NeuroSense Announces Year End 2023 Financial Results and Provides Business Update
- Positive topline clinical results from the Phase 2b PARADIGM ALS trial
- 37.4% difference in disease progression in ALSFRS-R patients treated with PrimeC
- Positive trends in quality of life and complication-free survival
- Upcoming presentation of data at a medical conference and submission for publication
- Increase in research and development expenses by 18% mainly due to salaries and clinical program expenses
- Decrease in general and administrative expenses by 20% attributed to less share-based compensation and insurance costs
- Cash balance of approximately $2.6 million as of December 31, 2023
- None.
Insights
The financial outcomes presented by NeuroSense Therapeutics indicate a strategic focus on advancing their clinical programs, as evidenced by the 18% increase in research and development expenses. This uptick is mainly due to a rise in staffing and subcontractor costs, which aligns with the company's efforts to accelerate its PrimeC treatment through clinical trials. However, the 44% decrease in share-based compensation suggests a shift in employee incentive structures, possibly to conserve cash or reflect a change in the company's valuation.
From an investor's perspective, the reduction in general and administrative expenses, particularly the 56% decrease in insurance costs, may point to improved risk management or a favorable renegotiation of terms. While the overall operating expenses saw a marginal decrease, the financial health of NeuroSense must be scrutinized in the context of its cash reserves. With $2.6 million in cash as of December 31, 2023, the burn rate and additional funding sources become critical factors for sustaining operations and continuing the development of their ALS treatment.
The reported 37.4% difference in slowing disease progression in the ALSFRS-R scale for patients treated with PrimeC is a significant milestone for NeuroSense and the ALS treatment landscape. This positive data could potentially lead to heightened investor interest and stock valuation, as the market responds to successful clinical trial results. Moreover, the improvements in quality of life and complication-free survival, along with the positive trends in neurofilament light chain levels, could position PrimeC as a promising candidate in a market with limited treatment options.
However, the long-term commercial success of PrimeC will depend on various factors, including the drug's efficacy in larger, more diverse patient populations, its safety profile, pricing strategy and the competitive landscape. Investors should also consider the regulatory pathway ahead and the potential for partnership or acquisition by larger pharmaceutical companies seeking to expand their neurodegenerative disease portfolio.
The ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) is a validated tool used to monitor the progression of ALS symptoms. The 37.4% difference observed in the Phase 2b PARADIGM trial suggests that PrimeC may offer a clinically meaningful benefit to patients. The neurofilament light chain (NfL) is a biomarker for neuronal damage and positive trends in its levels could indicate a neuroprotective effect of the drug. These results could be pivotal in defining the therapeutic's potential and may influence future research and development strategies.
It's important to note that while these results are promising, the next steps will likely involve larger Phase 3 trials to confirm efficacy and safety. The data's reception at upcoming medical conferences and its subsequent publication in a peer-reviewed journal will be critical to gaining the scientific community's endorsement, which is essential for regulatory approval and market adoption.
Corporate Highlights from Q4 and To Date
- Topline clinical results from the Phase 2b PARADIGM ALS trial demonstrated a statistically significant,
37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) analysis - Subsequent analyses of quality of life and complication-free survival demonstrated positive results as well as positive trends of key biomarker outcome of neurofilament light chain (NfL) levels, in patients participating in NeuroSense's Phase 2b PARADIGM study
- These data will be presented at an upcoming medical conference and submitted for publication in a peer-reviewed journal
"During the fourth quarter, we reported significant clinical results from our Phase 2b ALS study, followed by further encouraging results on additional pre-specified clinical parameters relating to quality of life and complication-free survival. This is perhaps one of the most significant outcomes seen to date. We are thankful for the study participants, their families and caregivers, principal investigators, study coordinators, and our supportive scientific advisory board and ALS community," stated NeuroSense's CEO, Alon Ben-Noon.
Financial Results
Research and development expenses for the years ended December 31, 2023 and 2022 were
General and administrative expenses for the years ended December 31, 2023 and 2022 were
Operating expenses for the years ended December 31, 2023 and 2022 were
As of December 31, 2023, 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, 2023 has been filed with the
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 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 the 6-month double blind portion of PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b ALS (NCT05357950) clinical trial, which met its safety and tolerability endpoints, also showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. 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.
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 PrimeC as a potential treatment for people with ALS and the timing for release of additional results from PARADIGM clinical trial. 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, a delay in patient enrollment in the planned Phase 3 pivotal ALS trial of PrimeC; 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 the company; the ability to regain compliance with Nasdaq's continued listing standards; 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 the Company is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 3, 2024. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.
NeuroSense Therapeutics Ltd. | |||||||||
As of December 31, | |||||||||
2023 | 2022 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalent | $ | 2,640 | $ | 3,543 | |||||
Short term deposits | - | 3,547 | |||||||
Other receivables | 236 | 255 | |||||||
Restricted deposits | 40 | 36 | |||||||
Total current assets | 2,916 | 7,381 | |||||||
Non-current assets: | |||||||||
Property, plant and equipment, net | 85 | 77 | |||||||
Right of use assets | 153 | 229 | |||||||
Restricted deposit | 22 | 23 | |||||||
Total non-current assets | 260 | 329 | |||||||
Total assets | $ | 3,176 | $ | 7,710 | |||||
Liabilities shareholders' and equity | |||||||||
Current liabilities: | |||||||||
Trade payables | $ | 1,459 | $ | 498 | |||||
Other payables | 2,000 | 1,228 | |||||||
Total current liabilities | 3,459 | 1,726 | |||||||
Non Current liabilities: | |||||||||
Long term lease liability | 73 | 147 | |||||||
Liability in respect of warrants | 1,518 | 218 | |||||||
1,591 | 365 | ||||||||
Total liabilities | 5,050 | 2,091 | |||||||
Shareholders' equity: | |||||||||
Ordinary shares | — | — | |||||||
Share premium and capital reserve | 30,192 | 26,405 | |||||||
Accumulated deficit | (32,066) | (20,786) | |||||||
Total shareholders' equity (deficit) | (1,874) | 5,619 | |||||||
Total liabilities and shareholders' equity | $ | 3,176 | $ | 7,710 | |||||
NeuroSense Therapeutics Ltd. | |||||||||||||
For the year ended | |||||||||||||
2023 | 2022 | 2021 | |||||||||||
Research and development expenses | $ | (7,588) | $ | (6,416) | $ | (3,082) | |||||||
General and administrative expenses | (5,714) | (7,136) | (2,505) | ||||||||||
Operating loss | (13,302) | (13,552) | (5,587) | ||||||||||
Financing expenses | (2,209) | (45) | (1,186) | ||||||||||
Financing income | 4,231 | 1,257 | 2,732 | ||||||||||
Total financing income, net | 2,022 | 1,212 | 1,546 | ||||||||||
Net loss and comprehensive loss | $ | (11,280) | $ | (12,340) | $ | (4,041) | |||||||
Basic and diluted net loss per share | $ | (0.83) | $ | (1.07) | $ | (0.65) | |||||||
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SOURCE NeuroSense
FAQ
What were the key clinical results from NeuroSense's Phase 2b PARADIGM ALS trial?
What were the financial results for NeuroSense for the years ended December 31, 2023, and 2022?
How much cash did NeuroSense have as of December 31, 2023?
