Core Insights - Equillium, Inc. has successfully closed financing of up to $50 million, with an initial tranche of $30 million expected to fund operations through 2027 [4][11] - The company is advancing the development of EQ504, a novel oral Aryl Hydrocarbon Receptor (AhR) modulator aimed at treating ulcerative colitis, with a Phase 1 clinical study planned for mid-2026 [3][6] Financial Highlights - For the third quarter of 2025, Equillium reported no revenue, a decrease from $12.2 million in the same period of 2024 [7] - Research and development expenses for the third quarter of 2025 were $1.3 million, down from $9.6 million in the same quarter of 2024, primarily due to reduced clinical development costs [8] - General and administrative expenses remained stable at $3.3 million for the third quarter of 2025, unchanged from the same period in 2024 [10] - The net loss for the third quarter of 2025 was $4.2 million, or $(0.06) per share, compared to a net loss of $7,000, or $(0.00) per share in the same quarter of 2024 [10] Corporate Developments - The company hosted a key opinion leader (KOL) event on November 5, 2025, discussing the role of AhR modulation in treating immune-mediated diseases and the potential of EQ504 in ulcerative colitis [5] - The financing was led by new investors including ADAR1 Capital Management and Janus Henderson Investors, with participation from other investors [4] Upcoming Milestones - The initiation of the Phase 1 clinical study for EQ504 is anticipated in mid-2026, with plans to include ulcerative colitis patient cohorts following initial study phases [6]

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Core Insights - The event focuses on the aryl hydrocarbon receptor and the EQ504 program, which targets immune-mediated disorders, particularly ulcerative colitis [2][3] Company Overview - Equillium Bio is presenting its EQ504 program aimed at treating ulcerative colitis, highlighting the high unmet medical need despite significant investments in existing therapies [3] Expert Involvement - The event features Dr. Francisco Quintana and Dr. Brian Feagan, who are specialists in immune-mediated disorders and gastroenterology, respectively, emphasizing the importance of their expertise in discussing the drug target [3]

EQ504: A Novel AhR Modulator for Ulcerative Colitis - Equillium, Inc is developing EQ504, a novel aryl hydrocarbon receptor (AhR) modulator for ulcerative colitis [1] - EQ504 is derived from ITE, a naturally-occurring, endogenous, non-toxic AhR modulator synthesized in the gut & lungs, and is a highly potent and selective modulator of AhR [143][144] - EQ504 has a multi-modal mechanism of action in mucosal homeostasis, modulating immune cell responses and promoting barrier function & tissue repair [148][149][150] - In vitro, EQ504 increases the number and function of suppressive Treg cells that inhibit activity of Th1 and Th17 cells and promote tissue homeostasis [156] - In a DSS colitis animal model, EQ504 blocks weight loss and induces anti-inflammatory cytokines in colon tissue [158][160] Clinical Validation and Market Opportunity - Modulation of AhR has been clinically validated in skin diseases, with up to 34% of patients achieving a PGA-Pso score of 0-1 by week 12 in psoriasis and up to 34% of patients achieving a vIGA-AD score of 0-1 by week 8 in atopic dermatitis [134][136] - Phase 2 trials of Indigo Naturalis in ulcerative colitis showed up to 50% of patients achieved clinical remission with total Mayo score ≤ 2, no individual subscore > 1, and up to 27% of treatment refractory patients achieved clinical remission with total Mayo score < 3, no individual subscore > 1 [138] - Studies of ulcerative colitis patients treated with indigo naturalis demonstrate on-target engagement of AhR through increased intestinal CYP1A1 and high levels of clinical remission [142] - In vivo experiments demonstrate localized delivery of EQ504 directly to the colon of rats, results in >25X greater peak exposures in colon tissues versus blood [167] - The US market for ulcerative colitis treatments is approximately $6 billion, with a substantial unmet need for new oral agents in the pre-biologic setting and opportunities in biologic failure patients and combination therapy [172][173]

Core Insights - Equillium, Inc. announced the granting of inducement awards consisting of nonstatutory stock options to a new employee, totaling 7,200 shares of common stock, under its 2024 Inducement Plan [1][2] - The stock options have an exercise price of $1.41 per share, which is equivalent to Equillium's closing stock price on October 31, 2025, and will vest over four years [2] Company Overview - Equillium is a biotechnology innovator focused on developing novel therapies for severe autoimmune and inflammatory disorders [3] - The company's lead therapeutic candidate, EQ504, is a potent and selective aryl hydrocarbon receptor (AhR) modulator designed to complement other anti-inflammatory and immunomodulatory agents, with potential applications in treating ulcerative colitis, pouchitis, and pulmonary diseases [3]

Core Insights - Equillium, Inc. is hosting a virtual key opinion leader event on November 5, 2025, focusing on the unmet needs and treatment landscape in ulcerative colitis, particularly the potential of Aryl Hydrocarbon Receptor (AhR) modulation [1][2] Company Overview - Equillium is a clinical-stage biotechnology company specializing in developing novel therapeutics for severe autoimmune and inflammatory disorders with high unmet medical needs [5] - The company's pipeline includes several novel immunomodulatory assets targeting immuno-inflammatory pathways [5] Event Details - The event will feature experts Francisco J. Quintana, PhD, and Brian Feagan, MD, discussing the evolving treatment landscape in ulcerative colitis and the promise of AhR targeting [2] - Company management will present a scientific overview of EQ504, an oral, colon-targeted AhR modulator, and its preclinical data demonstrating its mechanism of action [3] - A live Q&A session will follow the presentations, and a replay will be available on Equillium's website [4]

Core Insights - Equillium, Inc. announced changes to its Board of Directors and senior leadership to enhance its focus on advancing EQ504, a novel aryl hydrocarbon receptor modulator for treating severe inflammatory diseases [2][3][4] Corporate Governance Changes - Effective October 1, 2025, Equillium implemented changes to its corporate governance structure [3] - Stephen Connelly, Ph.D. has been promoted to President while retaining his role as Chief Scientific Officer [8] - Daniel M. Bradbury transitioned from Executive Chairman to Chairman of the Board [8] Termination of Collaboration - Equillium has terminated its collaboration and license agreement with Biocon regarding itolizumab as of September 30, 2025, indicating no further intention to develop this product [4] Product Development Focus - EQ504 is an investigational aryl hydrocarbon receptor modulator designed to treat severe inflammatory diseases with a non-immunosuppressive mechanism [5] - The drug aims for targeted delivery methods, including enteric coating for ulcerative colitis and inhaled formulations for inflammatory lung diseases [5] Company Overview - Equillium is a clinical-stage biotechnology company focused on developing therapeutics for severe autoimmune and inflammatory disorders, leveraging its expertise in immunobiology [6]

Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

EQ504 for Ulcerative Colitis - EQ504, an AhR modulator, is being developed for ulcerative colitis with topline Phase 1 data expected in the second half of 2026 [8] - In vivo experiments show that colonic delivery of EQ504 results in a greater than 25-fold increase in exposure in colon tissues compared to blood [57, 58] - Clinical remission rates with AhR modulation are approximately 50%, compared to 20%-30% with current therapeutics [69] - The ulcerative colitis market is expected to exceed $12 billion in annual worldwide sales by 2030 [74] Itolizumab for acute graft-versus-host disease (aGVHD) - The Phase 3 EQUATOR study of Itolizumab in aGVHD did not show improvement in Day 29 outcomes but achieved statistically significant benefit in longer-term outcomes [7] - In the EQUATOR study, 44.9% of patients in the Itolizumab group achieved complete response (CR) at Day 99, compared to 28.6% in the placebo group (p-value 0.0354) [133] - Itolizumab Complete Responders had a statistically significant Duration of Complete Response with a median of 336 days vs 72 days observed on placebo (p-value 0.0166) [135, 136] - Itolizumab demonstrated statistically significant Failure Free Survival with a median of 154 days vs 70 days observed on Placebo (p-value 0.0430) [139, 140] EQ302 for Gastrointestinal Indications - EQ302, an oral IL-15/21 inhibitor, is in the preclinical stage targeting gastrointestinal indications [7] - There are over 750,000 non-responsive celiac disease patients in the United States, representing a multi-billion dollar annual market opportunity [188] Financial Status - As of March 31, 2025, Equillium had $14.5 million in total cash and investments [92]