Full Press Release Details
NeuroSense Announces Third Quarter 2022 Financial
Results and Provides Business Update
Mass., December 1, 2022 -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments
for severe neurodegenerative diseases, today announced its financial results for the quarter ended September 30, 2022 and provided
"During and immediately following the end
of the third quarter, NeuroSense achieved multiple milestones, including FDA acceptance of our IND and approval from the Italian Medicines
Agency allowing us to commence patient enrollment in the U.S. and Europe for our Phase 2b ALS study, which we expect to begin in the coming
weeks. With over $8.4 million in cash and short-term deposits on our balance sheet at the end of Q3, we believe we are well positioned
to complete our Phase 2b study and report topline results during Q3 2023," stated NeuroSense's CEO, Alon Ben-Noon. "In
our multi-dose pharmacokinetic study, which highlighted PrimeC's novel formulation and enhanced PK profile, we observed favorable
synergism between the compounds, we believe further confirming our Phase 2b study design."
NeuroSense achieved several milestones
during Q3 in the clinical development plan for PrimeC, currently being evaluated in PARADIGM, a double-blind, placebo-controlled, multi-center
Phase 2b clinical trial. Over 40% of the patients necessary to complete the trial have been enrolled. Upon the recent announcement
that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) and the approval received
from the Italian Medicines Agency (AIFA), patient enrollment is expected to commence for PARADIGM in the U.S. and Europe in the
In Q3, NeuroSense released results from
a multi-dose pharmacokinetic (PK) study (NCT05436678). The PK open-label, randomized, multi-dose, three-treatment, three-period crossover
study evaluated the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin
tablets and celecoxib capsules in adult subjects in the U.S. under an FDA-cleared IND protocol. Based
on results, we believe the PK profile of PrimeC supports the formulation's extended-release properties, as the concentrations of
the active components have been synchronized, aiming to potentially maximize the synergism between the two compounds.
An article authored by NeuroSense's
scientific team, along with leading ALS researchers, titled "Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy
for ALS," which presented results from NeuroSense's Phase 2a study, was published in the peer-reviewed journal: Amyotrophic
Lateral Sclerosis and Frontotemporal Degeneration.
NeuroSense strengthened existing connections
and explored new scientific collaborations through ALS conferences during and following the end of Q3. NeuroSense's Chief Medical
Officer, Ferenc Tracik, MD, and Head of Scientific Program, Shiran Zimri, PhD, presented on the use of biomarkers in ALS clinical trials
in the TRICALS Consortium 2022 Masterclass, the largest European research initiative to find a cure for ALS, which took place in the Netherlands.
At U.S.-based ALS ONE's 5th Annual ALS
Research Symposium, Dr. Tracik presented NeuroSense's latest clinical updates and findings in his lecture titled: "Shifting the Paradigm-
PrimeC: A Potential Disease-Modifying Treatment for ALS Driven by Novel Biomarkers Measuring Mechanism of Action".
NeuroSense's CEO, Alon Ben-Noon,
participated as a panelist at "New Treatment Paradigm with More MoAs On the Way?" hosted by Cantor Fitzgerald's Neurology
and Psychiatry Conference in San Francisco. Prof. Jeremy Shefner, Chairman of NeuroSense's Scientific Advisory Board, was the Keynote
Speaker for the conference's Neurology section.
On October 13, 2022, NeuroSense had the
honor of leading the Nasdaq Opening Bell Ceremony. That day, the Company hosted the ALS Combination Therapy Summit, which covered topics
including the complexity of CNS indications, novel technologies targeting ALS mechanisms, market potential for an innovative and effective
cure, and combination therapies as frontline solutions. Among the participants and presenters were Dr. Charles Duncan, Cantor's Managing
Director and central nervous system (CNS) expert analyst, Dr. Jeffrey Rosenfeld, Professor of Neurology and Associate Chairman of Neurology
at Loma Linda University School of Medicine, Ms. Indu Navar, CEO and Founder of EverythingALS, a patient-focused non-profit advancing
assistive novel measurement tools for ALS biomarkers, Mr. Alon Ben-Noon, NeuroSense's CEO, Dr. Shiran Zimri, NeuroSense's
Head of the Scientific Program and others.
NeuroSense's VP of Business Development,
Nedira Salzman-Frenkel and VP of Discovery & IP Generator, Dr. Niva Russek-Bloom, participated
in the BIO-Europe Partnering Conference in Lepzing, Germany where 4,650 delegates came together
to explore potential collaboration and partnership opportunities.
At the Northeast Amyotrophic
Lateral Sclerosis Consortium (NEALS) 21st Annual Meeting, Dr. Tracik and Dr. Zimri
each presented posters on PrimeC's clinical development, Phase 2b study design, and biomarker research, developments, and findings.
poster presentation on NeuroSense's current clinical development and research plans was delivered at the Society for Neurosciences'
(SfN) NeuroScience 2022 by Dr. Zimri.
As of September 30, 2022, NeuroSense had cash
and short-term deposits of $8.44 million. Based on NeuroSense's current expected level of operating expenditures, NeuroSense believes
that its cash resources will be sufficient to continue the development of the Company's product into the fourth quarter of 2023.
A summary of the Company's unaudited financial
results is included in the tables below.
Interim Unaudited Statements of Financial Position
U.S. dollars in thousands
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | 4,411 | 11,063 | ||||||
| Short term deposits (*) | 4,033 | - | ||||||
| Other receivables | 425 | 310 | ||||||
| Restricted deposits | 23 | 39 | ||||||
| Total current assets | 8,892 | 11,412 | ||||||
| Non-current assets: | ||||||||
| Right of use assets | 249 | - | ||||||
| Non-current restricted deposit | 34 | - | ||||||
| Property, plant and equipment, net | 55 | 19 | ||||||
| Total non-current assets | 338 | 19 | ||||||
| Total assets | 9,230 | 11,431 | ||||||
| Liabilities and Equity | ||||||||
| Current liabilities: | ||||||||
| Trade payables | 206 | 39 | ||||||
| Other payables | 605 | 558 | ||||||
| Total current liabilities | 811 | 597 | ||||||
| Non Current liabilities: | ||||||||
| Long term lease liability | 173 | - | ||||||
| Liability in respect of warrants | 400 | 1,828 | ||||||
| 573 | 1,828 | |||||||
| Total liabilities | 1,384 | 2,425 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares | - | - | ||||||
| Share premium and capital reserve | 25,482 | 17,452 | ||||||
| Accumulated deficit | (17,636 | ) | (8,446 | ) | ||||
| Total Shareholders' equity | 7,846 | 9,006 | ||||||
| Total liabilities and shareholders' equity | 9,230 | 11,431 |
Interim Unaudited Statements of Income and Comprehensive Loss
U.S. dollars in thousands except share and
| Nine months | Nine months | For the year | ||||||||||
| ended | ended | ended | ||||||||||
| September 30, | September 30, | December 31, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| Research and development expenses | (4,872 | ) | (3,036 | ) | (3,082 | ) | ||||||
| General and administrative expenses | (5,301 | ) | (906 | ) | (2,505 | ) | ||||||
| Operating loss | (10,173 | ) | (3,942 | ) | (5,587 | ) | ||||||
| Financing income | 1,051 | 3 | 2,732 | |||||||||
| Financing expenses | (68 | ) | (1 | ) | (1,186 | ) | ||||||
| Financing income, net | 983 | 2 | 1,546 | |||||||||
| Net loss and comprehensive loss | (9,190 | ) | (3,940 | ) | (4,041 | ) | ||||||
| Basic and diluted net loss per share | (0.80 | ) | (0.69 | ) | (0.65 | ) | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 11,394,085 | 5,716,157 | 6,243,411 |
Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
| Ordinary | Share Premium And Capital | Accumulated | Total | |||||||||||||
| Shares | Reserve | deficit | Equity | |||||||||||||
| Nine months ended September 30, 2022: | ||||||||||||||||
| Balance as of January 1, 2022 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
| Share-based compensation | - | 3,812 | - | 3,812 | ||||||||||||
| Net loss and comprehensive loss | - | - | (9,190 | ) | (9,190 | ) | ||||||||||
| Cancelation of options | - | (96 | ) | - | (96 | ) | ||||||||||
| Exercise of warrants | - | 4,314 | - | 4,314 | ||||||||||||
| Balance as of September 30, 2022 | - | 25,482 | (17,636 | ) | 7,846 | |||||||||||
| Nine months ended September 30, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Share-based compensation | - | 3,161 | - | 3,161 | ||||||||||||
| Net loss and comprehensive loss | - | - | (3,940 | ) | (3,940 | ) | ||||||||||
| Exercise of warrants | - | 844 | - | 844 | ||||||||||||
| Issuance of SAFE instruments | - | 800 | - | 800 | ||||||||||||
| Balance as of September 30, 2021 | - | 9,869 | (8,345 | ) | 1,524 | |||||||||||
| For the year ended December 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Issuance of SAFE instruments | - | 800 | - | 800 | ||||||||||||
| Exercise of warrants and options | - | 1,311 | - | 1,311 | ||||||||||||
| Share-based compensation | - | 4,716 | - | 4,716 | ||||||||||||
| Issuance of ordinary shares, net upon IPO | - | 5,561 | - | 5,561 | ||||||||||||
| Net loss and comprehensive loss | - | - | (4,041 | ) | (4,041 | ) | ||||||||||
| Balance as of December 31, 2021 | - | 17,452 | (8,446 | ) | 9,006 |
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
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 company's PrimeC
and CogniC development programs; the timing of completion of the Company's Phase 2b study and report of topline results; the potential
for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials,
timing for reporting data; cash runway estimates; the nature, strategy and focus of the company and further updates with respect thereto;
and the development and commercial potential of any product candidates of the company. Such risks and uncertainties include the risk that
there will a delay in the timing of completion of the Company's Phase 2b study and the report of topline results, that expenses
for the remainder of 2022 will be higher than expected and other risks and uncertainties set forth in the Company's filings with the Securities
and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 14, 2022. Further, certain
forward-looking statements are based on assumptions as to future events that may not prove to be accurate. 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.
For further information: Email:
info@neurosense-tx.com, Tel: +972 (0)9 799 6183