XTL Biopharmaceuticals Ltd. Reports Third Quarter 2015 Results and Confirms Intention to Start Lupus Trial In 2016

RAANANA, Israel, Dec. 1, 2015 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of unmet clinical needs, particularly for autoimmune diseases, today provided its financial and operational results for the third quarter and the nine months ended September 30, 2015.

Josh Levine, Chief Executive Officer of XTL, commented, "During the third quarter we continued to make significant strides in developing our clinical asset, hCDR1 for the treatment of lupus (SLE) and preparing it for advanced clinical trials."

"Following the publication in August by the Lupus Science and Medicine journal of a peer reviewed article (http://lupus.bmj.com/content/2/1/e000104.full) analyzing the results of a Phase 2b trial on our lupus drug (PRELUDE trial) showing favorable safety and efficacy data on over 300 patients, the Company convened a meeting of its Clinical Advisory Board in September at which the Company finalized a draft protocol for its planned clinical trial. In November, the Company submitted a request to the FDA for a pre-IND meeting and expects a written response to its pre-meeting package in early 2016. Also in November, the Company contracted with BioConnection (www.bioconnection.eu) for the production of drug product for the upcoming clinical trial expected to commence in the middle of 2016. With few Phase 3 studies ongoing in this space and with hCDR1's unique mechanism of action, we believe there remains a substantial opportunity for the Company's lead drug candidate."

Financial Overview

The Company reported US$4.3 million in cash and cash equivalents as of September 30, 2015.

Research and development expenses for the three months ended September 30, 2015 were US$134,000 compared to US$40,000 for the same period in 2014. Research and development expenses for the three months ended September 30, 2015 were comprised mainly of expenses related to preparations for initiating an advanced clinical trial of the Company's clinical asset, hCDR1. The increase in research and development expenses reflects the Company's increased investment in bringing hCDR1 to an advanced clinical trial in the middle of 2016.

General and administrative expenses for the three months ended September 30, 2015 were US$262,000 compared to US$327,000 for the same period in 2014.

Financial expenses, net for the three months ended September 30, 2015 were US$47,000 compared to US$72,000 in the three months ended September 30, 2014. The decrease in financial expenses, net, was mainly due to changes in fair value of marketable securities held in InterCure, a former subsidiary.

Loss from continuing operations for the three months ended September 30, 2015 was US$443,000, compared to US$439,000 in the same period last year.

Total loss for the quarter ended September 30, 2015 was $443,000 compared to $568,000 during the same period in 2014. The decrease in loss was primarily attributable to an increase in research and development expenses offset by losses in 2014 from discontinued operations related to InterCure, a former subsidiary.

Research and development expenses for the nine months ended September 30, 2015 were US$245,000 compared to US$121,000 for the same period in 2014. Research and development expenses for the nine months ended September 30, 2015 were comprised mainly of expenses related to preparations for initiating an advanced clinical trial of the Company's clinical asset, hCDR1. The increase in research and development expenses reflects the Company's increased investment in bringing hCDR1 to an advanced clinical trial in the middle of 2016.

General and administrative expenses for the nine months ended September 30, 2015 were US$1,008,000 compared to US$1,243,000 for the same period in 2014. The decrease in general and administrative expenses was due to lower rent and maintenance costs, reflecting the Company's continued efforts to reduce overhead costs, as well as a reduction in salary and share based compensation costs in the nine months ended September 30, 2015.

Financial expenses, net for the nine months ended September 30, 2015 were US$233,000 compared to US$55,000 in the nine months ended September 30, 2014. The increase in financial expenses, net, was mainly due to changes in fair value of marketable securities held in InterCure, a former subsidiary.

Loss from continuing operations for the nine months ended September 30, 2015 was US$1,486,000, compared to US$1,419,000 for the same period last year.

Total loss for the nine months ended September 30, 2015 was US$1,946,000 compared to US$2,039,000 for the same period last year. The loss from discontinued operations for the nine months ended September 30, 2015 and 2014 relates to losses from XTL's investment in InterCure, a former subsidiary.

XTL's consolidated financial results for the nine months ended September 30, 2015 are presented in accordance with International Financial Reporting Standards.