Regulatory Filings • Oct 13, 2023
Regulatory Filings
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For the month of October 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 ☐
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 Purple Biotech Corporate Presentation October 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-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) and 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), 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 statements in this pess release that are forward-looking statements within the nearing of the sate hardor provisions of the Private Securities Litigation Reform 4ct of 1995. Such forward-looking statements that are not timited to, statements of historical for and nay beitlifed by words such as "believ", "geliere", "intend", "plan", "may", "should", "thigh", "seel", "will", "project", "tortinue" or "anticipate" or writitions of these words or other comparable words on the fact that these statements do not relates. You should not place under eliance on these forward-looking statements, vinich are not guarantee, on are looking statements rellect our currentions with respect to future events, and are subject to a number of assumptions, involve known and unionenn isla, may of which are beyond our control, as well as uncertainites and other factors hatual results, performance or achievents to be significantly different from any future results, performance or achievenen implied by the foward-looling statements. Innortant to such differences include, anong others, risks elating to the expected benfits, ynergies and osts of the transction management plans elsting to the potential future finaction; and any assumptions underling any of the foregoing the expected timing of the cransction and the parties ability to complete the plans, strategies of mangement for future operations; product development for WT229 and CM24 as well as immunizor Ltd.'s portfolio of investigational tri-specific antibody compunis to be any stage thenpeutic canditates could potentialy lead to an approved drug product is long and subject to highy significant isks, particularly with respect to ad that drug development and commercialization involves a lengthy and experisive process with uncertain outcome; our ablily to successfuly develop and commercial products; the expense, length, progress and results of any clanges in regulation and legistion that could affect the pharmaceuical industry the efficulty in receiving the recessary in order to commercialize our prodicing actions of the U.S. Food and Dug Administration or any the appicale egulator of playmacedical production and changes in the heath policies and regimes in which we operate, the uncertainty surrounding the actual makel reeption to our pharmaceutics once cleared on market the introduction of competing products; patents obtained by competitors; dependence of the effectives of our patents and other protections on informant and defend issued patents; the commencement of any patent interfreence or infringenent action against our patents, and our ability to previl, obtain a famage in any such action; and the exposure to litigation, including patent liigation, and or regulatory action, and or rectors that are discussed Annual Report on For the year ended December 31, 2022 and in our other filings with the U.S.C"), including our cationary discussion of risk and uneratines under "Nis Factor" in our Reports. These are factors that we believe could cause or actual results of fife materially from expected results. Other factor besides those we have listed could also atter. u. Any forward-looling statement in this press release speaks only interion or obligation or obligation o publici update or reise any forviatl-oking statenent or other information contained to the winter events or othersis, except as required by applicable lav. Your are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov

Purple Biotech (NASDAQ/TASE: PPBT)


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


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


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


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


Fabien Sebille, PhD Chief Business Officer Formerly at Debiopharm

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Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)
*Carcinoembryonic Antigen Cell Adhesion Molecule
PURPLE
| 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 efficacy |
• Favorable safety profile in monotherapy and in combination with nivolumab • Partial response and stable disease in dose escalation study with nivolumab · Potential biomarkers identified such as NETs and CEACAM1 levels on TILs • Randomized Phase 2 initiated in Q1 2023 |
| 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 |

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adenocarcinoma and normal tissues
intensity in pancreatic cancer (38 cases/76 cores) and normal (10 cases/20 cores) tissues

("Ill Bristol Myers Squibb"

4 лекса се продажен (1942 г.) (1942) (402) (402) 1942 г.) (1942) (494) (494 г.) (2012) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (494) (404) (404) (40
14 patients were evaluable for efficacy:


Higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1 are associated with longer survival


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
Secondary endpoints: PFS, OS rate @ 6 & 12 months,
PFS rate @ 3 & 6 months, ORR
-
Measurement of CEACAM1 and other bio-markers is ongoing


Lead indication: Recurrent/Metastatic Head & Neck Cancer (SCCHN)



Notes form at Clores Click (10) 2010) 16:64, 13:40) 10-6:40, Valle Part Pric 200, 2022, 2020, 20:20, 2020, 20:20, 2020, 20:00, Parte et A Moner Personal Police Concerners (


Non-small cell lung cancer (NSCLC) Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib
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


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 maximum tolerated dose (MTD)
Secondary endpoints: Obtain preliminary efficacy data





IM1240: CD3x5T4xNKG2A Conditionally-Activated Tri-Specific Antibody



Purple Biotech (NASDAQ/TASE: PPBT)

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URP
Immunology Cancer Biotherupya Experimental "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity aqainst 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"



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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% |


SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -
PREDOSE




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., Liu, B. et al. Targeting STAT3 in Cancer Immunotherapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12943-020-01258-7



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 β-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 anice 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

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