Purple Biotech : Immediate report on other matter

As filed with the Securities and Exchange Commission on October 30, 2023

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM F-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

PURPLE BIOTECH LTD.

(Exact name of Registrant as specified in its charter)

Israel	2834		Not applicable
(State or other jurisdiction of		(Primary Standard Industrial		(I.R.S. Employer
incorporation or organization)		Classification Code Number)		Identification No.)

4 Oppenheimer Street

Science Park

Rehovot 7670104, Israel

(Address including zip code, and telephone number, including area code, of Registrant's principal executive offices)

Lior Fhima, Chief Financial Officer

4 Oppenheimer Street

Science Park

Rehovot 7670104, Israel

Tel: [phone]; Fax: [phone]

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies of all communications, including communications sent to agent for service, should be sent to:

Rick A. Werner, Esq.	Sharon Rosen, Adv.
Jayun Koo, Esq.	FISCHER (FBC & Co.).
Haynes and Boone, LLP	Derech Menachem Begin 146
30 Rockefeller Plaza, 26th Floor	Tel Aviv-Yafo 6492103, Israel
New York, New York 10112	[phone]
Tel. [phone]
Fax [phone]

Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards † provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

• The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this Registration Statement shall become effective on such date as the SEC, acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. The selling shareholders named in this prospectus may not sell these securities until the Registration Statement filed with the Securities and Exchange Commission, of which this prospectus is a part, is effective. This prospectus is not an offer to sell these securities and the selling shareholders named in this prospectus are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED OCTOBER 30, 2023

PROSPECTUS

4,652,175 American Depositary Shares representing 46,521,750 Ordinary Shares

Purple Biotech Ltd.

This prospectus relates to the resale by the selling shareholders named in this prospectus from time to time of up to an aggregate of 4,652,175 American Depositary Shares (the "Offered ADSs"), with each American Depositary Share ("ADS") representing 10 of our ordinary shares, no par value per share ("Ordinary Shares"), or 46,521,750 Ordinary Shares in the aggregate, issued or issuable upon the exercise of warrants (the "Warrants", comprised of the October Warrants and Placement Agent Warrants as defined below), that include (i) warrants issued in a concurrent private placement in connection with our registered direct offering in October 2023 (the "October Warrants"), pursuant to the Securities Purchase Agreement, dated as of October 17, 2023, between us and the investor named therein (the "Securities Purchase Agreement"), and (ii) warrants issued in a private placement (the "Placement Agent Warrants") pursuant to an engagement letter dated as of September 26, 2023 (the "Engagement Letter"), between us and H.C. Wainwright & Co., LLC ("Wainwright").

We will not receive any of the proceeds from the sale of the Offered ADSs by the selling shareholders. Any ADSs subject to resale hereunder will have been issued by us and acquired by the selling shareholders prior to any resale of such shares pursuant to this prospectus.

The selling shareholders named in this prospectus and any of their pledgees, assignees and successors-in-interest, may offer or resell the Offered ADSs from time to time through public or private transactions at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. The selling shareholders will bear all commissions and discounts, if any, attributable to the sale of the Offered ADSs. We will bear all costs, expenses and fees in connection with the registration of the Ordinary Shares. For additional information on the methods of sale that may be used by the selling shareholders, see "Plan of Distribution" beginning on page 13 of this prospectus.

The ADSs are listed on The Nasdaq Capital Market ("Nasdaq") under the symbol "PPBT." On October 27, 2023, the last reported sale price of the ADSs on Nasdaq was $1.36 per ADS. Our Ordinary Shares are also listed on the Tel Aviv Stock Exchange ("TASE") under the symbol "PPBT." On October 29, 2023, the last reported sale price of our Ordinary Shares on the TASE was NIS 0.534, or USD 0.131 per ordinary share (based on the exchange rate reported by the Bank of Israel on such date, which was NIS 4.081 = USD 1.00).

For any taxable year that we determine that we are a Passive Foreign Investment Company ("PFIC"), we may in our sole discretion (i) provide notice of our status as a PFIC as soon as practicable following such taxable year; and (ii) comply with all reporting requirements necessary for U.S. Holders (as defined below) to make Qualified Electing Fund elections, including providing to shareholders upon request the information necessary for such an election.

Investing in our securities involves a high degree of risk. These risks are discussed in this prospectus under "Risk Factors" beginning on page 4 and the "Risk Factors" in "Item 3. Key Information - D. Risk Factors" of our most recent Annual Report on Form 20-F, which is incorporated by reference in this prospectus, as well as in any other recently filed reports and, if any, in any applicable prospectus supplement.

Neither the Securities and Exchange Commission (the "SEC") nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is	, 2023

	TABLE OF CONTENTS
		Page
About This Prospectus		ii
Cautionary Statement Regarding Forward-Looking Statements		iii
Prospectus Summary	1
The Offering	3
Risk Factors	4
Use of Proceeds	6
Capitalization and Indebtedness	7
Selling Shareholders	9
Plan of Distribution	13
Expenses	20
Legal Matters	21
Experts	21
Where You Can Find Additional Information	21
Incorporation of Documents by Reference	22
Enforceability of Civil Liabilities	23

i

ABOUT THIS PROSPECTUS

The selling shareholders named in this prospectus may resell, from time to time, in one or more offerings, the Offered ADSs. Information about the selling shareholders may change over time. When the selling shareholders sell Offered ADSs representing Ordinary Shares under this prospectus, we will, if necessary and required by law, provide a prospectus supplement that will contain specific information about the terms of that offering. Any prospectus supplement may also add to, update, modify or replace information contained in this prospectus. If a prospectus supplement is provided and the description of the offering in the prospectus supplement varies from the information in this prospectus, you should rely on the information in the prospectus supplement. You should carefully read this prospectus and the accompanying prospectus supplement, if any, along with all of the information incorporated by reference herein, before making an investment decision.

You should rely only on the information contained or incorporated by reference in this prospectus or any applicable prospectus supplement. We have not, and the selling shareholders have not, authorized any other person to provide you with different or additional information. If anyone provides you with different or additional information, you should not rely on it. This prospectus is not an offer to sell, nor are the selling shareholders seeking an offer to buy, the Offered ADSs in any jurisdiction where the offer or sale is not permitted. No offers or sales of any of the Offered ADSs are to be made in any jurisdiction in which such an offer or sale is not permitted. You should assume that the information contained in this prospectus or in any applicable prospectus supplement is accurate only as of the date on the front cover thereof or the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any applicable prospectus supplement or any sales of the Offered ADSs offered hereby or thereby.

You should read the entire prospectus and any prospectus supplement and any related issuer free writing prospectus, as well as the documents incorporated by reference into this prospectus or any prospectus supplement or any related issuer free writing prospectus, before making an investment decision. Neither the delivery of this prospectus or any prospectus supplement or any issuer free writing prospectus nor any sale made hereunder shall under any circumstances imply that the information contained or incorporated by reference herein or in any prospectus supplement or issuer free writing prospectus is correct as of any date subsequent to the date hereof or of such prospectus supplement or issuer free writing prospectus, as applicable. You should assume that the information appearing in this prospectus, any prospectus supplement or any document incorporated by reference is accurate only as of the date of the applicable documents, 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.

Unless the context otherwise requires, all references to "Purple Biotech," "we," "us," "our," the "Company" and similar designations refer to Purple Biotech Ltd. together with (i) its majority owned subsidiary, TyrNovo Ltd. ("TyrNovo"), (ii) its wholly owned subsidiary, FameWave Ltd. ("FameWave"), (iii) its wholly owned subsidiary, Immunorizon Ltd. ("Immunorizon"), and (iv) its wholly owned subsidiary Purple Biotech GmbH, except where otherwise stated or where it is clear that the terms mean only Purple Biotech Ltd. exclusive of any subsidiaries.

The term "NIS" refers to New Israeli Shekels, the lawful currency of the State of Israel, and the terms "dollar," "USD" or "$" refer to U.S. dollars, the lawful currency of the United States ("U.S."). Our functional and presentation currency is the U.S. dollar. Foreign currency transactions in currencies other than the U.S. dollar are translated in this prospectus into U.S. dollars using exchange rates in effect at the date of the transactions.

For purposes of this description, the term "U.S. Holder" means a beneficial owner of the ADSs that, for U.S. federal income tax purposes, is (i) a citizen or resident of the United States, (ii) a corporation (or entity treated 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 (x) 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 (y) that has elected to be treated as a domestic trust for U.S. federal income tax purposes.

ii

CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS

This prospectus and the information incorporated by reference herein may include forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. In addition, certain sections of this prospectus and the information incorporated by reference herein contain information obtained from independent industry and other sources that we have not independently verified. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements.

Our ability to predict our operating results or the effects of various events on our operating results is inherently uncertain. Therefore, we caution you to consider carefully the matters described under the caption "Risk Factors" on page 4 of this prospectus and certain other matters discussed in this prospectus, and the information incorporated by reference herein. Such factors and many other factors beyond our control could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by the forward-looking statements.

Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:

• the initiation, timing, progress and results of our research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, including the safety and efficacy of our drug candidates, as well as the extent and number of additional studies that we may be required to conduct;
• our ability to advance our therapeutic candidates into the next stages of clinical trials, or to successfully complete our planned and ongoing preclinical studies or clinical trials;
• our receipt of regulatory clarity and approvals for our therapeutic candidates and the timing of other regulatory filings and approvals;
• our ability to acquire or in-license additional therapeutic candidates, integrate acquired therapeutic candidates successfully into our business and to realize the anticipated benefits of acquisitions, such as our recent Immunorizon acquisition;
• a delay or rejection of an Investigational New Drug Application ("IND"), New Drug Application ("NDA") or Biologics License Application ("BLA") for one or more of our therapeutic candidates;
• our ability to maintain compliance with Nasdaq listing standards;
• the regulatory environment and changes in the health policies and regimes in the countries in which we operate including the impact of any change in regulation and legislation that could affect the pharmaceutical industry, and the difficulty of predicting actions of the Food and Drug Administration ("FDA"), or any other applicable regulator of pharmaceutical products;
• the research, manufacturing, preclinical and clinical development, commercialization, and market acceptance of our therapeutic candidates;
• our ability to successfully acquire, develop or commercialize our drug candidates;
• our ability to establish collaborations for our therapeutic candidates;
• the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials;
• the implementation of our business model, strategic plans for our business and therapeutic candidates;
• the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others;
• estimates of our expenses, revenues, capital requirements and our needs for additional financing;
• the impact of competitive companies, technologies on our industry; and
• the impact of the security, political and public health situation in Israel, the U.S. and other countries in which we may operate or obtain approvals for our products or our business.

iii

PROSPECTUS SUMMARY

This summary highlights selected information about us and information contained in greater detail elsewhere in this prospectus, and in the documents incorporated by reference herein. This summary is not complete and does not contain all of the information that you should consider before investing in the Offered ADSs. You should carefully read and consider this entire prospectus and information incorporated by reference into this prospectus, including the financial statements and related notes and "Risk Factors" starting on page 4 of this prospectus, before making an investment decision. If you invest in our securities, you are assuming a high degree of risk.

The Company

We are a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance.

We are focused on oncology and our pipeline includes: (i) CM24, a humanized monoclonal antibody that blocks the interactions of Carcinoembryonic Antigen Related Cell Adhesion Molecule 1 (CEACAM1), an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways, (ii) NT219, a small molecule that simultaneously targets and inhibits Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer and Activator of Transcription (STAT3), two signal transduction pathways involved in the development of cancer drug resistance mechanisms; and (iii) IM1240, a conditionally-activatedtri-specific antibody that engages both T cells and NK cells. The third arm of IM1240 specifically targets the Tumor Associated Antigen (TAA) 5T4. In developing these therapeutic candidates, we address not only the tumor itself but also the tumor microenvironment, which we believe may improve patient outcome.

• We are conducting a randomized, controlled, open label multicenter phase 2 study to investigate CM24 in combination with the anti-PD-1 checkpoint inhibitor nivolumab for the treatment of pancreatic ductal adenocarcinoma (PDAC) when administered in combination with standard of care chemotherapy compared to chemotherapy alone. We have entered into a clinical collaboration agreement with Bristol Myers Squibb to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab and nab-paclitaxel in this study. We expect to release interim data in the second half of 2023 and a topline report on the overall study by the end of 2024;
• We are conducting a phase 1/2 dose escalation study of NT219 as a single agent in patients with solid tumors, and a dose escalation phase of NT219 in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer or colorectal adenocarcinoma. These studies will be followed by an expansion phase of NT219 at its recommended phase 2 dose level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. We reported positive interim and preliminary results in which anti-tumor activity was noted in the highest dose cohort of NT219 in combination with cetuximab. We continue to explore higher dose optimization and are planning to enter into a phase 2 study in the first half of 2024; and
• We are conducting preclinical studies with IM1240 and expect to reach IND submission in approximately two years.

In addition, we are seeking the acquisition of additional oncology therapeutic candidates at various stages of development to expand and diversify our portfolio and to leverage our development capabilities.

1

October Registered Direct Offering and Concurrent Private Placement

On October 17, 2023, we entered into the Securities Purchase Agreement with an institutional investor, pursuant to which we issued and sold (A) in a registered direct offering, 2,430,000 ADSs and pre-funded warrants to purchase up to 1,917,827 ADS, and (B) in a concurrent private placement, the October Warrants to purchase up to 4,347,827 ADSs, which have an exercise price of $1.25 per ADS, are exercisable immediately and will expire on April 19, 2029, at an offering price of $1.15 per ADS and associated October Warrant and an offering price of $1.149 per pre-funded warrant and associated October Warrant (the "October Offering").

As part of the compensation to Wainwright in connection with the October Offering, we issued to Wainwright unregistered Placement Agent Warrants to purchase up to an aggregate of 304,348 ADSs at an exercise price of $1.4375 per ADS, pursuant to the Engagement Letter. The Placement Agent Warrants expire on October 17, 2028.

In connection with the October Offering, we expect to issue up to approximately 735,000 ADSs pursuant to an anti-dilution provision of that certain Lock-Up and Registration Rights Agreements entered into with former Immunorizon shareholders in connection with the acquisition of Immunorizon in February 2023 (the "Anti-Dilution Share Issuance").

Amendment of June 2020 Warrants and June 2018 Warrants

In connection with the October Offering, we agreed with the investor in the October Offering to amend (i) certain existing warrants to purchase an aggregate of 555,556 ADSs at an exercise price of $9.00 per ADS, issued on June 23, 2020 (the "June 2020 Warrants"), and (ii) certain existing warrants to purchase an aggregate of 76,000 ADSs at an exercise price of $28.00 per ADS issued on June 1, 2018 (the "June 2018 Warrants"), so that such amended warrants, in each case, will have a reduced exercise price of $1.25 per ADS and an expiration date of April 19, 2029 (the "Warrant Amendment").

Corporate Information

We were incorporated under the laws of the State of Israel (under a previous name) on August 12, 1968. Our Ordinary Shares were originally listed for trading on the TASE in 1978 and the ADSs have been traded on Nasdaq since November 2015. Our Ordinary Shares are currently traded on the TASE under the symbol "PPBT", and the ADSs are currently traded on Nasdaq under the symbol "PPBT". The Company is headquartered at 4 Oppenheimer Street, Science Park, Rehovot 7670104, Israel and our telephone number is [phone]. Our website address is www.purple-biotech.com. Information contained on, or that can be accessed through, our website does not constitute a part of this prospectus and is not incorporated by reference herein. We have included our website address in this prospectus solely for informational purposes. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, such as us, that file electronically with the SEC at www.sec.gov.

2

	THE OFFERING
Securities offered by the selling shareholders	Up to 4,652,175 ADSs representing 46,521,750 Ordinary Shares.
The ADSs	Each ADS represents 10 of our Ordinary Shares. The ADSs will be delivered by The Bank of New York
	Mellon, as depositary (the "Depositary").
	The Depositary, as depositary, or its nominee, will be the holder of the Ordinary Shares underlying the ADSs
	and you will have rights as provided in the Deposit Agreement, dated as November 20, 2015, among us, the
	Depositary and all owners and holders from time to time of ADSs issued thereunder (the "Deposit
	Agreement"), a form of which has been filed as Exhibit 1 to the Registration Statement on Form F-6 filed by
	the Depositary with the SEC on November 6, 2015.
	Subject to the terms of the Deposit Agreement and in compliance with the relevant requirements set out in the
	prospectus, you may turn in the ADSs to the Depositary for cancellation and withdrawal of the Ordinary
	Shares underlying the ADSs. The Depositary will charge you fees for such cancellations pursuant to the
	Deposit Agreement.
	You should carefully read the Deposit Agreement to better understand the terms of the ADSs.
Selling shareholders	All of the Offered ADSs are being offered by the selling shareholders named herein. See "Selling
	Shareholders" on page 9 of this prospectus for more information on the selling shareholders.
Use of proceeds	We will not receive any proceeds from the sale by the selling shareholders of the Offered ADSs issued or
	issuable upon exercise of the Warrants. However, we may receive the proceeds from any exercise of the
	Warrants if the holders exercise the Warrants for cash. We intend to use the proceeds from the exercise of the
	Warrants for cash, if any, to fund the development of our oncology drug candidates, acquisition of new assets
	and for general working capital purposes. We currently have no binding agreements or commitments to
	complete any transaction for the possible acquisition of new therapeutic candidates, though we are currently,
	and likely to continue, exploring possible acquisition candidates. See the section of this prospectus titled "Use
	of Proceeds."
Plan of Distribution	The selling shareholders, and any of their pledgees, and successors-in-interest, may offer or sell the Offered
	ADSs from time to time through public or private transactions at prevailing market prices, at prices related to
	prevailing market prices or at privately negotiated prices. The selling shareholders may also resell the Offered
	ADSs to or through underwriters, broker- dealers or agents, who may receive compensation in the form of
	discounts, concessions or commissions. See "Plan of Distribution" beginning on page 13 of this prospectus for
	additional information on the methods of sale that may be used by the selling shareholders.
Risk factors	See "Risk Factors" beginning on page 4 and the other information included elsewhere in this prospectus for a
	discussion of factors you should carefully consider before deciding to invest in the ADSs.
Listing	The ADSs are listed on Nasdaq under the symbol "PPBT" and our Ordinary Shares are listed on the TASE
	under the symbol "PPBT."
	3

RISK FACTORS

Investing in our securities involves a high degree of risk. In addition to the other information contained in this prospectus and in the documents we incorporate by reference herein, you should carefully consider the risks discussed below and under the heading "Risk Factors" in the Annual Report on Form 20-F for the year ended December 31, 2022, before making a decision about investing in our securities. The risks and uncertainties discussed below and in the Annual Report on Form 20-F are not the only ones facing us. Additional risks and uncertainties not presently known to us, or that we currently see as immaterial, may also harm our business. If any of these risks occur, our business, financial condition and operating results could be harmed, the trading price of the ADSs could decline, and you could lose part or all of your investment.

Please also read carefully the section above entitled "Cautionary Statement Regarding Forward-Looking Statements."

Risks Related to the Current Condition in Israel

We conduct our operations in Israel. Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel's war against them, may affect our operations.

Because we are incorporated under the laws of the state of Israel and our operations are conducted in Israel, our business and operations are directly affected by economic, political, geopolitical and military conditions in Israel. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist organizations active in the region. These conflicts have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively affected business conditions in Israel.

In October 2023, Hamas terrorists infiltrated Israel's southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel's border with the Gaza Strip and in other areas within the State of Israel. Following the attack, Israel's security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Moreover, the clash between Israel and Hezbollah in Lebanon, may escalate in the future into a grater regional conflict.

Any hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners could adversely affect our operations and results of operations and could make it more difficult for us to raise capital. Parties with whom we may do business have sometimes declined to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary. The conflict situation in Israel could cause situations where medical product certifying or auditing bodies could not be able to visit manufacturing facilities of our subcontractors in Israel in order to review our certifications or clearances, thus possibly leading to temporary suspensions or even cancellations of our product clearances or certifications. The conflict situation in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.

There have been travel advisories imposed as related to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be imposed in the future. An inability to receive supplies and materials, shortages of materials or difficulties in procuring our materials, among others, may adversely impact our ability to commercialize and manufacture our product candidates and products in a timely manner. This could cause a number of delays and/or issues for our operations, including delay of the review of our product candidates by regulatory agencies, which in turn would have a material adverse impact on our ability to commercialize our product candidates.

4