XTLB XTL Biopharmaceuticals Ltd

 

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 November, 2021

 

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 - (November 24, 2021) – XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or the “Company”), a clinical-stage biopharmaceutical Company, today announced financial results for the nine months ended September 30, 2021.

 

The Company is expanding its IP portfolio surrounding hCDR1 and has decided, at this time, to explore cooperation with a strategic partner in order to execute its clinical trials. In parallel, the Company will look to expand and identify additional assets to add to XTL’s portfolio.

 

The outbreak of the COVID-19 virus (hereafter, “Coronavirus”) in the world in the first half of 2020 and its spread, causes great uncertainty in the world capital markets and major macroeconomic implications, which are characterized by sharp declines and volatility in many securities’ prices.

 

As of the date of issuance of the financial reporting, there was no material effect of the Coronavirus on the operations and financial results of the Company. Although, due to the ongoing uncertainty around the scope and duration of the Coronavirus, as of the financial statement publication date, there is uncertainty regarding its impact on the economy and the market state at all, and those impacts on the value of the securities held by the Company.

 

The Company is monitoring and will continue to monitor the developments around the world in connection with the spread of the Coronavirus, and will examine the implications for its activities.

 

Financial Overview for Nine Months Ended September 30, 2021

 

XTL reported approximately $3.01 million in cash and cash equivalents as of September 30, 2021 and approximately $3.46 million in other current assets (mainly marketable securities). The decrease of $0.62 million since December 31, 2020, in cash and cash equivalents derives from operating expenses.

 

Research and development expenses for the nine months ended September 30, 2021 were $24 thousand compared to $26 thousand for the corresponding period in 2020. Research and development expenses are comprised mainly of expenses related to maintenance of our intangible assets. 

 

General and administrative expenses for the nine months ended September 30, 2021 were $721 thousand compared to $665 thousand for the corresponding period in 2020. The increase of $57 thousand derives mainly from expenses related to the restatement.

 

Finance expenses, net for the nine months ended September 30, 2021 were $915 thousand compared to $1,187 thousand for the corresponding period in 2020. The difference is primarily from revaluation of marketable securities and warrants to purchase ADS’s.

 

XTL reported an operating loss for the nine months ended September 30, 2021 of $745 thousand compared to $691 thousand for the corresponding period in 2020. The Company reported a total loss for the period ended September 30, 2021 of approximately $1,660 thousand or $0.003 per share, compared to $1,878 thousand or $0.004 per share in the corresponding period in 2020. The change is driven primarily by the revaluation of marketable securities and warrants as described above.

 

 

XTL Biopharmaceuticals, Ltd. and Subsidiary

 

(USD in thousands)

Consolidated Statements of Financial Position - Selected Data

 

		As of September 30, 2021				As of December 31, 2020 (Restated)
Cash, cash equivalents		$	3,011			$	3,631
Other current assets			3,462				2,490
Non-current assets			382				382
Total assets		$	6,855			$	6,503
Current liabilities		$	185			$	254
Non-current liabilities			3,591				2,637
Shareholders’ equity			3,079				3,612
Total liabilities and shareholders’ equity		$	6,855			$	6,503

 

 

XTL Biopharmaceuticals, Ltd. and Subsidiary

 

(USD in thousands, except per share amounts)

Consolidated Statements of Comprehensive Income - Selected Data

 

		For the nine months ended								For the year ended
		September 30,								December 31,
		2021				2020				2020
						As Restated				As Restated
Research and Development expenses		$	(24	)		$	(26	)		$	(38	)
General and administrative expenses			(721	)			(665	)			(910	)
Operating Loss		$	(745	)		$	(691	)		$	(948	)
Revaluation of marketable securities		$	841			$	(312	)		$	138
Revaluation of warrants to purchase ADS’s			(1,747	)			(891	)			(2,172	)
Other finance income (loss), net			(9	)			16				28
Finance income (expenses), net		$	(915	)		$	(1,187	)		$	(2,006	)
Total income (loss) for the period		$	(1,660	)		$	(1,878	)		$	(2,954	)
Basic and diluted income (loss) per share (in U.S. dollars):
From continuing operations		$	(0.003	)		$	(0.004	)		$	(0.006	)
Weighted average number of issued ordinary shares			527,785,640				514,205,799				514,205,799

 

 

Restatement of previously issued consolidated financial statements for Nine Months Ended September 30, 2020

 

In March 2018 the Company’s warrants were recorded as share premium as a result of the cancellation of the cashless exercise mechanism.

 

During the second quarter of 2021, the Company concluded that the cashless exercise mechanism was not in fact cancelled when the registration statement originally declared effective in March 2018 became stale, as a result of which the right to exercise the warrants on a cashless basis was again possible, resulting in the situation that the warrants should have been recorded as non-current liabilities, and not as equity instruments.

 

The financial statements for the year ended December 31, 2020 were restated and filed on May 13, 2021 

 

The impacts of the warrant change of classification for the nine months ended September 30, 2020 and for the year ended December 31, 2020 are as follows:

 

Impact on the consolidated statement of comprehensive income (loss):

 

		Nine months ended September 30,
		2020
		As previously reported				As restated				Adjustments
		U.S. dollars in thousands
Revaluation of warrants to purchase ADSs			-				891				891
Finance income (expenses), net			(296	)			(1,187	)			891
Total comprehensive income (loss) for the period			(987	)			(1,878	)			891
Basic and diluted earnings (loss) per share (in U.S. dollars):			(0.002	)			(0.004	)			(0.002	)

 

		Year ended December 31,
		2020*
		As previously reported				As restated				Adjustments
		U.S. dollars in thousands
Revaluation of warrants to purchase ADSs			-				(2,172	)			(2,172	)
Finance income (expenses), net			166				(2,006	)			(2,172	)
Total comprehensive income (loss) for the year			(782	)			(2,954	)			(2,172	)
Basic and diluted earnings (loss) per share (in U.S. dollars):			0.002				0.006				0.004

 

*

see also Company’s 20F/A. The disclosure in this 6-K is qualified in its entirety by reference to the Company’s Amended and Restated Annual Report on Form 20-F/A, filed on May 13, 2021.

 

Impact on the consolidated statements of financial position:

 

		September 30,
		2020
		As previously reported				As restated				Adjustments
		U.S. dollars in thousands
Non-current liabilities			-				1,356				1,356
Additional paid in capital			147,708				146,015				(1,693	)
Accumulated deficit			(154,882	)			(154,545	)			337
Total equity			6,028				4,672				(1,356	)

 

 

		December 31,
		2020*
		As previously reported				As restated				Adjustments
		U.S. dollars in thousands
Non-current liabilities			-				2,637				2,637
Additional paid in capital			147,708				146,015				(1,693	)
Accumulated deficit			(154,661	)			(152,605	)			(944	)
Total equity			6,249				3,612				(2,637	)

 

*

see also Company’s 20F/A. The disclosure in this 6-K is qualified in its entirety by reference to the Company’s Amended and Restated Annual Report on Form 20-F/A, filed on May 13, 2021.

 

In March 2021, as a result of a cashless exercise of warrants by an investor from the February 2017 offering, the Company issued 12,981,800 ordinary shares represented by 129,818 ADSs.

 

In April 2021, as a result of a cashless exercise of warrants by an investor from the March 2017 offering, the Company issued 968,550 ordinary shares represented by 9,685 ADSs.

 

In July 2021, as a result of exercises of warrants by two investors from the March 2017 offering, the Company issued 8,500,000 ordinary shares represented by 85,000 ADSs, in return to $195,500 (the exercise price, $2.3 per ADS).

 

In August 2021, as a result of an exercise of warrants by an investor from the March 2017 offering, the Company issued 3,500,000 ordinary shares represented by 35,000 ADSs, in return to $80,500 (the exercise price, $2.3 per ADS).

 

In September 2021, as a result of an exercise of warrants by an investor from the March 2017 offering, the Company issued 1,250,000 ordinary shares represented by 12,500 ADSs in return to $28,750 (the exercise price, $2.3 per ADS). 

 

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 focused on the development of pharmaceutical products for the treatment of autoimmune diseases. 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 Amended and Restated Annual Report on Form 20-F/A filed with the U.S. Securities and Exchange Commission on May 19, 2021.

 

 

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: November 24, 2021	XTL BIOPHARMACEUTICALS LTD.
	By:	/s/ Shlomo Shalev
		Shlomo Shalev Chief Executive Officer

 

 

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