Regulatory Filings • Jan 6, 2021
Regulatory Filings
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FORM 6-K
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.
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.

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.
By: /s/ Isaac Israel
Isaac Israel Chief Executive Officer


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.


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



CM24 - an α-CEACAM1 mAb



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

ા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

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


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

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.
• Nivolumab in selected cancer indications (Phase 1) and NSCLC (Phase 2)
• Nivolumab and nab-paclitaxel in pancreatic cancer (Phase 2)
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


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

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
PURPI
¹Reuveni et al. Cancer Res 2013
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 )

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



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

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

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






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



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


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

પારણ

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

| 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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