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

TL;DR

<b>Equillium, Inc. has submitted its 2023 10-K filing, providing a comprehensive overview of its financial status and operational details for the fiscal year ending December 31, 2023.</b>

AI Summary

Equillium, Inc. (EQ) filed a Annual Report (10-K) with the SEC on March 25, 2024. Equillium, Inc. filed its 2023 Form 10-K on March 25, 2024, reporting for the fiscal year ended December 31, 2023. The filing details various financial activities including retained earnings, additional paid-in capital, and employee stock options. Key dates mentioned include the fiscal year end of December 31, 2023, and the filing date of March 25, 2024. The company's business address is 2223 Avenida de la Playa, Suite 105, La Jolla, CA 92037, with a phone number of (858) 412-5302. The filing references specific agreements and plans such as the Asset Purchase Agreement with Ono Pharmaceutical Co., Ltd. and the 2018 Equity Incentive Plan.

Why It Matters

For investors and stakeholders tracking Equillium, Inc., this filing contains several important signals. This 10-K filing provides investors with the latest audited financial statements and management's discussion and analysis, crucial for understanding Equillium's performance and future outlook. The detailed information on stock options, agreements, and expenses offers insights into the company's capital structure, compensation practices, and strategic partnerships.

Risk Assessment

Risk Level: medium — Equillium, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by the numerous specific agreements and plans detailed in the filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Equillium's financial health and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-25 — Filing Date (Date of submission)
• 2019-09-01 — Term Loan Start Date (Loan agreement)
• 2022-02-14 — Bioniz Therapeutics Inc. Agreement Date (Contingent consideration)
• 2023-01-01 — Research and Development Expense Period (Fiscal year 2023)
• 2023-07-01 — Common Stock Transaction Period (July 2023)
• 2024-03-21 — Subsequent Event Date (Asset Purchase Agreement)

Key Players & Entities

• Equillium, Inc. (company) — Filer name
• 20231231 (date) — Fiscal year end
• 20240325 (date) — Filing date
• 2223 Avenida de la Playa, Suite 105, La Jolla, CA 92037 (address) — Business address
• Ono Pharmaceutical Co., Ltd. (company) — Mentioned in Asset Purchase Agreement
• Bioniz Therapeutics Inc. (company) — Mentioned in relation to agreements
• 2018 Equity Incentive Plan (plan) — Stock option plan
• 2834 (sic_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive regulation by government authorities, which can impact product development, approval, and marketing.
• Funding and Liquidity [medium — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance it will be able to secure such financing on favorable terms.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share EQ The Nasdaq Capital Mar
• $0.75 — rant's common stock on June 30, 2023 of $0.75 per share, as reported by the Nasdaq Gl
• $26.4 million — an amount equal to JPY 3.5 billion, or $26.4 million. If Ono exercises the Option, Ono wil
• $33.1 million — al to JPY 5.0 billion, or approximately $33.1 million based on the currency exchange rate quo
• $101.4 million — . We are also eligible to receive up to $101.4 million upon the achievement of certain develop
• $30 million — ted to pay Biocon up to an aggregate of $30 million in regulatory milestone payments upon t
• $565 million — ory approvals and up to an aggregate of $565 million in sales milestone payments upon the ac

Filing Documents

• eq-20231231.htm (10-K) — 2582KB
• eq-ex21_1.htm (EX-21.1) — 4KB
• eq-ex23_1.htm (EX-23.1) — 3KB
• eq-ex31_1.htm (EX-31.1) — 12KB
• eq-ex31_2.htm (EX-31.2) — 12KB
• eq-ex32_1.htm (EX-32.1) — 9KB
• eq-ex97_1.htm (EX-97.1) — 43KB
• img712127_0.jpg (GRAPHIC) — 497KB
• img712127_1.jpg (GRAPHIC) — 419KB
• img712127_2.jpg (GRAPHIC) — 296KB
• img712127_3.jpg (GRAPHIC) — 134KB
• img712127_4.jpg (GRAPHIC) — 137KB
• img712127_5.jpg (GRAPHIC) — 75KB
• img712127_6.jpg (GRAPHIC) — 96KB
• img712127_7.jpg (GRAPHIC) — 94KB
• img712127_8.jpg (GRAPHIC) — 531KB
• img712127_9.jpg (GRAPHIC) — 519KB
• img712127_10.jpg (GRAPHIC) — 370KB
• img712127_11.jpg (GRAPHIC) — 357KB
• img712127_12.jpg (GRAPHIC) — 510KB
• 0000950170-24-035919.txt (&nbsp;) — 19108KB
• eq-20231231.xsd (EX-101.SCH) — 1337KB
• eq-20231231_htm.xml (XML) — 1459KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 39 Item 1B. Unresolved Staff Comments 92 Item 1C. Cybersecurity 92 Item 2.

Properties

Properties 93 Item 3.

Legal Proceedings

Legal Proceedings 93 Item 4. Mine Safety Disclosures 93 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 107 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 107 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 107 Item 9A.

Controls and Procedures

Controls and Procedures 107 Item 9B. Other Information 107 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 108 PART III 109 Item 10. Directors, Executive Officers and Corporate Governance 109 Item 11.

Executive Compensation

Executive Compensation 109 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 109 Item 13. Certain Relationships and Related Transactions, and Director Independence 109 Item 14. Principal Accountant Fees and Services 109 PART IV 110 Item 15. Exhibits and Financial Statement Schedules 110 Item 16. Form 10-K Summary 112

SIGNATURES

SIGNATURES 113 2 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business." These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: our plans to research, develop and commercialize our product candidates and any future product candidates; our ability to obtain and maintain regulatory approval for our product candidates in any of the indications for which we plan to develop them; the potential benefits, risks and timing of the transactions contemplated by the Asset Purchase Agreement dated December 5, 2022, or the Asset Purchase Agreement, entered into by us and Ono Pharmaceutical Co., Ltd., or Ono; our estimated timeline for announcing data from our clinical studies, for interacting with regulatory authorities, and for initiating clinical studies; our ability to obtain funding for our operations, including funding necessary to commence and complete the clinical studies of our product candidates; the success, cost, and timing of our product development activities, including our ongoing and planned clinical studies; the beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates; the size of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of any of our product candidates; our ability to develop and maintain sales

Bus iness

Item 1. Bus iness. Overview We are a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory, or immuno-inflammatory, disorders with high unmet medical need. Our strategy is focused on advancing the clinical development of our product candidates, including potentially pursuing additional indications and acquiring new product candidates and platforms to expand our pipeline. We intend to commercialize our product candidates either independently or through partnerships or otherwise monetize our pipeline through strategic transactions. Our current clinical-stage product candidates consist of EQ101 and itolizumab (EQ001). EQ101 is a first-in-class, selective, tri-specific synthetic peptide engineered to specifically inhibit IL-2, IL-9 and IL-15, key disease-driving, clinically validated cytokine targets aimed at addressing unmet needs across a range of immuno-inflammatory indications. Itolizumab (EQ001) is a first-in-class monoclonal antibody that selectively targets the immune checkpoint receptor CD6, which plays a central role in the modulation of effector T cell, or T eff cell, activity and trafficking that drives a number of immuno-inflammatory diseases across multiple therapeutic areas. We are also engaged in the discovery and optimization of additional peptide-based product candidates that selectively target multiple cytokines and are currently advancing the preclinical development of EQ302, a first-in-class, orally delivered, bi-specific inhibitor of IL-15 and IL-21. Our novel and differentiated pipeline of first-in-class immunology assets has the potential to address unmet medical needs in numerous areas, including dermatology, gastroenterology, rheumatology, hematology, transplant science, oncology and pulmonology. We are focused on developing EQ101, EQ302 and itolizumab (EQ001) as potential best-in-class, disease modifying treatments for multiple se

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View this 10-K filing on SEC EDGAR