UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On October 5, 2026, Equillium, Inc. (the Company) announced that the Company has received Human Research Ethics Committee approval and clearance from the Therapeutic Goods Administration in Australia under the Clinical Trial Notification scheme for its Phase 1 clinical trial of EQ504. The Company expects to begin dosing healthy participants by early November 2026.
About the Phase 1 Trial
The Phase 1 trial is a randomized, double-blinded, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants, exploring once-daily oral doses ranging from 0.1 to 3.0 mg. The trial is structured into three distinct parts:
| • | Part A - Single Ascending Dose: Evaluates escalating, once-daily oral doses of EQ504 across five (5) sequential cohorts of healthy participants to determine initial safety parameters and PK. |
| • | Part B- Multiple Ascending Dose: Evaluates multiple escalating oral doses across three (3) cohorts, in healthy participants receiving once-daily dosing for ten (10) days to assess steady-state PK, safety, and cumulative tolerability. In addition to systemic plasma exposure and to validate the drug’s localized mechanism of action, the study protocol incorporates gastrointestinal (GI) mucosal biopsies to be collected longitudinally during the study. A primary pharmacodynamic focus of these biopsies will include the assessment of key tissue-specific biomarkers, including Cytochrome P450 1A1 (CYP1A1) expression. These mechanistic tissue data are designed to confirm localized biological activity and provide target validation ahead of the Phase 2 proof-of-concept study. |
| • | Part C - Food Effect Cohort: A dedicated crossover cohort to evaluate the impact of a high-fat meal on the bioavailability and systemic exposure of a single oral dose of EQ504. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future”, “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding the Company’s plans and strategies with respect to developing EQ504, including the expected timeline for dosing healthy participants and patients; the Company’s ability to initiate clinical trials and report data from any clinical trials which may be initiated, or the expected timeline for initiating any such studies or reporting data; the expected timeline for initiating and reporting data from a Phase 1 trial of EQ504; and the potential benefits of EQ504. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of the Company’s product candidates; changes in the competitive landscape; and the Company’s ability to raise sufficient financing, which may not be available on acceptable terms or at all, to advance EQ504 and fund the Company’s strategic plans. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website and on the Company’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EQUILLIUM, INC. | ||||||
| Date: October 5, 2026 |
By: /s/ Bruce D. Steel | |||||
| Bruce D. Steel | ||||||
| Chief Executive Officer | ||||||