Cellectar Biosciences, Inc. Q3 FY2025 earnings call

• Strengthened balance sheet with approximately $12.7 million raised in recent financings.
• Regulatory progress: iopofosine I-131 received confirmation of eligibility to file for conditional marketing approval in the EU based on Clover Wham study, and has FDA breakthrough designation for WM. Also, rare pediatric disease designations provide priority review voucher eligibility.
• Clinical program advancements: Initiated phase 1b study of CLR125 in triple-negative breast cancer; progress with CLR225 radiopharmaceutical; engaged in supply and trial support agreements for CLR225.
• Reductions in R&D and G&A expenses due to lower costs related to patient follow-up in Clover Wham study and reduced pre-commercialization efforts.

No distinct product segments with detailed absolute revenue and revenue contribution % provided. Overall, cash and cash equivalents were $12.6 million as of September 30, 2025, down from $23.3 million on December 31, 2024. Research and development expenses were $2.5 million for Q3 2025 vs. $5.5 million in Q3 2024; general and administrative expenses were $2.3 million vs. $7.8 million; net loss was $4.4 million vs. $14.7 million.

• Cash on hand is expected to fund budgeted operations into the third quarter of 2026.
• Plan to file for iopofosine conditional marketing approval in the EU in 2026 and initiate CLR125 phase 1b clinical trial.
• Advance plans to file for accelerated approval of iopofosine in the US pending funding to initiate the phase three confirmatory study.

• Uncertainties associated with regulatory approvals for iopofosine and other clinical programs.
• Risks related to clinical trial outcomes and the ability to advance programs as planned.
• Market adoption risks for radiopharmaceutical therapies.

Q: Could you help us better understand the specific data the EMA was considering for iopofosine?

A: The EMA evaluated the totality of data, focusing on the post-BTKi patient population in Europe where it identified a high unmet need. The Clover Wham study data showed strong response rates in post-BTKi patients.

Q: How much resources are needed to initiate a trial in the US for iopofosine and if current balance sheet is enough?

A: Estimated $10 million to initiate the trial, with approximately $15 million to full patient enrollment for the phase three confirmatory study. Current cash on hand is expected to fund operations into Q3 2026, but specific trial initiation details depend on funding.

Q: Comment on partnering discussions and CLR225 trial gating items?

A: Interest in partnering increases as regulatory approvals near. CLR225 phase 1 trial for pancreatic cancer is gateable by financing; ready to initiate once capital is secured.

Q: Where is PFS for iopofosine and status of CLR225 trial?

A: PFS data last updated in January at 11.4 months with 8 months follow-up; now have 12 months follow-up but data not yet announced for submission. CLR225 pancreatic trial is ready to initiate pending funding, with plans to use dosimetry and dose-escalation to evaluate safety and distribution.