Adial Pharmaceuticals(ADIL) - 2025 Q3 - Quarterly Report

Financial Performance - The company reported net losses of approximately $6.0 million and $13.2 million for the nine months ended September 30, 2025, and the year ended December 31, 2024, respectively[87]. - As of September 30, 2025, the company had accumulated deficits of approximately $88 million, up from $82 million as of December 31, 2024[87]. - Net loss for the nine months ended September 30, 2025, was $5,981,000, a decrease of $5,145,000 compared to a net loss of $11,126,000 in the same period in 2024[118]. - Total other income increased by $147,000 (118%) for the nine months ended September 30, 2025, due to a milestone payment of $150,000 received from Adovate[108]. - Net cash used in operating activities decreased by approximately $300,000 for the nine months ended September 30, 2025, compared to the same period in 2024[119]. - Financing activities provided approximately $5,874,000 for the nine months ended September 30, 2025, a decrease of $1,972,000 compared to $7,846,000 in the same period in 2024[121]. Expenses - Research and development expenses decreased by approximately $511,000 (50%) during the three months ended September 30, 2025, compared to the same period in 2024[99]. - General and administrative expenses increased by approximately $63,000 (5%) during the three months ended September 30, 2025, compared to the same period in 2024[100]. - Research and development expenses decreased by approximately $498,000 (20%) for the nine months ended September 30, 2025, compared to the same period in 2024[104]. - General and administrative expenses increased by approximately $69,000 for the nine months ended September 30, 2025, primarily due to higher compensation expenses[105]. - The inducement expense of approximately $4,464,000 was a one-time, noncash expense associated with the issuance of new warrants in the nine months ended September 30, 2024[107]. Cash Position and Funding - The company expects that current cash and cash equivalents will not be sufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[86]. - Cash and cash equivalents at September 30, 2025, were $4.6 million, expected to fund operations into the second quarter of 2026[115]. - The company has incurred recurring losses and needs to raise additional funds to sustain operations, raising substantial doubt about its ability to continue as a going concern[116]. - The company completed a warrant inducement transaction in May 2025, generating net proceeds of approximately $2.2 million[91]. - The June 2025 Offering resulted in aggregate net proceeds of approximately $3.0 million from the sale of shares and warrants[94]. - The company sold 1,869,996 shares under the At the Market Offering, receiving net proceeds of approximately $478,000 during the three and nine months ended September 30, 2025[96]. Future Plans - The company plans to begin a Phase III study of AD04 in the first half of 2026, pending adequate funding and regulatory approvals[115]. - The company is focused on completing the clinical development program for its investigational drug candidate AD04, primarily in the US and secondarily in Europe/UK[83].