[Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions readers about statements regarding future events and financial performance, subject to inherent risks [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements and management discussion [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, detailing financial positions and performance [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and equity as of September 30, 2024, and December 31, 2023 | Metric | Sep 30, 2024 | Dec 31, 2023 | | :-------------------------- | :------------ | :------------ | | Cash and cash equivalents | $34,263,371 | $9,564,988 | | Total current assets | $35,899,189 | $10,453,213 | | Total assets | $37,293,266 | $12,075,580 | | Total current liabilities | $20,314,374 | $25,358,522 | | Total liabilities | $20,746,303 | $25,852,525 | | Total stockholders' equity | $15,164,940 | $(15,158,968) | - Cash and cash equivalents significantly increased from **$9.56 million** at December 31, 2023, to **$34.26 million** at September 30, 2024, primarily due to financing activities[15](index=15&type=chunk) - Total stockholders' equity shifted from a deficit of **$(15.16) million** to a positive **$15.16 million**, indicating substantial equity financing during the period[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss for the periods ended September 30, 2024, and 2023 | Metric (Three Months Ended Sep 30) | 2024 | 2023 | | :--------------------------------- | :------------ | :------------ | | Research and development | $5,493,496 | $7,034,656 | | General and administrative | $7,834,181 | $2,378,804 | | Total operating expenses | $13,327,677 | $9,413,460 | | Loss from operations | $(13,327,677) | $(9,413,460) | | Net loss | $(14,664,719) | $(17,520,378) | | Net loss per share — basic | $(0.37) | $(1.55) | | Net loss per share — diluted | $(0.40) | $(1.55) | | Metric (Nine Months Ended Sep 30) | 2024 | 2023 | | :--------------------------------- | :------------ | :------------ | | Research and development | $19,927,019 | $19,528,898 | | General and administrative | $19,105,853 | $6,883,866 | | Total operating expenses | $39,032,872 | $26,412,764 | | Loss from operations | $(39,032,872) | $(26,412,764) | | Net loss | $(42,226,073) | $(34,889,488) | | Net loss per share — basic | $(1.21) | $(3.09) | | Net loss per share — diluted | $(1.39) | $(3.09) | - Net loss for the three months ended September 30, 2024, decreased to **$(14.66) million** from **$(17.52) million** in the prior year, while for the nine months, it increased to **$(42.23) million** from **$(34.89) million**[17](index=17&type=chunk) - General and administrative expenses saw a significant increase of **229%** for the three-month period and **178%** for the nine-month period, driven by commercialization infrastructure development[17](index=17&type=chunk)[169](index=169&type=chunk)[175](index=175&type=chunk) [Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=7&type=section&id=Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section outlines changes in convertible preferred stock and stockholders' equity, reflecting financing activities - Total stockholders' equity (deficit) improved from **$(15,158,968)** at December 31, 2023, to **$15,164,940** at September 30, 2024[19](index=19&type=chunk) - Significant changes include the issuance of Series E-4 preferred stock (net of issuance costs) for **$15,914,632** and conversions of various preferred stock series into common stock[19](index=19&type=chunk) - Additional paid-in capital increased from **$182,924,210** to **$246,536,080**, reflecting new equity issuances and warrant exercises[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents cash inflows and outflows from operating, investing, and financing activities for the nine months ended September 30, 2024 | Cash Flow Activity (Nine Months Ended Sep 30) | 2024 | 2023 | | :-------------------------------------------- | :------------ | :------------ | | Cash used in operating activities | $(36,669,523) | $(22,781,274) | | Cash used in investing activities | $(42,909) | $(597,282) | | Cash provided by financing activities | $61,410,815 | $22,498,641 | | Net increase (decrease) in cash | $24,698,383 | $(879,915) | | Cash and cash equivalents at end of period | $34,263,371 | $18,986,443 | - Cash used in operating activities increased to **$(36.67) million** in 2024 from **$(22.78) million** in 2023[23](index=23&type=chunk) - Cash provided by financing activities significantly increased to **$61.41 million** in 2024 from **$22.50 million** in 2023, primarily from preferred stock and warrant exercises[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed context for the financial statements, covering business, going concern, and accounting policies [1. Nature of Business and Organization](index=9&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20ORGANIZATION) This section describes the company's core business, financial condition, and restatement of prior financial statements - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer treatment using its proprietary phospholipid drug conjugate™ (PDC™) delivery platform[25](index=25&type=chunk) - The company has an accumulated deficit of approximately **$244.99 million** as of September 30, 2024, and expects to continue generating significant losses, raising substantial doubt about its ability to continue as a going concern beyond Q2 2025 without additional funding[26](index=26&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - The company restated previously issued consolidated financial statements for fiscal years 2023 and 2022, and interim periods in 2022 and 2023, due to material errors in accounting for warrants, preferred stock, and classification of operating costs[52](index=52&type=chunk) [2. Stockholders' Equity](index=13&type=section&id=2.%20STOCKHOLDERS'%20EQUITY) This section details significant changes in stockholders' equity, including new preferred stock issuances and warrant exercises - In July 2024, the company entered into a warrant exercise inducement, issuing new warrants (2024 Tranche A, B, C) and Series E-4 Convertible Voting Preferred Stock, generating gross proceeds of **$19.4 million** and net proceeds of **$17.5 million**[53](index=53&type=chunk)[59](index=59&type=chunk) - The 2024 Inducement Warrants are classified as liabilities due to a cash settlement feature in the event of a fundamental transaction outside the company's control[58](index=58&type=chunk) - In January 2024, Tranche A warrants from the September 2023 private placement were fully exercised, resulting in the issuance of **2,205.00 shares** of Series E-3 preferred stock and **$42.8 million** in net proceeds[70](index=70&type=chunk) - During the nine months ended September 30, 2024, **1,079,132 pre-funded warrants** were converted into common stock, and **547,177 warrants** from October 2022 were exercised, yielding approximately **$1.1 million** in net proceeds[73](index=73&type=chunk) [3. Fair Value](index=19&type=section&id=3.%20FAIR%20VALUE) This section details the fair value measurement of the company's liability-classified warrants and other financial instruments Outstanding Warrants as of September 30, 2024 | Offering | Shares Upon Exercise | Exercise Price | Expiration Date | | :-------------------------- | :------------------- | :------------- | :---------------- | | 2024 Tranche A Warrants | 6,739,918 | $2.52 | July 21, 2029 | | 2024 Tranche B Warrants | 8,214,278 | $4.00 | July 21, 2029 | | 2024 Tranche C Warrants | 4,267,152 | $5.50 | July 21, 2029 | | 2023 Tranche B Preferred Warrants | 439,560 | $4.7775 | September 8, 2028 | | 2022 Common Warrants | 4,201,044 | $1.96 | October 25, 2027 | | June 2020 Series H Common Warrants | 720,796 | $12.075 | June 5, 2025 | | October 2017 Series D Common Warrants | 31,085 | $178.00 | October 14, 2024 | | **Total** | **24,613,833** | | | - All listed warrants are liability-classified and valued using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model, falling under the Level 3 fair value hierarchy[75](index=75&type=chunk)[81](index=81&type=chunk)[83](index=83&type=chunk) Fair Value of Level 3 Liabilities | Metric | Amount | | :------------------------------------------ | :------------ | | Fair value of Level 3 liabilities as of Dec 31, 2023 | $13,131,691 | | Change in warrant fair value | $(4,566,773) | | Issuance of July 2024 Inducement Warrants | $12,000,000 | | Settlement of 2023 Tranche A Warrants to equity | $(4,800,000) | | Settlement of 2023 Tranche B Warrants to equity | $(2,610,000) | | Exercise of October 2022 Warrants | $(1,225,676) | | June 30, 2024, fair value of Level 3 liabilities | $11,929,242 | [4. Stock-Based Compensation](index=22&type=section&id=4.%20STOCK-BASED%20COMPENSATION) This section outlines the company's stock-based compensation plans, including stock options and restricted shares - The company uses stock-based compensation, primarily stock options and restricted shares, as part of its compensation philosophy, with awards becoming exercisable between one and three years and expiring after ten years[93](index=93&type=chunk)[94](index=94&type=chunk) - Stockholders approved an increase of **7,000,000 shares** for issuance under the 2021 Stock Incentive Plan, bringing the total to **9,368,900 shares**[95](index=95&type=chunk) Stock-Based Compensation Expense | Expense Category (Three Months Ended Sep 30) | 2024 | 2023 | | :------------------------------------------- | :------------ | :----------- | | Research and development | $309,933 | $89,172 | | General and administrative | $1,224,121 | $408,706 | | **Total stock-based compensation** | **$1,534,054**| **$497,878** | | Expense Category (Nine Months Ended Sep 30) | 2024 | 2023 | | :------------------------------------------- | :------------ | :----------- | | Research and development | $453,158 | $227,896 | | General and administrative | $2,334,508 | $1,097,945 | | **Total stock-based compensation** | **$2,787,666**| **$1,325,841**| [5. Income Taxes](index=24&type=section&id=5.%20INCOME%20TAXES) This section explains the company's income tax accounting, noting no provision due to losses and a full valuation allowance - The company accounts for income taxes using the liability method but did not record a provision or benefit for federal, state, or foreign income taxes due to continuous losses since inception[103](index=103&type=chunk) - A full valuation allowance has been provided against the gross deferred tax assets due to the uncertainty of utilizing net operating losses (NOLs) in the future[103](index=103&type=chunk) [6. Net Loss Per Share](index=25&type=section&id=6.%20NET%20LOSS%20PER%20SHARE) This section details the calculation of basic and diluted net loss per share for the periods ended September 30, 2024 Net Loss Per Share Calculation | Metric (Periods ended September 30, 2024) | Three Months | Nine Months | | :---------------------------------------- | :------------ | :------------ | | Net loss | $(14,664,719) | $(42,226,073) | | Dilutive effect of warrant liability | $(1,428,355) | $(7,283,786) | | Net loss allocated to common shares | $(16,093,074) | $(49,509,859) | | Weighted average common shares outstanding - basic | 39,335,924 | 34,850,441 | | Dilutive effect of warrant liability | 458,296 | 695,060 | | Weighted average common shares outstanding - diluted | 39,794,220 | 35,545,500 | | Net loss per share - diluted | $(0.40) | $(1.39) | - Basic net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted average number of common shares and pre-funded warrants outstanding[106](index=106&type=chunk) - Diluted net loss per share for the three and nine months ended September 30, 2024, was **$(0.40)** and **$(1.39)** respectively, with certain warrants being dilutive in the quarter ended September 30, 2024[106](index=106&type=chunk)[107](index=107&type=chunk) [7. Commitments and Contingencies](index=25&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) This section addresses potential legal matters and disputes, noting no anticipated material financial impact - The company may be involved in legal matters and disputes in the ordinary course of business, but it is not anticipated that the outcome will materially affect the financial statements[108](index=108&type=chunk) [8. Leases](index=26&type=section&id=8.%20LEASES) This section details the company's office lease agreement, including terms, rent obligations, and a maturity analysis - The company leases office space in Florham Park, New Jersey, under an Amended HQ Lease effective March 1, 2023, until April 30, 2029, with an option for a 60-month extension[111](index=111&type=chunk) - The aggregate rent due over the term is approximately **$893,000** after abatements, with monthly rent starting at **$11,800** and escalating by **2%** annually[112](index=112&type=chunk) Maturity Analysis of Undiscounted Lease Payments (as of Sep 30, 2024) | Period | Amount | | :------------------------- | :-------- | | Remaining period of 2024 | $36,000 | | 2025 | $146,000 | | 2026 | $150,000 | | 2027 | $153,000 | | 2028 | $155,000 | | Thereafter | $53,000 | | **Total undiscounted lease payments** | **$693,000**| | Less: Imputed interest | $(180,000)| | **Present value of lease liabilities** | **$513,000**| [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews Cellectar Biosciences' business, pipeline, and financial performance, including operating results and liquidity [Overview](index=27&type=section&id=Overview) This section introduces Cellectar Biosciences, its PDC platform, and the clinical and regulatory status of iopofosine I 131 - Cellectar Biosciences is a late-stage clinical biopharmaceutical company developing cancer treatments using its proprietary phospholipid ether drug conjugate™ (PDC™) delivery platform[117](index=117&type=chunk) - The lead therapeutic, iopofosine I 131, is a small-molecule PDC designed for targeted delivery of iodine-131 to cancer cells, with ongoing Phase 2b studies in multiple myeloma (MM) and central nervous system lymphoma (CNSL), and a Phase 1b study in pediatric high-grade glioma[118](index=118&type=chunk) - Iopofosine has received Fast Track Designation for lymphoplasmacytic lymphoma (LPL) and Waldenstrom's macroglobulinemia (WM), and Orphan Drug Designations (ODDs) for LPL/WM, MM, neuroblastoma, osteosarcoma, rhabdomyosarcoma, and Ewing's sarcoma[119](index=119&type=chunk) - The PDC platform's mechanism of action targets a unique change in tumor cell membranes, allowing accumulation in cancer cells and avoiding lysosomes, which enhances efficacy and reduces off-target effects[125](index=125&type=chunk)[126](index=126&type=chunk) [Clinical Pipeline](index=29&type=section&id=Clinical%20Pipeline) This section details the progress and results of iopofosine I 131 in various cancer studies, including pivotal and ongoing Phase 2b trials [CLOVER-WaM: Phase 2 Pivotal Study](index=29&type=section&id=CLOVER-WaM:%20Phase%202%20Pivotal%20Study%20in:%20Patients%20with%20r/r%20Waldenstrom's%20Macroglobulinemia) This section reports the successful completion of the CLOVER-WaM pivotal Phase 2b study, meeting its primary endpoint in r/r WM patients - The CLOVER-WaM pivotal Phase 2b study met its primary endpoint with a Major Response Rate (MRR) of **61%** (95% CI [44.50%, 75.80%], p < 0.0001) in relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM) patients, exceeding the **20%** statistical hurdle[129](index=129&type=chunk)[138](index=138&type=chunk) - Overall Response Rate (ORR) was **75.6%**, with **100%** disease control and a **7.3%** complete remission (CR) rate in this highly refractory WM population[129](index=129&type=chunk)[138](index=138&type=chunk) - Responses were durable, with median duration of response not reached and **76%** of patients remaining progression-free at a median follow-up of eight months[129](index=129&type=chunk)[138](index=138&type=chunk) - Iopofosine I 131 was well tolerated; common Grade 3 or greater treatment-related adverse events (TRAEs) included thrombocytopenia (**55%**), neutropenia (**37%**), and anemia (**26%**), with no treatment-related deaths[129](index=129&type=chunk)[138](index=138&type=chunk) [CLOVER-1: Phase 2 Study (B-Cell Malignancies)](index=32&type=section&id=CLOVER-1:%20Phase%202%20Study%20in%20Select%20B-Cell%20Malignancies) The CLOVER-1 Phase 2 study evaluated iopofosine in B-cell malignancies, showing promising efficacy and safety, leading to expansion cohorts [Phase 2a Study: r/r Waldenstrom's Macroglobulinemia Cohort](index=34&type=section&id=Phase%202a%20Study:%20Patients%20with%20r/r%20Waldenstrom's%20Macroglobulinemia%20Cohort) This section reports a 100% Overall Response Rate and 83.3% Major Response Rate in the r/r WM cohort of the Phase 2a study - In the r/r WM cohort, a **100%** Overall Response Rate (ORR) was observed in six patients, with an **83.3%** Major Response Rate (MRR) and one patient achieving a complete response (CR) lasting **39 months**[143](index=143&type=chunk) - Median treatment-free survival (TFS) and duration of response (DOR) have not been reached, with an average treatment TFS/TFR of **330 days**[143](index=143&type=chunk) [Phase 2a Study: r/r Multiple Myeloma Cohort](index=34&type=section&id=Phase%202a%20Study:%20Patients%20with%20r/r%20Multiple%20Myeloma%20Cohort) This section highlights a 40% ORR in triple-class refractory MM patients and an 80% ORR in quad/penta-drug refractory MM patients - A **40%** ORR was observed in triple-class refractory MM patients receiving **60 mCi** or greater total body dose (TBD)[144](index=144&type=chunk) - In a subset of five quad/penta-drug refractory MM patients, efficacy increased to an **80%** ORR and **100%** Clinical Benefit Rate (CBR)[145](index=145&type=chunk) - The most common treatment-emergent adverse events were cytopenias, consistent with prior observations, with no cardiotoxicities, neurological toxicities, or other severe non-hematologic events reported[145](index=145&type=chunk) [Phase 2a: r/r non-Hodgkin's lymphoma Cohort](index=34&type=section&id=Phase%202a:%20Patients%20with%20r/r%20non-Hodgkin's%20lymphoma%20Cohort) This section reports a 42% ORR in r/r NHL patients, including a 30% ORR in DLBCL, with hematologic toxicities as common adverse events - Patients with r/r NHL receiving **<60mCi TBD** and **>60mCi TBD** had ORRs of **42%** and **43%** respectively, with a combined rate of **42%**[146](index=146&type=chunk) - DLBCL patients demonstrated a **30%** ORR, with one patient achieving a CR lasting nearly **24 months** post-treatment[146](index=146&type=chunk) - The most common grade ≥3 adverse events at the highest dose (**75mCi TBD**) were hematologic toxicities including thrombocytopenia (**65%**), neutropenia (**41%**), leukopenia (**30%**), anemia (**24%**), and lymphopenia (**35%**)[149](index=149&type=chunk) [Phase 1 Study in Patients with r/r Multiple Myeloma](index=36&type=section&id=Phase%201%20Study%20in%20Patients%20with%20r/r%20Multiple%20Myeloma) This section presents results from a Phase 1 study in r/r MM patients, showing a 15.4% partial response rate and 100% disease control - A Phase 1 dose escalation trial in r/r MM patients showed a **15.4%** partial response rate and a **100%** disease control rate among **26 evaluable patients**[151](index=151&type=chunk) - Pooled median overall survival (mOS) data from the first four cohorts was **22.0 months**[152](index=152&type=chunk) - Common adverse events included fatigue (**26%**) and cytopenias (thrombocytopenia **90%**, anemia **65%**, neutropenia **55%**, leukopenia **61%**, lymphopenia **58%**)[154](index=154&type=chunk) [CLOVER 2: Phase 1 Study (Pediatric Patients)](index=37&type=section&id=CLOVER%202:%20Phase%201%20Study%20in%20r/r%20Pediatric%20Patients%20with%20select%20Solid%20tumors,%20Lymphomas%20and%20Malignant%20Brain%20Tumors) This section highlights the Phase 1 study in r/r pediatric patients, demonstrating iopofosine's blood-brain barrier penetration and disease control - The Phase 1 study in r/r pediatric patients demonstrated that iopofosine crosses the blood-brain barrier and is delivered into tumors, showing disease control in heavily pretreated patients with ependymomas[157](index=157&type=chunk) - Common adverse events included fatigue, headache, nausea, vomiting (**28%** each), and cytopenias (thrombocytopenia **67%**, anemia **67%**, neutropenia **61%**, leukopenia **56%**, lymphopenia **33%**)[157](index=157&type=chunk) - Iopofosine has Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma, making it eligible for a priority review voucher (PRV) upon approval[158](index=158&type=chunk) [Phase 1 Study in r/r Head and Neck Cancer](index=39&type=section&id=Phase%201%20Study%20in%20r/r%20Head%20and%20Neck%20Cancer) This section reports a Phase 1 study combining iopofosine with EBRT in r/r HNC patients, achieving a 64% complete remission rate and 73% ORR - A Phase 1 study combining iopofosine with external beam radiation treatment (EBRT) in r/r head and neck cancer (HNC) patients achieved complete remission in **64%** and an Overall Response Rate (ORR) of **73%** (n=11)[160](index=160&type=chunk) - The study demonstrated durability with overall survival of **67%** and progression-free survival of **42%** at **12 months**[160](index=160&type=chunk) - Treatment-related adverse events of grade 3 or higher included thrombocytopenia (**75%**), lymphopenia (**75%**), leukopenia (**75%**), neutropenia (**67%**), and anemia (**42%**), consistent with iopofosine's known toxicity profile[160](index=160&type=chunk) [Preclinical Pipeline](index=39&type=section&id=Preclinical%20Pipeline) This section describes the company's preclinical efforts, including an alpha-emitting radio-conjugate program and novel small molecule PDC development - The PDC platform is being leveraged for a CLR 12120 Series alpha-emitting radio-conjugate program, with a lead molecule using actinium-225 as the payload for highly refractory solid tumors[161](index=161&type=chunk) - Proprietary small molecule phospholipid drug conjugates are under development, employing novel payloads or linkers, with demonstrated efficacy and tolerability in preclinical mouse models[162](index=162&type=chunk) - Collaborations have validated the PDC platform's capability to deliver peptide and oligonucleotide (siRNA, mRNA) payloads systemically to tumors, leading to internal proprietary programs[163](index=163&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) This section analyzes operating expenses and other income/expense for the periods ended September 30, 2024, detailing R&D, G&A, and warrant valuation impacts [Three Months Ended September 30, 2024 and 2023](index=41&type=section&id=Three%20Months%20Ended%20September%2030,%202024%20and%202023) This section analyzes financial performance for the three months ended September 30, 2024, focusing on R&D and G&A expenses Research and Development Costs (Three Months Ended Sep 30) | Category | 2024 | 2023 | Variance | | :--------------------------------- | :------------ | :------------ | :------------ | | Clinical project costs | $1,510,000 | $3,412,000 | $(1,902,000) | | Manufacturing and related costs | $2,469,000 | $2,832,000 | $(363,000) | | Pre-clinical project costs | $49,000 | $206,000 | $(157,000) | | General research and development costs | $1,465,000 | $585,000 | $880,000 | | **Total R&D expense** | **$5,493,000**| **$7,035,000**| **$(1,542,000)**| - Research and development expenses decreased by approximately **$1.54 million** (**22%**) due to decreased clinical project costs from the conclusion of the WM pivotal study, partially offset by increased pediatric trial activity and personnel[168](index=168&type=chunk) - General and administrative expenses increased by approximately **$5.46 million** (**229%**) to **$7.83 million**, driven by infrastructure development for commercialization and related market preparation and personnel costs[169](index=169&type=chunk) - Other income (expense), net, improved from an **$8.11 million** expense in 2023 to a **$1.34 million** expense in 2024, primarily due to changes in warrant valuation. Interest income increased to **$318,000** from **$51,000** due to higher cash balances and interest rates[170](index=170&type=chunk) [Nine Months Ended September 30, 2024 and 2023](index=42&type=section&id=Nine%20Months%20Ended%20September%2030,%202024%20and%202023) This section analyzes financial performance for the nine months ended September 30, 2024, focusing on R&D and G&A expenses Research and Development Costs (Nine Months Ended Sep 30) | Category | 2024 | 2023 | Variance | | :--------------------------------- | :------------- | :------------- | :----------- | | Clinical project costs | $8,154,000 | $10,235,000 | $(2,081,000) | | Manufacturing and related costs | $8,410,000 | $7,007,000 | $1,403,000 | | Pre-clinical project costs | $101,000 | $422,000 | $(321,000) | | General research and development costs | $3,262,000 | $1,865,000 | $1,397,000 | | **Total R&D expense** | **$19,927,000**| **$19,529,000**| **$398,000** | - Research and development expenses increased by approximately **$398,000** (**2%**) due to increased manufacturing costs and general R&D personnel costs, largely offset by reduced clinical project costs[174](index=174&type=chunk) - General and administrative expenses increased by **$12.22 million** (**178%**) to **$19.11 million**, driven by commercialization infrastructure development and related market preparation and personnel costs[175](index=175&type=chunk) - Other income (expense), net, improved from an **$8.48 million** expense in 2023 to a **$3.19 million** expense in 2024, primarily due to warrant valuation changes. Interest income increased to **$967,000** from **$248,000**[176](index=176&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, operational cash burn, and plans to secure additional funding to address going concern uncertainties - The company incurred a net loss of approximately **$42.2 million** and used **$36.7 million** in cash for operations during the nine months ended September 30, 2024[177](index=177&type=chunk) - As of September 30, 2024, the consolidated cash balance was approximately **$34.3 million**, with available liquidity of **$28.6 million** to fund operations over the next twelve months beyond the issuance date[177](index=177&type=chunk) - Management plans to secure additional outside capital via equity/debt securities or strategic transactions and implement cost-saving measures to address liquidity concerns, as current funds may not sustain operations beyond Q2 2025[177](index=177&type=chunk)[178](index=178&type=chunk) - These uncertainties raise substantial doubt about the company's ability to continue as a going concern[179](index=179&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cellectar Biosciences is not required to provide detailed market risk disclosures - The company is a smaller reporting company and is not required to provide information on market risk[180](index=180&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) This section addresses the ineffectiveness of disclosure controls and internal control over financial reporting due to material weaknesses [Evaluation of Disclosure Controls and Procedures](index=43&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective due to material weaknesses in internal control - Management concluded that disclosure controls and procedures were not effective as of March 31, 2024, due to material weaknesses in internal control over financial reporting[181](index=181&type=chunk) - Despite the material weaknesses, management believes the consolidated financial statements fairly present the financial position, results of operations, and cash flows[182](index=182&type=chunk) [Management's Report on Internal Control over Financial Reporting](index=43&type=section&id=Management's%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) Management concluded that internal control over financial reporting was ineffective as of December 31, 2023, and through September 30, 2024 - Management concluded that internal control over financial reporting was not effective as of December 31, 2023, and continued to be ineffective through September 30, 2024, based on the COSO Framework criteria[183](index=183&type=chunk) [Material Weaknesses](index=43&type=section&id=Material%20Weaknesses) This section identifies material weaknesses across all internal control components, leading to financial statement restatements - Material weaknesses were identified in the control environment (lack of appropriate policies and resources, limited staff), risk assessment (no formal process for complex transactions), control activities (inaccurate accounting of preferred equity/warrants, stock-based compensation, fair value methodologies), information and communication (segregation of duties deficiencies, inadequate user access controls), and monitoring activities[185](index=185&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk)[192](index=192&type=chunk) - These weaknesses led to errors requiring the restatement of consolidated financial statements for fiscal years 2023 and 2022, and several interim periods[192](index=192&type=chunk) [Management's Plan to Remediate the Material Weaknesses](index=44&type=section&id=Management's%20Plan%20to%20Remediate%20the%20Material%20Weaknesses) Management initiated remediation efforts in early 2024, including hiring personnel, designing formal control processes, and implementing an ERP system - Management initiated remediation efforts in early 2024 by recruiting qualified accounting and financial reporting personnel to enhance knowledge and experience with internal control[193](index=193&type=chunk) - A formal control environment and risk assessment process is being designed and implemented, including the identification of risks and linkage to internal controls[193](index=193&type=chunk) - The company has also begun implementing an ERP system to provide a system-based control structure for financial transactions[193](index=193&type=chunk) [Changes in Internal Control over Financial Reporting](index=44&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the period, except for identified material weaknesses - Except for the identified material weaknesses, there has been no other change in internal control over financial reporting during the period ended September 30, 2024, that materially affected or is reasonably likely to materially affect it[195](index=195&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part includes disclosures on legal proceedings, risk factors, equity sales, defaults, and other information [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company does not anticipate material financial statement impact from ordinary course legal matters - The company does not anticipate that the outcome of ordinary course legal matters and disputes will materially affect its financial statements[198](index=198&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to detailed risk factors disclosed in the Annual Report on Form 10-K/A - Readers should refer to the Risk Factors section in the Annual Report on Form 10-K/A filed on October 28, 2024, for factors that could materially adversely affect the business and equity securities[199](index=199&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds to report[200](index=200&type=chunk) [Item 3. Default Upon Senior Securities](index=45&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) No defaults upon senior securities were reported for the period - No defaults upon senior securities to report[201](index=201&type=chunk) [Item 4. Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Mine Safety Disclosures are not applicable to the company[202](index=202&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No other information is reported under this item - No other information to report[203](index=203&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the 2021 Stock Incentive Plan and various certifications Exhibits Filed with Form 10-Q | Exhibit No. | Description | Filed with this Form 10-Q | | :---------- | :---------------------------------------------------------------------------------------------------------------------------------------- | :------------------------ | | 10.1 | Cellectar Biosciences, Inc. 2021 Stock Incentive Plan, as Amended | | | 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | | 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | | 32.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | | 101 | Interactive Data Files | X | | 104 | Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit). | X |

NorthStar to provide Cellectar with non-carrier-added Ac-225 for its expanded portfolio of clinical programs FLORHAM PARK, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB) a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c ...

Core Viewpoint - SpectronRx and Cellectar Biosciences have entered into a commercial supply agreement for the manufacture of iopofosine I 131, a novel cancer therapy aimed at treating advanced cancers, particularly Waldenstrom's macroglobulinemia [1][2][3] Company Overview - SpectronRx specializes in radiopharmaceutical contract development and manufacturing, with capabilities in isotope production and clinical trial support [5][6] - Cellectar Biosciences focuses on the discovery and commercialization of cancer treatments, leveraging its proprietary Phospholipid Drug Conjugate delivery platform [7][8] Partnership Details - The partnership aims to enhance Cellectar's supply network and manufacturing capabilities for iopofosine I 131, which has shown promising efficacy in clinical studies [2][3] - SpectronRx will utilize its facilities in Indiana and Belgium for the production of iopofosine I 131, facilitating global market distribution [2][3] Product Development - Iopofosine I 131 has demonstrated impressive results in the CLOVER-WaM pivotal study for patients with relapsed or refractory Waldenstrom's macroglobulinemia, with a New Drug Application submission planned soon [2][3] - The drug is also being evaluated in Phase 2 studies for relapsed or refractory multiple myeloma and central nervous system lymphoma, as well as in a Phase 1b study targeting pediatric patients with high-grade gliomas [2][3] Regulatory Status - Iopofosine I 131 is currently investigational and has received Orphan Drug and Fast Track Designations from the FDA for various cancer indications [3]

FLORHAM PARK, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that the company will report financial results for the three months ended September 30, 2024, and provide a corporate update on November 18, 2024, at 8:30 a.m. Eastern Time. Conference Call & Webcast Details:Date:Monday, November 18, 2024Time:8:30 am E ...

FLORHAM PARK, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company, announced today it received a letter dated October 31, 2024, from Nasdaq, Inc. informing the Company that it had regained compliance with Nasdaq Listing Rule 5250(c)(1). The Company filed the following on October 29, 2024, with the Securities and Exchange Commission: (i) restated audited consolidated financial statements for the fiscal years ended December 31, 20 ...

Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a median response rate (MRR) of 61% in patients with relapsed/refractory Waldenstrom's macroglobulinemia, exceeding the statistical hurdle of 20%[98] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[98] - The CLOVER-1 Phase 2 study has met its primary efficacy endpoints and is now enrolling an expansion cohort for multiple myeloma and CNS lymphoma patients[99] - The CLOVER WaM study achieved a major response rate (MRR) of 61% among patients, exceeding the statistical hurdle of 20%[104] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[104] - The study reported a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[104] - The Phase 2 CLOVER-1 study reported a 40% ORR in triple class refractory multiple myeloma patients receiving 60 mCi or greater[109] - In the r/r non-Hodgkin's lymphoma cohort, patients receiving <60mCi and >60mCi had ORRs of 42% and 43%, respectively[111] - Approximately 91% of patients in the CLOVER-1 study experienced a reduction in tumor markers, with about 73% showing a reduction greater than 37%[119] - The pooled median overall survival (mOS) data from the first four cohorts of the iopofosine study was reported at 22.0 months[117] - In the Phase 1 study of iopofosine for head and neck cancer, complete remission was achieved in 64% of patients, with an overall response rate (ORR) of 73%[123] Adverse Events - Adverse events included fatigue (39%) and various cytopenias, with thrombocytopenia occurring in 75% of patients[96] - The rates of Grade 3 or greater treatment-related adverse events included thrombocytopenia (55%), neutropenia (37%), and anemia (26%)[104] - Adverse events in the iopofosine studies included thrombocytopenia (75%), lymphopenia (75%), and neutropenia (67%) in head and neck cancer patients[123] Regulatory Designations - Iopofosine has received Fast Track Designation from the FDA for multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[90] - The FDA granted Fast Track Designation for iopofosine in WM for patients having received two or more prior treatment regimens[114] - The FDA granted Fast Track Designation for iopofosine in fourth line or later relapsed/refractory multiple myeloma in May 2019[119] Financial Performance - Research and development expenses for Q2 2024 were approximately $7,345,000, a 20% increase from $6,135,000 in Q2 2023, primarily due to increased clinical project costs[129] - General and administrative expenses for Q2 2024 were approximately $6,358,000, a 194% increase from $2,159,000 in Q2 2023, driven by infrastructure development costs for anticipated NDA approval[130] - Other income for Q2 2024 was approximately $12,784,000, compared to an expense of approximately $1,885,000 in Q2 2023, mainly due to changes in warrant valuation[131] - Research and development expense for the six months ended June 30, 2024, was approximately $14,434,000, an increase of $1,940,000 or 16% compared to $12,494,000 for the same period in 2023[133] - General and administrative expense for the six months ended June 30, 2024, was approximately $11,272,000, reflecting an increase of $6,767,000 or 150% compared to $4,505,000 in 2023[134] - The company incurred a net loss of approximately $27.6 million during the six months ended June 30, 2024, and used approximately $27.5 million in cash for operations[136] - As of June 30, 2024, the company's consolidated cash balance was approximately $25.9 million, with available liquidity limited to approximately $34.3 million of unrestricted cash and cash equivalents[136] - Clinical project costs for the six months ended June 30, 2024, were $6,644,000, an increase of $1,735,000 compared to $4,909,000 in 2023[138] - Manufacturing and related costs for the same period were $5,941,000, up by $1,766,000 from $4,175,000 in 2023[138] - Other income (expense), net, for the first six months of 2024 was an expense of approximately $1,856,000, compared to $370,000 in 2023[135] - Interest income for the year-to-date in 2024 was approximately $649,000, an increase from approximately $197,000 in 2023[135] Company Developments - The company is developing a PDC-based targeted alpha-emitter therapy (CLR121225) currently in IND enabling studies, alongside evaluating other alpha-emitting isotopes[92] - The CLOVER-2 Phase 1a study for pediatric cancers has concluded, with a Phase 1b study currently enrolling patients with high-grade gliomas[89] - The company has established three ongoing collaborations featuring four unique payloads to accelerate product candidate development[93] - The European Medicines Agency granted Small and Medium-Sized Enterprise (SME) status, allowing for significant financial incentives including a 90% to 100% fee reduction for regulatory services[91] - The company plans to secure additional outside capital via the sale of equity and/or debt securities to improve liquidity[136] - There are substantial doubts about the company's ability to continue as a going concern, necessitating potential asset sales or other measures if liquidity plans are not effectively implemented[137]

Company Overview - Cellectar Biosciences, Inc. (CLRB) announced two presentations regarding the treatment of Bing-Neel Syndrome (BNS) with iopofosine I 131 and a review of the CLOVER WaM pivotal study of iopofosine I 131, to be presented at the 12th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) on October 17, 2024, in Prague, Czech Republic [1][3] Product Information - Iopofosine I 131 is a potential first-in-class cancer-targeting agent that can cross the blood-brain barrier and has shown clinical activity in multiple hematologic malignancies, including relapsed/refractory primary CNS lymphoma [2] - The treatment of BNS, a rare and life-threatening complication of Waldenstrom's Macroglobulinemia (WM), requires agents that can penetrate the blood-brain barrier [4] Clinical Developments - At the IWWM, a case study will be presented demonstrating complete CNS clearance in a relapsed/refractory BNS patient treated with iopofosine I-131 [3] - The CLOVER WaM pivotal study, which is the first and largest WM study in a highly refractory patient population, has shown a 98% disease control rate and an 80% overall response rate with just four doses of iopofosine monotherapy [7] Strategic Partnerships - In July 2024, Cellectar Biosciences entered into a strategic partnership with City of Hope Cancer Center to focus on the clinical development of iopofosine I 131 in mycosis fungoides, a rare form of non-Hodgkin's lymphoma [8] Market Prospects - The WM treatment market is expected to grow at a CAGR of 5.2% from 2022 to 2027, driven by increasing prevalence of WM cases, drug approvals, and a rising geriatric population [5][6]

Jorge Castillo, M.D. to Present Iopofosine I 131 Activity in Bing-Neel Syndrome Andrei Shustov, M.D. to Review CLOVER WaM Pivotal Study FLORHAM PARK, N.J., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced two presentations: one regarding the treatment of a patient with Bing-Neel Syndrome (BNS), and a review of the compa ...

Cellectar Biosciences, Inc. (NASDAQ:CLRB) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET Company Participants Jim Caruso – President and Chief Executive Officer Andrei Shustov – Senior Vice President-Medical Jarrod Longcor – Chief Operating Officer Shane Lea – Chief Commercial Officer Chad Kolean – Chief Financial Officer Conference Call Participants Jonathan Aschoff – ROTH Jeff Jones – Oppenheimer Ted Tenthoff – Piper Sandler Operator Good morning, and welcome to Cellectar Biosciences Second Q ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): August 13, 2024 Cellectar Biosciences, Inc. (Exact name of Registrant as Specified in its Charter) Delaware (State or other jurisdiction of incorporation) | --- | --- | --- | |-------|-------------|-------| | | | | | | | | | | | | | | | | | | | | | | 1-36598 | | | | | | | | (Commission | | | | ...