On November 18, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the quarter ended September 30, 2024, and provided a corporate update (Press release, Cellectar Biosciences, NOV 18, 2024, View Source [SID1234648467]).
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"We achieved important clinical, operational and commercial corporate objectives during the quarter. We reported topline results from the CLOVER-WaM pivotal study in WM and look forward to filing our NDA submission with a request for accelerated regulatory approval in the coming months," said James Caruso, president and CEO of Cellectar Biosciences. "In addition to our lead iopofosine I 131 program, we plan to further advance the value of our phospholipid radioconjugate pipeline and are preparing alpha and Auger PRCs for initiation of solid tumor clinical studies as business conditions allow."
Third Quarter and Recent Corporate Highlights
· Reported positive results from the Phase 2 CLOVER-WaM pivotal study evaluating iopofosine I 131, the company’s potentially first-in-class, targeted radiotherapeutic candidate, for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM). These results support the company’s planned filing of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the near term.
· Selected to present data from the CLOVER-WaM study evaluating iopofosine I 131 in patients with WM at the upcoming 66th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (ASH) (Free ASH Whitepaper), in an oral presentation session. Details of the oral presentation are as follows:
o Abstract Title: Iopofosine I 131 in Previously Treated Patients with Waldenström Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM)
o Session Name: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Clinical Trials for Marginal Zone Lymphoma, Waldenstrom’s Macroglobulinemia and Hairy Cell Leukemia
o Session Date: Monday, December 9, 2024
o Presentation Time: 3:15 PM PST
· Delivered oral and poster presentations at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM) in October 2024 that highlighted the activity of iopofosine I 131 in WM.
o Oral presentation: Session XXII Clinical Trials in Progress for WM: Multi-center trial of iopofosine I-131 in relapsed/refractory WM
o Poster presentation: Treatment With iopofosine I 131 in a Patient With Bing-Neel Syndrome, A Rare Manifestation of Waldenström Macroglobulinemia: A Case Report
· Advanced sales, marketing and medical planning activities to support iopofosine I 131 commercialization
· Partnered with key national and regional community cancer networks to better understand the WM disease landscape, to advance iopofosine I 131 for WM patients in the community setting
· Established collaboration with the City of Hope Cancer Center to evaluate iopofosine I 131 in mycosis fungoides, a cutaneous T-cell lymphoma
· Executed supply and manufacturing agreements, further strengthening our multi-sourced supply network:
o Commercial finished product supply of iopfosine I 131 with SpectronRx
o Pre-clinical and clinical supply of alpha-emitting actinium 225 isotope with Northstar Medical Radioisotopes
· Raised $19.4 million through warrant exercises and issued new milestone-based warrants with the potential to raise up to an additional $73.3 million. Funds generated from the execution of these new warrants will further advance the company’s commercialization plans for iopofosine I 131 in the treatment of WM and support future clinical development.
Third Quarter 2024 Financial Highlights
· Cash and Cash Equivalents: As of September 30, 2024, the company had cash and cash equivalents of $34.3 million, including 19.4 million ($17.5 million, net) raised through investor exercises of Tranche B warrants and the purchase of new warrants in July 2024, compared to $9.6 million as of December 31, 2023. The company believes its cash balance as of September 30, 2024, is adequate to fund its basic budgeted operations into the second quarter of 2025.
· Research and Development Expenses: R&D expenses for the three months ended September 30, 2024, were approximately $5.5 million, compared to approximately $7.0 million for the three months ended September 30, 2023. The overall decrease was primarily a result of the conclusion of patient enrollment in our WM pivotal study having occurred earlier in the year, partially offset by increased activity in our ongoing pediatric trial and an increase in personnel.
· General and Administrative Expenses: G&A expenses for the three months ended September 30, 2024, were approximately $7.8 million, compared to approximately $2.4 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel cost.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, November 18, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.