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NeuroSense Therapeutics(NRSN) - 2024 Q4 - Annual Report

Executive Summary & Business Highlights NeuroSense Therapeutics achieved significant clinical and strategic milestones in 2024, including successful Phase 2b ALS study results, FDA alignment for Phase 3, and extended patent protection 2024 Business Highlights NeuroSense Therapeutics achieved significant clinical progress in 2024, successfully completing its Phase 2b study for PrimeC in ALS, demonstrating slowed disease progression and improved survival rates. The company also aligned its Phase 3 study design with the FDA for planned initiation in 2025, is pursuing partnership discussions, and plans for early commercialization in Canada, supported by an extended patent until 2042 PrimeC Phase 2b Study Results | Metric | Result | | :--- | :--- | | Slowed disease progression (ALSFRS-R) | ~33% after 18 months (p=0.007) | | Overall improvement in survival rates | 58% (reduced mortality, hospitalization, respiratory support) | | Slowed functional decline | Especially speaking and swallowing functions | | Safety and tolerability | Favorable profile (achieved primary endpoint) | - Phase 3 study design for PrimeC in ALS aligned with FDA; planned initiation in 20253 - Plans to file for early commercialization for PrimeC in Canada, with an estimated potential market opportunity of $100 million-$150 million in peak annual revenues3 - Key patent granted by U.S. Patent and Trademark Office (USPTO), extending patent protection for PrimeC until 20424 CEO Statement NeuroSense CEO, Alon Ben-Noon, highlighted 2024 as a year of significant clinical progress, emphasizing the transformative results of the PrimeC Phase 2b study in ALS and its disease-modifying potential, which strongly supports advancing PrimeC to a Phase 3 study with positive FDA feedback - NeuroSense CEO, Alon Ben-Noon, stated: "2024 was a year of significant clinical progress for NeuroSense"4 - The results conclude with PrimeC's disease-modifying potential and strongly support advancing PrimeC towards a Phase 3 study4 Financial Results NeuroSense Therapeutics reported a decrease in both research and development and general and administrative expenses for 2024, while increasing its cash position and significantly improving its equity from a deficit to a positive balance Summary of Key Financials NeuroSense Therapeutics reported a decrease in both research and development expenses and general and administrative expenses for the year ended December 31, 2024, compared to 2023, while increasing its cash position Research and Development Expenses (in thousands) | Year | Amount | Change (YoY) | | :--- | :--- | :--- | | 2024 | $5,700 | -$1,600 (-21.9%) | | 2023 | $7,300 | | General and Administrative Expenses (in thousands) | Year | Amount | Change (YoY) | | :--- | :--- | :--- | | 2024 | $4,200 | -$600 (-12.5%) | | 2023 | $4,800 | | - Cash as of December 31, 2024: approximately $3.4 million7 Consolidated Statements of Financial Position The Consolidated Statements of Financial Position show NeuroSense's financial health as of December 31, 2024, with total assets increasing to $4.575 million from $3.185 million in 2023, and a significant shift from a total shareholders' deficit of $(1.759) million in 2023 to a positive equity of $2.583 million in 2024 Consolidated Statements of Financial Position (U.S. dollars in thousands) | Item | As of December 31, 2024 | As of December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Current assets: | | | | Cash and cash equivalent | $3,378 | $2,640 | | Other receivables | 989 | 236 | | Restricted deposits | 35 | 40 | | Total current assets | 4,402 | 2,916 | | Non-current assets: | | | | Property and equipment, net | 66 | 85 | | Right of use assets | 84 | 162 | | Restricted deposit | 23 | 22 | | Total non-current assets | 173 | 269 | | Total assets | $4,575 | $3,185 | | Liabilities shareholders' and equity | | | | Current liabilities: | | | | Trade payables | $1,160 | $1,459 | | Other current liabilities | 832 | 2,000 | | Total current liabilities | 1,992 | 3,459 | | Non-current liabilities: | | | | Lease liability less current maturity | - | 73 | | Liability in respect of warrants | - | 1,412 | | Total non-current liabilities | - | 1,485 | | Total liabilities | 1,992 | 4,944 | | Shareholders' equity: | | | | Share Premium and Capital Reserve | 39,243 | 24,362 | | Accumulated deficit | (36,660) | (26,121) | | Total shareholders' equity (deficit) | 2,583 | (1,759) | | Total liabilities and shareholders' equity | $4,575 | $3,185 | Consolidated Statements of Income and Comprehensive Loss The Consolidated Statements of Income and Comprehensive Loss for 2024 show a net loss of $(10.210) million, a slight increase from $(10.107) million in 2023, despite a reduction in both research and development expenses and general and administrative expenses, primarily due to a negative shift in financing income (expenses), net Consolidated Statements of Income and Comprehensive Loss (U.S. dollars in thousands, except share and per share data) | Item | For the year ended December 31, 2024 | For the year ended December 31, 2023 | For the year ended December 31, 2022 | | :--- | :--- | :--- | :--- | | Research and development expenses | $(5,698) | $(7,274) | $(5,587) | | General and administrative expenses | $(4,204) | $(4,775) | $(4,967) | | Operating loss | $(9,902) | $(12,049) | $(10,554) | | Financing income (expenses), net | $(308) | $1,942 | $62 | | Net loss and comprehensive loss | $(10,210) | $(10,107) | $(10,492) | | Basic and diluted net loss per share | $(0.54) | $(0.74) | $(0.91) | Consolidated Statements of Changes in Equity (Deficit) The Consolidated Statements of Changes in Equity (Deficit) reflect a significant improvement in NeuroSense's equity position, moving from a deficit of $(1,759) thousand at the end of 2023 to a positive equity of $2,583 thousand by December 31, 2024, driven by issuance of shares and pre-funded warrants, reclassification of warrants, and bonus accruals, despite a net loss Consolidated Statements of Changes in Equity (deficit) (U.S. dollars in thousands, except share and per share data) | Item | Ordinary Shares Number | Ordinary Shares Amount | Share Premium and Capital Reserve | Accumulated Deficit | Total Equity (Deficit) | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance as of January 1, 2022 | 10,943,534 | $ - | $ 16,356 | $ (5,522) | $ 10,834 | | Repurchase of options | - | - | (96) | - | (96) | | Exercise of warrants and vested RSUs | 838,429 | - | 3,870 | - | 3,870 | | Share based payment compensation | - | - | 1,728 | - | 1,728 | | Net loss and comprehensive loss | - | - | - | (10,492) | (10,492) | | Balance as of December 31, 2022 | 11,781,963 | $ - | $ 21,858 | $ (16,014) | $ 5,844 | | Issuance of shares and pre-funded warrants, net | 1,333,600 | - | 806 | - | 806 | | Exercise of pre-funded warrants, options and vested RSUs | 2,263,479 | - | - | - | - | | Share based payment compensation | - | - | 1,698 | - | 1,698 | | Net loss and comprehensive loss | - | - | - | (10,107) | (10,107) | | Balance as of December 31, 2023 | 15,379,042 | $ - | $ 24,362 | $ (26,121) | $ (1,759) | | Issuance of shares and pre-funded warrants, net | 5,981,238 | - | 10,806 | - | 10,806 | | Exercise of pre-funded warrants, options and vested RSUs | 1,573,000 | - | () | - | () | | Issuance of shares due to SEPA agreement | 224,697 | - | 281 | - | 281 | | Reclassification of warrants into equity (see Note 8) | - | - | 1,695 | (329) | 1,366 | | Bonus accrual reclassification to equity (see Note 14) | - | - | 1,434 | - | 1,434 | | Share-based compensation | 70,964 | - | 665 | - | 665 | | Net loss and comprehensive loss | - | - | - | (10,210) | (10,210) | | Balance as of December 31, 2024 | 23,228,941 | $ - | $ 39,243 | $ (36,660) | $ 2,583 | Company and Product Information This section provides essential information about Amyotrophic Lateral Sclerosis (ALS), NeuroSense's lead drug candidate PrimeC, and the company's strategic focus on neurodegenerative disease treatments About ALS Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease leading to complete paralysis and death within 2-5 years. It affects over 5,000 people annually in the U.S., with a $1 billion annual disease burden, and is projected to increase by 24% by 2040 in the U.S. and EU - ALS is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis18 - More than 5,000 people are diagnosed with ALS in the U.S. alone each year, with an annual disease burden of $1 billion18 - The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU18 About PrimeC PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining ciprofloxacin and celecoxib. It targets multiple ALS mechanisms, has met safety and efficacy endpoints in a Phase 2a trial, and holds Orphan Drug Designation from the FDA and EMA - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib19 - PrimeC is designed to synergistically target multiple mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation19 - PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency19 About NeuroSense NeuroSense Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing combined therapies for severe neurodegenerative diseases such as ALS, Alzheimer's, and Parkinson's, addressing significant unmet medical needs through a multi-pathway targeting strategy - NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases20 - NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases20 Additional Information This section outlines forward-looking statements, emphasizing inherent risks and uncertainties, and provides contact information for NeuroSense Therapeutics Forward-Looking Statements This section contains forward-looking statements subject to substantial risks and uncertainties, including those related to partnership discussions, study initiation timing, regulatory filings, market potential, and financial resources. Investors are cautioned not to rely on these statements, and NeuroSense undertakes no duty to update them except as required by law - This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties22 - Risks include the risk that partnership discussions will not lead to a definitive agreement, delays in the planned Phase 3 study, lower than anticipated market opportunity, delayed or unobtained regulatory approvals, unexpected R&D costs, insufficient capital, and other risks detailed in SEC filings22 - NeuroSense undertakes no duty to update such information except as required under applicable law22 Contact Information Contact details for NeuroSense Therapeutics are provided for further information - Email: info@neurosense-tx.com23 - Tel: +972 (0)9 799 618323