Transforming Science into

Medicine

Corporate Presentation

January 2021

2 Forward-Looking Statements

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 Our Mission

Our mission is to become a leader in the development of novel

therapeutics for the treatment of cancer

4 Who are We?

Ticker / Exchange

BLRX (NASDAQ)

Headquarters

Tel Aviv, Israel

Market cap

~$65 million (15-Jan-21)

Shares outstanding

~23.4 million (American Depositary Shares)

Cash

~$20.8 million (as of 30-Sep-20)

Cash runway

Q1 2022

Employees

~40 (30 in R&D)

NASDAQ: BLRX

5 Investment Highlights

Singular focus on novel

Motixafortide (BL-8040) program - in phase 3 for SCM; phase 2 for

pancreatic cancer and AML

oncology compounds

AGI-134 program - in phase 1/2a for solid tumors

Advancing towards

potential registration of

Motixafortide in SCM

Multiple opportunities for

value enhancement

  • Positive IA for Phase 3 GENESIS trial in SCM, statistically significant improvement in primary endpoint
  • Enrollment completed at 122 patients (instead of 177 originally planned)
  • Company moving forward towards NDA submission
  • Final phase 2 PDAC data showed improvement in all endpoints; planning next development steps - randomized study under potential collaborations
  • Significant data readouts over next 12 months, including Phase 3 full results in SCM expected H1 2021
  • ~$65 million market cap (15-Jan-21)

Compelling valuation

  • ~$20.8 million cash as of Q3 2020
  • Cash runway - Q1 2022

SCM - stem cell mobilization; AML - acute myeloid leukemia

6 Pipeline Targeting Multiple Oncology Indications

PROGRAM

ONCOLOGY

Motixafortide (BL-8040)

AGI-134

OTHER

BL-5010

INDICATION

PRE-CLINICAL

PHASE 1

PHASE 2

PHASE 3

REGULATORY

PARTNERS

APPROVAL

Stem-cell mobilization

Pancreatic cancer *

AML

Solid tumors

Skin lesions

*BioLineRx retains all rights to BL-8040 under a clinical trial collaboration with

Motixafortide (BL-8040): CXCR4 Antagonist

Oncology Combination Platform for Solid and Hematological Indications

8 Motixafortide - Best-in-Class CXCR4 Antagonist for 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 trafficking of CXCR4 expressing cells such as HSPCs, immune and cancer cells

Phase 3

Phase 2

Phase 2

Stem Cell Mobilization for

Cancer Immunotherapy for

Acute Myeloid Leukemia

Multiple Myeloma

Solid Tumors

Robust mobilization of HSPCs for

Mobilization of immune cells to

Mobilization of leukemic cells from

transplant

peripheral blood; infiltration of

bone-marrow protective niche,

immune T cells into tumor;

sensitization to anti-cancer

reduction of immunosuppression in

treatment and induction of

tumor microenvironment

apoptosis

HSPC - Hematopoietic stem and progenitor cell

Motixafortide in SCM

10 SCM for Patients Undergoing Autologous HSC Transplantation

Patients with hematological malignancies often require HSC transplant after treatment to restore their immune system

Significant unmet medical need in SCM

Multiple apheresis sessions required

50-70% of patients are poor mobilizers

10

For poor mobilizers, 1-4 daily injections

of Mozobil on top of G-CSF are required

HSC - hematopoietic stem cell; SCM - stem cell mobilization

11 Stem Cell Mobilization Opportunity

Rare indication showing significant growth and major unmet need

Growing number of auto-HSCTs in MM

  • An estimate of ~45,000 auto-HSCTs were conducted in

EU and US in 2018*

  1. ~90% of auto-HSCTs are in MM and lymphomas
  • o Number of MM auto-HSCTs doubled since 2010

  • Mozobil's sales shown 40% growth since 2016 (~$235 million in 2019)#

Multiple

54%

16%

Myeloma

Lymphomas

38%

22%

36%

2% 8%

14%

10%

First Line mobilization

Other

Poor mobilizers

BL-8040best-in-class CXCR4 antagonist potentially offers a more effective and convenient mobilization option for patients

  • Robust HSCT mobilization
  • Single administration on top of SoC
  • Reduced number of apheresis sessions and hospitalization costs

BL-8040 could become new SoC and expand the

market

  • BL-8040could expand beyond poor mobilizers to first line treatment
  • Potential expansion in other autologous indications, such as lymphomas and sickle cell anemia

* CIMBTR 2019 Summary Slides (US) - https://www.cibmtr.org// EBMT Transplant Activity Survey 2018 Summary (EU) - https://www.ebmt.org/

# Mozobil WW sales - Source GlobalData

Split of market extrapolated based on EBMT indication split. Poor mobilizer data based on CMS Medicare Analysis of Mozobil Utilization/Qualitative Research 2017

12 BL-8040 GENESIS Phase 3 Study: Autologous SCM in MM Patients

Interim analysis successful; full results expected H1 2021; NCT03246529

Study design

  • Part 1: Lead-in period - dose confirmation (n=30)
  • Part 2: Randomized placebo-controlled study in combination with G-CSF (n=177)

Primary endpoint

Proportion of subjects mobilizing ≥6 x 106 CD34+ cells/kg following single dose of BL- 8040 in up to 2 apheresis sessions

Part 1: Lead-inperiod results (n=11; DMC recommended early initiation of Part 2 based on 11 patients)

  • BL-8040in combination with G-CSF is safe and tolerable
  • 82% of patients reached primary endpoint threshold with one administration of BL-8040 and in up to 2 apheresis sessions; 73% reached the threshold in 1 apheresis session; all patients reached threshold in up to 4 apheresis sessions

MM= Multiple Myeloma

13 GENESIS Phase 3 Study Interim Results

Interim analysis successful; full results expected H1 2021; NCT03246529

Successful interim analysis of randomized, placebo-controlled part 2 in Oct 2020

Planned interim analysis on 122 patients of study's primary endpoint was conducted independently by study's Data Monitoring Committee (DMC)

Based on statistically significant evidence favoring treatment with motixafortide in primary endpoint and overall safety profile, DMC recommended immediate halt of study enrollment

According to DMC recommendation, enrollment ceased at 122 patients, instead of 177 as planned

"Given the overall safety profile and the unambiguous efficacy of the experimental compound, the DMC unanimously suggests the study halt enrollment now and complete data collection."

BL-8040 on top of G-CSF may become new standard-of-care in autologous SCM

Motixafortide in Cancer

Immunotherapy - PDAC & Solid

Tumors

2L Pancreatic Cancer Market Represents Significant Opportunity

15

Cold tumor where IO has no effect; significant market opportunity with high unmet medical need

PDAC incidence significant and growing: 460K cases WW​

in 2018, estimated 815K in 2040

Estimated pancreatic cancer cases # 2018-2040

China

Europe

USA+CA

Japan

Poor outcomes in PDAC:

  • 5y survival rate 8-10%, minimal change in last 30y
  • Multiple late-stage failures
  • >50% PDAC patients diagnosed with (stage IV) disease = COMBAT Cohort 2 population
    • 5y survival rate ~3%, mOS of 3-5 months​

Lack of efficacious treatment options (in all lines):

  • 1L Gem/FOL-based; 2L vice versa​
  • 2L Onivyde is the only approved regimen
  • Immunotherapy has no effect* => need to co-target alternative pathways

2L PDAC represents a multi-billion $ addressable market

  • ~85% of patients treated 1L and then 40% 2L
  • ~130K 2L pts in major markets#

BL-8040 is the only CXCR4 antagonist in advanced clinical development for PDAC

  • Failed trials based on single promising endpoint, while BL- 8040 improves multiple endpoints in homogenous population => better prediction of future success
  • Plan to expand beyond PDAC 2L into additional treatment lines and other solid tumors (1L PDAC study initiated^)

GLOBOCAN 2018; graph produced from WHO Cancer Tomorrow website - link

# 2L calculation based on e2025: ~400K Pancreatic cancer pts in major markets (US&CA 68K, Europe 146K, China 146K, JP 47K) - link

* Pembro only approved in MSI-H PDAC (~1% of pts)

^ BL-8040/PD-1i/Chemotherapy - NCT04543071

16 Motixafortide - Addressing Unmet Needs in Cancer Immunotherapy

BL-8040 blockade of CXCR4 regulates immune cell trafficking and rebalances the TME immune cells for IO in solid tumors

Immune-cell trafficking regulator

BL-8040 is a powerful mobilizer of immune cells from the bone marrow and lymph nodes (e.g. T-cells,B-cells, immature DCs and NK cells) into the periphery

Induces T cell infiltration

BL-8040 affects CAFs to disrupt stromal interactions, increasing TILs into tumors, e.g. CTLs, shifting cold to hot tumors

TME modulator

BL-8040re-balances effector and immune suppressor cells (CTLs vs. MDSCs & Tregs) in the TME

* Zheng et al. J. Clin. Med. 2019, 8, 1472; doi:10.3390/jcm8091472

17 COMBAT Phase 2a Study- Cohort 1: Dual Combination

Phase 2a open-label,multi-center study to assess the safety and efficacy of BL-8040 and pembrolizumab in subjects with metastatic pancreatic cancer: NCT02826486 (n=37)

MoA demonstrated by mono / dual combination (in patient biopsies - representative MultiOmyxTM data*):

  1. Increased activated cytotoxic T cells
  1. Decreased myeloid derived suppressor cells in tumor microenvironment
  1. Reduction in tumor cell numbers

End Cycle 2 Screening

In collaboration with

*Representative MultiOmyxTM data taken SD patient and long treatment duration (11 combo

Bockorny et al., Nat Med (2020)

cycles ~34 weeks). Data shown before treatment vs. after ~7w of treatment (end of cycle 2)

18 Rationale for Motixafortide Triple Combo in Cohort 2

Tumors with low immune visibility require multi-modal approach to advance treatment beyond SoC limitations

Chemotherapy induces tumor death, reducing tumor burden

Chemotherapy induces immunogenic cell death, leading to activation & expansion of new tumor-reactiveT-cell clones

Chemotherapy

Motixafortide facilitates effector T cell mobilization/ trafficking from BM/LN to periphery and infiltration into TME;

Motixafortide facilitates TME modulation: ↑activated CTLs and ↓MDSCs/Tregs

Motixafortide (BL-8040)

PD1 maintains & restores activity of T cells within tumor

Checkpoint Inhibitor

Adapted from Chen and Mellman

19 Design of Triple Combination - Cohort 2

Triple combination: BL-8040 and pembro on top of SOC in 2L PDAC

Main inclusion/exclusion criteria

Endpoints

18 years old and above

ORR according to RECIST 1.1 criteria

Metastatic disease at first diagnosis (Stage IV)

Disease control rate (DCR)

Progressed after first-linegemcitabine-based treatment

Duration of response

No previous surgeries for PDAC, no previous locally advanced disease

PFS and OS

No prior PD-1 or PD-L1 treatment

Safety and tolerability

Study completed; final results presented in December 2020 *

In collaboration with

Dr Hidalgo, Dec 2020 - KOL Webinar - Link

Bockorny et al., Nat Med (2020)

* All n=43, evaluable n=38

20 Encouraging Response Rates from Triple Combo Cohort 2

Change from Baseline* in Target Lesions

Change from Baseline in Target lesions

No. of

% of Subjects

Subjects

ORR (PR)

8

21.2%

cORR

5

13.2%

SD

16

42.1%

DCR

24

63.2%

PD

14

36.8%

According to RECIST v 1.1, confirmation of response (cORR) is required for non- randomized trials with response as the primary endpoint

Dr Hidalgo, Dec 2020 - KOL Webinar - Link* Baseline: Day 5 monotherapy

21 Triple Combo Shows Tumor Shrinkage Over Time (SDPR)

Majority of patients achieved PRs and SDs with triple combo

Change from Baseline in Target lesions

Data shown for subjects treated with the triple combination and have at least one Post Monotherapy D5 (BL) Scan

Dr Hidalgo, Dec 2020 - KOL Webinar - Link

22 Triple Combo mOS and mPFS are 6.5 mos and 4.0 mos, respectively

Overall Survival

Progression Free Survival

Dr Hidalgo, Dec 2020 - KOL Webinar - Link

*ITT data is similar

23 Favorable 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%

1https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdfDr Hidalgo, Dec 2020 - KOL Webinar - Link

24 Stage of Diagnosis Affects Survival Data

COMBAT patients all diagnosed at stage IV - i.e., benchmark is 4.7 mos

Data below from NAPOLI-1 registration trial for Onivyde/Leucovorin/5FU chemo combination - same used in COMBAT study

Macarulla Mercade et al, Pancreas 2020

25 Consistent and Meaningful Improvement Across All Study Endpoints

Demonstrated in hard-to-treat PDAC patients (caveated by limitations of small single-arm study)

COMBAT

HISTORICAL DATA#

mOS

6.5 months

4.7 months1

mPFS

4.0 months

2.7-3.1 months2,3

cORR

13.2%

7.7%3

DCR

63.2%

29-52%2,4

Summary of COMBAT Results

COMBAT 2 data showed improvement across all efficacy parameters compared to best matching population benchmark

Prolonged mOS and mPFS

Improved Confirmed ORR Responses and stable disease were generally durable

Favorable safety compared to Onivyde label

  • Based on benchmarking conducted - see KOL WebinarLink

1 Macarulla Mercade et al, Pancreas 2020; 2 Petrelli et al Eu J Cancer 2017; 3 Onivyde SMPC; 4 Wang Gillam Eu J cancer 2019

26 Motixafortide Highlights

A differentiated oncology platform with clinical POC in both solid and hematological indications

Differentiated, next-gen CXCR4 antagonist with high affinity and long receptor occupancy

MOA and clinical efficacy demonstrated in several different indications, including SCM, PDAC and AML Recent positive data in SCM and PDAC

  1. SCM: Positive Phase 3 IA data - advancing towards final results in H1 2021
  1. PDAC: Meaningful improvements across allendpoints vs historical data

Fast pathway to registration in SCM for multiple myeloma, with potential for extended LCM in other hematological indications requiring mobilization/transplantation

Significant upside as cancer immunotherapy platform in solid tumors and hematological diseases​

AGI-134

Cancer Immunotherapy

Universal Anti-Cancer Vaccine with Unique MoA

28 What is the Alpha-Gal and Anti-Gal Story?

Xenotransplantation experiments in the 1980's-90's found that, when introduced to humans, the alpha-Gal- positive tissue was bound by pre- existing human anti-Gal antibodies, which were the main cause of the rejection of porcine heart valves

AGI-134 coats tumor cells with alpha-Gal to make

AGI-134: a fully synthetic alpha-Gal glycolipid for IT injection

them look like foreign tissue and harness the pre-

existing immune machinery, to evoke an immune

response against the tumor

α-Gal

linker phospholipid

29 AGI-134 - Mechanism of Action

AGI-134 directs pre-existinganti-Gal antibodies to the tumor and induces activation of multiple immune system

effector arms against the patient's own neoantigens

30 AGI-134 Monotherapy - Phase 1/2a Study Design

Part 1 successfully completed

Open-label study to evaluate the safety and tolerability of AGI-134 intratumoral as a monotherapy, in unresectable/metastatic solid tumors (NCT03593226) (n=40)

PART 1

PART 2

AccelerateratedEscalationDose EscalationMonotherapy

MonothDoserapyExpansionsion

1

2

1

1

25mg

50mg

100mg

200mg

3

32

3 Deep Lesions

Deep & Superficial Lesions

Endpoints

Safety and tolerability

Determine MTD and RP2D

Pharmacodynamic and biomarker assessments

  • Part 1 of study successfully completed - AGI-134 was found to be safe and well tolerated with no dose-limiting toxicities observed
  • Part 2 initial results expected H2 2021

Looking Ahead

32 Upcoming Major Clinical Milestones in Next 12 Months

BL-8040

Phase 3 full results in SCM

H1 2021

AGI-134

Initial results from part 2 of Phase 1/2a trial

H2 2021

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BioLineRX Ltd. published this content on 17 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 January 2021 18:03:07 UTC