CLRBW Stock Price, News & Analysis

Cellectar Biosciences (NASDAQ:CLRB) has submitted a protocol to the FDA for a Phase 1b dose-finding study of CLR 125, an Auger-emitting radiopharmaceutical for treating triple-negative breast cancer (TNBC). The study will evaluate three different dosing regimens across 15 patients per arm, totaling 45 patients.

The trial aims to determine the recommended Phase 2 dose, assess safety and tolerability, and evaluate initial response using RECIST criteria and progression-free survival. CLR 125 showed promising preclinical results, demonstrating good tolerability and robust tumor uptake in TNBC animal models. The drug leverages the company's PDC-targeted delivery platform to deliver iodine-125 directly to cancer cell nuclei and mitochondria.

Cellectar Biosciences (CLRB) has announced a 1-for-30 reverse stock split effective June 24, 2025, at 12:01 a.m. Eastern Time. The company's stock will continue trading on Nasdaq under the same symbol with a new CUSIP number 15117F880. This corporate action will reduce outstanding shares from 54,361,197 to approximately 1,812,040. The split was approved by stockholders on June 13, 2025, and will not alter stockholders' ownership percentages except for fractional shares, which will be paid in cash. The reverse split will proportionally adjust equity incentive plans, outstanding stock options, warrants, and preferred stock conversion ratios. Equiniti Trust Company will manage the split process, with no action required from stockholders holding shares either directly or through brokers.

Cellectar Biosciences announced promising initial results from their CLOVER-2 Phase 1 trial of iopofosine I 131 in treating pediatric high-grade glioma (pHGG). Patients receiving a minimum 55 mCi dose (n=7) showed average progression-free survival (PFS) of 5.4 months, more than double the typical 2.25 months median. Overall survival reached 8.6 months, surpassing the standard 5.6 months. Notably, patients receiving four or more infusions (n=3) achieved 8.1 months PFS and 11.5 months overall survival, with two patients showing objective responses. The drug demonstrated good tolerability with manageable side effects, primarily hematologic in nature, with no cardiovascular, renal, liver toxicities, peripheral neuropathy, or significant bleeding reported.

Cellectar Biosciences (NASDAQ: CLRB) has announced agreements to raise $2.5 million through the sale of common stock at market price. The deal involves immediate exercise of outstanding warrants for 8,301,322 shares at a reduced price of $0.3041 per share. These warrants were previously issued between 2020-2024. The offering is expected to close around June 6, 2025, with Ladenburg Thalmann & Co. Inc. serving as exclusive placement agent. The company plans to use the net proceeds for general corporate purposes, including working capital and operating expenses. All shares issuable through warrant exercise are registered or have registered resale under effective registration statements.

Cellectar Biosciences (NASDAQ: CLRB) has received FDA Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class cancer targeting agent, for treating relapsed/refractory Waldenstrom macroglobulinemia (WM). The designation is supported by impressive Phase 2 CLOVER WaM study results, showing an 83.6% overall response rate and 58.2% major response rate, significantly exceeding the primary endpoint target of 20% MRR. The drug has already secured FDA Fast Track and Orphan Drug Designations, along with EMA Orphan Drug and PRIME Designations. Cellectar has submitted data to the EMA for potential fast-track, conditional marketing authorization, with a response expected in late July 2025. This development represents a significant advancement for WM patients, as current treatment options are limited and the condition remains incurable.

Cellectar Biosciences (NASDAQ: CLRB) reported Q1 2025 financial results and provided corporate updates. The company plans to seek conditional approval from EMA for Iopofosine I 131 in treating Waldenstrom Macroglobulinemia, with Phase 2 CLOVER WaM study showing a 59.0% major response rate in BTKi-treated patients. The company reported cash and equivalents of $13.9 million, down from $23.3 million in December 2024, sufficient to fund operations into Q4 2025. Q1 2025 saw reduced losses with net loss of $6.6 million ($0.14/share) compared to $26.6 million ($0.91/share) in Q1 2024. R&D expenses decreased to $3.4 million from $7.1 million, and G&A expenses reduced to $3.0 million from $4.9 million. The company is exploring strategic alternatives and has engaged Oppenheimer & Co. Inc. as financial advisor.

Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company specializing in cancer treatment drug development, has scheduled its first quarter 2025 financial results announcement and corporate update for May 13, 2025, at 8:30 AM ET. The company will host a conference call accessible via toll-free number 1-800-717-1738 (Conference ID: 53983) and webcast. A replay of the presentation will be made available in the Events section of the company's Investor Relations website.

Cellectar Biosciences (NASDAQ: CLRB) has announced plans to explore strategic alternatives to maximize stockholder value. The company, which focuses on cancer drug development, is considering various options including mergers, acquisitions, partnerships, joint ventures, and licensing arrangements.

The company has engaged Oppenheimer & Co as exclusive financial advisor for the strategic evaluation process. CEO James Caruso highlighted their key asset iopofosine I 131, along with alpha- and Auger-emitting radioconjugates (CLR 225 and CLR 125) for solid tumor treatments.

While no specific timetable has been set for the evaluation process, Cellectar emphasizes that no agreements have been reached, and there are no guarantees that the process will result in any transaction. The company will only disclose further information when deemed necessary.

Cellectar Biosciences (NASDAQ: CLRB) reported financial results for 2024 and provided corporate updates. The company achieved FDA alignment for potential accelerated approval of iopofosine I 131 for Waldenström macroglobulinemia (WM) treatment. The Phase 2 CLOVER-WaM study showed an 83.6% Overall Response Rate and 58.2% Major Response Rate.

Financial highlights include cash and equivalents of $23.3 million as of December 31, 2024, compared to $9.6 million in 2023. The company raised $44.1 million through warrant exercises in January 2024 and $19.4 million in July 2024. R&D expenses decreased to $26.1 million from $27.3 million, while G&A expenses increased to $25.6 million from $11.7 million. Net loss was $44.6 million ($1.22 per basic share).

The company plans Phase 1 solid tumor studies with two radioconjugate compounds: CLR 121125 for triple-negative breast cancer and CLR 121225 for pancreatic cancer, with an IND submission planned for first half 2025.