On March 9, 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 year ended December 31, 2022 and provided a corporate update (Press release, Cellectar Biosciences, MAR 9, 2023, View Source [SID1234628411]).

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!

Fourth Quarter and Recent Corporate Highlights

Presented preclinical data on the CLR 12120 series of targeted alpha therapies (TATs) at the 13th Annual World ADC Conference. The presentation, entitled: "Novel Conjugates – Radiotherapies," given by Cellectar’s Chief Operating Officer, Jarrod Longcor, highlighted data demonstrating the versatility of the phospholipid ether (PLE) targeting platform and the potential of the company’s alpha emitting precision medicines, supporting further development.

· Announced that Cellectar, the Wisconsin Alumni Research Foundation, and Drs. Jamey Weichert and Anatoly Pinchuk have resolved a lawsuit filed by Cellectar in October 2021 in the United States District Court for the Western District of Wisconsin concerning employee contracts and intellectual property rights in certain intellectual property pertaining to the diagnosis and treatment of cancer. The parties cannot further comment on that resolution, except to note that (i) all claims against Drs. Weichert and Pinchuk have been voluntarily dismissed, and (ii) Cellectar has secured an irrevocable, non-exclusive license to the patents at issue in the lawsuit.

· Announced Shane Lea as chief commercial officer, overseeing all marketing and commercialization efforts for Cellectar as it prepares for data from its pivotal trial in Waldenstrom’s macroglobulinemia.

· Appointed Dr. Andrei Shustov as senior vice president, medical to lead and provide oversight on all aspects of the Company’s clinical development program, medical affairs, and medical communications.

· Announced that a patient with primary central nervous system lymphoma enrolled in its Phase 2 CLOVER-1 Trial demonstrated a complete response according to the 2005 Response Criteria for CNS Lymphoma with total resolution of the tumor on imaging studies.

"2022 was highly productive for Cellectar. We currently have 43 global sites actively recruiting patients for our pivotal study in Waldenstrom’s macroglobulinemia (WM). In parallel, our technology demonstrated consistently positive outcomes across multiple indications. At the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference, we presented a 50% response rate achieved by iopofosine in post BCMA multiple myeloma patients and successfully concluded our phase 1a pediatric study and will initiate a phase 1b for High Grade Gliomas supported by a $2 million NCI grant. We also reported the extraordinary complete response in a patient with relapsed/refractory CNS lymphoma further demonstrating iopofosine’s ability to cross the blood/brain barrier and target cancer," said James Caruso, president and CEO of Cellectar. "Importantly, we strengthened our commercial leadership with several key hires, including Shane Lea, who has launched six new hematology/oncology products, and Dr. Andrei Shustov, who provides a wealth of hematology/oncology clinical as well as study experience

Fourth Quarter 2022 Financial Highlights

• Cash and Cash Equivalents: As of December 31, 2022, the company had cash and cash equivalents of $19.9 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the year ended December 31, 2022 was approximately $25.2 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 year ended December 31, 2022 was approximately $19.2 million, compared to approximately $17.6 million for the year ended December 31, 2021. The overall increase in research and development expense was primarily a result of an increase in manufacturing and costs related to production sourcing and pre-clinical costs.

• General and Administrative Expense: G&A expense for the year ended December 31, 2022 was $9.5 million, compared to $6.5 million for the same period in 2021. The increase in G&A costs was primarily a result of increased professional fees, a portion of which were non-recurring, as well as travel and personnel costs.

• Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2022 was ($28.6) million, or ($4.05) per share, compared to ($24.1) million, or ($4.35) per share, in the year ended December 31, 2021.