As
filed with the Securities and Exchange Commission on November 22, 2023.
Registration
No. 333-272722
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
AMENDMENT
NO. 1
TO
POST-EFFECTIVE
AMENDMENT
NO. 1
TO
FORM
F-1
ON
FORM F-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
GALMED
PHARMACEUTICALS LTD.
(Exact name of registrant as specified
in its charter)
State
of Israel |
|
2834 |
|
Not
Applicable |
(State
or other jurisdiction of
incorporation
or organization) |
|
(Primary
Standard Industrial
Classification
Code Number) |
|
(I.R.S.
Employer
Identification
Number) |
16
Tiomkin Street,
Tel
Aviv, Israel 6578317
Tel:
(+972) (3) 693-8448 |
|
Puglisi
& Associates
850
Library Ave.,Suite 204
Newark,
DE 19711
Tel:
(302) 738-6680 |
(Address, including zip code, and telephone number, including area code, of registrant’s principal
executive offices) |
|
(Name, address, including zip code, and telephone number, including area code, of agent
for service) |
Copies
to:
Gary
Emmanuel, Esq.
Greenberg
Traurig, P.A.
One
Azrieli Center
Round
Tower, 30th floor
132
Menachem Begin Rd
Tel
Aviv 6701101
Tel:
+972 (0) 3.636.6000 |
|
Mike
Rimon, Adv.
Elad
Ziv, Adv.
Meitar
| Law Offices
16
Abba Hillel Silver Rd.
Ramat
Gan 52506, Israel
Tel:
+972-3-610-3100 |
Approximate
date of commencement of proposed sale to the public: As soon as practicable after the effective date hereof.
If
any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act, check the following box. ☒
If
this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, 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 registration statement pursuant to General Instruction I.C. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to
a registration statement filed pursuant to General Instruction I.C. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
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 or until the registration statement shall become effective on such date as the
Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
Galmed
Pharmaceuticals Ltd., or the Registrant, filed with the Securities and Exchange Commission, or the SEC, a Registration Statement on Form
F-1 (Registration No. 333-272722) on June 16, 2023, as subsequently amended, which was declared effective by the SEC on July 14, 2023
(the “Registration Statement”). The Registration Statement originally covered a public offering of (i) 380,000 ordinary shares,
(ii) 5,220,000 pre-funded warrants to purchase 5,220,000 ordinary shares, (iii) 5,600,000 common warrants to purchase 5,600,000 ordinary
shares, (iv) 168,000 placement agent warrants to purchase 168,000 ordinary shares, and (v) the ordinary shares issuable upon exercise
of the pre-funded warrants, common warrants and placement agent warrants. This Post-Effective Amendment No. 1 covers the sale of ordinary
shares issuable from time to time upon exercise of such pre-funded warrants and common warrants and that remain unexercised as of the
date hereof.
This
Post-Effective Amendment No. 1 is being filed by the Registrant to update and supplement information contained in the Registration Statement,
and also to include updated financial information as well as to convert the Registration Statement on Form F-1 into a registration statement
on Form F-3.
No additional
securities are being registered under this Post-Effective Amendment No. 1. This Post-Effective Amendment No. 1 concerns only the offer
and sale of ordinary shares issuable from time to time upon exercise of the pre-funded warrants and common warrants that remain unexercised.
All
filing fees payable in connection with the registration of these securities were previously paid in connection with the initial filing
of the Registration Statement.
The
information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities
and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY
PROSPECTUS |
SUBJECT
TO COMPLETION |
DATED
NOVEMBER 22, 2023 |
9,053,000 Ordinary
Shares Issuable Upon Exercise of Warrants
Galmed
Pharmaceuticals Ltd.
This prospectus relates to the issuance of up
to 9,053,000 of our ordinary shares, par value NIS 0.15 per share, consisting of (i) 3,285,000 ordinary shares issuable upon the exercise
of pre-funded warrants to purchase ordinary shares that were issued as part of a public offering, exercisable immediately at an exercise
price of $0.001, and that will not expire until exercised in full, or the Pre-Funded Warrants, (ii) 5,600,000 ordinary shares issuable
upon the exercise of common warrants to purchase ordinary shares that were issued as part of a public offering, exercisable immediately
at an exercise price of $1.25, and expire on July 18, 2028, or the Common Warrants, and (iii) 168,000 ordinary shares issuable upon
the exercise of placement agent warrants to purchase ordinary shares that were issued as part of a public offering, exercisable immediately
at an exercise price of $1.5625, and expire on July 14, 2028, or the Placement Agent Warrants. The Pre-Funded Warrants, the Common Warrants
and the Placement Agent are collectively referred to herein as the Warrants.
Our ordinary shares are listed on the Nasdaq under
the symbol “GLMD.” On November 21, 2023, the last reported sale price of our ordinary shares on Nasdaq was $0.3601
per ordinary share.
We
are a “foreign private issuer,” as defined under the U.S. federal securities law and are subject to reduced public company
reporting requirements. See “Prospectus Summary – Implications of Being a Foreign Private Issuer” for additional information.
Effective
May 15, 2023, we effected a 1-for-15 reverse share split of our authorized ordinary shares, including our issued and outstanding ordinary
shares, and the par value of each share was accordingly increased from NIS 0.01 per share to NIS 0.15 per share. Unless specifically
provided otherwise herein, the share and per share information that follows in this prospectus, other than in the historical financial
statements and related notes included elsewhere in this prospectus, assumes the effect of the reverse share split.
Investing
in our securities involves a high degree of risk. See “Risk Factors” beginning on page 5.
Neither
the Securities and Exchange Commission (or the SEC), nor any state or other foreign securities commission has approved nor disapproved
these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 2023.
TABLE
OF CONTENTS
The
registration statement of which this prospectus forms a part that we have filed with the Securities and Exchange Commission, or SEC,
includes exhibits that provide more detail of the matters discussed in this prospectus. You should read this prospectus and the related
exhibits filed with the SEC before making your investment decision.
You
should rely only on the information provided in this prospectus or in a prospectus supplement or any free writing prospectuses or amendments
thereto. Neither we nor the placement agent have authorized anyone else to provide you with different information. We do not, and the
placement agent and its affiliates do not, take any responsibility for, and can provide no assurance as to the reliability of, any information
that others may provide to you. If anyone provides you with different or inconsistent information, you should not rely on it. You should
assume that the information in this prospectus is accurate only as of the date hereof, regardless of the time of delivery of this prospectus
or any sale of securities. Our business, financial condition, results of operations and prospects may have changed since that date.
For
investors outside of the United States: neither we nor the placement agent have done anything that would permit this offering or possession
or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You
are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.
In
this prospectus, “we,” “us,” “our,” the “Company” and “Galmed” refer to Galmed
Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise requires. All references to Aramchol mean Aramchol acid or Aramchol
meglumine (salt), unless the context otherwise requires. All references to “shares” or “ordinary shares” are
to our ordinary shares, NIS 0.15 nominal par value per share. All references to “Israel” are to the State of Israel. “U.S.
GAAP” means the generally accepted accounting principles of the United States.
Unless
otherwise stated, all of our financial information presented in this prospectus, or incorporated by reference into this prospectus, has
been prepared in accordance with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding.
Unless otherwise indicated, or the context otherwise requires, references in this prospectus, or incorporated by reference into this
prospectus, to financial and operational data for a particular year refer to the fiscal year of our company ended December 31 of that
year. Our reporting currency and financial currency is the U.S. dollar. In this annual report, “NIS” means New Israeli Shekel,
and “$,” “US$” and “U.S. dollars” mean United States dollars.
All
trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks
and trade names in this prospectus are referred to without the ® and ™ symbols, but such references should not be construed
as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do
not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship
of us by, any other companies.
This
prospectus includes statistical, market and industry data and forecasts which we obtained from publicly available information and independent
industry publications and reports that we believe to be reliable sources. These publicly available industry publications and reports
generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy
or completeness of the information.
Effective
May 15, 2023, we effected a 1-for-15 reverse share split of our authorized ordinary shares, including our issued and outstanding ordinary
shares, and the par value of each share was accordingly increased from NIS 0.01 per share to NIS 0.15 per share. Unless specifically
provided otherwise herein, the share and per share information that follows in this prospectus, other than in the historical financial
statements and related notes included elsewhere in this prospectus, assumes the effect of the reverse share split.
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere in or incorporated by reference into this prospectus that we consider important. This
summary does not contain all of the information you should consider before investing in our securities. Before you decide to invest in
our securities, you should read the entire prospectus carefully, including the “Risk Factors” section and the financial statements
and related notes incorporated by reference into this prospectus and the other documents incorporated by reference into this prospectus,
which are described under “Incorporation by Reference” before making an investment in our securities.
Company
Overview
We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver disease and are currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring the feasibility of developing Aramchol
for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development
of Amilo-5MER, a 5 amino acid synthetic peptide.
In
September 2019, we initiated our Phase 3 ARMOR Study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis.
The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology-based registrational
part and a clinically based part where subjects will continue with the same treatment for approximately five years. In December 2020,
we announced the addition of a 150-patient open label part to the ARMOR Study and suspended randomization of new patients into the double-blind,
placebo-controlled histology-based registrational part of ARMOR as all enrolled patients were transitioned to the open label part.
In
May 2022, we announced our plan to expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the same
time discontinuing the open label part of its ARMOR Study having reached its objectives. Simultaneously, we initiated a cost reduction
plan and initiated a process to evaluate our strategic alternatives. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study in the near term, but plan to resume the ARMOR Study
if the Food and Drug Administration and market conditions allow and also subject to securing sufficient financing.
In May 2023, we announced
the initiation of a new clinical program to evaluate Aramchol meglumine for the treatment of PSC
a rare chronic cholestatic disease that causes inflammation, scarring, and narrowing of the bile duct walls, leading to blockages
and bile accumulation in the liver. PSC, which can eventually result in liver damage, cirrhosis, and end-stage liver disease, and may
also cause infections, is a slowly progressing disease with no known cause. According to the American Liver Foundation, around 70% of
PSC cases occur in association with inflammatory bowl disease (IBD). Treatments are limited to symptom management and monitoring, with
liver transplant as an option in severe cases, which could still become recurrent.
While PSC is more
common in men, especially in Northern European heritage, and is often diagnosed between ages 30-40, we currently estimate that the number
of patients to be around 60,000, or 1 per 10,000, consisting of around 33,5000 patients in the United States and 32,500 patients collectively
in France, Germany, Italy, Spain and the United Kingdom. In the preclinical stage, PSC likely involves ulcerative colitis (UC) leading
to biliary inflammation. As biliary fibrosis progresses to cirrhosis, it is coupled with complications and competing risks, while about
50% of patients with PSC report clinical symptoms. While there are currently no approved drugs for the treatment of PSC, there is a potential
to gain orphan drug status.
We initially planned
to initiate a Phase 2 study in the last quarter of 2023 to evaluate Aramchol meglumine for the treatment of PSC in patients who may
also have IBD followed by a Phase 2/3 confirmatory adaptive design trial. As a result of the outbreak of the Hamas-Israel war, we anticipate a delay of six to nine months in the initiation
of the Phase 2 PSC study. As PSC is a fibro-obliterative cholangiopathy where
the disease progression is predominantly determined by biliary fibrosis, Aramchol meglumine has been shown to downregulate Stearoyl-CoA
desaturase 1 (SCD1), a key liver enzyme involved in lipid metabolism, attenuate fibrogenesis by hepatic stellate cells (HSCs). Aramchol
meglumine may have direct effects on cholangiocytes to reduce the production of fibrogenic and inflammatory signals that activate HSCs
suggesting that Aramchol meglumine may be beneficial in treating PSC.
The single-arm, open
label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with Aramchol meglumine in approximately 15
patients with PSC. The study’s endpoints will include the conventional relevant laboratory parameters (alkaline phosphatase and
bilirubin), sophisticated imaging including liver stiffness using MR Elastography (MRE), imaging of the biliary tract using MR cholangiopancreatography
(MRCP) and hepatocyte-specific contrast agents, histological fibrosis and molecular assessment as well as a range of biomarkers of disease
activity and fibrosis. These endpoints are expected to provide a robust assessment of the underlying disease and the effects of Aramchol.
In
addition, in May 2023, we entered into a definitive agreement, or the Agreement, for a $1.5 million equity investment in OnKai Inc.,
or OnKai, a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the
United States by facilitating alignment between healthcare stakeholders. The Agreement provides that we will invest $1.5 million in exchange
for series seed preferred shares of OnKai, or the Investment Round. Previously and in addition to the foregoing, on January 5, 2023 we
invested $1.5 million in OnKai through a Simple Agreement for Future Equity which will convert at a 15% discount into series seed preferred
shares upon closing of the Investment Round. The Agreement further provides that we shall have the right to appoint a member to OnKai’s
board of directors. On June 19, 2023, the Investment Round closed. Following the closing of the Investment Round, the Company holds
approximately 19% of the outstanding share capital of OnKai on an as-converted and fully diluted basis and the Company’s Chief
Executive Officer and director, Allen Baharaff serves as a board member of OnKai. In connection with the Agreement, our wholly-owned subsidiary, Galmed Research and
Development Ltd., or GRD, entered into a services agreement, or the Services Agreement, with OnKai. The Services Agreement provides that
GRD shall on a non-exclusive basis (i) provide support services to OnKai relating to finance, business development, strategic planning,
execution and others; and (ii) lend its experience to OnKai in building a strategy and for the development of treatments for the underserved
and that OnKai shall on a non-exclusive basis (i) take part in plan preparation to serve GDR’s vision of developing drugs for the
underserved population and (ii) when relevant, design a process on the clinical trial dashboard that could potentially serve GDR’s
future trial.
In July 2023,
we announced that OnKai will apply its artificial intelligence models for enrollment and execution of clinical trials in underserved
communities, starting with our PSC clinical program.
In
view of our initiation of our PSC clinical program and our investment and collaboration with Onkai, we are no longer evaluating our strategic
alternatives.
Amended
Compensation Policy
On
May 30, 2023, the board of directors of the Company, upon recommendation of the remuneration committee, approved the adoption of the
amended compensation policy for the Company’s directors and officers, or the Amended Compensation Policy, as described in Proposal
No. 3 the Proxy Statement, which was attached as Exhibit 99.1 to the Company’s Report of Foreign Private Issuer on Form 6-K, furnished
to the Securities and Exchange Commission, on March 30, 2023, or the Proxy Statement.
The
Amended Compensation Policy was approved in accordance with the mechanism set forth in the Israeli Companies Law, 5759-1999, or
the Companies Law, which allows the board of directors to approve the compensation policy, notwithstanding the resolution of the general
meeting on May 11, 2023, provided that the remuneration committee and thereafter the board of directors have concluded, following further
and detailed discussion of the matter and for specified reasons, that such approval is in the Company’s best interests.
To
that end, the remuneration committee and our board of directors considered the results of the general meeting vote, details of the Amended
Compensation Policy and its alignment with the Company’s compensation philosophy and other relevant considerations, including the
fact that the Amended Compensation Policy is mainly based on the previous form of Company’s compensation policy and reflects certain
adjustments that derive from changes in applicable law and regulation, and while noting the important role of a compensation policy
in the corporate governance of an Israeli public company; and thereafter determined that the approval of the Amended Compensation Policy
is in the best interest of the Company. Accordingly, the Amended Compensation Policy became effective on May 30, 2023, and shall remain
in effect for a period of three years according to the Companies Law, unless replaced prior. The material terms of the Amended Compensation
Policy are summarized in Proposal No. 3 to the Proxy Statement and the Amended Compensation Policy is attached to the registration statement
of which this prospectus forms a part as Exhibit 10.8.
Recent Developments Affecting Our Business
In October
2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along
Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of
deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s
security cabinet declared war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in
parallel to their continued rocket and terror attacks. While our executive offices are located in Tel Aviv, Israel, which is not
near Israel’s borders where the main hostilities are currently taking place and none of our employees have been called into
military reserve duty, to help mitigate the effects of Israel’s war with Hamas, we have taken several measures, including
work-from-home measures and have a business continuity plan. Nevertheless, we experienced disruptions to our work and over the past
few weeks have been returning to full activity together with our local vendors and consultants. As a result, we expect the
commencement of our Phase 2 PSC study to be delayed by six to nine months. It is still too early to assess the full impact of
Israel’s war against Hamas on our business and operations. See also Risk Factors – “Security,
political and economic instability in the Middle East may harm our business”.
Corporate
Information
Our
principal executive offices and registered office in Israel are located at 16 Tiomkin Street, Tel Aviv, Israel, 6578317 and our telephone
number is +972-3-693-8448. Our website address is http://www.galmedpharma.com. The information contained on, or that can be accessed
through, our website is neither a part of nor incorporated into this prospectus. We have included our website address in this prospectus
solely as an inactive textual reference. Puglisi & Associates, or Puglisi, serves as our authorized representative in the United
States for certain limited matters. Puglisi’s address is 850 Library Avenue, Newark, Delaware 19711.
Implications
of Being a Foreign Private Issuer
We
are subject to the information reporting requirements of the Exchange Act that are applicable to “foreign private issuers,”
and under those requirements we will file reports with the United States Securities and Exchange Commission, or SEC. As a foreign private
issuer, we are not subject to the same requirements that are imposed upon U.S. domestic issuers by the SEC. Under the Exchange Act, we
are subject to reporting obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting
companies. For example, although we report our financial results on a quarterly basis, we will not be required to issue quarterly reports,
proxy statements that comply with the requirements applicable to U.S. domestic reporting companies, or individual executive compensation
information that is as detailed as that required of U.S. domestic reporting companies. We also have four months after the end of each
fiscal year to file our annual reports with the SEC and are not required to file current reports as frequently or promptly as U.S. domestic
reporting companies. Furthermore, although the members of our management and supervisory boards will be required to notify the Israeli
Securities Authority, of certain transactions they may undertake, including with respect to our ordinary shares, our officers, directors
and principal shareholders will be exempt from the requirements to report transactions in our equity securities and from the short-swing
profit liability provisions contained in Section 16 of the Exchange Act. As a foreign private issuer, we are also not subject to the
requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. In addition, as a foreign private issuer, we are
permitted, and follow certain home country corporate governance practices instead of those otherwise required under the listing rules
of Nasdaq for domestic U.S. issuers. These exemptions and leniencies reduce the frequency and scope of information and protections available
to you in comparison to those applicable to a U.S. domestic reporting companies.
We
may take advantage of these exemptions until such time as we are no longer a foreign private issuer. We would cease to be a foreign private
issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances
applies: (i) the majority of our executive officers or directors are U.S. citizens or residents; (ii) more than 50% of our assets are
located in the United States; or (iii) our business is administered principally in the United States.
Foreign
private issuers are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we remain a foreign
private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither
an emerging growth company nor a foreign private issuer.
Summary
of the Offering
Ordinary
Shares to be offered |
|
Up
to 9,053,000 Ordinary Shares consisting of (i) 3.285,000 ordinary shares issuable upon the exercise of the Pre-Funded Warrants, (ii)
5,600,000 ordinary shares issuable upon the exercise of the Common Warrants and (iii) 168,000 ordinary shares issuable upon
the exercise of the Placement Agent Warrants. |
|
|
|
Pre-funded
warrants |
|
The
Pre-Funded Warrants have an exercise price of
$0.001 per ordinary share. The Pre-Funded Warrants are immediately exercisable (subject to the beneficial ownership
cap) and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. We are also registering
the ordinary shares issuable from time to time upon the exercise of the Pre-Funded Warrants and Common Warrants
offered hereby. See “Description of the Offered Securities” for more information. |
|
|
|
Common
Warrants |
|
Each
Common Warrant has an exercise price per ordinary share equal to $1.25 and expires on July 18, 2028. See “Description
of the Offered Securities” for more information. |
|
|
|
Placement
Agent Warrants |
|
The
Placement Agent Warrants have an exercise price of $1.5625 per ordinary share. The Representative’s Warrants are exercisable
after July 14, 2023, and expire on July 14, 2028. See “Description of the Offered Securities” for more information. |
|
|
|
Ordinary
shares outstanding after this offering |
|
13,059,832
ordinary shares (assuming the exercise in full
of the Warrants). |
|
|
|
Use
of proceeds |
|
In
the event of full exercise for cash of all of the Warrants that remain outstanding, we will receive gross proceeds of approximately
$7.3 million. |
|
|
|
|
|
We
currently intend to use the net proceeds from the exercise of the Warrants for continued development of our pipeline
products, as well as the advancement of new programs, business development activities, and general corporate purposes. We have not
determined the amount of net proceeds to be used specifically for such purposes. As a result, our management will have broad
discretion in the application of the net proceeds from the exercise of the Warrants. See “Use of Proceeds” for
additional information. |
|
|
|
Risk
factors |
|
Investing
in our securities involves a high degree of risk. You should read the “Risk Factors” section starting on page 5 of this
prospectus and “Item 3. – Key Information – D. Risk Factors” in our Annual Report on Form 20-F for the fiscal
year ended December 31, 2022, or the 2022 Annual Report, incorporated by reference herein, and other information included or incorporated
by reference in this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities. |
|
|
|
Nasdaq
Capital Market symbol |
|
“GLMD” |
The
number of the ordinary shares to be issued and outstanding immediately after this offering as shown above assumes that all of the ordinary
shares offered hereby are sold and is based on 4,006,832 ordinary shares issued and outstanding as of November 21, 2023. This
number excludes:
|
● |
248,664
ordinary
shares issuable upon exercise of outstanding stock options under our equity incentive plan,
at a weighted average exercise price of $37.5;
|
|
|
|
|
● |
1,390,000
ordinary shares issuable upon exercise of outstanding restricted shares units (RSU’s) under our equity incentive plan; and
|
|
|
|
|
● |
361,336
ordinary shares reserved for future awards under
our equity incentive plan. |
Unless
otherwise indicated, all information in this prospectus assumes or gives effect to:
|
● |
no
exercise of the options described above; and |
|
|
|
|
● |
the
reverse share split effected on May 15, 2023. |
RISK
FACTORS
You
should carefully consider the risks described below and the risks described in our 2022 Annual Report, which are incorporated by reference
herein, as well as the financial or other information included in this prospectus or incorporated by reference in this prospectus, including
our consolidated financial statements and the related notes, before you decide to buy our securities. The risks and uncertainties described
below are not the only risks facing us. We may face additional risks and uncertainties not currently known to us or that we currently
deem to be immaterial. Any of the risks described below, and any such additional risks, could materially adversely affect our business,
financial condition or results of operations. In such case, you may lose all or part of your original investment.
Risks
Related to an Investment in Our Securities and this Offering
There
is no public market for the pre-funded warrants or the common warrants being offered in this offering.
There
is no established public trading market for the pre-funded warrants or the common warrants being offered in this offering, and
we do not expect a market to develop. In addition, we do not intend to apply to list the pre-funded warrants or the common warrants
on any securities exchange or nationally recognized trading system. Without an active market, the liquidity of the pre-funded warrants
and the common warrants will be limited.
Holders
of our pre-funded warrants or the common warrants will have no rights as holders of ordinary shares until such warrants are exercised.
Until
you acquire ordinary shares upon exercise of your pre-funded warrants or the common warrants, you will have no rights with respect
to ordinary shares issuable upon exercise of your pre-funded warrants or common warrants. Upon exercise of your pre-funded warrants
or common warrants, you will be entitled to exercise the rights of a holder of ordinary shares only as to matters for which the record
date occurs after the exercise date.
The
pre-funded warrants are speculative in nature.
The
pre-funded warrants offered hereby do not confer any rights of ownership of our ordinary shares on their holders, such as voting rights
or the right to receive dividends, but rather merely represent the right to acquire ordinary shares at a fixed price. Specifically, commencing
on the date of issuance, holders of the pre-funded warrants may acquire ordinary shares issuable upon exercise of such warrants at an
exercise price of $0.001 per ordinary share. Moreover, following this offering, the market value of the pre-funded warrants is uncertain,
and there can be no assurance that the market value of the pre-funded warrants will equal or exceed their public offering price.
The
common warrants may not have any value.
Each
common warrant has an exercise price per ordinary share equal to $1.25 (equal to 100% of the public offering price of ordinary shares
in this offering) and expires on the fifth anniversary of its original issuance date. In the event the market price per our ordinary
share does not exceed the exercise price of the common warrants during the period when the warrants are exercisable, the common warrants
may not have any value.
Security,
political and economic instability in the Middle East may harm our business.
Our
executive office is located in Tel Aviv, Israel. In addition, certain of our key employees, officers and directors are residents of
Israel. Accordingly, political, economic and military conditions in the Middle East may affect our business directly. 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, including Hamas (an Islamist militia and political group in the Gaza Strip) and
Hezbollah (an Islamist militia and political group in Lebanon).
In
particular, in October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of
attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers
located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands
of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s security
cabinet declared war against Hamas and commenced a military campaign against Hamas and these terrorist organizations in parallel continued
rocket and terror attacks. While our executive offices are located in Tel Aviv, Israel, which is not near Israel’s borders where the main
hostilities are currently taking place and none of our employees have been called into military reserve duty, to help mitigate the effects
of Israel’s war with Hamas, we have taken several measures, including work-from-home measures and have a business continuity plan.
Nevertheless, we experienced disruptions to our work and over the past few weeks have been returning to full activity together with our
local vendors and consultants. As a result, we expect the commencement of our Phase 2 PSC study to be delayed by six to nine months.
Further disruptions that could
severely impact our business, clinical trials, and supply chains, include:
|
● |
limitations
on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups
in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees
and external partners; |
|
|
|
|
● |
delays
in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee
resources; and |
|
|
|
|
● |
impacts
from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans. |
In
addition, the current war between Israel and Hamas has had and may continue to impact the Israeli economy and the trading price of shares
of our ordinary shares and could impact our ability to raise additional capital on a timely basis or at all. The current war between
Israel and Hamas continues to rapidly evolve. The extent to which the current war between Israel and Hamas may impact our operations
will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of or an
escalation the war, a deterioration of the security situation in Israel and additional military reserve duty call-ups in the future.
The impact of the current war between Israel and Hamas may also have the effect of heightening many of the other risks described in this
section and in the “Risk Factors” section of our 2022 Annual Report.
Additionally,
political uprisings, social unrest and violence in various countries in the Middle East, including Israel’s neighbor Syria, have
affected the political stability of those countries. This instability may lead to deterioration of the political relationships that exist
between Israel and certain countries and have raised concerns regarding security in the region and the potential for armed conflict.
In addition, Iran has threatened to attack Israel. Iran is also believed to have a strong influence among the Syrian government, Hamas
and Hezbollah. These situations may potentially escalate in the future into more violent events which may affect Israel and us. These
situations, including conflicts which involved missile strikes against civilian targets in various parts of Israel have in the past negatively
affected business conditions in Israel.
Any
hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have a
material adverse effect on our business. The political and security situation in Israel may result in parties with whom we have contracts
claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions. These
or other Israeli political or economic factors could harm our operations and product development. Any hostilities involving Israel or
the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations and could
make it more difficult for us to raise capital. We could experience disruptions if acts associated with such conflicts result in any
serious damage to our facilities. Furthermore, several countries, as well as certain companies and organizations, continue to restrict
business with Israel and Israeli companies, which could have an adverse effect on our business and financial condition. Our business
interruption insurance may not adequately compensate us for losses, if at all, that may occur as a result of an event associated with
a security situation in the Middle East, and any losses or damages incurred by us could have a material adverse effect on our business.
If
we are unable for any reason to meet the continued listing requirements of Nasdaq, such action or inaction could result in a delisting
of the Ordinary Shares.
On
September 22, 2023, we announced that it received an initial notification letter from Nasdaq’s Listing Qualifications Department
notifying us that we had 180 days to regain compliance with the minimum bid price requirement set forth in Nasdaq’s continued listing
rules. Nasdaq’s continued listing rules require that listed securities maintain a minimum bid price of $1.00 per share, and that
a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days or
more. We have until March 18, 2024, to regain compliance with the minimum bid price requirement in order to maintain the listing. To
regain compliance with the minimum bid price requirement, our ordinary shares must have a closing bid price of at least $1.00 for a minimum
of 10 consecutive business days. In the event that we do not regain compliance by March 18, 2024, we may then be eligible for additional
180 days if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards
for the Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of our intention
to cure the deficiency during the second compliance period. If we do not qualify for the second compliance period or fail to regain compliance
during the second compliance period, then Nasdaq will notify us of its determination to delist our ordinary shares, at which point we
will have an opportunity to appeal the delisting determination to a hearings panel.
If
we fail to satisfy the continued listing requirements of Nasdaq, such as the minimum closing bid price requirement, Nasdaq may take steps
to delist our ordinary shares. Such a delisting would likely have a negative effect on the price of our ordinary shares and would impair
your ability to sell or purchase our ordinary shares when you wish to do so. In the event of a delisting, we can provide no assurance
that any action taken by us to restore compliance with listing requirements would allow our ordinary shares to become listed again, stabilize
the market price or improve the liquidity of our ordinary shares, prevent our ordinary shares from dropping below the Nasdaq minimum
bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and elsewhere, including in our 2022 Annual Report incorporated by reference herein, and other information included or incorporated
by reference in this prospectus, contains forward-looking statements concerning our expectations, beliefs or intentions regarding, among
other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. Any statements
contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,”
“contemplate,” “continue,” “could,” “due,” “estimate,” “expect,”
“goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,”
“positioned,” “seek,” “should,” “target,” “will,” “would,” and
other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other
comparable terminology. Many factors could cause our actual activities or results to differ materially from the activities and results
anticipated in forward-looking statements, including, but not limited to, the factors summarized below:
| ● | the
timing and cost of our planned PSC clinical trial and our pivotal Phase 3 ARMOR trial, or
the ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or
for any other pre-clinical or clinical trials; |
| | |
| ● | completion
and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if
re-initiated) for Aramchol or any other pre-clinical or clinical trial; |
| | |
| ● | regulatory
action with respect to Aramchol or any other product candidate by the U.S. Food and Drug
Administration or the European Medicines Authority, or EMA, including but not
limited to acceptance of an application for marketing authorization, review and approval
of such application, and, if approved, the scope of the approved indication and labeling; |
| | |
| ● | the
commercial launch and future sales of Aramchol and any future product candidates; |
| | |
| ● | our
ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER
or any other product candidate in the countries in which we seek to market the product; |
| | |
| ● | our
ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate; |
| | |
| ● | our
expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or
NASH, in patients or any other targeted indication; |
| | |
| ● | third-party
payor reimbursement for Aramchol, Amilo-5MER or any other product candidate; |
| | |
| ● | our
estimates regarding anticipated capital requirements and our needs for additional financing; |
| | |
| ● | market
adoption of Aramchol or any other product candidate by physicians and patients; |
| | |
| ● | the
timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; |
| | |
| ● | our
ability to obtain and maintain adequate protection of our intellectual property; |
| | |
| ● | the
possibility that we may face third-party claims of intellectual property infringement; |
| | |
| ● | our
ability to manufacture our product candidates in commercial quantities, at an adequate quality
or at an acceptable cost; |
| | |
| ● | our
ability to establish adequate sales, marketing and distribution channels; |
| ● | intense
competition in our industry, with competitors having substantially greater financial, technological,
research and development, regulatory and clinical, manufacturing, marketing and sales, distribution
and personnel resources than we do; |
| | |
| ● | the
development and approval of the use of Aramchol or any other product candidate for additional
indications or in combination therapy; |
| | |
| ● | our
expectations regarding licensing, acquisitions and strategic operations; |
| | |
| ● | current
or future unfavorable economic and market conditions and adverse developments with respect
to financial institutions and associated liquidity risk; |
| | |
| ● | our
ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; |
| | |
| ● | security,
political and economic instability in the Middle East that could harm our business, including
due to the current war between Israel and Hamas; and |
| | |
| ● | those
factors referred to in our 2022 Annual Report incorporated by reference herein in “Item
3. Key Information – D. Risk Factors,” “Item 4. Information on the
Company,” and “Item 5. Operating and Financial Review and Prospects,” as
well as in our 2022 Annual Report generally, which is incorporated by reference into this
prospectus. |
Forward-looking
statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the
industry in which we operate and our management’s beliefs and assumptions, and are not guarantees of future performance or development
and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all
of our forward-looking statements in this prospectus may turn out to be inaccurate. Important factors that may cause actual results to
differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere
in this prospectus. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements.
The
forward-looking statements included in this prospectus speak only as of the date of this prospectus. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance
and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Except as required by law, we
assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in
the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC
after the date of this prospectus. See “Where You Can Find More Information.”
USE
OF PROCEEDS
In the event of full exercise
for cash of all of the Warrants that remain outstanding, we will receive gross proceeds of approximately $7.3 million.
We currently intend to use the
net proceeds from the exercise of the Warrants for continued development of our pipeline products, as well as the advancement
of new programs, business development activities, and general corporate purposes. Although we have identified some potential uses of
the net proceeds to be received upon the exercise of the Warrants, we cannot specify these uses with certainty. Our management
will have broad discretion in the application of the net proceeds from the exercise of the Warrants and could use them for purposes
other than those contemplated at the time as of the date of this prospectus. Our shareholders may not agree with the manner in
which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate
purposes that may not result in our being profitable or increase our market value.
Pending
the use of the net proceeds from the exercise of the Warrants as described above, we intend to invest the net proceeds in a variety
of capital preservation investments, short and intermediate term, interest-bearing, investment-grade instruments, U.S. government securities
and highly rated corporate debt securities, although our investment policy may change following the date of this prospectus supplement.
It is possible that, pending their use, we may invest the net proceeds in a way that does not yield a favorable, or any, return for us.
DIVIDEND
POLICY
Dividends
may be distributed only out of profits available for dividends as determined by the Companies Law provided that the board of
directors determines that there is no reasonable concern that the distribution will prevent the Company from being able to meet its
existing and anticipated obligations when they become due. Under the Companies Law, the distribution amount is further limited to
the greater of retained earnings or earnings generated over the two most recent years legally available for distribution according
to the Company’s last reviewed or audited financial statements, provided that the end of the period to which the financial
statements relate is not more than six months prior to the date of distribution. In the event that we do not meet such criteria, we
may seek the approval of the court in order to distribute a dividend. The court may approve our request if it is convinced that
there is no reasonable concern that the payment of a dividend will prevent us from satisfying our existing and foreseeable
obligations as they become due.
Generally,
under the Companies Law, the decision to distribute dividends and the amount to be distributed is made by a company’s board of
directors. Our Articles of Association, or the Articles, provide that the board of directors may from time to time declare, and cause
the Company to pay, such dividends as may appear to it to be justified by the profits of the Company and that the board of directors
has the authority to determine the time for payment of such dividends and the record date for determining the shareholders entitled to
receive such dividends, provided the date is not before the date of the resolution to distribute the dividend. Declaration of dividends
does not require shareholder approval.
Pursuant
to our Articles, subject to the rights of holders of shares with limited or preferred rights, ordinary shares shall confer upon the holders
thereof equal rights to receive dividends and to participate in the distribution of the assets of the Company upon its winding-up, in
proportion to the amount paid up or credited as paid up on account of the nominal value of the shares held by them respectively and in
respect of which such dividends are being paid or such distribution is being made, without regard to any premium paid in excess of the
nominal value, if any.
We
have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends in the foreseeable
future. Payment of cash dividends, if any, in the future will be at the discretion of our Board and will depend on then-existing conditions,
including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors
our Board may deem relevant.
Payment
of dividends may also be subject to Israeli withholding taxes. See “Taxation — Israeli Tax Considerations” in the 2022
Annual Report for additional information.
CAPITALIZATION
The following table sets forth our total capitalization
as of September 30, 2023, on an actual basis:
The
information in this table should be read in conjunction with and is qualified by reference to the financial statements and notes thereto
and other financial information incorporated by reference into this prospectus.
| |
As
of September 30, 2023 (unaudited) | |
(U.S. dollars in thousands) | |
Actual | |
Cash and cash equivalents | |
$ | 1,482 | |
| |
| | |
Shareholders’ equity: | |
| | |
Ordinary shares par value NIS 0.15 per share; authorized 20,000,000; issued and outstanding 4,006,832 ordinary
shares | |
| 166 | |
Additional paid in capital | |
| 206,924 | |
Accumulated other comprehensive loss | |
| (607 | ) |
Accumulated deficit | |
| (190,936 | ) |
| |
| | |
Total shareholders’ equity | |
| 15,457 | |
The
number of the ordinary shares to be issued and outstanding immediately after this offering as shown above assumes that all of the ordinary
shares offered hereby are sold and the pre-funded warrants are exercised in full, and is based on 4,006,832 ordinary shares issued
and outstanding as of September 30, 2023. This number excludes:
|
● |
248,664
ordinary shares issuable upon exercise of outstanding
stock options under our equity incentive plan, at a weighted average exercise price of $37.5; |
|
|
|
|
● |
1,315,000 ordinary shares issuable
upon the exercise of outstanding restricted share units under our equity incentive plan; |
|
|
|
|
● |
3,285,000 ordinary shares issuable upon the exercise
of pre-funded warrants issued in our July 2023 financing; |
|
|
|
|
● |
5,600,000 ordinary shares issuable upon the exercise
of common warrants issued in our July 2023 financing; |
|
|
|
|
● |
168,000 ordinary shares issuable upon the exercise of
placement agent warrants issued in our July 2023 financing; and |
|
|
|
|
● |
436,336
ordinary shares reserved for future awards under
our equity incentive plan. |
DESCRIPTION
OF SHARE CAPITAL
General
The
registered share capital of the Company is NIS 3,000,000 divided into 20,000,000 ordinary shares, NIS 0.15 par value per share.
The
Nasdaq Capital Market
Our
ordinary shares are listed on the Nasdaq Capital Market under the symbol “GLMD”.
Memorandum
and Articles of Association
Our
registration number is 51-495351-2. Under Section 2 of our Articles, the purpose of the Company is to engage in any lawful activity.
Election
of Directors
Our
Board of Directors, or the Board, consists of three classes of directors, with one class being elected each year by shareholders
at the Company’s annual general meeting for a term of approximately three years. In accordance with our Articles, directors so
elected cannot be removed from office by the shareholders until the expiration of their term of office or until their office is vacated
in accordance with our Articles or the Companies Law. Ordinary shares do not have cumulative voting rights. As a result, the holders
of ordinary shares that represent a simple majority of the voting power represented at a shareholders’ meeting and voting at the
meeting have the power to elect all of the directors put forward for election.
Under
our Articles, a director shall vacate his or her office if that director dies; is declared bankrupt; is declared to be legally incompetent;
resigns such office by notice in writing given to the Company; is not re-elected by the shareholders upon expiration of his or her term
at the relevant annual general meeting of shareholders; or otherwise as provided in the Companies Law.
Our
Articles provide that a director may, by written notice to the Company, appoint another person to serve as an alternate director provided
that such appointment is approved by a majority of the directors then in office, and that such appointing director may remove such alternate
director. Any alternate director shall be entitled to notice of meetings of the Board and of relevant committees and to attend and vote
accordingly, except that the alternate has no standing at any meeting at which the appointing director is present or at which the appointing
director is not entitled to participate as provided in the Companies Law. A person who is not qualified to be appointed as a director,
or a person who already serves as a director or an alternate director, may not be appointed as an alternate director.
Unless
the appointing director limits the time or scope of the appointment, the appointment is effective for all purposes until the earlier
of (i) the appointing director ceasing to be a director; (ii) the appointing director terminating the appointment; or (iii) the occurrence,
with respect to the alternate, of any of the circumstances under which a director shall vacate his or her office. The appointment of
an alternate director does not in itself diminish the responsibility of the appointing director as a director. An alternate director
is solely responsible for his or her actions and omissions and is not deemed an agent of the appointing director. At present, there are
no effective appointments of alternate directors for our Board.
Borrowing
Powers
Our
Board may from time to time, and at its reasonable discretion, borrow or secure the payment of any sum or sums of money for reasonable
Company purposes. The directors may raise or secure the repayment of such sum or sums in such manner, at such times and upon such terms
and conditions in all respects as they see fit and, in particular, by issuing bonds, perpetual or redeemable debentures, debenture stock
or any mortgages, charges or other securities on the undertaking of the whole or any part of the property of the Company, both present
and future, including current uncalled capital and called but unpaid capital.
Fiduciary
Duties of Directors and Executive Officers
The
Companies Law codifies the fiduciary duties that Office Holders (as defined in the Companies Law) owe to a company.
An
Office Holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an Office Holder to
act with the level of care with which a reasonable Office Holder in the same position would have acted under the same circumstances.
The duty of loyalty requires that an Office Holder act in good faith and in the best interests of a company. The duty of care includes
a duty to use reasonable means to obtain:
|
● |
information
on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and |
|
|
|
|
● |
all
other important information pertaining to these actions. |
The
duty of loyalty requires an Office Holder to act in good faith and for the benefit of a company, and includes a duty to:
|
● |
refrain
from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal
affairs; |
|
|
|
|
● |
refrain
from any activity that is competitive with the company; |
|
|
|
|
● |
refrain
from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and |
|
|
|
|
● |
disclose
to the company any information or documents relating to the company’s affairs which the Office Holder received as a result
of his or her position as an Office Holder. |
Disclosure
of Personal Interests of an Office Holder
The
Companies Law requires that an Office Holder promptly disclose to Company, and in any event no later than the board of directors
meeting at which the transaction is first discussed, any personal interest that he or she may have concerning any existing or
proposed transaction with a company, as well as any substantial information or document with respect thereof. An interested Office Holder’s
disclosure must be made promptly and, in any event, no later than the first meeting of the board of directors at which the transaction
is considered.
Under
the Companies Law, a “personal interest” includes an interest of any person in an action or transaction of a company, including
a personal interest of one’s relative or of a corporate body in which such person or a relative of such person is a 5% or greater
shareholder, director or general manager or in which he or she has the right to appoint at least one director or the general manager,
but excluding a personal interest stemming from one’s ownership of shares in a company. A personal interest furthermore includes
the personal interest of a person for whom the Office Holder holds a voting proxy or the interest of the Office Holder with respect to
his or her vote on behalf of the shareholder for whom he or she holds a proxy, even if such shareholder itself has no personal interest
in the approval of the matter. An Office Holder is not, however, obliged to disclose a personal interest if it derives solely from the
personal interest of a relative of such Office Holder in a transaction that is not considered an extraordinary transaction.
Under
the Companies Law, an extraordinary transaction is defined as any of the following:
|
● |
a
transaction other than in the ordinary course of business; |
|
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|
● |
a
transaction that is not on market terms; or |
|
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|
|
● |
a
transaction that may have a material impact on a company’s profitability, assets or liabilities. |
Approval
Procedure
If
an Office Holder has a personal interest in a transaction, approval by the board of directors is required for the transaction, unless
the articles of association of a company provide for a different method of approval. Our Articles do not provide for any such different
method of approval. Further, so long as an Office Holder has disclosed his or her personal interest in a transaction, the board of directors
may approve an action by the Office Holder that would otherwise be deemed a breach of the duty of loyalty. However, a company may not
approve a transaction or action that is adverse to such company’s interest or that is not performed by the Office Holder in good
faith. Approval first by a company’s audit committee and subsequently by the board of directors is required for an extraordinary
transaction in which an Office Holder has a personal interest. Arrangements regarding the Office Holders’ terms of office and employment
(which includes compensation, indemnification or insurance) generally require the approval of the remuneration committee, board of directors
and, in certain circumstances, the shareholders, in that order, and must generally be consistent with the Company’s Amended Compensation
Policy.
Generally,
a person who has a personal interest in a matter which is considered at a meeting of the board of directors or the audit committee may
not be present at such a meeting or vote on that matter unless a majority of the directors or members of the audit committee have a personal
interest in the matter, or unless the chairman of the audit committee or board of directors (as applicable) determines that he or she
should be present in order to present the transaction that is subject to approval. Generally, if a majority of the members of the audit
committee and the board of directors (as applicable) has a personal interest in the approval of a transaction, then all directors may
participate in discussions of the audit committee and/or the board of directors on such transaction. In case a majority of the
members of the board of directors have personal interest in the matter discussed, the approval of such transaction will also
require shareholder approval.
Transactions
with Controlling Shareholders
Pursuant
to Israeli law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to
a controlling shareholder of a public company. In the context of a transaction involving a controlling shareholder or an officer who
is a controlling shareholder of a company, a controlling shareholder also includes any shareholder who holds 25% or more of the voting
rights if no other shareholder holds more than 50% of the voting rights. Two or more shareholders with a personal interest in the approval
of the same transaction are deemed to be a single shareholder and may be deemed a controlling shareholder for the purpose of approving
such transaction.
Extraordinary
transactions, including private placement transactions, with a controlling shareholder or in which a controlling shareholder has a personal
interest, and engagements with a controlling shareholder or his or her relative, directly or indirectly, including through a corporation
under his or her control, regarding the company’s receipt of services from the controlling shareholder, and if such controlling
shareholder is also an office holder or an employee of the company, regarding his or her terms of service or employment, require the
approval of the audit committee or remuneration committee, the board of directors and the shareholders of a company by a Special Majority,
in that order.
Arrangements
regarding the terms of office and employment of a controlling shareholder who is an Office Holder, and the terms of employment of a controlling
shareholder who is an employee of a company, require the approval of the remuneration committee, board of directors and the shareholders
by a Special Majority, in that order, with respect to Office Holders’ compensation.
To
the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval is required
once every three years, unless, with respect to extraordinary transactions with a controlling shareholder or in which a controlling shareholder
has a personal interest, the audit committee determines that the duration of the transaction is reasonable given the circumstances related
thereto.
Dividends
and Dividend Policy
Dividends
may be distributed only out of profits available for dividends as determined by the Companies Law, provided the board of directors determines
that that there is no reasonable concern that the distribution will prevent the Company from being able to meet its existing and anticipated
obligations when they become due. Under the Companies Law, the distribution amount is further limited to the greater of retained earnings
or earnings generated over the two most recent years legally available for distribution according to the Company’s last reviewed
or audited financial statements, provided that the end of the period to which the financial statements relate is not more than six months
prior to the date of distribution. In the event that we do not meet such criteria, we may seek the approval of the court in order to
distribute a dividend. The court may approve our request if it is convinced that there is no reasonable concern that the payment of a
dividend will prevent us from satisfying our existing and foreseeable obligations as they become due.
Generally,
under the Companies Law, the decision to distribute dividends and the amount to be distributed is made by a company’s board of
directors. The Articles provide that the Board may from time to time declare, and cause the Company to pay, such dividends as may appear
to it to be justified by the profits of the Company and that the Board has the authority to determine the time for payment of such dividends
and the record date for determining the shareholders entitled to receive such dividends, provided the date is not before the date of
the resolution to distribute the dividend. Declaration of dividends does not require shareholder approval.
Pursuant
to our Articles, subject to the rights of holders of shares with limited or preferred rights, ordinary shares shall confer upon the holders
thereof equal rights to receive dividends and to participate in the distribution of the assets of the Company upon its winding-up, in
proportion to the amount paid up or credited as paid up on account of the nominal value of the shares held by them respectively and in
respect of which such dividends are being paid or such distribution is being made, without regard to any premium paid in excess of the
nominal value, if any.
We
have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends in the foreseeable
future. Payment of cash dividends, if any, in the future will be at the discretion of our Board and will depend on then-existing conditions,
including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors
our Board may deem relevant.
Payment
of dividends may also be subject to Israeli withholding taxes.
Transfer
of Shares
Ordinary
shares which have been fully paid-up are transferable by submission of a proper instrument of transfer to the Company or its transfer
agent together with the certificate of the shares to be transferred and such other evidence, if any, as the directors may require to
prove the rights of the intending transferor in the transferred shares.
Our
ordinary shares that are fully paid for are issued in registered form and may be freely transferred under our Articles, unless the transfer
is restricted or prohibited by applicable law or the rules of a stock exchange on which the shares are traded. The ownership or voting
of our ordinary shares by non-residents of Israel is not restricted in any way by our Articles or the laws of the State of Israel, except
for ownership by nationals of some countries that are, or have been, declared as enemies of Israel.
Shareholder
Meetings
Our
Articles provide that an annual general meeting must be held at least once in every calendar year, not later than 15 months after the
last preceding annual general meeting, at such time and place as may be determined by the Board. The Board may, in its discretion, convene
additional shareholder meetings and, pursuant to the Companies Law, must convene a meeting upon the demand of two directors or one quarter
of the directors then in office or upon the demand of the holder or holders of 5% of the Company’s issued share capital and 1%
of its voting rights or upon the demand of the holder or holders of 5% of its voting rights. All demands for shareholder meetings must
set forth the items to be considered at that meeting. Pursuant to the Companies Law, the holder or holders of 1% of the Company’s
voting rights may request the inclusion of an item on the agenda of a future shareholder meeting, provided the item is appropriate for
discussion at a shareholder meeting.
The
agenda for a shareholder meeting is determined by the Board and must include matters in respect of which the convening of a shareholder
meeting was demanded and any matter requested to be included by holder(s) of 1% of the Company’s voting rights. According to regulations
promulgated pursuant to the Companies Law and governing the terms of notice and publication of shareholder meetings of public companies,
or the General Meeting Regulations, holder(s) of one percent or more of the Company’s voting rights may propose any matter appropriate
for deliberation at a shareholder meeting to be included on the agenda of a shareholder meeting, generally by submitting a proposal within
seven days of publicizing the convening of a shareholder meeting, or, if the Company publishes a preliminary notice at least 21 days
prior to publicizing the convening of a meeting (stating its intention to convene such meeting and the agenda thereof), within 14 days
of such preliminary notice. Any such proposal must further comply with the information requirements under applicable law and the Articles.
Pursuant
to the Companies Law and regulations promulgated thereunder with respect to the convening of general meetings in a public company, shareholder
meetings generally require prior notice of not less than 21 days, and for certain matters specified in the Companies Law, not less than
35 days. The function of the annual general meeting is to elect directors in accordance with the Articles, receive and consider the profit
and loss account, the balance sheet and the ordinary reports and accounts of the directors and auditors, appoint auditors and fix their
remuneration and transact any other business which under the Articles or applicable law may be transacted by the shareholders of a company
in general meeting. Under the Companies Law and our Articles, shareholders are not permitted to take action by way of written consent
in lieu of a meeting.
Our
Articles determine that the quorum required for either an annual (regular) or an extraordinary (special) general meeting of shareholders
consists of at least two shareholders present in person or by proxy holding shares comprising in the aggregate more than 33.33% of the
voting rights of the Company. If a meeting is convened by the Board upon the demand of shareholders or upon the demand of less than 50%
of the directors then in office or directly by such shareholders or directors and no quorum is present within half an hour from the time
appointed, it shall be cancelled. If a meeting is otherwise called and no quorum is present within such time, the meeting is adjourned
to the same day one week later at the same time and place or at such other time and place as the Board may determine and specify in the
notice of the general meeting and it shall not be necessary to give notice of such adjournment. If a quorum is not present within half
an hour from the time stated for such adjourned meeting, any two shareholders present in person or by proxy at such meeting shall constitute
a quorum even if, between them, they represent shares conferring 33.33% or less of the voting rights of the Company.
Generally,
under the Companies Law and the Articles, shareholder resolutions are deemed adopted if approved by the holders of a simple majority
of the voting rights represented at a meeting and voting unless a different majority is required by law or pursuant to the Articles.
The Companies Law provides that resolutions on certain matters, such as amending a company’s articles of association, assuming
the authority of the board of directors in certain circumstances, appointing auditors, appointing external directors (if applicable),
approving certain transactions, increasing or decreasing the registered share capital and approving most mergers must be made by the
shareholders at a general meeting. A company may determine in its articles of association certain additional matters in respect of which
resolutions by the shareholders in a general meeting will be required.
Access
to Corporate Records
Under
the Companies Law, all shareholders generally have the right to review minutes of our general meetings, our shareholder register and
register of significant shareholders (as defined in the Companies Law), our Articles, our financial statements, other documents as provided
in the Companies Law, and any document we are required by law to file publicly with the Israeli Companies Registrar. Any shareholder
who specifies the purpose of its request may request to review any document in our possession that relates to: (i) any action or transaction
with a related party which requires shareholder approval under the Companies Law; or (ii) the approval, by the board of directors, of
an action in which an office holder has a personal interest. We may deny a request to review a document if we determine that the request
was not made in good faith, or if such denial is necessary to protect our interest or protect a trade secret or patent.
Shareholder
Duties
Pursuant
to the Companies Law, a shareholder has a duty to act in good faith and in a customary manner toward a company and other shareholders
and to refrain from abusing his or her power in the company, including, among other things, in voting at the general meeting of shareholders
and at class shareholder meetings with respect to the following matters:
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an
amendment to the company’s articles of association; |
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an
increase of the company’s authorized share capital; |
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a
merger; or |
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approval
of interested party transactions and acts of Office Holders that require shareholder approval. |
In
addition, a shareholder also has a general duty to refrain from discriminating against other shareholders.
Certain
shareholders have a further duty of fairness toward a company. These shareholders include any controlling shareholder, any shareholder
who knows that it has the power to determine the outcome of a shareholder vote or a shareholder class vote and any shareholder who has
the power to appoint or to prevent the appointment of an Office Holder of the company or other power towards the company. The Companies
Law does not define the substance of this duty of fairness, except to state that the remedies generally available upon a breach of contract
will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position in the company into
account.
Mergers
and Acquisitions under Israeli Law
(U)
Merger
The
Companies Law permits merger transactions if approved by each party’s board of directors, and, unless certain requirements described
under the Companies Law are met, a majority of each party’s shareholders, by a majority of each party’s shares that are voted
on the proposed merger at a shareholders’ meeting.
The
board of directors of a merging company is required pursuant to the Companies Law to discuss and determine whether in its opinion there
exists a reasonable concern that as a result of a proposed merger, the surviving company will not be able to satisfy its obligations
towards its creditors, taking into account the financial condition of the merging companies. If the board of directors has determined
that such a concern exists, it may not approve a proposed merger. Following the approval of the board of directors of each of the merging
companies, the boards of directors must jointly prepare a merger proposal for submission to the Israeli Registrar of Companies.
For
purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares
voting at the shareholders meeting (excluding abstentions) that are held by parties other than the other party to the merger, any person
who holds 25% or more of the means of control of the other party to the merger or any one on their behalf including their relatives or
corporations controlled by any of them, vote against the merger. In addition, if the non-surviving entity of the merger has more than
one class of shares, the merger must be approved by each class of shareholders.
If
the transaction would have been approved but for the separate approval of each class of shares or the exclusion of the votes of certain
shareholders as provided above, a court may still rule that the company has approved the merger upon the request of holders of at least
25% of the voting rights of a company, if the court holds that the merger is fair and reasonable, taking into account the appraisal of
the merging companies’ value and the consideration offered to the shareholders.
Under
the Companies Law, each merging company must send a copy of the proposed merger plan to its secured creditors. Unsecured creditors are
entitled to receive notice of the merger, as provided by the regulations promulgated under the Companies Law. Upon the request of a creditor
of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern
that, as a result of the merger, the surviving company will be unable to satisfy the obligations of the target company. The court may
also give instructions in order to secure the rights of creditors.
In
addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger
was filed with the Israeli Registrar of Companies and 30 days from the date that shareholder approval of both merging companies was obtained.
(ii)
Special Tender Offer
The
Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if
as a result of the acquisition the purchaser would become a holder of 25% or more of the voting rights in the company. This rule does
not apply if there is already another holder of 25% or more of the voting rights in the company. Similarly, the Companies Law provides
that an acquisition of shares in a public company must be made by means of a special tender offer if as a result of the acquisition the
purchaser would become a holder of more than 45% of the voting rights in the company, if there is no other shareholder of the company
who holds more than 45% of the voting rights in the company.
These
requirements do not apply if the acquisition (i) occurs in the context of a private offering, on the condition that the shareholders’
meeting approved the acquisition as a private offering whose purpose is to give the acquirer at least 25% of the voting rights in the
company if there is no person who holds at least 25% of the voting rights in the company, or as a private offering whose purpose is to
give the acquirer 45% of the voting rights in the company, if there is no person who holds 45% of the voting rights in the company; (ii)
was from a shareholder holding at least 25% of the voting rights in the company and resulted in the acquirer becoming a holder of at
least 25% of the voting rights in the company; or (iii) was from a holder of more than 45% of the voting rights in the company and resulted
in the acquirer becoming a holder of more than 45% of the voting rights in the company.
The
special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s outstanding shares
will be acquired by the offeror and (ii) the special tender offer is accepted by a majority of the votes of those offerees who gave notice
of their position in respect of the offer; in counting the votes of offerees, the votes of a holder of control in the offeror, a person
who has personal interest in acceptance of the special tender offer, a holder of at least 25% of the voting rights in the company, or
any person acting on their or on the offeror’s behalf, including their relatives or companies under their control, are not taken
into account.
In
the event that a special tender offer is made, a company’s board of directors is required to express its opinion on the advisability
of the offer or shall abstain from expressing any opinion if it is unable to do so, provided that it gives the reasons for its abstention.
In addition, the board of directors must disclose any personal interest each of member of the board of directors have in the offer or
stems therefrom.
An
office holder in a target company who, in his or her capacity as an office holder, performs an action the purpose of which is to cause
the failure of an existing or foreseeable special tender offer or is to impair the chances of its acceptance, is liable to the potential
purchaser and shareholders for damages resulting from his acts, unless such office holder acted in good faith and had reasonable grounds
to believe he or she was acting for the benefit of the company. However, office holders of the target company may negotiate with the
potential purchaser in order to improve the terms of the special tender offer, and may further negotiate with third parties in order
to obtain a competing offer.
If
a special tender offer was accepted by a majority of the shareholders who announced their stand on such offer, then shareholders who
did not respond to the special offer or had objected to the special tender offer may accept the offer within four days of the last day
set for the acceptance of the offer. In the event that a special tender offer is accepted, then the purchaser or any person or entity
controlling it and any corporation controlled by them shall refrain from making a subsequent tender offer for the purchase of shares
of the target company and may not execute a merger with the target company for a period of one year from the date of the offer, unless
the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender offer.
(iii)
Full Tender Offer
Under
the Companies Law, a person may not acquire shares in a public company if, after the acquisition, he will hold more than 90% of the shares
or more than 90% of any class of shares of that company, unless a tender offer is made to purchase all of the shares or all of the shares
of the particular class. The Companies Law also provides, subject to certain exceptions, that as long as a shareholder in a public company
holds more than 90% of the company’s shares or of a class of shares, that shareholder shall be precluded from purchasing any additional
shares unless tendering an offer to purchase all of the outstanding shares of the company or the applicable class of the shares. If the
shareholders who do not respond to or accept the offer hold less than 5% of the issued and outstanding share capital of the company or
of the applicable class of the shares, and more than half of the shareholders who do not have a personal interest in the offer accept
the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However,
a tender offer will be accepted if the shareholders who do not accept it hold less than 2% of the issued and outstanding share capital
of the company or of the applicable class of the shares.
Upon
a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder
accepted the tender offer or not, has the right, within six months from the date of acceptance of the tender offer, to petition the court
to determine that the tender offer was for less than fair value and that the fair value should be paid as determined by the court. However,
under certain conditions, the purchaser may provide in its offer that an offeree who accepted the tender offer will not be entitled to
such rights.
If
the conditions set forth above are not met, the purchaser may not acquire additional shares of the company from shareholders who accepted
the tender offer to the extent that following such acquisition, the purchaser would own more than 90% of the company’s issued and
outstanding share capital.
Anti-Takeover
Measures under Israeli Law
The
Companies Law allows us to create and issue shares having rights different from those attached to our ordinary shares, including shares
providing certain preferred rights, distributions or other matters and shares having preemptive rights. As of the date hereof, no preferred
shares are authorized under our Articles. In the future, if we do authorize, create and issue a specific class of preferred shares, such
class of shares, depending on the specific rights that may be attached to it, may have the ability to frustrate or prevent a takeover
or otherwise prevent our shareholders from realizing a potential premium over the market value of their ordinary shares. The authorization
and designation of a class of preferred shares will require an amendment to our Articles, which requires the affirmative vote of at least
75% of the voting rights of the Company represented personally or by proxy and voting thereon at a general meeting at which a quorum
is present. The convening of the general meeting, the shareholders entitled to participate and the majority vote required to be obtained
at such a meeting will be subject to the requirements set forth in the Articles and the Companies Law as described above in “—
Shareholder Meetings.”
In
addition, certain provisions of the Articles may have the effect of rendering more difficult or discouraging an acquisition of the Company
deemed undesirable by the Board. The classification of the Board into three classes with terms of approximately three years each, may
make it more difficult for shareholders who oppose the policies of the Board to remove a majority of the then current directors from
office quickly. It may also, in some circumstances, together with the other provisions of the Articles and Israeli law, deter or delay
potential future merger, acquisition, tender or takeover offers, proxy contests or changes in control or management of the Company.
Changes
in Capital
Our
Articles enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the Companies Law and must
be approved by a resolution duly passed by our shareholders at a general meeting by voting on such change in the capital. In addition,
transactions that have the effect of reducing capital, such as the declaration and payment of dividends in the absence of sufficient
retained earnings or profits and an issuance of shares for less than their nominal value (under certain circumstances), require the approval
of both our Board and an Israeli court.
Changes
in Shareholder Rights
Pursuant
to our Articles, if at any time the share capital is divided into different classes of shares, the Company may by shareholder resolution,
unless otherwise provided by the terms of issue of the shares of that class, modify, convert, broaden, add or otherwise alter the rights,
privileges, advantages, restrictions and provisions related or unrelated at that time to the shares of any class with the sanction of
a resolution passed by a simple majority of those present, personally or by proxy, and voting thereon at a separate general meeting of
the holders of the shares of that class. Such majority approval is consistent with Israeli law.
DESCRIPTION
OF THE OFFERED SECURITIES
We are
also registering the ordinary shares issuable from time to time upon exercise of the Pre-funded warrants and Common warrants
offered hereby.
Ordinary
Shares
The
material terms and provisions of our ordinary shares are described under the caption “Description of Share Capital” in this
prospectus.
Pre-Funded
Warrants
The
following summary of certain terms and provisions of the pre-funded warrants offered hereby is not complete and is subject to, and qualified
in its entirety by, the provisions of pre-funded warrant the form of which is filed as an exhibit to the registration statement of which
this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant
for a complete description of the terms and conditions of the pre-funded warrants.
The
term “pre-funded” refers to the fact that the purchase price of our ordinary shares in this offering includes almost the
entire exercise price that will be paid under the pre-funded warrants, except for a nominal remaining exercise price of $0.001. The purpose
of the pre-funded warrants is to enable investors that may have restrictions on their ability to beneficially own more than 4.99% (or,
at the election of each purchaser, 9.99%) of our outstanding ordinary shares following the consummation of this offering the opportunity
to make an investment in the Company without triggering their ownership restrictions, by receiving pre-funded warrants in lieu of our
ordinary shares which would result in such ownership of more than 4.99% (or, at the election of each purchaser, 9.99%), and receive the
ability to exercise their option to purchase the shares underlying the pre-funded warrants at such nominal price at a later date.
Exercise
of pre-funded warrants. Each pre-funded warrant is exercisable for one ordinary share, with an exercise price equal to $0.001 per ordinary
share, at any time that the pre-funded warrant is outstanding. There is no expiration date for the pre-funded warrants. The holder of
a pre-funded warrant will not be deemed a holder of our underlying ordinary shares until the pre-funded warrant is exercised.
Subject
to limited exceptions, a holder of pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if
the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such
holder’s affiliates) would beneficially own a number of ordinary shares in excess of 4.99% (or, at the election of each purchaser,
9.99%) of the ordinary shares then outstanding after giving effect to such exercise.
The
exercise price and the number of ordinary shares issuable upon exercise of the pre-funded warrants is subject to appropriate adjustment
in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar
events affecting our ordinary shares. The pre-funded warrant holders must pay the exercise price in cash upon exercise of the pre-funded
warrants, unless such pre-funded warrant holders are utilizing the cashless exercise provision of the pre-funded warrants.
Upon
the holder’s exercise of a pre-funded warrant, we will issue the ordinary shares issuable upon exercise of the pre-funded warrant
within two trading days following our receipt of a notice of exercise, provided that payment of the exercise price has been made (unless
exercised to the extent permitted via the “cashless” exercise provision). Prior to the exercise of any pre-funded warrants
to purchase ordinary shares, holders of the pre-funded warrants will not have any of the rights of holders of ordinary shares purchasable
upon exercise, including the right to vote, except as set forth therein.
As
an alternative to payment in immediately available funds, the holder may elect to exercise the pre-funded warrant through a cashless
exercise, in which the holder would receive upon such exercise the net number of ordinary shares determined according to the formula
set forth in the pre-funded warrant (in which case, the pre-funded warrants may only be exercised via a “cashless” exercise
provision).
Fundamental
Transaction. In the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization,
recapitalization or reclassification of our ordinary shares, the sale, transfer or other disposition of all or substantially all of our
properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding ordinary
shares, or any person or group becoming the beneficial owner of more than 50% of the voting power represented by our outstanding ordinary
shares, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount
of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately prior
to such fundamental transaction without regard to any limitations on exercised contained in the pre-funded warrants.
Exchange
Listing. We do not intend to apply to list the pre-funded warrants on any securities exchange or other trading system. Without an
active trading market, the liquidity of the pre-funded warrants will be limited.
Common
Warrants
The
following summary of certain terms and provisions of the common warrants offered together with the ordinary shares hereby is not complete
and is subject to, and qualified in its entirety by the form of common warrant, which is filed as an exhibit to the registration
statement of which this prospectus is a part. Prospective investors should carefully review the terms and provisions set forth in the
form of common warrant.
Exercisability.
The common warrants are exercisable at any time after their original issuance and at any time up to the date that is five years
after their original issuance. The common warrants will be exercisable, at the option of each holder, in whole or in part by
delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the ordinary
shares underlying the common warrants under the Securities Act is effective and available for the issuance of such shares, by
payment in full in immediately available funds for the number of ordinary shares purchased upon such exercise. If a registration
statement registering the issuance of ordinary shares underlying the common warrants under the Securities Act is not effective or
available the holder may, in its sole discretion, elect to exercise the warrant through a cashless exercise, in which case the
holder would receive upon such exercise the net number of ordinary shares determined according to the formula set forth in the
common warrant. No fractional shares will be issued in connection with the exercise of a common warrant. In lieu of fractional
shares, we will either pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price or round up
to the next whole share.
Exercise
Limitation. A holder will not have the right to exercise any portion of the common warrant if the holder (together with its
affiliates) would beneficially own in excess of 4.99% (or, at the election of each purchaser, 9.99%) of the number of ordinary
shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with
the terms of the common warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess
of 9.99%, provided that any increase in such percentage shall not be effective until 61 days following notice from the holder to
us.
Exercise
Price. The exercise price per whole ordinary share purchasable upon exercise of the common warrants is $1.25 per share, which
is 100% of the public offering price of the offered securities. The exercise price is subject to appropriate adjustment in the
event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our
ordinary shares and also upon any distributions of assets, including cash, stock or other property to our stockholders.
Transferability.
Subject to applicable laws, the common warrants may be offered for sale, sold, transferred or assigned without our
consent.
Exchange
Listing. We do not intend to apply to list the common warrants on any securities exchange or nationally recognized trading system.
Fundamental
Transactions. In the event of a fundamental transaction, as described in the common warrants and generally including any reorganization,
recapitalization or reclassification of our ordinary shares, the sale, transfer or other disposition of all or substantially all of our
properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding ordinary
shares, or any person or group becoming the beneficial owner of more than 50% of the voting power represented by our outstanding ordinary
shares, the holders of the common warrants will be entitled to receive upon exercise of the common warrants the kind and amount of securities,
cash or other property that the holders would have received had they exercised the common warrants immediately prior to such fundamental
transaction without regard to any limitations on exercised contained in the common warrants. Additionally, as more fully described in the common warrants,
in the event of certain fundamental transactions, the holders of the common warrants will be entitled to receive consideration in an amount
equal to the Black Scholes value of the common warrants on the date of consummation of such transaction.
Rights
as a Stockholder. Except as otherwise provided in the common warrants or by virtue of such holder’s ownership of our ordinary
shares, the holder of a common warrant does not have the rights or privileges of a holder of our ordinary shares, including any voting
rights, until the holder exercises the common warrant.
Governing
Law. The common warrants are governed by New York law.
Placement
Agent Warrants
As part of our
public offering July 2023, we issued to the placement agent as compensation the Placement Agent Warrants to purchase 168,000 ordinary
shares (which represented 3.0% of the aggregate number of ordinary shares and pre-funded warrants issued in the offering). The Placement
Agent Warrants are exercisable at a per share exercise price of $1.5625. We are registering hereby the ordinary shares issuable upon
exercise of the Placement Agent Warrants. The Representative’s Warrants are exercisable at any time after July 14, 2023 until the
close of business on July 14, 2028.
The form of the Placement
Agent Warrant has included as an exhibit to the registration statement of which this prospectus forms a part. Pursuant to FINRA
Rule 5110I, the Placement Agent Warrants and any ordinary shares issued upon exercise of the Placement Agent Warrants shall not
be sold, transferred, assigned, pledged or hypothecated, or be the subject of any hedging, short sale, derivative, put or call transaction
that would result in the effective economic disposition of the securities by any person for a period of 180 days immediately following
the date of commencement of sales in this offering, except for the transfer of any security as permitted by FINRA Rule 5110(e)(2). The
Placement Agent Warrants will provide for cashless exercise and will contain provisions for one demand registration of the sale of the
underlying ordinary shares at the Company’s expense, an additional demand registration at the warrant holders’ expense and
unlimited “piggyback” registration rights for a period of five (5) years from the commencement of sales in the offering.
The Placement Agent Warrants will provide for adjustment in the number and price of shares in the event of recapitalization, merger,
share split or other similar transactions by us. The Placement Agent Warrants and the underlying ordinary shares are registered on the
registration statement of which this prospectus is a part.
MATERIAL
TAX CONSIDERATIONS
The
following is a general summary of certain material Israeli and U.S. federal income tax considerations. The discussion is not intended
to be, nor should it be construed as, legal or tax advice to any particular shareholder or prospective shareholder. The discussion is
based on laws and relevant interpretations thereof in effect as of the date hereof, all of which are subject to change or different interpretations,
possibly with retroactive effect.
Certain
Israeli Tax Considerations
The
following is a brief summary of the material Israeli income tax laws applicable to us. This section also contains a discussion of material
Israeli tax consequences concerning the ownership and disposition of our ordinary shares. This summary does not discuss all the aspects
of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some
types of investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of Israel or investors
in securities who are subject to special tax regimes not covered in this discussion. To the extent that the discussion is based on new
tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure you that the appropriate
tax authorities or the courts will accept the views expressed in this discussion. This summary is based on laws and regulations in effect
as of the date hereof and does not take into account possible future amendments which may be under consideration.
General
Corporate Tax Structure in Israel
Israeli
resident companies (as defined below), such as the Company, are generally subject to corporate tax at the rate of 23% on their taxable
income, as of January 1, 2018 (23% in 2023). However, the effective tax rate payable by a company that derives income from a Preferred
Enterprise or a Technology Enterprise, as discussed below, may be considerably less.
Capital
gains derived by an Israeli resident company are generally subject to tax at the same rate as the corporate tax rate. Under Israeli tax
legislation, a corporation will be considered an “Israeli resident” if it meets one of the following: (i) it was incorporated
in Israel; or (ii) the control and management of its business are exercised in Israel.
Law
for the Encouragement of Industry (Taxes), 5729-1969
The
Law for the Encouragement of Industry (Taxes), 5729-1969, which we refer to as the Industry Encouragement Law, provides several tax benefits
for “Industrial Companies,” which are defined as Israeli resident-companies which were incorporated in Israel, of which 90%
or more of their income in any tax year, other than income from certain government loans, is derived from an “Industrial Enterprise”
that it owns and located in Israel or in the “Area”, in accordance with the definition under Section 3A of the Israeli Tax
Ordinance. An “Industrial Enterprise” is Iefined as an enterprise whose principal activity in a given tax year is
industrial production. Eligibility for benefits under the Industry Encouragement Law is not contingent upon approval of any governmental
authority.
The
following tax benefits, among others, are available to Industrial Companies:
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amortization
over an eight year period of the cost of purchasing a patent, rights to use a patent and rights to know-how, which are used for the
development or advancement of the company, commencing in the year in which such rights were first exercised; |
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under
limited conditions, an election to file consolidated tax returns with related Industrial Companies controlled by it; and |
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deductions
of expenses related to a public offering in equal amounts over a three year period commencing on the year of the offering. |
We
believe that we qualify as an “Industrial Company” within the meaning of the Industry Encouragement Law. There can be no
assurance that we will continue to qualify as an Industrial Company in the future or that the benefits described above will be available
to us at all.
Law
for the Encouragement of Capital Investments, 5719-1959
The
Law for the Encouragement of Capital Investments, 5719-1959, which we refer to as the Investment Law, provides certain incentives for
capital investments in production facilities (or other eligible assets) by “Industrial Enterprises” (as defined under the
Investment Law). Generally, an investment program that is implemented in accordance with the provisions of the Investment Law, is entitled
to benefits. These benefits may include cash grants from the Israeli government and tax benefits, based upon, among other things, the
geographic location in Israel of the facility in which the investment is made. In order to qualify for these incentives, an Approved
Enterprise, a Beneficiary Enterprise or a Preferred Enterprise is required to comply with the requirements of the Investment Law.
The
Investment Law was significantly amended effective April 1, 2005, further amended as of January 1, 2011, or the 2011 Amendment, and as
of January 1, 2017, or the 2017 Amendment. The 2011 Amendment introduced new benefits to replace those granted in accordance with the
provisions of the Investment Law in effect prior to the 2011 Amendment. However, companies entitled to benefits under the Investment
Law as in effect up to January 1, 2011 were entitled to choose to continue to enjoy such benefits, provided that certain conditions are
met, or elect instead, irrevocably, to forego such benefits and elect the benefits of the 2011 Amendment. The 2017 Amendment introduces
new benefits for Technological Enterprises, alongside the existing tax benefits.
The
following discussion is a summary of the Investment Law following its most recent amendments:
Tax
Benefits Under the 2011 Amendment
The
2011 Amendment canceled the availability of the benefits granted to Industrial Companies under the Investment Law prior to 2011 and,
instead, introduced new benefits for income generated by a “Preferred Company” through its “Preferred Enterprise”
(as such terms are defined in the Investment Law) as of January 1, 2011.
The
definition of a Preferred Company includes a company incorporated in Israel that is not fully owned by a governmental entity, and that
has, among other things, a Preferred Enterprise and is controlled and managed from Israel. Pursuant to the 2011 Amendment, beginning
in 2014 and in each year thereafter until 2016, a Preferred Company may only be entitled to a reduced corporate tax rate of 16% with
respect to its preferred income derived by its Preferred Enterprise, unless the Preferred Enterprise is located in a specified development
zone, in which case the rate will be 9%. Pursuant to the 2017 Amendment, in 2017 and thereafter, the corporate tax rate for Preferred
Enterprise which is located in a specified development zone was reduced to 7.5%, while the reduced corporate tax rate for other development
zones remains 16%. Income derived by a Preferred Company from a “Special Preferred Enterprise” (as such term is defined in
the Investment Law) would be entitled, during a benefit period of ten years, to further reduced tax rates of 8%, or 5% if the Special
Preferred Enterprise is located in a certain development zone. As of January 1, 2017, the definition for ‘Special Preferred Enterprise’
includes less stringent conditions.
As
of January 1, 2014, dividends paid to Israeli shareholders out of income attributed to a Preferred Enterprise or to a Special Preferred
Enterprise are generally subject to withholding tax at source at the rate of 20% (in the case of non-Israeli sharehold–rs
- subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such a lower tax rate
as may be provided under an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to
be withheld (although, if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply).
New
Tax benefits under the 2017 Amendment
The
2017 Amendment was enacted as part of the Economic Efficiency Law that was published on December 29, 2016, and is effective as of January
1, 2017. The 2017 Amendment provides new tax benefits for two types of “Technology Enterprises”, as described below, and
is in addition to the other existing tax beneficial programs under the Investment Law.
The
2017 Amendment provides that a technology company satisfying certain conditions will qualify as a “Preferred Technology Enterprise”
and will thereby enjoy a reduced corporate tax rate of 12% on income that qualifies as “Preferred Technology Income”, as
defined in the Investment Law. The tax rate is further reduced to 7.5% for a Preferred Technology Enterprise located in development zone
A. In addition, a Preferred Technology Company will enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale of
certain “Benefitted Intangible Assets” (as defined in the Investment Law) to a related foreign company if the Benefitted
Intangible Assets were acquired from a foreign company on or after January 1, 2017 for at least NIS 200 million (approximately $56 million),
and the sale receives prior approval from the National Authority for Technological Innovation (previously known as the Israeli Office
of the Chief Scientist), to which we refer as IIA.
The
2017 Amendment further provides that a technology company satisfying certain conditions will qualify as a “Special Preferred Technology
Enterprise” and will thereby enjoy a reduced corporate tax rate of 6% on “Preferred Technology Income” regardless of
the company’s geographic location within Israel. In addition, a Special Preferred Technology Enterprise will enjoy a reduced corporate
tax rate of 6% on capital gain derived from the sale of certain “Benefitted Intangible Assets” to a related foreign company
if the Benefitted Intangible Assets were either developed by the Special Preferred Technology Enterprise or acquired from a foreign company
on or after January 1, 2017, and the sale received prior approval from IIA. A Special Preferred Technology Enterprise that acquires Benefitted
Intangible Assets from a foreign company for more than NIS 500 million will be eligible for these benefits for at least ten years, subject
to certain approvals as specified in the Investment Law.
Dividends
distributed by a Preferred Technology Enterprise or a Special Preferred Technology Enterprise to Israeli shareholders, paid out of Preferred
Technology Income, are subject to withholding tax at source at the rate of 20% (in the case of non-Israeli sharehold–rs
- subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such lower rate as may
be provided in an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld
(although, if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply). If such
dividends are distributed to a foreign parent company holding, alone or together with other foreign companies, at least 90% of the shares
of the distributing company and other conditions are met, the withholding tax rate will be 4% (or a lower rate under a tax treaty, if
applicable, subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate).
After
examining the impact of the 2017 Amendment, we submitted a request to receive a tax ruling from the Israel Tax Authority to be recognized
as a Preferred Technology Enterprise and we received a tax ruling from the Israel Tax Authority granting GRD a Preferred Technology Enterprise
status, subject to terms and conditions determined in the tax ruling.
Taxation
of Our Israeli Individual Shareholders on Receipt of Dividends
Israeli
residents who are individuals are generally subject to Israeli income tax for dividends paid on our ordinary shares (other than bonus
shares or share dividends) at a rate of 25%, or 30% if the recipient of such dividend is a Substantial Shareholder (as defined below)
at the time of distribution or at any time during the preceding 12-month period. However, dividends distributed from taxable income accrued
from Preferred Enterprise or Preferred Technology Enterprise to Israeli individuals are subject to withholding tax at the rate of 20%.
However, if such dividends are distributed to an Israeli company, no tax is imposed (although, if such dividends are subsequently distributed
to individuals or a non-Israeli company, withholding tax at a rate of 20% or such lower rate as may be provided in an applicable tax
treaty (subject to the receipt in advance of a valid certificate from the Israel Tax Authority, or the ITA, allowing for
a reduced tax rate will apply). An average rate will be set in case the dividend is distributed from mixed types of income (regular and
preferred income).
A
“Substantial Shareholder” is generally a person who alone, or together with his or her relative or another person who collaborates
with him or her on a regular basis, holds, directly or indirectly, at least 10% of any of the “means of control” of a corporation.
“Means of control” generally include the right to vote, receive profits, nominate a director or an officer, receive assets
upon liquidation or instruct someone who holds any of the aforesaid rights regarding the manner in which he or she is to exercise such
right(s), all regardless of the source of such right.
With
respect to individuals, the term “Israeli resident” is generally defined under Israeli tax legislation as a person whose
center of life is in Israel. The Israeli Tax Ordinance (as amended by Amendment Law No. 132 of 2002), states that in order to determine
the center of life of an individual, consideration will be given to the individual’s family, economic and social connections, including:
(i) place of permanent residence; (ii) place of residential dwelling of the individual and the individual’s immediate family; (iii)
place of the individual’s regular or permanent occupation or the place of his or her permanent employment; (iv) place of the individual’s
active and substantial economic interests; (v) place of the individual’s activities in organizations, associations and other institutions.
The center of life of an individual will be presumed to be in Israel if: (i) the individual was present in Israel for 183 days or more
in the tax year; or (ii) the individual was present in Israel for 30 days or more in the tax year, and the total period of the individual’s
presence in Israel in that tax year and the two previous tax years is 425 days or more. Such presumption may be rebutted either by the
individual or by the assessing officer.
Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.
Taxation
of Israeli Resident Corporations on Payment of Dividends
Israeli
resident corporations are generally exempt from Israeli corporate income tax with respect to dividends paid on ordinary shares of Israeli
resident corporations as long as the profits out of which the dividends were paid were derived in Israel.
Capital
Gains Taxes Applicable to Israeli Resident Shareholders
The
income tax rate applicable to real capital gains derived by an Israeli individual resident from the sale of shares that were purchased
after January 1, 2012, whether listed on a stock exchange or not, is 25%. However, if such shareholder is considered a Substantial Shareholder
at the time of sale or at any time during the preceding 12 month period and/or claims a deduction for interest and linkage differences
expenses in connection with the purchase and holding of such shares, such gain will be taxed at the rate of 30%.
Moreover,
capital gains derived by an individual shareholder who is a dealer or trader in securities, or to whom such income is otherwise taxable
as ordinary business income, are taxed in Israel at their marginal rates applicable to business income (up to 50% in 2022 and 2023, including
Excess Tax as detailed below).
At
the sale of securities traded on a stock exchange, a detailed return, including a computation of the tax due, must be filed and an advanced
payment must be paid on January 31 and July 31 of every tax year in respect of sales of securities made within the previous six months.
However, if all tax due was withheld at source according to applicable provisions of the Israeli Tax Ordinance and regulations promulgated
thereunder, the aforementioned return is not required to be filed and no advance payment must be paid. Capital gain is also reportable
on the annual income tax return.
Taxation
of Non-Israeli Shareholders on Receipt of Dividends
Non-Israeli
residents are generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25% (or
30% for individuals, if such person is a Substantial Shareholder at the time he or she receives the dividend or on any date in the 12
months preceding such date), or 20% if the dividend is distributed from income attributed to Preferred Enterprise unless a lower rate
is provided under an applicable tax treaty between Israel and the shareholder’s country of residence and provided that a certificate
from the Israel Tax Authority allowing for a reduced withholding tax rate is obtained in advance.
A
non-Israeli resident who has dividend income derived from or accrued in Israel, from which the full amount of tax was withheld at source,
is generally exempt from the duty to file tax returns in Israel in respect of such income; provided that (i) such income was not derived
from a business conducted in Israel by the taxpayer, (ii) the taxpayer has no other taxable sources of income in Israel with respect
to which a tax return is required to be filed, and (iii) the taxpayer is not obligated to pay excess tax (as further explained below).
For
example, under the Convention Between the Government of the United States of America and the Government of Israel with Respect to Taxes
on Income, as amended, or the U.S.-Israel Tax Treaty, Israeli withholding tax on dividends paid to a U.S. resident for treaty purposes
may not, in general, exceed 25%, subject to certain conditions. Where the recipient is a U.S. corporation owning 10% or more of the voting
shares of the paying corporation during the part of the paying corporation’s taxable year which precedes the date of payment of
the dividend and during the entirety of its prior taxable year (if any), the Israeli tax withheld may not exceed 12.5%, subject to certain
conditions.
Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.
Capital
Gains Income Taxes Applicable to Non-Israeli Shareholders
Non-Israeli
resident shareholders are generally exempt from Israeli capital gains tax on any gains derived from the sale, exchange or disposition
of our ordinary shares, provided that such shareholders did not acquire their shares prior to January 1, 2009 or acquired their shares
after the Company was listed for trading on NASDAQ and such gains were not derived from a permanent business or business activity of
such shareholders in Israel. These provisions dealing with capital gain are not applicable to a person whose gains from selling or otherwise
disposing of the shares are deemed to be business income. However, non-Israeli corporations will not be entitled to the foregoing exemptions
if an Israeli resident (i) has a controlling interest of more than 25% in such non-Israeli corporation or (ii) is the beneficiary of
or is entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly.
In
addition, a sale of securities by a non-Israeli resident may be exempt from Israeli capital gains tax under the provisions of an applicable
tax treaty. For example, under the U.S.-Israel Tax Treaty, the sale, exchange or disposition of our ordinary shares by a shareholder
who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) holding the ordinary shares as a capital asset and is entitled to
claim the benefits afforded to such a resident by the U.S.-Israel Tax Treaty, or a Treaty U.S. Resident, is generally exempt from Israeli
capital gains tax unless: (i) such Treaty U.S. Resident is an individual and was present in Israel for 183 days or more in the aggregate
during the relevant taxable year; (ii) such Treaty U.S. Resident holds, directly or indirectly, shares representing 10% or more of our
voting power of the Company during any part of the 12 month period preceding such sale, exchange or disposition, subject to certain conditions;
(iii) the capital gains arising from such sale, exchange or disposition are attributable to a permanent establishment of the Treaty U.S.
Resident maintained in Israel, subject to certain conditions; (iv) the capital gains arising from such sale, exchange or disposition
is attributed to real estate located in Israel; or (v) the capital gains arising from such sale, exchange or disposition is attributed
to royalties. In any such case, the sale, exchange or disposition of our ordinary shares would be subject to Israeli tax, to the extent
applicable. However, under the U.S.-Israel Tax Treaty, such Treaty U.S. Resident would be permitted to claim a credit for such taxes
against U.S. federal income tax imposed on any gain from such sale, exchange or disposition, under the circumstances and subject to the
limitations specified in the U.S.-Israel Income Tax Treaty.
Regardless
of whether shareholders may be liable for Israeli income tax on the sale of our ordinary shares, the payment of the consideration may
be subject to withholding of Israeli tax at the source. Accordingly, shareholders may be required to demonstrate that they are exempt
from tax on their capital gains in order to avoid withholding at source at the time of sale. Specifically, in transactions involving
a sale of all of the shares of an Israeli resident company, in the form of a merger or otherwise, the Israel Tax Authority may require
from shareholders who are not liable for Israeli tax to sign declarations in forms specified by this authority or obtain a specific exemption
from the Israel Tax Authority to confirm their status as non-Israeli resident, and, in the absence of such declarations or exemptions,
may require the purchaser of the shares to withhold taxes at source.
Excess
Tax
Individuals
who are subject to tax in Israel are also subject to an additional tax at a rate of 3% on annual income exceeding a certain threshold
(NIS 698,280 for 2023, which amount is linked to the annual change in the Israeli consumer price index), including, but not limited to,
dividends, interest and capital gains.
Estate
and Gift Tax
Israeli
law presently does not impose estate or gift taxes.
Certain
Material U.S. Federal Income Tax Considerations
The
following is a general summary of certain material U.S. federal income tax consequences relating to the purchase, ownership and disposition
of our ordinary shares, pre-funded warrants and common warrants by U.S. Holders (as defined below). This summary is based
on the Code, the regulations of the U.S. Department of the Treasury issued pursuant to the Code, or the Treasury Regulations, the income
tax treaty between the United States and Israel, or the U.S.-Israel Tax Treaty, and administrative and judicial interpretations thereof,
all as in effect on the date hereof and all of which are subject to change, possibly with retroactive effect, or to different interpretation.
No ruling has been sought from the Internal Revenue Service, or the IRS, with respect to any U.S. federal income tax consequences described
below, and there can be no assurance that the IRS or a court will not take a contrary position. This summary is no substitute for consultation
by prospective investors with their own tax advisors and does not constitute tax advice. This summary applies only to U.S. Holders that
hold our ordinary shares, pre-funded warrants or common warrants as capital assets for U.S. federal income tax purposes
(generally, property held for investment) and does not address all of the tax considerations that may be relevant to specific U.S. Holders
in light of their particular circumstances or to U.S. Holders subject to special treatment under U.S. federal income tax law (including,
without limitation, banks, insurance companies, tax-exempt entities, retirement plans, regulated investment companies, partnerships,
dealers in securities, brokers, real estate investment trusts, grantor trusts, certain former citizens or residents of the United States,
persons who acquire our ordinary shares, pre-funded warrants or common warrants as part of a straddle, hedge, conversion
transaction or other integrated investment, persons who acquire our ordinary shares, pre-funded warrants or common warrants
through the exercise or cancellation of employee stock options or otherwise as compensation for their services, persons that have a “functional
currency” other than the U.S. dollar, persons that own (or are deemed to own, indirectly, or by attribution) 10% or more of our
shares (by vote or value), or persons that mark their securities to market for U.S. federal income tax purposes). This summary does not
address any U.S. state or local or non-U.S. tax considerations, any U.S. federal estate, gift or alternative minimum tax considerations,
or any U.S. federal tax consequences other than U.S. federal income tax consequences.
As
used in this summary, the term “U.S. Holder” means a beneficial owner of our ordinary shares, pre-funded warrants
or common warrants that is, for U.S. federal income tax purposes, (i) an individual citizen or resident
of the United States, (ii) a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized
in or under the laws of the United States, any state thereof, or the District of Columbia, (iii) an estate the income of which is subject
to U.S. federal income tax regardless of its source, or (iv) a trust with respect to which a court within the United States is able to
exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of its substantial
decisions, or that has a valid election in effect under applicable Treasury Regulations to be treated as a “United States person.”
If
an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds our ordinary shares, pre-funded warrants
and the common warrants, the tax treatment of such entity or arrangement treated as a partnership and each person treated as a partner
thereof generally will depend upon the status and activities of the entity and such person. A holder that is treated as a partnership
for U.S. federal income tax purposes should consult its own tax advisor regarding the U.S. federal income tax considerations applicable
to it and its partners of the purchase, ownership and disposition of our ordinary shares, pre-funded warrants or common
warrants.
Prospective
investors should be aware that this summary does not address the tax consequences to investors who are not U.S. Holders. Prospective
investors should consult their own tax advisors as to the particular tax considerations applicable to them relating to the purchase,
ownership and disposition of our ordinary shares, pre-funded warrants or common warrants, including the applicability of
U.S. federal, state and local tax laws and non-U.S. tax laws.
Tax
Treatment of Pre-Funded Warrants
Although
it is not entirely free from doubt, we believe a pre-funded warrant should be treated as an ordinary share for U.S. federal income tax
purposes and a holder of pre-funded warrants should generally be taxed in the same manner as a holder of our ordinary shares, as described
below (except as otherwise noted below). However, our characterization is not binding on the U.S. Internal Revenue Services, or IRS,
and the IRS may treat the pre-funded warrants as warrants to acquire our ordinary shares. If so, the tax consequences, including the
amount and character of your gain, with respect to an investment in our pre-funded warrants could change. Accordingly, each U.S. Holder
should consult his, her or its own tax advisor regarding the risks associated with the acquisition of pre-funded warrants pursuant to
this offering (including potential alternative characterizations). The balance of this discussion generally assumes that the characterization
described above is respected for U.S. federal income tax purposes unless otherwise noted.
Taxation
of U.S. Holders
Distributions.
Subject to the discussion below under “Passive Foreign Investment Company,” a U.S. Holder that receives a distribution with
respect to an ordinary share generally will be required to include the amount of such distribution in gross income as a dividend (without
reduction for any Israeli tax withheld from such distribution) when actually or constructively received to the extent of the U.S. Holder’s
pro rata share of our current and/or accumulated earnings and profits (as determined under U.S. federal income tax principles). Any distributions
in excess of our earnings and profits will be applied against and will reduce (but not below zero) the U.S. Holder’s tax basis
in its ordinary shares, and, to the extent they exceed that tax basis, will be treated as gain from the sale or exchange of our ordinary
shares. We do not intend to calculate our earnings and profits under U.S. federal income tax principles. Therefore, a U.S. Holder should
expect that a distribution will be reported as a dividend even if that distribution would otherwise be treated as a non-taxable return
of capital or as capital gain under the rules described above.
As
noted above, we do not anticipate paying any cash dividends in the foreseeable future. If we were to pay dividends, we expect to pay
such dividends in NIS. A dividend paid in NIS, including the amount of any Israeli taxes withheld, will be includible in a U.S. Holder’s
income at a U.S. dollar amount calculated by reference to the exchange rate in effect on the date such dividend is received, regardless
of whether the payment is in fact converted into U.S. dollars. If the dividend is converted to U.S. dollars on the date of receipt, a
U.S. Holder generally will not recognize a foreign currency gain or loss. HowevIr, if the U.S. Holder converts the NIS into U.S.
dollars on a later date, the U.S. Holder must include, in computing its income, any gain or loss resulting from any exchange rate fluctuations.
The gain or loss will be equal to the difference between (i) the U.S. dollar value of the amount included in income when the dividend
was received and (ii) the amount received on the conversion of the NIS into U.S. dollars. Such gain or loss generally will be ordinary
income or loss and will be U.S. source income or loss for U.S. foreign tax credit purposes. U.S. Holders should consult their own tax
advisors regarding the tax consequences to them if we pay dividends in NIS or any other non-U.S. currency.
Subject
to certain significant conditions and limitations, any Israeli taxes paid on or withheld from distributions from us and not refundable
to a U.S. Holder may be credited against the U.S. Holder’s U.S. federal income tax liability or, alternatively, may be deducted
from the U.S. Holder’s taxable income. However, as a result of recent changes to the U.S. foreign tax credit rules, a withholding
tax generally will need to satisfy certain additional requirements in order to be considered a creditable tax for a U.S. Holder. We have
not determined whether these requirements have been met and, accordingly, no assurance can be given that any withholding tax on dividends
paid by us will be creditable. The election to deduct, rather than credit, foreign taxes, is made on a year-by-year basis and applies
to all foreign taxes paid by a U.S. Holder or withheld from a U.S. Holder that year. Dividends paid on our ordinary shares generally
will constitute income from sources outside the United States and be categorized as “passive category income” or, in the
case of some U.S. Holders, as “general category income” for U.S. foreign tax credit purposes. Because the rules governing
foreign tax credits are complex, U.S. Holders should consult their own tax advisors regarding the availability of foreign tax credits
in their particular circumstances.
Dividends
paid on our ordinary shares will not be eligible for the “dividends-received” deduction generally allowed to corporate U.S.
Holders with respect to dividends received from U.S. corporations.
Certain
distributions treated as dividends that are received by an individual U.S. Holder from a “qualified foreign corporation”
may be classified as “qualified dividend income,” — which is generally
taxed at the lower applicable long term capital gains rates provided certain holding period and other requirements are satisfied. A non-U.S.
corporation (other than a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered
to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive tax treaty with the United States which
the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange
of information program, or (ii) with respect to any dividend it pays on stock which is readily tradable on an established securities
market in the United States. We will not be a qualified foreign corporation if we are a passive foreign investment company, or PFIC,
for the taxable year in which we pay a dividend or for the preceding taxable year. As discussed below under “Passive Foreign Investment
Company,” we believe that we were a PFIC for our 2022 taxable year and expect to be a PFIC for the 2023 taxable year. Because the
PFIC determination is highly fact intensive, there can be no assurance that we will be a PFIC in 2023 or for any other taxable year.
Our ordinary shares will generally be considered to be readily tradable on an established securities market in the United States if they
are listed on the Nasdaq Capital Market, as we intend our ordinary shares will be. U.S. Holders should consult their own tax advisors
regarding the availability of the lower rate for dividends paid with respect to our ordinary shares.
The
additional 3.8% “net investment income tax” (described below) may apply to dividends received by certain U.S. Holders who
meet certain modified adjusted gross income thresholds.
Sale,
Exchange or Other Taxable Disposition of Ordinary Shares, Pre-Funded Warrants or Common Warrants. Subject to
the discussion under “Passive Foreign Investment Company” below, a U.S. Holder generally will recognize capital gain or loss
upon the sale, exchange, or other taxable disposition of our ordinary shares, pre-funded warrants or common warrants in
an amount equal to the difference between the amount realized on the sale, exchange, or other taxable disposition and the U.S. Holder’s
adjusted tax basis (determined under U.S. federal income tax rules) in such ordinary shares, pre-funded warrants or common
warrants. This capital gain or loss will be long-term capital gain or loss if the U.S. Holder’s holding period in our ordinary
shares, pre-funded warrants or common warrants exceeds one year. Preferential tax rates for long-term capital gain (currently,
with a maximum rate of 20%) will apply to individual U.S. Holders. The deductibility of capital losses is subject to limitations. The
gain or loss generally will be income or loss from sources within the United States for U.S. foreign tax credit purposes, subject to
certain possible exceptions under the U.S.-Israel Tax Treaty. The additional 3.8% “net investment income tax” (described
below) may apply to gains recognized upon the sale, exchange, or other taxable disposition of our ordinary shares, pre-funded
warrants or common warrants by certain U.S. Holders who meet certain modified adjusted gross income thresholds.
U.S.
Holders should consult their own tax advisors regarding the U.S. federal income tax consequences of receiving currency other than U.S.
dollars upon the disposition of their ordinary shares, pre-funded warrants or common warrants.
Exercise
and Expiration of Pre-Funded Warrants or Common Warrants. In general, a U.S. Holder will not recognize gain or loss
for U.S. federal income tax purposes upon the exercise of pre-funded warrants or common warrants into ordinary shares. The U.S.
federal income tax treatment of a cashless exercise of pre-funded warrants or common warrants into our ordinary shares is unclear.
U.S. Holders should consult their tax advisors regarding the U.S. federal income tax consequences of a cashless exercise of pre-funded
warrants or common warrants.
The
expiration of a pre-funded warrant or a common warrant will generally be treated as if the U.S. Holder sold or exchanged the warrant
and recognized a capital loss equal to the U.S. Holder’s tax basis in the pre-funded warrant or the common warrant.
Certain
Adjustments to the Pre-Funded Warrants and the Common Warrants. Under Section 305 of the Code, an adjustment to the
number of ordinary shares issued on the exercise of the pre-funded warrants or the common warrants, or an adjustment to the exercise
price of the pre-funded warrants or the common warrants, may be treated as a constructive distribution to a U.S. Holder of the
pre-funded warrants or the common warrants if, and to the extent that, such adjustment has the effect of increasing such U.S.
Holder’s proportionate interest in our “earnings and profits” or assets, depending on the circumstances of such adjustment
(for example, if such adjustment is to compensate for a distribution of cash or other property to our shareholders). U.S. Holders should
consult their tax advisors regarding the proper treatment of any adjustments to and distributions on the pre-funded warrants or the
common warrants.
Passive
Foreign Investment Company. In general, a non-U.S. corporation will be treated as a PFIC for U.S. federal income tax purposes in
any taxable year in which either (i) at least 75% of its gross income is “passive income,” or (ii) on average at least 50%
of its assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally
includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and
from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the
temporary investment of funds, including those raised in a public offering. Assets that produce or are held for the production of passive
income may include cash, even if held as working capital or raised in a public offering, as well as marketable debt securities and other
assets that may produce passive income. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income
and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.
A
foreign corporation’s PFIC status is an annual determination that is based on tests that are factual in nature, and our status
for any year will depend on our income, assets, and activities for such year. Based upon our review of our financial data, we believe
that we were a PFIC for our 2022 taxable year and expect to be a PFIC for the 2023 taxable year. Because PFIC status is determined annually
and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with certainty whether
we will be characterized as a PFIC for the 2023 taxable year until after the close of the year, and there can be no assurance that we
will not be classified as a PFIC in any future year.
Default
PFIC Rules. If we are a PFIC for any tax year, a U.S. Holder who does not make a timely “qualified electing fund” election,
or “QEF election” or a mark-to-market election (as described below), referred to in this summary as a “Non-Electing
U.S. Holder,” will be subject to special rules with respect to (i) any “excess distribution” (generally, the portion
of any distributions received by the Non-Electing U.S. Holder on the ordinary shares in a taxable year in excess of 125% of the average
annual distributions received by the Non-Electing U.S. Holder in the three preceding taxable years, or, if shorter, the Non-Electing
U.S. Holder’s holding period for the ordinary shares), and (ii) any gain realized on the sale or other disposition of such ordinary
shares, pre-funded warrants or common warrants. Under these rules:
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the
excess distribution or gain would be allocated ratably over the Non-Electing U.S. Holder’s holding period for such ordinary
shares, pre-funded warrants or common warrants; |
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the
amount allocated to the current taxable year and any year prior to us becoming a PFIC would be taxed as ordinary income; and |
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the
amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable
class of taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting
tax attributable to each such other taxable year. |
If
a Non-Electing U.S. Holder who is an individual dies while owning our ordinary shares, pre-funded warrants or common warrants,
the Non-Electing U.S. Holder’s successor would be ineligible to receive a step-up in tax basis of such ordinary shares,
pre-funded warrants or common warrants. Non-Electing U.S. Holders should consult their tax advisors regarding the application
of the “net investment income tax” (described below) to their specific situation.
To
the extent a distribution on our ordinary shares does not constitute an excess distribution to a Non-Electing U.S. Holder, such Non-Electing
U.S. Holder generally will be required to include the amount of such distribution in gross income as a dividend to the extent of our
current and/or accumulated earnings and profits (as determined for U.S. federal income tax purposes) that are not allocated to excess
distributions. The tax consequences of such distributions are discussed above under “Taxation of U.S. Holders—Distributions.”
Each U.S. Holder is encouraged to consult its own tax advisor with respect to the appropriate U.S. federal income tax treatment of any
distribution on our ordinary shares.
If
we are treated as a PFIC for any taxable year during the holding period of a Non-Electing U.S. Holder, we will continue to be treated
as a PFIC for all succeeding years during which the Non-Electing U.S. Holder is treated as a direct or indirect Non-Electing U.S. Holder
even if we are not a PFIC for such years. A U.S. Holder is encouraged to consult its tax advisor with respect to any available elections
that may be applicable in such a situation, including the “deemed sale” election of Section 1298(b)(1) of the Code (which
will be taxed under the adverse tax rules described above).
We
may invest in the equity of foreign corporations that are PFICs or may own subsidiaries that are PFICs, any such entity, a lower-tier
PFIC. If we are classified as a PFIC, under attribution rules, U.S. Holders will be subject to the PFIC rules with respect to
their indirect ownership interests in such lower-tier PFICs, such that a disposition by us of the shares of the lower-tier PFIC or receipt
by us of a distribution from the lower-tier PFIC generally will be treated as a deemed disposition of such shares or the deemed receipt
of such distribution by the U.S. Holder, subject to taxation under the PFIC rules even though the U.S. Holder does not receive any proceeds
from those dispositions or distributions. There can be no assurance that a U.S. Holder will be able to make a QEF election with respect
to any lower-tier PFICs in which we invest. Each U.S. Holder is encouraged to consult its own tax advisor with respect to tax consequences
of an investment by us in a lower-tier PFIC.
QEF
Election. Certain adverse consequences of PFIC status can be mitigated for holders of our ordinary shares if a U.S. Holder makes
a QEF election. A U.S. Holder who makes a timely QEF election, referred to in this disclosure as an “Electing U.S. Holder,”
with respect to us must report for U.S. federal income tax purposes its pro rata share of our ordinary earnings and net capital gain,
if any, for our taxable year that ends with or within the taxable year of the Electing U.S. Holder. The “net capital gain”
of a PFIC is the excess, if any, of the PFIC’s net long-term capital gains over its net short-term capital losses. The amount so
included in income generally will be treated as ordinary income to the extent of such Electing U.S. Holder’s allocable share of
the PFIC’s ordinary earnings and as long-term capital gain to the extent of such Electing U.S. Holder’s allocable share of
the PFIC’s net capital gains. Such Electing U.S. Holder generally will be required to translate such income into U.S. dollars based
on the average exchange rate for the PFIC’s taxable year with respect to the PFIC’s functional currency. Such income generally
will be treated as income from sources outside the United States for U.S. foreign tax credit purposes. Amounts previously included in
income by such Electing U.S. Holder under the QEF rules generally will not be subject to tax when they are distributed to such Electing
U.S. Holder. The Electing U.S. Holder’s tax basis in our ordinary shares generally will increase by any amounts so included under
the QEF rules and decrease by any amounts not included in income when distributed.
An
Electing U.S. Holder will be subject to U.S. federal income tax on such amounts for each taxable year in which we are a PFIC, regardless
of whether such amounts are actually distributed to such Electing U.S. Holder. However, an Electing U.S. Holder may, subject to certain
limitations, elect to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If an Electing
U.S. Holder is an individual, any such interest will be treated as non-deductible “personal interest.”
Any
net operating losses or net capital losses of a PFIC will not pass through to the Electing U.S. Holder and will not offset any ordinary
earnings or net capital gain of a PFIC recognized by Electing U.S. Holder in subsequent years.
So
long as an Electing U.S. Holder’s QEF election with respect to us is in effect with respect to the entire holding period for our
ordinary shares, any gain or loss recognized by such Electing U.S. Holder on the sale, exchange or other disposition of such shares generally
will be long-term capital gain or loss if such Electing U.S. Holder has held such shares for more than one year at the time of such sale,
exchange or other disposition. Preferential tax rates for long-term capital gain (currently, a maximum rate of 20%) will apply to individual
U.S. Holders. The deductibility of capital losses is subject to limitations.
In
general, a U.S. Holder must make a QEF election on or before the due date for filing its income tax return for the first year to which
the QEF election is to apply. A U.S. Holder makes a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance
with the instructions thereto. Upon request, we expect to provide U.S. Holders with the information needed to complete IRS Form 8621
(which form would be required to be filed with the IRS on an annual basis by the U.S. Holder) and to make and maintain a valid QEF election
for any year in which we or any of our subsidiaries that we control is a PFIC. There is no assurance, however, that we will have timely
knowledge of our status as a PFIC or the status of a lower-tier PFIC, or that the information that we provide will be adequate to allow
U.S. Holders to make a QEF election. A QEF election will not apply to any taxable year during which we are not a PFIC, but will remain
in effect with respect to any subsequent taxable year in which we become a PFIC.
Each
U.S. Holder should consult its own tax advisor with respect to the advisability of, the tax consequences of, and the procedures for making
a QEF election with respect to us.
Mark-to-Market
Election. Alternatively, if our ordinary shares are treated as “marketable stock,” a U.S. Holder would be allowed to
make a “mark-to-market” election with respect to our ordinary shares, provided the U.S. Holder completes and files IRS Form
8621 in accordance with the relevant instructions and related Treasury Regulations. If that election is made, the U.S. Holder generally
would include as ordinary income in each taxable year the excess, if any, of the fair market value of our ordinary shares at the end
of the taxable year over such holder’s adjusted tax basis in such ordinary shares. The U.S. Holder would also be permitted an ordinary
loss in respect of the excess, if any, of the U.S. Holder’s adjusted tax basis in our ordinary shares over their fair market value
at the end of the taxable year, but only to the extent of the net amount previously included in income as a result of the mark-to- market
election. A U.S. Holder’s tax basis in our ordinary shares would be adjusted to reflect any such income or loss amount. Gain realized
on the sale, exchange or other disposition of our ordinary shares would be treated as ordinary income, and any loss realized on the sale,
exchange or other disposition of our ordinary shares would be treated as ordinary loss to the extent that such loss does not exceed the
net mark-to-market gains previously included in income by the U.S. Holder, and any loss in excess of such amount will be treated as capital
loss. Amounts treated as ordinary income will not be eligible for the favorable tax rates applicable to qualified dividend income or
long-term capital gains.
Generally,
stock will be considered marketable stock if it is “regularly traded” on a “qualified exchange” within the meaning
of applicable Treasury Regulations. A class of stock is regularly traded on an exchange during any calendar year during which such class
of stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. To be marketable stock, our
ordinary shares must be regularly traded on a qualifying exchange (i) in the United States that is registered with the SEC or a national
market system established pursuant to the Exchange Act or (ii) outside the United States that is properly regulated and meets certain
trading, listing, financial disclosure and other requirements. Our ordinary shares are expected to constitute “marketable stock”
as long as they remain listed on the Nasdaq Capital Market and are regularly traded.
A
mark-to-market election will not apply to our ordinary shares held by a U.S. Holder for any taxable year during which we are not a PFIC,
but will remain in effect with respect to any subsequent taxable year in which we become a PFIC. Such election will not apply to any
lower-tier PFIC that we own. Each U.S. Holder is encouraged to consult its own tax advisor with respect to the availability and tax consequences
of a mark-to-market election with respect to our ordinary shares.
Each
U.S. Holder should consult its own tax adviser with respect to the applicability of the “net investment income tax” (discussed
below) where a mark-to-market election is in effect.
In
addition, U.S. Holders should consult their tax advisors regarding the IRS information reporting and filing obligations that may arise
as a result of the ownership of ordinary shares or warrants in a PFIC, including IRS Form 8621, Information Return by a Shareholder
of a Passive Foreign Investment Company or Qualified Electing Fund.
The
U.S. federal income tax rules relating to PFICs, QEF elections, and mark-to market elections are complex. U.S. Holders are urged to consult
their own tax advisors with respect to the purchase, ownership and disposition of our ordinary shares, pre-funded warrants or
common warrants, any elections available with respect to such ordinary shares, pre-funded warrants or common warrants
and the IRS information reporting obligations with respect to the purchase, ownership and disposition of our ordinary shares,
pre-funded warrants or common warrants.
Certain
Reporting Requirements
Certain
U.S. Holders may be required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign Corporation and IRS Form 5471,
Information Return of U.S. Persons With Respect to Certain Foreign Corporations, reporting transfers of cash or other property to us
and information relating to the U.S. Holder and us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. See
also the discussion regarding Form 8621, Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing
Fund, above.
In
addition, certain U.S. Holders must report information on IRS Form 8938, Statement of Specified Foreign Financial Assets, with respect
to their investments in certain “specified foreign financial assets,” which would include an investment in our ordinary shares,
pre-funded warrants or common warrants, if the aggregate value of all of those assets exceeds $50,000 on the last day of the
taxable year (and in some circumstances, a higher threshold). This reporting requirement applies to individuals and certain U.S. entities.
U.S.
Holders who fail to report required information could become subject to substantial penalties. U.S. Holders should consult their tax
advisors regarding the possible implications of these reporting requirements arising from their investment in our ordinary shares,
pre-funded warrants or common warrants.
Backup
Withholding Tax and Information Reporting Requirements
Generally,
information reporting requirements will apply to distributions on our ordinary shares or proceeds on the disposition of our ordinary
shares, pre-funded warrants or common warrants paid within the United States (and, in certain cases, outside the United
States) to U.S. Holders other than certain exempt recipients, such as corporations. Furthermore, backup withholding (currently at 24%)
may apply to such amounts if the U.S. Holder fails to (i) provide a correct taxpayer identification number, (ii) report interest and
dividends required to be shown on its U.S. federal income tax return, or (iii) make other appropriate certifications in the required
manner. U.S. Holders who are required to establish their exempt status generally must provide such certification on IRS Form W-9.
Backup
withholding is not an additional tax. Amounts withheld as backup withholding from a payment may be credited against a U.S. Holder’s
U.S. federal income tax liability and such U.S. Holder may obtain a refund of any excess amounts withheld by filing the appropriate claim
for refund with the IRS and furnishing any required information in a timely manner.
Medicare
Tax on Investment Income
Certain
U.S. persons, including individuals, estates and trusts, will be subject to an additional 3.8% Medicare tax, or “net investment
income tax,” on unearned income. For individuals, the additional net investment income tax applies to the lesser of (i) “net
investment income” or (ii) the excess of “modified adjusted gross income” over $200,000 ($250,000 if married and filing
jointly or $125,000 if married and filing separately). “Net investment income” generally equals the taxpayer’s gross
investment income reduced by the deductions that are allocable to such income. Investment income generally includes, among other things,
passive income such as interest, dividends, annuities, royalties, rents, and capital gains. U.S. Holders are urged to consult their own
tax advisors regarding the implications of the additional net investment income tax resulting from their ownership and disposition of
our ordinary shares, pre-funded warrants or common warrants.
THE
DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PROSPECTIVE INVESTOR. EACH PROSPECTIVE
INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES RELATING TO THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR
ORDINARY SHARES, PRE-FUNDED WARRANTS OR COMMON WARRANTS IN LIGHT OF THE INVESTOR’S OWN CIRCUMSTANCES, INCLUDING THE
CONSEQUENCES OF ANY PROPOSED CHANGE IN APPLICABLE LAWS.
LEGAL
MATTERS
Greenberg
Traurig, P.A., Tel Aviv, Israel, will pass upon certain legal matters regarding the securities offered hereby under U.S. federal
securities law and Meitar | Law Offices, Ramat Gan, Israel, will pass upon certain legal matters regarding the securities offered hereby
under Israeli law. Ellenoff Grossman & Schole LLP of New York, New York is acting as counsel for the placement agent in connection
with certain U.S. legal matters related to this offering.
EXPERTS
The
consolidated financial statements of the Company for the years ended December 31, 2022 and 2021 incorporated in this prospectus by reference
have been audited by the accounting firm of Brightman Almagor Zohar & Co., a firm in the Deloitte Global Network, an independent
registered public accounting firm, as set forth in their report thereon, included therein, and incorporated herein by reference. Such
consolidated financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm
as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
This
registration statement on Form F-1 under the Securities Act relating to this offering of our ordinary shares of which this prospectus
forms a part, including the exhibits and schedules thereto, and reports and other information are filed by us with, or furnished to,
the SEC. Our SEC filings are available to the public at the SEC’s website at http://www.sec.gov.
We
are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those
requirements we file reports, including annual reports on Form 20-F, with the SEC. As a
foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements,
and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained
in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file reports and financial statements with
the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. We 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.
We
maintain a corporate website at https:// www.galmedpharma.com/. Information contained on, or that can be accessed through, our website
does not constitute a part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to incorporate by reference information into this document. This means that we can disclose important information to you
by referring you to another document filed separately with the SEC. The information incorporated by reference is considered to be a part
of this document, except for any information superseded by information that is included directly in this prospectus or incorporated by
reference subsequent to the date of this prospectus.
We
incorporate by reference the following documents or information that we have filed with the SEC:
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the
Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2022, filed with the SEC on March 29, 2023; |
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the
Company’s Reports on Form 6-K filed with the SEC on March
30, 2023, May
4, 2023, May
4, 2023, May
9, 2023 (solely with respect to the first and third paragraphs of the press release attached thereto as Exhibit
99.1), May
11, 2023, May
12, 2023, June
1, 2023 (solely with respect to the Form 6-K and the text under the heading “Financial Summary – First Quarter 2023
vs. First Quarter 2022” in Exhibit
99.1 attached thereto), July 10, 2023 (solely with respect to the first paragraph of the press release attached thereto as Exhibit
99.1), July
14, 2023, July
18, 2023, August
2, 2023, August
9, 2023, August
9, 2023, September
13, 2023, September
20, 2023, September
21, 2023, September
22, 2023, September
26, 2023(solely with respect to the first paragraph of the press release attached thereto as Exhibit
99.1 ), November
20, 2023 (solely with respect to the first and third paragraphs of the press release attached thereto as Exhibit 99.1) and November 22, 2023;
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The
description of our ordinary shares, which is contained in our registration statement on Form 8-A filed with the SEC pursuant to the
Exchange Act on March 1, 2014 (File No. 001-36345), as amended by Exhibit 2.1 to the Company’s Annual Report on Form 20-F for
the fiscal year ended December 31, 2022, filed with the SEC on March 29, 2023. |
All subsequent annual reports
filed by us pursuant to the Exchange Act on Form 20-F prior to the termination of an offering shall be deemed to be incorporated by reference
to this prospectus and to be a part hereof from the date of filing of such documents. We may also incorporate part or all of any Form
6-K subsequently submitted by us to the SEC prior to the termination of an offering by identifying in such Forms 6-K that they, or certain
parts of their contents, are being incorporated by reference herein, and any Forms 6-K so identified shall be deemed to be incorporated
by reference in this prospectus and to be a part hereof from the date of submission of such documents. Any statement contained in a document
incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus
to the extent that a statement contained herein or in any other subsequently filed document which also is incorporated or deemed to be
incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this prospectus.
The information we incorporate
by reference is an important part of this prospectus, and later information that we file with the SEC will automatically update and supersede
the information contained in this prospectus.
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 us at Galmed Pharmaceuticals Ltd., 16 Tiomkin Street, Tel Aviv, Israel, 6578317, Attention: Yohai
Stenzler, Chief Accounting Officer, telephone number: +972-3-693-8448.
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 experts named in this prospectus, most of whom reside outside the United
States, may be difficult to obtain within the United States. Furthermore, because a major portion of our assets and most 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 been informed by our legal counsel in Israel, Meitar | Law Offices, that it may be difficult to initiate an action with respect
to U.S. securities law in original actions instituted in Israel or obtain a judgement based on
the civil liability provisions of the U.S. federal securities laws. 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 specified time limitations and legal procedures, an Israeli court may enforce a foreign 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, among other things, it finds that:
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judgment was rendered by a court which was, according to the laws of the state of the court, competent to render the judgment, |
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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 |
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the
judgment is executory in the state in which it was given. |
Even
if the above conditions are satisfied, an Israeli court will not enforce a foreign judgment if:
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the
judgement was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional
cases); |
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the
enforcement of the judgement is likely to prejudice the sovereignty or security of the State of Israel; |
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the
judgment was obtained by fraud, |
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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, |
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the
judgment was rendered by a court not competent to render it according to the laws of private international law in Israel, |
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the
judgment is at variance with another judgment that was given in the same matter between the same parties and which is still valid,
or |
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at
the time the action was brought in the foreign court a suit 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 Israel 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.
Puglisi
& Associates is the U.S. agent authorized to receive service of process in any action against us arising out of this offering. The
address of Puglisi & Associates is 850 Library Avenue, Newark, Delaware 19711.
9,053,000 Ordinary
Shares Issuable Upon Exercise of Warrants
Galmed Pharmaceuticals Ltd.
PRELIMINARY PROSPECTUS
,
2023
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
8. Indemnification of Directors, Officers and Employees.
Under
the Israeli Companies Law, 5759-1999, or 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 the duty of care but only if a provision authorizing such exculpation is
included in its articles of association. Our Articles 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 and the Israeli Securities Law, 5728-1968, or the Securities Law, a company may indemnify, or undertake in advance
to indemnify, an office holder for the following liabilities and expenses, imposed on office holder or incurred by office holder due
to acts performed by him or her as an office holder, provided its articles of association include a provision authorizing such indemnification:
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monetary
liability incurred by or 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 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; |
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reasonable
litigation expenses, including attorneys’ fees, incurred by the office holder 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 (i) no indictment
was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability 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 or as a monetary
sanction; |
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a
monetary liability imposed on him or her in favor of an injured party at an Administrative Procedure (as defined below) pursuant
to Section 52(54)(a)(1)(a) of the Securities Law; |
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expenses
incurred by an office holder in connection with an Administrative Procedure under the Securities Law, including reasonable litigation
expenses and reasonable attorneys’ fees; and |
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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. |
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An
“Administrative Procedure” is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities
Authority), H4 (Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent
Procedures or Interruption of procedures subject to conditions) to the Securities Law. |
Under
the Companies Law and the Securities Law, a company may insure an office holder against the following liabilities incurred for acts performed
by him or her as an office holder if and to the extent provided in the company’s articles of association:
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● |
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 such act would not prejudice the company; |
|
● |
a
breach of the duty of care to the company or to a third-party; |
|
|
|
|
● |
a
monetary liability imposed on the office holder in favor of a third-party; |
|
|
|
|
● |
a
monetary liability imposed on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54)(a)(1)(a)
of the Securities Law; and |
|
|
|
|
● |
expenses
incurred by an office holder in connection with an Administrative Procedure, including reasonable litigation expenses and reasonable
attorneys’ fees. |
Nevertheless,
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 in the
event office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; |
|
|
|
|
● |
a
breach of the 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 unlawful personal benefit; or |
|
|
|
|
● |
a
fine, monetary sanction, penalty or forfeit levied against the office holder. |
Under
the Companies Law, exculpation, indemnification and insurance of office holders require the approval of the remuneration committee, board
of directors and, in certain circumstances, the shareholders, as described under “Item 6 — Directors, Senior Management and
Employees—B. Compensation” in our Annual Report on Form 20-F for the fiscal year ended December 31, 2022, as filed with the
SEC on March 29, 2023.
Our
Articles permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted by the Companies Law and Securities
Law. Each of our office holders have entered into an indemnification agreement exculpating them, to the fullest extent permitted by Israeli
law, from liability to us for damages caused to us as a result of a breach of the duty of care and undertaking to indemnify them to the
fullest extent permitted by Israeli law, including with respect to liabilities resulting from certain acts performed by such office holders
in their capacity as an office holder of the Company, our subsidiaries or our affiliates. The indemnification is limited both in terms
of amount and coverage.
In
the opinion of the SEC, indemnification of directors and office holders for liabilities arising under the Securities Act, however, is
against public policy and therefore unenforceable.
Item
9. Exhibits.
EXHIBIT
INDEX
EXHIBIT
NUMBER |
|
EXHIBIT
DESCRIPTION |
|
|
|
3.1** |
|
Articles of Association of the Registrant, as currently in effect |
|
|
|
4.1**
|
|
Form of Pre-Funded Warrant |
|
|
|
4.2**
|
|
Form of Placement Agent Warrant |
|
|
|
4.3**
|
|
Form of Common Warrant |
|
|
|
4.4** |
|
Form of Warrant Agency Agreement |
|
|
|
5.1**
|
|
Opinion of Meitar | Law Offices, Israeli counsel to the registrant |
|
|
|
5.2**
|
|
Opinion of Greenberg Traurig, P.A., U.S. counsel to the registrant |
|
|
|
10.1 |
|
Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.2 to the registrant’s registration statement on Form F-1, as amended, filed with the SEC on February 28, 2014 (File No. 333-193792)) |
|
|
|
10.2 |
|
Galmed Pharmaceuticals Ltd. 2013 Incentive Share Option Plan (incorporated herein by reference to Exhibit A to the registrant’s Report on Form 6-K filed with the SEC on April 2, 2015) |
|
|
|
10.3 |
|
Registration and Information Rights Agreement, dated December 2013, by and among Galmed Pharmaceuticals Ltd., Shirat HaChaim Ltd., David & Debora Goldfarb, Medgal S.A. and G. Yarom Medical Research Ltd. (incorporated herein by reference to Exhibit 10.1 to the registrant’s registration statement on Form F-1, as amended, filed with the SEC on February 6, 2014 (File No. 333-193792)) |
|
|
|
10.4 |
|
Personal Employment Agreement, dated December 23, 2013, by and between Galmed Medical Research Ltd. and Allen Baharaff (incorporated herein by reference to Exhibit 10.8 to the registrant’s registration statement on Form F-1, as amended, filed with the SEC on February 6, 2014 (File No. 333-193792)) |
|
|
|
10.5 |
|
Amendment No. 1 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (incorporated herein by reference to Exhibit 4.6 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 13, 2018) |
|
|
|
10.6 |
|
Amendment No. 2 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (incorporated herein by reference to Exhibit 4.6 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 18, 2021) |
|
|
|
10.7 |
|
Amendment No. 3 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (incorporated herein by reference to Exhibit 4.7 to the registrant’s Annual Report on Form 20-F filed with the SEC on May 2, 2022) |
|
|
|
10.8** |
|
Compensation Policy of Galmed Pharmaceuticals Ltd. |
|
|
|
10.9 |
|
Lease, dated March 22, 2015, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (incorporated herein by reference to Exhibit 4.8 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 23, 2017) |
|
|
|
10.10 |
|
Addendum to Lease, dated February 27, 2017, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (incorporated herein by reference to Exhibit 4.9 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 23, 2017) |
|
|
|
10.11 |
|
Addendum to Lease, dated August 8, 2018, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (incorporated herein by reference to Exhibit 4.9 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 13, 2019) |
10.12 |
|
Addendum to Lease, dated March 11, 2021, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (incorporated herein by reference to Exhibit 4.11 to the registrant’s Annual Report on Form 20-F filed with the SEC on March 18, 2021) |
|
|
|
10.13 |
|
Sales Agreement, dated March 26, 2021, among Galmed Pharmaceuticals Ltd., Cantor Fitzgerald & Co. and Canaccord Genuity LLC (incorporated herein by reference to Exhibit 1.1 to the registrant’s Report on Form 6-K filed with the SEC on March 26, 2021) |
|
|
|
10.14**
|
|
Form of Placement Agency Agreement |
|
|
|
10.15**
|
|
Form of Securities Purchase Agreement |
|
|
|
23.1* |
|
Consent of Brightman Almagor Zohar & Co. |
|
|
|
23.2**
|
|
Consent of Meitar | Law Offices, Israeli counsel to the registrant (included in Exhibit 5.1) |
|
|
|
23.3**
|
|
Consent of Greenberg Traurig, P.A., U.S. counsel to the registrant (included in Exhibit 5.2) |
|
|
|
24.1** |
|
Power of Attorney (included in signature pages of Registration Statement) |
|
|
|
107**
|
|
Filing Fee Table |
*
|
Filed
herewith.
|
**
| Previously
filed. |
Item
10. Undertakings.
|
(a) |
The
undersigned Registrant hereby undertakes: |
|
(1) |
To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
|
i. |
To
include any prospectus required by section 10(a)(3) of the Securities Act; |
|
|
|
|
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. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end
of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set
forth in the “Calculation of Registration Fee” table in the effective 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, 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. Notwithstanding the foregoing, with
respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and
information required by Section 10(a)(3) of the Act or Rule 3-19 of this chapter if such financial statements and information are
contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d)
of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F-3. |
|
|
|
|
(5) |
That,
for the purpose of determining liability under the Securities Act to any purchaser: |
|
i. |
If
the registrant is relying on Rule 430B: |
|
A. |
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration statement; and |
|
B. |
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after effectiveness of the date of the first contract or sale of securities
in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is
at that date and placement agent, such date shall be deemed to be a new effective date of the registration statement relating to
the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into
the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract
sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that
was part of the registration statement or made in any such document immediately prior to such effective date; or |
|
ii. |
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating
to an offering, other than registration statements relying on Rule 430B or other prospectuses filed in reliance on Rule 430A, shall
be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately
prior to such date of first use. |
|
(6) |
That,
for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution
of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant
to this registration statement, regardless of the placement agent 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) |
The
undersigned registrant hereby undertakes to provide to the placement agent at the closing specified in the placement agent agreements,
certificates in such denominations and registered in such names as required by the placement agent to permit prompt delivery to each
purchaser. |
|
(c) |
Insofar
as indemnification for liabilities arising under the Securities Act 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. |
|
|
|
|
(d) |
The
undersigned registrant hereby undertakes that: |
|
(1) |
That
for purposes of determining any liability under the Securities Act, 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, 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, as amended, the Registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form F-3 and has duly caused this Registration Statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in Tel Aviv, Israel on this 22nd day of November, 2023.
|
GALMED
PHARMACEUTICALS LTD. |
|
|
|
|
By: |
/s/
Allen Baharaff |
|
|
Allen
Baharaff |
|
|
President
and Chief Executive Officer |
Pursuant
to the requirements of the Securities Act, this Registration Statement has been signed by the following persons in the capacities and
on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Allen Baharaff |
|
Chief
Executive Officer, President, Director |
|
November
22, 2023 |
Allen
Baharaff |
|
(Principal
Executive Officer) |
|
|
|
|
|
|
|
* |
|
Chief
Financial Officer |
|
November
22, 2023 |
Doron
Cohen |
|
(Principal
Financial Officer) |
|
|
|
|
|
|
|
/s/
Yohai Stenzler |
|
Chief
Accounting Officer |
|
November
22, 2023 |
Yohai
Stenzler |
|
(Principal
Accounting Officer) |
|
|
|
|
|
|
|
* |
|
Director |
|
November
22, 2023 |
David
Sidransky, M.D. |
|
|
|
|
|
|
|
|
|
* |
|
Director
|
|
November
22, 2023 |
Shmuel
Nir |
|
|
|
|
|
|
|
|
|
* |
|
Director
|
|
November
22, 2023 |
Amir
Poshinski |
|
|
|
|
|
|
|
|
|
* |
|
Director
|
|
November
22, 2023 |
Carol
L. Brosgart, M.D. |
|
|
|
|
|
|
|
|
|
/s/
Yohai Stenzler |
|
|
|
|
Yohai
Stenzler |
|
|
|
|
Attorney
in Fact |
|
|
|
|
SIGNATURE
OF AUTHORIZED REPRESENTATIVE IN THE UNITED STATES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the undersigned, the duly authorized representative in the United States
of Galmed Pharmaceuticals Ltd., has signed this Registration Statement on this 22nd day of November, 2023.
|
Puglisi
& Associates |
|
|
|
Authorized
U.S. Representative |
|
|
|
|
|
/s/
Donald J. Puglisi |
|
Name:
|
Donald
J. Puglisi |
|
Title: |
Managing
Director |
Exhibit
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in this Amendment No. 1 to Post-Effective Amendment No. 1 to the Registration Statement on Form F-3,
of our report dated March 29, 2023 relating to the financial statements of Galmed Pharmaceuticals Ltd. (“the Company”) appearing
in the Company’s Annual Report on Form 20-F for the year ended December 31, 2022. We also consent to the reference to us under
the heading “Experts” in such Registration Statement.
/s/
Brightman Almagor Zohar & Co.
Certified
Public Accountants
A
Firm in the Deloitte Global Network
Tel
Aviv, Israel
November
22, 2023
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