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ProMIS Neurosciences — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Cash position was $44.1 million as of September 30, 2026, compared to $6.1 million as of December 31, 2025, driven by $70.1 million in net proceeds from a January 2026 private placement.
    • Research and development expenses were $6.7 million for the three months ended September 30, 2026, a 32% decrease from $9.8 million in the same period of 2025, primarily due to a $3.6 million reduction in direct PMN310 expenses as the PRECISE-AD trial neared completion of patient visits.
    • General and administrative expenses were $1.9 million for the three months ended September 30, 2026, compared to $2.0 million in the same period of 2025, with lower professional fees offset by higher employee salaries and benefits.
    • Other income was $0.5 million for the three months ended September 30, 2026, compared to $0.2 million in the same period of 2025, attributed to higher interest income on increased cash balances.
    • Net loss was $8.2 million ($0.89 per share) for the three months ended September 30, 2026, compared to $11.6 million ($5.93 per share) for the same period in 2025.
    • For the nine months ended September 30, 2026, net loss was $28.1 million ($3.39 per share), compared to $29.0 million ($19.58 per share) for the same period in 2025.
    • Total current assets were $47.2 million as of September 30, 2026, compared to $9.2 million as of December 31, 2025.
    • Total liabilities decreased to $5.4 million as of September 30, 2026, from $10.4 million as of December 31, 2025.
    • Shareholders' equity turned positive at $41.8 million as of September 30, 2026, compared to a deficit of $1.3 million as of December 31, 2025.
  • Guidance and Future Outlook:

    • The PRECISE-AD Phase 1b clinical trial remains on track for unblinded 12-month topline data in the first quarter of 2027, including full safety, biomarker, and cognitive outcomes.
    • Management expects existing cash resources to fund operations through 2027, extending well beyond the anticipated first quarter 2027 topline data readout.
    • A subcutaneous formulation of PMN310 is under development to support patient convenience and is intended for incorporation into the next phase of clinical development.
    • The Company plans to request a meeting with the FDA in 2027 after analyzing the full dataset from the PRECISE-AD trial.
    • A registrational study for the subcutaneous formulation is anticipated to initiate toward the end of 2027, subject to FDA feedback.
    • Completion of all PRECISE-AD patient visits is expected in the fourth quarter of 2026.
  • Business Segments and Product Lines:

    • PMN310 (Alzheimer's Disease): The lead candidate is a humanized IgG1 monoclonal antibody designed to selectively bind toxic amyloid-beta oligomers while avoiding monomers, fibrils, and plaque. It has received Fast Track Designation from the FDA.
    • PRECISE-AD Trial Results: Blinded six-month interim data from 136 patients showed no ARIA-E in any APOE genotype (including 11% APOE4 homozygotes), ARIA-H of 4.4% (all mild and asymptomatic), no drug-related discontinuations, and no treatment-related serious adverse events. Biomarkers showed a decrease of approximately 15% in plasma pTau217 and 13.3% in CSF MTBR-tau243.
    • PMN267 (ALS): The program targeting misfolded TDP-43 is advancing a lead humanized monoclonal antibody for extracellular administration and an intrabody format for intracellular delivery.
    • PMN442 (Synucleinopathies): The lead candidate for dementia with Lewy Bodies, Parkinson's Disease, and Multiple System Atrophy was selected for its selective binding against pathogenic alpha-synuclein and has been humanized in an IgG1 framework for IND-enabling studies.
    • Vaccine Programs: Lead candidates include PMN311 (amyloid-beta oligomers in AD), PMN440 (pathogenic alpha-synuclein), and PMN260 (misfolded TDP-43). All have shown robust immunogenicity in mouse studies, with PMN440 demonstrating protective activity in synucleinopathy models.
    • Corporate Appointments: Ivana Rubino, Ph.D., a former senior Biogen and Roche executive with over 15 years of neuroscience leadership experience, was appointed Chief Commercial Officer effective October 5, 2026.
  • Market and Competitive Landscape:

    • Management states that PMN310 offers a differentiated approach by selectively targeting toxic amyloid-beta oligomers, whereas other antibodies have shown binding to multiple forms of amyloid-beta, including plaque, resulting in significant amyloid-related imaging abnormalities (ARIA).
    • The Company believes PMN310 could achieve a leadership position in treating early AD and potentially asymptomatic (preclinical) AD patients if it demonstrates a benefit-risk profile with ARIA rates similar to placebo and efficacy comparable to existing standards of care.
    • The PRECISE-AD trial is the first study to examine the effects of a monoclonal antibody directed solely against Aβ oligomers on biomarkers associated with AD pathology and clinical outcomes.
  • Risks and Challenges:

    • Forward-looking statements include risks that early or interim results may not be indicative of final or topline results.
    • The Company faces risks related to its accumulated deficit and expectations for continued losses.
    • Actual results may differ materially from projections due to known and unknown risks, uncertainties, and assumptions regarding the interpretation of clinical data, FDA interactions, and development timelines.
  • Management Commentary and Tone:

    • CEO Neil Warma described the third quarter of 2026 as productive, citing encouraging interim data from the PRECISE-AD trial.
    • Management expressed confidence that PMN310's distinct clinical hypothesis, supported by its selectivity and IgG1 backbone, could lead to an improved benefit-risk profile compared to existing therapies.
    • The tone is forward-looking and confident regarding the potential to shift the treatment paradigm for Alzheimer's disease by reducing ARIA liability associated with plaque binding.
  • Other Key Points:

    • The PRECISE-AD six-month interim data was selected for poster presentation at the 2026 Clinical Trials in Alzheimer's Disease (CTAD) conference in Boston (November 16–19, 2026).
    • Abstracts on the PRECISE-AD trial and PMN440 alpha-synuclein vaccine activity were selected for platform presentations at the 2027 AD/PD conference.
    • Management participated in six healthcare investor conferences, including Cantor and H.C. Wainwright, and the CEO participated in the Lausanne XIII Workshop and a Nasdaq interview for World Alzheimer's Day.
    • The Company utilizes the proprietary EpiSelect™ drug discovery engine to identify Disease Specific Epitopes (DSEs) on misfolded proteins.
    • The Company has offices in Cambridge, Massachusetts, and Toronto, Ontario.
Company
PROMIS NEUROSCIENCES INC
Sector
Healthcare
Industry
Biotechnology