Trisalus Life Sciences, Inc. · NASDAQ:TLSI
Trisalus Life Sciences — Investor Presentation (January 2024)
35 slides from Trisalus Life Sciences's investor presentation, Jan 5, 2024
Slide 1: TriSalus Life Sciences January 2024
1 TriSalus Life Sciences January 2024
Slide 2: Disclaimer
2 Disclaimer Certain statements in this presentation may constitute “forward looking statements” within the meaning of applicable United S tat es federal securities laws. Forward looking statements include, but are not limited to, statements regarding TriSalus’s expectations, hopes, beliefs, intenti
Slide 3: Overcoming Key Mechanical & Biological Bottlenecks in the Treatment of Solid Tumors
3 ` Overcoming Key Mechanical & Biological Bottlenecks in the Treatment of Solid Tumors Commercial high growth MedTech business with potential upside from device + immunotherapeutic combination Integrating unique device and therapeutic to overcome key challenges with drug delivery to liver and pancr
Slide 4: Novel approach to overcome key treatment barriers in liver and pancreas tumors
4 Novel approach to overcome key treatment barriers in liver and pancreas tumors Novel combination approach combines innovative Pressure Enabled Drug Delivery Π(PEDD) technology with a promising therapeutic, SD - 101, a TLR9 agonist, to overcome mechanical and biologic TME barriers to immunotherapy
Slide 5: Two important barriers to immunotherapy success in liver and pancreatic tumors
5 Two important barriers to immunotherapy success in liver and pancreatic tumors 1. Mechanical Barrier 1 - 3 H igh intra - tumoral pressure in solid tumors limits efficient drug delivery to tumor 2. Biologic Barrier 4 Immunosuppression in TME limits activity of therapeutic agents Limited drug uptake
Slide 6: PEDD: pressure enabled drug delivery
6 6 PEDD: pressure enabled drug delivery SECTION 1 Overcoming the Mechanical Barrier for Drug Delivery to Liver and Pancreatic Tumors
Slide 7: Addressing mechanical and biologic barriers in the TME of liver and pancreatic tumors
7 Addressing mechanical and biologic barriers in the TME of liver and pancreatic tumors Mechanical Barriers : high pressure within solid tumors • Limits delivery of sufficient therapeutic agent by standard catheters or by intravenous delivery Biologic Barriers : immunosuppressive TME limits efficac
Slide 8: TriNav Infusion System: a better solution for drug delivery
8 TriNav ® Infusion System: a better solution for drug delivery Additional technology expansion opportunities with potential immunotherapy partners Clinically validated in multiple studies Atraumatic, self - expanding/collapsing SmartValve technology Drug delivery technology to overcome mechanical b
Slide 9: PEDD procedures are routine and outpatient
9 PEDD procedures are routine and outpatient ENABLES OPTIMIZATION OF CATHETER - BASED EMBOLIC AND DRUG DELIVERY BY ADDRESSING DELIVERY BARRIER PRESENT ACROSS TUMOR TYPES • Standard - of - care interventional radiology (catheter) procedures • Regional administration of therapies to the tumor via targ
Slide 10: PEDD drives more drug into high pressure solid tumors
10 PEDD drives more drug into high pressure solid tumors 1 OVERCOMING THE MECHANICAL BARRIERS IN THE TUMOR MICROENVIRONMENT (TME) Angiogram of tumor vessels demonstrating that PEDD: Delivers contrast dye into liver tumor Opens collapsed tumor vessels Reflux of contrast dye into normal liver Surefire
Slide 11: FDA-cleared novel pancreatic infusion system
11 FDA - cleared novel pancreatic infusion system • Poor blood flow limits drug access to the pancreas 1,2,3 • Pancreatic arteries difficult to access 4,5 • Innovative retrograde venous approach eliminates need for balloons that eliminate blood flow 6,7 • Target vessel pressure monitoring for safety
Slide 12: Clinical and preclinical data demonstrate superiority of PEDD
12 Clinical and preclinical data demonstrate superiority of PEDD OVERCOMING THE MECHANICAL TME BARRIER WITH MULTIPLE THERAPEUTICS Therapeutic Modality TriNav Improvement vs. Standard Catheter TACE 60% ↑ in therapeutic delivery to liver tumors 1 vs. standard catheter Clinical liver study TARE (Y - 90
Slide 13: TriSalus technology pipeline: opportunities for further expansion
13 TriSalus technology pipeline: opportunities for further expansion Liver Pancreas Integrated pressure measurement Next Generation Pancreatic Infusion in Development Launch Planned 1H: 2024 Large Vessel TriNav 510k Cleared Currently in Phase 1 clinical trials with SD - 101 Pancreas TriSalus Infusio
Slide 14: Class C TLR9 Agonist: Overcoming the Biologic Barrier in Liver & Pancreas Tumors
14 14 SD - 101: Class C TLR9 Agonist SECTION 2 Overcoming the Biologic Barrier in Liver & Pancreas Tumors
Slide 15: Pipeline: potential commercial opportunities across range of liver and pancreas tumors
15 Pipeline: potential commercial opportunities across range of liver and pancreas tumors INDICATION TRIAL DESIGN IND ENABLING PHASE 1 PHASE 2 PHASE 3 Uveal Melanoma Liver Metastases (validation of combination) SD - 101 + PEDD HAI + CPI Hepatocellular Cancer (HCC) 1 SD - 101 + PEDD HAI + CPI Intrahe
Slide 16: Clinical trials leverage established biology (PERIO studies)
16 Clinical trials leverage established biology of SD - 101 Enrollment criteria • Liver or pancreas main site of disease • Failure or refusal of standard treatment • Good performance status Trial Design • Cohorts with SD - 101/PEDD alone • Cohorts with SD - 101/PEDD + IV checkpoint • Six outpatient
Slide 17: Dual mechanism of action overcomes biological TME barriers
17 SD - 101 dual mechanism of action overcomes biological TME barriers SD - 101 binds to TLR9 MDSC SD - 101 Endothelial cell 3 NK pDC Eliminates Immunosuppressive MDSCs 1 2 PEDD allows sufficient SD - 101 delivery into TME SD - 101 with immune adjuvant effect on multiple cell types Dual mechanism of
Slide 18: Clinical proof-of-concept
18 Clinical proof - of - concept DUAL MOA WITH POTENTIAL TO ENHANCE CHECKPOINT ACTIVITY BOTH IN TME AND SYSTEMICALLY Unresponsive “cold” Tumor Pre - SD - 101 Enhanced CPI Effects in Target Organ and Systemically Responsive “hot” Tumor Post - SD - 101 PEDD + SD - 101 MDSC accumulation T cell paucity
Slide 19: Clinical data consistent with established drug mechanism of action
19 SD - 101 clinical data consistent with established drug Mechanism of Action SD - 101 relieves immunosuppression in TME, may yield PFS/OS benefit in absence of robust RECIST ORR Liquid biopsy ( ctDNA levels) more accurate predictor of survival than imaging (RECIST ORR) 1,2,3 Optimal dose determ
Slide 20: Highly distinct from other TLR9 agonists
20 SD - 101 is highly distinct from other TLR9 agonists PEDD ENABLES MECHANISM OF ACTION ( MOA ) THAT ALIGNS WITH LIVER AND PANCREAS BIOLOGY MDSC – myeloid derived suppressor cells 1. TriSalus unpublished 2. Ghosh SITC 2022 3. Ghosh Cancer Gene Therapy 2022 4. Montazeri ASCO 2023 5. Patel SITC 2023
Slide 21: Liquid biopsy showing ctDNA reduction predicts survival in uveal melanoma
21 Liquid biopsy showing ctDNA reduction predicts survival in uveal melanoma PHASE 1 DATA CONSISTENT WITH CLINICAL ACTIVITY IN PREDICTED ACTIVE DOSE RANGE • SD - 101 causes substantial tumor inflammation and cell infiltration - tumor size increase unrelated to tumor cell proliferation and complicate
Slide 22: Dose optimization guided by clinical and immune signals
22 Dose optimization guided by clinical and immune signals DOSE WITHIN PREDICTED RANGE ELICITS EXPECTED IMMUNE SIGNALS WITHIN LIVER METASTASES, PHASE 1 At 2 mg SD - 101 via PEDD + nivolumab: x > 80% ctDNA response rate x > 80% disease control rate x 11.7 - month progression free survival (PFS) x Imm
Slide 23: Durable disease control and PFS in phase 1
23 Durable disease control and PFS in phase 1 1 NEXT PHASE WILL FURTHER EXPLORE PFS CONVERSION INTO OS BENEFIT A S CIRCULATING TUMOR DNA LEVELS MAY PREDICT 2,3,4 71% 2L and beyond, including 4L and 6L patients 59% ctDNA clearance 1 as best on - treatment response and 27% clearance at fixed time poin
Slide 24: Well tolerated with low level of serious adverse events
24 SD - 101 well tolerated with low level of serious adverse events TS - PERIO - 01 Phase 1 (1L if Kimmtrak ineligible; 2L+ if Kimmtrak eligible) TriSalus (SD - 101) N=56 (phase 1) 1 Stage IV UM LM population eligible 100% Grade 3 or 4 treatment related serious adverse events 11% (4% at optimal dose
Slide 25: Unmet needs create broad market opportunities across multiple indications
25 Unmet needs create broad market opportunities across multiple indications • Addressing unresectable disease in liver and pancreas • Target indications all areas of high unmet need with poor overall survival • Total available market > 80,000 1 in the U.S. • Dual mechanism of action and unique rout
Slide 26: 2023 – 2024: Anticipated Key Milestones
26 2023 – 2024: Anticipated Key Milestones Catalyst Indication Anticipated Timing Phase 1 PERIO Data Uveal Melanoma 2H 2023 (Complete) Confirmation of optimal dose Uveal Melanoma 1H 2024 Phase 1b PERIO Data Hepatocellular Cancer and Intrahepatic Cholangiocarcinoma 1H 2024 Launch of TriNav Large Hepa
Slide 27: Executive Team
27 Executive Team Jodi Devlin President, Therapeutics Mary Szela CEO & President Sean Murphy Chief Financial Officer Steven Katz, MD, FACS Chief Medical Officer, Chairman of SAB Jennifer Stevens Chief Regulatory Officer Bryan Cox, PHD Chief of Research Richard Marshak, VMD Senior Vice President, Bus
Slide 28: Capital structure and liquidity as of September 30, 2023
28 Capital structure and liquidity as of September 30, 2023 Share Listing – Current TLSI (Nasdaq) Common Shares Outstanding 26.3M Preferred Shares Outstanding 4.0M Warrants Outstanding 1 14.3M Cash and Cash Equivalents $21.4M Debt $0
Slide 29: Overcoming Key Mechanical & Biological Bottlenecks in the Treatment of Solid Tumors
29 ` Overcoming Key Mechanical & Biological Bottlenecks in the Treatment of Solid Tumors Commercial MedTech business with consistent growth and potential upside from device + immunotherapeutic combination Integrating unique device and therapeutic to overcome key challenges with drug delivery to live
Slide 30: Argot Partners contact details
30 Argot Partners New York 767 Third Avenue, 34th Floor New York, NY 10017 212.600.1902 trisalus@argotpartners.com | © 2024 TriSalus ® Life Sciences. All Rights Reserved.
Slide 31: Do liver tumors drive immunotherapy failure?
31 Do liver tumors drive immunotherapy failure? In multiple indications , liver mets predicted CPI failure in association with myeloid cell driven suppression 1 In cutaneous melanoma patients, liver mets predicted inferior PFS and OS 3 In lung carcinoma patients, the presence of liver mets was an in
Slide 32: Program design: key considerations and takeaways
32 SD - 101 program design: key considerations and takeaways METHODICAL AND DATA - DRIVEN DEVELOPMENT PLAN Preclinical Foundation Trial Design Pharmacokinetics + Pharmacodynamics Early Clinical POC Efficacy and Potential Regulatory Endpoints Predicted SD - 101 dose range with PEDD approach 1 Single
Slide 33: Deactivated key signaling molecule in MDSC
33 SD - 101 deactivated key signaling molecule in MDSC to align with immunosuppression biology in liver and pancreas SD - 101 Deactivated STAT3 in Murine Liver MDSC Human MDSC Express TLR9 1. STAT3 drives liver MDSC expansion, survival, and function 2. TLR9 signaling can deactivate STAT3 3. MDSC exp
Slide 34: Preclinical PEDD liver metastasis model enabled rational selection of clinical dose range
34 Preclinical PEDD liver metastasis model enabled rational selection of clinical dose range of 2 - 8 mg and support for use of PEDD Existence of effective dose range expected for TLR9 agonist, with lower doses potentially optimal. Optimal dose selection to be based on desired immune effects. Liver
Slide 35: Distinct from other TLR9 agonists in murine liver tumor model
35 SD - 101 is distinct from other TLR9 agonists in murine liver tumor model PEDD PEDD ENABLES MOA THAT ALIGNS WITH BIOLOGY IN LIVER AND PANCREAS -7.5 -5.0 -2.5 0.0 2.5 5.0 7.5 Angiogenesis Cell Migration and Adhesion Cytokine Signaling Differentiation and Maintenance of Myeloid Cells Interferon Sig
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