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 June 2023
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
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: June 20, 2023 | By: | /s/ Allan Shaw |
| Name: | Allan Shaw | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
1 Corporate Presentation Nasdaq: PRTG June 2023
2 Legal Disclaimer 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 .
3 Immuno - Oncology Company with Four First/Best in Class Compounds in the Clinic Investment Highlights Cost - Efficient Business Model, Potential Runway to Achieve Multiple Inflection Points Multiple Phase 1b/2 Data Catalysts in 2023 and 2024 Experienced Leadership Team from Bristol Myers Squibb
4 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 Over 10 Oncology Approvals, Several Billion $ Exits
5 Our Formula for Success De - Risked Development Structured to Create Significant Value Strong Academic & Industry Network First/Best in Class I/O Agents Potential for Large Returns • Compounds with broad targets, single agent activity • Address ~70 - 80% of patients that don’t respond • Randomized studies early • Enrich patient population when possible • Active CRADA with National Cancer Institute • Programs vetted with Big Pharma companies likely to transact • >$35B market growth to >$100B • Data catalysts create meaningful inflections • Partner with large oncology - focused companies • Retain IP exclusivity
6 Nine Phase 1b/2 Data Catalysts Anticipated to Drive Value iNKT Engager Platform Adenosine Plat Final Data Interim Data # of PTS STAGE INDICATION ASSET SITC 2023 ASCO 2023 18 Phase 1 Melanoma + NSCLC PORT - 2 12 Phase 1 Solid Tumors PORT - 3 SITC 2024 ASCO 2024 10 Phase 2 Refractory Melanoma PORT - 2 ᬚ ASCO 2025 SITC 2024 30 Phase 2 Front line PD - L1 + NSCLC PORT - 2+ Keytruda ® ᬛ SITC 2024 ASCO 2024 10 Phase 2 PD - L1 – NSCLC 2 nd /3 rd line PORT - 2+ Keytruda ® ᬜ SITC 2025 ASCO 2024 15 Phase 2 PD - L1 + NSCLC 2 nd line PORT - 2+ Keytruda ® ᬝ Final Data Interim Data # of PTS STAGE INDICATION ASSET SITC 2024 ASCO - GU 24 21 - 27 Phase 1a A2A exp Solid Tumors PORT - 6 (A2A) SITC 2024 ASCO 2024 18 Phase 1a A2B exp Solid Tumors PORT - 7 (A2B) for m SITC 2025 SITC 2024 20 Phase 1b A2B exp Solid Tumors PORT - 6 (A2A) ᬞ ASCO 2026 SITC 2025 20 Phase 1b A2A exp Solid Tumors PORT - 7 (A2B) ᬟ SITC 2025 SITC 2024 20 Phase 1b A2A exp Solid Tumors PORT - 6 (A2A) + CPI ᬠ ASCO 2026 SITC 2025 20 Phase 1b A2B exp Solid Tumors PORT - 7 (A2B) + CPI ᬡ ASCO 2026 SITC 2025 20 Phase 1b BM enriched PORT 6/7 (A2A/2B) +CPI ᬢ
iNKT Engagers PORT - 2, PORT - 3 Activating the innate, adaptive immune system and correcting the TME
8 Portage’s iNKT Agonist (PORT - 2): Rationally Designed Liposomal Formulation of 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
9 Innate Immune System: Adaptive Immune System: Tumor Microenvironment: Kills cancer cells & increased PD - L1 expression iNKT cell PORT - 2 Stimulates Multiple Arms of the Immune System to Produce a Robust Anti - Cancer Response
10 Antigen MDSC & TAM CD - 8 T cell B - cell Dendritic cell NK cell Target cells Companies in the space PD - 1 PD - L1 Tumor Cell • Upregulates PD - L1 • Monotherapy activity in PD - 1 resistant models • Combo restores sensitivity to PD - 1 Ab + Enhanced activation Multiple Cell Types Needed for Anti - Cancer Response PORT - 2 compound impacts all these pathways, including changing the tumor directly
11 PORT - 2 Demonstrates Robust Single Agent Activity Jukes et al Eur. J. Immunol. 2016. 00: 1 – 11 IMM60 (0.5ng/mouse) PORT - 2 Vehicle + anti PD - 1 Vehicle Untreated PORT - 2 shows better response rates vs. anti - PD - 1 in melanoma model B16 melanoma lung metastases
12 ASCO 2023 Data Further Supports PORT - 2 Favorable Safety & Tolerability Profile At All Doses Tested to Date Exposure • A total of 49 infusions given to 12 patients at doses up to 9 mg/m 2 , with a median of 5 doses per patient • Pk shows dose proportionality Safety • No DLT’s, related SAEs, or G3 - 5 related AEs • Only G1 related AEs have been observed at the highest dose of PORT - 2 • One patient treated with PORT - 2 + pembrolizumab experienced only low - grade AEs consistent with the safety profile of pembrolizumab Table 2: Adverse Events related to IMM60 (n=12) Grade 3 - 5 Grade 2 Grade 1 Adverse Event 0 0 1 (8%) Cough 0 0 1 (8%) Diarrhea 0 0 2 (17%) Dizziness 0 0 1 (8%) Dry mouth 0 0 1 (8%) Dyspnea 0 1 (8%) 1 (8%) Fatigue 0 0 1 (8%) Flu - like symptoms 0 0 1 (8%) Hair Loss 0 0 1 (8%) Headache 0 1 (17%) 0 Hypertension 0 0 1 (8%) Fever 0 0 1 (8%) Nausea 0 0 1 (8%) Pruritus 0 0 1 (8%) AST/ALT elevation 0 0 1 (8%) Vomiting Table 1: Demographics and Baseline Characteristics (n=12) Melanoma: 6 (50) NSCLC 6 (50) Tumor type (%) 64 (41,79) Age (range) 4 (2,7) Median prior therapies (range)* 11 (100) Prior PD - 1* (%) ECOG 0: 8 (67) ECOG 1: 4 (33) Performance status (%)
13 ASCO 2023 - Early Evidence of Single Agent Activity for PORT - 2 in Advanced Melanoma & NSCLC (IMP - MEL) - 100. 0% - 80.0% - 60.0% - 40.0% - 20.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% Lymph node Lung Kidney Liver Kidney Lymph node Lung Kidney Lymph node Sternum Liver Lung Lymph node Lymph node Lung Lymph node Lymph node Lymph node Liver Adrenal Lung Liver Lymph node Liver Liver Breast Small intestine Kidney Liver IM - 01 - 10008 IM - 01 - 10007 IM - 01 - 10006 IM - 01 - 10001 IM - 01 - 10006 IM - 01 - 10002 IM - 01 - 10004 IM - 01 - 10003 IM - 01 - 10003 IM - 01 - 10010 IM - 01 - 10010 IM - 01 - 10001 IM - 01 - 10002 IM - 01 - 10009 IM - 01 - 10010 IM - 01 - 10010 IM - 01 - 10003 IM - 01 - 10003 IM - 01 - 10001 IM - 01 - 10002 IM - 01 - 10009 IM - 01 - 10009 IM - 01 - 10007 IM - 01 - 10003 IM - 01 - 10009 IM - 01 - 10006 IM - 01 - 10006 IM - 01 - 10006 IM - 01 - 10009 Best change from baseline by individual target lesion IMM60 monotherapy IMM60 + pembrolizumab Single agent activity observed in select target lesions • Serum biomarker analyses provide evidence of iNKT, NK, DC activation, as well as increases in antigen - presenting CD86+ B cells following treatment with PORT - 2 • Combination with an anti - PD1 antibody is ongoing, with encouraging preliminary reduction in liver lesions observed • Based on the favorable safety and tolerability data at all doses tested to date, the Phase 1 portion of this trial is expanding to evaluate higher dose levels. Data by end of 2023 Baseline 3 months Mediastinal Lesion Decreased from 4cm to 1.9cm • Example patient treated at 3mg/m 2 had mixed response (melanoma patient failed anti - PD - 1 and targeted therapy)
14 Multi - arm study with four parallel development paths = multiple shots on goal IMPORT - 201: Phase 2 Evaluates Front Line NSCLC and Refractory Melanoma https:// www.isrctn.com/ISRCTN80472712 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 Validated mechanism impacting multiple immune cells Opportunity 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
16 Leveraging A2A and A2B Alone or in Combo Allows for Customization of Treatment 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 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
17 Difference in A2A Small Molecules 10+ hrs Only asset with single agent activity in mouse models Competitive inhibitors won’t block in settings of high adenosine ARCUS CORVUS Potency Selectivity 2.5 hrs Portage’s PORT - 6 is best in class for potency, selectivity and durability Relative profiles of A2A antagonists based on public profiles Bubble size illustrates how long receptors are occupied In Phase 1, no efficacy at QD 17% ORR at 80mg BID, need longer occupancy Couldn’t escalate due to tox (poor selectivity)
18 Fast Follower with Precedent for Biomarker Selection * Expression data from Labcorp Probability of Survival 100 50 0 A 2A R low A 2A R h HR=0.45 (0.19 - 1 P=0.02 % A2A high* Tumor type 50 RCC 38 BC 34 NSCLC 32 Gastric 26 Prostate Best % Change in Tumor Lesion by High/ Low A 2A R levels Enrich patient population with biomarker/clinical data iTEOS independent monotherapy activity in biomarker defined population (data from retrospective analysis ASCO 2021) Positive effect of adenosine antagonist in patients with high adenosine expression demonstrated Tumors with High Adenosine Survival curve by High/ Low A 2A R levels
19 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) Data on File Binding Affinity Functional Receptor Antagonism receptor Selectivity Ki (nm) Receptor 1 9 A2B >3000x >30,000 A1 >1000x >10,000 A2A >3000x >30,000 A3 Selectivity Ki (nm) Receptor 1 13 A2B 23x 300 A1 138x 1,800 A2A >4,000x 60,000 A3 Portage only company developing potent/selective A2B inhibitor
20 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 (Safety) 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 + CPI PORT - 7 + CPI COMBO (Safety) PORT - 6/PORT - 7 + other Portage agents Clinical Catalysts (Efficacy) COMBO 1b: MONOTHERAPY (Efficacy) ᬢ Cross over at progression PORT - 6 and/or PORT - 7 + SOC n=20 ᬠᬡ Randomized SOC n=10 PORT - 6 and/or PORT - 7 n=20 ᬞᬟ Monotherapy in biomarker defined patient population
21 iNKT Agonists • Composition, formulations with antigens, other I/O agents • Liposomes/particles 2031 - 2041 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 Key Upcoming Clinical Development Milestones* *At conferences we will present multiple arms & tumor types 2025 2024 2023 2H 1H 2H 1H Q4 Q3 IMPORT - 201 (PORT - 2) P2 PFS data (PORT - 2) data ADPORT - 601 ( Port - 7 ) P1b IMPORT - 201 P2 ORR IMPORT - 201 (PORT - 2) SITC ADPORT - 601 (Port - 6/7) SITC ADPORT - 601 (Port - 6) P1b start IMPORT - 201 (PORT - 2) ASCO ADPORT - 601 (PORT - 6/7) ASCO IMPORT - 201 (PORT - 2) Phase 2 ADPORT - 601 (PORT - 7) P1a start ADPORT - 601 (PORT - 6) P1a ASCO - GU 6) ADPORT - 601 (Port - study activation PORT - 201 (PORT - 2) SITC IM ADPORT - 601 (PORT - 6) SITC
23 Summary Financial Data ~$13.1 million Cash Balance (12/31/22) $29.8 million Committed Purchase Lincoln Park Capital Available ^ $ - Debt 17,403,594 Shares Outstanding (03/01/23)** 50% Insider Ownership 50% Public Float* 1,596,040 Options & RSUs Outstanding (12/31/22) $(~2.0 million) Cash Burn During Quarter Ended 12/31/22 ~$5 million Expected Quarterly Cash Burn in 2023 ^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. As of 2/28/23, approximately $28.5 million are available proceeds under the Purchase Agreement. *Includes ~3.5M Shares subject to lock - up agreements (6 - 12 mo) in recent 2 stock transactions. **Excludes 4,127 shares earned for services rendered in January and February 2023, accrued at February 28, 2023 but not yet issued.
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