Regulatory Filings • Feb 4, 2023
Regulatory Filings
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FORM 6-K
For the month of February 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 ☐
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 – February 2023
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/ Lior Fhima
Lior Fhima Chief Financial Officer


Certain steenents in this pees release that are forward-obling statements within the nearly of the safe hards within the nearing of the safe harder provisions of the Private Lifection Reform Act of 1995. Such finited to statements intlude, but are not linited to, statements of historical fact, and may be identified by words such as "believ"," req "intend", "plan", "may", "should", "might", "see", "torecas", "continue" or "anticipate" or their negatives or variations of the comparable word on the last that these statements do not relates. You should not place unive reliance on these or these forward-looking statenents, which are not guarantees of future performance. Forwar statements rellect our current views, expect to buture events, and are subject o a number of assumptions, involve known and unknown risk, may of which are beyond our control, as well as uncertainter and other for any cause or activements to be signitiantly different fron any itture results, performance or achievenents expressed or implied by the foward-looling satements. Important for out offerences include, anong others, risks relating to the expected benefits, snergies and ossof the transaction, management plans elating to the potential (tuore francial imped of the transaction, and any assumptions une the consected timing of the consetion of the cransction and the packer alliny to complete the tans, strategies and objectives of management for NT229 and CM2-as well as mmunition Ltd. sportally of investigational tri-specific andical the process by which such enry stage therapeutic condizion in an approved drug product is long and subject to highly significant isks, partularly with respect to ajoint the fact that drug development and commercialization involves a lengthy and experiences with uncertain outcomer, our ablil succesfuly develop and connection poducts the expense, length, progress and results of any chical trials; the impact of any charges in regulation and legistion that collal fi pharmaceutial industry in receing the regulatory approvative or product; the difficulty of prodicing actions of the U.S. Food and Ing Admisistation or any other applicale regulator of players, the regulatory environment and changes in the beath polices in thish we operate; the uncertains surrounding the actal narel reeption to or pharmaceultal products one particular market, the introduction of competing probucts; patents of the effectivens of our patents and other protections for ablily to obtain, maintain and defend issued patents; the connencement of any patent interference or infringement our patent, and our ability to preval, obtain a favor and action; and the exposure of ligation, including patent l'ingtion, and or registery action, and other factors that one of sussed in our Annual Report on Form 20-F or the year ended Becerities with the U.S. Securites and Exchange Comnission ("SC"), including our cautonary discussion of risk and unceratives under "Risk Factor" in ur Registration Statimation of Annual Peports. There and cause our actual to differ materially from expected results. Other factors besiles those we have listed could also adversely affect us. Any forward in this press release speaks only as of the data witchile of chigation or obligation or public) update or revise any forward-looking tatement or other information as a result of new information, future events or otherwise, except as required by applicable law. You are advised, howeve, to co additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov.

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 18.4M
\$35.7M cash as of September 30, 2022

Strong cash position to advance development of first-in-class cancer therapies

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 (Roche)

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

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


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

Fabien Sebille, PhD Chief Business Officer Formerly at Debiopharm
Debiopharm
14

*Clinical collaboration and supply agreement with: [1] Bristol Myers Squibb®

15

CM24: ana-CEACAM * mAb
*Carcinoembryonic Antigen Cell Adhesion Molecule


| 8 CM24 MOA | Immune Check Point Inhibitor & Anti - Metastatic Activity Markel et al, J Immunol 2002, 2006; Immunology, 2008; Cancer Immunol Immunother 2010; Ortenberg et al, Mol Cancer Ther 2012; Zhou, 2009; Li, 2013; Huang, 2015; Acharya N, et al. J Immunotherapy Canc 8:e911 - 22, 2020. ; Rayes RF, et al. Neutrophil Extracellular Trap - Associated CEACAM1 as a Putative Therapeutic Target to Prevent Metastatic Progression of Colon Car cinoma. J Immunol. 2020; Gerstel, D. et al. CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. Oncogene 30, 4275 – 4288 (2011), CM 24 Suppresses Neutrophil Extracellular Trap (NET) - Induced Migration and Metastasis of Cancer Cells Tumor CD 8 +T & NK Cells CEACAM 1 CEACAM1 CEACAM1 CEACAM5 Activation of enhanced cytotoxic activity & cytokine production CM 24 Primary Tumor Metastasizing CM 24 Metastatic Tumor CM24 Inhibits NET - Induced Migration of CEACAM1 Expressing Cancer Cells Direct Binding of CM24 to the NET Structure MPO( green ) DAPI ( blue ), CM24 ( red ) CM24 ( red ) Melanoma Immune Response Activation



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 | র্যা | 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 phase.




SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -
PREDOSE
| 13
· Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 11.5%4

(Ill Bristol Myers Squibb"

. 2006 000 000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | 14
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
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

NT219
STAT3
URPLE
veret al. Concelect of Chic. 2017, 2017, 2014. I Offic, Notes for Mol Porter in Mol Caree, Tre. 2122.2022 2022 222.20.00. et d. Chroner a Chicanovers, Color, Carona Conceres,
| 18

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



| 21 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

-Control (n=5)

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 | б | ნ | |||
| 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 |
| 25


| 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


IM1240:5T4xCD3xNKG2A Conditionally -Activated Tri-Specific Antibody



Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 18.4M
\$35.7M cash as of September 30, 2022

Strong cash position to advance development of first-in-class cancer therapies
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: ir@purple -biotech.com

"CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel maturation"
@ immunology "Neutrophil extracellular trapassociated CEACAM1 as a putative therapeutic target to prevent metastatic progression of colon carcinoma"


"Immune-checkpoint molecules on regulatory T-cells as a potential therapeutic target in head and neck squamous cell cancers"

"[Blockade] enhances natural killer cell cytotoxicity against tumor cells through blockade of the inhibitory CEACAM1 / CEACAM5 immune checkpoint pathway"
03 | IMMUNO-ONCOLOGY
"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion"
Shively, 20 B

"CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with B-catenin"



1 Target-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dose is administered
| 38
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.

| Median age, years (range) | 65 (49-76) | Prior Lines of Therapy, n (%) | |
|---|---|---|---|
| Sex, n (%) | 1 | 2 (18%) | |
| Male | 5 (45%) | 2 | 9 (82%) |
| Fernale | 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%) |
Demographics of patients treated with CM24 (10, 15, 20mg/kg)



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

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 | |
|---|---|
| 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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