Equillium Inc.

03/25/2026 | Press release | Distributed by Public on 03/25/2026 14:10

Equillium Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate and Clinical Highlights (Form 8-K)

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:
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

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.

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