As filed with the Securities and Exchange
Commission on December 22, 2023.
Registration No. 333-275217
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1 TO
FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Scinai Immunotherapeutics
Ltd.
(Exact Name of Registrant as Specified in Its Charter)
Not Applicable
(Translation of Registrant’s name into English)
State of Israel |
|
2836 |
|
Not Applicable |
(State or Other Jurisdiction of
Incorporation or Organization) |
|
(Primary Standard Industrial
Classification Code Number) |
|
(I.R.S. Employer
Identification Number) |
Jerusalem BioPark, 2nd Floor
Kiryat Hadassah, Building 1, JBP
Jerusalem, Israel 9112001
Tel: +972-8-930-2529
(Address, Including Zip Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)
Puglisi & Associates
850 Library Avenue, Suite 204
Newark, Delaware
+1 (302) 738-6680
(Name, Address, Including Zip Code, and Telephone
Number, Including Area Code, of Agent For Service)
Copies to:
Lawrence Metelitsa
Steven Lipstein
Lucosky Brookman LLP
101 Wood Avenue South
Woodbridge, New Jersey 08830
Tel: 732 395 4400 |
|
Perry Wildes
Goldfarb Gross Seligman & Co.
One Azrieli Center
Tel Aviv 6702100, Israel
+972 (3) 607-4444 |
Approximate date of commencement of proposed
sale to the public: As soon as practicable after the effective date of this Registration Statement.
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 of 1933, 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, 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 of 1933.
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 Commission, acting pursuant to
such Section 8(a), may determine.
The information in
this registration statement is not complete and may be changed. These securities may not be sold until the registration statement filed
with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities nor does
it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PROSPECTUS |
|
SUBJECT TO COMPLETION DATED DECEMBER
22, 2023 |
1,215,345 American Depositary
Shares representing 486,138,000 Ordinary Shares
This
prospectus relates to the resale, from time to time, by the selling shareholders identified in this prospectus under the section “Selling
Shareholders,” (the “selling shareholders”) of Scinai Immunotherapeutics Ltd. (“Scinai,” “we,”
“us”, “our” or the “Company”) of up to an aggregate of 1,215,345 American Depositary Shares
(“ADSs”), each representing four hundred (400) of our ordinary shares,
no par value, issuable upon exercise of warrants (“Warrants”) to purchase ADSs issued pursuant to (i) a securities purchase
agreement (the “Purchase Agreement”), dated September 15, 2023,
by and between the Company and the purchaser named on the signature page thereto, and (ii) an engagement letter dated as of September
18, 2023 (the “Engagement Letter”), by between us and H.C. Wainwright & Co., LLC (“Placement Agent”). The
Warrants and the underlying ADSs issuable upon the exercise of the Warrants were offered and sold pursuant to the exemptions provided
in Section 4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D
promulgated thereunder.
The selling shareholders will
receive all of the proceeds from any sales of the ADSs offered hereby. We will not receive any of the proceeds, but we will incur expenses
in connection with such offering. To the extent the Warrants are exercised for cash, if at all, we will receive the exercise price of
the Warrants.
The selling shareholders may
sell the ADSs covered by this prospectus through public or private transactions at market prices prevailing at the time of sale, at negotiated
prices or such other prices as the selling shareholders may determine. The timing and amount of any sale are within the sole discretion
of the selling shareholders. Our registration of the ADSs covered by this prospectus does not mean that the selling shareholders will
offer or sell any of the ADSs. For further information regarding the possible methods by which the shares may be distributed, see “Plan
of Distribution.”
The ADSs are listed on
The Nasdaq Capital Market (“Nasdaq”) under the symbol “SCNI.” On December 21, 2023, the last reported sale price
of the ADSs on Nasdaq was $0.69 per ADS.
Investing
in these securities involves a high degree of risk. Please carefully consider the risks discussed in this prospectus under
“Risk Factors” beginning on page 4 and the “Risk Factors” in “Item 1.A. Risk Factors” of our
most recent Annual Report on Form 10-K incorporated by reference in this prospectus for a discussion of the factors you should
consider carefully before deciding to purchase these securities.
Neither the Securities
and Exchange Commission nor any state securities commission has approved or disapproved of the securities being offered by this prospectus,
or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Prospectus dated ,
2023
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of
the registration statement on Form F-1 that we filed with the Securities and Exchange Commission (the “SEC”) for the offering
of the ADSs by the selling shareholders.
Before investing in the ADSs,
you should carefully read both this prospectus and the additional information in the documents we have incorporated by reference into
this prospectus that are listed under the heading “Where You Can Find More Information.”
We have not authorized anyone
to provide information different from that contained in this prospectus. If anyone provides you with different or inconsistent information,
you should not rely on it. We take no responsibility for, and can provide no assurance as to the reliability of, any other information
that others may give you. You should not assume that the information contained in this prospectus or any document incorporated by reference
in this prospectus, is accurate as of any date other than the date on the front cover of the applicable document. Neither the delivery
of this prospectus, nor the sale of our securities means that information contained in this prospectus is correct after their respective
dates. Our business, financial condition, results of operations and prospects may have changed since that date. It is important for you
to read and consider all information contained in this prospectus, including the information incorporated by reference into this prospectus
before making your investment decision.
Before purchasing any securities,
you should carefully read both this prospectus, together with the additional information described under the headings, “Where You
Can Find More Information” and “Incorporation of Information by Reference,” on pages 26 and 26 of this prospectus.
The term “NIS”
refers to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar,” “US$” or “$”
refer to U.S. dollars, the lawful currency of the United States (“U.S.”). Our functional and presentation currency is the
U.S. dollar. Foreign currency transactions in currencies other than the U.S. dollar are translated in this prospectus into U.S. dollars
using exchange rates in effect at the date of the transactions.
Effective November 25, 2022,
we effected a ratio change of the American Depositary Shares (ADSs) to our non-traded ordinary shares from the previous ratio of one (1)
ADS representing forty (40) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares. The ratio change
had the same effect as a reverse split of the existing ADSs of one (1) new ADS for every ten (10) old ADSs. Unless otherwise indicated,
ADSs and per ADS amount in this prospectus have been retroactively adjusted to reflect the changes in ratio for all periods presented.
We further note that the representations,
warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein
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.
This prospectus does not constitute
an offer to sell, or a solicitation of an offer to purchase, the securities offered by this prospectus in any jurisdiction where it is
unlawful to make such offer or solicitation. The distribution of this prospectus and the offering of the securities in certain jurisdictions
may be restricted by law. Persons outside the U.S. who come into possession of this prospectus must inform themselves about, and observe
any restrictions relating to, the offering of the securities and the distribution of this prospectus outside the U.S.
TRADEMARKS, SERVICE MARKS AND TRADENAMES
Solely for convenience, the
trademarks, service marks and trade names referred to or incorporated by reference 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. The Company 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.
MARKET AND INDUSTRY 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 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.”
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including
the information incorporated by reference into this prospectus, contains, may include 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,
including the “Item 3. Key Information - Risk Factors” in our Annual Report on Form 10-K for the year-ended December 31, 2022,
in full.
| ● | We are a developmental stage
biopharmaceutical company with a history of operating losses, with no product candidate that generates revenue and as such we are not
currently profitable, do not expect to become profitable in the near future, may never become profitable and as a result may need to
wind up our business and operation; |
| ● | 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 business strategy may not
be successful; |
| ● | If we breach certain provisions
of our 24 million Euro finance agreement with the EIB it could result in the EIB accelerating the loans thereunder and exercising secured
creditor remedies over collateral securing those loans, and that collateral consists of substantially all of our assets. The exercise
of such remedies may have a material adverse effect on our company. We do not have control over certain events that constitute a breach
of this finance documentation; |
| ● | 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, restrict our operations or require us to relinquish rights to our technologies or product
candidate(s); |
| ● | 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; |
| ● | Clinical trials are very expensive,
time-consuming and difficult to design and implement, and, as a result, we may suffer delays or suspensions in future trials which would
have a material adverse effect on our ability to generate revenues; |
| ● | Positive results from any 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; |
| ● | We may be unsuccessful in adapting
our Covid-19 NanoAbs to protect against variants of COVID-19. Furthermore, our ability to commercialize our Covid-19 NanoAbs may be adversely
affected to the extent that the coronavirus disease evolves worldwide; |
| ● | We may not be successful in
finding a partner to further develop our pre-clinical stage COVID19 program. Such partners may be commercial, pharmaceutical companies
or governmental agencies. In such case, we may not have sufficient capital to take the COVID19 program to clinical trials; |
| ● | 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 the collaboration agreement
with MPG, we have the option to in-license up to 9 total NanoAbs. To date, we have licensed anti-COVID-19 NanoAbs and anti-IL-17 NanoAbs.
We may be unsuccessful in in-licensing, developing, and/or commercializing additional NanoAbs from MPG; |
| ● | We are a developmental stage
biopharmaceutical company with no product candidate(s) in clinical development or approved, which makes it difficult to assess our future
viability; |
| ● | 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, worldwide license from the Max Planck Society, and we could lose our rights to this license if a dispute with MPG arises
or if we fail to comply with the financial and other terms of the license; |
| ● | We recently announced our plans to utilize our manufacturing site and
laboratories by launching a Contract Development and Manufacturing Organization business unit. There is no guarantee that our
strategy will succeed, that we will be able to ramp up operations, that we will become profitable; and |
| ● | We
are currently non-compliant with Nasdaq Listing Rule 5550(a)(2) regarding the minimum bid
price requirement for continued listing on Nasdaq. If we do not regain compliance, and if
we become non-compliant with other Nasdaq Listing Rules, we may be delisted from the Nasdaq
exchange. |
PROSPECTUS SUMMARY
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
and the documents incorporated by reference herein and therein. In particular, you should read the following summary together with the
more detailed information and consolidated financial statements and the notes thereto included elsewhere in, or incorporated by reference
into, this prospectus. You should review carefully the risks and uncertainties described under the heading “Risk Factors”
included elsewhere in, or incorporated by reference into, this prospectus.
Our Business
We
are a biopharmaceutical company focused on developing, manufacturing and commercializing innovative immunotherapeutic products
primarily for the treatment of infectious and autoimmune diseases. Since its inception, the Company has executed eight clinical
trials including a seven country, 12,400 participant phase 3 trial of its prior lead drug candidate, a universal influenza vaccine
candidate (“M-001”) and has built a GMP biologics manufacturing facility for biopharmaceutical products. After receiving
the phase 3 trial results in Q3 2020, indicating that M-001 did not meet its clinical endpoints, the Company performed a turnaround
process that included raising fresh capital, hiring new talent (including a new CEO), signing a research collaboration agreement
with and in-licensing new intellectual property from world leading academic research institutes. . Since then, the Company is in the
process of developing a pipeline of diversified and commercially viable products built around the licensed innovative nanosized
antibodies (NanoAb). NanoAbs are nanosized antibodies derived from camelid animals and are also known as VHH-antibodies or
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.
On
March 23, 2022, we signed a five-year Research Collaboration Agreement (“RCA”; collectively, with the LA and aRCA, the “MPG/UMG
Agreements”) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets
that have the potential to be further developed into drug candidates for the treatment of disease indications such as psoriasis, psoriatic
arthritis, asthma and wet macular degeneration. These are all large and growing markets with underserved medical needs. In each case,
the molecular target has been validated as an appropriate target for therapeutic intervention through inhibition by an antibody, thereby
significantly reducing the discovery work that typically entails many years of research, high cost and high risk of failure. We believe
that we can leverage our NanoAbs’ unique and strong binding affinity, stability at high temperatures, and potential for more effective
and convenient routes of administration towards competitive commercial viability. We believe that since these are clinical validated targets,
we can develop NanoAb treatments with reduced risk and cost and accelerate the time from NanoAb selection to initiation of clinical development.
Each NanoAb candidate is therefore positioned as a “biobetter” piggybacking on prior discoveries of others to mitigate risk
but with significant potential advantages over existing therapeutics. In addition, while each NanoAb constitutes a novel molecule for
which we file patent applications thereby creating a proprietary position, all of the developed NnoAbs when viewed together constitute
a pipeline that is built around the same drug discovery, development and manufacturing platform allowing us to reduce risks and save costs.
SCINAI has the exclusive option for an exclusive, pre-negotiated worldwide license agreement for the development and commercialization
of each of the NanoAbs covered by the RCA with MPG and UMG.
On
June 5, 2023, we announced that as part of our ongoing broad-based collaboration with the Max Planck Society and the University Medical
Center Gottingen (UMG), we signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting
Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.
In
June 2023, we disclosed that we were pursuing a strategic partnership for its COVID-19 self-administered inhaled NanoAb therapeutic/prophylactic
which demonstrated highly promising in vivo results in animals and that we will focus on developing the anti-IL-17 nanoAb.
During
Q3 2023, we focused on implementing our revised corporate strategy to reflect recent market changes and trends in a fashion that would
generate the most favorable value for its shareholders. The new strategy includes operating with two business units: an R&D business
unit, and a Contract Development and Manufacturing Organization (CDMO) business unit. The R&D business unit is focused on the development
of NanoAbs licensed from the Max Planck Society (MPG) and the University Medical Center Gottingen (UMG) and on management of the five-year
Research Collaboration Agreement between the Company and MPI/UMG, which is expected to yield additional nanoAbs to be exclusively licensed
to the Company. In particular, the R&D unit is focused on the development of a NanoAb for the treatment of psoriasis, which we expect
to start in human clinical trials in 2024. The CDMO business unit has been marketing its services to Israeli biotech companies and has
recently started targeting European and US based biotech companies. Our CDMO’s first contract was signed in October 2023, and we
plan additional contracts to be signed in the coming months. As such, the CDMO business unit is expected to generate revenues, which
would help us to absorb our fixed costs related to our manufacturing site, increase the cash available for our own R&D projects,
and provide essential experience to our team. We plan to utilize the added financial flexibility and team experience to accelerate the
development timelines for our own product.
On
November 29, 2023, we announced the execution of a formal amendment to our finance contract with the European Investment Bank (EIB).
The amendment extended the maturity date of the contract by four years from December 31, 2027 to December 31, 2031.
On
December 12, 2023, we issued a press release announcing the successful preclinical trial results of our innovative anti IL 17 VHH
antibody (NanoAb) as a local treatment for the large and underserved population of mild to moderate plaque psoriasis.
We
received notification letters from Nasdaq dated September 28, 2022 and May 1, 2023 advising us that we are not in compliance with
Listing Rule 5550(b)(1) requiring companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders’ equity for continued
listing. On August 1, 2023, we announced that Nasdaq reviewed our plan to regain compliance with Nasdaq’s Listing Rule 5550(b)
and provided us an extension until October 30, 2023, to demonstrate compliance. On November 20, 2023, we announced the receipt of formal
notification from Nasdaq that we had regained compliance with Nasdaq listing rules regarding minimum stockholders’ equity.
On
November 3, 2023, we announced receipt of a letter from Nasdaq dated November 1, 2023 regarding non-compliance with the requirement to
maintain a minimum bid price of $1.00 per share. The letter indicates that, based on the closing bid price of the Company’s ADSs for
the previous thirty-three consecutive business days, we do not meet this requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A),
we have been given an initial period of 180 calendar days to regain compliance. The letter states that the Nasdaq staff will provide
written confirmation that we have achieved compliance with Rule 5550(a)(2) if at any time before the 180-day period ends on April 29,
2024, the closing bid price of the ADSs is at $1.00 per share or more for a minimum of ten consecutive business days. We intend to monitor
the closing bid price of the ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum
bid price requirement.
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.
THE OFFERING
ADSs offered by the selling shareholders |
|
Up to 1,215,345 ADSs, upon the exercise of the Warrants |
|
|
|
ADSs outstanding immediately after this offering (1) |
|
5,567,272 ADSs representing 2,226,908,800 ordinary shares assuming the exercise in full of the Warrants offered in this offering. |
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|
Use of proceeds |
|
All of the ADSs offered by the selling shareholders pursuant to this prospectus will be sold by the selling shareholders. We will not receive any proceeds from such sales. However, to the extent the Warrants are exercised for cash, if at all, we will receive the exercise price of the Warrants. The exercise price of the Warrants may exceed the trading price of the ADSs. If the price of the ADSs is below the exercise price of the Warrants, we believe that holder of the Warrants will be unlikely to exercise its warrants, resulting in little to no cash proceeds to us. If all the Warrants were exercised, we would receive gross proceeds of approximately $1.43 million. See the section titled “Use of Proceeds” in this prospectus for more information. |
|
|
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Offering price |
|
The Warrants will have a per ADS exercise price of $1.16. The ADSs offered by the selling shareholders under this prospectus may be offered and sold at prevailing market prices, negotiated prices or such other prices as the selling shareholders may determine. See the section titled “Plan of Distribution” in this prospectus for more information. |
|
|
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Listing |
|
Our ADSs trade on Nasdaq under the symbol “SCNI”. |
|
|
|
Risk factors |
|
You should carefully read the section titled “Risk Factors” and other information included in this prospectus for a discussion of factors that you should consider before deciding to invest in our securities. |
| (1) | The number of ADSs to be outstanding immediately after the
offering, as shown above, is based on 4,351,927 ADSs (representing 2,226,908,800 Ordinary Shares) issued and outstanding as of
September 30, 2023. |
As
of September 30, 2023, we had issued and outstanding warrants to purchase an aggregate of 2,726,252 ADSs with the latest expiration date
of these warrants being between the years 2023 and 2025. As of September 30, 2023, we had issued and outstanding, pre-Funded warrants
to purchase an aggregate of 746,552 ADSs at an exercise price of 0.001. We also have options to purchase an aggregate of 252,301 ADSs
under the Employees Option Plan with the latest expiration date of the year 2033. In addition, as of September 30, 2023, we had an aggregate
of 311,345 RSUs for ADSs.
Except as otherwise indicated, all information
in this prospectus, including the number of Ordinary Shares that will be outstanding after this offering, excludes such outstanding securities
and assumes full exercise of the Warrants offered in this offering.
RISK FACTORS
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. You
should carefully consider the risk factors discussed under the caption “Item 1.A: Risk Factors” in our Annual Report on Form
10-K for the year ended December 31, 2022, and in any other filing we have made with the SEC, each of which are incorporated herein by
reference, before making your investment decision. The risks and uncertainties we have described 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. Past financial
performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends
in future periods. 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 our ADSs to decline, resulting in a loss of all or part of your investment.
Please also read carefully the section below entitled “Forward-Looking Statements.”
Risks Related to Our Financial Position and Capital Requirements
Our financial statements include a going concern reference. We will need to raise significant additional capital to finance our losses and negative cash flows from operations, and if we were to fail to do so, or if the European Investment Bank, or EIB, accelerate their loans to us under our finance contract with EIB, we may need to cease operations. Management has substantial doubt about our ability to continue as a going concern.
As
of September 30, 2023, the Company’s cash and cash equivalents totaled $6,362. In the nine months ended September 30, 2023, the
Company had an operating loss of $7,883 and negative cash flows from operating activities of $8,157. The Company’s current cash
and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the date of
the filing date of the financial statements. Those factors raise substantial doubt about the Company’s ability to continue as a
going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing to meet its
obligations and repay its liabilities arising from normal business operations when they become due. While the Company has successfully
raised funds in the past, there is no guarantee that it will be able to do so in the future. The inability to borrow or raise sufficient
funds on commercially reasonable terms, would have serious consequences on our financial condition and results of operations.
In
addition, we borrowed 24 million Euro under a finance contact with (the “Finance Contract”) with EIB with a maturity date
of December 31, 2031. Under the Finance Contract, the EIB may accelerate all loans extended thereunder if an event of default has occurred.
If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract,
making those amounts immediately due and payable. In such a case, we expect such events to adversely impact our ability to continue as
a going concern.
The
Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays
for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from
its existing working capital resources and additional sources of capital and financing that are in the advanced planning phase. However,
there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will
be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving
plan, a portion of which has been implemented to date. Additional measures approved in the cost reduction plan could further be implemented
at management discretion to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists
of reducing expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount
costs through non paid leave and lay-offs, and postponing and/or cancelling capital expenditures that would not be required for the implementation
of the revised business plan.
The Company’s financial
statements for the nine-months ended September 30, 2023 were prepared assuming the Company will continue as a going concern, which contemplates
the realization of assets and liabilities and commitments in the normal course of business. Such financial statements do not include
any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification
of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
Risks Related to our Operations in Israel
We conduct some of our operations
in Israel. Conditions in Israel, including the recent attack by Hamas from the Gaza Strip and Israel’s war against it, may affect
our operations.
Because
we are incorporated under the laws of the State of Israel and some of our operations are conducted in Israel, our business and operations
are directly affected by economic, political, geopolitical and military conditions in Israel. Since the establishment of the State of
Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist organizations active
in the region. These conflicts have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various
parts of Israel, which could have negatively affected business conditions in Israel, especially during times of active conflict.
In
October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s
border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping
of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against
this terrorist organization commenced in parallel to its continued rocket and terror attacks. Moreover, the clash between Israel and
Hezbollah in Lebanon may escalate in the future into a greater regional conflict.
Scinai
operates two business units: an innovative R&D unit and a Contract Development and Manufacturing Organization (“CDMO”)
unit. The R&D unit focuses on: (i) managing and guiding a research contract with the Max Planck Society and the University Medical
Center Gottingen, both in Germany; and (ii) developing licensed drug candidates throughout the pre-clinical and clinical steps required
for drug approval. The CDMO unit focuses on providing drug development services to small biotech companies.
Our
R&D unit is currently focused on advancing a novel VHH antibody for the treatment of psoriasis and related diseases. We plan to commence
a pre-clinical study at the Technion Institute in Haifa, Israel in Q1 2024. We are also planning a pre-clinical toxicology study in Ness
Ziona, in the Central District of Israel that we plan to commence in Q2 2024. In addition, the production of the drug substance and drug
product batches required for the studies is done at our site located in Jerusalem, Israel. As such, an escalation of the conflict in
Gaza or its expansion to include the northern border of Israel could potentially impact the studies planned in Israel. Risks include
delays in operations due to missile attacks and/or difficulty in recruiting additional employees or service providers due to their service
in the reserve forces of the Israel Defense Forces (the “IDF”), the national military of Israel.
We
currently do not anticipate any material risk that the drug production for the studies will not be to be produced in Jerusalem, Israel.
In the event we are not able to perform the drug production ourselves, we can approach alternative suppliers to perform the production.
If we need to approach alternative suppliers, our pre-clinical trials could be delayed. A delay or disruption in our pre-clinical trials
could impact the value of our securities, require us to raise additional capital, reduce operating expenses, including by reducing headcount,
and/or limit or terminate our product development activities.
In
October 2023, our CDMO unit signed its first contract to provide R&D services to a biotech client and we are in advanced contract
discussions with several other potential clients. Although we have not seen that the ongoing conflict has affected this business to date,
there can be no assurances that potential clients will not delay their engagement with us or not engage us for CDMO services due to conflict
or that the conflict will not otherwise have a material adverse effect on us or our operations in the future.
The
IDF is a conscripted military service, subject to certain exceptions. Since October 7, 2023, the IDF has called up more than 350,000
of its reserve forces to serve. We currently have 32 employees, all of whom reside in Israel, consisting of 10 management employees and
22 non-management employees. Our CEO has recently been called for reserve service near his home to be “on-call” for emergency
situations. He continues to perform his work duties partially remotely and partially from our Company’s offices in Jerusalem. Such
reserve duty has not materially affected the Company’s operations. In addition, two of our non-management employees who do not
perform critical functions have been called to reserve military service in the IDF with one of them having been released while the second
is still in active service. It is possible that there will be further military reserve duty call-ups in the future, which may affect
our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to
respond to a decrease in labor availability. These measures may include overtime and third-party outsourcing. These possible effects
on our business may adversely impact our results of operations, liquidity or cash flows.
Additionally,
shelter-in-place and work-from-home measures, government-imposed restrictions on movement and travel and other precautions taken to address
the ongoing conflict may temporarily disrupt our management and employees’ ability to effectively perform their daily tasks.
It
is currently not possible to predict the duration or severity of the ongoing conflict or its effect on our business, operations and financial
conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources
and availability of supply and hamper our ability to raise additional funds or sell our securities, among other possible effects.
Risks Related to The ADSs
Our failure to
meet the continued listing requirements of Nasdaq could result in a delisting of the ADSs. The delisting could adversely affect the market
liquidity of our shares and the market price of our shares could decrease significantly.
If
we fail to satisfy Nasdaq’s continued listing requirements, Nasdaq may take steps to delist the ADSs. On November 2, 2022, we received
a notice of non-compliance from Nasdaq that we were not in compliance with the Nasdaq listing rule regarding minimum bid price. To address
the minimum bid price non-compliance, on November 25, 2022, we effected a change of the ADSs to our non-traded ordinary shares from the
previous ratio of one (1) ADS representing forty (40) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary
shares. On December 12, 2022, we reported that we had received formal notifications from Nasdaq that we had regained compliance with these
listing rules.
In
addition, we received notification letters from Nasdaq dated September 28, 2022 and May 1, 2023 advising us that we are not in compliance with
Listing Rule 5550(b)(1) requiring companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders’ equity for continued
listing. On August 1, 2023, we announced that Nasdaq reviewed our plan to regain compliance with Nasdaq’s Listing Rule 5550(b)
and provided us with an extension until October 30, 2023 to demonstrate compliance. On November 20, 2023, we announced the receipt of
formal notification from Nasdaq that we had regained compliance with Nasdaq listing rules regarding minimum stockholders’ equity.
On
November 1, 2023, we received a notice of non-compliance from Nasdaq that we are not in compliance with the requirement to maintain a
minimum bid price of $1.00 per share. We have been given an initial period of 180 calendar days to regain compliance. The letter states
that the Nasdaq staff will provide written confirmation that we have achieved compliance with this requirement if at any time before
the 180-day period ends on April 29, 2024, the closing bid price of the ADSs is at $1.00 per share or more for a minimum of ten consecutive
business days. We intend to monitor the closing bid price of the ADSs and may, if appropriate, consider implementing available options
to regain compliance with the minimum bid price requirement.
If we are unable to
maintain compliance with this closing bid price requirement, the ADSs could be delisted from Nasdaq. If this were to occur, trading of
our securities would most likely take place in an over-the-counter market for unlisted securities. An investor would likely find it less
convenient to sell, or to obtain accurate quotations in seeking to buy, our securities in an over-the-counter market, and many investors
would likely not buy or sell our securities due to difficulty in accessing over-the-counter markets, policies preventing them from trading
in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our securities would be subject
to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating
to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions
generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability
of investors to trade in our securities. For these reasons and others, delisting would adversely affect the liquidity, trading volume
and price of our securities, causing the value of an investment in us to decrease and having an adverse effect on our business, financial
condition and results of operations, including our ability to attract and retain qualified employees and raise capital.
A
delisting from Nasdaq would likely have a negative effect on the price of the ADSs and would impair shareholders’ ability to sell
or purchase their ADSs when they wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to
restore compliance with listing requirements would allow the ADSs to become listed again, stabilize the market price or improve the liquidity
of the ADSs, prevent the ADSs from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s
listing requirements.
U.S. holders of ADSs may suffer adverse
tax consequences if we were characterized as a passive foreign investment company.
Based on the current composition
of our gross income and assets and on reasonable assumptions and projections, we believe we should not be treated as a passive foreign
investment company (a “PFIC”), for U.S. federal income tax purposes for 2023. However, there can be no assurance that this
will be the case in 2023 or in future taxable years. If we were characterized as a PFIC, U.S. holders of the ADSs may suffer adverse
tax consequences such as (i) having gains realized on the sale of the ADSs treated as ordinary income rather than capital gain, not qualifying
for the preferential rate otherwise applicable to dividends received in respect of the ADSs by individuals who are U.S. holders, and
(ii) having interest charges apply to certain distributions by us and upon certain sales of the ADSs.
Risks Related to the Offering
Future sales of the ADSs, including any
ADSs issuable upon the exercise of the Warrants, 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.
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 the
holders of a large number of ADSs intend to sell shares, may cause the market price of the ADSs to decline. To the extent that holders
of the Warrants or other existing warrants sell the ADSs issued upon the exercise of such warrants, the market price of the ADSs may decrease
due to the additional selling pressure in the market. Moreover, the risk of dilution from issuances of ADSs underlying the Warrants may
cause shareholders to sell their ADSs, which could cause a further decline in the market price.
You may experience future dilution as a
result of future equity offerings.
To raise additional capital,
we may in the future offer additional ADSs, Ordinary Shares or other securities convertible into or exchangeable for the ADSs or Ordinary
Shares at prices that may not be the same as the price per ADS in this offering. We may sell ADSs, Ordinary Shares or other securities
in any other offering at a price per ADS or per Ordinary Share, as appliable, that is less than the price per ADS paid by the investor
in this offering, and investors purchasing ADSs, Ordinary Shares or other securities in the future could have rights superior to the rights
of ADSs holders. The price per ADS or per share at which we sell additional ADSs, Ordinary Shares, as applicable, or securities convertible
or exchangeable into ADSs or Ordinary Shares, in future transactions, may be higher or lower than the price per ADS paid by the investor
in this offering.
THE SEPTEMBER 2023 FINANCING
Registered Direct and Concurrent Private Placement
On September 15, 2023, we
agreed, pursuant to the Purchase Agreement, to issue to the purchaser named on the signature page thereto (i) in a registered direct offering,
(A) 400,000 ADSs and pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 746,552 ADSs, at an exercise price of $0.001
per ADS, at a purchase price of $1.16 per ADS and $1.159 per pre-funded warrant and (iii) in a concurrent private placement, unregistered
Warrants exercisable for an aggregate of 1,215,345 ADSs at an exercise price of $1.16. Each Warrant became exercisable on the date of
issuance and will remain exercisable until five and one-half (5.5) years from the initial exercise date. The Warrants and the ADSs issuable
upon the exercise of the Warrants were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule
506(b) promulgated thereunder.
Pursuant to the Securities
Purchase Agreement, we agreed to file a registration statement on Form F-1, as soon as practicable and in any event within 45 calendar
days from the execution of the Securities Purchase Agreement, and to use commercially reasonable efforts to cause a registration statement
providing for the resale by holders of the Warrant ADSs, to become effective 181 days following the closing date, and to keep such registration
statement effective until such time as no holder owns any Warrants or Warrant ADSs issuable upon exercise thereof.
The foregoing descriptions
of the form of Purchase Agreement and the form of Warrant are not complete and are subject to and qualified in their entirety by reference
to the form of Purchase Agreement and the form of Warrant, respectively, copies of which are attached as Exhibits 1.1 and 1.3 respectively,
to the Current Report on Form 6-K dated September 19, 2023, and are incorporated herein by reference.
Placement Agent Warrants
As part of the compensation
to the Placement Agent in connection with the above-described transaction, pursuant to an engagement agreement, dated as of September
15, 2023, by between us and the Placement Agent, we issued to Placement Agent designees unregistered Warrants to purchase up to an aggregate
of 68,793 ADSs at an exercise price of $1.45 per ADS and a term of five years until September 18,
2028.
The resale of the ADSs issuable
upon exercise of the Warrants issued to the Placement Agent is being registered in this registration statement.
USE OF PROCEEDS
All of the ADSs offered by
the selling shareholders pursuant to this prospectus will be sold by the selling shareholders. We will not receive any of the proceeds
from such sales. The selling shareholders will receive all of the proceeds from any sales of the ADSs offered hereby. However, we will
incur expenses in connection with the registration of the ADSs offered hereby.
We will receive the exercise
price upon any exercise of the Warrants, to the extent exercised on a cash basis. If all the Warrants were exercised, we would receive
gross proceeds of approximately $1.33 million. However, the holders of the Warrants are not obligated to exercise the Warrants, and we
cannot predict whether or when, if ever, the holders of the Warrants will choose to exercise the Warrants, in whole or in part. The exercise
price of the Warrants may exceed the trading price of our ADSs. If the price of the ADSs is below their exercise price, we believe that
holder of the Warrants will be unlikely to exercise their warrants, resulting in little to no cash proceeds to us. Accordingly, we currently
intend to use the proceeds received upon such exercise, if any, for general corporate purposes and working capital.
MARKET FOR ORDINARY SHARES AND DIVIDEND POLICY
The
Ordinary Shares are traded on Nasdaq Capital Market under the symbol “SCNI.”
The last reported sale price of the ADSs on October 27, 2023 on Nasdaq was $0.62 per ADS.
We have never declared or
paid any cash dividends on the ADSs, and we anticipate that, for the foreseeable future, we will retain any future earnings to support
operations and to finance the growth and development of our business. Therefore, we do not expect to pay cash dividends for at least the
next several years.
The distribution of dividends
may also be limited by the Israeli Companies Law, 5759-1999 (the “Companies Law”), which permits the distribution
of dividends only out of retained earnings or earnings derived over the two most recent fiscal years, whichever is higher, provided
that there is no reasonable concern that payment of a dividend will prevent a company from satisfying its existing and foreseeable obligations
as they become due. As of December 31, 2022, we did not have distributable earnings pursuant to the Companies Law. Dividend distributions
may be determined by our board of directors, as our amended and restated articles of association do not provide that such distributions
require shareholder approval.
CAPITALIZATION
The following
table sets forth our cash and cash equivalents and capitalization as of September 30, 2023 as follows:
| ● | on an actual
basis; and |
| ● | on as adjusted
basis to reflect the issuance by us of 1,215,345 ADSs offered pursuant to this prospectus,
following an assumed exercise for cash of all of the Warrants for net proceeds of $1.43 million. |
The following table should be read in conjunction
with “Use of Proceeds,” our financial statements and related notes that are incorporated by reference into this prospectus
and the other financial information included or incorporated by reference into this prospectus. Our historical results do not necessarily
indicate our expected results for any future periods.
| |
As of September 30, 2023 | |
(In thousands, except share data) | |
Actual | | |
As Adjusted | |
Ordinary Shares, no par value per share | |
- | | |
- | |
Additional paid-in capital | |
| 119,053 | | |
| 120,483 | |
Accumulated deficit | |
| (120,005 | ) | |
| (120,005 | ) |
Accumulated other comprehensive loss | |
$ | (1,740 | ) | |
| (1,740 | ) |
Total shareholders’ deficit | |
| (2,692 | ) | |
| (1,262 | ) |
Total capitalization | |
$ | 17,044 | | |
| 18,474 | |
SELLING SHAREHOLDERS
The ADSs being offered by the
selling shareholders pursuant to this prospectus are those issuable to the selling shareholders upon exercise of the Warrants. For additional
information regarding the issuance of the Warrants, see “The September 2023 Financing” above. We are registering the resale
of the ADSs in order to permit the selling shareholder to offer the ADSs and Warrants for resale from time to time. To our knowledge,
the selling shareholders have not had any material relationship with us or our affiliates within the past three years. Our knowledge is
based on information provided by the selling shareholders in connection with the filing of this prospectus.
The table below lists the selling
shareholders and other information regarding the beneficial ownership of the ADSs by the selling shareholders. The second column lists
the number of ADSs beneficially owned by the selling shareholder, based on its ownership of ADSs and Warrants, as of September 30, 2023,
and assuming exercise of all of the Warrants held by the selling shareholders on that date, without regard to any limitations on exercises.
The fourth column lists the maximum number of ADSs that may be sold or otherwise disposed of by the selling shareholders pursuant to the
registration statement of which this prospectus forms a part. The selling shareholders may sell or otherwise dispose of some, all or none
of their ADSs in this offering. Pursuant to the rules of the SEC, beneficial ownership includes any of the Ordinary Shares as to which
a shareholder has sole or shared voting power or investment power, as well as any Ordinary Shares that the selling shareholder has the
right to acquire within 60 days of September 30, 2023. The percentage of beneficial ownership for the selling shareholder is based on
4,351,927 of the ADSs outstanding as of September 30, 2023 and the number of ADSs issuable upon exercise or conversion of convertible
securities that are currently exercisable or convertible or are exercisable or convertible within 60 days of September 30, 2023 beneficially
owned by the applicable selling shareholder. The fifth column assumes the sale of all of the ADSs offered by the selling shareholder pursuant
to this prospectus.
Under the terms of the Warrants,
the selling shareholder may not exercise the Warrants to the extent such exercise would cause the selling shareholder, together with its
affiliates and attribution parties, to beneficially own a number of ADSs which would exceed 4.99% of our then outstanding ADSs immediately
after giving effect to the issuance of ADS upon exercise of the Warrants held by the selling shareholders. Furthermore, under the terms
of the Pre-Funded Warrants, the selling shareholder may not exercise the Pre-Funded Warrants to the extent such exercise would cause the
selling shareholder, together with its affiliates and attribution parties, to beneficially own a number of Ordinary Shares which would
exceed 9.99% of our then outstanding Ordinary Shares immediately after giving effect to the issuance of Ordinary Shares upon exercise
of the Pre-Funded Warrants held by the selling shareholders. The number of ADSs in the second and fifth columns do not reflect these limitations.
See “Plan of Distribution.”
Name of Selling Shareholder | |
ADSs
Beneficially
Owned Prior
to the Offering(1) | | |
Percentage of
Outstanding
ADSs(1) | | |
Maximum Number of ADSs
To Be Sold
Pursuant
to this
Prospectus | | |
Number of
ADSs
Beneficially
Owned
After the
Offering(2) | | |
Percentage of
Outstanding
ADSs
after the
Offering(2) | |
Armistice Capital Master Fund LLC | |
| 2,293,104 | (3) | |
| 33.7 | % | |
| 2,293,104 | | |
| 1,146,552 | | |
| 20.85 | % |
Michael Vasinkevich (4) | |
| 44,113 | | |
| 1 | % | |
| 44,113 | | |
| - | | |
| * | |
Noam Rubinstein (4) | |
| 21,670 | | |
| * | | |
| 21,670 | | |
| - | | |
| * | |
Craig Schwabe (4) | |
| 2,322 | | |
| * | | |
| 2,322 | | |
| - | | |
| * | |
Charles Worthman (4) | |
| 688 | | |
| * | | |
| 688 | | |
| - | | |
| * | |
| (1) | Assumes all Warrants held by the selling shareholders on
September 30, 2023 are exercised. |
| (2) | Assumes that (i) all of the ADSs covered by the registration
statement of which this prospectus is a part are sold in this offering and (ii) the selling shareholders do not acquire additional
ADSs after the date of this prospectus and prior to completion of this offering. The percentage of beneficial ownership after the offering
is based on 5,567,272 ADSs outstanding as of September 30, 2023, consisting of (a) 4,351,927 ADSs outstanding September 30,
2023, and (b) the 1,215,345 ADSs underlying the Warrants offered under this prospectus. The number and percentage of ADSs listed
do not take into account any limitations on exercise of Pre-Funded Warrants and Warrants preventing the selling shareholders from exercising
any portion of such warrants if such exercise would result in the selling shareholder owning greater than 4.99% of the outstanding ADSs
(9.99% of the outstanding ADSs in the case of Pre-Funded Warrants) following such exercise. |
| (3) | Consists of (i) 400,000 ADSs, (ii) 746,552 ADSs issuable upon
exercise of the Pre-Funded Warrants and (iii) 1,146,552 ADSs issuable upon the exercise of the Warrants. The securities are directly
held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”) and may be deemed to be
beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund;
and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The Ordinary Warrants are subject to a beneficial ownership limitation
of 4.99%, which such limitation restricts the selling shareholder from exercising that portion of the warrants that would result in the
Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership
limitation. The number of Ordinary Shares set forth in the above table does not reflect the application of this limitation. The address
of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. |
| (4) | Each of the selling shareholders is affiliated with the Placement
Agent, a registered broker dealer with a registered address of H.C. Wainwright & Co., LLC, 430 Park Ave, 3rd Floor, New York, NY
10022, and has sole voting and dispositive power over the securities held. The number of shares beneficially owned prior to this offering
consist of Ordinary Shares issuable upon exercise of placement agent warrants, which were received as compensation. The selling stockholder
acquired the placement agent warrants in the ordinary course of business and, at the time the placement agent warrants were acquired,
the selling shareholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities. Each
selling shareholder may not exercise the placement agent warrants to the extent such exercise would cause each selling shareholders,
together with his affiliates and attribution parties, to beneficially own a number of ADSs which would exceed 4.99% of our then outstanding
Ordinary Shares following such exercise, or, upon notice to us, 9.99% of our then outstanding Ordinary Shares following such exercise,
excluding for purposes of such determination shares of Ordinary Shares issuable upon exercise of such securities which have not been
so exercised. |
TAXATION
The following description is
not intended to constitute a complete analysis of all tax consequences relating to the acquisition, ownership and disposition of our securities
offered hereby. You should consult your own tax advisor concerning the tax consequences of your particular situation, as well as any tax
consequences that may arise under the laws of any state, local, foreign or other taxing jurisdiction.
Material U.S. Federal Income Tax Considerations
The following is a summary
of the material U.S. federal income tax consequences relating to the acquisition, ownership, and disposition of the Warrants and ADSs
(collectively, the “Securities”) by U.S. Holders, as defined below. This summary addresses solely U.S. Holders who acquire
the Securities pursuant to this offering and who hold the Securities as capital assets for tax purposes. This summary is based on current
provisions of the Internal Revenue Code of 1986, as amended (the “Code”), current and proposed U.S. Treasury regulations promulgated
thereunder, and administrative and judicial decisions as of the date hereof, all of which are subject to change, possibly on a retroactive
basis. In addition, this section is based in part upon representations of the depositary and the assumption that each obligation in the
Deposit Agreement and any related agreement will be performed in accordance with its terms. This summary does not address all U.S. federal
income tax matters that may be relevant to a particular holder or all tax considerations that may be relevant with respect to an investment
in the Securities.
This summary does not address
tax considerations applicable to a holder of the Securities that may be subject to special tax rules including, without limitation, the
following:
| ● | dealers or traders in securities,
currencies, or notional principal contracts; |
| ● | banks, insurance companies,
and other financial institutions; |
| ● | real estate investment trusts
or regulated investment companies; |
|
● |
persons or corporations subject to an alternative minimum tax; |
|
● |
tax-exempt organizations; |
|
● |
traders that have elected mark-to-market accounting; |
|
● |
corporations that accumulate earnings to avoid U.S. tax; |
|
● |
investors that hold the Securities as part of a “straddle,” “hedge,” or “conversion transaction” with other investments; |
|
● |
persons that actually or constructively own 10 percent or more of our Ordinary Shares outstanding by vote or by value; |
|
● |
persons that are treated as partnerships or other pass-through entities for U.S. federal income purposes; and |
|
● |
U.S. Holders whose functional currency is not the U.S. dollar. |
This summary does not address
the effect of any U.S. federal taxation other than U.S. federal income taxation, and does not include any discussion of state, local,
or foreign tax consequences to a holder of the Securities. In addition, this summary does not include any discussion of the U.S. federal
income tax consequences to any holder of Securities that is not a U.S. Holder.
You are urged to consult
your own tax advisor regarding the foreign and U.S. federal, state, and local income and other tax consequences of an investment in the
Securities, including the potential effects of any proposed legislation, if enacted.
For purposes of this summary,
a “U.S. Holder” means a beneficial owner of a Security that is for U.S. federal income tax purposes:
|
● |
an individual who is a citizen or resident of the U.S.; |
|
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a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in the U.S. or under the laws of the U.S., any state thereof, or the District of Columbia; |
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an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
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a trust (1) if (a) a court within the U.S. is able to exercise primary supervision over the administration of the trust and (b) one or more U.S. persons have the authority to control all substantial decisions of the trust or (2) that has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person. |
If an entity or arrangement
that is classified as a partnership for U.S. federal tax purposes holds any Securities, the U.S. federal tax treatment of its partners
will generally depend upon the status of the partners and the activities of the partnership. Entities or arrangements that are classified
as partnerships for U.S. federal tax purposes and persons holding any Securities through such entities should consult their own tax advisors.
In general, and assuming
that all obligations under the Deposit Agreement will be satisfied in accordance with the terms of the Deposit Agreement, if you hold
ADSs, you will be treated as the holder of the underlying Ordinary Shares represented by those ADSs for U.S. federal income tax purposes.
Accordingly, gain or loss generally will not be recognized if you exchange ADSs for the underlying Ordinary Shares represented by those
ADSs.
Distributions
If we make any distribution
with respect to the Securities, subject to the discussion under “– Passive Foreign Investment Companies” below, the
gross amount of any distribution actually or constructively received by a U.S. Holder (through the Depositary) with respect to a Security
will generally be taxable to the U.S. Holder as foreign-source dividend income to the extent of our current and accumulated earnings and
profits as determined under U.S. federal income tax principles. The amount distributed will include the amount of any Israeli taxes withheld
from such distribution, as described above under the caption “Material Tax Considerations-Israeli Tax Considerations.” A U.S.
Holder will not be eligible for any dividends received deduction in respect of the dividends paid by us, which deduction is otherwise
available to a corporate U.S. Holder in respect of dividends received from a domestic corporation. Distributions in excess of earnings
and profits will be non-taxable to the U.S. Holder to the extent of the U.S. Holder’s adjusted tax basis in its Securities. Distributions
in excess of such adjusted tax basis will generally be taxable to a U.S. Holder as capital gain from the sale or exchange of property
as described below under “-Sale or Other Disposition of ADSs and Warrants.” If we do not report to a U.S. Holder the portion
of a distribution that exceeds earnings and profits, then the distribution will generally be taxable as a dividend. The amount of any
distribution of property other than cash will be the fair market value of that property on the date of distribution.
Under the Code, certain
qualified dividends received by non-corporate U.S. Holders will be subject to U.S. federal income tax at the preferential long-term capital
gains of, currently, a maximum of 20%. This preferential income tax rate is applicable only to dividends paid by a “qualified foreign
corporation” that is not a PFIC (as defined below under “– Passive Foreign Investment Companies,”) for the year
in which the dividend is paid or for the preceding taxable year, and only with respect to the Securities held by a qualified U.S. Holder
(i.e., a non-corporate holder) for a minimum holding period (generally 61 days during the 121-day period beginning 60 days before the
ex-dividend date) and certain other holding period requirements are met. If such holding period requirements are met, dividends we pay
with respect to the Securities generally will be qualified dividend income. However, if we were a PFIC, dividends paid by us to individual
U.S. Holders would not be eligible for the reduced income tax rate applicable to qualified dividends. As discussed below under “–
Passive Foreign Investment Companies,” we do not anticipate being treated as a PFIC for this year; however, there can be no assurance
that we will not be treated as a PFIC for our current taxable or future taxable years. You should consult your own tax advisor regarding
the availability of this preferential tax rate under your particular circumstances.
The amount of any distribution
paid in a currency other than U.S. dollars (a “foreign currency”), including the amount of any withholding tax thereon, will
be included in the gross income of a U.S. Holder in an amount equal to the U.S. dollar value of the foreign currency calculated by reference
to the exchange rate in effect on the date of the U.S. Holder’s (or, in the case of ADSs, the depositary’s) receipt of the
dividend, actively or constructively, regardless of whether the foreign currency is converted into U.S. dollars. If the foreign currency
is converted into U.S. dollars on the date of receipt, a U.S. Holder generally should not be required to recognize a foreign currency
gain or loss in respect of the dividend. If the foreign currency received in the distribution is not converted into U.S. dollars on the
date of receipt, a U.S. Holder will have a basis in the foreign currency equal to its U.S. dollar value on the date of receipt. Any gain
or loss on a subsequent conversion or other disposition of the foreign currency will be treated as U.S. source ordinary income or loss
and will not be eligible for the preferential rate applicable to qualified dividend income.
Subject to certain conditions
and limitations, any Israeli taxes withheld on dividends may be creditable against a U.S. Holder’s U.S. federal income tax liability,
subject to generally applicable limitations. The rules relating to foreign tax credits and the timing thereof are complex. You should
consult your own tax advisors regarding the availability of a foreign tax credit in your particular situation.
Sale, Exchange, or Other Disposition of ADSs and Warrants
Subject to the discussion
under “– Passive Foreign Investment Companies” below, a U.S. Holder that sells or otherwise disposes of its Securities
will recognize gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the amount realized on the
sale or other disposition and such U.S. Holder’s adjusted basis in the Securities. Such gain or loss generally will be capital gain
or loss and will be a long-term capital gain or loss if the U.S. Holder’s holding period of the Securities exceeds one year at the
time of the sale or other disposition. Long-term capital gains realized by non-corporate U.S. Holders are generally subject to a preferential
U.S. federal income tax rate. In general, gain or loss recognized by a U.S. Holder on the sale or other disposition of the Securities
will be U.S. source gain or loss for purposes of the foreign tax credit limitation. However, if we are a PFIC, any such gain will be subject
to the PFIC rules, as discussed below, rather than being taxed as a capital gain. As discussed below in “-Passive Foreign Investment
Companies,” we do not anticipate being a PFIC for this year; however, there can be no assurance that we will not be treated as a
PFIC for our current taxable year and future taxable years.
If a U.S. Holder receives
foreign currency upon a sale or exchange of the Securities, gain or loss will be recognized in the manner described above under “–
Distributions.” However, if such foreign currency is converted into U.S. dollars on the date received by the U.S. Holder, the U.S.
Holder generally should not be required to recognize any foreign currency gain or loss on such conversion.
As discussed above under
the heading “Material Tax Considerations-Israeli Tax Considerations-Taxation of Shareholders,” a U.S. Holder who holds Securities
through an Israeli broker or other Israeli intermediary may be subject to Israeli withholding tax on any capital gains recognized on a
sale or other disposition of the Securities. Any Israeli tax paid under circumstances in which an exemption from (or a refund of or a
reduction in) such tax was available will not be creditable for U.S. federal income tax purposes. U.S. Holders are advised to consult
their Israeli broker or intermediary regarding the procedures for obtaining an exemption or reduction.
Medicare Tax on Unearned Income
Non-corporate U.S. Holders
whose income exceeds certain thresholds are required to pay an additional 3.8% tax on their net investment income, which includes dividends
paid on the Securities and capital gains from the sale or other disposition of the Securities.
Passive Foreign Investment Companies
Although we do not anticipate
being treated as a passive foreign investment company (“PFIC”) for this year, the treatment of the Company as a PFIC is
based on the value and composition of our assets, and no assurance can be given that we will not be treated as a PFIC for U.S. federal
income tax purposes for our current taxable year or future taxable years. We will be considered a PFIC for any taxable year if:
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at least 75% of our gross income for such taxable year is passive income; or |
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at least 50% of the value of our assets (based on an average of the fair market values of the assets determined at the end of each quarter during a taxable year) is attributable to assets that produce or are held for the production of passive income. |
For purposes of the above
calculations, if we own, directly or indirectly, 25% or more of the total value of the outstanding shares of another corporation, we will
be treated as if we (a) held a proportionate share of the assets of such other corporation and (b) received a proportionate share of the
income of such other corporation directly. Passive income generally includes, among other things, dividends, interest, rents, royalties
and certain capital gain, but generally excludes rents and royalties that are derived in the active conduct of a trade or business and
which are received from a person other than a related person.
A separate determination
must be made each taxable year as to whether we are a PFIC (after the close of each such taxable year). Because the value of our assets
for purposes of the asset test will generally be determined by reference to the market price of the ADSs and Warrants, our PFIC status
will also depend in large part on the market price of the Securities, which may fluctuate significantly.
If we are a PFIC for any
year during which a U.S. Holder holds any Securities, we generally will be treated as a PFIC with respect to such U.S. Holder for all
succeeding years during which such U.S. Holder holds the Securities, unless we cease to be a PFIC and such U.S. Holder makes a “deemed
sale” election with respect to the Securities that such U.S. Holder holds. For this purpose, a U.S. Holder that acquired an ADS
through the exercise of a Warrant will be treated as holding such ADS for the period during which such Warrant was held. A U.S. Holder
that makes such an election will be deemed to have sold the Securities it holds at their fair market value on the last day of the last
taxable year in which we qualified as a PFIC, and any gain from such deemed sale will be subject to the U.S. federal income tax treatment
described below. After the deemed sale election, the Securities with respect to which the deemed sale election was made will not be treated
as shares in a PFIC unless we subsequently become a PFIC.
For each taxable year for
which we are treated as a PFIC with respect to a U.S. Holder, such U.S. Holder will be subject to special tax rules with respect to any
“excess distribution” it receives and any gain it realizes from a sale or other disposition (including a pledge) of the Securities,
unless it makes a “mark-to-market” election or a “qualified electing fund” election discussed below. Distributions
that a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions it received during the shorter
of the three preceding taxable years or its holding period for the Securities will be treated as an excess distribution. Under these special
tax rules, if a U.S. Holder receives any excess distribution or realizes any gain from a sale or other disposition of the Securities:
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the excess distribution or gain will be allocated ratably over the U.S. Holder’s holding period for the Securities; |
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the amount of excess distribution or gain allocated to the current taxable year, and any taxable year before the first taxable year in which we were a PFIC, must be included in the U.S. Holder’s gross income (as ordinary income) for the tax year of the sale or disposition; and |
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the amount allocated to each other year will be subject to the highest marginal tax rate in effect with respect to such U.S. Holder for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to such amounts allocated to each other year. |
The tax liability for amounts
allocated to years before the year of disposition or “excess distribution” cannot be offset by any losses for such years.
Additionally, any gains realized on the sale of the Securities cannot be treated as capital gains.
If we are treated as a PFIC
with respect to a U.S. Holder for any taxable year, to the extent any of our subsidiaries are also PFICs, such U.S. Holder will be deemed
to own its proportionate share of any such subsidiaries that are PFICs, and such U.S. Holder may be subject to the rules described in
the preceding two paragraphs with respect to the shares of such subsidiaries that are PFICs it will be deemed to own. As a result, a U.S.
Holder may incur liability for any “excess distribution” described above if we receive a distribution from such subsidiaries
that are PFICs or if we dispose of, or are deemed to dispose of, any shares in such subsidiaries that are PFICs. You should consult your
own tax advisor regarding the application of the PFIC rules to any of our subsidiaries.
Alternatively, a U.S. Holder
of “marketable stock” (as defined below) in a PFIC may make a mark-to-market election for such stock to elect out of the general
tax treatment for PFICs discussed above. If a U.S. Holder makes a mark-to-market election for the ADSs, such U.S. Holder will include
in income for each year we are a PFIC an amount equal to the excess, if any, of the fair market value of the ADSs as of the close of such
U.S. Holder’s taxable year over such U.S. Holder’s adjusted basis in such ADSs. A U.S. Holder is allowed a deduction for the
excess, if any, of the adjusted basis of the ADSs over their fair market value as of the close of the taxable year. However, deductions
are allowable only to the extent of any net mark-to-market gains on the ADSs included in a U.S. Holder’s income for prior taxable
years. Amounts included in a U.S. Holder’s income under a mark-to-market election, as well as gain on the actual sale or other disposition
of the ADSs, are treated as ordinary income. Ordinary loss treatment also applies to the deductible portion of any mark-to-market loss
on the ADSs, as well as to any loss realized on the actual sale or disposition of the ADSs to the extent the amount of such loss does
not exceed the net mark-to-market gains previously included for the ADSs. A U.S. Holder’s basis in the ADSs will be adjusted to
reflect any such income or loss amounts. If a U.S. Holder makes a valid mark-to-market election, the tax rules that apply to distributions
by corporations that are not PFICs will apply to distributions by us, except the lower applicable tax rate for qualified dividend income
will not apply. If we cease to be a PFIC when a U.S. Holder has a mark-to-market election in effect, gain or loss realized by such U.S.
Holder on the sale of the ADSs will be a capital gain or loss and taxed in the manner described above under “– Sale, Exchange,
or Other Disposition of ADSs and Warrants.”
The mark-to-market election
is available only for “marketable stock,” which is a stock that is traded in other than de minimis quantities on at least
15 days during each calendar quarter, or regularly traded, on a qualified exchange or another market, as defined in applicable U.S. Treasury
regulations. Any trades that have as their principal purpose meeting this requirement will be disregarded. The ADSs are listed on Nasdaq
and, accordingly, provided the ADSs are regularly traded, the mark-to-market election will be available to a U.S. Holder of ADSs if we
are a PFIC. Once made, the election cannot be revoked without the consent of the IRS unless the ADSs cease to be marketable stock. If
we are a PFIC for any year in which the U.S. Holder owns the ADSs but before a mark-to-market election is made, the interest charge rules
described above will apply to any mark-to-market gain recognized in the year the election is made. If any of our subsidiaries are or become
PFICs, the mark-to-market election will not be available with respect to the shares of such subsidiaries that are treated as owned by
a U.S. Holder. Consequently, a U.S. Holder could be subject to the PFIC rules with respect to income of the lower-tier PFICs the value
of which already had been taken into account indirectly via mark-to-market adjustments. You should consult your own tax advisors as to
the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier
PFICs.
In certain circumstances,
a U.S. Holder of stock in a PFIC can make a “qualified electing fund” election to mitigate some of the adverse tax consequences
of holding stock in a PFIC by including in income its share of the corporation’s income on a current basis. However, we do not currently
intend to prepare or provide the information that would enable a U.S. Holder to make a qualified electing fund election.
Unless otherwise provided
by the U.S. Treasury, each U.S. shareholder of a PFIC is required to file an annual information return on IRS Form 8621 (Information Return
by a Shareholder of a Passive Foreign Investment Company or Qualifying Electing Fund) containing such information as the U.S. Treasury
may require. A U.S. Holder’s failure to file such annual information return could result in the imposition of penalties and the
extension of the statute of limitations with respect to U.S. federal income tax. You should consult your own tax advisors regarding the
requirements of filing such information returns under these rules, taking into account the uncertainty as to whether we are currently
treated as or may become a PFIC.
YOU ARE STRONGLY URGED
TO CONSULT YOUR OWN TAX ADVISOR REGARDING THE IMPACT AND APPLICATION OF THE PFIC RULES ON YOUR INVESTMENT IN THE SECURITIES.
Backup Withholding and Information Reporting
Payments of dividends with
respect to the Securities and the proceeds from the sale, retirement, or other disposition of the Securities made by a U.S. paying agent
or other U.S. intermediary will generally be reported to the IRS and to the U.S. Holder as may be required under applicable U.S. Treasury
regulations. We, or an agent, a broker, or any paying agent, as the case may be, may be required to withhold tax (backup withholding),
currently at the rate of 24%, if a non-corporate U.S. Holder that is not otherwise exempt fails to provide an accurate taxpayer identification
number and comply with other IRS requirements concerning information reporting. Certain U.S. Holders (including, among others, corporations
and tax-exempt organizations) are not subject to backup withholding. Backup withholding is not an additional tax. Any amount of backup
withholding withheld may be used as a credit against your U.S. federal income tax liability or may be refunded provided that the required
information is timely furnished to the IRS. U.S. Holders should consult their own tax advisors as to their qualification for exemption
from backup withholding and the procedure for obtaining an exemption.
You should consult your
own tax advisors regarding the backup withholding tax and information reporting rules.
Foreign Asset Reporting
Certain U.S. Holders who
are individuals are required to report information relating to an interest in the Securities, subject to certain exceptions (including
an exception for shares held in accounts maintained by financial institutions) by filing IRS Form 8938 (Statement of Specified Foreign
Financial Assets) with their federal income tax return. U.S. Holders are urged to consult their tax advisors regarding their information
reporting obligations, if any, with respect to their ownership and disposition of the Securities.
EACH PROSPECTIVE INVESTOR
IS URGED TO CONSULT ITS OWN TAX ADVISOR REGARDING THE TAX CONSEQUENCES OF AN INVESTMENT IN THE SECURITIES IN LIGHT OF SUCH INVESTOR’S
PARTICULAR CIRCUMSTANCES.
Israeli Tax Considerations
General
The following is a summary
of the material tax consequences under Israeli law concerning the purchase, ownership and disposition of American Depositary Shares, representing
Ordinary Shares, Pre-funded Warrants and Warrants (collectively, the “Shares”) by persons who acquired the Shares in this
offering.
This discussion does not
purport to constitute a complete analysis of all potential tax consequences applicable to investors upon purchasing, owning or disposing
of our Shares. In particular, this discussion does not take into account the specific circumstances of any particular investor (such as
tax-exempt entities, financial institutions, certain financial companies, broker-dealers, investors that own, directly or indirectly,
10% or more of our outstanding voting rights, all of whom are subject to special tax regimes not covered under this discussion). To the
extent that issues discussed herein are based on legislation that has yet to be subject to judicial or administrative interpretation,
there can be no assurance that the views expressed herein will accord with any such interpretation in the future.
Potential investors are
urged to consult their own tax advisors as to the Israeli or other tax consequences of the purchase, ownership, and disposition of the
Shares, including, in particular, the effect of any foreign, state or local taxes.
General Corporate Tax Structure in Israel
Israeli companies are generally
subject to corporate tax on their taxable income at the rate of 23% for the 2023 tax year.
Taxation of Shareholders
Capital Gains
Capital gains tax is imposed
on the disposition of capital assets by an Israeli resident and on the disposition of such assets by a non-Israeli resident if those assets
are either (i) located in Israel; (ii) are shares or a right to a share in an Israeli resident corporation, or (iii) represent, directly
or indirectly, rights to assets located in Israel, unless an exemption is available or unless an applicable double tax treaty between
Israel and the seller’s country of residence provides otherwise. The Israeli Income Tax Ordinance distinguishes between “Real
Gain” and the “Inflationary Surplus”. “Real Gain” is the excess of the total capital gain over Inflationary
Surplus generally computed on the basis of the increase in the Israeli Consumer Price Index between the date of purchase and the date
of disposition. Inflationary Surplus is not subject to tax.
Real Gain accrued by individuals
on the sale of the Shares will be taxed at the rate of 25%. However, if the individual shareholder is a “Controlling Shareholder”
(i.e., a person who holds, directly or indirectly, alone or together with another, 10% or more of one of the Israeli resident company’s
means of control) at the time of sale or at any time during the preceding 12-month period, such gain will be taxed at the rate of 30%.
Corporate and individual
shareholders dealing in securities in Israel are taxed at the tax rates applicable to business income (23% in 2019 and thereafter), and
a marginal tax rate of up to 50% in 2023 for individuals, including an excess tax (as discussed below).
Notwithstanding the foregoing,
capital gains generated from the sale of our Shares by a non-Israeli shareholder may be exempt from Israeli tax under the Israeli Income
Tax Ordinance provided (among other conditions) that seller does not have a permanent establishment in Israel to which the generated
capital gain is attributed. However, non-Israeli resident corporations will not be entitled to the foregoing exemption if Israeli residents:
(i) have a 25% or more interest in such non-Israeli corporation or (ii) are the beneficiaries of, or are entitled to, 25% or more of the
income or profits of such non-Israeli corporation, whether directly or indirectly. In addition, such exemption would not be available
to a person whose gains from selling or otherwise disposing of the securities are deemed to be business income.
In addition, the sale of
the Shares may be exempt from Israeli capital gains tax under the provisions of an applicable double tax treaty. For example, the Convention
Between the Government of the United States of America and the Government of the State of Israel with Respect to Taxes on Income, or the
U.S.-Israel Double Tax Treaty, exempts a U.S. resident (for purposes of the U.S.-Israel Double Tax Treaty) from Israeli capital gain tax
in connection with the sale of the Shares, provided (among other conditions) that: (i) the U.S. resident owned, directly or indirectly,
less than 10% of the voting power of the company at any time within the 12-month period preceding such sale; (ii) the U.S. resident, being
an individual, is present in Israel for a period or periods of less than 183 days during the taxable year; and (iii) the capital gain
from the sale was not derived through a permanent establishment of the U.S. resident in Israel; however, under the U.S.-Israel Double
Tax Treaty, the taxpayer should be permitted to claim a credit for such taxes against the U.S. federal income tax imposed with respect
to such sale, exchange or disposition, subject to the limitations under U.S. law applicable to foreign tax credits. The U.S.-Israel Double
Tax Treaty does not relate to U.S. state or local taxes.
Payers of consideration
for the Ordinary Shares, including the purchaser, the Israeli stockbroker or the financial institution through which the Shares are held,
are obligated, subject to certain exemptions, to withhold tax upon the sale of Shares at a rate of 25% of the consideration for individuals
and corporations.
Upon the sale of traded
securities, a detailed return, including a computation of the tax due, must be filed and an advance payment must be paid to the Israeli
Tax Authority on January 31 and July 31 of every tax year in respect of sales of traded securities made within the previous six months.
However, if all tax due was withheld at source according to applicable provisions of the Israeli Income Tax Ordinance and regulations
promulgated thereunder, such return need not be filed, and no advance payment must be paid. Capital gains are also reportable on annual
income tax returns.
Exercise of Warrants and Certain Adjustments
to the Warrants
Investors will generally
not recognize gain or loss for Israeli tax purposes on the exercise of a Warrant and related receipt of an ordinary share (unless, for
instance, cash is received in lieu of the issuance of a fractional ordinary share). Nevertheless, the Israeli income tax treatment and
the tax consequences of a cashless exercise of Warrants into Ordinary Shares is unclear. Furthermore, the exercise terms of the Warrants
may be adjusted in certain circumstances. An adjustment to the number of Ordinary Shares that will be issued on the exercise of the Warrants
or an adjustment to the exercise price of a Warrant may be treated as a taxable event under Israeli tax law even if such holder does not
receive any cash or other property in connection with the adjustment. Investors should consult their tax advisors regarding the proper
treatment of any exercise of and/or adjustments to the Warrants.
Dividends
Dividends distributed by
a company to a shareholder who is an Israeli resident individual will generally be subject to income tax at a rate of 25%. However, a
30% tax rate will apply if the dividend recipient is a Controlling Shareholder, as defined above, at the time of distribution or at any
time during the preceding 12-month period. If the recipient of the dividend is an Israeli resident corporation, such dividend will generally
be exempt from Israeli income tax provided that the income from which such dividend is distributed, derived or accrued within Israel.
Dividends distributed by
an Israeli resident company to a non-Israeli resident (either an individual or a corporation) are generally subject to Israeli withholding
tax on the receipt of such dividends at the rate of 25% (30% if the dividend recipient is a Controlling Shareholder at the time of distribution
or at any time during the preceding 12-month period). These rates may be reduced under the provisions of an applicable double tax treaty.
For example, under the U.S.-Israel Double Tax Treaty, the following tax rates will apply in respect of dividends distributed by an Israeli
resident company to a U.S. resident: (i) if the U.S. resident is a corporation that holds during that portion of the taxable year which
precedes the date of payment of the dividend and during the whole of its prior taxable year (if any), at least 10% of the outstanding
shares of the voting stock of the Israeli resident paying corporation and not more than 25% of the gross income of the Israeli resident
paying corporation for such prior taxable year (if any) consists of certain types of interest or dividends the tax rate is 12.5%; (ii)
if both the conditions mentioned in clause (i) above are met and the dividend is paid from an Israeli resident company’s income
which was entitled to a reduced tax rate under The Law for the Encouragement of Capital Investments, 1959, the tax rate is 15%; and (iii)
in all other cases, the tax rate is 25%. The aforementioned rates under the U.S.-Israel Double Tax Treaty will not apply if the dividend
income is attributed to a permanent establishment of the U.S. resident in Israel.
Excess Tax
Individual holders who are
subject to tax in Israel (whether any such individual is an Israeli resident or non-Israeli resident) and who have taxable income that
exceeds a certain threshold in a tax year (NIS 698,280 for 2023, linked to the Israeli Consumer Price Index) will be subject to an additional
tax at the rate of 3% on his or her taxable income for such tax year that is in excess of such amount. For this purpose, taxable income
includes taxable capital gains from the sale of securities and taxable income from interest and dividends, subject to the provisions of
an applicable double tax treaty.
Estate and Gift Tax
Israel does not currently
impose estate or gift taxes if the Israeli Tax Authority is satisfied that the gift was made in good faith and on condition that the recipient
of the gift is not a non-Israeli resident.
Foreign Exchange Regulations
Non-residents of Israel
who hold our Shares are able to receive any dividends, and any amounts payable upon the dissolution, liquidation and winding up of our
affairs, repayable in non-Israeli currency at the rate of exchange prevailing at the time of conversion. However, Israeli income tax is
generally required to have been paid or withheld on these amounts. In addition, the statutory framework for the potential imposition of
currency exchange control has not been eliminated and may be restored at any time by administrative action.
PLAN OF DISTRIBUTION
The
selling shareholders and any of their respective pledgees, assignees and successors-in-interest may, from time to time, sell any
or all of their securities covered hereby on Nasdaq or any other stock exchange, market or trading facility on which the securities are
traded or in private transactions. These sales may be at fixed or negotiated prices. Selling shareholders may use any one or more of the
following methods when selling securities:
| ● | ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● | block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as
principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and the subsequent
resale by the broker-dealer for its account; |
| ● | an exchange distribution in accordance with the rules of the
applicable exchange; |
| ● | an over-the-counter distribution in accordance with the
rules of Nasdaq; |
| ● | through trading plans entered into by the selling shareholders
pursuant to Rule 10b5-1 under the Exchange Act that are in place at the time of an offering pursuant to this prospectus
and any applicable prospectus supplement hereto that provide for periodic sales of their securities on the basis of parameters described
in such trading plans; |
| ● | transactions other than on such exchanges or in the over-the-counter market; |
| ● | directly to purchasers, including through a specific bidding,
auction or other process or in privately negotiated transactions; |
| ● | settlement of short sales; |
| ● | in transactions through broker-dealers that agree with
the selling shareholders to sell a specified number of such securities at a stipulated price per security; |
| ● | through the writing or settlement of options or other hedging
transactions, whether through an options exchange or otherwise; |
| ● | a combination of any such methods of sale; or |
| ● | any other method permitted pursuant to applicable law. |
The selling shareholders may also sell securities
under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the selling shareholders
may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the
selling shareholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be
negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary
brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance
with FINRA Rule 2121.
In connection with the sale of the securities or
interests therein, the selling shareholders may enter into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The selling shareholders
may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that
in turn may sell these securities. The selling shareholders may also enter into option or other transactions with broker-dealers or
other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other
financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution
may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The selling shareholders and any broker-dealers or
agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities
Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the
resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. The selling
shareholders have informed the Company that they do not have any written or oral agreement or understanding, directly or indirectly, with
any person to distribute the securities.
The Company is required to pay certain fees and
expenses incurred by the Company incident to the registration of the ADSs issuable upon exercise of Warrants covered by this prospectus.
The Company has agreed to indemnify the selling shareholders against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
DESCRIPTION OF SECURITIES
The securities to be registered
on this registration statement on Form F-1 of which this prospectus forms a part are f up to an aggregate amount of 1,215,345
ADSs offered for resale by the selling shareholders issuable upon (i) exercise of Warrants to purchase 1,146,552 ADSs at an exercise price
of $1.16 per ADS granted pursuant to the Purchase Agreement and (ii) Warrants to purchase up to 68,793 ADSs at an exercise Price of $1.45
per ADS granted pursuant to the Engagement Letter.
History of Share Capital
Since September 30, 2020, our issued share capital
has changed as provided below.
On February 2, 2021, we closed an underwritten offering
in which we sold 243,478 ADSs at a public offering price of $49.5 per ADS. On February 10, 2021, Aegis Capital Corp., the
sole bookrunning manager for the underwritten offering, fully exercised its over-allotment option to purchase an additional 36,521 ADSs
bringing total gross proceeds to the Company from the offering including exercise of the over-allotment option of approximately $13,800.
The Company received a net amount of $12,480 after deduction of issuance expenses of $360
On December 27, 2021, we closed an underwritten
offering in which we sold 381,356 ADSs at a public offering price of $23.6 per ADS. On December 27, 2021, Aegis Capital
Corp., the sole bookrunning manager for the underwritten offering, fully exercised its over-allotment option to purchase an additional 33,058 ADSs
bringing total gross proceeds to the Company from the offering including exercise of the over-allotment option of approximately $9,780.
The Company received a net sum of $8,956 (after deduction of issuance expenses of $63)
On February 2, 2022, we issued to Max Planck Society
(“MPG”) 15,000 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.
We also issued 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.
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 after deduction of underwriter discount and issuance expenses of $769
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.
From February 1, 2023 until August 23, 2023, we
issued 1,662 ADSs to Prof. Matthias Dobbelstein as consideration for scientific advisory board services.
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 400,000 ADSs and pre-funded warrants to purchase up to 746,552 ADSs, at an exercise
price of $0.001 per ADS, at a purchase price of $1.16 per ADS and $1.159 per pre-funded warrant, and (ii) in concurrent private placement
unregistered warrants to purchase up to 1,146,552 ADSs. The warrants have an exercise price of $1.16 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.
During the period beginning September 30, 2020 through
September 30, 2023, we issued 311,345 RSUs ADSs to our officers, directors and employees.
American Depositary Shares
The material terms and provisions
of the ADSs and the ordinary shares represented thereby are described in Exhibit 4.1, Description of Securities, to our annual report
on Form 10-K for the year ended December 31, 2022, which is incorporated by reference into this prospectus.
Warrants
Duration and Exercise Price
The exercise price per ADS under this Warrant shall be $1.16, subject
to adjustment. Each Warrant became exercisable on the date of issuance and will remain exercisable until five and one-half (5.5) years
from the initial exercise date
Exercisability
The Warrants are exercisable,
at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full
for the number of ADSs purchased upon such exercise (except in the case of a cashless exercise as discussed below). Purchasers of the
Warrants in this offering may elect to deliver their exercise notice following the pricing of the offering and prior to the issuance of
the Warrants at closing to have their Warrants exercised immediately upon issuance and receive ADSs underlying the Warrants upon closing
of this offering. A holder (together with its affiliates) may not exercise any portion of the Warrants to the extent that the holder would
own more than 4.99% of the outstanding ADSs (or, at the election of the purchaser, 9.99%), except that upon at least 61 days’ prior
notice from the holder to us, a holder with a 4.99% ownership blocker may increase the amount of ownership of outstanding shares after
exercising the holder’s Warrants up to 9.99% of our outstanding ADSs. No fractional ADSs will be issued in connection with the exercise
of a Warrant. In lieu of fractional shares, we may, at our election, either pay a cash adjustment in respect of such final fraction in
an amount equal to such fraction multiplied by the exercise price of the Warrant or round up to the next whole ADS.
Cashless Exercise
In lieu of making the cash
payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead
to receive upon such exercise (either in whole or in part) the net number of ADSs determined according to a formula set forth in the Warrants.
Transferability
Subject to applicable laws, a Warrant may be transferred
at the option of the holder upon surrender of the Warrant to us together with the appropriate instruments of transfer.
Exchange Listing
There is no trading market
available for the Warrants on any securities exchange or nationally recognized trading system. We do not intend to list the Warrants on
any securities exchange or nationally recognized trading system, nor do we have any obligation to do so.
Right as a Shareholder
Except as otherwise provided
in the Warrants or by virtue of such holder’s ownership of the ADSs or Ordinary Shares, the holders of the Warrants do not have
the rights or privileges of holders of the ADSs or Ordinary Shares, including any voting rights, until they exercise their Warrants.
Fundamental Transaction
If, at any time while the
Warrants are outstanding, (1) we, directly or indirectly, consolidate or merge with or into another person, (2) we, directly or indirectly,
sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets, (3) any direct or indirect
purchase offer, tender offer or exchange offer (whether by us or another person) is completed pursuant to which holders of the Ordinary
Shares and/or ADSs are permitted to sell, tender or exchange their Ordinary Shares for other securities, cash or property and has been
accepted by the holders of more than 50% of our outstanding Ordinary Shares and/or ADSs, or more than 50% of the voting power of our common
equity, (4) we, directly or indirectly, effect any reclassification, reorganization or recapitalization of the Ordinary Shares and/or
ADSs or any compulsory share exchange pursuant to which the Ordinary Shares and/or ADSs are converted into or exchanged for other securities,
cash or property, or (5) we, directly or indirectly, consummate a stock or share purchase agreement or other business combination with
another person whereby such other person acquires more than 50% of our outstanding Ordinary Shares and/or ADSs or 50% or more of the voting
power of the common equity of the Company, each, a “Fundamental Transaction”, then upon any subsequent exercise of the Warrants,
a holder thereof will have the right to receive the same amount and kind of securities, cash or property as it would have been entitled
to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the
holder of the number of ADSs then issuable upon exercise of the Warrant, and any additional consideration payable as part of the Fundamental
Transaction.
EXPENSES
The following are the estimated expenses of this
offering payable by us with respect to the issuance and distribution of the securities covered by the registration statement of which
this prospectus forms a part. With the exception of the SEC registration fee, all amounts are estimates and may change:
SEC registration fee | |
$ | 115.52 | |
Legal fees and expenses | |
| 7,020 | |
Accountants’ fees and expenses | |
| 8,000 | |
Miscellaneous | |
| 5,000 | |
Total | |
$ | 20,135.52 | |
LEGAL MATTERS
Certain matters concerning
this offering will be passed upon for us by Lucosky Brookman, LLP, New York, New York. The validity of the securities being offered by
this prospectus will be passed upon for us by Goldfarb Gross Seligman & Co., Tel-Aviv, Israel.
EXPERTS
The financial statements
incorporated in this prospectus by reference to the annual report on Form 10-K for the year ended December 31, 2022 have been so incorporated
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.
SERVICE OF PROCESS AND 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 will not declare a foreign civil judgment enforceable if:
| ● | the judgment was given in a
state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases); |
| ● | the enforcement of the judgment
is likely to prejudice the sovereignty or security of the State of Israel; |
| ● | the judgment was obtained by
fraud; |
| ● | the opportunity given to the
defendant to bring its arguments and evidence before the court was not reasonable in the opinion of the Israeli court; |
| ● | the judgment was rendered by
a court not competent to render it according to the laws of private international law as they apply in Israel; |
| ● | the judgment is contradictory
to another judgment that was given in the same matter between the same parties and that is still valid; or |
| ● | at the time the action was brought
in the foreign court, a lawsuit in the same matter and between the same parties was pending before a court or tribunal in Israel. |
If a foreign judgment is
enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non-Israeli currency
and transferred out of Israel. The usual practice in an action before an Israeli court to recover an amount in a non-Israeli currency
is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in force on the date
of the judgment, but the judgment debtor may make payment in foreign currency. Pending collection, the amount of the judgment of an Israeli
court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus interest at the annual statutory rate
set by Israeli regulations prevailing at the time. Judgment creditors must bear the risk of unfavorable exchange rates.
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 securities offered by this prospectus. However, as
is permitted by the rules and regulations of the SEC, this prospectus, which is part of our registration statement on Form F-1, omits
certain non-material information, exhibits, schedules and undertakings set forth in the registration statement. For further information
about us, and the securities offered by this prospectus, please refer to the registration statement.
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 10-K filed this year and an annual report on Form 20-F to be filed in 2024. 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.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
We file annual
and special reports and other information with the SEC (File Number 001-37353). 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 10-K
for the fiscal year ended on December 31, 2022, filed with the SEC on April 17, 2023. |
| ● | our Quarterly Report on Form 10-Q for the period ended on
March 31, 2023, filed with the SEC on May 15, 2023. |
| ● | Our
reports on Form 6-K furnished to the Commission on July
3, 2023 (two reports), July
5, 2023 (relating to our Annual General Meeting of Shareholders), July
12, 2023, August
1, 2023, August
11, 2023 (the text under “Second Quarter 2022
Financial Summary” in Exhibit 99.1), August
24, 2023, September
6, 2023 (the report regarding new corporate name only), September
19, 2023, September
20, 2023, November
2, 2023, November
3, 2023 (excluding the fourth paragraph in Exhibit 99.1), November
7, 2023 (excluding sixth and seventh paragraphs in Exhibit 99.1), November
13, 2023, November
20, 2023 and December
14, 2023 (excluding the fourth through seventh paragraphs in Exhibit 99.1 and the sixth
and seventh paragraphs in Exhibit 99.2), and reports on Form 6-K/A furnished to the Commission
on August
14, 2023 and August
18, 2023. |
| ● | the description of our ordinary
shares contained under the heading “Item 1. Description of Registrant’s Securities to be Registered” in our registration
statement on Form 8-A, as filed with the SEC on April 20, 2015, including any subsequent amendment or any report filed for the purpose
of updating such description. |
Certain statements in and portions of this prospectus
update and replace information in the above listed documents incorporated by reference.
We will provide you without
charge, upon your written or oral request, a copy of any of the documents incorporated by reference in this prospectus, other than exhibits
to such documents which are not specifically incorporated by reference into such documents. Please direct your written or telephone requests
to Scinai Immunotherapeutics Ltd., Jerusalem BioPark, 2nd Floor, Hadassah Ein Kerem Campus, Jerusalem, Israel, Attn: Uri Ben Or, telephone
number +972 8-930-2529. You may also obtain information about us by visiting our website at www.scinai.com. Information contained on our
website is not part of this prospectus.
1,215,345 American Depositary
Shares representing 486,138,000 Ordinary Shares
Prospectus
December , 2023
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 6. Indemnification of Directors and Officers
Exculpation, Insurance and Indemnification of Directors and Officers
Under
the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. 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 out of a prohibited
dividend or distribution to shareholders.
Under
the Companies Law, a company may indemnify an office holder in respect of the following liabilities and expenses incurred for acts performed
by him or her as an office holder, either pursuant to an undertaking made in advance of an event or following an event, provided its articles
of association include a provision authorizing such indemnification:
| ● | financial liability imposed on him or her in favor of another
person pursuant to a judgment, including a settlement or arbitrator’s award approved by a 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 reasonably 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 attorneys’
fees, incurred by the office holder (i) as a result of an investigation or proceeding instituted against him or her by an authority authorized
to conduct such investigation or proceeding, provided that (A) no indictment was filed against such office holder as a result of such
investigation or proceeding; and (B) no financial liability, such as a criminal penalty, was imposed upon him or her as a substitute
for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed
with respect to an offense that does not require proof of criminal intent; and (ii) in connection with a monetary sanction; and; |
| ● | reasonable litigation expenses, including attorneys’
fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf,
or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction
for an offense that does not require proof of criminal intent. |
Under
the Companies Law and the Israeli Securities Law 5728-1968 (the “Israeli 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 duty of loyalty 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 compan; |
| ● | 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; and |
| ● | a financial liability imposed on the office holder in favor
of a third party. |
Under
our articles of association, we may insure an office holder against the aforementioned liabilities as well as the following liabilities:
| ● | any other action against which we are permitted and/or will
be permitted by law to insure an office holder; |
| ● | expenses paid by the office holder or which he was ordered
to pay, in connection with an administrative enforcement proceeding held in his case, including reasonable litigation expenses, and including
legal fees; and |
| ● | a financial liability in favor or a victim of a felony pursuant
to Section 52ND of the Israeli Securities Law. |
Under the Companies Law, a company may not indemnify,
exculpate or insure an office holder against any of the following:
| ● | a breach of the duty of loyalty, except for indemnification
and insurance for a breach of the duty of loyalty 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 harm 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 in a public company must be approved by the compensation
committee and the board of directors and, with respect to certain office holders or under certain circumstances, 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 the Companies Law and the Israeli Securities Law, including expenses incurred and/or paid by the office holder in connection with an
Administrative Enforcement Procedure.
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.
In
the opinion of the SEC, indemnification of directors and office holders for liabilities arising under the Securities Act of 1933, however,
is against public policy and therefore unenforceable.
We
have obtained directors’ and officers’ liability insurance for the benefit of our office holders and intend to continue to
maintain such coverage and pay all premiums thereunder to the fullest extent permitted by the Companies Law. In addition, we entered into
agreements with each of our office holders undertaking to indemnify them to the fullest extent permitted by the Companies Law, including
with respect to liabilities resulting from the initial public offering in the U.S., to the extent that these liabilities are not covered
by insurance.
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 150,000 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 transaction.
On November 9, 2022, we
issued 17,694 ADSs to Hybrid Financial Ltd. as consideration for investor relations services.
From February 1, 2023 until
August 23, 2023, we issued 1,662 ADSs to Prof. Matthias Dobbelstein as consideration for scientific advisory board services.
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.
Item 8. Exhibits and Financial Statement Schedules
| (a) | The following documents are filed as part of this registration statement: |
Exhibit No. |
|
Exhibit
Description |
3.1* |
|
Articles
of Association of Scinai Immunotherapeutics Ltd. (incorporated by reference to Exhibit 3.1 to the Registration Statement on Form
F-1 filed with the SEC on October 30, 2023) |
4.1 |
|
Description
of Securities (incorporated by reference to Exhibit 4.1 to the Annual Report on form 10-K filed with the SEC on April 17, 2023) |
4.2 |
|
Form
of Pre-Funded Warrant (incorporated by reference to Exhibit 4.4 to the Registration Statement Annual Report on Form F-1/A filed with
the SEC on December 14, 2022). |
4.3 |
|
Form
of Exchangeable Warrant, (incorporated by reference to the Registration Statement on Form F-1/A filed with the SEC on December 14,
2022). |
4.4 |
|
Form
of Non-Exchangeable Warrant, (incorporated by reference to the Registration Statement on Form F-1/A filed with the SEC on December
14, 2022). |
4.5 |
|
Form
of Warrant (incorporated by reference to Exhibit 1.3 to Form 6-K submitted with the SEC on September 19, 2023). |
4.6 |
|
Form
of Pre-Funded Warrant, (incorporated by reference to Exhibit 1.2 to Form 6-K submitted with the SEC on September 19, 2023). |
4.7 |
|
Form
of Placement Agent Warrant (incorporated by reference to Exhibit 1.4 to Form 6-K filed with the SEC on September 19, 2023). |
5.1* |
|
Opinion
of Goldfarb Gross Seligman & Co., Israeli counsel to the Company, regarding the validity of the ADSs being registered (incorporated
by reference to Exhibit 5.1 to the Registration Statement on Form F-1 filed with the SEC on October 30, 2023) |
10.1 |
|
Form
of Deposit Agreement between BiondVax Pharmaceuticals Ltd., The Bank of New York Mellon as Depositary, and owners and holders from
time to time of ADSs issued thereunder, (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form F-1 filed
with the SEC on April 6, 2015). |
10.2** |
|
2005
Share Incentive Plan, (incorporated by reference to Exhibit 4.1 to the Annual Report on Form 20-F filed with the SEC on June 12,
2020). |
10.3** |
|
2018
Share Incentive Plan, (incorporated by reference to Exhibit 4.2 to the Annual Report on Form 20-F filed with the. SEC on June 12,
2020). |
10.4** |
|
Compensation
Policy, (incorporated by reference to Appendix B to the Exhibit 99.1 to the Form 6-K filed with the SEC on November 22, 2021). |
10.5** |
|
Employment
Agreement, dated January 20, 2021, between BiondVax Pharmaceuticals Ltd. And Mr. Amir Reichman, (incorporated by reference to Exhibit
4.4 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022). |
10.6** |
|
Employment
Agreement dated March 15, 2005, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar Ben-Yedidia, (incorporated by reference
to Exhibit 10.6 to the Registration Statement on Form F-1 filed with the SEC on December 29, 2014). |
10.7** |
|
Addendum
to Employment Agreement dated April 1, 2012, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia, (incorporated by reference
to Exhibit 10.11 to the Registration Statement on Form F-1 filed with the SEC on December 29, 2014). |
10.8** |
|
Addendum
to Employment Agreement dated May 28, 2015, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia (incorporated by reference
to Exhibit 10.8 to the Annual Report on form 10-K filed with the SEC on April 17, 2023). |
10.9** |
|
Addendum
to Employment Agreement dated April 1, 2012, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia (incorporated by
reference to Exhibit 10.9 to the Annual Report on form 10-K filed with the SEC on April 17, 2023) |
10.10** |
|
Employment
Agreement dated September 5, 2018, between BiondVax Pharmaceuticals Ltd. and Elad Mark (incorporated by reference to Exhibit 10.10
to the Annual Report on form 10-K filed with the SEC on April 17, 2023). |
10.11 |
| Form
of Indemnification Letter (unofficial English translation from Hebrew original), (incorporated
by reference to Exhibit 10.9 to the Registration Statement on Form F-1 filed with the SEC
on December 29, 2014). |
10.12 |
| Form
of Indemnification and Exculpation Agreement, (incorporated by reference to Exhibit 10.18 to the Registration
Statement on Form F-1 filed with the SEC on April 6, 2015). |
10.13 |
|
Finance
Contract between BiondVax Pharmaceuticals Ltd. and the European Investment Bank, (incorporated by reference to Exhibit 99.2 to Form
6-K filed with the SEC on June 19, 2017). |
10.14 |
|
Amendment
No. 1, dated January 11, 2021, to Finance Contract dated June 19, 2017, by and between BiondVax Pharmaceuticals Ltd. and the
European Investment Bank (incorporated by reference to Exhibit 4.16 to the Annual Report on Form 20-F filed with the SEC on May 13,
2021). |
10.15 |
|
Lease
Agreement dated July 10, 2017 between BiondVax Pharmaceuticals Ltd. and Unihad BioPark Ltd., (incorporated by reference to Exhibit
4.19 to the Form 20-F filed with the SEC on April 30, 2018). |
10.16 |
|
Services
Agreement between BiondVax Pharmaceuticals Ltd. and Mark Germain, (incorporated by reference to Appendix C to the Form 6-K filed
with the SEC on April 23, 2019). |
10.17+ |
|
License
Agreement, dated December 11, 2021, between BiondVax Pharmaceuticals Ltd. and Max-Planck-Innovation GmbH, (incorporated by reference
to Exhibit 4.16 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022). |
10.18+ |
|
Accompanying
Research Collaboration Agreement, dated December 11, 2021, between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung
der Wissenschaften e.V and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin
Göttingen, (incorporated by reference to Exhibit 4.17 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022). |
10.19+ |
|
Research
Collaboration Agreement, dated March 23, 2022, between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung
der Wissenschaften e.V and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin
Göttingen, (incorporated by reference to Exhibit 4.18 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022). |
10.20+ |
|
Form
of License Agreement between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V and
Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen (incorporated
by reference to Exhibit 4.19 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022). |
10.21 |
|
Amendment
Agreement dated August 9, 2022, to Finance Contract dated June 19, 2017 and as amended from time to time, by and between BiondVax
Pharmaceuticals Ltd. and the European Investment Bank (incorporated by reference
to Exhibit 10.21 to the Annual Report on form 10-K filed with the SEC on April 17, 2023), |
10.22 |
|
Form
of Securities Purchase Agreement (incorporated by reference to Exhibit 1.1 to Form 6-K submitted with the SEC on September 19, 2023) |
14.1 |
|
Code
of Conduct (incorporated by reference to Exhibit 14.1 to the Annual Report on form 10-K filed with the SEC
on April 17, 2023) |
23.1 |
|
Consent
of Kost Forer Gabbay & Kasierer, Certified Public Accountant (Isr.), a member of Ernst & Young Global, independent registered
public accounting firm for the Registrant |
23.2* |
|
Consent
of Goldfarb Gross Seligman & Co. (included in Exhibit 5.1) |
24.1* |
|
Powers
of Attorney (included on signature page) (incorporated by reference to Exhibit 24.1 to the Registration Statement on Form F-1 filed
with the SEC on October 30, 2023) |
107* |
|
Filing
Fee Table (incorporated by reference to Exhibit 107 to the Registration Statement on Form F-1 filed with the SEC on October 30, 2023) |
| ** | Indicates a management contract
or compensatory plan or arrangement. |
| + | 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. |
Item 9. Undertaking
| (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. |
SIGNATURES
Pursuant to the requirements
of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets 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 Herzliya, Israel on December 22, 2023.
|
SCINAI IMMUNOTHERAPEUTICS LTD. |
|
|
|
By: |
/s/ Amir Reichman |
|
Name: |
Amir Reichman |
|
Title: |
Chief Executive Officer |
Pursuant to the requirements
of the Securities Act of 1933, as amended, this registration statement has been signed below by the following persons on the dates
and in the capacities indicated.
Name |
|
Title |
|
Date |
|
|
|
|
|
* |
|
Chairman
of the Board of Directors |
|
December
22, 2023 |
Mark
Germain |
|
|
|
|
|
|
|
|
|
/s/
Amir Reichman |
|
Chief Executive Officer and Director |
|
December
22, 2023 |
Amir
Reichman |
|
(Principal Executive Officer
and Director) |
|
|
|
|
|
|
|
/s/
Uri Ben Or |
|
Chief Financial Officer |
|
December
22, 2023 |
Uri
Ben Or |
|
(Principal Financial Officer and Principal Accounting Officer) |
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Avner
Rotman |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Yael
Margolin |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Morris
Laster |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Adi
Raviv |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Samuel
Moed |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
December
22, 2023 |
Jay
Green |
|
|
|
|
*By: |
/s/
Amir Reichman |
|
|
Amir Reichman |
|
|
Attorney-in-fact |
|
SIGNATURE OF AUTHORIZED U.S. REPRESENTATIVE
OF 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 Form F-1 on December 22, 2023.
|
By: |
/s/ Donald J, Puglisi |
|
Name: |
Donald J. Puglisi |
|
Title: |
Donald J. Puglisi |
II-7
Exhibit
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference 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 10-K) for the year ended December 31, 2022, filed with the Securities and Exchange Commission.
/s/ Kost
Forer Gabbay & Kasierer |
|
Kost
Forer Gabbay & Kasierer |
|
A
member firm of Ernst & Young Global
Tel
Aviv, Israel
December
22, 2023
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