ProMIS Neurosciences (NASDAQ:PMN) CEO Neil Warma told investors at Guggenheim’s Emerging Outlook Biotech Summit 2026 that the company is entering what he described as a “watershed year,” with key data expected from its ongoing Phase 1b Alzheimer’s disease trial and what he characterized as a strengthened financial position following a recent financing.
Company focus and recent milestones
Warma said ProMIS is focused on neurodegenerative diseases, primarily in the dementia space, and is advancing programs in Alzheimer’s disease as well as other indications including ALS, Parkinson’s disease, and Lewy body dementia.
In terms of catalysts, Warma said ProMIS expects an interim analysis around mid-year 2026 that will provide a qualitative view of trial data, with final top-line results expected toward the end of the year.
PMN310 and the “toxic oligomer” thesis
Warma centered the company’s Alzheimer’s strategy on selectively targeting what he described as the “most toxic species” of amyloid beta: oligomers. He contrasted this approach with historical efforts that focused on clearing amyloid plaque, noting that, in his view, the link between plaque clearance and cognitive outcomes has not been proven, and stating that plaque can be eliminated while patients continue to decline.
He argued that low molecular weight, highly toxic oligomers are “upstream” drivers of cognitive decline and described them as particularly harmful to synapses. Warma said the central challenge in the field has been designing antibodies that hit oligomers without meaningfully binding other amyloid beta species such as monomers or plaque.
According to Warma, ProMIS believes PMN310 is differentiated because it is designed to avoid binding monomers and plaque while targeting oligomers, which he said could have two implications:
- Safety: reduced liability for ARIA (amyloid-related imaging abnormalities), which can involve swelling or bleeding in the brain and is associated with plaque-binding antibodies.
- Efficacy:
Warma also referenced multiple assays the company has conducted comparing plaque binding across marketed and in-development antibodies, stating PMN310 was the only antibody in those comparisons that did not bind plaque. He additionally described a 26-week mouse toxicology study with dosing up to 800 mg/kg that was intended to evaluate bleeding and microhemorrhage in the brain.
EpiSelect platform and broader pipeline
Warma said PMN310 and the broader pipeline were generated using ProMIS’s proprietary EpiSelect platform, which he described as an approach for predicting protein misfolding and designing antibodies against conformational epitopes associated with misfolded proteins. He attributed the scientific foundation of the platform to founding scientist Dr. Neil Cashman.
Beyond amyloid beta, Warma said ProMIS has generated antibodies targeting misfolded forms of TDP-43 (relevant to ALS) and misfolded alpha-synuclein (relevant to Lewy body dementia and Parkinson’s disease). He added that proof of concept in Alzheimer’s could serve as validation for the wider platform and pipeline.
Phase 1b trial design: endpoints and patient population
Warma said ProMIS designed its ongoing Phase 1b study—called the Precise AD trial—to provide a more definitive signal than shorter, smaller biomarker-focused studies. He described the trial as placebo-controlled, double-blind, and randomized, enrolling early Alzheimer’s patients with mild cognitive impairment (MCI) due to Alzheimer’s disease, and screening participants to confirm the presence of Alzheimer’s disease.
He said the study is a 12-month, monthly-dosing trial with dose escalation across three ascending doses: 5, 10, and 20 mg/kg.
Warma grouped the endpoints into three “buckets”:
- Biomarkers:
- Safety and ARIA:
- Clinical signal:
ARIA expectations, interim biomarker readout, and next steps
On ARIA, Warma said ProMIS is not claiming it will eliminate all cases, citing an underlying spontaneous ARIA rate seen in placebo groups in other trials. He pointed to placebo ARIA rates of roughly 9% to 14% in large studies of lecanemab and donanemab, and said ProMIS expects ARIA-H and ARIA-E to be similar to placebo.
He also said that in other studies, more than 90% of ARIA cases occur in the first six months (and roughly 70% in the first three months). To address this, he said ProMIS “front-loaded” MRI monitoring and claimed the study is “95+% powered” to detect a single ARIA case if one exists.
Warma said that as of the conference, ProMIS had observed no treatment-related serious adverse events to date in the ongoing trial, while emphasizing that dosing remains ongoing and that the company needs to be careful in what it says. He also noted patient retention has exceeded expectations relative to historical dropout rates he cited of roughly 28% to 30% in other studies, attributing interest from investigators and patients to the potential for reduced ARIA risk.
Regarding biomarkers, Warma said the mid-year interim update will be qualitative and focused on trends rather than specific quantitative reductions. He named biomarkers of interest including p-tau217, p-tau243, synaptic markers (neurogranin and SNAP-25), NfL, and GFAP, and said most biomarkers would be expected to decrease if the drug is having a beneficial effect, with Abeta 42/40 expected to increase due to an inverse relationship. He also referenced a publication co-authored with Pentara examining p-tau217 and said it supported p-tau217 as a strong predictor of clinical outcomes.
Looking beyond the Phase 1b readouts, Warma said the company’s objective is to generate sufficient evidence on safety, target engagement, dosing, and clinical signal to potentially move directly into a pivotal Phase 3 study, and he indicated the company has had discussions with pharmaceutical companies about partnering and the possibility of advancing straight to Phase 3.
About Promis Neurosciences (NASDAQ:PMN)
Promis Neurosciences, Inc is a clinical‐stage biopharmaceutical company focused on the discovery and development of novel therapeutics for central nervous system disorders. The company’s research programs target cognitive impairment and other neurological symptoms associated with diseases such as Alzheimer’s disease and multiple sclerosis.
Leveraging a proprietary small‐molecule discovery platform, Promis Neurosciences advances both preclinical and early clinical candidates designed to modulate neural pathways involved in memory, learning and neuroinflammation.
