ADDED
As of March 20, 2026, there were 63,226,556 shares of the registrant s common stock outstanding.
We have incurred significant losses since our inception, expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability; We will require substantial additional funding to complete the planned or future development and any commercialization of EQ504, EQ302 and any future product candidates.
Overview We are a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders with the mission to develop life-changing therapeutics for patients.
Our primary goal is to advance EQ504, a novel aryl hydrocarbon receptor, or AhR, modulator, into and through clinical development.
EQ504 is a preclinical-stage, novel AhR modulator that in multiple translational models has been shown to have a therapeutically beneficial impact inducing anti-inflammatory cells and cytokines while reducing proinflammatory cells and cytokines and improving intestinal tissue barrier function and repair.
We initially intend to develop EQ504 for the treatment of ulcerative colitis, or UC, and other gastrointestinal, or GI, diseases with potential indication expansion opportunities for the treatment of inflammatory lung diseases.
We have conducted preclinical development of EQ302, including in vivo pharmacology studies and formulation development, to further characterize and optimize the product candidate.
We are evaluating further advancement of EQ302, including product manufacturing and toxicology studies capable of supporting a potential investigational new drug, or IND, filing and a first-in-human clinical study.
Our novel and differentiated pipeline of therapeutic candidates has the potential to address unmet medical needs in numerous areas, including gastroenterology, dermatology and pulmonology.
To achieve our goal, we intend to: Complete the preclinical and clinical development of EQ504.
REMOVED
As of March 20, 2025, there were 35,609,907 shares of the registrant s common stock outstanding.
We have incurred significant losses since our inception, expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability; Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
We will require substantial additional funding to complete the development and any commercialization of itolizumab (EQ001) and EQ302, if we resume development activities, and any future product candidates.
If CMOs, including Biocon, our exclusive CMO for itolizumab (EQ001), encounter such difficulties, our ability to provide supply of our product candidates for clinical studies, our ability to obtain marketing approval, or our ability to obtain commercial supply of our products, if approved, could be delayed or stopped; We rely, and intend to continue to rely, on CROs to conduct our clinical studies and perform some of our research and preclinical studies.
Overview We are a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory, or immuno-inflammatory, disorders with high unmet medical need.
Our strategy is focused on advancing the preclinical and clinical development of our product candidates, including potentially pursuing additional indications and acquiring new product candidates and platforms to expand our pipeline.
We intend to commercialize our product candidates either independently or through partnerships or otherwise monetize our pipeline through strategic transactions.
Itolizumab (EQ001), our most advanced clinical-stage product candidate, is a first-in-class anti-CD6 immune-modifying monoclonal antibody, or mAb, that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response.
This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.
In March 2025, we announced topline results from our Phase 3 EQUATOR study of itolizumab (EQ001) in patients with acute graft-versus-host disease, or aGVHD, where itolizumab (EQ001) did not meet the Day 29 outcomes of complete response, or CR, a primary outcome, and overall response rate, or ORR, a key secondary outcome, but there was a clinically meaningful improvement in durable CR from Day 29 to 99, a key secondary outcome, and statistically significant evidence of clinical benefit was observed on pre-specified secondary endpoints of duration of CR and failure free survival.