Q2 2026 Cellectar Biosciences Inc Earnings Call Transcript
Key Points
- Cellectar Biosciences Inc (CLRB) reported strong clinical data from the CLOVER WaM study, with a 79.2% major response rate and 87.5% overall response rate in patients treated immediately after BTKi therapy, and a median duration of response of 16 months.
- The company completed an oversubscribed financing in May, securing up to $140 million in potential capital, including $35 million upfront, to support its regulatory and clinical programs.
- Cellectar Biosciences Inc (CLRB) has initiated site activation for its confirmatory Phase 3 study of iopofosine I 131 in Waldenström macroglobulinemia, with first patient dosing expected late 2026 or early 2027.
- The company is on track to submit a New Drug Application (NDA) for accelerated approval of iopofosine I 131 in mid-2027, with a potential six-month FDA review due to Breakthrough Therapy designation.
- Cellectar Biosciences Inc (CLRB) is advancing its versatile PDC platform, with CLR 125 (Auger-emitting) and CLR 225 (alpha-emitting) programs, and has dosed the first patients in the Phase 1b trial for triple-negative breast cancer.
- The company has a robust commercial supply chain, with the ability to produce up to 100 patients' worth of finished product per week, and has multi-sourced key components like actinium-225 to mitigate supply risks.
- Cellectar Biosciences Inc (CLRB) reported a net loss of $6.9 million for Q2 2026, with R&D expenses nearly doubling year-over-year to $4.6 million due to increased clinical activity.
- The company's cash position of $34.0 million is relatively low, and it relies on future milestone-based warrant exercises (up to $105 million) to fund operations, which are contingent on achieving specific clinical and regulatory milestones.
- The confirmatory Phase 3 study initiation is still in early stages, with first patient dosing not expected until late 2026 or early 2027, and the FDA submission is dependent on having 10-20 sites open and a few patients enrolled, which may be challenging to achieve.
- The company faces uncertainty regarding the FDA's definition of 'ongoing' for the confirmatory study, which could impact the timing of the accelerated approval submission and potential approval.
- Cellectar Biosciences Inc (CLRB) has not yet provided specific data updates for CLR 125, and initial dosimetry, safety, and efficacy data are not expected until late 2026 or early 2027, leaving a gap in pipeline visibility.
- The company's commercial strategy for iopofosine is still undecided, with options including self-commercialization or partnering, which could lead to delays or additional costs in the launch process.
Good morning, ladies and gentlemen. Thank you for standing by and welcome. (Operator Instructions) Please be advised that today's call may be recorded.
I would now like to hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead.
Thank you, operator. Good morning, and welcome to Cellectar Biosciences second-quarter 2026 financial results and business update conference call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceutical.
Cellectar issued a press release earlier this morning detailing the contents of today's call. A copy can be found on the Investor page of Cellectar's corporate website. I want to remind callers that
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