Clearside Biomedical(US:CLSD)2025-11-14 21:10Financial Performance - The company recorded a net loss of $6.0 million for the three months ended September 30, 2025, compared to a net loss of $7.7 million for the same period in 2024, representing a decrease of approximately 22.3%[110] - As of September 30, 2025, the company had an accumulated deficit of $374.0 million[110] - Total operating expenses for the three months ended September 30, 2025, were $7.2 million, compared to $7.0 million for the same period in 2024, an increase of approximately 3.9%[130] - The company incurred net cash used in operating activities of $16.0 million for the nine months ended September 30, 2025, compared to $19.4 million for the same period in 2024, reflecting ongoing research and development expenses and severance costs[162] - The company anticipates incurring additional losses and negative cash flows from operations until it can generate significant milestone payments and royalties from its product candidates[158] - The net change in cash and cash equivalents for the nine months ended September 30, 2025, was a decrease of $13.2 million, compared to a decrease of $15.0 million in 2024[162] Revenue and Expenses - Research and development expenses for the three months ended September 30, 2025, were $2.9 million, down from $4.1 million in the same period of 2024, a reduction of approximately 29.0%[130] - The company recognized $0.2 million in license and other revenue for the three months ended September 30, 2025, compared to $1.0 million in the same period of 2024, a decline of approximately 80.0%[130] - Research and development expenses decreased by $5.4 million from $14.3 million for the nine months ended September 30, 2024 to $9.0 million for the nine months ended September 30, 2025[140] - General and administrative expenses increased by $0.9 million from $8.7 million for the nine months ended September 30, 2024 to $9.6 million for the nine months ended September 30, 2025[141] - License and other revenue increased by $1.7 million from $1.4 million for the nine months ended September 30, 2024 to $3.0 million for the nine months ended September 30, 2025[138] - Other income, net was $5.5 million for the nine months ended September 30, 2025, compared to $0.8 million for the same period in 2024[143] - Interest income for the three months ended September 30, 2025, was $65,000, down from $338,000 in the same period of 2024, a decrease of approximately 80.8%[130] - Interest income decreased by $0.8 million from $1.1 million for the nine months ended September 30, 2024 to $0.3 million for the nine months ended September 30, 2025[142] - Non-cash interest expense on liability related to the sales of future royalties was $8.0 million for the nine months ended September 30, 2025, compared to $7.2 million for the same period in 2024[144] Strategic Actions - The company has paused all internal research and development programs while exploring strategic alternatives to advance its SCS platform and drug development pipeline[121] - The company is considering various strategic alternatives, including potential sales, licenses, or partnerships, to maximize stockholder value[111] - The company expects to require additional capital to fund ongoing operations and may seek financing through equity offerings or debt financings[155] - The company plans to raise additional capital through equity or debt financings, monetizing royalties, or entering into strategic collaborations[158] - The company aims to establish commercial manufacturing capabilities and obtain marketing approvals for its product candidates[161] Going Concern - The company does not believe it will be able to fund its operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[113] - Cash and cash equivalents are projected to be insufficient to fund operations for the next 12 months, prompting the company to pause all internal research and development programs[159] - The company has raised substantial doubt regarding its ability to continue as a going concern, as its consolidated financial statements do not reflect potential future adjustments related to asset recoverability[160] Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $6.8 million[146] - The company sold 109,957 shares of common stock for net proceeds of $1.4 million under the Sales Agreement during the nine months ended September 30, 2025[152] - The company received an additional $3.0 million from the Purchaser in exchange for remaining assets related to its SCS Microinjector technology[149] - Investing activities resulted in a net cash outflow of $9,000 for the nine months ended September 30, 2025, down from $9.9 million in 2024, primarily due to the acquisition of property and equipment[163] - Financing activities provided net cash of $2.8 million for the nine months ended September 30, 2025, a significant decrease from $14.3 million in 2024, mainly from net proceeds of $2.9 million from a Purchase and Sale Agreement[164] - The company has incurred $2.3 million in severance and related costs due to a reduction in force during the nine months ended September 30, 2025[162]