Purple Biotech Ltd.

Regulatory Filings • May 7, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934

For the month of May 2025 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 ☐

On May 6, 2025, Purple Biotech Ltd. (the "Company" or the "Registrant") 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.

Exhibit

99.1 Purple Biotech Corporate Presentation May 2025

Incorporation by Reference

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), the Registrant's Registration Statement on Form F-1, as amended, originally filed with the Securities and Exchange Commission on October 30, 2023 (Registration file number 333-275216) and the Registrant's Registration Statement on Form F-1, filed with the Securities and Exchange Commission on July 22, 2024 (Registration file number 333-280947), 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

SIGNATURES

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.

May 6, 2025 PURPLE BIOTECH LTD.

By: /s/ Gil Efron

Gil Efron Chief Executive Officer

Forward-looking Statements and Safe Harbor

Certain stateneuts in this presentation that are forvad-looking and the are forward-looking statements within the meaning of the safe hardon provisions of the Private Securities Litigation Act of 1995. Such forvarly sinche, but are not linited on statements of historial fact, and may be identified by words schar "believ", "expec", "intend", "plan", "should", "seek", "target", "will", "troped", "treess", "contine" or "anicipate" or waritions of these words of these words of these word other couparable words or by the fact there strently to historial maters. You should not place under eliance on these forvard-looking statements, which are not guarantees of fiture performance. For warent views, expectations, beliefs or intentions with respect to fiture events, and are subject to anumber of assumptions, involve laown and uslaren risks, nany of villeh are betainies and other factors that may cause our actual lessults, performance or actually differant from any fitter results, performance or acinel by the forward-looking statements. Inportant factors that could cause or contribute to such differences include, anong obest is relating to the plans, strategies and objectives of mangement for NT219, CM24 and M1240; the process by which such sage therapetic candidates could potentialy lead to an approved is long and subject to lights significant risks, particularly with respect to a joint development onlaboration, the dug development and commercialization invess lengthy process with uncome; our ability to successfuly develop and commercial poduct; the expense, length, progess and results of any clanges in regulation and legistation that could affect the plammentical industry, the diffically in receiving the regulatory approvals neessary in oder to commercialize of predicing actions of the U.S. Food and Drug Administration or any other applicable regulato of plamaceutical products; the regulatory environment and regimes in the countes in which we operate; the uncertainty survounding the actual maker reeption to our phamaceuical products one cleared for maket the introducion of compeing products; patents obtained by competitors; dependence of our patents and other protections for inovative por toiling to obtain and defend issued patents; the commencement of any patent interference or infringener or infringener or infr patents, and ou ability to preval, obtain a forwares in any such actor, and the exposue to liigation, including patent liighing pations; the inpact of the economic, public health, political and security situation in which we may operate or obtain approvals for our products or our products or our products or our products or are discussed in our Annual Report on Form 2024 and in our of the filings with the U.S. Securities and Exclange Commission ("SEC"), including on cautionary discussion of isks and uneralines under "Risk Frences and Annual Reports. These are factors that we believe could cause our actual posits of differ materialy from expected resuls. Other factory being is a may forward-ooking statener in this press clease speaks only as of the date with it is made. We discussion any intention or obliance or evise any forward-looking strement or other information contained beginny information, fittere as a result of gew information or otherwise, except as required by applied, however, to consult any additional discoses we make in our reports to the SEC's website, https://www.sec.gov.

Corporate highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

• Two First-in-Class clinical stage drugs
• · A preclinical tri-specific immuno-engagers platform
• Lean & global operation
• Cash runway into mid 2026 .

Purple Biotech (NASDAQ/TASE: PPBT)

As of December 31, 2024

• ADS Outstanding: 2.6 M .
• Cash Balance: \$8.2 M

Well positioned to advance next clinical milestones

A pipeline dedicated to advancing oncology therapies

Advancing First-in-Class Oncology Therapies

CM24: an α-CEACAM1* mAb

Significant opportunity in multiple large indications with unmet medical need

Clinical POC achieved

*Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: POC of a potential CEACAM1-targeting therapy

CM24 MOA (#1) lmmune modulation

CM24 MOA (#2) Blocks NET oncogenic potential through CEACAM1 blockage

• Neutrophil extracellular traps (NETs) are web-like structures involved in:

  • Tumor immune evasion (1, 3)

  • Tumor progression (1, 2, 6)

  • Metastasis (2, 3, 5, 6) >

  • Cancer-associated thrombosis (4)

• · CEACAM1 is a part of the NET structure
• NETs are present in various types of

JRPLE

cancers (pancreatic, breast, GI, etc.)

( CM24 binds to CEACAM1 on NETs, inhibiting NET-related activities

ion of Colon Carcinoma. J Immunol. 2020; om 'Chen, Q et al. Cancers 2021, 13, 2832'); Rayes RF, et al. Neutrophil Extrocellular Trap-Associated CEACAMI os o Public Theropeutic Tarearch (2023) 11:24)

CM24 MOA (#2 cont.) Blocks NET oncogenic potential thru CEACAM1blockage

CM24 binds to CEACAM1 on NETs CM24 Inhibits NET-Induced CM24-Nivo treatment significantly reduced the migration of CEACAM1 expressing enhanced NET levels in patient's serum cancer cells 70% C1D1 PRE- CLD1 EOI C1D1 EOI C1D15 PRE- C1D15 FOI DOSE 1 SHD Level of MPO in patient serum 8,000 cells/tir 7,000 (% of Pre-treatment) 6,000 AUCo2a (migrating cancer 5,000 4,000 3,000 2,000 p = 0.034 1.000 p = 0.037 No treat No treat Isotype CM24 C1D1 = Cycle 1 Day 1; EOI = End of CM24 Infusion; C1D15 = Cycle 1 Day 15 No NETS with NETs Melanoma cell line

. CM24 binds to CEACAM1 on NETs , inhibits NET-induced cancer cell migration, and reduces NET levels in patients' sera

• · MPO (myeloperoxidase) is a NET marker, an integral part of the NET structure
• In the randomized P2, NET-related MPO was found as a potential predictive biomarker for CM24-based treatment

Significant opportunity in multiple large indications with unmet medical need

• CEACAM1 is upregulated in different cancer indications: >90% in Colon and Bladder and >70% in Lung, Gastric, breast, and other 1
• · Elevated levels of neutrophil extracellular traps (NETs) have been observed in various cancers such as Lung, Breast, gastrointestinal cancers, and others2,3
• •

CM24 opportunity in PDAC

• · Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 12. The 5-year overall survival rate with chemotherapy in 2nd line patients is 3%4
• · Two main interchangeable regimens are used worldwide in 2™ line with limited benefit, OS ranging from 6 to 8 months5,6
• · CEACAM1 expression correlates with poor prognosis in Pancreatic cancer7
• Clinical and preclinical data support synergy of CM24 with currently marketed IO therapies

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Phase 2 Combination Study Design (NCT04731467)

A study of CM24 in combination with nivolumab* plus chemotherapy in patients with PDAC in the 2nd line

18 centers in the US, Spain & Israel

Each cohort was a separate study Patients were randomized after assignment to chemo regimen

A substantial rate of early discontinuation in the control arm of the gemcitabine/ Abraxane regimen created an imbalance between the two arms, leading to informative censoring. Consequently, the efficacy analysis of this regimen was deemed biased and uninterpretable.

Measurement of biomarkers: CEACAM1. NET marker (Myeloperoxidase-MPO), PDL1

Primary endpoint : ೧೯

Secondary endpoints:

OS rate @ 6 & 12 months, PFS, PFS rate @ 3 & 6 months, ORR

Phase 2 final analysis

Intent to Treat (ITT) Population demographics and patient characteristics

	Nal-IRI/5FU/LV
Characteristic	Experimental (n=16)	Control (n=15)
Age (median)	66.0	68.0
Male (n, %)	10 (62.5)	8 (53.3)
Female (n, %)	6 (37.5)	7 (46.7)
Race/ white (n, %)	15 (93.8)	14 (93.3)
BMI (median)	23.4	23.1
0 ECOG (n, %)	5 (31.3)	3 (20.0)
1	11 (68.8)	12 (80.0)
Time from initial diagnosis (median, m)	17.8	17.6
Time from most recent disease progression (median, m)	1.0	1.0
BOR CR/PR to prior line (%)	6.3	33.3
BOR SD to prior line (%)	37.5	26.7
BOR CR/PR/SD to prior line (%)	43.8	60.0
Tumor M1 stage at study entry: N (%)	14 (87.5)	14 (93.3)
Pancreaticoduodenectomy	0 (0.0)	1 (6.7)

Phase 2 final analysis

Safety Population the most frequent related Grade ≥3 TEAEs

Grade ≥3 TEAE	Nal-IRI/5FU/LV
	Experimental (n=16) N (%)	Control (n=15) N (%)
Neutropenia	2 ( 12.5)	0 ( 0.0)
Diarrhea	4 ( 25.0)	1 ( 6.7)
Fatigue	2 ( 12.5)	0 ( 0.0)
Anaemia	0 ( 0.0)	0 ( 0.0)
Nausea	1 ( 6.3)	0 ( 0.0)
Vomiting	1 ( 6.3)	0 ( 0.0)
Thrombocytopenia	0 ( 0.0)	0 ( 0.0)
White blood cell count decreased	0 ( 0.0)	0 ( 0.0)

( The CM24+nivolumab+Nal/IRI//5FU/LV regimen was well tolerated

19% reduction in risk of death (HR=0.81) and 25% reduction in the risk of progression or death (HR=0.75)

Prolongation of 2.3 months in median overall survival and 1.9 months in median progression-free survival

Phase 2 final analysis CM24+nivolumab+Nal-IRI/5FU/LV sub-study

• Higher objective response rate (ORR) (25% vs 6.7%)

• Higher disease control rate (DCR) (62.5% vs 46.7%)

• Consistent and continuous decrease in CA19-9 was observed

% change in tumor size

Median CA 19-9 levels

Phase 2 final analysis-Efficacy summary

CM24+nivolumab+Nal-IRI/5FU/LV sub-study

Parameter		Nal-IRI/5FU/LV
	Experimental	Control
OS (median, m; 95% CI)	7.92 (4.14, 8.02)	5.55 (3.45, 7.56)
OS HR (95% CI)		0.81 (0.38,1.71)
6m OS rate (%)	53.6	46.7
PFS (median, m; 95% Cl)	3.91 (1.84, 5.13)	1.97 (0.95, 3.78)
PFS HR (95% CI)		0.75 (0.35, 1.61)
3m PFS rate (%)	66.7	46.7
6m PFS rate (%)	26.7	13.3
ORR (%)	25.0	6.7
DCR (%)	62.5	46.7

Concordant and consistent improvement in the primary and all secondary efficacy endpoints

Phase 2 final biomarker analysis data

Results for pre-treatment serum CEACAM1

Statistically significant results in patients with pre-treatment serum CEACAM1 level between 6K to 15K:

• 79% reduction in the risk of death (HR = 0.21) and > 90% reduction in the risk of progression or death (HR < 0.1)

• Prolongation of 5.1 months in median overall survival and 2.9 months in median progression-free survival

Phase 2 final biomarker analysis data Results for serum or tumor CEACAM1 levels

Statistically significant results in patients with pre-treatment serum CEACAM1 levels (6K-15K pg/mL) or turnor CEACAM1 expression (Hscore 115-275)

• 78% reduction in risk of death (HR 0.22, p 0.006) and 95% reduction in the risk of progression or death (HR 0.05, p 0.003)

• Prolongation of 3.7 months in median overall survival and 2.9 months in median progression-free survival

CEACAM1*Tumor cell H score 115-275 or Serum CEACAM1 6K-15K pg/mL

Serum and tumor CEACAM1as potential predictive biomarkers for CM24based therapy, suggesting a multifaceted MoA

Phase 2 final biomarker analysis Results for pre-treatment serum CEACAM1 or NET marker MPO levels

Statistically significant results in patients with defined pre-treatment serum CEACAM1 or MPO levels in the study:

• 61% reduction in risk of death (HR = 0.39) and 72% reduction in the risk of progression or death (HR=0.28)

• Prolongation of 2.4 months in median overall survival and 2.2 months in median progression-free survival

Phase 2 final biomarker analysis data Results for CEACAM1 and PDL1 levels in tumors

Statistically significant results for patients with High CEACAM1 (H-score>100) and Low PDL1 (CPS ≤ 1 ) expression in tumors:

• 90% reduction in risk of death (HR = 0.1) and 81% reduction in the risk of progression or death (HR = 0.19)

• Prolongation of 4 months in median overall survival and 2 months in median progression-free survival

CM24 path forward Novel MoA-directed opportunity

JRPLE

• Potential targeting patients per pre-treatment serum CEACAM1 and MPO levels
• Biomarkers data opens new opportunity for patients who are not eligible for anti-PD1 therapy in various . indications

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Advancing First-in-Class Oncology Therapies

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

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

NT219, a new solution to improve treatment outcome for cancer patients

Innovative MOA	• NT219 is a First-in-Class, small molecule dual inhibitor of IRS1/2 and STAT3 · Covalently binds to IRS1/2 and leads to their degradation · Affects both the tumor and the TME · Suppresses cancer stem cells
Robust preclinical package	• Outstanding efficacy in various PDX models in monotherapy and in combination · Uniquely positioned to tackle resistance to cancer treatment such as EGFRi, MAPKi and ICI
Clinical Stage	· No DLTs in monotherapy or in combination · Early clinical activity demonstrated ® Activated IGF1R and STAT3 identified as potential predictive biomarkers RP2D determined at 100 mg/kg, Phase 1 concluded. Phase 2 initiation 1H25
Broad Market Potential	Opportunity to establish a Standard of Care in 2L r/m SCCHN patients • Multiple market upsides in combination with major cancer treatments • NT219 is the only IRS inhibitor available for clinical investigations
		23

NT219 blocks 2 critical signalling pathways at once

IRS1/2

• Scaffold proteins, mediating mitogenic, metastatic, angiogenic and antiapoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumors
• Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and WNT/βcatenin
• · Activated as a feedback response to anti-cancer therapies
• IRS plays an important role in promoting a tumor-protective microenvironment, by mediating upregulation of TAMs and CAFs

STATS

• Well-established transcription factor associated with the tumorigenic phenotype
• STAT3 is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis and metastasis
• · STAT3 pathway is required for TGFBinduced EMT and cancer cell migration and invasion
• STAT3 is a critical player in tumor immune evasion, suppressing immune stimulators and enhancing immunosuppressive factors

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hem. 2018;119:9419-9432.

NT219 restores sensitivity to EGFRi in PDX models

Lung Cancer

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

Head & Neck Cancer

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

| 26 NT219 re - sensitizes PD1 - refractory model 6 8 10 12 14 16 18 20 22 0 500 1000 1500 2000 Control α-PD-1 NT219 NT219+α-PD-1 Days post tumor challenge T u m o r v o l u m e ( m m 3 ) Days following tumor challenge PD 1 - resistant melanoma cells (FACS analysis) PDL1 expression (MFI) NT219 ( M) treatment in culture 0 1 10 NT 219 + PD 1 reverse resistant tumors NT 219 induces PDL 1 expression (n=10) (n=10) (n= 10 ) (n=10) * Collaboration with Prof. Bareli and Prof. Curran, M.D. Anderson cancer center ; presented at AACR 2023

NT219 combination with αPD1 achieves a profound reprograming of the TME

First Market Opportunity

Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Targeting the unmet medical need

• SCCHN is the 6th most common cancer type ; 175k new cases/year are expected by 2024
• 1L standard of care has shifted from chemotherapy towards immuno-oncology + chemotherapy
• < 20% of R/M SCCHN patients respond to Pembrolizumab
• · Market size forecasted to >\$5b in 2030

Phase 1 dose escalation in combination with cetuximab: Well tolerated, target exposure reached, patient's responses observed

• No DLTs reported, NT219 was well tolerated as monotherapy and in combination with cetuximab
• Dose-proportional increase in AUC and Cmax values
• · Human Equivalent Dose exposure was reached at 50 mg/kg
• Target engagement demonstrated in patients' biopsies
• · RP2D determined at 100 mg/kg

Post-treatment

Phase 1 Dose Escalation (cont.): Anti-tumor activity at target exposure level, 2 confirmed responses in SCCHN patients

Efficacy overview of monotherapy arm:

· 20 evaluable patients (all doses): 2 PR (confirmed-GEJ, unconfirmed-PDAC), 5 SD

Efficacy overview of combination arm in SCCHN patients*:

• · 16 evaluable patients (all doses 6, 12, 24, 50, 100 mg/kg)
• ·
• Out of 8 treated with 50&100 mg/kg:
  • 2 confirmed PR
  • 3 SD .
  • ORR:25%, DCR: 62.5% .

Numbers under horizontal line designate NT219 dose in mg/kg; P = HPV positive; N = HPV negative

Advancing phase 2 study in combination with cetuximab or pembrolizumab in R/M SCCHN in collaboration with Uni. Of Colorado

Activated IGF1R and STAT3 as potential predictive biomarkers

Biomarker analysis at the 50mg/kg dose of NT219 with cetuximab:

• Significant differences in the activated pIGF1R and pSTAT3 were revealed in the 2 responders (PR) compared to the 2 non-responders (PD)

Advancing First-in-Class Oncology Therapies

CAPTN-3: Conditionally-Activated Tri-Specific Antibody Platform

Lead candidate: IM1240 (CD3x5T4xNIKG2A)

CAPTN-3 Platform A novel mechanism of action tri-specific antibody

• · Multi-specific biologics is an expanding class of drugs getting a lot of interest in the industry
• · After initial success in hemato-oncology, new formats are being investigated in solid tumors
• · Platform displays several distinctive features:
  • · Dual engagement of T cells and NK cells to mount an optimal anti-tumoral immune response
  • · A tumor-restricted activation through a cleavable capping system designed to provide a wide therapeutic index
  • Plug & Play Carefully selected Tumor Associated Antigens (TAAs) allowing patient-centric development. portfolio includes several assets, targeting different receptors and TAA

CAPTN-3 platform technology advantages

■ Molecule size similar to mAb (~170 kDa)

Human Serum Albumin (HSA)

■ Improved stability in blood circulation

αCD3 arm:

■ T cell engager

■ T cell activation Efficient anti-tumor effect

αTAA arm:

■ Tumor Associated Antigen Targeted activation against tumor cells 34

| 35 Unleashing both innate and adaptive immune systems

POC: αNKG2A arm contributes substantially to tumor cell killing and synergizes with the CD3 Arm

• . Tribody induces cytotoxicity at pM EC50 against NSCLC A549 cells
• . Up to 20-fold more potent than the bi-specific CD3x5T4 • Cell killing validated on multiple 5T4* cell lines (MDA-
• MB-231, HCT116, NCI-H226)

· Synergistic effect of the αCD3 and α.NKG2A arms in suppressing 5T4*NCSLC Patient-Derived Explant (PDE)* at 10nM concentration

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In vivo efficacy - significant and sustained tumor regression

• . Effective cleavage leads to significant tumor regression by both capped and non-capped tribodies (p<0.0001).
• No tumor recurrence observed
• Frequency of administration QOD

TNC MD-MB-231 cells were s. . noculated 1.1 with PMCs on day 1 realimalar dose 1.7 mg/lg (capped, 1240) till dy 2, 9 mice per goup, Follow p 20 day follow in 20 day follow in treatment completion

Improved safety profile: Cytokine release is 5T4-dependent and suppressed by the cap

· The capped variant vs the non capped, showed a decreased IFNy release > 150-fold (Safety factor #1). •

| 39 5T4: a Novel Target in Oncology 5 T 4 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 5 T 4 is a Tumor Associated Antigen prevalent to several large indications Opportunity of patient stratification strategy ( 5 T 4 + )

Corporate highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

• Two First-in-Class clinical stage drugs
• · A preclinical tri-specific immuno-engagers platform
• Lean & global operation
• Cash runway into mid 2026 .

Purple Biotech (NASDAQ/TASE: PPBT)

As of December 31, 2024

• ADS Outstanding: 2.6 M .
• Cash Balance: \$8.2 M

Well positioned to advance next clinical milestones

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

оз | IMMUNO-ONCOLOGY 01 | ADHESION 02| IMMUNE CELLS/ IMMUNE EXCLUSION Tsuzuki, 2020 Horst, 2011 Blumberg, 2015 ୍ତର ପ୍ରଦା 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 Concer Biotherapy ac

Radiopharmiceuticals C Experimental
Cell Research "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 tumor cells through blockade of the therapeutic target to prevent interaction with в-catenin" metastatic progression of colon inhibitory CEACAM1 / CEACAM5 carcinoma" immune checkpoint pathway"

CM24 Reduces Tumor Burden & Synergetic with α-PD-1

Phase 1 Dose Escalation Interim Results CM24 is Safe and Well Tolerated in Combination with Nivolumab

Study Design

• · patients were evaluable for DLT determination (8 PDAC, 2 CRC and 1 PTC).
• ﺓ ﺍﻟﻤ 9 patients had received 2 prior regimens for metastatic disease, 2 patients had one previous line.

Safety

• No DLTs were observed across all dose levels; no Grade 4 . AEs or treatment-related deaths have been reported.
• Grade 3 AEs were noted in 6/13 patients (46%). .

	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	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

CM24 Phase 1 Combination Study (NCT04731467) Demographics

In the Phase 1 part, patients with indicated refractory cancers were administered CM24 at 10, 15, and 20mg/kg q2w and nivolumab 480mg q4w.

• The primary objective of this part was to evaluate safety, tolerability, pharmacokinetics and determine the RP2D
• Safety was assessed according to CTCAE v5 and preliminary anti-tumor activity was assessed by the investigators according to RECISTv1.1 using CT/MRI
• CM24 and CEACAM1 measurements in serum, biopsy specimens, . . and TILs, as well as tumor and TILs PD-L1 levels are being determined

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) mg)

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%

Confirmed Partial Response in a 3L PDAC Patient

Patient Profile

• . 65 y/o female, pancreatic cancer
• 2 prior lines of treatments: FOLFIRINOX and gemcitabine/nab-paclitaxel
• . Post Whipple Procedure
• . Patient had a germline NF1 VUS, with MSI-S and PDL-1 IHC 2+ and 5% staining
• . Confirmed Partial Response: after initial treatment, the patient had a Partial Response of 40%, with a definite reduction of the para-tracheal adenopathy and liver lesions and 58% reduction in CA19-9 levels
• . Under treatment for 6 months, still under monitoring.

SCREENING

PREDOSE

CM24 Phase 1 Dose Escalation Results Encouraging data in 2L/3L Pancreatic Ductal Adenocarcinoma (PDAC) patients

Study Results

14 patients were evaluable for efficacy:

• . Best overall response included 1 Partial Response (PR) (PDAC) and 4 Stable Disease (SD) (3 PDAC and 1 papillary thyroid cancer (PTC))
• Pharmacokinetic analysis of CM24 shows exposure is dose-proportional across the 3 doses in this study
• Well tolerated with no Dose Limiting Toxicities (DLTs) and no grade ≥ 4 Adverse Events (AEs)
• Median Overall Survival 4.5 months (95% Cl 2.0-11.1) for 11 PDAC patients

Appendix B | NT219

Novel MOA: IRS Degradation By NT219 Blocking IGF1R-AKT Pathway¹

| 51 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®) 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) * Double autologous model - Tumors & PBMCs are from the same patient (#RA 236 ) | Keytruda - 6 mg/kg IP, NT 219 - 60 mg/kg IV

Novel MOA Signal Transducer and Activator of Transcription 3 (STAT3) Inhibition

• · Point of convergence for numerous oncogenic signaling pathways
• · Central in regulating the anti-tumor immune response
• · Broadly hyperactivated both in cancer and non-cancerous cells within the tumor ecosystem and plays important roles in inhibiting the expression of crucial immune activation regulators and promoting the production of immunosuppressive factors
• Targeting the STAT3 signaling pathway has emerged as a promising therapeutic strategy for numerous cancers

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

Selected Publications

NT219 inhibits the IRS to ß-Catenin pathway and synergizes with 5FU to suppress CRC tumor growth in mouse brain

overcomes chemo-resistance, and inhibits LS-513 cell viability and tumor growth in intracranial model.

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 | 55 Medical Center

Reduced expression of IRS1, Ki67, FOXM1 & TGFb is RNA Sequencing | exhibited by pancreatic cancer treated with NT219 alone and Analysis of Tumors in combination with gemcitabine Following Treatment Ki67 (Proliferation marker) IRS1 PDX model 17% Control NT219 Gemzar Gemzar Pancreatic Cancer Gemzar Control NT219 Gemzar +NT219 +NT219 FOXM1 TGFbeta (EMT Driver) 100% 101% Drug Gemcitabine (Gemzar®) Control NT219 Gemzar Gemzar Control NT219 Gemzar Gemzar +NT219 +NT219 | 57

NT219 suppresses cancer stem cell (CSC)-mediated resistance to KRAS02C inhibitors and synergizes with sotorasib to combat NSCLC

NT219 overcomes resistance to KRASG2D inhibitors and synergizes with MRTX1133 to combat pancreatic cancer

Higher sensitivity of mKRAS(G12D) resistant PDAC and synergy of NT2133-resistant PDAC clone vas developed. Inhibition of mKRAS G12Dsensitive (AsPC-1) and resistant (AsPCI-MRTX113-R) by NT219 (2D cell proliferation) shows 8-fold line (A). NT219 is effective both as monotherapy and in combination with MRTX133 in colory of sensive and resistant PDAC cell lines (B). Synergistic effect (C(CL) of NT219 and MRX133 was demonstrated in 2D growth (C) and in spheroid 3D growth (D) of HPAC PDAC cells.

Collaborationn with Dr. Azmi, Karmanos. Presented at AACR Annual Meeting 2024

JRPLE