Purple Biotech Ltd.

Regulatory Filings • Nov 22, 2023

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 November 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 .

Form 20-F 図 Form 40-F ロ Purple Biotech Ltd. (the "Company" or the "Registran") is announcing that it has made wailable an updated Company 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

Purple Biotech Corporate Presentation November 2023 99.1

Incorporation by Reference

This Report on Form 6-K, including attached hereby incorporated by reference into each of the Registration Statenent on Form S-S filel with the Securities and Exchange Commission on May 20, 2016 (Registration file number 33-211478), the Registration Statement on Form S-8 filed with the Sexurities and Exchange Commission on June 6, 2017 (Registrant's Registran's Registration Statement on Form F-3, as annended, originally filed with the Seurties and Exchange Commission on July 16, 2018 (Registration fle number 33-26195), the Registration Statement on Form S-8 filed with the Securites and Exchange Commission on March 28, 2019 (Registration file negistran's Registration Statenent on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration Statemis Registration Statement on Form F-3 filed with the Searnies and Exchange Commission on December 2, 2019 (Registration file number 33-23527), the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on December 27, 2019 (Registration States) is Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 33-238229), the Registration Statement on Form S-8 filed with the Securities and Exchange Commisson on May 18, 2020 (Registration file number 33-23481), each of the Registration Statements on Form F-5 filed with the Securities and Exchange Commission on July 10, 2020 (Registation file numbers 33-2399), the Registrant's Registration Statement on Form S-S fleet with the Securities and Exchange Commission on April 4, 2022 (Registration file number 33-264107) and the Registration Statenent on Form F-3 filed with the Securities and Exchange Comission on March 23, 2022 (Registration file number 33-20769) and the Registration Statement on Form F-3, as anned, originally filed with the Searchies and Exchange Commission on December 8, 2022 (Registration file number 33-268710), to be a part thereof from the date on which this report is superseded by documents or reports subsequently filed or furnished.

SIGNATURES

Pursuant to the requirements of the Securities Exchant has duly caused this report to be signed on its behalf by the undersiged, thereunto duly authorized.

November 21, 2023

PURPLE BIOTECH LTD.

/s/ Lior Fhima By: Lior Fhima

Chief Financial Officer

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Forward-looking Statements and Safe Harbor

Certain statements in this pers relose that are forward-looling statements within the nearing of the safe habor provisions of the Priste Scurities Lifigation Act of 1995. Such forward violade, but are not linted to, statements that are not statements of historial fact, and may be identified by vords such a" believe", "e "intend", "plan","may","should","might","see","toreast","toreast","tontinue" or "antinue" or "antitions of ther companable vords or dher companable vords or dy the lat that these statenents do not relate stictly to historial not place under eliance on these forward-looking statements, which are not guarantees of foure performance. Fornar-lo statenents relect our current views, expect of the respect of thure events, and are subject to a number di assumptions, involve known and unknown risk, may of which are beyon control, as well as untertaintes and other seriormance or achievents to be significantly different from any future results, performance or achiements expressed or implied by the forward-losing statements. Inportant for such differences indube, anong others, risks relaing to the expected benflt, synargic sand osts of the transction, management plans elating the potential inpact of the transaction; and any assumptions underlyg any of the foregoing the consection and the parties ' allify to complete the plants of management for future operations product development for NT229 and CM24 as well as well as well as well as well as hell of investigational tri-specific anthody compunis to be active site and stage therpentic andidates could potentially lead to an approved in long and subject to highy significant risks, particularly with respect to a joint that triug development and comnercialization involves alorthy and expensive process with uncertain outcome, our abilit successfuly devision and connercialize ou pharmaceutic of any clinical that, the inpact of any chical that the impact of regulation and legistion that could affect the pharmaceuical industry in receing the regulatory approals neer to commercialize or products the difficulty of predicing any other last of the U.S. Food and Inc. applicable equator of products the regulatory environment and change in the countries in the countries in virith ve operate; the uncertainy surrounding the actual natie reception to our pharmaceuital products on a particular market; the introduction of computing products; patented by competitors; dependente on the effectives; of our patents and other protections for includin, maintin and efend issued patents; the commencement of any patent interference or infringenent action againt our patents, and our ability to precil, obtain a favorale decision or recover and the exposure to litigation, including atching and or regulatory actions and or registers and other factors that a Annual Report on For he year ended December 31, 2022 and in our other filings with the U.S. Securities on cationary discussion of risk and uneralrities under "Risk Factors" in our Registation Station of Annual Paule could cause our actual results on offier materially from expected results. Other factors besides those we have listed could also adversely aftect us. Any forvard-boking to the discial it is mate. We discialm any intertion or oblight update or rebise any foward-looking statement or other information, whether as a result of new information, (uture events or oplicable live. Your are advised, hovere, to onsult 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 2024
• · Two First-in-Class clinical stage drugs
• · A preclinical tri-specific immuno-engagers platform
• · Lean & global operation
• . Cash runway into 2H25

Purple Biotech (NASDAQ/TASE: PPBT)

As of September 30, 2023

• . ADS Outstanding: 22.0 M
• Cash Balance : \$15.9 M

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

A Pipeline Dedicated to Advancing Oncology Therapies

Project	Target	Indications	Development Stage				Value Drivers
			Pre-Clinical	Phase I	Phase II	Phase III
CM24*	CEACAM1 mAb	Pancreatic Cancer (+nivolumab+SoC)					* Phase 2 interim analysis 1H24 * Phase 2 top line results 2H24
NT219	STAT3xIRS1/2 Dual Inhibitor	Solid tumors monotherapy) Head and Neck ಬ್ Colorectal Cancer (+Cetuximab)					* Additional results from the combination arm 1H24 * Initiation of Phase 2 1H24
IM1240	CD3x5T4xNKG2A Tri-specific Ab	Solid Tumors
	* Clinical collaboration and supply agreement with: (11) Bristol Myers Squibb)

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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 Immune Checkpoint Inhibitor

CM24 MOA Immune Check Point Inhibitor & Anti-Metastatic Activity

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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 microstellite instability (MS-H) or high tunor 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: Gemchts, Progression Free Survival (PFS) 4.3 months or Nal-RR/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

(Illı Bristol Myers Squibb"

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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

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

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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;

** 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

Dose Escalation Design

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

SCCHN patient 50 mg/kg NT219 + cetuximab

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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

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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 2024
• · Two First-in-Class clinical stage drugs
• · A preclinical tri-specific immuno-engagers platform
• · Lean & global operation
• Cash runway into 2H25 .

Purple Biotech (NASDAQ/TASE: PPBT)

As of September 30, 2023

• . ADS Outstanding: 22.0 M
• Cash Balance : \$15.9 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

02| IMMUNE CELLS/

01 | ADHESION

IMMUNE EXCLUSION Tsuzuki, 2020 Blumberg, 2015 Horst, 2011 อ้างอิง 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 supports tumor vessel maturation" therapeutic target in head and neck exhaustion" squamous cell cancers" Shively, 2013 Ferri, 2020 Tsang, 2020 Immunology Cancer Illinherage. Cell Research "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity against 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"

03 | IMMUNO-ONCOLOGY

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

• . 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%).

AE Term	Total	Grade
		1	2	3	4/5
Diarrhea	5	A		1
Abdominal pain	ਪ	1	3
Fever	4	2	2
Headache	प	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
Gl bleed	1			1
Leukocytosis	1			1
Small bowel obstruction	1			1

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%)	O	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.

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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., Lu, B. et al. Targeting STAT3 in Cancer Immunotherapy. Mol Cancer 19, 145 (2020). https://dol.org/10.1186/s1294

Simultaneous Blockade of STAT3 and AKT Pathways are Required to Overcome Resistance to EGFRi

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 ß-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 extended mice survival.

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