Celldex Therapeutics Files 2023 10-K

TL;DR

<b>Celldex Therapeutics filed its annual 10-K report for the fiscal year ending December 31, 2023, detailing financial and operational information.</b>

AI Summary

Celldex Therapeutics, Inc. (CLDX) filed a Annual Report (10-K) with the SEC on February 26, 2024. Celldex Therapeutics, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company's principal business address is 53 Frontage Road, Suite 220, Hampton, NJ 08827. Celldex Therapeutics was formerly known as AVANT IMMUNOTHERAPEUTICS INC and T CELL SCIENCES INC. The filing includes data related to common stock, employee stock, retained earnings, and additional paid-in capital for various fiscal years. Information on stock options and incentive plans, as well as grants from Rockefeller and the National Institute of Health, is also present.

Why It Matters

For investors and stakeholders tracking Celldex Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Celldex Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed financial statements and disclosures within the 10-K are essential for understanding the company's capital structure, equity, and any significant grants or stock-based compensation, informing investment decisions.

Risk Assessment

Risk Level: low — Celldex Therapeutics, Inc. shows low risk based on this filing. The filing is a standard 10-K report, which is a routine disclosure for publicly traded companies and does not inherently contain new, high-risk information.

Analyst Insight

Review the detailed financial statements and disclosures in the 10-K to understand Celldex Therapeutics' financial position and operational performance for fiscal year 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-26 — Filing Date (Date of submission)
• 100000 — Common Stock (Value for 2023-01-01 to 2023-12-31)
• 2500000 — Employee Stock (Value for 2023-01-01 to 2023-12-31)
• 1000000 — Employee Stock Option (Value for 2023-01-01 to 2023-12-31)

Key Players & Entities

• Celldex Therapeutics, Inc. (company) — Filer name
• 0000744218 (company) — Central Index Key
• AVANT IMMUNOTHERAPEUTICS INC (company) — Former company name
• T CELL SCIENCES INC (company) — Former company name
• Rockefeller (company) — Grantor
• National Institute of Health (company) — Grantor

FAQ

Industry Context

Celldex Therapeutics operates in the biotechnology sector, focusing on the development of novel therapeutics.

Regulatory Implications

The filing is a standard 10-K, adhering to the regulations set forth by the Securities and Exchange Commission (SEC) for annual financial reporting.

What Investors Should Do

1. Analyze the financial statements for revenue, net income, and cash flow.
2. Review disclosures on executive compensation and stock-based awards.
3. Examine any risk factors or legal proceedings mentioned in the report.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-26: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the 2023 10-K filing, providing updated financial and operational data compared to previous filings.

Filing Documents

• cldx-20231231x10k.htm (10-K) — 2246KB
• cldx-20231231xex1d1.htm (EX-1.1) — 355KB
• cldx-20231231xex5d1.htm (EX-5.1) — 10KB
• cldx-20231231xex21d1.htm (EX-21.1) — 6KB
• cldx-20231231xex23d1.htm (EX-23.1) — 5KB
• cldx-20231231xex31d1.htm (EX-31.1) — 13KB
• cldx-20231231xex31d2.htm (EX-31.2) — 15KB
• cldx-20231231xex32.htm (EX-32) — 10KB
• cldx-20231231xex97.htm (EX-97) — 29KB
• cldx-20231231x10k002.jpg (GRAPHIC) — 31KB
• 0001410578-24-000076.txt (&nbsp;) — 8660KB
• cldx-20231231.xsd (EX-101.SCH) — 50KB
• cldx-20231231_cal.xml (EX-101.CAL) — 63KB
• cldx-20231231_def.xml (EX-101.DEF) — 202KB
• cldx-20231231_lab.xml (EX-101.LAB) — 509KB
• cldx-20231231_pre.xml (EX-101.PRE) — 370KB
• cldx-20231231x10k_htm.xml (XML) — 1201KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 22 Item 1B. Unresolved Staff Comments 50 Item 1C. Cybersecurity 50 Item 2.

Properties

Properties 51 Item 3.

Legal Proceedings

Legal Proceedings 51 Item 4. Mine Safety Disclosures 51 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6. [Reserved] 52 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 53 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 70 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 71 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 94 Item 9A.

Controls and Procedures

Controls and Procedures 94 Item 9B. Other Information 95 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 95 Part III Item 10. Directors, Executive Officers and Corporate Governance 96 Item 11.

Executive Compensation

Executive Compensation 96 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 96 Item 13. Certain Relationships and Related Transactions, and Director Independence 96 Item 14. Principal Accountant Fees and Services 96 Part IV Item 15. Exhibits, Financial Statement Schedules 97 Item 16. Form 10-K Summary 100

Signatures

Signatures 101 i Table of Contents Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This Annual Report on Form 10-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as "may," "will," "can," "anticipate," "assume," "should," "indicate," "would," "believe," "contemplate," "expect," "seek," "estimate," "continue," "plan," "point to," "project," "predict," "could," "intend," "target," "potential" and other similar words and expressions of the future. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to: our dependence on product candidates that are still in development stages; our ability to successfully complete research and further development, including preclinical and clinical studies; our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; our ability to negotiate strategic partnerships, where app

BUSINESS

Item 1. BUSINESS Overview Celldex Therapeutics, Inc., which we refer to as "Celldex," "we," "us," "our" or the "Company," is a biopharmaceutical company dedicated to exploring the science of mast cell biology and developing therapeutic antibodies which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Our drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated diseases for which available treatments are inadequate. We are focusing our efforts and resources on the continued research and development of Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which is currently being studied across multiple mast cell driven diseases including - Chronic Urticarias: In November 2023, we announced that our Phase 2 study in chronic spontaneous urticaria (CSU) achieved the primary efficacy endpoint (statistically significant mean change from baseline to week 12 of urticaria activity score compared to placebo) and was well tolerated. The study is ongoing and patients will continue to receive barzolvolimab for 52 weeks of treatment; we plan to report topline 52 week data in the second half of 2024. We are currently planning for the initiation of Phase 3 studies in CSU in summer 2024. A Phase 2 study in chronic inducible urticaria (CIndU) is currently enrolling patients and we expect to report data from this study in the second half of 2024; - Prurigo Nodularis (PN): In November 2023, we reported positive data from a Phase 1b study in PN that supports further development of barzolvolimab in this indication and we are currently planning for the initiation of a Phase 2 study in PN in early 2024; - Eosinophilic Esophagitis (EoE): A Phase 2 study in EoE was initiated in June 2023 and enroll

View Full Filing

View this 10-K filing on SEC EDGAR