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Purple Biotech Ltd.

Regulatory Filings Jan 6, 2021

7004_rns_2021-01-06_ac139574-d733-4cf6-bdc0-d34a1839fc80.pdf

Regulatory Filings

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UNITED STATES 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 January 2021 Commission File Number: 001-37643

PURPLE BIOTECH LTD.

(Translation of registrant's name into English)

4 Oppenheimer Street, Science Park, Rehovot 7670104, Israel (Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover 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 Regulation S-T Rule 101(b)(1): ☐

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

Purple Biotech Ltd. (the "Company" or the "Registrant") is announcing that it has made available an updated Company Presentation on its website. A copy of the updated Company Presentation is attached hereto as Exhibit 99.1 and may be viewed at the Company's website at www.kitovpharma.com.

Exhibits

99.1 Purple Bio Company Presentation January 2021.

Incorporation by Reference

This Form 6-K, including all exhibits attached hereto, is hereby incorporated by reference into each of the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 20, 2016 (Registration file number 333-211478), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number 333-218538), the Registrant's Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on December 2, 2019 (Registration file number 333-235327), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 333- 238229), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 28, 2020 (Registration file number 333-238481) and each of the Registrant's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807 and 333-233793), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

SIGNATURES

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.

January 6, 2021 PURPLE BIOTECH LTD.

By: /s/ Isaac Israel

Isaac Israel Chief Executive Officer

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that are forward-looking statements within the meaning of the safe harbor provisions of the safe hardor provisions of the Private Securities Litization Act of 1995. Such forward-looking statements hat are not inited to, statements of historical fact, and may be identified by words such as "believe", "exped", "intend", "night", "seek", "targe", "will", "project", "toreast", "continu" or "antipiate" or their negatives or variations of these words or other comparable words. You should reliance on these forward-looking statements, which are not guarartes of future performance. Forward-looking statements reflect our current views, expectations with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, may of which are beyond our control, as well as uncertaining and our actual results, performance or activements to be significantly different from any future esult, performance on achievenents expressed or implied by the strements. Important factors that could cause or contribute to such differences indude, anong others, risks relating to the plans, strategies and difectives of nanagement for NT2.9 and CM24; the process by which early stage therapeutic candidates such as NT2.9 and CM24 could potentially lead to and subject on highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive our ability to successilly develop and commercialize our pharmacedical products the experse, ength, progress and results of any clinical the lack of sufficial trials the impact of any changes in regulation and legistion that could affect the pharmaceuical industry the difficulty in receiving the recessary in order to commercialize our products; the difficulty of pedicting actions of the U.S. Food and Doug Administration or any other applicable regulator of pharmaceutical production on the heath policies and regimes in the countries in which we operate; the unertainty surounding the actual market reeption to our cleared for marketing in a particular market, the introduction of competing podents attained by competitors; dependence on the effectivenes of our protections for innovative products; our ability to obtain, maintain and defend issued patent of any patent interforence or infringenent action agaility to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and other factors that are disussed in our in our Annual Report on Form 20-F for the year ended Deember 31, 2019 and in our other filings with the U.S. Securites and Exchange Commission of risks and uncertainties under "Risk Factor" in our Registation Statements and Annual Reports. These are factors that we believe could cause our actually from expected results. Other factors besides those we have lised could also adversely affect us. Any forward-looking statenent in this presentation it is made. We disclaim any intention or oblicy update or revise any forward-looking statement, or other information contained herein, whether as a result or otherwise, exept as required by applicable law. You are advised, however, to onsult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.

Our Transformation into Oncology

Advancing Clinical-stage Novel Oncology Therapies

CM24 - First-in-class a-CEACAM1 mAb, Validating clinical collaboration with ("Bristol Myers Squibb"

NT219 - First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3

H2:21 - Two phase 1 study readouts

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.2M

\$61M cash as of December 31st, 2020

CONSENSI® commercial royalties supports pipeline development

Cash runway through 2024

Expanding Pipeline Preclinical Program Indication Solid tumors (monotherapy) (Completed) Solid tumors (combination with Expansion arms on (الله Bristol Myers Squibb" RP2D: Jnitiation Q4:21 CM24 nivolumab) (CEACAM-1) NSCLC (combination with nivolumab) Topline data: H2:21 Pancreatic Cancer (combination with nivolumab and nab-paclitaxale) Solid tumors (monotherapy) Expansion arms on NT219 RP2D: Initiation Q4:21 R/M HNSCC & CRC (dose escalation with (IRS1/2 & cetuximab); R/M HNSCC (expansion -STAT3) Topline data: H2:21 combination with cetuximab on RP2D) Expansion 5 Multiple data read-outs expected in the next 12 months

Advancing First-in-Class Oncology Therapies

CM24 - an α-CEACAM1 mAb

CEACAM1* Plays a Key Role in Cancer Biology

CM24 MOA | Immuno-oncology

10 CM 24 MOA | Adhesion Neutrophil extracellular trap - associated CEACAM1 as a putative therapeutic target to prevent metastatic progression: CEACAM 1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. CM 24 is proposed to attenuate/block tumor growth and metastatic processes. Rayes RF, et al. Neutrophil Extracellular Trap - Associated CEACAM 1 as a Putative Therapeutic Target to Prevent Metastatic Progression of Colon Carcinoma. J Immunol. 2020 ; Gerstel, D. et al. CEACAM 1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. Oncogene 30 , 4275 – 4288 ( 2011 ) Primary Tumor Metastasizing CM24 Metastatic Tumor

Anti-cancer Effect Following Treatment Preclinical Data With CM24 + TIL and CM24 + α-PD1

ારણ Significant benefits as both single agent and in combination with x-PD-1

PURPLE No DLTs up to
10 mg/kg
No discontinuation of
study drug due to an AE
No drug related
mortalities
33.3% SD
(RECIST)
-------- --------------------------- -------------------------------------------------- -------------------------------- ---------------------- --

12 • Open - label, multi - dose escalation monotherapy study to assess safety and tolerability • Heavily pre - treated patients with a median of 4 prior regimens (range 2 - 8 ) Overall, treatment was well tolerated • Most of the responding patients were treated with the highest dose levels of 3 mg/kg & 10 mg/kg • PK analysis revealed non - linearity, modeling recommended to continue administration of higher doses to reach saturation CM24 Phase 1 Monotherapy Trial No DLTs up to 10 mg/kg No discontinuation of study drug due to an AE No drug related mortalities 33.3 % SD (RECIST) * 24 patients evaluated # pts 27 patients: Colorectal 11 Melanoma 7 Ovarian 4 Gastric 3 NSCLC 2 0.01mg/kg ϭ 0.03 mg/kg ϭ 0.1 mg/kg ϯ 0.3 mg/kg ϯ 1.0 mg/kg ϯ 3.0 mg/kg ϵ 10.0 mg/kg ϳ Q2wks x 20 6 - week observation q2wks X 4

PK/PD Modeling Provides Dosage & Schedule Guidance

clinical and commercial fit for CM24 Florget-mediated drug disposition. ^ OPDVO® is a registed trademark of Bristol-Myers Squib. Crough is the drag concentration reched by CM24 before the next dose is administe

Large Market Opportunity in NSCLC & Pancreatic Cancer

  • · NSCLC accounts for ~200K new cases/year in the US; with a 5-year relative survival rate of 23%2
  • Immunotherapy is now recommended as first line therapy in all patients with NSCLC and no driver mutations3
  • · 5-year overall survival rates with chemotherapy in 2L is 2.6% and with I/O Opdivo® is 13.4%4

• Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%2

  • I/O approaches have been limited to patients with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H)
  • 5-year overall survival rates with chemotherapy in 2L is 3%2

Combining nivolumab with CM24 in a clinical collaboration with

(Ill Bristol Myers Squibb"

  • · CEACAM1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer1
  • · Preclinical data support significant synergy
  • · Receptor saturation with CM24 is better achieved with a Q2W regimen, aligning with the nivolumab regimen

1 Dango et al, Lung Cancer 2008; 60:426 & Calinescu et al, Journal of Immunology Research 2018: 7169081. 2 American Cancer Society, Cancer Facts & Figures 2019, and the ACS website, https://seer.concer.gov/statfacts/html/pancreas.html 3 Economopolou P, Mountios C. The eneging treat mor-small cell lung career. Ann Transl Med. 2003/602.23. Adri. 2021.1.2021.1.2021.1.2021.1.2021.1.0.1.1.0.1.1.0.1.1.0.1.1.0.1.

CM24 Phase 1/2 Combination Study Design

A Phase 1/2 open label multi center study of CM24 in combination with:

• Nivolumab in selected cancer indications (Phase 1) and NSCLC (Phase 2)

• Nivolumab and nab-paclitaxel in pancreatic cancer (Phase 2)

Primary endpoints:

Phase 1: Evaluate the safety, PK and the MTD/RP2 dose

Phase 2: Evaluate preliminary efficacy in 2nd line NSCLC and pancreatic cancer

Measurement of CEACAM1 based bio-marker.

Exploring further studies in other tumor types as well as monotherapy

Advancing First-in-Class Oncology Therapies

NT219 - A Dual Inhibitor of IRS 1/2 and STAT3

NT219 - Dual Inhibitor of IRS1/2 & STAT3

IRS1/2

  • · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and antiapoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumor types
  • Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and Wnt/ß-catenin
  • · Activated as a feedback response to anti-cancer therapies

NT219 |

STATB

  • Well-established transcription factor associated with the tumorigenic phenotype
  • · Provides a crucial axis to support cell proliferation and survival
  • Active in tumor JAK/STAT3 and TGF beta resistance mechanisms

Washever et d., Career He 202,3:4343-434, 202 ; Mondo, News, No. 7, 3,404, 6:42, 2020, 6:00, 2020, 05:00, 2020, 05:50, 2020, 05:50, 2020, 05:50, 2020, 05:50, 2020, 05:20, 202 PMID: 26477311 Philia 2017 21 17

226-04/27 News/2015/12/2015/10/2015/10/2015/10/2015/10/21/2015/10/2019/10/2019/10/2019/10/2019/10/2019/10/2010/10/2010/10/2010/10/2010/10/2010/10/2010/10/2010/10/2010/10/2010

Novel MOA: IRS Degradation By NT219 Blocking IGF1R-AKT Pathway¹ 1 Binding to IRS 3 Degradation 2) Ser-phosphorylation IRS NT (ps) irs (ps) ps SURVIVAL APOPTOSIS APOPTOSIS APOPTOSIS Covalent binding to IRS1/2 leads to the IRS1/2 is degraded by the Serine phosphorylation prevents dissociation of IRS1/2 from IGF1R re-binding of IRS1/2 to the receptor proteasome

PURPI

¹Reuveni et al. Cancer Res 2013

NT219 Efficacy as Monotherapy

Animal model Head & Neck Cancer (SCC-9) NSG™, PBMCsinjected1

Drugs α-PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/kg

1 NSG mice were injected SC with SCC-9 cells. PBMCs (18*10* cells per mouse) administered 4 weeks prior to first treatment. NT219, a-PD1, and cetuximal were administered IV (NT219) and IP (a-PD1 and cetuximab) twice oweek for 4 weeks. Groph reflects

20 By blocking both STAT 3 and IRS pathways, NT 219 prevents tumor resistance and re - sensitizes tumors to anti - cancer therapies STAT 3 and IRS are Essential in Therapeutic Resistance STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib Blocking survival pathways NT 219 NT 219 STAT 3 IRS ONCOPROTEIN DRUG MEK / ERK TUMOR REGRESSION Proof of Concept: PDX model of Head and Neck Cancer Erlotinib+Ruxolitinib (n= 6 ) Erlotinib+Buparlisib (n= 6 ) Control (n= 6 ) Erlotinib (n= 8 ) Erlotinib+NT 219 (n= 6 ) Erlotinib+Ruxolitinib+Buparlisib (n= 8 )

NT219 + Targeted Therapies Established Efficacy in PDX Models

NSCLC

Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

R/M HNSCC metastasis, patient previously progressed on

chemoradiation, several chemotherapies, and pembrolizumab

Osimertinib 5 mg/kg, NT219 65 mg/kg, mean tumor volume at the end point, 3 mice/group;

Treatments on days 0, 3 and 10, cetuximab - 1mg/mouse, 3 mice/group; PBMCs (1.4M cells/mouse) were injected on day 621 ** p<0.01, * p<0.02 based on one-way ANOVA with post hoc Tukey's HSD test

First Market Opportunity

Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Targeting the unmet medical need

  • · 1L Standard of care has shifted from chemotherapy towards immuno-
  • oncology + chemotherapy
  • Only < 20% of R/M SCCHN patients respond to α-PD1s
  • 175k new cases/year are expected by 2024

NT219 Monotherapy and Combination Phase 1/2 Study Design

Study title

A phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone in adults with recurrent or metastatic solid tumors and in combination with Erbitux® (cetuximab) in head and neck cancer

Endpoints

Primary endpoints: Safety, pharmacokinetics and to determine the MTD Secondary endpoints: Obtain preliminary efficacy data

Advancing Clinical-stage Novel Oncology Therapies

CM24 - First-in-class a-CEACAM1 mAb, Validating clinical collaboration with ("Bristol Myers Squibb"

NT219 - First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3

H2:21 - Two phase 1 study readouts

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.2M

\$61M cash as of December 31st, 2020

CONSENSI® commercial royalties supports pipeline development

Cash runway through 2024

We are committed

to providing cancer patients with first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression

Appendix A - CM24

Inhibition of Melanoma Growth Following CM24 and CM24 + TIL Treatment

CM24 activity is Demonstrated as Single Agent and in Combination with TILS

30 PHASE 1 PK DATA Target saturation was not reached with doses up to 10 mg/kg Slower clearance with increasing dose Higher half - life with increasing dose 0.1 mg/ kg 0.3 mg/ kg 1 mg/ kg 3 mg/ kg 10 mg/ kg

Appendix B - NT219

Selected Publications

NT219 | Suppresses ß-Catenin activity in CRC Cells

Colon cancer LS-513 cells overexpressing IRS2 demonstrate enhanced β-catenin activity. Targeted inhibition of IRS2 by NT219 or IRS2-SH RNA, suppresses the increased ß-catenin activity and inhibit LS-513 cell viability.

AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020 Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center

RNA Sequencing | Analysis of Tumors Following Treatment

Gemcitabine (Gemzar®)

Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine

35

17%

+NT219

Gemzar

+NT219

Appendix C - CONSENSI®

CONSENSI® | From IND to the U.S. Market CONSENSI® is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and death consensions and creleroxil tablets Full U.S. Prescribing Information is available at http://www.consensi.com Fixed dose combination of Celecoxib, Amlodipine a blood pressure-lowering agent (a calcium a COX-2 selective NSAID channel blocker) (the active ingredient in Pfizer's Norvasc®) (the active ingredient in Pfizer's Celebrex®) Acceptis Launched in the USA- Coeptis Pharmaceuticals > 콘셉트™ Partnered in China- CSBio Partnered in S. Korea- Kuhnil Pharmaceutical KUHA Purple Biotech's clinical, regulatory and medical teams developed CONSENSI® internally from IND, through successful Phase III clinical trials, to FDA approval

પારણ

CONSENSI® Phase III Trial Results

Consensi® demonstrated even better BP reduction than same amount of amlodipine given without celecoxib

  • Primary efficacy endpoint was successfully achieved (P=0.001)
  • Demonstrated 2.5x better blood pressure reduction than FDA requirement ... (50% of amlodipine arm)
  • Demonstrated consistent reduction in all measures of blood pressure .
  • Observed beneficial renal functions:
Measure Consensi® Amlodipine
Creatinine
plasma level
reduction
-3.22
umol/L
-2.55
umol/L
Peripheral
edema
(% patients)
8.2% 15.6%

· Additional Phase III/IV clinical trial to scientifically validate the renal benefits (not required for NDA submission) was completed. Topline results were announced in October, 2017

*Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.).
Norvasc® is a registered trademark of Pfizer Inc.

40 CONSENSI ® U.S. Target Markets CONSENSI® targets osteoarthritis (OA) patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension OSTEOARTHRITIS 50 million patients* NSAIDs 60 % of all OA Rxs * Arthritis Foundation: http://www.arthritis.org/ ** Hypertension Among Adults in the United States: National Health and Nutrition Examination Survey, 2011 – 2012 ARTHRITIS PREVALENCE* • More than 50 million adults in the U.S. have doctor - diagnosed osteoarthritis • 67 million people are expected to have doctor - diagnosed osteoarthritis by 2030 HYPERTENSION PREVALENCE** • 29 % of U.S. adults older than 18 • 65 % of U.S. adults older than 60 COMORBIDITIES • 44 % of adults with high blood pressure have osteoarthritis** HYPERTENSION Celecoxib 24 % of all NSAIDs Consensi 䉼

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