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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2022

 

Commission File Number: 001-40086

 

Portage Biotech Inc.

(Translation of registrant’s name into English)

 

N/A

(Translation of registrant’s name into English)

 

British Virgin Islands

(Jurisdiction of incorporation or organization)

 

Clarence Thomas Building, P.O. Box 4649, Road Town, Tortola, British Virgin Islands, VG1110

(Address of principal executive offices)

 

c/o Portage Development Services Inc., Ian Walters, 203.221.7378

61 Wilton Road, Westport, Connecticut 06880

(Name, telephone, e-mail and/or facsimile number and Address of Company Contact Person)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of 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):  ☐

 

Exhibits

 

The following Exhibit is filed with this report:

 

Exhibit		Description
99.1		Corporate Presentation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SIGNATURE

 

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.

 

	Portage Biotech, Inc.
Date: November 30, 2022	By:	/s/ Allan Shaw
	Name:	Allan Shaw
	Title:	Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

Corporate Presentation 1 Nasdaq: PRTG December 2022

Legal Disclaimer 2 This presentation is for information purposes only . This presentation does not constitute a general advertisement or general solicitation or an offer to sell or a solicitation to buy any securities in any jurisdiction . Such an offer can only be made by prospectus or other authorized offering document . This presentation and materials or fact of their distribution or communication shall not form the basis of, or be relied on in connection with any contract, commitment or investment decision whatsoever in relation thereto . No securities commission or similar authority in Canada, the United States or any other jurisdiction has in any way passed upon the adequacy or accuracy of the information contained in this presentation . Forward - Looking Information This presentation contains "forward - looking statements" that involve risks and uncertainties . Our actual results could differ materially from those discussed in the forward - looking statements . The statements contained in this presentation that are not purely historical are forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 , as amended, or the "Securities Act," and Section 21 E of the Securities Exchange Act of 1934 , as amended, or the Exchange Act . Forward - looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "plan," "project," "seek," "should," "strategy," "target," "will," "would" and similar expressions or variations intended to identify forward - looking statements . These statements are based on the beliefs and assumptions of our management based on information currently available to management . Such forward - looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward - looking statements . Factors that could cause or contribute to such differences include, but are not limited to, those discussed in our reports filed with the Securities and Exchange Commission from time to time . Except as required by law, we undertake no obligation to update any forward - looking statements to reflect events or circumstances after the date of such statements . No representation or warranty, express or implied, is or will be given by Portage Biotech Inc . (the “Company”) or any of its affiliates, directors officers, employees or advisers or any other person as to the accuracy or completeness of the information in this presentation, and no responsibility or liability whatsoever is accepted for the accuracy or sufficiency of this presentation or for any errors, omissions, misstatements, negligent or otherwise, contained herein . A shelf registration statement on Form F - 3 relating to the public offering of the Company’s common stock was declared effective by the Securities and Exchange Commission on March 8 , 2021 . Before you invest, you should read the prospectus in the registration statement and related preliminary prospectus supplement that the Company will file with the Securities and Exchange Commission for more complete information about the Company and the offering . An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be available on the website of the Securities and Exchange Commission at www . sec . gov .

I/O Company with 4 First/Best in Class Small Molecules in the Clinic Who We Are Cash Runway for Current Programs Potentially Extended into 2024 Veteran Team from BMS, with 10 Oncology Approvals and Multiple Billion $ Exits Nine Phase 1b/2 Data Catalysts in Eight Tumor Types Over Next 12 - 24 Months 3

Allan Shaw CFO Justin Fairchild VP Clin Dev Proven Leadership with Oncology and Financing Expertise Board of Directors Gregory Bailey, MD Rob Glassman, MD Linda M. Kozick Jim Mellon Mark Simon Ian Walters, MD CEO, Chairman Rob Kramer, PhD CSO Steve Innaimo VP PM & Operations Brian Wiley CBO Steven Mintz St. Germain Capital Corp >10 Oncology Approvals, Several Billion $ Exits 4

Our Formula for Success De - Risked Research Innovative Structure Strong Academic & Industry Network Developing First/Best in class I/O agents Potential for Large Returns Right experiments at the right time Capital efficient model Big pharma insights Targeting ~70 - 80% of patients that do not respond Track record of high value exits 5

Our Strategic Approach for Success in Immuno - Oncology 6 Implement strategies to avoid late - stage clinical failure Look for broad targets Only test agents with single agent activity Test non - overlapping MOA’s Do randomized studies early Enrich patient population when possible Create competitive tension in a commoditized field $70B IO market expected to grow in next 5 years Engage regularly with companies likely to transact Pre - vet all development programs Partner with companies Retain exclusivity

Advantageous Approach to Immuno - Oncology Therapeutics Development Drug Class Adaptive Immune System Tumor Microenvironment Innate Immune System Direct Tumor Checkpoint iNKT agonists DC, B, & T - cells MDSC, M  PMN NK In CD1d + cells Combine with approved PD - 1 Adenosine compounds DC & T - cells MDSC, M  , Treg, PMN NK Decreased proliferation and metastasis Combine with approved CPI IDO T - cells Combine with approved PD - 1 Bempeg IL - 2 T - cells Combine with approved PD - 1 iNKT and Adenosine modulate multiple components of the immune system to produce a durable response Broad targets are more likely to have single agent activity and offer greater clinical benefit 7

Nine Near Term Phase 1b/2 Data Catalysts PLATFORM TECHNOLOGY ASSET INDICATION STAGE # of PTS PORT - 2 iNKT Agonists Liposomal Formulations IMM60 Melanoma + NSCLC Phase 1 18 ᬚ PORT - 2 iNKT Agonists Liposomal Formulations IMM60 Refractory Melanoma Phase 2 10 ᬛ PORT - 2 iNKT Agonists Liposomal Formulations IMM60 + Keytruda ® Front line PD - L1 + NSCLC Phase 2 30 ᬜ PORT - 2 iNKT Agonists Liposomal Formulations IMM60 + Keytruda ® PD - L1 – NSCLC 2 nd /3 rd line Phase 2 10 ᬝ PORT - 2 iNKT Agonists Liposomal Formulations IMM60 + Keytruda ® PD - L1 + NSCLC 2 nd line Phase 2 15 PLATFORM TECHNOLOGY ASSET INDICATION STAGE # of PTS PORT - 6 PORT - 7 A2AR Inhibitor A2BR Inhibitor TT - 10 TT - 4 A2A and A2B exp Solid Tumors Phase 1a 21 - 27 ᬞ PORT - 7 A2BR Inhibitor TT - 4 A2B exp Solid Tumors Phase 1b 20 ᬟ PORT - 6 A2AR Inhibitor TT - 10 A2A exp Solid Tumors Phase 1b 20 ᬠ PORT - 6 combo A2AR Inhibitor TT - 10 + CPI A2A exp Solid Tumors Phase 1b 20 ᬡ PORT - 7 combo A2BR Inhibitor TT - 4 + CPI A2B exp Solid Tumors Phase 1b 20 ᬢ PORT 6/7 combo A2AR Inhibitor A2BR Inhibitor TT - 10 + TT - 4 + CPI BM enriched Phase 1b 20 8 iNKT Platform Adenosine Platform

iNKT agonists PORT - 2, PORT - 3 Activating the innate, adaptive immune system and correcting the TME

PORT - 2 is a rationally designed liposome containing IMM60 iNKT cell iNKT in charged liposome to protect lipid chain, aggregate in tumor, and promote Type 1 cytokine release IMM60 Binds to CD1d on APC and other myeloid cells TCR CD1d PORT 2 Immune Activation 10

Innate Immune System IFN  CD1d TCR PD - L1 dendritic TCR CD40L PD - L1 IL - 12 MHC - 1 Adaptive Immune System CD40 NK cell CD8 T cell IL - 12 IFN  Portage’s iNKT agonist (PORT - 2) stimulates multiple arms of the immune system for a robust anti - cancer response IFN  Tumor Microenvironment Macrophage MDSC Neutrophil iNKT cell c D e l C l B B c c e e ll ll 11

12 Source: Jukes et al Eur. J. Immunol. 2016. 00: 1 – 11 PORT - 2 (IMM60) Demonstrates Superior Response Versus PD - 1 Antibody IMM60 (0.5ng/mouse) PORT - 2 Vehicle + anti PD - 1 Vehicle untreated PORT - 2 shows better response rates vs anti - PD - 1 in melanoma animals B16 melanoma lung metastases

13 Source: https:// www.isrctn.com/ISRCTN80472712 IMPORT - 201: Dose Escalation with Best - in - Class Design for NSCLC and Melanoma PORT - 2 PORT - 2 + PD - 1 Phase 1 in refractory melanoma and NSCLC Phase 1/2 Trial Primary investigator Mark Middleton, Churchill Hospital, Oxford: 3 additional sites Primary endpoint Safety Secondary endpoints Response, PFS at 6 months, frequency of iNKT cells, frequency of Ag specific T cells, frequency MDSC’s & other immune related parameters Dose escalation (monotherapy) 3+3 design 6 x iv infusions q3w @ 1/3/9 mg/m 2 Max. n=18 ↓ MTD Dose escalation (combination therapy) 3+3 design 6 x iv infusions q3w @ MTD - 1 Max. n=12 ↓ Combination MTD (‘CMTD’)

14 SITC 2022, Interim Data Confirms PORT - 2 MOA and Shows Good Safety SITC 2022 a Wennhold et al., Cancer Immunol Res 2021;9:1098 - 108. Tumor type 2 Melanoma 4 NSCLC Age 64 (41,79) Median prior therapies 5(3,7) Prior PD - 1 100% Performance status 50% ECOG 0 50% ECOG 1 Exposure/Safety: • 27 infusions administered to 6 patients [median 4 per patient ] • No SAEs, no DLTs were observed. Baseline 3 months • MCP - 1 ( Figure 3 ) and IP - 10 ( Figure 4 ) showed increases in most subjects, no increases in IL - 6, IL - 4 and IL - 10 • iNKTs downregulate their TCR when the agonist binds to the receptor, indicating activation of the iNKT ( Figure 5 ). • Increase in CD86+ B cells which is associated with tumor - specific antigen presentation and sensitivity to checkpoint inhibition a ( Figure 6 ) Evidence of monotherapy activity Mediastinal Lesion Decreased. 4cm to 1.9cm Table 2: Adverse Events related to IMM60 (n=6) Adverse Event Grade 1 Grade 2 Grade 3 - 5 Dizziness 1 (17%) 0 0 Fatigue 0 1 (17%) 0 Flu - like symptoms 1 (17%) 0 0 Hair Loss 1 (17%) 0 0 Headache 1 (17%) 0 0 Hypertension 0 1 (17%) 0 Vomiting 1 (17%) 0 0 Best response by RECIST was PD in all 3 patients at 1 mg/m 2 dose . One of 3 patients treated at 3 mg/m 2 had mixed response (melanoma patient previously failed anti - PD - 1 and targeted therapy), see images below Figure 6 Figure 5 Figure 3 Figure 4

15 Multi - arm study with four Phase 2 readouts in 2023/2024 IMPORT - 201: Phase 2 Evaluates Front Line NSCLC and Refractory Melanoma PD - 1 q3wk iv infusions n=15 PD - 1 naïve patients PORT - 2 One dose @ MTD n=15 PORT - 2 + PD - 1 6 x iv infusions q3wk @ CMTD n=30 PD - 1 naïve patients Biopsy at 2 - 3wk Pre - Rx Biopsy NSCLC N=60 Progression PD - L1 ≥ 50% PD - L1 <1% PORT - 2 6 x iv infusions q3w @ MTD n=10 PD - 1 refractory Melanoma N=10 ᬛ PORT - 2 + PD - 1 q3wk iv x 5 ᬚ ᬜ ᬝ PORT - 2 + PD - 1 q3wk iv x 6 Clinical Catalysts In collaboration with

Adenosine Portfolio Unique position to modulate Adenosine in 4 different ways PORT - 6 A2AR Inhibitor PORT - 7 A2BR Inhibitor PORT - 8 A2AR/A2BR Dual Inhibitor PORT - 9 Gut - restricted A2BR Inhibitor

17 Targeting Adenosine in Cancer Immunotherapy to Enhance T - Cell Function; Virgano, et al; Frontiers in Immunology 2019 modified slightly and used under CC BY 4.0 Leveraging A2A and A2B Alone or in Combo Allows for Customization of Treatment Macrophage Treg T cell NK Cell Endothelial Cell CAF MDSC Tumor Cell Neutrophil DC Promote adaptive response (A2A and A2B) Correct the TME (A2A and A2B) Decrease proliferation, metastasis and survival (A2A and A2B) Tumor is complex system governed by numerous immune cells

1. ASCO 2021 2. AACR 2021/2022 18 * Expression data from Labcorp A2A (TKI’s from iTeos, Corvus, Arcus, AZ, BMS, Merck, Schering Plough and more): • iTeos monotherapy activity demonstrated only at high doses and with BID administration (more durable blockade) 1 • 17% ORR at 80mg BID (RP2 dose) • Other agents with limited response in PC,RCC, NSCLC, H&N, CRC • CNS/CV toxicity limits dose (felt due to hitting A1) 1 • Biomarker selection possible (gene expression vs IHC) 2 Fast Follower with Superior Profile Enables Best in Class Development Portage Strategy is to utilize more potent, selective and durable inhibition in selected population Tumor type % A2A high* RCC 50 BC 38 NSCLC 34 Gastric 32 Prostate 26 Best % Change in Tumor Lesion by High/ Low A 2A R levels

19 PORT - 6: Best - in - Class A2A - More Selective, More Potent, & More Durable 1 Data on File 2 AACR 2019 3 Cancer Immunology Research 2018 4 ASCO GU 2020, SITC 2018 Key Parameters PORT - 6 Portage 1 EOS - 850 iTeos 2 CPI - 444 Corvus 3 AB928 Arcus 4 Significance Potency (cAMP functional inhibition of A2AR) IC50 0.40 nM 2.24 nM 17.03 nM - - PORT - 6 is >5x more potent than next best IC50 Ki 0.065 nM - - - - 1.4 nM Port - 6 22x more potent than Arcus on Ki measure Selectivity against A1 Receptor (Safety) >150,000x 270x 54x 43x A1R associated with CNS and CV toxicity Receptor Occupancy 10+ hours 2.5 hours 0.3 hours - - Prolonged PD effect: Key attribute given high concentrations of adenosine in TME Tumor Concentration 10x vs plasma - - - - 1.6x vs plasma High concentration in tumor tissue required for effective antagonism of tumor expressed receptors Single Agent Efficacy (% Tumor Reduction) 54% (p<0.05) CT26 Colon Cancer <10% (p=ns) CT26 Colon Cancer <10% (p=ns) CT26 Colon Cancer ~20% B16f10 Melanoma Competing compounds only show effect in combination with other agents

20 Data on File PORT - 7: Highly Selective and Potent A2B Adenosine Receptor Antagonist High potency and selectivity may provide important safety and efficacy advantages • Activity in 4T1, CT26, and other disease models (Asthma, fibrosis, sickle cell) • IND approved for pro - drug Binding Affinity Functional Receptor Antagonism receptor Receptor Ki (nm) Selectivity A2B 9 1 A1 >30,000 >3000x A2A >10,000 >1000x A3 >30,000 >3000x Receptor Ki (nm) Selectivity A2B 13 1 A1 300 23x A2A 1,800 138x A3 60,000 >4,000x

21 ADPORT - 601 : Adaptive Phase 1a/1b Study Phase 1a Starting Dose (10 mg BID) (n=12 - 15) A2AR (PORT - 6) indications: A2BR (PORT - 7) indications: Colorectal Cancer, Non - small Cell Lung Cancer, Endometrial Cancer, Ovarian Cancer with high A2B expression Prostate Cancer, Non - small Cell Lung Cancer, Head & Neck Cancer, Renal Cell Cancer with high A2A expression PORT - 6 1a: MONOTHERAPY Phase 1a Starting Dose (200 mg QD) (n=9 - 12) PORT - 7 100 mg 800 mg Recommended P2 Dose Recommended P2 Dose PORT - 6 + PORT - 7 PORT - 6 + PD - 1 PORT - 7 + PD - 1 Possible COMBO options PORT - 6/PORT - 7 + other Portage agents SOC n=10 PORT - 6 and/or Port - 7 + SOC n=20 PORT - 6 and/or Port - 7 n=20 Monotherapy in enriched patient population 1b: MONOTHERAPY RANDOMIZED VS SOC ᬞᬟ ᬢ Cross over at progression ᬠᬡ Clinical Catalysts

iNKT Agonists • Composition, formulations with antigens, other I/O agents • Liposomes/particles 2031 - 2036 Patent Exclusivity Many Applications Pending Worldwide Strong U.S. and Global IP Positions on Platforms and Products Broad and deep intellectual property covering: >60 Issued Patents Adenosine Inhibitors • Composition of matter patents • Use patents filed Nanolipogel & DNA Aptamers • Optimized co - delivery platforms • New IP for aptamers • Composition patents for products VLP Delivery Platform • First - in - class systemic STING agonist 22

Summary Financial Data Cash Balance (9/30/22) ~$15.0 million Committed Purchase Lincoln Park Capital ^ $30 million Debt $ - Shares Outstanding (11/29/22) 17,061,744 Insider Ownership 51% Public Float* 49% Options & RSUs Outstanding (9/30/22) 1,596,040 Warrants Outstanding (9/30/22), expired unexercised October 2022 33,888 Net Cash Used in Operating Activities (Quarter Ended 9/30/22) $(2.5 million) Expected Quarterly Burn in 2023 ~$5 million 23 *Includes ~3.5M Shares subject to lock - up agreements (6 - 12 mo) in recent 2 stock transactions ^ Portage has the right (sole discretion/no obligation), to sell up to $30 million shares over agreement’s 36 - month term based on prevailing market prices at the time of each sale, subject to certain conditions

Key Upcoming Clinical Development Milestones* 2022 2023 2024 Q4 Q1 Q2 Q3 Q4 1H 2H IMPORT - 201 (PORT - 2) P2 start PORT - 5 IND submission IMPORT - 201 (PORT - 2) P2 ORR data ADPORT - 601 (Port - 6/7) study activation ADPORT - 601 (Port - 6/7) P1b start IMPORT - 201 (PORT - 2) US IND/ EU CTA IMPORT - 201(PORT - 2) ASCO IMPORT - 201 (PORT - 2) SITC IMPORT - 201 (PORT - 2) P2 PFS data * At conferences we will present multiple arms & tumor types ADPORT - 601 (PORT - 6) P1a SITC IMPORT - 201 (PORT - 2) SITC ADPORT - 601 (Port - 6/7) SITC IMPORT - 201 (PORT - 2) ASCO ADPORT - 601 (PORT - 6/7) ASCO 24

Novel, Clinical Stage I/O Portfolio with Small Molecule Focus • Manufacturing simplicity, low capital investment • Nine phase 1b/2 clinical data reads over next 2 years Engine for Efficient Drug Development & Commercialization • Expert scientific oversight • Lean structure with financial flexibility/good cash runway Preferred Partner for Pharma in I/O • Deep industry network facilitates engagement with big pharma and biotech • Packaged for commercialization/acquisition Expert Leadership with Track Record of Success • Proven success, more than 10 oncology approvals • Formation of Biohaven Pharmaceuticals, sale to Pfizer Accelerating I/O Development in Untapped Growth Areas 25