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 2013
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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 13, 2013, at 10:00 am EST, the Registrant will conduct a conference call concerning its operating results for the quarter and nine months ended September 30, 2013. 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 13, 2013
Exhibit 1
Third Quarter 2013
Earnings Presentation
Earnings Presentation
November 13, 2013
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
3
Pipeline
Chief Executive Officer
Kinneret Savitsky, Ph.D.
Kinneret Savitsky, Ph.D.
4
Update on Operations and Selected Programs
Highlights of BioLineRx’s Quarterly Activities
• Progress in key clinical programs:
– BL-1040 - Recruitment on track for CE Mark registration trial
– BL-5010 - On schedule to begin EU pivotal study by end of this year
– BL-8040 - Partial phase 2 results expected by end of this year
– BL-7010 - All approvals received to start phase 1/2 trial by end of this year
• Partnership discussions
– BL-5010 - advanced discussions with potential partners
– BL-7040 - initial co-development discussions
– BL-9020 - advanced discussions with optimization and manufacturing partners
• Appointment of Dr. BJ Bormann to Board of Directors
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PROGRESS ON KEY PROGRAMS
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BL-1040: First-In-Class Myocardial Implant for
Prevention of Ventricular Remodeling Following AMI
Prevention of Ventricular Remodeling Following AMI
Continued progress in pivotal trial:
– Pivotal CE-mark registration trial continuing
to progress at full steam
to progress at full steam
– Over 55 sites recruiting (including 14 sites
in the U.S.)
in the U.S.)
– Approximately 306 patients in total to be
recruited
recruited
– Results expected in 2014
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Substantial progress on many fronts:
• Received orphan drug designation by FDA
• Ongoing phase 2 study:
• All eight sites now open
• Memorial Sloan Kettering Cancer Center joined
the study
the study
• Partial results to be announced by end of year
• Received patent allowance from USPTO through 2029
as method of obtaining stem cells
as method of obtaining stem cells
• Additional trials for other hematological indications
expected to commence in first half of 2014
expected to commence in first half of 2014
• Publication in British Journal of Hematology of positive
pre-clinical results for BL-8040 in treatment of
thrombocytopenia
pre-clinical results for BL-8040 in treatment of
thrombocytopenia
BL-8040: Best-in-Class CXCR4 Antagonist
for Treatment of Hematological Cancers
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BL-5010: Novel Formulation for
Non-Surgical Removal of skin Lesions
Positioned for Commercial Success:
• Pivotal CE-mark study in seborrheic keratosis expected
to begin by end of year
to begin by end of year
• Submissions made to regulatory authorities in Germany;
approval already granted by ethical committees
approval already granted by ethical committees
• Study results expected mid-2014, pending approval from
German Federal Institute for Drugs and Medical Devices
(BfArM)
German Federal Institute for Drugs and Medical Devices
(BfArM)
• CE mark by end of 2014
• Additional pivotal trial(s) in actinic keratosis and other
indications planned for 2014
indications planned for 2014
• In meaningful discussions with interested potential
partners
partners
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BL-7010: Novel Gliadin Binding
Polymer for Celiac Disease
Polymer for Celiac Disease
Great potential in a fast growing market:
• Received all regulatory approvals to start phase
1/2 study by end of 2013
1/2 study by end of 2013
• 32-patients at world-leading site in Finland for
celiac disease research
celiac disease research
• Single and repeated ascending dose study
• Results expected in mid-2014
• Efficacy study planned to commence by end
of 2014
of 2014
• Made oral presentation of BL-7010 at 15th
International Celiac Disease Symposium
International Celiac Disease Symposium
• Exploring multiple commercialization
pathways for product to maximize opportunity
pathways for product to maximize opportunity
• Significantly increased interest in celiac
disease by pharma industry
disease by pharma industry
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HCV Programs
BL-8020:
• Novel HCV therapy in midst of Phase 1/2
clinical trial
clinical trial
• Primary endpoint of study is effect of 16-
week combination therapy with Ribavirin and
BL-8020
week combination therapy with Ribavirin and
BL-8020
• Received USPTO patent
BL-8030:
• NS3/4A inhibitor - demonstrated high genetic
barrier to development of resistant variant
barrier to development of resistant variant
• Partnered with CTTQ
• Chemistry studies and pre-clinical
development advancing on-track with CTTQ
development advancing on-track with CTTQ
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Chief Financial & Operating Officer
Philip A. Serlin, CPA, MBA
Philip A. Serlin, CPA, MBA
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Third Quarter 2013 Financial Overview
Financial Overview (based on nine-month data)
(in USD at 30-Sep-13 exchange rate)
(in USD at 30-Sep-13 exchange rate)
• Research and development
• Total R&D expenses decreased $1.9 million to $11.3 million in 2013 period
• 2013 includes $1.7 million one-time reversal of OCS liability
• “Normalized” R&D decreased by $0.2 million
• Decrease resulted primarily from:
• Lower expenses in 2013 associated with the CLARITY trial
• Partially offset by significant increase in spending on other clinical-stage projects
• Sales and marketing
• S&M expenses were $0.7 million for both 2013 and 2012 periods
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Financial Overview (based on nine-month data)
(in USD at 30-Sep-13 exchange rate)
(in USD at 30-Sep-13 exchange rate)
• General and administrative
• G&A increased $0.2 million to $2.8 million in 2013 period
• Increase resulted primarily from one-time expense for professional services.
• Non-operating income
• Non-operating increased $1.9 million to $2.6 million in 2013 period
• Increase primarily due to fair-value adjustment related to warrant liability
• Financial income/expenses
• Net financial expenses were $0.9 million for the 2013 period, compared to net
financial income of $1.2 million for the 2012 period
financial income of $1.2 million for the 2012 period
• Changes results primarily from changes in the average exchange rate of NIS to
USD, since we hold net assets in USD
USD, since we hold net assets in USD
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Financial Overview (based on nine-month data)
(in USD at 30-Sep-13 exchange rate)
(in USD at 30-Sep-13 exchange rate)
• Cash and burn rate information
• Cash and short-term deposits amounted to $20.3 million at 30-Sep-13
• Our burn rate is ~$12 million per year (~$1 million per month)
• Cash expected to last into mid-2015, without regard to any upfront or milestone
payments from current/potential partners
payments from current/potential partners
• Analyst Coverage
• Aegis Capital Corporation - Raghuram Selvaraju
• Roth Capital Partners, LLC - Robert Hazlett
• Analyst/Investor Day
• November 21, 2013 from 9:00 am to 11:45 am in NYC
• Presentations from BioLineRx’s senior management team
• Keynote presentation by Dr. BJ Bormann, BioLineRx Director
• Several KOLs will be speaking in reference to selected programs
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BL-8020 (HCV) phase I/II initiation
BL-8020 (HCV) partial results
BL-8040 (AML) partial results
BL-7010 (Celiac Disease) pilot study initiation
BL-8040 (AML) topline results
BL-7010 (Celiac Disease) pivotal study initiation
BL-5010 (Skin Lesions) pivotal EU study initiation
BL-1040 (AMI) pivotal CE mark study results
BL-5010 (Skin Lesions) EU study topline results
BL-7040 (IBD) phase II POC study results
BL-7010 (Celiac Disease) topline results
2013-14 Clinical and Commercial Milestones
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BL-8030 (HCV) collaboration deal with Chinese
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QUESTIONS?