UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
the month of May, 2023
Commission
File Number: 001-36000
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant’s name into English)
5
Badner St.
Ramat
Gan,
4365603,
Israel
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ________
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): _______
RAMAT
GAN, ISRAEL - (May 16, 2023) – XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or the “Company”),
a clinical-stage biopharmaceutical Company, today announced financial results for the three months ended March 31, 2023.
The
Company has an IP portfolio surrounding hCDR1 for the treatment of Lupus disease (SLE) and Sjögren’s Syndrom (SS) and has
decided, at this time, to explore collaboration with a strategic partner in order to execute the clinical trials. In parallel, the Company
is looking to expand and identify additional assets to add to XTL’s portfolio.
We
are currently operating in a period of economic uncertainty and capital markets disruption. Our business, financial condition and results
of operations may be materially adversely affected by any negative impact on the global economy and capital markets resulting from any
geopolitical tensions.
Financial
Overview for Three Months Ended March 31, 2023
XTL
reported approximately $1.9 million in cash and cash equivalents as of March 31, 2023 and approximately $1.0 million in other current
assets (mainly marketable securities) compared to $2.1 million in cash and cash equivalents as of December 31, 2022 and approximately
$1.7 million in other current assets (mainly marketable securities). The decrease of $0.2 million since December 31, 2022, in cash and
cash equivalents derives from operating expenses.
Research
and development expenses for the three months ended March 31, 2023 were $13 thousand compared to $6 thousand for the corresponding period
in 2022. Research and development expenses are comprised mainly of expenses related to maintenance of our intangible assets.
General
and administrative expenses for the three months ended March 31, 2023 were $238 thousand compared to $243 thousand for the corresponding
period in 2022. The decrease of $5 thousand considers as immaterial.
Finance
expense, net for the three months ended March 31, 2023 were $668 thousand compared to finance income, net of $755 thousand for the corresponding
period in 2022. The difference is primarily from revaluation of marketable securities and warrants to purchase ADS’s.
XTL
reported an operating loss for the three months ended March 31, 2023 of $251 thousand compared to $249 thousand for the corresponding
period in 2022. The Company reported a total loss for the period ended March 31, 2023 of approximately $919 thousand, compared to total
income of $506 thousand in the corresponding period in 2022. The change is driven primarily by the revaluation of marketable securities
and warrants as described above.
XTL
Biopharmaceuticals, Ltd. and Subsidiary
(USD
in thousands)
Unaudited
Condensed Consolidated Statements of Financial Position
| |
March 31, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
U.S. dollars in thousands | |
ASSETS | |
| | |
| |
| |
| | |
| |
CURRENT ASSETS: | |
| | | |
| | |
Cash and cash equivalents | |
| 1,904 | | |
| 2,094 | |
Marketable securities – InterCure Ltd. | |
| 972 | | |
| 1,627 | |
Prepaid expenses and other current assets | |
| 66 | | |
| 85 | |
| |
| | | |
| | |
| |
| 2,942 | | |
| 3,806 | |
| |
| | | |
| | |
NON-CURRENT ASSETS: | |
| | | |
| | |
Intangible assets, net | |
| 380 | | |
| 380 | |
| |
| | | |
| | |
Total assets | |
| 3,322 | | |
| 4,186 | |
| |
| | | |
| | |
LIABILITIES AND EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable | |
| 241 | | |
| 187 | |
| |
| | | |
| | |
Total liabilities | |
| 241 | | |
| 187 | |
| |
| | | |
| | |
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | |
| | | |
| | |
Share capital - ordinary shares of NIS 0.1 par value: authorized shares - 1,450,000,000 on March 31, 2023 and December 31, 2022; issued and outstanding: 544,906,149 on March 31, 2023 and December 31, 2022; | |
| 14,120 | | |
| 14,120 | |
Additional paid in capital | |
| 146,326 | | |
| 146,326 | |
Reserve from transactions with non-controlling interests | |
| 20 | | |
| 20 | |
Accumulated deficit | |
| (157,385 | ) | |
| (156,467 | ) |
| |
| | | |
| | |
Total equity | |
| 3,081 | | |
| 3,999 | |
| |
| | | |
| | |
Total liabilities and equity | |
| 3,322 | | |
| 4,186 | |
XTL
Biopharmaceuticals, Ltd. and Subsidiary
(USD
in thousands, except per share amounts)
Unaudited
Condensed Consolidated Statements of Comprehensive Loss
| |
For the three months ended | |
| |
March 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Research and Development expenses | |
$ | (13 | ) | |
$ | (6 | ) |
General and administrative expenses | |
| (238 | ) | |
| (243 | ) |
Operating Loss | |
$ | (251 | ) | |
$ | (249 | ) |
| |
| | | |
| | |
Revaluation of marketable securities | |
$ | (655 | ) | |
$ | 224 | |
Revaluation of warrants to purchase ADS’s | |
| - | | |
| 537 | |
Other finance income | |
| 12 | | |
| 3 | |
Other finance expense | |
| (25 | ) | |
| (9 | ) |
| |
| | | |
| | |
Finance income (expenses), net | |
| (668 | ) | |
| 755 | |
| |
| | | |
| | |
Total comprehensive income (loss) for the period | |
$ | (919 | ) | |
$ | 506 | |
| |
| | | |
| | |
Basic earnings (loss) per share (in U.S. dollars): | |
| (0.000 | ) | |
$ | 0.001 | |
Diluted earnings (loss) per share (in U.S. dollars): | |
| (0.000 | ) | |
$ | 0.000 | |
| |
| | | |
| | |
Weighted average number of issued ordinary shares (basic and diluted) | |
| 544,906,149 | | |
| 544,906,149 | |
Significant
events during the reporting period
On
March 2, 2023, the Company’s shareholders approved the grant of options exercisable into 150,000 of the Company’s ordinary
shares to one of the Company’s directors for an exercise price of NIS 0.0495 per share (USD 0.014 per share, respectively, based
on the exchange rate reported by the Bank of Israel on the same day). The options were fully vested on the day of grant.
About
hCDR1
hCDR1
is a novel compound with a unique mechanism of action and clinical data on over 400 patients in three clinical studies. The drug has
a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint.
For more information, please see the peer reviewed article in Lupus Science and Medicine journal titled “Safety and efficacy of
hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study”.
About
XTL Biopharmaceuticals Ltd. (XTL)
XTL
Biopharmaceuticals Ltd. is a clinical-stage biotech company. The Company’s lead drug candidate, hCDR1, is a clinical asset
for the treatment of autoimmune diseases including systemic lupus erythematosus (SLE) and Sjögren’s Syndrome (SS). The few
treatments currently on the market for these diseases are not effective enough for many patients and some have significant side effects.
hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more
than 40 peer reviewed scientific journals.
XTL
is traded on the Nasdaq Capital Market (NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTLB.TA). XTL shares are included in
the following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Tech Index.
For
further information, please contact:
Investor
Relations, XTL Biopharmaceuticals Ltd.
Tel:
+972 3 611 6666
Email:
ir@xtlbio.com
www.xtlbio.com
Cautionary
Statement
This
disclosure may contain forward-looking statements, about XTL’s expectations, beliefs or intentions regarding, among other things,
its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time
to time, XTL or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements
can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,”
“may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable
words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements
may be included in, but are not limited to, various filings made by XTL with the U.S. Securities and Exchange Commission, press releases
or oral statements made by or with the approval of one of XTL’s authorized executive officers. Forward-looking statements relate
to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause XTL’s
actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could
cause XTL’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking
statements, including, but not limited to, the factors summarized in XTL’s filings with the SEC and in its periodic filings with
the TASE. In addition, XTL operates in an industry sector where securities values are highly volatile and may be influenced by economic
and other factors beyond its control. XTL does not undertake any obligation to publicly update these forward-looking statements, whether
as a result of new information, future events or otherwise. Please see the risk factors associated with an investment in our ADSs or
ordinary shares which are included in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March
22, 2023.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Date: May 16, 2023 |
XTL BIOPHARMACEUTICALS LTD. |
|
|
|
By: |
/s/
Shlomo Shalev |
|
|
Shlomo Shalev
Chief Executive Officer |
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