Regulatory Filings • Mar 7, 2024
Regulatory Filings
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For the month of March 2024 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 March 2024
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-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), 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) and the Registrant's Registration Statement on Form F-1 filed with the Securities and Exchange Commission on October 30, 2023 (Registration file number 333-275216), 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/ Lior Fhima
Lior Fhima Chief Financial Officer


Certain stateneus in this presention that are forvard of historical for are forvant-looking statements within the neaming of the safe include of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements that are not satements of historial finct and navy be identified by words soul as "believe", "sipen", "intend", "plan", "tould", "week", "trage", "will", "will", "will", "tropes", "tomine" or "anticipate" or their negative or wannions of thes words of thes other comparative words or by the first there strictly to historial natters. You should not place under celiance on these forward-looking statements, which are not guarantees of fiture performate for ourent view, expectations, belief or intentions with respect to fitture evens, and an events, and an expect to annuve of assupplion, involve laown and uklown risks, many of will as well as uncertaintes and other factors that realse our actual results, performance or actively and our active sensements of e different from any fine results, performants expensed or implied by the forward-looling statements. Inportant factors that could cause or contribute to such differences inclu anong obest risks relating to: the plans, strangement for fittere opentions; poduct development for NT219, CM24 and M1240; the process by which such sage therapettic candidates could potentials long and subject to lights significant inks, particularly with respect on joint development onlaboration, the fort that drug development and commercialization involves a leagues with uncome; our ability to successfuly develop and commercialize our phamacentical poduct; the expense, length, pogess and reals, the impact of any changes in regultion and legistation that could affect the plammentical industry the difficulty in receining the regulatory appovals neessary in oder to commercialize of predicting actions of the U.S. Food and Drug Administation or any other applicable of phamacentical products; the regulatory environment and regimes in the countes in which we perate; the meetainly surrounding the actual narket reseption o our pharmaceuical products one cleared for market the introducion of compeing products; patents obtained by competitors; dependence of our patent and other products; our ability to obtain and defend issued patents; the commencement of any patent interference or infingener or infinisment or infinisment or informa patents, and ou ability to prevail, obtain a favored damages in any such action, and the exposure to lingtion, and or regulatory actions; the inpact of the economic political and security situation in I.S. and other commiss in which ve nay operate or obtain approvals for our products or our products or our business, and ober are discussed in our Annual Report on Form 20-7 for the year ended December 31, 2023 and in our official to the U.S. Securities and Exchange Commission ("SE"), including on cantionary discussion of fisk Focus" in our Registration Statemats and Annual Reports. These are factors that we believe could case our actual results to differ naterially four expected results. Other lised could also adversely affect us. Any forward-ooking statener in this press release speals only as of the date which i is nade. We disclaim any intention or oblight to public to revise any forward-looking statement or other as a result of new information, fittre events or otherwise, except as required by applical law. You are anditional disclosures we make in our reports o the SEC, which are wailable on the SEC's website, https://www.sec.gov.

Purple Biotech (NASDAQ/TASE: PPBT)


| 4

Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)
*Carcinoembryonic 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 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 is ongoing, last patient enrolled in Dec-23, top line data 2H24 |
|
| 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 |

Medel d. J. hmmode, 2006, innunder 2000, Orceiner et 1, McCorer in 1, McCorer The 202, 2007, Mor 2012, Arier, 202, 2007, Mor, 202, 2007, Mor, 202, 2007, Mor, 202, 2007, Moren


and normal (10 cases/20 cores) tissues

("Ill Bristol Myers Squibb"

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
PFS, OS rate @ 6 & 12 months, PFS rate @ 3 & 6 months, ORR Interim analysis: 1H24 Top line data: 2H24
Measurement of CEACAM1 and other bio-markers is ongoing


NT219: A Small Molecule Dual Inhibitor of IRS 1/2 and STAT3
Lead indication: Recurrent/Metastatic Head & Neck Cancer (SCCHN)



veni et al. Cancer Res 2013;73:4383-4394; Machado-38-434; Marialo et al. Cinis 2010; 21:41 PM (14) 14) 414 How in t. Mc Career in: 2014; 121) 2020-03-20 (36) 255-2 Filmer 4. Clinci news: Clinci andrevs, Clincle on Clincle o Reuveni Hadas, Levitzki Alexander et al. Or
| 15

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
| 16





SCCHN patient 50 mg/kg NT219 + cetuximab
Post-treatmen
60
50
40 30
20
10 o
-10
-20 -30
-40
-50 -60
-70
6 24 12 24 50 100 24 12 100 12 (P)
Numbers under horizontal line designate NT219 dose in mg/kg; P = HPV positive; N = HPV negative
Best % change from baseline
· 20 evaluable patients (all doses): 2 PR (confirmed-GEJ, unconfirmed-PDAC), 5 SD
* Interim data analysis, cut-off date Jan 25, 2024

In preparation of a phase 2 study of NT219 in combination with cetuximab w/wo chemotherapy in 2L R/M SCCHN
| 21

Conditionally-Activated Tri-Specific Antibody Platform
Lead candidate: IM1240 (CD3x5T4xNIKG2A)


| 24 N K - c ells CD4 + - T - cells CD8 + - NKG2A + - T - cells NK cell activation by inhibition of HLAE - NKG 2 A/CD 94 binding CD4 + - T - cells activation through CD3 binding CD8 + - NKG2A + T - cells double activation through CD3 binding and NKG2A - HLA - E axis blocking Unleashing both Innate and Adaptive Immune Systems


| 25

Purple Biotech (NASDAQ/TASE: PPBT)

| 27


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"


| 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 |
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 tracranial 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


PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar®) RN A Seq u enc i n g | Analysis of Tumors Fo l lo w ing Treatment Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine | 43
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