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Purple Biotech Ltd.

Regulatory Filings Jan 7, 2023

7004_rns_2023-01-07_6051be04-3508-4146-aaac-34eb974e0dbe.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 January 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 – January 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.

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.

January 6, 2023 PURPLE BIOTECH LTD.

By: /s/ Gil Efron

Gil Efron Chief Executive Officer

| 1 NASDAQ/TASE: PPBT January 2023 CORPORATE PRESENTATION

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that statenents of historical lact are forward-looking statements within the meaning of the sale harbor provisions of the Private Securities Litigation Act of by identified be nay and , fat historical of statements , o limited not , netude statements looking-forward Such . 195 " a such wordsbelleve", "expect", "intent", "night", "might", "seek", "continue" or "antinue" or "anticipate "or their negatives or variations of these words or other comparable words. You should not on these on these forward-looking statements, which are not guarantees of tuture performance. Forward-looking statements reflect our current views, expections with respect of uture events, and are subject to a number of assumptions, involve known and unhown risks, may of which are beyond our control, as well as uncertainies and other may cause our actual results, performance or achievents to be significantly different from any future esuls, performance achievenents expressed or inpried by the forwards. Important lactors that could cause or continue anong others, risks relating to the plans, strategies and objectives of nangement or NT2.9 and CM2.9 N' as such cardidates therapectic stage early which by process the 24and CM24 could potentially lead to an approved to highly significant risks, particularly with respect to a joint development collaboration; the latt dong development and commercialization involves a lengthy and establity to successilly develop and connecialize our pharmaceuital products; the experse, length, progress and results of any clinical trails to finance the clinical trials; the impact of any changes in regulation that could affect the pharmaceutal industry; the difficulty in receing the recessary in order to commercialize our products; the difficulty of pedicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceuting enviroment and changes in the heath policies and regimes in the countries in which we operater, the unertain surounding the actual market reeption to our cleared for market, in a particular market; the introduction of compeling patents atained by competitors, dependence on the effectivenes of our protections for innovative products, our ability to obtain, maintain and defend issued patent. of any patent interference or infringenent action agains to preval, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and other factors that are disussed in our in our Anual Report on Form , 3. December ended year the for F-20222 and in our other fillings with the U.S. Securities and Exchange Commission this of discusion cautionary our including , "Risk Factors" in our Registration Statements and Annual Reports. There are lators that we believe our actually from expected results. Other factors besides those we have listed could also adversel affect us. Ary forward-looling statement in this presentation speals. It is made. We diction or obligation to publicy update or revise any forward-looking statement, or other information contained heein whether in the events or cherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://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
  • · Multiple data read-outs expected in 2023
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Extended cash runway to end of 2024

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 Systems

Michael Schickler, PhD Head of Clinical and Regulatory Affairs Formerly at Hoffmann-La Roche, CEO at CureTech

Gil Efron Chief Executive Officer Former Deputy CEO & CFO at Kamada (NASDAQ:KMDA) @KAMADA

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

A Pipeline Dedicated to Advancing Oncology Therapies

Program Indication Phase I Phase 2 Phase 3 Value Drivers
CM24 Solid tumors (monotherapy) Completed V RP2D in combination: 20 mg/kg
Solid tumors (combination with nivolumab") V Initiation of phase II in 2L PDAC
Follow up OS data from P1
(CEACAM-1) Pancreatic Cancer (combination with
nivolumab+chemo*)
Interim analysis P2 2H23
Top line P2 2H24
Combination with SOC, undisclosed indication Investigation in a second indication
NIPI9
(IRS1/2 & STAT3)
Solid tumors (monotherapy) RP2D monotherapy & combination
1H23
R/M SCCHN & CRC (dose escalation + P2 with
cetuximab)
Initiation of P2 combination with
cetuximab 2Q23
Combination with SOC, undisclosed indication Investigation in a second indication

| 5

*Clinical collaboration and supply agreement with: الله Bristol Myers Squibb

Advancing First-in-Class Oncology Therapies

CM24: an α-CEACAM1* mAb

Carcinoem bryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional Immune Checkpoint Inhibitor

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
MOA
· CM24 increases T cell and NK cells cytotoxicity against tumors
· CM24 shows benefit in combination with IO 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
· 1 PR and 3 SD in dose escalation study with nivolumab
· Phase 2 at RP2D initiated in Q2 2022
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
17

CM24 MOA | Immune Check Point Inhibitor & Anti-Metastatic Activity

Medel ri (, ) Menoriotto, 2005, Care manni manorier 200, Orderor et 4, Mo Care, D 201, Abor, 2012, Abor, 2012, Abor, 2012, 2007, 40:57, Ph, V. L. L. Inc., 2002, Rhora, 2002, | 8

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

CEACAM1 is Over-Expressed in PDAC

Wilcoxon, p = 2e-15

Comparison between CEACAM1 staining intensity in pancreatic cancer (38 cases/76 cores) and normal (10 cases/20 cores) tissues

Representative examples of CEACAM1 immunohistochemical images of pancreatic adenocarcinoma and normal tissues

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

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.

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

  • 21 SoC regimens efficacy data: Gemcitabine/Nab-paclitaxel²: OS 7.9 months or Nal-RI/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"

. Anticio Corp. Core Fore Aller. (Anternator) (Anternet Mallers (Arc.) (All.) 2, 5 m 6 o blombres (Arc. 2021.21/2010).
2. Online C. (Annology Resert 2022 (2008): Crister and

de:3.0.77/2788593909608
4. Way-Gilleri, Hotel NAPO-L phae 3 suby of leosean innessatic career Fial overal cancer. Find overal survival and charcerisis of bree- 2002007-87.
de | 14

Phase 2 Combination Study Design (NCT04731467)

Primary efficacy endpoint of Measurement of Interim analysis: A study of CM24 in CEACAM1 and other biothe randomized sub-study: - PFS rate @ 6M combination with nivolumab markers is ongoing OS plus chemotherapy in PDAC planned in 2H23 Planning of further studies patients in 2L Secondary endpoints: Top line data: in other tumor types is 11 centers are currently active PFS, OS rate @ 6 & 12 months, - planned in 2H24 ongoing in US, EU & Israel PFS rate @ 3 & 6 months, ORR 2023 2022 2024 Experimental arm (n=30) CM24+nivolumab and: Gemcitabine/nab-paclitaxel OR Safety Study (n=18) n=60 CM24+nivolumab &
Nal-IRI/5FU/LV PDAC patients progressing on or OR after 1L SoC Gemcitabine/nabchemotherapy Control arm (n=30) paclitaxel Gemcitabine/nab-paclitaxel OR Nal-IRI/5FU/LV | 15

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 EGFRi and 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 |

de Norem et 10 and Alexander et Lanc 2017, 1949 to 4942 el Maria Marker et Mod Rey The 2012 122 2022 222 2022 2022 2020, Marros, 2014 2020, 20:00, Alanco, Chica Marcher Clic

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

Hadas Re URPLE

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

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.

S., Tong, Q., Liu, B. et al. Targeting STAT3 in Cancer Immu

rapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12943

Simultaneous Blockade of STAT3 and AKT Pathways are Required to Overcome Resistance to EGFRi

NT219 is Effective as Monotherapy

Drugs α-PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/kg

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mice (18M cells per mouse) and treatments initiated when tumors were established. (NT219) and cetuximab) twice a week for 4 weeks. Graph reflects relevant data adapted from 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

NT219 Restores Sensitivity to EGFRi in PDX Models

NSCLC

Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

R/M SCCHN

metastasis, patient previously 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

NT219 Phase 1 Dose 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)
  • 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 6 6
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
Ede ma 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

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).

Durable PR in a GEJ patient and SDs in 3 out of 4 mutated KRAS CRC patients

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)

  • 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

NT219 Monotherapy 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

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
  • · Multiple data read-outs expected in 2023
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Extended cash runway to end of 2024

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

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: [email protected]

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

02| IMMUNE CELLS/

01 | ADHESION

IMMUNE EXCLUSION
Horst, 2011 Tsuzuki, 2020 Blumberg, 2015
Oncogene nature
"CEACAM1 creates a pro-angiogenic
tumor microenvironment that
supports tumor vessel maturation"
"Immune-checkpoint molecules on
regulatory T-cells as a potential
therapeutic target in head and neck
squamous cell cancers"
"CEACAM1 regulates
TIM-3-mediated tolerance and
exhaustion"
Ferri, 2020 Tsang, 2020 Shively, 2013
@ Immunology
"Neutrophil extracellular trap-
associated CEACAM1 as a putative
therapeutic target to prevent
metastatic progression of colon
carcinoma"
Cancer Biotherapy as
"[Blockade] enhances natural
killer cell cytotoxicity against
tumor cells through blockade of the
inhibitory CEACAM1 / CEACAM5
immune checkpoint pathway"
Cell Researc
"CEACAM1 regulates Fas-mediated
apoptosis in Jurkat T-cells via its
interaction with 6-catenin"

03 | IMMUNO-ONCOLOGY

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

Simulated TMDD4 saturation at Ctrough2 with Q2W

Predictions with Q3W regimen

4Target-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dose is administered

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) in combination with nivolumab (480mg)

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 170261 V

Appendix B | NT219

Selected Publications

URPLI

NT219 | Suppresses ß-Catenin activity in CRC Cells and 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 β-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 Speciol Conference on Epigenetics and Metobalism, Oct 2020, Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center

NT219 | Highly effective anti cancer activity exhibited by NT219 in combination with Gemcitabine Pancreatic Cancer in Combination Pancreatic cancer (Patient A) PDX Pancreatic cancer (Patient B) PDX 3.0 with Gemcitabine Tumor volume (cm3) 2.7

2.4 2.0 Tumor volume (cm³) ននៃនត់ដត់ដត់ដ (n=15) 2.1
1.8 NT219 (n=7) 15
12 ol {n=7} ន ន 0.3 Days
30 PDX model NT219 (n=5) 0 0 10 15 20 25 0 I o 10 15 20 Pancreatic Cancer Pancreatic cancer (Patient C) PDX Pancreatic cancer (Patient D) PDX Tumor volume (cm³) 1.6 1.4 Tumor volume (cm3) 1.2 itabine
=5) 12
1.0 1.0 0.8 0.8
0.6 0.6 Drug 0.4 0.4 1219 (n=5) Gemcitabine
NT219 n=9 0.2 Gemcitabine (Gemzar®) 17219 (n=5) 0.2 0 0 0 Days 5 15 20 10 25 15 0 0 ે ર 10 | 39

RNA Sequencing | Analysis of Tumors Following Treatment

PDX model Pancreatic Cancer

Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine

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)
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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