TriSalus Life Sciences, Inc. · NASDAQ:TLSI
TriSalus Life Sciences — Investor Presentation (January 2025)
32 slides from TriSalus Life Sciences's investor presentation, January 2025
Slide 1: TriSalus Life Sciences
TriSalus Life Sciences January 2025
Slide 2: Disclaimer
Disclaimer Certain statements in this presentation may constitute “forward-looking statements” within the meaning of applicable United States federal securities laws. Forward-looking statements include, but are not limited to, statements regarding TriSalus’s expectations, hopes, beliefs, intentions
Slide 3: Improving Therapeutic Delivery to Liver & Pancreatic Tumors
Improving Therapeutic Delivery to Liver & Pancreatic Tumors Core Med Tech • A high-growth MedTech business with strong commercial potential, significant upside from expansion in Business existing and new applications • Pressure Enabled Drug Delivery (PEDD ) infusion, which improves therapeutic deliv
Slide 4: Tumor microenvironment limits drug delivery in liver and pancreatic tumors
Tumor microenvironment limits drug delivery in liver and pancreatic tumors • High intra-tumoral pressure in solid tumors limits efficient drug delivery to tumor Limited drug uptake due to collapsed vessel • Elevated interstitial fluid pressures reduce movement (<1% in some of fluid from vessel into
Slide 5: PEDD opens collapsed vessels, improving drug delivery in high pressure tumors
PEDD opens collapsed vessels, improving drug delivery in high pressure tumors1 Angiogram of liver tumor vessels demonstrating PEDD method: Surefire Surefire increases Surefire Surefire pressure increases Standard during pressure Catheter Standard infusion, during Catheter overcom infusion, ingPEDD o
Slide 6: Increased delivery of Y90 beads to tumor correlated with improved survival
Increased delivery of Y90 beads to tumor correlated with improved survival 6
Slide 7: TriNav Infusion System: a better solution for drug delivery
TriNav® Infusion System: a better solution for drug delivery 510(k) cleared device for vascular access throughout the body except the heart and brain Unique HCPCS reimbursement code for procedures using the TriNav system Validated in multiple clinical and HEOR studies TriNav Infusion System Commerci
Slide 8: Combined U.S. PEDD total addressable market is >$1.5 billion annually
Combined U.S. PEDD total addressable market is >$1.5 billion annually Liver (HCC + Colorectal liver Mets + Neuro endocrine) 62,000 patients1,2,3 30,000 TACE/TARE procedures Multinodular Goiter 50,000 patients2 Locally Advanced Pancreas 20,000 patients3,* Uterine Fibroid Embolization 15,000 pts4 Pros
Slide 9: Analysis of real-world data provides evidence TriNav treats complex liver cancer patients
Analysis of real-world data provides evidence that TriNav system successfully treats complex liver cancer patients1 Population/Setting Comparative Findings • Retrospective analysis of 300 million patient claims over 3 • In chemoembolizations, TriNav delivered 40% more years doxorubicin • 98% of all
Slide 10: Focused, accessible hospital market with attractive reimbursement
Focused, accessible hospital market with attractive reimbursement Traditional Medicare Patients Highly Targeted Market • CMS issued HCPCS procedural code C9797, reimbursed under APC 5194 (Level 4 endovascular procedures), effective January 1, 2024 • ~400 hospitals cover 95% of procedure volume • C97
Slide 11: Technology pipeline: opportunities for further expansion
Technology pipeline: opportunities for further Next Generation expansion TriNav System with Next Generation Integrated Sensing Pancreatic Infusion in Development Large Vessel 2.0 in Development TriNav 2.0 TriNav System Integrated pressure 510k Cleared measurement Pancreas TriSalus Integrated pressur
Slide 12: Future Areas of Growth
SECTION 2 Future Areas of Growth New applications and product launches 12
Slide 13: Data support for TriNav system in complex patients
Data support for TriNav system in “complex patients” Multiple comorbidities Deliver Program initial focus is on four studies: Previous • PEDD benefits in multinodular goiter embolization • Registry study for uterine fibroid embolizations Multi-focal disease – breast cancer liver mets • PEDD benefits
Slide 14: MultiNodular Goiter
MultiNodular Goiter Novel minimally invasive approach via PEDD with potential to become standard-of-care 14
Slide 15: Multinodular goiter - large U.S. market opportunity
Multinodular goiter - large U.S. market opportunity High unmet need in thyroid artery embolization with continued expected growth ~5% of population affected Treatment Risk factors Watchful waiting, Iodine deficiency Medical therapy Female sex Surgery (Thyroidectomy) Metabolic syndrome Radioactive io
Slide 16: TriNav system has potential to be standard of care for multinodular thyroid disease
TriNav system has potential to be standard of care for treatment of multinodular thyroid disease TriNav system enables treatment of the Radioiodine Embolization Ablation Surgery entire gland through the inferior thyroid Therapy with PEDD arteries minimizing complication of stroke Recurrent Limited t
Slide 17: Novel pancreatic infusion technology for use with Y90 and nelitolimod
Novel pancreatic infusion technology for use with standard of care treatments (y90) and in combination with nelitolimod Locally Advanced Pancreatic Cancer 17
Slide 18: Large, growing market opportunity in locally advanced pancreatic cancer
Large, growing market opportunity in locally advanced pancreatic cancer High unmet need for Multi-agent improved treatments ~30-50% of patient chemotherapy primary Locally Advanced Adenocarcinoma ineligible for surgery treatment for most patients Outcomes: 2L + overall survival approximately 25,000
Slide 19: TriSalus developed a separate, novel PEDD method for the pancreas
TriSalus developed a separate, novel PEDD method for the pancreas FDA-cleared And In Phase 1 Clinical Trials With Nelitolimod Poor blood flow limits drug access to pancreas1,2,3 Pancreatic arteries difficult to access4,5 Innovative retrograde venous approach eliminates need for balloons that elimina
Slide 20: Collaboration with Y90 partner for pancreatic infusion of Y90 beads
Collaboration with Y90 partner for pancreatic infusion of Y90 beads Summary of Objectives Met and Goals for Further Development Pre-clinical • Locally Advanced PDAC 1L+ In normal swine (n=12, 6 head and 6 body) • Cohort 1 – 3 dose levels, 3 per level 25, 100, and 500 Gy to head or body of pancreas (
Slide 21: PERIO-3: nelitolimod + PEDD method for locally advanced pancreatic carcinoma
PERIO-3: nelitolimod + PEDD method for locally advanced pancreatic carcinoma PERIO-3 (PDAC) Phase 1 Study Design • Phase 1 trial currently enrolling at MD Anderson Cancer Center Cohort A* Nelitolimod Single Agent Dose Escalation • First time use of novel device with PEDD method to (4 mg) infuse into
Slide 22: Nelitolimod dual mechanism of action overcomes immunosuppression
Nelitolimod dual mechanism of action overcomes immunosuppression 1. Nelitolimod binds to TLR9 receptors in the tumor 2. PEDD method allows for high concentration of therapeutic into the tumor TLR9 3. Nelitolimod is taken into tumor agonist cells and eliminates immunosuppressive cells 4. Nelitolimod
Slide 23: Clinical proof-of-concept
Clinical proof-of-concept Dual moa with potential to enhance checkpoint activity both in tme and systemically Unresponsive “Cold” Responsive “Hot” Enhanced immune Effects in Tumor Pre-Nelitolimod Tumor Post-Nelitolimod Target Organ and Systemically PEDD + Nelitolimod (SD-101) MDSC accumulation MDSC
Slide 24: TS-PERIO-03 Phase 1 study for locally advanced PDAC
TS-PERIO-03 Phase 1 study for locally advanced PDAC Phase 1 Single-agent Safety Summary of Objectives Met and Goals for Further Development Enrollment Completed • Enrolled 13 patients (0.5, 2, and 4 mg), mostly 3L and 2 patients 2L 0.5 2 4 Dose escalation mg mg mg • Awaiting data to mature • Potenti
Slide 25: Nelitolimod: SITC 2024 Phase 1 durable disease control and PFS in uveal melanoma liver metastases
Nelitolimod: SITC 2024 Phase 1 durable disease control and PFS in uveal melanoma liver metastases (UMLM) Median PFS 10.2 Months o 67 patients and 69% were pre-treated (45% ICI, 18% tebentafusp) o Grade 3/4 treatment-related AEs (TRAEs) in 13% of pts 1-yr OS 77.9% o Recommended phase 2 dose was 2 mg
Slide 26: Corporate Update
Corporate Update Q3 2024 ATriSalus
Slide 27: Strong multi-year growth forecasted
Strong multi-year growth forecasted 50% CAGR Projected Beyond 2024 2022 2023 Projected 2024 $12M Sales 80% + GM $18.5M Sales 80% + GM $28 - $30M Sales 85% + GM 27
Slide 28: Q3 2024 Highlights
Q3 2024 Highlights 42% total revenue growth over Q3 Capitalization TLSI (NASDAQ) 2023 Shares Outstanding1 30.5M Gross margins YTD of 86% Cash and Investments of $11.3M at Warrants Outstanding2 7.3M September 30, 2024 52 Week Low – High3 $3.32 - $10.42 Total debt of $25M as of Q2 2024 with $25M addit
Slide 29: 2024 and 2025 key milestones
2024 and 2025 key milestones Catalyst Indication Timing Launch of Pressure-enabled Retrograde Occlusive Therapy with Embolization PROTECT Launched for Control of Thyroid disease clinical study Launch of TriNav Large Hepatocellular Cancer, Uterine Fibroid and Liver metastases Launched 2nd year data c
Slide 30: Veteran Industry Leadership
Veteran Industry Leadership Jim Young Richard Marshak, VMD Mary Szela Sean Murphy Jennifer Stevens Jodi Devlin Bryan Cox, PHD Chief Financial Officer Chief Commercial Officer CEO & President Chief Manufacturing, Strategy Chief Regulatory Officer Chief of Clinical Strategy & Chief of Research & Busin
Slide 31: Improving Therapeutic Delivery to Liver & Pancreatic Tumors
Improving Therapeutic Delivery to Liver & Pancreatic Tumors • A high-growth MedTech business with strong commercial potential, significant upside from expansion in We are existing and new applications • Pressure Enabled Drug Delivery (PEDD ) infusion, which improves therapeutic delivery for Our Tech
Slide 32: Thank you
Thank you Contacts James Young, Chief Financial Officer James.young@Trisaluslifesci.com LifeSci Advisors Jeremy Feffer, Managing Director jfeffer@lifesciadvisors.com
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