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 2014
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BioLineRx Ltd.
(Translation of Registrant’s name into English)
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P.O. Box 45158
19 Hartum Street
Jerusalem 91450, Israel
(Address of Principal Executive Offices)
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F o
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
Yes o No x
On November 10, 2014, at 10:00 am EDT, the Registrant will conduct a conference call concerning its operating results for the quarter ended September 30, 2014. The presentation with information relating to such conference call is filed as Exhibit 1 to this Report on Form 6-K.
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the Company under the Securities Act of 1933.
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.
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BioLineRx Ltd.
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By:
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/s/ Philip Serlin
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Philip Serlin
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Chief Financial and Operating Officer
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Dated: November 10, 2014
Exhibit 1
Third Quarter 2014
Earnings Presentation
Earnings Presentation
November 10, 2014
This presentation contains "forward-looking statements."
These statements include words like "may," "expects,"
"believes," “plans,” “scheduled," and "intends," and describe
opinions about future events. These forward-looking
statements involve known and unknown risks and
uncertainties that may cause the actual results, performance
or achievements of BioLineRx to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statements.
These statements include words like "may," "expects,"
"believes," “plans,” “scheduled," and "intends," and describe
opinions about future events. These forward-looking
statements involve known and unknown risks and
uncertainties that may cause the actual results, performance
or achievements of BioLineRx to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statements.
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Forward Looking Statements
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Pipeline
Chief Executive Officer
Kinneret Savitsky, Ph.D.
Kinneret Savitsky, Ph.D.
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Update on Operations and Lead Programs
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BL-8040: BEST-IN-CLASS CXCR4 ANTAGONIST
Promising Platform for AML and Other Hematological Indications
ü Robust apoptosis of cancer cells
ü Substantial mobilization of cancer cells from bone marrow
ü Synergizes with other AML treatments
ü Strong global IP estate: 13 issued/25 patents pending worldwide
ü Received orphan drug status for two lead indications
Significant Current and Future Potential for BL-8040
ü AML (Phase 2)
ü Stem cell mobilization (Phase 1)
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BL-8040: Acute Myeloid Leukemia (AML)
Current Status - Completing Phase 2 dose escalation stage
ü Dec. 2013: Announced promising partial dose escalation phase results
ü Nov. 2014: Increased dosing based on encouraging efficacy and excellent safety
• Unanimous recommendation by Clinical Advisory Board to amend study protocol
• Increasing total number of patients from 50 to 70
– Early 2015: Complete dose escalation phase
– H2 2015: Complete full study
FLT3-Positive AML - ~30% of AML; associated with poor prognosis
ü Jun/Jul. 2014: Presented data showing synergy with AC220 (Quizartinib)
• Minimized residual AML disease (mouse model)
• Reduces level of BM cancer cells in vivo by at least one order of magnitude
• Prevented reduction in normal white blood cells seen with AC220 alone
ü September 2014: Daiichi Sankyo announced acquisition of Ambit for ~$410 million
• Potential high-value future opportunity for BL-8040
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BL-8040: CONTINUED
Stem Cell Mobilization
ü Jun. 2014: Received approval from Israeli Ministry of Health to begin human studies
ü Sep. 2014: Initiated two-part Phase 1 study
Part 1: Safety and tolerability as a standalone therapy
• Dose escalation (randomized, double-blind, placebo-controlled); 32 volunteers
Part 2: Quantify stem cell mobilization capacity and yield
• Open-label study; eight volunteers (at optimal dose from Part 1)
– Late 2014/Early 2015: Report final results
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BL-7010: NOVEL GLIADIN BINDING POLYMER FOR CELIAC DISEASE
Exciting progress in a fast-growing market
– Significantly increased Pharma interest
– Very high-need and underserved population
Phase 1/2 study completed in celiac patients:
ü Mar. 2014: Completed dose escalation stage; initiated repeated-dose stage
ü Jul. 2014: Reported unblinded results of repeated-dose stage (14 days, 3x per day)
• No serious or dose-limiting toxicity; No systemic absorption
• Investigated lower repeated doses due to certain gastrointestinal (GI) adverse events
ü Aug. 2014: Received notice of allowance for U.S. patent covering BL-7010 until 2026
ü Nov. 2014: Reported final results fully confirming previous findings
• No systemic absorption - likely to support medical device classification in EU
• Substantially reduced level GI-related adverse events
• Optimal safe dose selected for randomized, placebo controlled efficacy study to
commence in H2 2015
BL-1040: FIRST-IN-CLASS BIOABSORABLE CARDIAC MATRIX FOR
PREVENTION OF VENTRICULAR REMODELING FOLLOWING AMI
PREVENTION OF VENTRICULAR REMODELING FOLLOWING AMI
• Pivotal CE Mark registration trial continues on schedule
– Trial enrolled >280 patients of ~300 patients
– Endpoints: End diastolic volume index, QLQ, six-minute walk test
• Still expect to complete enrollment by year-end 2014
• Study completion anticipated in mid-2015
• Will be followed by CE Mark filing
• Previous Phase 1/2 study results published in peer-reviewed
Circulation
– BL-1040 was well tolerated following the coronary injection
– Sustained safety profile after six months of follow up
– ECG at six months showed preservation of left ventricular functional indices
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Chief Financial & Operating Officer
Philip A. Serlin, CPA, MBA
Philip A. Serlin, CPA, MBA
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Third Quarter 2014 Financial Overview
Corporate Highlights
• Strong current cash position: $29.6 million at September 30, 2014
• Funds operational capital through end of 2016
• Expect to reach several value inflection points during this time
• Broad U.S. institutional investor base
• U.S. investors hold roughly 60% of total shares outstanding
• Upcoming conferences
• Investor/Analyst Breakfast in December on BL-8040 2015 development plans
• Biotech Showcase in San Francisco in January
• Bio-CEO Conference in New York in February
• Roth Conference in LA in March
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Financial Overview
(in USD at 30-Sep-14 exchange rate)
(in USD at 30-Sep-14 exchange rate)
• Research and development
• Total R&D expenses decreased by $4.4 million, to $8.0 million for the nine
months ended September 30, 2014
months ended September 30, 2014
• Primarily from termination of the BL-1020 CLARITY clinical trial in March
2013, as well as certain one-time costs associated with several clinical-stage
projects in 2013
2013, as well as certain one-time costs associated with several clinical-stage
projects in 2013
• Decrease partially offset by increased spending on the BL-7010 (celiac)
project
project
• Sales and marketing
• S&M expenses increased by $0.2 million, to $0.9 million for the nine months
ended September 30, 2014
ended September 30, 2014
• Increase resulted primarily from professional fees in connection with
increased business development activities
increased business development activities
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• General and administrative
• G&A expenses decreased by $0.2 million, to $2.5 million for the nine months
ended September 30, 2014
ended September 30, 2014
• Primarily due to a one-time expense for professional services in the 2013
period
period
• Non-operating income
• Non-operating income increased by $0.7 million, to $3.2 million in for the nine
months ended September 30, 2014
months ended September 30, 2014
• Primarily stems from fair-value adjustment related to warrant liability
• Financial income/expenses
• Net financial income was $1.7 million for the nine months ended September 30,
2014, compared to net financial expenses of $0.9 million in the 2013 period
2014, compared to net financial expenses of $0.9 million in the 2013 period
• Changes result primarily from changes in average exchange rate of NIS to
USD
USD
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Financial Overview
(in USD at 30-Sep-14 exchange rate)
(in USD at 30-Sep-14 exchange rate)
Major Development Milestones - 2014 and 2015
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BL-7010 (Celiac Disease) CE pivotal study initiation
BL-8040 (AML) phase 2 partial results*
BL-8040 (SC Mobilization) phase 1 completion
* End of dose escalation phase
BL-1040 (AMI) complete CE mark study enrollment
BL-7010 (Celiac Disease) US study initiation
BL-7010 (Celiac Disease) phase 1/2 completion
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BL-8040 (AML) announcement of next steps
BL-8040 (SC Mobilization) phase 1 initiation
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BL-9020 (Type 1 Diabetes) collaboration with JHL
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BL-7010 (Celiac Disease) phase 1/2 study update*
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BL-7010 (Celiac Disease) pre-IND mtg with FDA
BL-8040 platform initiation of 2 new clinical trials
BL-8040 (SC Mobilization) phase 1 apheresis data
QUESTIONS?
THANK YOU!