[Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements%20Content) 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](index=7&type=chunk) - 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](index=8&type=chunk)[9](index=9&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) 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](index=5&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=14&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) 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](index=15&type=chunk) [Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=7&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONSOLIDATED%20STATEMENTS%20OF%20CONVERTIBLE%20PREFERRED%20STOCK%20AND%20STOCKHOLDERS'%20EQUITY%20(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](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) 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](index=21&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) 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](index=9&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20ORGANIZATION) 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](index=23&type=chunk) - 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](index=24&type=chunk) - 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](index=26&type=chunk)[27](index=27&type=chunk) - 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](index=45&type=chunk) [Note 2. Stockholders' Equity](index=13&type=section&id=2.%20STOCKHOLDERS'%20EQUITY) 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 **$2.5 million** in gross proceeds[50](index=50&type=chunk) - A 1:30 reverse stock split was effected on June 24, 2025, to meet Nasdaq listing requirements, retroactively applied to all periods presented in the financial statements[51](index=51&type=chunk) Outstanding Liability-Classified Warrants (as of June 30, 2025) | Offering | Number of Common Shares Issuable Upon Exercise of Outstanding Warrants | Exercise Price ($) | 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 | $58.80 | October 25, 2027 | | Total | 522,008 | | | [Note 3. Fair Value](index=17&type=section&id=3.%20FAIR%20VALUE) This note describes the company's Level 3 fair value measurements for liability-classified warrants, determined using a probability-weighted expected return method with Monte Carlo simulation and Black-Scholes model - The company classifies its liability-classified warrants (2024, 2023, and 2022 Common Warrants) within the Level 3 fair value hierarchy due to the unobservable nature of significant inputs and valuation techniques used[71](index=71&type=chunk)[74](index=74&type=chunk)[76](index=76&type=chunk) Warrant Fair Value Changes (Six Months Ended June 30) | Metric | 2025 ($) | 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 **$15,000** over the same period[71](index=71&type=chunk)[74](index=74&type=chunk) [Note 4. Stock-Based Compensation](index=19&type=section&id=4.%20STOCK-BASED%20COMPENSATION) The company uses stock-based compensation, primarily stock options, estimated using the Black-Scholes model and amortized over the service period, with an increase of **233,333** shares approved for the 2021 Stock Incentive Plan in June 2024 Stock-Based Compensation Expense (Three Months Ended June 30) | Category | 2025 ($) | 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 **$125,484 (10.0%)** for the six months ended June 30, 2025, compared to the prior year periods[79](index=79&type=chunk) [Note 5. Income Taxes](index=21&type=section&id=5.%20INCOME%20TAXES) The company accounts for income taxes using the liability method but has not recorded a provision or benefit due to accumulated losses, with a full valuation allowance against gross deferred tax assets - No income tax provision or benefit was recorded for the six months ended June 30, 2025, or 2024, due to the company's history of tax losses[85](index=85&type=chunk) - A full valuation allowance has been established against the company's gross deferred tax assets due to continuing losses and uncertainty regarding future utilization of net operating losses (NOLs)[85](index=85&type=chunk) [Note 6. Net Loss Per Share](index=21&type=section&id=6.%20NET%20LOSS%20PER%20SHARE) This note details the calculation of basic and diluted net loss per share, considering pre-funded warrants as common shares for basic, and excluding most potential common stock equivalents as antidilutive for diluted EPS Net Loss Per Share (Three Months Ended June 30) | Metric | 2025 ($) | 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](index=88&type=chunk) [Note 7. Commitments and Contingencies](index=22&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) 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](index=89&type=chunk) [Note 8. Leases](index=22&type=section&id=8.%20LEASES) The company leases its headquarters office space until April 2029, with an option for extension, and the present value of lease liabilities is approximately **$454,000** as of June 30, 2025 - The company's HQ Lease for office space extends until April 30, 2029, with an option for a 60-month extension[91](index=91&type=chunk) Undiscounted Lease Payments Maturity (as of June 30, 2025) | Period | Amount ($) | | :-------------------------- | :----------- | | 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 | $454,000 | [Note 9. Operating Segment](index=23&type=section&id=9.%20OPERATING%20SEGMENT) The company operates as a single reportable segment, focused on developing cancer drugs using its PDC platform, with the CEO managing operations and assessing performance on a consolidated basis - Cellectar Biosciences operates as one reportable segment, focused on developing cancer drugs using its PDC platform[95](index=95&type=chunk) Segment Financial Data (Three Months Ended June 30) | Category | 2025 ($) | 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](index=23&type=section&id=10.%20SUBSEQUENT%20EVENTS) 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](index=98&type=chunk) - The common warrants issued in the offering have an exercise price of **$5.25** per share and a five-year term[98](index=98&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=24&type=section&id=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](index=100&type=chunk) - The company is exploring strategic alternatives (mergers, acquisitions, partnerships, etc.) to advance its platform and radiopharmaceutical drug development pipeline[100](index=100&type=chunk) - 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](index=101&type=chunk) - 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](index=101&type=chunk) [Clinical and Preclinical Pipeline](index=25&type=section&id=Clinical%20and%20Preclinical%20Pipeline) 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](index=25&type=section&id=CLR%20125%20Proposed%20Study) 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](index=103&type=chunk) - 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](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) [Preclinical Evaluations of CLR 225](index=25&type=section&id=Preclinical%20Evaluations%20of%20CLR%20225) 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](index=107&type=chunk) - 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](index=101&type=chunk) [Clinical Studies in Iopofosine](index=25&type=section&id=Clinical%20Studies%20in%20Iopofosine) 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](index=109&type=chunk) - 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](index=109&type=chunk) - 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](index=109&type=chunk) - The company is pursuing strategic options, including identifying a strategic partner, for the further development and commercialization of iopofosine I 131[102](index=102&type=chunk) [PDC Platform](index=28&type=section&id=PDC%20Platform) 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](index=117&type=chunk) - 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](index=117&type=chunk)[119](index=119&type=chunk) - The platform supports collaborations and internal programs, including novel small molecule, peptide, and oligonucleotide payloads, and is exploring other alpha-emitting isotopes[116](index=116&type=chunk)[139](index=139&type=chunk) [Recent Developments](index=35&type=section&id=Recent%20Developments) 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](index=138&type=chunk) [Regulatory Pathway – FDA](index=35&type=section&id=Regulatory%20Pathway%20%E2%80%93%20FDA) 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](index=139&type=chunk)[140](index=140&type=chunk) - 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](index=114&type=chunk) [Regulatory Pathway – EMA](index=37&type=section&id=Regulatory%20Pathway%20%E2%80%93%20EMA) 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](index=141&type=chunk) - The EMA submission included data from the CLOVER WaM clinical trial and an integrated safety summary for iopofosine I 131 in hematologic malignancies[141](index=141&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) 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](index=37&type=section&id=Three%20Months%20Ended%20June%2030,%202025%20and%202024) 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](index=146&type=chunk)[147](index=147&type=chunk) - 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](index=148&type=chunk) [Six Months Ended June 30, 2025 and 2024](index=39&type=section&id=Six%20Months%20Ended%20June%2030,%202025%20and%202024) 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](index=150&type=chunk) - 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](index=151&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=152&type=chunk) - 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](index=152&type=chunk) - Management plans to secure additional outside capital via equity/debt sales or strategic transactions and implement cost-saving measures to improve liquidity[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=41&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Disclosure controls and procedures were deemed ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting[157](index=157&type=chunk) [Management's Report on Internal Control over Financial Reporting](index=41&type=section&id=Management's%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) - 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](index=159&type=chunk) [Material Weaknesses](index=41&type=section&id=Material%20Weaknesses) - 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](index=161&type=chunk)[165](index=165&type=chunk) - These material weaknesses resulted in errors that required the restatement of prior annual and interim consolidated financial statements[162](index=162&type=chunk) [Management's Plan to Remediate the Material Weaknesses](index=42&type=section&id=Management's%20Plan%20to%20Remediate%20the%20Material%20Weaknesses) - 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](index=163&type=chunk) - 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](index=164&type=chunk) [Changes in Internal Control over Financial Reporting](index=43&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - 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](index=166&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=169&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) 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](index=171&type=chunk)[172](index=172&type=chunk) - 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](index=173&type=chunk)[175](index=175&type=chunk) - 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](index=174&type=chunk)[179](index=179&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) 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](index=184&type=chunk) - Interactive Data Files (XBRL) are included as exhibits, along with the Cover Page Interactive Data File[184](index=184&type=chunk)

Core Insights - Cellectar Biosciences, Inc. is set to report its financial results for Q2 2025 and provide a corporate update on August 14, 2025, at 8:30 a.m. Eastern Time [1] - The company focuses on the discovery, development, and commercialization of cancer treatment drugs, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company dedicated to developing proprietary drugs for cancer treatment, both independently and through collaborations [3] - The company's primary goal is to enhance cancer treatment efficacy and safety by minimizing off-target effects through its PDC delivery platform [3] Product Pipeline - The product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, designed for targeted delivery of iodine-131 [4] - CLR 121225 targets solid tumors with high unmet needs, such as pancreatic cancer, using actinium-225 [4] - CLR 121125 focuses on iodine-125 Auger-emitting treatments for various solid tumors, including triple-negative breast cancer, lung cancer, and colorectal cancer [4] - The company also has proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has been evaluated in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric patients with high-grade gliomas [5] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Core Viewpoint - Cellectar Biosciences, Inc. (CLRB) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to significant buying or selling activity that affects stock prices [4]. Company Performance and Outlook - The upgrade reflects an improvement in Cellectar Biosciences' underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - Over the past three months, the Zacks Consensus Estimate for Cellectar Biosciences has increased by 26.1% [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have averaged a +25% annual return since 1988 [7]. - Cellectar Biosciences' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - Cellectar Biosciences, Inc. has successfully closed a public offering, raising approximately $6.9 million to support its cancer treatment drug development efforts [1][4]. Offering Details - The offering consists of 1,045,000 Class A Units and 335,000 Class B Units, with Class A Units priced at $5.00 each and Class B Units at $4.99999 each [2]. - Each Class A Unit includes one share of common stock and one common warrant, while each Class B Unit includes one pre-funded common stock purchase warrant and one common warrant [2]. - The common warrants have an exercise price of $5.25 per share and are exercisable upon issuance for a term of five years [2]. Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital and operating expenses, as well as to initiate a Phase 1b clinical study of CLR 121125 in triple-negative breast cancer [4]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ delivery platform to enhance treatment efficacy and safety [7].

Core Insights - Cellectar Biosciences has signed a multi-year supply agreement with Nusano for iodine-125 and actinium-225, essential for its clinical studies and future commercial needs [1][2] - This partnership is crucial for advancing Cellectar's targeted radiotherapy programs, including CLR-125 for triple-negative breast cancer and CLR-225 for pancreatic cancer [2][5] - Nusano's next-generation production facility in Utah will produce these isotopes, addressing supply chain challenges and enabling innovation in cancer treatment [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4] - The company's product pipeline includes iopofosine I-131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [5][6] - Cellectar has received multiple designations from the FDA for its products, including Breakthrough Therapy Designation and Orphan Drug Designation [6] Industry Context - Nusano aims to stabilize the supply of medical radioisotopes, which are critically undersupplied in the market, and to support innovation across multiple industries [3] - The partnership between Cellectar and Nusano highlights the growing importance of reliable access to high-quality radioisotopes for advancing cancer therapies [2][3]

Core Insights - Cellectar Biosciences has submitted a protocol to the FDA for a Phase 1b dose-finding study of CLR 125, an iodine-125 Auger-emitting radiopharmaceutical targeting relapsed triple-negative breast cancer (TNBC) [1][2] - The study aims to evaluate the safety, tolerability, and optimal dosing of CLR 125, with a focus on its ability to deliver iodine-125 directly to tumor cells [2][3] - TNBC is a challenging subtype of breast cancer with limited treatment options, affecting approximately 12% of breast cancer diagnoses in the U.S. [4] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [5] - The company's pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and other programs targeting various solid tumors [6][7] Clinical Study Details - The Phase 1b study will assess three doses of CLR 125 (32.75 mCi for 4 cycles, 62.5 mCi for 3 cycles, and 95 mCi for 2 cycles) across 15 patients per arm, with the primary endpoint being the recommended Phase 2 dose [2] - The study will also evaluate initial response assessments, including RECIST and progression-free survival [2] Industry Context - TNBC is characterized by the absence of common therapeutic targets, leading to a high recurrence rate of approximately 25% after standard treatments [4] - There is a critical need for innovative therapies to improve outcomes for patients with TNBC, highlighting the potential significance of CLR 125 in addressing this unmet medical need [4]

Core Viewpoint - Cellectar Biosciences, Inc. announced a one-for-thirty reverse stock split effective June 24, 2025, aimed at consolidating shares to potentially enhance stock performance and meet listing requirements on Nasdaq [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. Reverse Stock Split Details - The reverse stock split was approved by stockholders on June 13, 2025, reducing the number of shares from approximately 54.36 million to about 1.81 million [2]. - Each stockholder's percentage ownership will remain unchanged, except for fractional shares, which will be compensated in cash [3]. - The reverse stock split will proportionately affect the number of shares available under equity incentive plans and adjust the terms of outstanding stock options and warrants accordingly [4]. Administrative Aspects - Equiniti Trust Company, LLC will act as the transfer agent for the reverse stock split, managing the issuance of post-split shares without requiring action from stockholders [5]. - Additional information regarding the reverse stock split is available in the company's definitive proxy statement filed with the SEC [6]. Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and other programs targeting various solid tumors [8][10]. - The company is also developing CLR 121225 and CLR 121125, targeting significant unmet needs in cancer treatment [8][9].

Core Insights - Cellectar Biosciences, Inc. announced promising initial results from the CLOVER-2 Phase 1 clinical trial of iopofosine I 131 for treating relapsed/refractory pediatric high-grade glioma (pHGG) patients, showing an average progression-free survival (PFS) of 5.4 months, which is more than double the previously reported median of 2.25 months [1][2][4] Group 1: Clinical Trial Results - The CLOVER-2 trial involved 14 patients diagnosed with various forms of pHGG, including diffuse midline gliomas and anaplastic ependymomas, with poor historical outcomes of approximately 2.25 months for median PFS and 5.6 months for overall survival (OS) [2] - Patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and an OS of 8.6 months, with all patients achieving disease control [3] - Three patients who received additional dosing cycles had an average PFS of 8.1 months and an OS of 11.5 months, with two achieving an objective response rate [3] Group 2: Safety and Tolerability - Iopofosine I 131 was well tolerated, with a safety profile consistent with previous data, showing no significant cardiovascular, renal, or liver toxicities, and manageable hematologic adverse events [4] - The most common treatment-emergent adverse events were hematologic, including thrombocytopenia, neutropenia, and anemia, all of which were predictable and manageable [4] Group 3: Trial Design and Objectives - The ongoing Phase 1b trial is designed to evaluate the safety and tolerability of iopofosine I 131 in children, adolescents, and young adults with relapsed/refractory high-grade glioma, with two dosing cohorts planned [5] - The study aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction, and to identify the recommended Phase 2/3 dose [5] Group 4: Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [6] - The company's pipeline includes iopofosine I 131 and other programs targeting various solid tumors, with iopofosine I 131 also studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7][9]

Core Viewpoint - Cellectar Biosciences, Inc. has entered into definitive agreements to raise $2.5 million through the sale of common stock, with the closing expected around June 6, 2025, pending customary conditions [1] Group 1: Financial Details - The company will raise $2.5 million from the sale of shares priced at-market for Nasdaq purposes [1] - The agreements include the immediate exercise of existing warrants for a total of 8,301,322 shares at a reduced exercise price of $0.3041 per share, expected to generate approximately $2.5 million in gross proceeds [3] - The net proceeds will be used for general corporate purposes, including working capital and operating expenses [3] Group 2: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [5] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various cancers with significant unmet needs [6] Group 3: Product Development and Designations - Iopofosine I 131 has received Breakthrough Therapy Designation from the FDA and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7] - The product has also received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [7]

Core Insights - Cellectar Biosciences, Inc. has received Breakthrough Therapy Designation from the FDA for iopofosine I 131, a novel cancer targeting agent for relapsed/refractory Waldenstrom macroglobulinemia [2][4] - The Phase 2 CLOVER WaM study reported an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the primary endpoint of 20% MRR [4][6] - The company is seeking guidance from the European Medicines Agency (EMA) to determine if the Phase 2 data meets the criteria for fast-track, conditional marketing authorization, with an answer expected in late July 2025 [6] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [8] - The company's product pipeline includes iopofosine I 131, CLR 121225 targeting solid tumors, and CLR 121125 for other solid tumors, along with various preclinical PDC chemotherapeutic programs [9][10] - iopofosine I 131 has also been studied in Phase 2b trials for multiple myeloma and CNS lymphoma, and the company is eligible for a Pediatric Review Voucher from the FDA upon approval [11]