TriSalus Life Sciences, Inc. · NASDAQ:TLSI
TriSalus Life Sciences — SPAC Merger (February 2023)
47 slides from TriSalus Life Sciences's SPAC merger presentation, February 2023
Slide 1: Investor Presentation February 2023
February 2023 Investor Presentation © 2023 TriSalus™ Life Sciences. All Rights Reserved.
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by MedTech Acquisition Corporation (“MedTech”), formed as a special purpose acquisition company, and TriSalus Life Sciences, Inc. (“TriSalus”) for use in connection with a proposed business combination and related transactions between MedTech and TriSal
Slide 3: Forward-Looking Statements
Forward-Looking Statements Certain statements in this presentation may constitute “forward-looking statements” within the meaning of applicable United States federal securities law s. Forward-looking statements include, but are not limited to, statements regarding MedTech’s or TriSalus’s expectation
Slide 4: Use of Projections
Use of Projections The financial projections, estimates and targets in this presentation are forward-looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of w hich are beyond MedTech’s and TriSalus’s control. Neither MedTec
Slide 5: Participation in Solicitation
Participation in Solicitation MedTech and TriSalus and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of MedTech’s stockholders in connection w ith the Proposed Business Combination. Investors and security holders m
Slide 6: Risk Factors
Risk Factors All references to “TriSalus,” the “Company,” “we,” “us” or “our” refer to TriSalus and its consolidated subsidiaries prior to the closing of the proposed Business Combination (the “Business Combination”) w ith MedTech Acquisition Corp. (“MTAC”) and to references to the “Combined Company
Slide 7: Risk Factors
Risk Factors Risks Related to Our Business: • We currently rely on, and may in the future rely on, third-party contractors, including certain sole-source suppliers and manufacturers, to supply and manufacture preclinical, clinical and commercial drug supplies for SD 101 and any future product candid
Slide 8: Risk Factors
Risk Factors Legal and Regulatory Risks: • There may not be an active trading market for the Combined Company Common Stock or Combined Company w arrants, which may make it difficult to sell such securities. • The price of Combined Company Common Stock and Combined Company w arrants may be volatile.
Slide 9: TriSalus Life Sciences: Well-Positioned for Value Creation
TriSalus Life Sciences: Well-Positioned for Value Creation by Helping More Patients with Liver and Pancreatic Tumors Benefit From Immunotherapy Differentiated, fast-growing, commercial medtech business with potential transformational upside from a therapeutic platform focused on tumors in the liver
Slide 10: MTAC Team
MTAC Team Multi-billion Dollar Value Creation Liquidity Events Across an Array of Medical Device Companies Karim Karti Chris Dewey David Matlin Martin Roche, MD Thierry Thaure Manuel Aguero Chairman Chief Executive Officer Chief Financial Officer Director Director Director David Treadwell Michael St
Slide 11: The TriSalus Team
The TriSalus Team A Powerful Combination of Proven Clinical, Strategic and Commercial Capabilities Mats Mary Richard Steven Katz, Sean Jennifer Bryan Cox, Wahlstrom Szela Marshak MD, FACS Murphy Stevens PHD Executive Chief Executive Senior Vice President, Chief Medical Chief Financial Chief Regulato
Slide 12: Two Key Barriers in Treatment of Tumors in the Liver and the Pancreas
Two Key Barriers in Treatment of Tumors in the Liver and the Pancreas TriSalus’ Proprietary Platform is Designed to Address Both High intra-tumoral pressures NK limit drug delivery cell 1 Myeloid-derived suppressor cell <1% (MDSCs) of therapeutic may be delivered into tumor with systemic infusion1,2
Slide 13: TriSalus' Two-pronged, Two-solution Approach
TriSalus’ Two-pronged, Two-solution Approach Combining Commercial Fast-growing Device Business With a Potential Best-in-class Therapeutic TriNav Infusion System SD-101 • Class C TLR9 agonist studied in >300 patients • Commercial-stage, high margin, and FDA cleared drug delivery technology • Tolerabi
Slide 14: Our Platform: US Annual Addressable Market Opportunity >$15B
Our Platform: US Annual Addressable Market Opportunity >$15B 1 SD-101 + PEDD ESTIMATED ANNUAL NEW ADDRESSABLE CURRENT 5-YEAR INDICATION CASES – US2 POPULATION – US3 SURVIVAL4 Uveal 1,250 • Lead indications of all 2,500 10–15% melanoma (with LM) areas of high unmet Intrahepatic 3,000–6,000 2,400–4,80
Slide 15: Fast-Growing Device Business: TriNav Infusion System
Fast-Growing Device Business: TriNav® Infusion System © 2023 TriSalus™ Life Sciences. All Rights Reserved. 15
Slide 16: TriNav Infusion System: A Better Solution for Drug Delivery
TriNav® Infusion System: A Better Solution for Drug Delivery Commercial-stage Technology Launched in 2020 Using the Proprietary Pressure-Enabled Drug Delivery (“PEDD”) Approach • Innovative drug delivery platform designed to overcome the barriers of the high-pressure tumor microenvironment (“TME”) •
Slide 17: Proprietary Pressure-Enabled Drug Delivery (PEDD) Technology
Proprietary Pressure-Enabled Drug Delivery (“PEDD”) Technology TriNav PEDD with SmartValve Technology Routine Outpatient Intravascular Regional Drug Delivery to the Liver Performed for tumors that cannot be surgically resected4 A small puncture is made, usually into the femoral artery near the groin
Slide 18: PEDD Drives More Therapeutic Into High Pressure Tumors
PEDD Drives More Therapeutic Into High Pressure Tumors Improved Therapeutic Tumor Payload Delivery as Evidenced by Angiography and CT Angiograms CT Angiograms Standard Catheter Surefire Standard Surefire End-hole increases pressure during infusion, overcom ing tum or pressure Standard End-hole PEDD
Slide 19: PEDD Increases Delivery of Multiple Therapeutics
PEDD Increases Delivery of Multiple Therapeutics Additional Clinical and Pre-clinical Data Points Support a Singular Conclusion 60% 33% to 90% 500% (>1000 ng/g) 6.7–10.1 fold Increase in Increase in Increase in Minimal Improved therapeutic MAA tumor CAR-T systemic delivery vs. delivery to deposition
Slide 20: Strong Customer Base with Support of Key Opinion Leaders
Strong Customer Base with Support of Key Opinion Leaders Top TriNav Customers Select Key Opinion Leaders’ Reviews1 “The combination of SD-101 “The TriNav device offers a and the PEDD is about as legitimate innovation in the exciting of a potential treatment catheter space.” I have seen in the IR spa
Slide 21: Reimbursement Strategy
Reimbursement Strategy Reimbursed 50% Through Private Insurance, 50% Through CMS With Action Plan Detailed Below = Current Status 2022 Legislative Action Action Plan Section 4141 – Extension of Pass-through Status for Certain Devices Included in the 2023 Consolidated Appropriations Act Short-term 20
Slide 22: PRVI: Our Separate 510(k) Cleared Technology For Direct Pancreas Infusion
PRVI: Our Separate 510(k) Cleared Technology For Direct Pancreas Infusion To Enable SD-101 for Pancreas Tumors Not Treatable With Surgery The venous system drains defined segments of the pancreas. 6 As a tumor grows, the veins enlarge7 providing vascular conduits for delivery of therapeutic agents b
Slide 23: TriSalus Technology Pipeline
TriSalus Technology Pipeline To Drive Growth of Existing Markets (Liver + Pancreas) and Potential For Creation of New Opportunities (Including Prostate) Technology Products Pressure Modulation TriNav – 510K cleared Catheter/SmartValve with range of vessel size TriNav Large Targeted for launch 1H 202
Slide 24: Significant Potential Upside from SD-101 Program in Development
Significant Potential Upside from SD-101 Program in Development © 2023 TriSalus™ Life Sciences. All Rights Reserved. 24
Slide 25: Candidate SD-101: Class C TLR9 Agonist
Candidate SD-101: Class C Toll- like Receptor 9 (TLR9) Agonist • Broad immune system reactivation within the liver and pancreas • MDSC reduction • Expected to enable deeper and more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) • Enabled by SmartValve delivery technolog
Slide 26: SD-101 Dual MoA Well Suited for Liver and Pancreas Indications
SD-101 Dual MoA Well Suited for Liver and Pancreas Indications Reversing Immunosuppression to Enhance Tumor Responsiveness 1,2 Broad Immune Modulation 1 of the Tumor5,6,7 SD-101 binding to TLR9 on MDSC results • Stimulates multiple immune cell types in depletion MDSC are key • Drives T-cell infiltra
Slide 27: Pressure Enabled Infusion of Immunomodulators Directly Into the Vascular Bed
Pressure Enabled Infusion of Immunomodulators Directly Into the Vascular Bed of Unresponsive Liver and Pancreas Tumors Targets Dysfunctional Immune Cells in the Tumor and Organ to Enhance Checkpoint Inhibitor Performance Unresponsive TriSalus PEDD + Responsive Potent Immune Stimulation Tumor Immunom
Slide 28: SD-101 Improved Responsiveness to Anti-PD1 Therapy in CPI Naive Patients
SD-101 Improved Responsiveness to Anti-PD1 Therapy in CPI Naive Patients In Dynavax1 Phase 2 for Cutaneous Melanoma Checkpoint Response Rate Increased from 35% to 78% PD-L1 Status 100 Unknown Positive Pembro + SD-101 • SD-101 + pembro ORR of 78%2 TUMOR GROWTH 80 Negative Synergy Study compared to OR
Slide 29: Platform Has the Potential to Set New Immunotherapy Benchmarks
Platform Has the Potential to Set New Immunotherapy Benchmarks Building on Previous Phase 2 SD-101 + CPI Data with ORR of 78% in Cutaneous Melanoma 100% UM HCC Target ORR Range 80% SD-101/PEDD + CPI ICC Overall Response Rate 60% ✓ Approved Therapy “TRANSFORMATIVE” “COMPELLING” 40% ✓ ✓ 20% PERIO Tria
Slide 30: SD-101/PEDD Platform Milestone
SD-101/PEDD Platform Milestone Anticipated Track for Clinical Trial Programs 2023 2023 2024 Therapeutic Clinical Indication Q1 Q2 Q3 Q4 Area Program 1H 2H 1H 2H Ph 1 Uveal 1L Liver Ph 1 Start Ph 2 Interim Ph 2 PERIO-1 Response Data Ph 2 Durable Analy sis Completion Melanoma Metastases Response Data
Slide 31: Pressure-Enabled Regional Immuno-Oncology Studies
Pressure-Enabled Regional Immuno-Oncology™-Studies © 2023 TriSalus™ Life Sciences. All Rights Reserved. 31
Slide 32: Studies Run by Internationally Renowned Cancer Centers
Studies Run by Internationally Renowned Cancer Centers Clinical Investigators Highly Enthusiastic by Approach and Data Driving Strong Enrollment – 42 Subjects Treated With 138 SD-101 Infusions in PERIO-01 and -021 * © 2023 TriSalus™ Life Sciences. All Rights Reserved. 32
Slide 33: Pipeline Designed to Enable CPI in Liver and Pancreas Tumors
Pipeline Designed to Enable CPI in Liver and Pancreas Tumors Platform Creates Opportunities for Orphan and Ultra-orphan Indications With Rapid Approval Potential INDICATION TRIAL DESIGN IND ENABLING PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Uveal Melanoma Liver SD-101 + PEDD • 1H 2023: Phase 1 res
Slide 34: Clinical and Pre-clinical Data Supportive of PEDD Method Being Effective
Clinical and Pre-clinical Data4 Supportive of PEDD Method Being Effective Shows PEDD Method is Effective in Delivery of Therapeutics, Including SD-101, Into High-pressure Liver Tumors Compared With Alternative Approaches DYNAVAX PHASE 1/2 SUPERFICIAL TUMOR PROGRAMS TRISALUS PHASE 1 LIVER (SD-101 VIA
Slide 35: Initial Data Indicate TriNav Can Achieve High Liver SD-101 Levels
Initial Data Indicate that TriNav® can Achieve High Liver SD-101 Levels with Limited Systemic Exposure Initial Clinical Data Aligns With Previous Phase 2 SD-101 Experience Cohort A 4 mg SD-101 Plasma PK • High SD-101 levels in liver following infusion 101-006 300 with TriNav® 102-007 111-008 200 106
Slide 36: Initial PERIO-01 and -02 Data
Initial PERIO-01 and -02 Data Subjects Treated at Lowest SD-101 Dose Levels With ctDNA Molecular Responses to Treatment (42 Enrolled and 138 Infusions) 1 Molecular Reponses – ctDNA clearance in majority of patients receiving SD-101 via PEDD in combination with checkpoint inhibitors; ctDNA has been a
Slide 37: Potential for Approval of SD-101 as Early as 2025
Potential for Approval of SD-101 as Early as 2025 Orphan and Ultra-orphan Indications Offer a Potential Pathway For Expedited Development ✓ Both ICC and uveal melanoma have potential to be designated as orphan indications which often qualify for expedited development programs/review pathways (i.e.,
Slide 38: Extensive Patent Protection Position With Potential for Significant Value Creation
Extensive Patent Protection Position With Potential for Significant Value Creation © 2023 TriSalus™ Life Sciences. All Rights Reserved. 38
Slide 39: Interweaving Patents and Exclusivity to Increase Long Term Protection
Interweaving Patents and Exclusivity to Increase Long Term Protection of Intellectual Property Multiple Layers of Protection • TriNav and SD-101 Product-specific IP • Methods of Treatment (MoT) PEDD and ― New Indications SD-101 ― Combo Therapies Product Specific IP ― Optimal Pressure Range and Dose
Slide 40: Patent Overview
Patent Overview 32 Patent Families, 119 Issued Patents, 51 Pending Applications and 2 Pending US Provisional Applications 2016 2018 2020 2022 2024 2038 2049 SD-101 Composition – e.g., U.S. Patent No. 9,422,554 Expires: 12-18-23 Dynavax SD-101 Combo Method – Dynavax U.S. Patent No. 10,751,412 Expires
Slide 41: Investment Opportunity
Investment Opportunity © 2023 TriSalus™ Life Sciences. All Rights Reserved. 41
Slide 42: Investment Highlights
Investment Highlights Commercial-stage FDA cleared device with an estimated $19.2 mm sales 1 in 2023, an estimated $42.5 mm sales in 2024, and a cash flow positive device business anticipated in 2024 Additional upside with pipeline of additional devices for liver is expected to 2 launch in 2024 Leve
Slide 43: Go-Forward Priorities
Go-Forward Priorities Continue to advance Develop pipeline of PERIO™-01 and Expand adoption of additional technology PERIO™-02 clinical PEDD method devices for liver and trials to seek approval of pancreas indications SD-101 43 © 2023 TriSalus™ Life Sciences. All Rights Reserved.
Slide 44: TriSalus Has Opportunities for Significant TAM Upside
TriSalus Has Opportunities for Significant TAM Upside 2022A Revenue TriNav Annual TAM SD-101 Annual TAM $15,000mm3 $368.0mm2 $12.4mm1 © 2023 TriSalus™ Life Sciences. All Rights Reserved. 44
Slide 45: Comparable Companies
Putting the Valuation of TriSalus into Context This Business Combination is an Opportunity to Invest in a Differentiated, Fast-growing, Commercial Medtech Business With the Potential Upside From a Therapeutic Platform Medical Device Business Average + Therapeutics Business EV / ’24E ’21A – ’24E ’24E
Slide 46: Transaction Summary
Transaction Summary Transaction Overview Sources1 Uses1 ($ in millions) ($ in millions) ▪ The transaction is expected to close in Q2 2023. Cash in Trust $15.0 Cash on Balance Sheet $31.0 ▪ Post-closing, the combined company is anticipated to be listed on t he Nasdaq, and will be named TriSalus Life
Slide 47: Thank You
Thank You trisaluslifesci.com © 2023 TriSalus ™ Life Sciences. All Rights Reserved.