Promis Neurosciences NASDAQ: PMN reported second-quarter 2026 results and highlighted blinded six-month interim data from its Phase 1b PRECISE-AD study of PMN310, an investigational antibody for early Alzheimer’s disease.
President and Chief Executive Officer Neil Warma said the company is using its EpiSelect platform to develop antibody therapies and therapeutic vaccines targeting misfolded proteins implicated in neurodegenerative diseases. Its lead program, PMN310, is designed to selectively target toxic amyloid-beta oligomers while avoiding amyloid plaque. The company also has preclinical programs targeting misfolded TDP-43 in amyotrophic lateral sclerosis and pathogenic alpha-synuclein in dementia with Lewy bodies and Parkinson’s disease.
PRECISE-AD Interim Safety and Biomarker Data
Chief Medical Officer Dr. Larry Altstiel said PRECISE-AD is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study in patients with mild cognitive impairment due to early Alzheimer’s disease. The trial enrolled 144 subjects at 21 U.S. sites and randomized them in a three-to-one ratio to PMN310 or placebo across monthly intravenous dose cohorts of 5, 10 and 20 milligrams per kilogram for 12 months.
The interim safety analysis included 136 patients as of a July 22 data cutoff. Their average age was 73.3 years, 58% were female and 61% carried at least one ApoE4 allele, including 11% who were ApoE4 homozygotes. ApoE4 carriers are associated with a higher risk of amyloid-related imaging abnormalities, or ARIA, with plaque-binding anti-amyloid treatments.
Altstiel said the company observed no cases of ARIA-E, a form of ARIA involving brain swelling, across all genotypes in the analysis. Total ARIA was 4.4%, including milder ARIA-H microhemorrhage findings, and all reported cases were mild and asymptomatic. The company also reported no treatment-related serious adverse events, no drug-related discontinuations and one non-serious infusion reaction.
“These are descriptive comparisons against published data and not head-to-head studies,” Altstiel said when discussing the safety profile relative to approved anti-amyloid therapies.
The blinded, pooled biomarker analysis included patients receiving both PMN310 and placebo. Plasma p-tau217 declined about 15% from baseline, while cerebrospinal fluid MTBR-tau243 declined about 13.3%, with approximately 62.5% of patients showing a decline in the latter biomarker. Altstiel characterized the findings as early exploratory signals rather than efficacy data, noting that the study remains blinded.
Management said all patients are expected to complete 12 months of dosing during the fourth quarter of 2026. Following database lock and statistical analysis, Promis expects to report unblinded top-line data in the first quarter of 2027. That update is expected to include safety data, additional biomarker results and clinical cognitive outcome measures.
Development Plans for PMN310
Warma said the company is preparing for the potential next stage of PMN310 development rather than waiting for the top-line readout. If the data are positive, Promis anticipates pursuing a single registration study and expects to meet with the FDA after the final data set is available. PMN310 has received Fast Track designation, according to the company.
Dr. Altstiel said the FDA recommends the Clinical Dementia Rating-Sum of Boxes, or CDR-SB, as a primary clinical outcome measure for Alzheimer’s trials because it evaluates both cognitive and functional measures. He said additional measures could include ADAS-Cog and composite scores such as the Integrated Alzheimer’s Disease Rating Scale.
The company is also developing a subcutaneous formulation of PMN310. Warma said the current study uses monthly intravenous dosing, but Promis views a subcutaneous option as important for patient convenience and compliance. He said the company is evaluating formulation considerations, dosing, pharmacokinetics, delivery devices and how a subcutaneous version could be incorporated into future development plans.
During the call, management also discussed an assay designed to measure amyloid-beta oligomers in cerebrospinal fluid. Altstiel said the company presented Phase 1a data at the Alzheimer’s Association International Conference showing that the assay detected a dose response following a single dose of PMN310. Promis plans to use the refined assay in the Phase 1b study and expects to present related data after the study is completed.
Pipeline and Financial Position
Beyond PMN310, Warma said PMN267, an antibody candidate targeting misfolded TDP-43 for ALS, and PMN442, targeting pathogenic alpha-synuclein for synucleinopathies, have been humanized in an IgG1 framework and are advancing toward investigational new drug-enabling studies. The company aims to advance the candidates over the next six to nine months, subject to data and available resources.
- Cash and short-term investments totaled approximately C$53.4 million at June 30, compared with C$6.1 million at Dec. 31, 2025.
- The increase reflected approximately C$70.1 million in net proceeds from a January 2026 private placement.
- Second-quarter net loss was approximately C$11.7 million, or C$1.28 per share, compared with a loss of C$10.1 million, or C$7.26 per share, a year earlier.
- Research and development expense rose to approximately C$9.5 million from C$8.7 million in the prior-year quarter.
- General and administrative expense increased to C$2.7 million from C$1.4 million, which the company attributed to higher professional fees and headcount.
For the first half of 2026, Promis reported a net loss of approximately C$20 million, compared with C$17.5 million in the prior-year period. Net cash used in operating activities was approximately C$22.8 million, compared with C$8.8 million a year earlier, reflecting increased clinical activity. The company said its current cash and investments are expected to fund operations through 2027, including the anticipated first-quarter 2027 PMN310 top-line readout.
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.
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