NeuroSense Management Provides Corporate Update and First Quarter 2024 Financial Results
NeuroSense Therapeutics (NASDAQ: NRSN) announced a corporate update and Q1 2024 financial results. Their Phase 2b PARADIGM clinical trial showed a significant 43% slowing of disease progression in high-risk ALS patients treated with PrimeC. Upcoming milestones include 12-month clinical results in June 2024 and an FDA meeting in Q3 2024. Financially, the company reported stable R&D and administrative expenses at $1.88M and $1.11M, respectively. However, it faced a net loss of $5.4M for the quarter, with cash reserves at $0.74M as of March 31, 2024. Additional funding of $4.5M was secured in April 2024 through a direct offering.
- Statistically significant 43% slowing of disease progression in high-risk ALS patients treated with PrimeC.
- Expected 12-month clinical results and survival data in June 2024.
- Anticipated FDA meeting in Q3 2024.
- Secured $4.5M in additional funding in April 2024.
- Net loss of $5.4M for Q1 2024.
- Cash reserves at only $0.74M as of March 31, 2024.
- Significant shareholders' deficit of $6.99M.
Insights
NeuroSense Therapeutics' Q1 2024 financial results indicate stability in R&D and G&A expenses. However, the operating loss of
Potential investors should consider the shareholder's deficit of
In the short-term, the upcoming FDA meeting and 12-month clinical results could be key catalysts for the stock. However, the company’s ongoing losses and reliance on additional financing are notable risks. Long-term viability hinges on successful Phase 3 trials and regulatory approvals.
Overall, the financials present a mixed bag: promising clinical results juxtaposed with financial challenges. Investors should weigh the potential for groundbreaking treatments against the company's current fiscal health.
PrimeC’s 43% reduction in disease progression for high-risk ALS patients is remarkable. The ALSFRS-R score improvement by 5.04 points is clinically meaningful. These results, along with upcoming survival data and biomarkers, could significantly impact ALS treatment paradigms.
Understanding the significance of biomarkers like iron, ferritin and transferrin is essential. These markers could offer insights into disease mechanisms and treatment efficacy, making future data releases highly anticipated.
However, the Phase 2b results must be validated in larger Phase 3 trials to ensure reliability and generalizability. The anticipation of the FDA meeting in Q3 2024 is crucial, as it will shape the regulatory path forward.
For stakeholders, the clinical data thus far is promising but requires cautious optimism until further validation through rigorous trials and regulatory review.
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:
- 12-month clinical results, including survival, expected in June 2024
- FDA meeting anticipated in Q3 2024
- Started preparations for Phase 3 clinical trial in the US, including protocol submission expected by year-end 2024
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 biomarker data. These will include iron, ferritin and transferrin. We are looking forward to presenting target-engagement biomarkers alongside the clinical outcomes. In the meantime, we continue our discussions with several potential partners in order to drive our clinical programs forward efficiently."
In addition, the Company hereby provides its Q1 2024 financial results:
- Research and development expenses for the three months ended March 31, 2024 and 2023 were
$1.88 and$1.85 million - General and administrative expenses for the three months ended March 31, 2024 and 2023 were
$1.11 and$1.14 million - Operating expenses for the three months ended March 31, 2024 and 2023 were
$3 million due to the reasons described above.
As of March 31, 2024, NeuroSense had cash of
Following the end of the first quarter of 2024, the Company determined to change its accounting method from IFRS to
A summary of NeuroSense's unaudited consolidated financial results is included in the tables below.
Ben-Noon concluded, "We continue to build strong clinical evidence for PrimeC and are looking forward to upcoming announcements. Concurrently, we are working to safeguard our financial future and ability to continue our clinical activities so as to ensure that there is adequate cash on the balance sheet to complete these milestones. We plan to meet with the FDA in Q3 2024 to discuss the clinical path forward towards an NDA submission, which we believe will be a major inflection point for NeuroSense. The coming months hold tremendous potential, and we are optimistic about the outcomes and the future for NeuroSense Therapeutics."
[1] High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately
NeuroSense Therapeutics Ltd. | ||||||||
Condensed Interim Balance Sheets | ||||||||
March 31, | December 31, | |||||||
2024 | 2023 | |||||||
Unaudited | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalent | 735 | 2,640 | ||||||
Other receivables | 421 | 236 | ||||||
Restricted deposit | 36 | 40 | ||||||
Total current assets | 1,192 | 2,916 | ||||||
Non-current assets: | ||||||||
Property and equipment, net | 88 | 85 | ||||||
Operating right of use assets | 143 | 162 | ||||||
Restricted deposit | 23 | 22 | ||||||
Total non-current assets | 254 | 269 | ||||||
Total assets | 1,446 | 3,185 | ||||||
Liabilities and Shareholders' Deficit | ||||||||
Current liabilities: | ||||||||
Trade payables | 2,384 | 1,459 | ||||||
Other payables | 2,151 | 2,000 | ||||||
Total current liabilities | 4,535 | 3,459 | ||||||
Non-Current liabilities: | ||||||||
Operating long-term lease liability | 55 | 73 | ||||||
Liability in respect of warrants | 3,849 | 1,412 | ||||||
3,904 | 1,485 | |||||||
Total liabilities | 8,439 | 4,944 | ||||||
Shareholders' deficit: | ||||||||
Authorized: 60,000,000 shares at March 31, 2024 and December 31, 2023; Issued | - | - | ||||||
Share premium and capital reserve | 24,532 | 24,362 | ||||||
Accumulated deficit | (31,525) | (26,121) | ||||||
Total Shareholders' deficit | (6,993) | (1,759) | ||||||
Total liabilities and shareholders' deficit | 1,446 | 3,185 | ||||||
NeuroSense Therapeutics Ltd. | |||||||||||||||
Condensed Interim Statements of Operations and Comprehensive Loss | |||||||||||||||
Three months | Three months | For the year | |||||||||||||
ended | ended | ended | |||||||||||||
March 31, | March 31, | December 31, | |||||||||||||
2024 | 2023 | 2023 | |||||||||||||
Unaudited | |||||||||||||||
Research and development expenses | (1,882) | (1,852) | (7,274) | ||||||||||||
General and administrative expenses | (1,112) | (1,139) | (4,775) | ||||||||||||
Operating loss | (2,994) | (2,991) | (12,049) | ||||||||||||
Financing income (expenses), net | (2,410) | 67 | 1,942 | ||||||||||||
Net loss and comprehensive loss | (5,404) | (2,924) | (10,107) | ||||||||||||
Basic and diluted net loss per share | (0.35) | (0.25) | (0.74) | ||||||||||||
Weighted average number of shares outstanding used in | 15,405,253 | 11,785,603 | 13,640,168 | ||||||||||||
NeuroSense Therapeutics Ltd. | ||||||||||||||||||
Condensed Interim Unaudited Statements of Changes in Shareholders' Equity | ||||||||||||||||||
Ordinary Shares | Share | Accumulated | Total | |||||||||||||||
Number | Amount | Reserve | Deficit | (Deficit) | ||||||||||||||
Three months ended March 31, 2024: | ||||||||||||||||||
Balance as at January 1, 2024 | 15,379,042 | - | 24,362 | (26,121) | (1,759) | |||||||||||||
Share based compensation | 203,000 | - | 170 | - | 170 | |||||||||||||
Net loss and comprehensive loss | - | - | - | (5,404) | (5,404) | |||||||||||||
Balance as at March 31, 2024 | 15,582,042 | - | 24,532 | (31,525) | (6,993) | |||||||||||||
Three months ended March 31, 2023: | ||||||||||||||||||
Balance as at January 1, 2023 | 11,781,963 | - | 21,858 | (16,014) | 5,844 | |||||||||||||
Share based compensation | - | - | 406 | - | 406 | |||||||||||||
Net loss and comprehensive loss | - | - | - | (2,924) | (2,924) | |||||||||||||
Balance as at March 31, 2023 | 11,781,963 | - | 22,264 | (18,938) | 3,326 | |||||||||||||
For the year ended December 31, 2023: | ||||||||||||||||||
Balance as at January 1, 2023 | 11,781,963 | - | 21,858 | (16,014) | 5,844 | |||||||||||||
Issuance of shares and pre-funded | 1,333,600 | - | 806 | - | 806 | |||||||||||||
Exercise of pre-funded warrants, | 2,263,479 | - | - | - | - | |||||||||||||
Share based compensation | - | - | 1,698 | - | 1,698 | |||||||||||||
Net loss and comprehensive loss | - | - | - | (10,107) | (10,107) | |||||||||||||
Balance as at December 31, 2023 | 15,379,042 | - | 24,362 | (26,121) | (1,759) | |||||||||||||
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 patients are diagnosed with ALS in the
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
As previously reported, top-line data from the 6-month double-blind segment of the trial showed clinically meaningful signs of efficacy with a
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 and X.
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 timing of top-line results and regulatory meetings and submissions. 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 unexpected R&D costs or operating expenses, 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 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: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/neurosense-management-provides-corporate-update-and-first-quarter-2024-financial-results-302180268.html
SOURCE NeuroSense
FAQ
What were the key results of NeuroSense's Phase 2b PARADIGM clinical trial?
When will NeuroSense announce the 12-month clinical results?
What is the status of NeuroSense's cash reserves as of Q1 2024?
How much additional funding did NeuroSense secure in April 2024?
What were NeuroSense's research and development expenses for Q1 2024?
When is NeuroSense's FDA meeting scheduled?
What was NeuroSense's net loss for Q1 2024?
