Regulatory Filings • Jan 7, 2023
Regulatory Filings
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FORM 6-K
For the month of January 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 – January 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.

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/ Gil Efron
Gil Efron Chief Executive Officer

| 1 NASDAQ/TASE: PPBT January 2023 CORPORATE PRESENTATION
Certain statements in this presentation that statenents of historical lact are forward-looking statements within the meaning of the sale harbor provisions of the Private Securities Litigation Act of by identified be nay and , fat historical of statements , o limited not , netude statements looking-forward Such . 195 " a such wordsbelleve", "expect", "intent", "night", "might", "seek", "continue" or "antinue" or "anticipate "or their negatives or variations of these words or other comparable words. You should not on these on these forward-looking statements, which are not guarantees of tuture performance. Forward-looking statements reflect our current views, expections with respect of uture events, and are subject to a number of assumptions, involve known and unhown risks, may of which are beyond our control, as well as uncertainies and other may cause our actual results, performance or achievents to be significantly different from any future esuls, performance achievenents expressed or inpried by the forwards. Important lactors that could cause or continue anong others, risks relating to the plans, strategies and objectives of nangement or NT2.9 and CM2.9 N' as such cardidates therapectic stage early which by process the 24and CM24 could potentially lead to an approved to highly significant risks, particularly with respect to a joint development collaboration; the latt dong development and commercialization involves a lengthy and establity to successilly develop and connecialize our pharmaceuital products; the experse, length, progress and results of any clinical trails to finance the clinical trials; the impact of any changes in regulation that could affect the pharmaceutal industry; the difficulty in receing the recessary in order to commercialize our products; the difficulty of pedicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceuting enviroment and changes in the heath policies and regimes in the countries in which we operater, the unertain surounding the actual market reeption to our cleared for market, in a particular market; the introduction of compeling patents atained by competitors, dependence on the effectivenes of our protections for innovative products, our ability to obtain, maintain and defend issued patent. of any patent interference or infringenent action agains to preval, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and other factors that are disussed in our in our Anual Report on Form , 3. December ended year the for F-20222 and in our other fillings with the U.S. Securities and Exchange Commission this of discusion cautionary our including , "Risk Factors" in our Registration Statements and Annual Reports. There are lators that we believe our actually from expected results. Other factors besides those we have listed could also adversel affect us. Ary forward-looling statement in this presentation speals. It is made. We diction or obligation to publicy update or revise any forward-looking statement, or other information contained heein whether in the events or cherwise, except as required by applicable law. You are advised, however, 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.

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 Systems

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) @KAMADA

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


| Program | Indication | Phase I | Phase 2 | Phase 3 | Value Drivers | ||
|---|---|---|---|---|---|---|---|
| CM24 | Solid tumors (monotherapy) | Completed | V RP2D in combination: 20 mg/kg | ||||
| Solid tumors (combination with nivolumab") | V Initiation of phase II in 2L PDAC Follow up OS data from P1 |
||||||
| (CEACAM-1) | Pancreatic Cancer (combination with nivolumab+chemo*) |
Interim analysis P2 2H23 Top line P2 2H24 |
|||||
| Combination with SOC, undisclosed indication | Investigation in a second indication | ||||||
| NIPI9 (IRS1/2 & STAT3) |
Solid tumors (monotherapy) | RP2D monotherapy & combination 1H23 |
|||||
| R/M SCCHN & CRC (dose escalation + P2 with cetuximab) |
Initiation of P2 combination with cetuximab 2Q23 |
||||||
| Combination with SOC, undisclosed indication | Investigation in a second indication |
| 5

*Clinical collaboration and supply agreement with: الله Bristol Myers Squibb

CM24: an α-CEACAM1* mAb
Carcinoem bryonic Antigen Cell Adhesion Molecule
| 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 MOA |
· CM24 increases T cell and NK cells cytotoxicity against tumors · CM24 shows benefit in combination with IO 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 · 1 PR and 3 SD in dose escalation study with nivolumab · Phase 2 at RP2D initiated in Q2 2022 |
|
| 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 |
|
| 17 |

Medel ri (, ) Menoriotto, 2005, Care manni manorier 200, Orderor et 4, Mo Care, D 201, Abor, 2012, Abor, 2012, Abor, 2012, 2007, 40:57, Ph, V. L. L. Inc., 2002, Rhora, 2002, | 8

Wilcoxon, p = 2e-15

Comparison between CEACAM1 staining intensity in pancreatic cancer (38 cases/76 cores) and normal (10 cases/20 cores) tissues


Representative examples of CEACAM1 immunohistochemical images of pancreatic adenocarcinoma and normal tissues

| AE Term | Grade | ||||
|---|---|---|---|---|---|
| Total | 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 Colitis | 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 has been initiated at the conclusion of this dose-escalation phase.





(Ill Bristol Myers Squibb"

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Primary efficacy endpoint of Measurement of Interim analysis: A study of CM24 in CEACAM1 and other biothe randomized sub-study: - PFS rate @ 6M combination with nivolumab markers is ongoing OS plus chemotherapy in PDAC planned in 2H23 Planning of further studies patients in 2L Secondary endpoints: Top line data: in other tumor types is 11 centers are currently active PFS, OS rate @ 6 & 12 months, - planned in 2H24 ongoing in US, EU & Israel PFS rate @ 3 & 6 months, ORR 2023 2022 2024 Experimental arm (n=30) CM24+nivolumab and: Gemcitabine/nab-paclitaxel OR Safety Study (n=18) n=60 CM24+nivolumab &
Nal-IRI/5FU/LV PDAC patients progressing on or OR after 1L SoC Gemcitabine/nabchemotherapy Control arm (n=30) paclitaxel Gemcitabine/nab-paclitaxel OR Nal-IRI/5FU/LV | 15

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

NT219 |
de Norem et 10 and Alexander et Lanc 2017, 1949 to 4942 el Maria Marker et Mod Rey The 2012 122 2022 222 2022 2022 2020, Marros, 2014 2020, 20:00, Alanco, Chica Marcher Clic
STAT3
Hadas Re URPLE

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


S., Tong, Q., Liu, B. et al. Targeting STAT3 in Cancer Immu
rapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12943


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

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mice (18M cells per mouse) and treatments initiated when tumors were established. (NT219) and cetuximab) twice a week for 4 weeks. Graph reflects relevant data adapted from 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib
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 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 | 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 | ||
| Abdominal pain | 2 | 1 | 1 | ||
| Belching | 2 | 2 | |||
| Cough | 2 | 2 | |||
| Dizziness | 2 | 2 | |||
| Dyspnea | 2 | 2 | |||
| Ede ma 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 |


Durable PR in a GEJ patient and SDs in 3 out of 4 mutated KRAS CRC patients

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

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: [email protected]

02| IMMUNE CELLS/
| IMMUNE EXCLUSION | ||
|---|---|---|
| Horst, 2011 | Tsuzuki, 2020 | Blumberg, 2015 |
| Oncogene | nature | |
| "CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel maturation" |
"Immune-checkpoint molecules on regulatory T-cells as a potential therapeutic target in head and neck squamous cell cancers" |
"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion" |
| Ferri, 2020 | Tsang, 2020 | Shively, 2013 |
| @ Immunology "Neutrophil extracellular trap- associated CEACAM1 as a putative therapeutic target to prevent metastatic progression of colon carcinoma" |
Cancer Biotherapy as "[Blockade] enhances natural killer cell cytotoxicity against tumor cells through blockade of the inhibitory CEACAM1 / CEACAM5 immune checkpoint pathway" |
Cell Researc "CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with 6-catenin" |
03 | IMMUNO-ONCOLOGY



4Target-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dose is administered
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 | 170261 V |

Appendix B | NT219
URPLI


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 and extended mice survival.

AACR Annual Meeting, April 2021, AACR Virtual Speciol Conference on Epigenetics and Metobalism, Oct 2020, Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center
2.4 2.0 Tumor volume (cm³) ននៃនត់ដត់ដត់ដ (n=15) 2.1
1.8 NT219 (n=7) 15
12 ol {n=7} ន ន 0.3 Days
30 PDX model NT219 (n=5) 0 0 10 15 20 25 0 I o 10 15 20 Pancreatic Cancer Pancreatic cancer (Patient C) PDX Pancreatic cancer (Patient D) PDX Tumor volume (cm³) 1.6 1.4 Tumor volume (cm3) 1.2 itabine
=5) 12
1.0 1.0 0.8 0.8
0.6 0.6 Drug 0.4 0.4 1219 (n=5) Gemcitabine
NT219 n=9 0.2 Gemcitabine (Gemzar®) 17219 (n=5) 0.2 0 0 0 Days 5 15 20 10 25 15 0 0 ે ર 10 | 39

PDX model Pancreatic Cancer




As of data cutoff date of May 12th , 2022, a total of 14 patients were enrolled to 4 NT219 dose levels (3 - 24mg/kg)
| 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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