NeuroSense Therapeutics Ltd. filings document foreign private issuer disclosures for a clinical biotechnology company developing PrimeC for severe neurodegenerative diseases. Its Form 6-K reports cover clinical and regulatory updates, PrimeC patent protection, scientific publication of PARADIGM trial results, Nasdaq continued-listing notifications, and incorporation of selected reports into Form S-8 and Form F-3 registration statements.
The company’s regulatory record also addresses shareholder voting matters, including amendments to registered share capital, capital-structure disclosures, governance changes, material agreements, operating and financial results, and leadership or advisory arrangements tied to the PrimeC development program.
NeuroSense Therapeutics Ltd. plans to add newly generated neurofilament light chain (NfL) analysis and additional unpublished Phase 2b data to its planned New Drug Submission to Health Canada for PrimeC, with a March 2027 filing target replacing the previously announced December 2026 timetable. Health Canada confirmed it has no concerns with the revised timing. NeuroSense reported a greater NfL reduction among PrimeC-treated participants than among placebo participants, with a more pronounced effect in participants with higher baseline functionality; further statistical analyses are underway. The planned submission would be PrimeC’s first marketing application in any jurisdiction.
After acceptance of the submission for review, Health Canada’s standard review target for an NDS is approximately 300 calendar days. If approved, PrimeC would address a population of approximately 4,000 Canadians living with ALS, with approximately 1,000 new diagnoses each year. NeuroSense is advancing discussions with potential commercialization partners in Canada and preparing for its FDA-cleared U.S. Phase 3 PARAGON trial while working with the FDA on an optimized study design.
NeuroSense Therapeutics Ltd. signed a strategic collaboration agreement with an advisor to advance a potential revenue-generating supply of PrimeC to eligible patients through a licensed clinical treatment center in a U.S. state. A potential pathway may permit access to and commercialization of certain investigational therapies before traditional marketing approval. The company targets first revenues in the first half of 2027, subject to completion of applicable legal, regulatory and operational requirements.
The agreement follows sustained demand from ALS patients and physicians seeking access outside clinical trials. The potential supply effort would be alongside the company’s ongoing clinical programs in ALS and Alzheimer’s disease.
NeuroSense Therapeutics Ltd. filed a U.S. patent application covering methods of treating traumatic brain injury (TBI) and related central nervous system injuries with ciprofloxacin and celecoxib, the active ingredients of PrimeC. The application describes a range from concussion and mild TBI to moderate and severe TBI, including blast-related injuries and longer-term consequences such as chronic traumatic encephalopathy. If granted, protection is expected through 2047, subject to any extensions. The company says no approved disease-modifying therapies specifically target secondary neurological injury associated with TBI.
NeuroSense says ALS remains its primary development priority while it evaluates future TBI research and development through strategic collaborations, research grants and other non-dilutive funding opportunities. It has FDA clearance to initiate its Phase 3 PARAGON ALS trial, which is to be conducted primarily in the United States, and is working with FDA on an optimized design. The company also reported that long-term follow-up analysis from its Phase 2b ALS study was published in JAMA Neurology; participants who received PrimeC from study start showed slower functional decline than participants who initially received placebo.
NeuroSense Therapeutics Ltd. said its Nasdaq Hearings Panel hearing is scheduled for November 10, 2026, following its appeal of the October 1, 2026 Staff Delisting Determination. The appeal stays suspension and delisting action, and its ordinary shares and warrants are expected to continue trading on The Nasdaq Capital Market pending the Panel’s decision. NeuroSense has regained compliance with the $1.00 minimum bid-price requirement; the remaining deficiency is the $35 million minimum market value of listed securities requirement. At the hearing, the company intends to present a plan to meet that requirement or the alternative $2.5 million stockholders’ equity standard, and to request an exception of up to 180 days from October 1. The Panel may grant an exception, with no assurance it will do so or that compliance will be regained and maintained.
NeuroSense is targeting a New Drug Submission for PrimeC to Health Canada in December 2026 and expects a decision in Q1 2027 on non-dilutive grant funding for the Phase 3 PARAGON trial; if awarded, funding could support Phase 3 development. FDA clearance to initiate PARAGON has been received, and the company is working with FDA on an optimized study design. Published Phase 2b follow-up results reported slower functional decline among participants who received PrimeC from study start than among those who initially received placebo, with changes across multiple ALS-associated biomarkers, including microRNAs.
NeuroSense Therapeutics Ltd. said Nasdaq determined on October 1, 2026, that the company had not met the $35 million minimum market value of listed securities (MVLS) requirement by September 29, 2026. Nasdaq said its ordinary shares and warrants would be delisted unless NeuroSense requests an appeal. The company intends to timely request a Nasdaq Hearings Panel hearing and seek additional time. Under Nasdaq rules, a timely request stays suspension and the Form 25-NSE filing pending the Panel’s decision; the Panel may grant an exception of up to 180 days from the Staff Determination. The securities are expected to continue trading on The Nasdaq Capital Market as NRSN and NRSNW while the hearing is pending.
Nasdaq separately confirmed NeuroSense regained the $1.00-per-share minimum bid-price requirement: after a 1-for-20 reverse share split, closing bid prices were at least $1.00 for 10 consecutive business days, from September 15 through September 28, 2026, and Nasdaq closed that matter. NeuroSense intends to present its MVLS compliance plan at the hearing. The company said there can be no assurance that the Panel will grant continued listing or an exception, or that NeuroSense will regain MVLS compliance or maintain bid-price compliance.
NeuroSense Therapeutics Ltd. reported a net loss of $3.563 million for the six months ended June 30, 2026, compared with $4.709 million a year earlier, and used $1.990 million in operating cash. At June 30, cash and cash equivalents were $231,000 and current liabilities were $2.999 million. Management said cash resources would not fund 12 months of operations from approval of the statements under its original development plan without delays, and said these factors raise substantial doubt about the company’s ability to continue as a going concern.
For PrimeC, NeuroSense reported a statistically significant reduction in TDP-43 versus placebo at Day 180 (p=0.0421), with lower levels maintained at Day 540 (p<0.001). The FDA cleared initiation of the planned PARAGON Phase 3 trial, while study design elements remain under evaluation; first enrollment is anticipated in the third quarter of 2027, subject to funding. The company said it intends to submit a New Drug Submission to Health Canada in coming months. NeuroSense effected a 1-for-20 reverse share split on September 14, 2026, and had until September 29, 2026, to regain Nasdaq bid-price and market-value compliance.
NeuroSense Therapeutics Ltd. (NRSN) approved a 1-for-20 reverse share split of its ordinary shares, consolidating every twenty existing shares into one new share. Trading on the Nasdaq Capital Market on a reverse-split-adjusted basis will begin on September 14, 2026.
The reverse split will reduce issued and outstanding ordinary shares from 37,938,036 to 1,896,902, while the authorized share capital will remain unchanged. Fractional shares will not be issued and will instead be rounded up to the nearest whole share, and outstanding warrants and options will be adjusted proportionately.
NeuroSense Therapeutics Ltd. (NRSN) reports that shareholders, at a Special Meeting on August 26, 2026, approved authorizing the Board of Directors to implement one or more reverse share splits of the company’s ordinary shares. The Board may select a ratio between 1-for-4 and 1-for-40 and choose an effective date, if any, within 12 months of the meeting. Shareholders also approved that no amendment to the company’s Articles of Association is required in connection with any such reverse share split. The company states that this report is incorporated by reference into several existing Form S-8 and Form F-3 registration statements.
NeuroSense Therapeutics Ltd. outlines preparations for PARAGON, its pivotal Phase 3 study of PrimeC in ALS, cleared by the FDA and expected to enroll about 300 participants, primarily in the U.S. Initiation requires substantial funding, and the company states that securing appropriate financial and strategic resources has taken longer than first expected. Management is pursuing multiple options in parallel, including pharmaceutical and strategic partnerships, investors, grants and other non-dilutive funding, emphasizing the quality and strategic value of any capital raised. In April 2026, the CEO and CFO each invested $200,000 alongside a significant existing investor.
Based on existing Phase 2b data, NeuroSense plans to submit a New Drug Submission (NDS) for PrimeC in Canada, currently targeted for December 2026, and is evaluating similar regulatory opportunities in other territories. The company also highlights ongoing strategic discussions around development and commercialization of PrimeC and potential portfolio expansion. Separately, NeuroSense is addressing Nasdaq continued-listing deficiencies, with a focus on the minimum bid price requirement. A forthcoming shareholder meeting includes a proposal to authorize the board to effect a reverse share split in a range of 1:4 to 1:40 if other avenues, including requesting an additional compliance period from Nasdaq, do not resolve the issue. Maintaining the Nasdaq listing is described as important for the company and its shareholders.
NeuroSense Therapeutics has completed the Pre-NDS process with Health Canada for PrimeC, its lead candidate for amyotrophic lateral sclerosis (ALS), with final meeting minutes reflecting alignment on the planned content and structure of a New Drug Submission. Health Canada indicated it has no concerns with the company’s proposed timeline and advised targeting early December.
NeuroSense is aiming to file the NDS in December 2026, after completing remaining clinical, biomarker, manufacturing and regulatory components. The company highlights the unmet need for ALS treatments in Canada and is also preparing PARAGON, a pivotal Phase 3 ALS trial of PrimeC, cleared by the FDA and expected to enroll about 300 participants.