Preclinical and translational data supports EQ101 for the treatment of alopecia areata

Multi-Cytokine Inhibitors may provide a more selective and potent approach to treatment than direct JAK inhibition

A phase 2 study of EQ101 in patients with alopecia areata to be initiated in Q4 2022

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced a presentation at the 6^th Annual Dermatology Drug Development Summit. The presentation highlights Equillium’s Multi-Cytokine Inhibitor EQ101 as a novel molecular compound to treat alopecia areata. Data on the first-in-class tri-specific inhibitor, targeting Il-2, IL-9 and IL-15, were presented by Dr. Stephen Connelly, co-founder and chief scientific officer of Equillium. The Summit is taking place at the Boston Park Plaza November 1-3.

“Responsible for the signaling of more than 50 cytokines, the JAK/STAT pathways have become key targets for drug development, with multiple JAK inhibitors approved over the last decade. The problem, however, is that only a handful of these cytokines contribute to disease pathology, while the rest are physiologically important, thus leading to treatment emergent toxicities and long-term safety concerns by regulators,” said Dr. Connelly. “EQ101 is a first-in-class, tri-specific cytokine inhibitor selectively targeting IL-2, IL-9 and IL-15 at the receptor level that may afford significant advantages over other approaches, including JAK inhibition. These cytokines have shown to be important in multiple dermatological diseases and with EQ101 previously achieving favorable safety profile and clinical validation in treating cutaneous T cell lymphoma patients, we look forward to initiating a Phase 2 clinical study in subjects with alopecia areata, very soon.”

The presentation, titled “EQ101: A Multi-specific Cytokine Inhibitor to treat Alopecia Areata”, focuses on how the Multi-Cytokine Inhibitor (MCi) platform has been used to target the common gamma receptor to generate EQ101. First-in-human studies of EQ101 were safe and well tolerated while a previous Phase 1/2 Proof-of-Concept study in cutaneous T cell lymphoma (CTCL) demonstrated clinically meaningful improvement in skin scores. EQ101 was also shown to be more effective than ruxolitinib at hair regrowth and suppression of cytotoxic CD8+ T-cells in a model of immune-mediated hair loss. The differentiated approach of EQ101 to block multiple cytokines at the receptor level may provide a more selective and potent approach to treatment than direct JAK inhibition and may position the molecule well as an alternative or substitution to JAK inhibitors.

The presentation is available on the Multi-Cytokine tab of the Presentations page under the Technology section of the company website.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.

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 immunomodulatory assets targeting immuno-inflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells, is currently in a Phase 3 study for patients with acute graft-versus-host disease (aGVHD) and is in a Phase 1b study for patients with lupus/lupus nephritis. EQ101 is a first-in-class tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15. Equillium expects to begin enrolling patients in an alopecia areata Phase 2 study of EQ101 in the fourth quarter of 2022. EQ102 is a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21. Equillium is currently enrolling patients in a Phase 1 study of EQ102, including healthy volunteers and celiac disease patients.

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” and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to statements regarding the potential benefits of using our multi-cytokine platform to develop treatments for patients with certain autoimmune and inflammatory diseases, Equillium’s plans and expected timing for developing EQ101 and EQ102 including the expected timing of initiating, completing and announcing further results from Phase 2 and Phase 1 studies, respectively, the potential for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, Equillium’s anticipated timing of regulatory review and feedback, and Equillium’s plans and expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; 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 EDGAR on the SEC web site at http://www.sec.gov and on the Company’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.

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