Northwest Biotherapeutics Inc. Files 2023 10-K Report

TL;DR

<b>Northwest Biotherapeutics Inc. filed its 2023 10-K, detailing significant assets and debt, alongside convertible note and preferred stock information.</b>

AI Summary

NORTHWEST BIOTHERAPEUTICS INC (NWBO) filed a Annual Report (10-K) with the SEC on March 5, 2024. Northwest Biotherapeutics Inc. reported total assets of $106,840,000 for the fiscal year ended December 31, 2023. The company's total debt was $1,175,500,000 as of December 31, 2023. Revenue for the period was not explicitly stated but related party revenue was $1,400,000. Net income figures were not detailed in the provided snippet. The filing includes details on Series C Convertible Preferred Stock and August/September Convertible Notes.

Why It Matters

For investors and stakeholders tracking NORTHWEST BIOTHERAPEUTICS INC, this filing contains several important signals. The substantial debt ($1.175B) relative to assets ($106.8M) indicates a highly leveraged financial position, potentially impacting future operations and investor confidence. The mention of convertible notes and preferred stock suggests ongoing financing activities and potential dilution for common shareholders.

Risk Assessment

Risk Level: high — NORTHWEST BIOTHERAPEUTICS INC shows elevated risk based on this filing. The company's debt of $1,175,500,000 significantly outweighs its total assets of $106,840,000 as of December 31, 2023, indicating a high risk of financial distress.

Analyst Insight

Investors should closely examine the company's debt repayment strategies and cash flow generation capabilities given the significant debt load.

Financial Highlights

total Assets

1068400000

total Debt

1175500000

Key Numbers

• 106,840,000 — Total Assets (As of December 31, 2023)
• 1,175,500,000 — Total Debt (As of December 31, 2023)
• 1,400,000 — Related Party Revenue (For the fiscal year ended December 31, 2023)
• 0.04 — Derivative Gain/Loss Ratio (As of December 31, 2023)

Key Players & Entities

• NORTHWEST BIOTHERAPEUTICS INC (company) — Filer name
• NWBO (company) — Ticker symbol
• 2023-12-31 (date) — Fiscal year end
• 2024-03-05 (date) — Filing date
• AugustSeptember Convertible Notes (company) — Specific financial instrument
• Series C Convertible Preferred Stock (company) — Specific financial instrument

FAQ

Risk Factors

• High Leverage and Debt Obligations [high — financial]: The company has substantial total debt of $1,175,500,000 compared to total assets of $106,840,000 as of December 31, 2023.

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 10-K
• 2024-03-05: Filing Date — Date the 10-K was officially submitted
• 2024-01-22: Subsequent Event — A significant event occurring after the fiscal year end

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), giving a comprehensive summary of a company's financial performance. (Provides a detailed overview of the company's financial health and operations for the fiscal year.)

Key Financial Figures

• $0.001 — h registered: Common Stock, par value $0.001 per share NWBO OTCQB Securities r

Filing Documents

• nwbo-20231231x10k.htm (10-K) — 3239KB
• nwbo-20231231xex10d89.htm (EX-10.89) — 64KB
• nwbo-20231231xex10d90.htm (EX-10.90) — 128KB
• nwbo-20231231xex23d1.htm (EX-23.1) — 3KB
• nwbo-20231231xex31d1.htm (EX-31.1) — 14KB
• nwbo-20231231xex32d1.htm (EX-32.1) — 7KB
• nwbo-20231231x10k001.jpg (GRAPHIC) — 87KB
• 0001410578-24-000133.txt (&nbsp;) — 16139KB
• nwbo-20231231.xsd (EX-101.SCH) — 101KB
• nwbo-20231231_cal.xml (EX-101.CAL) — 70KB
• nwbo-20231231_def.xml (EX-101.DEF) — 490KB
• nwbo-20231231_lab.xml (EX-101.LAB) — 695KB
• nwbo-20231231_pre.xml (EX-101.PRE) — 684KB
• nwbo-20231231x10k_htm.xml (XML) — 3519KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 6 Item 1B. Unresolved Staff Comments 19 Item 1C. Cybersecurity 19 Item 2.

Properties

Properties 19 Item 3.

Legal Proceedings

Legal Proceedings 20 Item 4. Mine Safety Disclosures 20 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 21 Item 6. Reserved 23 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 23 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 33 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 33 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures 33 Item 9A.

Controls and Procedures

Controls and Procedures 33 Item 9B. Other Information 34 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 34 PART III Item 10. Directors, Executive Officers and Corporate Governance 35 Item 11.

Executive Compensation

Executive Compensation 35 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 35 Item 13. Certain Relationships and Related Transactions, and Director Independence 35 Item 14. Principal Accountant Fees and Services 35 PART IV Item 15. Exhibits and Financial Statement Schedules 35 Item 16. Form 10-K Summary 37

SIGNATURES

SIGNATURES 38 2 Table of Contents PART I This Report on Form 10-K for Northwest Biotherapeutics, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as "may," "will," "expect," "intend," "anticipate," believe," "estimate" and "continue" or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions, and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Item 1A of this Report, including the uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate safety and efficacy in larger-scale clinical trials, the risk that we will not obtain approval to market our products, the risks associated with dependence upon key personnel and the need for additional financing. We do not assume any obligation to update forward-looking statements as circumstances change. Unless the context otherwise requires, "Northwest Biotherapeutics," the "Company," "we," "us," "our" and similar names refer to Northwest Biotherapeutics, Inc. DCVax is a registered trademark of the Company.

BUSINESS

ITEM 1. BUSINESS. Overview We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax, which uses activated dendritic cells to mobilize a patient's own immune system to attack their cancer. Our lead product, DCVax-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit. The Company's programs and operations continue to be impacted by supply chain issues and backlogs.These involve service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The Company is hopeful that the various backlog circumstances will improve in 2024. The DCVax Technology Our platform technology, DCVax, is a personalized immune therapy that uses a patient's own dendritic cells, or DCs, the master cells of the immune system, as the therapeutic agent. The patient's DCs are obtained through a blood draw, or leukapheresis. The DCs are then activated and loaded with biomarkers ("antigens") from the patient's own tumor. For DCVax-L, the antigen loading process takes place during the manufacturing of the product

RISK FACTORS

ITEM 1A. RISK FACTORS Our business, financial condition, operating results and prospects are subject to the following material risks. Additional risks and uncertainties not presently foreseeable to us may also impair our business operations. If any of the following risks actually occurs, our business, financial condition or operating results could be materially adversely affected. In such case, the trading price of our common stock could decline, and our stockholders may lose all or part of their investment in the shares of our common stock. Risks Related to our Operations We will need to raise substantial funds, on an ongoing basis, for general corporate purposes and operations, including our clinical trials. Such funding may not be available or may not be available on acceptable terms. We will need substantial additional funding, on an ongoing basis, in order to continue execution of our clinical trials, to move our product candidates towards commercialization, to continue prosecution and maintenance of our large patent portfolio, to continue development and optimization of our manufacturing and distribution arrangements, and for other corporate purposes. Any financing, if available, may include restrictive covenants and provisions that could limit our ability to take certain actions, preference provisions for the investors, and/or discounts, warrants, anti-dilution rights, the provision of collateral, or other incentives. Any financing will involve issuance of equity and/or debt, and such issuances will be dilutive to existing shareholders. There can be no assurance that we will be able to complete any of the financings, or that the terms for such financings will be acceptable. If we are unable to obtain additional funds on a timely basis or on acceptable terms, we may be required to curtail or cease some or all of our operations at any time. We are likely to continue to incur substantial losses and may never achieve profitability. As of December 31, 2023,