Regulatory Filings • Jun 6, 2021
Regulatory Filings
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FORM 6-K
For the month of June 2021 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): ☐
On June 4, 2021, Purple Biotech Ltd. (the "Company" or the "Registrant") issued a press release, "Purple Biotech Presents New Clinical Data from NT219 at the 2021 ASCO Annual Meeting", which is attached hereto as Exhibit 99.1. The Company also announced that it has made available an updated Company Presentation on its website. A copy of the updated Company Presentation is attached hereto as Exhibit 99.2 and may be viewed at the Company's website at www.purple-biotech.com.
| 99.1 | Press Release |
|---|---|
| 99.2 | Purple Bio Company Presentation June 2021 |
This 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 28, 2020 (Registration file number 333-238481) and 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), 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
By: /s/ Isaac Israel
Isaac Israel Chief Executive Officer
NT219 was Well-tolerated with Minimal Adverse Events in Initial Clinical Data from Ongoing Phase 1/2 Clinical Trial in Adults with Advanced Solid Tumors
REHOVOT, Israel, June 4, 2021 - Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, announced today the presentation of new data from the first dose level cohort of its ongoing Phase 1/2 clinical trial of NT219, at the 2021 ASCO Annual Meeting, being held virtually June 4-8, 2021. The Phase 1/2 study is evaluating NT219 as monotherapy for the treatment of solid tumors, in addition to a subsequent dose escalation of NT219 in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.
As of the cutoff date (April 25th, 2021), six patients have been enrolled into the study, including three subjects with advanced solid tumors in the first cohort receiving 3 mg/kg of NT219 as a single agent, and three subjects in the second cohort receiving 6mg/kg of NT219 as monotherapy.
Initial results from the first dose level cohort revealed NT219 was well-tolerated with minimal adverse events. In addition, a partial response was observed in a patient with refractory gastroesophageal junction cancer, previously treated with four prior lines of therapies. For this patient, who has been treated for 22 weeks, a complete remission was seen at the largest target lesion and at one non-target lesion, while stable disease was observed at the other non-target lesion.
"We are encouraged by these initial safety and efficacy results from this first-in-human study of NT219," said Alberto Bessudo, M.D., a medical oncologist and hematologist at California Cancer Associates for Research & Excellence, who presented the data at ASCO. "This study is especially compelling because NT219 uniquely targets the IRS protein to degradation by utilizing a covalent, irreversible inhibition strategy. Based on the preclinical results observed to date, by targeting the IRS1/2 and STAT3 pathways NT219 has the potential to significantly shrink tumors, prevent and reverse tumor resistance when administered as a monotherapy, as well as in combination with existing oncology therapies."
"Our innovative approach to overcoming tumor immune evasion and drug resistance is focused on interactions within the microenvironment of the tumor, not just targeting the tumor as an isolated feature," said Bertrand C. Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "It has been demonstrated clinically that IRS and STAT3 proteins are central in defining tumor responsiveness to therapy. Indeed, STAT3 has been seen to play a role in treatment response, and IRS is a novel target with recent promising findings and interest in oncology. While still early in the trial, we are very excited by these initial clinical results and expect to report additional data from higher dose levels of this study in the second half of this year."
NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3, known important oncogenic drivers and major drug resistance pathways in hardto-treat cancers. The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the recommended dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose level of NT219, a second cohort of patients, with recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be administered weekly with NT219, and dose escalated, in combination with cetuximab.
Purple Biotech Ltd. is a clinical-stage company developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. The Company's oncology pipeline includes NT219 and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Company is currently advancing NT219 as a monotherapy treatment of solid tumors, followed by a dose escalation of NT219 in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) or colorectal adenocarcinoma in a phase 1/2 study, and an expansion phase of NT219 at its recommended phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a phase 1b study followed by a phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. The Company has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the planned phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo®) in patients with non-small cell lung cancer and in combination with nivolumab in addition to nabpaclitaxel (ABRAXANE®) in patients with pancreatic cancer. The Company is also the owner of Consensi®, an FDA-approved fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S. Consensi® is being sold in the U.S. by Burke Therapeutics, the marketing partner of the Company's U.S. distributor, Coeptis Pharmaceuticals. The Company has also partnered to commercialize Consensi in China and South Korea. The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://www.purple-biotech.com.
Certain statements in this press release 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 forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219 and CM24; the process by which early stage therapeutic candidates such as NT219 and CM24 could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2020 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, 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, https://www.sec.gov.
Gil Efron Deputy CEO & Chief Financial Officer [email protected] +972-3-933-3121 ext. #105
Chuck Padala [email protected] +1 646-627-8390
Megan Humphreys [email protected]


Certain statements in this presentation that are forward-looking statements of historical fact are forward-looking statements within the meaning of the sale hardor provisions Private Securities Litigation Reform Act of 1995. Such enterents include, but are not inted to, statements of historical fact, and may be identified by words such as "belleve", "intend", "plan", "nay", "should", "might", "seek", "toreast", "contine" or "anticipate" or their negatives of their negatives of these words or other conparable words. You should reliance on these forward-looking statements, which are performance. Forward-oding statements reflect our current views, expections with respect to future events, and are subject to a number of assumptions, inovel known and unknown risks, mary of which are beyond our control, as vell as uncertainies and other may case our actual results, performance or activements to be significantly different from any future esults, performanc achievenents expressed or inplied by the forward looks or contribute to such differences intude, anong others, risks relating to the plans, strategies and objectives of nanagement for NT2.9 and CM24; the process by which early sage therapeulic cardidates such as NTZ19 and CM24 could potentially lead to an approved drish is lighty significant risks, particularly with respect to a joint development collaboration; the fact that thug development and commercialization involves a lengthy and expensive pur ability to successfilly develop and connecialize our pharmacedical products, the experse, length, progress and results of any clinical trials; the linical trials; the inpact of any changes in regulation and legislation that could affect the pharmaceuical industry the difficulty in receiving the regulation of the difficuly of products; the difficuly of preticing actions of the U.S. Fod and Drug Administration or any other applicable regulator of pharmated and charge in the heath policies and regims in the contries in which we operatery the unerating surounding the actual market reception to our cleared for market in a particular market, the introduction of competing poducts; patents attained by competitors, dependence on the effectivers of our protections for inrovative products; our ability to obtain and defend issued patents; the comnencenen of any patent interference or infingenent action against our pailly to prevail, obtain a favorable decision or recover damages in any such action; and the expoure to litigation, including patent litigation, and other facors that are discussed in our in our Annual Repor on Form 20-F for the year ended December 31, 2020 and in ur other filings with the U.S. Securities and Exchange Commission of fisks and untertainties under "Risk Factor" in our Registration Statements and Annual Reports. These are leat we believe could couse our actually from expected results. Other factors besides those we have lised could also adversely affect us. Any forward-looking statenent in this presentation is made. We distain any intention or obligation to publicly update or revise any forward-looking statenert, on other information contained heels, whether as a result of other events or otherwise, exept as required by applicable law. Your additions disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.


CM24 - First-in-class α-CEACAM1 mAb, validating clinical collaboration with Bristol Myers Squibb
NT219 - First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3
H2:21 - Two phase 1 study readouts
Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 17.5M
\$61M cash as of December 31st, 2020
Cash runway through 2024



CM24 - an α-CEACAM1 mAb





12 • Open - label, multi - dose escalation monotherapy study to assess safety and tolerability • Heavily pre - treated patients with a median of 4 prior regimens (range 2 - 8) Overall, treatment was well tolerated • Most of the responding patients were treated with the highest dose levels of 3 mg/kg & 10 mg/kg • PK analysis revealed non - linearity, modeling recommended to continue administration of higher doses to reach saturation CM24 Phase 1 Monotherapy Trial N o D L T s u p t o 10 mg/kg N o dis c o n t i nu a t i o n of stu d y d r u g d u e to a n AE N o drug r e l a te d mortalities 33 .3 % SD (RECIST) # pts 27 patients: Colorectal 11 Melanoma 7 Ovarian 4 Gastric 3 NSCLC 2 *24 patients evaluated 0.01 mg / k g 1 0.03m g / k g 1 0.1 mg / k g 3 0.3 mg / k g 3 1.0 mg / k g 3 3.0 mg / k g 9 10.0 mg / k g 7 Q2wks x 20 6 - week o b serva t ion q 2 wks X 4


-Targe-mediated drup dispositon. - OPDIO® is a registed to Bristol-Myers Squib. Crough is the drug concention reched by CM24 befor the next dose s administered

· NSCLC accounts for ~200K new cases/year in the US; with a 5-year relative survival rate of 23%2

· Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%2
(III Bristol Myers Squibb"

1 Dango et ol, Lung Cancer 2008; 60:426 & Calinescu et al, Journal of Immunology Research 2018: 7169081. 2 American Cancer Society, Concer Facts & Figures 2019, and the ACS website, https://seer.concer.gov/statforts/html/panzreas.html 3 Economopolva P, Mountais C. The energing teather Londones on and cell long concer. And Tour Med. 2020/600.2021.12.07
4 Gettinger S, et d'Free-year outcomes (rom this CheckM
Phase 1: Evaluate the safety, PK and the MTD/RP2 dose
Phase 2: Evaluate preliminary efficacy in 2nd line NSCLC and pancreatic cancer
Exploring further studies in other tumor types as well as monotherapy


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

Washendr in Li Cacer Hs 2037 24834 2023 , Manashim (18) 2017) 20:21 2017, 12:56: 12 02:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:20 20:2
NT219
റിയ വിശ്വാസഭ (1920) 2017-07-07 07:10:10) 2015.2015 2015. In 2015. (1942. 1942. 2019. 19:19 PMD 201992. (1942. 1941.0000000000000000000000. 04. 04: 01.10000000000000000000000 17 2006/02/10/2012/02/2012/02/2015/02/2012/02/2012/02/2012/02/2015/02/2015/02/2015/01/2010/02/2012/02/2017/09/2010/01/2010/01/2010/01/2010/01/2010/01/2010/01/2010/01/2010/01/20
Blocking IGFIR-AKT Pathway1




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

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 621 ** p<0.01, * p<0.02 based on one-way ANOVA with post hoc Tukey's HSD test




3 mg/kg Dose Level as a Single Agent
| PURPLE | |
|---|---|
| Cancer Type |
Prior Lines of Therapy |
Treatment Duration(Weeks) |
Best Response* | |
|---|---|---|---|---|
| Pancreatic Cancer |
3 | 8 | PD | |
| NT219 3mg/kg |
GE Junction Cancer |
4 | 22 | Target lesion: Absent Non target lesion 1: PR Absent Non target lesion 2: Stable |
| Breast Cancer |
11 | 8 | PD |
CM24 - First-in-class α-CEACAM1 mAb, validating clinical collaboration with Bristol Myers Squibb
NT219 - First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3
H2:21 - Two phase 1 study readouts
Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)
ADSs outstanding: 17.5M
\$61M cash as of December 31st, 2020
Cash runway through 2024
to providing cancer patients with first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression





Target saturation was not reached with doses up to 10mg/kg






Targeted inhibition of IRS2 by NT219 or IRS2-SH RNA, suppresses the increased fo-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 Virual Special Conference on Epigenetiss and Medobolsm, Oct. 2020, Ido Wolf, MD, Herdical Center


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


| Demographics of Patients treated with NT219 3mg/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 (33.3%) | |
| Diagnosis, n | ||
| Pancreatic Cancer | 1 | |
| Gastroesophag | 1-2 | |
| eal Junction | ||
| Cancer | ||
| Breast Cancer | 1 | |
| ECOG, n (%) | ||
| 1 | 3 (100%) | |
| Median time from initial | 62 (22-90) | |
| Diagnosis, | ||
| Months (range) |
| Adverse Event Description |
Grade 1 n (#Events) |
Grade 2 n (#Events) n (#Events) |
Grade 3 |
|---|---|---|---|
| Abdominal Pain | 1(2) | 1(1) | |
| Alanine Aminotransferase Increased |
1(1) | ||
| Alkaline Phosphatase Increased |
1(1)* | ||
| Aspartate Aminotransferase Increased |
1(1) | ||
| Back Pain | 1(1) | ||
| Belching | 2(2) | ||
| Cellulitis Left Foot | 1(1) | ||
| Dyspnea | 2(2) | ||
| Fatigue | 2(1) | ||
| Nausea | 1(1) | 1(1) | |
| Rash Pustular | 1(1) | ||
| Retching | 1(2) | ||
| Toxic Encephalopathy |
1/1) ** |

Presented at the ASCO annual meeting June 2021



Consensi® demonstrated even better BP reduction than same amount of amlodipine given without celecoxib

| Measure | Consensi® | Amlodipine |
|---|---|---|
| Creatinine plasma level reduction |
-3.22 umol/L |
-2.55 umol/L |
| Peripheral edema (% patients) |
8.2% | 15.6% |
· Additional Phase III/IV clinical trial to scientifically validate the renal benefits (not required for NDA submission) was completed. Topline results were announced in October, 2017

41 Purple Biotech Commercial Drug: CONSENSI® Simultaneous treatment of osteoarthritic pain and hypertension Fixed dose combination of Celecoxib , a COX - 2 selective NSAID (the active ingredient in Pfizer's Celebrex®) + Amlodipine, a blood pressure - lowering agent (a calcium channel blocker) (the active ingredient in Pfizer's Norvasc®) *Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc. CONSENSI® is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and death Full U.S. Prescribing Information is available at: : http://www.consensi.com • Approved for marketing by U.S. FDA on May 31, 2018 • Clinical data showed Consensi™ was more effective at lowering blood pressure than amlodipine alone • Clinical data also demonstrated beneficial renal function measures • Formulated with 200 mg celecoxib and three different dosages (2.5, 5, 10 mg) of amlodipine • Manufactured by Dexcel Pharma – Israel's largest private pharmaceutical company

42 CON S ENS I ® U.S . T arge t Markets CONSENSI® targets osteoarthritis (OA) patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension OSTEOARTHRITIS 50 million patients* N S A I Ds 60 % of all O A Rxs * Arthritis Foundation: http://www.arthritis.org/ ** Hypertension Among Adults in the United States: National Health and Nutrition Examination Survey, 2011 – 2012 ARTHRITIS PREVALENCE* • More than 50 million adults in the U.S. have doc t or - diag n os ed osteoarthritis • 67 million people are expected to have doctor - diagnosed osteoarthritis by 2030 H Y P E R TENSION PREVALENCE** • 29% of U.S. adults older than 18 • 65% of U.S. adults older than 60 COMORBIDITIES • 44% of adults with high blood pressure have osteoarthritis** HYPERTENSION C e l e coxib 24 % of all NSAIDs Consensi ™
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