EX-99.3 4 ea183614ex99-3_neurosense.htm OPERATING AND FINANCIAL REVIEW AND PROSPECTS AS OF JUNE 30, 2023

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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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