Purple Biotech Ltd.

Regulatory Filings • Nov 17, 2021

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 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): ☐

The Company 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 Company Presentation

Incorporation by Reference

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.

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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.

November 16, 2021 PURPLE BIOTECH LTD.

By: /s/ Isaac Israel

Isaac Israel Chief Executive Officer

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that not statements of historical fact are forward-looking statements within the meaning of the safe hardor provisions of the Private Securities Life.tim Act of 1995. Such forward-looking statements include, but are not statements of historical fact, and may be identified by words such as "believ", "and", "nten", "thould", "cold", "might", "seel", "taree", "torecas", "continue" or their negatives of variations of these words or other comparable words. You should not parents, which are not purantees of tuture performance. Forward-looking statements reflect our current views, expectations with respect of uture events, and are subject to a number of assumptions, involve inown and unlown risis, many of which are beyond our control, as well as uncertaining and other may cause our actual results, performants to be significantly different from any future esults, performance on achievenents expressed or inplied by the forward-looking that could cause or contribute to such differences include, anong others, risks relating to: the plans, strategies and objectives of nanagement for NT2.9 and CM24; the process by which early stage therapeut candidates such as N72.9 and CMZ4 could potentially lead to an approved drively significant risks, particularly with respect to a joint development collaboration; the fact that that that that that that drug d commercialization involves a lengthy and expenses, our ability to successfuly develop and conmecialize our pharmacedical products, the experse, length, progress and results of any clinical that of sifical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry the difficulty in receiving approvals necessary in order to commercialize our products; the U.S. Food and Dug Administration or any other applicable regulator of pharmaceutical production in the health policies and regims in the countries in which we operate, the unercraity surounding the actual market reception to our cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; degentence or the effectivenes of our protections for inrovative products; our ability to obtain, maintain and defend issued patents; of any patent interference or infingenent action against our ablity to prevall, obtain a favorable decision or recover damages in any such action, and the exposure to litigation, 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, 2020 and in our other filings with the U.S. Securities and Exchange our cautionary discussion of risks and uncertainies under "Risk Factor" in our Rejstration Statements and Annual Reports. These are lectors that we believe our actual results. Other factors besides those we have listed could also adversely affect us Any forward-looking statement in this presentation is made. We distain any intention or obligation to publicly update or revise any forward-ooking stagent, or other information contained herein who have events or otherwise, except as required by applicable inv. You are advised, however, to consult any additions disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.

Business Highlights

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

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.7M

\$50.5M cash as of September 30th, 2021

Cash runway into 2024

3

Multiple data read-outs expected in the next 12 months

Advancing Clinical-stage Novel Oncology Therapies

Program	Indication	Preclinical	Phase 1	Phase 2 Phase 3	Partner	Value Drivers
CM24 CEACAM-1	Solid tumors (monotherapy) (Completed) Solid tumors (combination with nivolumab) NSCLC (combination with nivolumab) Pancreatic Cancer (combination with nivolumab and nab-paclitaxale)				( Bristol Myers Squibb	Expansion arms on RP2D: Initiation Q4:21 Topline data: H2:21
NT219 IRS1/2& STATE	Solid tumors (monotherapy) R/M SCCHN & CRC (dose escalation with cetuximab); R/M SCCHN (expansion - combination with cetuximab on RP2D)					Expansion arms on RP2D: Initiation Q1:22 Topline data: H1:22

Advancing First-in-Class Oncology Therapies

CM24 - an α-CEACAM1 mAb

CEACAM1* Plays a Key Role in Cancer Biology

CM24 MOA | Immuno-oncology

10 Significant benefits as both single agent and in combination with α - PD - 1 Anti - cancer Effect Following Treatment Preclinical Data With CM24 + TIL and CM24 + α - PD1 • Xenograft, lung lesion, Mel 526 (IV) • Tumor burden was monitored 26 days post last CM24 treatment TIL + IgG TIL + CM 24 Naïve Combination index ( CI) = 0.15 < 1 64; synergy

11 • 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 Q 2 wks x 20 6 - week observation q2wks X 4

PK/PD Modeling Provides Dosage & Schedule Guidance

• · Consistent with observed PK showing high clearance at doses <10 mg/kg, plot shows low TMDD saturation at low doses
• · 10 mg/kg has a broad range of saturation, and >10 mg/kg, Q2W dose is needed for saturation across population
• · Nivolumab administered Q2W or Q4W, representing good clinical and commercial fit for CM24

Simulated TMDD1 saturation at Ctrough with Q2W regimen

Phase 1b/2a study will continue escalating the CM24 dose above 10mg/kg q2wk, in combination with nivolumab

-Torget-mediated drug disposition. ^OPDVO® is a registered toders Squib. Crough is the drag concentration reched by CM24 before the next dose is administeed

Large Market Opportunity in NSCLC & Pancreatic Cancer

• · NSCLC accounts for ~200K new cases/year in the US; with a 5-year relative survival rate of 23%2
• Immunotherapy is now recommended as first line therapy in all patients with NSCLC and no driver mutations3
• · 5-year overall survival rates with chemotherapy in 2L is 2.6% and with I/O Opdivo® is 13.4%4

Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%2

• 1/O approaches have been limited to patients with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H)
• · 5-year overall survival rates with chemotherapy in 2L is 3%2

Combining nivolumab with CM24 in a clinical collaboration with

(Ill Bristol Myers Squibb"

• · CEACAM1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer1
• · Preclinical data support significant synergy
• · Receptor saturation with CM24 is better achieved with a Q2W regimen, aligning with the nivolumab regimen

1 Dango et al. Lung Concer 2008; 60:426 & Calinescu et al. Journal of Immunology Research 2018: 7169081. 2 Anerican Concer Focts & Figures 2019, nd the ACS website, https://set.comer.gov/stort.glv.nl/ported.html
3 Economopolios / The energing treatment lanstope of obvenced non 4 Gettinger S, et al "Five-year outcomes from the check frais Check Mate 0.7/057. Nivolumably treated NSCC" WCLC 2019, Abstract DA1.0.

CM24 Phase 1/2 Combination Study Design (NCT04731467)

A Phase 1/2 open label multi center Measurement of CEACAM1 based Primary endpoints: study of CM24 in combination with: bio-marker. Phase 1: Evaluate the safety, PK and the MTD/RP2 dose · Nivolumab in selected cancer indications Exploring further studies in other (Phase 1) and NSCLC (Phase 2) Phase 2: Evaluate preliminary efficacy in tumor types as well as monotherapy 2nd line NSCLC and pancreatic cancer · Nivolumab and nab-paclitaxel in pancreatic cancer (Phase 2) 2021 2022 2023-24 Dose Escalation Expansions Doses: 10, 15, 20mg/kg q2wk CM24 (@RP2 dose) + nivolumab (480mg) q4w + nivolumab (480mg q4w) I/O refractory NSCLC; 2nd line n=13+14 (Simon 2 Stage Design) 3+3 design Clinical collaboration with: 9 ≤ n ≤ 15 (III Bristol Myers Squibb" CM24 (@RP2 dose) + nivolumab (480mg) q4w Indications: NSCLC, Pancreatic, + nab-paclitaxel Ovarian, CRC, Melanoma, Locally advanced, unresectable pancreatic cancer; 2nd line Papillary Thyroid Carcinoma n=13+14 (Simon 2 Stage Design) 14

1st Cohort Analysis - SAFETY and RESPONSE

10mg/kg Dose Level in combination with nivolumab

• · The administration of CM24 at 10mg/kg q2wks in combination with nivolumab at 480mg q4wks was well tolerated with no SAEs in patients with refractory PDAC
• · Three patients were enrolled into the first dose cohort, all with PDAC. Two patients progressed after 1.5 and 2 months of treatment
• · The third patient, previously treated with FOLFIRINOX and gemcitabine/nab-paclitaxel, had a germline NF1 VUS, with MSI-S and PDL-1 IHC 2+ and 5% staining
• · After initial treatment, the patient had a Partial Response of 40%, with a definite reduction of the para-tracheal adenopathy and liver lesions and 56% reduction in CA19-9 levels

Advancing First-in-Class Oncology Therapies

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

NT219 - Dual Inhibitor of IRS1/2 & STAT3

IRS1/2

• · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and antiapoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumor types
• · Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and WNT/β-catenin
• · Activated as a feedback response to anti-cancer therapies

NT219

· Well-established transcription factor associated with the tumorigenic phenotype

STAT3

• · Provides a crucial axis to support cell proliferation and survival
• · Active in tumor JAK/STAT3 and TGF-B resistance mechanisms

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18 Novel MOA: IRS Degradation By NT 219 Blocking IGF 1 R - AKT Pathway 1 Binding to IRS 1 1 Reuveni et al. Cancer Res 2013 Ser - phosphorylation 2 Degradation 3 Covalent binding to IRS 1 / 2 leads to the dissociation of IRS 1 / 2 from IGF 1 R Serine phosphorylation prevents re - binding of IRS 1 / 2 to the receptor SURVIVAL APOPTOSIS IRS 1 / 2 is degraded by the proteasome IGF 1 IGF 1 R IRS AKT PI 3 K IGF 1 IGF 1 R IRS NT AKT IGF 1 IGF 1 R IRS pS pS AKT IGF 1 IGF 1 R AKT

NT219 Efficacy as Monotherapy

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 )

NT219 + Targeted Therapies Established Efficacy in PDX Models

NSCILC Exon 19 deletion EGFR and T790M, biopsy of bone

marrow metastasis, patient previously progressed on afatinib and osimertinib

R/M SCCHN

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 62 1 ** 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

• · 1L Standard of care has shifted from chemotherapy towards immuno-
• oncology + chemotherapy
• · < 20% of R/M SCCHN patients respond to α-PD1s
• · 175k new cases/year are expected by 2024

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 MTD Secondary endpoints: Obtain preliminary efficacy data

Interim Analysis - SAFETY and RESPONSE

3 mg/kg Dose Level as a Single Agent

• · NT219 has been found to be well-tolerated with minimal adverse events
• · In a patient with refractory GE junction disease, NT219 administration was associated with a partial response (PR):
  • Complete remission at the largest target lesion and one non-target central mesenteric lymph node
  • Stable Disease at the other non-target lesion pre-carinal lymph node

	Cancer Type	Prior Lines of Therapy	Treatment Duration(Weeks)		Best Response *
	Pancreatic Cancer	3	8		PD
NT219	GE 4 Junction 22 Cancer				Target lesion: Absent
				PR	Non target lesion 1: Absent
3mg/kg				Non target lesion 2: Stable
	Breast Cancer	11	8		PD

Business Highlights

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

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.7M

\$50.5M cash as of September 30th, 2021

Cash runway into 2024

26

Multiple data read-outs expected in the next 12 months

We are committed

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

Appendix A - CM24

Inhibition of Melanoma Growth Following CM24 and CM24 + TIL Treatment

CM24 activity is Demonstrated as Single Agent and in Combination with TILS

PHASE 1 PK DATA

Target saturation was not reached with doses up to 10mg/kg

• Modeling with increased interval between doses demonstrates lower TMDD at 10mg/kg dose
• · With Q3W, 20mg/kg dosing is not sufficient for saturation across population

Appendix B - NT219

Selected Publications

NT219 | Suppresses ß-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 ()-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 Anval Meeting, April 2021, AACR Virual Special Corpence on Enigenetis ond Medobilism, Oct 2020, Ido Wolf, MD, Herboldy Division, Tel Aviv Sourcel Center

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

NT219 - DEMOGRAPHICS & SAFETY 3 mg/kg Dose Level as a Single Agent

Median age (range)	74 (69-79)
Male/Female, n (%)	2(66.6%)/1(33.3%)
Race
White n (%)	3 (100%)
Prior Lines of Therapy
3 n (%)	1 (33.3%)
4, n (%)	1 (33.3%)
11, n (%)	1 (33.3%)
Diagnosis, n
Pancreatic Cancer	1
Gastroesophageal Junction Cancer	1
Breast Cancer	1
ECOG, n (%)
1	3 (100%)
Median time from initial Diagnosis, Months (range)	62 (22-90)

Presented at the ASCO annual meeting June 2021

URPLE

*Transient- G2 after 2 weeks, **Transient- less than 24h