Foreign Filer Report • Jun 6, 2022
Foreign Filer Report
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FORM 6-K
For the month of June 2022
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 – June 2022
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 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.

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/ Isaac Israel
Isaac Israel Chief Executive Officer


Certain statements in this presentation that and not statements of historical lact are forward-looking statements within the meaning of the safe farlor provisions of the Phate Securities Litigation Referm Act of 1955. Such re not imited to, statements that are not statements of historical fact, and the be be illed by words such as "believ", "ntend", "nay", "should", "might", "see", "targe", "will", "projec", "toreast", "continue" or their negatives of variations of these words or other comparable words. You should not person on hese forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our curent views, expectations with respect o future events, and are subject to a number of assumptions, involve inown and unhown risk, may of which are beyond our control, as well as uncertaining and our actual results, performance or achievements to be significantly different from any future esults, performance on achievenents expressed or implied by the enterents. Important factors that could cause or contribute to such offerences include, anong others, risks relating to: the plans, strategies and objectives of nanagement for NT219 and CM24; the process by virith early stage therapeutic andidates such as N7219 and CM24 could potentially lead to an approved drighty significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization invives a lengthy and expense; our ability to successfully develop and commercialize our pharmaceutial product; the expense, length, proges and results of any clinical trials; the linical trials; the impat of any changes in regulation and legislation that could affect the pharmacutical industry the difficulty in receiving the recessary in order to commercialize our products; the difficulty of preticing actions of the U.S. Food and Dug Administration or any other applicable regulator of pharmaced and charges in the heath policies and regims in the countries in which we operate; the uneratiny surrounding the actual market reception to or celeared for marketing in a particular market, the introduction of competing podents attained by competitors; dependence on the effectivenes of our protections for inrovative probility to obtain, maintain and defend issued patents; the commencenent 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 expoure to litigation, including patent litigation, and other factors that are discussed in our in our Annual Report on Form 20-F for the year ended December 3, 2021 and in our other filings with the U.S. Securities and Exchange our castionary discussion of risk and uncertaintes under "Risk Factor" in our Registation Statements and Annal Reports. These are lactors 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 it is made. We distain any intention or obligation to publicy update or revise any forward-ooking statenert, on other information contained hew information, future events or otherwise, except as required by applicable law. You are advised, lowever, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients
Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 17.8M
\$42.2M cash as of March 31st, 2022


We focus on MOAs that impact both tumor cells and infiltrating cells
| Program | Indication | Phase I | Phase 2 | Phase 3 | Value Drivers |
|---|---|---|---|---|---|
| Solid tumors (monotherapy) | Completed | V RP2D in combination: 20 mg/kg | |||
| Solid tumors (combination with nivolumab") | cetuximab | V Initiation of phase II in 2L PDAC | |||
| CM24 (CEACAM-1) |
Pancreatic Cancer (combination with nivolumab | Follow up OS data from P1 | |||
| and 5-fluorouracil and liposomal irinotecan or nab-paclitaxel") |
Analysis part 1 of P2 (Simon 2-stages) | ||||
| Combination with SOC, undisclosed indication | Investigation in a second indication | ||||
| Solid tumors (monotherapy) | RP2D monotherapy & combination | ||||
| NIP 19 (IRS1/2 & STAT3) cetuximab) |
R/M SCCHN & CRC (dose escalation + P2 with | Initiation of P2 combination with | |||
| Combination with SOC, undisclosed indication | Investigation in a second indication | ||||

*Carcinoembryonic Antigen Cell Adhesion Molecule

@ immunology "Neutrophil extracellular trapassociated CEACAM1 as a putative therapeutic target to prevent metastatic progression of colon carcinoma"


"Immune-checkpoint molecules on requlatory 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
Blumberg, 2015
"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion"
Shively, 2013

"CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with B-catenin"
18

Market d. Jannunol 2020, 2006; Inmunol Imnunother 2010; Orenberg et of, Mol Concer The 2012; 2009; U., 203; Hung, 2015; Hong, 2015; Achayo N, et al. J. Inmundheropy Car URPLE 8:01.22, 2020, Roys 8, et al. Neutrophil Extracellated CEACAM zo Perent Metsotic Progetto of Color Corone of Colon Corcinona. Inmuni. 2020 Gersel, O color Corconomi. Innuno.


adenocarcinoma and normal tissues

| 11

| Total | Grade | ||||
|---|---|---|---|---|---|
| AE Term | 1 | 2 | 3 4/5 | ||
| Diarrhea | 5 | 4 | 1 | ||
| Abdominal pain | 4 | 1 | 3 | ||
| Fever | 4 | 2 | 2 | ||
| Headache | 4 | 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 Collitis | 1 | 1 | |||
| GI bleed | 1 | 1 | |||
| Leukocytosis | 1 | 1 | |||
| Small bowel obstruction | 1 | 1 |
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 have been initiated at the conclusion of this dose-escalation part.




SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -
PREDOSE


· Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%3
(Illi Bristol Myers Squibb"

1 American Cancer Society, Cancer Facts & Figures 2019, and the ACS website,
https://seer.cancer.gov/statfacts/html/poncreas.html 2 Colinescu et al, Journal of Immunology Research 2018: 7169081; Carcinoembryonic antigen-related cell adhesion molecules (CEACAM) 1, 5 and 6 as biomarkers in pancreatic cancer, DOI: 10.1371/journal.pone.0113023
| 15


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

NT219
STATS

भारत के द्वादर को 2012 - 12:42 AM #12 - 2017 - 12:42 PM #1 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1

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





α-PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/kg
Drugs

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mousel and treatments initeded when
tumors were established. (NT219) and IP (c-PDI and cetuximob) tw 2020 Multidisciplinary Head and Neck Concers Symposium Poster presentation


| Grade | |||||
|---|---|---|---|---|---|
| AE Term | Total | 1 | 2 | 3 | 4/5 |
| Fatigue | 6 | 6 | |||
| 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 | ||
| Andominal 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 | |||
| Abdominopelvic Ascites | 1 | 1 | |||
| 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 |
| 26


| 27


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

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients
Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 17.8M
\$42.2M cash as of March 31st, 2022

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: [email protected]


Simulated TMDD1 saturation


4Torget-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dase is administered
| 34
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%) | |
| 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% |



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 Annuol 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

PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar ® ) NT219 | Pancreatic Cancer in Combination with Gemcitabine | 39 Highly effective anti cancer activity exhibited by NT219 in combination with Gemcitabine
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 | |
|---|---|
| Demographics of patients treated with NT219 (3, 6, 12, 24mg/kg) | |||
|---|---|---|---|
| Median age, years (range) | 67 (39-79) | Diagnosis _ n (%) | |
| Sex, n (%) | Pancreatic | 3(25%) | |
| Male | 4(33%) | GE Junction | 118%) |
| Fernale | 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%) | б | 1(8%) |
| Median Time from Initial Diagnosis | |||
| months (range) | 36(10-153) | 8 | 118%) |
| 11 | 118%1 |
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