FLORHAM PARK, N.J., March 14, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that Jim Caruso, president and chief executive officer of Cellectar, will present an overview of the company in a fireside chat at the upcoming 36th Annual Roth Conference taking place on March 17 to 19, 2024 in Laguna Niguel, CA. Details of the fire ...

Complete Remission rate of 64% and Overall Response Rate of 73% demonstrated in highly refractory patients Durability of clinical activity achieved 67% Overall Survival and 42% Progression Free Survival at One Year FLORHAM PARK, N.J., March 04, 2024 (GLOBE NEWSWIRE) --  Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that iopofosine I 131 in combinatio ...

woraput/E+ via Getty Images Topline Summary Cellectar Biosciences (NASDAQ:CLRB) is a long-toothed developmental biotech focused on the development of a radiolabeled phospholipid for the management of hematologic malignancies, with Waldenstrom's macroglobulinemia being their main shot on goal. Very recently, they had a trial read out with what they believe are strong-enough data to justify and Accelerated Approval, and yet the company remains a microcap stock. While they have cash concerns and pipeline r ...

FLORHAM PARK, N.J., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that James Caruso, president and chief executive officer of Cellectar, will present an overview of the company at the upcoming Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually. Details of the presentation are as follows: ...

FLORHAM PARK, N.J., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that James Caruso, president and chief executive officer of Cellectar, will present an overview of the company at the upcoming Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually. Details of the presentation are as follows ...

FLORHAM PARK, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed or refractory malignant high-grade gliomas (pHGG). "Treatment of pediatr ...

FLORHAM PARK, N.J., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that the Tranche A warrants issued as part of the private placement announced in September 2023 have been exercised in full. All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling appr ...

FLORHAM PARK, N.J., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that its novel phospholipid radiotherapeutic conjugate, iopofosine I 131, demonstrated a pathological response with complete clonal clearance in a relapsed/refractory Waldenstrom's macroglobulinemia (WM) patient with CNS involvement, also known as Bing- ...

[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]