Cellectar Biosciences(CLRB) - 2025 Q2 - Quarterly Report

Forward-Looking Statements Forward-Looking Statements This section outlines forward-looking statements in the Form 10-Q regarding business strategy, product development, operating results, funding, regulatory approvals, and market conditions, noting actual results may differ due to risks and uncertainties - The report contains forward-looking statements regarding business strategy, R&D, clinical testing, operating results, funding, and regulatory approvals for product candidates like iopofosine I 131 and CLR 125[7] - These statements involve estimates, assumptions, and uncertainties that could cause actual results to differ materially, and readers should not place undue reliance on them[8][9] PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, statements of convertible preferred stock and stockholders' equity (deficit), and statements of cash flows, along with their accompanying notes Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :----- | | Total Current Assets | $12,617,606 | $24,250,272 | $(11,632,666) | | Total Assets | $13,695,183 | $25,474,047 | $(11,778,864) | | Total Current Liabilities | $5,866,661 | $9,387,757 | $(3,521,096) | | Total Liabilities | $6,228,148 | $9,797,343 | $(3,569,195) | | Total Stockholders' Equity (Deficit) | $6,085,012 | $14,294,681 | $(8,209,669) | - Cash and cash equivalents decreased significantly from $23.3 million at December 31, 2024, to $11.0 million at June 30, 2025[14] Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------- | :----------- | :----------- | :----------- | | Research and development | $2,389,801 | $7,345,480 | $(4,955,679) | | General and administrative | $3,647,728 | $6,358,229 | $(2,710,501) | | Total operating expenses | $6,037,529 | $13,703,709 | $(7,666,180) | | Net Loss | $(5,447,911) | $(919,371) | $(4,528,540) | | Net Loss Per Share - Basic | $(3.39) | $(0.77) | $(2.62) | Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------- | :------------ | :------------ | :------------ | | Research and development | $5,816,896 | $14,433,523 | $(8,616,627) | | General and administrative | $6,621,624 | $11,271,673 | $(4,650,049) | | Total operating expenses | $12,438,520 | $25,705,196 | $(13,266,676) | | Net Loss | $(12,051,940) | $(27,561,355) | $15,509,415 | | Net Loss Per Share - Basic | $(7.66) | $(25.38) | $17.72 | - Net loss significantly increased for the three months ended June 30, 2025, compared to 2024, but decreased for the six months ended June 30, 2025, primarily due to changes in warrant valuation[15] Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) Stockholders' Equity (Deficit) Changes (Six Months Ended June 30, 2025) | Item | Amount | | :------------------------------------ | :----------- | | Balance at December 31, 2024 | $14,294,681 | | Stock-based compensation | $1,128,128 | | Exercise of warrants for common stock | $2,714,140 | | Net loss | $(12,051,940) | | Balance at June 30, 2025 | $6,085,012 | - Total stockholders' equity decreased from $14.3 million at December 31, 2024, to $6.1 million at June 30, 2025, primarily due to net loss, partially offset by stock-based compensation and warrant exercises[19] Condensed Consolidated Statements of Cash Flows Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 | 2024 | Change | | :-------------------------------- | :------------- | :------------- | :------------- | | Net loss | $(12,051,940) | $(27,561,355) | $15,509,415 | | Cash used in operating activities | $(14,498,960) | $(27,502,640) | $13,003,680 | | Cash used in investing activities | $0 | $(42,909) | $42,909 | | Cash provided by financing activities | $2,251,380 | $43,849,468 | $(41,598,088) | | Net (Decrease) Increase in Cash | $(12,247,580) | $16,303,919 | $(28,551,499) | | Cash and cash equivalents at end of period | $11,041,027 | $25,868,907 | $(14,827,880) | - The company experienced a net decrease in cash and cash equivalents of $12.2 million for the six months ended June 30, 2025, compared to a net increase of $16.3 million in the prior year, primarily due to significantly lower cash provided by financing activities[21] Notes to Condensed Consolidated Financial Statements The notes provide detailed information on the company's business, significant accounting policies, and specific financial statement line items, including going concern uncertainty, equity transactions, fair value measurements, and lease obligations Note 1. Nature of Business and Organization Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing cancer treatments using its proprietary PDC™ delivery platform, facing going concern uncertainty due to significant accumulated deficits and insufficient liquidity beyond Q2 2026 - Cellectar Biosciences is a late-stage clinical biopharmaceutical company developing cancer drugs using its proprietary PDC™ delivery platform[23] - The company has an accumulated deficit of approximately $259.4 million as of June 30, 2025, and incurred a net loss of $12.1 million for the six months ended June 30, 2025[24] - Management believes the company's available liquidity of approximately $15 million is insufficient to fund operations beyond Q2 2026, raising substantial doubt about its ability to continue as a going concern, with plans to secure additional capital or explore strategic transactions[26][27] - The company received no NCI grant funding in the six months ended June 30, 2025, compared to $465,000 in the same period of 2024, which was reported as a reduction of R&D expenses[45] Note 2. Stockholders' Equity This note details significant changes in stockholders' equity, including a June 2025 warrant inducement generating $2.5 million in gross proceeds, a 1:30 reverse stock split, and a summary of outstanding liability-classified warrants - On June 6, 2025, the company completed a warrant inducement, resulting in the exercise of 276,044 common stock warrants at a reduced price of $9.123 per share, generating approximately $2.5 million in gross proceeds[50] - A 1:30 reverse stock split was effected on June 24, 2025, to meet Nasdaq listing requirements, retroactively applied to all periods presented in the financial statements[51] Outstanding Liability-Classified Warrants (as of June 30, 2025) | Offering | Number of Common Shares Issuable Upon Exercise of Outstanding Warrants | Exercise Price ($) | Expiration Date | | :-------------------------- | :----------------------------------------------------- | :------------- | :-------------- | | 2024 Tranche A Warrants | 158,728 | $75.60 | July 21, 2029 | | 2024 Tranche B Warrants | 149,107 | $120.00 | July 21, 2029 | | 2024 Tranche C Warrants | 75,912 | $165.00 | July 21, 2029 | | 2023 Tranche B Preferred Warrants | 14,652 | $143.25 | September 8, 2028 | | 2022 Common Warrants | 123,609 | $58.80 | October 25, 2027 | | Total | 522,008 | | | Note 3. Fair Value This note describes the company's Level 3 fair value measurements for liability-classified warrants, determined using a probability-weighted expected return method with Monte Carlo simulation and Black-Scholes model - The company classifies its liability-classified warrants (2024, 2023, and 2022 Common Warrants) within the Level 3 fair value hierarchy due to the unobservable nature of significant inputs and valuation techniques used[71][74][76] Warrant Fair Value Changes (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :-------------------------- | :----------- | :----------- | | Beginning warrant fair value | $1,718,000 | $13,131,691 | | Change in warrant fair value | $421,986 | $1,521,582 | | Settlement of warrants to equity | $(1,044,060) | $(6,025,676) | | Ending warrant fair value | $1,095,926 | $8,627,597 | - The fair value of 2024 warrants decreased from $1.2 million at December 31, 2024, to $830,000 at June 30, 2025, while 2023 warrants decreased from $26,000 to $15,000 over the same period[71][74] Note 4. Stock-Based Compensation The company uses stock-based compensation, primarily stock options, estimated using the Black-Scholes model and amortized over the service period, with an increase of 233,333 shares approved for the 2021 Stock Incentive Plan in June 2024 Stock-Based Compensation Expense (Three Months Ended June 30) | Category | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------- | :----------- | :----------- | :----------- | | Research and development | $104,253 | $74,450 | $29,803 | | General and administrative | $461,138 | $724,799 | $(263,661) | | Total | $565,391 | $799,249 | $(233,858) | Stock-Based Compensation Expense (Six Months Ended June 30) | Category | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------- | :----------- | :----------- | :----------- | | Research and development | $203,363 | $143,225 | $60,138 | | General and administrative | $924,765 | $1,110,387 | $(185,622) | | Total | $1,128,128 | $1,253,612 | $(125,484) | - Total stock-based compensation expense decreased by $233,858 (29.3%) for the three months ended June 30, 2025, and by $125,484 (10.0%) for the six months ended June 30, 2025, compared to the prior year periods[79] Note 5. Income Taxes The company accounts for income taxes using the liability method but has not recorded a provision or benefit due to accumulated losses, with a full valuation allowance against gross deferred tax assets - No income tax provision or benefit was recorded for the six months ended June 30, 2025, or 2024, due to the company's history of tax losses[85] - A full valuation allowance has been established against the company's gross deferred tax assets due to continuing losses and uncertainty regarding future utilization of net operating losses (NOLs)[85] Note 6. Net Loss Per Share This note details the calculation of basic and diluted net loss per share, considering pre-funded warrants as common shares for basic, and excluding most potential common stock equivalents as antidilutive for diluted EPS Net Loss Per Share (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :------------------------------------ | :----------- | :----------- | | Net loss per share - basic | $(3.39) | $(0.77) | | Weighted average common shares outstanding - basic | 1,608,799 | 1,193,981 | | Net loss per share - diluted | $(3.39) | $(5.43) | | Weighted average common shares outstanding - diluted | 1,608,799 | 1,248,210 | - Potentially dilutive securities, including warrants, preferred shares, and stock options, totaling 750,918 shares as of June 30, 2025, were excluded from diluted EPS calculation as their inclusion would be antidilutive[88] Note 7. Commitments and Contingencies The company may be involved in legal matters in the ordinary course of business but does not anticipate material effects on its financial statements - The company does not expect legal proceedings in the ordinary course of business to materially affect its financial statements[89] Note 8. Leases The company leases its headquarters office space until April 2029, with an option for extension, and the present value of lease liabilities is approximately $454,000 as of June 30, 2025 - The company's HQ Lease for office space extends until April 30, 2029, with an option for a 60-month extension[91] Undiscounted Lease Payments Maturity (as of June 30, 2025) | Period | Amount ($) | | :-------------------------- | :----------- | | Remaining 2025 | $73,000 | | 2026 | $150,000 | | 2027 | $153,000 | | 2028 | $156,000 | | Thereafter | $52,000 | | Total Undiscounted | $584,000 | | Less: Imputed Interest | $(130,000) | | Present Value | $454,000 | Note 9. Operating Segment The company operates as a single reportable segment, focused on developing cancer drugs using its PDC platform, with the CEO managing operations and assessing performance on a consolidated basis - Cellectar Biosciences operates as one reportable segment, focused on developing cancer drugs using its PDC platform[95] Segment Financial Data (Three Months Ended June 30) | Category | 2025 ($) | 2024 ($) | | :------------------------------------ | :----------- | :----------- | | Research and development | $2,389,801 | $7,345,480 | | General and administrative | $3,647,728 | $6,358,229 | | Other segment items (net) | $(589,618) | $(12,784,338) | | Segment and consolidated net loss | $5,447,911 | $919,371 | Segment Financial Data (Six Months Ended June 30) | Category | 2025 ($) | 2024 ($) | | :------------------------------------ | :----------- | :----------- | | Research and development | $5,816,896 | $14,433,523 | | General and administrative | $6,621,624 | $11,271,673 | | Other segment items (net) | $(386,580) | $1,856,159 | | Segment and consolidated net loss | $12,051,940 | $27,561,355 | Note 10. Subsequent Events On July 2, 2025, the company completed an underwritten public offering, raising approximately $6.9 million in gross proceeds by issuing Class A and Class B Units, with common warrants exercisable at $5.25 per share - On July 2, 2025, the company completed a public offering, raising approximately $6.9 million in gross proceeds by issuing Class A Units (common stock + common warrants) and Class B Units (pre-funded warrants + common warrants)[98] - The common warrants issued in the offering have an exercise price of $5.25 per share and a five-year term[98] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results, highlighting its focus on developing cancer treatments using its PDC platform, progress of lead drug candidates, recent regulatory milestones, and the ongoing need for additional funding Overview Cellectar Biosciences is a late-stage clinical biopharmaceutical company leveraging its proprietary PDC™ platform to develop targeted cancer treatments, actively exploring strategic alternatives to advance its pipeline - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing cancer drugs using its proprietary PDC™ delivery platform[100] - The company is exploring strategic alternatives (mergers, acquisitions, partnerships, etc.) to advance its platform and radiopharmaceutical drug development pipeline[100] - The three lead radioconjugate PDC programs are CLR 125 (iodine-125 Auger-emitting), CLR 225 (actinium-225 alpha-emitting), and iopofosine I 131 (iodine-131 beta-emitting)[101] - On June 4, 2025, the FDA granted Breakthrough Therapy Designation for iopofosine I 131 as a monotherapy for relapsed/refractory Waldenstrom macroglobulinemia (r/r WM)[101] Clinical and Preclinical Pipeline This section details the progress of Cellectar's lead drug candidates, including CLR 125 for TNBC, CLR 225 for pancreatic cancer, and iopofosine I 131 for r/r WM, MM, and CNSL, with ongoing clinical studies and strategic partnership pursuits CLR 125 Proposed Study CLR 125, an Auger-emitting PRC, showed high tumor uptake and minimal toxicity in preclinical TNBC models, with a planned Phase 1b dose-finding study in advanced r/r TNBC patients to assess safety, tolerability, and initial response - CLR 125 demonstrated high tumor uptake and tolerability with minimal toxicities in preclinical triple-negative breast cancer (TNBC) models[103] - A Phase 1b dose-finding study for CLR 125 in advanced r/r TNBC is planned, with three dose levels, a maximum of 75 patients, and endpoints including safety, tolerability, and initial response[104][105][106] Preclinical Evaluations of CLR 225 CLR 225, an alpha-emitting PRC, demonstrated tumor volume reduction and improved survival in pancreatic cancer models, with a Phase 1 imaging and dose escalation safety study prepared for the second half of 2025, contingent on additional funding - CLR 225 showed tumor volume reduction and improved survival in pancreatic cancer models, with excellent biodistribution and tumor uptake[107] - A Phase 1 imaging and dose escalation safety study for CLR 225 is prepared for the second half of 2025, subject to additional funding[101] Clinical Studies in Iopofosine Iopofosine I 131 achieved statistically significant outcomes in the CLOVER WaM Phase 2 study for r/r WM, with ongoing Phase 2b studies for r/r MM and CNSL, and a Phase 1b pediatric study for high-grade glioma, while the company seeks a strategic partner for its further development - Iopofosine I 131 achieved a 58.2% major response rate (MRR) and 83.6% overall response rate (ORR) in the CLOVER WaM Phase 2 study for r/r WM, exceeding the FDA's statistical hurdle of 20%[109] - The CLOVER WaM study demonstrated durable responses, with median duration of response not reached at 11.4 months and 76% of patients remaining progression-free at eight months[109] - Iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in highly refractory WM patients, with a toxicity profile consistent with previously reported safety data, and no treatment-related deaths[109] - The company is pursuing strategic options, including identifying a strategic partner, for the further development and commercialization of iopofosine I 131[102] PDC Platform Cellectar's proprietary PDC platform enables selective delivery of diverse oncologic payloads to cancer cells by targeting unique changes in tumor cell membranes, enhancing drug efficacy, and reducing off-target toxicities, with potential for various payloads and isotopes - The PDC platform enables selective delivery of oncologic payloads to cancer cells by targeting unique changes in tumor cell membranes, not relying on specific cell surface epitopes[117] - This mechanism allows PDCs to accumulate in tumor cells, avoid lysosomes, and deliver payloads that were previously untargetable, potentially enhancing efficacy and reducing off-target toxicities[117][119] - The platform supports collaborations and internal programs, including novel small molecule, peptide, and oligonucleotide payloads, and is exploring other alpha-emitting isotopes[116][139] Recent Developments On June 4, 2025, the FDA granted Breakthrough Therapy Designation for iopofosine I 131 as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) - The FDA granted Breakthrough Therapy Designation for iopofosine I 131 as a radioconjugate monotherapy for r/r WM on June 4, 2025[138] Regulatory Pathway – FDA The company plans to submit an NDA to the FDA for accelerated approval of iopofosine I 131 for WM, contingent on sufficient funding and a confirmatory trial, following discussions on a one-trial design (randomized Phase 3) - The company plans to submit an NDA to the FDA for accelerated approval of iopofosine I 131 for WM, subject to sufficient funding and initiation of a confirmatory trial[139][140] - An End-of-Phase-2 meeting with the FDA on March 6, 2025, clarified a path for potential accelerated and full approval via a randomized Phase 3 trial for WM patients previously treated with a BTKi[114] Regulatory Pathway – EMA The company is awaiting a final decision from the EMA regarding support for a Conditional Market Authorization (CMA) submission for iopofosine I 131, with a response expected by late Q3 or early Q4 2025, based on CLOVER WaM trial data and an integrated safety summary - The company is awaiting the EMA's final decision on supporting a Conditional Market Authorization (CMA) submission for iopofosine I 131, expected by late Q3 or early Q4 2025[141] - The EMA submission included data from the CLOVER WaM clinical trial and an integrated safety summary for iopofosine I 131 in hematologic malignancies[141] Results of Operations This section analyzes the company's operating expenses, including R&D and G&A costs, and other income (expense) for the three and six months ended June 30, 2025, compared to 2024, noting significant decreases in R&D and G&A, and fluctuations in other income due to warrant valuation changes Three Months Ended June 30, 2025 and 2024 For the three months ended June 30, 2025, R&D expenses decreased by 67% to $2.39 million, G&A expenses decreased by 43% to $3.65 million, and other income (expense), net, was $0.59 million, primarily due to reduced clinical trial activities, pre-commercialization efforts, and non-cash warrant valuation changes R&D Expenses (Three Months Ended June 30) | Category | 2025 ($) | 2024 ($) | Variance ($) | | :-------------------------------- | :----------- | :----------- | :----------- | | Clinical project costs | $738,000 | $3,951,000 | $(3,213,000) | | Manufacturing and related costs | $871,000 | $2,628,000 | $(1,757,000) | | Pre-clinical project costs | $145,000 | $31,000 | $114,000 | | General R&D costs | $636,000 | $735,000 | $(99,000) | | Total R&D | $2,390,000 | $7,345,000 | $(4,955,000) | - General and administrative expense decreased by approximately $2.71 million (43%) to $3.65 million for the three months ended June 30, 2025, driven by reduced pre-commercialization activities and personnel costs[146][147] - Other income (expense), net, was $0.59 million in Q2 2025, down from $12.78 million in Q2 2024, primarily due to non-cash changes in warrant valuation and decreased interest income from lower invested funds[148] Six Months Ended June 30, 2025 and 2024 For the six months ended June 30, 2025, R&D expenses decreased by 60% to $5.82 million, G&A expenses decreased by 41% to $6.62 million, and other income (expense), net, was $0.39 million, primarily due to reduced clinical and manufacturing costs, and warrant valuation changes R&D Expenses (Six Months Ended June 30) | Category | 2025 ($) | 2024 ($) | Variance ($) | | :-------------------------------- | :----------- | :----------- | :----------- | | Clinical project costs | $2,104,000 | $6,644,000 | $(4,540,000) | | Manufacturing and related costs | $1,580,000 | $5,941,000 | $(4,361,000) | | Pre-clinical project costs | $652,000 | $52,000 | $600,000 | | General R&D costs | $1,481,000 | $1,797,000 | $(316,000) | | Total R&D | $5,817,000 | $14,434,000 | $(8,617,000) | - General and administrative expense decreased by approximately $4.65 million (41%) to $6.62 million for the six months ended June 30, 2025, due to decreased pre-commercialization and personnel costs[150] - Other income (expense), net, was $0.39 million in H1 2025, compared to an expense of $1.86 million in H1 2024, primarily driven by non-cash changes in warrant valuation and reduced interest income[151] Liquidity and Capital Resources The company incurred significant losses and used $14.5 million in cash for operations, resulting in a $11 million cash balance, with current liquidity of $15 million projected to fund operations only until Q2 2026, raising substantial doubt about its going concern ability and necessitating additional capital or strategic transactions - The company reported a net loss of $12.1 million and used $14.5 million in cash for operations during the six months ended June 30, 2025[152] - As of June 30, 2025, the cash balance was approximately $11 million, and available liquidity of $15 million is projected to fund operations only until Q2 2026, raising substantial doubt about the company's ability to continue as a going concern[152] - Management plans to secure additional outside capital via equity/debt sales or strategic transactions and implement cost-saving measures to improve liquidity[152] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were ineffective as of June 30, 2025, due to continuing material weaknesses in internal control over financial reporting, specifically in the control environment, risk assessment, control activities, information and communication, and monitoring activities Evaluation of Disclosure Controls and Procedures - Disclosure controls and procedures were deemed ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting[157] Management's Report on Internal Control over Financial Reporting - Management concluded that internal control over financial reporting was not effective as of December 31, 2024, continuing through June 30, 2025, due to material weaknesses[159] Material Weaknesses - Material weaknesses include deficiencies in the control environment (lack of policies/resources, limited staff), risk assessment (no formal process for complex transactions), control activities (inaccurate accounting for preferred equity, warrants, stock-based compensation), information and communication (lack of segregation of duties, user access controls), and monitoring activities[161][165] - These material weaknesses resulted in errors that required the restatement of prior annual and interim consolidated financial statements[162] Management's Plan to Remediate the Material Weaknesses - Management is remediating material weaknesses by recruiting qualified accounting and financial reporting personnel, designing and implementing a formal control environment and risk assessment process, and initiating the implementation of an ERP system[163] - Remediation efforts are ongoing and will not be considered complete until controls have operated effectively for a sufficient period and are evidenced through testing[164] Changes in Internal Control over Financial Reporting - Except for the identified material weaknesses, there has been no other material change in internal control over financial reporting during the period ended June 30, 2025[166] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company may be involved in legal matters in the ordinary course of business but does not anticipate that the outcome of such proceedings will materially affect its financial statements - The company does not expect legal proceedings in the ordinary course of business to materially affect its financial statements[169] Item 1A. Risk Factors This section highlights additional risks concerning the regulatory approval pathway for iopofosine I 131 and the company's ability to secure sufficient funding, potentially leading to strategic alternatives or bankruptcy - The company's regulatory strategy for iopofosine I 131 may not result in FDA or EMA approval, as regulatory authorities have substantial discretion and may require additional studies or find data insufficient[171][172] - Existing cash and cash equivalents are insufficient to execute the regulatory strategy for iopofosine I 131 or to progress CLR 125 through its Phase 1b study[173][175] - Failure to obtain additional funding could materially adversely affect the business and may require seeking alternatives such as asset sales, discontinuing operations, or filing for bankruptcy protection[174][179] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and CFO (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act) and interactive data files - The report includes certifications from the CEO and CFO as required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[184] - Interactive Data Files (XBRL) are included as exhibits, along with the Cover Page Interactive Data File[184]