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    SEC Form 424B3 filed by Polyrizon Ltd.

    5/12/25 5:00:16 PM ET
    $PLRZ
    Get the next $PLRZ alert in real time by email
    424B3 1 ea0241699-424b3_polyrizon.htm PROSPECTUS

     

    PROSPECTUS Filed pursuant to Rule 424(b)(3)
      Registration No. 333-286849

     

    1,513,858,167 Ordinary Shares

     

     

    Polyrizon Ltd.

     

    This prospectus relates to the resale by the selling shareholders, or the Selling Shareholders, identified in this prospectus of up to 1,513,858,167 ordinary shares, with no par value, or the Ordinary Shares, as further described below under “Prospectus Summary — Recent Developments — Private Placement” of Polyrizon Ltd., consisting of (i) 2,245,834 Ordinary Shares issued in our private placement transaction in March 2025, or the Private Placement and the PIPE Shares, (ii) up to 33,170,833 Ordinary Shares issuable upon the exercise of pre-funded warrants, or the Pre-Funded Warrants, (iii) up to 1,330,897,717 Ordinary Shares issuable upon the exercise of series A warrants, or the Series A Warrants and (iv) up to 147,543,783 Ordinary Shares issuable upon the exercise of exchange warrants, or the Exchange Warrants and together with the Pre-Funded Warrants and the Series A Warrants, the Warrants.

     

    The Selling Shareholders are identified in the table commencing on page 22. No Ordinary Shares are being registered hereunder for sale by us. We will not receive any proceeds from the sale of the Ordinary Shares by the Selling Shareholders. All net proceeds from the sale of the Ordinary Shares covered by this prospectus will go to the Selling Shareholders. We may receive cash proceeds equal to the total exercise price of Warrants that are exercised for cash, of approximately $47.2 million, based on an exercise price of $1.20 per share in the case of the Series A Warrants and Exchange Warrants and $0.00001 per share in the case of the Pre-Funded Warrants, in each case subject to adjustments, if all Warrants are exercised. See “Use of Proceeds.” The Selling Shareholders may sell all or a portion of the Ordinary Shares from time to time in market transactions through any market on which our Ordinary Shares are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principal or by a combination of such methods of sale. See “Plan of Distribution.

     

    Our Ordinary Shares are listed on The Nasdaq Capital Market, or Nasdaq, under the symbol “PLRZ”. The last reported sale price of our Ordinary Shares on Nasdaq on April 29, 2025, was $0.3070 per share.

     

    We are both an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and a “foreign private issuer,” as defined under the U.S. federal securities laws and are subject to reduced public company reporting requirements. See “Prospectus Summary — Implications of Being an Emerging Growth Company and a Foreign Private Issuer” for additional information.

     

    Investing in our Ordinary Shares involves a high degree of risk. See “Risk Factors” beginning on page 9 and in the documents incorporated by reference into this for a discussion of information that should be considered in connection with an investment in the ordinary shares.

     

    Neither the Securities and Exchange Commission (or the SEC), nor any state or other foreign securities commission has approved nor disapproved these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

     

    The date of this prospectus is May 12, 2025.

     

     

     

    TABLE OF CONTENTS

     

    PROSPECTUS SUMMARY 1
    SUMMARY FINANCIAL DATA 8
    RISK FACTORS 9
    SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 12
    USE OF PROCEEDS 14
    DIVIDEND POLICY 15
    CAPITALIZATION 16
    DESCRIPTION OF SHARE CAPITAL 17
    SELLING SHAREHOLDERS 22
    PLAN OF DISTRIBUTION 27
    EXPENSES 29
    LEGAL MATTERS 29
    EXPERTS 29
    ENFORCEMENT OF CIVIL LIABILITIES 30
    INCORPORATION OF CERTAIN INFORMATION BY REFERENCE 31
    WHERE YOU CAN FIND MORE INFORMATION 32

     

    i

     

    You should rely only on the information contained in this prospectus, including information incorporated by reference herein, and any free writing prospectus prepared by or on behalf of us or to which we have referred you. Neither we nor the Selling Shareholders have authorized anyone to provide you with different information other than those contained in, or incorporated by reference into, this prospectus. Neither we nor the Selling Shareholders are offering to sell the Ordinary Shares, nor we are seeking offers to buy the Ordinary Shares, at any jurisdictions where offers and sales are not permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of the Ordinary Shares.

     

    For investors outside of the United States: Neither we nor the Selling Shareholders have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.

     

    The terms “shekel,” “Israeli shekel” and “NIS” refer to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar,” “U.S. dollar” or “$” refer to United States dollars, the lawful currency of the United States of America. All references to “shares” in this prospectus refer to Ordinary Shares of Polyrizon Ltd., no par value per share. 

     

    On September 29, 2022, the Company effected (i) a reverse stock split of our issued and outstanding shares at a ratio of 1-for-8.80, pursuant to which holders of our shares received one Ordinary Share for every 8.80 Ordinary Shares held, and (ii) cancelled the par value of our Ordinary Shares and Preferred Shares, or collectively, the Initial Reverse Share Split.

     

    On December 19, 2022, the Company effected the issuance of an aggregate of 858,148 bonus shares to the holders of our Ordinary Shares on a basis of 1.25 bonus shares for each Ordinary Share outstanding (equivalent to a forward share split at a ratio of 1.25-for-1), or the Forward Share Split.

     

    On June 18, 2023, the Company effected a reverse stock split of our issued and outstanding shares at a ratio of 1-for-1.7, pursuant to which holders of our shares received one Ordinary Share for every 1.7 Ordinary Shares held, or the Second Reverse Share Split.

     

    On May 12, 2024, the Company effected a reverse stock split of our issued and outstanding shares at a ratio of 1-for-2, pursuant to which holders of our shares received one (1) Ordinary Share for every two (2) Ordinary Shares held, or the Third Reverse Share Split.

     

    On August 16, 2024, the Company effected the issuance of an aggregate of 420,618 bonus shares to the holders of our Ordinary Shares on a basis of 0.1494 bonus shares for each Ordinary Share outstanding (equivalent to a forward share split at a ratio of 0.1494-for-1), or the Second Forward Share Split.

     

    Unless the context expressly dictates otherwise, all references to share and per share amounts referred to herein reflect the foregoing share splits, or collectively, the Share Splits.

     

    TRADEMARKS

     

    “Capture and Contain” and “Trap and Target” are trademarks of ours that we use in this prospectus or the information incorporated by reference herein. This prospectus and the information incorporated by reference herein also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus or the information incorporated by reference herein often appear without the ® or ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to our trademark and tradenames.

     

    MARKET, INDUSTRY AND OTHER DATA

     

    This prospectus, including the information incorporated by reference herein, contains estimates, projections and other information concerning our industry, our business, and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. None of the reports or studies cited in this prospectus or the information incorporated by reference herein were commissioned by the Company.

     

    In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors” in this prospectus and the information incorporated by reference herein. These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Special Note Regarding Forward-Looking Statements.”

     

    ii

     

    PROSPECTUS SUMMARY

     

    This summary highlights information contained elsewhere in or incorporated by reference into this prospectus that we consider important. This summary does not contain all of the information you should consider before investing in our securities. Before you decide to invest in our securities, you should read the entire prospectus carefully, including the “Risk Factors” section and the financial statements and related notes incorporated by reference into this prospectus and the other documents incorporated by reference into this prospectus, which are described under “Incorporation of Certain Information by Reference” before making an investment in our securities. Unless the context otherwise requires, references in this prospectus to the “company,” “Polyrizon,” “we,” “us,” “our” and other similar designations refer to Polyrizon Ltd.

     

    Company Overview

     

    We are a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Our proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. We are further developing certain aspects of our proprietary C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. We refer to our separate platform technology that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T.

     

    Our Product Candidates

     

    Our nasal hydrogels have been designed to serve as a non-invasive and fast-acting system. The hydrogels are formulated as an innovative mixture of mucoadhesive polymers (e.g., sodium alginate) which are Generally Recognized as Safe, or GRAS, by the Federal Drug Administration, or the FDA. Our mucoadhesive polymers derived from seaweed polysaccharides possess promising features as they are renewable, biodegradable, biocompatible, and environment friendly. The formulated hydrogel is sprayed into the nose to create a physical barrier with long-lasting adhesion to the mucosal membranes. Our polymers have an atomic mass much higher than the upper cell penetration limit, the polymers will simply lay on top of the cells and act as a physical barrier to viruses and allergens from contacting the nasal epithelial tissue, as opposed to penetrating the cells and causing a chemical reaction. Therefore, the C&C product candidates are not expected to be considered as drugs by the FDA but as medical devices.

     

    Our leading technologies are C&C and T&T. The C&C provides a barrier against a wide range of allergen particulates and viruses.

     

    PL-14 – Nasal Allergies Blocker

     

      o We expect our PL-14 product candidate to be regulated as a Class II medical device by the FDA under its 510(k) pathway.

     

      o Our PL-14 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025. In addition, we have structured our clinical strategy for the PL-14 product candidate, our proprietary intranasal allergy blocker designed to treat seasonal allergic rhinitis, which includes a clinical study to evaluate the efficacy and safety of PL-14 under natural allergen exposure conditions during peak allergy seasons, a human factors study to assess usability and patient acceptance, a dedicated study evaluating nasal residence time and preparation for a pre-submission meeting with the FDA. we expect the clinical trials on our PL-14 product candidate to commence between the fourth quarter of 2025 and first quarter of 2026 , following which we plan to submit a 510(k) application for FDA clearance.

     

      o For our PL-14 product candidate, we will pursue the 510(k) pathway which requires a manufacturer to demonstrate substantial equivalence to an FDA-cleared device (i.e., predicate device) to a subject device (i.e., our product candidate). This process for clearing our device with the FDA entails performing a medical device analysis of the product candidates (e.g., PL-14 product candidate) description, operational principle, potential accessories and proposed intended use, for the purpose of identifying a predicate device that has already been cleared by the FDA. Through this review, we found three possible predicate devices for establishing substantial equivalence, Alzair, Nasalease and Bentrio. There is no guarantee that PL-14 product candidate will advance in the FDA 510(k) process at the same rate as the aforementioned predicate devices or will reach commercialization.

     

      o The estimated timeline for obtaining 510(k) clearance for our PL-14 product candidate is based on the estimated time needed for the following activities: (i) GMP manufacturing of our clinical trial materials, which usually requires 9-12 months; (ii) Biocompatibility preclinical studies, which usually requires 3-6 months (although these studies may be performed concurrently with the GMP manufacturing mentioned above); (iii) Clinical trials, which usually requires 6-12 months; and (iv) FDA submission and clearance, which usually requires 3-12 months. Regarding FDA submission and clearance, generally 510(k) applicants can expect submission acceptance review decisions within 15 calendar days, substantive review decisions within 60 days, and final decisions within 90 days. In the case of our predicate devices for our PL-14 product candidate, Alzair, Nasalese and Bentrio, the FDA submission and clearance process took 86 and 140 days, respectively.

    1

     

    PL-15 – COVID-19 and PL-16 – Influenza Blockers

     

      o We expect our PL-15 and PL-16 product candidates, which provide a barrier against COVID-19 and influenza from contacting the nasal epithelial tissue, respectively, to be regulated as a Class II medical device under a De Novo Classification request. For the clinical studies planned for PL-15 and PL-16 which will include human subjects; the Investigational Device Exemptions regulation describes three types of device studies: significant risk, nonsignificant risk, and exempt studies. During the second half of 2025, the company intends to schedule a pre-submission meeting with the FDA to determine the IDE regulation type of device studies for PL-15 and PL-16. Our proposed 12-month interval from the scheduled FDA pre-sub meeting to the planned IDE clinical trial initiation should provide ample time to fulfill the necessary tasks for the IDE filing, such as 1) reporting previous studies to support the IDE, 2) preparing IDE required design and manufacturing control documentation, 3) conducting bench and biocompatibility tests to support safety of the device prior to starting the a human study, and 4) obtaining clinical protocol and ethics committee approvals as well as FDA IDE approval to start the clinical trial. Once IDE has been initiated, Polyrizon will comply with FDA Guidance “Changes or Modifications During the Conduct of a Clinical Investigation”, 2001.

     

      o Our PL-15 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025, and subject to securing additional financing, we intend to initiate feasibility clinical trials in the third quarter of 2026 and pivotal clinical trials in the second quarter of 2027. Following these trials, we plan to submit De Novo Classification requests for each product candidate. Our PL-16 product candidate is scheduled to initiate preclinical safety trials in the second quarter of 2025, and subject to securing additional financing, we intend to initiate feasibility clinical trials in the first quarter of 2026 and pivotal clinical trials in the third quarter of 2026. Following these trials, we plan to submit De Novo Classification requests for each product candidate.

     

      o Upon a review similar to the one performed for our PL-14 product candidate, we found that there were no potential predicate devices in the FDA’s database matching the proposed intended uses of our PL-15 and PL-16 product candidates. Because of this, we will pursue a De Novo Classification request for each product candidate. This pathway involves demonstrating that the product candidates provide a reasonable assurance of safety and effectiveness. During the second half of 2025 we intend to submit a Q-submission (Pre-submission) for each product candidate and request a pre-submission meeting with FDA’s CDRH to confirm the potential for this regulatory path. For more information, please see “Business – Our Product Candidates – The determination process for the C&C product candidates as a Class II medical devices.”

     

      o The estimated timeline for marketing authorization via De Novo Classification grant for our PL-15 and PL-16 product candidates is based on taking similar steps as the steps described above for obtaining 510(k) clearance for our PL-14 product candidate. We estimate a longer period of time for the entire grant process for each of these product candidates due to possibly extended clinical trials requested by the FDA and also due to a longer review timeframe. For additional information, please see “Business – FDA clearance plan for our C&C product candidates.”

     

    In the event the FDA does not agree with our regulatory assessments regarding the C&C product candidates 510(k) for our PL-14 product candidate, and Class II De Novo pathway for our PL-15 and PL-16 product candidates), the FDA may require us to go through a lengthier, more rigorous examination than we had expected (such as PMA, which is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. If we are required to pursue a PMA, the introduction of our product candidates into the market could be delayed.

     

    2

     

    Trap and Target ™ Product Candidates

     

    In contrast to our C&C product candidates, the hydrogel in the T&T product candidates is formulated differently in order to provide for sustained release of the API. The content of the hydrogel (quantity and quality) in the T&T product candidates is formulated differently than the content of C&C product candidates, and therefore enable different functions: physical barrier for the C&C product candidates and API sustained release for the T&T product candidates. It is through these differences that we rationalize the different regulatory treatment of our C&C and T&T product candidates.

     

    The T&T platform technology is designed to allow a long residence time and an intimate contact with the mucosal tissue for a targeted delivery of medicines. We expect that our T&T platform product candidates will be regulated as a combination-product consisting of a nasal sprayer and formulation consisting of a hydrogel and a generic API, which we intend to pursue under the FDA’s 505(b)(2) pathway. In addition, we have initiated preclinical studies for intranasal administration of Naloxone and intranasal administration of benzodiazepines using our T&T platform. These studies are designed to evaluate drug loading capacity, release kinetics, nasal deposition and stability, with the aim of enhancing the bioavailability and optimizing the rapid reversal effect of Naloxone in opioid overdose and benzodiazepines effect in epileptic seizures. We aim to conduct feasibility studies for our T&T platform product candidates with corticosteroids, beginning in the fourth quarter of 2025 through the first quarter of 2027. Pre-clinical studies for selected indications will follow and are expected to begin in the second quarter of 2026. Phase I clinical trials for the leading T&T technology product candidate are planned for the fourth quarter of 2027. In addition, we plan to start an initial testing to explore the potential of our SCI-160 platform when combined with the T&T technology, in the fourth quarter of 2025.

     

    People

     

    Our leadership team has a vast industry experience. Our management team has over 15 years (on average) of experience in life science companies. Our board of directors have vast experience in the life sciences industry as well as strong financial background. We believe that the holistic knowhow of our group will strongly contribute to a successful path from clinical development, regulatory approvals and commercialization of our product candidates. In addition, our management is supported by our Scientific Advisory Board which is an advisory panel of world-renowned academics and thought leaders with expertise in drug delivery systems, chemistry and pharmaceuticals. 

     

    Market Opportunities

     

    We believe that our technologies have the potential to provide solutions to a broad range of unmet needs in the healthcare market. With our C&C technology, we aim to introduce solutions to address common medical and public health challenges, such as allergic rhinitis and nasal viral infections, including COVID-19. Looking towards the future, the COVID-19 pandemic highlighted the need for action at the global level to invest in technologies, tools and solutions that will help overcome the next world health crisis. We believe our technology can play an important role in aiding nations and global organizations to combat viral outbreaks. While people across the world have become accustomed to preventative measures such as vaccination, wearing masks, keeping social distance and maintaining proper hygiene, we believe that there is an obvious need for a broader arsenal of more technologically advanced tools to help protect people as they return to normal routine.

     

    With our T&T technology, we aim to address challenges in the markets of: allergic and non-allergic rhinitis by local intranasal delivery of corticosteroids; for systemic delivery of central nervous system, or CNS, related drugs for the growing markets of combatting opioid overdose using intranasal naloxone, and benzodiazepines for seizure clusters 

     

    3

     

    Recent Developments

     

    Private Placement

     

    On March 31, 2025, we entered into a definitive securities purchase agreement, or the Purchase Agreement, with institutional investors who are named as Selling Shareholders in this prospectus for the purchase and sale in the Private Placement of approximately $17.0 million of ordinary units, or the Ordinary Units, and pre-funded units, the Pre-Funded Units, at purchase price of $0.48 per Ordinary Unit and $0.47999 per Pre-Funded Unit, respectively.

     

    Each Ordinary Unit consists of (i) one PIPE Share and (ii) one Series A Warrant. Each Pre-Funded Unit consists of (i) one Pre-Funded Warrant and (ii) one Series A Warrant. In the Private Placement, we issued 2,245,834 Ordinary Units and 33,170,833 Pre-Funded Units.

     

    The initial exercise price of each Series A Warrant is $1.20 per share or pursuant to an alternative cashless exercise option. The Series A Warrants are exercisable following shareholder approval and have a term of 30 months. The number of securities issuable under the Series A Warrant is subject to adjustment as described in more detail in the Series A Warrant.

     

    On March 31, 2025, we also entered into an exchange agreement, or the Exchange Agreement with certain holders, or the Holders, of warrants to purchase Ordinary Shares previously issued by us in October 2024. Under the Exchange Agreement, the Holders agreed to exchange with us such existing warrants for 3,926,304 Exchange Warrants, which are substantially in the form of the Series A Warrants. The initial exercise price of each Exchange Warrant is $1.20 per share or pursuant to an alternative cashless exercise option. The Exchange Warrants are exercisable following shareholder approval and have a term of 30 months. The number of securities issuable under the Exchange Warrant is subject to adjustment as described in more detail in the Exchange Warrant.

     

    Each Pre-Funded Warrant is exercisable for one Ordinary Share for $0.00001 following shareholder approval until all of the Pre-Funded Warrants are exercised in full. The number of Ordinary Shares issuable upon the exercise of the Pre-Funded Warrants are subject to adjustments for share splits, recapitalizations, and reorganizations.

     

    In connection with the Private Placement, we also entered into a registration rights agreement with the institutional investors who are named as Selling Shareholders in this prospectus on March 31, 2025, or the Registration Rights Agreement, pursuant to which we are required to file a registration statement covering the resale of the PIPE Shares and the Ordinary Shares issuable upon the exercise of the Warrants within 30 calendar days of the closing of the Private Placement.

     

    On March 31, 2025, we also entered into a placement agent agreement, or the Placement Agent Agreement, with Aegis Capital Corp., or Aegis or the placement agent, pursuant to which we engaged Aegis to act as our sole placement agent in connection with the offering. Pursuant to the terms of the Placement Agent Agreement, the placement agent agreed to use its best efforts to arrange for the sale of the PIPE Shares and Warrants in the offering. As compensation to the placement agent, we agreed paid the placement agent placement a commission equal to 10.0% of the aggregate gross proceeds from the offering. In addition, we reimbursed the placement agent for certain of out-of-pocket expenses, including for reasonable legal fees and disbursements for its counsel.

     

    The aggregate gross proceeds to us from the Private Placement were approximately $17.0 million, before deducting fees to the placement agent and other expenses payable by us in connection with the offering. In addition, $5.0 million is being held in escrow pending our performance of certain post-closing obligations.

     

    The foregoing summaries of the terms and conditions of each of the Purchase Agreement, the Series A Warrant, the Pre-Funded Warrant, the Placement Agent Agreement, the Registration Rights Agreement and the Exchange Agreement are subject to, and qualified in their entirety by reference to the full text of such agreement, copies of which are filed with the SEC on our Report on Form 6-K, as filed with the SEC on April 1, 2025.

     

    We recently signed a non-binding letter of intent with Clearmind Medicine Inc., a biotech company specializing in psychedelic-derived therapeutics. Under this collaboration, we will leverage our proprietary T&T platform to develop an innovative intranasal formulation aimed at optimizing absorption and therapeutic efficacy of psychedelic-based treatments. The partnering company will finance the related research and development, including initial feasibility studies.

     

    4

     

    Corporate Information

     

    We are an Israeli corporation, incorporated in January 2005. Our principal executive offices are located at 5 Ha-Tidhar Street, Raanana, 4366507, Israel. Our telephone number is +972-9-3740120. Our website address is www.polyrizon-biotech.com. The information contained on our website and available through our website is not incorporated by reference into and should not be considered a part of this prospectus, and the reference to our website in this prospectus is an inactive textual reference only.

     

    Implications of Being an “Emerging Growth Company” and a Foreign Private Issuer

     

    Emerging Growth Company

     

    As a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. In particular, as an emerging growth company, we:

     

      ● may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registration statement;

     

      ● are not required to provide a detailed narrative disclosure discussing our compensation principles, objectives and elements and analyzing how those elements fit with our principles and objectives, which is commonly referred to as “compensation discussion and analysis”;

     

      ● are not required to obtain a non-binding advisory vote from our shareholders on executive compensation or golden parachute arrangements (commonly referred to as the “say-on-pay,” “say-on frequency” and “say-on-golden-parachute” votes);

     

      ● will not be required to conduct an evaluation of our internal control over financial reporting;

     

      ● are exempt from certain executive compensation disclosure provisions requiring a pay-for-performance graph and chief executive officer pay ratio disclosure; and

     

      ● an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.

     

    We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earlier to occur of: (1) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (2) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; (3) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC; or (4) the last day of the fiscal year following the fifth anniversary of our initial public offering (i.e., December 31, 2029). We may choose to take advantage of some but not all of these reduced burdens, and therefore the information that we provide holders of our Ordinary Shares may be different than the information you might receive from other public companies in which you hold equity. In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies. We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies which may make comparison of our financials to those of other public companies more difficult. In addition, the information that we provide in this prospectus may be different than the information you may receive from other public companies in which you hold equity interests.

     

    5

     

    Foreign Private Issuer

     

    We report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we continue to qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

     

      ● the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act;

     

      ● the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

     

      ● the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial statements and other specified information, and current reports on Form 8-K upon the occurrence of specified significant events.

     

    We are required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we intend to publish our results on a quarterly basis through press releases, distributed pursuant to the rules and regulations of the Nasdaq Stock Exchange. Press releases relating to financial results and material events will also be furnished to the SEC on Form 6-K. However, the information we are required to file with or furnish to the SEC will be less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information, which would be made available to you, were you investing in a U.S. domestic issuer.

     

    We may take advantage of these exemptions until such time as we are no longer a foreign private issuer. We would cease to be a foreign private issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (i) the majority of our executive officers or directors are U.S. citizens or residents; (ii) more than 50% of our assets are located in the United States; or (iii) our business is administered principally in the United States.

     

    Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.

     

    6

     

    THE OFFERING

     

    Ordinary Shares currently issued and outstanding   6,805,210 Ordinary Shares.
         
    Ordinary Shares offered by the Selling Shareholders   Up to 1,513,858,167 Ordinary Shares consisting of (i) 2,245,834 PIPE Shares, (ii) up to 33,170,833 Ordinary Shares issuable upon the exercise of the Pre-Funded Warrants, (iii) up to 1,330,897,717 Ordinary Shares issuable upon the exercise of the Series A Warrants and (iv) up to 147,543,783 Ordinary Shares issuable upon the exercise of the Exchange Warrants.
         
    Ordinary shares to be outstanding assuming exercise of the Warrants   1,518,417,543 Ordinary Shares.
         
    Use of proceeds   We will not receive any proceeds from the sale of the PIPE Shares or the Ordinary Shares issuable upon the exercise of the Warrants held by the Selling Shareholders being registered in the registration statement of which this prospectus is a part. However, we may receive the proceeds from the exercise of the Warrants if the Selling Shareholders do not exercise on a cashless basis, if and when exercised. See the section of this prospectus titled “Use of Proceeds.”
         
    Nasdaq Capital Market symbol   PLRZ.
         
    Risk Factors   You should read the “Risk Factors” section starting on page 9 of this prospectus, and “Item 3. - Key Information – D. Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2024, or the 2024 Annual Report, incorporated by reference herein, and other information included or incorporated by reference in this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities.

     

    Unless otherwise stated, all information in this prospectus is based on 6,805,210 Ordinary shares outstanding as of April 29, 2025, and does not include the following as of that date:

     

      ● 5,363,007 Ordinary Shares issuable upon the exercise of warrants (including the Pre-Funded Warrants, Series A Warrants and Common Warrants), with a weighted average exercise price of 4.38, subject to adjustment as set forth in each such warrant.

     

      ● 246,129 Ordinary Shares issuable upon the exercise of options issued to directors, employees and consultants under our incentive option plan outstanding as of such date, with exercise prices ranging from $0.02 to $1.1335 per share, of which options to purchase 230,473 Ordinary Shares were vested as of such date;

     

      ● 400,502 Ordinary Shares issuable upon the issuance of RSUs consisting of (i) 13,000 RSUs granted to certain of the Company’s consultants and (ii) 387,502 RSUs to be granted to Company’s directors and executive officers, which such grants are subject to the approval of the Company’s shareholders.

     

      ● 153,369 Ordinary Shares reserved for future issuance under our equity incentive plan, or the 2021 Equity Incentive Plan.

     

    Unless otherwise indicated, all information in this prospectus assumes or gives effect to: 

     

      ● no exercise of the Warrants; and

     

      ● the Initial Reverse Share Split, the Forward Share Split, the Second Reverse Share Split, the Third Reverse Share Split, and the Second Forward Share Split.

     

    See “Description of Share Capital” for additional information.  

     

    7

     
    SUMMARY FINANCIAL DATA

     

    The following table summarizes our financial data. We have derived the following statements of comprehensive loss data for the years ended December 31, 2024 and 2023 and the balance sheet data as of December 31, 2024, from our audited financial statements as of December 31, 2024, that are incorporated by reference into this prospectus. Such financial statements have been prepared in accordance with U.S. GAAP. Our historical results are not necessarily indicative of the results that may be expected in the future. The following summary financial data should be read in conjunction with our financial statements and related notes that are incorporated by reference into this prospectus and the other financial information included or incorporated by reference into this prospectus.

     

       For the Years Ended
    December 31,
     
    (U.S. dollars in thousands except share and per share data)  2024   2023 
    Statement of Comprehensive Loss:        
    Research and development expenses  $534    332 
    General and administrative expenses   768    303 
    Operating loss   1,302    635 
    Financing expense (income), net   243    (35)
    Net loss and comprehensive loss   1,545    600 
    Basic and diluted net loss per share  $0.5    0.3 
    Weighted average number of shares outstanding used in computing basic and diluted net loss per share   2,991,193    2,030,327 

     

       As of December 31, 2024 
    (U.S. dollars in thousands)  Actual   Pro Forma(1) 
    Balance Sheet:        
    Cash and cash equivalents  $2,554   $17,519 
    Other current assets  $99   $99 
    Property and equipment, net  $10   $10 
    Intangible asset, net  $2,884   $2,884 
    Total assets  $5,547   $20,512 
               
    Employees and payroll related liabilities  $45   $45 
    Other payables and accrued expenses  $216   $216 
    Warrant liability       $4,073 
    Total current liabilities  $261   $4,334 
               
    Ordinary shares  $-   $- 
    Additional paid-in capital  $10,352   $21,731 
    Accumulated deficit  $(5,066)  $(5,553)
    Total shareholders’ equity  $5,286   $16,178 
               
    Total liabilities and shareholders’ equity  $5,547   $20,594 

     

    (1) Pro Forma data gives effect to (i) the issuance of 364,931 Ordinary Shares as a results of the exercise of  pre-funded warrants originally issued in October 2024 for aggregate gross proceeds of $364.93, (ii) the issuance and sale of (A) 2,245,834 PIPE Shares, (B) 33,170,833 Pre-Funded Warrants, (C) 35,416,667 Series A Warrants and (D) 3,926,304 Exchange Warrants in connection with the Private Placement for aggregate gross proceeds of approximately $17.0 million, before deducting fees to the placement agent and other expenses payable by us in connection with the offering and (iii) the increase of our authorized share capital to 2,000,000,000 ordinary shares as approved by our shareholders at our annual general meeting of shareholders held in April 2025, as if such events had occurred on December 31, 2024.

     

    8

     

    RISK FACTORS

     

    You should carefully consider the risks described below and the risks described in our 2024 Annual Report, which are incorporated by reference herein, as well as the financial or other information included in this prospectus or incorporated by reference in this prospectus, including our consolidated financial statements and the related notes, before you decide to buy our securities. The risks and uncertainties described below are not the only risks facing us. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial. Any of the risks described below, and any such additional risks, could materially adversely affect our business, financial condition or results of operations. In such case, you may lose all or part of your original investment.

     

    The sale of a substantial amount of our ordinary shares, including resale of the ordinary shares issuable upon the exercise of the warrants held by the selling shareholders in the public market could adversely affect the prevailing market price of our ordinary shares.

     

    We are registering for resale an aggregate of 1,513,858,167 Ordinary Shares consisting of the PIPE Shares and the Ordinary Shares issuable upon the exercise of Warrants held by the Selling Shareholders. Sales of substantial amounts of our Ordinary Shares in the public market, or the perception that such sales might occur, could adversely affect the market price of our Ordinary Shares, and the market value of our other securities. We cannot predict if and when Selling Shareholders may sell such shares in the public markets. Furthermore, in the future, we may issue additional Ordinary Shares or other equity or debt securities convertible into Ordinary Shares. Any such issuance could result in substantial dilution to our existing shareholders and could cause our share price to decline.

     

    Raising additional capital or the issuance of additional equity securities would cause dilution to our existing shareholders and may affect the rights of existing shareholders or the market price of our ordinary shares.

     

    We may seek additional capital through a combination of private and public equity offerings, debt financings and collaborations and strategic arrangements. To the extent that we raise additional capital through the issuance of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a holder of our ordinary shares.

     

    In addition, our authorized share capital consists of 2,000,000,000 ordinary shares, with no par value. As of April 29, 2025, we had 6,805,210 ordinary shares issued and outstanding. As of April 29, 2025, we also had warrants to purchase 5,363,007 ordinary shares outstanding, options to purchase 246,129 ordinary shares outstanding, of which 230,483 are currently vested and 400,502 RSUs outstanding. Our board of directors may issue, or reserve for issuance, an additional 1,987,185,152 ordinary shares, which might dilute your holdings substantially.

     

    To the extent that ordinary shares are issued, options and warrants are exercised or anti-dilution protections are triggered in our equity instruments, holders of our ordinary shares will experience dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable for ordinary shares, holders of our ordinary shares may experience dilution. We also consider from time to time various strategic alternatives that could involve issuances of additional ordinary shares, including but not limited to acquisitions and business combinations, but do not currently have any definitive plan to enter into any such transaction.

     

    9

     

    If we are unable for any reason to meet the continued listing requirements of Nasdaq, such action or inaction could result in a delisting of our ordinary shares.

     

    As previously disclosed, on April 8, 2025, we received an initial notification letter from Nasdaq’s Listing Qualifications Department notifying us that we had 180 days to regain compliance with the minimum bid price requirement set forth in Nasdaq’s continued listing rules. Nasdaq’s continued listing rules require that listed securities maintain a minimum bid price of $1.00 per share, and that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days or more. We have until October 6, 2025, to regain compliance with the minimum bid price requirement in order to maintain the listing. To regain compliance with the minimum bid price requirement, our ordinary shares must have a closing bid price of at least $1.00 for a minimum of 10 consecutive business days. In the event that we do not regain compliance by October 6, 2025, we may then be eligible for additional 180 days if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq, with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period. If we do not qualify for the second compliance period or fail to regain compliance during the second compliance period, then Nasdaq will notify us of its determination to delist our ordinary shares, at which point we will have an opportunity to appeal the delisting determination to a hearings panel. Trading of our ordinary shares will be automatically moved to the OTC market during the pendency of the hearing panel’s review.

     

    If we fail to satisfy the continued listing requirements of Nasdaq, such as the minimum closing bid price requirement, Nasdaq may take steps to delist our ordinary shares. Such a delisting would likely have a negative effect on the price of our ordinary shares and would impair your ability to sell or purchase our ordinary shares when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our ordinary shares to become listed again, stabilize the market price or improve the liquidity of our ordinary shares, prevent our ordinary shares from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

     

    Our headquarters and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them.

     

    Our executive offices, research and development laboratories are located in Ra’anana, Israel. In addition, the majority of our key employees, officers and directors are residents of Israel. Accordingly, political, geopolitical, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and groups in its neighboring countries, and between Israel and the Hamas (an Islamist militia and political group in the Gaza Strip), Hezbollah (an Islamist militia and political group in Lebanon) and other terrorist organizations active in the region.

     

    In particular, 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. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and kidnapping of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and these terrorist organizations in parallel continued rocket and terror attacks. As a result of the events of October 7, 2023 whereby Hamas terrorists invaded southern Israel and launched thousands of rockets in a widespread terrorist attack on Israel, the Israeli government declared that the country was at war and the Israeli military began to call-up reservists for active duty. None of our employees or contractors were called up for active duty; however military service call ups that result in absences of personnel from us for an extended period of time may materially and adversely affect our business, prospects, financial condition and results of operations. As of March 10, 2025, we currently have one full-time employee, four part-time contractors and one full-time contractor (our Chief Executive Officer), with four employees/contractors located in Israel and 2 employee/contractors located outside of Israel.

     

    10

     

    Since the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced disruptions to our development. Our commercial operations, including Product Development, Regulatory Compliance, Market Research, Commercialization Strategy, Partnerships and Collaborations, Intellectual Property Management take place in the Tel Aviv, Israel area and remain unaffected by the war against Hamas. During January 2025, a ceasefire was negotiated between Israel and Hamas, the result of which is uncertain.. However, the intensity and duration of the security situation in Israel is difficult to predict at this stage, as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general. If the ceasefires declared collapse or a new war commences or hostilities expand to other fronts our operations may be adversely affected.

     

    Since the commencement of these events, there have been continued hostilities along Israel’s northern border with the Hezbollah terror organization), with Iran, the Houthis in Yemen and on other fronts with various extremist groups in the region, such as various rebel militia groups in Syria and Iraq. In October 2024, Israel began limited ground operations against Hezbollah in Lebanon, and in November 2024, a ceasefire was brokered between Israel and Hezbollah. It is possible that hostilities with Iran, Hezbollah, the Houthis and terrorist groups in Syria will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank, will join the hostilities. Iran, who launched direct attacks on Israel involving drones and missiles, is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthis in Yemen and various rebel militia groups in Syria and Iraq. In addition, in December 2024, the Assad regime in Syria was overthrown and there can be no assurance that this will lead to peace or stability. These situations may potentially escalate in the future to more violent events which may affect Israel and us. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our results of operations and could make it more difficult for us to raise capital. Parties with whom we do business may decline to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in order to meet our business partners face to face. In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating results, financial condition or the expansion of our business. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations.

     

    Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on our business, financial condition and results of operations. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.

     

    Finally, political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest. Actual or perceived political instability in Israel, or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

     

    11

     

    SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

     

    This prospectus and elsewhere, including in our 2024 Annual Report incorporated by reference herein, and other information included or incorporated by reference in this prospectus, 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. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

     

      ● the ability of our clinical trials to demonstrate safety and efficacy of our future product candidates, and other positive results;
         
      ● the timing and focus of our future preclinical studies and clinical trials, and the reporting of data from those studies and trials;
         
      ● the size of the market opportunity for our future product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
         
      ● the success of competing therapies that are or may become available;
         
      ● the beneficial characteristics, safety, efficacy and therapeutic effects of our future product candidates;
         
      ● our ability to obtain and maintain regulatory approval of our future product candidates;
         
      ● our plans relating to the further development of our future product candidates, including additional disease states or indications we may pursue;
         
      ● existing regulations and regulatory developments in the United States and other jurisdictions;
         
      ● our plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available and our ability to avoid infringing the intellectual property rights of others;
         
      ● the need to hire additional personnel and our ability to attract and retain such personnel;
         
      ● our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
         
      ● our dependence on third parties;

     

    12

     

      ● our financial performance;
         
      ● the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
         
      ● our ability to generate revenue and profit margin under our anticipated contracts which is subject to certain risks;
         
      ● difficulties in our and our partners’ ability to recruit and retain qualified physicians and other healthcare professionals, and enforce our non-compete agreements with our physicians;
         
      ● our ability to restructure our operations to comply with future changes in government regulation;
         
      ● our ability to maintain the listing of our ordinary shares on Nasdaq;
         
      ● security, political and economic instability in the Middle East that could harm our business, including due to current security situation in Israel; and
         
      ● those factors referred to in our 2024 Annual Report incorporated by reference herein in “Item 3. Key Information – D. Risk Factors,” “Item 4. Information on the Company,” and “Item 5. Operating and Financial Review and Prospects,” as well as in our 2024 Annual Report generally, which is incorporated by reference into this prospectus.

     

    Forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this prospectus may turn out to be inaccurate. Important factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in this prospectus. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements.

     

    The forward-looking statements included in this prospectus speak only as of the date of this prospectus. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this prospectus. See “Where You Can Find More Information.”

    13

     

    USE OF PROCEEDS

     

    We will not receive any of the proceeds from the sale of the Ordinary Shares being offered for sale by the Selling Shareholders. Upon the exercise of the Pre-Funded Warrants, the Series A Warrants and the Exchange Warrants by payment of cash, we will receive the applicable exercise price of the Pre-Funded Warrants, the Series A Warrants and the Exchange Warrants. We will bear all fees and expenses incident to our obligation to register the PIPE Shares and the Ordinary Shares issuable upon the exercise of the Pre-Funded Warrants, the Series A Warrants and the Exchange Warrants. Brokerage fees, commissions and similar expenses, if any, attributable to the sale of shares offered hereby will be borne by the Selling Shareholders.

     

    There is no assurance the Pre-Funded Warrants, the Series A Warrants and the Exchange Warrants will be exercised for cash. We intend to use such proceeds, if any, together with our existing cash, for general corporate purposes and working capital.

     

    14

     

    DIVIDEND POLICY

     

    We have never declared or paid any cash dividends to our shareholders of our Ordinary Shares, and we do not anticipate or intend to pay cash dividends in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors in compliance with applicable legal requirements and will depend on a number of factors, including future earnings, our financial condition, operating results, contractual restrictions, capital requirements, business prospects, our strategic goals and plans to expand our business, applicable law and other factors that our board of directors may deem relevant.

     

    The Israeli Companies Law, 5759-1999, imposes further restrictions on our ability to declare and pay dividends.

     

    Payment of dividends may be subject to Israeli withholding taxes. See “Taxation—Material Israeli Tax Considerations” in the 2024 Annual Report for additional information.

     

    15

     

    CAPITALIZATION

     

    The following table sets forth our cash and cash equivalents and our capitalization as of December 31, 2024:

     

      ● on an actual basis.

     

      ● On a pro forma basis to give effect to (i) the issuance of 364,931 Ordinary Shares as a results of the exercise of  pre-funded warrants originally issued in October 2024 for aggregate gross proceeds of $364.93, (ii) the issuance and sale of (A) 2,245,834 PIPE Shares, (B) 33,170,833 Pre-Funded Warrants, (C) 35,416,667 Series A Warrants and (D) 3,926,304 Exchange Warrants in connection with the Private Placement for aggregate gross proceeds of approximately $17.0 million, before deducting fees to the placement agent and other expenses payable by us in connection with the offering and (iii) the increase of our authorized share capital to 2,000,000,000 ordinary shares as approved by our shareholders at our annual general meeting of shareholders held in April 2025, as if such events had occurred on December 31, 2024.

     

    The following table should be read in conjunction our financial statements and related notes that are incorporated by reference into this prospectus and the other financial information included or incorporated by reference into this prospectus. Our historical results do not necessarily indicate our expected results for any future periods.

     

       As of December 31, 2024 
    U.S. dollars in thousands 

    Actual
    (Audited)

       Pro Forma
    (Unaudited)
     
         
    Shareholders’ equity:        
    Ordinary shares, no par value per share; 20,000,000 shares authorized, 4,194,445 shares issued and outstanding; 2,000,000,000 shares authorized and 6,805,220 shares issued and outstanding, pro forma;  $-    - 
    Additional paid-in capital  $10,352    21,731 
    Accumulated deficit  $(5,066)   (5,553)
    Total shareholders’ equity  $5,286    16,178 
    Total capitalization  $5,286    16,178 

     

    The foregoing pro forma presentation of our capitalization is based on 4,194,445, Ordinary Shares issued and outstanding as of December 31, 2024. This number excludes:

     

      ● 5,363,007 Ordinary Shares issuable upon the exercise of warrants, with an average exercise price of $4.38, subject to adjustment as set forth in each such warrant.

     

      ● 246,129 Ordinary Shares issuable upon the exercise of options issued to directors, employees and consultants under our incentive option plan outstanding as of such date, with exercise prices ranging from $0.02 to $1.1335 per share, of which options to purchase 208,290 Ordinary Shares were vested as of such date; 

     

      ● 400,502 Ordinary Shares issuable upon the issuance of RSUs consisting of (i) 13,000 RSUs granted to certain of the Company’s consultants and (ii) 387,502 RSUs to be granted to Company’s directors and executive officers, which such grants are subject to the approval of the Company’s shareholders;

     

      ● 153,369 Ordinary Shares reserved for future issuance under our 2021 Equity Incentive Plan;

     

      ● 364,931 Ordinary Shares issued upon the exercise of pre-funded warrants after such date;

     

      ● 2,245,834 Ordinary Shares issued in the Private Placement;

     

      ● 33,170,833 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants issued in the Private Placement, subject to adjustments;

     

      ● 35,416,667 Ordinary Shares issuable upon the exercise of Series A Warrants issued in the Private Placement, subject to adjustments; and

     

      ● 3,926,304 Ordinary Shares issuable upon the exercise of Exchange Warrants issued in the Private Placement, subject to adjustments.

     

    16

     

    DESCRIPTION OF SHARE CAPITAL

     

    The following descriptions of our share capital and provisions of our articles of association are summaries and do not purport to be complete. A form of our amended and restated articles of association is filed with the SEC as an exhibit to our registration statement, of which this prospectus forms a part.

     

    General

     

    On April 17, 2025, our shareholders approved an increase in our authorized share capital from 20,000,000 ordinary shares, with no par value, to 2,000,000,000 ordinary shares, with no par value. Accordingly, our registered share capital consists of 2,000,000,000 ordinary shares, with no par value. All of our outstanding Ordinary Shares have been validly issued, fully paid and non-assessable. Our Ordinary Shares are not redeemable and are not subject to any preemptive right. All Ordinary Shares have identical voting and other rights in all respects.

     

    The Nasdaq Capital Market

     

    Our ordinary shares are listed on the Nasdaq Capital Market under the symbol “PLRZ”.

     

    Articles of Association

     

    Articles of Association

     

    The following are summaries of material provisions of our amended and restated articles, or the Articles, of association and the Israeli Companies Law, 5759-1999, or the Companies Law, insofar as they relate to the material terms of our ordinary shares.

     

    Purposes and Objects of the Company

     

    Our purpose as set forth in our Articles is to engage in any lawful activity.

     

    Registration Number

     

    Our registration number with the Israeli Registrar of Companies is 513637025.

     

    The Powers of the Directors

     

    Our Board of Directors shall direct our policy and shall supervise the performance of our Chief Executive Officer and his actions. Our Board of Directors may exercise all powers that are not required under the Companies Law or under our Articles to be exercised or taken by our shareholders.

     

    Rights Attached to Shares

     

    Our Ordinary Shares shall confer upon the holders thereof:

     

      ● equal right to attend and to vote at all of our general meetings, whether regular or special, with each Ordinary Share entitling the holder thereof, which attend the meeting and participate at the voting, either in person or by a proxy or by a written ballot, to one vote;

     

      ● equal right to participate in distribution of dividends, if any, whether payable in cash or in bonus shares, in distribution of assets or in any other distribution, on a per share pro rata basis; and    

     

      ● equal right to participate, upon our dissolution, in the distribution of our assets legally available for distribution, on a per share pro rata basis.

     

    17

     

    Election of Directors

     

    Pursuant to our Articles, our directors are divided into three classes with staggered three-year terms. Each class of directors consists, as nearly as possible, of one-third of the total number of directors constituting the entire board of directors (other than the external directors, to the extent applicable). At each annual general meeting of our shareholders, the election or re-election of directors following the expiration of the term of office of the directors of that class of directors is for a term of office that expires on the third annual general meeting following such election or re-election, such that at each annual general meeting the term of office of only one class of directors expires. Each director will hold office until the annual general meeting of our shareholders in which his or her term expires, unless they are removed by a vote of 70%% of the total voting power of our shareholders at a general meeting of our shareholders (and provided such majority constitutes more than 50% of the Company’s then issued and outstanding share capital) or upon the occurrence of certain events, in accordance with the Companies Law and our articles. External directors, if applicable, are elected for an initial term of three years, may be elected for additional terms of three years each under certain circumstances, and may be removed from office pursuant to the terms of the Companies Law.

     

    Annual and Special Meetings

     

    Under the Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year, at such time and place which shall be determined by our Board of Directors, that must be no later than 15 months after the date of the previous annual general meeting. All meetings other than the annual general meeting of shareholders are referred to as special general meetings. Our Board of Directors may call special meetings whenever it sees fit and upon the request (i) any two of our directors or such number of directions equal to ¼ of the directors then at office (ii) any shareholder or shareholders holding at least five percent (5%) or a higher percent of our outstanding and issued shares and 1% of our outstanding voting rights or (iii) any shareholder or shareholders holding at least five percent (5%) of our outstanding voting rights. 

     

    Subject to the provisions of the Companies Law and the regulations promulgated thereunder, shareholders entitled to participate and vote at general meetings are the shareholders of record on a date to be decided by the board of directors, which may be between four and twenty-one days prior to the date of the meeting. Resolutions regarding the following matters must be passed at a general meeting of our shareholders:

     

      ● amendments to our Articles;

     

      ● the exercise of our Board of Director’s powers by a general meeting if our Board of Directors is unable to exercise its powers and the exercise of any of its powers is required for our proper management;

     

      ● appointment or termination of our auditors;

     

      ● appointment of directors, including external directors;

     

      ● approval of acts and transactions requiring general meeting approval pursuant to the provisions of the Companies Law (mainly certain related party transactions) and any other applicable law;

     

      ● increases or reductions of our authorized share capital;

     

      ● a merger (as such term is defined in the Companies Law); and

     

      ● a dissolution of the company by its shareholders (as such term is defined in the Company’s Law).

     

    18

     

    Notices

     

    The Companies Law and our Articles require that a notice of any annual or special shareholders meeting be published in at least two widely circulated newspapers, in addition to the company’s internet website, at least 21 days prior to the meeting, and if the agenda of the meeting includes the appointment or removal of directors, the approval of transactions with office holders or interested or related parties, approval of the company’s general manager to serve as the chairman of the board of directors or an approval of a merger, notice must be provided at least 35 days prior to the meeting.

      

    Quorum

     

    As permitted under the Companies Law, the quorum required for our general meetings consists of at least two shareholders present in person, by proxy, written ballot or voting by means of electronic voting system, who hold or represent between them at least 25% of the total outstanding voting rights. If within half an hour of the time set forth for the general meeting a quorum is not present, the general meeting shall stand adjourned the same day of the following week, at the same hour and in the same place, or to such other date, time and place as prescribed in the notice to the shareholders and in such adjourned meeting, if no quorum is present within half an hour of the time arranged, any number of shareholders participating in the meeting, shall constitute a quorum.

     

    If a special general meeting was summoned following the request of a shareholder, and within half an hour a legal quorum shall not have been formed, the meeting shall be canceled.

     

    Adoption of Resolutions

     

    Our Articles provide that all resolutions of our shareholders require a simple majority vote, unless otherwise required under the Companies Law or our Articles. A shareholder may vote in a general meeting in person, by proxy, by a written ballot.

     

    Changing Rights Attached to Shares

     

    Unless otherwise provided by the terms of the shares and subject to any applicable law, any modification of rights attached to any class of shares must be adopted by the holders of a majority of the shares of that class present a general meeting of the affected class or by a written consent of all the shareholders of the affected class.

     

    The enlargement of an existing class of shares or the issuance of additional shares thereof, shall not be deemed to modify the rights attached to the previously issued shares of such class or of any other class, unless otherwise provided by the terms of the shares.

     

    Limitations on the Right to Own Securities in Our Company

     

    There are no limitations on the right to own our securities. In certain circumstances the Warrants being offered hereby have restrictions upon the exercise of such warrants if such exercise would result in the holders thereof owning more than 4.99% or 9.99% of our Ordinary Shares upon such exercise, as further described below.

     

    19

     

    Provisions Restricting Change in Control of Our Company

     

    There are no specific provisions of our Articles that would have an effect of delaying, deferring or preventing a change in control of our company or that would operate only with respect to a merger, acquisition or corporate restructuring involving us (or our Subsidiary). However, as described below, certain provisions of the Companies Law may have such effect.

     

    The Companies Law includes provisions that allow a merger transaction and requires that each company that is a party to the merger have the transaction approved by its board of directors and, unless certain requirements described under the Companies Law are met, a vote of the majority of shareholders, and, in the case of the target company, also a majority vote of each class of its shares.  For purposes of the shareholder vote of each party, unless a court rules otherwise, the merger will not be deemed approved if shares representing a majority of the voting power present at the shareholders meeting and which are not held by the other party to the merger (or by any person or group of persons acting in concert who holds 25% or more of the voting power or the right to appoint 25% or more of the directors of the other party) vote against the merger. If, however, the merger involves a merger with a company’s own controlling shareholder or if the controlling shareholder has a personal interest in the merger, then the merger is instead subject to the same Special Majority approval that governs all extraordinary transactions with controlling shareholders. Upon the request of a creditor of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that as a result of the merger the surviving company will be unable to satisfy the obligations of any of the parties to the merger, and may further give instructions to secure the rights of creditors. If the transaction would have been approved by the shareholders of a merging company but for the separate approval of each class or the exclusion of the votes of certain shareholders as provided above, a court may still approve the merger upon the petition of holders of at least 25% of the voting rights of a company. For such petition to be granted, the court must find that the merger is fair and reasonable, taking into account the value of the parties to the merger and the consideration offered to the shareholders. In addition, a merger may not be completed unless at least (1) 50 days have passed from the time that the requisite proposals for approval of the merger were filed with the Israeli Registrar of Companies by each merging company and (2) 30 days have passed since the merger was approved by the shareholders of each merging company.

     

    The Companies Law also provides that, subject to certain exceptions, an acquisition of shares in an Israeli public company must be made by means of a “special” tender offer if as a result of the acquisition (1) the purchaser would become a controlling shareholder if there is no controlling shareholder in the company or (2) the purchaser would become a holder of 45% or more of the voting rights in the company, unless there is already a holder of more than 45% of the voting rights in the company. These requirements do not apply if, in general, the acquisition (1) was made in a private placement that received shareholders’ approval, subject to certain conditions, (2) was from a controlling shareholder in the company which resulted in the acquirer becoming a controlling shareholder in the company, or (3) was from a holder of more than 45% of the voting rights in the company which resulted in the acquirer becoming a holder of more than 45% of the voting rights in the company. A “special” tender offer must be extended to all shareholders. In general, a “special” tender offer may be consummated only if (1) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by the offeror and (2) the offer is accepted by a majority of the offerees who notified the company of their position in connection with such offer (excluding the offeror, controlling shareholders, holders of 25% or more of the voting rights in the company or anyone on their behalf, or any person having a personal interest in the acceptance of the tender offer). If a special tender offer is accepted, then the purchaser or any person or entity controlling it or under common control with the purchaser or such controlling person or entity may not make a subsequent tender offer for the purchase of shares of the target company and may not enter into a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender offer.

     

    If, as a result of an acquisition of shares, the acquirer will hold more than 90% of an Israeli company’s outstanding shares or of certain class of shares, the acquisition must be made by means of a tender offer for all of the outstanding shares, or for all of the outstanding shares of such class, as applicable. In general, if less than 5% of the outstanding shares, or of applicable class, are not tendered in the tender offer and more than half of the offerees who have no personal interest in the offer tendered their shares, all the shares that the acquirer offered to purchase will be transferred to it by operation of law. However, a tender offer will also be accepted if the shareholders who do not accept the offer hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of shares. Any shareholders that was an offeree in such tender offer, whether such shareholder accepted the tender offer or not, may request, by petition to an Israeli court, (i) appraisal rights in connection with a full tender offer, and (ii) that the fair value should be paid as determined by the court, for a period of six months following the acceptance thereof. However, the acquirer is entitled to stipulate, under certain conditions, that tendering shareholders will forfeit such appraisal rights.

     

    Lastly, Israeli tax law treats some acquisitions, such as stock-for-stock exchanges between an Israeli company and a foreign company, less favorably than U.S. tax laws. For example, Israeli tax law may, under certain circumstances, subject a shareholder who exchanges his Ordinary Shares for shares in another corporation to taxation prior to the sale of the shares received in such stock-for-stock swap.

     

    20

     

    Exclusive Forum

     

    Our articles of association provide that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions, and accordingly, both state and federal courts have jurisdiction to entertain such claims. While the federal forum provision in our articles of association does not restrict the ability of our shareholders to bring claims under the Securities Act, we recognize that it may limit shareholders’ ability to bring a claim in the judicial forum that they find favorable and may increase certain litigation costs, which may discourage the filing of claims under the Securities Act against the Company, its directors and officers. However, the enforceability of similar forum provisions (including exclusive federal forum provisions for actions, suits or proceedings asserting a cause of action arising under the Securities Act) in other companies’ organizational documents has been challenged in legal proceedings, and there is uncertainty as to whether courts would enforce the exclusive forum provisions in our articles of association. Any person or entity purchasing or otherwise acquiring any interest in our share capital shall be deemed to have notice of and to have consented to the choice of forum provision of our articles of association described above. It is clarified that the federal district courts of the United States of America shall be the exclusive forum for suits brought to enforce a duty or liability created by the Exchange Act or the rules and regulations thereunder.

     

    Our Articles also provide that unless we consent in writing to the selection of an alternative forum, the competent courts in Tel Aviv, Israel shall be the exclusive forum for any derivative action or proceeding brought on behalf of the Company, any action asserting a breach of a fiduciary duty owed by any of our directors, officers or other employees to the Company or our shareholders or any action asserting a claim arising pursuant to any provision of the Companies Law or the Israeli Securities Law, 5728-1968.

     

    Changes in Our Capital

     

    The general meeting may, by a simple majority vote of the shareholders attending the general meeting:

     

      ● increase our registered share capital by the creation of new shares from the existing class or a new class, as determined by the general meeting;

     

      ● cancel any registered share capital which have not been taken or agreed to be taken by any person;

     

      ● consolidate and divide all or any of our share capital into shares of larger nominal value than our existing shares;

     

      ● subdivide our existing shares or any of them, our share capital or any of it, into shares of smaller nominal value than is fixed; and

     

      ● reduce our share capital and any fund reserved for capital redemption in any manner, and with and subject to any incident authorized, and consent required, by the Companies Law.

     

    21

     

    SELLING SHAREHOLDERS

     

    This prospectus covers the offering for resale of up to 1,513,858,167 Ordinary Shares by the Selling Shareholders consisting of the PIPE Shares and the Ordinary Shares issuable upon the exercise of the Warrants. This prospectus and any prospectus supplement will only permit the Selling Shareholders to sell the number of Ordinary Shares identified in the column “Maximum Number of Ordinary Shares to be Sold Pursuant to this Prospectus.” The Ordinary Shares issued to the Selling Shareholders are “restricted” securities under applicable U.S. federal and state securities laws and are being registered to provide the Selling Shareholders the opportunity to sell those Ordinary Shares. 

     

    The following table sets forth the name of the Selling Shareholders who are offering the Ordinary Shares for resale by this prospectus, the number and percentage of Ordinary Shares beneficially owned by each such Selling Shareholder, the maximum number of Ordinary Shares that may be offered for resale by this prospectus and the number of Ordinary Shares each such Selling Shareholder will own after the offering, assuming each such Selling Shareholder sells the maximum number of Ordinary Shares to be sold by it pursuant to this prospectus. The information appearing in the table below is based on information provided by or on behalf of each such Selling Shareholder. We will not receive any proceeds from the resale of the Ordinary Shares by the Selling Shareholders. The Selling Shareholder may sell all, some or none of their shares in this offering. See “Plan of Distribution” in this prospectus for additional information.

     

    Name of Selling Shareholder   Ordinary
    Shares Beneficially
    Owned Prior to Offering
        Maximum
    Number of
    Ordinary
    Shares to
    be Sold
    Pursuant
    to this
    Prospectus
        Ordinary Shares
    Owned
    Immediately
    After Sale of
    Maximum
    Number of
    Shares in this
    Offering
        Percentage of
    Ordinary
    Shares Owned
    After the
    Offering
     
    SciSparc Ltd. (1)     27,340,984 (2)     27,340,984 (2)                 -                   - %
    L.I.A. Pure Capital Ltd. (3)     162,041,064 (4)     162,041,064 (4)     -       - %
    Capitalink Ltd. (5)     22,913,548 (6)     22,913,548 (6)     -       - %
    Hudson Bay Master Fund Ltd. (7)     157,122,325 (8)     157,122,325 (8)     -       - %
    L1 Capital Global Opportunities Master Fund (9)     156,333,181 (10)     156,333,181 (10)     -       - %
    S.H.N Financial Investments Ltd. (11)     155,769,507 (12)     155,769,507 (12)     -       - %
    Sabby Volatility Warrant Master Fund, Ltd. (13)     150,696,438 (14)     150,696,438 (14)     -       - %
    Anson Investments Master Fund LP (15)     130,394,996 (16)     130,394,996 (16)     -       - %
    Anson East Master Fund LP (17)     33,153,216 (18)     33,153,216 (18)     -       - %
    Funds managed by Empery Asset Management, LP (19)     150,696,439 (20)     150,696,439 (20)     -       - %
    Bigger Capital Fund LP (21)     80,703,125 (22)     80,703,125 (22)     -       - %
    District 2 Capital Fund (23)     80,703,125 (24)     80,703,125 (24)     -       - %
    Boothbay Absolute Returns Strategies, LP (25)     78,561,163 (26)     78,561,163 (26)     -       - %
    Meteora Select Trading Opportunities Master, LP (27)     78,561,163 (28)     78,561,163 (28)     -       - %
    Clearmind Medicine Inc. (29)     25,093,089 (30)     25,093,089 (30)     -       - %
    Itamar David (31)     10,561,077 (32)     10,561,077 (32)     -       - %
    Gabriel Kabazo (33)     8,551,765 (34)     8,551,765 (34)     -       - %
    Amir Uziel Economic Consultant Ltd. (35)     4,661,962 (36)     4,661,962 (36)     -       - %

     

     

    (1) The address of SciSparc Ltd. is 20 Raul Wallenberg Street, Tower A, Tel Aviv 6971916, Israel. SciSparc Ltd. is a publicly traded company. To the best of our knowledge, SciSparc Ltd. does not have any controlling shareholders. The chief executive officer of SciSparc Ltd. is Oz Adler.

     

    (2) Consists of  (i) 208,333 PIPE Shares, (ii) up to 7,828,797 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to 19,303,854 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 12.36% of our outstanding Ordinary Shares prior to this offering.

     

    22

     

    (3) Kfir Silberman is the controlling shareholder of L.I.A. Pure Capital Ltd., and its address is 20 Raoul Wallenberg Street, Tel Aviv, Israel 6971916.

     

    (4) Consists of (i) 2,552,083 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (ii) up to 95,902,910 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to  63,586,071 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 49.97% of our outstanding Ordinary Shares prior to this offering.

      

    (5) Lavi Krasney is the officer, sole director, chairman of the board of directors and controlling shareholder of Capitalink Ltd., and its address is 20 Raoul Wallenberg Street, Tel Aviv, Israel 6971916.

     

    (6) Consists of (i) 216,667 PIPE Shares, (ii) 200,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 15,657,633 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  6,839,248 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 13.35% of our outstanding Ordinary Shares prior to this offering.

     

    (7) Hudson Bay Master Fund Ltd. ("Hudson Bay"). Hudson Bay Capital Management LP, the investment manager of Hudson Bay, has voting and investment power over these securities. Sander Gerber is the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management LP. Each of Hudson Bay and Sander Gerber disclaims beneficial ownership over these securities. The principal business address of Hudson Bay is c/o Hudson Bay Capital Management LP, 290 Harbor Dr., 3rd Floor, Stamford, CT 06902.

     

    (8) Consists of (i) 206,250 PIPE Shares, (ii) 3,700,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 146,790,188 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to 6,425,887 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 54.75% of our outstanding Ordinary Shares prior to this offering.

     

    (9) The shares will be directly held by L1 Capital Global Opportunities Master Fund, a Cayman Islands exempted company (the “L1 Fund”). David Feldman, the portfolio manager of L1 Capital Global Opportunities Master Fund, has voting and investment power over these securities. David Feldman and Joel Arber have voting and dispositive powers and disclaim beneficial ownership. The address of L1 Capital Global Opportunities Master Fund is 161A Shedden Road, 1 Artillery Court, PO Box 10085, Grand Cayman KY1-1001, Cayman Islands.

     

    (10) Consists of (i) 206,250 PIPE Shares, (ii) 3,700,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 146,790,188 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to 5,636,743 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 54.68% of our outstanding Ordinary Shares prior to this offering.

     

    (11) The shares will be directly held by S.H.N. Financial Investments Ltd., an Israeli corporation (“S.H.N.”), and may be deemed to be indirectly beneficially owned by Mr. Hadar Shamir and Mr. Nir Shamir who each own 50% of the company and have shared voting and dispositive power over the common shares. Mr. Hadar Shamir and Mr. Nir Shamir disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. The address of S.H.N. is c/o S.H.N. Financial Investments Ltd., 3 Arik Einstein Street, Herzilya, Israel.

     

    23

     

    (12) Consists of (i) 206,250 PIPE Shares, (ii) 3,700,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 146,790,188 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to 5,073,069 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 54.64% of our outstanding Ordinary Shares prior to this offering.

     

    (13) Sabby Management, LLC is the investment manager of Sabby Volatility Warrant Master Fund, Ltd. (“Sabby VWMF”) and shares voting and investment power with respect to these shares in this capacity. As manager of Sabby Management, LLC, Hal Mintz also shares voting and investment power on behalf of Sabby VWMF. Each of Sabby Management, LLC and Hal Mintz disclaims beneficial ownership over the securities listed except to the extent of their pecuniary interest therein. The address of the registered office of Sabby VWMF is Captiva (Cayman) Ltd, Governors Square, Bldg 4, 2nd Floor, 23 Lime Tree Bay Avenue, P.O. Box 32315, Grand Cayman KY1-1209, Cayman Islands.

     

    (14) Consists of (i) 3,906,250 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants and (ii) up to 146,790,188 Ordinary Shares issuable upon the exercise of Series A Warrants, assuming that (A) the exercise price of the Series A is adjusted down to the floor price and (B) the Series A Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 53.45% of our outstanding Ordinary Shares prior to this offering.

     

    (15) Anson Advisors Inc and Anson Funds Management LP, the Co-Investment Advisers of Anson Investments Master Fund LP (“Anson”), hold voting and dispositive power over the ordinary shares held by Anson. Tony Moore is the managing member of Anson Management GP LLC, which is the general partner of Anson Funds Management LP. Moez Kassam and Amin Nathoo are directors of Anson Advisors Inc. Mr. Moore, Mr. Kassam and Mr. Nathoo each disclaim beneficial ownership of these ordinary shares except to the extent of their pecuniary interest therein. The principal business address of Anson is Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands.

     

    (16) Consists of (i) 3,046,875 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (ii) up to 114,496,347 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to 12,851,775 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 48.60% of our outstanding Ordinary Shares prior to this offering.

     

    (17) Anson Advisors Inc and Anson Funds Management LP, the Co-Investment Advisers of Anson East Master Fund LP (“Anson”), hold voting and dispositive power over the ordinary shares held by Anson. Tony Moore is the managing member of Anson Management GP LLC, which is the general partner of Anson Funds Management LP. Moez Kassam and Amin Nathoo are directors of Anson Advisors Inc. Mr. Moore, Mr. Kassam and Mr. Nathoo each disclaim beneficial ownership of these ordinary shares except to the extent of their pecuniary interest therein. The principal business address of Anson is Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands.

     

    (18) Consists of (i) 859,375 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants and (ii) up to 32,293,841 Ordinary Shares issuable upon the exercise of Series A Warrants, assuming that (A) the exercise price of the Series A Warrants is adjusted down to the floor price and (B) the Series A Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 20.16% of our outstanding Ordinary Shares prior to this offering.

     

    (19) Empery Asset Management LP, the authorized agent of each of Empery Asset Master Ltd ("EAM"), Empery Tax Efficient, LP ("ETE") and Empery Tax Efficient III, LP ("ETE III"), has discretionary authority to vote and dispose of the shares held by EAM, ETE and ETE III and may be deemed to be the beneficial owner of these shares. Martin Hoe and Ryan Lane, in their capacity as investment managers of Empery Asset Management LP, may also be deemed to have investment discretion and voting power over the shares held by EAM, ETE and ETE III. EAM, ETE, ETE III, Mr. Hoe and Mr. Lane each disclaim any beneficial ownership of these shares.

     

    (20) Consists of (i) 2,079,403 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants held by EAM, (ii) 685,042 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants held by ETE, (iii) 1,141,805 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants held by ETE III, (iv) up to 78,140,406 Ordinary Shares issuable upon the exercise of Series A Warrants held by EAM, assuming that (A) the exercise price of the Series A Warrants is adjusted down to the floor price and (B) the Series A Warrants are exercised on an alternative cashless basis, (v) up to 25,742,706 Ordinary Shares issuable upon the exercise of Series A Warrants held by ETE, assuming that (A) the exercise price of the Series A Warrants is adjusted down to the floor price and (B) the Series A Warrants are exercised on an alternative cashless basis, and (vi) up to 42,907,077 Ordinary Shares issuable upon the exercise of Series A Warrants held by ETE III, assuming that (A) the exercise price of the Series A Warrants is adjusted down to the floor price and (B) the Series A Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. The number of shares set forth in the second column do not give effect to such beneficial ownership limitation.

    24

     

    (21) The shares will be directly held by Bigger Capital Fund LP, a Delaware limited partnership (the “Capital Fund”), and may be deemed to be indirectly beneficially owned by: (i) Bigger Capital Fund GP, LLC (“Bigger GP”), as the investment manager of the Capital Fund; and (ii) Michael Bigger, as the Managing Member of Bigger GP. Bigger GP and Michael Bigger disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. The address of the Capital Fund is c/o Bigger Capital Fund LP, 11700 W Charleston Blvd, 170-659, Las Vegas, Nevada 89135.

     

    (22) Consists of (i) 103,125 PIPE Shares, (ii) 1,850,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 73,395,094 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  5,354,906 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 37.66% of our outstanding Ordinary Shares prior to this offering.

     

    (23) The shares will be directly held by District 2 Capital Fund LP, a New York limited partnership (“District 2”), and may be deemed to be indirectly beneficially owned by: (i) District 2 GP LLC (“District 2 GP”), as the general partner of the Capital Fund; and (ii) Michael Bigger, as the Managing Member of District 2 GP. District 2 GP and Michael Bigger disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. The address of District 2 is c/o District 2 Capital Fund LP, 14 Wall Street, 2nd Floor, Huntington, New York 11743.

     

    (24) Consists of (i) 103,125 PIPE Shares, (ii) 1,850,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 73,395,094 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  5,354,906 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 37.66% of our outstanding Ordinary Shares prior to this offering.

     

    (25) Boothbay Absolute Return Strategies LP, a Delaware limited partnership (the “Fund”), is managed by Boothbay Fund Management, LLC, a Delaware limited liability company (the “Adviser”). The Adviser, in its capacity as the investment manager of the Fund, has the power to vote and the power to direct the disposition of all securities held by the Fund.  Ari Glass is the Managing Member of the Adviser.   Each of the Fund, the Adviser and Mr. Glass disclaim beneficial ownership of these securities, except to the extent of any pecuniary interest therein.

     

    (26) Consists of (i) 103,125 PIPE Shares, (ii) 1,850,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 73,395,094 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  3,212,944 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 37.33% of our outstanding Ordinary Shares prior to this offering.

     

    25

     

    (27)

    Vikas Mittal may be deemed to have sole voting and dispositive power with respect to the shares held by Meteora Select Trading Opportunities Master, LP.  Mr. Mittal disclaims beneficial ownership of these securities, except to the extent of any pecuniary interest therein. The address of Meteora Select Trading Opportunities Master, LP is 1200 N Federal Highway Suite 200. Boca Raton, FL 33432.

     

    (28) Consists of (i) 103,125 PIPE Shares, (ii) 1,850,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 73,395,094 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  3,212,944 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 37.33% of our outstanding Ordinary Shares prior to this offering.

     

    (29) The address of Clearmind Medicine Inc. is 101 – 1220 W. 6th Ave, Vancouver, BC V6H1A5, Canada. Clearmind Medicine Inc. is a publicly traded company. To the best of our knowledge, Clearmind Medicine Inc. does not have any controlling shareholders. The chief executive officer of Clearmind Medicine Inc. is Adi Zuloff-Shani.

     

    (30) Consists of (i) 216,667 PIPE Shares, (ii) 200,000 Ordinary Shares issuable upon the exercise of Pre-Funded Warrants, (iii) up to 15,657,633 Ordinary Shares issuable upon the exercise of Series A Warrants and (iv) up to  9,018,789 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 14.01% of our outstanding Ordinary Shares prior to this offering.

     

    (31) The address of Itamar David is 601-283 Davie St., Vancouver BC V6B5T6 Canada.

     

    (32) Consists of (i) 260,417 PIPE Shares, (ii) up to 9,786,025 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to  514,635 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 7.55% of our outstanding Ordinary Shares prior to this offering.

     

    (33) The address of Gabriel Kabazo is 2264E 11th Avenue, Vancouver , BC, V5N1Z6.

     

    (34) Consists of (i) 208,333 PIPE Shares, (ii) up to 7,828,797 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to 514,635 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 6.12% of our outstanding Ordinary Shares prior to this offering.

     

    (35) Amir Uziel is the officer, sole director, chairman of the board of directors and controlling shareholder of Amir Uziel Economic Consultant Ltd., and its address is 20 Raoul Wallenberg Street, Tel Aviv, Israel 6971916.

     

    (36) Consists of (i) 104,167 PIPE Shares, (ii) up to 3,914,418 Ordinary Shares issuable upon the exercise of Series A Warrants and (iii) up to 643,378 Ordinary Shares issuable upon the exercise of Exchange Warrants, assuming that (A) the exercise prices of the Series A Warrants and the Exchange Warrants are adjusted down to the floor price and (B) the Series A Warrants and the Exchange Warrants are exercised on an alternative cashless basis. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Shareholder from exercising that portion of the warrants that would result in the Selling Shareholder and its affiliates owning, after exercise, a number of ordinary shares in excess of the beneficial ownership limitation. If the foregoing securities did not contain such beneficial ownership limitation, the Selling Shareholder would have beneficially owned approximately 3.25% of our outstanding Ordinary Shares prior to this offering.

     

    26

     

    PLAN OF DISTRIBUTION

     

    We are registering the PIPE Shares and the Ordinary Shares issuable upon exercise of the Warrants to permit the resale of these Ordinary Shares by the Selling Shareholders from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the Selling Shareholders of the Ordinary Shares. We will bear all fees and expenses incident to our obligation to register the PIPE Shares and the Ordinary Shares issuable upon exercise of the Warrants.

     

    The Selling Shareholders may sell all or a portion of the PIPE Shares and Ordinary Shares issuable upon exercise of the Warrants beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the Ordinary Shares are sold through underwriters or broker-dealers, the Selling Shareholders will be responsible for underwriting discounts or commissions or agent’s commissions. The Ordinary Shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions,

     

      ● on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;

     

      ● in the over-the-counter market;

     

      ● in transactions otherwise than on these exchanges or systems or in the over-the-counter market;

     

      ● through the writing of options, whether such options are listed on an options exchange or otherwise;

     

      ● ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

     

      ● block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

     

      ● purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

     

      ● an exchange distribution in accordance with the rules of the applicable exchange;

     

      ● privately negotiated transactions;

     

      ● short sales;

     

      ● sales pursuant to Rule 144;

     

      ● broker-dealers may agree with the selling securityholders to sell a specified number of such shares at a stipulated price per share;

     

      ● a combination of any such methods of sale; and

     

      ● any other method permitted pursuant to applicable law.

     

    If the Selling Shareholders effect such transactions by selling Ordinary Shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the Selling Shareholders or commissions from purchasers of the Ordinary Shares for whom they may act as agent or to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved). In connection with sales of the Ordinary Shares or otherwise, the Selling Shareholders may enter into hedging transactions with broker-dealers, which may in turn engage in short sales of the Ordinary Shares in the course of hedging in positions they assume. The Selling Shareholders may also sell Ordinary Shares short and Ordinary Shares covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The Selling Shareholders may also loan or pledge Ordinary Shares to broker-dealers that in turn may sell such shares.

     

    27

     

    The Selling Shareholders may pledge or grant a security interest in some or all of the Warrants or Ordinary Shares owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the Ordinary Shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act of 1933, as amended, amending, if necessary, the list of selling shareholders to include the pledgee, transferee or other successors in interest as selling shareholders under this prospectus. The Selling Shareholders also may transfer and donate the Ordinary Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

     

    The Selling Shareholders and any broker-dealer participating in the distribution of the Ordinary Shares may be deemed to be “underwriters” within the meaning of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the Ordinary Shares is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of Ordinary Shares being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the Selling Shareholders and any discounts, commissions or concessions allowed or reallowed or paid to broker-dealers.

     

    Under the securities laws of some states, the Ordinary Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the Ordinary Shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

     

    There can be no assurance that the Selling Shareholders will sell any or all of the Ordinary Shares registered pursuant to the registration statement, of which this prospectus forms a part.

     

    The Selling Shareholders and any other person participating in such distribution will be subject to applicable provisions of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, including, without limitation, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the Ordinary Shares by the Selling Shareholders and any other participating person. Regulation M may also restrict the ability of any person engaged in the distribution of the Ordinary Shares to engage in market-making activities with respect to the Ordinary Shares. All of the foregoing may affect the marketability of the Ordinary Shares and the ability of any person or entity to engage in market-making activities with respect to the Ordinary Shares.

     

    We will pay all expenses of the registration of the Ordinary Shares, estimated to be $14,000 in total, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, that a selling shareholder will pay all underwriting discounts and selling commissions, if any.

     

    Once sold under the registration statement, of which this prospectus forms a part, the Ordinary Shares will be freely tradable in the hands of persons other than our affiliates.

     

    28

     

    EXPENSES

     

    Set forth below is an itemization of the total expenses, excluding underwriting discounts, expected to be incurred in connection with the offer and sale of the securities offered by us and the Selling Shareholders. With the exception of the SEC registration fee, all amounts are estimates:

     

    SEC registration fee  $82,511 
    Legal fees and expenses  $205,300 
    Accounting fees and expenses  $35,000 
    Miscellaneous  $12,750 
    Total  $335,561 

      

    LEGAL MATTERS

     

    The validity of the issuance of our Ordinary Shares offered in this prospectus and certain other matters of Israeli law will be passed upon for us by Keren Law Firm. Certain matters of U.S. federal law will be passed upon for us by Greenberg Traurig, P.A., Tel Aviv, Israel.

     

    EXPERTS

     

    The financial statements of Polyrizon Ltd. as of December 31, 2024 and 2023 and for each of the three years in the period ended December 31, 2024, incorporated by reference in this prospectus, have been audited by Brightman Almagor Zohar & Co., a firm in the Deloitte global network, an independent registered public accounting firm, as stated in their report. Such financial statements are incorporated by reference in reliance upon the report of such firm given the firm’s authority as experts in accounting and auditing.

     

    29

     

    ENFORCEMENT OF CIVIL LIABILITIES

     

    We are incorporated under the laws of the State of Israel. Service of process upon us and upon our directors and officers and the Israeli experts named in this registration statement, most of whom reside outside of the United States, may be difficult to obtain within the United States. Furthermore, because substantially all of our assets and substantially all of our directors and officers are located outside of the United States, any judgment obtained in the United States against us or any of our directors and officers may not be collectible within the United States.

     

    We have been informed by our legal counsel in Israel, Keren Law Firm, that it may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws reasoning that Israel is not the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law.

     

    We have irrevocably appointed Puglisi & Associates as our agent to receive service of process in any action against us in any U.S. federal or state court arising out of this offering or any purchase or sale of securities in connection with this offering.

     

    Subject to specified time limitations and legal procedures, Israeli courts may enforce a U.S. judgment in a civil matter which, subject to certain exceptions, is non-appealable, including a judgment based upon the civil liability provisions of the Securities Act and the Exchange Act and including a monetary or compensatory judgment in a non-civil matter, provided that among other things:

     

      ● the judgment was rendered by a court which was, according to the laws of the state of the court, competent to render the judgment;

     

      ● the obligation imposed by the judgment is enforceable according to the rules relating to the enforceability of judgments in Israel and the substance of the judgment is not contrary to public policy; and

     

      ● the judgment is executory in the state in which it was given Even if these conditions are met, an Israeli court may not declare a foreign civil judgment enforceable if:
         
      ● the judgment was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases);
         
      ● the enforcement of the judgment is likely to prejudice the sovereignty or security of the State of Israel;
         
      ● the judgment was obtained by fraud;
         
      ● the opportunity given to the defendant to bring its arguments and evidence before the court was not reasonable in the opinion of the Israeli court;
         
      ● the judgment was rendered by a court not competent to render it according to the laws of private international law as they apply in Israel;

     

      ● the judgment is contradictory to another judgment that was given in the same matter between the same parties and that is still valid; or

     

      ● at the time the action was brought in the foreign court, a lawsuit in the same matter and between the same parties was pending before a court or tribunal in Israel.

     

    If a foreign judgment is enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non- Israeli currency and transferred out of Israel. The usual practice in an action before an Israeli court to recover an amount in a non-Israeli currency is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in force on the date of the judgment, but the judgment debtor may make payment in foreign currency. Pending collection, the amount of the judgment of an Israeli court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus interest at the annual statutory rate set by Israeli regulations prevailing at the time. Judgment creditors must bear the risk of unfavorable exchange rates.

     

    30

     

    INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

      

    We file annual and special reports and other information with the SEC (File Number 001-42375). These filings contain important information which does not appear in this prospectus. The SEC allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to other documents which we have filed with the SEC. We are incorporating by reference in this prospectus the documents listed below:

     

      ● our Annual Report on Form 20-F for the fiscal year ended on December 31, 2024, filed with the SEC on March 11, 2025;

     

      ● our Reports on Form 6-K filed with the SEC March 10, 2025, March 13, 2025, March 14, 2025, March 25, 2025, March 27, 2025, April 1, 2025, April 2, 2025, April 11, 2025, April 17, 2025 and April 25, 2025 (to the extent expressly incorporated by reference into our effective registration statements filed by us under the Securities Act); and

     

      ● the description of the ordinary shares contained under the heading “Item 1. Description of Registrant’s Securities to be Registered” in our registration statement on Form 8-A, as filed with the SEC on October 21, 2024, including any subsequent amendment or any report filed for the purpose of updating such description.

     

    The information relating to us contained in this prospectus does not purport to be comprehensive and should be read together with the information contained in the documents incorporated or deemed to be incorporated by reference in this prospectus.

     

    As you read the above documents, you may find inconsistencies in information from one document to another. If you find inconsistencies between the documents and this prospectus, you should rely on the statements made in the most recent document. All information appearing in this prospectus is qualified in its entirety by the information and financial statements, including the notes thereto, contained in the documents incorporated by reference herein.

     

    We will provide each person, including any beneficial owner to whom a prospectus is delivered, without charge, upon a written or oral request, a copy of any of the documents incorporated by reference in this prospectus, other than exhibits to such documents which are not specifically incorporated by reference into such documents. Please direct your written or telephone requests to Polyrizon Ltd., 5 Ha-Tidhar Street, Raanana, 4366507, Israel, Attn: Tomer Izraeli, telephone number +972-9-3740120. You may also obtain information about us by visiting our website at www. polyrizon-biotech.com. Information contained in our website is not part of this prospectus

     

    31

     

    WHERE YOU CAN FIND MORE INFORMATION

     

    We have filed with the SEC a registration statement on Form F-1 under the Securities Act relating to this offering of our securities. This prospectus does not contain all of the information contained in the registration statement. The rules and regulations of the SEC allow us to omit certain information from this prospectus that is included in the registration statement. Statements made in this prospectus concerning the contents of any contract, agreement or other document are summaries of all material information about the documents summarized, but are not complete descriptions of all terms of these documents. If we filed any of these documents as an exhibit to the registration statement, you may read the document itself for a complete description of its terms.

     

    Our SEC filings are available to the public at the SEC’s website at http://www.sec.gov. We are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those requirements will file reports with the SEC.

     

    We are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those requirements are filing reports with the SEC. Those other reports or other information may be inspected without charge at the locations described above. As a foreign private issuer, we will be exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act to file reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we will file with the SEC, within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm, and will submit to the SEC, on Form 6-K, unaudited quarterly financial information.

     

    We maintain a corporate website at www.polyrizon-biotech.com. Information contained on, or that can be accessed through, our website does not constitute a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference. We will post on our website any materials required to be so posted on such website under applicable corporate or securities laws and regulations, including, posting any XBRL interactive financial data required to be filed with the SEC and any notices of general meetings of our shareholders.

     

    32

     

    1,513,858,167 Ordinary Shares 

     

     

     

     

    Polyrizon Ltd.

     

     

     

     

     
    PRELIMINARY PROSPECTUS
     

     

     

     

     

    May 12, 2025

     

     

     

     

     

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      The Company demonstrated strong mucoadhesion and broad surface coverage in ex vivo nasal tissue models Raanana, Israel, May 21, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (NASDAQ:PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced compelling results from recent ex vivo studies demonstrating the mucoadhesive strength and extensive nasal surface coverage of its proprietary formulation platform. The studies were conducted in collaboration with Prof. Fabio Sonvico's laboratory, utilizing excised rabbit nasal mucosa as a surrogate for human nasal tissues. The research aimed to characterize two ke

      5/21/25 7:10:00 AM ET
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    • Polyrizon Targets $3.15B Epilepsy Market with Preclinical Studies for Innovative Rescue Treatment

      Raanana, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (NASDAQ:PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, recently announced the initiation of preclinical studies for intranasal Benzodiazepines (BZDs), a first-line treatment for acute repetitive seizures (ARS) and status epilepticus, using its proprietary drug delivery platform. According to the World Health Organization (WHO), epilepsy is a neurological condition affecting about 50 million people worldwide. Many existing therapies fail to provide adequate control of acute repetitive seizures and may come with undesirable adverse

      5/13/25 7:45:00 AM ET
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    • Polyrizon Reports Successful Safety Study of a Formulation of PL-14 Allergy Blocker in Human Nasal Tissue Model

      Raanana, Israel, April 25, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (NASDAQ:PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced today the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product's development path.  Conducted on fully differentiated human nasal tissue using the MucilAir™ model, the study demonstrated strong local tolerability, a critical benchmark in the product development roadmap. The study was designed to assess local tolerance and tissue response following a 4-hour application of a formulation

      4/25/25 7:37:00 AM ET
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    Leadership Updates

    Live Leadership Updates

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    • Polyrizon Appoints Dr. Michal Meir as Senior Director of Regulatory and Clinical Affairs

      Raanana, Israel, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (NASDAQ:PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announce today the appointment of Dr. Michal Meir, Senior Consultant at MedTech SME Ltd., as Senior Director of Regulatory and Clinical Affairs. The appointment was made as part of the Company's preparations towards its clinical trial for PL-14 that is expected to commence in 2025. Dr. Meir brings over a decade of experience in the medical device and pharmaceutical industries, with a proven track record in regulatory strategy, clinical affairs management and product developmen

      12/19/24 7:22:00 AM ET
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    • Polyrizon Announces Appointment of VP of Regulatory Affairs and Quality Assurance

      Raanana, Israel, Dec. 13, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (NASDAQ:PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announces today the appointment of Asaf Azulay, the Managing Director of Eurofins' Li-Med team, to its leadership as its VP of Regulatory Affairs and Quality Assurance (RA/QA). This strategic appointment reflects Polyrizon's ongoing commitment to maintaining the highest industry standards as it advances its pipeline of cutting-edge solutions. Asaf Azulay brings over 20 years of extensive experience in the medical devices industry, with expertise in leading quality teams and i

      12/13/24 6:25:00 AM ET
      $PLRZ