Celecoxib/Ciprofloxacin

Initial Phase 2 RoAD trial results demonstrate improvements in brain-cell connectivity and health, with a favorable safety profile CAMBRIDGE, Mass., Sept. 10, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive initial results from its collaboration with NeuroKaire in the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD). Using NeuroKaire's proprietary technology to generate brain cells from each patient's blood, analysis of samples from clinically characterized AD patients demonstrated that: PrimeC treatment enhanced neuroplasticity, a key feature in supporting brain health and function and underlying memory formation and retention. No treatment-related toxicity was observed, demonstrating the safety of PrimeC combination. NeuroSense's RoAD study is a randomized, double-blind, placebo-controlled Phase 2 trial enrolling mild-to-moderate AD patients, designed to evaluate safety, efficacy, and biological activity of PrimeC over 12 months. These results provide an early, patient-specific view of how PrimeC may affect disease-relevant human neurons, reinforcing the program's mechanistic rationale and guiding precision development in AD. NeuroKaire's proprietary technology reprograms blood sample cells into induced pluripotent stem cells (iPSCs) and differentiates them into mature human cortical neurons. After validation, neurons are exposed to PrimeC, and advanced high-content imaging using AI-driven analytics quantifies key features of neuronal structure. This generates composite response profiles tied to neuroplasticity, connectivity, and cell health. Alon Ben-Noon, CEO of NeuroSense, stated: "This is exactly the kind of early, decision-enabling signal RoAD was designed to uncover. By integrating NeuroKaire's patient-derived neuron platform with our clinical program, we observed measurable gains in brain-cell connectivity and a favorable safety profile. These findings strengthen PrimeC's mechanistic rationale in Alzheimer's and enable us to focus development with greater precision." Dr. Daphna Laifenfeld, CSO of NeuroKaire, commented: "Our platform is designed to detect subtle, disease-relevant changes in human neurons with the sensitivity modern drug development requires. This collaboration demonstrates how a bench-to-clinic 360° workflow can transform a simple blood draw into actionable, patient-specific insights, accelerating innovation for people living with AD." These results will be presented at the CNS Summit 2025 in Boston, November 2nd – 5th by David Pattison, VP Business Development at NeuroKaire. NeuroSense and NeuroKaire will continue evaluating PrimeC's cellular effects in parallel with clinical outcomes from the RoAD trial, with top-line data expected following study completion. 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 NeuroKaire NeuroKaire, founded in 2018 by Talia Cohen-Solal, Ph.D., and Daphna Laifenfeld, Ph.D., is developing personalized medicine solutions to optimize treatment for psychiatric and neurological diseases. The company's proprietary AI-powered platform, Stemifai, leverages stem cell differentiation and machine learning to inform and advance CNS drug development processes. To learn more, follow us on LinkedIn or on Twitter @Genetikaplus. 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 results of the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD). Further, certain forward-looking statements 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 risk that final results of the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD) will not be consistent with its positive initial results, the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; 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 4, 2024 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. Logo: SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CAMBRIDGE, Mass., July 31, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today provided business update with corporate highlights to date and financial results of the first half of 2025. NeuroSense is advancing PrimeC, its investigational combination therapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways while preparing for a pivotal Phase 3 trial. "The first half of 2025 has been transformational for NeuroSense. We regained compliance with Nasdaq's stockholders' equity requirement, generated additional long–term data from our Phase 2b ALS, PARADIGM study, and advanced our manufacturing capabilities," said Alon Ben–Noon, Chief Executive Officer of NeuroSense. "Our team is focused on accelerating the path to a pivotal Phase 3 trial as the next step in potentially bringing a meaningful treatment to people living with ALS as quickly as possible." Upcoming Corporate Highlights for H2 2025 include: NOC/c Submission in Canada – Following feedback from Health Canada that the Company's initial request did not fulfill the criteria for advanced consideration under the Notice of Compliance with conditions (NOC/c) policy, and in line with Health Canada's suggestion, NeuroSense plans to submit a new request supported by additional data, with the goal of securing an NOC/c for PrimeC. Phase 3 trial commencement – Following positive regulatory feedback from the FDA, NeuroSense plans to begin a multinational Phase 3 study of PrimeC in ALS in the second half of 2025. Advancing binding term sheet with a global pharmaceutical partner – Following the execution of a binding term sheet in the fourth quarter of 2024 to advance the development and commercialization of PrimeC, its proprietary treatment drug for ALS in certain key territories, discussions are continuing and may yield a definitive partnership agreement in the near future. First Half 2025 Corporate Highlights Nasdaq listing compliance restored In January 2025 NeuroSense received formal notice from Nasdaq that it had regained compliance with the stockholders' equity requirement after completing a $5 million private placement in December 2024. The financing strengthened the Company's balance sheet and raised shareholders' equity above Nasdaq's minimum requirement. Additional long –term data from the Phase 2b PARADIGM study In February 2025 NeuroSense reported new analyses from the completed 18–month Phase 2b PARADIGM study in ALS. The new analysis revealed that in the per-protocol population (participants who adhered to the protocol), treatment with PrimeC slowed functional decline by ~40%. Overall survival improved by 74%, complication–free survival improved by 79%, and patients experienced slower decline in slow vital capacity by 26%. These data reinforce the disease–modifying potential of PrimeC and underpin the design of the planned Phase 3 study. Presentation of biomarker and mechanistic data At the Annual Meeting of the American Academy of Neurology (AAN) in April 2025, members of NeuroSense's scientific advisory board presented further analyses from the PARADIGM study. Dr. Jeremy Shefner highlighted safety, efficacy and biomarker data showing that PrimeC has disease–modifying potential and may redefine ALS treatment. Dr. Jeffrey Rosenfeld discussed microRNA modulation and iron–related biomarkers as evidence of multi–target engagement. These findings were later expanded upon in a release describing how PrimeC consistently modulated microRNAs associated with ALS, providing mechanistic insight consistent with observed clinical improvements. Manufacturing scale –up to commercial levels In May 2025 NeuroSense successfully scaled production of PrimeC to a commercial level and selected a global contract development and manufacturing organization (CDMO) to ensure supply chain readiness for potential commercialization. The Company validated the manufacturing process, qualified suppliers, and demonstrated product stability supporting a 36–month shelf–life. H1 2025 Financial Results: Research and development expenses for the six months ended June 30, 2025 and 2024 were $2,503 thousand and $3,733 thousand, respectively. The decrease of $1,230 thousand, or 32.9%, was mainly attributed to the decrease in clinical activity. General and administrative expenses for the six months ended June 30, 2025 and 2024 were $2,189 thousand and $2,291 thousand, respectively. The decrease of $102 thousand, or 4.4%, is considered immaterial. Operating expenses for the six months ended June 30, 2025 and 2024 were $4.7 million and $6 million, respectively due to the reasons described above. A summary of NeuroSense's unaudited consolidated financial results is included in the tables below. About 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. About PARADIGM 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. During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation. 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. 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 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. 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 a commercial launch in Canada and market potential. Further, certain forward-looking statements 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 risk that that the commercial launch of PrimeC will not expeditious, that there will not be dependable and compliant sourcing for commercial-scale production volumes of PrimeC, that the shelf life of PrimeC will not be as anticipated, lower than anticipated market opportunity in Canada and elsewhere, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; insufficient capital to complete development of PrimeC, the timing of expected regulatory and business milestones; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; the development and commercial potential of any product candidates of Neurosense; 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. Logo: SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED