Foreign Filer Report • Nov 10, 2022
Foreign Filer Report
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FORM 6-K
For the month of November 2022 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.purple-biotech.com.
99.1 Company Presentation – November 2022
This Report on 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 18, 2020 (Registration file number 333-238481), 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) and the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 4, 2022 (Registration file number 333-264107), 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.
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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/ Gil Efron
Gil Efron Chief Executive Officer


Certain statements in this presentation that and not statements of historical fact are forward-looking statements within the meaning of the safe hardor provisions of the Private Securities Litigation Reform Act of 1995. Such entry include, but are not initied to, statements of historical fact, and may be identified by words such as "believ", "ened", "nten", "nay", "should", "might", "seel", "toreast", "continu" or "anticipat" or their negatives or variations of these words or other comparable words. You should reliance on these forward-looking statements, which are not guarantees of tuture performance. Foward-looking statements reflect our current views, expections with respect of future events, and are subject to a number of assumptions, incole known isks, may of which are beyond our control, as well as uncertaining and our actual results, performance or achievenents to be significantly different from any future esults, performance or achievenents expressed or implied by the towards. Important factors that could cause or contribute to such differences include, among others, risks relating to the plans, strategies and objectives of nanagement for tuture development for NT219 and CM24; the process by wicits early stage therapeutic candidates such as NTZ19 and CMZ4 could potentially lead to an approved drighty significant risk, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expense; our ability to successilly develop and commercialize our pharmaceutical product; the experse, lergh, progress and results of any clinical tinate the clinical tiols; the impact of any changes in regulation and legislation that could affect the pharmaceuical industry the difficulty in receiving approvals neessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Admisistation o other applicable regulator of pharmaced and changes in the health policies and regims in the countries in which we operate, the uneratiny surounding the actual market reception to our cleared for marketing in a particular market; the introduction of compeint products; patents atained by competitors; dependence on the effections of our protections for inrovative probility to obtain, maintain and defent issued patents; the commencement of any patent interference or infingenent action agains and our ablity to prevall, obtain a favorable decision or recover damages in any such action, and the exposure to fitigation, including patent litigation, and other factors that are discussed in our in our Anual Report on Form 20-F for the year ended December 3, 2021 and in our other filings with the U.S. Securities and Exchange our cationary discussion of risk and uncertaintes under "Risk Factor" in our Registration Statements and Annual Reports. These are factors that we believe our actual results. Other factors besides those we have lised could also adversely affect us Anv forward-looking statenent in this presentation it is nade. We distain any intention or obligition to publicy update or revise any forward-looking statenert, on other information contained herein whether future events or otherwise, except as required by applicable low You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients
Strong balance sheet and cash position
Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 18.4M
\$35.7M cash as of September 30, 2022


14
· The current focus is largely on lymphoid cells while the "myeloid" component is largely overlooked
1 47-68, 3 Jun, 2020, doi:10,1002/mco2,6
| Program | Indication | Phase I | Phase 2 | Phase 3 | Value Drivers |
|---|---|---|---|---|---|
| Solid tumors (monotherapy) | Completed | V RP2D in combination: 20 mg/kg | |||
| Solid tumors (combination with nivolumab") | V Initiation of phase II in 2L PDAC Follow up OS data from P1 |
||||
| CM24 (CEACAM-1) |
Pancreatic Cancer (combination with nivolumab+chemo") |
Interim analysis P2 2H23 Top line P2 2H24 |
|||
| Combination with SOC, undisclosed indication | Investigation in a second indication | ||||
| Solid tumors (monotherapy) | RP2D monotherapy & combination 1H23 |
||||
| NT219 R/M SCCHN & CRC (dose escalation + P2 with (IRSI/2 & STAT3) cetuximab) |
Initiation of P2 combination with cetuximab 2Q23 |
||||
| Combination with SOC, undisclosed indication | Investigation in a second indication | ||||
| Planned study Ongoing |
|||||
| *Clinical collaboration and supply agreement with: (1) Bristol Myers Squibb |

CM24: an α-CEACAM1* mAb
*Carcinoembryonic Antigen Cell Adhesion Molecule

18

Market d, Inmund 2002, 2005; Inmunol immunther 2012; Otenberg et al, Mol Concer The 2012; 200; 200; Hung, 2015; Hung, 2015; Adaryo N, et al. J Immundheroy Cac 8:e11-22, 2020, Royes R, et al. Neutrophil Extrand Crum (1974) 1978) by Preven Metstole Progresion of Colon Corcinoma. I mmund. 2020, Gersel, P. g.
el. CEACM1 cerates a pro-n



and normal (10 cases/20 cores) tissues

| AE Term | Total | Grade | |||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4/5 | ||
| Diarrhea | 5 | 4 | 1 | ||
| Abdominal pain | 4 | 1 | 3 | ||
| Fever | 4 | 2 | 2 | ||
| Headache | 4 | 3 | 1 | ||
| Fatigue | 4 | 4 | |||
| Nausea | 3 | 1 | 2 | ||
| Creatinine increased | 3 | 2 | 1 | ||
| Hypokalemia | 2 | 2 | |||
| Dyspnea | 2 | 1 | 1 | ||
| Constipation | 2 | 2 | |||
| Cough | 2 | 2 | |||
| Abdominal pain aggravated | 1 | 1 | |||
| Alkaline phosphatase increase | 1 | 1 | |||
| Atrial flutter | 1 | 1 | |||
| C-Diff Colitis | 1 | 1 | |||
| GI bleed | 1 | 1 | |||
| Leukocytosis | 1 | 1 | |||
| Small bowel obstruction | 1 | 1 |
CM24 Phase 1 Dose Escalation Interim Results (cont.) Sustained Clinical Benefit Even After Treatment Cessation
For the 11 evaluable patients as of March 8th, 2022, best overall response included 1 confirmed PR (PDAC patient) 3 SD (2 PDAC and 1 PTC) for a disease control rate of 36%
The Phase 2 portions of the study has been initiated at the conclusion of this dose-escalation part.




SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -
PREDOSE

• Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 11.5%¹
• I/O approaches have been limited to patients with high microsatellite instability (MS-H) or high tumor mutational burden (TMB-H)

(Illı Bristol Myers Squibb"

ﺎ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﺴﻴﺎﺭﻳﺔ ﺍﻟﺴﻴﺎﺳﻴﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | 15
A study of CM24 in combination with nivolumab plus chemotherapy in PDAC patients in 2L 11 centers are currently active in US, EU & Israel
Primary efficacy endpoint of the randomized sub-study: OS
Secondary endpoints:
PFS, OS rate @ 6 & 12 months, PFS rate @ 3 & 6 months, ORR
Interim analysis: - PFS rate @ 6M planned in 2H23 Top line data: - planned in 2H24 Measurement of CEACAM1 and other biomarkers is ongoing Planning of further studies in other tumor types is ongoing


NT219: A Small Molecule Dual Inhibitor of IRS 1/2 and STAT3

| 18 NT219 - A Novel Approach to Overcome Resistance to EGFRi and Beyond • NT219 is a First - in - Class , small molecule • Dual inhibitor of IRS1/2 and STAT3 Innovative MOA • Outstanding efficacy in various PDX models in monotherapy and in combination • Modulation of the tumor microenvironment • Uniquely suited to tackle resistance to EGFRi and other agents Robust preclinical package • Early signs of clinical efficacy as single agent • No DLTs observed to date, RP2D has not been determined yet Clinical Stage • Short path to registration in 2L r/ mSCCHN and m ultiple market upsides Broad Market Potential
NT219
STATB

menner at a 10, 2014 20:47 Andre de A. Chic 2017, 10:06 Planes (R. M.) Roman of t. M. M. 2020 2022 2222 2222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 2
| 19

NT219 demonstrates a durable and dose-dependent suppression of STAT3 tyrosine phosphorylation, affecting both the tumor cells and the tumor microenvironment.



| 22 Simultaneous Blockade of STAT 3 and AKT Pathways are Required to Overcome Resistance to EGFRi Overcoming drug resistance NT 219 NT 219 STAT 3 IRS EGFR EGFRi 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 ) STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib NT 219 NT 219 JAK By blocking both STAT 3 and IRS resistance pathways, NT 219 re - sensitizes tumors to anti - cancer therapies

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mousl not treatments initiated when
tumors were established. (NT219) and IP (α-PD1 and cetuximab) twi 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib
metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pembrolizumab
R/M SCCHN

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 6 ** p<0.01, * p<0.02 based on one-way ANOVA with post hoc Tukey's HSD test


| Grade | |||||
|---|---|---|---|---|---|
| AE Term | Total | 1 | 2 | 3 | 4/5 |
| Fatigue | 6 | 6 | |||
| Constipation | 4 | 4 | |||
| ALP increased | 3 | 2 | 1 | ||
| ALT increased | 3 | 1 | 2 | ||
| Anemia | 3 | 1 | 2 | ||
| AST increased | 3 | 1 | 1 | 1 | |
| Diarrhea | 3 | 2 | 1 | ||
| Headache | 3 | 3 | |||
| Nausea | 3 | 2 | 1 | ||
| Abdominal pain | 2 | 1 | 1 | ||
| Belching | 2 | 2 | |||
| Cough | 2 | 2 | |||
| Dizziness | 2 | 2 | |||
| Dyspnea | 2 | 2 | |||
| Edema limbs | 2 | 2 | |||
| Fever | 2 | 2 | |||
| Hot flashes | 2 | 2 | |||
| Hyperhidrosis | 2 | 2 | |||
| Urinary tract infection | 2 | 2 | |||
| Closed displaced fracture of right | |||||
| femoral neck | 1 | 1 | |||
| Intractable right hip pain | 1 | 1 | |||
| Malignant hypercalcemia | 1 | 1 | |||
| Toxic Encephalopathy | 1 | 1 | |||
| Worsening back pain | 1 | 1 | |||
| Abdominopelvic Ascites | 1 | 1 |
| 26



GEJ tumor at baseline screening
CT imaging of the GEJ tumor after 5 months of treatment with NT219



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

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients
Strong balance sheet and cash position
Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 18.4M
\$35.7M cash as of September 30, 2022

We are committed to provide cancer patients with first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression
Contact Us: [email protected]




1 Target-mediated drug disposition. 3 trough is the drug concentration reached by CM24 before the next dose is administered
| 34
In the Phase 1 part, patients with indicated refractory cancers were administered CM24 at 10, 15, and 20mg/kg q2w and nivolumab 480mg q4w.
As of March 8th, 2022, a total of 13 patients were enrolled and 11 patients were evaluable for dose-limiting toxicity (DLT) determination (8 PDAC, 2 CRC and 1 PTC)
. 9 patients had received 2 prior regimens for metastatic disease and 2 patients had one previous line.

| cs of patients treated with CM24 (10, 15, 20mg/kg) | |
|---|---|
| n combination with nivolumab (480mg) | |
| Median age, years (range) | 65 (49-76) | Prior Lines of Therapy, n (%) | |
|---|---|---|---|
| Sex, n (%) | 1 | 2 (18%) | |
| Male | 5 (45%) | 2 | 9 (82%) |
| Female | 6 (55%) | Diagnosis , n (%) | |
| Ethnicity, n (%) | Pancreatic cancer | 8 (73%) | |
| Not Hispanic or Latino | 10 (91%) | Papillary Thyroid cancer | 1 (9%) |
| Hispanic or Latino | 1 (9%) | Colorectal cancer | 2 (18%) |
| Race, n (%) | Median Time from Initial Diagnosis months (range) |
23 (11-73) | |
| White | 10 (91%) | ECOG, n (%) | |
| Black or African American | 1 (9%) | 0 | 7 (64%) |
| 1 | 4 (36%) |
Demograph



Colon cancer LS-513 cells overexpressing IRS2 demonstrate enhanced ß-catenin activity. Targeted inhibition of IRS2 by NT219 or IRS2-SH RNA, suppresses the increased β-catenin activity and inhibit LS-513 cell viability. Combination of 5-FU and NT219 significantly inhibited the growth of CRC tumors in brain, using intracranial model and exurvival.

AACR Annuol Meeting, April 2021, AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020, Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center


| 40 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ®) RNA Sequencing | Analysis of Tumors Following Treatment Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine
As of data cutoff date of May 12th , 2022, a total of 14 patients were enrolled to 4 NT219 dose levels (3 - 24mg/kg)
| PURPLE | |
|---|---|
| Demographics of patients treated with NT219 (3, 6, 12, 24mg/kg) | |||
|---|---|---|---|
| Median age, years (range) | 67 (39-79) | Diagnosis , n (%) | |
| Sex, n (%) | Pancreatic | 3(25%) | |
| Male | 4(33%) | GE Junction | 1(8%) |
| Female | 8 (67%) | Breast | 2(17%) |
| Ethnicity, n (%) | Colorectal | 4(33%) | |
| Not Hispanic or Latino | 11 (92%) | Appendiceal | 1(8%) |
| Hispanic or Latino | 1 (8%) | SCC of the esophagus | 1(8%) |
| Race, n (%) | Prior Lines of Therapy, n (%) | ||
| White | 10 (83%) | 2 | 2 (17%) |
| Black or African American | 2 (17%) | 3 | 3 (25%) |
| ECOG, n (%) | 4 | 2(17%) | |
| 0 | 5 (42%) | 5 | 2(17%) |
| 1 | 7 (58%) | 6 | 1(8%) |
| Median Time from Initial Diagnosis | |||
| months (range) | 36(10-153) | 8 | 1(8%) |
| 11 | 1(8%) |
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