[FORM 10-Q](index=1&type=section&id=FORM%2010-Q) [FORWARD-LOOKING STATEMENTS](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section outlines forward-looking statements, emphasizing inherent uncertainties and the Company's non-obligation to update them - Forward-looking statements are identified by terms like '**expects**,' '**anticipates**,' '**intends**,' '**estimates**,' '**plans**,' '**believes**,' '**seeks**,' '**may**,' '**should**,' '**could**,' '**would**,' or similar expressions[106](index=106&type=chunk) - These statements involve estimates, assumptions, and uncertainties that could cause actual results to differ materially from expectations[106](index=106&type=chunk) - The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made[146](index=146&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 unaudited condensed consolidated financial statements and notes, prepared under U.S. GAAP for interim reporting - The condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and instructions to Form 10-Q[6](index=6&type=chunk) - Operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results expected for the full year ending December 31, 2023[136](index=136&type=chunk) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The Balance Sheets show the Company's financial position, including a significant increase in warrant liability and a shift to stockholders' deficit Condensed Consolidated Balance Sheet Highlights | Item | Sep 30, 2023 ($) | Dec 31, 2022 ($) | | :------------------------------------- | :--------------- | :--------------- | | Cash and cash equivalents | $18,986,443 | $19,866,358 | | Total current assets | $20,109,910 | $20,529,601 | | Total assets | $21,550,765 | $21,589,790 | | Accounts payable & accrued liabilities | $7,814,590 | $5,478,443 | | Warrant liability | $8,600,000 | — | | Total current liabilities | $16,470,853 | $5,529,290 | | Total liabilities | $16,983,603 | $6,082,271 | | Total stockholders' (deficit) equity | $(13,352,838) | $15,507,519 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The Statements of Operations reveal a higher net loss due to increased R&D and substantial warrant-related expenses Condensed Consolidated Statements of Operations Highlights | Item | 3 Months Sep 30, 2023 ($) | 3 Months Sep 30, 2022 ($) | 9 Months Sep 30, 2023 ($) | 9 Months Sep 30, 2022 ($) | | :---------------------------------------------------- | :------------------------ | :------------------------ | :------------------------ | :------------------------ | | Research and development | $7,312,504 | $5,380,190 | $20,275,004 | $13,765,846 | | General and administrative | $2,100,956 | $2,435,296 | $6,137,760 | $7,625,391 | | Total costs and expenses | $9,413,460 | $7,815,486 | $26,412,764 | $21,391,237 | | Loss from operations | $(9,413,460) | $(7,815,486) | $(26,412,764) | $(21,391,237) | | Warrant issuance expense | $(470,000) | — | $(470,000) | — | | Loss on revaluation of warrants | $(3,900,000) | — | $(3,900,000) | — | | Net loss | $(13,732,350) | $(7,811,322) | $(30,534,839) | $(21,386,162) | | Basic and Diluted Net Loss per Share | $(1.21) | $(1.28) | $(2.71) | $(3.50) | | Shares Used in Computing Basic and Diluted Net Loss per Share | 11,308,738 (shares) | 6,110,119 (shares) | 11,277,231 (shares) | 6,110,123 (shares) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows show a net decrease in cash, driven by operating activities, partially offset by financing proceeds from preferred stock and warrants Condensed Consolidated Statements of Cash Flows Highlights | Item | 9 Months Sep 30, 2023 ($) | 9 Months Sep 30, 2022 ($) | | :-------------------------------------------------------------------- | :------------------------ | :------------------------ | | Net loss | $(30,534,839) | $(21,386,162) | | Cash used in operating activities | $(22,781,274) | $(17,810,538) | | Cash used in investing activities | $(597,282) | $(108,115) | | Proceeds from issuance of preferred stock and warrants, net of issuance costs | $22,150,000 | — | | Cash provided by financing activities | $22,498,641 | — | | Net decrease in cash and cash equivalents | $(879,915) | $(17,918,653) | | Cash and cash equivalents at end of period | $18,986,443 | $17,785,322 | [Consolidated Statements of Stockholders' (Deficit) Equity](index=8&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20(Deficit)%20Equity) Stockholders' Equity reflects a shift to a deficit position, primarily from accumulated losses and warrant revaluation, offset by stock-based compensation Consolidated Statements of Stockholders' (Deficit) Equity Highlights | Item | Dec 31, 2022 ($) | Sep 30, 2023 ($) | | :------------------------------------- | :--------------- | :--------------- | | Preferred Stock Amount | $1,382,023 | $1,382,023 | | Common Stock Amount | $94 | $99 | | Additional Paid-In Capital | $193,624,445 | $195,298,922 | | Accumulated Deficit | $(179,499,043) | $(210,033,882) | | Total Stockholders' (Deficit) Equity | $15,507,519 | $(13,352,838) | - The accumulated deficit increased from **$(179.5 million)** at December 31, 2022, to **$(210.0 million)** at September 30, 2023, reflecting ongoing net losses[152](index=152&type=chunk) - Stock-based compensation expense contributed **$1.33 million** to additional paid-in capital during the nine months ended September 30, 2023[152](index=152&type=chunk)[174](index=174&type=chunk) [Notes to Condensed Consolidated Financial Statements (UNAUDITED)](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(UNAUDITED)) These notes provide essential context for the financial statements, detailing accounting policies, fair value, equity, compensation, taxes, and subsequent events - The notes are an integral part of the condensed consolidated financial statements[3](index=3&type=chunk)[4](index=4&type=chunk)[129](index=129&type=chunk)[151](index=151&type=chunk) - The statements do not include all information and footnotes required by U.S. GAAP for complete financial statements[6](index=6&type=chunk) [1. NATURE OF BUSINESS AND ORGANIZATION](index=10&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20ORGANIZATION) Cellectar Biosciences, a late-stage biopharmaceutical company, faces going concern doubt due to significant accumulated losses and future funding needs - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer treatment using its proprietary phospholipid drug conjugate (PDC™) delivery platform[183](index=183&type=chunk) - The preparation of financial statements requires management to make estimates and assumptions, including for potential liabilities, warrant valuation, and deferred tax valuation allowances[7](index=7&type=chunk) - The Company has an accumulated deficit of **approximately $210.0 million** as of September 30, 2023, and expects to continue generating operating losses, raising substantial doubt about its ability to continue as a going concern without additional funding[155](index=155&type=chunk) [2. FAIR VALUE](index=13&type=section&id=2.%20FAIR%20VALUE) Financial instruments are classified by fair value input observability, with September 2023 Warrants valued at $8.6 million as Level 3 - Financial instruments are grouped into three levels based on the reliability of assumptions used to determine fair value: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[191](index=191&type=chunk)[192](index=192&type=chunk) - The September 2023 Warrants, valued at **$8.6 million**, are classified within the Level 3 hierarchy due to the nature of their inputs and the valuation technique (PWERM with Monte Carlo simulation and Black-Scholes model)[13](index=13&type=chunk)[195](index=195&type=chunk) Changes in Fair Market Value of Level 3 Warrants (Sep 8 - Sep 30, 2023) | Item | Amount ($) | | :------------------------------------ | :------------ | | Beginning fair value of warrants | $4,700,000 | | Loss from change in fair value | $3,900,000 | | September 30, 2023 fair value of warrants | $8,600,000 | [3. STOCKHOLDERS' EQUITY](index=15&type=section&id=3.%20STOCKHOLDERS'%20EQUITY) This section details equity transactions, including the September 2023 Private Placement of Series E-1 preferred stock and warrants, and the 2022 Reverse Stock Split - In September 2023, the Company issued 1,225 shares of Series E-1 preferred stock and Tranche A and B warrants in a private placement, generating gross proceeds of **$24.5 million** and net proceeds of **approximately $22.1 million**[165](index=165&type=chunk) - The Series E-1 preferred stock is classified as mezzanine equity due to a redemption feature, which will cease upon stockholder approval of the transaction[167](index=167&type=chunk) Outstanding Warrants as of September 30, 2023 | Offering / Warrant Type | Outstanding Warrants (shares) | Exercise Price ($) | Expiration Date | | :-------------------------------- | :---------------------------- | :----------------- | :------------------------ | | 2023 Tranche A Preferred Warrants | 13,846,154 | $3.185 | September 8, 2026 | | 2023 Tranche B Preferred Warrants | 7,179,487 | $4.7775 | September 8, 2028 | | 2022 Common Warrants | 4,973,221 | $1.96 | October 25, 2027 | | 2022 Pre-Funded Warrants | 1,520,710 | $0.00001 | N/A | | June 2020 Series H Warrants | 720,796 | $12.075 | June 5, 2025 | | May 2019 Series F Warrants | 195,700 | $24.00 | May 20, 2024 | | May 2019 Series G Warrants | 201,800 | $24.00 | May 20, 2024 | | October 2017 Series D Warrants | 31,085 | $178.00 | October 14, 2024 | | Total | 28,668,953 | | | [4. STOCK-BASED COMPENSATION](index=19&type=section&id=4.%20STOCK-BASED%20COMPENSATION) Stock-based compensation expense for the nine months ended September 30, 2023, totaled $1.33 million, with 1.54 million options granted - The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards, recognizing compensation expense on a straight-line basis over the service period (1 to 3 years)[186](index=186&type=chunk) Stock-Based Compensation Expense | Category | 3 Months Sep 30, 2023 ($) | 3 Months Sep 30, 2022 ($) | 9 Months Sep 30, 2023 ($) | 9 Months Sep 30, 2022 ($) | | :--------------------------- | :------------------------ | :------------------------ | :------------------------ | :------------------------ | | Research and development | $89,172 | $37,211 | $227,896 | $123,638 | | General and administrative | $408,706 | $330,548 | $1,097,945 | $967,879 | | Total stock-based compensation | $497,878 | $367,759 | $1,325,841 | $1,091,517 | - During the nine months ended September 30, 2023, **1.54 million stock options** were granted, compared to **340,250 options** in the same period of 2022[232](index=232&type=chunk) [5. INCOME TAXES](index=20&type=section&id=5.%20INCOME%20TAXES) Due to a history of losses, a full valuation allowance is applied against deferred tax assets, resulting in no income tax provision or benefit - Income taxes are accounted for using the liability method, with deferred tax assets and liabilities based on temporary differences and net operating loss (NOL) carryforwards[9](index=9&type=chunk)[42](index=42&type=chunk) - Management has provided a full valuation allowance against the Company's gross deferred tax asset due to limited operating history, continuing losses, and uncertainty regarding future NOL utilization[9](index=9&type=chunk)[42](index=42&type=chunk) - No provision or benefit for federal, state, or foreign income taxes was recorded for the three or nine months ended September 30, 2023 or 2022, as the Company has experienced tax losses since inception[42](index=42&type=chunk) [6. NET LOSS PER SHARE](index=20&type=section&id=6.%20NET%20LOSS%20PER%20SHARE) Basic and diluted net loss per share are identical due to the antidilutive effect of common stock equivalents during periods of net loss - Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of common stock and pre-funded warrants outstanding[25](index=25&type=chunk) - Diluted net loss per share is the same as basic net loss per share for all periods presented because the inclusion of common stock equivalents (stock options, warrants, convertible preferred shares) would be antidilutive due to the net loss[25](index=25&type=chunk) Potentially Dilutive Securities Excluded from Diluted EPS Calculation | Item | Nine Months Sep 30, 2023 (shares) | Nine Months Sep 30, 2022 (shares) | | :---------------------------------------------- | :-------------------------------- | :-------------------------------- | | Warrants | 27,148,243 | 1,563,381 | | Preferred shares as convertible into common stock | 111,111 | 111,111 | | Stock options | 2,280,756 | 654,263 | | Total potentially dilutive shares | 29,540,110 | 2,328,755 | [7. COMMITMENTS AND CONTINGENCIES](index=22&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) The Company is involved in ordinary course legal matters but does not expect them to materially affect financial statements - The Company may be involved in legal matters and disputes in the ordinary course of business[235](index=235&type=chunk) - Management does not anticipate that the outcome of such matters and disputes will materially affect the Company's financial statements[235](index=235&type=chunk) [8. LEASES](index=22&type=section&id=8.%20LEASES) The Company accounts for material leases under FASB ASC Topic 842, including an Amended HQ Lease extending until April 2029 - The Company accounts for all material leases in accordance with FASB ASC Topic 842, Leases[138](index=138&type=chunk) - An Amended HQ Lease for office space in Florham Park, New Jersey, commenced on March 1, 2023, and extends until April 30, 2029, with an option for a 60-month extension[207](index=207&type=chunk) Maturity Analysis of Undiscounted Lease Payments (as of Sep 30, 2023) | Year | Amount ($) | | :--------- | :---------- | | 2023 | $35,000 | | 2024 | $132,000 | | 2025 | $147,000 | | 2026 | $150,000 | | 2027 | $153,000 | | Thereafter | $207,000 | | Total undiscounted lease payments | $824,000 | | Less: Imputed interest | $(255,000) | | Present value of lease liabilities | $569,000 | [9. SUBSEQUENT EVENT](index=23&type=section&id=9.%20SUBSEQUENT%20EVENT) Stockholders approved proposals post-period, including potential common stock issuance and an increase in authorized common stock - On October 25, 2023, stockholders approved the potential issuance of common stock in excess of 19.99% of currently outstanding common stock upon conversion of Series E preferred stock at less than the 'minimum price' under Nasdaq Listing Rule 5635(d)[210](index=210&type=chunk) - Stockholders also approved an increase in the Company's authorized common stock from 160,000,000 to 170,000,000 shares[210](index=210&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) Management discusses the Company's financial condition, operations, clinical pipeline, liquidity, and capital resources, highlighting ongoing losses and funding needs - The discussion should be read in conjunction with the unaudited financial information and notes in this Quarterly Report on Form 10-Q[241](index=241&type=chunk) - Forward-looking statements in this section involve risks and uncertainties, and actual results could differ materially from expectations[241](index=241&type=chunk) [Overview](index=24&type=section&id=Overview) Cellectar Biosciences, a late-stage biopharmaceutical company, develops targeted cancer treatments using its PDC™ platform, with iopofosine I 131 in pivotal studies - The Company is a late-stage clinical biopharmaceutical company focused on discovering, developing, and commercializing drugs for cancer treatment using its proprietary phospholipid ether drug conjugate (PDC™) delivery platform[28](index=28&type=chunk) - Iopofosine I 131, the lead PDC therapeutic, is being evaluated in the CLOVER-WaM Phase 2 pivotal study (r/r WM), a Phase 2b study (r/r MM and CNSL), and the CLOVER-2 Phase 1a/1b studies (pediatric cancers)[50](index=50&type=chunk)[217](index=217&type=chunk) - Iopofosine has received Fast Track Designation for LPL/WM, r/r MM, and r/r DLBCL, and Orphan Drug Designations (ODDs) for LPL/WM, MM, neuroblastoma, soft tissue sarcomas, and Rare Pediatric Disease Designation (RPDD) for several pediatric cancers[243](index=243&type=chunk) [Clinical Pipeline](index=25&type=section&id=Clinical%20Pipeline) The clinical pipeline focuses on iopofosine I 131 in multiple trials for B-cell malignancies and pediatric cancers, supported by regulatory designations - The PDC platform is designed for selective delivery of oncologic payloads to cancer cells, leveraging a metabolic pathway utilized by nearly all tumor cell types, which allows accumulation in tumor cells and avoids lysosomal degradation[245](index=245&type=chunk) - Common adverse events across all iopofosine studies have been largely restricted to fatigue and cytopenias (thrombocytopenia, anemia, neutropenia, leukopenia, lymphopenia)[217](index=217&type=chunk)[222](index=222&type=chunk) [CLOVER-WaM: Phase 2 Pivotal Study in: Patients with r/r Waldenstrom's Macroglobulinemia](index=26&type=section&id=CLOVER-WaM%3A%20Phase%202%20Pivotal%20Study%20in%3A%20Patients%20with%20r%2Fr%20Waldenstrom's%20Macroglobulinemia) The CLOVER-WaM study is a pivotal Phase 2 trial for r/r WM patients, targeting a major response rate, with top-line data expected in January 2024 - The CLOVER-WaM study is a single-arm, pivotal study in WM patients who have received and relapsed or were refractory to two prior lines of therapy, including BTKi therapy[34](index=34&type=chunk) - The study expects to enroll at least **50 WM patients**, with a primary endpoint of major response rate (MRR)[35](index=35&type=chunk) - An independent data monitoring committee (IDMC) performed an interim safety and futility evaluation in 2022, determining the study exceeded the futility threshold and should continue enrollment with no change to the dosing regimen; top-line data are expected in **January 2024**[35](index=35&type=chunk) [CLOVER-1: Phase 2 Study in Select B-Cell Malignancies](index=27&type=section&id=CLOVER-1%3A%20Phase%202%20Study%20in%20Select%20B-Cell%20Malignancies) CLOVER-1 showed promising response rates for iopofosine in WM, MM, and NHL patients, expanding to highly refractory MM and CNSL - The Phase 2a CLOVER-1 study showed a **100% Overall Response Rate (ORR)** in **6 WM patients** and an **83.3% major response rate**, with one patient achieving a complete response (CR) lasting nearly **27 months**[37](index=37&type=chunk) - In r/r MM patients, initial results showed an **ORR of 45.5%** and a Clinical Benefit Rate (CBR) of **72.7%**, with efficacy increasing to **80% ORR** and **100% CBR** in a subset of **5 quad/penta drug refractory patients**[61](index=61&type=chunk) - In r/r NHL patients, a combined **ORR of 42%** was observed, with DLBCL patients demonstrating a **30% ORR** and one patient achieving a CR lasting nearly **24 months**[225](index=225&type=chunk) [Phase 1 Study in Patients with r/r Multiple Myeloma](index=29&type=section&id=Phase%201%20Study%20in%20Patients%20with%20r%2Fr%20Multiple%20Myeloma) A Phase 1 study in r/r MM patients demonstrated a 15.4% partial response rate and 100% disease control, with manageable cytopenias - A Phase 1 dose escalation study in r/r MM patients showed a partial response in **4 out of 26 evaluable patients (15.4%)** and stable disease or minimal response in **22 out of 26 patients (84.6%)**, resulting in a **100% disease control rate**[64](index=64&type=chunk) - Pooled mOS data from the first four cohorts of the Phase 1 study was **22.0 months**[38](index=38&type=chunk) - The most frequently reported adverse events were cytopenias (thrombocytopenia, anemia, neutropenia, leukopenia, lymphopenia), which followed a predictable course and were treatable[63](index=63&type=chunk)[65](index=65&type=chunk) [CLOVER 2: Phase 1 Study in r/r Pediatric Patients with select Solid tumors, Lymphomas and Malignant Brain Tumors](index=30&type=section&id=CLOVER%202%3A%20Phase%201%20Study%20in%20r%2Fr%20Pediatric%20Patients%20with%20select%20Solid%20tumors%2C%20Lymphomas%20and%20Malignant%20Brain%20Tumors) CLOVER-2 Phase 1a determined iopofosine's MTD in pediatric cancers, confirmed blood-brain barrier crossing, and initiated a pHGGs study with NCI support - The CLOVER-2 Phase 1a pediatric study determined the maximum tolerated dose (MTD) of iopofosine to be **greater than 60mCi/m2** administered as a fractionated dose in children and adolescents with r/r cancers[55](index=55&type=chunk) - Clinical data confirmed iopofosine crosses the blood-brain barrier and is delivered into pediatric brain tumors, showing disease control in heavily pretreated patients with ependymomas and relapsed HGGs[83](index=83&type=chunk) - A Phase 1b dose-finding study in pediatric high-grade gliomas (pHGGs) was initiated in Q3 2023, supported by a **$1.9 million NCI SBIR Phase 2 grant**[83](index=83&type=chunk) [Phase 1 Study in r/r Head and Neck Cancer](index=32&type=section&id=Phase%201%20Study%20in%20r%2Fr%20Head%20and%20Neck%20Cancer) A Phase 1 study combining iopofosine with EBRT for r/r HNC has fully enrolled Part B, showing preliminary safety and tolerability - A Phase 1 clinical study combining iopofosine and external beam radiation treatment (EBRT) for recurrent Head and Neck Cancer (HNC) was initiated in Q4 2019 in collaboration with UWCCC[68](index=68&type=chunk) - Preliminary data from Part A suggest safety and tolerability of iopofosine in combination with EBRT in r/r HNC[68](index=68&type=chunk) - Part B of the study, assessing safety and potential benefits in up to **24 patients**, has fully enrolled, with common adverse events being fatigue and cytopenias[68](index=68&type=chunk) [Preclinical Pipeline & Collaborations](index=25&type=section&id=Preclinical%20Pipeline%20%26%20Collaborations) The preclinical pipeline includes CLR 1900 Series for solid tumors and CLR 12120 Series alpha-emitters, supported by strategic collaborations - The CLR 1900 Series is an internally developed proprietary PDC program leveraging a novel small molecule cytotoxic compound as the payload, targeting select solid tumors by inhibiting mitosis[85](index=85&type=chunk)[215](index=215&type=chunk) - The CLR 12120 Series is an alpha-emitting radio-conjugate program, with a collaboration with Orano Med successfully demonstrating significant tumor volume reduction in animal models, and Cellectar now focusing on actinium and astatine[69](index=69&type=chunk)[215](index=215&type=chunk) - Collaborations include co-development with LegoChemBio for their linker-toxin platform and a successful collaboration with IntoCell Inc. for selecting highly potent cytotoxic small molecule payloads[70](index=70&type=chunk)[86](index=86&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) The Company saw increased R&D expenses due to manufacturing and personnel, while G&A expenses decreased primarily from reduced professional fees [Research and Development Expense](index=34&type=section&id=Research%20and%20Development%20Expense) R&D expense increased by $1.9 million for three months and $6.5 million for nine months, driven by manufacturing, clinical, and general R&D costs Research and Development Costs (Three Months Ended Sep 30) | Category | 2023 ($) | 2022 ($) | Variance ($) | | :----------------------------------- | :------------ | :------------ | :------------ | | Clinical project costs | $3,412,000 | $3,720,000 | $(308,000) | | Manufacturing and related costs | $2,832,000 | $1,049,000 | $1,783,000 | | Pre-clinical project costs | $206,000 | $89,000 | $117,000 | | General research and development costs | $863,000 | $522,000 | $341,000 | | Total | $7,313,000 | $5,380,000 | $1,933,000 | Research and Development Costs (Nine Months Ended Sep 30) | Category | 2023 ($) | 2022 ($) | Variance ($) | | :----------------------------------- | :------------ | :------------ | :------------ | | Clinical project costs | $10,235,000 | $9,715,000 | $520,000 | | Manufacturing and related costs | $7,007,000 | $3,011,000 | $3,996,000 | | Pre-clinical project costs | $422,000 | $191,000 | $231,000 | | General research and development costs | $2,611,000 | $849,000 | $1,762,000 | | Total | $20,275,000 | $13,766,000 | $6,509,000 | - The increase in R&D expense for the nine months was primarily due to increased manufacturing and related costs (**$4.0 million**), increased clinical project costs (**$0.5 million**) driven by pivotal trial timing, and higher general R&D costs (**$1.8 million**) due to personnel and professional fees[73](index=73&type=chunk) [General and Administrative Expense](index=34&type=section&id=General%20and%20Administrative%20Expense) G&A expense decreased by $334,000 for three months and $1.49 million for nine months, mainly due to lower professional fees - General and administrative expense for the three months ended September 30, 2023, was approximately **$2,101,000**, a decrease of **$334,000 (14%)** from $2,435,000 in 2022[91](index=91&type=chunk) - General and administrative expense for the nine months ended September 30, 2023, was approximately **$6,138,000**, a decrease of **$1.49 million (20%)** from $7,625,000 in 2022[95](index=95&type=chunk) - The decrease in G&A expense was primarily driven by a decrease in professional fees, offset by a slight increase in personnel costs[91](index=91&type=chunk)[95](index=95&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The Company incurred a $30.5 million net loss and used $23 million cash in operations, raising substantial doubt about its going concern ability beyond Q2 2024 - During the nine months ended September 30, 2023, the Company generated a net loss of **approximately $30.5 million** and used **approximately $23 million** in cash for operations[96](index=96&type=chunk) - As of September 30, 2023, the consolidated cash balance was **approximately $19 million**, which is believed to be adequate to fund basic budgeted operations into the **second quarter of 2024**[96](index=96&type=chunk) - The Company's ability to execute its operating plan beyond Q2 2024 depends on obtaining additional funding via equity/debt sales or strategic transactions, raising substantial doubt about its ability to continue as a going concern[96](index=96&type=chunk) [Change in Significant Accounting Policies](index=36&type=section&id=Change%20in%20Significant%20Accounting%20Policies) No material changes to accounting policies occurred, except for new policies related to warrants and preferred stock - No material changes to significant accounting policies occurred during the nine months ended September 30, 2023, except for the addition of accounting policies for warrants and preferred stock[97](index=97&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to a material weakness in fair value methodologies for Level 3 instruments [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Disclosure controls were ineffective as of September 30, 2023, due to a material weakness in fair value methodologies for Level 3 instruments - As of September 30, 2023, the Company's disclosure controls and procedures were not effective to ensure timely recording, processing, summarizing, and reporting of required information[76](index=76&type=chunk) - The ineffectiveness is due to a material weakness in internal control over financial reporting related to the proper fair value methodologies and assumptions used to value Level 3 instruments[107](index=107&type=chunk) [Changes in internal control over financial reporting](index=38&type=section&id=Changes%20in%20internal%20control%20over%20financial%20reporting) No significant changes occurred in internal control over financial reporting, apart from the identified material weakness and ongoing remediation efforts - No significant changes in internal control over financial reporting occurred during the quarter ended September 30, 2023, other than the material weakness and related remediation measures[109](index=109&type=chunk) - Management, with Audit Committee oversight, is developing and implementing remediation plans for the identified material weakness[107](index=107&type=chunk) [Important Considerations](index=38&type=section&id=Important%20Considerations) Control systems offer reasonable, not absolute, assurance, subject to inherent limitations like cost, judgment, human error, and fraud - Any system of controls can provide only reasonable, not absolute, assurance that objectives are met[111](index=111&type=chunk) - The effectiveness of disclosure controls is subject to inherent limitations, including cost, judgments, assumptions about future events, human error, and the risk of fraud[111](index=111&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The Company resolved a lawsuit against former director and employee regarding intellectual property diversion, securing an irrevocable license to the disputed patents - The Company filed a lawsuit in October 2021 against former director Dr. Jamey Weichert and former employee Dr. Anatoly Pinchuk for diverting intellectual property[114](index=114&type=chunk) - The lawsuit was resolved in November 2022, with all claims voluntarily dismissed[114](index=114&type=chunk) - The Company secured an irrevocable, non-exclusive license to the patents at issue in the lawsuit[114](index=114&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section directs readers to the comprehensive Risk Factors in the Annual Report on Form 10-K for detailed business and equity security risks - Other factors that could materially adversely affect the business and equity securities are described in the Risk Factors previously disclosed in the Annual Report on Form 10-K filed on March 9, 2023[115](index=115&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds are reported for the period - No information is provided under this item[116](index=116&type=chunk) [Item 3. Default Upon Senior Securities](index=39&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - No defaults upon senior securities are reported[45](index=45&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - This item is not applicable[46](index=46&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No other information is disclosed under this item - No other information is provided under this item[47](index=47&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certificates, warrants, agreements, and CEO/CFO certifications List of Exhibits | Exhibit No. | Description | Filed with this Form 10-Q | | :---------- | :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :------------------------ | | 3.1 | Certificate of Elimination of the Series A Convertible Preferred Stock, the Series B Convertible Preferred Stock and the Series C Convertible Preferred Stock | | | 3.2 | Amendment No. 1 to Certificate of Designation of the Series D Preferred Stock | | | 3.3 | Certificate of Designation of Preferences, Rights and Limitations of the Series E Convertible Voting Preferred Stock | | | 3.4 | Certificate of Amendment of Second Amended and Restated Certificate of Incorporation of Cellectar Biosciences, Inc. | | | 4.3 | Form of Tranche A Warrant | | | 4.4 | Form of Tranche B Warrant | | | 10.1 | Form of Securities Purchase Agreement, dated September 5, 2023, by and among the Company and the purchasers named therein | | | 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 | 30 Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit). | X | [SIGNATURES](index=41&type=section&id=SIGNATURES) This section contains the official signatures, certifying the due authorization and submission of the report - The report is signed by James V. Caruso, President and Chief Executive Officer, on November 13, 2023[104](index=104&type=chunk)

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2023 were $7.3 million, an increase from $5.4 million in the same period last year, reflecting accelerated enrollment in pivotal trials and new study initiatives [10] - Cash and cash equivalents for Q3 2023 stood at $19.0 million, bolstered by net proceeds from a PIPE transaction, with total gross proceeds expected to reach $102.9 million based on milestone achievements [11][34] - General and administrative expenses for Q3 2023 were $2.1 million, slightly reduced from the previous year, with modest increases in personnel offset by lower professional services expenditures [36] Business Line Data and Key Metrics Changes - The company is focused on the FDA approval and commercial launch of Iopofosine for Waldenstrom macroglobulinemia (WM), with plans to submit an NDA in March or Q2 2024 and a potential launch in Q4 2024 [8][26] - Iopofosine is positioned to address significant unmet needs in the WM market, with a target addressable population of approximately 4,300 patients in the third line or greater treatment setting [39] Market Data and Key Metrics Changes - The U.S. prevalence of WM is estimated at 26,000 patients, with about 80% currently receiving active therapy, indicating a substantial market opportunity for new treatment options [13] - Market research indicates that half of third-line patients not currently receiving therapy would consider new treatment options, highlighting the demand for innovative therapies [14] Company Strategy and Development Direction - The company aims to build smart data and commercial capabilities, advance Iopofosine's positioning, optimize the radiotherapy buy process, and ensure effective payer access and reimbursement [15][41] - A strategic collaboration with Florida Cancer Specialists has been established to enhance patient care and define the U.S. WM treatment landscape [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential of Iopofosine to improve treatment outcomes for WM patients, emphasizing the drug's novel mechanism of action and fixed dosing schedule [41][47] - The company anticipates that Iopofosine will represent a paradigm shift for relapsed/refractory patients requiring treatment for WM, with a focus on achieving complete responses and meaningful progression-free survival [17][24] Other Important Information - The company has secured PRIME designation in Europe for Iopofosine, which is expected to expedite marketing authorization [4] - The company is committed to supporting WM patients and is moving forward with urgency in its strategic plans [41] Q&A Session Summary Question: What extent of commercial infrastructure will be needed? - The company plans to utilize smart data sets for targeting and resource allocation, aiming for a lower operational expense compared to traditional oncology launches [27][52] Question: What clinical data is needed for multiple myeloma inclusion in NCCN compendia? - Management indicated ongoing discussions with the FDA to ensure alignment on the approval process and potential future studies [29][79] Question: What are the plans for ex-U.S. commercial efforts? - The company is considering partnerships for ex-U.S. commercialization, particularly in Europe, based on initial patient data and ongoing discussions [70] Question: How will top line data be presented? - The company plans to disclose top line data related to primary and major secondary objectives, including major response rates and overall survival [96][100] Question: What is the expected safety profile of Iopofosine? - Management highlighted a cleaner safety profile compared to BTK inhibitors, with predictable and manageable adverse events expected [103]

2022 Reverse Stock Split Equity Distribution Agreement Common Stock Warrants The Company maintains the 2021 Stock Incentive Plan (the "2021 Plan"). All outstanding awards under the 2015 Stock Incentive Plan (the "2015 Plan") remained in effect according to the terms of the 2015 Plan. Any shares that are currently available under the 2015 Plan and any shares underlying 2015 Plan awards which are forfeited, cancelled, reacquired by the Company or otherwise terminated are added to the number of shares availabl ...

[FORM 10-Q Details](index=1&type=section&id=FORM%2010-Q) This report details the company's Q1 2023 financial status as a non-accelerated, smaller reporting company - Filing Type: Quarterly Report on Form 10-Q for the period ended March 31, 2023[4](index=4&type=chunk) - Shares outstanding as of May 2, 2023: **9,740,507 shares** of common stock[7](index=7&type=chunk) Registrant Status | Status | Value | | :--- | :--- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | [Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section outlines the report's forward-looking statements and cautions readers about inherent risks and uncertainties - Forward-looking statements cover business strategy, product development, clinical testing, operating results, funding, and impacts of COVID-19 and regulatory changes[11](index=11&type=chunk) - Readers are cautioned that actual future results may differ materially due to estimates, assumptions, and uncertainties, and should not place undue reliance on forward-looking statements[13](index=13&type=chunk)[14](index=14&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's analysis for Q1 2023 [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the period ended March 31, 2023 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a decrease in total assets and an increase in total liabilities as of March 31, 2023 Condensed Consolidated Balance Sheets (Unaudited) | ASSETS | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,682,691 | $19,866,358 | | Prepaid expenses and other current assets | $1,163,745 | $663,243 | | Total current assets | $13,846,436 | $20,529,601 | | Fixed assets, net | $376,084 | $418,641 | | Right-of-use asset, net | $546,505 | $560,334 | | Long-term assets | $63,217 | $75,000 | | Other assets | $6,214 | $6,214 | | TOTAL ASSETS | $14,838,456 | $21,589,790 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable and accrued liabilities | $6,904,545 | $5,478,443 | | Lease liability (current) | $51,106 | $50,847 | | Total current liabilities | $6,955,651 | $5,529,290 | | Long-term lease liability, net of current portion | $548,344 | $552,981 | | TOTAL LIABILITIES | $7,503,995 | $6,082,271 | | Preferred stock | $1,382,023 | $1,382,023 | | Common stock | $97 | $94 | | Additional paid-in capital | $194,032,651 | $193,624,445 | | Accumulated deficit | $(188,080,310) | $(179,499,043) | | Total stockholders' equity | $7,334,461 | $15,507,519 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $14,838,456 | $21,589,790 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations detail a higher net loss for Q1 2023 compared to the prior-year period Condensed Consolidated Statements of Operations (Unaudited) | COSTS AND EXPENSES | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $6,654,094 | $3,887,039 | | General and administrative | $2,051,207 | $2,253,188 | | Total costs and expenses | $8,705,301 | $6,140,227 | | LOSS FROM OPERATIONS | $(8,705,301) | $(6,140,227) | | Interest income, net | $124,034 | $430 | | NET LOSS | $(8,581,267) | $(6,139,797) | | BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $(0.76) | $(1.00) | | SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS | 11,261,217 | 6,110,125 | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) This statement shows changes in stockholders' equity, reflecting the net loss and stock-based compensation for Q1 2023 Consolidated Statements of Stockholders' Equity (Unaudited) | | Preferred Shares | Preferred Stock Amount | Common Shares | Common Stock Par Amount | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | BALANCE AT DECEMBER 31, 2022 | 111 | $1,382,023 | 9,385,272 | $94 | $193,624,445 | $(179,499,043) | $15,507,519 | | Stock-based compensation | — | — | — | — | $408,206 | — | $408,206 | | Conversion of pre-funded warrants into common shares | — | — | 355,235 | $3 | — | — | $3 | | Net loss | — | — | — | — | — | $(8,581,267) | $(8,581,267) | | BALANCE AT MARCH 31, 2023 | 111 | $1,382,023 | 9,740,507 | $97 | $194,032,651 | $(188,080,310) | $7,334,461 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statements indicate a net decrease in cash primarily driven by cash used in operating activities Condensed Consolidated Statements of Cash Flows (Unaudited) | CASH FLOWS FROM OPERATING ACTIVITIES | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net loss | $(8,581,267) | $(6,139,797) | | Cash used in operating activities | $(7,183,670) | $(5,039,783) | | CASH FLOWS FROM INVESTING ACTIVITIES | | | | Purchases of fixed assets | — | $(30,070) | | Cash used in investing activities | — | $(30,070) | | CASH FLOWS FROM FINANCING ACTIVITIES | | | | Proceeds from exercise of pre-funded warrants | $3 | — | | Cash provided by financing activities | $3 | — | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(7,183,667) | $(5,069,853) | | CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | $19,866,358 | $35,703,975 | | CASH AND CASH EQUIVALENTS AT END OF PERIOD | $12,682,691 | $30,634,122 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides detailed disclosures supporting the financial statements, including policies and going concern uncertainty [Nature of Business and Organization](index=9&type=section&id=Nature%20of%20Business%20and%20Organization) The company is a late-stage clinical biopharmaceutical firm focused on cancer treatment via its proprietary PDC™ platform - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer treatment using its proprietary phospholipid drug conjugate (PDC™) delivery platform[36](index=36&type=chunk) - The company has incurred significant losses since inception, with an **accumulated deficit of approximately $188.08 million** as of March 31, 2023, and expects continued operating losses[30](index=30&type=chunk) - The company's cash balance of **$12.68 million** as of March 31, 2023, is expected to fund operations into Q4 2023, but additional funding is required, raising **substantial doubt about its ability to continue as a going concern**[30](index=30&type=chunk) [Summary of Significant Accounting Policies](index=9&type=section&id=Summary%20of%20Significant%20Accounting%20Policies) This section details the accounting principles applied in preparing the financial statements [Principles of Consolidation](index=9&type=section&id=Principles%20of%20Consolidation) Financial statements include the company and its wholly-owned subsidiary, with intercompany transactions eliminated - Consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, with all significant intercompany accounts and transactions eliminated[39](index=39&type=chunk) [Fixed Assets](index=9&type=section&id=Fixed%20Assets) Property and equipment are stated at cost and depreciated using the straight-line method over their useful lives - Property and equipment are stated at cost and depreciated using the straight-line method over estimated useful lives (3 to 10 years)[40](index=40&type=chunk) - No long-lived fixed asset impairment charges were recorded during the three months ended March 31, 2023[40](index=40&type=chunk) [Right-of-Use (ROU) Asset and Lease Liabilities](index=9&type=section&id=Right-of-Use%20(ROU)%20Asset%20and%20Lease%20Liabilities) The company accounts for all material leases in accordance with FASB ASC Topic 842 - The Company accounts for all material leases in accordance with FASB ASC Topic 842, Leases, with ROU Assets amortized over their estimated useful life (full lease term)[41](index=41&type=chunk) [Stock-Based Compensation](index=9&type=section&id=Stock-Based%20Compensation) The Black-Scholes model is used to value stock option awards, with expense recognized over the service period - The Black-Scholes option-pricing model is used to calculate grant-date fair value of stock option awards, with compensation expense recognized on a straight-line basis over the service period (1 to 3 years)[42](index=42&type=chunk) [Research and Development](index=11&type=section&id=Research%20and%20Development) R&D costs are expensed as incurred, with government grants recognized as a reduction of related expenses - Research and development costs are expensed as incurred[44](index=44&type=chunk) - During Q1 2023, the Company received approximately **$406,000 in NCI grants**, reported as a reduction of R&D expenses[48](index=48&type=chunk) [Income Taxes](index=11&type=section&id=Income%20Taxes) A full valuation allowance is provided against deferred tax assets due to historical losses and uncertainty of use - Income taxes are accounted for using the liability method[45](index=45&type=chunk) - No uncertain tax positions require accrual or disclosure as of March 31, 2023, and December 31, 2022[45](index=45&type=chunk) [Fair Value of Financial Instruments & Credit Risk](index=11&type=section&id=Fair%20Value%20of%20Financial%20Instruments%20%26%20Credit%20Risk) The carrying amounts of short-term financial instruments approximate their fair value - The carrying amounts of cash equivalents, prepaid expenses, other current assets, and accounts payable approximate their fair value due to their short-term nature[46](index=46&type=chunk) - Uninsured cash balances totaled approximately **$12.2 million** as of March 31, 2023, and **$19.4 million** as of December 31, 2022[46](index=46&type=chunk) [Recently Adopted Accounting Pronouncements & Government Grants](index=11&type=section&id=Recently%20Adopted%20Accounting%20Pronouncements%20%26%20Government%20Grants) The company adopted ASU 2021-10 for government assistance disclosure and received additional NCI grant funding - Adopted ASU 2021-10 (Government Assistance) for fiscal year 2022, requiring disclosure of government assistance[47](index=47&type=chunk) - Awarded **$1.98 million** in additional NCI grant funding in September 2022 to expand the Phase 1 study of iopofosine I 131 in pediatric high-grade gliomas[47](index=47&type=chunk) [Fair Value](index=11&type=section&id=Fair%20Value) Financial instruments are categorized into three levels based on the observability of valuation inputs - Financial assets and liabilities are grouped into three levels based on market observability of inputs (Level 1: active market quotes, Level 2: similar assets/liabilities in active markets, Level 3: unobservable inputs)[49](index=49&type=chunk)[51](index=51&type=chunk) - The carrying value of cash and cash equivalents and other current financial assets and liabilities approximates fair value due to short maturities or short-term nature[52](index=52&type=chunk) [Stockholders' Equity](index=13&type=section&id=Stockholders'%20Equity) This section details changes in stockholders' equity, including offerings, a reverse stock split, and outstanding warrants [October 2022 Public Offering and Private Placement](index=13&type=section&id=October%202022%20Public%20Offering%20and%20Private%20Placement) An October 2022 offering generated approximately $9.6 million in net proceeds - Completed a registered direct offering and concurrent private placement in October 2022, generating approximately **$10.7 million in gross proceeds** and **$9.6 million net proceeds**[56](index=56&type=chunk) - The offering included **3,275,153 common shares** and warrants, plus **1,875,945 pre-funded warrants** and warrants[56](index=56&type=chunk) - During Q1 2023, **355,235 pre-funded warrants** were converted into common shares[56](index=56&type=chunk) [2022 Reverse Stock Split](index=13&type=section&id=2022%20Reverse%20Stock%20Split) A 1-for-10 reverse stock split was effected in July 2022 to meet Nasdaq listing requirements - A **1-for-10 reverse stock split** was effected on July 21, 2022, to meet Nasdaq listing requirements[57](index=57&type=chunk) [Equity Distribution Agreement](index=13&type=section&id=Equity%20Distribution%20Agreement) An equity distribution agreement allows for the sale of up to $14.5 million in common stock - An equity distribution agreement allows the sale of up to **$14.5 million** in common stock through Oppenheimer & Co. Inc., with a **3.0% commission**[58](index=58&type=chunk) - The ATM program was suspended in conjunction with the October 2022 offering but remains in full force and effect[60](index=60&type=chunk) [Common Stock Warrants](index=15&type=section&id=Common%20Stock%20Warrants) This section provides a summary of outstanding common stock warrants as of March 31, 2023 Outstanding Warrants to Purchase Common Stock as of March 31, 2023 | Warrant Type | Number of Outstanding Warrants | Exercise Price | Expiration Date | | :--- | :--- | :--- | :--- | | Offering 2022 Common Warrants | 5,151,098 | $1.96 | October 25, 2027 | | 2022 Pre-Funded Warrants | 1,520,710 | $0.00001 | N/A | | June 2020 Series H Warrants | 720,796 | $12.075 | June 5, 2025 | | May 2019 Series F Warrants | 195,700 | $24.00 | May 20, 2024 | | May 2019 Series G Warrants | 201,800 | $24.00 | May 20, 2024 | | July 2018 Series E Warrants | 414,000 | $40.00 | July 31, 2023 | | October 2017 Series D Warrants | 31,085 | $178.00 | October 14, 2024 | | Total | 8,235,189 | | | [Stock-Based Compensation](index=15&type=section&id=Stock-Based%20Compensation) This section details the company's stock-based compensation plans, activity, and valuation assumptions [2021 Stock Incentive Plan](index=15&type=section&id=2021%20Stock%20Incentive%20Plan) The 2021 Stock Incentive Plan authorizes various equity awards, with shares available for future grants - The 2021 Stock Incentive Plan authorizes grants of various equity awards, with **3,254 shares available** for future grants as of March 31, 2023[61](index=61&type=chunk) - Stockholders approved an increase of **500,000 shares** for issuance under the 2021 Plan in June 2022[62](index=62&type=chunk) [Stock Option Activity](index=17&type=section&id=Stock%20Option%20Activity) This section summarizes stock option activity and related compensation expense for the quarter - Total unrecognized compensation cost related to unvested stock-based compensation was approximately **$2.366 million** as of March 31, 2023, expected to be recognized through 2026[105](index=105&type=chunk) - During Q1 2023, **732,500 options were granted**, compared to 277,850 in Q1 2022[65](index=65&type=chunk) Stock Option Activity Summary | | Number of Shares Issuable Upon Exercise of Outstanding Options | Weighted Average Exercise Price | | :--- | :--- | :--- | | Outstanding at December 31, 2022 | 746,257 | $13.48 | | Granted (Q1 2023) | 732,500 | $1.68 | | Forfeited (Q1 2023) | (14,800) | $14.80 | | Outstanding at March 31, 2023 | 1,478,756 | $7.59 | | Exercisable March 31, 2023 | 370,959 | $20.06 | | Unvested, March 31, 2023 | 1,107,797 | $3.42 | Stock-Based Compensation Expense | Expense Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $66,195 | $41,928 | | General and administrative | $342,011 | $261,877 | | Total stock-based compensation | $408,206 | $303,805 | [Assumptions Used in Determining Fair Value](index=17&type=section&id=Assumptions%20Used%20in%20Determining%20Fair%20Value) The fair value of stock awards is estimated using the Black-Scholes model with specific assumptions - Fair value of stock awards estimated using Black-Scholes model, amortized straight-line over service period[67](index=67&type=chunk) - Volatility based on historical volatility; risk-free interest rate based on U.S. Treasury yield curve; expected term uses simplified method[85](index=85&type=chunk)[86](index=86&type=chunk) - Forfeitures are accounted for as they occur; no historical dividends related to stock options[87](index=87&type=chunk)[88](index=88&type=chunk) [Income Taxes](index=18&type=section&id=Income%20Taxes) No income tax provision was recorded due to historical losses and a full valuation allowance on deferred tax assets - No provision or benefit for federal, state, or foreign income taxes recorded for Q1 2023 or Q1 2022 due to historical losses[106](index=106&type=chunk) - A full valuation allowance is maintained against gross deferred tax assets due to limited operating history and uncertainty of NOL utilization[106](index=106&type=chunk) [Net Loss Per Share](index=19&type=section&id=Net%20Loss%20Per%20Share) Basic and diluted net loss per share are identical as all potential common stock equivalents were antidilutive - Basic and diluted net loss per share are the same due to net loss, making common stock equivalents antidilutive[109](index=109&type=chunk) Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share | Security Type | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Warrants | 6,714,479 | 1,563,381 | | Preferred shares as convertible into common stock | 111,111 | 111,111 | | Stock options | 1,478,756 | 606,470 | | Total potentially dilutive shares | 8,304,346 | 2,280,962 | [Commitments and Contingencies](index=19&type=section&id=Commitments%20and%20Contingencies) The company does not anticipate any legal matters to have a material effect on its financial statements - The Company may be involved in legal matters, but does not anticipate material effects on financial statements[110](index=110&type=chunk) [Leases](index=19&type=section&id=Leases) This section details the company's operating lease for its headquarters, including terms and valuation [Operating Lease Liability](index=19&type=section&id=Operating%20Lease%20Liability) The company amended its headquarters lease, extending the term to April 2029 - Entered an Amended Agreement of Lease on December 30, 2022, for HQ office space in Florham Park, NJ, extending the term from March 1, 2023, to April 30, 2029[112](index=112&type=chunk) - Aggregate rent over the amended lease term is approximately **$918,000**, reduced to **$893,000** after abatements[113](index=113&type=chunk) [Discount Rate](index=19&type=section&id=Discount%20Rate) A 14% interest rate is used as the incremental borrowing rate for lease liability valuation - A **14% per annum interest rate** is used as the incremental borrowing rate for evaluating the present value of the Amended Lease liability[114](index=114&type=chunk)[121](index=121&type=chunk) [Maturity Analysis of Leases](index=21&type=section&id=Maturity%20Analysis%20of%20Leases) This section provides a maturity analysis of undiscounted lease payments as of March 31, 2023 Maturity Analysis of Undiscounted Lease Payments as of March 31, 2023 | Years ending March 31, | Undiscounted Lease Payments | | :--- | :--- | | 2023 | $106,000 | | 2024 | $132,000 | | 2025 | $147,000 | | 2026 | $150,000 | | 2027 | $153,000 | | Thereafter | $207,000 | | Total undiscounted lease payments | $895,000 | | Less: Imputed interest | $(295,000) | | Present value of lease liabilities | $600,000 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, business strategy, clinical pipeline, and liquidity [Overview of Business and Strategy](index=22&type=section&id=Overview%20of%20Business%20and%20Strategy) The company is a late-stage biopharmaceutical firm developing cancer treatments via its proprietary PDC™ delivery platform [Company Overview and PDC Platform](index=22&type=section&id=Company%20Overview%20and%20PDC%20Platform) The company's PDC™ platform enables selective delivery of oncologic payloads to cancer cells - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on cancer treatment using its proprietary phospholipid drug conjugate (PDC™) delivery platform[36](index=36&type=chunk)[119](index=119&type=chunk) - The PDC platform is designed for selective delivery of diverse oncologic payloads to cancer cells, leveraging a metabolic pathway utilized by nearly all tumor cell types[132](index=132&type=chunk)[133](index=133&type=chunk) - The platform aims to improve the therapeutic index of oncologic drugs by enhancing delivery to cancerous cells and cancer stem cells while minimizing exposure to healthy cells[133](index=133&type=chunk) [Iopofosine I 131 Clinical Pipeline](index=22&type=section&id=Iopofosine%20I%20131%20Clinical%20Pipeline) The lead therapeutic, iopofosine I 131, is being evaluated in multiple clinical studies for various cancers [CLOVER-WaM: Phase 2 Pivotal Study in WM](index=26&type=section&id=CLOVER-WaM%3A%20Phase%202%20Pivotal%20Study%20in%20WM) The CLOVER-WaM pivotal study is evaluating iopofosine in relapsed or refractory Waldenstrom's Macroglobulinemia - CLOVER-WaM is a single-arm, pivotal study in WM patients who have received and relapsed or were refractory to two prior lines of therapy, including BTKi failure[143](index=143&type=chunk) - The study aims to enroll **50 WM patients**, with a primary endpoint of major response rate (MRR) defined as **≥50% reduction in IgM**[144](index=144&type=chunk) - An interim safety and futility evaluation on the first 10 patients determined the study exceeded the futility threshold, allowing enrollment to continue[144](index=144&type=chunk) [CLOVER-1: Phase 2 Study in B-Cell Malignancies](index=26&type=section&id=CLOVER-1%3A%20Phase%202%20Study%20in%20B-Cell%20Malignancies) The CLOVER-1 study evaluated iopofosine in various B-cell malignancies, showing promising response rates - The CLOVER-1 Phase 2 study evaluated iopofosine in select B-cell malignancies; study arms for most indications were closed as of March 2022, with MM and CNSL expansion ongoing[137](index=137&type=chunk)[145](index=145&type=chunk) - In r/r WM cohort, current data show **100% ORR** in 6 patients and **83.3% major response rate**[149](index=149&type=chunk) - In r/r MM, a **40% ORR** was observed in triple class refractory patients receiving >60 mCi TBD[90](index=90&type=chunk)[91](index=91&type=chunk) - In r/r NHL, patients receiving ≥60mCi TBD had a **43% ORR**, with DLBCL patients showing a **30% ORR**[92](index=92&type=chunk) - Common adverse events across CLOVER-1 were fatigue (39%) and cytopenias (thrombocytopenia 75%, anemia 61%, neutropenia 54%)[147](index=147&type=chunk) [CLOVER-2: Phase 1 Study in Pediatric Cancers](index=23&type=section&id=CLOVER-2%3A%20Phase%201%20Study%20in%20Pediatric%20Cancers) The CLOVER-2 study evaluates iopofosine in pediatric patients with r/r cancers, including high-grade gliomas - CLOVER-2 Phase 1a pediatric study evaluated iopofosine safety and tolerability in children and adolescents with r/r malignant solid tumors, lymphomas, or brain tumors[127](index=127&type=chunk)[138](index=138&type=chunk) - The Phase 1b study is initiating to determine appropriate dosing in pediatric patients with r/r high-grade gliomas (HGGs), supported by a **$1.9M NCI SBIR Phase 2 grant**[155](index=155&type=chunk) - Clinical data confirmed iopofosine crosses the blood-brain barrier and is delivered into pediatric brain tumors, showing disease control in heavily pretreated patients[155](index=155&type=chunk) - Adverse events in pediatric studies included fatigue, headache, nausea, vomiting (28% each), and cytopenias (thrombocytopenia 67%, anemia 67%)[155](index=155&type=chunk) [Phase 1 Study in Head and Neck Cancer](index=32&type=section&id=Phase%201%20Study%20in%20Head%20and%20Neck%20Cancer) A Phase 1 study is assessing iopofosine combined with external beam radiation for recurrent head and neck cancer - UWCCC initiated a Phase 1 clinical study combining iopofosine and external beam radiation treatment (EBRT) for recurrent HNC, with Part A suggesting safety and tolerability[1](index=1&type=chunk) - Part B of the study, assessing safety and benefits in up to 24 patients, has fully enrolled[1](index=1&type=chunk) - The reduction in EBRT fractions with iopofosine has the potential to diminish severe adverse events associated with traditional EBRT[1](index=1&type=chunk) [Preclinical Pipeline and Collaborations](index=23&type=section&id=Preclinical%20Pipeline%20and%20Collaborations) The preclinical pipeline includes chemotherapeutic and alpha-emitter radiotherapeutic programs advanced through collaborations - The preclinical pipeline includes CLR 1900 Series (chemotherapeutic for solid tumors) and CLR 12120 Series (alpha-emitter radiotherapeutic)[130](index=130&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) - Collaborations with IntoCell Inc. and LegoChemBio have led to selecting highly potent cytotoxic small molecule payloads[68](index=68&type=chunk) - A collaboration with Orano Med successfully validated the potential of PDC radio-conjugates with an alpha emitter (lead 212), demonstrating significant tumor volume reduction in animal models[159](index=159&type=chunk) [Regulatory Designations](index=23&type=section&id=Regulatory%20Designations) Iopofosine has received multiple Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA - Iopofosine has **Fast Track Designation** for LPL/WM, r/r MM, and r/r DLBCL[128](index=128&type=chunk)[139](index=139&type=chunk) - **Orphan Drug Designations (ODDs)** granted for LPL/WM, MM, neuroblastoma, osteosarcoma, rhabdomyosarcoma, and Ewing's sarcoma in the U.S. and for r/r MM and WM in Europe[128](index=128&type=chunk)[139](index=139&type=chunk) - **Rare Pediatric Disease Designation (RPDD)** granted for neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma, potentially leading to a Priority Review Voucher (PRV)[128](index=128&type=chunk)[140](index=140&type=chunk)[156](index=156&type=chunk) - European Medicines Agency (EMA) granted **Small and Medium-Sized Enterprise (SME) status**, providing significant financial incentives[129](index=129&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section analyzes changes in operating expenses for Q1 2023 compared to Q1 2022 [Research and Development Expense](index=32&type=section&id=Research%20and%20Development%20Expense) R&D expenses increased by 71% due to pivotal trial activities, manufacturing, and personnel costs - Overall R&D expense increased by approximately **$2.767 million (71%)** primarily due to increased clinical project costs for the pivotal trial, higher manufacturing costs, and increased personnel[72](index=72&type=chunk) Research and Development Expense Comparison (Q1 2023 vs. Q1 2022) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Variance | | :--- | :--- | :--- | :--- | | Clinical project costs | $2,625,000 | $1,452,000 | $1,173,000 | | Manufacturing and related costs | $1,914,000 | $1,090,000 | $824,000 | | Pre-clinical project costs | $183,000 | $60,000 | $123,000 | | General research and development costs | $1,932,000 | $1,285,000 | $647,000 | | Total research and development | $6,654,000 | $3,887,000 | $2,767,000 | [General and Administrative Expense](index=34&type=section&id=General%20and%20Administrative%20Expense) G&A expenses decreased by 9% primarily due to lower professional fees - Overall G&A expense decreased by **$202,000 (9%)** primarily due to a decrease in professional fees, partially offset by an increase in personnel costs[73](index=73&type=chunk) General and Administrative Expense Comparison (Q1 2023 vs. Q1 2022) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | General and administrative expense | $2,051,000 | $2,253,000 | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash is expected to fund operations into Q4 2023, raising going concern uncertainty - The company incurred a net loss of approximately **$8.6 million** and used **$7.2 million** in cash for operations during Q1 2023, with an accumulated deficit of **$188.08 million**[30](index=30&type=chunk)[74](index=74&type=chunk) - Consolidated cash balance was approximately **$12.7 million** as of March 31, 2023, expected to fund operations into Q4 2023[74](index=74&type=chunk) - Additional funding is required to execute the operating plan beyond Q4 2023, raising **substantial doubt about the company's ability to continue as a going concern**[30](index=30&type=chunk)[74](index=74&type=chunk) - The COVID-19 pandemic has caused material delays in patient recruitment and enrollment for clinical studies[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, these disclosures are not required - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[75](index=75&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirms the effectiveness of disclosure controls and procedures as of the quarter-end [Evaluation of Disclosure Controls and Procedures](index=35&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023 - Management concluded that disclosure controls and procedures were effective as of March 31, 2023, ensuring timely and accurate reporting of required information[77](index=77&type=chunk) [Changes in Internal Control Over Financial Reporting](index=35&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) No significant changes in internal control over financial reporting occurred during the quarter - No significant changes in internal control over financial reporting occurred during the quarter ended March 31, 2023[78](index=78&type=chunk)[79](index=79&type=chunk) [Important Considerations](index=35&type=section&id=Important%20Considerations) Any control system provides only reasonable, not absolute, assurance due to inherent limitations - Any system of controls provides only reasonable, not absolute, assurance due to inherent limitations such as cost, judgment, human error, and fraud risk[80](index=80&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, other information, and exhibits [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company resolved a lawsuit concerning intellectual property, securing a non-exclusive license to the disputed patents - Lawsuit against Dr. Jamey Weichert and Dr. Anatoly Pinchuk regarding diverted intellectual property was resolved in November 2022[83](index=83&type=chunk) - All claims were dismissed, and Cellectar secured an irrevocable, non-exclusive license to the patents at issue[83](index=83&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the comprehensive risk factors disclosed in the company's 2022 Annual Report - Readers are directed to the Risk Factors section in the Annual Report on Form 10-K for the year ended December 31, 2022[84](index=84&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report under this item - No other information to report under this item[103](index=103&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including required officer certifications and interactive data files Exhibits Filed with Form 10-Q | Exhibit No. | Description | Filed with this Form 10-Q | | :--- | :--- | :--- | | 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 | [SIGNATURES](index=38&type=section&id=SIGNATURES) The report was duly signed by the President and Chief Executive Officer on May 4, 2023 - Report signed by James V. Caruso, President and Chief Executive Officer, on May 4, 2023[173](index=173&type=chunk)

| --- | --- | --- | |---------------------------|-------|-------| | | | | | | | | | | | | | | | | | CELLECTAR BIOSCIENCES (3) | | | | | | | | lopofosine l 131 | | | | | | | | | | | Iopofosine I 131: Lead Candidate First-in-class Phospholipid Ether Radiotherapeutic to Target Cancer 5 Iopofosine I 131: WM Phase 2a Response Rates Forward Looking Statements and Disclaimers This presentation contains forward-looking statements. Such statements are valid only as of today and we disclaim any obligation to update t ...

B-cell Non-Hodgkin's Lymphoma (BCNHL) represents cancers of the lymphatic system. The lymphoma may be indolent or aggressive and circulate in the blood or form tumors in lymph nodes. According to the American Cancer Society, the estimated 2023 US incidence of BCNHL was 68,468 cases. Nine types of B-cell lymphomas include CLL, SLL, MCL, MZL, and the most common lymphoma, DLBCL. According to a report dated June 2019 by Global Data Research Group, the BCNHL market was valued at $7.2 billion for 2022, with a fo ...

| --- | --- | --- | |----------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | Corporate | | | | | | | | | | | | Presentation | | | | November 2022 | | | | NASDAQ: CLRB | | | Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements. Such statements are valid only as of today and we disclaim any obligation to update this information. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that m ...

Table of Contents U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [mark one] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 1-36598 CELLECTAR BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) ...

[Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section outlines the inherent uncertainties and risks associated with the company's forward-looking business projections and financial estimates - The report contains forward-looking statements regarding business strategy, R&D activities, COVID-19 impacts, product development, operating results, funding, and market conditions[6](index=6&type=chunk) - Readers are cautioned that actual results may differ materially from expectations due to inherent estimates, assumptions, and uncertainties, and the company undertakes no obligation to update these statements[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 Cellectar Biosciences, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with accompanying notes. The financial data reflects a decrease in cash and stockholders' equity, and continued net losses, raising concerns about the company's going concern ability [Condensed Consolidated Balance Sheets](index=5&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) | Metric | June 30, 2022 | Dec 31, 2021 | Change (Absolute) | Change (%) | | :--------------------------- | :------------ | :----------- | :---------------- | :--------- | | Cash and cash equivalents | $24,805,565 | $35,703,975 | $(10,898,410) | -30.52% | | Total current assets | $25,285,233 | $36,571,460 | $(11,286,227) | -30.86% | | Total assets | $25,892,396 | $37,201,809 | $(11,309,413) | -30.40% | | Total current liabilities | $5,606,110 | $3,990,363 | $1,615,747 | 40.49% | | Total liabilities | $5,698,324 | $4,156,655 | $1,541,669 | 37.09% | | Total stockholders' equity | $20,194,072 | $33,045,154 | $(12,851,082) | -38.89% | | Accumulated deficit | $(164,472,629)| $(150,897,789)| $(13,574,840) | 9.00% | [Condensed Consolidated Statements of Operations](index=6&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) | Metric (Unaudited) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $4,498,657 | $4,627,636 | $8,385,656 | $9,260,830 | | General and administrative | $2,936,867 | $1,401,053 | $5,190,095 | $3,127,391 | | Total costs and expenses | $7,435,524 | $6,028,689 | $13,575,751 | $12,388,221 | | Loss from operations | $(7,435,524) | $(6,028,689) | $(13,575,751) | $(12,388,221) | | Net loss | $(7,435,043) | $(6,028,030) | $(13,574,840) | $(12,385,200) | | Basic and diluted net loss per common share | $(1.22) | $(1.14) | $(2.22) | $(2.45) | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS'%20EQUITY) | Metric | Dec 31, 2021 | Mar 31, 2022 | June 30, 2022 | | :--------------------------- | :------------- | :------------- | :------------- | | Preferred Stock Amount | $1,382,023 | $1,382,023 | $1,382,023 | | Common Stock Par Amount | $61 | $61 | $61 | | Additional Paid-In Capital | $182,560,859 | $182,864,664 | $183,284,617 | | Accumulated Deficit | $(150,897,789) | $(157,037,586) | $(164,472,629) | | Total Stockholders' Equity | $33,045,154 | $27,209,162 | $20,194,072 | - Stock-based compensation contributed **$303,805** and **$419,953** to additional paid-in capital for the three months ended March 31, 2022, and June 30, 2022, respectively[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) | Metric (Six Months Ended June 30) | 2022 | 2021 | Change (Absolute) | Change (%) | | :-------------------------------- | :------------- | :------------- | :---------------- | :--------- | | Net loss | $(13,574,840) | $(12,385,200) | $(1,189,640) | 9.61% | | Cash used in operating activities | $(10,797,361) | $(11,628,761) | $831,400 | -7.15% | | Cash used in investing activities | $(101,049) | $(7,559) | $(93,490) | 1236.89% | | Cash provided by financing activities | $0 | $1,248,798 | $(1,248,798) | -100.00% | | Net decrease in cash | $(10,898,410) | $(10,387,522) | $(510,888) | 4.92% | | Cash at end of period | $24,805,565 | $46,777,855 | $(21,972,290) | -47.00% | - Cash used in operating activities decreased by **$831,400**, or **7.15%**, primarily due to changes in accounts payable and accrued liabilities[26](index=26&type=chunk) - Purchases of fixed assets increased significantly from **$7,559** in 2021 to **$101,049** in 2022[26](index=26&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=CELLECTAR%20BIOSCIENCES,%20INC.%20NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20(Unaudited)) [1. Nature of Business and Organization](index=9&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20ORGANIZATION) - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer drug discovery and development using its proprietary phospholipid drug conjugate (PDC™) delivery platform[29](index=29&type=chunk) - As of June 30, 2022, the company had an accumulated deficit of approximately **$164.5 million** and a net loss of approximately **$13.6 million** for the six months ended June 30, 2022[30](index=30&type=chunk) - The company's cash balance is expected to fund operations into **Q3 2023**, but additional funding is required, raising substantial doubt about its ability to continue as a going concern[30](index=30&type=chunk) [2. Fair Value](index=10&type=section&id=2.%20FAIR%20VALUE) - Financial instruments are grouped into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1 prices), and Level 3 (unobservable inputs) based on market observability[43](index=43&type=chunk)[44](index=44&type=chunk)[46](index=46&type=chunk) - The carrying value of cash, cash equivalents, and other current financial assets and liabilities approximates their fair value due to their short-term nature[47](index=47&type=chunk) [3. Stockholders' Equity](index=12&type=section&id=3.%20STOCKHOLDERS'%20EQUITY) - A **1-for-10 reverse stock split** was approved by stockholders on June 24, 2022, and became effective on July 21, 2022, to satisfy Nasdaq listing requirements[48](index=48&type=chunk) - In February 2021, the authorized common stock was increased from **80,000,000 shares** to **160,000,000 shares**[49](index=49&type=chunk) - A December 2020 public offering and private placement generated approximately **$41.4 million** in net proceeds, involving the sale of common stock and Series D convertible preferred stock[52](index=52&type=chunk)[53](index=53&type=chunk)[56](index=56&type=chunk) [4. Stock-Based Compensation](index=14&type=section&id=4.%20STOCK-BASED%20COMPENSATION) - Stockholders approved an increase of **500,000 shares** available for issuance under the 2021 Stock Incentive Plan[59](index=59&type=chunk) | Stock-Based Compensation (Employee & Director) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :--------------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $44,499 | $41,400 | $86,427 | $70,795 | | General and administrative | $375,454 | $159,217 | $637,331 | $254,386 | | Total stock-based compensation | $419,953 | $200,617 | $723,758 | $325,181 | - As of June 30, 2022, there was approximately **$1.34 million** of total unrecognized compensation cost related to unvested stock-based compensation arrangements[71](index=71&type=chunk) [5. Income Taxes](index=18&type=section&id=5.%20INCOME%20TAXES) - No income tax provision or benefit was recorded for the six months ended June 30, 2022, or 2021, due to continuous tax losses since inception[72](index=72&type=chunk) - A full valuation allowance has been provided against the company's gross deferred tax assets due to limited operating history and uncertainty of NOL utilization[72](index=72&type=chunk) [6. Net Loss Per Share](index=20&type=section&id=6.%20NET%20LOSS%20PER%20SHARE) - Potentially dilutive securities, including warrants, preferred shares, and stock options, were excluded from diluted net loss per share calculations because their inclusion would be antidilutive due to the net loss[76](index=76&type=chunk)[77](index=77&type=chunk) | Potentially Dilutive Securities (Six Months Ended June 30) | 2022 | 2021 | | :------------------------------------------------------- | :-------- | :-------- | | Warrants | 1,563,381 | 1,607,961 | | Preferred shares as convertible into common stock | 111,111 | 694,444 | | Stock options | 657,317 | 470,178 | | Total potentially dilutive shares | 2,331,809 | 2,772,583 | [7. Commitments and Contingencies](index=20&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) - The company's corporate headquarters lease in Florham Park, NJ, commenced in October 2018 and terminates in February 2024, with an option for a **60-month extension**[77](index=77&type=chunk) - As of June 30, 2022, the HQ Lease's net Right-of-Use (ROU) asset was approximately **$161,000**, and the lease liability was approximately **$236,000**[84](index=84&type=chunk) | Undiscounted Lease Payments (as of June 30, 2022) | Amount | | :------------------------------------------------ | :--------- | | Remainder of 2022 | $79,000 | | 2023 | $161,000 | | 2024 | $14,000 | | Total undiscounted lease payments | $254,000 | | Less: Imputed interest | $(18,000) | | Present value of lease liabilities | $236,000 | - The company is involved in a lawsuit against former director Dr. Jamey Weichert and former employee Dr. Anatoly Pinchuk, alleging breach of contractual and fiduciary duties by diverting intellectual property[157](index=157&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Cellectar Biosciences' business, its clinical and preclinical pipeline, and a detailed analysis of its financial condition and results of operations. The company is a late-stage biopharmaceutical firm focused on cancer treatments, facing clinical trial delays due to COVID-19 and ongoing liquidity challenges requiring additional funding [Overview](index=23&type=section&id=Overview) - Cellectar is a late-stage clinical biopharmaceutical company focused on cancer drug development using its proprietary Phospholipid Drug Conjugate (PDC™) delivery platform[90](index=90&type=chunk) - The CLOVER-WaM pivotal clinical study has experienced material delays in patient recruitment and enrollment due to COVID-19 related issues at study sites[91](index=91&type=chunk) - Iopofosine has received Fast Track Designation for LPL/WM, MM, and DLBCL, and Orphan Drug Designations for LPL/WM, MM, neuroblastoma, and sarcomas[92](index=92&type=chunk)[104](index=104&type=chunk) - The PDC platform is designed for selective delivery of oncologic payloads to cancer cells, leveraging a metabolic pathway utilized by all tumor cell types, aiming to improve efficacy and safety[95](index=95&type=chunk)[96](index=96&type=chunk) [Clinical Pipeline](index=24&type=section&id=Clinical%20Pipeline) [CLOVER-WaM: Phase 2 Study Pivotal Study in: Patients with r/r Waldenstrom's Macroglobulinemia](index=26&type=section&id=CLOVER-WaM:%20Phase%202%20Study%20Pivotal%20Study%20in:%20Patients%20with%20r/r%20Waldenstrom's%20Macroglobulinemia) - The CLOVER-WaM study is a single-arm, pivotal Phase 2 study enrolling **50 r/r WM patients** who have failed BTKi therapy[106](index=106&type=chunk)[108](index=108&type=chunk) - The primary endpoint is major response rate (MRR), defined as a partial response (≥50% IgM reduction) or better, in patients receiving a minimum total body dose (TBD) of **60 mCi**[108](index=108&type=chunk) - An independent data monitoring committee (DMC) unanimously recommended continuation of the trial after an interim safety and futility evaluation of the first **10 patients** in April 2022[108](index=108&type=chunk) [CLOVER-1: Phase 2 Study in Select B-Cell Malignancies](index=27&type=section&id=CLOVER-1:%20Phase%202%20Study%20in%20Select%20B-Cell%20Malignancies) - The CLOVER-1 study arms for CLL/SLL, LPL/WM, MZL, MCL, and DLBCL are closed, with further evaluation in r/r MM patients ongoing in the Phase 2b study[109](index=109&type=chunk)[102](index=102&type=chunk) - The study received a **$2 million NCI Fast-Track Small Business Innovation Research grant** to advance clinical development in r/r MM and other niche hematologic malignancies[110](index=110&type=chunk) - Adverse events in CLOVER-1 included fatigue (**39%**) and cytopenias (thrombocytopenia **75%**, anemia **61%**, neutropenia **54%**, leukopenia **51%**, lymphopenia **25%**)[111](index=111&type=chunk) [Phase 2a Study: Patients with r/r Waldenstrom's Macroglobulinemia Cohort](index=27&type=section&id=Phase%202a%20Study:%20Patients%20with%20r/r%20Waldenstrom's%20Macroglobulinemia%20Cohort) - The r/r WM cohort of the Phase 2a CLOVER-1 study showed a **100% overall response rate (ORR)** and **83.3% major response rate** in **6 patients**, with one complete response lasting nearly **27 months**[112](index=112&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**[112](index=112&type=chunk) [Phase 2a Study: Patients with r/r Multiple Myeloma Cohort](index=28&type=section&id=Phase%202a%20Study:%20Patients%20with%20r/r%20Multiple%20Myeloma%20Cohort) - A **40% overall response rate (ORR)** was observed in triple-class refractory MM patients receiving **60 mCi** or greater total body dose (TBD) of iopofosine[114](index=114&type=chunk) - Patients were heavily pre-treated, with an average of **nine prior multi-drug regimens**[114](index=114&type=chunk) - The most common treatment-emergent adverse events were cytopenias (thrombocytopenia, neutropenia, anemia)[114](index=114&type=chunk) [Phase 2a: Patients with r/r non-Hodgkin's lymphoma Cohort](index=28&type=section&id=Phase%202a:%20Patients%20with%20r/r%20non-Hodgkin's%20lymphoma%20Cohort) - r/r NHL patients receiving **<60mCi TBD** and **>60mCi TBD** had ORRs of **42%** and **43%** respectively, with a combined rate of **42%**[115](index=115&type=chunk) - Patients were heavily pre-treated (median of **three prior lines**) and refractory to rituximab and/or ibrutinib[115](index=115&type=chunk) - The most common grade ≥3 events at the highest dose (**75mCi TBD**) were hematologic toxicities including thrombocytopenia (**65%**), neutropenia (**41%**), leukopenia (**30%**), anemia (**24%**), and lymphopenia (**35%**)[117](index=117&type=chunk) [Phase 1 Study in Patients with r/r Multiple Myeloma](index=28&type=section&id=Phase%201%20Study%20in%20Patients%20with%20r/r%20Multiple%20Myeloma) - The Phase 1 dose escalation study of iopofosine in r/r MM successfully completed, showing tolerability up to approximately **95mCi TBD**[119](index=119&type=chunk)[122](index=122&type=chunk) - Pooled median overall survival (mOS) data from the first four cohorts was **22.0 months**[121](index=121&type=chunk) - In a subset of **5 quad/penta drug refractory patients**, efficacy increased, demonstrating an ORR of **80%** and CBR of **100%**[124](index=124&type=chunk) [CLOVER 2: Phase 1 Study in r/r Pediatric Patients with select Solid tumors, Lymphomas and Malignant Brain Tumors](index=31&type=section&id=CLOVER%202:%20Phase%201%20Study%20in%20r/r%20Pediatric%20Patients%20with%20select%20Solid%20tumors,%20Lymphomas%20and%20Malignant%20Brain%20Tumors) - The CLOVER 2 Phase 1 study is an open-label, dose-escalation study evaluating iopofosine in children and adolescents with r/r cancers[126](index=126&type=chunk) - Clinical data confirmed iopofosine crosses the blood-brain barrier and showed disease control in heavily pretreated ependymoma patients[127](index=127&type=chunk) - The company may be eligible for a Priority Review Voucher (PRV) if iopofosine is approved for neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, or osteosarcoma, with the program extended through **September 2026**[128](index=128&type=chunk) [Phase 1 Study in r/r Head and Neck Cancer](index=31&type=section&id=Phase%201%20Study%20in%20r/r%20Head%20and%20Neck%20Cancer) - A Phase 1 study combining iopofosine with external beam radiation treatment (EBRT) for recurrent head and neck cancer (HNC) patients is ongoing, with preliminary data suggesting safety and tolerability[129](index=129&type=chunk) - The reduction in EBRT amount or fractions has the potential to diminish associated adverse events[129](index=129&type=chunk) [Preclinical Pipeline](index=33&type=section&id=Preclinical%20Pipeline) - CLR 1900 Series is an internally developed PDC program leveraging a novel small molecule cytotoxic compound targeting mitosis inhibition for solid tumors[131](index=131&type=chunk) - CLR 2000 Series is a collaboration with Avicenna Oncology to design PDCs using Avicenna's cytotoxic payload, demonstrating improved safety, efficacy, and tissue distribution in animal models[132](index=132&type=chunk) - CLR 12120 Series is an alpha emitting radio-conjugate program in collaboration with Orano Med, which successfully demonstrated significant tumor volume reduction in animal models[133](index=133&type=chunk) - Expanded collaborations with IntoCell Inc. and LegoChemBio aim to create next-generation PDC therapeutics using novel linker chemistry and drug conjugate linker-toxin platforms[134](index=134&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) [Three Months Ended June 30, 2022 and 2021](index=33&type=section&id=Three%20Months%20Ended%20June%2030,%202022%20and%202021) [Research and Development](index=33&type=section&id=Research%20and%20Development_3M) | R&D Expense Category (3 Months Ended June 30) | 2022 | 2021 | Variance | | :-------------------------------------------- | :------------ | :------------ | :------------ | | Clinical project costs | $2,454,000 | $3,620,000 | $(1,166,000) | | Manufacturing and related costs | $1,353,000 | $651,000 | $702,000 | | Preclinical project costs | $120,000 | $11,000 | $109,000 | | General research and development costs | $572,000 | $346,000 | $226,000 | | Total Research and Development | $4,499,000 | $4,628,000 | $(129,000) | - The overall decrease in R&D expense of approximately **$129,000 (3%)** was primarily due to reduced clinical project costs of **$1,166,000**, partially offset by increases in manufacturing, preclinical, and general R&D costs[141](index=141&type=chunk) [General and administrative](index=34&type=section&id=General%20and%20administrative_3M) | G&A Expense (3 Months Ended June 30) | 2022 | 2021 | Variance | Change (%) | | :----------------------------------- | :----------- | :----------- | :----------- | :--------- | | General and administrative expense | $2,937,000 | $1,401,000 | $1,536,000 | 110% | - The increase in general and administrative expense was primarily driven by increased professional fees, personnel costs (including stock-based compensation), and travel[142](index=142&type=chunk) [Six Months Ended June 30, 2022 and 2021](index=34&type=section&id=Six%20Months%20Ended%20June%2030,%202022%20and%202021) [Research and Development](index=34&type=section&id=Research%20and%20Development_6M) | R&D Expense Category (6 Months Ended June 30) | 2022 | 2021 | Variance | | :-------------------------------------------- | :------------ | :------------ | :------------ | | Clinical project costs | $3,916,000 | $7,291,000 | $(3,375,000) | | Manufacturing and related costs | $2,268,000 | $1,157,000 | $1,111,000 | | Preclinical project costs | $180,000 | $19,000 | $161,000 | | General research and development costs | $2,022,000 | $794,000 | $1,228,000 | | Total Research and Development | $8,386,000 | $9,261,000 | $(875,000) | - The overall decrease in R&D expense of approximately **$875,000 (9%)** was primarily due to reduced clinical project costs of **$3,375,000**, partially offset by increases in manufacturing, preclinical, and general R&D costs[144](index=144&type=chunk) [General and administrative](index=34&type=section&id=General%20and%20administrative_6M) | G&A Expense (6 Months Ended June 30) | 2022 | 2021 | Variance | Change (%) | | :----------------------------------- | :----------- | :----------- | :----------- | :--------- | | General and administrative expense | $5,190,000 | $3,127,000 | $2,828,000 | 66% | - The increase in general and administrative expense was primarily driven by increased professional fees and personnel costs, including stock-based compensation expense and travel[145](index=145&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) | Metric | June 30, 2022 | Dec 31, 2021 | Change (Absolute) | Change (%) | | :--------------------------- | :------------ | :----------- | :---------------- | :--------- | | Cash and cash equivalents | $24,806,000 | $35,704,000 | $(10,898,000) | -30.52% | - Net cash used in operating activities for the six months ended June 30, 2022, was approximately **$10.8 million**[147](index=147&type=chunk) - The company has an accumulated deficit of approximately **$164.5 million** as of June 30, 2022, and expects current cash to fund operations into **Q3 2023**, but requires additional funding, raising substantial doubt about its going concern ability[148](index=148&type=chunk)[149](index=149&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cellectar Biosciences, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide disclosures about market risk[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022. No significant changes in internal control over financial reporting were identified during the quarter, though the company acknowledges inherent limitations in any control system - Management concluded that disclosure controls and procedures were effective as of **June 30, 2022**[151](index=151&type=chunk) - No significant changes in internal control over financial reporting were identified during the quarter ended **June 30, 2022**[152](index=152&type=chunk)[153](index=153&type=chunk) - Any system of controls has inherent limitations, providing only reasonable assurance, and is subject to human error and fraud risk[154](index=154&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company filed a lawsuit against a former director and former employee, alleging breach of contractual and fiduciary duties by diverting intellectual property. The company is seeking monetary damages, injunctive relief, and attorneys' fees - Cellectar filed a lawsuit against former director Dr. Jamey Weichert and former employee Dr. Anatoly Pinchuk for allegedly diverting intellectual property[157](index=157&type=chunk) - The disputed intellectual property, while not directly affecting current clinical studies, may enhance future research, development, and commercialization[157](index=157&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the Risk Factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021, for a comprehensive understanding of factors that could materially adversely affect the business and equity securities - Readers are directed to the Risk Factors section in the **2021 Form 10-K** for a detailed discussion of factors that could materially adversely affect the business and equity securities[158](index=158&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported[159](index=159&type=chunk) [Item 3. Default Upon Senior Securities](index=37&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities were reported[160](index=160&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[161](index=161&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - No other information was reported[162](index=162&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a Certificate of Amendment to the Certificate of Incorporation, certifications from the CEO and CFO, and interactive data files - Exhibits include a Certificate of Amendment to the Certificate of Incorporation (8-K filed July 21, 2022), CEO and CFO certifications (Sections 302 and 906 of Sarbanes-Oxley Act), and Interactive Data Files[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)

Table of Contents U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [mark one] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 1-36598 CELLECTAR BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) DELA ...