Company Overview - NeuroSense Therapeutics Ltd. is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, addressing significant unmet medical needs with limited therapeutic options available [3][4] Compliance with Nasdaq - NeuroSense has regained compliance with Nasdaq's minimum bid price requirement, achieving a closing bid price of $1.00 or more for at least 10 consecutive business days as of September 20, 2024, thus closing the prior bid price deficiency matter [1][2] Future Developments - The CEO of NeuroSense expressed optimism about advancing their treatment PrimeC, highlighting the positive momentum following Phase 2b trial results and the anticipation of initiating the Phase 3 trial in the US while continuing discussions with potential partners [3]

CAMBRIDGE, Mass., Aug. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares and warrants in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 800,000 ordinary shares and warrants to purchase an aggregate of ...

Core Insights - NeuroSense Therapeutics has announced positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), indicating the potential of PrimeC as a transformative therapy for ALS, with improved survival rates by 43% and slowed disease progression by 36% [1][5] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [11] - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [11] Study Results - The 12-month study results showed a significant decrease in ferritin levels and an increase in transferrin levels, indicating improved iron metabolism and disease mitigation [3][4] - 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 placebo [3] Clinical Implications - The positive changes in iron metabolism correlate with improved clinical outcomes, as patients on PrimeC exhibited better functionality and survival rates compared to those on placebo [4] - The study's findings support the advancement to Phase 3 testing of PrimeC in ALS, as highlighted by Dr. Merit Cudkowicz [5] Background on ALS - ALS is an incurable neurodegenerative disease that leads to complete paralysis and death within 2-5 years from diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [6] - The disease burden in the U.S. is approximately $1 billion annually, and the number of people living with ALS is projected to grow by 24% by 2040 in the U.S. and EU [6] About PrimeC - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [10] - The drug has shown efficacy in reducing functional and respiratory deterioration and has received Orphan Drug Designation from the FDA and EMA [10] About the PARADIGM Study - The PARADIGM trial is a multinational, randomized, double-blind, placebo-controlled Phase 2b study involving 68 ALS participants across Canada, Italy, and Israel [8] - In the 6-month double-blind segment, PrimeC demonstrated a 29% efficacy difference compared to placebo, with a statistically significant slowing of disease progression observed [9]

Logo:https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg SOURCE NeuroSense Previously, NeuroSense reported that PrimeC significantly slowed disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Per-Protocol analysis revealed even greater benefits, with a 40% (p=0.003) improvement in ALSFRS-R scores and a 63% increase in survival rates, representing a distinguished advancement in outcomes for a controlled 12-month ALS study. Other positive clin ...

Following positive 6-month clinical outcomes from phase 2b (PARADIGM) clinical trial, Company expects additional biomarker and 12-month clinical in the near term Corporate Highlights for the near term include: NeuroSense CEO Alon Ben-Noon states, "We are continuing to see additional results coming in from the PARADIGM trial and as they are being analyzed and verified, we intend to share them with shareholders. We anticipate sharing 12-month survival data, ALSFRS-R –as well as providing some additional bioma ...

Exhibit 99.1 INDEX TO CONSOLIDATED FINANCIAL STATEMENTS | | Page | | --- | --- | | Report of Independent Registered Public Accounting Firm | F-2 | | Consolidated Balance Sheets as of December 31, 2023 and 2022 | F-3 | | Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023, 2022 and | F-4 | | 2021 | | | Consolidated Statements of Changes in Shareholders' Equity for the Years Ended December 31, 2023, 2022 and 2021 | F-5 | | Consolidated Statements of Cash Flows fo ...

CAMBRIDGE, Mass., May 20, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces that Vice President of R&D, Dr. Shiran Zimri will be a key presenter at the ALS Drug Development Summit in Boston, Mass. on May 22, 2024, which gathers the top drug developers in the field to present findings and collaborate toward a cure for the disease. Dr. Shiran Zimri, VP of R&D at NeuroSenseDr. Shiran Zimri, VP ...

Financial Position and Performance - As of December 31, 2023, the company had cash and cash equivalents of $2.6 million[45] - The company incurred net losses of $11.28 million and $12.34 million for the years ended December 31, 2023 and 2022, respectively[50] - The company anticipates continuing to incur significant losses and negative cash flows for the foreseeable future[50] - The company has not generated any material revenue to date and relies on equity or debt financing for cash needs[53] - The company has limited financial resources and experience in managing larger operations, which could hinder effective growth management and lead to operational disruptions[115] Research and Development - The company has invested almost all resources in the research and development of its lead product candidate, PrimeC, which has yet to receive marketing approval[55] - The FDA accepted the IND filing for PrimeC, allowing the company to commence clinical trials in the United States[57] - The company completed a Phase 2b trial for PrimeC, meeting primary safety and tolerability endpoints and achieving secondary clinical efficacy endpoints[66] - The company plans to initiate a pivotal clinical trial for PrimeC as early as 2025, pending agreement with the FDA on trial design[66] - The company has generated limited clinical data for its product candidates, and positive results in early trials do not guarantee success in later trials[63] - The company has initiated a nine-month non-rodent toxicity study to further evaluate PrimeC[66] Regulatory and Compliance Risks - The company has not yet obtained regulatory approval for any product candidates in the United States or other countries[59] - The FDA's approval process is lengthy and complex, with potential delays due to various regulatory requirements[65] - Regulatory compliance failures could lead to sanctions, including clinical trial holds or product seizures, adversely affecting business[86] - The company must comply with federal and state healthcare fraud and abuse laws, with potential penalties for non-compliance[195] - The company faces risks related to the marketing and manufacturing of products, including potential fines and product recalls[199] Market and Competitive Landscape - The company faces significant competition for its product candidates, which may hinder market penetration[44] - Competition in the biopharmaceutical industry is intense, with large companies having significant advantages in resources and experience[90] - Even with regulatory approval, product candidates may struggle to achieve broad physician adoption and market acceptance necessary for commercial success[87] - The company may face challenges in patient enrollment for clinical trials, which can significantly impact trial timing and success[73] Intellectual Property and Legal Risks - The company relies on a combination of patents and trade secret protections for its technologies, with U.S. Patent 10,980,780 related to ALS treatment expiring in 2038[134] - The patent application process is complex, lengthy, and costly, which may hinder the ability to secure necessary patents for product candidates[142] - The company may face challenges to its granted patents, including opposition and reexamination proceedings, which could result in loss of exclusivity or invalidation of patent claims[138] - The company may incur substantial costs in enforcing patent rights in foreign jurisdictions, which could divert resources from other business areas[158] - The company is at risk of third-party claims alleging infringement of intellectual property rights, which could hinder product development and commercialization[170] Financial and Market Conditions - The company received a notice from Nasdaq on December 21, 2023, indicating non-compliance with the Minimum Equity Rule, requiring at least $2.5 million in shareholders' equity[213] - The company must complete a fundraising of $20 million by April 30, 2024, to regain compliance with Nasdaq listing requirements[213] - The market price of the company's ordinary shares and Warrants may fluctuate significantly due to various factors, including operational results and market conditions[216] - Economic conditions, including inflation and geopolitical events, may adversely affect the company's operating results and growth rates, leading to challenges in sales cycles and market share[129] Management and Operational Challenges - The company emphasizes the importance of attracting and retaining senior management and key scientific personnel for successful product development and commercialization[120] - The company incurs significant increased costs due to operating as a public company in the U.S., requiring substantial management time for compliance initiatives[224] - The independent registered public accounting firm has not been engaged to audit the company's internal control over financial reporting, which may lead to additional costs once the company ceases to qualify as an emerging growth company[225] Healthcare and Legislative Risks - Legislative changes in the healthcare industry could increase limitations on reimbursement and adversely affect third-party coverage of the company's products[181] - The ACA includes a 23.1% minimum rebate requirement for branded drugs under Medicaid, impacting the company's pricing strategy[184] - The Inflation Reduction Act allows Medicare to negotiate prices for a limited number of drugs starting in 2026, which may affect the company's revenue[186] - The company faces significant uncertainty regarding insurance coverage and reimbursement for newly approved products, impacting market acceptance[206]

Exhibit 99.1 NeuroSense CEO Provides Q1 2023 Update: Phase 2b ALS Trial Achieves 80% Enrollment CAMBRIDGE, Mass., April 17, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today provided an update from its CEO, Alon Ben-Noon, on the Company's clinical and operational developments during the first quarter of 2023. Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Achieves 80% Patient Enrollment P ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the ...