Cellectar Biosciences, Inc. Q1 FY2025 earnings call

Key Points

• Jim Caruso noted the company entered 2025 with focus on PDC platform, radio conjugate pipeline, and finalizing FDA/EMA requirements for iopofosine I 131 in Waldenstrom's Macroglobulinemia (WM). A rapid FDA meeting was completed regarding accelerated approval path for iopofosine I 131 in WM. The Phase 2 CLOVER WaM trial showed efficacy and safety. The company is seeking EMA conditional approval for iopofosine I 131. Solid tumor-focused radioisotope programs, including alpha emitter for pancreatic cancer and Auger emitter for triple negative breast cancer, were mentioned. The company engaged Oppenheimer as an exclusive financial advisor for strategic alternatives.
• Chad Kolean reported cash and cash equivalents were $13.9 million as of March 31, 2025, vs $23.3 million on Dec 31, 2024. Cash on hand is expected to fund budgeted operations into Q4 2025. R&D expenses for Q1 2025 were ~$3.4 million vs ~$7.1 million in Q1 2024, driven by reduced patient follow-up and personnel costs. G&A expenses were $3.0 million vs $4.9 million in Q1 2024, due to reduced pre-commercialization and personnel costs. Net loss was $6.6 million or $0.14 per share vs $26.6 million or $0.91 per share in Q1 2024.
• Jarrod Longcor reviewed regulatory and clinical status of iopofosine, CLR 121225 (alpha emitting actinium-based compound), and CLR 121125 (Auger-emitting radiotherapeutic). Details on iopofosine Phase 3 trial design, CLR 121225 Phase 1 trial dosimetry and dose escalation plans, and CLR 121125 Phase 1b trial in triple negative breast cancer were provided.

No specific product segment financial performance data on absolute revenue and contribution % provided in the transcript.

Guidance Points

• Cash on hand is adequate to fund budgeted operations into the fourth quarter of 2025.
• Expect to know the EMA conditional approval timeline in the third quarter of 2025.
• The Phase 3 trial for iopofosine I 131 is expected to enroll approximately 100 patients per arm.

Risks

• Actual results could differ materially from forward-looking statements due to risks and uncertainties associated with the business, as cautioned by the safe harbor provisions.
• Dependence on securing necessary funds for the initiation and timing of clinical trials.

Q: Hypothetical match of iopofosine I 131 against rituximab in early lines of therapy.

A: Jim Caruso discussed evaluating study designs, comparator arms, and efficacy considerations in relapsed refractory and earlier lines of therapy. Jarrod Longcor added insights on study size implications, major response rates, progression-free survival, and patient population eligibility.

Q: Assessment of commercial opportunity in Europe for conditional approval.

A: Jarrod Longcor mentioned a 60% likelihood of EMA conditional approval, highlighted the prime designation and strong data set, discussed EMA's previous scientific advice meeting, and commented on pricing, market size, and comparator utilization in Europe