Cellectar Biosciences, Inc. Q2 FY2025 earnings call

• Cellectar has shifted regulatory strategy for iopofosine I-131 to submit an NDA under accelerated approval pathway for Waldenstrom's Macroglobulemia (WM) with CLOVER-WaM study as primary efficacy basis, with FDA breakthrough therapy designation and EU prime designation.
• Advancing next-generation radiopharmaceuticals: CLR 125 on track for Phase I trial late 2025/early 2026, submitted Phase I protocol to FDA; CLR 225 in Phase I trial planning contingent on funding, showing good biodistribution and tolerability in animal models.
• Strengthened foundation with long-term isotope supply agreement and raised nearly $10 million in recent financings to support clinical programs and milestones.

For the quarter ended June 30, 2025, research and development expenses were approximately $2.4 million compared to $7.3 million in the same period in 2024. General and administrative expenses were $3.6 million compared to $6.4 million in 2024. Cash and cash equivalents ended the quarter at $11 million, including $2.3 million from the June financing. Net loss for the quarter was $5.4 million or $3.39 per basic and diluted share.

• Plan to submit NDA for iopofosine I-131 under accelerated approval pathway for WM, contingent on sufficient funding and confirmatory study underway. Anticipate EMA response late 3rd quarter/early 4th quarter 2025.
• CLR 125 Phase I trial to initiate late 2025/early 2026; CLR 225 Phase I trial initiation dependent on funding.

• Uncertainties in securing sufficient funding to support clinical trials and regulatory submissions.
• Risks associated with regulatory approvals taking longer than anticipated or not being granted as expected, which could impact the timeline for bringing products to market.

Q: For WM program, where do you stand with the EU on the path to approval? And for 125 programs, what are the off-target sites of the greatest concern with that platform?

A: Jarrod Longcor stated that for iopofosine I-131, they are in discussions with the EMA regarding conditional market authorization, with a decision expected late 3rd or early 4th quarter 2025. Regarding CLR125, biodistribution shows approximately 25%-30% in tumor, and off-target tissues have less than 5% activity, with liver being the most common off-target site but well below concerning levels.

Q: When do you think you would submit the NDA for iopofosine I-131? And how much has it cost to submit and get it approved?

A: James V. Caruso estimated the study for WM program is approximately $40 million-$45 million, with $20 million-$25 million needed to complete study enrollment and initial data. Jarrod Longcor added that they are ready to run the study if funded or with a partner, with timing potentially later this year or early next year, and enrollment expected to be rapid due to WM patient population awareness and drug performance.