NeuroSense Therapeutics Reports Year End 2024 Financial Results and Provides Business Updates
Rhea-AI Summary
NeuroSense Therapeutics (NRSN) has reported significant clinical progress in 2024, with its lead drug PrimeC showing promising results in a Phase 2b ALS study. The trial demonstrated a 33% slowdown in disease progression (p=0.007) and a 58% improvement in survival rates after 18 months.
The company has aligned Phase 3 study design with FDA and plans initiation in 2025. NeuroSense is pursuing partnership discussions for PrimeC's advancement and plans early commercialization in Canada, with estimated peak annual revenues of $100m-$150m.
Financial results show R&D expenses decreased by 21.9% to $5.7M in 2024, while G&A expenses reduced by 12.5% to $4.2M. The company ended 2024 with $3.4M in cash and reported a net loss of $10.2M.
Positive
- Phase 2b trial showed significant 33% reduction in ALS disease progression
- 58% improvement in survival rates from PrimeC treatment
- FDA alignment achieved for Phase 3 study design
- Patent protection for PrimeC extended until 2042
- 21.9% reduction in R&D expenses from $7.3M to $5.7M
Negative
- Net loss of $10.21M in 2024
- cash position of $3.4M may require additional funding
- Accumulated deficit increased to $36.66M
- Partnership discussions still ongoing without definitive agreement
News Market Reaction
On the day this news was published, NRSN declined 2.29%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Phase 2b study completed in amyotrophic lateral sclerosis (ALS) demonstrated lead asset PrimeC slows disease progression and functional decline
- Ongoing partnership discussions to advance PrimeC to Phase 3 study in ALS and commercialization
- Phase 3 study design for PrimeC in ALS aligned with FDA; planned initiation in 2025
Business highlights from 2024 and to date
- PrimeC achieved primary and secondary clinical endpoints in PARADIGM Phase 2b study investigating PrimeC in ALS (n=68) with data showing the following:
- PrimeC slowed disease progression (measured by ALSFRS-R) by approximately33% after 18 months (p=0.007)
- PrimeC reduced likelihood of mortality, hospitalization and respiratory support, resulting in an overall58% improvement in survival rates.
- PrimeC slowed functional decline, especially speaking and swallowing functions.
- PrimeC demonstrated favorable safety and tolerability profile, achieving the study's primary endpoint. - Phase 3 study design for PrimeC for ALS aligned with FDA following Type C meeting.
- Partnership discussions are continuing in order to advance PrimeC towards regulatory approval and eventual commercialization.
- Plans to file for early commercialization for PrimeC in
Canada , with an estimated potential market opportunity of$100m -$150m - Key patent granted by
U.S. Patent and Trademark Office (USPTO), extending the patent protection for the novel formulation of PrimeC until 2042.
"2024 was a year of significant clinical progress for NeuroSense," stated NeuroSense CEO, Alon Ben-Noon. "We successfully completed our Phase 2b study for PrimeC in ALS, with data showing transformative results in a neurodegenerative indication of immense medical need. The results conclude with PrimeC's disease-modifying potential and strongly support advancing PrimeC towards a Phase 3 study. With positive FDA feedback on the proposed study design, we are putting everything in place for the next stage of NeuroSense's growth, driven by PrimeC's continued clinical development."
Financial Results
Research and development expenses for the years ended December 31, 2024 and 2023 were
General and administrative expenses for the years ended December 31, 2024 and 2023 were
As of December 31, 2024, NeuroSense had cash of approximately
A summary of NeuroSense's consolidated financial results is included in the tables below.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the
NeuroSense Therapeutics Ltd. | ||||||||||
Consolidated Statements of Financial Position | ||||||||||
( | ||||||||||
As of December 31, | ||||||||||
2024 | 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 | ||||||||
- | 1,485 | |||||||||
Total liabilities | 1,992 | 4,944 | ||||||||
Shareholders' equity: | ||||||||||
Ordinary shares, no par value: | ||||||||||
Authorized: 90,000,000 shares at December 31, 2024 and 60,000,000 | - | |||||||||
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 | ||||||
NeuroSense Therapeutics Ltd. | ||||||||||||||
Consolidated Statements of Income and Comprehensive Loss | ||||||||||||||
( | ||||||||||||||
For the year ended | ||||||||||||||
2024 | 2023 | 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) | ||||||||
NeuroSense Therapeutics Ltd. | ||||||||||||||||||||
Consolidated Statements of Changes in Equity (deficit) | ||||||||||||||||||||
( | ||||||||||||||||||||
Ordinary | Share | Accumulated | Total | |||||||||||||||||
Number | Amount | Reserve | Deficit | (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 | 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 | 1,573,000 | - | (*) | - | (*) | |||||||||||||||
Issuance of shares due to SEPA agreement | 224,697 | 281 | - | 281 | ||||||||||||||||
Reclassification of warrants into equity (see | - | - | 1,695 | (329) | 1,366 | |||||||||||||||
Bonus accrual reclassification to equity (see | - | - | 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 | |||||||||||
(*) less than | ||||||||||||||||||||
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
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
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 ongoing partnership discussions, the timing of initiation of studies, regulatory filings, meetings and regulatory decisions, market potential and expected growth in the market. 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 the partnership discussions will not lead to execution of a definitive agreement, or that, if executed, will not lead to the current anticipated benefits to NeuroSense, a delay in the planned Phase 3 study for PrimeC in ALS, lower than anticipated market opportunity in
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SOURCE NeuroSense
FAQ
What were the key clinical results of NRSN's PrimeC Phase 2b trial in ALS?
When will NeuroSense (NRSN) begin Phase 3 trials for PrimeC?
What is the potential market value for PrimeC in Canada for NRSN?
How much cash does NRSN have as of December 31, 2024?
What was NRSN's net loss for the fiscal year 2024?
