NeuroSense Provides Business Update and Third Quarter 2024 Financial Results
Rhea-AI Summary
NeuroSense Therapeutics (Nasdaq: NRSN) reported Q3 2024 financial results and provided business updates. Key highlights include completion of their 18-month Phase 2b PARADIGM study for PrimeC in ALS treatment, showing 33% slower disease progression and 58% improved survival rates. The company secured a $5 million private placement in December 2024 and received positive FDA feedback for their planned Phase 3 study.
Financial results show R&D expenses decreased 14% to $4.61 million for the nine months ended September 30, 2024. The company had $0.34 million in cash as of September 30, 2024, not including the December financing. NeuroSense plans early commercialization in Canada with potential market opportunity of $100M-$150M in peak annual revenue, targeting a 2026 launch.
Positive
- Phase 2b PARADIGM study showed 33% slower disease progression and 58% improved survival rates
- Secured $5 million private placement financing
- Received positive FDA feedback for Phase 3 study design
- R&D expenses decreased by 14% to $4.61 million
- Potential Canadian market opportunity of $100M-$150M in peak annual revenue
- Key U.S. patent granted extending protection until 2042
Negative
- Cash position decreased to $0.34 million as of September 30, 2024
- Net loss of $8.409 million for nine months ended September 30, 2024
- Negative shareholders' equity of $2.818 million
News Market Reaction 1 Alert
On the day this news was published, NRSN gained 4.59%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
"The completion of the 18-month Phase 2b PARADIGM study was a major milestone for NeuroSense. The results highlight PrimeC's potential impact on slowing disease progression and survival benefits in people living with ALS. Furthermore, the positive feedback from a Type C meeting with the FDA on the pivotal study design has the Company on track to commence a Phase 3 study in mid-2025. In parallel, the Company is taking steps toward early commercialization in
Upcoming Corporate Highlights for H1 2025 include:
- Additional results from the 18-month Phase 2b PARADIGM study
- Meeting with EMEA
- Dossier Submission to Health Canada
- Phase 3 study commencement
Secured
In December 2024, NeuroSense announced a
Phase 2b Results Presented at the 2024 ALS/MND & ALS ONE Research Symposiums
At the 2024 International Symposium on ALS/MND on December 6-8, 2024, in Montreal,
Positive FDA Feedback on Future Phase 3 study
In November 2024, the Company concluded a Type C meeting with the
Study Completion Concludes PrimeC's Disease-modifying Potential
In October 2024, NeuroSense completed PARADIGM (NCT05357950), a multinational, randomized, double-blind, placebo-controlled, 18-month Phase 2b clinical trial of PrimeC in ALS. In participants who received PrimeC compared to those who were initially on placebo before transitioning to PrimeC, disease progression was slowed by
Plans to File for Early Commercialization in
The Company estimates that the potential market opportunity in
Participation in 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Consortium Meeting
NeuroSense presented two abstracts highlighting the groundbreaking data from the Phase 2b PARADIGM study at the NEALS Consortium meeting on October 21-24, 2024. Clinical outcomes were delivered by renowned clinician Prof. Cudkowicz. Biomarker analysis was presented by Dr. Cristian Lunetta, a leading neurologist and ALS specialist from the NeuroMuscular Omnicentre (NEMO) in Milan,
Key
In September 2024, a pivotal patent was granted by the United States Patent and Trademark Office (USPTO), entitled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), relating to the novel formulation of PrimeC. This patent is expected to extend PrimeC's protection by an additional four years, with coverage until 2042.
Encouraging Biomarker Data from the Phase 2b PARADIGM Study Underscores Drug's Target Engagement
- PrimeC Significantly Improves Key miRNAs
In collaboration with Professor Noam Shomron, a world-leading scientist in the field of genetics from
- PrimeC Regulates Iron Metabolism
Data from the 12-month read-out of the PARADIGM study confirmed our hypothesis that positive changes in iron metabolism are aligned with improved clinical outcomes. Patients on PrimeC demonstrated a significant decrease in ferritin levels and an increase in transferrin levels, corresponding to slowing of disease progression. This new analysis highlights PrimeC's ability to regulate the iron in people living with ALS, underscoring the drug's target engagement.
Q3 2024 Financial Results:
- Research and development expenses for the nine months ended September 30, 2024 and 2023 were
$4.61 and$5.39 million , respectively. Research and development expenses decreased by 0.78 million, or14% , primarily due to a decrease in expenses to subcontractors and consultants as well as share-based compensation expenses. NeuroSense expects research and development expenses to remain steady through the remainder of 2024 as a result of the conclusion activities of the Phase 2b ALS clinical study and the ongoing of the Phase 2 AD study. - General and administrative expenses for the nine months ended September 30, 2024 and 2023 were
$3.52 and$3.62 million , respectively. General and administrative expenses remained at the same level primarily due to a decrease in salaries and social benefits, share-based compensation and insurance expenses, which were fully offset by an increase in professional services. NeuroSense expects general and administrative expenses to remain steady through the remainder of 2024. - Operating expenses for the nine months ended September 30, 2024 and 2023 were
$8.1 and$9 million
As of September 30, 2024, NeuroSense had cash of
A summary of NeuroSense's unaudited consolidated financial results is included in the tables below.
Ben-Noon concluded, "The most recent capital raise has strengthened our near-term financial position and supports the continuation of our clinical development plan. We are making steady progress toward partnering opportunities that will enable the pivotal Phase 3 study and advance efforts to bring PrimeC to the Canadian market. With significant milestones achieved this quarter, the coming months hold great potential for the Company to reach a key inflection point and move into the next phase of development."
NeuroSense Therapeutics Ltd. | ||||||||
Condensed Interim Balance Sheets | ||||||||
September 30, | December 31, | |||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalent | 344 | 2,640 | ||||||
Other receivables | 406 | 236 | ||||||
Restricted deposit | 35 | 40 | ||||||
Total current assets | 785 | 2,916 | ||||||
Non-current assets: | ||||||||
Property, plant and equipment, net | 72 | 85 | ||||||
Operating right of use assets | 104 | 162 | ||||||
Restricted deposit | 23 | 22 | ||||||
Total non-current assets | 199 | 269 | ||||||
Total assets | 984 | 3,185 | ||||||
Liabilities and Equity | ||||||||
Current liabilities: | ||||||||
Trade payables | 1,392 | 1,459 | ||||||
Other payables | 2,391 | 2,000 | ||||||
Total current liabilities | 3,783 | 3,459 | ||||||
Non Current liabilities: | ||||||||
Operating long term lease liability | 19 | 73 | ||||||
Liability in respect of warrants | - | 1,412 | ||||||
19 | 1,485 | |||||||
Total liabilities | 3,802 | 4,944 | ||||||
Shareholders' equity: | ||||||||
Authorized: 60,000,000 shares at September 30, 2024 and December 31, 2023; Issued and outstanding: 19,808,909 and 15,379,042 shares at September 30, 2024 and December 31, 2023, respectively | - | - | ||||||
Share premium and capital reserve | 31,712 | 24,362 | ||||||
Accumulated deficit | (34,530) | (26,121) | ||||||
Total Shareholders' equity (deficit) | (2,818) | (1,759) | ||||||
Total liabilities and shareholders' equity (deficit) | 984 | 3,185 | ||||||
NeuroSense Therapeutics Ltd. | ||||||||||||
Condensed Interim Statements of Operations and Comprehensive Loss | ||||||||||||
Nine months | Nine months | For the year | ||||||||||
ended | ended | ended | ||||||||||
September 30, | September 30, | December 31, | ||||||||||
2024 | 2023 | 2023 | ||||||||||
Unaudited | ||||||||||||
Research and development expenses | (4,612) | (5,368) | (7,274) | |||||||||
General and administrative expenses | (3,519) | (3,619) | (4,775) | |||||||||
Operating loss | (8,131) | (8,987) | (12,049) | |||||||||
Financing income (expenses), net | (278) | 2,067 | 1,942 | |||||||||
Net loss and comprehensive loss | (8,409) | (6,920) | (10,107) | |||||||||
Basic and diluted net loss per share | (0.48) | (0.55) | (0.74) | |||||||||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 17,585,582 | 12,464,189 | 13,640,168 | |||||||||
NeuroSense Therapeutics Ltd. | ||||||||||||||||
Condensed Interim Unaudited Statements of Changes in Shareholders' Equity | ||||||||||||||||
Ordinary shares | Share | Accumulated | Total equity | |||||||||||||
Number | Amount | |||||||||||||||
Balance as of January 1, 2024 | 15,379,042 | $ - | $ | 24,362 | $ | (26,121) | $ | (1,759) | ||||||||
Issuance of shares and pre-funded warrants, net | 2,532,000 | - | 4,794 | - | 4,794 | |||||||||||
Exercise of pre-funded warrants, options and vested RSUs | 1,507,000 | - | - | - | - | |||||||||||
Issuance of shares following ATM | 319,903 | 230 | - | 230 | ||||||||||||
Reclassification of warrants into equity (Note 3) | - | - | 1,695 | - | 1,695 | |||||||||||
Share-based compensation | 70,964 | - | 631 | - | 631) | |||||||||||
Net loss and comprehensive loss | - | - | - | (8,409) | (8,409) | |||||||||||
Balance as of September 30, 2024 | 19,808,909 | $ - | $ | 31,712 | $ | (34,530) | $ | (2,818) | ||||||||
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 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
During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation.
Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.
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 the timing of submission of regulatory submissions to the FDA or other regulatory authorites, the timing of commencement of enrollment for clinical trials, if any, the market opportunity in
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SOURCE NeuroSense
FAQ
What were the key results from NRSN's Phase 2b PARADIGM trial for PrimeC?
How much funding did NRSN secure in their December 2024 private placement?
What is NRSN's timeline for PrimeC commercialization in Canada?
What is the estimated market opportunity for NRSN's PrimeC in Canada?
When does NRSN plan to begin their Phase 3 trial for PrimeC?
