On May 14, 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 March 31, 2024, and provided a corporate update (Press release, Cellectar Biosciences, MAY 14, 2024, View Source [SID1234643212]).
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"We plan to announce data from our CLOVER WaM pivotal study evaluating iopofosine I 131 in Waldenstrom’s macroglobulinemia in June and are on track to submit our NDA in the second half of 2024. We remain pleased with patient enrollment in the phase 1b pediatric high-grade glioma study and expect to announce data in the second half of 2024," said James Caruso, president, and CEO of Cellectar. "Either alone or in collaboration, we continue to assess the versatility of our delivery platform with a wide range of cancer targeting compounds including peptides, oligos and our alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225, which is planned to enter a phase 1 study in either triple negative breast or pancreatic cancer no later than first quarter 2025."
First Quarter and Recent Corporate Highlights
· Announced positive topline data achieving its primary endpoint in its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potentially first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients with a median of four prior lines of therapy. The CLOVER WaM study met its primary endpoint with a major response rate of 61%. The overall response rate was 75.6%. The Company plans to announce data for all evaluable patients in June 2024.
· Reported a complete remission rate of 64% and overall response rate of 73% in highly refractory patients in an investigator-initiated Phase I study of iopofosine in combination with External Beam Radiotherapy in recurrent head and neck cancer. In addition to the high rate of complete remission, durability of clinical activity achieved a 67% overall survival and 42% progression free survival at one year.
· Reported the complete central nervous system clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia patient, providing further validation for iopofosine I 131 to treat solid and hematologic tumors, including those located across the blood-brain barrier.
· Enrolled the first patient in the company’s Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG). The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data.
· Announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225 (225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound expands the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs).
· Announced strategic partnerships with leading community-based oncology networks Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting.
First Quarter 2024 Financial Highlights
· Cash and Cash Equivalents: As of March 31, 2024, the company had cash and cash equivalents of $40.0 million, compared to $9.6 million as of December 31, 2023. Net cash used in operating activities during the three months ended March 31, 2024, was approximately $13 million. The company believes its cash balance as of March 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2024.
· Research and Development Expense: R&D expense for the three months ended March 31, 2024, was approximately $7.4 million, compared to approximately $6.7 million for the three months ended March 31, 2023. The overall increase in R&D expense was primarily a result of increased manufacturing and related costs related to the development of supply chain and production sourcing enhancements, partially offset by a decrease in general research and development costs.
· General and Administrative Expense: G&A expense for the three months ended March 31, 2024, was $4.6 million, compared to $2.1 million for the same period in 2023. The increase in G&A costs 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 costs.
· Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2024, was ($21.6) million, or $(0.74) per share, compared to $(8.6) million, or ($0.76) per share in the three months ended March 31, 2023.
Conference Call & Webcast Details
Cellectar management will host a conference call for investors today, May 14, 2024, beginning 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. The call will be available via webcast by clicking HERE or on the Events page of the company’s website after the conclusion of the call.