Cellectar Biosciences (CLRB) Q2 2026 earnings summary

Executive summary

• Achieved significant progress in clinical development and regulatory strategy, focusing on iopofosine I-131 for relapsed/refractory Waldenström macroglobulinemia (WM), with site activation for a confirmatory Phase III trial and NDA submission planned for mid-2027 under FDA Accelerated Approval.

• Reported full 12-month follow-up results from the CLOVER WaM study, meeting primary and secondary endpoints, and presented positive efficacy and safety data at ASCO 2026.

• Expanded the clinical pipeline with CLR 125 (triple-negative breast cancer) and CLR 225 (solid tumors), initiating Phase 1b trials and advancing the PDC platform.

• Received FDA Breakthrough Therapy Designation for iopofosine I-131 in WM and positive scientific advice from the EMA for potential conditional marketing authorization.

• Strengthened balance sheet with $34.0 million in cash as of June 30, 2026, following a $35 million upfront financing in May 2026.

Financial highlights

• Ended Q2 2026 with $34.0 million in cash and equivalents, up from $13.2 million at year-end 2025, reflecting proceeds from May financing.

• Research and development expenses rose to $4.6 million for Q2 2026, up 91.7% year-over-year, driven by increased clinical activity.

• General and administrative expenses decreased to $2.6 million for Q2 2026, down 27.8% year-over-year, mainly due to lower professional fees and personnel costs.

• Net loss for Q2 2026 was $6.9 million ($0.57/share), compared to $5.4 million ($3.39/share) in Q2 2025.

• Accumulated deficit reached $281.7 million as of June 30, 2026.

Outlook and guidance

• Confirmatory Phase III study for iopofosine in WM is on track, with first patient enrollment expected late 2026 or early 2027 and full enrollment projected within 18–24 months.

• NDA submission for iopofosine I-131 in WM planned for mid-2027, with an anticipated six-month FDA review.

• Initial data from CLR 125 in triple-negative breast cancer expected later in 2026 or early 2027.

• Cash balance is expected to fund operations into Q2 2027; additional capital will be required for regulatory strategy and continued development.