PMN

EX-99.1

2 pmn-20260512xex99d1.htm

EX-99.1

Exhibit 99.1

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ProMIS Neurosciences Announces First Quarter 2026 Financial Results and Provides Corporate Highlights

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●Company closed PIPE financing with gross proceeds of up to $175 million, including the possible exercise of warrants, from long-term global investors. Proceeds are expected to fund the Company through 2027, including completion of the ongoing Phase 1b clinical trial in Alzheimer's disease (AD).

●PRECISE-AD Phase 1b trial is fully enrolled and progressing on schedule, with the blinded 6-month interim analysis anticipated in early Q3 2026 and 12-month top-line data anticipated in early 2027.

●The planned interim analysis is expected to include a qualitative assessment of aggregated safety data, including amyloid-related imaging abnormalities (ARIA) incidence, as well as key biomarker trends across all study participants at the 6-month timepoint.

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Cambridge, Massachusetts, May 12, 2026 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, today announced its financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"2026 has the potential to be a significant year for patients with Alzheimer's disease and their caregivers,” said Neil Warma, Chief Executive Officer of ProMIS Neurosciences.  “We believe ProMIS is well-positioned with PMN310 as a potentially differentiated treatment for patients with early AD.  We are coming off a productive quarter, having closed a transformational financing of up to $175 million, including potential proceeds from warrant exercises, and have executed well on our Phase 1b clinical trial. Near-term data catalysts, including the blinded 6-month interim analysis, are anticipated in early Q3 2026, and could provide important insight into the potential of our lead drug candidate, PMN310.

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With currently marketed AD therapies, safety remains a central concern. Both approved plaque-directed antibodies carry black box warnings for a serious side effect known as ARIA, which encompasses cerebral edema (ARIA-E) and microhemorrhages (ARIA-H) in the brain. ARIA is believed to be associated with therapies that bind amyloid plaque. Given the modest clinical benefit observed with these therapies, ARIA-related risk has been a meaningful consideration in real-world treatment decisions for many patients and physicians.

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A growing body of evidence supports the view that toxic soluble amyloid-beta oligomers, small soluble species that form upstream of plaque, are a primary driver of cognitive decline in AD. PMN310 has been designed to selectively target these toxic oligomers while sparing plaque, a mechanism we believe may enable improved efficacy and a differentiated safety profile relative to plaque-directed antibodies.

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ProMIS’s Phase 1b trial, PRECISE-AD, was fully enrolled in December 2025, exceeding the company’s target, and we are now approaching the 6-month timepoint of the trial. The upcoming blinded interim data analysis anticipated in early Q3 2026 will summarize aggregate safety data and overall trends in key biomarkers across all study participants, without revealing treatment assignments. Because the analysis pools active and placebo groups under the blind, even modest directional changes could provide early indications of target engagement while preserving the integrity of the trial.

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ProMIS expects to complete 12-month dosing for all patients by year-end and to report unblinded top-line results in early 2027, providing a comprehensive view of PMN310's safety, biomarker, and clinical outcomes by treatment group, and an important clinical test of PMN310’s selective targeting approach."

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Corporate Highlights

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Alzheimer’s Disease (AD) Program (PMN310)

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●The Company is conducting the PRECISE-AD Phase 1b clinical trial, which is fully enrolled with 144 participants across three dosing cohorts receiving treatment over a 12-month period.

●A blinded interim analysis is anticipated in early third quarter 2026, providing a mid-study review of aggregated safety data and overall biomarker trends across all participants. As this analysis remains blinded, individual treatment assignments will not

be disclosed, and results will represent combined data from both active and placebo groups. While this interim analysis is not designed to assess clinical efficacy, this early look may reveal directional biomarker trends that offer early insight into target engagement.

●Full patient dosing is expected to be completed by year-end 2026, with unblinded top-line results anticipated in early 2027. At that time, the Company expects to evaluate biomarker outcomes and clinical measures by treatment group, providing a comprehensive understanding of PMN310’s potential in Alzheimer’s disease.

Pipeline Progress an

EX-99.1

2 pmn-20260325xex99d1.htm

EX-99.1

Exhibit 99.1

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ProMIS Neurosciences Announces Full Year 2025 Financial Results and Provides Corporate Highlights

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PRECISE-AD Phase 1b trial fully enrolled. Completion of six-month assessments expected in Q2 2026 with blinded interim analysis anticipated early Q3 2026; twelve-month top-line data anticipated in early 2027

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PMN310 continues to demonstrate a favorable safety profile, with no treatment-related serious adverse events reported to date

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Cambridge, Massachusetts, March 25, 2026 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD), today announced its financial results for the year ended December 31, 2025, and provided a corporate update.

"We are extremely pleased with the significant progress our team achieved in 2025 and the strong momentum we have carried into 2026," said Neil Warma, Chief Executive Officer of ProMIS Neurosciences. "We believe 2026 has the potential to be a watershed year for patients living with Alzheimer's disease.

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In 2025, our primary focus was the enrollment and treatment of patients in PRECISE-AD, our Phase 1b clinical trial in Alzheimer's disease. We are proud to report that enrollment was completed on time in December 2025 and was oversubscribed with a total of 144 patients; an outcome we believe reflects meaningful interest in PMN310's therapeutic potential.

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A key differentiating feature of PMN310, in our view, is its potential to meaningfully reduce treatment-related side effects, including the incidence of Amyloid-Related Imaging Abnormalities (ARIA). PMN310 has been purposefully designed to avoid binding to amyloid plaque, a mechanism we believe to be a primary driver of ARIA. After more than 12 months of dosing, PMN310 has continued to demonstrate a favorable safety profile. To date, there have been no Serious Adverse Events (SAEs) associated with study treatment, and overall patient retention and reported safety data are meeting or exceeding our expectations.

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We are on track to complete a six-month interim analysis of blinded safety and biomarker data in mid-2026. Full patient dosing is expected to be completed by year-end 2026, with presentation of unblinded top-line data anticipated in early 2027.

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In early 2026, the Company closed a transformational financing of up to $175 million in proceeds, including $75 million up front and $100 million tied to future potential exercise of warrants, providing a cash runway through 2027. This financing was supported by a distinguished syndicate of new and existing institutional investors.

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With this financing, we have accelerated the development of a subcutaneous formulation of PMN310 and the design of our next clinical study. Subject to the results of the PRECISE-AD Phase 1b trial and feedback from the United States Food and Drug Administration (FDA), our current strategic goal is to advance directly into a single registrational study. PMN310 was granted Fast Track Designation by the FDA in July 2025, which we believe may facilitate our development efforts by providing opportunity for engagement with the FDA.

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We are also closely monitoring the evolution of preclinical and asymptomatic Alzheimer's disease trials. Should PMN310 continue to demonstrate a differentiated safety profile, we believe this earlier patient population may represent a longer-term area of scientific interest, though any expansion into this space would be subject to clinical data, regulatory guidance, and further study design.”

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Corporate Highlights

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Alzheimer’s Disease (AD) Program (PMN310)

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ProMIS’ lead candidate, PMN310, is a humanized IgG1 antibody directed toward toxic amyloid-beta oligomers (AβO) that are believed to be a major driver of AD. This selectivity may reduce or eliminate amyloid-related imaging abnormalities (ARIA) commonly associated with plaque-binding antibodies. PMN310 was granted Fast Track Designation by the U.S. Food and Drug Administration.

●The Company completed enrollment of the Phase 1b trial in December 2025 with 144 participants enrolled (vs a target of 128) across 3 dosing cohorts. PMN310 continues to demonstrate a generally favorable safety profile.

●Based on current clinical trial patient visit schedules, the Company expects to complete the six-month assessments in the second quarter of 2026. The blinded interim analysis is anticipated in early third quarter 2026. Completion of all patient

visits is expected in the fourth quarter of 2026, with top-line data anticipated in early 2027 following database lock and statistical analysis.

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Recent and Upcoming Milestones

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●Closed a private placement led by distinguished biotechnology investors in February 2026 f

PROMIS NEUROSCIENCES INC._November 12, 2025 0001374339false00013743392025-11-122025-11-12 ​ ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2025

PROMIS NEUROSCIENCES INC.

(Exact name of registrant as specified in its charter)

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Canada

001-41429

98-0647155

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

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Suite 200, 1920 Yonge Street, Toronto, Ontario

M4S 3E2

(Address of principal executive offices)

(Zip Code)

​ Registrant’s telephone number, including area code: (416) 847-6898 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common Shares, no par value per share ​ PMN The Nasdaq Capital Market

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter) Emerging growth company  ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ ​ ​

Item 2.02 Results of Operations and Financial Condition On May 12, 2025, ProMIS Neurosciences Inc. (the "Company") issued a press release, which is available on its website (www.promisneurosciences.com under “Investors/Financial Results”), reporting its financial condition and financial results as of and for the three months and nine months ended September 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this report and is incorporated by reference into this Item 2.02. ​ ​ ​ ​ Item 9.01 Financial Statements and Exhibits. (d) Exhibits ​

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Exhibit No.

Description

99.1 ​ Press Release, dated November 12, 2025

104 ​ Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ​

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PROMIS NEUROSCIENCES INC.

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Date: November 12, 2025 By: /s/ Neil Warma

​ ​ Name: Neil Warma

​ ​ Title: Chief Executive Officer

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