Carisma Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Carisma Therapeutics Inc. has filed its 2023 10-K report detailing its operations and financial standing.</b>

AI Summary

Carisma Therapeutics Inc. (CARM) filed a Annual Report (10-K) with the SEC on April 1, 2024. Carisma Therapeutics Inc. filed its 2023 Annual Report on Form 10-K on April 1, 2024. The company was formerly known as Sesen Bio, Inc. and Eleven Biotherapeutics, Inc. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is 3675 Market Street, Suite 200, Philadelphia, PA 19104. The SIC code for the company is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking Carisma Therapeutics Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Carisma Therapeutics' financial performance, operational activities, and strategic direction for the fiscal year 2023. Understanding the details within this report is crucial for investors and stakeholders to assess the company's current health, risks, and future prospects in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Carisma Therapeutics Inc. shows moderate risk based on this filing. The company's financial performance and future prospects are subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, clinical trial success, and market competition, as detailed in their 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to assess Carisma Therapeutics' financial health and strategic positioning.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-04-01 — Filing Date (Date of submission)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• Carisma Therapeutics Inc. (company) — Filer name
• Sesen Bio, Inc. (company) — Former company name
• Eleven Biotherapeutics, Inc. (company) — Former company name
• Novartis Pharmaceuticals Corporation (company) — Mentioned in relation to a manufacturing and supply agreement
• Philadelphia, PA (location) — Business and mailing address

FAQ

Industry Context

Carisma Therapeutics Inc. operates within the pharmaceutical preparations industry, focusing on the development and commercialization of therapeutic products.

Regulatory Implications

As a pharmaceutical company, Carisma Therapeutics is subject to extensive regulation by bodies such as the FDA, governing drug development, manufacturing, and marketing.

What Investors Should Do

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

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-04-01: Filing Date — Date Carisma Therapeutics Inc. submitted its 10-K report.

Year-Over-Year Comparison

This is the company's 2023 Form 10-K filing, providing an annual update on its financial and operational status.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 par value per share CARM The Nasdaq Sto

Filing Documents

• carm-20231231.htm (10-K) — 1841KB
• carm-20231231xexx1017.htm (EX-10.17) — 44KB
• carm-20231231xexx211.htm (EX-21.1) — 4KB
• carm-20231231xexx231.htm (EX-23.1) — 2KB
• carm-20231231xexx311.htm (EX-31.1) — 10KB
• carm-20231231xexx312.htm (EX-31.2) — 10KB
• carm-20231231xexx321.htm (EX-32.1) — 5KB
• carm-20231231xexx322.htm (EX-32.2) — 5KB
• carm-20231231xexx97.htm (EX-97) — 19KB
• carm-20231231_g1.jpg (GRAPHIC) — 693KB
• 0001485003-24-000005.txt (&nbsp;) — 9201KB
• carm-20231231.xsd (EX-101.SCH) — 54KB
• carm-20231231_cal.xml (EX-101.CAL) — 79KB
• carm-20231231_def.xml (EX-101.DEF) — 187KB
• carm-20231231_lab.xml (EX-101.LAB) — 727KB
• carm-20231231_pre.xml (EX-101.PRE) — 459KB
• carm-20231231_htm.xml (XML) — 744KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 35 Item 1B. Unresolved Staff Comments 91 I tem 1C. C ybersecurity 92 Item 2.

Properties

Properties 92 Item 3.

Legal Proceedings

Legal Proceedings 92 Item 4. Mine Safety Disclosures 92 PART II. 94 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters , and Issuer Purchases of Equity Securities 94 Item 6. [Reserved] 94 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 95 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 108 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 109 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 135 Item 9A.

Controls and Procedures

Controls and Procedures 135 Item 9B. Other Information 135 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 136 PART III. 137 Item 10. Directors, Executive Officers and Corporate Governance 137 Item 11.

Executive Compensation

Executive Compensation 137 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 137 Item 13. Certain Relationships and Related Transactions, and Director Independence 137 Item 14. Principal Accounting Fees and Services 137 PART IV. 138 Item 15. Exhibits and Financial Statement Schedules 138 I tem 1 6. Form 10-K Summary 140

SIGNATURES

SIGNATURES 141 Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Annual Report on Form 10-K may include, but are not limited to, statements about: the timing and conduct of our pre-clinical studies and clinical trial of CT-0525 for solid tumors that over-express human epidermal growth factor receptor 2, or HER2; our plans to conduct discovery and pre-clinical testing of the development of in vivo chimeric antigen receptor macrophage and monocyte, or CAR-M, therapeutics for up to twelve oncology targets, as well as multiple other targets and indications in connection with our collaboration with ModernaTX, Inc., or Moderna ; expenses associated with our Phase 1 clinical trial of CT-0508 and our sub-study utilizing CT-0508 in combination with pembrolizumab; our ability to obtain additional financing; our ability to replicate in later clinical trials positive results found in pre-clinical studies and early-stage clinical trials of our product candidates; our ability to successfully enroll patients in our Phase 1 clinical trial of CT-0525 and complete clinical trials; ou r plans to conduct discovery and pre-clinical testing of other product candidates; our ability to realize the anticipated benefits of our research and development programs, strategic partnerships, research and licensing programs and acade

Business

Item 1. Business. Overview We are a clinical-stage cell therapy company focused on using our proprietary CAR-M cell therapy platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive cell therapy platform to enable the therapeutic use of engineered macrophages and monocytes, which belong to a subgroup of white blood cells called myeloid cells. Our focus is our proprietary CAR-M cell therapy platform, which redirects macrophages against specific tumor associated antigens and enables targeted anti-tumor immunity by utilizing genetically modified myeloid cells (macrophages and monocytes) to express chimeric antigen receptors, or CARs, enabling these potent innate immune cells to recognize specific tumor associated antigens on the surface of tumor cells. On March 7, 2023, we completed a business combination in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of September 20, 2022, pursuant to which the Merger was consummated. Pursuant to the Merger Agreement, we changed our name from "Sesen Bio, Inc." to "Carisma Therapeutics Inc." Following the completion of the Merger, our business became primarily the business conducted by Legacy Carisma. In late March 2024, following a strategic review of our operating plan for 2024 and future periods, we approved a revised operating plan intended to balance value creation and expense management with our available cash resources. The objective of our revised operating plan is to focus our clinical development efforts on high potential value programs with meaningful near-term milestones and eliminate non-essential expenses and headcount to extend our cash runway. Under this plan, we intend to focus our ex vivo oncology clinical development efforts on our follow-on product candidate CT-0525, a CAR-Monocyte intended to treat solid tumors that over-express HER2. CT-0525 utilizes a novel approach to CAR-M therapy that e

View Full Filing

View this 10-K filing on SEC EDGAR