Full Press Release Details
Announces Year End 2023 Financial Results and Provides Business Update
Mass., April 5, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company
developing novel treatments for severe neurodegenerative diseases, today reported its financial results for the year ended
December 31, 2023 and provides a business update.
Highlights from Q4 and To Date
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
of December 31, 2023, NeuroSense had cash of approximately $2.6 million.
summary of NeuroSense's consolidated financial results is included in the tables below.
copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and
Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://neurosense.investorroom.com/.
The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of
charge, to its shareholders upon request at info@neurosense-tx.com.
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 U.S. alone, with an annual disease burden of $1 billion. The
number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.
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, as well
as showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. PrimeC was granted
Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
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.
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.
further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183
Consolidated Statements of Financial Position
(U.S. dollars in thousands)
| 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 |
Consolidated Statements of Income and Comprehensive Loss
(U.S. dollars in thousands, except share and per share data)
| For the year ended December 31 | ||||||||||||
| 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 | ) |