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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of August 2025

 

Commission File Number: 001-41084

 

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

 

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9- 7996183
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒     Form 40-F ☐

 

 

 

 


 

Explanatory Note

 

Attached are the Company’s press release providing a business update for the first half of 2025, condensed interim unaudited financial statements and a summary of its operating and financial review and prospects, each as of June 30, 2025, furnished herewith as Exhibits 99.1, 99.2 and 99.3, respectively.

 

This Report on Form 6-K (including the three bullet points following “Upcoming Corporate Highlights for H2 2025 include:” in Exhibit 99.1 and Exhibits 99.2 and 99.3) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480) and Form F-3 (File No. 333-269306333-260338333-283656 and 333-284051), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1


 

Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated August 1, 2025
99.2   Condensed Interim Unaudited Financial Statements as of June 30, 2025
99.3   Operating and Financial Review and Prospects as of June 30, 2025
101.INS   Inline XBRL Instance Document
101.SCH   Inline XBRL Taxonomy Extension Schema Document
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF   Inline XBRL Taxonomy Extension Label Linkbase Document
101.LAB   Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.PRE   Inline XBRL Taxonomy Extension Definition Linkbase Document
104   Cover Page Interactive Data File formatted as Inline XBRL and contained in Exhibit 101

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NeuroSense Therapeutics Ltd.
     
Date: August 1, 2025 By: /s/ Alon Ben-Noon
    Alon Ben-Noon
    Chief Executive Officer

 

 

3

 
EX-99.1 2 ea025084301ex99-1_neurosense.htm PRESS RELEASE DATED AUGUST 1, 2025

Exhibit 99.1

 

NeuroSense Provides Business Update and Progress for the First Half of 2025

 

CAMBRIDGE, Mass., August 1, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today provided business update with corporate highlights to date and financial results of the first half of 2025.

 

 

NeuroSense is advancing PrimeC, its investigational combination therapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways while preparing for a pivotal Phase 3 trial.

 

“The first half of 2025 has been transformational for NeuroSense. We regained compliance with Nasdaq’s stockholders’ equity requirement, generated additional long–term data from our Phase 2b ALS, PARADIGM study, and advanced our manufacturing capabilities,” said Alon Ben–Noon, Chief Executive Officer of NeuroSense. “Our team is focused on accelerating the path to a pivotal Phase 3 trial as the next step in potentially bringing a meaningful treatment to people living with ALS as quickly as possible.”

 

Upcoming Corporate Highlights for H2 2025 include:

 

NOC/c Submission in Canada – Following feedback from Health Canada that the Company’s initial request did not fulfill the criteria for advanced consideration under the Notice of Compliance with conditions (NOC/c) policy, and in line with Health Canada’s suggestion, NeuroSense plans to submit a new request supported by additional data, with the goal of securing an NOC/c for PrimeC.

 

Phase 3 trial commencement – Following positive regulatory feedback from the FDA, NeuroSense plans to begin a multinational Phase 3 study of PrimeC in ALS in the second half of 2025.

 

Advancing binding term sheet with a global pharmaceutical partner – Following the execution of a binding term sheet in the fourth quarter of 2024 to advance the development and commercialization of PrimeC, its proprietary treatment drug for ALS in certain key territories, discussions are continuing and may yield a definitive partnership agreement in the near future.

 

 


 

First Half 2025 Corporate Highlights

 

Nasdaq listing compliance restored
In January 2025 NeuroSense received formal notice from Nasdaq that it had regained compliance with the stockholders’ equity requirement after completing a $5 million private placement in December 2024. The financing strengthened the Company’s balance sheet and raised shareholders’ equity above Nasdaq’s minimum requirement.

 

Additional long–term data from the Phase 2b PARADIGM study
In February 2025 NeuroSense reported new analyses from the completed 18–month Phase 2b PARADIGM study in ALS. The new analysis revealed that in the per-protocol population (participants who adhered to the protocol), treatment with PrimeC slowed functional decline by ~40%. Overall survival improved by 74%, complication–free survival improved by 79%, and patients experienced slower decline in slow vital capacity by 26%. These data reinforce the disease–modifying potential of PrimeC and underpin the design of the planned Phase 3 study.

 

Presentation of biomarker and mechanistic data
At the Annual Meeting of the American Academy of Neurology (AAN) in April 2025, members of NeuroSense’s scientific advisory board presented further analyses from the PARADIGM study. Dr. Jeremy Shefner highlighted safety, efficacy and biomarker data showing that PrimeC has disease–modifying potential and may redefine ALS treatment. Dr. Jeffrey Rosenfeld discussed microRNA modulation and iron–related biomarkers as evidence of multi–target engagement. These findings were later expanded upon in a release describing how PrimeC consistently modulated microRNAs associated with ALS, providing mechanistic insight consistent with observed clinical improvements.

 

Manufacturing scale–up to commercial levels
In May 2025 NeuroSense successfully scaled production of PrimeC to a commercial level and selected a global contract development and manufacturing organization (CDMO) to ensure supply chain readiness for potential commercialization. The Company validated the manufacturing process, qualified suppliers, and demonstrated product stability supporting a 36–month shelf–life.

 

H1 2025 Financial Results:

 

Research and development expenses for the six months ended June 30, 2025 and 2024 were $2,503 thousand and $3,733 thousand, respectively. The decrease of $1,230 thousand, or 32.9%, was mainly attributed to the decrease in clinical activity.

 

General and administrative expenses for the six months ended June 30, 2025 and 2024 were $2,189 thousand and $2,291 thousand, respectively. The decrease of $102 thousand, or 4.4%, is considered immaterial.

 

Operating expenses for the six months ended June 30, 2025 and 2024 were $4.7 million and $6 million, respectively due to the reasons described above.

 

2


 

A summary of NeuroSense’s unaudited consolidated financial results is included in the tables below.

 

NeuroSense Therapeutics Ltd.

 

Condensed Interim Unaudited balance sheets

 

U.S. dollars in thousands

 

    June 30,     December 31,  
    2025     2024  
Assets            
Current assets:            
Cash and cash equivalent     666       3,378  
Other receivables     847       989  
Restricted deposit     43       35  
Total current assets     1,556       4,402  
Non-current assets:                
Property, plant and equipment, net     63       66  
Operating right of use assets     42       84  
Restricted deposit     23       23  
Total non-current assets     128       173  
Total assets     1,684       4,575  
Liabilities and Equity                
Current liabilities:                
Trade payables     1,093       1,160  
Other payables     1,110       832  
Total current liabilities     2,203       1,992  
Total liabilities     2,203       1,992  
Shareholders’ equity:                
Authorized: 90,000,000 shares at March 31, 2025 and December 31, 2024; Issued and outstanding: 24,602,405 and 23,228,941 shares at June 30, 2025 and December 31, 2024, respectively     -       -  
Share premium and capital reserve     40,850       39,243  
Accumulated deficit     (41,369 )     (36,660 )
Total Shareholders’ equity (deficit)     (519 )     2,583  
Total liabilities and shareholders’ equity (deficit)     1,684       4,575  

 

3


 

NeuroSense Therapeutics Ltd.

 

Condensed Interim Unaudited Statements of Comprehensive Loss

 

U.S. dollars in thousands except share and per share data

 

    Six months
ended
June 30,
2025
    Six months
ended
June 30,
2024
 
             
Research and development expenses     (2,503 )(*)     (3,733 )
General and administrative expenses     (2,189 )(*)     (2,291 )
Operating loss     (4,692 )     (6,024 )
Financing expenses, net     (17 )     (237 )
Net loss and comprehensive loss     (4,709 )     (6,261 )
Basic and diluted net loss per share     (0.19 )     (0.37 )
Weighted average number of shares outstanding used in computing basic and diluted net loss per share     25,402,649       16,773,806  

 

(*) Reclassified

 

4


 

NeuroSense Therapeutics Ltd.

 

Condensed Interim Unaudited Statements of Changes in Equity

 

U.S. dollars in thousands (except for share and per share data)

 

    Ordinary shares     Share
premium
and
capital
reserve
    Accumulated
deficit
    Total
equity
 
    Number     Amount                    
                               
Balance as of January 1, 2025     23,228,941     $              -     $ 39,243     $ (36,660 )   $ 2,583  
Issuance of shares, net     883,952       -       1,288       -       1,288  
Exercise of options and vested RSUs     194,000               13               13  
Share-based compensation     295,512               306               306  
Net loss and comprehensive loss     -       -       -       (4,709 )     (4,709 )
Balance as of June 30, 2025     24,602,405     $ -     $ 40,850     $ (41,369 )   $ (519 )

 

5


 

About ALS

 

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

 

About PARADIGM

 

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 

 

During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation. 

 

Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.   

 

About PrimeC

 

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC’s biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

 

6


 

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, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

 

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 a commercial launch in Canada and market potential. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that that the commercial launch of PrimeC will not expeditious, that there will not be dependable and compliant sourcing for commercial-scale production volumes of PrimeC,  that the shelf life of PrimeC will not be as anticipated, lower than anticipated market opportunity in Canada and elsewhere, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; insufficient capital to complete development of PrimeC, the timing of expected regulatory and business milestones; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

 

 

7

 

Exhibit 99.2

 

NeuroSense Therapeutics Ltd.

Condensed Interim Unaudited balance sheets

U.S. dollars in thousands

 

    June 30,     December 31,  
    2025     2024  
Assets            
             
Current assets:            
Cash and cash equivalent     666       3,378  
Other receivables     847       989  
Restricted deposit     43       35  
Total current assets     1,556       4,402  
                 
Non-current assets:                
Property, plant and equipment, net     63       66  
Operating right of use assets     42       84  
Restricted deposit     23       23  
Total non-current assets     128       173  
                 
Total assets     1,684       4,575  
                 
Liabilities and Equity                
                 
Current liabilities:                
Trade payables     1,093       1,160  
Other payables     1,110       832  
Total current liabilities     2,203       1,992  
                 
Total liabilities     2,203       1,992  
                 
Shareholders’ equity:                
Authorized: 90,000,000 shares at March 31, 2025 and December 31, 2024; Issued and outstanding: 24,602,405 and 23,228,941 shares at June 30, 2025 and December 31, 2024, respectively    
-
     
-
 
Share premium and capital reserve     40,850       39,243  
Accumulated deficit     (41,369 )     (36,660 )
Total Shareholders’ equity (deficit)     (519 )     2,583  
                 
Total liabilities and shareholders’ equity (deficit)     1,684       4,575  

 

Date of approval of the interim financial statements: July 30, 2025

 

The accompanying notes are an integral part of the condensed interim financial statements.

 

F-1


 

NeuroSense Therapeutics Ltd.

Condensed Interim Unaudited Statements of Comprehensive Loss

U.S. dollars in thousands except share and per share data

 

    Six months     Six months  
    ended     ended  
    June 30,     June 30,  
    2025     2024  
             
Research and development expenses     (2,503 )   (*) (3,733 )
                 
General and administrative expenses     (2,189 )   (*) (2,291 )
                 
Operating loss     (4,692 )     (6,024 )
                 
Financing expenses, net     (17 )     (237 )
                 
Net loss and comprehensive loss     (4,709 )     (6,261 )
Basic and diluted net loss per share     (0.19 )     (0.37 )
Weighted average number of shares outstanding used in computing basic and diluted net loss per share     25,402,649       16,773,806  

 

(*) Reclassified

 

The accompanying notes are an integral part of the condensed interim financial statements.

 

F-2


 

NeuroSense Therapeutics Ltd.

Condensed Interim Unaudited Statements of Changes in Equity

U.S. dollars in thousands (except for share and per share data)

 

    Ordinary shares     Share premium and capital reserve     Accumulated deficit     Total equity  
    Number     Amount                    
                               
Balance as of January 1, 2025     23,228,941     $
       -
    $ 39,243     $ (36,660 )   $ 2,583  
                                         
Issuance of shares, net     883,952      
-
      1,288      
-
      1,288  
                                         
Exercise of options and vested RSUs     194,000      
-
      13      
-
      13  
                                         
Share-based compensation     295,512      
-
      306      
-
      306 )
                                         
Net loss and comprehensive loss     -      
-
     
-
      (4,709 )     (4,709 )
                                         
Balance as of June 30, 2025     24,602,405     $
-
    $ 40,850     $ (41,369 )   $ (519 )

 

    Ordinary shares     Share premium and capital reserve     Accumulated deficit     Total equity  
    Number     Amount                    
                               
Balance as of January 1, 2024     15,379,042     $
     -
    $ 24,362     $ (26,121 )   $ (1,759 )
                                         
Issuance of shares and pre-funded warrants, net     1,732,000      
-
      4,209      
-
      4,209  
                                         
Exercise of pre-funded warrants, options and vested RSUs     873,000      
-
     
-
     
-
     
-
 
                                         
Reclassification of warrants into equity (Note 3)     -      
-
      1,695      
-
      1,695  
                                         
Share-based compensation     70,964      
-
      413      
-
      413 )
                                         
Net loss and comprehensive loss     -      
-
     
-
      (6,261 )     (6,261 )
                                         
Balance as of June 30, 2024     18,055,006     $
-
    $ 30,679     $ (32,382 )   $ (1,703 )

 

The accompanying notes are an integral part of the condensed interim financial statements.

 

F-3


 

NeuroSense Therapeutics Ltd.

Condensed Interim Unaudited Statements of Cash Flows

U.S. dollars in thousands

 

    Six months     Six months  
    ended     ended  
    June 30,     June 30,  
    2025     2024  
Cash flows from operating activities            
Net loss for the period     (4,709 )     (6,261 )
Adjustments:                
                 
Depreciation and Amortization     8       11  
Share-based compensation     306       306  
Revaluation of liability in respect to warrants    
-
      283  
Finance expenses (income), net    
-
     
-
 
                 
Changes in assets and liabilities:                
Decrease in operating right of use asset     42       39  
Decrease in operating lease liability     (33 )     (37 )
Decrease (increase) in other receivables     141       (140 )
Increase (decrease) in trade payables     (67 )     24  
Increase in other payables     312       25  
                 
Net cash used in operating activities     (4,000 )     (5,750 )
                 
Cash flows from investing activities                
Change in restricted deposit     (8 )     4  
Purchase of property, plant and equipment     (5 )     (3 )
Net cash provided by (used in) investing activities     (13 )     1  
                 
Cash flows from financing activities                
Exercise of options     13      
-
 
Issuance of shares     1,353       4,395  
Issuance costs     (65 )     (78 )
Net cash provided by financing activities     1,301       4,317  
                 
Effects of exchange rate changes on cash and cash equivalents    
-
     
-
 
                 
Net decrease in cash and cash equivalents     (2,712 )     (1,432 )
                 
Cash and cash equivalents at beginning of the period     3,378       2,640  
                 
Cash and cash equivalents at end of the period     666       1,208  
                 
Non-cash activity                
Supplemental disclosure of cash flow information:                
Interest received    
-
      2  

 

The accompanying notes are an integral part of the condensed interim financial statements.

 

F-4


 

NeuroSense Therapeutics Ltd.

Notes to the Condensed Interim Unaudited Financial Statements

 

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 negative networks capital and also 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, 2025 shall not be sufficient to fund the Company’s operations for a period of 12 months from the approval of these consolidated interim 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 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.

 

These consolidated financial statements have been prepared in accordance with US generally accepted accounting principles (GAAP) assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. 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 interim financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.

 

F-5


 

NeuroSense Therapeutics Ltd.

Notes to the Condensed Interim Unaudited Financial Statements

 

Note 1 — General (Cont.)

 

C. In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas. In addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization), Israel’s southern border with the Gaza Strip (with the Hamas terrorist organization) and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq. Further, on April 13, 2024, and on October 1, 2024, Iran launched a series of drone and missile strikes against Israel. As of June 30, 2025 a ceasefire agreement has been reached between Israel the Hezbollah terror organization in Lebanon. On June 13, 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a pre-emptive strike directly targeting military and nuclear infrastructure inside Iran aimed to disrupt Iran’s capacity to coordinate or launch further hostilities against Israel, as well as disrupt its nuclear program. On June 25, 2025, a ceasefire between Israel and Iran took effect. Nonetheless, hostilities between Israel and Iran may resume and further escalate, with both sides launching attacks against one another. The Company experienced disruptions to its work during such period. Since June 25, 2025, The Company has been returning to full activity together with its local vendors and consultants. The Company doesn't expect a material adverse effect on its business.

 

To date, the Company’s operations and financial results have not been materially affected. The Company’s operations have not been adversely affected by this situation, and it has not experienced disruptions to its clinical studies. As such, its clinical and business development activities remain on track. However, the intensity and duration of Israel’s current war against Hamas, Hezbollah and Iran is difficult to predict at this stage, as are such war’s economic implications on its business and operations and on Israel’s economy in general. If the ceasefire declared collapses or a new war commences or hostilities expand to other fronts, its operations may be adversely affected.    

 

Note 2 — Significant accounting policies

 

These unaudited Condensed interim financial statements have been prepared as of June 30, 2025 and for the six months period then ended. Accordingly, In the opinion of the Company, the accompanying unaudited condensed financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of its financial position as of June 30, 2025, and its results of operations for the six months ended June 30, 2025, and 2024, and cash flows for the same periods. The condensed balance sheet at December 31, 2024, was derived from audited annual financial statements but does not contain all of the footnote disclosures from the annual financial statements. The significant accounting policies that have been applied in the preparation of the unaudited consolidated Condensed financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements for the year ended December 31, 2024. These unaudited Condensed financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2024 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on April 7, 2025 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2025.

 

F-6


 

NeuroSense Therapeutics Ltd.

Notes to the Condensed Interim Unaudited Financial Statements

 

Note 2 — Significant accounting policies (Cont.)

 

Recently issued accounting pronouncements, not yet adopted

 

As an emerging growth company, the Jumpstart Our Business Startup Act (“JOBS Act”) allows the Company to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The Company has elected to use this extended transition period under the JOBS Act.

 

Note 3 - Shareholders’ Equity

 

a. On August 16, 2024, the Company entered into a Capital on Demand Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC, as sales agent (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, to or through the Sales Agent, ordinary shares, having an aggregate offering price of up to gross sale proceeds of up to $2,524 thousand. On February 21, 2025, the Company increased the aggregate offering price under the Sales Agreement to $2,556 thousand, which did not include the ordinary shares having an aggregate sales price of approximately $1,410 thousand that were sold under the Sales Agreement as of such date. The Company agreed to pay the Sales Agent a commission equal to 3.0% of the gross proceeds from the sale of the ordinary shares pursuant to the Sales Agreement. The Company reimbursed the Sales Agent for certain specified expenses in connection with entering into the Sales Agreement in the amount of $50 thousand. During the six month period ended June 30, 2025, the Company sold 708,952 ordinary shares at an average gross sales price of $1.45 per share for aggregate gross proceeds of $1,031 thousand (net proceeds of $975 thousand) under the Sales Agreement.

 

b. On October 31, 2024, the “Company entered into a standby equity purchase agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited partnership (“Yorkville”).

 

F-7


 

NeuroSense Therapeutics Ltd.

Notes to the Condensed Interim Unaudited Financial Statements

 

Note 3 - Shareholders’ Equity (Cont.)

 

Pursuant to the SEPA, the Company has the right, but not the obligation, to sell to Yorkville from time to time (each such occurrence, an “Advance”) up to $30.0 million (the “Commitment Amount”) of the Company’s ordinary shares, during the 36 months following the execution of the SEPA, subject to the restrictions and satisfaction of the conditions in the SEPA. At the Company’s option, the ordinary shares would be purchased by Yorkville from time to time at a price equal to 97% of the lowest of the three daily VWAPs (as hereinafter defined) during a three consecutive trading day period commencing on the date that the Company, subject to certain limitations, delivers a notice to Yorkville that the Company is committing Yorkville to purchase such ordinary shares (the “Advance Shares”). The Company may also specify a certain minimum acceptable price per share in each Advance. “VWAP” means, for any trading day, the daily volume weighted average price of the Company’s ordinary shares for such trading day on the Nasdaq Stock Market during regular trading hours as reported by Bloomberg L.P. During the six month period ended June 30, 2025, the Company sold 175,000 ordinary shares at an average gross price of $1.85 per share for aggregate gross proceeds of $323 thousand (net proceeds of $313 thousand) under the SEPA.

 

c. During the six month period ended June 30, 2025, the Company issued 180,000 ordinary shares following exercise of vested RSUs.

 

d. During the six month period ended June 30, 2025, the Company issued 14,000 ordinary shares following exercise of options.

 

Note 4 - Share Based Payment

 

On March 31, 2025, the Company’s board of directors approved the grant of an aggregate amount of 295,512 RSUs to several consultants and service providers. The fair value was estimated at the amount of $275 thousand.

 

On March 31, 2025, the Company’s board of directors approved the grant of aggregate amount of 108,000 options to several employees. The options have an exercise price of $0.93 per share. The options vest quarterly over three years commencing first anniversary and expire 10 years after grant date.

 

The following table lists the inputs used for calculation of fair value of the options granted for the six-month period ended June 30, 2025:

 

    June 30,
2025
Expected volatility   92.06%
Exercise price   0.93
Share price   0.93
Risk-free interest rate   4.38%
Dividend yield   0
Expected life (years)   10

 

F-8


 

NeuroSense Therapeutics Ltd.

Notes to the Condensed Interim Unaudited Financial Statements

 

Note 4 - Share Based Payment (Cont.)

 

The share-based expense recognized in the statements of operations were as follows:

 

    June 30,  
    2025     2024  
    U.S dollars in thousands  
Share-based compensation expense - Research and development   $ 18     $ 154  
Share-based compensation expense - General and administrative (*)     288       152  
    $ 306     $ 306  

 

(*) Including $275 thousands in respect with RSUs granted to service providers in March 2025, see Note 4 above.

 

 

F-9

 

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EX-99.3 4 ea025084301ex99-3_neurosense.htm OPERATING AND FINANCIAL REVIEW AND PROSPECTS AS OF JUNE 30, 2025

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 United States of America, or U.S. GAAP. 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 3.372 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2025.

 

Forward Looking Statements

 

This exhibit contains forward-looking statements concerning among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our ability to enter into and maintain strategic collaborations, our intellectual property position; our results of operations, cash needs; financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us. 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 April 7, 2025, or the Annual Report, 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 (the “U.S.”);

 

  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;

 

  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 such regulatory clarity and approvals and 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;

 

  our ability to maintain the listing of our ordinary shares on Nasdaq;

 

  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; and

 

  the impacts on our ongoing and planned trials and manufacturing as a result of the war in Israel.

 

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.

 

2


 

Overview

 

We are a clinical-stage biotechnology company focused on discovering and developing treatments for people living with neurodegenerative diseases, including ALS AD and PD. We believe 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 utilizing 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 pathology. The U.S. Food and Drug Administration, or the FDA and the European Medicines Agency, or the EMA have granted PrimeC orphan drug designation for the treatment of ALS. In addition, the EMA has granted PrimeC the Small and Medium-Sized Enterprise, or SME, status, which offers significant potential benefits leading up to and following drug regulatory approval. We believe PrimeC’s multifunctional 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.

 

PrimeC was evaluated in PARADIGM, a Phase 2b randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, to evaluate safety, tolerability, and efficacy of PrimeC in 68 people living with ALS. Participants were being administered PrimeC or placebo at a 2:1 ratio, respectively, for the six-month double-blind part. Study participants were allowed to continue standard of care treatment of approved products. The primary endpoints of the study are an evaluation of ALS-biomarkers as well as safety and tolerability assessment. Secondary and exploratory endpoints are the evaluation of clinical efficacy (ALS Functional Rating Scale — Revised, or ALSFRS-R, and slow vital capacity), survival, and improvement in quality of life. All subjects who completed the six-month double-blind, placebo-controlled dosing period had the opportunity to be transferred to the PrimeC active arm for a 12-month open label extension. The study completed enrollment in May 2023, enrolling 69 participants, in which 68 are living with ALS and one participant who was misdiagnosed for ALS and was excluded from the evaluations. Four ALS clinical centers participated in the study in three territories: Israel, Italy, and Canada. In December 2023, we reported that we met the primary safety and tolerability endpoints and achieved secondary clinical efficacy endpoints in the top-line results of our 6-month double-blind phase of PARADIGM. In May 2024, we announced new positive data analysis from PARADIGM clinical trial demonstrating statistically significant slowing of disease progression in high-risk ALS patients. In July 2024, we announced results from the 12-month analysis of the PARADIGM clinical trial which showed a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo. In August 2024, we announced positive 12-month biomarker data from the PARADIGM clinical trial, which showed a significant decrease in ferritin levels and a corresponding increase in transferrin levels, both indicating alleviation of the pathology. In October 2024, we completed the full 18-month dosing in PARADIGM, and in December 2024, we announced results from the 18-month analysis of the PARADIGM clinical trial which showed statistically significant positive results from the 18-month data analysis of the PARADIGM study, evaluating the efficacy of PrimeC in the treatment of ALS. In February 2025, we announced additional findings from an 18-month analysis of the PARADIGM clinical trial showing improvements in two additional endpoints, complication-free survival (analysis which includes death from any cause or respiratory insufficiency or hospitalization due to ALS-related complications) and Slow Vital Capacity (SVC), measuring respiratory function.

 

Following the FDA’s recommendation for additional non-clinical data to support long term use of Ciprofloxacin (as PrimeC is intended for long-term administration in treating ALS) a long-term tox study was initiated.

 

In September 2024, we announced the successful completion of the in-life phase of the study, as we move towards the initiation of a Phase 3 study in the U.S.

 

In December 2024, we concluded a productive Type C meeting with the FDA. The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. In light of the FDA’s feedback, we plan to submit a final protocol to the FDA during the second half of 2025 and approach the EMA, with the aim of commencing enrollment of the pivotal Phase 3 study in the second half of 2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeC to placebo. The Phase 3 study is expected to be a randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open label extension (OLE), to evaluate the efficacy and safety of PrimeC in people living with ALS. Following 12 months of treatment, it is expected that all participants will transition to PrimeC for a 12-month open label extension.

 

3


 

In December 2024, we entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC, in certain key territories. We retain full rights to PrimeC in other key territories. The binding term sheet outlines substantial financial terms from the pharmaceutical company, including: (i) a substantial upfront payment upon signing a definitive agreement, (ii) funding for the Phase 3 clinical trial, (iii) regulatory and net sales milestone payments, and (iv) a tiered royalty structure reaching double-digit percentage on annual net sales. The pharmaceutical company would have an exclusive license to distribute, market, promote, sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing for PrimeC for ALS, subject to terms and conditions in the definitive agreement. The pharmaceutical company would have an exclusive license to distribute, market, promote, sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing for PrimeC for ALS, subject to terms and conditions in the definitive agreement. The closing of this transaction is subject to a definitive agreement. While both parties are communicating to find solutions to the remaining open matters, there can be no assurance as to the timing of, or whether, such an agreement will ultimately be executed, and if executed, what would be the final terms of such an agreement.

 

PrimeC was previously evaluated in a Phase IIa clinical trial, or NST002, in 15 people living with ALS, conducted at the Tel Aviv Sourasky Medical Center, Israel. The primary endpoint of the NST002 trial, which was safety and tolerability, was met. In this trial, the safety profile observed was consistent with known safety profiles of ciprofloxacin and celecoxib. Side effects were mild and transient in nature. There were no new or unexpected safety signals detected during the trial.

 

Additionally, we observed positive clinical signals in comparison to virtual controls, and a serum biomarker analysis showed significant changes following treatment, indicating biological activity of the drug in comparison to untreated matched ALS patients. All 12 patients who completed the NST002 trial elected to continue into an extension study with PrimeC, that was conducted as an Investigator Initiated Study. To date, we are still supporting the drug supply for a few of the participants in this study, which is over than 40 months since NST002 was initiated.

 

We completed three additional studies in 2022 as part of our drug development program to further support our future regulatory submissions. In April 2022, we initiated a pharmacokinetic, or PK, study, or NCT05232461, of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-period crossover study evaluated the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in adult subjects in the U.S. under an FDA cleared IND protocol.

 

In August 2022, we completed enrollment and dosing of all subjects in a multi-dose PK study, or NCT05436678. On September 28, 2022, we released the results of the NCT05436678 study. Based on results, we believe the PK profile of PrimeC supports the formulation’s extended-release properties, as the concentrations of the active components have been synchronized, aiming to potentially maximize the synergism between the two compounds. In June 2022, we reported the successful completion of the “in-life” phase of its 90-day GLP toxicology study. In this study, the components of PrimeC, celecoxib and ciprofloxacin, were administered to rodents at doses 4x the maximal clinical dose. All animals appeared normal, with no significant findings observed. We intend to present the data from these studies to the FDA as part of PrimeC’s drug development plan.

 

We believe we have a strong patent estate, including patents on method of use, combination, and formulation. We have secured U.S. Patent 10,980,780 relating to methods for treatment of ALS using ciprofloxacin and celecoxib, the components of PrimeC, which expires in 2038. Equivalent patents also have been issued in the European Patent Office, Canada, Australia, Israel and Japan. The patent estate also includes US Patent 12,097,185, which relates to Prime C formulations. This patent will expire in December 2042. Equivalent applications are pending in many jurisdictions worldwide. We also expect to take advantage of orphan drug exclusivity for PrimeC, if approved, for seven years in the United States and ten years in the European Union. In addition, U.S. patent application 16/623,467, which relates to methods of treatment of neurodegenerative disease using combinations of ciprofloxacin and celecoxib, is currently pending. This patent application, once granted, is expected to expire on June 20, 2038.

 

4


 

Our organization is built around a management team with extensive experience in the pharmaceutical industry, with a particular focus on ALS research and clinical trials. We believe that our leadership team is well-positioned to lead us through clinical development, regulatory approval and commercialization of our product candidates. Furthermore, we maintain steadfast and extensive communication and collaboration with patient advocacy groups and associations, underscoring the importance of patient perspectives in advancing therapeutic strategies.

  

In addition to PrimeC, we extended our pipeline and conducted research and development efforts for AD and PD, with a similar strategy of combined products. The following chart represents our current product development pipeline:

 

 

We have incurred operating losses in each year since our inception. We incurred net losses of $4.71 million and $6.26 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $41.37 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.

 

5


 

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; and

 

  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, 2025, 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 our Annual Report. 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.

 

6


 

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, 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 $24.7 million as of June 30, 2025. 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, 2025 and 2024 were as follows:

 

    For the Six Months Ended
June 30,
 
(U.S. dollars in thousands except share and per share data)   2025     2024  
Statement of Operations:            
Research and Development Expenses     (2,503 )     (3,733 )
General and Administrative Expenses     (2,189 )     (2,291 )
Operating Loss     (4,692 )     (6,024 )
Financing expense, net     (17 )     (237 )
Net Loss and Comprehensive Loss     (4,709 )     (6,261 )
Basic and Diluted Net Loss per Share     (0.19 )     (0.37 )
Weighted average number of shares outstanding used in computing basic and diluted net loss per share     25,402,649       16,773,806  

 

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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)   2025     2024  
Subcontractors and consultants   $ 1,547       2,571  
Share-based compensation     18       154  
Salaries and social benefits     938       1,008  
                 
Total research and development expenses   $ 2,503       3,733  

 

Our research and development expenses for the six months ended June 30, 2025 and 2024 were $2,503 thousand and $3,733 thousand, respectively. The decrease of $1,230 thousand, or 32.9%, was mainly attributed to the decrease in clinical activity.

 

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,
 
    2025     2024  
    U.S. dollars in thousands  
Professional services   $ 1,034       1,155  
Share-based compensation     288       152  
Salaries and social benefits     316       441  
Insurance     160       157  
Traveling abroad     110       83  
Others     281       303  
    $ 2,189       2,291  

 

Our general and administrative expenses for the six months ended June 30, 2025 and 2024 were $2,189 thousand and $2,291 thousand, respectively. The decrease of $102 thousand, or 4.4%, is considered immaterial.

 

Financing Expenses, net

 

Our financing expenses, net for the six months ended June 30, 2025 and 2024, were $17 thousand and $237 thousand, respectively. The decrease of $220 thousand, or 92.8%, was mainly attributed to change in fair value revaluation expenses.

 

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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, 2025, we incurred a net loss of $4.71 million while net cash of $4.0 million was used in our operating activities. As of June 30, 2025, we had a negative working capital of $0.64 million, and an accumulated deficit of $41.37 million. As of June 30, 2025, our cash totaled approximately $0.66 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, 2025, we have financed our operations primarily through our initial public offering, public and private offerings of our equity securities, proceeds from the exercise of warrants and options, and crowd funding of equity securities. Total gross invested capital as of June 30, 2025 was approximately $37.2 million, which included ordinary shares, SAFE agreements, options and warrants to purchase ordinary shares.

 

Cash flows

 

The following table summarizes our statement of cash flows for the six months ended June 30, 2025 and 2024:

 

    For the Six Months Ended
June 30,
 
(U.S. dollars in thousands except share and per share data)   2025     2024  
Net cash used in operating activities and exchange rates   $ (4,000 )     (5,750 )
Net cash used in investing activities     (13 )     1  
Net cash provided by financing activities     1,301       4,317  
(Decrease) increase in cash and cash equivalents   $ (2,712 )     (1,432 )

 

Net cash used in operating activities

 

Net cash used in operating activities was $4,000 thousand and $5,750 thousand for the six months ended June 30, 2025 and 2024, respectively. The decrease of $1,750 thousand was mainly attributable to decrease in our net loss for the period.

 

Net cash provided by (used in) investing activities

 

Net cash provided by (used in) investing activities was $(13) thousand and $1 thousand for the six months ended June 30, 2025 and 2024, respectively. The decrease of $14 thousand was mainly attributed to change in restricted deposit and purchase of property and equipment.

 

Net cash provided by financing activities

 

Net cash provided by financing activities was $1,301 thousand and $4,317 thousand for the six months ended June 30, 2025 and 2024, respectively. The decrease of $3,016 thousand was mainly attributed to lower proceeds from issuance of shares.

 

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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, 2025, we had cash of $0.66 million.

 

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 — Our financial statements include a going concern reference. 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 our Annual Report. 

 

Contractual Obligations and Commitments

 

As of June 30, 2025, we did not have any material contractual obligation and commitments, except for lease agreements with respect to offices. In December 2021, we entered into an office space lease agreement in Herzilya, Israel (which commenced on January 1, 2022). Monthly rent payments including utilities amount to approximately $7 thousand and are indexed to CPI. The lease period was for 24 months with an option to extend the lease period for additional two periods of 24 months each. We exercised the first period option, and we expect to exercise the second option for an additional lease period.

 

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.

 

 

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