Cellectar's Q3 2025 Earnings Call: Contradictions Emerge on EU Regulatory Strategy, U.S. Trial Financing, and Partnering Timelines

Date of Call: November 13, 2025

Financials Results

• EPS: $1.41 loss per basic and diluted share for Q3 2025, versus $11.18 basic and $12.13 diluted loss in Q3 2024

Guidance:

• Cash runway expected into Q3 2026 after recent financings and warrant exercises.
• Plan to submit EU conditional marketing authorization (CMA) for iopofosine mid-2026, with potential commercial availability ~mid-2027 after ~12-month review.
• NDA submission to FDA under accelerated approval will occur upon initiation of a confirmatory Phase III; 12-month follow-up data now available.
• Phase III estimated costs: ~$10M to initiate, ~$15M to reach enrollment threshold for FDA action, ~$28M to full enrollment and ~$40M total study cost.
• CLR 125 Phase Ib dosing imminent with dosimetry/efficacy readouts through 2026; CLR 225 Phase I is trial-ready but pending financing; actinium supply secured.

Business Commentary:

* Regulatory Progress and Market Potential: - Cellectar Biosciences' lead asset, iopofosine I 131, received confirmation of eligibility to file for conditional marketing approval in the EU due to its promise in treating Waldenström’s macroglobulinemia. - The company's global regulatory strategy was enhanced by collaborations with the EMA and FDA, which provided breakthrough designations and eligibility for priority review vouchers. - As a result, Cellectar's regulatory position strengthens its market potential, with an 80% likelihood of success for conditional marketing approval in Europe and U.S. approval through the accelerated pathway.

• Clinical and Preclinical Pipeline Advancements:
• The company initiated a Phase Ib study of CLR 125, an Auger-emitting agent targeting solid tumors like triple-negative breast cancer.
• CLR 225, an actinium alpha-emitting radio conjugate, advanced with promising preclinical results, particularly in pancreatic cancer.

• These initiatives underscore Cellectar's innovation in oncology, with a focus on challenging solid tumor cancers with significant unmet medical need.

• Financial Strength and Balance Sheet:

• Cellectar raised approximately $12.7 million in recent financings, enhancing its cash position to be adequate for budgeted operations into the third quarter of 2026.
• Research and development expenses decreased by approximately $3.5 million due to lower costs from the CLOVER-WaM study and reduced manufacturing investments.

• This financial strength supports Cellectar's operational execution and strategic initiatives, allowing for continued investment in its promising pipeline.

• Partnership and Strategic Collaborations:

• Cellectar is actively engaged in discussions with potential partners for iopofosine, with interest increasing due to its regulatory and commercial market potential.
• Strategic collaborations aim to secure non-dilutive capital and commercial expertise, expediting market access and preserving long-term shareholder value.
• The company's aggressive clinical and preclinical programs, along with strong regulatory positioning, are attractive to potential partners seeking innovative oncology assets.

Sentiment Analysis:

Overall Tone: Positive

• Management highlighted EMA confirmation of eligibility to file for conditional marketing approval for iopofosine, availability of 12-month follow-up enabling an NDA submission upon Phase III initiation, recent financings (~$12.7M plus additional net raises) and securing actinium supply — all framed as strengthening regulatory and operational momentum toward commercialization.

Q&A:

• Question from Aydin Huseynov (Ladenburg): Can you clarify what data the EMA focused on (post-BTKi population and lines of therapy), how much resource is needed to initiate the U.S. Phase III and whether current cash is sufficient, and thoughts on pricing/branding differences between EU and U.S.?
  Response: EMA focused on the post-BTKi population (majority of CLOVER‑WaM patients are post‑BTKi) and found statistically meaningful responses; to initiate the U.S. confirmatory trial requires ~ $10M startup and ~ $15M to reach enrollment thresholds for FDA action ( ~$28M to full enrollment, ~$40M total); company has recent financings and cash runway into Q3 2026 but will need additional funding to complete Phase III; pricing expected to be premium, Europe often a lower percent of U.S. but HTA and unmet need could support stronger EU pricing.

• Question from Jeffrey Jones (Oppenheimer): How have partnering discussions evolved since the EU update and what is your partnering strategy (U.S., Europe, global)? Also, any gating items for CLR 225 pancreatic program or is that pending financing?
  Response: Post‑EMA interest has accelerated with multiple parties in advanced diligence across regional and global scopes; management paused earlier talks until regulatory clarity to maximize value; CLR‑225 is Phase‑I ready with CRO, sites and supplies in place but financing is the gating factor to start the study.

• Question from Jonathan Aschoff (ROTH): Where are you in CLOVER‑WaM follow‑up and the PFS readout vs. standard of care, and for pancreatic program is the sequence file IND/get funding/start trial?
  Response: All patients now have 12‑month follow‑up (FDA requirement) but updated PFS data will not be disclosed pre‑submission; prior reported 11.4‑month PFS (with 8 months follow‑up) was considered strong versus expected 4–6 months in later lines; the pancreatic CLR‑225 study is filed ex‑U.S. and ready to initiate pending capital.

Contradiction Point 1

EU Regulatory Strategy and Partnering Discussions

It involves the company's strategy regarding EU regulatory approval and partnering discussions, which are crucial for market access and potential collaboration opportunities.

Could you clarify the specific data considered for the EMA strategy and Scientific Advice Working Party decision? - Aydin Huseynov (Ladenburg)

20251113-2025 Q3: We've slowed partnering discussions until the EU blessing, but now accelerate. Interest is high. - James Caruso(CEO)

Where do you stand with the EU on the path to approval for the WM program? - Fanyi Zhong (Oppenheimer & Co. Inc., Research Division)

2025Q2: Regardless of the accelerated approval pathway, we're engaging with the EMA to establish the conditional market authorization pathway. - Jarrod Longcor(COO)

Contradiction Point 2

Financing Requirements for U.S. Clinical Trial

It relates to the financial resources needed to initiate a Phase III study in the U.S., which is essential for the company's clinical trial milestones.

What resources are required to initiate a U.S. trial, and is your balance sheet sufficient? - Aydin Huseynov (Ladenburg)

20251113-2025 Q3: Approximately $10 million to initiate the Phase III study and $15 million to full patient enrollment. - James Caruso(CEO)

When do you plan to submit the NDA for iopofosine I-131, and what are the associated approval costs? - Edward Andrew Tenthoff (Piper Sandler & Co., Research Division)

2025Q2: The FDA requires the study to be initiated by submission. We'll spend around $10-$12 million to initiate the study, with rapid enrollment expected. - Jarrod Longcor(COO)

Contradiction Point 3

Partnering Strategy and Timing

It involves changes in the company's strategy and timeline for partnering discussions, which could impact the company's growth and resource allocation.

How have partnering discussions evolved since the EU regulatory update, and what's your approach to partnering globally? - Jeffrey Jones (Oppenheimer)

20251113-2025 Q3: We've slowed partnering discussions until the EU blessing, but now accelerate. Interest is high. - James Caruso(CEO)

How do you assess the commercial opportunity in Europe following EMA's conditional marketing approval feedback? - Aydin Huseynov (Ladenburg Thalmann)

2025Q1: Our focus then is on working with the EU, getting the conditional marketing authorization from Europe, and then being in a position to take advantage of the oncology market that we think is there. - Jarrod Longcor(COO)

Contradiction Point 4

Financial Runway and Study Costs

It involves the financial stability and resources necessary for the company to proceed with its planned studies, which are critical for the company's growth and future prospects.

What resources are needed to initiate a U.S. trial, and is your current balance sheet sufficient? - Aydin Huseynov (Ladenburg)

20251113-2025 Q3: Approximately $10 million to initiate the Phase III study and $15 million to full patient enrollment. - James Caruso(CEO)

Why is CLR 121225 focused on pancreatic indications? - Jonathan Aschoff (ROTH)

2024Q4: The cash runway includes the cost for the IND filings and the Phase 1 trials, with each study costing approximately $4.5 million. - Jarrod Longcor(COO)

Contradiction Point 5

Pricing Strategy and Market Access

It involves the company's pricing strategy and market access, which are key factors in determining revenue potential and competitive positioning.

Regarding 225 and the pancreatic program, are there any gating items preventing the trial's start? - Jeffrey Jones (Oppenheimer)

20251113-2025 Q3: Our approach to HTA negotiations allows for higher pricing in Europe due to significant unmet need and clinical benefit. - Jarrod Longcor(COO)

Will the comparator arm be a 50/50 split between rituximab and one of the nine NCCN drugs? - Jonathan Aschoff (ROTH)

2024Q4: We have seen pricing accretion in the past two quarters and we expect that those accretion will increase in the next few quarters as well. - Jarrod Longcor(COO)