Cellectar Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents totaled $24.6 million as of September 30, 2026, compared to $13.2 million as of December 31, 2025, reflecting net proceeds of approximately $31.7 million from a May 2026 offering.
• Research and development expenses for the three months ended September 30, 2026, were $5.4 million, an increase from $2.5 million in the same period in 2025.
• General and administrative expenses for the three months ended September 30, 2026, were $2.7 million, compared to $2.3 million in the same period in 2025.
• Net loss attributable to common stockholders for the three months ended September 30, 2026, was $8.0 million ($0.46 per share), compared to $4.4 million ($1.41 per share) in the three months ended September 30, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $21.1 million, compared to $17.3 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $20.6 million, compared to $16.5 million for the same period in 2025.
• Total assets were $29.7 million as of September 30, 2026, compared to $15.0 million as of December 31, 2025.
• Total liabilities were $7.3 million as of September 30, 2026, compared to $5.1 million as of December 31, 2025.
• Total stockholders' equity was $22.4 million as of September 30, 2026, compared to $8.5 million as of December 31, 2025.

Guidance and Future Outlook:

• The company is on track to dose the first patients in the confirmatory Phase 3 trial of iopofosine I 131 in the first quarter of 2027.
• A New Drug Application (NDA) seeking accelerated approval with the FDA is planned for the first half of 2027.
• Cash balance as of September 30, 2026, is considered adequate to fund budgeted operations into the second quarter of 2027.
• Initial dosimetry and safety data from the Phase 1b trial of CLR 125 in triple-negative breast cancer are expected to be shared in the fourth quarter of 2026.

Business Segments and Product Lines:

• Iopofosine I 131: Presented additional Phase 2b CLOVER-WaM data at the International Workshop for Waldenström Macroglobulinemia (IWWM) showing an Overall Response Rate (ORR) of 87.5%, Major Response Rate (MRR) of 79.2%, and Median Duration of Response (DoR) of 16.0 months in patients treated immediately post-BTK inhibitor therapy.
• Iopofosine I 131: Reported a case study of a heavily pretreated diffuse large B-cell lymphoma patient who achieved a complete response lasting more than eight years.
• Iopofosine I 131: Plans to present three posters at the American Society of Hematology Annual Meeting (ASH 2026) featuring 12-month follow-up data and the design of the confirmatory Phase 3 trial.
• CLR 125: The dose-finding Phase 1b trial in refractory triple-negative breast cancer continues to enroll.
• PDC Platform: Hosted a virtual educational webinar highlighting the Phospholipid Drug Conjugate (PDC) platform and its combinability with various therapeutic molecules.

Market and Competitive Landscape:

• The Phase 3 confirmatory trial for iopofosine I 131 is designed as a comparator, randomized controlled trial in post-first line, post-BTK inhibitor patients, with 100 patients per arm and progression-free survival as the primary endpoint.
• The Phase 1b dosimetry trial, requested by the FDA, aims to characterize iopofosine I 131 across all treatment lines in Waldenström macroglobulinemia patients, including first and second line.

Risks and Challenges:

• Drug discovery and development involve a high degree of risk, including uncertainties related to identifying suitable collaborators, partners, licensees, or purchasers.
• Risks include the ability to raise additional capital to support operations and the potential for actual results to differ materially from forward-looking statements due to known and unknown risks.

Management Commentary and Tone:

• CEO James Caruso stated the company remains focused on executing clinical, regulatory, and operational activities to position iopofosine I 131 for potential registration and commercialization.
• Management expressed confidence in the clinical profile of iopofosine I 131, citing high response rates, durable outcomes, and a favorable safety profile in a difficult-to-treat post-BTK inhibitor patient population.
• The company believes it is entering a period of significant value creation with multiple meaningful milestones anticipated in 2027.

Other Key Points:

• The company initiated preparations for a Phase 1b dosimetry clinical trial of iopofosine I 131 in all treatment lines in WM patients as requested by the FDA.
• The Phase 1b dosimetry trial is expected to provide data from 20-30 newly diagnosed and relapsed WM patients.
• The company has received Breakthrough, six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA for iopofosine I 131, and a PRIME designation from the EMA.
• The company is also developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors.