Cellectar Biosciences Files 8-K on Exit Costs and Disclosures

TL;DR

Cellectar Biosciences filed an 8-K detailing exit costs and other disclosures.

AI Summary

Cellectar Biosciences, Inc. filed an 8-K on December 10, 2024, reporting on cost associated with exit or disposal activities, Regulation FD disclosure, and other events. The filing also includes financial statements and exhibits. The company was formerly known as Novelos Therapeutics, Inc. and Common Horizons Inc.

Why It Matters

This filing indicates potential restructuring or discontinuation of certain business activities, which could impact the company's future operations and financial performance.

Risk Assessment

Risk Level: medium — Filings related to exit or disposal activities often signal significant business changes that carry inherent risks.

Key Players & Entities

• Cellectar Biosciences, Inc. (company) — Registrant
• Novelos Therapeutics, Inc. (company) — Former company name
• Common Horizons Inc (company) — Former company name
• December 10, 2024 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.00001 — ch registered Common Stock, par value $0.00001 per share CLRB The Nasdaq Capital M
• $7.5 million — annual operating costs by approximately $7.5 million. Additionally, the Company estimates th
• $1.7 m — regate severance costs of approximately $1.7 million, which will be recorded primarily

Filing Documents

• tm2430732d1_8k.htm (8-K) — 34KB
• tm2430732d1_ex99-1.htm (EX-99.1) — 18KB
• tm2430732d1_ex99-1img001.jpg (GRAPHIC) — 13KB
• 0001104659-24-127487.txt ( ) — 248KB
• clrb-20241210.xsd (EX-101.SCH) — 3KB
• clrb-20241210_lab.xml (EX-101.LAB) — 33KB
• clrb-20241210_pre.xml (EX-101.PRE) — 22KB
• tm2430732d1_8k_htm.xml (XML) — 3KB

05 Costs Associated with Exit or Disposal Activities

Item 2.05 Costs Associated with Exit or Disposal Activities On December 10, 2024, the Board of Directors of Cellectar Biosciences, Inc. (the "Company") approved and management began implementing a workforce reduction plan to reduce operating costs and better align its workforce with the needs of its business following recent communications with the U.S. Food and Drug Administration (the "FDA") regarding its confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, as described in more detail in Item 8.01 below. The implementation of the workforce reduction plan should be complete by the end of the fourth quarter 2024. Under the workforce reduction plan, the Company is reducing its overall workforce by approximately 60%. Impacted employees are eligible to receive severance benefits, including: (a) salary continuation for period to be determined on an individual basis, but in no event for less than six weeks, (b) COBRA premium subsidies for the full months that encompass the severance period, and (c) a severance incentive. These severance benefits are contingent upon an impacted employee's execution (and non-revocation) of a separation agreement, which includes a general release of claims against the Company. In addition, any unvested and outstanding stock option grant held by impacted employees that would have vested within 90 days of the termination date will be immediately fully vested and all vested stock options held by such employees shall remain exercisable for 180 days from date of such employee's termination. The Company expects that the workforce reduction will decrease its annual operating costs by approximately $7.5 million. Additionally, the Company estimates that it will incur aggregate severance costs of approximately $1.7 million, which will be recorded primarily in the fourth quarter of 2024 and first quarter of 2025. The cost that the Company expects to incur in connection with the workforce reduction

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 10, 2024, the Company issued a press release announcing a strategic update on clinical developments, pipeline programs and corporate restructuring. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events. Due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of iopofosine I 131. Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the major response rate (MRR) data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS). Cellectar will now focus on those assets it believes have the highest therapeutic potential and opportunity for value creation. The Company believes that precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest. Consequently, the Company will now focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225 based program, and CLR 121125, its iodine-125 Auger-emitting program into the clinic. Cellectar expects to file Investigational New Drug ("IND") applications in the first half of 2025 for both CLR 121225 and CLR 121125 which will allow the initiation of Phase 1 clinical studies in solid tumor cancers. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The Company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients. The Company's strategic reprioritization will impact all departments and result in an immediate reduction in headcount of approximately 60% and should be complete by the end of the fourth quarter 2024. The Company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025. This Item 8.01 contains forward-looking

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. Number Title 99.1 Press Release, dated December 10, 2024 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CELLECTAR BIOSCIENCES, INC. Date: December 11, 2024 By: /s/ Chad J. Kolean Name: Chad J. Kolean Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR