Equillium Stock Price, News & Analysis

Equillium (Nasdaq: EQ), a biotechnology company focused on autoimmune and inflammatory disorders, announced a significant shift in its treasury strategy to include cryptocurrency investments. Under CEO Bruce Steel's leadership, the company aims to leverage digital currencies for diversification, liquidity, and potential capital appreciation.

The company reported $11.5 million in cash and equivalents as of June 30, 2025, projecting runway into Q4 2025. While implementing this new financial strategy, Equillium continues its biotech mission, particularly advancing EQ504, its novel aryl hydrocarbon receptor modulator, towards clinical development.

Equillium (Nasdaq: EQ) presented three posters highlighting EQ504, their novel AhR agonist drug candidate, at IMMUNOLOGY2025. The presentations demonstrated EQ504's potential in treating ulcerative colitis through multiple mechanisms. The research showed that EQ504:

1) Promotes immune tolerance by enhancing Treg stability while suppressing inflammatory Th17 responses 2) Demonstrates superior potency compared to its parent compound ITE in inducing CYP1A1 activity and anti-inflammatory cytokines 3) Effectively reduces gut pathology in mouse models of ulcerative colitis 4) Preserves barrier function and promotes healing of intestinal epithelial cells through IL22RA and IL10 expression

According to CSO Dr. Stephen Connelly, these findings highlight EQ504's potential as a treatment for ulcerative colitis, where poor mucosal healing currently limits patient remission.

Equillium (Nasdaq: EQ) has announced the advancement of EQ504, a novel aryl hydrocarbon receptor (AhR) modulator, acquired through Ariagen. The acquisition was made on favorable terms with no upfront payment and milestone payments starting upon FDA approval. EQ504 targets the AhR pathway, which is clinically validated for treating skin and gastrointestinal diseases. The drug candidate features excellent drug-like properties suitable for targeted, local delivery through enteric coating or inhaled formulations. The AhR pathway is crucial for barrier organ tissue physiology and immunology, maintaining barrier function, promoting tissue repair, and regulating immune responses. This development follows the success of tapinarof (VTAMA®), the first AhR-activating drug approved for psoriasis and atopic dermatitis treatment. Equillium plans to initiate a phase 1 study pending additional capital, focusing on ulcerative colitis treatment where EQ504 could potentially improve mucosal healing.

Equillium (Nasdaq: EQ) received feedback from the FDA regarding itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD). The FDA declined to grant Breakthrough Therapy designation and did not support an Accelerated Approval pathway based on the EQUATOR study data.

The FDA emphasized the importance of Day 29 response outcomes but showed openness to evaluating other endpoints, including longer-term outcomes, if supported by independent data. In response, Equillium plans to accelerate the closure of the EQUATOR study.

The company reported cash and cash equivalents of $14.5 million as of March 31, 2025, which is expected to fund operations into the third quarter of 2025.

Equillium (Nasdaq: EQ) announced topline data from its Phase 3 EQUATOR study evaluating itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD). While the study did not show improvement in complete response (CR) or overall response rate (ORR) at Day 29, it achieved statistical significance in key longer-term outcomes.

Key findings include:

• Duration of CR: 336 days vs. 72 days (p=0.017)
• Failure-free survival: 154 vs. 70 days (p=0.043)
• Complete response at Day 99: 44.9% vs. 28.6% (p=0.035)
• Positive trend in overall survival with mortality of 24.4% vs. 32.5%

Itolizumab demonstrated a favorable safety profile without increasing infection or sepsis risks. The company has submitted for Breakthrough Therapy designation and expects FDA feedback in May 2025. If positive, they plan to submit a biologics license application in H1 2026.

Equillium (Nasdaq: EQ) announced topline data from its Phase 3 EQUATOR study evaluating itolizumab for first-line acute graft-versus-host disease (aGVHD). While the study missed its primary endpoint of Day 29 complete response, it showed significant longer-term benefits including:

• Duration of complete response: 336 days vs. 72 days (p=0.017)
• Failure-free survival: 154 days vs. 70 days (p=0.043)
• Day 99 complete response: 44.9% vs. 28.6% (p=0.035)

The company reported Q4 2024 revenue of $4.4M (down from $9.2M in Q4 2023) and full-year 2024 revenue of $41.1M (up from $36.1M in 2023). Net loss for 2024 improved to $8.1M compared to $13.3M in 2023. Cash position stands at $22.6M, expected to fund operations into Q3 2025. FDA feedback on Breakthrough Therapy designation is expected in May 2025.

Equillium (NASDAQ: EQ) announced positive topline results from its Phase 2 study of itolizumab in treating moderate to severe ulcerative colitis (UC). The study involved 90 biologic-naïve patients randomized 1:1:1 to receive itolizumab, placebo, or adalimumab.

Key findings after 12 weeks of treatment include:

• Clinical remission rate: 23.3% for itolizumab vs 20.0% for adalimumab and 10.0% for placebo
• Clinical response rate: 63.3% for itolizumab vs 60.0% for adalimumab and 46.7% for placebo
• Endoscopic remission: 16.7% for both itolizumab and adalimumab vs 6.7% for placebo

The drug was generally well tolerated, showing comparable efficacy to adalimumab, despite having more severe patients in the itolizumab arm at baseline. Additional data is expected to be presented at a scientific conference during 2025.

Equillium (EQ) reported Q3 2024 financial results, highlighting revenue of $12.2 million, up from $8.9 million in Q3 2023. The company retained rights to itolizumab following the end of Ono Pharmaceutical partnership. R&D expenses increased to $9.6 million from $9.0 million year-over-year, while G&A expenses decreased to $3.3 million. Net loss improved significantly to $7,000 compared to $3.7 million in Q3 2023. Cash position stands at $25.9 million, expected to fund operations into Q4 2025. The company is evaluating accelerating its Phase 3 EQUATOR study in aGVHD with topline data expected in Q1 2025, alongside Phase 2 ulcerative colitis study results.

Equillium (Nasdaq: EQ) has announced its participation in the upcoming Stifel Healthcare Conference in New York on November 18-19, 2024. The company will present on Tuesday, November 19 at 12:40 PM ET, highlighting its clinical programs, including the Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease (aGVHD) and the Phase 2 study of itolizumab in ulcerative colitis. The presentation will be held at the Lotte New York Palace Hotel, with management available for one-on-one meetings. A webcast will be accessible through the company's website with a 90-day replay available.