Announcement • Mar 17

Neurosense Therapeutics Ltd. Publishes Paradigm Phase 2B Trial Results of PrimeC in ALS

NeuroSense Therapeutics Ltd. announced that results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology. PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension. PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways. Key highlights from the PARADIGM phase 2b study published include: PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events mild to moderate and transient. Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001). Early initiation of PrimeC was associated with a 64% relative reduction in risk of ALS-related complications (p=0.02), including respiratory failure, hospitalization, or death. PrimeC treatment was associated with significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting its biological activity and reinforcing the potential for disease-modifying effects. These findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS. PARADIGM was a multinational Phase 2b randomized, double-blind, placebo-controlled clinical trial conducted at ALS referral centers in Italy, Canada, and Israel. The study enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo for six months. The double-blind phase was followed by a 12-month open-label extension, during which all participants received PrimeC while maintaining blinding to original treatment assignment. Even though the trial was not powered to demonstrate definitive efficacy, participants who received PrimeC from the outset maintained a clinically meaningful 7.92-point functional advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007), with the largest improvement observed in the bulbar domain (p=0.001), a key determinant of speech, swallowing, and quality of life in ALS. In addition, ALS complication-free survival demonstrated a 64% relative risk reduction favoring early treatment (p=0.02), suggesting potential long-term clinical benefit. The trial also demonstrated biological activity consistent with PrimeC's proposed multi-pathway mechanism. Markers of iron metabolism, which are frequently dysregulated in ALS, showed favorable significant changes, including preservation of transferrin levels and stabilization of ferritin. In parallel, plasma microRNA analysis revealed statistically significant downregulation of ALS-associated microRNAs miR-199a-3p, miR-199a-5p, miR-181a-5p, and miR-181b-5p, which have been linked to disease severity and prognosis. Together, these findings provide biological evidence that PrimeC engages disease-relevant pathways and support its continued development as a potential disease-modifying therapy. PrimeC is an investigational fixed-dose oral combination therapy composed of celecoxib and ciprofloxacin in a synchronized extended-release formulation. The therapy is designed to simultaneously target multiple biological mechanisms implicated in ALS progression, including neuroinflammation, iron dysregulation, and microRNA dysregulation. The therapeutic rationale for PrimeC is supported by preclinical evidence across ALS disease models and human induced pluripotent stem cell–derived motor neuron systems and has now been evaluated in a randomized Phase 2b clinical trial.

Announcement • Aug 02

NeuroSense Therapeutics Ltd. Announces Positive Biomarker Data from ALS Phase 2B Clinical Trial

NeuroSense Therapeutics Ltd. announced positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), which evaluated the safety and efficacy of PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS). This data provides additional insights that align with the Company's recent announcements of improved survival by 43% and slowed disease progression by 36%. ALS is a multifactorial disease in which iron and its related proteins play a critical role in its pathophysiology. These new results demonstrate the target engagement of PrimeC in iron regulation, which is linked to disease mitigation and improved survival. Iron metabolism is crucial in ALS pathology, with transferrin and ferritin being significant contributors to the progress of the disease. Iron accumulation in various brain regions of ALS patients has been linked to neuronal damage. Elevated ferritin levels, an indicator of iron storage, are consistently observed in ALS patients and are associated with reduced survival and potential oxidative stress. Conversely, lower levels of transferrin, the primary iron transport protein, contribute to iron dysregulation and disease progression. The 12-month study results show a significant decrease in ferritin levels and a corresponding increase in transferrin levels, both indicating alleviation of the pathology. Iron levels remained stable over the 12-month dosing period, with a mean difference of 4.536 µmol/L (95% CI [1.143, 7.929], p=0.01) compared to those who started on placebo and transitioned to PrimeC after the initial 6-month double-blind phase. These positive changes in iron metabolism align with improved clinical outcomes. Patients on PrimeC maintained better functionality and survival rates compared to those on placebo. The Company is currently compiling additional data to share with the FDA for discussion to determine the clinical and regulatory path forward. Additionally, the Company is continuing advanced discussions with several potential development partners to explore marketing opportunities following the potential completion and approval of PrimeC for ALS. Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator. PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. 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 that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

Total Shareholder Yield	-21.4%
Future Dividend Yield	n/a
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (NRSN)	n/a
Market Bottom 25% (US)	1.3%
Market Top 25% (US)	4.1%
Industry Average (Biotechs)	2.2%
Analyst forecast (NRSN) (up to 3 years)	n/a

Data	Last Updated (UTC time)
Company Analysis	2026/07/26 22:31
End of Day Share Price	2026/07/24 00:00
Earnings	2025/12/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
James Molloy	Alliance Global Partners
Robert LeBoyer	NOBLE Capital Markets, Inc.
Boobalan Pachaiyappan	Roth Capital Partners

NeuroSense Therapeutics Dividends and Buybacks

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Key information

Recent dividend and buyback updates

Recent updates

NeuroSense Therapeutics Ltd. Advances PrimeC Toward New Drug Submission To Health Canada For ALS

Neurosense Therapeutics Ltd. Achieves Primary Endpoint in Phase 2B Als Study with Statistically Significant Reduction of Tdp-43

NeuroSense Therapeutics Reports Positive Biomarker Findings from Phase 2 RoAD Proof-Of-Concept Study of PrimeC in Alzheimer's Disease

NeuroSense Therapeutics Ltd. announced that it expects to receive $0.6 million in funding

Neurosense Therapeutics Ltd. Publishes Paradigm Phase 2B Trial Results of PrimeC in ALS

Neurosense Therapeutics Ltd. Presents Long-Term Survival Data for Primec in Amyotrophic Lateral Sclerosis

NeuroSense Therapeutics Ltd. Announces Availability of Additional Long-Term Survival Data from Its Previously Completed PARADIGM Phase 2b Clinical Trial Evaluating PrimeC in Patients with Amyotrophic Lateral Sclerosis

New minor risk - Financial data availability

New major risk - Shareholder dilution

NeuroSense Therapeutics Ltd. Appoints Prof. Steven E. Arnold to Scientific Advisory Board

New minor risk - Shareholder dilution

NeuroSense Therapeutics Ltd. Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS

NeuroSense Therapeutics Ltd. Announces New Positive Findings Based on Plasma Samples from Its Phase-2B Paradigm Study

NeuroSense Therapeutics Ltd. Announces Positive Initial Results from Its Collaboration with NeuroKaire in the Ongoing RoAD Phase 2 Clinical Trial Evaluating PrimeC for Alzheimer's Disease

NeuroSense Therapeutics Ltd. announced that it expects to receive $0.500001 million in funding from Lior Tamar Investments Ltd.

NeuroSense Therapeutics Ltd., Annual General Meeting, Sep 25, 2025

New major risk - Share price stability

NeuroSense Therapeutics Ltd. Completes Its Pre-New Drug Submission (Pre-NDS) Meeting with Health Canada

New minor risk - Share price stability

Price target increased by 48% to US$10.75

NeuroSense Therapeutics Announces Successful Completion of Commercial Manufacturing Scale-Up for PrimeC in Preparation for Potential Canadian Market Launch

NeuroSense Therapeutics Announces Transformative Phase 2b MicroRNA Data, Highlighting PrimeC's Promise as a Disease-Modifying ALS Treatment

No longer forecast to breakeven

NeuroSense Therapeutics Ltd. announced that it has received $5 million in funding

New major risk - Shareholder dilution

NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC

NeuroSense Therapeutics Ltd. Announces Completion of PARADIGM Study Highlighting PrimeC's Significant Efficacy and Survival Benefits in ALS

NeuroSense Therapeutics Ltd. Advances Plans for Early Commercialization of ALS Treatment in Canada

Neurosense Therapeutics Plans to File for Early Commercialization of ALS Treatment in Canada

NeuroSense Regains Compliance with NASDAQ Minimum Bid Price Rule

New major risk - Share price stability

NeuroSense Therapeutics Announces Receipt of Nasdaq Minimum Bid Price Notification

NeuroSense Therapeutics Ltd. has filed a Follow-on Equity Offering in the amount of $2.524437 million.

NeuroSense Therapeutics Ltd. announced that it expects to receive $0.6 million in funding

NeuroSense Therapeutics Ltd. Announces Positive Biomarker Data from ALS Phase 2B Clinical Trial

NeuroSense Therapeutics Ltd. Announces Additional Positive Results from its 12-Month PARADIGM Phase 2b Study of PrimeC in ALS Patients

NeuroSense Therapeutics Ltd. Reports Statistically Significant Results from the 12-Month Paradigm Study Evaluating PrimeC in People Living with Amyotrophic Lateral Sclerosis

New major risk - Shareholder dilution

NeuroSense Therapeutics Ltd., Annual General Meeting, Jun 27, 2024

NeuroSense Announces New Positive Data Analysis from PARADIGM Clinical Trial Demonstrating Statistically Significant Slowing of Disease Progression in High-Risk ALS Patients

NeuroSense Therapeutics Ltd. Presents Positive Data Validating Phase 2b Topline Readout During Emerging Science Presentation at the American Academy of Neurology Annual Meeting

NeuroSense Therapeutics Ltd. announced that it expects to receive $4.47 million in funding

NeuroSense Therapeutics (NASDAQ:NRSN) Will Have To Spend Its Cash Wisely

Neurosense Therapeutics Ltd. Reports Additional Positive Results from Its ALS Phase 2B Paradigm Trial

NeuroSense Regains Compliance with NASDAQ Minimum Bid Price Rule

Neurosense Therapeutics Ltd. Reports Additional Positive Efficacy Data from Further Evaluation of Its Phase 2B Als Trial

Can NeuroSense Therapeutics (NASDAQ:NRSN) Afford To Invest In Growth?

NeuroSense Therapeutics Ltd.'s Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints

New major risk - Share price stability

New major risk - Revenue and earnings growth

Neurosense Receives U.S. Fda Confirmation of Cmc Strategy for Primec in Preparation for Pivotal Phase 3 in Als and Commercial Readiness

Neurosense Therapeutics Ltd. Announces Results of Non-Sponsored in Vitro Study of PrimeC in Amyotrophic Lateral Sclerosis

European Medicines Agency Grants the Small and Medium-Sized Enterprise Status of Neurosense Therapeutics Ltd

New major risk - Negative shareholders equity

New minor risk - Shareholder dilution

High number of new and inexperienced directors

Will NeuroSense Therapeutics (NASDAQ:NRSN) Spend Its Cash Wisely?

NeuroSense Therapeutics Ltd. Receives Approval in Germany to Enroll Patients in its Phase 2b ALS Trial

NeuroSense Therapeutics Ltd. Expands its Phase 2b ALS PARADIGM Trial to Canada and Withdraws Protocol from U.S. IND to Align its Clinical Strategy with the FDA for a Potential Pivotal Phase 3 Study

NeuroSense Therapeutics Reports Positive Final Results from Alzheimer's Biomarker Study

Will NeuroSense Therapeutics (NASDAQ:NRSN) Spend Its Cash Wisely?

NeuroSense Therapeutics Ltd. Receives Regulatory Approval to Commence Patient Enrollment in Italy for Its Phase 2B Trial in Als

Neurosense Receives FDA Clearance of IND for Its ALS Phase 2b Study

Less than half of directors are independent

NeuroSense Announces Positive PrimeC Pharmacokinetic Study Results & Anticipates Phase IIb ALS Enrollment to Expand into the US

Neurosense Therapeutics Ltd. Announces Positive Primec Toxicology Data Supportive of Current Phase IIb Paradigm Als Clinical Trial

NeuroSense Therapeutics GAAP EPS of -$0.55

NeuroSense Therapeutics Ltd. Reports Strong Patient Enrollment in Its Phase IIb PARADIGM Trial for Its Lead Drug Candidate PrimeC for the Treatment of ALS

NeuroSense Joins Everything ALS Open Innovation Consortium; Set to Enroll US and EU Patients in Phase IIb Study

We're Not Very Worried About NeuroSense Therapeutics' (NASDAQ:NRSN) Cash Burn Rate

Neurosense Therapeutics Ltd. Reports Completion of the "In-Life" Phase of Its 90-Day Glp Toxicology Study Successfully

NeuroSense climbs 66% after early data supporting Alzheimer’s candidate

NeuroSense Therapeutics Ltd. Reports Positive Results from Stage III ALS Biomarker Study

NeuroSense Therapeutics Ltd. Enrolls First Patient in Phase IIb ALS Trial for its Combination Therapy PrimeC

NeuroSense Therapeutics Ltd., Annual General Meeting, Jun 21, 2022