NImmune Biopharma Announces Presentations at Digestive Disease Week 2026 Supporting a Differentiated Profile and Superior Efficacy of Oral, Once-Daily NIM-1324 for IBD

New data presented at DDW demonstrates that NIM-1324 outperforms current IBD medications, establishes Phase 1 safety, tolerability and LANCL2 target engagement in humans

Supports the efficacy of NIM-1324, a de-risked, safe and well-tolerated, oral, once-daily LANCL2 medicine for ulcerative colitis and Crohn's disease

A well-powered Phase 2 clinical trial of NIM-1324 will test 125, 250, and 1000 mg doses versus placebo to evaluate clinical remission and target engagement in ulcerative colitis patients

NIM-1324 novel mechanism of action—the LANCL2 pathway—is clinically validated to provide clinical remission in both ulcerative colitis and Crohn's disease patients

I&I oral therapeutic platform provides enhanced strategic capability positioning at the interface of immunity and metabolism across multiple inflammatory and autoimmune disease indications

NImmune Biopharma ("NImmune"), a private, late-stage precision inflammation and immunology ("I&I") biopharmaceutical company, presented two studies at Digestive Disease Week (DDW), which together demonstrate that NIM-1324 meets all primary and secondary endpoints for the treatment of IBD, successfully engages the LANCL2 target, shows an improved pharmacokinetic (PK) profile, and possesses a favorable safety profile with no dose limiting toxicities.

The abstracts, titled "Safety, Tolerability and LANCL2 Target Engagement of NIM-1324 in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study" and "NIM-1324: A Next-Generation LANCL2 Therapeutic Outperforms Current IBD Medications," presented Phase 1 clinical data and preclinical evidence highlighting NIM-1324's safety, target engagement, and therapeutic potential in IBD. NIM‑1324 targets a dual LANCL2 mechanism that activates Tregs' anti-inflammatory actions and enhances mitochondrial metabolism. Given its improved PK profile, NIM-1324 elicits its pharmacological actions by combining gut localized activity with systemic immunoregulatory effects via LANCL2 pathway activation to address symptoms both inside and outside the gut, including extraintestinal manifestations of disease.

"DDW provided an important forum to share how NImmune and NIM-1324 have the potential to reshape the treatment paradigm for ulcerative colitis and Crohn's disease," said Dr. Josep Bassaganya‑Riera, Founder, Executive Chairman, President and Chief Executive Officer of NImmune Biopharma. "The breadth and consistency of the efficacy and safety data presented reinforce the therapeutic promise of NIM-1324 in IBD and further validate our ecosystem-driven approach to translating novel scientific discoveries into clinically meaningful medicines. Beyond IBD, NIM-1324 has shown consistent signals of therapeutic efficacy across lupus, rheumatoid arthritis, psoriasis, asthma, multiple sclerosis, Alzheimer's disease, and Parkinson's disease—supporting its transformative pipeline-in-a-drug potential."

The preclinical, translational and clinical findings presented at DDW demonstrate that pharmacological activation of LANCL2 by NIM-1324 reprograms immune cell metabolism to support durable immunoregulation through multiple synergistic mechanisms of action. Research now demonstrates consistent and powerful signals of leading therapeutic efficacy through pharmacological activation of the LANCL2 pathway across inflammatory bowel disease (IBD), NIM-1324's lead indication, as well as follow on indications including lupus, psoriasis, rheumatoid arthritis, multiple sclerosis, Alzheimer's disease, Parkinson's disease, and asthma. These critical findings further support the paradigm-shifting science, robust clinical validation and enormous commercial potential of LANCL2 precision medicines.

"The consistency of LANCL2 efficacy signals across disease models and patients continues to inform the development of NIM‑1324 while validating a safe and effective broader immunoregulatory strategy grounded in a dual targeted immunometabolic mechanism mediated through LANCL2, compared to the broad and unsafe immune suppression typical of current IBD drugs, many of which have black box warnings due to significant adverse side effects," added Dr. Bassaganya‑Riera. "These findings highlight how our unique R&D ecosystem is working synergistically to expand our inflammation and immunology (I&I) oral drug development platform and to accelerate the clinical development and commercialization of biomarker-driven LANCL2 precision medicines."

The findings presented at DDW reflect more than two decades of sustained scientific collaboration led by Dr. Josep Bassaganya-Riera enabled by an I&I drug development platform that continues to generate new IP and provides enhanced strategic capability positioning at the interface of immunity and metabolism across multiple disease indications over the next few decades. This burgeoning I&I BioHub comprises highly synergistic R&D collaborations between NImmune, BioTherapeutics, the NIMML Institute, and Dr. Bassaganya-Riera's latest clinical program for the development of NIM-1324. This unique transdisciplinary model aligns discovery research, disease modeling, biomarker development, and clinical translation, enabling assets such as NIM‑1324 to advance efficiently and cost-effectively from fundamental scientific discoveries through late‑stage clinical development and commercialization. This team and its innovative drug development ecosystem have demonstrated significant clinical and commercial success, having enabled the foundation of Landos Biopharma in 2017, a company that Dr. Bassaganya-Riera built from the ground up, took public (NASDAQ:LABP) in 2021 and was acquired by AbbVie, Inc. (NYSE:ABBV) in May 2024.

About NImmune Biopharma

NImmune is a private late-stage precision inflammation and immunology ("I&I") biopharmaceutical company that leverages a proprietary A.I. platform to rapidly and capital efficiently develop novel best-in-class biomarker-driven immunoregulatory therapeutics for inflammatory and autoimmune diseases. Underpinned by the TITAN-X computational platform that utilizes advanced A.I., advanced computational modeling, and bioinformatics and biomedical research capabilities to pioneer innovation in the development and commercialization of novel best-in-class I&I therapies, NImmune's business model enables the rapid and capital-efficient clinical development of high conviction drug candidates to New Drug Application (NDA) filing and commercialization. Additional information: www.NIMMUNEBIO.COM.

About NIMML

The NIMML Institute is a 501(c)(3) non‑profit foundation dedicated to combining advanced artificial intelligence–driven computational modeling with translational research and clinical testing to accelerate development of the next wave of precision medicines for inflammatory and autoimmune diseases. The Institute applies its TITAN‑X™ advanced A.I.‑powered platform to large‑scale, transdisciplinary projects aimed at solving important public health challenges through precision immunology. The NIMML Institute is headquartered in Blacksburg, Virginia.

For more information, please visit www.NIMML.org.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260505738752/en/

Media Contact

Alex Jeffrey / Jonathan Warren

Gasthalter & Co.

nimmune@gasthalter.com

212‑257‑4170