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BioLineRx Ltd.
Regulatory Filings • Feb 5, 2019
6692_rns_2019-02-05_06a2407e-92dd-4e6c-ac7d-d33580a01a62.pdf
Regulatory Filings
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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 February 2019
BioLineRx Ltd.
(Translation of registrant's name into English)
2 HaMa'ayan Street Modi'in 7177871, Israel (Address of Principal Executive Offices)
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 ☒ Form 40-F ☐
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 ☐ No ☒
Item 7.01. Regulation FD Disclosure
A copy of the Management Presentation of BioLineRx Ltd. (the "Company") is furnished as Exhibit 99.1 to this Item 7.01.
The information contained in Item 7.01 of this report and in Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On February 4, 2019, the Company issued a press release announcing that it has commenced an underwritten offering of American Depositary Shares ("ADSs"), each representing one of its ordinary shares, par value NIS 0.10 per share with each ADS to be sold together in a fixed combination with a warrant to purchase ADSs. pursuant to a preliminary prospectus supplement, dated February 4, 2019 to the Company's prospectus dated January 19, 2018, filed as part of its effective shelf registration statement on Form F-3 (File No. 333-222332) previously filed with, and declared effective by, the Securities and Exchange Commission.
The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. A copy of the press release is furnished as Exhibit 99.2.
This Current Report on Form 6-K shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities described above in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following Exhibits are filed as part of this report:
| Exhibit No. | Description of Exhibit | |
|---|---|---|
| 99.1 | Company Presentation | |
| 99.2 | Press Release dated February 4, 2019 |
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.
BioLineRx Ltd.
By: /s/ Philip Serlin
Philip Serlin Chief Executive Officer
Dated: February 4, 2019
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.
3 | Offering Summary
| ssuer | BioLineRx Ltd. (NASDAQ:BLRX; TASE:BLRX) |
|---|---|
| Offering size | \$15 million |
| Offering type | Confidentially marketed public offering (CMPO) |
| Securities offered | American depositary shares (1 ADS = 1 ordinary share) and warrants to purchase ADSs |
| Use of proceeds | BL-8040 - complete phase 3 in SCM; complete phase 2 trial in consolidation AML; complete phase 2 trials in pancreatic cancer and gastric cancer · AGI-134 - complete phase 1/2a in solid tumors (monotherapy and combo arms) |
| Expected pricing | February 5, 2019 (before market opens) |
| Sole bookrunner | Oppenheimer & Co. Inc. |
Our mission is to become a leader in the development of novel therapeutics for the treatment of cancer
5 / Who are We?
| Ticker / Exchange | BLRX (NASDAQ) |
|---|---|
| Headquarters | Tel Aviv, Israel |
| Market cap | ~\$70 million (25-Jan-19) |
| Shares outstanding | ~115 million |
| Cash | ~\$35 million (30-Sep-18) |
| Cash runway | Through 1H 2020 |
| Employees | 45 (35 in R&D) |
NASDAQ: BRLX
BL-8040 – Best-In-Class CXCR4 Antagonist for Multiple Oncology and Hematology Indications
For treatment of solid tumors, AML and indications requiring hematopoietic stem cell transplantation
9 | BL-8040 - A Best-in-Class CXCR4 Antagonist Targeting Multiple Indications
- A 14-amino acid synthetic cyclic peptide, high-affinity CXCR4 antagonist with long receptor occupancy (>48 hours)
- · CXCR4 is over-expressed in more than 70% of cancers and its high expression levels correlate with disease severity
- CXCR4 and its ligand CXCL12 (SDF-1) play a critical role in the trafficking of CXCR4 expressing cells such as HSPCs, immune cells and cancer cells
11 Stem-Cell Mobilization or Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Patients with hematological malignancies often require HSC transplant after treatment to restore their immune system
12 | GENESIS Phase 3 Study: Mobilization of HSCs for Autologous Transplantation in Multiple Myeloma Patients
14 | BL-8040's Potential Role in AML Treatment Landscape
15 | BL-8040.01 Phase 1/2a Study: Encouraging Results in Patients with Relapsed/Refractory AML
Phase 1/2a dose escalation/expansion study (n=42): NCT01838395
* Ravandi F, The Lancet Oncology, 2015;16 (9):1025-1036.
CR, complete response; CRi, complete response with incomplete hematological recovery
16 | BLAST Phase 2b Study: Consolidation Therapy for AML Patients in First Remission
Phase 2b double-blind, multi-center placebo controlled study (n=194): NCT02502968 (in collaboration with German Leukenia Study Alliance)
Treatment: Two or three cycles (age-based) of high-dose Ara-C in combination with either BL-8040 or placebo
Despite significant advances in cancer immunotherapy, material unmet needs remain:
- Improving efficacy of immunotherapy in "cold" tumors, such as pancreatic cancer
- Increasing rates and durability of response to existing therapies such as anti-PD1 and anti-PDL1 antibodies
BL-8040 addresses these needs by:
- Mobilizing immune cells to peripheral blood circulation
- Increasing immune cell infiltration into tumors
- · Reducing immunosuppression in tumor microenvironment
19 | Ongoing Collaborations with Global Pharma Companies Validate BL-8040's Novel Mechanism of Action
NCT02826484, NCT03193190, NCT03281369, NCT03154827
- COMBAT Phase 2a study for BL-8040 + pembrolizumab (Keytruda )
- Study in metastatic pancreatic cancer
- Open-label multi-center study
- Commenced Sep-16; top-line results of BL-8040-Keytruda combination announced Oct-18
- Collaboration expanded in July 2018 to include additional cohort with triple combo of BL-8040, Keytruda + chemotherapy
Genentech
- Four phase 1/2 studies planned for BL-8040 + atezolizumab (Tecentriq®)
- 3 studies in solid tumors (pancreatic, gastric, NSCLC)
- 1 study in AML
- Open-label multi-center single arm studies
- Pancreatic and gastric studies commenced H2 2017
20 | COMBAT/KEYNOTE-202 Phase 2a Study in Advanced Pancreatic Cancer
Phase 2a open-label, multi-center study in combination with pembrolizumab (n=37): NCT02826486
To assess the safety and efficacy of BL-8040 in combrolizumab (Keytruda) in patients with advanced pancreatic cancer
RECIST - Response Evaluation Criteria in Solid Tumors
21 COMBAT/KEYNOTE-202 Phase 2a Study - Dual Combination Results
- = 34.5% for 29 evaluable patients showed disease control activity (response + stable disease):
- " 40% reduction in tumor burden was seen in 1 patient with partial response
- " 1.5-13% reduction in tumor burden was seen in 6 out of 9 patients with stable disease
- = 34.4% of patients in all lines of therapy (2L-5L) were still alive after 6 months (N=37), OS: 3.3 months)
- = 51.1% of patients in 2L were still alive after 6 months (N=17) OS: 7.5 months)
- ڪ Safety profile of each individual drug was not compromised by the combination, enabling it to serve as an immunotherapy platform for additional combinations
- Mechanism of action demonstrated by the combination:
- Increased activated cytotoxic T cells
- Decreased myeloid derived suppressor cells in tumor microenvironment
- · Reduction in tumor cell numbers
BIOLINERX
22 Encouraging Results - Comparison with Other Second Line Treatments
- In a number of clinical studies, Keytruda alone has not demonstrated any activity in PDAC
- The COMBAT results show extended disease control and survival for combination of BL-8040+Keytruda, with a very good safety and tolerability profile
Overall survival results of second-line in COMBAT vs other trials in PDAC
BL-8040+Keytruda, as non-chemo combination, showed better OS than the only approved second-line chemotherapy, as well as other chemo monotherapy treatments seen in a number of clinical trials
23 Addition of Chemotherapy - Rationale and Design
- " Cytotoxic chemotherapy induces tumor death, reducing tumor burden
- · Cytotoxic chemotherapy induces immunogenic cell death, leading to activation/expansion of new tumor-reactive T-cell clones
- BL-8040 facilitates infiltration of T cells into tumor core
- · Pembrolizumab maintains/restores activity of T cells within tumor
Design of additional cohort:
Endpoints
Objective response rate according to RECIST 1.1 criteria Disease control rate Progression-free and overall survival Safety and tolerability of the combination Multiple pharmacodynamic parameters
AGI-134 – Cancer Immunotherapy
A universal anti-cancer vaccine with a unique mechanism of action
27
| Oncolytic viruses (e.g .: T-Vec) |
PAMPs (e.g.:TLR-9 and STING agonists) |
AGI-134 | |
|---|---|---|---|
| Injected tumor cells identified by naturally occurring pre-existing antibodies | > | ||
| Antibody-bound tumor cells destroyed by activated CDC and ADCC | V | ||
| Tumor neoantigens release by tumor cell lysis | > | > | |
| Generation of IgG-tagged immune complexes, which activate antigen presenting cells (APCs) |
> | ||
| The antibody-activated complement system creates pro-inflammatory milieu in the tumor microenvironment |
> | ||
| Complement chemo-attractants recruit immune cells to the tumor | V | ||
| Activation of antigen presenting cells and increased uptake of tumor antigens |
V | V | > |
| APCs induce a follow-on systemic immune response by the stimulation and clonal expansion of T cells |
V | V | > |
Intratumoral immunotherapies have validated proof of concept
PAMPs =Pathogen-associated molecular pattern
TME = Tumor Microenvironment
30
Multiple opportunities for value creation
| BL-8040 | Partial results from Phase 2a COMBAT pancreatic cancer study (with Merck) | 1Q 2018 | |
|---|---|---|---|
| 1 | BL-8040 | Top-line results from Phase 2 allogenic stem cell mobilization (Auto SCM) study | 2Q 2018 |
| AGI-134 | Initiation of Phase 1/2a trial in solid tumors | 3Q 2018 | |
| 1 | BL-8040 | Lead-in results from Phase 3 GENESIS Auto SCM study | 3Q 2018 |
| BL-8040 | Top-line results from dual combo Phase 2a pancreatic cancer study (with Merck) | 4Q 2018 | |
| 1 | BL-8040 | Initiation of Phase 2a triple combo pancreatic cancer trial (with Merck) | 4Q 2018 |
| BL-8040 | Top-line results from Phase 2 study in pancreatic cancer (with MDACC) | 1H 2019 | |
| BL-8040 | Interim results from Phase 2b AML consolidation study | 2H 2019 | |
| AGI-134 | Initial safety results from Phase 1/2a solid tumor study | 2H 2019 | |
| BL-8040 | Top-line results from Phase 1b/2 pancreatic cancer trial (with Genentech) | 2H 2019 | |
| BL-8040 | Top-line results from Phase 2 triple combo pancreatic cancer trial (with Merck) | 2H 2019 |
For Immediate Release
BioLineRx Announces Proposed Underwritten Public Offering of its American Depositary Shares and Warrants
Tel Aviv, Israel – February 4, 2019 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, today announced that it has commenced an underwritten public offering of American Depositary Shares ("ADSs"), each representing one of its ordinary shares with each ADS to be sold together in a fixed combination with a warrant to purchase ADSs. All of the securities in the offering are to be sold by BioLineRx. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
BioLineRx anticipates using the net proceeds from the proposed offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.
Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering.
The securities described above will be issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected] .
This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory acute myeloid leukemia ("AML") and is in the midst of a Phase 2b study as an AML consolidation treatment and has initiated a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which has recently initiated a Phase 1/2a study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the United States and Canada), on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and KEYTRUDA® (pembrolizumab), and a collaboration agreement with Genentech Inc., a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications and AML.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," 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. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 6, 2018 and BioLineRx's other filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy LifeSci Advisors, LLC +1-212-915-2564 [email protected]
or
Tsipi Haitovsky Public Relations +972-52-598-9892 [email protected]