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Purple Biotech Ltd.

Regulatory Filings Feb 4, 2023

7004_rns_2023-02-04_31515230-0f0d-4c88-b173-b1097dae8e5a.pdf

Regulatory Filings

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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 February 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 ☐

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

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.

Exhibit

99.1 Company Presentation – February 2023

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-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-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) and 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), 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.

February 3, 2023 PURPLE BIOTECH LTD.

By: /s/ Lior Fhima

Lior Fhima Chief Financial Officer

Forward -looking Statements and Safe Harbor

Certain steenents in this pees release that are forward-obling statements within the nearly of the safe hards within the nearing of the safe harder provisions of the Private Lifection Reform Act of 1995. Such finited to statements intlude, but are not linited to, statements of historical fact, and may be identified by words such as "believ"," req "intend", "plan", "may", "should", "might", "see", "torecas", "continue" or "anticipate" or their negatives or variations of the comparable word on the last that these statements do not relates. You should not place unive reliance on these or these forward-looking statenents, which are not guarantees of future performance. Forwar statements rellect our current views, expect to buture events, and are subject o a number of assumptions, involve known and unknown risk, may of which are beyond our control, as well as uncertainter and other for any cause or activements to be signitiantly different fron any itture results, performance or achievenents expressed or implied by the foward-looling satements. Important for out offerences include, anong others, risks relating to the expected benefits, snergies and ossof the transaction, management plans elating to the potential (tuore francial imped of the transaction, and any assumptions une the consected timing of the consetion of the cransction and the packer alliny to complete the tans, strategies and objectives of management for NT229 and CM2-as well as mmunition Ltd. sportally of investigational tri-specific andical the process by which such enry stage therapeutic condizion in an approved drug product is long and subject to highly significant isks, partularly with respect to ajoint the fact that drug development and commercialization involves a lengthy and experiences with uncertain outcomer, our ablil succesfuly develop and connection poducts the expense, length, progress and results of any chical trials; the impact of any charges in regulation and legistion that collal fi pharmaceutial industry in receing the regulatory approvative or product; the difficulty of prodicing actions of the U.S. Food and Ing Admisistation or any other applicale regulator of players, the regulatory environment and changes in the beath polices in thish we operate; the uncertains surrounding the actal narel reeption to or pharmaceultal products one particular market, the introduction of competing probucts; patents of the effectivens of our patents and other protections for ablily to obtain, maintain and defend issued patents; the connencement of any patent interference or infringement our patent, and our ability to preval, obtain a favor and action; and the exposure of ligation, including patent l'ingtion, and or registery action, and other factors that one of sussed in our Annual Report on Form 20-F or the year ended Becerities with the U.S. Securites and Exchange Comnission ("SC"), including our cautonary discussion of risk and unceratives under "Risk Factor" in ur Registration Statimation of Annual Peports. There and cause our actual to differ materially from expected results. Other factors besiles those we have listed could also adversely affect us. Any forward in this press release speaks only as of the data witchile of chigation or obligation or public) update or revise any forward-looking tatement or other information as a result of new information, future events or otherwise, except as required by applicable law. You are advised, howeve, to co additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov.

Business 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
  • · Preclinical tri-specific immuno-engagers platform
  • · Multiple data read-outs expected in 2023
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Cash runway to 2H24

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 18.4M

\$35.7M cash as of September 30, 2022

Strong cash position to advance development of first-in-class cancer therapies

Leadership Team

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) OKAMADA

Hadas Reuveni, PhD VP Research & Development Formerly at Keryx (NASDAQ:KERX)

Lior Fhima Chief Financial Officer Formerly at Kamada (NASDAQ:KMDA) CKAMADA

Fabien Sebille, PhD Chief Business Officer Formerly at Debiopharm

Debiopharm

14

A Pipeline Dedicated to Advancing Oncology Therapies

*Clinical collaboration and supply agreement with: [1] Bristol Myers Squibb®

Multiple data read -outs expected in the next 12months

15

Advancing First -in-Class Oncology Therapies

CM24: ana-CEACAM * mAb

*Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional Immune Checkpoint Inhibitor

| 8 CM24 MOA | Immune Check Point Inhibitor & Anti - Metastatic Activity 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. ; Rayes RF, et al. Neutrophil Extracellular Trap - Associated CEACAM1 as a Putative Therapeutic Target to Prevent Metastatic Progression of Colon Car cinoma. J Immunol. 2020; Gerstel, D. et al. CEACAM1 creates a pro - angiogenic tumor microenvironment that supports tumor vessel maturation. Oncogene 30, 4275 – 4288 (2011), CM 24 Suppresses Neutrophil Extracellular Trap (NET) - Induced Migration and Metastasis of Cancer Cells Tumor CD 8 +T & NK Cells CEACAM 1 CEACAM1 CEACAM1 CEACAM5 Activation of enhanced cytotoxic activity & cytokine production CM 24 Primary Tumor Metastasizing CM 24 Metastatic Tumor CM24 Inhibits NET - Induced Migration of CEACAM1 Expressing Cancer Cells Direct Binding of CM24 to the NET Structure MPO( green ) DAPI ( blue ), CM24 ( red ) CM24 ( red ) Melanoma Immune Response Activation

CM24 Reduces Tumor Burden & Synergetic witha-PD-1

CEACAM1 is OverExpressed in PDAC

and normal (10 cases/20 cores) tissues

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

Study Design

  • · As of March 8th, 2022, a total of 13 patients were enrolled and 11 patients were evaluable for DLT determination (8 PDAC, 2 CRC and 1 PTC).
  • · 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%).
AE Term Total Grade
1 2 3 4/5
Diarrhea 5 4 1
Abdominal pain 4 1 3
Fever 4 2 2
Headache র্যা 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 Dose Escalation Interim Results (cont.) Sustained Clinical Benefit Even After Treatment Cessation

For the 11 evaluable patients as of March 8th, 2022, best overall response included 1 confirmed PR (PDAC patient) 3 SD (2 PDAC and 1 PTC) for a disease control rate of 36%

  • · 9/11 of the evaluable patients are in study follow-up
  • · Pharmacokinetic analysis of CM24 shows exposure is doseproportional across the 3 doses in this study with a complete receptor occupancy of peripheral CEACAM1 receptors on T cells and neutrophils at CM24 doses of 15 or 20mg/kg
  • · Median overall survival has not yet been reached

The Phase 2 portions of the study has been initiated at the conclusion of this dose-escalation phase.

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 FIRST VISIT - PREDOSE 2 MONTH VISIT -

PREDOSE

| 13

Large Market Opportunity in Pancreatic Cancer

· Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 11.5%4

  • I/O approaches have been limited to patients with high microsatellite instability (MS-H) or high tumor mutational burden (TMB-H)
  • · 5-year overall survival rate with chemotherapy in 2L is 3%1

  • 2L SoC regimens efficacy data: Gemcitabine/Nab-pacitaxel³: OS 7.9 months or Nal-IRI/5FU/LV*: OS 6.2 months, PFS 3.1 months
  • · CEACAM1 expression correlates with poor prognosis in Pancreatic cancer2
  • Preclinical data support significant synergy of CM24 with currently marketed IO therapies

Combining nivolumab with CM24 in a clinical collaboration with Bristol Myers Squibb

(Ill Bristol Myers Squibb"

. 2006 000 000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | 14

Phase 2 Combination Study Design (NCT04731467)

A study of CM24 in combination with nivolumab plus chemotherapy in PDAC patients in 2L 11 centers are currently active

in US, EU & Israel

Primary efficacy endpoint of the randomized sub-study: OS

Secondary endpoints:

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

Interim analysis: - PFS rate @ 6M planned in 2H23 Top line data: - planned in 2H24 Measurement of CEACAM1 and other biomarkers is ongoing Planning of further studies in other tumor types is ongoing

Advancing First -in-Class Oncology Therapies

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

NT219- A Novel Approach to Overcome Resistance to EGFRiand Beyond

NT219- Dual Inhibitor of IRS1/2 & STAT3

IRS1/2

  • · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti-apoptotic 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/β-catenin
  • · Activated as a feedback response to anticancer therapies
  • · IRS plays an important role in promoting a tumor-protective microenvironment, by mediating upregulation of TAMs and CAFs

NT219

STAT3

  • · 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

URPLE

veret al. Concelect of Chic. 2017, 2017, 2014. I Offic, Notes for Mol Porter in Mol Caree, Tre. 2122.2022 2022 222.20.00. et d. Chroner a Chicanovers, Color, Carona Conceres,

| 18

Novel MOA: IRS Degradation By NT219 Blocking IGF1RAKT Pathway 1

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.

| 21 Simultaneous Blockade of STAT 3 and AKT Pathways are Required to Overcome Resistance to EGFRi Overcoming drug resistance NT 219 NT 219 STAT 3 IRS EGFR EGFRi MEK / ERK TUMOR REGRESSION Proof of Concept: PDX model of Head and Neck Cancer Erlotinib+Ruxolitinib (n= 6 ) Erlotinib+Buparlisib (n= 6 ) Control (n= 6 ) Erlotinib (n= 8 ) Erlotinib+NT 219 (n= 6 ) Erlotinib+Ruxolitinib+Buparlisib (n= 8 ) STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib NT 219 NT 219 JAK By blocking both STAT 3 and IRS resistance pathways, NT 219 re - sensitizes tumors to anti - cancer therapies

NT219 is Effective as Monotherapy

-Control (n=5)

NT219Restores Sensitivity to EGFRiin PDX Models

NSCLC Exon 19 deletion EGFR and

T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pembrolizumab

R/M SCCHN

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

NT219Phase 1Dose Escalation Monotherapy Interim Results

Study Design

  • · As of data cutoff date of May 12th, 2022, a total of 14 patients were enrolled and 12 patients were evaluable for DLT determination (4 CRC, 3 pancreatic cancer, 2 breast cancer, 1 GEJ, 1 esophageal, and 1 appendiceal cancer)
  • · Median number of prior treatment regimens for metastatic disease was 4 (2-11).

Safety

  • No DLTs were observed across all dose levels. .
  • · Nine Grade 3 adverse events (AEs) were observed, two of which possibly related to NT219
Grade
AE Term Total 1 2 3 4/5
Fatigue б
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

| 25

NT219 Phase 1 Dose Escalation Monotherapy Interim Results: Encouraging Initial Efficacy Signals

  • · For the 12 evaluable patients, best overall response included one confirmed PR (GEJ patient, > 5.5 months duration of response following end of treatment), and 3 SD with one patient awaiting follow up MRI/CT scans
  • · As of the cutoff date (May 12th , 2022), 10/12 patients are either on treatment or in follow up (range 1.1 to 18 months).

| 26

Confirmed PR as Single Agent in a GEJ Cancer Patient

  • · In a patient with refractory GE junction disease (mutated KRAS, TP53), NT219 administration (3mg/kg as a single agent) was associated with a confirmed partial response (PR):
    • · Complete remission at the largest target lesion (right)
    • · Complete resolution of all non-target lesions (two lymph nodes) has also been demonstrated
    • · The patient remained on treatment for nearly 6 months.

GEJ tumor at baseline screening

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

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

NT219Monotherapy and Combination Phase 1/2 Study Design (NCT04474470)

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 NT219, alone in adults with recurrent or metastatic solid tumors and in combination with Erbitux® (cetuximab) in Head and Neck cancer

Endpoints

Primary endpoints: Safety, pharmacokinetics and to determine the MTD Secondary endpoints:

Obtain preliminary efficacy data

Advancing First -in-Class Oncology Therapies

IM1240:5T4xCD3xNKG2A Conditionally -Activated Tri-Specific Antibody

An Innovative Tri-Specific Antibody Technology

  • · Multi-specific biologics is an expending class of drugs getting a lot of interest in our industry
  • · After initial success in hemato-oncology, new formats are being investigated in solid tumors
  • · Our technology 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
    • . Carefully selected Tumor Associated Antigens allowing patient-centric development

Promising Proof of Concept Data

Business 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
  • · Preclinical tri-specific immuno-engagers platform
  • · Multiple data read-outs expected in 2023
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Cash runway to 2H24

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 18.4M

\$35.7M cash as of September 30, 2022

Strong cash position to advance development of first-in-class cancer therapies

PURPLE

THANK YOU

We are committed to provide cancer patients with first -in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression

Contact Us: ir@purple -biotech.com

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

01 ADHESION

Horst, 2011 Oncogene

"CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel maturation"

Ferri, 2020

@ immunology "Neutrophil extracellular trapassociated CEACAM1 as a putative therapeutic target to prevent metastatic progression of colon carcinoma"

02 | IMMUNE CELLS/ IMMUNE EXCLUSION

"Immune-checkpoint molecules on regulatory T-cells as a potential therapeutic target in head and neck squamous cell cancers"

Concer Biotherspy.

"[Blockade] enhances natural killer cell cytotoxicity against tumor cells through blockade of the inhibitory CEACAM1 / CEACAM5 immune checkpoint pathway"

03 | IMMUNO-ONCOLOGY

Blumberg, 2015

nature

"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion"

Shively, 20 B

"CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with B-catenin"

PK/PD Modeling Provides Dosage & Schedule Guidance

  • · CM24 completed Phase 1 monotherapy open-label, dose-escalation study to assess safety and tolerability
  • · Heavily pre-treated 24 evaluable patients with a median of 4 prior regimens
  • · Overall, treatment was well tolerated, no DLTs
  • · 33% SD (RECIST 1.0), mostly at the highest dose levels of 3mg/kg & 10mg/kg
  • · PK analysis revealed non-linearity, modeling recommended continuing administration of higher doses to reach saturation, consistent with observed PK showing high clearance at doses <10 mg/kg
  • · 10 mg/kg has a broad range of saturation
  • · Q2W regimen preferable to Q3W

Predictions with Q3W regimen

1 Target-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dose is administered

| 38

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.

Median age, years (range) 65 (49-76) Prior Lines of Therapy, n (%)
Sex, n (%) 1 2 (18%)
Male 5 (45%) 2 9 (82%)
Fernale 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%)

Demographics of patients treated with CM24 (10, 15, 20mg/kg)

Appendix B | NT219

Selected Publications

NT219| Suppresses ß-Catenin activity in CRC Cellsand Inhibited CRC Brain Metastasis

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 ß-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

RNA Sequencing | Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and Analysis of Tumors in combination with gemcitabine Following Treatment Ki67 (Proliferation marker) IRS1 1000 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 | 44

NT219 Phase 1 Dose Escalation Monotherapy Demographics

As of data cutoff date of May 12th , 2022, a total of 14 patients were enrolled to 4 NT219 dose levels (3 - 24mg/kg)

  • · 12 patients were evaluable for DLT determination including 4 CRC, 3 pancreatic cancer, 2 breast cancer, and one of each of the following cancers: GEJ, esophageal and appendiceal cancer
  • · Median number of prior treatment regimens for metastatic disease was 4 (2-11)
PURPLE
Median age, years (range) 67 (39-79) Diagnosis , n (%)
Sex, n (%) Pancreatic 3(25%)
Male 4(33%) GE Junction 1(8%)
Female 8 (67%) Breast 2(17%)
Ethnicity, n (%) Colorectal 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 5 (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(8%)

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