Cellectar Biosciences, Inc. (CLRB): Business Model Canvas [Dec-2025 Updated]

You're looking at Cellectar Biosciences, Inc., trying to figure out if this late-stage radiopharma firm, built around its proprietary Phospholipid Drug Conjugate (PDC) platform, is worth the risk as they push toward potential approval for their lead asset. Honestly, the science is compelling, showing a 58.2% Major Response Rate in Waldenstrom's Macroglobulinemia, but you know the drill: they are pre-commercial and burning capital, with R&D costs hitting $2.5 million in Q3 2025 alongside $2.3 million in G&A. We mapped out their entire Business Model Canvas, showing you the key partnerships, like the one for Actinium-225 supply, the reliance on financing-they pulled in $5.8 million gross proceeds in October 2025-and the clear path they need to clear with the FDA to turn that clinical data into actual revenue streams.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Key Partnerships

You're looking at the core alliances Cellectar Biosciences, Inc. (CLRB) has locked down to fuel its late-stage pipeline development and future commercialization efforts. These partnerships are critical for securing specialized resources and de-risking capital-intensive clinical programs, so let's break down the key players and the numbers we know as of late 2025.

Isotope Supply and Radiopharmaceutical Development

Securing a reliable source for specialized isotopes is non-negotiable in this sector. Cellectar Biosciences, Inc. addressed this directly with a key supplier.

• Entered a supply agreement with ITM Isotope Technologies Munich SE (ITM) on September 11, 2025, for GMP-Grade Actinium-225 (Ac-225).
• This supply supports the clinical development of actinium-labeled phospholipid ether (PLE) candidates, specifically the Phase 1-ready compound, CLR 121225.
• ITM will supply the required quantities of Ac-225, which is produced by Actineer™ Inc., their joint venture with Canadian Nuclear Laboratories.

Clinical Trial Execution Support

Moving drugs through the clinic requires specialized Contract Research Organization (CRO) expertise. Cellectar Biosciences, Inc. formalized a relationship to support a specific trial.

The partnership with Evestia Clinical, announced on September 24, 2025, is for full CRO services supporting the upcoming Phase 1b study of CLR 125 in triple-negative breast cancer (TNBC). Evestia Clinical brings significant experience to the table, having participated in over 300 oncology studies across solid tumors and hematologic malignancies.

Intellectual Property and Pediatric Cancer Focus

The foundation of the platform is protected by licensing agreements, particularly those focusing on pediatric indications where unmet needs are high. The relationship with the Wisconsin Alumni Research Foundation (WARF) is central here.

Cellectar Biosciences, Inc. holds an exclusive license from WARF for intellectual property covering iopofosine I-131 use in pediatric solid cancers, including high-grade glioma, neuroblastoma, and sarcoma. This collaboration is tied to non-dilutive funding support:

Metric	Value	Context
NCI Grant Amount	$2 million	Awarded to further evaluate iopofosine in pediatric high-grade gliomas based on prior Phase 1a study performance.
Pediatric Indication Covered	High-Grade Glioma, Neuroblastoma, Sarcoma	Specific solid cancers covered under the exclusive WARF license.

The CLOVER-2 Phase 1b study is currently enrolling patients with high-grade glioma, aligning with this IP focus. While direct financial terms of the WARF license aren't public, the associated $2 million NCI grant provides a concrete financial anchor to this research area.

Investigator-Sponsored Trials and Clinical Sites

Beyond the CRO, site relationships are key for patient access. The ongoing Phase 1b study for iopofosine I-131 in pediatric high-grade glioma is enrolling at up to fifteen leading pediatric cancer centers in North America.

For the CLR 125 TNBC trial, Cellectar Biosciences, Inc. selected a Mayo Clinic Network site as a treatment center, with Dr. Pooja Advani serving as the lead investigator.

Commercialization Partnership Strategy for Iopofosine I-131

The path to market for the lead asset, iopofosine I-131, is heavily dependent on securing a strategic partner, especially given the capital requirements for the confirmatory study needed for FDA accelerated approval.

• The company is in active discussions with multiple potential partners to support the NDA filing for accelerated approval in Waldenstrom's Macroglobulinemia (WM).
• The European Medicines Agency (EMA) confirmed eligibility for conditional marketing authorization, with Cellectar Biosciences, Inc. planning to submit the application in 2026 for refractory WM.
• The Phase 2 CLOVER WaM study demonstrated an 83.6% overall response rate and a 58.2% major response rate in WM patients.

The urgency for a partnership is underscored by the balance sheet. As of September 30, 2025, Cellectar Biosciences, Inc. held $12.6 million in cash and cash equivalents, which is budgeted to fund operations into the third quarter of 2026.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Key Activities

You're looking at the core engine driving Cellectar Biosciences, Inc. right now, which is all about pushing their radioconjugates through the clinic and securing the necessary capital to get them across the finish line. Here's the quick math on what they are actively doing as of late 2025.

Conducting and Managing Clinical Trials

Managing the trials for iopofosine I 131 and getting CLR 125 into the clinic are massive undertakings. The data coming out of these studies dictates everything else.

For the lead asset, iopofosine I 131 in Waldenstrom Macroglobulinemia (WM), the Phase 2b CLOVER WaM study enrolled a total of 55 patients in the modified Intent to Treat (mITT) population. This trial achieved a 58.2% Major Response Rate (MRR), significantly beating the 20% statistical hurdle agreed upon with the FDA. The Overall Response Rate (ORR) in evaluable patients hit 83.6%, with 98.2% of patients experiencing disease control.

In the pediatric high-grade glioma study (CLOVER-2 Phase 1b), the Maximum Tolerated Dose was determined to be greater than 60mCi/m2. Clinical data showed an average of 5.4 months Progression-Free Survival (PFS) and 8.6 months Overall Survival (OS), alongside a 100% disease control rate.

For the next-generation asset, CLR 125, the company initiated a Phase 1b dose finding study for relapsed triple-negative breast cancer (TNBC). This study is designed to assess three dose levels:

Dose Level	Cycles Administered	Target Patients Per Arm
32.75 mCi	4	Minimum of 15
62.5 mCi	3	Minimum of 15
95 mCi	2	Minimum of 15

The company planned to initiate this Phase 1b study in late 2025.

Regulatory Submissions to FDA for NDA and EMA for Conditional Marketing Approval

Regulatory activity is focused on securing market access for iopofosine I 131. Cellectar Biosciences has secured multiple designations, including Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA, and Orphan Drug and PRIME designations from the EMA for WM. Furthermore, on October 27, 2025, the company received Rare Pediatric Drug Designation (RPDD) from the FDA for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma (r/r pHGG).

For the EMA, the Scientific Advice Working Party (SAWP) confirmed eligibility to submit for a Conditional Marketing Authorization (CMA). The company had submitted data to the EMA, with a response expected in late July 2025. The planned CMA submission is now targeted for 2026. For the FDA, the company continues to support a path toward a New Drug Application (NDA) for accelerated approval, which is contingent on securing sufficient funding and starting a confirmatory trial.

Research and Development of Next-Generation Radioconjugates (CLR 125, CLR 225)

The R&D key activity involves advancing the pipeline beyond the lead asset. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, including triple-negative breast cancer (TNBC), lung, and colorectal cancers. CLR 225 is an actinium-225 (Ac-225) based alpha-emitting program that has shown activity in multiple solid tumor animal models, including pancreatic cancer. Cellectar Biosciences has completed the required IND-enabling studies for CLR 225.

Financial tracking shows that Research and Development Expenses for the three months ended September 30, 2025, were approximately $2.5 million.

Manufacturing and Supply Chain Management for Radioisotopes

Securing the necessary radioisotopes is a critical operational activity. Cellectar Biosciences entered into two key agreements:

• A long-term multi-isotope supply agreement with Nusano to provide iodine-125 and actinium-225 for clinical studies and future commercial needs.
• A supply agreement with ITM Isotope Technologies Munich (ITM) specifically for Actinium-225 (Ac-225) to support the clinical development of CLR 225.

Securing Capital Through Financing and Strategic Collaborations

The company's near-term operations are heavily reliant on capital management. As of September 30, 2025, Cellectar Biosciences reported cash and cash equivalents of $12.6 million, down from $23.3 million at the end of 2024. This cash balance is believed to be adequate to fund budgeted operations into the third quarter of 2026.

Financing activities in 2025 included several capital raises:

• The company raised approximately $12.7 million in Q3 2025.
• In July 2025, they raised approximately $5.8 million from the exercise of existing warrants.
• An underwritten public offering in July 2025 was priced to raise approximately $6 million in gross proceeds.

Financially, the net loss attributable to common stockholders for Q3 2025 was $4.4 million, with General and Administrative Expenses at approximately $2.3 million for the same period. To maximize shareholder value, Cellectar engaged Oppenheimer as an exclusive financial advisor to evaluate strategic alternatives, which may include mergers, acquisitions, or partnerships.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Key Resources

You're looking at the core assets Cellectar Biosciences, Inc. (CLRB) relies on to drive value right now. These aren't just line items; they are the foundation of their near-term commercial and development strategy.

Proprietary Phospholipid Drug Conjugate (PDC) delivery platform

Cellectar Biosciences, Inc. uses its proprietary Phospholipid Drug Conjugate (PDC) delivery platform to create drugs that specifically target cancer cells, aiming for better efficacy and safety.

• The platform supports the development of PDCs for targeted delivery of payloads like iodine-131 (iopofosine) and chemotherapeutics such as paclitaxel (CLR 1602-PTX) in the preclinical stage.
• The company is advancing next-generation radiopharmaceuticals using this platform, including CLR 125, with an Investigational New Drug (IND) filing planned for late 2025 or early 2026.

Iopofosine I-131 clinical data (83.6% ORR in CLOVER-WaM)

The clinical results for iopofosine I-131 in relapsed/refractory Waldenstrom's Macroglobulinemia (WM) provide significant leverage for regulatory discussions.

Metric	Value	Context
Overall Response Rate (ORR)	83.6%	Phase 2 CLOVER-WaM Study
Major Response Rate (MRR)	58.2%	Phase 2 CLOVER-WaM Study
Primary Endpoint Target (MRR)	20%	Exceeded in CLOVER-WaM
Confirmatory Study Enrollment (Per Arm)	40-60 patients	Projected full enrollment within 18 months of first patient

FDA Breakthrough Therapy and Orphan Drug Designations

Regulatory designations streamline development and can support premium pricing upon approval. Cellectar Biosciences, Inc. has secured several key designations for iopofosine I-131 across various indications.

• FDA Breakthrough Therapy Designation
• Six Orphan Drug Designations
• Five Rare Pediatric Drug Designations (one for inoperable relapsed/refractory pediatric high-grade glioma)
• Two Fast Track Designations

Cash and cash equivalents of $12.6 million as of September 30, 2025

This figure represents the immediate liquidity available to Cellectar Biosciences, Inc. to fund operations.

Financial Metric	Amount as of September 30, 2025	Comparison Point
Cash and Cash Equivalents	$12.6 million	$23.3 million as of December 31, 2024
Projected Cash Runway	Into the third quarter of 2026	Based on budgeted operations
Subsequent Capital Raise (October 2025)	Approximately $5.8 million (gross proceeds)	From exercising existing warrants

Licensed intellectual property from the Wisconsin Alumni Research Foundation

The relationship with the Wisconsin Alumni Research Foundation (WARF) provides Cellectar Biosciences, Inc. with foundational, exclusive rights to key technology.

• Cellectar Biosciences, Inc. holds an exclusive license from WARF to develop and commercialize iopofosine in various pediatric solid cancers, including high-grade glioma, neuroblastoma, and sarcoma.
• The company has established exclusivity on a broad U.S. and international intellectual property rights portfolio around its proprietary cancer-targeting PLE technology platform, including iopofosine.
• The encouraging performance of iopofosine in the pediatric Phase 1a study, which stems from WARF-related research, led to a $2 million NCI grant.

Finance: draft next quarter's cash burn projection by next Tuesday.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Cellectar Biosciences, Inc. (CLRB) offers a compelling proposition to patients and potential partners right now. It all centers on their proprietary Phospholipid Drug Conjugate (PDC) delivery platform, which is designed to use a phospholipid ether to deliver therapeutic radioisotopes directly to cancer cells, aiming for improved efficacy and fewer off-target effects.

For Waldenstrom's Macroglobulinemia (WM), iopofosine I-131 is positioned as a potential first-in-class treatment for refractory patients. This is strongly supported by the regulatory momentum, including the FDA granting it Breakthrough Therapy Designation, alongside Fast Track and Orphan Drug Designations from the FDA, and Orphan Drug and PRIME Designations from the EMA.

The clinical data in WM is what really drives this value. The Phase 2 CLOVER WaM study showed remarkable results against the disease in a heavily pretreated population, including those refractory to Bruton Tyrosine Kinase inhibitors (BTKi).

Metric	Value/Status	Context
Major Response Rate (MRR)	58.2%	Phase 2 CLOVER WaM study result, significantly exceeding the primary endpoint target of 20% MRR.
Overall Response Rate (ORR)	83.6%	Phase 2 CLOVER WaM study result.
Regulatory Status (US)	Breakthrough Therapy Designation	Granted by the FDA for relapsed/refractory WM.
Regulatory Status (EU)	Eligibility for Conditional Marketing Authorization (CMA)	Confirmed by EMA's SAWP, with a planned CMA submission in 2026.
Cash Position (9/30/2025)	$12.6 million	Cash and cash equivalents reported as of the end of Q3 2025.

Beyond WM, Cellectar Biosciences, Inc. is addressing significant unmet needs in rare cancers and solid tumors through pipeline expansion. They received Rare Pediatric Disease Designation from the FDA for iopofosine I-131 in inoperable relapsed/refractory pediatric high-grade glioma (r/r pHGG) on October 27, 2025. Furthermore, the company initiated a Phase 1b study for CLR 125 targeting triple-negative breast cancer (TNBC).

The potential financial upside tied to these pediatric designations is a clear value driver. If the New Drug Application (NDA) for iopofosine I-131 is approved, Cellectar Biosciences, Inc. is eligible to receive a Pediatric Review Voucher from the FDA upon reauthorization of the program. This voucher can be used to accelerate the review of another product or be sold, which represents a non-dilutive financial asset.

Here's a quick look at the recent financial context supporting these operations:

• Cash balance of $12.6 million as of September 30, 2025, down from $23.3 million at the end of 2024.
• Budgeted operations are funded into the third quarter of 2026 based on the September 30, 2025, balance.
• Q3 2025 net loss was $4.4 million.
• R&D expenses for Q3 2025 were approximately $2.5 million.
• G&A expenses for Q3 2025 were approximately $2.3 million.
• Gross proceeds of approximately $5.8 million were raised in October 2025 from warrant exercises.

The value proposition is built on delivering targeted radiotherapeutics with demonstrated, high-level efficacy in hard-to-treat cancers, backed by multiple regulatory advantages that streamline the path to market access, which is defintely key for a company of this size.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Customer Relationships

You're looking at how Cellectar Biosciences, Inc. (CLRB) manages its critical external connections as of late 2025. For a late-stage clinical company, these relationships are the lifeblood, directly impacting clinical trial progress, regulatory success, and capital availability. It's all about trust and demonstrated progress.

Close, high-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

The engagement with the medical community is centered on validating the Phospholipid Drug Conjugate (PDC) platform, especially with iopofosine I 131. The data presented from the Phase 2 CLOVER-WaM study, showing an 83.6% Overall Response Rate (ORR) and a 58.2% Major Response Rate (MRR), is the core currency used in these high-level discussions with KOLs like Dr. Sikander Ailawadhi from Mayo Clinic, who presented those results in late 2024.

For the newer pipeline assets, the relationship building is focused on trial initiation and early data generation. For instance, the Phase 1b study of CLR 125 in triple-negative breast cancer (TNBC) was recently initiated, with Pooja Advani acting as the lead investigator, signaling a direct, hands-on relationship to drive that program forward. You can expect dosimetry and efficacy data from this CLR 125 study throughout 2026.

Here's a snapshot of the progress that fuels these KOL relationships:

Program/Trial	Key Metric	Value/Status (as of late 2025)
Iopofosine I 131 (CLOVER-WaM)	Overall Response Rate (ORR)	83.6%
Iopofosine I 131 (CLOVER-WaM)	Major Response Rate (MRR)	58.2%
CLR 125 (pHGG Trial, n=7)	Average Overall Survival (OS)	8.6 months
CLR 125 (pHGG Trial, n=7)	Patients with Disease Control	100% (All 7 patients)

That kind of clinical evidence is what keeps the top oncologists engaged. It's definitely the primary driver for scientific collaboration.

Direct communication with regulatory agencies (FDA, EMA) for accelerated pathways

Regulatory engagement is a high-stakes, high-touch relationship for Cellectar Biosciences, Inc., given its focus on rare and refractory cancers. The company has secured key designations that shape these ongoing dialogues.

For the European Medicines Agency (EMA), there was productive engagement resulting in Scientific Advice Working Party (SAWP) advice confirming eligibility to seek a Conditional Marketing Authorization (CMA) for iopofosine I 131 in post-BTKi refractory Waldenstrom macroglobulinemia, with a planned submission in 2026 and potential commercialization in 2027.

On the U.S. side, the relationship with the FDA has resulted in the receipt of Rare Pediatric Drug Designation for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma (r/r pHGG). Furthermore, the company maintains ongoing plans for a New Drug Application (NDA) to the FDA for accelerated approval, though this is contingent on securing sufficient funding.

• FDA Designation Secured: Rare Pediatric Drug Designation (r/r pHGG)
• EMA Pathway: Eligibility confirmed for Conditional Marketing Authorization (CMA)
• Planned CMA Submission Year: 2026

Relationships with patient advocacy and support groups for rare diseases

While specific partnership dollar amounts or the exact number of formal advocacy group agreements aren't public, the entire strategy for iopofosine I 131 is anchored in serving patient populations with significant unmet need, which inherently requires strong ties to advocacy groups. The focus on Waldenstrom's macroglobulinemia (WM) and pediatric high-grade glioma (pHGG) means these groups are crucial for trial recruitment and patient support.

The company's commitment to these groups is evidenced by the pursuit of expedited pathways for these specific indications. The FDA's Rare Pediatric Drug Designation itself is a direct acknowledgment of the relationship with the rare disease community, signaling a commitment to this patient base.

The company's investor base also shows engagement from healthcare-dedicated funds, with 14 institutional investors adding shares in the most recent quarter, suggesting confidence from specialized financial partners who often track patient impact closely.

Investor relations and capital market communications

Investor relations is a constant, high-frequency relationship for a company needing to fund clinical development. Cellectar Biosciences, Inc. actively manages this through regular filings and specific capital raises throughout 2025.

You saw significant capital activity in the second half of 2025, which required direct communication with institutional investors and placement agents like Ladenburg Thalmann & Co. Inc. The company closed an underwritten public offering in July 2025 for gross proceeds of approximately $6.9 million. Later, in October 2025, they raised an additional gross amount of approximately $5.8 million through warrant exercises.

The cash position and runway dictate the tone of these communications. As of September 30, 2025, the cash balance stood at $12.6 million, down from $23.3 million at December 31, 2024. Management stated this cash balance funds budgeted operations into the third quarter of 2026. The Q3 2025 net loss was $4.4 million.

The investor base itself is relatively concentrated, with a total of 11 institutional investors listed. In the most recent quarter, 14 institutional investors added to their positions, while 24 decreased theirs. Even the Chief Operating Officer, Jarrod Longcor, showed conviction by purchasing 30,000 shares for an estimated $8,400.

Here's the capital relationship summary:

Activity/Metric	Date/Period	Amount/Count
Cash & Equivalents	September 30, 2025	$12.6 million
Cash & Equivalents	December 31, 2024	$23.3 million
Gross Proceeds from Warrant Exercise	October 2025	Approx. $5.8 million
Gross Proceeds from Public Offering	July 2025	Approx. $6.9 million
Net Loss	Q3 2025	$4.4 million
Institutional Investors (Total)	As of late 2025	11

Finance: draft 13-week cash view by Friday.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Channels

You're looking at how Cellectar Biosciences, Inc. (CLRB) gets its data, regulatory clearances, and eventually, its specialized radiopharmaceuticals to the market as of late 2025. It's a multi-pronged approach built on clinical validation and securing the supply chain.

Clinical trial sites and research institutions form the bedrock for generating the data needed for regulatory submissions. While the prompt mentions Florida Cancer Specialists, the recent focus has been on advancing trials for iopofosine I 131 and initiating new ones for pipeline assets. The Phase 2b CLOVER WaM study for Waldenstrom Macroglobulinemia (WM) has seen patient follow-up decline as patients move off study, which is a natural progression for a late-stage trial. Looking ahead, the company is preparing to launch a new trial channel for its next-generation asset.

Here's a look at the active and planned clinical development channels:

Drug Candidate	Indication	Trial Phase/Status	Key Metric/Target
Iopofosine I 131	Post-BTKi refractory WM	Phase 2b Data Finalizing/CMA Submission Prep	Major Response Rate (MRR) of 58.2% achieved in Phase 2b.
Iopofosine I 131	Pediatric High-Grade Glioma (r/r pHGG)	IND-Enabling/Designation Received	Received Rare Pediatric Drug Designation (RPDD) on October 27, 2025.
CLR 125	Relapsed Triple-Negative Breast Cancer (TNBC)	Phase 1b Protocol Submitted (June 2025)	Planned initiation in late 2025 or early 2026; study involves 15 patients per dosing arm.
CLR 225	Solid Tumors (e.g., Pancreatic Cancer)	IND-Enabling Studies Complete	Phase 1 study contingent upon securing sufficient company funding.

Direct regulatory submissions to the FDA and EMA are a critical channel for market access. For iopofosine I 131 in WM, Cellectar Biosciences has been highly active. The company completed a key FDA meeting and made submission progress with the EMA. Specifically, in October 2025, the EMA's Scientific Advice Working Party advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 could be acceptable. A decision on this EMA recommendation was expected by late third quarter or early fourth quarter 2025. For the U.S. FDA, the intent is to pursue accelerated approval, which is contingent upon securing additional funding and starting a confirmatory trial. The FDA granted Breakthrough Therapy Designation for WM in the second quarter of 2025, and data suggests that 79% of oncology drugs with this designation are successfully awarded accelerated approval by the FDA. Furthermore, the FDA granted Rare Pediatric Disease Designation for iopofosine I 131 in relapsed or refractory pediatric high-grade glioma on October 27, 2025.

The future specialized distribution network for radiopharmaceuticals is being built now, well ahead of potential commercialization. This is key because radiopharmaceuticals require specialized handling and logistics. Cellectar Biosciences broadened its global manufacturing network in preparation for potential commercialization of iopofosine I 131 in 2025. This involved signing a commercial supply agreement with SpectronRx, which will use its facilities in Indiana and Belgium to produce the therapy. The company also secured long-term agreements for necessary isotope supplies, such as iodine-125 and actinium-225, including a supply agreement with ITM Isotope Technologies Munich (ITM) for Actinium-225 to support CLR 225. The commercial work conducted previously indicated that iopofosine possesses a profile supporting 'off-the-shelf global distribution.'

Disseminating data through scientific publications and medical conferences is the channel used to build credibility and inform the medical community. Cellectar Biosciences has been active in this area throughout 2025. Management showcased data from its programs at medical meetings in the third quarter of 2025, including posters and oral presentations at the American Association for Cancer Research and other special conferences in cancer research. For instance, preclinical data was presented in a poster presentation at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research on October 14, 2025. The efficacy data from the CLOVER-WaM study, which showed an overall response rate (ORR) of 83.6%, was previously presented as a podium presentation during the 66th Annual American Society of Hematology Conference in December 2024.

• Data from the CLOVER-WaM trial was presented to the EMA during the second quarter of 2025 as part of the registration package.
• The company actively engages with investors through quarterly conference calls, such as the one held on November 13, 2025, for Q3 2025 results.
• The company is actively exploring strategic alternatives, including partnerships, which is another key channel for advancing its pipeline.

The company is defintely using these channels to push its lead asset toward potential approval and to advance its pipeline assets into the clinic.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Customer Segments

You're looking at the specific groups Cellectar Biosciences, Inc. (CLRB) targets with its targeted radiotherapeutic candidates, primarily iopofosine I 131 and CLR 125. These segments are defined by rare and difficult-to-treat cancer indications where existing options are limited or failing.

The primary focus areas for iopofosine I 131 involve hematologic malignancies, while the newer pipeline assets like CLR 125 target specific solid tumors. The professional segment comprises the specialists who treat these patients.

Here is a breakdown of the key customer segments Cellectar Biosciences, Inc. (CLRB) is addressing as of late 2025:

• Patients with refractory Waldenstrom's Macroglobulinemia (WM).
• Pediatric patients with inoperable relapsed/refractory high-grade glioma.
• Patients with solid tumors like Triple-Negative Breast Cancer (TNBC) in clinical trials.
• Oncologists and hematologists specializing in rare cancers.

For the Waldenstrom's Macroglobulinemia (WM) segment, the market size is substantial given the lack of curative options, especially post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy. The data from the CLOVER WaM pivotal study, which focused on heavily pretreated patients, directly informs the value proposition for this group.

WM Patient Sub-Segment	Estimated US Population/Metric	Clinical Trial Data Context (Iopofosine I 131)
Total US Prevalence	Approximately 26,000	N/A
Require Relapsed/Refractory Treatment	Approximately 11,500 patients	N/A
Require 3rd Line or Greater Therapy	Approximately 4,700 patients	N/A
Exhausted All 3rd Line Options	Approximately 1,000 patients	N/A
CLOVER WaM Patients Refractory to All Therapies	Approximately 27% of the study population	58.2% Major Response Rate (MRR) in post-BTKi refractory patients

The pediatric high-grade glioma (pHGG) segment is targeted with iopofosine I 131 under Rare Pediatric Drug Designation. The CLOVER-2 Phase 1b trial provides the initial engagement metrics for this customer group.

The data from the CLOVER-2 trial as of June 10, 2025, shows a clear differentiation against historical benchmarks:

• Total pHGG patients enrolled in CLOVER-2: n=14.
• Patients receiving a minimum of 55 mCi total dose (n=7): Average Progression-Free Survival (PFS) of 5.4 months.
• Literature median PFS for relapsed pHGG: Approximately 2.25 months.
• Patients receiving a minimum of four total infusions (n=3): Average Overall Survival (OS) of 11.5 months.

For solid tumors, Cellectar Biosciences, Inc. (CLRB) is initiating a Phase 1b study for CLR 125 in relapsed/refractory Triple-Negative Breast Cancer (TNBC) in the fourth quarter of 2025. This segment is defined by patients who have failed at least one prior therapy.

The structure of the initial engagement with TNBC patients is precise:

• Trial Phase: Phase 1b Dose Finding study for CLR 125.
• Target Population: Relapsed/refractory TNBC patients.
• Dose Levels Assessed: Three dose levels in parallel.
• Enrollment Expectation: Minimum of 15 evaluable patients per arm.

The final segment, the prescribers and influencers, are the oncologists and hematologists. Their engagement is evidenced by the presentation of data at major medical conferences and the granting of regulatory designations, which signal clinical relevance to this professional group. For instance, data was presented at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer in late September 2025. Furthermore, the company's lead asset has received multiple designations, including FDA Breakthrough Therapy Designation and five Rare Pediatric Drug Designations.

The financial context of Cellectar Biosciences, Inc. (CLRB) as of late 2025 also frames the commercial viability for these segments. As of September 30, 2025, cash and cash equivalents were reported at $12.6 million. Research and Development Expenses for the third quarter ended September 30, 2025, were approximately $2.5 million.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Cost Structure

You're looking at the major outlays for Cellectar Biosciences, Inc. (CLRB) as they push their radiopharmaceutical pipeline forward. For a late-stage clinical company, the cost structure is heavily weighted toward development and regulatory hurdles, not sales yet. Honestly, this is where the cash burn happens before any revenue hits the books.

The biggest recurring costs are the operational expenses tied to keeping the science moving and the company compliant. For the third quarter ending September 30, 2025, we saw Research and Development (R&D) expenses come in around $2.5 million. General and Administrative (G&A) expenses were slightly lower for the same period at about $2.3 million. These figures show a reduction compared to the prior year, which management attributed to disciplined spending, but they are still substantial fixed costs to cover.

Here's a quick look at those key operating expenses for the first three quarters of 2025:

Metric	Q1 2025 ($USD Millions)	Q2 2025 ($USD Millions)	Q3 2025 ($USD Millions)
Research & Development (R&D)	3.43	2.39	2.52
General & Administrative (G&A)	2.97	3.65	2.33
Total Operating Expenses	6.40	6.04	4.85

The clinical trial costs are a massive variable within R&D. You know the confirmatory Phase 3 trial for iopofosine I-131 in Waldenstrom's Macroglobulinemia (WM) is the next big financial hurdle. Management has detailed that this trial is estimated to cost approximately $40 million in total to complete. To even start the process, they need to secure between $10 million and $12 million, which represents about 25% to 30% of the total projected cost, just to initiate enrollment and get the necessary data for a potential New Drug Application (NDA) submission. Patient follow-up and site management are the day-to-day drains here.

Then you have the specialized costs related to the product itself. Manufacturing and procurement costs for radioisotopes are critical. Cellectar Biosciences has secured a supply agreement with ITM Isotope Technologies Munich (ITM) specifically for Actinium-225 (Ac-225) to support the development of their compound CLR 225. While the dollar amount for procurement isn't public, securing a long-term supply agreement is a major operational commitment that locks in future costs for these specialized, often scarce, materials.

Finally, you can't forget the non-clinical spending that keeps the lights on and the patents active. This includes:

• Regulatory and intellectual property maintenance costs.
• Costs associated with engaging with the European Medicines Agency (EMA) for the Conditional Marketing Authorization (CMA) submission eligibility.
• Fees to maintain the Rare Pediatric Drug Designation (RPDD) for iopofosine I-131.
• General legal and patent upkeep for the Phospholipid Drug Conjugate (PDC) platform.

If onboarding takes 14+ days, churn risk rises. Finance: draft 13-week cash view by Friday.

Cellectar Biosciences, Inc. (CLRB) - Canvas Business Model: Revenue Streams

You're looking at the current financial lifeblood of Cellectar Biosciences, Inc. (CLRB) as of late 2025. Since this is a late-stage clinical company, the revenue picture is all about financing the pipeline, not selling the drug yet. It's a capital-intensive phase, so non-product funding is the main story right now.

Current Operating Revenue Status

Cellectar Biosciences, Inc. is currently pre-commercial. This means the primary revenue stream you'd see for a mature company-product sales-is absent. For instance, in the first quarter of 2025, the reported revenue was $0.00. The Q3 2025 financial report confirmed this status, showing no product revenue, with the net loss for that quarter being $4.4 million. The company's cash position as of September 30, 2025, stood at $12.6 million.

Financing Activities: Equity and Warrant Proceeds

The most immediate and concrete revenue source comes from financing activities, which keep the lights on and fund clinical trials. You saw significant activity here in 2025.

Here's a quick look at the capital raised through equity and warrant exercises leading up to the end of Q3 2025 and shortly after:

Financing Event	Date Reference	Gross Proceeds Amount
Exercise of Certain Existing Warrants	October 2025	Approximately $5.8 million
July 2025 Underwritten Public Offering (Closing)	July 2025	$6.9 million
Separate June and July 2025 Financings (Aggregate)	June/July 2025	Nearly $9.5 million
Total Raised (Financings & Subsequent Exercises)	Through Q3 2025	Approximately $12.7 million

These proceeds are critical; the cash balance as of September 30, 2025, was deemed adequate to fund budgeted operations into the third quarter of 2026.

Future Potential: Milestones and Partnerships

The next layer of potential revenue involves non-dilutive funding through strategic alliances for the lead asset, iopofosine I-131. The company is actively engaged in discussions with multiple potential partners to support the New Drug Application (NDA) filing for accelerated approval.

Key revenue drivers here are:

• Future milestone payments contingent on achieving specific clinical or regulatory goals set by a strategic partner.
• Potential upfront payments or research collaboration fees related to pipeline assets like CLR 125 or CLR 225.
• The company views these collaborations as a way to secure nondilutive capital.

Product Sales and Regulatory Value

The ultimate revenue goal is commercial sales of iopofosine I-131, which is targeted for potential commercialization in 2027.

The revenue potential is tied directly to regulatory success:

The path involves:

• Submitting an NDA to the U.S. Food and Drug Administration (FDA) for accelerated approval, with a target submission of late 2025 or early 2026, contingent on funding and a confirmatory trial being underway.
• Seeking Conditional Marketing Authorization (CMA) from the European Medicines Agency (EMA), with eligibility confirmed following Scientific Advice Working Party (SAWP) guidance.

Furthermore, there is a significant, non-sales-related value attached to pediatric development. Cellectar Biosciences, Inc. is eligible to receive a Pediatric Review Voucher from the FDA upon approval of iopofosine I-131 for pediatric high-grade gliomas, which is a tradable asset with substantial market value.