Mustang Bio, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Mustang Bio, Inc. has submitted its 2023 annual 10-K filing, providing a detailed financial and operational overview.</b>

AI Summary

MUSTANG BIO, INC. (MBIO) filed a Annual Report (10-K) with the SEC on March 11, 2024. Mustang Bio, Inc. filed its annual report for the fiscal year ended December 31, 2023. The company's principal executive offices are located at 377 Plantation Street, Worcester, MA 01605. The filing is a Form 10-K, indicating a comprehensive overview of the company's financial performance and business operations. Mustang Bio, Inc. is classified under the Pharmaceutical Preparations industry (SIC code 2834). The report covers the fiscal year ending December 31, 2023.

Why It Matters

For investors and stakeholders tracking MUSTANG BIO, INC., this filing contains several important signals. This 10-K filing provides investors and stakeholders with the most current and comprehensive financial data and business insights for Mustang Bio, Inc. for the fiscal year 2023. Understanding the details within this filing is crucial for assessing the company's financial health, strategic direction, and potential risks and opportunities in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — MUSTANG BIO, INC. shows moderate risk based on this filing. The company operates in the highly regulated and competitive pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market adoption, which are inherent to drug development and commercialization.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to evaluate Mustang Bio's current financial position and future prospects.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-11 — Filing Date (Filed as of date)
• 0001680048 — Central Index Key (Company identifier)
• 2834 — SIC Code (Pharmaceutical Preparations)

Key Players & Entities

• Mustang Bio, Inc. (company) — Filer name
• 377 Plantation Street, Worcester, MA 01605 (location) — Business address
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations
• 2023-12-31 (date) — Conformed period of report
• 2024-03-11 (date) — Filed as of date

FAQ

Industry Context

Mustang Bio, Inc. operates within the pharmaceutical preparations sector, focusing on the development of novel cell and gene therapies.

Regulatory Implications

As a pharmaceutical company, Mustang Bio is subject to stringent regulations from bodies like the FDA concerning drug development, clinical trials, and manufacturing processes.

What Investors Should Do

1. Review the financial statements for revenue, expenses, and cash flow.
2. Analyze the 'Risk Factors' section for potential challenges and uncertainties.
3. Examine management's discussion and analysis for strategic insights and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-11: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This filing represents the company's comprehensive annual update for the fiscal year 2023, following previous quarterly and annual filings.

Key Financial Figures

• $0.0001 — h registered Common Stock, par value $0.0001 per share MBIO Nasdaq Capital Marke
• $381.0 million — 2023, we have an accumulated deficit of $381.0 million. We are a majority-controlled subsidia

Filing Documents

• tmb-20231231x10k.htm (10-K) — 2632KB
• tmb-20231231xex4d2.htm (EX-4.2) — 34KB
• tmb-20231231xex10d28.htm (EX-10.28) — 173KB
• tmb-20231231xex10d29.htm (EX-10.29) — 54KB
• tmb-20231231xex10d30.htm (EX-10.30) — 24KB
• tmb-20231231xex23d1.htm (EX-23.1) — 3KB
• tmb-20231231xex31d3.htm (EX-31.3) — 15KB
• tmb-20231231xex31d4.htm (EX-31.4) — 15KB
• tmb-20231231xex32d5.htm (EX-32.5) — 7KB
• tmb-20231231xex32d6.htm (EX-32.6) — 7KB
• tmb-20231231xex97.htm (EX-97) — 36KB
• tmb-20231231xex10d29001.jpg (GRAPHIC) — 5KB
• 0001558370-24-002899.txt (&nbsp;) — 9539KB
• tmb-20231231.xsd (EX-101.SCH) — 63KB
• tmb-20231231_cal.xml (EX-101.CAL) — 60KB
• tmb-20231231_def.xml (EX-101.DEF) — 335KB
• tmb-20231231_lab.xml (EX-101.LAB) — 455KB
• tmb-20231231_pre.xml (EX-101.PRE) — 461KB
• tmb-20231231x10k_htm.xml (XML) — 1283KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 25 Item 1B. Unresolved Staff Comments 60 Item 1C. Cybersecurity 60 Item 2.

Properties

Properties 60 Item 3.

Legal Proceedings

Legal Proceedings 61 Item 4. Mine Safety Disclosures 61 PART II 61 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 61 Item 6. Reserved 62 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 62 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 74 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 74 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 75 Item 9A.

Controls and Procedures

Controls and Procedures 75 Item 9B. Other Information 76 Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevents Inspections 76 PART III 76 Item 10. Directors, Executive Officers and Corporate Governance 76 Item 11.

Executive Compensation

Executive Compensation 81 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 84 Item 13. Certain Relationships and Related Transactions, and Director Independence 86 Item 14. Principal Accountant Fees and Services 88 PART IV 89 Item 15. Exhibits and Financial Statement Schedules 89 Item 16. Form 10-K Summary 94 Table of Contents SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS Certain matters discussed in this Annual Report on Form 10-K (this "Form 10-K") may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended (the "Securities Act") and the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and similar expressions are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under the caption "Risk Factors," set forth in Part I, Item 1A of this Form 10-K. Such forward-looking statements include, but are not limited to, statements about our: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidates or any other products we may acquire or in-license; use of clinical research centers and other contractor

Business

Item 1. Business OVERVIEW Mustang Bio, Inc. ("Mustang," "we," "us," "our" or the "Company") is a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. We aim to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. Our pipeline is currently focused in three core areas: CAR T therapies for hematologic malignancies, CAR T therapies for solid tumors and gene therapies for rare genetic disorders. For each therapy we have partnered with world class research institutions. For our CAR T therapies we have partnered with the City of Hope National Medical Center ("COH" or "City of Hope"), Fred Hutchinson Cancer Center ("Fred Hutch"), Nationwide Children's Hospital ("Nationwide") and the Mayo Foundation for Medical Education and Research ("Mayo Clinic"). For our gene therapies, we have partnered with St. Jude Children's Research Hospital ("St. Jude") and with Leiden University Medical Centre ("LUMC") in the development of first-in-class ex vivo lentiviral ("LV") treatments for X-linked severe combined immunodeficiency ("XSCID") and RAG1 severe combined immunodeficiency ("RAG1-SCID"), respectively. CAR T Therapies Our pipeline of CAR T therapies is being developed under exclusive licenses from several world class research institutions. Our strategy is to license these technologies, support preclinical and clinical research activities by our partners and transfer the underlying technology to our or our contract manufacturer's cell processing facility in order to conduct our own clinical trials. We are developing CAR T therapy for hematologic malignancies in partnership with Fred Hutch targeting CD20 (MB-106). In May 2021, we announced that the U

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