Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Investor Presentation (February 2022)
36 slides from Purple Biotech's investor presentation, Feb 4, 2022
Slide 1: Corporate Presentation February 2022
NASDAQ/TASE: PPBT February 2022 CORPORATE PRESENTATION
Slide 2: Forward-looking Statements and Safe Harbor
2 Forward - looking Statements and Safe Harbor Certain statements in this presentation that are forward - looking and not statements of historical fact are forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 . Such for
Slide 3: Business Highlights
3 Business Highlights Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM24 - First - in - class α - CEACAM1 mAb NT219 - First - in - class, small molecule, dual inhibitor of IRS 1/2 and STAT3 $47.5M cash as of December 31 st , 2021 Cash runway into 2024 ADSs outstanding: 17
Slide 4: Advancing Clinical-stage Novel Oncology Therapies
4 Program Indication Phase 1 Phase 2 Phase 3 Value Drivers CM24 (CEACAM - 1) S olid tumors (monotherapy) (Completed) P 1 data: H 1:22 Expansion arms on RP 2 D: Initiation Q 1:22 (NSCLC & PDAC) S olid tumors (combination with nivolumab * ) NSCLC (combination with nivolumab * ) Pancreatic Cancer (comb
Slide 5: Experienced Leadership
5 Experienced Leadership Isaac Israel Chief Executive Officer Former CEO of BeeContact Ltd. (TASE:BCNT), NextGen Biomed (TASE: NXGN) Fabien Sebille, Ph.D Chief Commercial Officer Formerly at Debiopharm . Gil Efron President and Chief Financial Officer Former Deputy CEO & CFO at Kamada (NASDAQ:KMDA)
Slide 6: Advancing First-in-Class Oncology Therapies: CM24
Advancing First - in - Class Oncology Therapies CM24 - an α - CEACAM1 mAb
Slide 7: CEACAM1 Plays a Key Role in Cancer Biology
7 CEACAM 1 Ύ Plays a Key Role in Cancer Biology 01 | ADHESION Horst, 2011 “ CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation ” “ Neutrophil extracellular trap - associated CEACAM 1 as a putative therapeutic target to prevent metastatic progression of co
Slide 8: CM24 MOA: Immuno-oncology
8 CM 24 MOA | Immuno - oncology Markel et al, J Immunol 2002, 2006; Immunology, 2008; Cancer Immunol Immunother 2010; Ortenberg et al, Mol Cancer Ther 2012; Zhou, 2009; Li, 2013; Huang, 2015; Acharya N, et al. J Immunotherapy Canc 8:e911 - 22, 2020. Tumor CD8+T & NK Cells CEACAM 1 CEACAM1 CEACAM1 CE
Slide 9: CM24 MOA: Adhesion
9 CM24 MOA | Adhesion Neutrophil extracellular trap - associated CEACAM1 as a putative therapeutic target to prevent metastatic progression: CEACAM 1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. CM 24 is proposed to attenuate/block tumor growth and metasta
Slide 10: Anti-cancer Effect Following Treatment: Preclinical Data
10 Anti - cancer Effect Following Treatment Preclinical Data With CM24 + TIL and CM24 + α - PD1 • Xenograft, lung lesion, Mel 526 (IV) • Tumor burden was monitored 26 days post last CM24 treatment TIL + IgG TIL + CM 24 Naïve Combination index ( CI) = 0.15 < 1 synergy Significant benefits as both sin
Slide 11: CM24 Phase 1 Monotherapy Trial PK/PD Modeling
11 CM 24 Phase 1 Monotherapy Trial PK/PD Modeling Provides Dosage & Schedule Guidance Simulated TMDD 1 saturation at Ctrough 2 with Q2W regimen • Completed Phase 1 monotherapy open - label, dose - escalation study to assess safety and tolerability • Heavily pre - treated 24 evaluable patients with a
Slide 12: Large Market Opportunity in NSCLC & Pancreatic Cancer
12 12 Large Market Opportunity in NSCLC & Pancreatic Cancer • CEACAM 1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer 1 • Preclinical data support significant synergy • Receptor saturation with CM 24 is better achieved with a Q 2 W regimen, aligning with the nivolumab regim
Slide 13: CEACAM1 Over-expression in PDAC
13 CEACAM1 Over - expression in PDAC CEACAM1 Immunostaining in Pancreatic Cancer and Normal Tissues Representative examples of CEACAM1 immunohistochemical images of pancreatic adenocarcinoma and normal tissues Comparison between CEACAM 1 staining intensity in pancreatic cancer ( 40 cases/ 80 cores)
Slide 14: CM24 Phase 1/2 Combination Study Design
14 CM24 Phase 1/2 Combination Study Design (NCT04731467) A Phase 1 / 2 open label multi center study of CM 24 in combination with: • Nivolumab in selected cancer indications (Phase 1 ) and NSCLC (Phase 2 ) • Nivolumab and nab - paclitaxel in pancreatic cancer (Phase 2 ) • 9 centers are currently act
Slide 15: 1st Cohort Analysis – Safety and Response
15 1 st Cohort Analysis – SAFETY and RESPONSE ϭϬ mg/kg Dose Level in combination with nivolumab • The administration of CM 24 at 10 mg/ kg q 2 wks in combination with nivolumab at 480 mg q 4 wks was well tolerated with no SAEs in patients with refractory PDAC • Three patients were enrolled into the
Slide 16: Advancing First-in-Class Oncology Therapies: NT219
Advancing First - in - Class Oncology Therapies NT 219 – A Small Molecule Dual Inhibitor of IRS 1 / 2 and STAT 3
Slide 17: NT219 - Dual Inhibitor of IRS1/2 & STAT3
17 NT219 - Dual Inhibitor of IRS1/2 & STAT3 NT 219 IRS 1 / 2 • Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti - apoptotic signals from IGF 1 R, IR, IL 4 R and other oncogenes, overexpressed in multiple tumor types • Regulates major survival pathways such as the PI 3 K/AKT, M
Slide 18: Novel MOA: IRS Degradation by NT219
18 Novel MOA: IRS Degradation By NT219 Blocking IGF1R - AKT Pathway 1 Binding to IRS 1 1 Reuveni et al. Cancer Res 2013 Ser - phosphorylation 2 Degradation 3 Covalent binding to IRS1/2 leads to the dissociation of IRS1/2 from IGF1R Serine phosphorylation prevents re - binding of IRS 1 / 2 to the rec
Slide 19: NT219 Efficacy as Monotherapy
19 NT 219 Efficacy as Monotherapy Animal model Head & Neck Cancer (SCC - 9 ) NSG Ρ , PBMCs - injected 1 Drugs α - PD 1 Cetuximab (Erbitux®) NT 219 20 mg/kg NT 219 60 mg/kg 1 NSG mice were injected SC with SCC - 9 cells. PBMCs ( 18 * 10 6 cells per mouse) administered 4 weeks prior to first treatment
Slide 20: STAT3 and IRS are Essential in Therapeutic Resistance
20 STAT 3 and IRS are Essential in Therapeutic Resistance STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib Blocking survival pathways NT 219 NT 219 STAT 3 IRS ONCOPROTEIN DRUG MEK / ERK TUMOR REGRESSION Proof of Concept: PDX model of
Slide 21: NT219 + Targeted Therapies Established Efficacy in PDX Models
21 NT 219 + Targeted Therapies Established Efficacy in PDX Models NSCLC Exon 19 deletion EGFR and T 790 M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib R/M SCCHN metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pe
Slide 22: NT219 + α-PD1 Re-sensitizes Refractory Tumors
22 NT 219 + α - PD 1 Re - sensitizes to Refractory α - PD 1 Tumors PDX Model Humanized PDX of Esophagus 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 0
Slide 23: First Market Opportunity: Recurrent or Metastatic SCCHN
23 23 First Market Opportunity Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Global Data 2018 : Head and Neck Squamous Cell Carcinoma: Opportunity Analysis and Forecasts to 2026 ; Internal best current estimates of patient numbers based on external research, 5 major global
Slide 24: NT219 Monotherapy and Combination Phase 1/2 Study Design
24 NT 219 Monotherapy and Combination Phase 1 / 2 Study Design ( NCT 04474470 ) Study title 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 NT 219 , alone in adults with recurrent or metastatic
Slide 25: Interim Analysis – Safety and Response, 3 mg/kg Single Agent
25 Cancer Type Prior Lines of Therapy Treatment Duration(Weeks) Best Response* NT219 3mg/kg Pancreatic Cancer 3 8 PD GE Junction Cancer 4 22 PR Target lesion: Absent Non target lesion 1: Absent Non target lesion 2: Stable Breast Cancer 11 8 PD Interim Analysis – SAFETY and RESPONSE 3 mg/kg Dose Leve
Slide 26: Business Highlights
26 Business Highlights Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT) CM 24 - First - in - class α - CEACAM 1 mAb NT 219 - First - in - class, small molecule, dual inhibitor of IRS 1 / 2 and STAT 3 $ 47.5 M cash as of December 31 st , 2021 Cash runway into 2024 ADSs outsta
Slide 27: Committed to providing cancer patients first-in-class therapies
27 We are committed to providing cancer patients with first - in - class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression
Slide 28: Thank You
THANK YOU Contact Us: ir@purple - biotech.com
Slide 29: Appendix A | CM24
Appendix A | CM 24
Slide 30: CM24 Phase 1 PK Data
30 PHASE 1 PK DATA Target saturation was not reached with doses up to 10mg/kg Slower clearance with increasing dose Higher half - life with increasing dose 0.1 mg/ kg 0.3 mg/ kg 1 mg/ kg 3 mg/ kg 10 mg/ kg Predictions with Q 3 W regimen • Modeling with increased interval between doses demonstrates l
Slide 31: Appendix B | NT219
Appendix B | NT 219
Slide 32: Selected Publications
32 Selected Publications Menashe Bar - Eli Michael Karin Michael Cox Alexander Levitzki
Slide 33: NT219 Suppresses β-Catenin Activity in CRC Cells
33 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
Slide 34: NT219 in Combination with Gemcitabine, Pancreatic Cancer
34 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
Slide 35: RNA Sequencing Analysis of Tumors Following Treatment
35 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
Slide 36: NT219 Demographics & Safety, Single Agent
36 NT 219 | DEMOGRAPHICS & SAFETY 3 mg/kg Dose Level as a Single Agent Demographics of Patients treated with NT 219 3 mg/kg (n= 3 ) Median age (range) 74 (69 - 79) Male/Female, n (%) 2(66.6%)/1(33.3%) Race White n (%) 3 (100%) Prior Lines of Therapy 3 n (%) 1 (33.3%) 4, n (%) 1 (33.3%) 11, n (%) 1 (
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