Earnings release
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VERASTEM ONCOLOGY Verastem Oncology Reports Third Quarter 2021 Financial Results and Highlights Recent Company Progress November 4 , 2021 Announced Clinical Collaboration with Amgen to Evaluate VS - 6766 with LUMAKRASTM in Non - Small CelLung Cancer in Upcoming Clinical Trial Updated Data from Investigator - Sponsored Phase 1/2 FRAME Study of VS - 6766 and Defactinib in Low - Grade Serous Ovarian Cancer Presented at ESMO 2021 Appointed Louis J. Denis , M.D. , as Chief Medical Officer BOSTON -- ( BUSINESS WIRE ) -- Nov . 4 , 2021-- Verastem Oncology ( Nasdaq : VSTM ) , a biopharmaceutical company committed to advancing new medicines for patients with cancer , today reported financial results for the three months ended September 30 , 2021 and highlighted recent progress . " The third quarter was marked by several significant milestones for Verastem as we continued to advance our development program to establish VS - 6766 as a backbone therapy across RAS pathway - driven solid tumors , including our entry into a clinical collaboration with Amgen to evaluate VS - 6766 in combination with LUMAKRASTM ( sotorasib ) in patients with KRAS G12C - mutant NSCLC . This Phase 1/2 study will investigate the potential of a more complete vertical blockade along the RAS pathway , " said Brian Stuglik , Chief Executive Officer of Verastem Oncology . " We were also pleased to highlight updated data from the investigator - initiated Phase 1/2 FRAME study that were presented at ESMO 2021 and continue to demonstrate encouraging response rates , along with 23.0 months PFS , in patients with low - grade serous ovarian cancer ( LGSOC ) , including in patients who had previously received a MEK inhibitor . " Recent Corporate Highlights Low - Grade Serous Ovarian Cancer ( LGSOC ) • Updated data from the LGSOC cohort of the ongoing , investigator - sponsored Phase 1/2 FRAME study evaluating VS - 6766 in combination with defactinib in patients with LGSOC were presented at the European Society of Medical Oncology ( ESMO ) Congress 2021. Results show encouraging response rates and progression - free survival ( PFS ) . The initial results of the FRAME study were the basis for the U.S. Food and Drug Administration granting Breakthrough Therapy designation for the combination in LGSOC . • Median PFS across all patients was 23.0 months ( n = 24 ) • Overall response rate ( ORR ) across all patients was 46 % ( 11 of 24 patients ) • ORR across patients with KRAS mutant LGSOC was 64 % ( 7 of 11 patients ) • ORR across patients with KRAS wild type LGSOC was 44 % ( 4 of 9 patients ) • Continued progress with the company - sponsored , registration - directed Phase 2 study ( RAMP 201 ) investigating VS - 6766 alone and in combination with defactinib for the treatment of recurrent LGSOC . The Company expects to report top - line results from the selection phase of RAMP 201 and commence expansion phase during the first half of 2022 . KRAS Mutant Non - small Cell Lung Cancer ( NSCLC ) • Announced strategic partnership with Amgen to evaluate the safety , tolerability , and efficacy of VS - 6766 in combination with LUMAKRASTM ( sotorasib ) , Amgen's KRAS G12C inhibitor , in patients with locally advanced or metastatic KRAS G12C - mutant NSCLC . This Phase 1/2 clinical trial is expected to initiate by the end of 2021 . • Continued progress in company - sponsored , registration - directed Phase 2 study ( RAMP 202 ) investigating VS - 6766 alone and in combination with defactinib for the treatment of patients with KRAS G12V mutant NSCLC . The Company expects to report top - line results from the selection phase of RAMP 202 and commence expansion phase during first half of 2022 . Corporate and Financial . Appointed Michelle Robertson to join the Verastem Board of Directors . Ms. Robertson is the Chief Financial Officer at Editas Medicine and brings more than 25 years of Finance and Commercial Operations leadership to the Board . • Appointed Louis J. Denis , M.D. , as Chief Medical Officer . Dr. Denis brings more than 25 years of clinical development and oncology experience to Verastem having served at several biotech and pharmaceutical companies during his career , including Asana BioSciences , Boehringer Ingelheim and Pfizer . • Converted all of the $ 28.0 million aggregate principal of the Company's 2020 5.00 % Convertible Senior Notes due 2048 in exchange for approximately 8.6 million shares of common stock . The conversion eliminates substantially all outstanding debt and preserves approximately $ 31.2 million in cash , including $ 3.2 million in future interest payments that would have been payable through November 1 , 2023 .