On August 14, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Cellectar Biosciences, AUG 14, 2023, View Source [SID1234634390]).
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Second Quarter and Recent Corporate Highlights
· In June, the company provided an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom’s macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform. The updates included:
o Top-line data from its WM CLOVER-WaM pivotal trial is expected in 2H23 and assuming NDA approval, the company remains on target for a 2024 product launch.
o The company plans to initiate its Phase 1b study in pediatric high-grade gliomas (pHGG) in the third quarter of 2023.
o The central nervous system lymphoma (CNSL) cohort from its Phase 2a trial expanded to further evaluate iopofosine I 131 in this indication. The company previously reported a complete response in a CNSL patient
o The company’s COO, Jarrod Longcor, delivered an oral presentation of iopofosine I 131 for the treatment of multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference. Iopofosine I 131 has been evaluated in over 125 multiple myeloma patients with response rates ranging from 40% to 62% in triple class refractory, quad/penta refractory, post-BCMA and high-risk patients.
o The company presented updates on its phospholipid ether cancer targeting platform at several conferences, including SNMMI, Targeted Radiotherapy Conference, Oncology 2023, and Therapeutic Area Partnership Oncology. The presentations highlighted the platform’s broad utility to provide targeted intracellular delivery of multiple cancer treatment modalities.
"We look forward to reporting top-line data from our WM pivotal trial in the second half of this year. We believe the novel method of action and product profile for iopofosine I 131 is clearly differentiated and can address patients’ needs in relapsed or refractory WM with the potential to establish a new standard of care. Our commercialization efforts will strategically take advantage of the highly scalable and concentrated WM market to drive early use and adoption," said James Caruso, president and CEO of Cellectar. "We also continue to develop iopofosine I 131 across multiple indications, including CNSL and pHGG’s as well as multiple myeloma, and are looking forward to a transformational second half of 2023."
Second Quarter 2023 Financial Highlights
· Cash and Cash Equivalents: As of June 30, 2023, the company had cash and cash equivalents of $5.2 million, compared to $19.9 million as of December 31, 2022. Net cash used in operating activities during the three months ended June 30, 2023 was approximately $7.5 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2023.
· Research and Development Expense: R&D expense for the three months ended June 30, 2023 was approximately $6.3 million, compared to approximately $4.5 million for the three months ended June 30, 2022. The overall increase in research and development expense was primarily a result of increased manufacturing costs, production sourcing, and general research and development costs due to an increase in personnel, slightly offset by a reduction in clinical project cost and pre-clinical project costs.
· General and Administrative Expense: G&A expense for the three months ended June 30, 2023 was $2.0 million, compared to $2.9 million for the same period in 2022. The overall decrease in G&A costs was primarily driven by a decrease in professional fees and personnel costs.
· Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2023 was ($8.2) million, or ($0.73) per share, compared to ($7.4) million, or ($1.22) per share, for the three months ended June 30, 2022.