Full Press Release Details
NeuroSense Announces First Quarter 2022 Financial
Results and Provides Business Update
CAMBRIDGE, Mass., May 31, 2022 /PRNewswire/
-- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative
diseases, today reported its financial results for the quarter ended March 31, 2022 and provided a business update.
Initiated Biomarker Studies for ALS and Alzheimer's
Throughout Q1 2022, NeuroSense has been working vigorously
to meet key drug development milestones. As an integral part of its clinical program, NeuroSense is pioneering the identification and
use of novel disease related biomarkers in neurodegenerative diseases. During Q1 2022, the 3rd stage of the Company's
amyotrophic lateral sclerosis (ALS) biomarker study was initiated in collaboration with Massachusetts General Hospital (MGH) in Boston,
and a new study on Alzheimer's disease (AD) biomarkers also commenced. Results from both studies are expected in Q2 2022.
Received FDA Clearance of IND for PrimeC in Treatment
NeuroSense continues to advance its regulatory strategy
via the U.S. Food and Drug Administration (FDA). In Q1 2022, the FDA cleared NeuroSense's Investigational New Drug (IND) application to
initiate a pharmacokinetic (PK) study of PrimeC, its lead combination drug candidate developed for the treatment of ALS. In addition,
a Fast Track application was submitted to the FDA and not granted at this time. The Company is planning to resubmit the application upon
further generation of data. PrimeC was previously granted Orphan Drug Designation by the FDA and EMA.
Commenced Enrollment and Dosing in U.S. PK Study
In April 2022, NeuroSense enrolled and dosed the
first healthy volunteer in its PK study (NCT05232461) of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-period
crossover study is evaluating the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered
ciprofloxacin tablets and celecoxib capsules in 12 healthy adult subjects in the U.S. under an FDA cleared IND protocol. Data are expected
in Q3 2022. The combined data from both this PK study and the Company's upcoming Phase IIb ALS study will assist in designing a pivotal
Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements.
On Track to Initiate Phase IIb PrimeC Study for
In Q2 2022, NeuroSense expects to commence its double
blind, placebo controlled, multicenter Phase IIb clinical trial using a unique upgraded formulation of PrimeC which maximizes the synergistic
effect between the compounds in its combination drug. The clinical trial endpoints include assessment of ALS-biomarkers, evaluation
of clinical efficacy, and improvement in quality of life to demonstrate an attenuation in disease progression. Elucidation of the mechanism
of action of PrimeC utilizing statistically significant biomarker data from the upcoming Phase IIb trial may enable patient stratification
and increased likelihood of success in a pivotal trial.
Patents Granted for PrimeC in Australia and Canada
NeuroSense continues to bolster its intellectual
property estate, with patents granted for PrimeC, during Q1 2022 in Australia and Canada. The same patent, titled "Compositions comprising
an anti-inflammatory drug and DICER activator for treatment of neuronal diseases" was previously granted in the U.S.
Collaborations & Strategic Partnerships
In expanding its business development objectives,
NeuroSense is discussing potential partnerships with pharmaceutical companies devoted to rare and central nervous system diseases. NeuroSense
is currently establishing new scientific collaborations, as well as strengthening existing connections.
"The upcoming initiation of our Phase IIb ALS
study is a major milestone for NeuroSense. We move forward in a strong financial position, poised to execute our clinical development
plans for the benefit of patients and shareholders. With our current cash position, we expect to complete preclinical studies for Alzheimer's
and Parkinson's diseases and, most importantly complete our ALS Phase IIb study, leading to a potential inflection point in value for
our Company," stated NeuroSense's CEO, Alon Ben-Noon.
As of March 31, 2022, NeuroSense had cash and
short-term deposits in a total amount of $13.74 million, compared to $11.06 million as of December 31, 2021. The increase was due to proceeds
received from the exercise of warrants in the amount of $3.87 million, partly offset by ongoing expenses.
Research and development expenses for the three months
ended March 31, 2022 were $1.29 million, a decrease of $0.73 million, or 36.14%, compared to $2.02 million for the three months ended
March 31, 2021. The decrease is primarily due to the reduction in share-based compensation expenses, offset by an increase in expenses
to subcontractors and consultants as a result of preparations to commence a Phase IIb ALS clinical study in Q2 2022. NeuroSense expects
research and development expenses will continue to increase through 2022 and beyond.
General and administrative expenses for the three
months ended March 31, 2022 were $1.97 million an increase of $1.88 million, or 2,089%, compared to $0.09 million for the three months
ended March 31, 2021. This increase is primarily due to the increase in salaries and professional services, director's and officer's insurance
expenses, and share-based compensation related to the costs of being a public company. NeuroSense expects that general and administrative
expenses will remain at the same level through 2022.
Financing expenses for the three months ended March
31, 2022 were $23,000 an increase of $10,000, or 77%, compared to $13,000 for the three months ended March 31, 2021. The increase was
mainly due to higher exchange rate expenses.
Financing income for the three months ended March
31, 2022 was $0.57 million an increase of $0.57 million, compared to $0 for the three months ended March 31, 2021. The increase
in financing income was mainly due to the devaluation of the Company's liability with respect to warrants which were issued at the end
of 2021 as part of NeuroSense's initial public offering.
Net loss for the three months ended March 31, 2022
was $2.71 million an increase of $0.59 million, compared with a net loss of $2.12 million for the three months ended March 31, 2021. The
increase was primarily due to an increase in general and administrative expenses, partly offset by a decrease in research and development
expenses and an increase in financing income.
A summary of Company's unaudited financial results
is included in the tables below.
| Condensed Interim Unaudited Statements of Financial Position | ||||||||
| U.S. dollars in thousands | ||||||||
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | 8,735 | 11,063 | ||||||
| Short term deposits | 5,004 | - | ||||||
| Other receivables | 225 | 310 | ||||||
| Restricted deposits | 64 | 39 | ||||||
| Total current assets | 14,028 | 11,412 | ||||||
| Non-current assets: | ||||||||
| Right of use assets | 287 | - | ||||||
| Property, plant and equipment, net | 42 | 19 | ||||||
| Total non-current assets | 329 | 19 | ||||||
| Total assets | 14,357 | 11,431 | ||||||
| Liabilities and Equity Current liabilities: | ||||||||
| Trade payables | 180 | 39 | ||||||
| Other payables | 1,048 | 558 | ||||||
| Total current liabilities | 1,228 | 597 | ||||||
| Non-current liabilities: | ||||||||
| Long term lease liability | 207 | - | ||||||
| Liability in respect of warrants | 816 | 1,828 | ||||||
| 1,023 | 1,828 | |||||||
| Total liabilities | 2,251 | 2,425 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares | - | - | ||||||
| Share premium and capital reserve | 23,267 | 17,452 | ||||||
| Accumulated deficit | (11,161 | ) | (8,446 | ) | ||||
| Total Shareholders' equity | 12,106 | 9,006 | ||||||
| Total liabilities and shareholders' equity | 14,357 | 11,431 |
| Condensed Interim Unaudited Statements of Income and Comprehensive Loss | ||||||||||||||||
| U.S. dollars in thousands except share and per share data | ||||||||||||||||
| Three months ended | Three months ended | For the year ended | ||||||||||||||
| March 31, | March 31, | December 31, | ||||||||||||||
| Note | 2022 | 2021 | 2021 | |||||||||||||
| Research and development expenses | 5 | (1,296 | ) | (2,019 | ) | (3,082 | ) | |||||||||
| General and administrative expenses | 6 | (1,968 | ) | (92 | ) | (2,505 | ) | |||||||||
| Operating loss | (3,264 | ) | (2,111 | ) | (5,587 | ) | ||||||||||
| Financing expenses | (23 | ) | (13 | ) | (1,186 | ) | ||||||||||
| Financing income | 572 | - | 2,732 | |||||||||||||
| Financing income (expenses), net | 549 | (13 | ) | 1,546 | ||||||||||||
| Net loss and comprehensive loss | (2,715 | ) | (2,124 | ) | (4,041 | ) | ||||||||||
| Basic and diluted net loss per share | (0.24 | ) | (0.38 | ) | (0.65 | ) | ||||||||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 10,994,264 | 5,582,922 | 6,243,411 |
| Condensed Interim Unaudited Statements of Changes in Equity | ||||||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
| Ordinary Shares | Share Premium And Capital Reserve | Accumulated deficit | Total Equity | |||||||||||||
| Three months ended March 31, 2022: | ||||||||||||||||
| Balance as of January 1, 2022 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
| Share-based compensation | - | 1,597 | - | 1,597 | ||||||||||||
| Net loss and comprehensive loss | - | - | (2,715 | ) | (2,715 | ) | ||||||||||
| Cancelation of options | - | (96 | ) | - | (96 | ) | ||||||||||
| Exercise of warrants | - | 4,314 | - | 4,314 | ||||||||||||
| Balance as of March 31, 2022 | - | 23,267 | (11,161 | ) | 12,106 | |||||||||||
| Three months ended March 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Share-based compensation | - | 1,975 | - | 1,975 | ||||||||||||
| Net loss and comprehensive loss | - | - | (2,124 | ) | (2,124 | ) | ||||||||||
| Issuance of SAFE instrument | - | 100 | - | 100 | ||||||||||||
| Balance as of March 31, 2021 | - | 7,139 | (6,529 | ) | 610 | |||||||||||
| For the year ended December 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Issuance of SAFE instrument | - | 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 |
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
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 patent applications; the company's PrimeC development program; the potential
for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials;
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. 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