Cellectar Biosciences Inc. (NASDAQ:CLRB) Q4 2024 Earnings Conference Call March 13, 2025 8:30 AM ET Company Participants Anne Marie Fields ??? Managing Director-Precision AQ Jim Caruso ??? President and Chief Executive Officer Chad Kolean ??? Chief Financial Officer Jarrod Longcor ??? Chief Operating Officer Conference Call Participants Jonathan Aschoff ??? ROTH Operator Ladies and gentlemen, thank you for standing by, and welcome. At this time all participants are in listen-only mode. Following the present ...

Financial Performance - Cellectar Biosciences achieved a net loss of $44.6 million or $1.22 per basic share for the year ended December 31, 2024, compared to a net loss of $42.8 million or $3.50 per basic share in 2023[12]. - Other income and expense netted approximately $7.3 million in 2024, compared to a net expense of approximately $3.9 million in 2023, primarily due to non-cash items related to equity securities[12]. - Total operating expenses for 2024 were approximately $51.8 million, compared to $39.0 million in 2023, reflecting increased costs associated with the company's growth initiatives[18]. Cash Position - Cash and cash equivalents increased to $23.3 million as of December 31, 2024, up from $9.6 million at the end of 2023, supported by $44.1 million from warrant exercises and $19.4 million from inducement financing[6]. Research and Development - Research and Development expenses decreased to approximately $26.1 million in 2024 from approximately $27.3 million in 2023, primarily due to the timing of expenditures for the WM Phase 2 study[6]. - The company finalized a study design for the potential FDA accelerated approval of iopofosine I 131, with a total study cost expected to be between $40 million and $45 million[4]. - Cellectar plans to submit an IND application for its alpha-emitting radioconjugate in the first half of 2025, with Phase 1 clinical studies expected to begin by mid-2025[3]. - The company is preparing to initiate a Phase 1b/2a dose-finding study with CLR 121125 in triple-negative breast cancer, targeting significant unmet needs[6]. Clinical Study Results - The Phase 2 CLOVER-WaM study demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, exceeding the FDA's primary endpoint of 20% MRR[6]. General and Administrative Expenses - General and Administrative expenses rose significantly to approximately $25.6 million in 2024 from approximately $11.7 million in 2023, driven by costs related to commercialization infrastructure[6].

Core Viewpoint - Cellectar Biosciences has achieved alignment with the FDA on the regulatory path for the accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia, showcasing its efficacy and safety in clinical studies [1][2][3] Corporate Updates - The company plans to submit an IND for an alpha-emitting radioconjugate and is preparing for Phase 1 clinical studies for both CLR 121225 and CLR 121125 targeting triple negative breast cancer and pancreatic cancer, respectively [2][3] - Cellectar has finalized the study design for a randomized, controlled trial of iopofosine I 131, expecting to enroll 100 patients per arm and complete enrollment within 24 months [3] - The total cost for the study is estimated to be between $40 million and $45 million, with approximately $30 million allocated for full enrollment [3] Clinical Data Highlights - The Phase 2 CLOVER-WaM study demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the FDA's primary endpoint of 20% MRR [3] - The treatment was well tolerated with a manageable toxicity profile across various patient subgroups [3] - An investigator-led study published in eBioMedicine reported a 63.6% complete response rate among patients treated with iopofosine I 131 in combination with external beam radiation [3] Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of $23.3 million, a significant increase from $9.6 million in 2023 [8] - Research and development expenses for 2024 were approximately $26.1 million, a decrease from $27.3 million in 2023, primarily due to the timing of expenditures [8] - General and administrative expenses rose to approximately $25.6 million in 2024 from $11.7 million in 2023, driven by commercialization infrastructure development [8] - The net loss for the year ending December 31, 2024, was $44.6 million, or $1.22 per basic share, compared to a net loss of $42.8 million, or $3.50 per basic share in 2023 [8][8]

Financial Position and Performance - As of December 31, 2024, the company's consolidated cash balance was approximately $23.3 million, which is expected to fund basic operations into the fourth quarter of 2025[193]. - The company has incurred significant losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern[379]. - The company reported a net loss of $44.58 million in 2024, compared to a net loss of $42.77 million in 2023, with a basic net loss per share of $1.22[394]. - The company's accumulated deficit increased to $(247.34) million in 2024 from $(202.76) million in 2023, indicating ongoing financial challenges despite capital raises[391]. - Cash used in operating activities for 2024 was approximately $47.58 million, an increase from $32.38 million in 2023[399]. - The company expects to continue incurring significant losses and using net cash until product candidates are approved and commercialized[403]. - The company has restated its previously issued financial statements for the years ended December 31, 2022, and 2023, exposing it to additional risks and uncertainties[317]. - The restatement has led to potential liabilities and reputational harm, as well as increased costs related to accounting and legal fees[318]. Capital and Funding - The company expects to require additional capital to continue operations and may have difficulty raising such capital, impacting its ability to execute its operating plan[194]. - Management plans to secure additional outside capital to fund operations, with available liquidity limited to approximately $14.9 million as of the issuance date[405]. - Proceeds from the exercise of warrants amounted to approximately $61.41 million in 2024, compared to $0.79 million in 2023[399]. - The company entered into a warrant exercise inducement transaction, resulting in gross proceeds of $19.4 million and net proceeds of $17.5 million from the exercise of 1,610 shares of Series E-4 preferred stock, convertible to 6,739,919 shares of common stock at a price of $2.52 per share[385]. Research and Development - The company is focused on the discovery, development, and commercialization of drugs for cancer treatment using its PDC platform, which can target nearly all tumor cells[212]. - The company may need to delay, scale back, or eliminate research and development programs if it cannot secure adequate financing when needed[199]. - The company has engaged AtomVie and SpectronRx as sources to supply drug products for ongoing research and clinical studies[202]. - The company has received orphan drug designation (ODD) in the U.S. for iopofosine, which is intended for the treatment of multiple myeloma and other conditions[252]. - The FDA has granted rare pediatric disease designation to iopofosine for treating neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma, but the company may not realize value from this designation[189]. - Clinical studies are lengthy and expensive, with uncertain outcomes, and earlier study results may not predict future results[238]. Regulatory and Compliance Risks - The company must comply with extensive regulations governing the testing, manufacturing, and marketing of its products, which can delay or limit product introduction[229]. - The company may face significant challenges in obtaining sufficient quantities of its products at reasonable prices, even if they are shown to be safe and effective[213]. - The company must demonstrate substantial clinical evidence for safety and efficacy to obtain FDA approval, which can take many years and require significant resources[217]. - The company may face litigation from third parties claiming infringement of intellectual property rights, which could result in substantial costs[258]. - Regulatory changes and increased litigation scrutiny could negatively impact the company's business and financial condition[247]. Market and Competitive Landscape - The market for the company's proposed products is rapidly changing and competitive, which could impair its ability to develop its business[191]. - The potential for widespread acceptance of alternative therapies may limit market acceptance of the company's products, even if they are commercialized[294]. - The commercial success of the company's products will depend significantly on reimbursement from third-party payors, with ongoing trends to reduce costs impacting revenue[304]. - Market acceptance of the company's products is uncertain, and failure to achieve this could delay revenue generation[270]. Internal Controls and Governance - The company is required to establish and maintain effective internal controls over financial reporting, with evolving and complex standards that may incur significant expenses[322]. - There are identified material weaknesses in the company's internal controls that have previously resulted in restatements of historical financial statements[322]. - The company has experienced high volatility in its stock price, which may be affected by the issuance of additional shares or convertible securities[327]. - The company has received a deficiency letter from Nasdaq due to the closing bid price of its common stock being below the minimum requirement of $1.00 per share for 30 consecutive business days[324]. Personnel and Intellectual Property - The company's success significantly relies on the continued services of key personnel, including the CEO, James V. Caruso, and the ability to attract and retain highly skilled personnel[266]. - The company faces risks related to the protection of trade secrets and proprietary information, which could adversely affect its competitive position[267]. - The patent positions for biotechnology products are often uncertain, and the company may not be able to adequately protect its intellectual property rights[260].

Company Overview - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for cancer treatment [2] - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments, enhancing efficacy and safety by reducing off-target effects [2] Product Pipeline - The company's lead assets include iopofosine I 131, designed for targeted delivery of iodine-131 (radioisotope), CLR 121225 targeting solid tumors like pancreatic cancer, and CLR 121125 aimed at other solid tumors such as triple negative breast, lung, and colorectal cancers [3] - iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is part of the CLOVER-2 Phase 1b study for pediatric patients with high-grade gliomas [4] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [4] Upcoming Events - Members of Cellectar's management team will present an overview of the company at the 37th Annual Roth Conference on March 17, 2025, at 8:30 AM Eastern Time [1]

Group 1 - Cellectar Biosciences, Inc. will report financial results for the full year ended December 31, 2024, and provide a corporate update on March 13, 2025, at 8:30 a.m. Eastern Time [1] - The company is focused on the discovery, development, and commercialization of drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [3] - Cellectar's product pipeline includes lead assets such as iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors and utilizing advanced drug delivery methods [4] Group 2 - Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval [5] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Core Insights - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer treatment through drug discovery and development [2][3] - The company will present an overview at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025 [1] Company Overview - Cellectar's primary objective is to utilize its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer treatments with improved efficacy and safety [2] - The company is engaged in independent research and development as well as collaborations to enhance its drug pipeline [2] Product Pipeline - Key assets include: - Iopofosine I 131, a PDC for targeted delivery of iodine-131, currently in Phase 2b trials for multiple myeloma and CNS lymphoma [3][4] - CLR 121225, targeting solid tumors like pancreatic cancer using actinium-225 [3] - CLR 121125, aimed at other solid tumors such as triple negative breast cancer, lung cancer, and colorectal cancer [3] - The company has multiple partnered PDC assets and preclinical PDC chemotherapeutic programs [3] Regulatory Designations - Iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA for various cancer indications [4]

Clinical Trial Results - Iopofosine I 131 demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER-WaM study, exceeding the primary endpoint of a 20% MRR [1] - The results were presented at the 66th Annual American Society of Hematology Conference in December 2024 [1] Product Pipeline - The company's lead asset is iopofosine I 131, a Phospholipid Drug Conjugate (PDC) designed for targeted delivery of iodine-131 [7] - Other pipeline assets include CLR 121225 (actinium-225 based program) and CLR 121125 (iodine-125 Auger-emitting program) targeting solid tumors [7] - The company is advancing radioconjugate PDC programs, including alpha- and Auger-emitting radioconjugates, into Phase 1/2a solid tumor studies [8] Regulatory and Market Strategy - Iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA [4] - The company is pursuing conditional U.S. market approval through the FDA's accelerated approval process and aligning with the European Medicines Agency for global approval [5] - A confirmatory study with 40-60 patients per arm is expected to be completed within 18 months of the first patient enrollment [5] Strategic Initiatives - The company plans to advance iopofosine I 131 through internal development, strategic partnerships, and other approaches [8] - CLR 121225, an alpha-emitting actinium-225 radioconjugate, has shown activity in pancreatic, colorectal, and breast cancer animal models, with an IND application planned for Q1 2025 [9] - The company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125 [6] Corporate Updates - The company will present its 2025 strategic initiatives at the Biotech Showcase during the 43rd Annual JP Morgan Healthcare Conference in January 2025 [8] - A live webcast and replay of the presentation will be available on the company's investor relations website [10]

Core Insights - Cellectar Biosciences, Inc. has announced a strategic update regarding its clinical development programs for its proprietary phospholipid ether drug conjugate platform targeting cancer [1] - The company is pursuing strategic options for the further development and commercialization of its product candidate, iopofosine I 131, following recent communications with the FDA [1][3] Group 1: Clinical Development and Regulatory Updates - The CLOVER-WaM study was conducted based on earlier FDA communications, indicating that positive results for major response rate (MRR) could support accelerated approval for iopofosine I 131 in treating Waldenstrom's macroglobulinemia (WM) [2] - A Type-C meeting with the FDA indicated that a submission for accelerated approval would need to be based on MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study focused on progression-free survival (PFS) [3] Group 2: Strategic Focus and Resource Allocation - The company plans to concentrate its resources on targeting solid tumors by advancing its actinium-225-based program CLR 121225 and iodine-125 Auger-emitting program CLR 121125 into clinical trials [4] - Cellectar expects to file Investigational New Drug applications for both CLR-121225 and CLR-121125 in the first half of 2025, initiating Phase 1 clinical studies in solid tumor cancers [5] Group 3: Financial and Operational Adjustments - The company will reduce its headcount by approximately 60%, expected to be completed by the end of the fourth quarter of 2024, to extend its cash runway into the third quarter of 2025 [5] - Following these developments, CLRB stock has seen a significant decline of 73.40%, trading at $0.34 [6]

Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash and cash equivalents of $34.3 million, a significant increase from $9.6 million as of December 31, 2023, due to funds raised from investor exercises of Tranche B warrants [21] - Net loss for the period was $14.7 million or $0.37 per basic share, compared to a net loss of $17.5 million or $1.55 per basic share during the same period in 2023, indicating a reduction in losses [26] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $5.5 million in Q3 2024 from approximately $7.0 million in Q3 2023, primarily due to reduced clinical study costs [24] - General and administrative expenses increased to $7.8 million in Q3 2024 from $2.4 million in Q3 2023, driven by costs associated with commercialization infrastructure development [25] Market Data and Key Metrics Changes - The U.S. market for Waldenstrom's macroglobulinemia (WM) includes approximately 26,000 patients, with 1,500 to 1,900 new diagnoses annually, and about 11,500 patients requiring treatment in the relapsed/refractory setting [44] - There are approximately 5,700 patients in the total addressable market for third-line or greater therapy, highlighting a significant unmet need for new FDA-approved treatments [45][47] Company Strategy and Development Direction - The company is focused on the NDA submission for iopofosine I 131 in WM, with a planned product launch in the second half of 2025, despite a delay in NDA submission to potentially Q2 2025 [10][14] - Expansion of iopofosine I 131 to other indolent lymphomas is viewed as a smart investment to increase overall revenue opportunities [15] - The company is also exploring collaborations for clinical development in other indications, such as mycosis fungoides, and has plans for ongoing development in pediatric high-grade gliomas [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of iopofosine I 131 to become a first-in-class treatment for relapsed/refractory WM patients, supported by strong clinical data [31][77] - The company remains engaged with the FDA regarding the regulatory pathway and is committed to expediting the NDA submission process [58] Other Important Information - The company has secured a second manufacturing source for iopofosine I 131, enhancing production capacity and supply redundancy [15] - A strategic master supply agreement has been signed with Northstar Medical Radioisotopes for the procurement of Actinium-225, ensuring a reliable source for future development [74] Q&A Session Summary Question: Concerns about FDA's interest in confirmatory studies - Management clarified that the FDA has indicated that a confirmatory study is not required to be ongoing prior to NDA submission [82][83] Question: Financial guidance regarding cash runway and warrant exercises - Management noted that an interim raise may be required before the first tranche of warrants is exercised, but the overall $73 million from warrant exercises should satisfy commercial launch needs [86][88]