NeuroSense Therapeutics Ltd. (NRSNW) SEC Filings

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.

NeuroSense Therapeutics Ltd. has called a Special Meeting of Shareholders for 4 p.m. (Israel time) on August 26, 2026 to seek approval to authorize its Board to implement, in its discretion, one or more reverse share splits of ordinary shares within a 1-for-4 to 1-for-40 ratio range during the 12 months following the meeting.

The company discloses that on April 2, 2026 it received Nasdaq notices for failing the $1.00 minimum bid price and $35 million market value of listed securities requirements, with a compliance period running until September 29, 2026, after which its shares would likely be delisted from the Nasdaq Capital Market if compliance is not regained. The Board believes a reverse split could help lift the trading price but notes there is no assurance on price performance or liquidity.

Any reverse split would affect all shareholders proportionally, avoid issuing fractional shares by rounding up to whole shares, and, according to the company, effectively increase authorized share capacity without itself issuing new shares. There were 37,766,098 ordinary shares outstanding on July 29, 2026, each entitled to one vote, and the Board unanimously recommends voting in favor of the proposal.

NeuroSense Therapeutics Ltd. entered into Amendment No. 1 to its Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC. The amendment updates the agreement to reference NeuroSense’s new Form F-3 registration statement (File No. 333-293060), declared effective on July 31, 2026.

Under this updated framework, the company may offer and sell ordinary shares having an aggregate offering price of up to $3,789,822 through the sales agent. As of July 31, 2026, NeuroSense had sold 6,762,825 ordinary shares under the Sales Agreement for net proceeds of approximately $6.7 million. The Sales Agreement otherwise remains in full force and effect, and this disclosure is incorporated by reference into multiple existing Form S-8 and Form F-3 registration statements.

NeuroSense Therapeutics plans to file a New Drug Submission with Health Canada for its lead candidate PrimeC to treat amyotrophic lateral sclerosis, following a constructive Pre-New Drug Submission meeting in which regulators reviewed updated Phase 2b data.

The company presented achievement of the trial’s prespecified primary TDP-43 biomarker endpoint (p=0.0421) and long-term survival results, including a 14.9-month median survival benefit with PrimeC (hazard ratio 0.35, p=0.0037), alongside external natural history analyses and mechanistic and translational data. NeuroSense describes this regulatory interaction as an important milestone and intends to continue working with Health Canada while preparing the filing. PrimeC is an oral fixed-dose combination of ciprofloxacin and celecoxib, and the FDA has cleared a pivotal Phase 3 ALS trial (PARAGON) expected to enroll approximately 300 participants.

NeuroSense Therapeutics reported that its Phase 2b trial of PrimeC in amyotrophic lateral sclerosis (ALS) met its primary efficacy endpoint. PrimeC produced a statistically significant reduction in TDP-43, a core pathological hallmark present in more than 97% of ALS cases, versus placebo at Day 180 (p=0.0421).

The reduction in neuron‑derived TDP-43, measured using NeuroDex’s ExoSORT platform, deepened and remained statistically significant through 18 months (Day 540, p<0.001). Company and academic experts state that these biomarker results align with previously reported slowing of disease progression, survival benefit, and consistent biomarker data from the same study.

NeuroSense has FDA clearance to initiate its pivotal Phase 3 PARAGON trial in ALS, which is expected to enroll about 300 participants, primarily in the United States, advancing PrimeC as a potential disease‑modifying oral therapy targeting multiple ALS pathways.

NeuroSense Therapeutics furnished a Form 6-K highlighting early clinical data from its Phase 2 RoAD proof-of-concept study of PrimeC in Alzheimer’s disease. The eight-patient trial generated biomarker data from three participants who completed 12 months of follow-up with plasma and CSF sampling.

Analyses showed distinctive changes in hallmark Alzheimer’s biomarkers, including brain-derived tau (total), phospho-tau proteins, and the amyloid-beta 42/40 ratio. Additional changes appeared in misfolded proteins linked to other neurodegenerative diseases, such as alpha-synuclein and TDP-43, as well as markers of oxidative stress and inflammation. These shifts were directionally consistent with PrimeC’s proposed multi-target mechanism and with biomarker effects previously observed in the company’s ALS program, while maintaining a favorable safety and tolerability profile with no serious adverse events reported in RoAD.

NeuroSense Therapeutics Ltd. Chief Financial Officer Or Eisenberg reported an open-market-style purchase of the company’s ordinary shares. On June 16, 2026, he acquired 250,000 ordinary shares at a price of $0.80 per share under a Securities Purchase Agreement dated April 28, 2026, executed as a private placement exempt from registration under Section 4(a)(2) of the Securities Act of 1933. Following this transaction, his direct holdings increased to 1,504,050 ordinary shares.