Cellectar Biosciences Files 2023 10-K Amendment

TL;DR

Cellectar filed a 10-K/A for 2023, updating financials and warrant values.

AI Summary

Cellectar Biosciences, Inc. filed an amendment (10-K/A) on October 29, 2024, for their fiscal year ending December 31, 2023. The filing details financial information, including costs and expenses, and fair value adjustments for warrants. The company, formerly known as NOVELOS THERAPEUTICS, INC., is based in Florham Park, NJ.

Why It Matters

This amendment provides updated financial disclosures for Cellectar Biosciences, Inc., offering a clearer picture of their financial health and warrant valuations for investors.

Risk Assessment

Risk Level: medium — Amendments to 10-K filings often indicate a need for clarification or correction of previously reported information, which can introduce uncertainty.

Key Numbers

• $319.76 — Costs and Expenses (Part of the financial disclosures in the 10-K/A.)
• $9385272 — Fair Value Adjustment of Warrants (Indicates changes in the valuation of outstanding warrants.)
• $20744110 — Fair Value Adjustment of Warrants (Indicates changes in the valuation of outstanding warrants.)
• $42770610 — Fair Value Adjustment of Warrants (Indicates changes in the valuation of outstanding warrants.)

Key Players & Entities

• Cellectar Biosciences, Inc. (company) — Filer
• NOVELOS THERAPEUTICS, INC. (company) — Former Company Name
• 20231231 (date) — Fiscal Year End
• 20241029 (date) — Filing Date
• Florham Park, NJ (location) — Business Address

FAQ

Key Financial Figures

• $0.00001 — ch registered Common stock, par value $0.00001 CLRB Nasdaq Capital Market Securi
• $2M — omas). This study is partially funded (~$2M) by a National Institutes of Health SBI

Filing Documents

• clrb-20231231x10ka.htm (10-K/A) — 5678KB
• clrb-20231231xex21d1.htm (EX-21.1) — 3KB
• clrb-20231231xex23d1.htm (EX-23.1) — 4KB
• clrb-20231231xex31d1.htm (EX-31.1) — 11KB
• clrb-20231231xex31d2.htm (EX-31.2) — 11KB
• clrb-20231231xex32d1.htm (EX-32.1) — 6KB
• 0001410578-24-001704.txt ( ) — 26405KB
• clrb-20231231.xsd (EX-101.SCH) — 60KB
• clrb-20231231_cal.xml (EX-101.CAL) — 50KB
• clrb-20231231_def.xml (EX-101.DEF) — 364KB
• clrb-20231231_lab.xml (EX-101.LAB) — 419KB
• clrb-20231231_pre.xml (EX-101.PRE) — 550KB
• clrb-20231231x10ka_htm.xml (XML) — 8287KB

Forward-Looking Statements

Forward-Looking Statements 4 PART I 6 Item 1.

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 55 Item 1C. Cybersecurity 55 Item 2.

Properties

Properties 55 Item 3.

Legal Proceedings

Legal Proceedings 55 Item 4. Mine Safety Disclosures 55 PART II 56 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 56 Item 6. Reserved 57 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 57 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 62 Item 8.

Financial Statements

Financial Statements 63 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 121 Item 9A.

Controls and Procedures

Controls and Procedures 121 Item 9B. Other Information 122 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 123 PART III 123 Item 10. Directors, Executive Officers, and Corporate Governance 123 Item 11.

Executive Compensation

Executive Compensation 123 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 123 Item 13. Certain Relationships and Related Transactions, and Director Independence 123 Item 14. Principal Accounting Fees and Services 123 PART IV 124 Item 15. Exhibits, Financial Statement Schedules 124 Item 16 Summary 125

Signatures

Signatures 126 Table of Contents EXPLANATORY NOTE On July 15, 2024, the Audit Committee of Cellectar Biosciences, Inc.'s (the "Company") Board of Directors engaged Deloitte & Touche, LLP ("Deloitte") as the Company's independent registered public accounting firm for the year ending December 31, 2024. The Company's prior auditors, Baker Tilly US, LLP, were discharged on July 8, 2024, as reported in the Company's Form 8-K dated July 11, 2024. On August 9, 2024, the Board of Directors of the Company (the "Board") concluded that the Company's previously-issued (i) audited consolidated financial statements for the fiscal years ended December 31, 2023 and December 31, 2022, contained in its Annual Reports on Form 10-K and (ii) unaudited interim condensed consolidated financial statements for the periods ending March 31, 2023, June 30, 2023, September 30, 2023, and March 31, 2024 contained in its Quarterly Reports on Form 10-Q (collectively, the "Non-Reliance Periods"), as well as its disclosures related to such financial statements, including any reports, earnings releases, and investor presentations, and related communications issued by or on behalf of the Company with respect to the Non-Reliance Periods, should no longer be relied upon due to errors in such financial statements, and therefore a restatement of these prior financial statements is required. The determination by the Board was made upon the recommendation of the Audit Committee of the Board and after consultation with the Company's management team. On August 28, 2024, the Audit Committee of the Board engaged Deloitte to re-audit the Company's financial statements for the fiscal years ended December 31, 2023 and 2022. Management had determined that the accounting for certain warrants and preferred stock issued by the Company was incorrect, necessitating an in-depth review. Management's review identified material misstatements related to the accounting treatment for the warrants in question, previous

, Item 1A. Risk Factors

Part I, Item 1A. Risk Factors Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) related to the years ended December 31, 2023 and 2022.

, Item 8. Financial Statements

Part II, Item 8. Financial Statements

, Item 9A. Controls and Procedures

Part II, Item 9A. Controls and Procedures We do not intend to file a separate amended Annual Report on Form 10-K/A for the fiscal year ended December 31, 2022, or amended Quarterly Reports on Form 10-Q/A for the quarterly periods ended March 31, 2023, June 30, 2023, September 30, 2023, March 31, 2022, June 30, 2022, or September 30, 2022. The financial statements presented for each quarter as included in Note 15, Restatement of Previously Issued Quarterly Financial Statements, in Item 8. Financial Statements, of this Annual Report have also been restated. For more information, see Note 14, Restatement of Previously Issued Financial Statements, and Note 15, Restatement of Previously Issued Quarterly Financial Statements, in Item 8. Financial Statements, of this Annual Report. In connection with the restatement, the Audit Committee of the Board concluded, with the concurrence of management, that there were deficiencies in the principles associated with the control environment, risk assessment, control activities, information and communication and monitoring components of internal control, based on the criteria established by the COSO Framework, that constitute material weaknesses, either individually or in the aggregate, as of December 31, 2023 and 2022. As further discussed in Item 9A. Controls and Procedures of this Annual Report, management has concluded that the Company did not maintain an effective internal control environment over financial reporting resulting in material weaknesses as of December 31, 2023 and 2022, and further concluded that the material weaknesses applied to the interim periods ended September 30, 2023, June 30, 2023, March 31, 2023, September 30, 2022, June 30, 2022, and March 31, 2022. 2 Table of Contents In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), new certifications by the Company's principal executive officer and principal financial officer are filed herewith

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This annual report on Form 10-K/A of Cellectar Biosciences, Inc. (the "Company", "Cellectar", "we", "us", "our") contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. Examples of our forward-looking statements include: our current views with respect to our business strategy, business plan and research and development activities; the progress of our product development programs, including clinical testing and the timing of commencement and results thereof; our projected operating results, including research and development expenses; our ability to continue development plans for iopofosine I 131 (iopofosine, also known as CLR 131), CLR 1900 series, CLR 2000 series, and CLR 12120; our ability to continue development plans for our Phospholipid Drug Conjugates (PDC); our ability to maintain orphan drug designation in the U.S. for iopofosine as a therapeutic for the treatment of multiple myeloma, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing's sarcoma and lymphoplasmacytic lymphoma, and the expected benefits of orphan drug status; any disruptions at our sole supplier of iopofosine; our ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or otherwise; our ability to advance our technologies into product candidates; our enhancement and consumption of current resources along with ability to obtain additional funding; our current view regarding general economic and market conditions, including our competitive strengths; the future impacts of the COVID-19 pandemic on our business, employees, operating results, ability to recruit patients for clinical studies, ability to obtain additional funding, product development programs, research and development programs, suppliers and third-party manufacturers; uncertainty and economic instability resulting from conflicts, militar

Business

Item 1. Business. Business Overview We are a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer. Our core objective is to leverage our proprietary phospholipid ether drug conjugate (PDC) delivery platform to develop PDCs that are designed to specifically target cancer cells and deliver improved efficacy and better safety as a result of fewer off-target effects. We believe that our PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting treatments, and we plan to develop PDCs both independently and through research and development collaborations. Our lead PDC therapeutic, iopofosine I 131 (iopofosine) is a small-molecule PDC designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments and radiotherapeutics. Our CLOVER-WaM Phase 2 pivotal study of iopofosine in patients with relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM) has completed, and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing. The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatric patients with high grade glioma is enrolling. Additionally, a Phase 1 Investigator-initiated study conducted by the University of Wisconsin Madison of iopofosine I 131 in combination with external beam radiation in patients with recurrent head and neck cancer has also completed. As with all clinical trials, adverse events, serious adverse events or fatalities may arise during a clinical trial resulting from medical problems that may not be related to clinical trial treatments. The CLOVER-1 Phase 2 study, conducted in r/r B-cell malignancies, met the primary efficacy endpoints from the Part A

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View this 10-K/A filing on SEC EDGAR