Regulatory Filings • Sep 13, 2023
Regulatory Filings
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FORM 6-K
For the month of September 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 September 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.
1
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 press release that are forward-looking statements within the nearing of the sate harlor provisions of the Private Securites Lligation Reform Act of 1995. Such forward-looking statements that are not limited to, statements of historical fact, and may be llentified by words such a "believ"," expect" "intend", "plan", "may", "shuld", "night", "see", "will", "project", "toritiopat" or their negatives or wristions of thee words or the comparable words or the comparable word that these statements do not relates. You should not place under eliance on these forward-looking satements, which are not guarantees of future performance. Ioneard-looking statements reflect our current views, expect to future events, and are subject to a number of assumptions, include inoun and unionewn risk, may of which are beend our control, as well as uncertaintes and the factor that specificantly different for activements to be signitiation of actives of actives on activernents expressed or implied by the forward-coling statements. Inportant to such differences include, anong others, risk relating to the expected benfits, synergies and costs of the transction, management plans election the octential fruge fransal imped of the transction and any assumptions any of the creasing the expected ining of the cranaction and the parties' allin to complete the tansactives of management for future operations; product development for NT229 and 0M24 as well as Immunizati Ltd. sportfolio of inestigational tri-specific antibody compounts to be aring sage therapeutic candidates could potentially ed to an approved trup, product is loga and subject to highly significant isks, particularly with respect to act that drug development and commercialization invives a lengthy and expersive protes with unertial outcome; our ablily to successfuly develop and commecialize ou pharmateuts of any divical trais; the impact of any changes in regulation and legistion that could affect the pharmaceutcal hously in receing the regulatory approals neessary in orders, the difficulty of products of the U.S. Food and Inq-Admisistation or any the applicable regulator of pharmazeutial products and change in the heath policies and regimes in the countries in vicit we operating surrounding the accoal market reeption to our pharmacedial products one particular market; the introduction of competing product; patents datained by competitor; dependence on the ffectivens of our patents and other protections for informative products and defend issed patents; the commencement of any patent interference of infringener action agains our patents, and ou ability to previl, obtain a favor damages in any such action, and the exposure to litigation, and/or regulatory actions, and other factors that are discused in our Annual Report of For the year ended December 31, 2022 and in other filings with the U.S.C., including our cartionary discussion of risks and unerataines under "Risk Factors" in our Registation Statimate of that we believe cuse our actual results to differ naterially from expected results. Other factor beider hos we have lised could also adversely affect us. Any forward-looking in this press reless only as of the date with it is made. We discain any intertion or obligation to publicy use foward-looking statement or other information on the winter as a result of new inframation, future events or opticable law. You are advised, howeve, 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
(Roche)


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)


Fabien Sebille, PhD Chief Business Officer Formerly at Debiopharm Debiopharm
And State of Addition Commenses of the
Development Stage Value Drivers Project Target Indications Pre-Clinical | Phase I | Phase II | Phase III | Phase III * Phase 2 interim analysis 2H23 & CEACAM1 Pancreatic Cancer CM24* 1H24 mAb (+nivolumab+SoC) ✈ Phase 2 top line results 2H24 Solid tumors (monotherapy) + Phase 1 results STAT3xIRS1/2 2H23 NT219 Head and Neck Dual Inhibitor & Phase 2 1H24 Colorectal Cancer (+Cetuximab) CD 3x 5T 4xNKG2A IM1240 Solid Tumors Tri-specific Ab * Clinical collaboration and supply agreement with: {|| Bristol Myers Squilbb" Multiple data read-outs expected in the next 12 months

Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)
*Carcinoembryonic Antigen Cell Adhesion Molecule
| 7 CM24: a New Multi - Functional Immune Checkpoint Inhibitor • CEACAM1 is overexpressed on certain tumor cells and infiltrating immune cells • CEACAM1 interacts with CEACAM1 and CEACAM5 and creates a tumor - protective environment Attractive new target • 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) Demonstrated mechanism of action • 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 Signals of clinical efficacy • 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 Sizable market potential | ||
|---|---|---|

Morki d 1, Menus 102, 2005, Innuncion 2002, Cancel mand Imments 2012, Inc., McConce, 10, 2002, Hong. 2002, Mary, 2012, Mary, 2012, Mary, 2012, 2012, Ports, 2012, 2012, Ports

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


• Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 11.5%²
(Ill Bristol Myers Squibb"

doi:10.1016/j.ejca.2018.12.007
el
14 patients were evaluable for efficacy:




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


Anti-apoptotic signal netastasis, EMT and immune evasio

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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



| 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 | ||||
| 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 |
JRPLE

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 end points:
Secondary end points:
maximum tolerated dose (MTD)
Obtain preliminary efficacy data
Safety, pharmacokinetics and to determine the

IM1240: CD3x5T4xNKG2A Conditionally-Activated Tri-Specific Antibody


5T4, a Novel Target in Oncology 5T4 is highly expressed on certain tumors and correlates with poor prognosis Am J Cancer Res 2018;8(4):610 - 623 www.ajcr.us /ISSN:2156 - 6976/ajcr0074519 5T4 is a Tumor Associated Antigen prevalent to several large indications Opportunity of patient stratification strategy (5T4 + ) | 24





• Sustained regressions in Breast Cancer xenograft model (MDA-MB-231) · The Pro-Tribody Capped-CD3x5T4xNKG2A performed better than the
uncapped variant .
No change in body weight
Purple Biotech (NASDAQ/TASE: PPBT)





| 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 | A | |||
| 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 |
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.

| Demographics of patients treated with CM24 (10, 15, 20mg/kg) |
|---|
| in combination with nivolumab (480mg) |
| 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

ଦିନ Oncogene nature "CEACAM1 creates a pro-angiogenic "Immune-checkpoint molecules on "CEACAM1 regulates tumor microenvironment that regulatory T-cells as a potential TIM-3-mediated tolerance and supports tumor vessel maturation" therapeutic target in head and neck exhaustion" squamous cell cancers" Ferri, 2020 Tsang, 2020 Shively, 2013 @ immunology Cancer Bioshcrapy at
Ratfordarencementscalls Cell Research "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity against apoptosis in Jurkat T-cells via its therapeutic target to prevent tumor cells through blockade of the interaction with B-catenin" metastatic progression of colon inhibitory CEACAM1 / CEACAM5 carcinoma" immune checkpoint pathway"

URPI

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


| 37 Zou, S., Tong, Q., Liu, B. et al. Targeting STAT3 in Cancer Immunotherapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12

| 38 Simultaneous Blockade of STAT3 and AKT Pathways are Required to Overcome Resistance to EGFRi Overcoming drug resistance NT219 NT219 STAT3 IRS EGFR EGFRi MEK / ERK TUMOR REGRESSION Proof of Concept: PDX model of Head and Neck Cancer Control (n=6) Erlotinib (n=8) Erlotinib+NT219 (n=6) Erlotinib+Ruxolitinib (n=6) Erlotinib+Buparlisib (n=6) Erlotinib+Ruxolitinib+Buparlisib (n=8) STAT3 IRS EGFR MEK Tumor Regression ERK PI3K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib NT219 NT219 JAK By blocking both STAT3 and IRS resistance pathways, NT219 re - sensitizes tumors to anti - cancer therapies
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 | 1(8%) |
| Fernale | 8 (67%) | Breast | 2(17%) |
| Ethnicity, n (%) | Colorecta | 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 | S (42%) | 5 | 2(17%) |
| 1 | 7 (58%) | 6 | 1(8%) |
| Median Time from Initial Diagnosis | |||
| months (range) | 36(10-153) | 8 | 1(8%) |
| 11 | 1/20/1 |


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



GEJ tumor at baseline screening
CT imaging of the GEJ tumor after 5 months of treatment with NT219
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