CervoMed (CRVO) - 2024 Q2 - Quarterly Report

Financial Performance - The net loss for the six months ended June 30, 2024, was $4.8 million, compared to a net loss of $2.0 million for the same period in 2023[106]. - Net loss for the three months ended June 30, 2024, was $2.3 million, a 63% increase from a net loss of $1.4 million in 2023[114]. - The company has not generated any revenue from product sales and does not expect to do so in the near future[108]. - The company expects to continue incurring losses and will require additional financing to support ongoing operations and product development[131]. Cash and Funding - As of June 30, 2024, the company had cash and cash equivalents of approximately $50.9 million and an accumulated deficit of $59.3 million[105][106]. - The company raised approximately $50.0 million in a private placement in April 2024, with potential additional proceeds of up to $99.4 million if Series A Warrants are fully exercised[96]. - Cash provided by financing activities for the six months ended June 30, 2024, was $46.4 million, resulting from the sale of common stock[138]. - The net increase in cash and cash equivalents for the six months ended June 30, 2024, was $2.2 million, compared to a decrease of $3.4 million in the same period of 2023[135]. - Cash used in investing activities for the six months ended June 30, 2024, was $40.6 million due to the purchase of marketable securities following a private placement[138]. Grant Funding - Grant funding recognized for the six months ended June 30, 2024, was $5.6 million, up from $3.1 million in the same period in 2023[108]. - Grant revenue increased to $3.3 million for the three months ended June 30, 2024, up 91% from $1.7 million in the same period of 2023, driven by the $21.0 million NIA Grant for the RewinD-LB Trial[115]. - For the six months ended June 30, 2024, grant revenue was $5.6 million, an 80% increase from $3.1 million in 2023, attributed to increased services for the RewinD-LB Trial[123]. Expenses - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and regulatory approvals for neflamapimod[110]. - Research and development expenses rose to $3.8 million for the three months ended June 30, 2024, a 93% increase from $2.0 million in 2023, primarily due to outsourced CRO and related site expenses for the RewinD-LB Trial[116]. - Research and development expenses for the six months ended June 30, 2024, were $6.6 million, a 74% increase from $3.8 million in 2023[124]. - General and administrative expenses are anticipated to rise due to increased headcount and compliance costs associated with being a public company[112]. - General and administrative expenses surged to $2.5 million for the three months ended June 30, 2024, a 153% increase from $1.0 million in 2023, mainly due to costs associated with being a public company post-merger[118]. - General and administrative expenses for the six months ended June 30, 2024, reached $4.6 million, a 133% increase from $2.0 million in 2023[125]. - Total operating expenses for the three months ended June 30, 2024, were $6.3 million, reflecting a 113% increase from $3.0 million in 2023[114]. Clinical Trials - Enrollment in the RewinD-LB Trial was completed in June 2024, with topline data expected in December 2024, funded by a $21.0 million grant from the NIA[96]. - The RewinD-LB Trial enrolled 159 patients with Early-Stage DLB, with an estimated 66% of these patients being Early-Stage DLB based on screening data[100]. - The RewinD-LB Trial is designed to have greater than 95% statistical power to demonstrate improvement relative to placebo on change in CDR-SB, a global measure of dementia severity[100]. Operational Insights - The company experienced a cash outflow from operations primarily due to a net loss and changes in operating assets and liabilities[136]. - For the six months ended June 30, 2024, net cash used in operating activities was $3.6 million, compared to $3.4 million for the same period in 2023, reflecting an increase of approximately 5.9%[136]. - The company has no off-balance sheet arrangements that could materially affect its financial condition or results of operations[140]. - The company is not exposed to significant financing, liquidity, market, or credit risk from off-balance sheet arrangements[140]. - There were no material changes to critical accounting policies and estimates during the six months ended June 30, 2024[141]. - The company may enter into additional collaborative research and manufacturing agreements in the future, which could require upfront payments or long-term cash commitments[139].