On November 3, 2022 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 third quarter ended September 30, 2022 and provided a corporate update (Press release, Cellectar Biosciences, NOV 3, 2022, View Source [SID1234623018]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Third Quarter and Recent Corporate Highlights
·In October, the company closed concurrent registered direct and private placement offerings totaling $10.7 million in gross proceeds with institutional investors including the company’s top three stockholders. The company sold 3,275,153 shares of the company’s common stock at $2.085 per share in the registered direct offering, while warrants to purchase up to an aggregate of 3,275,153 shares of common stock were sold in a concurrent private placement priced at-the-market under Nasdaq rules. In a separate concurrent private placement offering, the company sold institutional investors pre-funded warrants to purchase an aggregate of 1,875,945 shares of common stock and warrants to purchase an aggregate of 1,875,945 shares of common stock. The company intends to use the net proceeds from the registered direct offering and the private placements for funding clinical studies, research and development, working capital and general corporate purposes.
·Announced publication of data from the company’s expansion cohort of the Phase 2 CLOVER-1 Study of iopofosine in relapsed/refractory multiple myeloma in the September issue of Blood Cancer Journal, a peer-reviewed Nature journal. The paper, entitled "Iopofosine I-131 treatment in late-line patients with relapsed/refractory multiple myeloma post anti-BCMA immunotherapy," Initial patient data showed an overall response rate (ORR) of 50% in quad-class refractory multiple myeloma who have failed anti-BCMA Immunotherapy with a median of nine lines of therapy. The mean overall survival at the time of data cutoff was 9.1 months, with median overall survival not yet reached.
·Awarded $2 million grant to expand its ongoing Phase 1 study of iopofosine I 131 in pediatric brain tumors. The grant was awarded by the National Institute of Health’s National Cancer Institute (NCI) based upon initial signals of efficacy. The funding allows for an expansion from the Part 1a to the Part 1b portion of the company’s ongoing Phase 1 pediatric study. The ongoing Phase 1a is designed to determine the safety, tolerability, and initial efficacy of iopofosine in pediatric brain tumors whereas the Phase 1b is designed to identify the dose and dosing regimen that results in optimal efficacy. Previously announced preliminary data demonstrated therapeutic responses to iopofosine as evidenced by changes in multiple tumor parameters and patients experiencing extended progression free survival.
"Iopofosine continues to demonstrate its potential as a novel targeted radiotherapeutic in multiple ongoing trials in Waldenstrom’s macroglobulinemia (WM), multiple myeloma, CNS lymphoma, pediatric brain tumors and sarcomas. Additionally, we appreciate the recognition and additional grant from the NCI to support the expansion of our pediatric brain tumor trial into a Phase 1b based on demonstrated safety and activity," said James Caruso, president and CEO of Cellectar. "Our third quarter cash balance of $17.8 million, combined with the net proceeds from our successful October financing, provide the necessary capital to achieve several key milestones. We look forward to sharing topline data from our pivotal Phase 2b WM trial in the first half of 2023, and anticipate providing additional data from our phase 2a trial and our phase 1 pediatric trial in the near term."
Third Quarter 2022 Financial Highlights
·Cash and Cash Equivalents: As of September 30, 2022, the company had cash and cash equivalents of $17.8 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the nine months ended September 30, 2022 was approximately $17.8 million. Subsequent to the end of the quarter, the Company raised $10.7 million in gross proceeds through a combined registered direct and PIPE offering. The company believes its cash on hand, inclusive of the October raise, is adequate to fund planned budgeted operations into the fourth quarter of 2023.
·Research and Development Expense: R&D expense for the three months ended September 30, 2022 was approximately $5.4 million, compared to approximately $3.9 million for the three months ended September 30, 2021. For the nine months ended September 30, 2022, R&D expense was approximately $13.8 million, while the comparable period in 2021 was $13.2 million. The increase for both the three- and nine-month periods was primarily a result of the timing of activities related to our ongoing WM pivotal trial.
·General and Administrative Expense: G&A expense for the three months ended September 30, 2022 was $2.4 million, compared to $1.9 million for the same period in 2021. G&A expense in the nine months ended September 30, 2022 was approximately $7.6 million, as compared to approximately $5.0 million in the prior year. These increases were driven largely by professional fees and personnel costs.
·Net Loss: The net loss attributable to common stockholders for the quarter ended September 30, 2022 was ($7.8) million, or ($1.28) per share, compared to ($5.8) million, or ($0.97) per share, in the quarter ended September 30, 2021, while the loss attributable to common stockholders for the nine months ended September 30, 2022 was ($21.4) million, or ($3.50) per share, compared to ($18.2) million, or ($3.39) per share, in 2021.