Full Press Release Details
NeuroSense Provides Business Update and Third Quarter 2024 Financial Results
CAMBRIDGE, Mass., Dec. 18, 2024 /PRNewswire/ -- NeuroSense
Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments
for severe neurodegenerative diseases, today provided business update with corporate highlights to date and third quarter financial
"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 Canada, with
an anticipated potential launch in 2026, bringing us closer to delivering a much-needed solution to the ALS community," stated Alon
Ben-Noon, CEO of NeuroSense.
Upcoming Corporate Highlights for H1 2025 include:
Secured $5 Million Private Placement
In December 2024, NeuroSense announced a $5 million private placement
at premium to market price. The Company entered into a definitive agreement with a single investor and with NeuroSense's Chief Executive
Officer, Mr. Alon Ben-Noon, to purchase an aggregate of $5,000,000 of ordinary shares (or ordinary share equivalents) and
warrants in a private placement. The transaction closed in December 2024.
Phase 2b Results Presented at the 2024 ALS/MND & ALS ONE Research
At the 2024 International Symposium on ALS/MND on December 6-8,
2024, in Montreal, Canada, Prof. Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital, Director of the Sean M. Healey
& AMG Center for ALS, and the Julieanne Dorn Professor of Neurology at Harvard Medical School, presented the compelling results of
the 18-month Phase 2b PARADIGM read-out. "The data strongly support the advancement of PrimeC to a Phase 3 trial," stated Prof.
Cudkowicz, following her presentation. In addition, Prof. Cudkowicz and Dr. Shiran Zimri, NeuroSense's VP of R&D, presented the results
from PARADIGM at the 7th Annual ALS ONE Research Symposium on November 14th, 2024.
Positive FDA Feedback on Future Phase 3 study
In November 2024, the Company concluded a Type C meeting with the U.S.
Food and Drug Administration (FDA) for PrimeC in the treatment of ALS. The Company received positive feedback on the design of a proposed
Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application.
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 33% (p=0.007), demonstrated
in a 58% improvement in survival rates. The 18-month results indicate the potential for PrimeC to deliver disease-modifying
effects, with earlier treatment initiation possibly leading to more favorable outcomes.
Plans to File for Early Commercialization in Canada
The Company estimates that the potential market opportunity in
Canada is between $100M to $150M in peak annual revenue. As such, NeuroSense has initiated the regulatory process
to seek early commercialization approval for PrimeC under Health Canada. The Company expects to submit a dossier in Q2 2025, with a regulatory
decision expected by Q1 2026.
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, Italy.
Key U.S. Patent Granted for Novel Formulation
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
Encouraging Biomarker Data from the Phase 2b PARADIGM
Study Underscores Drug's Target Engagement
In collaboration with Professor Noam Shomron, a world-leading
scientist in the field of genetics from Tel Aviv University, PrimeC demonstrated beneficial regulation of key miRNAs, supporting the therapeutic
potential to engage critical genetic targets involved in ALS progression. The two-fold reduction of several microRNAs (miRNAs) following
PrimeC treatment is particularly striking, offering both a powerful biomarker for tracking ALS and a potential pathway for new therapeutic
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:
As of September 30, 2024, NeuroSense had cash of $0.34 million, which
does not include gross proceeds of $5 million from the financing completed in December 2024. As of the date of this report, the Company
believes it has shareholders' equity above the $2.5 million required by Nasdaq's Listing Rule 5550(b) requiring a minimum stockholders'
equity of $2.5 million ("Equity Rule"). Therefore, the Company believes it has regained compliance with the Equity Rule and
awaits Nasdaq's confirmation that the Company has evidenced compliance with the Equity Rule and that the matter has been closed.
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
U.S. dollars in thousands except share and per share data
| 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
U.S. dollars in thousands except share and per share data
| 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'
U.S. dollars in thousands
| Ordinary shares | Share premium and capital reserve | Accumulated deficit | 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 | ) |
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 U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24%
by 2040 in the U.S. and EU.
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 Canada,
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.
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