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Purple Biotech Ltd.

Regulatory Filings May 5, 2024

7004_rns_2024-05-04_a653223e-5f14-49b8-b1b8-9c4680738cd1.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 May 2024 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 May 2024

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-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), 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) and the Registrant's Registration Statement on Form F-1 filed with the Securities and Exchange Commission on October 30, 2023 (Registration file number 333-275216), 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.

May 2, 2024 PURPLE BIOTECH LTD.

By: /s/ Lior Fhima

Lior Fhima Chief Financial Officer

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that are forward for are forward-looking statements within the meaning of the safe hards of the Private Securities Litigation Referm Ae of 1995. Such forwards include, but are not mitted or not satements of historical for not saternation of historical for world sock as "believe", "served", "plan", "nay", "should", "migh", "well", "will", "project", "inil", "project", "contine" or "anticipate" or wanitions of these words of these words of other companible worls or by the fact that there strictly to historial mates. You should not place under celance on these forward-looking satements, which are not guarantees of future performance. Forvant view, expectations, belief or intentions with respect to finance vers, and are subject to anniber of assumpion, invitye known and unknown risks, many of which as well as uncertainies and other factors that may cause our retual results, performance or achievements of esignifically different from any fitter reals, performance expressed or implied by the forward-looking statenents. Important for such differences include, annong obes, risks relating to the plans, stransgeners for fittere openions; product development for NT2 9, CM24 and M1240; the process by which such sath sath sath sath sath therapetive candidates could potection is long product is long and subject to highly significant isks, particularly with respect to a joint development on for hat that drug development and commercialization involves with uncertain outcome; our ability to successfuly develop and commercial podects, the expense, length, progess and esals; the inpact of any changes in regultion and legislation that could offect the pharmaceatical industry; the diffically in receiring the regulatory approvals necessary in order to commercialize of predictions of the U.S. Food and Drug Administmion or any other opplicable regulator of pharmacented products; the regilatory environment and regimes in the countries in which we operate the uncertains surventing the actual market reception to our pharmacential products one cleared for market the introducion of competition of competitions, departeres of on patents and other preceions for internation in the interior and defend issued patents; of any patent interference of infingenent of infingence or infingenent of internent act patent, and or thility to preval, obtain a five a mages in any such action; and the exposue to liigation, including patient life.grion, and or regulator, and or regulator act the economic publical and security sination in Isnel, the U.S. and other countries in vinch we may generals for our products or our business, and ober haves and ober haves ha are discussed in our Amal Report on Port 20-F for the year end December 11, 2025 and in our office and Exclange Commission ("SE"), including ou cautionary discussion of fisk Factors' in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results (o differ materially from expected results. Other listed could also adversely affect us. Any foward-looking statement in this press elese spaks only as of the date which is is nade. We dischin any intention or obligation to public to revise any forward-looking satement or other information vintene in result of new information, finan everse or otherwise, except as required by applications in consult any additional disclosures we make in our reports to the SEC, which are are are SEC's when https://www.sec.gov.

12

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 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 December 31, 2023

  • · ADS Outstanding: 25.2 M
  • Cash Balance: \$15.3 M

Strong position to reach short and mid term value creating clinical data catalysts

A Pipeline Dedicated to Advancing Oncology Therapies

Advancing First-in-Class Oncology Therapies

CM24: an a-CEACAM1* mAb

Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)

* Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional Immune Checkpoint Inhibitor

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
erncacy
Favorable safety profile in monotherapy and in combination with nivolumab
· Interim P2 results suggest reduced risk of progression or death as demonstrated by
PFS in the NAL/IRI arm
· Potential biomarkers identified such as NETs and CEACAM1 levels on TILs
Randomized Phase 2 is ongoing, last patient enrolled in Dec-23, top line data 2H24
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
16

CM24 MOA Immune Check Point Inhibitor & Anti-Metastatic Activity

Merine 18, 2002, 2004 (not more manager 2002, Denery of Mollaner Ter 202, 2002, Norg, 020, 202, North, Nammal Park 22, 22, 2020, (not 7 d. 1
Remove Treature Cal.All In Pute

CEACAM1 is Over-Expressed in Pancreatic Cancer

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 12%1
  • · Immuno-oncology approaches have been limited to patients with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H)
  • · 5-year overall survival rate with chemotherapy in 2nd line patients is 3%2
  • · Two main interchangeable regimens are used worldwide in 2nd line:
    • Gemcitabine/Nab-paclitaxel3: OS 7.9 months, PFS 4.3 months (weighted average)
    • Irinotecan (or Nal-IRI)/5FU/LV4: 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; Purple Biotech retains all worldwide rights to CM24

er.gov/statfacts/html/p . Z. Grand (minutes) Arcent 2017 2007) Cricemone of the Marcel Colombres (processor con Coll. C. C. (0.12.12.10.) L. C. (0.12.12.10.) L. C. (0.10.12.1. L. (0.10.10.)

Del 217 e.0113023 es in Medical Oncology, 2020:12.

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)
  • · Median Overall Survival 4.5 months (95% Cl 2.0-11.1) for 11 PDAC patients

Phase 1 study results (cont.): Identification 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

  • · consistent with the CM24 MoA in suppressing the immune evasion
  • · suggest CEACAM1 expressing lymphocytes as a potential biomarker

CM24 treatment significantly reduced NET marker in serum

  • · especially relevant in PDAC patients
  • · 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: 1H24 Top line data: 2H24

Measurement of CEACAM1 and other bio-markers is ongoing

Phase 2 interim data (cut off Feb 2024):

  • · CM24/nivolumab + Nal-IRI/5FU/LV experimental arm vs. the Nal-IRI/5FU/LV control arm suggests:
    • · Reduced risk of progression or death as demonstrated by PFS
    • · Higher objective response rate (ORR) and disease control rate (DCR)
    • · Decreasing CA19-9 in the experimental arm vs. increasing in the control arm
  • · Data from the gemcitabine/nab-paclitaxel arm is not yet mature, and OS data continues to mature for all arms.

Full data will be presented in a late-breaking abstract poster presentation at ASCO 2024 Annual Meeting

1 13

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

STATE

  • · 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

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

| 17

NT219 induces PDL1 and re-sensitizes aPD1-refractory model

| 19 NT 219 combination with α PD 1 achieves a profound reprograming of the TME NT219 and aPD1 combination converted immuno - suppressive TME to immuno - reactive * Collaboration with Prof. Bareli and Prof. Curran, M.D. Anderson cancer center, presented at AACR 2023 Activated cytotoxic T cells (% CD8 + GZMB + ) Activated NK cells (% NK 1.1 + GZMB + ) NT219+ a PD1 leads to a significant increase in cytotoxic effector cells (T & NK cells) NT219+ a PD1 leads to a significant reduction in myeloid derived suppressor cells (MDSC) % Mo - MDSC (out of CD45 + ) % Gr - MDSC (out of CD 45 + )

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

Phase 1 dose escalation in combination with cetuximab: Well tolerated, target exposure reached, patient's responses observed

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

SCCHN patient 50 mg/kg NT219 + cetuximab

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

Advancing First-in-Class Oncology Therapies

Conditionally-Activated Tri-Specific Antibody Platform

Lead candidate: IM1240 (CD3x5T4xNIKG2A)

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

| 26

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 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 December 31, 2023

  • · ADS Outstanding: 25.2 M
  • Cash Balance: \$15.3 M

Strong position to reach short and mid term value creating clinical data catalysts

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

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

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

Study Design

  • · As of March 8th, 2022, a total of 13 patients were enrolled and 11 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%).
Total Grade
AE Term 16 2 3 4/5
Diarrhea 5 4 1
Abdominal pain 4 1 3
Fever 4 2 2
Headache 3 1
Fatigue 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 I
Small bowel obstruction 1 I

CM24 Phase 1 Combination Study (NCT04731467) Demographics

Med

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.

In Commingtion MITL Hispinuan (400ml)
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 (%)

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

Pancreatic cancer 8 (73%)
10 (91%) Papillary Thyroid cancer 1 (9%)
1 (9%) Colorectal cancer 2 (18%)
Median Time from Initial
Diagnosis months (range)
23 (11-73)
10 (91%) ECOG, n (%)
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.

Appendix B | NT219

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

| 38 0 200 400 600 800 1000 1200 0 5 10 15 20 Tumor volume (mm 3 ) Days following treatment initiation Control (n=3) NT219 (n=3) Keytruda (n=3) Keytruda + NT219 (n=3) Autologous PBMCs ( 2.1 M/mouse) NT 219 Re - sensitizes Tumors Refractory to α - PD 1 PDX Model Humanized PDX of GastroEsophageal Junction (GEJ) Cancer (refractory to pembrolizumab) Drug Pembrolizumab (Keytruda®) * Double autologous model - Tumors & PBMCs are from the same patient (#RA 236 ) | Keytruda - 6 mg/kg IP, NT 219 - 60 mg/kg IV

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.

Selected Publications

| 42 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 Colon cancer LS - 513 cells overexpressing IRS 2 demonstrate enhanced b - catenin activity. Targeted inhibition of IRS 2 by NT 219 or IRS 2 - SH RNA, suppresses the increased b - catenin activity and inhibit LS - 513 cell viability. Combination of 5 - FU and NT 219 significantly inhibited the growth of CRC tumors in brain , using intracranial model and extended mice survival. Active β - Catenin IRS 2 β - actin NT 219 + - NT 219 concentrations ( m M) CRC Cell Viability ( 72 hr) IRS 2 NT 219 downregulates IRS 2 and suppresses the b - catenin activity Silencing IRS 2 inhibits b - catenin activity NT 219 Suppresses β - Catenin activity in CRC Cells and Inhibited CRC Brain Metastasis 5 - FU NT 219 + 5 Ͳ FU In Vitro In Vivo

| 43 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ® ) NT 219 | Pancreatic Cancer in Combination with Gemcitabine Highly effective anti cancer activity exhibited by NT 219 in combination with Gemcitabine

| 44 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ®) RNA Sequencing | Analysis of Tumors Following Treatment Reduced expression of IRS 1 , Ki 67 , FOXM 1 & TGFb is exhibited by pancreatic cancer treated with NT 219 alone and in combination with gemcitabine

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