Period, while it sold 6,769,559 shares for net proceeds of approximately $12.2 million in the 2020 Period[193]. - The company expects to finance a portion of its business through future milestones and royalties received pursuant to the Secura APA[184]. - The company anticipates financing its cash needs through equity offerings, debt financings, and collaborations[225]. Agreements and Obligations - A clinical collaboration agreement was signed with Amgen to evaluate the combination of VS-6766 with Amgen's KRAS G12C inhibitor LUMAKRAS in a Phase 1/2 trial[139]. - Secura made an upfront payment of $70.0 million and agreed to regulatory milestone payments up to $45.0 million related to COPIKTRA[210]. - Sales milestone payments of up to $50.0 million are contingent on total worldwide net sales of COPIKTRA exceeding $100.0 million, $200.0 million, and $300.0 million[210]. - The company recognized $0.9 million in revenue from the sale of COPIKTRA license and related assets for the nine months ended September 30, 2021, primarily from a regulatory milestone[213]. - The Chugai Agreement includes a non-refundable payment of $3.0 million and double-digit royalties on net sales of products containing VS-6766[217]. - The company may terminate the Chugai Agreement with 180 days' written notice under certain conditions[219].