XTL Biopharmaceuticals : Report of Periodic or Interim Report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES

EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT

OF 1934

For the fiscal year ended December 31, 2021

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE

ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the transition period from ____________to ___________.

Commission file number: 001-36000

XTL BIOPHARMACEUTICALS LTD.

(Exact name of registrant as specified in its charter)

N/A

(Translation of Registrant's Name into English)

Israel

(Jurisdiction of incorporation or organization)

5 Badner St.

Ramat Gan, 4365603, Israel

(Address of principal executive offices)

Shlomo Shalev

Chief Executive Officer

5 Badner St.

Ramat Gan, 4365603, Israel Tel: [phone] Fax: [phone]

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

American Depositary Shares, each representing one hundred Ordinary Shares, par

value NIS 0.1	XTLB	The Nasdaq Capital Market
(Title of Class)	Trading Symbol	(Name of each exchange on which
registered)

Securities registered or to be registered pursuant to Section 12(g) of the Act: None.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.

Indicate the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered by the annual report.

2,899,541 American Depositary Shares

544,906,149 Ordinary Shares

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐

No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes ☐

No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒

No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files.)

Yes ☒

No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of "large accelerated filer", "accelerated filer", and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☒

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 13(a) of the Exchange 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.

Indicate by check mark whether the registrant has fi led a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

US GAAP

☐ International Financial Reporting Standards as issued by ☒ Other ☐ the International Accounting Standards Board

If "Other" has been check in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17 ☐

Item 18 ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐

No ☒

XTL BIOPHARMACEUTICALS LTD. ANNUAL REPORT ON FORM 20-F

TABLE OF CONTENTS

Page

EXPLANATORY NOTE
SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS	ii
PART I	1
ITEM 1 Identity of Directors, Senior Management and Advisers	1
ITEM 2 Offer Statistics and Expected Timetable	1
ITEM 3 Key Information	1
ITEM 4 Information on the Company	20
ITEM 4A Unresolved Staff Comments	33
ITEM 5 Operating and Financial Review and Prospects	33
ITEM 6 Directors, Senior Management and Employees	39
ITEM 7 Major Shareholders and Related Party Transactions	49
ITEM 8 Financial Information	50
ITEM 9 The Offer and Listing	51
ITEM 10 Additional Information	51
ITEM 11 Quantitative and Qualitative Disclosures About Market Risk	72
ITEM 12 Description of Securities other than Equity Securities	72
PART II	73
ITEM 13 Defaults, Dividend Arrearages and Delinquencies	73
ITEM 14 Material Modifications to the Rights of Security Holders and Use of Proceeds	73
ITEM 15 Controls and Procedures	73
ITEM 16 Reserved	73
ITEM 16A Audit Committee Financial Expert	74
ITEM 16B Code of Ethics	74
ITEM 16C Principal Accountant Fees And Services	74
ITEM 16D Exemptions From The Listing Standards For Audit Committees	75
ITEM 16E Purchases Of Equity Securities By The Issuer And Affiliated Purchasers	75
ITEM 16F Change In Registrant's Registered Accountant	75
ITEM 16G Corporate Governance	75
ITEM 16I Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	75
PART III	F-1
ITEM 17 Consolidated Financial Statements	F-1
ITEM 18 Consolidated Financial Statements	F-1
ITEM 19 Exhibits	76
SIGNATURES	78

i

SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS

Certain matters discussed in this report, including matters discussed under the caption "Item 5. Operating and Financial Review and Prospects," may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. In some instances, you can identify these forward-looking statements by words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plan," "potential," "will," "should," "would," or similar expressions, including their negatives. These forward-looking statements include, without limitation, statements relating to our expectations and beliefs regarding:

• ● fluctuations in the market price of our securities;

• ● the possibility that our securities could be delisted from Nasdaq or the Tel-Aviv Stock Exchange ("TASE");

• ● potential dilution to the holders of our securities as a result of future issuances of our securities;

• ● fluctuations in our results of operations;

• ● the accuracy of our financial forecasts in our drug development activity and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives;

• ● the timing and cost of the in-licensing, partnering and acquisition of new product opportunities;

• ● the timing of expenses associated with product development and manufacturing of the proprietary drug candidates that we have acquired - hCDR1 for the treatment of SLE and SS, and those that may be in-licensed, partnered or acquired;

• ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

• ● other risks and uncertainties described in this report.

Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under "Item 3. Key Information-Risk Factors,"

"Item 4. Information on the Company," "Item 5. Operating and Financial Review and Prospects," and elsewhere in this report, as well as factors which may be identified from time to time in our other filings with the Securities and Exchange Commission, or the SEC, or in the documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements.

Forward-looking statements contained in this report reflect our views and assumptions only as of the date this report is filed. Therefore, you should not place undue reliance on any forward-looking statement as a prediction of future results. Forward-looking statements made in this report and the documents incorporated by reference are made as of the date of the respective documents, and we undertake no obligation to update them in light of new information or future results. Except as required by law, we assume no responsibility for updating any forward-looking statements.

ii

PART I

Unless the context requires otherwise, references in this report to "XTL," the "Company," "we," "us" and "our" refer to XTL Biopharmaceuticals Ltd, an Israeli company and our consolidated subsidiary. We have prepared

our consolidated financial statements in United States, or US, dollars and in accordance with International Financial

Reporting Standards, or IFRS. All references herein to "dollars" or "$" are to US dollars, and all references to "Shekels" or "NIS" are to New Israeli Shekels.

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

Not applicable

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable

ITEM 3. KEY INFORMATION

• A. Selected Financial Data

  Reserved.

• B. Capitalization And Indebtedness

  Not applicable.

• C. Reasons For Offer And Use Of Proceeds

  Not applicable.

• D. Risk Factors