Regulatory Filings • May 5, 2024
Regulatory Filings
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FORM 6-K
For the month of May 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 May 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.
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 presentation that are forward for are forward-looking statements within the meaning of the safe hards of the Private Securities Litigation Referm Ae of 1995. Such forwards include, but are not mitted or not satements of historical for not saternation of historical for world sock as "believe", "served", "plan", "nay", "should", "migh", "well", "will", "project", "inil", "project", "contine" or "anticipate" or wanitions of these words of these words of other companible worls or by the fact that there strictly to historial mates. You should not place under celance on these forward-looking satements, which are not guarantees of future performance. Forvant view, expectations, belief or intentions with respect to finance vers, and are subject to anniber of assumpion, invitye known and unknown risks, many of which as well as uncertainies and other factors that may cause our retual results, performance or achievements of esignifically different from any fitter reals, performance expressed or implied by the forward-looking statenents. Important for such differences include, annong obes, risks relating to the plans, stransgeners for fittere openions; product development for NT2 9, CM24 and M1240; the process by which such sath sath sath sath sath therapetive candidates could potection is long product is long and subject to highly significant isks, particularly with respect to a joint development on for hat that drug development and commercialization involves with uncertain outcome; our ability to successfuly develop and commercial podects, the expense, length, progess and esals; the inpact of any changes in regultion and legislation that could offect the pharmaceatical industry; the diffically in receiring the regulatory approvals necessary in order to commercialize of predictions of the U.S. Food and Drug Administmion or any other opplicable regulator of pharmacented products; the regilatory environment and regimes in the countries in which we operate the uncertains surventing the actual market reception to our pharmacential products one cleared for market the introducion of competition of competitions, departeres of on patents and other preceions for internation in the interior and defend issued patents; of any patent interference of infingenent of infingence or infingenent of internent act patent, and or thility to preval, obtain a five a mages in any such action; and the exposue to liigation, including patient life.grion, and or regulator, and or regulator act the economic publical and security sination in Isnel, the U.S. and other countries in vinch we may generals for our products or our business, and ober haves and ober haves ha are discussed in our Amal Report on Port 20-F for the year end December 11, 2025 and in our office and Exclange Commission ("SE"), including ou cautionary discussion of fisk Factors' in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results (o differ materially from expected results. Other listed could also adversely affect us. Any foward-looking statement in this press elese spaks only as of the date which is is nade. We dischin any intention or obligation to public to revise any forward-looking satement or other information vintene in result of new information, finan everse or otherwise, except as required by applications in consult any additional disclosures we make in our reports to the SEC, which are are are SEC's when https://www.sec.gov.

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Purple Biotech (NASDAQ/TASE: PPBT)



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 erncacy |
Favorable safety profile in monotherapy and in combination with nivolumab · Interim P2 results suggest reduced risk of progression or death as demonstrated by PFS in the NAL/IRI arm · 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 |
|
| 16 |

Merine 18, 2002, 2004 (not more manager 2002, Denery of Mollaner Ter 202, 2002, Norg, 020, 202, North, Nammal Park 22, 22, 2020, (not 7 d. 1
Remove Treature Cal.All In Pute




Del 217 e.0113023 es in Medical Oncology, 2020:12.

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
OS
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


Full data will be presented in a late-breaking abstract poster presentation at ASCO 2024 Annual Meeting
1 13

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




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
| 17


| 19 NT 219 combination with α PD 1 achieves a profound reprograming of the TME NT219 and aPD1 combination converted immuno - suppressive TME to immuno - reactive * Collaboration with Prof. Bareli and Prof. Curran, M.D. Anderson cancer center, presented at AACR 2023 Activated cytotoxic T cells (% CD8 + GZMB + ) Activated NK cells (% NK 1.1 + GZMB + ) NT219+ a PD1 leads to a significant increase in cytotoxic effector cells (T & NK cells) NT219+ a PD1 leads to a significant reduction in myeloid derived suppressor cells (MDSC) % Mo - MDSC (out of CD45 + ) % Gr - MDSC (out of CD 45 + )



SCCHN patient 50 mg/kg NT219 + cetuximab


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



| 26

Purple Biotech (NASDAQ/TASE: PPBT)






| Total | Grade | ||||
|---|---|---|---|---|---|
| AE Term | 16 | 2 | 3 | 4/5 | |
| Diarrhea | 5 | 4 | 1 | ||
| Abdominal pain | 4 | 1 | 3 | ||
| Fever | 4 | 2 | 2 | ||
| Headache | ਧ | 3 | 1 | ||
| Fatigue | 4 | শ | |||
| 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 | I | |||
| Small bowel obstruction | 1 | I |
Med
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.

| In Commingtion MITL Hispinuan (400ml) | |||||||
|---|---|---|---|---|---|---|---|
| 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 (%) |
Demographics of patients treated with CM24 (10, 15, 20mg/kg)
| Pancreatic cancer | 8 (73%) | |
|---|---|---|
| 10 (91%) | Papillary Thyroid cancer | 1 (9%) |
| 1 (9%) | Colorectal cancer | 2 (18%) |
| Median Time from Initial Diagnosis months (range) |
23 (11-73) | |
| 10 (91%) | ECOG, n (%) | |
| 1 (9%) | 0 | 7 (64%) |
| 1 | 4 (36%) | |




| 38 0 200 400 600 800 1000 1200 0 5 10 15 20 Tumor volume (mm 3 ) Days following treatment initiation Control (n=3) NT219 (n=3) Keytruda (n=3) Keytruda + NT219 (n=3) Autologous PBMCs ( 2.1 M/mouse) NT 219 Re - sensitizes Tumors Refractory to α - PD 1 PDX Model Humanized PDX of GastroEsophageal Junction (GEJ) Cancer (refractory to pembrolizumab) Drug Pembrolizumab (Keytruda®) * Double autologous model - Tumors & PBMCs are from the same patient (#RA 236 ) | Keytruda - 6 mg/kg IP, NT 219 - 60 mg/kg IV
NT219 demonstrates a durable and dose-dependent suppression of STAT3 tyrosine phosphorylation, affecting both the tumor cells and the tumor microenvironment.




| 42 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 Colon cancer LS - 513 cells overexpressing IRS 2 demonstrate enhanced b - catenin activity. Targeted inhibition of IRS 2 by NT 219 or IRS 2 - SH RNA, suppresses the increased b - catenin activity and inhibit LS - 513 cell viability. Combination of 5 - FU and NT 219 significantly inhibited the growth of CRC tumors in brain , using intracranial model and extended mice survival. Active β - Catenin IRS 2 β - actin NT 219 + - NT 219 concentrations ( m M) CRC Cell Viability ( 72 hr) IRS 2 NT 219 downregulates IRS 2 and suppresses the b - catenin activity Silencing IRS 2 inhibits b - catenin activity NT 219 Suppresses β - Catenin activity in CRC Cells and Inhibited CRC Brain Metastasis 5 - FU NT 219 + 5 Ͳ FU In Vitro In Vivo
| 43 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ® ) NT 219 | Pancreatic Cancer in Combination with Gemcitabine Highly effective anti cancer activity exhibited by NT 219 in combination with Gemcitabine
| 44 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ®) RNA Sequencing | Analysis of Tumors Following Treatment Reduced expression of IRS 1 , Ki 67 , FOXM 1 & TGFb is exhibited by pancreatic cancer treated with NT 219 alone and in combination with gemcitabine
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