LANCL2

First-in-human clinical trial of NIM-1324 met all primary and secondary endpoints Daily oral treatment with NIM-1324 is well-tolerated and safe with no dose-limiting toxicities Oral treatment with NIM-1324 induces a dose-proportional change in plasma exposure within the therapeutic range of 250 to 1000 mg/d with no accumulation Results support further development of a whole blood biomarker generated by TITAN-X A.I.-powered platform that predict SLE responders to NIM-1324 Phase 2 program for NIM-1324 in SLE patients is planned for 2024; Top line Phase 2 data by 2025 BLACKSBURG, Va.--(BUSINESS WIRE)-- NImmune Biopharma, (“NImmune”), a private late-clinical-stage precision immunology biopharmaceutical company focused on the discovery and development of best-in-class biomarker-driven immunoregulatory therapeutics, led by omilancor, a Phase 3 best in class once daily oral therapy for Ulcerative Colitis, announced that an abstract on positive Phase 1 clinical results of NIM-1324, a once-daily, oral, systemically distributed LANCL2 agonist therapeutic for the treatment of rheumatic diseases, will be presented at the American College of Rheumatology’s (ACR) annual meeting. ACR Convergence 2023 will take place from November 10-15, 2023, at the San Diego Convention Center in San Diego, California, with NImmune’s poster presentation to take place on Tuesday, November 14 from 9:00 am – 11:00 am. “Systemic lupus erythematosus (SLE) has a very high unmet medical need. First in human results of our wholly-owned NIM-1324 in SLE met all primary and secondary endpoints of safety and tolerability. Together with results of a companion blood-based precision medicine diagnostic, we are highly encouraged by the potential of NIM-1324 to offer the first-in-class precision therapeutic for SLE with a novel mechanism of action with no dose-limiting toxicities,” said Dr. Josep Bassaganya-Riera, Founder and CEO of NImmune. “Following our recent announcement of positive Phase 2 results of Omilancor and clinical validation of the LANCL2 pathway in Ulcerative Colitis and Crohn’s disease, we are pleased to report the advancement of our second therapeutic candidate into Phase 2 clinical development for Lupus with fast follower opportunities in other autoimmune diseases. First patient in the planned Phase 2 trial of NIM-1324 in SLE is anticipated in 2024 with top line results likely by 2025.” Clinical results of NIM-1324 presented at ACR’23 leverage the TITAN-X platform, an A.I. discovery and development platform that has guided the development of NImmune’s LANCL portfolio of therapeutics, includes NIM-1324 and omilancor. Both omilancor and NIM-1324 are oral, once-daily agonistic therapeutics that bind and activate the LANCL2 pathway. Omilancor is designed for targeted delivery in the gastrointestinal tract for IBD indications, and NIM-1324 is designed to be highly systemically distributed for indications such as lupus and rheumatoid arthritis. Presentation Details Title: Safety and Tolerability of NIM-1324, an Oral, Once-daily LANCL2 Agonist, in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study in Normal Healthy Volunteers. Poster: Session SLE, Treatment Poster III, Tuesday November 14th, 9:00 AM – 11:00 AM. Single or multiple oral dosing with NIM-1324 for up to 1500 mg/d did not result in severe adverse effects (AE) or increased total AE rates compared to placebo. No significant findings were observed by biochemistry, coagulation, hematology, or urinalysis relative to placebo. Dose-proportional change in plasma exposure within the range of 250 to 1000 mg/d was reported with no accumulation during the dosing period. Oral NIM-1324 upregulated expression of mitochondrial metabolism genes, while downregulated markers of phagocyte activation, in correlation with the whole blood transcriptomic signature generated in preclinical therapeutic efficacy programs. The poster will be available under the “Publications” section of NIMML’s website at and at the ACR Convergence 2023 virtual poster gallery. Additionally, the peer-reviewed accepted abstracts will be published in a special online supplement of the Arthritis & Rheumatology Journal. About Systemic Lupus Erythematosus (SLE) SLE is a chronic autoimmune disorder that causes systemic inflammation and organ damage. SLE can affect the skin, joints, blood vessels, kidneys, lungs, brain, and heart, resulting in fatigue, skin rashes or lesions, fevers, arthritis, lung, heart and kidney damage, seizures, and psychosis. SLE symptomatology often results in low quality of life, and 17% of SLE patients will need a kidney transplant. SLE affects over 1.5 million patients in the United States and over 5 million patients worldwide. With more than half of patients experiencing at least one flare per year or presenting persistently active disease, there is an unmet medical need in SLE for the development of safer and more effective therapeutics. About NIM-1324 NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. NIM-1324 target U.S. market size is expected to be valued at $226.0 billion 2021-2030, of which a peak annual market size of $23.1 billion is expected to occur in 2030. NImmune expects unadjusted revenue estimates from all of NIM-1324 therapeutics to be valued at $2.3 billion from the 2028-2030 projections. About Omilancor By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023. Omilancor's target U.S. market size is expected to be valued at $394.9 billion 2021-2030, of which a peak annual market size of $49.5 billion is expected to occur in 2030. NImmune expects peak unadjusted revenue of $12.5 billion in 2030. About NImmune Biopharma NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety. Additional information: or contact media@nimmunebio.com.

Once-a-day oral dosing with omilancor induced clinical remission in 30.4% of active Ulcerative Colitis (UC) patients versus 3.7% in the placebo group (Δ=26.7%, P = 0.01) Once-a-day oral dosing with omilancor in active Crohn’s disease (CD) patients shows promising efficacy in preliminary data with placebo-adjusted clinical remission of 32.6% TITAN-X, proprietary A.I.-powered discovery platform generated highly predictive gene-based biomarkers to enable identification of likely omilancor responders in UC and CD BLACKSBURG, Va.--(BUSINESS WIRE)-- NImmune Biopharma, (“NImmune”), a private late-clinical-stage precision immunology biopharmaceutical company focused on the discovery and development of best-in-class biomarker-driven immunoregulatory therapeutics, led by omilancor, a Phase 3 best in class once daily oral therapy for Ulcerative Colitis, announced that it will present three abstracts, including final Phase 2 data for omilancor in active Ulcerative Colitis patients at the American College of Gastroenterology (“ACG”) 2023 Annual Scientific Meeting (“ACG 2023”), taking place at the Vancouver Convention Center in Vancouver, Canada, between October 20 and October 25, 2023. Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune, said, “Final and complete Phase 2 data for omilancor in mild to severe UC patients with active disease affirms best-in-class efficacy and unrivaled safety. Omilancor is a first-in-class wholly-owned therapeutic, developed with the guidance of TITAN-X, a proprietary computational modeling and AI-powered precision medicine discovery engine that efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics. Meeting the primary endpoint of clinical remission in UC patients with active disease substantially de-risks omilancor’s regulatory path to New Drug Application (NDA) and commercialization and provides clinical validation of the LANCL2 pathway as a novel mechanism of action for addressing the significant unmet clinical needs of patients with autoimmune diseases. These positive clinical findings further underscore the importance of our recently announced research collaboration with the NIMML Institute and the value of its advanced computational modeling and A.I.-powered TITAN-X precision medicine platform, which efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics.” “As we approach a significant milestone—the initiation of the pivotal global Phase 3 clinical program of omilancor for the treatment of UC by year-end 2023—we are pleased to present our results at ACG 2023 and encouraged by the continued scientific validation of our clinical findings and the overall momentum of omilancor’s clinical and regulatory development. We look forward to continuing to realize the significant potential of omilancor as the first-in-class LANCL2 agonist for UC and additional autoimmune indications including Crohn’s disease and psoriasis.” Presentation Details Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Ulcerative Colitis. Poster: Board Number P2216, Monday October 23, 2023, 10:30 AM – 4:15 PM Clinical remission in the approvable UC population of active disease mild to severe patients was induced in 30.4% of patients treated with omilancor relative to 3.7% of patients given placebo (Δ=26.7, P = 0.01), meeting the primary endpoint. Endoscopic and histological remission were achieved in 41.7% of omilancor given patients relative to 18.6% and 22.2%, respectively, patients in the placebo group (Δ=23.1, Δ=19.5). Durable remission was induced in 38.5% of patients in the omilancor group versus 21.4% of patients given placebo (Δ=17.1, P = 0.05). Endoscopic response was achieved in 73.1% of patients treated with omilancor relative to 53.6% of patients given placebo (Δ = 19.5, P = 0.02). Omilancor exhibited statistically significant decreases in TNF-a expressing myeloid cells (p = 0.037) in the colonic mucosa and statistically significant normalization of fecal calprotectin levels (P = 0.048). Oral omilancor was well-tolerated in patients with UC with no trends in AE pro and no dose-limiting toxicities. Pharmacokinetic analysis validated a gut-restricted pro stable drug levels in stool over the treatment period, penetration into colonic biopsy tissue and limited systemic exposure. Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Crohn’s Disease. Poster: Board Number P2215, Monday October 23, 2023, 10:30 AM – 4:15 PM PRO-2 clinical remission was achieved in 41.7% of moderate to severe CD patients in the omilancor group relative to 9.1% give placebo (Δ=32.6). Crohn’s disease activity index (CDAI) clinical remission was achieved in 25.0% of omilancor-treated patients relative to 9.1% of the placebo group (Δ=15.9). Omilancor demonstrated a promising efficacy signal in both biologic naïve and biologic-experienced moderate to severe CD patients. Normalization of fecal calprotectin was induced in 33.3% of patients treated with omilancor compared to 14.3% in the placebo group (Δ=19.0). In patients with histological activity in at least one segment at baseline, omilancor induces remission in all segments in 42.9% of patients relative to 20.0% in the placebo group (Δ=22.9). Oral omilancor was well tolerated in patients with CD and displayed a benign safety profile. Title: Transcriptional Analysis of Colonic Biopsies from Patients with Ulcerative Colitis Treated with Omilancor. Poster: Board Number P2217, Monday October 23, 2023, 10:30 AM – 4:15 PM Predictive biomarker signatures from colonic biopsies were identified by using the RandomForest A.I. algorithm within NIMML’s TITAN-X drug development platform. A newly identified precision immunology biomarker signature predicts omilancor responders from non-responders with 75% accuracy and patients treated with omilancor and achieving clinical remission were identified with 100% accuracy. Predictive modeling of gene expression changes from baseline accurately differentiated patients treated with omilancor from those given placebo with 83% accuracy. Biomarkers upregulated by omilancor were associated with lipid metabolism, ion balance, and known critical elements of the LANCL2 pathway. Biomarkers downregulated by omilancor were associated with immune systems processes, mainly linked to neutrophils and leukocyte trafficking. The posters will be available under the “Publications” section of the NIMML’s website at and at the ACG 2023 ePoster Hall during and after the meeting. Additionally, the peer-reviewed accepted abstracts will be published verbatim in a special supplement to the October 2023 issue of The American Journal of Gastroenterology. About Ulcerative Colitis (UC) UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient’s life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics. About Crohn’s Disease (CD) CD is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation and ulcers in any segment of the gastrointestinal tract. CD impacts the end of the small bowel and beginning of the colon most commonly, which in turn can lead to symptoms of abdominal pain, increased abdominal sounds, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss and malnutrition. There are four classes of CD and treatment depends on the level of severity. Current therapeutic options for severe disease, primarily biologics, have several limitations, which include but are not limited to safety risks for malignancies and infections, limited efficacy and lack of long-term maintenance options. There is an urgent need to establish a consensus for a first-line therapy for CD and improve upon the existing constraints in administration and efficacy. About Omilancor By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023. Omilancor's target U.S. market size is expected to be valued at $394.9 billion 2021-2030, of which a peak annual market size of $49.5 billion is expected to occur in 2030. NImmune expects peak unadjusted revenue of $12.5 billion in 2030. About NIM-1324 NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis, and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. NIM-1324 target U.S. market size is expected to be valued at $226.0 billion 2021-2030, of which a peak annual market size of $23.1 billion is expected to occur in 2030. NImmune expects unadjusted revenue estimates from NIM-1324 therapeutics to be valued at $2.3 billion from the 2028-2030 projections. About NImmune Biopharma NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety. To learn more, visit or contact media@nimmunebio.com.

Approvable population of ulcerative colitis (UC) patients for upcoming Phase 3 trials agreed upon with the U.S. Food and Drug Administration (FDA) Analysis of Phase 2 data using approvable UC patient population for Phase 3 demonstrated statistical significance in the primary endpoint of clinical remission of 26.7% (p=0.01) for the 440 mg dose at 12 weeks and early normalization of fecal calprotectin levels at 2 weeks Clinical results from a small study of omilancor in biologic naïve and biologic experienced Crohn’s disease patients show a promising clinical efficacy signal Enrollment in the pivotal global Phase 3 study of omilancor for the treatment of UC anticipated to commence by year-end 2023 BLACKSBURG, Va.--(BUSINESS WIRE)-- NImmune Biopharma ("NImmune”), a late-clinical-stage precision immunology biopharmaceutical company that develops novel biomarker-driven immunoregulatory therapeutics, today announced Phase 2 data on an approvable population of ulcerative colitis (UC) patients and its plans to initiate a registration directed global Phase 3 program for omilancor for the treatment of UC. Omilancor is a wholly-owned, once-daily gut-restricted oral first-in-class LANCL2 therapeutic entering Phase 3 clinical testing in UC patients. Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune, said, "Following our successful acquisition of the LANCL therapeutic portfolio, we have made meaningful progress in advancing our clinical development programs for omilancor in IBD and NIM-1324 in lupus. Each of our programs remain on track, and now with the original leadership team that developed these medicines from inception we expect to dose the first patient in the global pivotal Phase 3 PACIFY program of omilancor for UC by year-end. Importantly, the omilancor program has taken just over four years since inception to reach Phase 3 initiation, representing significant cost savings compared to traditional drug development timelines. NImmune will continue to address the unmet clinical needs of patients with autoimmune diseases while building substantial and enduring value in lean and capital-efficient ways.” “We are thrilled to bring omilancor’s best-in-class potential to Phase 3 clinical evaluation. Statistical significance of the approvable primary endpoint of clinical remission using the 440 mg drug formulation provides a robust regulatory path to filing a New Drug Application (NDA) and commercialization of omilancor in UC. We remain highly motivated by the potential for omilancor to be the first-in-class LANCL2 agonist for UC, with immediate follow-on opportunities in Crohn’s disease, psoriasis and additional autoimmune indications." Phase 2 UC Approvable Population Data In the approvable UC patient population, clinical remission was induced in 30.4% of omilancor treated patients relative to 3.7% of patients given placebo (Δ = 26.7, p = 0.01), thereby meeting the primary endpoint. Endoscopic remission was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo (Δ = 23.1, p = 0.07). In patients with elevated baseline FCP, normalization occurred in 43.8% of the omilancor 880 mg group and 40.6% of the omilancor 440 mg group relative to 21.4% of the placebo group after 2 weeks (p = 0.048). PK analysis validated a gut-restricted pro stable drug levels in stool over the 12-week treatment period and penetration into colonic biopsy tissue with limited systemic exposure. The 440 mg formulation was sufficient to saturate the target and produced target engagement and elicited the downstream immunological changes associated with clinical remission. Omilancor showed 55% lower IL-6 concentrations and 44% lower TNF concentrations after 12 weeks of treatment, consistent with increased levels of regulatory CD4+ T cells and myeloid cells and increased IL-10 expression in remitters (p = 0.036). Additionally, omilancor exhibited statistically significant decreases in TNF-a expressing myeloid cells (p = 0.037) in the colonic mucosa and statistically significant normalization of fecal calprotectin levels (p = 0.048). Omilancor maintained low Mayo scores following 1 year of treatment, with nearly 90% of patients achieving remission thresholds in stool frequency and rectal bleeding after 36 weeks of open-label treatment. Omilancor was well tolerated with no trends in adverse event (AE) pro and most AEs of mild severity and no dose-limiting toxicities. In a small clinical trial in biologic naïve and biologic experienced moderate to severe Crohn’s disease patients omilancor showed encouraging efficacy signals in clinical remission at week 12 as measured by the percentage of patients in remission as measured by Crohn’s disease activity (CDAI) less than 150 and PRO-2 remission (abdominal pain equal or less than 1 and loose stools equal or less than 3). The Global Pivotal Phase 3 Program PACIFY is a global registration directed double-blind randomized placebo-controlled Phase 3 program of omilancor in active UC patients ranging from mild to severe that aims to enroll 1,378 patients across 250 global clinical sites. Patient identification and selection is anticipated to be aided by a proprietary gene-based biomarker of response to treatment with omilancor developed by the company’s proprietary A.I. biomarker discovery platform in collaboration with the NIMML Institute. As agreed with the US FDA, the Phase 3 program will consist of two simultaneous trials, PACIFY I and PACIFY II each evaluating the 440 mg once daily oral dose of omilancor versus placebo. PACIFY I aims to randomize 726 active disease UC patients, with 363 patients receiving 440 mg of omilancor and 363 receiving a placebo. PACIFY II aims to randomize 652 active disease UC patients, with 326 patients receiving 440mg of omilancor and 326 patients receiving placebo. Both trials will complete a 12-week induction portion with an approvable primary endpoint of clinical remission. Following the 12-week induction period, PACIFY I patients will continue to a 52-week maintenance portion followed by the opportunity to continue in an Open Label Extension. PACIFY II patients will be offered the opportunity to enroll in the Open Label Extension immediately after completing the 12-week induction period. Top line results from the 12-week induction portion of the global phase 3 program in UC are anticipated within 12-18 months from dosing the first patient. The primary endpoints will be clinical remission at week 12 and week 52. Attainment of either endpoint can serve as a basis for a New Drug Application (“NDA”). Mucosal healing at week 12 as measured by an endoscopic subscore of 0 or 1 with the Geboes histologic index <3.1 will also be taken. About Ulcerative Colitis (UC) UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient’s life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics. About Omilancor By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an approvable active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023. About NIM-1324 NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus and rheumatoid arthritis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. About NImmune Biopharma NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other auto-immune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety. Additional information: or contact media@nimmunebio.com.