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Cellectar Biosciences Inc (CLRB) Q1 2024 Earnings Call Transcript Highlights: Strategic ...

  • Cash and Cash Equivalents: $40.0 million as of March 31, 2024, up from $9.6 million as of December 31, 2023.

  • Net Proceeds: Generated $43.9 million from the exercise of warrants.

  • Net Cash Used in Operating Activities: Approximately $13.4 million during the quarter.

  • R&D Expense: $7.4 million for the quarter, compared to $6.7 million in Q1 2023.

  • G&A Expense: $4.6 million for Q1 2024, up from $2.1 million in the same period last year.

  • Non-Cash Charge: $9.9 million related to warrant valuation impact on P&L.

  • Net Loss Attributable to Common Stockholders: $21.4 million, or $0.74 per share for Q1 2024, compared to $8.6 million, or $0.76 per share in Q1 2023.

Release Date: May 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Cellectar Biosciences Inc (NASDAQ:CLRB) announced positive top-line data from the CLOVER WaM pivotal study for iopofosine I-131, with a detailed update expected in June.

  • The company secured approximately $44 million in funding in January, with potential for an additional $34 million, enhancing their financial stability.

  • Strategic partnership with the American Oncology Network to advance treatment and ensure patient access to iopofosine I-131.

  • Promising preclinical data for three unique internally developed alpha emitters, planning to initiate a Phase 1 study in solid tumor cancers by Q1 2025.

  • Reported high rates of complete remission and overall response in an investigator-initiated study of iopofosine in combination with external beam radiotherapy in recurrent head and neck cancer.

Negative Points

  • Net loss attributable to common stockholders for the quarter ended March 31, 2024, was $21.4 million, an increase from $8.6 million in the previous year.

  • Significant increase in G&A expenses, primarily due to preparations for the expected product launch of iopofosine I-131 in 2025.

  • The company faces a $9.9 million non-cash charge related to the accounting for warrants, impacting financial results.

  • Despite securing funding, the company's cash on hand is projected to fund operations only into the fourth quarter of 2024, indicating a potential need for additional capital soon.

  • The ongoing need to manage and mitigate risks associated with the supply chain and manufacturing scalability of their products.

Q & A Highlights

Q: Can you give us a sense on the FDA filing timeline where you are at and what is the timeline that you are looking at? A: James Caruso - Cellectar Biosciences Inc - President, Chief Executive Officer, Director: The regulatory filing timeline remains consistent with the second half of this year. With the FDA Fast Track Designation, we expect a six-month review period.

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Q: Have you hired any sales members? What will be the first target given the commercial efforts? A: Shane Lea - Cellectar Biosciences Inc - Chief Commercial Officer: We are leveraging segmentation in our approach and still refining our target areas. We are confident in placing a highly talented sales team to drive awareness and adoption.

Q: Could you provide a little bit more color on the pricing? What should we take as a base? A: James Caruso - Cellectar Biosciences Inc - President, Chief Executive Officer, Director: We have the opportunity to premium price in this market. Early market research and pricing work support this, along with discussions with advisory boards built around pharmacy benefit managers from large third-party payers.

Q: On pricing, you mentioned some of the analogs you're looking at. Could you share, perhaps what some of those examples are? A: Shane Lea - Cellectar Biosciences Inc - Chief Commercial Officer: We are looking at a wide range of products, including CAR T, Azedra for pheochromocytoma, and BTKi therapy in WM, looking at its cost from a total cost of care perspective.

Q: What should we be expecting from the Waldenstroms data update in June? A: James Caruso - Cellectar Biosciences Inc - President, Chief Executive Officer, Director: We will report on response rate, including types of responses and durability of response at the time of our announcement. The full enrollment is in the mid-50 range, which is a significant increase in the number of patients.

Q: What can you share about ex-US negotiations? Maybe what those potential collab, partners might be waiting for before getting any more deep into those discussions? A: Jarrod Longcor - Cellectar Biosciences Inc - Chief Operating Officer: We continue to advance dialogues with a number of parties in different regions. We are evaluating additional regional partnerships and also engaged in dialogues for a more global strategy.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.