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Purple Biotech Ltd.

Regulatory Filings Oct 13, 2023

7004_rns_2023-10-13_3b87f16c-6250-4f92-b598-6e6e68bd467c.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 October 2023 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 ☐

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.

Exhibit

99.1 Purple Biotech Corporate Presentation October 2023

Incorporation by Reference

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-1 filed with the Securities and Exchange Commission on December 27, 2019 (Registration file number 333-235729), 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), 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) and the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on March 23, 2023 (Registration file number 333-270769) and the Registrant's Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on December 8, 2022 (Registration file number 333-268710), 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.

1

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.

October 13, 2023 PURPLE BIOTECH LTD.

By: /s/ Lior Fhima

Lior Fhima Chief Financial Officer

Forward-looking Statements and Safe Harbor

Certain statements in this pess release that are forward-looking statements within the nearing of the sate hardor provisions of the Private Securities Litigation Reform 4ct of 1995. Such forward-looking statements that are not timited to, statements of historical for and nay beitlifed by words such as "believ", "geliere", "intend", "plan", "may", "should", "thigh", "seel", "will", "project", "tortinue" or "anticipate" or writitions of these words or other comparable words on the fact that these statements do not relates. You should not place under eliance on these forward-looking statements, vinich are not guarantee, on are looking statements rellect our currentions with respect to future events, and are subject to a number of assumptions, involve known and unionenn isla, may of which are beyond our control, as well as uncertainites and other factors hatual results, performance or achievents to be significantly different from any future results, performance or achievenen implied by the foward-looling statements. Innortant to such differences include, anong others, risks elating to the expected benfits, ynergies and osts of the transction management plans elsting to the potential future finaction; and any assumptions underling any of the foregoing the expected timing of the cransction and the parties ability to complete the plans, strategies of mangement for future operations; product development for WT229 and CM24 as well as immunizor Ltd.'s portfolio of investigational tri-specific antibody compunis to be any stage thenpeutic canditates could potentialy lead to an approved drug product is long and subject to highy significant isks, particularly with respect to ad that drug development and commercialization involves a lengthy and experisive process with uncertain outcome; our ablily to successfuly develop and commercial products; the expense, length, progress and results of any clanges in regulation and legistion that could affect the pharmaceuical industry the efficulty in receiving the recessary in order to commercialize our prodicing actions of the U.S. Food and Dug Administration or any the appicale egulator of playmacedical production and changes in the heath policies and regimes in which we operate, the uncertainty surrounding the actual makel reeption to our pharmaceutics once cleared on market the introduction of competing products; patents obtained by competitors; dependence of the effectives of our patents and other protections on informant and defend issued patents; the commencement of any patent interfreence or infringenent action against our patents, and our ability to previl, obtain a famage in any such action; and the exposure to litigation, including patent liigation, and or regulatory action, and or rectors that are discussed Annual Report on For the year ended December 31, 2022 and in our other filings with the U.S.C"), including our cationary discussion of risk and uneratines under "Nis Factor" in our Reports. These are factors that we believe could cause or actual results of fife materially from expected results. Other factor besides those we have listed could also atter. u. Any forward-looling statement in this press release speaks only interion or obligation or obligation o publici update or reise any forviatl-oking statenent or other information contained to the winter events or othersis, except as required by applicable lav. Your are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov

Corporate Highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

  • Multiple data read-outs expected in 2023 & 2024
  • · Two First-in-Class clinical stage drugs
  • Lean & global operation
  • . Cash runway into 1H25

Purple Biotech (NASDAQ/TASE: PPBT)

As of June 30, 2023

  • ADS Outstanding: 21.4 M
  • Cash Balance : \$18 M

Leadership Team

Eric K. Rowinsky, MD Chairman of the Board Former CMO at ImClone, Stemline, Board member at Biogen Inc.

Biogen & Incorporated

Michael Schickler, PhD Head of Clinical and Regulatory Affairs Formerly at Hoffmann-La Roche, CEO at CureTech

Gil Efron Chief Executive Officer Former Deputy CEO & CFO at Kamada (NASDAQ:KMDA)

Hadas Reuveni, PhD VP Research & Development Formerly at Keryx (NASDAQ:KERX)

Lior Fhima Chief Financial Officer Formerly at Kamada (NASDAQ:KMDA)

Fabien Sebille, PhD Chief Business Officer Formerly at Debiopharm

| 4

A Pipeline Dedicated to Advancing Oncology Therapies

| 5

Advancing First-in-Class Oncology Therapies

CM24: an α-CEACAM1* mAb

Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)

*Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional lmmune Checkpoint Inhibitor

PURPLE

Attractive
new target
· CEACAM1 is overexpressed on certain tumor cells and infiltrating immune cells
· CEACAM1 interacts with CEACAM1 and CEACAM5 and creates a
tumor-protective environment
Demonstrated
mechanism
of action
· CM24 increases T cell and NK cells cytotoxicity against tumors
• CM24 shows benefit in combination with immuno-oncology treatments
· CM24 blocks adhesion of tumor cells to Neutrophil Extra cellular Traps (NETs)
Signals of
clinical
efficacy
• Favorable safety profile in monotherapy and in combination with nivolumab
• Partial response and stable disease in dose escalation study with nivolumab
· Potential biomarkers identified such as NETs and CEACAM1 levels on TILs
• Randomized Phase 2 initiated in Q1 2023
Sizable
market
potential
• Significant unmet medical need in pancreatic ductal adenocarcinoma (PDAC),
most common form of pancreatic cancer
· Strong IP position and well ahead of competitors
• Multiple opportunities to leverage the MoA in other clinical settings

CM24 MOA | Immune Check Point Inhibitor & Anti-Metastatic Activity

| 8

CEACAM1 is Over-Expressed in Pancreatic Cancer

adenocarcinoma and normal tissues

intensity in pancreatic cancer (38 cases/76 cores) and normal (10 cases/20 cores) tissues

Large Market Opportunity in Pancreatic Cancer

  • Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 11.5%²
  • Immuno-oncology approaches have been limited to patients with high microsatellite instability (MS-H) or high tumor mutational burden (TMB-H) • 5-year overall survival rate with chemotherapy in 2nd line patients is 3%¹
  • 3 L standard of care regimens efficacy data: patients treapy: Overall Survival (OS) 2 months, OS of 3-4 months with chemotherapy
  • 2 L standard of care regimens efficacy data: Gemcitaxel? OS 7.9 months, Progression Free Survival (PFS) 4.3 months or Nal-RK/5FU/V+ OS 6.2 months, PFS 3.1 months
  • · CEACAM1 expression correlates with poor prognosis in Pancreatic cancer2
  • Preclinical data support significant synergy of CM24 with currently marketed immuno-oncology therapies

Combining nivolumab with CM24 in a clinical collaboration with Bristol Myers Squibb

("Ill Bristol Myers Squibb"

4 лекса се продажен (1942 г.) (1942) (402) (402) 1942 г.) (1942) (494) (494 г.) (2012) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (404) (404) (40

CM24 Phase 1 Dose Escalation Results Encouraging data in 2L/3L Pancreatic Ductal Adenocarcinoma (PDAC) patients

Study Results

14 patients were evaluable for efficacy:

  • . Best overall response included 1 Partial Response (PR) (PDAC) and 4 Stable Disease (SD) (3 PDAC and 1 papillary thyroid cancer (PTC))
  • Pharmacokinetic analysis of CM24 shows exposure is dose-proportional across the 3 doses in this study
  • Well tolerated with no Dose Limiting Toxicities (DLTs) and no grade ≥ 4 Adverse Events (AEs)
  • 2.0-11.1) for 11 PDAC patients

Phase 1 study results (cont.): ldentification of potential exploratory biomarkers supporting CM24's mechanism of action

Higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1 are associated with longer survival

  • · suggest CEACAM1 expressing lymphocytes as a potential biomarker

CM24 treatment significantly reduced NET marker in serum

  • may be used as a pharmacodynamic marker

Phase 2 Combination Study Design (NCT04731467)

A study of CM24 in combination with nivolumab plus chemotherapy in PDAC patients in 2L treatment 18 centers are currently active in

US, EU & Israel

Primary endpoint :

OS

Secondary endpoints: PFS, OS rate @ 6 & 12 months,

PFS rate @ 3 & 6 months, ORR

Interim analysis:

  • PFS 2H23 OS 1H24
  • Top line data:
    • OS 2H24

-

Measurement of CEACAM1 and other bio-markers is ongoing

Advancing First-in-Class Oncology Therapies

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

Lead indication: Recurrent/Metastatic Head & Neck Cancer (SCCHN)

NT219, a new solution to improve treatment outcome for cancer patients

NT219 blocks 2 critical signalling pathways at once

IRS1/2

  • · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and antiapoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumors
  • Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and WNT/βcatenin
  • Activated as a feedback response to anti-cancer therapies
  • IRS plays an important role in promoting a tumor-protective microenvironment, by mediating upregulation of TAMs and CAFs

STAT3

  • Well-established transcription factor associated with the tumorigenic phenotype
  • STAT3 is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis and metastasis
  • · STAT3 pathway is required for TGFBinduced EMT and cancer cell migration and invasion
  • STAT3 is a critical player in tumor immune evasion, suppressing immune stimulators and enhancing immunosuppressive factors

Notes form at Clores Click (10) 2010) 16:64, 13:40) 10-6:40, Valle Part Pric 200, 2022, 2020, 20:20, 2020, 20:20, 2020, 20:00, Parte et A Moner Personal Police Concerners (

NT219 Restores Sensitivity to EGFRi in PDX Models

Lung Cancer

Non-small cell lung cancer (NSCLC) Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

Head & Neck Cancer

Recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) metastasis, patient 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 6 ** 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

  • SCCHN is the 6th most common cancer type ; 175k new cases/year are expected by 2024
  • 1L standard of care has shifted from chemotherapy towards immuno-oncology + chemotherapy
  • < 20% of R/M SCCHN patients respond to Pembrolizumab
  • Market size forecasted to >\$5b in 2030

NT219 Monotherapy and Combination Phase 1/2 Study Design (NCT04474470)

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 maximum tolerated dose (MTD)

Secondary endpoints: Obtain preliminary efficacy data

Phase 1 dose escalation in combination with cetuximab: Combination is well tolerated, target exposure reached

  • No DLTs reported, NT219 was well tolerated as monotherapy and in combination with cetuximab
  • · Dose-dependent increase in AUC and Cmax values
  • Human Equivalent Dose exposure was reached at 50 mg/kg
  • Target engagement demonstrated in patients' biopsies

Phase 1 Dose Escalation (cont.): Anti-tumor activity at target exposure level, 2 confirmed responses in SCCHN patients at 50 mg/Kg

Advancing First-in-Class Oncology Therapies

IM1240: CD3x5T4xNKG2A Conditionally-Activated Tri-Specific Antibody

A Novel Mechanism of Action Tri-Specific Antibody

  • · Multi-specific biologics is an expanding class of drugs getting a lot of interest in the industry
  • After initial success in hemato-oncology, new formats are being investigated in solid tumors
  • Technology displays several distinctive features:
    • Dual engagement of T cells and NK cells to mount an optimal anti-tumoral immune response
    • · A tumor-restricted activation through a cleavable capping system designed to provide a wide therapeutic index
    • Carefully selected Tumor Associated Antigens allowing patient-centric development

Promising Proof of Concept Data

Corporate Highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

  • Multiple data read-outs expected in 2023 & 2024
  • Two First-in-Class clinical stage drugs
  • A preclinical tri-specific immuno-engagers platform
  • Lean & global operation
  • . Cash runway into 1H25

Purple Biotech (NASDAQ/TASE: PPBT)

As of June 30, 2023

  • ADS Outstanding: 21.4 M .
  • Cash Balance : \$18 M

| 27

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

URP

02| IMMUNE CELLS/ оз | IMMUNO-ONCOLOGY 01 | ADHESION IMMUNE EXCLUSION Tsuzuki, 2020 Horst, 2011 Blumberg, 2015 ្រឹត្តិស្ថិតនៅ Oncogene nature "CEACAM1 creates a pro-angiogenic "Immune-checkpoint molecules on "CEACAM1 regulates tumor microenvironment that regulatory T-cells as a potential TIM-3-mediated tolerance and therapeutic target in head and neck supports tumor vessel maturation" exhaustion" squamous cell cancers" Shively, 2013 Ferri, 2020 Tsang, 2020 @ ™Journal』

Immunology Cancer Biotherupya Experimental "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity aqainst apoptosis in Jurkat T-cells via its therapeutic target to prevent tumor cells through blockade of the interaction with в-catenin" metastatic progression of colon inhibitory CEACAM1 / CEACAM5 carcinoma" immune checkpoint pathway"

CM24 Reduces Tumor Burden & Synergetic with α-PD-1

Phase 1 Dose Escalation Interim Results CM24 is Safe and Well Tolerated in Combination with Nivolumab

Study Design

  • patients were evaluable for DLT determination (8 PDAC, 2 CRC and 1 PTC).
  • 9 patients had received 2 prior regimens for metastatic disease, 2 . patients had one previous line.

Safety

  • . No DLTs were observed across all dose levels; no Grade 4 AEs or treatment-related deaths have been reported.
  • . Grade 3 AEs were noted in 6/13 patients (46%).

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CM24 Phase 1 Combination Study (NCT04731467) Demographics

In the Phase 1 part, patients with indicated refractory cancers were administered CM24 at 10, 15, and 20mg/kg q2w and nivolumab 480mg q4w.

  • The primary objective of this part was to evaluate safety, tolerability, pharmacokinetics and determine the RP2D
  • Safety was assessed according to CTCAE v5 and preliminary anti-tumor activity was assessed by the investigators according to RECISTv1.1 using CT/MRI
  • . CM24 and CEACAM1 measurements in serum, biopsy specimens, and TILs, as well as tumor and TILs PD-L1 levels are being determined

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.

Demographics of patients treated with CM24 (10, 15, 20mg/kg) in 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%

Confirmed Partial Response in a 3L PDAC Patient

Patient Profile

  • . 65 y/o female, pancreatic cancer
  • 2 prior lines of treatments: FOLFIRINOX and gemcitabine/nab-paclitaxel
  • . Post Whipple Procedure
  • . Patient had a germline NF1 VUS, with MSI-S and PDL-1 IHC 2+ and 5% staining
  • Confirmed Partial Response: after initial treatment, the patient had a Partial Response of 40%, with a definite reduction of the para-tracheal adenopathy and liver lesions and 58% reduction in CA19-9 levels
  • . Under treatment for 6 months, still under monitoring.

SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -

PREDOSE

Appendix B | NT219

Novel MOA: IRS Degradation By NT219 Blocking IGF1R-AKT Pathway¹

Novel MOA Signal Transducer and Activator of Transcription 3 (STAT3) Inhibition

  • · Point of convergence for numerous oncogenic signaling pathways
  • · Central in regulating the anti-tumor immune response
  • · Broadly hyperactivated both in cancer and non-cancerous cells within the tumor ecosystem and plays important roles in inhibiting the expression of crucial immune activation regulators and promoting the production of immunosuppressive factors
  • Targeting the STAT3 signaling pathway has emerged as a promising therapeutic strategy for numerous cancers

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

Zou, S., Tong, Q., Liu, B. et al. Targeting STAT3 in Cancer Immunotherapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12943-020-01258-7

Selected Publications

NT219 Suppresses β-Catenin activity in CRC Cells and Inhibited CRC Brain Metastasis

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 anice survival.

AACR Annual 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

Reduced expression of IRS1, Ki67, FOXM1 & TGFb is RNA Sequencing| exhibited by pancreatic cancer treated with NT219 alone and Analysis of Tumors in combination with gemcitabine Following Treatment Ki67 (Proliferation marker) IRS1 PDX model 17% Pancreatic Cancer Control NT219 Gemzar Gemzar NT219 Gemzar Gemzar Control +NT219 +NT219 FOXM1 TGFbeta (EMT Driver) 101% Drug Gemcitabine (Gemzar®) Control NT219 Gemzar Control NT219 Gemzar Gemzar Gemzar +NT219 +NT219 | 43

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