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Equillium (EQ) shifts to EQ504 focus, raises $85M and funds into 2029

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Equillium, Inc. reported fourth quarter and full-year 2025 results showing a shift to a development-stage model focused on its EQ504 program. Full-year 2025 revenue was $0 compared with $41.1M in 2024, reflecting the conclusion of prior Ono-related revenue.

Research and development expenses fell sharply to $12.8M from $37.4M, and general and administrative expenses declined to $10.8M from $11.9M. Despite lower operating costs, the full-year net loss widened to $22.4M, or $(0.39) per share, versus a $8.1M loss, or $(0.23) per share, in 2024, mainly because revenue dropped.

Cash, cash equivalents and short-term investments were $30.3M as of December 31, 2025, up from $22.6M a year earlier. Together with a $50M private placement announced in August 2025 and a $35M private placement in March 2026, the company believes it can fund planned operations into 2029. Equillium plans to initiate a Phase 1 proof-of-mechanism study of EQ504 in mid-2026, with data expected about six months later.

Positive

  • Strengthened balance sheet and runway: Cash, cash equivalents and short-term investments of $30.3M at December 31, 2025, combined with $50M August 2025 and $35M March 2026 private placements, are expected to fund planned operations into 2029.
  • Material reduction in R&D spend: Full-year 2025 research and development expenses declined to $12.8M from $37.4M in 2024, significantly lowering the company’s operating cost base as it refocuses on EQ504.

Negative

  • Loss of prior revenue stream: Full-year 2025 revenue was $0 versus $41.1M in 2024, reflecting the end of Ono-related revenue and leaving the company fully dependent on external financing rather than operating income.
  • Wider annual net loss despite cost cuts: Net loss for 2025 increased to $22.4M, or $(0.39) per share, from $8.1M, or $(0.23) per share, in 2024, driven mainly by the drop in revenue.

Insights

Equillium trades prior revenue for a cash-backed, EQ504-focused pipeline.

Equillium exited its Ono revenue stream, posting full-year 2025 revenue of $0 versus $41.1M in 2024, while cutting R&D to $12.8M from $37.4M. The business now looks more like a classic early-stage biotech centered on EQ504.

Two private placements – up to $50M in August 2025 and $35M in March 2026 – plus $30.3M on the balance sheet at year-end 2025 support management’s view that operations are funded into 2029, subject to assumptions.

The key execution test is the Phase 1 proof-of-mechanism study of EQ504, planned to start in mid-2026 with data about six months later. Subsequent disclosures on that trial’s progress and readout will be central to assessing the company’s trajectory.

0001746466false00017464662026-03-252026-03-25

 

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): March 25, 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, CA

 

 

 

92037

(Address of Principal Executive Offices)

 

(Zip Code)

 

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

 

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 (see General Instruction A.2. below):

 

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, par value $0.0001 per share

EQ

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 2.02 Results of Operations and Financial Condition.

 

On March 25, 2026, Equillium, Inc. (the “Company”) announced its financial results for the fourth quarter and full year ended December 31, 2025 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The information in this Item 2.02 of this Current Report on 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibit

Number

Description.

99.1

Press release, dated March 25, 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: March 25, 2026

By: /s/ Bruce D. Steel

 

Bruce D. Steel

 

Chief Executive Officer

 

 

 

 

 


Exhibit 99.1

img162018617_0.jpg

 

Equillium Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate and Clinical Highlights

 

Initiation of Phase 1 proof-of-mechanism study of EQ504 planned for mid-2026, with data expected approximately six months thereafter


Cash and cash equivalents, inclusive of the March 2026 financing, expected to fund operations into 2029

 

 

LA JOLLA, California, March 25, 2026 – Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for its fourth quarter and fiscal year ended December 31, 2025.

 

“2025 was a transformative year as we sharpened our strategic focus on EQ504 and strengthened our financial position to support its advancement into the clinic,” said Bruce Steel, Chief Executive Officer of Equillium. “Our financing in August 2025 of up to $50 million, together with our recently completed $35 million financing, further reinforces confidence in our strategy and provides the resources to efficiently execute our EQ504 clinical development plan. With operating runway expected into 2029, we are well-positioned to advance EQ504’s differentiated, non-immunosuppressive approach targeting the AhR pathway to address significant unmet needs across inflammatory diseases, and we believe it has the potential to be a best-in-class oral therapy in ulcerative colitis (UC), with additional opportunities across gastrointestinal (GI) and inflammatory lung diseases.”

 

Recent Corporate & Clinical Highlights:

In March 2026, announced a private placement financing of $35 million with RA Capital Management. In August 2025, announced a private placement financing of up to $50 million with a syndicate of leading healthcare investors, including ADAR1 Capital Management, Janus Henderson Investors, Adage Capital Partners LP, Coastlands Capital, and Woodline Partners LP.

 

Continuing to advance EQ504, a potent and selective AhR modulator with potential for targeted local delivery in GI diseases including UC, as well as inhaled formulations for inflammatory lung diseases. The Company has completed the preclinical work and plans to initiate a Phase 1 proof-of-mechanism study in mid-2026, with data expected approximately six months thereafter.

 

Evaluating further advancement of EQ302, its oral, bi-specific inhibitor of IL-15 and IL-21 being developed for GI indications, including celiac disease.

 

Hosted a virtual KOL investor event with Dr. Francisco J. Quintana of Harvard Medical School and the late Dr. Brian Feagan of Western Ontario, on Wednesday, November 5, 2025. A replay of the KOL event can be accessed here, and key takeaways include:

 

 


img162018617_1.jpg

 

o
AhR modulation is i) a differentiated and multi-modal approach to decreasing tissue inflammation while promoting tissue repair; and ii) clinically validated in skin and GI diseases, through VTAMA® and the botanical indigo naturalis, respectively.

 

o
EQ504 i) is a potent and selective AhR modulator that may be administered orally and is formulated to target the colon, representing a next-generation therapeutic to treat UC locally; and ii) has broad therapeutic potential in UC as a potential standalone oral therapy, or in combination with other therapeutic approaches.

 

Fourth Quarter and Full Year 2025 Financial Results

Revenue for the fourth quarter of 2025 was $0, compared with $4.4 million for the same period in 2025. For the full year of 2025, there was no revenue recognized, compared with $41.1 million under the Asset Purchase Agreement with Ono Pharmaceutical for the full year of 2024.

 

Research and development (R&D) expenses for the fourth quarter of 2025 were $1.5 million, compared with $7.3 million for the same period in 2024. For the full year of 2025, R&D expenses were $12.8 million, compared with $37.4 million for the full year of 2024. The significant year-over-year decrease in R&D expenses was primarily driven by the wind down of our clinical studies in 2025.

 

General and administrative (G&A) expenses for the fourth quarter of 2025 were $2.4 million, compared with $1.8 million for the same period in 2024. For the full year of 2025, G&A expenses were $10.8 million, compared with $11.9 million for the full year of 2024. The year-over-year decrease was primarily driven by lower general overhead expenses.

 

Net loss for the fourth quarter of 2025 was $3.8 million, or $(0.04) per basic and diluted share, compared with a net loss of $5.8 million, or $(0.16) per basic and diluted share for the same period in 2024. Net loss for the full year of 2025 was $22.4 million, or $(0.39) per basic and diluted share, compared with a net loss of $8.1 million, or $(0.23) per basic and diluted share for the full year of 2024. The increase in net loss for the year-over-year period was primarily due to lower revenue, partially offset by lower operating expenses.

 

Cash, cash equivalents and short-term investments totaled $30.3 million as of December 31, 2025, compared to $22.6 million as of December 31, 2024. Equillium believes that its cash and cash equivalents on the balance sheet as of December 31, 2025, together with the recently completed financing of $35 million in March 2026, are capable of funding its currently planned operations into 2029, based on certain assumptions and estimates that may prove to be inaccurate.

 

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. EQ504’s preclinical properties provide the potential for

 


img162018617_1.jpg

 

targeted, local delivery via enteric coating for the treatment of ulcerative colitis and other gastrointestinal diseases or inhaled formulations for the treatment of inflammatory lung diseases.

 

About Equillium

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of several novel immunomodulatory assets and product platform targeting immuno-inflammatory pathways.

 

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” 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 expectation that the cash and cash equivalents on its balance sheet as of December 31, 2025, together with the recently completed financing of $35 million in March 2026, are capable of funding its currently planned operations into 2029; Equillium’s ability to efficiently execute or advance its EQ504 clinical development plan; the potential benefits of Equillium’s product candidates; and other statements that are not historical facts. These statements are based on Equillium’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. 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, but are not limited to: market conditions; volatility in the trading price of Equillium’s common stock; the sufficiency of Equillium’s capital resources and need for additional capital to achieve its goals; Equillium’s ability to raise additional capital on terms acceptable to Equillium, or at all; Equillium’s ability to continue as a going concern; risks inherent in achieving clinical milestones and stock price thresholds; Equillium’s ability to initiate or progress a Phase 1 clinical study, or any clinical trials, or the ability of such Phase I clinical study or any clinical trials to generate favorable data, on the anticipated timelines, if at all; Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies, if and when initiated; 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; and changes in Equillium’s strategic plans. The foregoing list of risk factors is not exhaustive. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the Securities and Exchange Commission (SEC), which may be accessed for free by visiting the SEC’s website at www.sec.gov, and on

 


img162018617_1.jpg

 

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 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


img162018617_1.jpg

 

 

 

 

 

 

 

Equillium, Inc.

 

Condensed Consolidated Balance Sheets

 

(In thousands)

 

(unaudited)

 

 

 

December 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

30,277

 

 

$

22,575

 

Prepaid expenses and other assets

 

 

952

 

 

 

2,665

 

Operating lease right-of-use assets

 

 

658

 

 

 

364

 

Total assets

 

$

31,887

 

 

$

25,604

 

Current liabilities

 

 

 

 

 

 

Accounts payable and other current liabilities

 

$

2,934

 

 

$

6,356

 

Total current liabilities

 

 

2,934

 

 

 

6,356

 

Long-term operating lease liabilities

 

 

356

 

 

 

187

 

Total liabilities

 

 

3,290

 

 

 

6,543

 

Total stockholders' equity

 

 

28,597

 

 

 

19,061

 

Total liabilities and stockholders' equity

 

$

31,887

 

 

$

25,604

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


img162018617_1.jpg

 

 

 

 

 

 

 

Equillium, Inc.

 

Condensed Consolidated Statements of Operations

 

(In thousands, except share and per share data)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
December 31,

 

 

Twelve Months Ended
December 31,

 

 

2025

 

 

 

2024

 

 

2025

 

 

 

2024

 

Revenue

$

-

 

 

 

$

4,392

 

 

$

-

 

 

 

$

41,095

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

1,536

 

 

 

 

7,314

 

 

 

12,843

 

 

 

 

37,428

 

General and administrative

 

2,426

 

 

 

 

1,775

 

 

 

10,791

 

 

 

 

11,936

 

Total operating expenses

 

3,962

 

 

 

 

9,089

 

 

 

23,634

 

 

 

 

49,364

 

Loss from operations

 

(3,962

)

 

 

 

(4,697

)

 

 

(23,634

)

 

 

 

(8,269

)

Total other income (expense), net

 

187

 

 

 

 

(734

)

 

 

1,236

 

 

 

 

563

 

Loss before income tax expense

 

(3,775

)

 

 

 

(5,431

)

 

 

(22,398

)

 

 

 

(7,706

)

Income tax expense

 

-

 

 

 

 

361

 

 

 

-

 

 

 

 

361

 

Net loss

$

(3,775

)

 

 

$

(5,792

)

 

$

(22,398

)

 

 

$

(8,067

)

Net loss per share, basic and diluted

$

(0.04

)

 

 

$

(0.16

)

 

$

(0.39

)

 

 

$

(0.23

)

Weighted-average number of common shares outstanding, basic and diluted

 

91,881,058

 

 

 

 

35,457,559

 

 

 

57,304,181

 

 

 

 

35,357,641

 

 

 

 

 

 

 

 

 


FAQ

How did Equillium (EQ) perform financially in full year 2025?

Equillium reported full-year 2025 revenue of $0, down from $41.1 million in 2024, after prior Ono revenue ended. Net loss widened to $22.4 million, or $(0.39) per share, compared with a $8.1 million loss, or $(0.23) per share.

What were Equillium’s Q4 2025 results versus Q4 2024?

In Q4 2025, Equillium generated $0 revenue versus $4.4 million a year earlier. Net loss was $3.8 million, or $(0.04) per share, compared with a $5.8 million loss, or $(0.16) per share, in Q4 2024 as expenses decreased.

How much cash and runway does Equillium (EQ) have after recent financings?

Equillium held $30.3 million in cash, cash equivalents and short-term investments at December 31, 2025. Including an August 2025 financing of up to $50 million and a March 2026 $35 million financing, management believes this can fund planned operations into 2029.

What is Equillium’s lead program EQ504 and its development timeline?

EQ504 is a potent, selective AhR modulator designed as a non-immunosuppressive, locally delivered therapy for ulcerative colitis and other inflammatory diseases. Equillium plans to start a Phase 1 proof-of-mechanism study in mid-2026, with initial data expected about six months later.

How did Equillium’s operating expenses change in 2025?

Research and development expenses fell to $12.8 million in 2025 from $37.4 million in 2024, mainly from winding down clinical studies. General and administrative expenses decreased to $10.8 million from $11.9 million, reflecting lower general overhead and cost control efforts.

What major financings did Equillium (EQ) complete around 2025–2026?

Equillium announced a private placement of up to $50 million in August 2025 with a syndicate of healthcare investors. In March 2026, it announced a separate $35 million private placement with RA Capital Management to further support its EQ504-focused strategy.

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