XTL Biopharmaceuticals Ltd.

Foreign Filer Report • Nov 8, 2018

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, 2018

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): ____

The management of XTL Biopharmaceuticals Ltd. will be presenting at an investor conference on November 11, 2018. A copy of the presentation is furnished as Exhibit 99.1 to this Report on Form 6-K.

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 8, 2018 By: /s/ Josh Levine

XTL BIOPHARMACEUTICALS LTD.

Josh Levine Chief Executive Officer Exhibit Index

Exhibit Number		Exhibit Title
99.1	XTL Biopharmaceuticals Ltd. Investor Presentation

November 2018

XTL Biopharmaceuticals

(NASDAQ: XTLB) (TASE: XTLB.TA)

www.xtlbio.com

Forward Looking Statements

Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forwards such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on XTL Biopharmaceuticals Ltd.'s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the accuracy of our financial forecasts in our product candidates' development activity and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; the timing and cost of the inlicensing, partnering and acquisition of new product opportunities; the timing of expenses associated with product development and manufacturing of the proprietary product candidates that we have acquired, and those that may be inlicensed, partnered or acquired; substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government; and risks related to failure to obtain regulatory clearances or approvals and noncompliable drug development regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this presentation will be completed or successful or that any product candidate will receive regulator any indication or prove to be commercially successful. Investors should read the risk factors set forth in our Form 20-F filed with the Securities and Exchange Commission and periodic reports filed with the Securities and Exchange Commission and the Tel Aviv Stock Exchange. While the ist of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and we do not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances, except as required by law.

Overview

· Current asset, hCDR1, for the treatment of autoimmune diseases:

Indication	Preclinical Phase Phase Phase Phase
SLE (lupus)
Sjogren's Syndrome

• · Strategic shareholding in Intercure
  • · Intercure recently purchased Canndoc, entering the medical cannabis space
  • = XTL holds ~2.5% of Intercure
• · XTL has ~\$9 million in cash and Intercure's securities
• = XTL is in the process of identifying additional assets to add to XTL's portfolio

hCDR1 Overview

• · Novel compound with unique MoA and robust clinical data
  • · Clinical data in >400 patients with Systemic Lupus Erythematosus (SLE)
    • · Demonstrated favorable safety profile and well tolerated by patients
    • · "Demonstrated efficacy in ... clinically meaningful endpoints" (Lupus Science & Medicine Journal - August 2015)

• · Encouraging data in Sjogren's Syndrome (pSS), similar to data previously obtained in SLE
• = Lead indications represent significant unmet medical needs
  • · GSK acquired HGS (2012) for SLE drug Benlysta for \$3 billion (only approved drug in >50 years)
• " No effective therapy on the market for many/most patients; weak competitive pipeline
  • · Many recent Phase 3 failures in SLE; no new drugs approved for systemic pSS
  • · Lack of effective/safe steroid sparing agents for many SLE manifestations
  • · Current treatments: anti-malarials, corticosteroids, immunosuppressants, cytotoxics
  • · Severe side effects with current treatments (hypertension, osteoporosis, bone marrow suppression, increased cancer risk, etc.)
  • · Aurinia "success" in Lupus Nephritis: FDA allows single Phase 3 study; following Phase 2 success, raised >\$200 million and share price increased 5x

SLE/Lupus: Market Overview

• Prevalence1 ■
  • = 1.5 million patients in U.S. (5 million worldwide) across various ethnicities/geographies
  • · Vast majority at onset are women / majority between ages of 15 and 45
• 0 Prognosis
  • · Dermatologic & musculoskeletal manifestations are the most common but major organ involvement such as renal, central nervous system and serosal occur frequently
  • · Major organs may become involved as disease progresses
  • · Most common causes of death
    • · Initial active disease or infection
    • · Later Renal failure, Cardiovascular disease, CNS disorders
  • · 80-90% of patients survive beyond 10 years1
• · Market expected to grow dramatically

1Lupus Foundation of America

hCDR1 (Edratide): Clinical Trial History

• · Three clinical trials completed (by Teva): Phase la, Ib and IIb trials
  • · Over 400 patients enrolled in prior trials
  • · Well tolerated and demonstrated favorable safety profile
• = Phase IIb (PRELUDE) trial (conducted by Teva)
  • · Did not meet primary endpoint (SLEDAI)
  • · Did not enforce steroid withdrawal algorithm
  • Encouraging results in secondary clinical endpoint, BILAG index (see below)
    • = 0.5 mg weekly dose showed a substantial effect
• Opportunity I
  • · Teva returned product to Yeda in 2009
  • " FDA published revised guidelines in 2010 with BILAG as preferred primary endpoint
  • XTL in-licensed in 2014
  • = FDA confirmed to XTL that BILAG should be primary endpoint in clinical development

hCDR1 Clinical Data - PRELUDE Study

Secondary Endpoint - BILAG Responder Analysis (Placebo vs. Edratide 0.5 mg)

SS: Market Overview

• Prevalence ■
  • = ~ 0.7%1 of U.S. population- estimated 2.5 to 4 million patients2
  • · Vast majority at onset are women (at least 9:1)2
  • · Average age at diagnosis: 40-50 years2
  • · Market expected to grow to 3.5 million cases globally by 20241
• Prognosis
  • · Hallmark symptoms are dry eyes/mouth, fatigue and joint pain
  • · May impact other organs (extra-glandular): kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas and nervous system
  • · Increased risk of non-Hodgkin's B cell lymphoma (relative risk: 13x chance of developing disease vs. general population)1
• · Weak pipeline: only 1 Phase III product
  • · Orencia (BMS) approved for Rheumatoid Arthritis
    • · 1 open-label proof-of-concept study and then straight to Phase 3
  • · Other trials early stage & no reported data; off-label use of other Al drugs

1 Global Data Research 2016

hCDR1: Pre-clinical Data on pSS Patients

• · Blood mononuclear cells (PBMC) from blood samples of patients with pSS incubated in-vitro with hCDR1 and a control peptide
• · Promising in-vitro/ex-vivo study results:
  • · Reduction in gene expression of 5 cytokines involved in SS/lupus and upregulation of immunosuppressive genes
  • · Similar to results in SLE patients using same method
• · Similar studies in PBMCs of RA and APS patients yielded no significant effect

Effect on Gene Expression of Cytokines/Immunosuppressive Genes

* P values calculated from % responses of all tested patients (responders) as compared to medium=100%.

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Strategic Investment in Intercure CANNDOC

• · Intercure recently purchased 100% of Canndoc, an Israeli licensed producer of Pharma-Grade Cannabis based products, under IMC-GAP/GMP standard
• · Canndoc has been active in medical cannabis for >10 years, growing thousands of kilos and providing to thousands of patients and leading institutes and R&D centers for clinical trials
• · Intercure share price increased >10x since beginning 2018 to company value of >\$100 million
• · XTL owns 2.5% of Intercure (~\$3 million value)

Intercure/Canndoc (Competitive Environment)

Company	Sector	Market cap (Founded, employees	Existing capacity (production until June 30th)	Expected growing capacity (Expected harvest)	Cost* / Selling price (uso, g)	Revenues (H1 2018, USD)
TILRAY (TLRY)	Medical/ Recreational	\$8.46B (2013, 310)	85,000 SOM (by the end of 2018) (2,800KG)	353,000 SQM	\$2.81 / \$6.18	\$17.55M
475 CANCET GHOWTH 1966 Stars of A (CGC)	Medical/ Recreational	\$7.618 (2014, 1,000-1,400)	62,000 SOM (5,200KG)	464,000 SQM	52.98 / 26.81	\$37.06M
AURORA (ACB:CA)	Medical/ Recreational	\$7.38B (2013, 1400)	WOS 000 6 (3,000KG)	176,000 SQM (500T)	\$2.35 / \$6.11	\$35.25M
CRONOS (CRON)	Medical/ Recreational	\$1.28 (2013, 160)	6,000 SQM (1,000KG)	111,000 SQM (110T)	\$2.15 / \$5.49	\$4.87M
+ CANNDOC (INCR.TA)	Pharma	S0.18 (2008, 65)	5,000 SQM (300 KG - which is 1/3 of full capacity)	200,000 SQM (100T)	\$1.01 / \$2.70	\$0.9M

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Summary

• = XTL is looking to develop assets for the treatment of diseases with high unmet medical needs
• = Its current asset, hCDR1, is being developed for the treatment of SLE/lupus and Sjogren's Syndrome and the company is exploring options for further development
  • = hCDR1 has robust clinical data on >400 SLE patients
• · XTL has a strategic shareholding in Intercure
  • · Intercure recently entered the medical cannabis space with its purchase of Canndoc
  • = XTL holds ~2.5% of Intercure valued at ~\$3 million
• · XTL is in the process of identifying additional assets to add to XTL's portfolio
• = XTL currently has \$9 million in cash and marketable securities

XTLbio

Thank You

www.xtlbio.com

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