Clearside Biomedical(US:CLSD)2025-05-15 20:05PART I Item 1. Financial Statements (unaudited) Unaudited Q1 2025 financials reflect a net loss improvement, yet declining cash and increased deficit raise substantial doubt about going concern Consolidated Balance Sheets Total assets decreased, liabilities increased, and stockholders' deficit widened as of March 31, 2025 Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $13,628 | $20,020 | | Total current assets | $15,964 | $21,274 | | Total assets | $19,668 | $25,126 | | Liabilities & Stockholders' Deficit | | | | Total current liabilities | $5,012 | $4,794 | | Liability related to the sales of future royalties, net | $53,440 | $51,767 | | Total liabilities | $65,578 | $63,981 | | Total stockholders' deficit | ($45,910) | ($38,855) | Consolidated Statements of Operations Net loss improved in Q1 2025 to $8.2 million, driven by higher revenue and lower R&D expenses Consolidated Statements of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | | Research and development | $4,463 | $5,615 | | General and administrative | $2,824 | $2,824 | | Loss from operations | ($5,205) | ($8,209) | | Net loss | ($8,223) | ($11,763) | | Net loss per share — basic and diluted | ($0.11) | ($0.17) | Consolidated Statements of Cash Flows Net cash used in operations improved, but financing activities shifted to a net use, leading to a cash decrease Consolidated Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,830) | ($7,851) | | Net cash used in investing activities | ($9) | ($57) | | Net cash (used in) provided by financing activities | ($553) | $14,343 | | Net (decrease) increase in cash and cash equivalents | ($6,392) | $6,435 | | Cash and cash equivalents, end of period | $13,628 | $35,355 | Notes to the Consolidated Financial Statements Notes highlight significant liquidity concerns, raising substantial doubt about the company's ability to continue as a going concern - The company's financial condition raises substantial doubt about its ability to continue as a going concern. Cash and cash equivalents as of May 15, 2025, are expected to fund operations only into the fourth quarter of 202529 - In February 2024, the company raised net proceeds of $13.9 million through a registered direct offering of common stock and warrants24 - The company sold rights to future royalties and milestone payments from key license agreements to HCR in exchange for up to $65 million. As of March 31, 2025, the liability related to this sale was $53.4 million5460 - The company has exclusive license agreements with Bausch + Lomb for XIPERE in the U.S. and Canada, Arctic Vision in the Asia Pacific region, and BioCryst for use of the SCS Microinjector with avoralstat808387 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses CLS-AX development and Q1 2025 financials, highlighting reduced net loss but significant going concern risks Overview and Clinical Development The company focuses on its SCS platform, with lead candidate CLS-AX for wet AMD showing positive Phase 2b results and preparing for Phase 3 - The company's lead product candidate, CLS-AX (axitinib), is being developed for wet AMD. The ODYSSEY Phase 2b trial demonstrated durability, with 67% of participants going 6 months without needing additional treatment before mandatory re-dosing103107 - An End-of-Phase 2 meeting with the FDA was completed in Q1 2025, gaining alignment on the Phase 3 program for CLS-AX. The company is preparing to initiate two pivotal trials in H2 2025, contingent on securing funding111 - The company is also evaluating two small molecules in preclinical models for the potential treatment of geographic atrophy (GA)112 Results of Operations Q1 2025 saw increased license revenue and decreased R&D expenses, leading to a reduced net loss compared to Q1 2024 Comparison of Results of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $2,330 | $230 | $2,100 | | Research and development | $4,463 | $5,615 | ($1,152) | | General and administrative | $2,824 | $2,824 | $0 | | Loss from operations | ($5,205) | ($8,209) | $3,004 | | Net loss | ($8,223) | ($11,763) | $3,540 | - The $1.2 million decrease in R&D expenses was primarily due to a $1.8 million reduction in costs for the CLS-AX program following the completion of the ODYSSEY trial, partially offset by a $0.4 million increase in costs for the GA program140 Liquidity and Capital Resources As of March 31, 2025, cash was $13.6 million, expected to fund operations only into Q4 2025, raising substantial doubt about going concern - The company had cash and cash equivalents of $13.6 million as of March 31, 2025145146 - Based on current plans, the company expects its cash to fund planned operating expenses and capital expenditure requirements into the fourth quarter of 2025158 - The company will require additional capital to complete the clinical development of CLS-AX and has stated these factors raise substantial doubt about its ability to continue as a going concern158159 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Clearside Biomedical is not required to provide quantitative and qualitative disclosures about market risk164 Item 4. Controls and Procedures Management concluded disclosure controls were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (March 31, 2025)167 - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting168 PART II Item 1. Legal Proceedings The company reports no material legal proceedings, pending or threatened, that could adversely affect its business - The company reports no material legal proceedings170 Item 1A. Risk Factors This section refers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K for FY2024 - The report directs investors to review the risk factors described in the company's Annual Report on Form 10-K for the year ended December 31, 2024171 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or issuer purchases during the period - There were no unregistered sales of equity securities or no issuer purchases of equity securities in the quarter172 Item 5. Other Information No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter173 Item 6. Exhibits This section lists the exhibits filed with the quarterly report, including Sarbanes-Oxley certifications and Inline XBRL documents - The report includes standard exhibits, such as Sarbanes-Oxley certifications (31.1, 31.2, 32.1) and XBRL data files175