Cellectar Biosciences (CLRB) Company Report

Cellectar Biosciences' lead product, CLR 131 (Iodine-131), demonstrated strong results in its Phase 2b CLOVER-WaM study for Waldenstrom's macroglobulinemia, achieving a 58.2% major response rate and 84% overall response rate in a highly relapsed, refractory patient population.
CLR 131 has received FDA Breakthrough Designation and EMA PRIME designation, with a conditional marketing authorization (CMA) submission to the EMA anticipated in early Q3 2026, potentially leading to approval and market entry in H1 2027.
The company initiated a Phase 1B study for CLR 125 (Auger emitter) in triple-negative breast cancer (TNBC) in Q1 2026, with initial response data expected in the first half of 2026.
As of September 30, the company reported $12.6 million in cash, supplemented by an additional $5.2 million in October, bringing the total to just under $18 million.

Jan 14, 2026, 9:30 PM

Transcript

Cellectar Biosciences Reports Strong CLR 131 Data and Outlines Regulatory Timelines, Initiates New Study

CLRB

New Projects/Investments

Guidance Update

Cellectar Biosciences reported exceptional Phase 2b data for its lead radiopharmaceutical, CLR 131, in Waldenstrom's macroglobulinemia, achieving a 58.2% major response rate and 84% overall response rate in highly relapsed, refractory patients. This data led to FDA Breakthrough Designation and EMA PRIME designation.
The company anticipates submitting a conditional marketing authorization application to the EMA in early 3Q 2026, with potential approval and market entry in the first half of 2027. A U.S. FDA accelerated application is also being prepared, with an estimated $15 million cost to approval for the U.S. study, which would be initiated post-partnership.
Cellectar has initiated a Phase 1b study for CLR 125 in triple-negative breast cancer in Q1 2026, with imaging data expected in Q1 and initial response data in the first half of 2026.
As of September 30, the company had $12.6 million in cash, supplemented by an additional $5.2 million in October, bringing the total to just under $18 million. The EU market for Waldenstrom's macroglobulinemia is approximately 30% larger than the U.S., presenting a significant opportunity.

Jan 14, 2026, 9:30 PM

Transcript

Cellectar Biosciences Provides Update on CLR 131 Regulatory Progress and New Study Initiation

CLRB

New Projects/Investments

Guidance Update

Cellectar Biosciences' lead product, CLR 131, demonstrated strong efficacy in its CLOVER-WaM phase 2b study for Waldenstrom's macroglobulinemia, achieving a 58.2% major response rate and 84% overall response rate in a highly relapsed, refractory patient population.
CLR 131 has received Breakthrough Designation from the FDA and PRIME designation from the EMA, with an EMA conditional marketing authorization application anticipated in early 3Q 2026 and potential approval in the first half of 2027.
The company initiated a study for CLR 125 in triple-negative breast cancer in Q1 2026, with initial response data expected in the first half of 2026.
Cellectar reported a cash position of just under $18 million as of October, following an addition of $5.2 million to its $12.6 million balance from September 30.

Jan 14, 2026, 9:30 PM

Transcript

Cellectar Biosciences Provides Regulatory and Clinical Updates for Oncology Pipeline

CLRB

New Projects/Investments

Guidance Update

Product Launch

Cellectar Biosciences anticipates submitting its conditional marketing authorization (CMA) application to the EMA in early 3Q 2026 for CLR 131 (iopofosine) for Waldenstrom's macroglobulinemia, with potential approval and market entry in the first half of 2027. The company also achieved breakthrough designation from the FDA and PRIME designation from the EMA for CLR 131.
A study for CLR 125 in triple-negative breast cancer was initiated in Q1 2026, with imaging data expected in Q1 2026 and initial response data in the first half of 2026.
The company reported cash of just under $18 million as of October, comprising $12.6 million as of September 30 and an additional $5.2 million in October.
The likelihood of approval for CLR 131 is high, with 79% for FDA breakthrough designation and 80% for EMA CMA eligibility.

Jan 13, 2026, 9:30 PM

Transcript

Cellectar Biosciences Provides Positive Regulatory and Clinical Updates

CLRB

New Projects/Investments

Guidance Update

Cellectar Biosciences' lead product, CLR 131 (iopofosine), demonstrated strong results in its Phase 2b CLOVER WaM study for Waldenstrom's macroglobulinemia, achieving a 58.2% major response rate, and has received FDA Breakthrough Designation and EMA PRIME designation.
The company anticipates submitting a conditional marketing authorization application for CLR 131 to the EMA in early 3Q 2026, with potential approval and market entry in the first half of 2027.
A Phase 1b study for CLR 125 in triple-negative breast cancer was initiated in Q1 2026, with imaging data expected in Q1 2026 and initial response data in the first half of 2026.
Cellectar reported cash of $12.6 million as of September 30 (presumably 2025), which increased to just under $18 million after adding $5.2 million in October.

Jan 13, 2026, 9:30 PM

Transcript

Cellectar Biosciences Provides Updates on Radiopharmaceutical Programs and Regulatory Timelines

CLRB

New Projects/Investments

Guidance Update

Product Launch

Cellectar Biosciences' lead radioconjugate, CLR 131 (iopofosine), for Waldenstrom's macroglobulinemia (WM), has received FDA Breakthrough Designation and EMA PRIME designation. The company plans to submit a conditional marketing authorization application to the EMA in early 3Q 2026, targeting potential approval and market entry in the first half of 2027.
Clinical data for CLR 131 in highly relapsed, refractory WM patients demonstrated a 58.2% major response rate, 84% overall response rate, and 99% disease control rate, with a duration of response and progression-free survival of 11.4 months.
A phase I-B study for CLR 125 in triple-negative breast cancer was initiated in Q1 2026, with imaging data expected in Q1 2026 and initial response data in the first half of 2026.
As of October 2025, the company reported a cash balance of just under $18 million.

Jan 13, 2026, 9:30 PM

Transcript

Cellectar Biosciences Announces Supply Agreement with Ionetix

CLRB

New Projects/Investments

Cellectar Biosciences (CLRB) has entered into a multi-year supply agreement with Ionetix Corporation for two critical alpha-emitting radioisotopes: Actinium-225 (Ac-225) and Astatine-211 (At-211).
This agreement ensures a reliable, clinical and commercial-scale supply of cGMP-grade Ac-225 and At-211 to support Cellectar's drug development programs through clinical trials and into potential commercial launches of targeted alpha therapy (TAT) candidates.
The supply is essential for advancing Cellectar's CLR-225 into clinical trials as a potential treatment for challenging solid tumor cancers, such as pancreatic cancer.

Dec 16, 2025, 1:05 PM

Press Release

Cellectar Biosciences Reports Q3 2025 Results and Advances Regulatory Strategy for Iopofosine I 131

CLRB

Earnings

Guidance Update

New Projects/Investments

Cellectar Biosciences ended Q3 2025 with $12.6 million in cash and cash equivalents as of September 30, 2025, and expects its cash on hand to fund budgeted operations into the third quarter of 2026. The company raised a net of $5.8 million in July 2025 and an additional $5 million net after the quarter close through warrant exercises.
The company received confirmation of eligibility to file for conditional marketing approval (CMA) in the EU for iopofosine I 131 in Waldenstrom's macroglobulinemia (WM), with a potential launch as early as 2027. This follows the Breakthrough Therapy Designation granted by the FDA in Q2 2025 for the same indication.
For US accelerated approval, Cellectar plans to submit an NDA upon initiation of a confirmatory Phase 3 trial, which is estimated to cost approximately $10 million to initiate and $15 million to reach sufficient enrollment for FDA action.
Cellectar has initiated a Phase 1b study for CLR 125 in triple-negative breast cancer, with dosimetry and early efficacy data expected throughout 2026.

Nov 13, 2025, 1:30 PM

Transcript

Cellectar Biosciences Reports Q3 2025 Results and Regulatory Progress for Iopofosine

CLRB

Earnings

Guidance Update

New Projects/Investments

Cellectar Biosciences has received confirmation of eligibility from the EMA to file for conditional marketing approval for iopofosine I 131 in Waldenstrom’s macroglobulinemia (WM), potentially leading to market entry as early as 2027. The company also plans to submit an NDA for accelerated approval in the U.S. after initiating a confirmatory Phase III trial, for which the FDA has received the requested 12-month follow-up data from the CLOVER-WaM study.
The estimated cost to initiate the U.S. confirmatory Phase III trial for iopofosine is approximately $10 million, with a total cost of about $40 million.
The company reported cash and cash equivalents of $12.6 million as of September 30, 2025, and expects this to fund budgeted operations into the third quarter of 2026.
For Q3 2025, Cellectar Biosciences reported a net loss of $4.4 million (or $1.41 per basic and diluted common share) and reduced research and development expenses to $2.5 million.
Cellectar initiated a Phase 1b study for CLR 125 in triple-negative breast cancer, with dosimetry and early efficacy data readouts expected in the first half of 2026.

Nov 13, 2025, 1:30 PM

Transcript

Cellectar Biosciences Reports Q3 2025 Results, Advances Iopofosine Regulatory Strategy

CLRB

Earnings

New Projects/Investments

Guidance Update

Cellectar Biosciences reported a Q3 2025 net loss of $4.4 million or $1.41 per share, with research and development expenses decreasing to $2.5 million from $5.5 million in Q3 2024. The company ended the quarter with $12.6 million in cash and cash equivalents, projecting a cash runway into Q3 2026.
The EMA confirmed eligibility for conditional marketing approval of iopofosine I 131 in the EU, potentially leading to market entry as early as 2027. For U.S. accelerated approval, an NDA submission is planned upon initiation of a confirmatory Phase 3 trial, requiring approximately $15 million to reach sufficient patient enrollment for FDA action.
The company has initiated a Phase 1b study for CLR 125, targeting solid tumors, with dosimetry and early efficacy data expected in the first half of 2026. Active discussions are ongoing with potential partners for iopofosine to secure non-dilutive capital and commercial expertise.