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 that Ono Pharmaceutical Co., Ltd. (Ono) has made the strategic business decision to allow its option to acquire Equillium’s rights to itolizumab to expire. The decision was not related to data from any clinical program and there have been no observed or reported safety concerns. As a result, Equillium maintains all of its commercial rights to itolizumab.

“We are very grateful to our colleagues at Ono for the close partnership and support we have received, providing substantial non-dilutive financing that has fully funded itolizumab research and development since July 2022. This enabled us to advance the program through two important milestones – positive interim review from the EQUATOR study and positive topline data from the EQUALISE study in lupus nephritis. We are informed that Ono’s decision was strategic in nature, and that the data we have delivered from these studies met expectations,” said Bruce Steel, chief executive officer at Equillium.

“To date we have enrolled over 150 patients in EQUATOR. At this time, we are temporarily pausing enrollment to review clinical options for the program, including the potential to accelerate our timeline to topline data to early 2025 while preserving registrational integrity of the study. We maintain orphan drug and fast track designations for first-line acute graft-versus-host disease, where currently no drugs are approved. In addition, in collaboration with Equillium, our partner Biocon has recently completed a robust placebo-controlled Phase 2 study of itolizumab in biologic-naïve patients with moderate to severe ulcerative colitis, and we expect topline data from this study also early in the new year,” continued Mr. Steel. “We remain enthusiastic about the therapeutic potential and commercial opportunity for itolizumab, and we are very pleased to maintain our rights to the program as we approach the two most important data events in Equillium’s history.”

Anticipated Upcoming Milestones:

• Itolizumab: Topline data from Phase 3 EQUATOR study in aGVHD – potential acceleration to Q1 2025
• Itolizumab: Topline data from Phase 2 study in ulcerative colitis – Q1 2025

Equillium believes it has cash sufficient to achieve the above milestones, assuming acceleration of EQUATOR study completion, and is taking operational steps expected to extend operating runway into Q4 2025. With the repositioning of itolizumab as the top priority in the pipeline, these measures include pausing further activities related to EQ101 and EQ302.

Webcast and Conference Call

Management will host a conference call accompanied by a slide presentation to provide a corporate update focused on Equillium’s retention of rights to itolizumab, for analysts and institutional investors, at 8:30 am ET today, October 31, 2024. To access the call, please dial (800) 715-9871 or (646) 307-1963 for international callers, and if needed provide conference ID number 2574379. A live webcast of the call will also be available on the company’s Investor Relations page. The webcast will be archived for 180 days.

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 the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells that drive a number of immuno-inflammatory diseases; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and announced positive data from a Phase 1b clinical study of patients with lupus/lupus nephritis in April 2024. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited, who also provides commercial manufacturing for the product. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; recently announced positive results from a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21 at pre-clinical stage.

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 plans and strategies with respect to developing itolizumab, including repositioning itolizumab as the top priority in the pipeline, the importance of anticipated upcoming milestones, timelines for topline data for itolizumab, the temporary pausing and potential acceleration of the EQUATOR study, the pausing of further activities related to EQ101 and EQ302, the extension of Equillium’s cash runway and related assumptions, and the potential benefits of Equillium’s product candidates. 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; changes in Equillium’s strategic plans; uncertainties related to Equillium’s capital requirements and ability to obtain sufficient financing to fund Equillium’s strategic plans; the potential impact on the registrational integrity that would be caused by Equillium’s decision to accelerate the completion of EQUATOR; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241031983949/en/