BioLineRx Ltd.

Foreign Filer Report • Dec 16, 2020

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 December 2020

Commission file number: 001-35223

_______________________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 if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____

On December 16, 2020, management of the registrant will hold a KOL webinar at 8:00 a.m. ET to discuss the results of the COMBAT/KEYNOTE-202 clinical study. A copy of the presentation being used in connection with this webinar is furnished herewith as Exhibit 1 to this Report on Form 6-K.

In addition, on December 16, 2020 the registrant issued the press release which is filed as Exhibit 2 to this Report on Form 6-K.

The first, second, and third paragraphs, the table containing the data summary and the paragraph following immediately thereafter in the press release attached to this Form 6-K are hereby incorporated by reference into all effective registration statements filed by the registrant 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.

BioLineRx Ltd.

By:/s/ Philip A. Serlin

Philip A. Serlin Chief Executive Officer

Dated: December 16, 2020

Forward-Looking Statements

Various statements in this presentation concerning BioLineRs'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 many future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLinelx's preclinical trials and other therapeutic candidate development efforts; BioLineRs's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integratic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's and of the results obtained with its therapeutic candidates in preclinical trials; the implementation of BioLineR's business model and strategic plans for its business and therapeutic candidates; the sope of protection BioLineRx is able to intellectual property rights covering its therapeutic cand its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineR's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as 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.

Featured KOLs

Gulam Manji, M.D., Ph.D. is an Assistant Professor of Medicine and Director of Medical Oncology & Translational Research for The Pancreas Center at Columbia University Medical Center. Dr. Manji completed his PhD from the University of Wisconsin-Madison and Internal Medicine Residency at Albany Medical College. He then completed his fellowship in Hematology/Oncology at New York-Presbyterian/Columbia, where he remained as faculty within the Division of Hematology and Oncology.

Talia Golan, M.D. is a highly qualified medical oncologist and researcher in the field of pancreatic cancer. She specializes in gastrointestinal malignancies and serves as a director of the Phase I clinical trials unit at Sheba's Pancreatic Cancer Center. She has earned a world-renowned reputation for her studies in the field of pancreatic cancer. Her current research trials are being carried out in conjunction with two of the world's largest biopharmaceutical companies, AstraZeneca and MSD (Merck).

Manuel Hidalgo, M.D., Ph.D., is currently the Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/New York-Presbyterian Hospital. Dr. Hidalgo received his M.D. from the University of Navarra in Pamplona, Spain in 1992, and Ph.D. from University Autonoma of Madrid in 1997. He trained in medical oncology at Hospital "12 de Octubre" in Madrid and at the University of Texas Health Science Center in San Antonio, Texas. He also completed a fellowship program in anticancer drug development at the Institute of Drug Development in San Antonio.

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Agenda

• I. Philip Serlin, Chief Executive Officer, BioLineRx Introductory comments
• II. Gulam Abbas Manji, MD/PhD
• Dr. Golan Talia Golan, MD III.
• IV. Manuel Hidalgo, M.D., Ph.D.
• V. Q&A
• VI. Philip Serlin Closing remarks

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Targeting CXCR4 with combination chemotherapy and immunotherapy in Pancreas Ductal Adenocarcinoma

Gulam Abbas Manji, MD/PhD

Assistant Professor, Division of Hematology and Oncology Director of Pancreas Medical Oncology and Translational Medicine Columbia University Irving Medical Center

December 16, 2020

Columbia University COLUMBIA HERBERT IRVING COMPREHENSIVE

Disclosures

Research Funding

• · Genentech/Roche
• · Merck
• · BioLineRx
• · Regeneron
• · Plexxikon

Advisory Role

• · Genentech/Roche
• · BioLineRx
• . lpsen

COLUMBIA HERBERT IRVING COMPREHENSIVE
CANCER CANCER CENTER

Immune Checkpoint Blockade (ICB) and Pancreas Cancer

status and TILs		Table 2. Inverse correlation between tumor PD-L1
PD-L1	CD4		CD8
	Positive	Negative	Positive	Negative
Positive Negative	ರಿ 24	11 7	5 25	15 6

Nomi, T. CCR. 2007; 13:251-7

PDL1 and TIL

COLUMBIA UNIVERSIT COLUMBIA HERBERT IRVING COMPREHENSIVE
CANCER CANCER CENTER Survivales Results: Overall Survival 1 -Gem+Nab-P+Durva+Treme -Gem+Nab-P 0.8 Stratified Hazard Ratio = 0.94; 90% CI (0.71-1.25); p=0.72 Adjusted Cox Model HR = 0.90; 90% CI (0.67-1.20); p=0.54 Proportion Alive Median Gem+Nab-P = 8.8 months; 90% CI (8.3-12.2) 0.6 Median Gem+Nab-P+Durva+Treme = 9.8 months; 90% Cl (7.2-11.2) 0.4 0.2 0 0 12 32 4 8 16 20 24 28 36 Time (Months) 71 31 20 G+N+D+T:119 97 48 15 7 1 0 G+N: 61 51 32 21 13 11 7 4 0 0

Dr. Daniel Renouf, BC Cancer, University of British Columbia, Vancouver, Canada Renouf D. Knox J. Kavan P. Jonker D. Welch S. Couture F. Lemay F Tehfe M, Harb M, Aucoin N, Ko Y, Tang P, Ramjeesingh R, Meyers B, Kim C, Schaeffer D, Lorge J, Graham B, Tu D, O'Callaghan Canadian Cancer - Groupe canadien
Trials Group des essais sur le can 40 des essais sur le cance

7

Feig C, et al. PNAS. 2013. 110:20212-7

COLUMBIA HERBERT IRVING COMPREHENSIVE -NewYork-Presbyterian

CXCR4 inhibition (CXCR4i) Leads to T-cell Infiltration

Feig C, et al. PNAS. 2013. 110:20212-7

COLUMBIA HERBERT IRVING COMPREHENSIVE
CANCER CENTER = NewYork-Presbyterian

CXCL12 Colocalizes with Tumor Cells in Pancreatic Cancer

CXCR4i Increases CD8 T-cell Infiltration

Biasci D, et al. Proc Natl Acad Sci U S A. 2020 Nov 17;117(46):28960-28970.

CXCR4i, ICB, & Gemcitabine Improve Survival - Preclinical

COLUMBIA COLUMBIA HERBERT IRVING COMPREHENSIVE
CANCER CENTER

Chemotherapy Enhances Efficacy of CXCR4i and ICB

DOLUMBIA HERBERT IRVING COMPREHENSIVE
CONFREHENSIVE CANCER CENTER

CXCR4i Improves Tumor Immune Profile

KPC Mice Triple Therapy

Manji GA and K Olive, Unpublished Bockorny B et al. Nature Medicine. 26, pages878-885(2020)

COLUMBIA | HERBERT IRVING COMPREHENSIVE
CANCER CENTER

Chemotherapy, CXCR4i and ICB results in T cell clustering

Manji GA and Rabadan R, Unpublished

COLUM BIA HERBERT IRVING COMPREHENSIVE
CANCER CANCER CENTER

Summary

· Inhibition of CXCR4 in combination with chemotherapy and ICB in KPC mice -

Increases CD 8+ T cell/FoxP3+ Improves proximity of CD8+ T cells to neoplastic cells Improves survival

· Inhibition of CXCR4 in patients with pancreas cancer -

Increases CD8+ T cells (AM3100 and Motixafortide with ICB) Decreases MDSCs (Motixafortide with ICB) Encouraging efficacy in preliminary study with combination with 5-FU, liposomal irinotecan and ICB

COLUMBIA HERBERT IRVING COMPREHENSIVE

Updates in PDAC

Talia Golan, MD

Medical Director, Phase I Program & Sheba Pancreatic Cancer Program Sheba Medical Center, Israel

December 2020

17

Disclosures

Receipt of grants/research supports: Astra Zeneca and MSD Merck Receipt of honoraria or consultation fees: Abbvie, BioLineRx, MSD Merck, Bayer and Teva

Agenda

19

The current state of pancreatic cancer treatment

Benchmarks for PDAC

Immunotherapy in pancreatic cancer

Summary

The majority of PDAC patients are diagnosed with metastatic disease

https://seer.cancer.gov/statfacts/html/pancreas.html

The current state of pancreatic cancer treatment

Within this decade, pancreatic cancer will become the 2nd leading cause of cancer death in the United States

→ Pancreatic cancer is the only one of the top 5 cancer killers for which deaths are projected to increase

Multiple Drugs and Targets Have Failed in Clinical Trials PDAC: Dec 2015 - Dec 2020

Drug	Target/Mechanism	Phase	Number of Patients
Evofosfamide	Alkylator (Hypoxia)	=	694
Ruxolitinib	JAK1/2		Early termination
Necuparanib	Heparan mimetic	1/11	128
Masitinib	TKI (Kit, Lyn, Fyn)		323
Vandetanib	TKI (VEGFR2, RET, EGFR)	=	142
Algenpantucel-L	Vaccine	=	722
CRS-207 + GVAX	Vaccine	lib	240
Tarextumab	Notch2/3	=	177
Demcizumab	DIL4	II	204
90Y-Clivatuzumab Tetraxetan	MUC1		334
Apatorsen	HSP27	II	132
Z-360	CCK2	II	167
Simtuzumab	LOX-2	II	240 (159)
MM-141	IGF-1R/ErbB-3	=	88
Ibrutinib	BTK	111	424
Napabucasin	STAT3		>1,100
Pegilodecakin (AM0010)	pegylated IL-10	=	567
PEGPH20	Hyaluron		500
Cabiralizumab	CSFR-1	Ilb	160

Therapeutics in advanced PDAC Over 2 Decades

Benchmark for Pancreatic Cancer

There is a significant unmet need to prolong disease control and survival as part of first-line treatment for patients with pancreatic cancer ORR

There is also an unmet need to prolong survival in second line treatment for patients with pancreatic cancer

28 Summary Pancreatic Cancer Benchmark for 2L PDAC Diagnosed at Metastatic Stage

Endpoint	NAPOLI-1 stage IV at diagnosis subgroup (n=61)	Meta-analysis IRI based 2L (7 studies n=396 ) Includes all stages at diagnosis
mOS (mos)	4.7	5.5
mPFS (mos)	3.1 (stage III-IV n=117)	2.7
ORR (%)	16%	8.7%
cORR (%)	7.7% (stage III-IV n=117)	NA
DCR (%)	52% (stage III-IV n=117)	29.4% 28

Immunotherapy in pancreatic cancer

Immunotherapy for Pancreatic Cancer

• · Pancreatic cancer has been regarded as non-immunogenic
  • · immunosuppressive cells and cytokines
  • · low tumor mutational burden
  • paucity of T cells in tumor (number and function)?? Controversial since recent studies demonstrate that the majority of primary tumors are infiltrated with Tcells
  • · efficacy of checkpoint inhibitors in PDAC was found to be absent
  • multiple immune inhibitory mechanisms in the tumor microenvironment
  • · Single-agent therapeutic approaches focusing on overcoming T-cell immunologic endpoints with immune checkpoint inhibitors or vaccines are not encouraging

Royal RE, et al. J Immunother. 2010,33(8):228-833. Topalian SL, et al. N Engl J Med. 2012;366(26):2443-2454. Morrison AH et al Trends Cancer. 2018;4(6):418-28. Poschke I et al Oncoimmunology. 2016;5(12):e1240859.

PD-1 inhibitor (durvalumab) with or without CTLA4 inhibitor (tremelimumab) in 2nd line : did not work!

Combination of Checkpoint inhibitor and chemotherapy did not improve the chemotherapy efficacy in first line

Renouf et al, ESMO 2020

Triple combination approaches are promising in PDAC APX005M (CD40 agonist) mAb together with gemcitabine/nabpaclitaxel +/- nivolumab as 1st Line treatment

Summary

• Cytotoxic therapy is the mainstay of systemic therapy resulting in modest benefit in pancreatic cancer
• · Single molecule/pathway targeting is unlikely to result in significant clinical benefit
• · Single-agent therapeutic approaches focusing on overcoming T-cell immunologic endpoints with immune checkpoint inhibitors or vaccines are not encouraging
• · Immuno combinatorial therapy is the likelier strategy to succeed
• · Strong scientific rationale for which combinations is needed
• · Pancreatic cancer is a tough disease and incremental improvements are clinically meaningful

COMBAT Study- Cohort 2 results

Manuel Hidalgo, M.D., Ph.D. COMBAT Study Principal Investigator

December 16th 2020

Disclosure

• · Founder and Stockholder: Champions Oncology, Inc; Nelum Pharmaceuticals
• · Stockholder: Agenus, Pharmacyte, InxMed, BioOncotech
• · Research support from: Erytech, BioExcell, TopAlliance, PanCan
• · Honorarium from: Agenus, Oncomatrix, InxMed, Takeda, PanCan, AACR, Tolero Pharmaceuticals.
• · Royalties: Myriad for PALB2 patent.

= NewYork-Presbyterian @ @ Weill Cornell Medicine

COMBAT - Study Design

Main inclusion/exclusion criteria

• 11 13 18 years old and above
• Metastatic disease at first diagnosis (Stage IV) .
• · Progressed after first-line gemcitabine-based treatment
• · No previous surgeries for PDAC, no previous locally advanced disease
• · No prior PD-1 or PD-L1 treatment

Endpoints

• ORR according to RECIST 1.1 criteria .
• Disease control rate (DCR) .
• Duration of response .
• PFS and OS .
• Safety and tolerability .

37

=NewYork-Presbyterian @ @ Weill Cornell Medicine

Disposition

Baseline characteristics

EVALUABLE	N=43
Gender	Female 44.2%/Male 55.8%
Diagnosed at stage 4	97.6%
Median age	68 (40-85)
ECOG 0/1	31.3%/68.7%
% of MSI-H (MSS status tested in 38 subjects)	0%
% of Patients with Liver Metastasis	74.4%

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= NewYork-Presbyterian @ @ Weill Cornell Medicine

Safety profile

	ALL	Grade≥ 3
Nausea and vomiting	74.4%	18.6%
Asthenia	67.4%	16.3%
Injection site reactions	55.8%	4.7%
Diarrhea	53.5%	14%
Appetite disorders	41.9%	9.3%
Pruritus	39.5%
Anemias	37.2%	11.6%
Rashes, eruptions and exanthems	30.2%
Gastrointestinal and abdominal pains	30.2%
Musculoskeletal and connective tissue pain and discomfort	30.2%	4.6%
Dermal and epidermal conditions	25.6%
Edema	23.3%	4.7%
Weight decrease	20.9%	2.3%
Hyperpigmentation disorders	20.9%
Gastrointestinal atonic and hypomotility disorders	20.9%

40

Adverse events reported in >20% of patients

= NewYork-Presbyterian @ @ Weill Cornell Medicine

COMBAT/Keynote-202 Cohort 2-Change from Baseline in Target lesions (N=38)

COMBAT/Keynote-202 Cohort 2-Change from Baseline in Target lesions (N=38)

COMBAT/Keynote-202 Cohort 2 Median Progression Free Survival (mPFS) (N=38)

Study COMBAT Cohort 2 - mITT Analysis Set (N=38): Progression Free Survival

COMBAT/Keynote-202 Cohort 2- Duration of Clinical benefit

Study COMBAT Cohort 2 - Duration of Clinical Benefit (RECIST1.1)

COMBAT/Keynote-202 Cohort 2 Median Overall Survival (mOS) (N=38)

Study COMBAT Cohort 2 - mITT Analysis Set (N=38): Overall Survival (OS) Months from Monotherapy D1 to Death (Based on data retrievd from AEs, EOS, Survival FU)

Safety- Low incidence of Neutropenia and Infections

• · The triple combination was generally well tolerated
• · Incidence of AEs is consistent with the profile of each drug, however
• The incidence of neutropenia and infections is lower than the expected with chemotherapy alone

	COMBAT	NAPOLI1
Neutropenia >=G3	7%	20%
Infections/infestations All Grades	21%	38%
Infections/infestations >=G3	7%	17%

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https://www.accessdata.fda.gov/drugsatfda docs/label/2015/207793lbl.pdf

=NewYork-Presbyterian @ @ Weill Cornell Medicine

COMBAT Study Results Showed Improvement Across All Endpoints

Endpoint	COMBAT	NAPOLI-1 stage IV at diagnosis subgroup (n=61)	Meta-analysis IRI based 2L (n=396) Stage III-IV at diagnosis
mOS (mos)	6.5	4.7	5.5
mPFS (mos)	4.0	3.1 (stage III-IV n=117)	2.7
ORR (%)	21.2%	16%	8.7%
cORR (%)	13.2%	7.7% (stage III-IV n=117)	NA
DCR (%)	63.2%	52% (stage III-IV n=117)	29.4%

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1. Macarulla Mercade et al, Pancreas 2020;2. Petrelli et al EJC 2017 (Iri-based),

2. Wang Gillam et al EJC 2016;

= NewYork-Presbyterian @ @ Weill Cornell Medicine

Summary

• · COMBAT Study results showed improvement across all endpoints
• · Despite the triple combination regimen, the incidence of neutropenia and infection is much lower than with standard chemotherapy
• · The COMBAT results are highly encouraging in light of the extremely challenging population, even among PDAC patients
• · The COMBAT results strongly support further development

= NewYork-Presbyterian @ @ Weill Cornell Medicine

48

Q&A and Closing Remarks

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