Form 8-K

8-K — Equillium, Inc.

Accession: 0001193125-26-432158

Filed: 2026-10-26

Period: 2026-10-26

CIK: 0001746466

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Unregistered Sales of Equity Securities

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — d67574d8k.htm (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 26, 2026

Equillium, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-38692

82-1554746

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

2223 Avenida de la Playa

Suite 105

La Jolla, California

92037

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 240-1200

(Former Name or Former Address, if Changed Since Last Report)

Not Applicable

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 3.02

Unregistered Sales of Equity Securities.

The disclosure regarding the securities sold and issued under the Securities Purchase Agreement by and among Equillium, Inc., a Delaware corporation (the “Company”) and certain institutional and accredited investors (the “Investors”), dated August 10, 2025 (the “Purchase Agreement”) set forth under Item 8.01 of this Current Report on Form 8-K is incorporated by reference under this Item 3.02. The Company expects to use the net proceeds from the Milestone Closing (as defined below) of the Private Placement (as defined below), together with the Company’s existing cash and cash equivalents, to fund the development of EQ504, as well as for working capital and other general corporate purposes.

The securities described below under Item 8.01 have not been registered under the Securities Act of 1933, as amended (“Securities Act”), or any state securities laws. The Company is relying on the exemption from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof. Each of the Investors provided representations appropriate for a private placement of securities. Restrictive legends will be affixed to the securities issued in the Private Placement.

Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of common stock or other securities of the Company.

Item 7.01

Regulation FD Disclosure.

On October 26, 2026, the Company issued a press release announcing the dosing of its first patient in its single ascending dose trial of EQ504 in Australia and the achievement of the Milestone Event (as defined below). The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

The information in Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01

Other Events.

As previously disclosed by the Company in the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 11, 2025 (the “Private Placement 8-K”), on August 10, 2025, the Company entered into the Purchase Agreement with the Investors, pursuant to which the Company agreed to sell and issue shares (“Shares”) of the Company’s common stock, par value $0.0001 (“Common Stock”), and pre-funded warrants to purchase shares of Common Stock (“Warrant Shares”), in up to two closings in a private placement transaction (the “Private Placement”).

Pursuant to the Purchase Agreement and subject to the occurrence of (i) the Milestone Event (as defined below) and (ii) either (x) the price of a share of the Company’s Common Stock maintaining a $2.50 weighted average price for 10 consecutive days during a 30 day measurement period (the “Price Threshold Requirement”) or (y) the Company’s receipt of a waiver of the Price Threshold Requirement from the Investors who held a majority of the securities sold at the initial closing in the Private Placement, the Investors agreed to purchase at a closing (the “Milestone Closing”) up to 35,087,717 Shares or pre-funded warrants in lieu thereof at a purchase price per Share of $0.57 (the “Share Price”) or per pre-funded warrant of $0.5669 (the “Warrant Price”), for gross proceeds to the Company of up to approximately $20.0 million. The Company announced that it had dosed the first patient in a single ascending dose trial of EQ504 in Australia (the “Milestone Event”) on October 26, 2026 (the “Milestone Event Date”). Also on October 26, 2026, the requisite Investors waived the Price Threshold Requirement and consented to causing the Milestone Closing to occur on the Milestone Event Date.

At the Milestone Closing, the Company issued and sold 14,957,260 Shares at the Share Price and 20,130,457 pre-funded warrants at the Warrant Price. The Milestone Closing resulted in aggregate gross proceeds to the Company of $20.0 million, before deducting fees and other expenses.

The pre-funded warrants have an exercise price of $0.0001 per Warrant Share, subject to customary adjustments, and will be exercisable at any time after original issuance and will not expire until exercised in full. The pre-funded warrants will also be exercisable on a net exercise “cashless” basis. The pre-funded warrants may not be exercised if the aggregate number of shares of Common Stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation, not to exceed 19.99%.

The securities issued in the Milestone Closing are subject to the Registration Rights Agreement, dated August 12, 2025, previously entered into in connection with the Purchase Agreement and disclosed by the Company in the Private Placement 8-K. The Company has agreed to prepare and file, within 30 days of the Milestone Closing, subject to certain allowable delays, one or more registration statements with the SEC to register for resale the Common Stock and, as applicable, the Warrant Shares, in each case that were issued under the Purchase Agreement, and generally to cause the applicable registration statements to promptly become effective. Certain cash penalties will apply to the Company in the event of registration failures, as described in the Registration Rights Agreement.

The foregoing summary of the pre-funded warrants does not purport to be complete and is qualified in its entirety by reference to the complete text of the form of pre-funded warrant, which was previously filed as Exhibit 4.2 to the Private Placement 8-K.

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 expressed or implied in this Current Report on Form 8-K include, but are not limited to, statements regarding the Company’s expected use of the net proceeds from the Private Placement and other statements that are not historical facts. These statements are based on the Company’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: market conditions; volatility in the trading price of the Common Stock; risks inherent in achieving clinical milestones and stock price thresholds; the Company’s ability to initiate or progress clinical trials on the anticipated timelines, if at all; implementation of the Company’s strategic plans for its business and product candidates; the sufficiency of the Company’s capital resources and need for additional capital to achieve its goals; and other risks described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 13, 2026. Forward-looking statements contained in this report are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

Description

99.1

Press Release dated October 26, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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 26, 2026

By:

/s/ Bruce D. Steel

Bruce D. Steel

President and Chief Executive Officer

EX-99.1

Filename: d67574dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Equillium Announces First Subject Dosed in Phase 1 Clinical Trial of EQ504

Topline Phase 1 proof-of-mechanism data anticipated in Q2

2027

Randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, PK and PD of EQ504

Triggers Milestone Closing of $20 million in additional funding under previously announced equity private placement agreement; cash

expected to fund currently planned operations into 2029

LA JOLLA, California, October 26, 2026 – Equillium,

Inc. (Nasdaq: EQ), a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders, today announced that the first subject has been dosed in Australia in its Phase 1 clinical trial of EQ504, an

investigational oral, colon-targeted aryl hydrocarbon receptor (AhR) modulator being developed for the treatment of serious inflammatory diseases (the Milestone Event). In connection with the occurrence of the Milestone Event, the Company also

announced the anticipated milestone closing under its August 2025 equity private placement of an additional $20 million of shares of its common stock, or pre-funded warrants in lieu thereof (the Milestone

Closing), which is expected to occur later today.

“Dosing the first participant in our Phase 1 trial marks an important milestone as we advance

EQ504, our differentiated, oral, colon-targeted AhR modulator, into clinical development,” said Bruce Steel, Chief Executive Officer of Equillium. “We believe EQ504’s locally acting and

non-immunosuppressive approach has the potential to address important unmet medical needs in ulcerative colitis and other serious inflammatory diseases. The Phase 1 trial is designed to evaluate safety and

tolerability, as well as characterize EQ504’s pharmacokinetic and pharmacodynamic profile to assess proof of mechanism. Subject to supportive Phase 1 data, we anticipate initiating a placebo-controlled proof-of-concept study in patients with moderately to severely active ulcerative colitis in the second half of 2027.”

The Phase 1 trial (NCT07869225), being conducted in Australia, is a randomized, double-blind, placebo-controlled, single-center study designed to

evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of EQ504 in approximately 70 healthy subjects exploring once-daily oral doses ranging from 0.1–3.0 mg. The study consists of a single ascending dose portion

evaluating escalating oral doses of EQ504 across five sequential cohorts, and a multiple ascending dose (MAD) portion evaluating once-daily oral dosing over 10 days across three cohorts.

The MAD portion will also evaluate EQ504’s pharmacodynamic activity through multiple gastrointestinal (GI) mucosal biopsies, including measurement of

cytochrome P450 1A1 (CYP1A1) expression, a biomarker of AhR pathway activation. These assessments are designed to provide early clinical evidence of localized target engagement and biological activity in the GI tract, supporting EQ504’s

differentiated, colon-targeted approach. An optional food-effect cohort will examine whether food affects EQ504 exposure.

Milestone Closing of $20 Million Under the August 2025 Equity Private Placement

At the Milestone Closing, investors are expected to purchase and the Company expects to issue and sell 14,957,260 shares of common stock at a purchase price of

$0.57 per share and 20,130,457 pre-funded warrants to purchase common stock at a purchase price of $0.5669 per pre-funded warrant, for aggregate gross proceeds of

approximately $20.0 million, bringing the total equity private placement proceeds to approximately $50 million. With the proceeds from the Milestone Closing, the Company expects its cash and cash equivalents to be sufficient to fund its

currently planned operations into 2029.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and

have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an

effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The investors have been granted customary resale Form

S-3 registration rights for the shares of common stock issued to them in the financing.

This press release shall

not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification

under the securities laws of any such state or jurisdiction.

About EQ504

EQ504 is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator with a multi-modal,

non-immunosuppressive mechanism of action designed to be complementary to other inflammation and immunology agents. AhR is critical to barrier organ tissue physiology and immunology, maintaining barrier

function and promoting tissue repair and regeneration, while regulating resident immune cells with anti-inflammatory responses. For ulcerative colitis, EQ504 is formulated as an oral, colon-targeted delayed-release drug product. Equillium is also

evaluating the potential of EQ504 for additional indications, including inflammatory lung diseases through inhaled formulations.

About Equillium

Equillium is a biotechnology innovator with a mission to develop highly impactful therapies to treat severe autoimmune and inflammatory disorders.

For more information, visit www.equilliumbio.com.

Forward Looking Statements

Statements

contained in this press release regarding matters that are not historical facts are “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”, “will”, “designed to” 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 Equillium’s plans and strategies with respect to developing EQ504, including the initiation of clinical studies and the reporting of data therefrom; the expected timeline for reporting data

from a

Phase 1 study of EQ504; the potential benefits of EQ504; the anticipated initiation of a placebo-controlled

proof-of-concept study in patients with ulcerative colitis; the expected Milestone Closing for the additional $20 million tranche under Equillium’s 2025

equity private placement, including receipt of the Price Threshold Waiver; the expected use of proceeds from the private placement; and Equillium’s expectations that its financial position and cash runway will fund currently planned operations

into 2029. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’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: Equillium’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 Equillium’s product candidates; changes in the competitive landscape; risks involving the

expected Milestone Closing, including the occurrence and anticipated time and the impact the sale will have on the Company’s stock price; and Equillium’s ability to raise sufficient financing, which may not be available on acceptable

terms or at all, to advance EQ504 and fund Equillium’s strategic plans. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports, which

may be accessed for free by visiting the Securities and Exchange Commission’s website and on Equillium’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 press release speak only as of the date on which they were made. Equillium 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.

Investor Contact

PJ Kelleher

LifeSci Advisors, LLC

+1-617-430-7579

pkelleher@lifesciadvisors.com

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