Scinai Immunotherapeutics Ltd F-1, filed Sep 22, 2025
Scinai Immunotherapeutics Ltd. (SCNI)
As filed with the United States Securities and Exchange Commission on September 22, 2025.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Scinai Immunotherapeutics Ltd.
(Exact name of registrant as specified in its charter)
| Israel | 2836 | Not Applicable | ||
| (State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification No.) |
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
Tel: +972-8-930-2529
Fax: +972-8-930-2531
(Address and telephone number of Registrant’s principal executive offices)
Puglisi & Associates
850 Library Avenue, Suite 204
Newark, Delaware
+1 (302) 738-6680
(Name, address and telephone number of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
|
Perry Wildes Ephraim Friedman 1 Azrieli Center, Tel: +972-3-607-4444 |
Lawrence Metelitsa Steven Lipstein Lucosky Brookman LLP 101 Wood Avenue South Woodbridge, New Jersey 08830 Tel: 732-395-4400 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box: ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act.
Emerging growth company ☐
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
| † | The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated September 22, 2025.
PRELIMINARY PROSPECTUS
4,800,000 American Depositary Shares representing 19,200,000,000 Ordinary Shares
Scinai Immunotherapeutics Ltd.
This prospectus relates to the offer and sale of up to 4,800,000 American Depositary Share (“ADSs”), by YA II PN, Ltd., or YA or the Selling Shareholder, a Cayman Islands limited partnership. Each ADS represents 4,000 of our ordinary shares, no par value (“Ordinary Shares”).
The Ordinary Shares represented by ADSs being offered by the Selling Shareholder are to be issued pursuant to the Standby Equity Purchase Agreement dated September 10, 2025 that we entered into with YA, or the Purchase Agreement. We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of ADSs by the Selling Shareholder. However, we may receive up to $15.0 million in aggregate gross proceeds from sales of ADSs to YA that we may make under the Purchase Agreement from time to time during the 36 months following the execution of the Purchase Agreement, or the Advance Shares. Pursuant to the Purchase Agreement, we issued an aggregate of 35,461 ADSs to YA upon execution of the Purchase Agreement as consideration for its irrevocable commitment to purchase ADSs under the Purchase Agreement, or the Commitment Shares. The additional 4,764,539 ADSs representing Advance Shares that may be offered pursuant to this prospectus would be purchased by YA from time to time pursuant to the Purchase Agreement at a price equal to 97% of the lowest of the three daily volume weighted average prices, or VWAPs, during a pricing period as set forth in the Purchase Agreement and would be subject to certain limitations.
The Selling Shareholder may sell the ADSs included in this prospectus in a number of different ways and at varying prices. We provide more information about how the Selling Shareholder may sell the shares in the section entitled “Plan of Distribution.” The Selling Shareholder is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended, the Securities Act.
The Selling Shareholder will pay all brokerage fees and commissions and similar expenses in connection with the offer and sale of the shares by the Selling Shareholder pursuant to this prospectus. We will pay the expenses (except brokerage fees and commissions and similar expenses) incurred in registering under the Securities Act the offer and sale of the shares included in this prospectus by the Selling Shareholder. See “Plan of Distribution.”
The ADSs are listed on the Nasdaq Capital Market, or Nasdaq, under the symbol “SCNI.” On September 19 2025, the last reported sale price of the ADSs on Nasdaq was $1.57 per ADS.
We are a “foreign private issuer,” as defined under the U.S. federal securities law and are subject to reduced public company reporting requirements. See “Prospectus Summary – Implications of Being a Foreign Private Issuer” for additional information.
Investing in our securities involves a high degree of risk. See the section entitled “Risk Factors” appearing on page 9 of this prospectus and elsewhere in this prospectus and the accompanying base prospectus for a discussion of information that should be considered in connection with an investment in our securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2025.
TABLE OF CONTENTS
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This prospectus is part of a registration statement on Form F-1 that we filed with the Securities and Exchange Commission (“SEC”).
Before investing in the ADSs, you should carefully read this entire prospectus and any prospectus supplement and any free writing prospectus prepared by or on behalf of us or to which we have referred you. We have not, and the Selling Shareholder has not, authorized anyone to provide you any information other than that contained in, or incorporated by reference into, this document or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for and can provide no assurance as to the reliability or accuracy of, any other information that others may give you. Neither we, nor the Selling Shareholder, are making an offer to sell, or seeking an offer to buy, the ADSs in any jurisdiction where the offer or sale is not permitted. You should not assume that the information contained in, or incorporated by reference into, this prospectus is accurate as of any date other than their respective dates.
This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed as exhibits to the registration statement.
We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to the registration statement of which this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus are without the ® and ™ symbols, but such 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 rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. Scinai has no affiliation with and is not endorsed by Sanofi. We do not intend our use or display of other companies’ trademarks, service marks or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
In this prospectus, unless the context otherwise requires,
| ● | references to “Scinai,” the “Company,” “us,” “we” and “our” refer to Scinai Immunotherapeutics Ltd., an Israeli company; |
| ● | references to “Ordinary Shares” refer to our Ordinary Shares, no par value; |
| ● | references to “ADS”, “our shares” and similar expressions refer to American Depositary Shares, each representing 4,000 Ordinary Shares; and |
| ● | references in this prospectus to “NIS” are to the legal currency of Israel, and “U.S. dollars,” “$” or “dollars” are to United States dollars. |
Market, Industry and Other Data
This prospectus includes or incorporates by reference 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.
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 and incorporated into this prospectus. These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Note Regarding Forward-Looking Statements.”
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, but these are not the only ways these statements are identified. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements. Readers are encouraged to consult the Company’s filings made on Form 6-K, which are periodically filed with or furnished to the SEC.
The following is a summary of some of the principal risks we face. The list below is not exhaustive, and investors should read the “Risk Factors” section, “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” incorporated into this Prospectus, in full.
| ● | We are an early-stage biopharmaceutical company with a history of operating losses. While our CDMO business unit generates revenue and provides us with a complementary source of income, our therapeutic product candidates have not yet generated revenue. We are not currently profitable, and despite the contribution of our CDMO business, we do not expect to achieve overall profitability in the near term and may never achieve profitability. As a result, we may be required to raise additional capital, curtail operations, or wind up our business.; |
| ● | We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts; |
| ● | Our failure to meet the continued listing requirements of The Nasdaq Stock Market LLC (“Nasdaq”) could result in a delisting of the ADSs which could adversely affect the market liquidity of our shares and the market price of our shares could decrease significantly; |
| ● | Our business strategy may not be successful; |
| ● | We conduct most of our operations in Israel. Conditions in Israel, including Israel’s war with Hamas and other terrorist organizations in the Gaza Strip and Israel’s conflict with Hezbollah and with Iran, may affect our operations; |
| ● | We are highly dependent upon our ability to enter into agreements with partners to develop, commercialize, and market any current and future product candidate(s) or enter into other strategic partnerships; |
| ● | Raising additional capital may cause dilution to our existing shareholders, and debt financing, if available, may restrict our operations or require us to relinquish rights to our technologies or product candidate(s); |
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| ● | Our novel nanosized antibodies, also known as VHH-antibodies, Nanobodies or NanoAbs, represent a relatively new approach to treating diseases, and we must overcome significant challenges in order to successfully develop, commercialize and manufacture product candidates based on this technology; |
| ● | Our product candidates are at the preclinical stage, and clinical trials are expensive, time-consuming, and inherently uncertain. Even if we successfully complete preclinical studies, we will not be able to advance our pipeline into clinical trials without raising significant additional capital. There is no assurance that such funding will be available to us on acceptable terms, if at all. If we are unable to secure the capital needed to initiate and conduct clinical trials, our ability to develop our product candidates and achieve regulatory approval would be materially impaired.; |
| ● | Positive results from earlier preclinical data and clinical trials we conduct may not be predictive of the results in later clinical trials of current and future product candidates, and the results of any clinical trials we conduct may not be replicated in additional clinical trials that we may be required to conduct, which could result in development delays or a failure to obtain marketing approval; |
| ● | As part of our portfolio prioritization, and given the continued emergence of new COVID-19 variants and the difficulty of developing broad-spectrum NanoAbs, we suspended this program. In agreement with our partners at MPG and UMG, we made the strategic decision to abandon the related patents. Current market interest in and funding for COVID-19 therapeutics are limited, and resources are being directed toward programs with stronger commercial potential. ; |
| ● | If we are not successful in discovering, developing and commercializing current and future product candidates, our ability to expand our business and achieve our strategic objectives may be impaired; |
| ● | Under our collaboration with MPG and UMG, we may in-license up to nine NanoAbs, of which we have in-licensed candidates targeting COVID-19 and IL-17. The IL-17 field is highly competitive, and there is no assurance that we will in-license additional NanoAbs or successfully develop or commercialize those already licensed.; |
| ● | We face significant competition. If we cannot successfully compete with new or existing product candidate(s), our marketing and sales will suffer, and we may never be profitable; |
| ● | Our NanoAbs program is based on an exclusive license from MPG and UMG, and we could lose our rights to this license if a dispute with MPG and/or UMG arises or if we fail to comply with the financial and other terms of the license; |
| ● | CDMO services are highly complex and failure to provide quality and timely services to our CDMO clients, could adversely impact our business; |
| ● | Our CDMO business is dependent upon the demand for our services by our customers; | |
| ● | Significant delays in product manufacturing or development and in our ability to produce sufficient quantities to meet the needs of our clients could cause delays in recognizing revenues, which would harm our business, financial condition, operating results and cash flows; and |
| ● | A disruption to our GMP biologics manufacturing facility in Jerusalem could impede our ability to deliver our CDMO services, which could adversely affect our business. |
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This summary description of our business and this offering may not contain all of the information that may be important to you before making a decision to invest in the ADSs. For a more complete understanding of our business and this offering, we encourage you to read this entire prospectus. In particular, you should read the following summary together with the more detailed information and consolidated financial statements and the notes thereto incorporated into this prospectus and the other documents incorporated by reference into this prospectus, which are described under “Incorporation by Reference”. You should review carefully the risks and uncertainties described under the heading “Risk Factors” included elsewhere in and incorporated into this prospectus.
Our Business
We are a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked, pipeline of VHH antibody fragments (NanoAbs) aimed at treating diseases with large unmet medical needs, and the other a boutique CDMO providing services to help biotech companies efficiently bring their products to market by leveraging Scinai’s drug development and cGMP manufacturing capabilities for pre-clinical and clinical studies. We have also recently signed an option agreement to acquire the Italian biotech company, Pincell srl, the owner of PC111, a fully human, monoclonal antibody that binds to the human soluble Fas ligand and blocks its activation of apoptosis of skin cells (keratinocytes) and is aimed for the treatment of rare skin diseases such as pemphigus, Steven Johnsons Syndrome and Toxic Epidermal Necrolysis.
Development of I&I biological therapeutic products
NanoAbs
Since inception, we have executed eight clinical trials including a seven country, 12,400 participant phase 3 trial of our prior lead drug candidate, a universal influenza vaccine candidate (“M-001”) and have built a GMP biologics manufacturing facility for biopharmaceutical products. After receiving the phase 3 trial results in Q42020, indicating that M-001 did not meet its clinical endpoints, we performed a turnaround process that included raising fresh capital, hiring new talent (including a new CEO), signing a five year research collaboration agreement with and in-licensing new intellectual property from world leading academic research institutes. Since then, we are in the process of developing a pipeline of diversified and commercially viable products built around innovative NanoAb. NanoAbs are VHH antibody fragments derived from camelid animals and are also known as Nanobodies. “Nanobody” is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. SCINAI has no affiliation with and is not endorsed by Sanofi.
As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement (“LA”) with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19. The agreement provides for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues. In addition, the Company signed an accompanying Research Collaboration Agreement (“aRCA”) with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb by MPI and UMG. The aRCA provided for monthly payments to MPG and UMG and had a term until the earlier of two years or the date the Company enters into first in-human clinical trials with the COVID-19 NanoAb. Due to the continued emergence of new COVID-19 variants and the difficulty of identifying broad-spectrum NanoAbs, we suspended further development of this program. In agreement with MPG and UMG, we terminated the aRCA and decided to abandon the related patents. Current market interest in and funding for COVID-19 therapeutics remain limited, and we do not intend to continue this program.
On March 23, 2022, the Company entered into a Research Collaboration Agreement (“RCA”) with MPG and UMG with an initial term of five years. The agreement covers the discovery, selection, and characterization of nanoAbs directed at several molecular targets implicated in diseases where the Company believes there is significant unmet need. The Company aims to address these unmet needs by harnessing the unique attributes of nanoAbs, such as their strong binding affinity, stability at elevated temperatures, and ability to support more effective and convenient routes of administration. The molecular targets and related diseases were identified through a consulting project with the global healthcare management firm L.E.K., and they correspond to validated targets of currently marketed monoclonal antibodies for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. Under the RCA, the Company holds an exclusive option to enter into a license agreement with MPG and UMG for the development and commercialization of each of the nanoAbs covered by the collaboration.
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On June 5, 2023, we announced that as part of our ongoing broad-based collaboration with MPG and UMG, we signed an exclusive worldwide license agreement to develop and commercialize NanoAbs targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.
On June 4, 2024, we met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S. Consequently, on July 23, 2024, we announced the receipt of positive regulatory feedback from the PEI for our drug development program towards Phase 1/2a clinical trial of our anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis. The Phase 1/2a study is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2026 with a readout in 2027.
On July 15, 2024, we announced a successful in-vivo preclinical study results of our innovative anti IL-17A/F NanoAb as a local, first of its kind, intralesional biological treatment for the large and underserved population of patients suffering from mild to moderate plaque psoriasis. The study aimed to demonstrate that local, intralesional treatment with Scinai’s NanoAb, which targets the two isoforms of the cytokine IL-17 (A and F) implicated in plaque psoriasis, has at least a non-inferior anti-inflammatory effect on the psoriatic lesions compared to topical corticosteroids and systemic biologics. The unique ability of our NanoAb to neutralize both IL-17A and IL-17F isoforms was confirmed, this time in-vivo, by the histopathology analysis, which demonstrated that our NanoAb led to reduced levels of both IL-17 isoforms in the psoriatic skin tissue. In addition, the statistical analysis of these markers confirmed that the effect of our NanoAb on the tested inflammatory markers was similar to that of the two abovementioned comparator drugs, supporting the hypothesis that intralesional injection of a NanoAb blocking the IL-17 cytokine can impact the inflammatory cytokine cascade, and lead to reduction in psoriatic lesion severity and improvement of the skin’s integrity. The results confirm and build upon previous reported results from ex-vivo studies we have done with human skin specimens (conducted by Genoskin) and in a plaque psoriasis in vitro model with human skin tissue grown in a dish.
To support the financing of our novel target product profile involving local intradermal delivery of our anti-IL-17A/F NanoAb for the treatment of plaque psoriasis, on September 5, 2025 we applied through our Polish subsidiary for a Euro 15 million grant from the Strategic Technologies for Europe Platform (STEP). STEP, established by the EU under the European Funds for Smart Economy 2021–2027, aims to support European industry and boost investment in critical technologies. We expect award decisions in the first quarter of 2026. If granted, the funding is expected to cover approximately 80% of the budget required for development of this drug candidate through completion of a first-in-human proof-of-concept phase 1/2a trial.
On September 5, 2025, we also applied through our Polish subsidiary for a second Euro 15 million STEP grant to support the development of a novel long-acting tri-specific antibody. This antibody is designed to simultaneously neutralize three synergistic drivers of psoriatic inflammation and disease progression, with the potential to provide superior efficacy, durable remission, and significantly reduced dosing frequency compared to current therapies. A decision on this grant application is likewise expected in the first quarter of 2026, and if awarded, the funding is expected to cover approximately 80% of the budget required to advance the program through IND-enabling activities and into a first-in-human phase 1/2a clinical trial targeted for 2028.
PC111
On March 27, 2025, we announced that we had entered into a binding option agreement for the acquisition of the Italian biotech company Pincell srl, the owner of PC111, a monoclonal antibody in development for the treatment of pemphigus vulgaris, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). PC111 has already received an Orphan Drug Designation in Pemphigus by the European Medicine’s Agency. On June 5, 2025, we announced receipt of Italian government clearance for the potential acquisition of Pincell S.r.l.
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Pursuant to the terms of the option agreement, we have the right to exercise, at our sole discretion (pending our satisfaction of closing requirements), a full sale and transfer of Pincell’s shares by February 28, 2026. Such requirements include either the award of a grant to our wholly owned Polish subsidiary under the European Funds for a Modern Economy (FENG) program in Poland referred to below or our securing $3 million. If such share sale and transfer is exercised, Pincell’s current shareholders will be eligible for development milestone payments, pass through payments from sublicenses with a staggered percentage based on the stage of development at the time of the sublicense, and royalties out of future net sales of PC111 in the low single digits. In addition, the management team of Pincell will join Scinai’s wholly owned, newly created subsidiary in Poland and Pincell’s founder, Prof. Carlo Pincelli, will join Scinai’s Scientific Advisory Board. In the event we or our affiliates have not filed an IND application for PC111 to the FDA, or any similar dossier application in a country other than the U.S., by December 31, 2028, the option agreement grants each seller the right to repurchase the shares of Pincell it sold to us for the lower of (i) the fair market value of Pincell and (ii) the sum funded by us or our affiliates into Pincell.
PC111 is a fully human, monoclonal antibody that binds to the human soluble Fas ligand and thus blocks its activation of apoptosis of skin cells (keratinocytes). This pathway has a major role in several skin blistering disorders, characterized by a very high unmet medical need with significant market sizes. Importantly, PC111 does not suppress the immune system, at variance with many other biologicals treating inflammatory conditions that can lead to significant, at times fatal side effects. Pincell has successfully developed a proprietary FasL humanized mouse model, with which it studied the involvement of the Fas/FasL pathway in these diseases, and that can be successfully used in other dermatological and non-dermatological diseases, where this pathway may play a key role in disease development and progression.
In anticipation of the signing of the option agreement, the parties jointly prepared and submitted a grant application by our wholly owned Polish subsidiary, seeking Euro 12 million of non-dilutive funding to support the next stage of development of PC111. To facilitate the submission of the application, Pincell exclusively licensed PC111 to our subsidiary. The grant application was submitted -under the European Funds for a Modern Economy (FENG) program in Poland. On September 18, 2025, we were notified by the National Center for Research and Development in Poland that our grant application was not selected for funding. Under the applicable procedures, this notification represents an interim decision that becomes final only if no appeal is filed within 14 days of receipt or if an appeal, once filed, is ultimately rejected. We intend to file an appeal, which is expected to be reviewed within approximately one month after submission, with a final determination anticipated before the end of 2025. We believe that certain aspects of our proposed project were misconstrued or misanalyzed in the initial review, and our appeal will focus on addressing these issues. There can be no assurance, however, that the appeal will be successful or that the grant will ultimately be awarded.
Pincell has carried out a large number of in-vitro, ex-vivo and in-vivo experiments using PC111 without steroids in validated models of pemphigus, to prove that soluble FasL is a critical target in this disease. Most importantly, Pincell has demonstrated that PC111 can block blister formation without steroids in a transgenic humanized FasL mouse model of pemphigus, indicating that the antibody can work also in a humanized setting and thus suggesting that it may be a novel targeted therapy for this disease at the clinical level. As there is abundant and convincing data supporting the critical role of soluble FasL also in the pathogenesis of SJS/TEN, PC111 could inhibit the mechanisms underlying the progression of this disease, as shown by the in vivo model where it ameliorates ocular conjunctivitis and edema, two main early features of this disease in humans, as well as its progression towards more severe forms.
Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are severe dermatological conditions that significantly impact the skin and mucous membranes. Pemphigus is a rare autoimmune blistering disease of the skin and mucous membranes with the incidence of new cases ranging between 0.5 and 3.0 new cases per year per 100,000 people and prevalence of between 15 to 30 per 100,000 people at any point in time. The disease often requires long-term immunosuppressive medications for disease management, generates severe impact on the patient’s quality of life, is associated with chronic pain and visible lesions and results in dietary restrictions for the patients alongside emotional and social distress. Pemphigus often relapses, can be life-threatening without treatment and can leave the patient with long-term complications even with current treatments. Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis are rare but severe mucocutaneous reactions and are both part of the same disease spectrum, which is a serious reaction to medications. SJS has an incidence rate of between one and six cases per million people annually, and TEN has an incidence rate of 0.4 to 1.2 cases per million people annually. Both SJS and TEN result in massive epidermal cell death, resembling severe burns, rapid progression to skin blistering and detachment with involvement of mucosal tissues. SJS has a mortality rate of up to 10% while Toxic Epidermal Necrolysis, has a mortality rate of 30-50%. Pemphigus is being treated these days with systemic corticosteroids, steroid-sparing agents and rituximab while SJS/TEN have no approved drug on the market and are treated by supportive care (similar to burn management) and can sometimes be treated with systemic immunomodulators, such as cyclosporine, etanercept, and corticosteroids. The efficacy of these treatments, however, is controversial and case-dependent. These conditions highlight a significant unmet medical need for more effective treatments and better management strategies to improve patient outcomes and reduce mortality rates.
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CDMO services
On September 6, 2023, we announced the launch of a new business unit named Scinai Bioservices to serve as a CDMO offering a multitude of services to support biotech companies through process development, as well as GMP manufacturing for clinical supplies. We seek to provide high quality, yet affordable CDMO services to accelerate the drug development processes of small biotech companies, including cGMP aseptic processing required for manufacturing of clinical batches.
Our biological drug development and manufacturing services for early-stage pre-clinical and clinical programs of protein-based biological drugs includes highly advanced laboratories and a cGMP pilot plant (designed to meet EMA and FDA regulatory requirements) , upstream and downstream process development, process optimization and scaleup, cGMP manufacturing, Fill & Finish operations (F&F), analytical method development and quality control under GLP conditions supported by a robust quality management system . The manufacturing facility features modular, single-use infrastructure, which enables us to adapt the facility to various manufacturing platforms (such as, for example, fermenters or bioreactors).
We perform our CDMO services at our approximately 1,850 square meters (20,000 square feet) facility which we lease in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospital and the Hebrew University’s Medical School.
Standby Equity Purchase Agreement with YA
On September 10, 2025, we entered into the Purchase Agreement with YA, pursuant to which YA has committed to purchase up to $15.0 million of Advance Shares, or the Commitment Amount, at our direction from time to time, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, during the period commencing on the date of execution of the Purchase Agreement until the earlier of (i) the 36-month anniversary of the date of execution of the Purchase Agreement, and (ii) YA’s purchase of the total Commitment Amount under the Purchase Agreement, such period the Commitment Period. Pursuant to the terms of the Purchase Agreement, as consideration for YA’s irrevocable commitment to purchase the Advance Shares under the Purchase Agreement, we agreed to pay a commitment fee of $108,000 as follows: (i) 50% on or about the date of execution of the Purchase Agreement by the issuance by the Company to YA of the Commitment Shares and (ii) 50% in cash on the earlier of (A) the date of the first issuance of Advance ADSs under the Purchase Agreement (in which event the amount due may be paid from the cash proceeds of the first Advance) and (B) 90 calendar days following the date on which the registration statement of which this prospectus is a part is declared effective by the SEC. The Commitment Shares are also covered by this prospectus.
This prospectus covers the resale of up to 4,800,000 ADSs, comprised of: (i) 35,461 ADSs issued as Commitment Shares upon execution of the Purchase Agreement and (ii) 4,764,539 ADSs as the Advance Shares that we have reserved for issuance and sale to YA as Advance Shares under the Purchase Agreement from time to time during the Commitment Period, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, if and when we determine to sell additional ADSs to YA under the Purchase Agreement.
YA has no right to require us to sell any ADSs to YA, but YA is obligated to make purchases of the Advance Shares as directed by us, subject to the restrictions and satisfaction of conditions set forth in the Purchase Agreement upon receipt of a notice sent by us to YA setting forth the number of ADSs that we desire to issue and sell to YA, or an Advance Notice. Actual sales of the Advance Shares to YA from time to time will depend on a variety of factors, including, among others, market conditions, the trading price of the ADSs and determinations by us as to the appropriate sources of funding for us and our operations. The purchase price of the Advance Shares that we may direct YA to purchase from time to time under the Purchase Agreement will be equal to 97% of the lowest daily VWAP during the three consecutive trading day period commencing on the date that we deliver any Advance Notice to YA, or the Pricing Period. We have the right to set a floor price in the Advance Notice that sets a lower limit of the ADS price at which we are willing to sell ADSs to YA.
4
As of September 17, 2025, there were 3,187,679 ADSs outstanding, of which 3,001,464 ADSs were held by non-affiliates. The number of ADSs covered by this prospectus reflects approximately the number of ADSs authorized and available for issuance under the Company’s articles of association after taking into account ADSs reserved for issuance for other purposes, such as ADSs underlying outstanding warrants and ADSs issuable in connection with employee and executive compensation. The actual number of ADSs sold will depend on the ADS price at the time of each Advance. If all of the 4,800,000 ADSs offered by YA under this prospectus were issued and outstanding, such shares would represent approximately 60.1% of the total number of ADSs outstanding and approximately 61.51% of the total number of outstanding ADSs held by non-affiliates, in each case as of September 17, 2025. The Purchase Agreement provides that we may sell up to an aggregate of $15.0 million of ADSs to YA. We have filed the registration statement that includes this prospectus so that we may issue and sell to YA up to 4,764,539 ADSs from time to time during the Commitment Period, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, through sales under the Purchase Agreement. Depending on the market prices of our ADSs at the time we elect to issue such shares to YA under the Purchase Agreement, we may need to sell more ADSs to YA than are offered under this prospectus to receive aggregate gross proceeds equal to the approximately $15.0 million total commitment of YA under the Purchase Agreement, in which case we must first register for resale under the Securities Act additional shares, which could cause additional substantial dilution to our shareholders. The number of shares ultimately offered for resale by YA is dependent upon the number of shares we issue and sell to YA under the Purchase Agreement.
The net proceeds under the Purchase Agreement to us will depend on the frequency and prices at which we sell ADSs, our ability to meet the conditions set forth in the Purchase Agreement and any impacts of the Ownership Limitation (as defined below). We expect that any proceeds received by us from such sales of ADSs under the Purchase Agreement will be used continued development of our pipeline products, as well as the advancement of new programs, business development activities, and general corporate purposes.
There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In addition, YA has agreed that, during the term of the Purchase Agreement, neither YA nor its affiliates will engage in any short sales or hedging transactions with respect to ADSs, provided YA or its affiliates may (i) sell “long”, as such term is defined in Rule 200 of Regulation SHO of the Exchange Act, the Commitment Shares and any Advance Shares issued and sold by us to YA pursuant to an Advance Notice, and (ii) sell a number of ADSs equal to the number of Advance Shares that YA is unconditionally obligated to purchase under a pending Advance Notice but has not yet received from us or our transfer agent pursuant to the Purchase Agreement, or (i) and (ii) collectively, the Permitted Sales.
The Purchase Agreement prohibits us from directing YA to purchase ADSs represented by Ordinary Shares if those shares, when aggregated with all other Ordinary Shares then beneficially owned by YA and its affiliates, would result in YA and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding Ordinary Shares, as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 13d-3 thereunder, which limitation we refer to as the Ownership Limitation.
The Purchase Agreement contains customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.
The Purchase Agreement will automatically terminate upon the earliest of (i) the 36-month anniversary of the date of execution of the Purchase Agreement, and (ii) YA’s purchase of the total Commitment Amount under the Purchase Agreement. We have the right to terminate the Purchase Agreement at any time, at no cost or penalty, upon five trading days’ prior written notice to YA, provided that (i) there are no outstanding Advance Notices, the Advance Shares under which have yet to be issued and (ii) we have paid all amounts owed to YA pursuant to the Purchase Agreement.
5
There are substantial risks to our shareholders as a result of the sale and issuance of ADSs to YA under the Purchase Agreement. These risks include substantial dilution, significant declines in our share price and our inability to draw sufficient funds when needed. See “Risk Factors.” Issuances of our ADSs under the Purchase Agreement will not affect the rights or privileges of our existing shareholders, except that the economic and voting interests of each of our existing shareholders will be diluted as a result of any such issuance. Although the number of ADSs that our existing shareholders own will not decrease, the ADSs owned by our existing shareholders will represent a smaller percentage of our total outstanding ADSs after any such issuances pursuant to the Purchase Agreement.
March 2025 Standby Equity Purchase Agreement with YA
On March 3, 2025, we entered into the Standby Equity Purchase Agreement, or the March 2025 Purchase Agreement, with YA, pursuant to which YA committed to purchase up to $10.0 million of ADSs at our direction from time to time, subject to the restrictions and satisfaction of the conditions in the March 2025 Purchase Agreement, during the period, called the March 2025 Commitment Period, commencing on the date of execution of the March 2025 Purchase Agreement until the earlier of (i) the 36-month anniversary of the date of execution of the March 2025 Purchase Agreement, and (ii) YA’s purchase of the total $10.0 million under the March 2025 Purchase Agreement, or the March 2025 Advance Shares. We filed a registration statement on Form F-1 to register the resale of up to 3,022,796 ADSs issuable to YA under the 2025 Purchase Agreement from time to time during the March 2025 Commitment Period, subject to the restrictions and satisfaction of the conditions in the 2025 Purchase Agreement, if and when we determined to sell additional ADSs to YA under the 2025 Purchase Agreement. We issued 28,874 ADSs to YA as consideration for its irrevocable commitment to purchase the March 2025 Advance Shares under the 2025 Purchase Agreement. In addition to the Commitment Shares, to date, we have sold 1,638,062 March 2025 Advance Shares to YA for the aggregate consideration of approximately $5.8 million.
Pursuant to the Purchase Agreement, upon the registration statement of which this prospectus is a part first being declared effective by the SEC, the March 2025 Purchase Agreement shall, without any further action or notice by us or YA, automatically terminate and be of no further force or effect as of such time, other than certain indemnification provisions in the March 2025 Purchase Agreement which shall survive termination of the March 2025 Purchase Agreement.
Corporate Information
Our legal and commercial name is Scinai Immunotherapeutics Ltd. (formerly known as BiondVax Pharmaceuticals Ltd.). We are a company limited by shares organized under the laws of Israel. We were incorporated in Israel in 2003 as a privately held company and started operating in 2005. In February 2007, we completed an initial public offering of our Ordinary Shares on the Tel Aviv Stock Exchange (TASE), and we voluntarily delisted from the TASE in January 2018. In May 2015, we completed an initial public offering of ADSs and ADSs warrants (which have since expired) on Nasdaq.
Our principal executive offices are located at Kiryat Hadassah, Building 1, Jerusalem BioPark, 2nd Floor, Jerusalem, Israel 9112001, and our telephone number is 972-8-930-2529. Our website address is http://www.scinai.com. The information on our website does not constitute a part of this prospectus. Our agent for service of process in the United States is Puglisi & Associates, located at 850 Library Avenue, Suite 204, Newark, Delaware.
6
| ADSs Outstanding Prior to this Offering | 3,187,679 ADSs (representing 12,750,715,584 Ordinary Shares) (as of September 17, 2025). | |
| Securities offered by the Selling Shareholder | 4,800,000 ADSs, represented as (i) 35,461 ADSs issued as the Commitment Shares upon execution of the Purchase Agreement and (ii) 4,764,539 ADSs as the Advance Shares that we may sell to YA under the Purchase Agreement from time to time. | |
| ADSs outstanding immediately after this offering | The number of ADSs to be outstanding immediately after the offering is 7,987,679 ADSs. | |
| The ADSs |
Each ADS represents 4,000 Ordinary Shares, no par value. The ADSs will be delivered by The Bank of New York Mellon, as depositary (the “Depositary”).
The Depositary, as depositary, or its nominee, will be the holder of the Ordinary Shares underlying your ADSs and you will have rights as provided in the Deposit Agreement, dated as of May 11, 2015, among us, the Depositary and all owners and holders from time to time of ADSs issued thereunder (the “Deposit Agreement”), a form of which has been filed as Exhibit 1 to the Registration Statement on Form F-6 filed by the Depositary with the SEC on April 10, 2015.
You should carefully read the “Description of American Depositary Shares” section of the accompanying prospectus and the Deposit Agreement to better understand the terms of the ADSs. | |
| ADS Depositary | The Bank of New York Mellon. | |
| Use of Proceeds | We will not receive any proceeds from the sale of the YA Shares included in this prospectus by the Selling Shareholder. We may receive up to $15.0 million aggregate gross proceeds under the Purchase Agreement from sales of ADSs that we elect to make to YA as Advance Shares pursuant to the Purchase Agreement, if any, from time to time in our sole discretion, although the actual amount of proceeds that we may receive cannot be determined at this time and will depend on the number of ADSs we sell under the Purchase Agreement and market prices at the times of such sales. Any proceeds that we receive from sales of ADSs under the Purchase Agreement will be used for continued development of our pipeline of innovative drug candidates , support of our CDMO business as well as general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. See “Use of Proceeds.” | |
| Nasdaq Symbol | The ADSs are listed on the Nasdaq Capital Market under the symbol “SCNI”. |
| Risk Factors | Investing in our securities involves significant risks. See “Risk Factors” on page 9 of this prospectus and “Item 3. - Key Information – D. Risk Factors” in our Annual Report on Form 20-F for the fiscal 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 you should carefully consider before deciding to invest in the securities. | |
| Dividend policy | We have never declared or paid any cash dividends to our shareholders, and we currently do not expect to declare or pay any cash dividends in the foreseeable future. |
7
The number of ADSs to be outstanding immediately after the offering, as shown above, is based on 3,187,679 ADSs (representing 12,750,715,584 Ordinary Shares) outstanding as of September 17, 2025 and does not include, as of such date:
| ● | 364,000 ADSs issuable upon conversion of the preferred shares issued in August 2024; |
| ● | pre-funded warrants to acquire 565,706 ADSs at an exercise price of $0.001 per share; |
| ● | the following ADSs underlying outstanding warrants: |
| o | 14,000 ADSs underlying warrants at an exercise price of $50.00 per ADS expiring December 16, 2025; |
| o | 292,000 ADSs underlying warrants at an exercise price of $6.50 per ADS expiring January 4, 2027; |
| o | 8,760 ADSs underlying warrants at an exercise price of $8.125 per ADS expiring January 4, 2027; |
| o | 6,879 underlying warrants ADSs at an exercise price of $8.125 per ADS July 3, 2029; |
| o | 229,310 ADSs underlying warrants at an exercise price of $6.50 per ADS expiring July 3, 2029; |
| o | 6,879 ADSs underlying warrants at an exercise price of $14.50 per ADS expiring September 15, 2028; and |
| ● | the following ADSs issuable in connection with employee and executive compensation: |
| o | 24,307 ADSs issuable upon exercise of options outstanding under our 2018 Share Incentive Plan at a weighted exercise price of $18.10; |
| o | 100,836 ADSs issuable upon vesting of 100,836 restricted share units outstanding under our 2018 Share Incentive Plan; and |
| ● | the Subsequent Commitment Shares, the Advance Shares and any additional shares we may issue to YA pursuant to the Purchase Agreement should we elect to sell such shares to YA. |
Unless otherwise stated, all information in this prospectus assumes no exercise of the outstanding options or warrants into ADSs and no conversion of preferred shares into ADSs shares as described above.
Implications of Being a Foreign Private Issuer
We are a non-U.S. company with foreign private issuer status. 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 in respect of 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. |
Notwithstanding these exemptions, we will file with the SEC, within four months 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.
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 U.S.; or (iii) our business is administered principally in the U.S.
We are also exempt from certain more stringent executive compensation disclosure rules. As long as we remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are not a foreign private issuer.
8
An investment in our securities involves a high degree of risk. Our business, financial condition or results of operations could be adversely affected by any of these risks. Before making an investment in our securities, you should carefully consider all of the information included into this prospectus, including the risks described below. The risks and uncertainties we have described below and in our 2024 Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. If any of these risks actually occurs, our business, business prospects, financial condition or results of operations could be seriously harmed. This could cause the trading price of the ADSs to decline, resulting in a loss of all or part of your investment. Please also read carefully the section above entitled “Cautionary Note Regarding Forward-Looking Statements.”
Risks Related to the Offering
It is not possible to predict the actual number of shares we will sell under the Purchase Agreement to the Selling Shareholder, or the actual gross proceeds resulting from those sales.
On September 10, 2025, we entered into the Purchase Agreement with YA, pursuant to which YA has committed to purchase up to $15.0 million in ADSs, subject to certain limitations and conditions set forth in the Purchase Agreement. The ADSs that may be issued under the Purchase Agreement may be sold by us to YA at our discretion from time to time during the Commitment Period.
We generally have the right to control the timing and amount of sales of the ADSs to YA under the Purchase Agreement. Sales of ADSs, if any, to YA under the Purchase Agreement will depend upon market conditions and other factors. We may ultimately decide to sell to YA all, some or none of the ADSs that may be available for us to sell to YA pursuant to the Purchase Agreement.
Because the purchase price per share to be paid by YA for the ADSs that we may elect to sell to YA under the Purchase Agreement, if any, will fluctuate based on the market prices of the ADSs during the applicable Pricing Period for each purchase made pursuant to the Purchase Agreement, if any, it is not possible for us to predict, as of the date of this prospectus and prior to any such sales, the number of ADSs that we will sell to YA under the Purchase Agreement, the purchase price per share that YA will pay for shares purchased from us under the Purchase Agreement, or the aggregate gross proceeds that we will receive from those purchases by YA under the Purchase Agreement, if any.
Limitations in the Purchase Agreement, including the Ownership Limitation, and our ability to meet the conditions necessary to deliver an Advance Notice, could prevent us from being able to raise funds up to the Commitment Amount.
Moreover, 4,800,000 ADSs are being registered for resale by YA under the registration statement that includes this prospectus, consisting of (i) the 35,461 Commitment Shares that we issued to YA upon execution of the Purchase Agreement and (ii) the Advance Shares that we may elect to sell to YA, in our sole discretion, from time to time during the Commitment Period, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, through sales under the Purchase Agreement. Even if we elect to sell to YA all of the shares being registered for resale under this prospectus, depending on the market prices of the ADSs at the time of such sales, the actual gross proceeds from the sale of all such shares may be substantially less than the approximately $15.0 million total commitment of YA under the Purchase Agreement, which could materially adversely affect our liquidity.
9
If we desire to issue and sell to YA under the Purchase Agreement a number of ADSs in excess of the YA Shares being registered for resale under this prospectus, and the Ownership Limitation and other limitations in the Purchase Agreement would allow us to do so, we would need to file with the SEC one or more additional registration statements to register under the Securities Act the resale by YA of any such additional ADSs, and the SEC would have to declare such registration statement or statements effective before we could sell additional ADSs.
Any issuance and sale by us of a substantial amount of ADSs under the Purchase Agreement in addition to the ADSs being registered for resale by YA under this prospectus could cause additional substantial dilution to our shareholders. The number of our ADSs ultimately offered for sale by YA is dependent upon the ADSs, if any, we ultimately sell to YA under the Purchase Agreement.
The resale by YA of a significant number of shares registered for resale in this offering at any given time, or the perception that these sales may occur, could cause the market price of the ADSs to decline and to be highly volatile.
We will have broad discretion in how to use the net proceeds of this offering, and we may not use these proceeds in a manner currently contemplated.
We will have broad discretion as to the use of the net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity as part of your investment decision to assess whether the proceeds are being used consistently with current expectations. Our needs may change as the business and the industry that we address evolves. As a result, the proceeds to be received in this offering may be used in a manner significantly different from our current expectations. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return. The failure of our management to use such funds effectively could have a material adverse effect on our business, financial condition, operating results and cash flow.
The sale of a substantial amount of ADSs, including resale of the ADSs held by the selling shareholder in the public market, could adversely affect the prevailing market price of the ADSs and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of the ADSs.
We are registering for resale 4,800,000 ADSs that we may issue to YA from time to time pursuant to the Purchase Agreement, including 35,461 ADSs that we issued to YA as Commitment Shares upon execution of the Purchase Agreement. Sales of substantial amounts of ADSs in the public market, or the perception that such sales might occur, could adversely affect the market price of the ADSs and could impair our ability to raise capital through the sale of additional equity securities. We cannot predict if and when YA may sell such shares in the public markets. Furthermore, in the future, we may issue additional ADSs or other equity or debt securities convertible into ADSs.
Future sales of the ADSs, including any ADSs issuable upon the exercise of the warrants to acquire ADSs or conversion of the preferred shares issued to the EIB, or the perception that future sales may occur, may cause the market price of the ADSs to decline, even if our business is doing well.
To raise capital, we may sell ADSs, convertible securities or other equity securities in one or more transactions other than those contemplated by the Purchase Agreement, at prices and in a manner we determine from time to time. Sales by us or sales by the ADS holders of a substantial number of ADSs in the public market could occur in the future. These sales, or the perception in the market that we or the holders of a large number of ADSs intend to sell shares, may cause the market price of the ADSs to decline. In addition, to the extent that holders of warrants to purchase ADSs sell the ADSs issued upon the exercise of their warrants to purchase ADSs or holders of the preferred shares sell the ADSs issued upon the conversion of the preferred shares, the market price of the ADSs may decrease due to the additional selling pressure in the market. The risk of dilution from issuances of ADSs underlying the warrants to purchase ADSs may cause shareholders to sell their ADSs, which could cause a further decline in the market price.
10
This prospectus relates to ADSs that may be offered and sold from time to time by YA. All of the ADSs offered by the Selling Shareholder pursuant to this prospectus will be sold by the Selling Shareholder for its own account. We will not receive any of the proceeds from these sales.
We may receive up to approximately $15.0 million in aggregate gross proceeds under the Purchase Agreement from any sales of ADSs we make to YA pursuant to the Purchase Agreement. However, we are unable to estimate the actual amount of proceeds that we may receive, as it will depend on the number of ADSs that we choose to sell, our ability to meet the conditions to purchases set forth in the Purchase Agreement, market conditions and the price of the ADSs, among other factors.
We currently intend to use the net proceeds from YA pursuant to the Purchase Agreement, if any, for the continued development of our pipeline of innovative drug candidates, support of our CDMO business as well as general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. Although we have identified some potential uses of the net proceeds to be received from YA, we cannot specify these uses with certainty. Our management will have broad discretion in the application of the net proceeds and could use them for purposes other than those contemplated as of the date of this prospectus. Our shareholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not result in our being profitable or increasing our market value.
Our expected use of net proceeds under the Purchase Agreement represents our current intentions based on our present plans and business condition, which could change in the future as our plans and business conditions evolve. As of the date of this prospectus, we cannot predict with certainty any or all of the particular uses for the net proceeds to be received under the Purchase Agreement, or the amounts, if any, that we will actually spend on the uses set forth above. The amounts and timing of our actual use of the net proceeds may vary depending on numerous factors, including our ability to obtain additional financing and changes we may make to our development plan. As a result, our management will have broad discretion in the application of the net proceeds, which may include uses not set forth above, and investors will be relying on our judgment regarding the application of the net proceeds from this offering.
Pending the use of the net proceeds from sales of ADSs by us pursuant to the Purchase Agreement as described above, we intend to invest the net proceeds in a variety of capital preservation investments, short and intermediate term, interest-bearing, investment-grade instruments, U.S. government securities and highly rated corporate debt securities, although our investment policy may change following the date of this prospectus supplement. It is possible that, pending their use, we may invest the net proceeds in a way that does not yield a favorable, or any, return for us.
11
The following table sets forth our total capitalization:
| ● | on an actual basis as of June 30, 2025; | |
| ● | on a pro forma basis to reflect the issuance of an aggregate of 1,638,062 Advance Shares to YA for the aggregate consideration of approximately $4.2 million from sales under the March 2205 Purchase Agreement (the “Pro Forma Adjustment”); and | |
| ● | on a pro forma as adjusted basis, to give effect to the Pro Forma Adjustment and to (i) the issuance of 35,461 ADSs as the Commitment Shares upon execution of the Purchase Agreement and (ii) the issuance of 4,764,539 ADSs as Advance Shares at an assumed offering price of $1.63 per ADSs before expenses, which is the last reported sales price of the ADSs on the Nasdaq on September 15, 2025, assuming all the Commitment Shares and Advance Shares will be sold under the Purchase Agreement, after deducting the estimated offering expenses by us. |
The pro forma as adjusted information set forth below is illustrative only and will be adjusted based on the actual public offering price and number of ADSs sold under the Purchase Agreement. You should read this information together with our consolidated financial statements.
The information included in the table below is unaudited. The information set forth in the following table should be read in conjunction with and is qualified in its entirety by reference to the unaudited and audited financial statements and notes thereto that are incorporated by reference into this prospectus and the other financial information included or incorporated by reference into this prospectus.
| As of June 30, 2025 | ||||||||||||
| (In thousands, except share data) | Actual | Pro Forma | Pro Forma as adjusted | |||||||||
| Cash and cash equivalents | 989 | 5,192 | 12,402 | |||||||||
| Ordinary Shares, no par value: 40,000,000,000 Ordinary Shares authorized; 6,056,623,584 Ordinary Shares issued and outstanding (actual); 12,750,715,584 Ordinary Shares issued and outstanding (pro forma) and 31,590,715,584 Ordinary Shares issued and outstanding (pro forma as adjusted) | - | - | - | |||||||||
| Preferred Shares, no par value: 1,000 preferred shares authorized and issued and outstanding | 5,627 | 5,627 | 5,627 | |||||||||
| Additional paid-in capital | 125,644 | 129,847 | 137,057 | |||||||||
| Accumulated deficit | (121,673 | ) | (121,673 | ) | (121,673 | ) | ||||||
| Accumulated other comprehensive loss | (1,740 | ) | (1,740 | ) | (1,740 | ) | ||||||
| Total shareholders’ equity (deficit) | 7,858 | 12,061 | 19,271 | |||||||||
| Total liabilities and shareholders | 11,840 | 16,043 | 23,253 | |||||||||
12
As of June 30, 2025, we had outstanding 1,514,155 ADSs (representing 6,056,623,684. Ordinary Shares), not including, as of such date:
| ● | ADSs underlying outstanding warrants: |
| o | 14,000 ADSs underlying warrants at an exercise price of $50.00 per ADS expiring December 16, 2025; |
| o | 292,000 ADSs underlying warrants at an exercise price of $6.50 per ADS expiring January 4, 2027; |
| o | 8,760 ADSs underlying warrants at an exercise price of $8.125 per ADS expiring January 4, 2027; |
| o | 6,879 underlying warrants ADSs at an exercise price of $8.125 per ADS July 3, 2029; |
| o | 229,310 ADSs underlying warrants at an exercise price of $6.50 per ADS expiring July 3, 2029; |
| o | 6,879 ADSs underlying warrants at an exercise price of $14.50 per ADS expiring September 15, 2028; |
| ● | the following ADSs issued in connection with our employee and executive compensation: |
| o | 24,307 ADSs issuable upon exercise of options outstanding under our 2018 Share Incentive Plan at a weighted exercise price of $18.10; |
| o | 100,836 ADSs issuable upon vesting of 100,836 restricted share units outstanding under our 2018 Share Incentive Plan; and |
| ● | The Commitment Shares, the Advance Shares and any additional shares we may issue to YA pursuant to the Purchase Agreement should we elect to sell such shares to YA. |
Unless otherwise stated, all information in this prospectus assumes no exercise of the outstanding options or warrants into ADSs and no conversion of preferred shares into ADSs as described above.
13
SELLING SHAREHOLDER
This prospectus relates to the possible resale from time to time by YA of any or all of the ADSs that are to be issued by us to YA under the Purchase Agreement. For additional information regarding the issuance of Ordinary Shares covered by this prospectus, see the section titled “Prospectus Summary—Standby Equity Purchase Agreement with YA” above. Except for the transactions contemplated by the Purchase Agreement and the March 2025 Purchase Agreement described above, YA does not, and has not had, any material relationship with us.
The table below presents information regarding the Selling Shareholder and the ADSs that it may offer from time to time under this prospectus. This table is prepared based on information supplied to us by the Selling Shareholder. The number of shares in the column “Maximum Number of ADSs to be Offered Pursuant to this Prospectus” represents all of the ADSs that the Selling Shareholder may offer under this prospectus. The Selling Shareholder may sell some, all or none of its ADSs in this offering. We do not know how long the Selling Shareholder will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the Selling Shareholder regarding the sale of any of the shares.
The beneficial ownership of our ADSs is determined in accordance with the rules of the SEC.
The percentage of ADSs beneficially owned by the Selling Shareholder prior to the offering shown in the table below is based on an aggregate of on 3,187,679 ADSs outstanding on September 17, 2025. The number of ADS that may actually be sold by us under the Purchase Agreement may be fewer than the number of ADSs being offered by this prospectus. The fourth column assumes the sale of all of the ADSs offered by the Selling Shareholder pursuant to this prospectus.
Number of ADSs Owned Prior to Offering | Maximum Number of ADSs to
be Offered Pursuant to this | Number of ADSs Owned After Offering | ||||||||||||||||||
| Name of Selling Shareholder | Number(1) | Percent | Prospectus (2) | Number(3) | Percent | |||||||||||||||
| YA II PN, LTD. (5) | 35,461 | * | 4,800,000 | - | - | |||||||||||||||
| * | Represents ownership of less than 1%. |
|
(1) |
In accordance with Rule 13d-3(d) under the Exchange Act, we have excluded from the number of ADSs beneficially owned prior to the offering all of the ADSs that YA may be required to purchase under the Purchase Agreement, because the issuance of such ADS is solely at our discretion and is subject to conditions contained in the Purchase Agreement, the satisfaction of which are entirely outside of YA’s control, including the registration statement that includes this prospectus becoming and remaining effective. |
| (2) | This includes the 35,461 Commitment Shares we issued to YA in consideration of YA’s obligation to purchase ADSs at our direction under the Purchase Agreement and, for which we will receive no cash proceeds. Therefore, only 4,764,539 of such ADSs represent shares that we may issue and sell to YA for cash consideration in purchases under the Purchase Agreement from time to time, at our sole discretion, during the 36-month period following execution of the Purchase Agreement. Depending on the price per ADS at which we sell the Advance Shares to YA pursuant to the Purchase Agreement, we may need to sell to YA under the Purchase Agreement more ADSs than are offered under this prospectus in order to receive aggregate gross proceeds equal to the approximately $15.0 million Commitment Amount under the Purchase Agreement. If we choose to do so and otherwise satisfy the conditions in the Purchase Agreement, we must first register for resale under the Securities Act such additional ADSs. The number of ADSs ultimately offered for resale by YA is dependent upon the number of ADSs we sell to YA under the Purchase Agreement. |
| (3) | Assumes the sale of all ADSs being offered pursuant to this prospectus. |
| (4) | All investment decisions for YA II PN, Ltd. (“YA”) are made by Mr. Mark Angelo. The business address of YA is 1012 Springfield Avenue, Mountainside, NJ 07092. |
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| Articles of Association |
Our number with the Israeli Registrar of Companies is 51-343610-5. Our purpose as set forth in our Articles of Association is to engage in every lawful purpose in the field of biotechnology.
Our authorized share capital consists of (i) 40,000,000,000 Ordinary Shares, no par value, the equivalent of 10 million ADSs (each ADS representing 4,000 Ordinary Shares), and (ii) 1,000 preferred shares, no par value per share. As of September 17, 2025, there were 12,750,715,584 Ordinary Shares issued and outstanding (all of which were represented by ADSs other than 416 Ordinary Shares). All of our outstanding Ordinary Shares are validly issued, fully paid and non-assessable. Our Ordinary Shares are not redeemable and do not have any preemptive rights.
Voting Rights
Holders of our Ordinary Shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholder meeting. Shareholders may vote at shareholder meetings either in person, by proxy or by written ballot. Israeli law does not allow public companies to adopt shareholder resolutions by means of written consent in lieu of a shareholder meeting. According to the Companies Law and the regulations promulgated thereunder, for purposes of determining the shareholders entitled to notice and to vote at such meeting, the board of directors may fix the record date not more than 60 nor less than four calendar days prior to the date of the meeting, provided that an announcement regarding the general meeting be given prior to the record date. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Except as otherwise disclosed herein, an amendment to our articles of association requires the prior approval of the holders of at least 75% of our Ordinary Shares, represented and voting at a general meeting.
Our Ordinary Shares do not have cumulative voting rights for the election of directors. As a result, the holders of a majority of the voting power represented at a shareholders meeting have the power to elect all of our directors, subject to the special approval requirements for external directors under the Israeli Companies Law.
Transfer of Shares
Our Ordinary Shares that are fully paid for are issued in registered form and may be freely transferred under our articles of association, unless the transfer is restricted or prohibited by applicable law or the rules of a stock exchange on which the shares are traded. The ownership or voting of our Ordinary Shares by non-residents of Israel is not restricted in any way by our articles of association or Israeli law, except for ownership by nationals of some countries that are, or have been, in a state of war with Israel.
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The Powers of the Directors
Our board of directors shall direct the Company’s policy and shall supervise the performance of the Company’s Chief Executive Officer. Pursuant to the Companies Law and our articles of association, our board of directors may exercise all powers and take all actions that are not required under law or under our articles of association to be exercised or taken by our shareholders, including the power to borrow money for company purposes.
Amendment of share capital
Our articles of association enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the Companies Law and must be approved by a resolution duly passed by our shareholders at a general or special meeting by voting on such change in the capital. In addition, transactions that have the effect of reducing capital, such as the declaration and payment of dividends in the absence of sufficient retained earnings and profits and an issuance of shares for less than their nominal value, require a resolution of our board of directors and court approval.
Dividends
Under Israeli law, we may declare and pay dividends only if, upon the determination of our board of directors, there is no reasonable concern that the distribution will prevent us from being able to meet the terms of our existing and foreseeable obligations as they become due. Under the Companies Law, the distribution amount is further limited to the greater of retained earnings or earnings generated over the two most recent years legally available for distribution according to our then last reviewed or audited financial statements, provided that the date of the financial statements is not more than six months prior to the date of distribution. In the event that we do not have retained earnings or earnings generated over the two most recent years legally available for distribution, we may seek the approval of the court in order to distribute a dividend. The court may approve our request if it is determined that there is no reasonable concern that the payment of a dividend will prevent us from satisfying our existing and foreseeable obligations as they become due. In addition, no dividends may be paid on our ordinary shares until all of our preferred shares have been fully redeemed.
Shareholder Meetings
Under Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year and in any event 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 meetings. Our board of directors may call special meetings whenever it sees fit, at such time and place, within or outside of Israel, as it may determine. In addition, as a company whose shares are listed for trade on an exchange outside of Israel, the Companies Law provides that our board of directors is required to convene a special meeting upon the written request of (i) any two of our directors or one quarter of the directors then in office; or (ii) one or more shareholders holding, in the aggregate either (a) 10% of our issued share capital and 1% of our outstanding voting power, or (b) 10% of our outstanding voting power.
Under Israeli law, one or more shareholders holding at least 1% of the voting rights at the general meeting may request that the board of directors include a matter in the agenda of a general meeting to be convened in the future (or, with respect to a company whose shares are listed for trade on an exchange outside of Israel, such as us, 5% if the matter is the appointment or removal of a director), provided that it is appropriate to discuss such any other matter at the general meeting
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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. Furthermore, the Companies Law and our articles of association require that resolutions regarding the following matters must be passed at a general meeting of our shareholders:
| ● | amendments to our articles of association; | |
| ● | appointment or termination of our auditors; | |
| ● | appointment of directors and appointment and dismissal of external directors; |
| ● | approval of acts and transactions requiring general meeting approval pursuant to the Companies Law; | |
| ● | director compensation, indemnification and change of the principal executive officer; | |
| ● | increases or reductions of our authorized share capital; | |
| ● | a merger; | |
| ● | the exercise of our board of directors’ 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; and | |
| ● | authorizing the chairman of the board of directors or his relative to act as the company’s chief executive officer or act with such authority; or authorize the company’s chief executive officer or his relative to act as the chairman of the board of directors or act with such authority. |
The Companies Law requires that a notice of any annual or special shareholders meeting be provided 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, or an approval of a merger, notice must be provided at least 35 days prior to the meeting.
Quorum
The quorum required for our general meetings of shareholders consists of one or more shareholders present in person, by proxy or by other voting instrument in accordance with the Companies Law who hold or represent, in the aggregate, at least 10% (or, for so long we do not qualify as a foreign private issuer and for only so long as required by the Nasdaq Stock Market, 33 1/3% of the Company’s outstanding Ordinary Shares) of the total outstanding voting rights, within half an hour from the appointed time.
A meeting adjourned for lack of a quorum is adjourned to the same day in the following week at the same time and place or on a later date if so specified in the summons or notice of the meeting. At the reconvened meeting, any number of our shareholders present in person or by proxy shall constitute a lawful quorum.
Resolutions
Our articles of association provide that all resolutions of our shareholders require a simple majority vote, unless otherwise required by applicable law or by another provision of the articles of association.
Israeli law provides that a shareholder of a public company may vote in a meeting and in a class meeting by means of a written ballot in which the shareholder indicates how he or she votes on resolutions relating to the following matters:
| ● | an appointment or removal of directors; | |
| ● | an approval of transactions with office holders or interested or related parties, that require shareholder approval; | |
| ● | an approval of a merger; |
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| ● | authorizing the chairman of the board of directors or his relative to act as the company’s chief executive officer or act with such authority; or authorize the company’s chief executive officer or his relative to act as the chairman of the board of directors or act with such authority; |
| ● | any other matter that is determined in the articles of association to be voted on by way of a written ballot. Our articles of association do not stipulate any additional matters; and | |
| ● | other matters which may be prescribed by Israel’s Minister of Justice. |
The provision allowing the vote by written ballot does not apply where the voting power of the controlling shareholder is sufficient to determine the vote.
The Companies Law provides that a shareholder, in exercising his or her rights and performing his or her obligations toward the company and its other shareholders, must act in good faith and in a customary manner, and avoid abusing his or her power. This is required when voting at general meetings on matters such as changes to the articles of association, increasing the company’s registered capital, mergers and approval of certain interested or related party transactions. A shareholder also has a general duty to refrain from depriving any other shareholder of its rights as a shareholder. In addition, any controlling shareholder, any shareholder who knows that its vote can determine the outcome of a shareholder vote and any shareholder who, under such company’s articles of association, can appoint or prevent the appointment of an office holder or other power towards the company, is required to act with fairness towards the company. The Companies Law does not describe the substance of this duty except that the remedies generally available upon a breach of contract will also apply to a breach of the duty to act with fairness, and, to the best of our knowledge, there is no binding case law that addresses this subject directly.
Under the Companies Law, unless provided otherwise in a company’s articles of association, a resolution at a shareholders meeting requires approval by a simple majority of the voting rights represented at the meeting, in person, by proxy or written ballot, and voting on the resolution. Generally, a resolution for the voluntary winding up of the company requires the approval of holders of 75% of the voting rights represented at the meeting, in person, by proxy or by written ballot and voting on the resolution.
In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of our Ordinary Shares in proportion to their shareholdings. This right, as well as the right to receive dividends, may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights that may be authorized in the future.
Access to Corporate Records
Under the Companies Law, all shareholders of a company generally have the right to review minutes of the company’s general meetings, its shareholders register and principal shareholders register, articles of association, financial statements and any document it is required by law to file publicly with the Israeli Companies Registrar and the ISA. Any of our shareholders may request to review any document in our possession that relates to any action or transaction with a related party, interested party or office holder that requires shareholder approval under the Companies Law. We may deny a request to review a document if we determine that the request was not made in good faith, that the document contains a commercial secret or a patent or that the document’s disclosure may otherwise prejudice our interests.
Acquisitions under Israeli Law
Full Tender Offer
A person wishing to acquire shares of a public Israeli company and who would as a result hold over 90% of the target company’s issued and outstanding share capital is required by the Companies Law to make a tender offer to all of the company’s shareholders who hold shares of the same class for the purchase of all of the issued and outstanding shares of the company. If the shareholders who do not accept the offer hold less than 5% of the issued and outstanding share capital of the company or of the applicable class, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law (provided that a majority of the offerees that do not have a personal interest in such tender offer shall have approved the tender offer except that if the total votes to reject the tender offer represent less than 2% of the company’s issued and outstanding share capital, in the aggregate, approval by a majority of the offerees that do not have a personal interest in such tender offer is not required to complete the tender offer). However, a shareholder that had its shares so transferred may petition the court within six months from the date of acceptance of the full tender offer, whether or not such shareholder agreed to the tender or not, to determine whether the tender offer was for less than fair value and whether the fair value should be paid as determined by the court unless the acquirer stipulated in the tender offer that a shareholder that accepts the offer may not seek appraisal rights, so long as prior to the acceptance of the full tender offer, the acquirer and the company disclosed the information required by law in connection with the full tender offer. If the shareholders who did not accept the tender offer hold 5% or more of the issued and outstanding share capital of the company or of the applicable class, the acquirer may not acquire shares of the company that will increase its holdings to more than 90% of the company’s issued and outstanding share capital or of the applicable class from shareholders who accepted the tender offer.
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Special Tender Offer
The Companies Law provides that an acquisition of shares of a public Israeli company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of 25% or more of the voting rights in the company, unless one of the exemptions in the Companies Law is met. This rule does not apply if there is already another holder of at least 25% of the voting rights in the company. Similarly, the Companies Law provides that an acquisition of shares in a public company must be made by means of a tender offer if as a result of the acquisition the purchaser would become a holder of 45% or more of the voting rights in the company, if there is no other shareholder of the company who holds 45% or more of the voting rights in the company, unless one of the exemptions in the Companies Law is met.
A special tender offer must be extended to all shareholders of a company, but the offeror is not required to purchase shares representing more than 5% of the voting power attached to the company’s outstanding shares, regardless of how many shares are tendered by shareholders. A special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by the offeror and (ii) the number of shares tendered in the offer exceeds the number of shares whose holders objected to the 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.
Under regulations enacted pursuant to the Companies Law, the above special tender offer requirements may not apply to companies whose shares are listed for trading on a foreign stock exchange if, among other things, the relevant foreign laws or the rules of the stock exchange, include provisions limiting the percentage of control which may be acquired or that the purchaser is required to make a tender offer to the public. However, the Israeli Securities Authority’s opinion is that such leniency does not apply with respect to companies whose shares are listed for trading on stock exchanges in the United States, including the NASDAQ Capital Market, which do not provide for sufficient legal restrictions on obtaining control or an obligation to make a tender offer to the public, therefore the special tender offer requirements shall apply to such companies.
Merger
The Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described under the Companies Law are met, a majority of each party’s shares voted on the proposed merger at a shareholders’ meeting called with at least 35 days’ prior notice.
For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares represented at the shareholders meeting that are held by parties other than the other party to the merger, or by any person who holds 25% or more of the outstanding shares or the right to appoint 25% or more of the directors of the other party, vote against the merger. If the transaction would have been approved 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 request of holders of at least 25% of the voting rights of a company, if the court holds 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.
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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.
In addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed by each party with the Israeli Registrar of Companies and 30 days have passed from the date the merger was approved by the shareholders of each party.
Antitakeover Measures
The Companies Law allows us to create and issue shares having rights different from those attached to our Ordinary Shares, including shares providing certain preferred rights, distributions or other matters and shares having preemptive rights. As of the date of this prospectus, we have authorized and issued ordinary shares and preferred shares. In the future, if we do create and issue a class of shares other than Ordinary Shares, such class of shares, depending on the specific rights that may be attached to them, may delay or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium over the market value of their Ordinary Shares. The authorization of a new class of shares will require an amendment to our articles of association which requires the prior approval of the holders of at least 75% of our Ordinary Shares at a general meeting. Shareholders voting in such meeting will be subject to the restrictions provided in the Companies Law as described above.
Preferred Shares
Conversion Terms of Preferred Shares
On August 21, 2024, we announced that we had closed a Loan Restructuring Agreement (the “Restructuring Agreement”) with our lender, EIB, which included an amendment to the amended Finance Contract (the “Finance Contract”) between the parties (the transactions contemplated by the Restructuring Agreement called the “EIB Restructuring Transaction”).
In connection with the EIB Restructuring Transaction, an amount equal to approximately EUR 26.6 million (equal to approximately $31.35 million as of September 18, 2025), including interest accrued to date, owed by us to the EIB under the Finance Contract was converted into 1,000 of our preferred shares, no par value per share (“Preferred Shares”).
The Preferred Shares are convertible (in whole or in part), at the option of the EIB (the current holder of al, into 1,456,000,000 Ordinary Shares in the aggregate, which will then automatically be converted into ADSs, with each Preferred Share convertible 1,456,000 Ordinary Shares (represented by ADSs). The number of ADSs that can be acquired upon conversion of the Preferred Shares is also subject to adjustment in the event of any share split, share dividend and similar events involving the Ordinary Shares.
Stated Redemption Value of the Preferred Shares
The Preferred Shares entitle the holders thereof to redemption payments in the aggregate amount of $34 million ($34,000 per Preferred Share). In the event a Preferred Share is converted into Ordinary Shares, the right to receive such payment for such Preferred Share will be extinguished. The Company will pay the redemption payment only if and at such time (i) as the Company elects, at its sole discretion, to make any such redemption payments, provided that such redemption is in compliance with applicable law, including the Company’s legal ability to pay a dividend to its shareholders, or (ii) in the event of Liquidation (as defined in our articles of association) of the Company, in which event the Company will first make the redemption payment (either in whole or, if less than the entire amount, on a pro rata basis based on the number of Preferred Shares held by each holder) before making any payment to holders of Ordinary Shares. The Preferred Shares will not be entitled to cumulative dividends.
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Limit on Holdings of 4.99% of the Outstanding ADSs at any time
The Preferred Shares contain a provision preventing the holder from converting such number of Preferred Shares into ADSs to the extent that if, as a result of such conversion, the holder would become the beneficial owner of more than 4.99% of the Company’s outstanding shares as determined under the rules promulgated in the Securities Exchange Act of 1934, as amended.
Veto Rights
The holders of a majority of the Preferred Shares have veto rights over the ability of the Company to (i) incur Indebtedness (as defined in our articles of association), subject to certain exceptions, (ii) enter into an M&A Event (as defined in our articles of association), (iii) voluntarily delist the trading of the Company’s securities on Nasdaq and (iv) authorize the creation of any security having rights, preferences and privileges equal to or greater than those of the Preferred Shares, including the issuance of additional Preferred Shares.
Right of First Refusal.
The Company would have a right of first refusal in the event that the EIB intends to sell, transfer, assign or otherwise dispose of any or all of the Preferred Shares.
American Depositary Shares
The Bank of New York Mellon, as depositary, registered and delivered American Depositary Shares, also referred to as ADSs. Each ADS represents 4,000 ordinary shares (or a right to receive 4,000 ordinary shares) deposited with the principal Tel Aviv office of either of Bank Leumi or Bank Hapoalim, as custodian for the depositary. Each ADS also represents any other securities, cash or other property which may be held by the depositary. The depositary’s office at which the ADSs are administered is located at 101 Barclay Street, New York, New York 10286. The Bank of New York Mellon’s principal executive office is located at One Wall Street, New York, New York 10286.
You may hold ADSs either (A) directly (i) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs, registered in your name, or (ii) by having ADSs registered in your name in the Direct Registration System, or DRS, or (B) indirectly by holding a security entitlement in ADSs through your broker or other financial institution. If you hold ADSs directly, you are a registered ADS holder, also referred to as an ADS holder. This description assumes you are an ADS holder. If you hold the ADSs indirectly, you must rely on the procedures of your broker or other financial institution to assert the rights of ADS holders described in this section. You should consult with your broker or financial institution to find out what those procedures are.
The DRS is a system administered by The Depository Trust Company, or DTC, under which the depositary may register the ownership of uncertificated ADSs, which ownership is confirmed by periodic statements sent by the depositary to the registered holders of uncertificated ADSs.
As an ADS holder, we will not treat you as one of our shareholders and you will not have shareholder rights. Israeli law governs shareholder rights. The depositary will be the holder of the ordinary shares underlying your ADSs. As a registered holder of ADSs, you will have ADS holder rights. A deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs.
The following is a summary of the material provisions of the deposit agreement. For more complete information, you should read the entire deposit agreement and the form of ADR.
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Dividends and Other Distributions
How will you receive dividends and other distributions on the shares?
The depositary has agreed to pay to ADS holders the cash dividends or other distributions it or the custodian receives on ordinary shares or other deposited securities, after deducting its fees and expenses. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent.
Cash. The depositary will convert any cash dividend or other cash distribution we pay on the ordinary shares into U.S. dollars, if it can do so on a reasonable basis and can transfer the U.S. dollars to the United States. If that is not possible or if any government approval is needed and cannot be obtained, the deposit agreement allows the depositary to distribute the foreign currency only to those ADS holders to whom it is possible to do so. It will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest.
Before making a distribution, the depositary will deduct any withholding taxes, or other required governmental charges. The depositary will distribute only whole U.S. dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, you may lose some or all of the value of the distribution.
Shares. The depositary may distribute additional ADSs representing any ordinary shares we distribute as a dividend or free distribution. The depositary will only distribute whole ADSs. It may sell ordinary shares which would require it to deliver a fraction of an ADS and distribute the net proceeds in the same way as it does with cash. If the depositary does not distribute additional ADSs, the outstanding ADSs will also represent the new shares. The depositary may sell a portion of the distributed ordinary shares sufficient to pay its fees and expenses in connection with that distribution.
Rights to purchase additional shares. If we offer holders of our securities any rights to subscribe for additional ordinary shares or any other rights, the depositary may make these rights available to ADS holders. If the depositary decides it is not legal and practical to make the rights available but that it is practical to sell the rights, the depositary will use reasonable efforts to sell the rights and distribute the proceeds in the same way as it does with cash. The depositary will allow rights that are not distributed or sold to lapse. In that case, you will receive no value for them.
If the depositary makes rights available to ADS holders, it will exercise the rights and purchase the ordinary shares on your behalf. The depositary will then deposit the ordinary shares and deliver ADSs to the persons entitled to them. It will only exercise rights if you pay it the exercise price and any other charges the rights require you to pay.
U.S. securities laws may restrict transfers and cancellation of the ADSs represented by ordinary shares purchased upon exercise of rights. For example, you may not be able to trade these ADSs freely in the United States. In this case, the depositary may deliver restricted depositary shares that have the same terms as the ADSs described in this section except for changes needed to put the necessary restrictions in place.
Other Distributions. The depositary will send to ADS holders anything else we distribute on deposited securities by any means it thinks is legal, fair and practical. If it cannot make the distribution in that way, the depositary will have a choice. It may decide to sell what we distributed and distribute the net proceeds, in the same way as it does with cash. Or, it may decide to hold what we distributed, in which case ADSs will also represent the newly distributed property. However, the depositary is not required to distribute any securities (other than ADSs) to ADS holders unless it receives reasonably satisfactory evidence from us that it is legal to make that distribution. The depositary may sell a portion of the distributed securities or property sufficient to pay its fees and expenses in connection with that distribution
The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. We have no obligation to register ADSs, shares, rights or other securities under the Securities Act. We also have no obligation to take any other action to permit the distribution of ADSs, shares, rights or anything else to ADS holders. This means that you may not receive the distributions we make on our ordinary shares or any value for them if it is illegal or impractical for us to make them available to you.
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Deposit, Withdrawal and Cancellation
How are ADSs issued?
The depositary will deliver ADSs if you or your broker deposits ordinary shares or evidence of rights to receive ordinary shares with the custodian. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the appropriate number of ADSs in the names you request and will deliver the ADSs to or upon the order of the person or persons that made the deposit.
How can ADS holders withdraw the deposited securities?
You may surrender your ADSs at the depositary’s office. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver the ordinary shares and any other deposited securities underlying the ADSs to the ADS holder or a person the ADS holder designates at the office of the custodian. Or, at your request, risk and expense, the depositary will deliver the deposited securities at its office, if feasible.
How do ADS holders interchange between certificated ADSs and uncertificated ADSs?
You may surrender your ADR to the depositary for the purpose of exchanging your ADR for uncertificated ADSs. The depositary will cancel that ADR and will send to the ADS holder a statement confirming that the ADS holder is the registered holder of uncertificated ADSs. Alternatively, upon receipt by the depositary of a proper instruction from a registered holder of uncertificated ADSs requesting the exchange of uncertificated ADSs for certificated ADSs, the depositary will execute and deliver to the ADS holder an ADR evidencing those ADSs.
Voting Rights
How do you vote?
ADS holders may instruct the depositary how to vote the number of deposited ordinary shares their ADSs represent. Otherwise, you won’t be able to exercise your right to vote unless you withdraw the shares. However, you may not know about the meeting sufficiently in advance to withdraw the shares.
The depositary will notify ADS holders of shareholders’ meetings and arrange to deliver our voting materials to them if we ask it to. Those materials will describe the matters to be voted on and explain how ADS holders may instruct the depositary how to vote. For instructions to be valid, they much reach the depositary by a date set by the depositary.
The depositary will try, as far as practical, subject to the laws of Israel and of our articles of association or similar documents, to vote or to have its agents vote the ordinary shares or other deposited securities as instructed by ADS holders. The depositary will only vote or attempt to vote as instructed or as described in the following sentence. If we ask the depositary to solicit your instructions at least 30 days before the meeting date but the depositary does not receive voting instructions from you by the specified date, it will consider you to have authorized and directed it to give a discretionary proxy to a person designated by us to vote the number of deposited securities represented by your ADSs. The depositary will give a discretionary proxy in those circumstances to vote on all questions at to be voted upon unless we notify the depositary that:
| ● | we do not wish to receive a discretionary proxy; | |
| ● | there is substantial shareholder opposition to the particular question; or | |
| ● | the particular question would have an adverse impact on our shareholders. |
We are required to notify the depositary if one of the conditions specified above exists.
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We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that you may not be able to exercise your right to vote and there may be nothing you can do if your ordinary shares are not voted as you requested.
In order to give you a reasonable opportunity to instruct the Depositary as to the exercise of voting rights relating to Deposited Securities, if we request the Depositary to act, we agree to give the Depositary notice of any such meeting and details concerning the matters to be voted upon at least 30 days in advance of the meeting date.
Fees and Expenses
| Persons depositing or withdrawing ordinary shares or ADS holders must pay: | For: | ||
| $5.00 (or less) per 100 ADSs (or portion of 100 ADSs) | ● | Issuance of ADSs, including issuances resulting from a distribution of ordinary shares or rights or other property Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | |
| $.05 (or less) per ADS | ● | Any cash distribution to ADS holders | |
| A fee equivalent to the fee that would be payable if securities distributed to you had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs | ● | Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders | |
| $.05 (or less) per ADS per calendar year | ● | Depositary services | |
| Registration or transfer fees | ● | Transfer and registration of ordinary shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw ordinary shares | |
| Expenses of the depositary | ● | Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) converting foreign currency to U.S. dollars | |
| Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or ordinary shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes | ● | As necessary | |
| Any charges incurred by the depositary or its agents for servicing the deposited securities | ● | As necessary | |
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.
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Payment of Taxes
You will be responsible for any taxes or other governmental charges payable on your ADSs or on the deposited securities represented by any of your ADSs.
Reclassifications, Recapitalizations and Mergers
| If we: | Then: | |||
| ● | Change the nominal or par value of our shares | The cash, ordinary shares or other securities received by the depositary will become deposited securities. Each ADS will automatically represent its equal share of the new deposited securities. | ||
| ● | Reclassify, split up or consolidate any of the deposited securities | |||
| ● | Distribute securities on the ordinary shares that are not distributed to you | The depositary may distribute new ADSs representing the new deposited securities or ask you to surrender your outstanding ADRs in exchange for new ADRs identifying the new deposited securities. | ||
| ● | Recapitalize, reorganize, merge, liquidate, sell all or substantially all of our assets, or take any similar action | |||
Amendment and Termination
How may the deposit agreement be amended?
We may agree with the depositary to amend the deposit agreement and the ADSs without your consent for any reason. If an amendment adds or increases fees or charges, except for taxes and other governmental charges or expenses of the depositary for registration fees, facsimile costs, delivery charges or similar items, or prejudices a substantial right of ADS holders, it will not become effective for outstanding ADSs until 30 days after the depositary notifies ADS holders of the amendment. At the time an amendment becomes effective, you are considered, by continuing to hold your ADSs, to agree to the amendment and to be bound by the ADRs and the deposit agreement as amended.
How may the deposit agreement be terminated?
The depositary will terminate the deposit agreement at our direction by mailing notice of termination to the ADS holders at least 30 days prior to the date fixed in such notice for such termination. The depositary may also terminate the deposit agreement by mailing notice of termination to us and the ADS holders if 60 days have passed from the date on which the depositary told us it wants to resign but a successor depositary has not been appointed and accepted its appointment.
After termination, the depositary and its agents will do the following under the deposit agreement but nothing else: collect distributions on the deposited securities, sell rights and other property, and deliver ordinary shares and other deposited securities upon cancellation of ADSs. Four months after termination, the depositary may sell any remaining deposited securities by public or private sale. After that, the depositary will hold the money it received on the sale, as well as any other cash it is holding under the deposit agreement for the pro rata benefit of the ADS holders that have not surrendered their ADSs. It will not invest the money and has no liability for interest. The depositary’s only obligations will be to account for the money and other cash. After termination our only obligations will be to indemnify the depositary and to pay fees and expenses of the depositary that we agreed to pay.
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Limitations on Obligations and Liability
Limits on our Obligations and the Obligations of the Depositary; Limits on Liability to Holders of ADSs
The deposit agreement expressly limits our obligations and the obligations of the depositary. It also limits our liability and the liability of the depositary. We and the depositary:
| ● | are only obligated to take the actions specifically set forth in the deposit agreement without negligence or bad faith; | |
| ● | are not liable if we are or it are prevented or delayed by law or circumstances beyond our or its control from performing our or its obligations under the deposit agreement; | |
| ● | are not liable if we or it exercise discretion permitted under the deposit agreement; | |
| ● | are not liable for the inability of any holder of ADSs to benefit from any distribution on deposited securities that is not made available to holders of ADSs under the terms of the deposit agreement, or for any special, consequential or punitive damages for any breach of the terms of the deposit agreement; | |
| ● | have no obligation to become involved in a lawsuit or other proceeding related to the ADSs or the deposit agreement on your behalf or on behalf of any other person; |
| ● | are not liable for the acts or omissions of any securities depository, clearing agency or settlement system; and | |
| ● | may rely upon any documents we believe or it believe in good faith to be genuine and to have been signed or presented by the proper person. |
In the deposit agreement, we and the depositary agree to indemnify each other under certain circumstances.
Requirements for Depositary Actions
Before the depositary will deliver or register a transfer of ADSs, make a distribution on ADSs, or permit withdrawal of shares, the depositary may require:
| ● | payment of stock transfer or other taxes or other governmental charges and transfer or registration fees charged by third parties for the transfer of any ordinary shares or other deposited securities; | |
| ● | satisfactory proof of the identity and genuineness of any signature or other information it deems necessary; and | |
| ● | compliance with regulations it may establish, from time to time, consistent with the deposit agreement, including presentation of transfer documents. |
The depositary may refuse to deliver ADSs or register transfers of ADSs when the transfer books of the depositary or our transfer books are closed or at any time if the depositary or we think it advisable to do so.
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Your Right to Receive the Ordinary Shares Underlying your ADSs
ADS holders have the right to cancel their ADSs and withdraw the underlying ordinary shares at any time except:
| ● | when temporary delays arise because: (i) the depositary has closed its transfer books or we have closed our transfer books; (ii) the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting; or (iii) we are paying a dividend on our shares; | |
| ● | when you owe money to pay fees, taxes and similar charges; or | |
| ● | when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities. |
This right of withdrawal may not be limited by any other provision of the deposit agreement.
Pre-release of ADSs
The deposit agreement permits the depositary to deliver ADSs before deposit of the underlying shares. This is called a pre-release of the ADSs. The depositary may also deliver ordinary shares upon cancellation of pre-released ADSs (even if the ADSs are canceled before the pre-release transaction has been closed out). A pre-release is closed out as soon as the underlying ordinary shares are delivered to the depositary. The depositary may receive ADSs instead of ordinary shares to close out a pre-release. The depositary may pre-release ADSs only under the following conditions: (1) before or at the time of the pre-release, the person to whom the pre-release is being made represents to the depositary in writing that it or its customer owns the ordinary shares or ADSs to be deposited; (2) the pre-release is fully collateralized with cash or other collateral that the depositary considers appropriate; and (3) the depositary must be able to close out the pre-release on not more than five business days’ notice. In addition, the depositary will limit the number of ADSs that may be outstanding at any time as a result of pre-release, although the depositary may disregard the limit from time to time if it thinks it is appropriate to do so.
Direct Registration System
In the deposit agreement, all parties to the deposit agreement acknowledge that DRS and the Profile Modification System, or Profile, will apply to uncertificated ADSs upon acceptance thereof to DRS by DTC. DRS is the system administered by DTC under which the depositary may register the ownership of uncertificated ADSs, which ownership will be confirmed by periodic statements sent by the depositary to the registered holders of uncertificated ADSs. Profile is a required feature of DRS that allows a DTC participant, claiming to act on behalf of a registered holder of ADSs, to direct the depositary to register a transfer of those ADSs to DTC or its nominee and to deliver those ADSs to the DTC account of that DTC participant without receipt by the depositary of prior authorization from the ADS holder to register that transfer.
In connection with and in accordance with the arrangements and procedures relating to DRS/Profile, the parties to the deposit agreement understand that the depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an ADS holder in requesting registration of transfer and delivery described in the paragraph above has the actual authority to act on behalf of the ADS holder (notwithstanding any requirements under the Uniform Commercial Code). In the deposit agreement, the parties agree that the depositary’s reliance on and compliance with instructions received by the depositary through the DRS/Profile System and in accordance with the deposit agreement will not constitute negligence or bad faith on the part of the depositary.
Shareholder communications; inspection of register of holders of ADSs
The depositary will make available for your inspection at its office all communications that it receives from us as a holder of deposited securities that we make generally available to holders of deposited securities. The depositary will send you copies of those communications if we ask it to. You have a right to inspect the register of holders of ADSs, but not for the purpose of contacting those holders about a matter unrelated to our business or the ADSs.
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History of Share Capital
Since January 1, 2022, our issued share capital has changed as provided below.
On February 2, 2022, we issued to Max Planck Society 1,500 ADSs at no cost as an upfront payment for the license under the License Agreement, dated December 11, 2021, between us and Max-Planck-Innovation GmbH.
On April 12, 2022, we issued 4,316 ADSs to Mr. Ron Babecoff, the former CEO of the Company, upon vesting of RSUs granted to him as part of his service to the Company.
Also on April 12, 2022, we issued 944 ADSs in the aggregate to the non-executive directors of the Company, including Mr. Isaac Devash a former director of the Company, upon the vesting of RSUs granted to directors in consideration for their service to the Company.
On November 9, 2022, we issued 17,694 ADSs to Hybrid Financial Ltd. as consideration for investor relations services.
On December 20, 2022, we closed an underwritten public offering with gross proceeds to us of $8 million, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each unit consisted of one ADSs and two warrants, each to purchase one ADS, and each pre-funded unit consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.99 per pre-funded unit after reducing $0.01 attributable to the exercise price of the pre-funded warrants). The Company received a net sum of $7,231,000 after deduction of underwriter discount and issuance expenses of $769,000.
From January 20, 2023 until October 23, 2024, we issued 1,662 RSUs to Prof. Matthias Dobbelstein as consideration for scientific advisory board services, of which 1,000 were converted into 1,000 ADSs.
On June 12, 2023, we issued (i) 1,038 ADSs in aggregate upon the vesting of RSUs granted to non-executive directors as part of their service to the Company and (ii) 24,000 ADSs upon the vesting of RSUs granted to Mr. Amir Reichman, the Company’s CEO, in consideration for his service to the Company.
On July 31, 2023, we issued 15,852 ADSs to MPG and 1,148 ADSs to MBM Science Bridge GmbH pursuant to the License Agreement, dated June 4, 2023, by and among the Company, Max Planck Innovation GmbH and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen.
On September 19, 2023, we issued (i) in a registered direct offering 40,000 ADSs and pre-funded warrants to purchase up to 74,655 ADSs, at an exercise price of $0.01 per ADS, at a purchase price of $11.6 per ADS and $11.59 per pre-funded warrant, and (ii) in concurrent private placement unregistered warrants to purchase up to 114,655 ADSs. The warrants have an exercise price of $11.6 per ADS and are immediately exercisable upon issuance for a period of five and one-half years. The Company received a net sum of $1,151 after deduction of underwriter discount and issuance expenses of $165.
On December 22, 2023, we issued 121,534 ADSs, issuable upon exercise of warrants to purchase ADSs issued pursuant to (i) a securities purchase agreement, dated September 15, 2023, by and between us and the purchaser named on the signature page thereto, and (ii) an engagement letter dated as of September 18, 2023, by between us and H.C. Wainwright & Co., LLC.
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On December 29, 2023 in connection with the Inducement Letters we issued 260,655 ADSs in the aggregate from the exercise of the Existing Warrants at an exercise price of 6.50 per ADS, and issued 521,310 New Warrants with an exercise price of $6.50 per ADS, in addition to Placement Agent Warrants to acquire 156,393 ADSs to our Placement Agent or its designees, each with an exercise price of $8.125.
On January 4, 2024, we closed a transaction in which we issued new unregistered warrants to purchase up to 521,310 ADSs in consideration for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 260,655 ADSs, issued by us in December 2022 and September 2023, at a reduced exercise price of $6.50 per ADS. The new warrants have an exercise price of $6.50 per ADS and have a term of exercise equal to three years or five and one-half years, as applicable, based on the term of the exercised warrants, from the date of issuance. We received gross proceeds of approximately $1.69 million and a net sum of approximately $1.42 million, after deduction of underwriter discount and issuance expenses of $275,000.
On August 21, 2024, we issued 1,000 preferred shares to the EIB in connection with the EIB Restructuring Transactions pursuant to which approximately $29 million, including interest accrued to date, owed by the Company to the EIB under the Finance Contract was converted into 1,000 preferred shares. See “Prospectus Summary – Recent Developments – Conversion of EIB Loan into Equity.”
From August 2024 until December 2024, we issued RK Stone Miami LLC pre-funded warrants to acquire an aggregate of 646,442 ADSs for an aggregate purchase price of $2.0 million.
On February 19, 2025, we issued 80,736 ADSs to LCK JNK 1, LLC upon its cashless exercise of pre-funded warrants to acquire 80,757 ADSs that it acquired from RK Stone Miami LLC.
Between March 24, 2025, and August 28, 2025, we issued to YA an aggregate of 2,210,282 Advance Shares for the aggregate consideration of approximately $5.8 million.
During the period beginning September 1, 2021 through December 31, 2024, we issued RSUs and options to acquire ADSs to our officers, directors and employees. We currently have outstanding RSUs for 100,836 ADSs and options to acquire 24,307 ADSs.
Transfer Agent and Depositary
The transfer agent and registrar for our Ordinary Shares is Vstock Transfer, LLC. The ADSs were issued pursuant to a Depositary Agreement entered into with The Bank of New York Mellon, which acts as depositary.
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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 prospectus, substantially all of whom reside outside 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 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 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. The address of our agent is 850 Library Avenue, Suite 204, Newark, Delaware.
We have been informed by our legal counsel in Israel, Goldfarb Gross Seligman & Co., that it may be difficult to initiate an action with respect to U.S. securities law 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 hear 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 by expert witnesses which can be a time-consuming and costly process. Certain matters of procedure may also be governed by Israeli law.
Subject to certain 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 judgments 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:
| ● | 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. Under existing Israeli law, a foreign judgment payable in foreign currency may be paid in Israeli currency at the rate of exchange in force on the date of the payment. Current Israeli exchange control regulations also permit a judgment debtor to 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.
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On September 10, 2025, we entered into the Purchase Agreement with YA. The Purchase Agreement provides that, upon the terms and subject to the conditions set forth therein, YA is committed to purchase up to $15.0million in ADSs during the Commitment Period. From time to time, and at our sole discretion, we may present YA with Advance Notices to purchase our ADSs. The ADSs would be purchased pursuant to the Purchase Agreement at 97% of the lowest daily VWAP during the period of three consecutive trading days commencing on the trading day immediately following the YA receipt of an Advance Notice.
The ADSs offered by this prospectus are being offered by the Selling Shareholder. The Selling Shareholder is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act. We have agreed in the Purchase Agreement to provide customary indemnification to YA.
It is possible that our shares may be sold from time to time by YA in one or more of the following manners:
| ● | ordinary brokers’ transactions; |
| ● | transactions involving cross or block trades; |
| ● | through brokers, dealers, or underwriters who may act solely as agents; |
| ● | “at the market” into an existing market for our common stock; |
| ● | in other ways not involving market makers or established business markets, including direct sales to purchasers or sales effected through agents; |
| ● | in privately negotiated transactions; or |
| ● | any combination of the foregoing. |
In order to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for sale in the state or an exemption from the state’s registration or qualification requirement is available and complied with.
YA is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act.
YA has agreed that, during the term of the Purchase Agreement, neither YA or its affiliates will engage in any short sales or hedging transactions with respect to the ADSs, provided that YA and its affiliates may enter into Permitted Sales.
We have advised YA that it is required to comply with Regulation M promulgated under the Exchange Act. With certain exceptions, Regulation M precludes the Selling Shareholder, any affiliated purchasers, and any broker-dealer or other person who participates in the distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of a security in connection with the distribution of that security. All of the foregoing may affect the marketability of the securities offered by this prospectus.
We will pay the expenses incident to the registration under the Securities Act of the offer and sale of our ADSs covered by this prospectus by the Selling Shareholder. We estimate that our total expenses for the offering will be approximately $0.1 million (excluding the Commitment Shares). As consideration for its irrevocable commitment to purchase our ADSs under the Purchase Agreement, we agreed to issue the Commitment Shares to the Selling Shareholder, calculated as 1% of the Commitment Amount. 51150.09
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Expenses Relating to the Offering
The following table sets forth the costs and expenses payable in connection with the sale of ADSs in the offering. All amounts are estimated except the SEC registration fee. Except as otherwise noted, all the expenses below will be paid by us.
| Expense | Amount | |||
| SEC registration fee | US$ | 1,175.81 | ||
| Legal fees and expenses | 20,000 | |||
| Accounting fees and expenses | 30,000 | |||
| Miscellaneous fees and expenses | 48,824.19 | |||
| Total | US$ | 100,000 | ||
The validity of our Ordinary Shares and other legal matters concerning this offering relating to Israeli law will be passed upon for us by Goldfarb Gross Seligman & Co., Israel. Certain legal matters in connection with this offering relating to U.S. federal law will be passed upon for us by Lucosky Brookman LLP, Woodbridge, New Jersey.
The financial statements as of December 31, 2024 and 2023 and for the two-year period ended December 31, 2024 incorporated in this Form F-1 by reference to the Annual Report on Form 20-F for the year ended December 31, 2024 have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as described in Note 1f to the financial statements) of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The financial statements as of December 31, 2022 and for the year ended December 31, 2022 have been incorporated herein in reliance on the report of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
Where You Can Find More Information
We have filed with the SEC a Registration Statement on Form F-1 under the Securities Act with respect to the ADSs offered in this prospectus. This prospectus, which forms a part of the Registration Statement, does not contain all of the information included in the Registration Statement. Certain information is omitted and you should refer to the Registration Statement and its exhibits for that information. With respect to references made in this prospectus to any contract or other document of Scinai, such references are not necessarily complete and you should refer to the exhibits attached to the Registration Statement for copies of the actual contract or document.
We are subject to the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. In accordance with the Exchange Act, we file reports, including annual reports on Form 20-F. We also furnish to the SEC under cover of Form 6-K material information required to be made public in Israel, filed with and made public by any stock exchange or distributed by us to our shareholders.
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, such as us, that file electronically with the SEC (http://www.sec.gov).
As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements to shareholders and our officers, directors and principal shareholders are exempt from the “short-swing profits” reporting and liability provisions contained in Section 16 of the Exchange Act and related Exchange Act rules.
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
We file annual and special reports and other information with the SEC (File Number 00-1611747). 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 May 7, 2025; | |
| ● | our Current Reports on Form 6-K filed with the SEC on June 2, 2025, June 5, 2025, June 12, 2025, September 2, 2025 and September 11, 2025; and |
| ● | the description of the ADSs contained under the heading “Item 1. Description of Registrant’s Securities to be Registered” in our registration statement on Form 8-A12B, as filed with the SEC on April 20, 2015, as amended on April 29, 2015, 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 requests to Scinai Immunotherapeutics Ltd., Attn: Uri Ben-Or, our Chief Financial Officer, at uri.benor@scinai.com. You may also obtain information about us by visiting our website at www.scinai.com. Information contained in our website is not part of this prospectus.
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Up to 4,800,000 American Depositary Shares representing 19,200,000,000 Ordinary Shares
Scinai Immunotherapeutics Ltd.
PROSPECTUS
, 2025
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 6. Indemnification of Directors and Officers.
Under the Companies Law, a company may not exculpate an office holder from liability for a breach of the fiduciary duty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our articles of association include such a provision. The company may not exculpate in advance a director from liability arising due to the breach of his or her duty of care in the event of a prohibited dividend or distribution to shareholders.
Under the Companies Law and the Israeli Securities Law, 5728-1968 (the “Securities Law”) a company may indemnify an office holder in respect of the following liabilities, payments and expenses incurred for acts performed by him or her as an office holder, either in advance of an event or following an event, provided its articles of association include a provision authorizing such indemnification:
| ● | a monetary liability incurred by or imposed on the office holder in favor of another person pursuant to a court judgment, including pursuant to a settlement confirmed as judgment or arbitrator’s decision approved by a competent court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria; |
| ● | reasonable litigation expenses, including reasonable attorneys’ fees, which were incurred by the office holder as a result of an investigation or proceeding filed against the office holder by an authority authorized to conduct such investigation or proceeding, provided that such investigation or proceeding was either (i) concluded without the filing of an indictment against such office holder and without the imposition on him of any monetary obligation in lieu of a criminal proceeding; (ii) concluded without the filing of an indictment against the office holder but with the imposition of a monetary obligation on the office holder in lieu of criminal proceedings for an offense that does not require proof of criminal intent; or (iii) in connection with a monetary sanction; |
| ● | a monetary liability imposed on the office holder in favor of a payment for a breach offended at an Administrative Procedure (as defined below) as set forth in Section 52(54)(a)(1)(a) to the Securities Law; |
| ● | expenses expended by the office holder with respect to an Administrative Procedure under the Securities Law, including reasonable litigation expenses and reasonable attorneys’ fees; |
| ● | reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or which were imposed on the office holder by a court (i) in a proceeding instituted against him or her by the company, on its behalf, or by a third party, (ii) in connection with criminal indictment of which the office holder was acquitted, or (iii) in a criminal indictment which the office holder was convicted of an offense that does not require proof of criminal intent; and |
| ● | any other obligation or expense in respect of which it is permitted or will be permitted under applicable law to indemnify an office holder, including, without limitation, matters referenced in Section 56H(b)(1) of the Securities Law. |
An “Administrative Procedure” is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities Authority), H4 (Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent Procedures or Interruption of procedures subject to conditions) to the Securities Law.
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Under the Companies Law and the Securities Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided in the company’s articles of association:
| ● | a breach of the fiduciary duty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company; |
| ● | a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; |
| ● | a monetary liability imposed on the office holder in favor of a third party; |
| ● | a monetary liability imposed on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54)(a)(1)(a) of the Securities Law; and |
| ● | expenses incurred by an office holder in connection with an Administrative Procedure, including reasonable litigation expenses and reasonable attorneys’ fees. |
Under the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:
| ● | a breach of the fiduciary duty, except for indemnification and insurance for a breach of the fiduciary duty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; |
| ● | a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder; |
| ● | an act or omission committed with intent to derive illegal personal benefit; or |
| ● | a fine or forfeit levied against the office holder. |
Under the Companies Law, exculpation, indemnification and insurance of office holders must be approved by the compensation committee and the board of directors and, with respect to directors or controlling shareholders, their relatives and third parties in which controlling shareholders have a personal interest, also by the shareholders.
Our articles of association permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted or to be permitted by law. Our office holders are currently covered by a directors’ and officers’ liability insurance policy. As of the date of this registration statement, no claims for directors’ and officers’ liability insurance have been filed under this policy and we are not aware of any pending or threatened litigation or proceeding involving any of our office holders, including our directors, in which indemnification is sought.
We have entered into agreements with each of our directors and executive officers exculpating them, to the fullest extent permitted by law and our articles of association, and undertaking to indemnify them to the fullest extent permitted by law and our articles of association. This indemnification is limited to events determined as foreseeable by the board of directors based on our activities, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances.
The maximum indemnification amount set forth in such agreements is limited to an amount which shall not exceed 25% of our net assets based on our most recently audited or reviewed financial statements prior to actual payment of the indemnification amount. Such maximum amount is in addition to any amount paid (if paid) under insurance and/or by a third-party pursuant to an indemnification arrangement. However, in the opinion of the SEC, indemnification of office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.
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ITEM 7. Recent Sales of Unregistered Securities.
On December 22, 2021, the Company signed a definitive exclusive license agreement with MPG and UMG for the development and commercialization of innovative Covid-19 NanoAbs. Pursuant to the agreement, on February 2, 2022, the Company issued 15,000 ADSs to MPG, in reliance on the exemption from registration under Regulation S under the under the Securities Act of the 1933, as amended, regarding sales by an issuer in offshore transactions.
On November 9, 2022, we issued 17,694 ADSs to Hybrid Financial Ltd. as consideration for investor relations services.
From January 20, 2023 until October 23, 2024, we issued 1,662 RSUs to Prof. Matthias Dobbelstein as consideration for scientific advisory board services, of which 1,000 were converted into 1,000 ADSs.
On June 12, 2023, we issued (i) 1,038 ADSs in aggregate upon the vesting of RSUs granted to non-executive directors as part of their service to the Company and (ii) 24,000 ADSs upon the vesting of RSUs granted to Mr. Amir Reichman, the Company’s CEO, in consideration for his service to the Company.
On July 31, 2023, we issued 15,852 ADSs to MPG and 1,148 ADSs to MBM Science Bridge GmbH pursuant to the License Agreement, dated June 4, 2023, by and among the Company, Max Planck Innovation GmbH and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen.
On December 29, 2023 in connection with the Inducement Letters we issued 260,655 ADSs in the aggregate from the exercise of the Existing Warrants at an exercise price of 6.50 per ADS, and issued 521,310 New Warrants with an exercise price of $6.50 per ADS, in addition to Placement Agent Warrants to acquire 156,393 ADSs to our Placement Agent or its designees, each with an exercise price of $8.125.
On January 4, 2024, we closed a transaction in which we issued new unregistered warrants to purchase up to 521,310 ADSs in consideration for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 260,655 ADSs, issued by us in December 2022 and September 2023, at a reduced exercise price of $6.50 per ADS. The new warrants have an exercise price of $6.50 per ADS and have a term of exercise equal to three years or five and one-half years, as applicable, based on the term of the exercised warrants, from the date of issuance. We received gross proceeds of approximately $1.69 million and a net sum of approximately $1.42 million, after deduction of underwriter discount and issuance expenses of $275,000
On August 21, 2024, we issued 1,000 preferred shares to the EIB in connection with the EIB Restructuring Transactions pursuant to which approximately $29 million, including interest accrued to date, owed by the Company to the EIB under the Finance Contract was converted into 1,000 preferred shares. See “Prospectus Summary – Recent Developments – Conversion of EIB Loan into Equity.”
From August 2024 until December 2024, we issued RK Stone Miami LLC pre-funded warrants to acquire an aggregate of 646,442 ADSs for an aggregate purchase price of $2.0 million.
On February 19, 2025, we issued 80,736 ADSs to LCK JNK 1, LLC upon its cashless exercise of pre-funded warrants to acquire 80,757 ADSs that it acquired from RK Stone Miami LLC.
Between March 24, 2025, and August 28, 2025, we issued to YA an aggregate of 2,210,282 Advance Shares for the aggregate consideration of approximately $5.8 million.
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ITEM 8. Exhibits and Financial Statement Schedules.
(a) Exhibits
EXHIBIT INDEX
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| * | Filed herewith. |
| + | Certain confidential portions of this exhibit have been redacted from the publicly filed document because such portions are (i) not material and (ii) would be competitively harmful if publicly disclosed. |
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ITEM 9. Undertakings.
| (a) | The undersigned Registrant hereby undertakes: |
| (1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
| i. | To include any prospectus required by section 10(a)(3) of the Securities Act of 1933; |
| ii. | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. |
| iii. | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement. |
| (2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| (3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
| (4) | To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (a)(4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. |
| (5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell securities to such purchaser: |
| i. | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; | |
| ii. | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; | |
| iii. | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and | |
| iv. | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(b) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described in Item 6 hereof, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
| c) | The undersigned registrant hereby undertakes: |
| (1) | That for purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4), or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. |
| (2) | That for the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
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Pursuant to the requirements of the Securities Act, the Registrant certifies that it has reasonable grounds to believe that it complies with all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Jerusalem, Israel on September 22, 2025.
| SCINAI IMMUNOTHERAPEUTICS LTD. | ||
| By: | /s/ Amir Reichman | |
| Name: | Amir Reichman | |
| Title: | Chief Executive Officer | |
NOW ALL PERSONS BY THESE PRESENTS, each director and officer whose signature appears below constitutes and appoints, Amir Reichman or Uri Ben-Or, or either of these, his true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, to sign in any and all capacities any and all amendments or post-effective amendments to this registration statement on Form F-1, and to sign any and all additional registration statements relating to the same offering of securities of the Registration Statement that are filed pursuant to Rule 462(b) of the Securities Act, and to file the same with all exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, granting such attorney-in-fact and agent full power and authority to do all such other acts and execute all such other documents as he may deem necessary or desirable in connection with the foregoing, as fully as the undersigned may or could do in person, hereby ratifying and confirming all that such attorney-in-fact and agent may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this registration statement has been signed below by the following persons on the dates and in the capacities indicated.
| Name | Title | Date | ||
| /s/ Mark Germain | Chairman of the Board of Directors | September 22, 2025 | ||
| Mark Germain | ||||
| /s/ Amir Reichman | Chief Executive Officer and Director | September 22, 2025 | ||
| Amir Reichman | (Principal Executive Officer and Director) | |||
| /s/ Uri Ben Or | Chief Financial Officer | September 22, 2025 | ||
| Uri Ben Or | (Principal Financial Officer and Principal Accounting Officer) | |||
| /s/ Avner Rotman | Director | September 22, 2025 | ||
| Avner Rotman | ||||
| /s/ Yael Margolin | Director | September 22, 2025 | ||
| Yael Margolin | ||||
| /s/ Morris Laster | Director | September 22, 2025 | ||
| Morris Laster | ||||
| /s/ Adi Raviv | Director | September 22, 2025 | ||
| Adi Raviv | ||||
| /s/ Samuel Moed | Director | September 22, 2025 | ||
| Samuel Moed | ||||
| /s/ Jay Green | Director | September 22, 2025 | ||
| Jay Green |
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Signature of Authorized U.S. Representative of the Registrant
Pursuant to the requirements of the Securities Act of 1933, as amended, the undersigned, the duly authorized representative in the United States of Scinai Immunotherapeutics Ltd. has signed this Registration Statement on September 22, 2025.
| By: | /s/ Donald J. Puglisi | |
| Name: | Donald J. Puglisi | |
| Title: | Managing Director |
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Exhibit 5.1
Tel Aviv, September 22, 2025
Scinai Immunotherapeutics Ltd.
Jerusalem BioPark
Hadassah Ein Kerem Campus, 2nd floor
Jerusalem 9112001, Israel
Re: Registration on Form F-1.
Ladies and Gentlemen:
We have acted as special Israeli counsel to Scinai Immunotherapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), in connection with the preparation and filing of a Registration Statement on Form F-1 (the “Registration Statement”) under the Securities Act of 1933, as amended (the “Act”), to be filed with the Securities and Exchange Commission. The Registration Statement relates to the proposed resale by the selling shareholder named in the Registration Statement (the “Selling Shareholder”) of up to an aggregate of 4,800,000 American Depositary Shares (the “ADSs”), each representing 4,000 ordinary shares, no par value per share (the “Ordinary Shares”), consisting of (i) 35,461 ADSs (the “Commitment Shares) that were issued to the Selling Shareholder as consideration for the Selling Shareholder’s irrevocable commitment to purchase the Ordinary Shares pursuant to a Standby Equity Purchase Agreement, dated September 10, 2025, between the Company and the Selling Shareholder (the “Purchase Agreement”) and (ii) 4,764,539 ADSs that may be issued from time to time by the Company to the Selling Shareholder pursuant to the Purchase Agreement (the “Advance Shares”), as described in the Registration Statement and the prospectus contained therein.
This opinion is being furnished in connection with the requirements of Items 601(b)(5) and (b)(23) of Regulation S-K under the Act, and no opinion is expressed herein as to any matter pertaining to the contents of the Registration Statement or the prospectus contained therein, other than as expressly stated herein with respect to the issuance of the Ordinary Shares.
In connection with this opinion, we have examined and relied upon the Registration Statement, the Company’s Articles of Association, and such statutes, regulations, corporate records, documents, certificates and such other instruments that we have deemed relevant and necessary as the basis of our opinions hereinafter expressed. In such examination, we have assumed: (i) the authenticity of original documents and the genuineness of all signatures; (ii) the conformity to the originals of all documents submitted to us as copies; (iii) the truth, accuracy and completeness of the information, representations and warranties contained in the corporate records, documents, certificates and instruments we have reviewed; (iv) the due execution and delivery of all documents where due execution and delivery are a prerequisite to the effectiveness thereof; and (v) the legal capacity of all natural persons.
We are members of the Israel Bar, and we express no opinion as to any matter relating to the laws of any jurisdiction other than the laws of the State of Israel, and have not, for the purpose of giving this opinion, made any investigation of the laws of any jurisdiction other than the State of Israel.
The opinions set forth herein are made as of the date hereof. We assume no obligation to revise or supplement any of these opinions to reflect any changes of law or fact that may occur after the date hereof. This opinion is expressly limited to the matters set forth above, and we render no opinion, whether by implication or otherwise, as to any other matters.
On the basis of the foregoing, and in reliance thereon, we are of the opinion that (i) the Ordinary Shares represented by the Commitment Shares, as described in the Registration Statement, have been duly authorized, and when issued pursuant to the terms of the Purchase Agreement, will be validly issued, fully paid and non-assessable and (ii) Ordinary Shares represented by the Advance Shares have been duly authorized and, assuming that prior to the issuance of any Advance Shares under the Purchase Agreement, the price, number of Advance Shares, dollar amount and certain other terms of issuance with respect to any specific advance notice delivered under the Purchase Agreement will be authorized and approved by the Board of Directors of the Company (the “Board”) or a pricing committee of the Board in accordance with applicable law, all corporate proceedings necessary for the authorization, issuance and delivery of the Ordinary Shares represented by the Advance Shares shall have been taken and, upon issuance pursuant to the terms of the Purchase Agreement and in accordance with resolutions of the Board related to the offering of the Advance Shares, the Ordinary Shares represented by the Advance Shares will be validly issued, fully paid and non-assessable.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and we further consent to the reference to this firm in the section entitled “Legal Matters” in the Registration Statement and in the prospectus contained therein. This consent is not to be construed as an admission that we are a party whose consent is required to be filed as part of the Registration Statement under the provisions of the Act.
| Very truly yours, | |
| /s/ Goldfarb Gross Seligman & Co. |
 | Exhibit 23.1 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in this Registration Statement on Form F-1 of Scinai Immunotherapeutics Ltd. of our report dated May 7, 2025 relating to the financial statements, which appears in Scinai Immunotherapeutics Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2024.
/s/ Kesselman & Kesselman
Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel Aviv, Israel
September 22, 2025
Kesselman & Kesselman, 146 Derech Menachem
Begin St. Tel-Aviv 6492103, Israel,
P.O Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
Kesselman & Kesselman is a member firm of PricewaterhouseCoopers International Limited, each member firm of which is a separate legal entity
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the inclusion in this Registration Statement (Form F-1) and related prospectus of Scinai Immunotherapeutics Ltd. of our report dated April 17, 2023, with respect to the financial statements of Scinai Immunotherapeutics Ltd. included in its Annual Report (Form 20-F) for the year ended December 31, 2024, filed with the Securities and Exchange Commission.
| /s/ Kost Forer Gabbay & Kasierer | |
| Kost Forer Gabbay & Kasierer |
A member firm of EY Global
Tel Aviv, Israel
September 22, 2025