Cellectar Biosciences(CLRB) - 2021 Q1 - Quarterly Report

Forward-Looking Statements This report contains forward-looking statements regarding business strategy, clinical development, and projected operating results, cautioning readers about inherent risks - This report contains forward-looking statements regarding the company's business strategy, clinical development progress, projected operating results, and the potential impacts of the COVID-19 pandemic These statements involve risks and uncertainties, and the company cautions readers not to place undue reliance on them[9][11][12] - Key areas covered by forward-looking statements include the development plans for CLR 131 and other product candidates, the ability to obtain additional funding, and the maintenance of orphan drug designations[9] PART I. FINANCIAL INFORMATION Financial Statements This section presents the unaudited condensed consolidated financial statements for Q1 2021, including balance sheets, statements of operations, cash flows, and accompanying notes Condensed Consolidated Balance Sheets Total assets decreased to $55.1 million as of March 31, 2021, from $58.7 million, while total liabilities increased from $3.9 million to $5.3 million Condensed Consolidated Balance Sheet Highlights (in USD) | Metric | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $53,626,722 | $57,165,377 | | Total current assets | $54,401,608 | $57,939,809 | | Total Assets | $55,064,779 | $58,659,370 | | Total current liabilities | $5,019,624 | $3,563,101 | | Total Liabilities | $5,288,932 | $3,864,841 | | Total Stockholders' Equity | $49,775,847 | $54,794,529 | Condensed Consolidated Statements of Operations The company reported a net loss of $6.4 million for Q1 2021, or ($0.13) per share, primarily due to higher research and development expenses Condensed Consolidated Statement of Operations (in USD) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $4,633,194 | $2,616,337 | | General and administrative | $1,726,338 | $1,342,318 | | Loss from operations | ($6,359,532) | ($3,958,655) | | Net Loss | ($6,357,170) | ($3,957,608) | | Net Loss Per Share | ($0.13) | ($0.42) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $4.8 million for Q1 2021, with cash and cash equivalents decreasing by $3.5 million to $53.6 million Condensed Consolidated Statement of Cash Flows (in USD) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Cash used in operating activities | ($4,752,579) | ($3,512,070) | | Cash used in investing activities | $0 | ($10,553) | | Cash provided by financing activities | $1,213,924 | $0 | | Net Decrease in Cash | ($3,538,655) | ($3,522,623) | | Cash at End of Period | $53,626,722 | $7,092,099 | Notes to Condensed Consolidated Financial Statements Notes detail the company's biopharmaceutical business, management's liquidity assessment, significant accounting policies, and recent financing activities - The company is a late-stage clinical biopharmaceutical company focused on developing cancer drugs using its proprietary phospholipid drug conjugate™ (PDC™) delivery platform[30] - Management believes the cash balance at March 31, 2021, is sufficient to fund budgeted operations for at least 12 months from the filing date[31] - On February 25, 2021, stockholders approved an increase in authorized common stock from 80,000,000 to 160,000,000 shares[46] - In December 2020, the company raised approximately $41.4 million in net proceeds from a public offering and concurrent private placement[49] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's PDC platform, CLR 131 clinical progress, Q1 2021 financial results, and liquidity, confirming sufficient cash for 12 months Overview Cellectar is a late-stage biopharmaceutical company developing cancer drugs via its PDC platform, with lead candidate CLR 131 in pivotal Phase 2 studies - The company's lead PDC therapeutic, CLR 131, is being evaluated in the CLOVER-WaM Phase 2 pivotal study for relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM)[88] - CLR 131 has received multiple regulatory designations, including FDA Fast Track for WM, MM, and DLBCL, as well as Orphan Drug Designations for several cancers in the U.S. and Europe[91] - The company's PDC platform is designed to selectively deliver oncologic payloads to cancer cells, aiming to improve efficacy and safety by minimizing off-target effects[95][96] - In January 2021, the company initiated the CLOVER-WaM pivotal study following an agreement with the FDA on the study design, dose, endpoints, and size (50 patients)[105] Results of Operations Research and development expenses increased by 77% to $4.6 million in Q1 2021, driven by higher clinical project costs, while G&A expenses also rose Research and Development Expense Comparison (in USD) | Category | Q1 2021 | Q1 2020 | Variance | | :--- | :--- | :--- | :--- | | Clinical project costs | $2,987,000 | $890,000 | $2,097,000 | | Manufacturing and related costs | $506,000 | $879,000 | ($373,000) | | General research and development costs | $1,132,000 | $761,000 | $371,000 | | Total R&D Expense | $4,633,000 | $2,616,000 | $2,017,000 | - General and administrative expenses increased by $384,000 (29%) in Q1 2021 compared to Q1 2020, primarily due to an increase in professional fees and insurance[129] Liquidity and Capital Resources As of March 31, 2021, the company held $53.6 million in cash, with $4.8 million used in operations, deemed sufficient for 12 months - The company had cash and cash equivalents of approximately $53.6 million as of March 31, 2021[130] - Net cash used in operating activities during Q1 2021 was approximately $4.8 million[130] - The company believes its cash balance is adequate to fund basic budgeted operations for at least 12 months from the filing of the financial statements[132] Controls and Procedures Management concluded disclosure controls and procedures were effective as of March 31, 2021, with no significant changes to internal control over financial reporting - Based on management's evaluation, the company's disclosure controls and procedures were deemed effective as of March 31, 2021[134] - No significant changes were made to the company's internal control over financial reporting during the fiscal quarter ended March 31, 2021[135][136] PART II. OTHER INFORMATION Legal Proceedings The company reports no legal proceedings to disclose for the period - The company reported no legal proceedings[138] Risk Factors This section refers readers to the comprehensive risk factors previously disclosed in the company's Annual Report on Form 10-K - The company refers to the Risk Factors section of its Form 10-K filed with the SEC on March 2, 2021, for a description of factors that could materially affect its business[139] Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Interactive Data Files - The exhibits filed with this report include certifications by the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[141]