NeuroSense Confirms Favorable Safety and Tolerability of PrimeC in an Alzheimer's Phase 2 Study

Rhea-AI Summary

NeuroSense (NASDAQ: NRSN) reported completion of the safety analysis from its Phase 2 randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC in Alzheimer's disease on Dec 22, 2025.

The safety review found a favorable tolerability profile, with no serious adverse events reported and no new or unexpected safety signals identified. Clinical outcome measures in this exploratory proof-of-concept study are descriptive by design.

NeuroSense will analyze clinical observations together with biomarker data to aid interpretation, and full clinical and biomarker results are expected in Q1 2026.

Positive

• Phase 2 safety analysis completed on Dec 22, 2025
• No serious adverse events reported in NST-AD-001
• No new or unexpected safety signals identified
• Biomarker and clinical results planned for Q1 2026

Negative

• Study is exploratory; clinical outcomes are descriptive by design
• No efficacy or quantitative clinical results reported yet
• Timing limited to a quarterly window: results expected in Q1 2026

Key Figures

RoAD Phase 2 enrollment 8 patients Proof-of-concept Alzheimer’s RoAD study database locked per <b>Dec 8, 2025</b> 6-K

Topline timing Q1 2026 Clinical and biomarker outcomes for Alzheimer’s Phase 2 study expected

Registered shares 333,334 ordinary shares Form F-3 resale registration for selling shareholder

Shares outstanding 29,550,970 shares Ordinary shares outstanding as of <b>Oct 27, 2025</b>

Private placement price $1.50 per share September 2025 private placement terms

Private placement proceeds $0.5 million gross September 2025 financing round

ALS survival (PrimeC) 50% (15 of 30) Participants originally randomized to PrimeC remaining alive in 6-K sample

ALS survival (placebo) 7% (1 of 14) Participants originally randomized to placebo remaining alive in 6-K sample

Market Reality Check

$0.8100 Last Close

Volume Volume 479,505 is above the 20-day average of 403,962 (relative volume 1.19). normal

Technical Price 0.81 is trading below the 200-day MA of 1.32, near the 52-week low of 0.7632.

Peers on Argus

NRSN was down 1% while biotech peers showed mixed moves (e.g., TENX +0.38%, DARE -8.33%, ITRM -2.04%), suggesting stock-specific trading rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Regulatory planning	Positive	-3.5%	Pre-NDS meeting for PrimeC in ALS with potential mid-2026 NDS submission.
Nov 24	Phase 3 clearance	Positive	-3.6%	FDA clearance to initiate pivotal Phase 3 PARAGON trial in ALS.
Nov 03	Investor webinar	Positive	-3.6%	Announcement of investor webinar covering Phase 3 ALS and RoAD updates.
Oct 06	Biomarker data	Positive	-6.4%	Statistically significant reductions in multiple Alzheimer’s-linked microRNAs.
Sep 10	Early trial signal	Positive	+16.2%	Early RoAD Phase 2 data showing enhanced neuroplasticity with no toxicity.

Pattern Detected

Recent news has often been followed by negative price reactions despite generally constructive clinical and regulatory updates, with one notable positive spike on early Alzheimer’s signals.

Recent Company History

Over the last few months, NeuroSense has reported multiple advances for PrimeC. On Sep 10, 2025, early RoAD Phase 2 Alzheimer’s data showed enhanced neuroplasticity and improved neuron health, with a 16.24% price jump. Subsequent ALS‑focused updates in Oct–Dec 2025, including statistically significant Alzheimer’s biomarker reductions and FDA clearance for a pivotal Phase 3 ALS trial, saw share price declines despite positive clinical and regulatory signals. Today’s favorable Alzheimer’s Phase 2 safety readout adds to this sequence of largely constructive but variably received milestones.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-28

An effective Form F-3 dated Oct 28, 2025 registers 333,334 ordinary shares for resale by an existing shareholder. The company receives no proceeds from these sales, and the filing facilitates secondary liquidity rather than new capital raising.

Market Pulse Summary

This announcement adds an important safety milestone for PrimeC in Alzheimer’s disease, confirming a favorable tolerability profile with no serious adverse events or new safety signals. It follows earlier biomarker and neuroplasticity findings across ALS and Alzheimer’s programs, contributing to a broader clinical picture for PrimeC. With clinical and biomarker outcomes expected in Q1 2026, attention may focus on how those data integrate with prior ALS survival and microRNA results and what they imply for future trial design.

Key Terms

biomarker medical

"NeuroSense will analyze clinical observations alongside biomarker data to enable..."

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

randomized medical

"proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study..."

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study..."

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study..."

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

adverse events medical

"No serious adverse events were reported, and no new or unexpected safety signals..."

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

AI-generated analysis. Not financial advice.

Clinical and Biomarker Outcomes Expected to Be Reported in Q1 2026

CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's disease.

The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified.

As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results expected in the first quarter of 2026.

About Alzheimer's Disease

Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

About PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer's disease, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

What did NeuroSense (NRSN) announce about PrimeC safety on Dec 22, 2025?

NeuroSense announced completion of the Phase 2 safety analysis showing a favorable tolerability profile with no serious adverse events and no new safety signals.

When will NeuroSense (NRSN) report clinical and biomarker results for PrimeC?

NeuroSense expects to report combined clinical and biomarker results from NST-AD-001 in Q1 2026.

Does the Dec 22, 2025 announcement from NeuroSense (NRSN) include PrimeC efficacy data?

No; the announcement covers only the safety analysis and states clinical outcome measures are descriptive in this exploratory study.

What type of Phase 2 study was NST-AD-001 for PrimeC (NeuroSense NRSN)?

NST-AD-001 is a randomized, double-blind, placebo-controlled proof-of-concept Phase 2 study in Alzheimer's disease.

How should investors interpret the PrimeC safety findings from NeuroSense (NRSN)?

The safety findings are positive—no serious adverse events and no new safety signals—but efficacy remains unreported until the Q1 2026 data release.