Verve Therapeutics(US:VERV)2025-05-14 11:30Financial Performance - The net losses for the three months ended March 31, 2025, and 2024 were $31.0 million and $48.7 million, respectively, with an accumulated deficit of $774.0 million as of March 31, 2025 [89]. - The net loss for the three months ended March 31, 2025, was $31.0 million, an improvement of $17.7 million compared to a net loss of $48.7 million in 2024 [123]. - Total operating expenses increased to $69.6 million for the three months ended March 31, 2025, compared to $62.5 million in 2024, reflecting a change of $7.1 million [123]. - Research and development expenses rose to $54.5 million for the three months ended March 31, 2025, up from $48.4 million in 2024, an increase of $6.1 million [125]. - General and administrative expenses increased to $15.2 million for the three months ended March 31, 2025, compared to $14.2 million in 2024, reflecting a change of $1.0 million [127]. - Interest and other income, net decreased by $2.7 million for the three months ended March 31, 2025, primarily due to lower interest rates on marketable securities [129]. - For the three months ended March 31, 2025, net cash used in operating activities was $27.8 million, a decrease from $43.1 million in the same period of 2024, reflecting improved operational efficiency [136][137]. - Cash used in investing activities for the three months ended March 31, 2025, was $48.2 million, compared to $41.6 million in 2024, primarily due to increased purchases of marketable securities [138][139]. Cash and Funding - The company had cash, cash equivalents, and marketable securities of $497.1 million as of March 31, 2025, expected to fund operations into mid-2027 [94]. - As of March 31, 2025, the company had cash and cash equivalents of $96.6 million and marketable securities of $400.5 million, with interest income sensitive to changes in interest rates [152]. - The company anticipates substantial increases in operating expenses as it advances its portfolio of programs, necessitating additional funding [142][143]. - The company has no committed external funding sources and may face challenges in raising additional capital due to market volatility [146][147]. Collaboration and Revenue - The company recognized $33.0 million in collaboration revenue during the three months ended March 31, 2025, under the Vertex Agreement and the Lilly Agreement [107]. - Collaboration revenue increased to $33.0 million for the three months ended March 31, 2025, compared to $5.7 million for the same period in 2024, reflecting a change of $27.3 million [124]. - A milestone payment of $20.0 million was triggered in January 2025 upon achieving candidate selection criteria under the Lilly Agreement [107]. - A milestone payment of $20.0 million was received from Lilly under the Lilly Agreement during the three months ended March 31, 2025 [133]. Clinical Trials and Product Development - Initial data from the Heart-2 trial showed that VERVE-102 achieved a mean blood LDL-C reduction of 53% and a PCSK9 protein reduction of 60% in the highest dose cohort of 0.6 mg/kg [97]. - The Heart-2 trial is currently enrolling participants in the fourth dose cohort of 0.7 mg/kg, with final data expected in the second half of 2025 [99]. - The FDA granted Fast Track designation for VERVE-102 for treating patient groups with hyperlipidemia and high lifetime cardiovascular risk [100]. - VERVE-201, targeting ANGPTL3, is being evaluated in the Pulse-1 trial, with an update expected in the second half of 2025 [103]. - The company is conducting ongoing clinical trials for VERVE-102 and VERVE-201, with plans for a Phase 2 clinical trial of VERVE-102, subject to regulatory clearance [145]. Operational Focus - The company plans to establish a sales, marketing, and distribution infrastructure to commercialize any products that may receive marketing approval [91]. - The company is focused on expanding its intellectual property portfolio and may seek collaborations and licensing agreements to support its product development efforts [145][147]. Economic Factors - Inflation has not had a material effect on the company's business or financial condition during the three months ended March 31, 2025 [155].