NRSN NeuroSense Therapeutics Ltd

Exhibit 99.1

 

NeuroSense Announces Second Quarter 2023 Financial Results and Provides Business Update

 

●

ALS Phase 2b PARADIGM Trial Completed Patient Enrollment

●

Topline results expected in Q-4 2023

●

Cash runway beyond topline clinical study readouts, into Q-2 2024

 

CAMBRIDGE, Mass., Aug. 16, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today published its financial results for the quarter ended June 30, 2023 and provided a business update.

 

 

 

“Throughout this quarter NeuroSense achieved multiple milestones, including the completion of patient enrollment of our Phase 2b ALS study. Results observed from several biomarker studies are promising, especially in that they support our clinical strategy. The findings, along with the data we collect from our Phase 2b study, could inform the optimization of a pivotal Phase 3 study of PrimeC in ALS,” stated NeuroSense’s CEO, Alon Ben-Noon. “We are well positioned to complete our Phase 2b study and report topline results in Q-4 2023.”

 

Business Update

 

Capital Raise of $4.5 Million

 

In Q-2 2023, NeuroSense raised $4.5 million in capital and based on our current expense projections is now funded into Q-2 2024, well beyond the expected timing for the release of topline results from the PARADIGM study.

 

Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed Patient Enrollment

 

In Q-2 2023, NeuroSense completed enrollment of its double-blind, placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, which is designed to maximize 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 data from the upcoming Phase 2b trial may enable patient stratification and increase the likelihood of success in a pivotal trial. Topline results are expected in Q-4 2023. Significantly, over 96% of participants who completed the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension.

 

Strategic Scientific Agreement with Biogen

 

In May 2023, NeuroSense announced a collaboration agreement with Biogen to evaluate the impact of PrimeC on neurofilament levels in the plasma of participants in NeuroSense’s Phase 2b ALS PARADIGM trial. Biogen will fund this meaningful neurofilament biomarker study and upon receipt of results has the right of first refusal to co-develop and/or commercialize PrimeC for the treatment of ALS for a limited time.

 

 

Phase 2 Alzheimer’s Disease (AD) Trial Under Preparation

 

In Q-1 2023, NeuroSense published data from a biomarker study, which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls. NeuroSense believes these results support the therapeutic potential of its combination drug platform for AD. NeuroSense is preparing to commence a Phase 2 double-blind proof-of-concept clinical study, with regulatory submissions and site readiness ongoing during Q-2 2023 and first patient enrolled expected in the next few weeks.

 

Parkinson’s Disease (PD) Biomarker Study Completed

 

In Q-2 2023, NeuroSense published data from a biomarker study in Parkinson’s disease, which observed a statistically significant decrease in levels of AGO2, a novel PD biomarker, in newly diagnosed PD patients when compared to the healthy control group. The Company is exploring potential co-development for the PD indication.

 

Key Industry Conferences

 

In addition, NeuroSense joined EverythingALS in the EverythingALS Digital Biomarkers Summit in July 2023.

 

Financial Summary 

 

Six Months Ended June 30, 2023

 

●

Research and development expenses for the six months ended June 30, 2023 increased to $4.0 million compared to $3.17 million for the six months ended June 30, 2022. This increase was primarily attributable to subcontractors and consultants with respect to our Phase 2b clinical study that started in May 2022. NeuroSense expects research and development expenses to remain steady until the end of 2023, and then slightly decrease as a result of completing the double blind stage of the clinical study.

●

General and administrative expenses for the six months ended June 30, 2023 decreased to $3.11 million compared to $3.69 million for the six months ended June 30, 2022. This decrease was primarily attributable to lower share-based compensation and insurance expenses. NeuroSense expects that general and administrative expenses will remain at the same level through 2023.

●

Financing expenses for the six months ended June 30, 2023 and 2022, were $2.2 million and $58,000, respectively. The increase of $2.14 million, or 3,686%, was mainly attributed to liability with respect to warrants and prefunded warrants.

●

Financing income for the six months ended June 30, 2023 and 2022 were $200,000 and $716,000, respectively. The decrease of $516,000, or 72%, was mainly attributed to change in rate differentials and warrants.

●

Operating expenses for the six months ended June 30, 2023 were $7.12 million compared to $6.85 million for the six months ended June 30, 2022 due to the reasons described above.

 

As of June 30, 2023, NeuroSense had cash and short-term deposits of $7.1 million. NeuroSense reported a $1.55 million deficit in shareholder equity as of June 30, 2023, resulting from the required accounting treatment under IFRS related to the pre-funded warrants and warrants that the Company issued as part of the $4.5 million financing completed on June 26, 2023. A summary of the Company’s unaudited financial results is included in the tables below.

 

 

Condensed Interim Unaudited Statements of Financial Position
U.S. dollars in thousands

 

		June 30, 2023				December 31, 2022
Assets
Current assets:
Cash			7,089				3,543
Short term deposits			-				3,547
Other receivables			434				255
Restricted deposit			38				36
Total current assets			7,561				7,381
Non-current assets:
Property, plant and equipment, net			93				77
Right of use assets			191				229
Non-current restricted deposit			23				23
Total non-current assets			307				329
Total assets			7,868				7,710
Liabilities and Equity
Current liabilities:
Trade payables			1,090				498
Other payables			1,915				1,228
Total current liabilities			3,005				1,726
Non Current liabilities:
Long term lease liability			104				147
Liability in respect of warrants and pre-funded warrants			6,304				218
			6,408				365
Total liabilities			9,413				2,091
Shareholders’ equity:
Ordinary shares			-				-
Share premium and capital reserve			28,355				26,405
Accumulated deficit			(29,900	)			(20,786	)
Total Shareholders’ equity (deficit)			(1,545	)			5,619
Total liabilities and shareholders’ equity (deficit)			7,868				7,710

 

 

Condensed Interim Unaudited Statements of Income and Comprehensive Loss
U.S. dollars in thousands except share and per share data

 

		Six months ended June 30, 2023				Six months ended June 30,  2022				For the year ended December 31, 2022
Research and development expenses			(4,005	)			(3,166	)			(6,416	)
General and administrative expenses			(3,113	)			(3,688	)			(7,136	)
Operating loss			(7,118	)			(6,854	)			(13,552	)
Financing expenses			(2,196	)			(58	)			(45	)
Financing income			200				716				1,257
Financing income (expenses), net			(1,996	)			658				1,212
Net loss and comprehensive loss			(9,114	)			(6,196	)			(12,340	)
Basic and diluted net loss per share			(0.77	)			(0.55	)			(1.07	)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share			13,623,042				11,294,701				11,504,521

 

 

Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands

 

		Ordinary Shares				Share Premium And Capital  Reserve				Accumulated Deficit				Total Equity (Deficit)
Six months ended June 30, 2023:
Balance as at January 1, 2023			-				26,405				(20,786	)			5,619
Share-based compensation			-				1,945				-				1,945
Exercise of options			-				5				-				5
Net loss and comprehensive loss			-				-				(9,114	)			(9,114	)
Balance as at June 30, 2023			-				28,355				(29,900	)			(1,545	)
Six months ended June 30, 2022:
Balance as at January 1, 2022			-				17,452				(8,446	)			9,006
Share-based compensation			-				2,808				-				2,808
Net loss and comprehensive loss			-				-				(6,196	)			(6,196	)
Cancelation of options							(96	)			-				(96	)
Exercise of warrants			-				4,314				-				4,314
Balance as at June 30, 2022			-				24,478				(14,642	)			9,836
For the year ended December 31, 2022:
Balance as at January 1, 2022			-				17,452				(8,446	)			9,006
Share-based compensation			-				4,735				-				4,735
Net loss and comprehensive loss			-				-				(12,340	)			(12,340	)
Cancelation of options			-				(96	)			-				(96	)
Exercise of warrants			-				4,314				-				4,314
Balance as at December 31, 2022			-				26,405				(20,786	)			5,619

 

 

Condensed Interim Unaudited Statements of Cash Flows 
U.S. dollars in thousands

 

		Six months ended June 30, 2023				Six months ended June 30, 2022				For the year ended December 31, 2022
Cash flows from operating activities
Net loss for the period			(9,114	)			(6,196	)			(12,340	)
Adjustments:
Depreciation and Amortization			47				41				89
Share-based compensation			1,784				2,808				5,105
Revaluation of liability in respect to warrants and pre-funded warrants			(73	)			(693	)			(1,166	)
Loss from financial instruments issuance as of the date of issuance			1,659
Finance expenses (income), net			365				65				(24	)
Changes in assets and liabilities:
Decrease (increase) in other receivables			(179	)			(397	)			55
Increase in trade payables			592				81				459
Increase in other payables			841				5				236
Net cash used in operating activities			(4,078	)			(4,286	)			(7,586	)
Cash flows from investing activities
Interest received			47				-				49
Change in short term deposit			3,500				(6,000	)			(3,500	)
Investment in restricted deposit			(2	)			(19	)			(20	)
Purchase of property, plant and equipment			(25	)			(30	)			(70	)
Net cash provided by (used in) investing activities			3,520				(6,049	)			(3,541	)
Cash flows from financing activities
Payment in respect of cancellation of options			-				(96	)			(96	)
Exercise of warrants and options			5				3,870				3,870
Issuance of shares, warrants and pre-funded warrants, net			4,142				-				-
Repayment of lease liability			(44	)			(67	)			(79	)
Net cash provided by financing activities			4,103				3,707				3,695
Effects of exchange rate changes on cash and cash equivalents			1				(86	)			(88	)
Net increase (decrease) in cash and cash equivalents			3,546				(6,714	)			(7,520	)
Cash and cash equivalents at beginning of the period			3,543				11,063				11,063
Cash and cash equivalents at end of the period			7,089				4,349				3,543

 

 

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 and Twitter.

 

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 top-line results of, and the results of, the PARADIGM clinical trial, cash runway estimate and the timing of patient enrollment in our Alzheimer’s Disease (AD) clinical trial. Further, forward-looking statements are subject to a number of risks and uncertainties as a result of which actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include a delay in the reporting of top-line results from PARADIGM clinical trial and a delay in patient enrollment in our AZ clinical trial; greater than anticipated costs and expenses; 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; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC), including NeuroSense’s Annual Report on Form 20-F filed with the SEC on March 22, 2023. 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.

 

Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

 

For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183

 

 

7

 

Exhibit 99.3

 

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

 

You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board. Unless otherwise indicated or the context otherwise requires, all references herein to the terms “NeuroSense,” “NeuroSense Therapeutics,” the “Company,” “we,” “us” and “our” refer to NeuroSense Therapeutics Ltd. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar” or “$” refer to U.S. dollars, the lawful currency of the United States. Unless derived from our financial statements or otherwise indicated, U.S. dollar translations of NIS amounts presented in this exhibit are translated using the rate of NIS 3.7 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2023.

 

Forward Looking Statements

 

This exhibit contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Many of the forward-looking statements contained in this exhibit can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and other similar expressions that are predictions of or indicate future events and future trends, although not all forward-looking statements contain these identifying words.

 

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to substantial risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors, including, but not limited to, those identified under the section titled “Risk Factors” in our Annual Report on Form 20-F, filed with the SEC on March 22, 2023 (the “20-F”), and our other filings with the SEC from time to time. These risks and uncertainties include factors relating to:

 

	●	the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals;
	●	our limited operating history and history of incurring significant losses and negative cash flows since our inception, which we anticipate will continue for the foreseeable future;

 

●

our dependence on the success of our lead product candidate, PrimeC, including our obtaining of regulatory approval to market PrimeC in the United States;

 

●

our limited experience in conducting clinical trials and reliance on clinical research organizations and others to conduct them;

 

●

our ability to advance our preclinical product candidates into clinical development and through regulatory approval and commercialization;

 

 

●

the results of our clinical trials, which may fail to adequately demonstrate the safety and efficacy of our product candidates;

 

●

our ability to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success;

 

●

our reliance on third parties in marketing, producing or distributing products and research materials for certain raw materials, compounds and components necessary to produce PrimeC for clinical trials and to support commercial scale production of PrimeC, if approved;

 

●

our receipt of regulatory clarity and approvals for our therapeutic candidates and the timing of other regulatory filings and approvals;

 

●

estimates of our expenses, revenues, capital requirements and our needs for additional financing;

 

●

our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our product candidates and technologies; and

 

●

the impact of the public health, political and security situation in Israel, the U.S. and other countries in which we may obtain approvals for our products or our business.

 

The preceding list is not intended to be an exhaustive list of all of our risks and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this exhibit will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of the 6-K that accompanies this exhibit, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.

 

The forward-looking statements and opinions contained in this exhibit are based upon information available to us as of the date of the 6-K that accompanies this exhibit and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The forward-looking statements contained in this exhibit speak only as of the date of the 6-K that accompanies this exhibit, and unless otherwise required by law, we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

 

You should read this exhibit, and the documents that we reference herein, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

 

 

Overview

 

We are a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease (AD), and Parkinson’s disease (PD). We believe that these diseases represent some of the most significant unmet medical needs of our time, with limited effective therapeutic options available. The burden of these diseases on both patients and society is substantial. For example, the average annual cost of ALS alone is $180,000 per patient, and its estimated annual burden on the U.S. healthcare system is greater than $1 billion. Due to the complexity of neurodegenerative diseases, our strategy is to utilize a combined therapeutic approach to target multiple disease-related pathways.

 

Our lead therapeutic candidate, PrimeC, is a novel extended-release oral formulation, fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib. PrimeC is designed to treat ALS by modulating microRNA, synthesis, iron accumulation and neuroinflammation, all of which are hallmarks of ALS pathologies. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have granted PrimeC orphan drug designation for the treatment of ALS. We believe PrimeC’s multifactorial mechanism of action has the potential to significantly prolong lifespan and improve ALS patients’ quality of life, thereby reducing the burden of this debilitating disease on both patients and healthcare systems.

 

In addition to PrimeC, we have conducted research and development efforts in Alzheimer’s disease and Parkinson’s disease, with a similar strategy of combined products.

 

We have incurred operating losses in each year since our inception. We incurred net losses of $9.11 million and $6.2 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of $29.9 million. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates from formulation development through preclinical development and clinical trials, seek regulatory approval and pursue commercialization of any approved product candidate. In addition, we expect that our expenses will increase substantially in connection with our ongoing activities as we:

 

●

continue the clinical development of PrimeC;

 

●

continue the preclinical development of our other product candidates;

 

●

file an NDA seeking regulatory approval for any product candidates;

 

●

establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we obtain manufacturing approval;

 

●

maintain, expand and protect our intellectual property portfolio;

 

●

add equipment and physical infrastructure to support our research and development;

 

●

hire additional clinical development, quality control and manufacturing personnel;

 

●

incur additional expenses associated with operating as a U.S. public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company; and

 

●

add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization.

 

 

Operating Results

 

Revenue

 

We have not recognized any revenue to date and we do not expect to generate revenue from the sale of products in the near future.

 

Operating Expenses

 

Our current operating expenses consist primarily of research and development as well as general and administrative expenses.

 

Research and Development Expenses

 

Research and development expenses consist primarily of:

 

●

salaries for research and development staff and related expenses, including employee benefits and share-based compensation expenses;

 

●

expenses for production of our product candidates by contract manufacturers;

 

●

expenses paid to contract research organizations and other third parties in connection with the performance of preclinical studies, clinical trials and related expenses;

 

●

expenses incurred under agreements with other third parties, including subcontractors, suppliers and consultants that conduct formulation development, regulatory activities and preclinical studies;

 

●

expenses incurred to acquire, develop and manufacture preclinical study and clinical trial materials.

 

Expenses on research activities is recognized in profit or loss when incurred. Development expenditures, including patent registration costs, are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and we intend to and have sufficient resources to complete development and to use or sell the asset. As of June 30, 2023, no development expenditures have met the recognition criteria and thus we have expensed all of our development expenditures as incurred.

 

We are currently focused on advancing our product candidates, and our future research and development expenses will depend on their clinical success. Research and development expenses will continue to be significant and will increase over at least the next several years as we continue to develop our product candidates and conduct preclinical studies and clinical trials of our product candidates.

 

 

We do not believe that it is possible at this time to accurately project total expenses required for us to reach commercialization of our product candidates. Due to the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with certainty the costs we will incur and the timelines that will be required in the continued development and approval of our product candidates. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. See “Risk Factors—Risks Related to Our Business and Strategy” in the 20-F. In addition, we cannot forecast which product candidates may be subject to future collaborations, if and when such arrangements will be entered into, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of personnel costs, including share-based compensation, related to directors, executive, finance, and human resource functions, insurance costs, facility costs and external professional service costs, including legal, accounting, marketing and audit services and other consulting fees.

 

We anticipate that our general and administrative expenses will increase in the future as we increase our administrative headcount and infrastructure to support our continued research and development programs and the potential approval and commercialization of our product candidates. We also anticipate that we will incur increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance premiums, director compensation, and other costs associated with being a public company.

 

In addition, if any of our product candidates receives regulatory approval and if we determine to invest in building a commercial infrastructure to support the marketing of our products, we expect to incur greater expenses.

 

Financing income (Expenses), net

 

Our net financing expenses (income), net consist primarily of fair value revaluation of warrants and prefunded warrants, issuance costs, interest income on deposits, interest expenses on lease liability and differences in the exchange rate between NIS and the U.S. Dollar.

 

Income Taxes

 

We have yet to generate taxable income in Israel, as we have historically incurred operating losses resulting in carry forward tax losses totaling approximately $13 million as of June 30, 2023. We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.

 

 

Results of Operations

 

Our results of operations for the six months ended June 30, 2023 and 2022 were as follows:

 

		For the Six Months Ended June 30,
(U.S. dollars in thousands except share and per share data)		2023				2022
Statement of Operations:
Research and Development Expenses			(4,005	)			(3,166	)
General and Administrative Expenses			(3,113	)			(3,688	)
Operating Loss			(7,118	)			(6,854	)
Financing Expenses			(2,196	)			(58	)
Financing Income			200				716
Net Loss and Comprehensive Loss			(9,114	)			(6,196	)
Basic and Diluted Net Loss per Share			(0.77	)			(0.55	)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share			13,623,042				11,294,701

 

Research and Development Expenses

 

The following table describes the breakdown of our research and development expenses for the indicated periods:

 

		For the Six Months Ended June 30,
(U.S. dollars in thousands except share and per share data)		2023				2022
Subcontractors and consultants		$	2,385				1,782
Share-based compensation			1,008				855
Salaries and social benefits			612				529
Others			-				-
Total research and development expenses		$	4,005				3,166

 

Our research and development expenses for the six months ended June 30, 2023 and 2022 were $4,005 thousand and $3,166 thousand, respectively. The increase of $839 thousand, or 27%, was mainly attributed to subcontractors and consultants with respect to our phase 2b clinical study that started in May 2022.

 

 

General and Administrative Expenses

 

The following table describes the breakdown of our general and administrative expenses for the indicated periods:

 

		For the Six Months Ended June 30,
		2023				2022
		U.S. dollars in thousands
Professional services		$	529				457
Share-based compensation			1,271				1,953
Salaries and social benefits			700				406
Insurance			266				645
Traveling abroad			98				56
Others			249				171
		$	3,113				3,688

 

Our general and administrative expenses for the six months ended June 30, 2023 and 2022 were $3,113 thousand and $3,688 thousand, respectively. The decrease of $575 thousand, or 15.6%, was mainly attributed to lower share-based compensation and insurance expenses.

 

Financing Expenses

 

Our financing expenses for the six months ended June 30, 2023 and 2022, were $2,196 thousand and $58 thousand, respectively. The increase of $2,138 thousand, or 3,686%, was mainly attributed to liability in respect of warrants and prefunded warrants.

 

Financing Income

 

Our financing income for the six months ended June 30, 2023 and 2022 was $200 thousand and $716 thousand, respectively. The decrease of $516 thousand, or 72%, was mainly attributed to change in rate differentials and warrants.

 

 

Liquidity and Capital Resources

 

Overview

 

Since our inception, we have incurred losses and negative cash flows from our operations. For the six months ended June 30, 2023, we incurred a net loss of $9.1 million while net cash of $4.1 million was used in our operating activities. As of June 30, 2023, we had working capital of $4.56 million, and an accumulated deficit of $29.9 million. As of June 30, 2023, our cash totaled approximately $7.1 million. Our financial statements have been prepared on a going concern basis under which an entity is considered to be able to realize its assets and satisfy its liabilities in the ordinary course of business, and our financial status creates a doubt whether we will continue as a going concern. Our future operations are dependent upon the identification and successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future. There can be no assurances that we will be successful in completing an equity or debt financing or in achieving or maintaining profitability. The financial statements do not give effect to any adjustments relating to the carrying values and classification of assets and liabilities that would be necessary should we be unable to continue as a going concern.

 

Through June 30, 2023, we have financed our operations primarily through our initial public offering, private placements, crowd funding and a registered direct offering of equity securities. In May, June and July of 2021, we received $0.80 million from SAFE agreements; in September 2021, we received an additional $1.23 million from previous investors as a result of their exercise of outstanding warrants; in December 2021, we received gross proceeds of approximately $12.0 million from our initial public offering; during 2022, we received approximately $3.87 million as a result of exercise of outstanding warrants; and in June 2023 we received additional gross proceeds of approximately $4.5 million before deducting placement agent fee and related offering expenses million from a registered direct offering.

 

Cash flows

 

The following table summarizes our statement of cash flows for the six months ended June 30, 2023 and 2022:

 

		For the Six Months Ended June 30,
(U.S. dollars in thousands except share and per share data)		2023				2022
Net cash used in operating activities and exchange rates		$	(4,077	)			(4,372	)
Net cash used in investing activities			3,520				(6,049	)
Net cash provided by financing activities			4,103				3,707
(Decrease) increase in cash and cash equivalents		$	3,546				(6,714	)

 

Net cash used in operating activities

 

Net cash used in operating activities (including $1 thousand from the effect of exchange rate changes on cash and cash equivalents) was $4,077 thousand and $4,372 thousand for the six months ended June 30, 2023 and 2022, respectively. The decrease of $295 thousand was mainly attributed to a decrease in operational expenditures during the period.

 

 

Net cash used in investing activities

 

Net cash used in investing activities was $3,520 thousand and $(6,049( thousand for the six months ended June 30, 2023 and 2022, respectively. The increase of $9,569 thousand was mainly attributed to the Change in short term deposit.

 

Net cash provided by financing activities

 

Net cash provided by financing activities was $4,103 thousand and $3,707 thousand for the six months ended June 30, 2023 and 2022, respectively. The increase of $396 thousand was mainly attributed to increase in Issuance of shares, warrants and prefunded warrants, net which was partially offset by decrease in Exercise of warrants and options.

 

Funding Requirements

 

Since our inception, almost all of our resources have been dedicated to the preclinical and clinical development of our lead product candidate, PrimeC. As of June 30, 2023, we had cash of $7.1 million. We believe that our existing cash as of June 30, 2023 will be sufficient to fund our operations into the second quarter of 2024.

 

Our present and future funding requirements will depend on many factors, including, among other things:

 

●

the progress, timing and completion of clinical trials for PrimeC;

 

●

preclinical studies and clinical trials for our other product candidates;

 

●

the costs related to obtaining regulatory approval for PrimeC and any of our other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of these product candidates;

 

●

selling, marketing and patent-related activities undertaken in connection with the commercialization of PrimeC and any of our other product candidates, and costs involved in the development of an effective sales and marketing organization;

 

●

the costs involved in filing and prosecuting patent applications and obtaining, maintaining and enforcing patents or defending against claims or infringements raised by third parties, and license royalties or other amounts we may be required to pay to obtain rights to third party intellectual property rights;

 

●

potential new product candidates we identify and attempt to develop; and

 

●

revenues we may derive either directly or in the form of royalty payments from future sales of PrimeC and any other product candidates.

 

For more information as to the risks associated with our future funding needs, see “Risk Factors — We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations” in the 20-F.

 

Off-Balance Sheet Arrangements

 

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Research and Development, Patents and Licenses, Etc.

 

For a description of our research and development programs and the amounts that we have incurred pursuant to those programs, please see above, “Operating and Financial Review and Prospects — Operating Results — Research and Development Expenses.”

 

Trend Information.

 

Other than as disclosed elsewhere in this exhibit and the accompanying 6-K, we are not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2023 to June 30, 2023 that are reasonably likely to have a material adverse effect on our revenue, income, profitability, liquidity or capital resources, or that caused that disclosed financial information to be not necessarily indicative of future operating results or financial condition.

 

 

 

v3.23.2

Document And Entity Information	6 Months Ended
	Jun. 30, 2023
Document Information Line Items
Entity Registrant Name	NeuroSense Therapeutics Ltd.
Document Type	6-K
Current Fiscal Year End Date	--12-31
Amendment Flag	false
Entity Central Index Key	0001875091
Document Period End Date	Jun. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Entity File Number	001-41084

v3.23.2

Condensed Interim Unaudited Statements of Financial Position - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash	$ 7,089	$ 3,543
Short term deposits		3,547
Other receivables	434	255
Restricted deposit	38	36
Total current assets	7,561	7,381
Non-current assets:
Property, plant and equipment, net	93	77
Right of use assets	191	229
Non-current restricted deposit	23	23
Total non-current assets	307	329
Total assets	7,868	7,710
Current liabilities:
Trade payables	1,090	498
Other payables	1,915	1,228
Total current liabilities	3,005	1,726
Non Current liabilities:
Long term lease liability	104	147
Liability in respect of warrants and pre-funded warrants	6,304	218
Total non current liabilities	6,408	365
Total liabilities	9,413	2,091
Shareholders’ equity:
Ordinary shares
Share premium and capital reserve	28,355	26,405
Accumulated deficit	(29,900)	(20,786)
Total Shareholders’ equity (deficit)	(1,545)	5,619
Total liabilities and shareholders’ equity (deficit)	$ 7,868	$ 7,710

v3.23.2

Condensed Interim Unaudited Statements of Income and Comprehensive Loss - USD ($) $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Profit or loss [abstract]
Research and development expenses	$ (4,005)	$ (3,166)	$ (6,416)
General and administrative expenses	(3,113)	(3,688)	(7,136)
Operating loss	(7,118)	(6,854)	(13,552)
Financing expenses	(2,196)	(58)	(45)
Financing income	200	716	1,257
Financing income (expenses), net	(1,996)	658	1,212
Net loss and comprehensive loss	$ (9,114)	$ (6,196)	$ (12,340)
Basic and diluted net loss per share (in Dollars per share)	$ (0.77)	$ (0.55)	$ (1.07)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share (in Shares)	13,623,042	11,294,701	11,504,521

v3.23.2

Condensed Interim Unaudited Statements of Income and Comprehensive Loss (Parentheticals) - $ / shares	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Profit or loss [abstract]
Diluted net loss per share	$ (0.77)	$ (0.55)	$ (1.07)
Weighted average number of shares outstanding used in computing diluted net loss per share	13,623,042	11,294,701	11,504,521

v3.23.2

Condensed Interim Unaudited Statements of Changes in Equity - USD ($) $ in Thousands	Ordinary Shares	Share Premium and Capital Reserve	Accumulated Deficit	Total
Balance at Dec. 31, 2021		$ 17,452	$ (8,446)	$ 9,006
Share-based compensation		2,808		2,808
Net loss and comprehensive loss			(6,196)	(6,196)
Cancelation of options		(96)		(96)
Exercise of warrants		4,314		4,314
Balance at Jun. 30, 2022		24,478	(14,642)	9,836
Balance at Dec. 31, 2021		17,452	(8,446)	9,006
Share-based compensation		4,735		4,735
Net loss and comprehensive loss			(12,340)	(12,340)
Cancelation of options		(96)		(96)
Exercise of warrants		4,314		4,314
Balance at Dec. 31, 2022		26,405	(20,786)	5,619
Share-based compensation		1,945		1,945
Exercise of options		5		5
Net loss and comprehensive loss			(9,114)	(9,114)
Balance at Jun. 30, 2023		$ 28,355	$ (29,900)	$ (1,545)

v3.23.2

Condensed Interim Unaudited Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Cash flows from operating activities
Net loss for the period	$ (9,114)	$ (6,196)	$ (12,340)
Adjustments:
Depreciation and Amortization	47	41	89
Share-based compensation	1,784	2,808	5,105
Revaluation of liability in respect to warrants and pre-funded warrants	(73)	(693)	(1,166)
Day 1 loss from issuance of financial instruments	1,659
Finance expenses (income), net	365	65	(24)
Changes in assets and liabilities:
Decrease (increase) in other receivables	(179)	(397)	55
Increase in trade payables	592	81	459
Increase in other payables	841	5	236
Net cash used in operating activities	(4,078)	(4,286)	(7,586)
Cash flows from investing activities
Interest received	47		49
Change in short term deposit	3,500	(6,000)	(3,500)
Investment in restricted deposit	(2)	(19)	(20)
Purchase of property, plant and equipment	(25)	(30)	(70)
Net cash provided by (used in) investing activities	3,520	(6,049)	(3,541)
Cash flows from financing activities
Payment in respect of cancellation of options		(96)	(96)
Exercise of warrants and options	5	3,870	3,870
Issuance of shares, warrants and pre-funded warrants, net	4,142
Repayment of lease liability	(44)	(67)	(79)
Net cash provided by financing activities	4,103	3,707	3,695
Effects of exchange rate changes on cash and cash equivalents	1	(86)	(88)
Net increase (decrease) in cash and cash equivalents	3,546	(6,714)	(7,520)
Cash and cash equivalents at beginning of the period	3,543	11,063	11,063
Cash and cash equivalents at end of the period	7,089	4,349	3,543
Non-cash activity
Exercise of warrants		444	444
Recognition of right of use assets		306	306
Share based payment modification	$ 161

v3.23.2

General and Basis for Presentation	6 Months Ended
	Jun. 30, 2023
General and Basis for Presentation [Abstract]
General and Basis for Presentation	Note 1 - General and Basis for Presentation   Note 1 — General   A. NeuroSense Therapeutics Ltd. (“NeuroSense” or the “Company”) was incorporated in Israel on February 13, 2017. NeuroSense is a clinical-stage pharmaceutical company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. The Company’s lead product candidate, PrimeC, is a novel oral formulation of a fixed dose combination composed of a specific ratio and doses of two FDA-approved drugs.   In addition to PrimeC, the Company has initiated research and development efforts in Alzheimer’s disease and Parkinson’s disease, with a similar strategy of combined products.   The Company’s ordinary shares and warrants began trading on the Nasdaq Capital Market on December 9, 2021 under the ticker symbols “NRSN” and “NRSNW,” respectively.   B. The Company currently has no products approved for sale, and the Company’s operations have been funded primarily by its shareholders. To date, the Company has generated no sales or revenues, has incurred losses and expects to incur significant additional losses due to the continuing focus on the research, development, clinical activities of its product candidates, preclinical programs, business development, organizational structure and to advance the programs within the Company’s pipeline. Consequently, its operations are subject to all the risks inherent in the establishment of a pre-revenue business enterprise as well as those risks associated with a company engaged in the research and development of pharmaceutical compounds.   Based on current expected level of operating expenditures, the Company’s cash resources as at June 30, 2023 shall not be sufficient to fund the Company’s operations for a period of at least 12 months from the approval of these interim consolidated financial statements, assuming that the Company will continue its development plan in accordance with the original pipeline and without delaying or slowing down the progress of its plans. The Company will require additional cash to fund the execution of its mid-term and long-term development program. The Company anticipates raising additional funds through public or private sales of debt or equity securities, collaborative arrangements, or some combination thereof. Whilst management is progressing with its plans to secure external financing, these still require approval by third parties, and accordingly, there is no assurance that any such arrangement will be entered into or that financing will be available when needed in order to allow it to continue its operations, or if available, on terms favorable or acceptable to it.   In the event financing is not obtained, the Company may pursue cost cutting measures or may be required to delay, reduce the scope of, or eliminate any of its development programs or clinical trials, these events could have a material adverse effect on its business. These factors raise significant doubt about the Company ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

v3.23.2

Basis of Preparation	6 Months Ended
	Jun. 30, 2023
Basis of Preparation [Abstract]
Basis of Preparation	Note 2 — Basis of Preparation   A. Statement of compliance   These condensed interim financial statements have been prepared in accordance with International Accounting Standards (“IAS”) 34 “Interim Financial Reporting”. The condensed interim financial statements do not include all of the information required for full annual financial statements and should be read in conjunction with the Company’s financial statements for the year ended December 31, 2022 (“annual financial statements”).   These condensed interim financial statements were authorized for issuance by the Company’s Board of Directors on August 15, 2023.   B. Use of estimates and judgments   The preparation of interim financial statements in accordance to IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expense. Actual results may differ from these estimates.   In preparing these condensed consolidated interim financial statements, the significant judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those that applied to the annual financial statements except for the described below:   Fair value measurement of liability in respect of Warrants   Warrants that provide the holders with an option for cashless exercise are considered a derivative liability and are classified as financial liabilities at fair value through profit or loss. Accordingly, these warrants are measured at fair value and the changes in fair value in each reporting period are recognized in profit or loss.. The fair values of these instruments are determined by using the Black-Scholes model.   For information on details regarding fair value measurement at Level 2 see Note 4.

v3.23.2

Significant Accounting Policies	6 Months Ended
	Jun. 30, 2023
Significant Accounting Policies [Abstract]
Significant Accounting Policies	Note 3 — Significant Accounting Policies   The accounting policies applied by the Company in these condensed interim financial statements are the same as those applied by the Company in its annual financial statements.

v3.23.2

Financial instruments	6 Months Ended
	Jun. 30, 2023
Financial instruments [Abstract]
Financial instruments	Note 4 — Financial instruments   On June 22, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company agreed to issue and sell, in a registered direct offering: (i) an aggregate of 1,330,000 ordinary shares, no par value, and (ii) an aggregate of 1,670,000 Pre-Funded warrants, each representing the right to acquire one ordinary share with exercise price of $0.0001, exercisable at any time until exercised in full and (iii) an aggregate of 3,000,000 Warrants. The Warrants are exercisable immediately upon issuance at an exercise price of $1.50 per Ordinary Share and will expire on the fifth anniversary of the original issuance date. The gross proceeds were approximately $4.5 million before deducting the placement agent fee and related offering expenses. Total issuance expenses in connection with the offering were $455 thousands.   In certain cases, the Warrants and Pre-Funded warrants above may be exercised on a cashless basis. Therefore, the Pre-Funded Warrants accounted for as financial liability and the Warrants are accounted for as derivative instruments and accordingly also classified as a liability. Both liabilities are measured at fair value through profit or loss. In accordance with IFRS 9, the consideration received from the issuance of different financial instruments in a single transaction is attributed initially to financial liabilities that are measured at each period at fair value through profit or loss, and then to financial liabilities that are measured only upon initial recognition at fair value and the remaining amount is recognized as equity component. At the closing, the fair value of the Warrants and Pre-Funded warrants was greater that the gross proceeds received. Therefore, the Company recognized an immediate loss of $1,659 thousand and the entire consideration of $4,500 thousand was allocated to the Warrants and Pre- Funded warrant liability and no consideration has been allocated to equity component. As a result, applicable issuance costs have been recorded as an expense under financing expenses.   The table below presents an analysis of the fair value of the liability in respect to the warrants and prefunded warrants as of June 30, 2023:   Description   Fair value     Level 1     Level 2     Level 3                             Liability in respect of Pre-Funded Warrants (*)   $ 2,488     $ 2,488            -     $          -   Liability in respect of Warrants (**)   $ 3,495       -     $ 3,495     $ -   Liability in respect of Warrants (***)   $ 321     $ 321       -     $ -     (*) The fair value of the Pre-Funded Warrant was determined by using the Company’s share price.   (**) The fair value of the Warrants was determined by using Black & Sholes method. The following inputs were used to determine the fair value of the Warrant:       June 30, 2023   Financial liabilities:       Expected volatility (%)     104.97   Share price (in $)     1.49   Risk-free interest rate (%)     4.17   Expected life (years)     4.98     (***) The fair value of the liability in respect Warrants under level 1 was determined by using the those Warrants price in market.

v3.23.2

Shareholders’ Equity	6 Months Ended
	Jun. 30, 2023
Shareholders’ Equity [Abstract]
Shareholders’ Equity	Note 5 — Shareholders’ Equity   Share capital      1. On April 14, 2023, the Company entered into a sales agreement with Alliance Global Partners, pursuant to which the Company may offer and sell, from time to time, to or through the Alliance Global Partners as agent or principal, ordinary shares an at-the-market offering, having an aggregate offering price of up to $5,744 thousands. On June 22, 2023, the Company filed a prospectus supplement reflecting a reduction in the size of the at-the-market offering to $502 thousands. During the reporting period, the Company sold 3,600 ordinary shares for a gross proceed of $7 thousands through the at-the-market offering. Issuance expenses were equal to the proceeds received.   2. On June 23, 2023, one of the Company’s employees exercised 126,000 options into 126,000 ordinary shares for a total consideration of $5 thousands.   The following table summarizes the movement in share capital:       Ordinary shares       Six months ended June 30, 2023           Issued and paid-in share capital as at January 1     11,781,963   ATM     3,600   RSU vesting     381,479   Exercise of options to shares     126,000   Fund raising     1,330,000   Total     13,623,042

v3.23.2

Share Based Payment	6 Months Ended
	Jun. 30, 2023
Share Based Payment [Abstract]
Share Based Payment	Note 6 — Share Based Payment   On March 20, 2023, the Company’s board of directors, approved the following awards:   ● Grant of 132,040 RSUs to certain officers, in lieu of cash with respect to the 2022 bonus plan grants in the amount of $161 thousand (as described in Note 14(C) to the Company’s 2022 annual financial statement). The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones.   ● A bonus for certain employees in the form of 100,000 and 60,000 RSU’s. The RSUs vest on a quarterly basis over one year following the grant and on an annual basis over three years following the grant, respectively.   ● In addition to the grants in accordance with the 2022 bonus plan mentioned above, additional amount of 137,844 RSUs were granted to one officer. The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones.   ● In addition to the grants in accordance with the 2022 bonus plan mentioned above, a grant of additional amount 50,594 RSUs to one officer. The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones.   ● In addition to the grants in accordance with the 2022 bonus plan mentioned above, a raise of additional 30% of the annual 2022 bonus will be granted to the Company’s CEO.   ● The grant of 13,628 Options to a consultant of the Company in in a total fair value of $22,500. The options have an exercise price of $1.82 per share. The options will vest monthly, over 9 months commencing January 1, 2023. The options expire 10 years after their grant date.   On May 30, 2023, the Company granted 160,000 RSUs to directors of the Company. The RSUs have an exercise price of $1.53 per share. The RSUs shall vest entirely on the first anniversary of the Vesting Commencement Date, provided that no Termination of Employment of the Grantee occurs prior to such anniversary.   The following table lists the inputs used for calculation of fair value of the options granted to consultants as follows:       Six months       ended       June 30,       2023           Expected volatility     100.37%-99.19%   Exercise price     1.82-2.18   Share price     1.49   Risk-free interest rate     3.95%-3.94%   Dividend yield     0   Expected life (years)     9.07-9.72     The share-based expense recognized in the statements of income were as follows:       Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Share-based compensation expense – Research and development     562       855       1,592   Share-based compensation expense – General and administrative     1,222       1,953       3,513                                   1,784       2,808       5,105

v3.23.2

Research and Development Expenses	6 Months Ended
	Jun. 30, 2023
Research and Development Expenses [Abstract]
Research and development expenses	Note 7 — Research and development expenses.       Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Subcontractors and consultants     2,385       1,782       3,612   Share-based compensation     1,008       855       1,592   Salaries and social benefits     612       529       1,212                                   4,005       3,166       6,416

v3.23.2

General and Administrative Expenses	6 Months Ended
	Jun. 30, 2023
General and Administrative Expenses [Abstract]
General and administrative expenses	Note 8 — General and administrative expenses.       Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Professional services     529       457       1,085   Share-based compensation     1,271       1,953       3,513   Salaries and social benefits     700       406       837   Insurance     266       645       1,174   Traveling abroad     98       56       165   Others     249       171       362                                   3,113       3,688       7,136

v3.23.2

Financing Income (Expenses), Net	6 Months Ended
	Jun. 30, 2023
Financing Income (Expenses), Net [Abstract]
Financing income (expenses), net	Note 9 — Financing income (expenses), net       Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Fair value revaluation of warrants and pre-funded warrants     73       693       1,166   Day 1 loss from issuance of financial instruments     (1,659 )     -       -   Bank management fees and commissions     91       23       90   Exchange rate differences     36       (50 )     (29 ) Interest on lease liabilities     (6 )     (8 )     (15 ) Issuance expenses     (531 )     -       -         (1,996 )     658       1,212

v3.23.2

Subsequent Events	6 Months Ended
	Jun. 30, 2023
Subsequent Events [Abstract]
Subsequent events	Note 10 — Subsequent events   On August 15, 2023 the Company’s board of directors approved (i) the grant of aggregate amount of 60,000 options to several employees. The options have an exercise price of $0.96 per share and vest quarterly over 3 years starting August 15, 2023, and (ii) the grant of 9,000 options to an employee. The options have an exercise price of $0.96 per share and vest annually over 3 years starting August 15, 2023

v3.23.2

Financial instruments (Tables)	6 Months Ended
	Jun. 30, 2023
Financial instruments [Abstract]
Schedule of Fair Value Liability Warrants and Prefunded Warrants	The table below presents an analysis of the fair value of the liability in respect to the warrants and prefunded warrants as of June 30, 2023: Description   Fair value     Level 1     Level 2     Level 3                             Liability in respect of Pre-Funded Warrants (*)   $ 2,488     $ 2,488            -     $          -   Liability in respect of Warrants (**)   $ 3,495       -     $ 3,495     $ -   Liability in respect of Warrants (***)   $ 321     $ 321       -     $ -   (*) The fair value of the Pre-Funded Warrant was determined by using the Company’s share price. (**) The fair value of the Warrants was determined by using Black & Sholes method. The following inputs were used to determine the fair value of the Warrant: (***) The fair value of the liability in respect Warrants under level 1 was determined by using the those Warrants price in market.
Schedule of Financial Liabilities	June 30, 2023   Financial liabilities:       Expected volatility (%)     104.97   Share price (in $)     1.49   Risk-free interest rate (%)     4.17   Expected life (years)     4.98

v3.23.2

Shareholders’ Equity (Tables)	6 Months Ended
	Jun. 30, 2023
Shareholders’ Equity [Abstract]
Schedule of Summarizes the Movement in Share Capital	The following table summarizes the movement in share capital:     Ordinary shares       Six months ended June 30, 2023           Issued and paid-in share capital as at January 1     11,781,963   ATM     3,600   RSU vesting     381,479   Exercise of options to shares     126,000   Fund raising     1,330,000   Total     13,623,042

v3.23.2

Share Based Payment (Tables)	6 Months Ended
	Jun. 30, 2023
Share Based Payment [Abstract]
Schedule of Fair Value of the Options Granted	The following table lists the inputs used for calculation of fair value of the options granted to consultants as follows:     Six months       ended       June 30,       2023           Expected volatility     100.37%-99.19%   Exercise price     1.82-2.18   Share price     1.49   Risk-free interest rate     3.95%-3.94%   Dividend yield     0   Expected life (years)     9.07-9.72
Schedule of Share-Based Expense Recognized in the Statements of Income	The share-based expense recognized in the statements of income were as follows:     Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Share-based compensation expense – Research and development     562       855       1,592   Share-based compensation expense – General and administrative     1,222       1,953       3,513                                   1,784       2,808       5,105

v3.23.2

Research and Development Expenses (Tables)	6 Months Ended
	Jun. 30, 2023
Research and Development Expenses [Abstract]
Schedule of research and development expenses	Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Subcontractors and consultants     2,385       1,782       3,612   Share-based compensation     1,008       855       1,592   Salaries and social benefits     612       529       1,212                                   4,005       3,166       6,416

v3.23.2

General and Administrative Expenses (Tables)	6 Months Ended
	Jun. 30, 2023
General and Administrative Expenses [Abstract]
Schedule of General and Administrative Expenses	General and administrative expenses     Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Professional services     529       457       1,085   Share-based compensation     1,271       1,953       3,513   Salaries and social benefits     700       406       837   Insurance     266       645       1,174   Traveling abroad     98       56       165   Others     249       171       362                                   3,113       3,688       7,136

v3.23.2

Financing Income (Expenses), Net (Tables)	6 Months Ended
	Jun. 30, 2023
Financing Income (Expenses), Net [Abstract]
Schedule of Financing Income (Expenses), Net	Financing income (expenses), net     Six months     Six months     For the year       ended     ended     ended       June 30,     June 30,     December 31,       2023     2022     2022                       Fair value revaluation of warrants and pre-funded warrants     73       693       1,166   Day 1 loss from issuance of financial instruments     (1,659 )     -       -   Bank management fees and commissions     91       23       90   Exchange rate differences     36       (50 )     (29 ) Interest on lease liabilities     (6 )     (8 )     (15 ) Issuance expenses     (531 )     -       -         (1,996 )     658       1,212

v3.23.2

Financial instruments (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	6 Months Ended
	Jun. 22, 2023	Jun. 30, 2023
Financial instruments [Abstract]
Ordinary shares, no par value (in Shares)	1,330,000
Pre-Funded warrants (in Shares)	1,670,000
Exercise price (in Dollars per share)	$ 0.0001
Warrants (in Shares)	3,000,000
Issuance at exercise price (in Dollars per share)	$ 1.5
Gross proceeds	$ 4,500
Issuance expense	$ 455
Immediate loss		$ 1,659
Pre- funded warrant liability		$ 4,500

v3.23.2

Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants	Jun. 30, 2023 USD ($)
Fair value [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Pre-Funded Warrants	$ 2,488	[1]
Liability in respect of Warrants	321	[2]
Level 1 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Pre-Funded Warrants	2,488	[1]
Liability in respect of Warrants	321	[2]
Level 2 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Pre-Funded Warrants		[1]
Liability in respect of Warrants		[2]
Level 3 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Pre-Funded Warrants		[1]
Liability in respect of Warrants		[2]
Warrants [Member] | Fair value [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Warrants	3,495	[3]
Warrants [Member] | Level 1 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Warrants		[3]
Warrants [Member] | Level 2 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Warrants	3,495	[3]
Warrants [Member] | Level 3 [Member]
Financial instruments (Details) - Schedule of Fair Value Liability Warrants and Prefunded Warrants [Line Items]
Liability in respect of Warrants		[3]
[1] The fair value of the Pre-Funded Warrant was determined by using the Company’s share price. [2] The fair value of the liability in respect Warrants under level 1 was determined by using the those Warrants price in market. [3] The fair value of the Warrants was determined by using Black & Sholes method. The following inputs were used to determine the fair value of the Warrant:

v3.23.2

Financial instruments (Details) - Schedule of Financial Liabilities	6 Months Ended
	Jun. 30, 2023 $ / shares
Financial liabilities:
Expected volatility	104.97%
Share price (in Dollars per share)	$ 1.49
Risk-free interest rate	4.17%
Expected life (years)	4 years 11 months 23 days

v3.23.2

Shareholders’ Equity (Details) - USD ($) $ in Thousands		6 Months Ended
	Jun. 23, 2023	Jun. 30, 2023	Jun. 22, 2023	Apr. 14, 2023
Shareholders’ Equity [Abstract]
Aggregate offering price				$ 5,744
Market offering cost			$ 502
Ordinary shares sold (in Shares)		3,600
Gross proceed		$ 7
Employees exercised (in Shares)	126,000
Ordinary shares (in Shares)	126,000
Consideration value	$ 5

v3.23.2

Shareholders’ Equity (Details) - Schedule of Summarizes the Movement in Share Capital	6 Months Ended
	Jun. 30, 2023 shares
Schedule of Summarizes the Movement in Share Capital [Abstract]
Issued and paid-in share capital as at January 1	11,781,963
ATM	3,600
RSU vesting	381,479
Exercise of options to shares	126,000
Fund raising	1,330,000
Total	13,623,042

v3.23.2

Share Based Payment (Details) - USD ($)	1 Months Ended		3 Months Ended	6 Months Ended
	May 30, 2023	Mar. 20, 2023	Mar. 20, 2023	Jun. 30, 2023
Share Based Payment (Details) [Line Items]
Aggregate cash payment (in Dollars)		$ 161,000
Percentage of grant bonus		30.00%
Number of share grant options		13,628	13,628
Total fair value (in Dollars)		$ 22,500	$ 22,500
Exercise price per share (in Dollars per share)			$ 1.82
Grant date				10 years
Restricted Stock Units [member]
Share Based Payment (Details) [Line Items]
Number of shares options granted	160,000
Employee [Member] | Restricted Stock Units [member]
Share Based Payment (Details) [Line Items]
Number of shares options granted		137,844
Employee bonus		100,000	100,000
Employee One [Member] | Restricted Stock Units [member]
Share Based Payment (Details) [Line Items]
Number of shares options granted		50,594
Employee bonus		60,000	60,000
Options Granted to Employee [member]
Share Based Payment (Details) [Line Items]
Number of shares options granted		132,040
Options Granted to Service Providers [Member]
Share Based Payment (Details) [Line Items]
Exercise price per share (in Dollars per share)	$ 1.53

v3.23.2

Share Based Payment (Details) - Schedule of Fair Value of the Options Granted - Options Granted to Consultants [Member]	6 Months Ended
	Jun. 30, 2023 $ / shares
Share Based Payment (Details) - Schedule of Fair Value of the Options Granted [Line Items]
Share price (in Dollars per share)	$ 1.49
Dividend yield	0.00%
Top of Range [Member]
Share Based Payment (Details) - Schedule of Fair Value of the Options Granted [Line Items]
Expected volatility	100.37%
Exercise price (in Dollars per share)	$ 1.82
Risk-free interest rate	3.95%
Expected life (years)	9 years 25 days
Bottom of Range [Member]
Share Based Payment (Details) - Schedule of Fair Value of the Options Granted [Line Items]
Expected volatility	99.19%
Exercise price (in Dollars per share)	$ 2.18
Risk-free interest rate	3.94%
Expected life (years)	9 years 8 months 19 days

v3.23.2

Share Based Payment (Details) - Schedule of Share-Based Expense Recognized in the Statements of Income - USD ($) $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Share Based Payment (Details) - Schedule of Share-Based Expense Recognized in the Statements of Income [Line Items]
Total share-based compensation expense	$ 1,784	$ 2,808	$ 5,105
Share-based compensation expense [Member]
Share Based Payment (Details) - Schedule of Share-Based Expense Recognized in the Statements of Income [Line Items]
Share-based compensation expense – Research and development	562	855	1,592
Share-based compensation expense – General and administrative	$ 1,222	$ 1,953	$ 3,513

v3.23.2

Research and Development Expenses (Details) - Schedule of Research and Development Expenses - USD ($) $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Schedule of research and development expenses [Abstract]
Subcontractors and consultants	$ 2,385	$ 1,782	$ 3,612
Share-based compensation	1,008	855	1,592
Salaries and social benefits	612	529	1,212
Research and development expenses, total	$ 4,005	$ 3,166	$ 6,416

v3.23.2

General and Administrative Expenses (Details) - Schedule of General and Administrative Expenses - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Dec. 31, 2022	Jun. 30, 2022
Schedule of General and Administrative Expenses [Abstract]
Professional services	$ 529	$ 1,085	$ 457
Share-based compensation	1,271	3,513	1,953
Salaries and social benefits	700	837	406
Insurance	266	1,174	645
Traveling abroad	98	165	56
Others	249	362	171
Total general and administrative expenses	$ 3,113	$ 7,136	$ 3,688

v3.23.2

Financing Income (Expenses), Net (Details) - Schedule of Financing Income (Expenses), Net - USD ($) $ in Thousands	6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Schedule of Financing Income (Expenses), Net [Abstract]
Fair value revaluation of warrants and pre-funded warrants	$ 73	$ 693	$ 1,166
Day 1 loss from issuance of financial instruments	(1,659)
Bank management fees and commissions	91	23	90
Exchange rate differences	36	(50)	(29)
Interest on lease liabilities	(6)	(8)	(15)
Issuance expenses	(531)
Total	$ (1,996)	$ 658	$ 1,212

v3.23.2

Subsequent Events (Details)	Aug. 15, 2023
Subsequent Events [Member]
Subsequent Events (Details) [Line Items]
Description of aggregate grant	(i) the grant of aggregate amount of 60,000 options to several employees. The options have an exercise price of $0.96 per share and vest quarterly over 3 years starting August 15, 2023, and (ii) the grant of 9,000 options to an employee. The options have an exercise price of $0.96 per share and vest annually over 3 years starting August 15, 2023

---