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

TL;DR

<b>TScan Therapeutics, Inc. has filed its 2023 Form 10-K detailing its fiscal year operations and financial standing.</b>

AI Summary

TScan Therapeutics, Inc. (TCRX) filed a Annual Report (10-K) with the SEC on March 6, 2024. TScan Therapeutics, Inc. filed its 2023 Form 10-K on March 6, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 880 Winter Street, Waltham, MA 02451. The company's business phone number is 857-399-9500. TScan Therapeutics operates in the Biological Products sector.

Why It Matters

For investors and stakeholders tracking TScan Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of TScan Therapeutics' business, financial condition, and results of operations for the fiscal year ended December 31, 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information within the 10-K, including risk factors and financial statements, allows stakeholders to understand the company's strategic direction, potential challenges, and overall health.

Risk Assessment

Risk Level: medium — TScan Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and rapidly evolving biotechnology industry, facing significant risks related to clinical trial success, regulatory approvals, and market adoption of its therapeutic candidates.

Analyst Insight

Investors should review the detailed risk factors and financial disclosures in the 10-K to understand the specific challenges and opportunities facing TScan Therapeutics in the development and commercialization of its gene-edited T cell therapies.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the report)
• 2024-03-06 — Filing Date (Date the 10-K was filed)
• 001-40603 — SEC File Number (SEC file number associated with the company)
• 0000950170-24-026875 — Accession Number (Unique identifier for the filing)

Key Players & Entities

• TScan Therapeutics, Inc. (company) — Filer name
• Waltham, MA (location) — Business address city and state
• 880 Winter Street (location) — Business address street
• 02451 (location) — Business address zip code
• 857-399-9500 (phone_number) — Business phone number
• 2836 (industry_code) — Standard Industrial Classification code for Biological Products
• DE (state) — State of incorporation
• Novartis (company) — Mentioned in relation to agreements and research funding

FAQ

Risk Factors

• Competition [high — market]: The company faces intense competition from other biotechnology companies, including large pharmaceutical companies and smaller, more agile firms, which could adversely affect its ability to achieve market penetration and profitability.
• Regulatory Approval [high — regulatory]: The development and commercialization of the company's product candidates are subject to extensive regulatory review and approval processes by agencies such as the FDA, which can be lengthy, costly, and uncertain.
• Research and Development Risks [high — operational]: The company's success depends heavily on the successful development of its gene-edited T cell therapies, which involves significant R&D risks, including the possibility of unexpected results, delays, or failure to demonstrate efficacy and safety.
• Need for Additional Funding [high — financial]: The company anticipates that it will require substantial additional capital to fund its ongoing operations, clinical trials, and potential commercialization efforts, and there is no assurance that such funding will be available on acceptable terms.

Key Financial Figures

• $0.0001 — which registered Voting Common Stock, $0.0001 par value per share TCRX The Nasdaq

Filing Documents

• tcrx-20231231.htm (10-K) — 2669KB
• tcrx-ex10_14.htm (EX-10.14) — 90KB
• tcrx-ex10_17.htm (EX-10.17) — 84KB
• tcrx-ex21.htm (EX-21) — 4KB
• tcrx-ex23_1.htm (EX-23.1) — 4KB
• tcrx-ex31_1.htm (EX-31.1) — 17KB
• tcrx-ex31_2.htm (EX-31.2) — 15KB
• tcrx-ex32_1.htm (EX-32.1) — 9KB
• tcrx-ex32_2.htm (EX-32.2) — 9KB
• tcrx-ex97.htm (EX-97) — 37KB
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• img180088726_19.jpg (GRAPHIC) — 70KB
• 0000950170-24-026875.txt (&nbsp;) — 11874KB
• tcrx-20231231.xsd (EX-101.SCH) — 1288KB
• tcrx-20231231_htm.xml (XML) — 1108KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 53 Item 1B. Unresolved Staff Comments 110 Item 1C. Cybersecurity 111 Item 2.

Properties

Properties 111 Item 3.

Legal Proceedings

Legal Proceedings 112 Item 4. Mine Safety Disclosures 112 PART II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 113 Item 6. [Reserved] 113 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 114 Item 7A. Quantitative and Qualitative Data About Market Risk 124 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 124 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 124 Item 9A.

Controls and Procedures

Controls and Procedures 124 Item 9B. Other Information 125 Item 9C. Disclosures Regarding Foreign Jurisdictions that Prevent Inspections 125 PART III. Item 10. Directors, Executive Officers and Corporate Governance 126 Item 11.

Executive Compensation

Executive Compensation 126 Item 12.

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

Security Ownership and Certain Beneficial Owners and Management and Related Stockholder Matters 126 Item 13. Certain Relationships and Related Transactions, and Director Independence 126 Item 14. Principal Accounting Fees and Services 126 PART IV. Item 15. Exhibits, Financial Statement Schedules 127 Item 16. Form 10-K Summary 129 i Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as "may," "can," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "seek," "contemplate," "believe," "estimate," "predict," "potential," "possible" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements contained in this Annual Report include, but are not limited to, statements about: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of our T cell receptor (TCR)-engineered T cell, or TCR-T, therapy candidates; our expectations regarding our preclinical studies being predictive of clinical trial results; the timing of the initiation, progress and expected results of our preclinical studies, clinical trials and our research and development programs; the timing of and our ability to submit applications for, and obtain and, if approved, maintain regulatory approvals for our TC

Business

Item 1. Business Overview We are a clinical-stage biopharmaceutical company focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell, or TCR-T, therapies for the treatment of patients with cancer. Our approach is based on the central premise that we can learn from patients who are winning their fight against cancer to treat those who are not. Over the past several years, we have built our ImmunoBank, a repository of therapeutic TCRs that recognize diverse targets and are associated with multiple human leukocyte antigen, or HLA, types. These TCRs are then used to manufacture enhanced TCR-T therapies to treat a broad population of patients with both heme and solid tumor malignancies. Every TCR in our ImmunoBank has come from our proprietary platform technologies, and we are continuing to expand our ImmunoBank. Using TargetScan, we analyze the T cells of cancer patients with exceptional responses to immunotherapy to discover how the immune system naturally recognizes and eliminates tumor cells in these patients. This allows us to precisely identify the targets of TCRs that are driving these exceptional responses. We then use these anti-cancer TCRs to treat patients by genetically engineering T cells to recognize and eliminate their cancer. In addition to discovering TCRs against novel targets, we are using our ReceptorScan technology to identify high affinity naturally occurring TCRs for known targets. Once we identify therapeutic candidates using these technologies, we reduce the safety risk of clinical development by comprehensively screening these TCRs against the human proteome using SafetyScan to identify potential off-target interactions. We then eliminate any TCR-T candidates that cross-react with proteins expressed at high levels in normal tissues. Our in-house good manufacturing practices, or GMP, T-cell engineering platform, which we refer to as T-Integrate, enables the rapid, cost-effective, and consistent manufacturing of TCR

View Full Filing

View this 10-K filing on SEC EDGAR