Sensei Biotherapeutics, Inc. · NASDAQ:SNSE
Sensei Biotherapeutics — Investor Presentation (March 2025)
44 slides from Sensei Biotherapeutics's investor presentation, Mar 27, 2025
Slide 1: Conditionally Active Antibodies for Immuno-oncology
Conditionally Active Antibodies for Immuno-oncology March 2025 Exhibit 99.2
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Sensei Biotherapeutics, Inc. (the “Company,” "we," "us") and is made for informational purposes only. The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein ar
Slide 3: Leadership Team with History of Oncology Antibody Success
Leadership Team with History of Oncology Antibody Success Josiah Craver, CPA SVP, Finance John Celebi, MBA President and CEO Christopher Gerry, J.D. SVP, General Counsel Edward van der Horst, Ph.D. Chief Scientific Officer Stephanie Krebs, M.S., MBA Chief Business Officer Ron Weitzman, M.D. Chief Me
Slide 4: Sensei Investment Highlights
Sensei Investment Highlights Unique, conditionally active MOA of lead VISTA targeted candidate solnerstotug designed to maximize anti-tumor activity and minimize negative side effects characteristic of other first generation, VISTA targeted approaches Expression of VISTA in multiple solid tumor type
Slide 5: Innovative Pipeline of IO Drugs with Broad Commercial Potential
Program (Target) Indication Discovery IND-enabling Phase 1 Phase 2 Upcoming Milestone Full expansion data by year-end 2025 Innovative Pipeline of IO Drugs with Broad Commercial Potential *Sensei has entered into a clinical supply agreement with Regeneron supporting the planned evaluation of solnerst
Slide 6: Differentiated Features of Solnerstotug (SNS-101) VISTA Targeting mAb
Differentiated Features of Solnerstotug (SNS-101) VISTA Targeting mAb
Slide 7: Solnerstotug is a Potential First-in-Class VISTA Targeting mAb
Solnerstotug is a Potential First-in-Class VISTA Targeting Mab That Binds Selectively in the Tumor Microenvironment Tumor cells Periphery Solnerstotug bound to VISTA Solnerstotug unbound Targets VISTA: An immune checkpoint protein and B7 family member that drives immunosuppression analogous to PD-1/
Slide 8: The VISTA Commercial Opportunity
The VISTA Commercial Opportunity Source: Nishizaki, D. et al. ESMO Open, Volume 9, Issue 4, 102942, Incidence and Survival: NCI SEER Data 2024, Expression: internal data and publications Unlike, PD-(L)1, VISTA is Found in Nearly All Solid Tumors with High Unmet Need Tumors with VISTA expression Tumo
Slide 9: The Challenge of Targeting VISTA
The Challenge of Targeting VISTA Dose-limiting toxicity Grade 3 CRS-associated encephalopathy JNJ-61610588 Human Plasma Concentration JNJ-61610588 (CI-8993) was the first anti-VISTA antibody to be studied in clinical trials in 2016 (NCT02671955)1 Transient Cytokine Release Syndrome (CRS) observed in
Slide 10: Solnerstotug Binds VISTA Selectively at the Tumor
Solnerstotug Binds VISTA Selectively at the Tumor Pierre Fabre JNJ Solnerstotug Control Periphery (Neutral pH) = No Binding Solnerstotug has no detectable binding in peripheral or normal tissues Solnerstotug rapidly accumulates in the tumor Solnerstotug 6h post-dosing Isotype control 6h post-dosing
Slide 11: Clinical Trial Collaboration to Evaluate Solnerstotug with Libtayo (cemiplimab)
Clinical Trial Collaboration to Evaluate Solnerstotug with Libtayo® (cemiplimab) Clinical supply agreement with Regeneron’s Libtayo (cemiplimab) to evaluate solnerstotug + cemiplimab as a treatment for solid tumors Libtayo® (cemiplimab): anti-PD-1 monoclonal antibody Solnerstotug: Conditionally acti
Slide 12: Solnerstotug is Designed to Be Unique and Differentiated
Solnerstotug is Designed to Be Unique and Differentiated Johnston et al., Nature 2019; Kineta website; Snyder et al, AACR Annual Meeting 2016; Pierre Fabre website; Hummingbird website; Thakkar et al, J of Immunother Cancer, 2022; PharmAbcine website Solnerstotug Sensei Bio HMBD-002 (Hummingbird) PM
Slide 13: Solnerstotug Dose Escalation Data
Solnerstotug Dose Escalation Data
Slide 14: Solnerstotug Phase 1 Dose Escalation Study
Solnerstotug Phase 1 Dose Escalation Study Cohort A1 0.3 mg/kg N=1 Cohort B1 3.0 mg/kg + cemi* N=6 Cohort A2 1.0 mg/kg N=3 Cohort A3 3.0 mg/kg N=3 Cohort A4 10.0 mg/kg N=3 Cohort A5 15.0 mg/kg N=6 Cohort B2 10.0 mg/kg + cemi* N=6 Cohort B3 15.0 mg/kg + cemi* N=6 Monotherapy Dose Escalation Solnersto
Slide 15: Phase 1 Dose Escalation Data Affirms Solnerstotug's MOA
Phase 1 Dose Escalation Data Affirms Solnerstotug’s MOA and Focused Patient Population in Dose Expansion Solnerstotug positioned to be the first VISTA-targeted mAb to test the VISTA IO hypothesis Well-tolerated Commercially acceptable and potentially best-in-class PK profile First and only agent to
Slide 16: Solnerstotug Dose Expansion Data
Solnerstotug Dose Expansion Data
Slide 17: Dose Expansion Cohort Designed to Explore Efficacy in Hot Tumor Population
Dose Expansion Cohort Designed to Explore Efficacy in "Hot" Tumor Population * Libtayo (cemiplimab) 350 mg "Hot" tumors: Responsive to PD-1 monotherapy "Cold" tumors: Unresponsive to PD-1 monotherapy MSS CRC “Cold” N=10 MSS CRC “Cold” N=10 Phase 1 Dose Expansion ~ 60 patients Phase 1 Study Objective
Slide 18: Patient Disposition Phase 1 Dose Expansion
Patient Disposition Phase 1 Dose Expansion Expansion Cohort Basket of “Hot” Tumors Monotherapy Combination solnerstotug N = 10 (%) solnerstotug + cemi N = 50 (%) Enrolled 10 50 Dose Received 3 mg/kg 15 mg/kg 0 10 (100) 16 (32) 34 (68) Treatment Ongoing 1 (10) 23 (46) Discontinued 9 (90) 27 (54) Reas
Slide 19: Patient Demographics (Patients with Hot Tumors)
Patient Demographics (Patients with “Hot” Tumors) Phase 1 Dose Expansion solnerstotug + cemi N = 40 (%) Gender, n (%) Male 29 (73) Female 11 (27) Age, years Median (min, max) 73.5 (28, 85) Baseline ECOG, n (%) 0 11 (27) 1 29 (73) Prior lines metastatic therapy Median (min/max) 2 (0, 7) Prior PD-1/PD
Slide 20: Historical Response Rates Highlight Difficulties of Re-Challenging with PD-(L)1
Historical Response Rates Highlight Difficulties of Re-Challenging with PD-(L)1 NSCLC Example 1 Fujita et al, 2018 Watanabe et al, 2019 Katayama et al, 2019 Fujita et al, 2020 No. of Patients 12 14 35 15 Reason for discontinuation PD PD PD PD 1st course Re-challenge 1st course Re-challenge 1st cours
Slide 21: Preliminary Efficacy Data in PD-(L)1-Refractory Hot Tumor Patients is Favorable
Preliminary Efficacy Data in PD-(L)1-Refractory “Hot” Tumor Patients is Favorable Phase 1 Dose Expansion Data as of March 17, 2025 -100% * * * * * * * -30% * Patients who received a prior PD-(L)1 (n=21) solnerstotug (3 or 15 mg/kg) + cemiplimab -100% All of PD-(L)1 resistant patients on study with t
Slide 22: Hot Tumor PD-(L)1 Refractory Patients Have Favorable Duration on Study
“Hot” Tumor PD-(L)1 Refractory Patients Have Favorable Duration on Study and Achieved Responses or Long-Term Stable Disease Data as of March 17, 2025 Patients who received a prior PD-(L)1 (n=21) solnerstotug (3 or 15 mg/kg) + cemiplimab Ongoing treatment 07-001 (H&N) and 08-001 (NSCLC): continued be
Slide 23: Merkel Cell Carcinoma Patient (03-009) Complete Response
Merkel Cell Carcinoma Patient (03-009) Complete Response 15 mg/kg solnerstotug + cemiplimab 85 yo male with Merkel Cell Carcinoma of skin (right nasal sidewall) Diagnosed June 2022 TMB 91, MSS. ATR, BLM, RB1 TP53 RASA1, CDKN1B and ARID1B K1250fs Prior treatment: 20Oct2022 to 18Jan2024: Avelumab (Bav
Slide 24: Merkel Cell Carcinoma Patient (01-046) Partial Response
Merkel Cell Carcinoma Patient (01-046) Partial Response 15 mg/kg solnerstotug + cemiplimab 58 yo female with Metastatic Merkel cell carcinoma Diagnosed 2Dec2022 TMB 15.16 mut/Mb KMT2D, DPTOR, EPHA5, CREBBP+ Hx of follicular lymphoma (received chemo followed by Zydelig maintenance until 2021, remissi
Slide 25: MSI-High CRC Patient (01-031) Partial Response
MSI-High CRC Patient (01-031) Partial Response 15 mg/kg solnerstotug + cemiplimab 51 yo male with MSI High CRC (adenocarcinoma of the transverse colon) Diagnosed 18Nov2019 RAS (wild type); NRAS (wild type); BRAF(wild type); MSI-High; MMR- Deficient; MSH2 (S77fs) Prior anti-cancer treatment Dec 2019
Slide 26: Renal Cell Carcinoma Patient (03-011) Stable Disease
59 yo male with metastatic Renal Clear Cell Carcinoma (malignant neoplasm of left kidney, except renal pelvis) Diagnosed 8Mar2017 Evidence of a PTEN deletion in his tumor MSI-high not detected Prior Treatment/Surgery: Apr 2018 to Feb 2019: Pembro + Lenvatinib, best response SD, stopped due to progre
Slide 27: Hepatocellular Patient (01-038) Durable Stable Disease
Hepatocellular Patient (01-038) Durable Stable Disease and Tumor Kinetics and AFP Consistent with a Pattern of Pseudo-Progression 15 mg/kg solnerstotug + cemiplimab 67 yo male with hepatocellular carcinoma Diagnosed 2017 RAD51C; ATM; TP53; CTNNB1 Prior Treatment/Surgery: 2017 and 2018: Chemoemboliza
Slide 28: Solnerstotug is demonstrating favorable early signs of efficacy
Solnerstotug is demonstrating favorable early signs of efficacy in patients with acquired resistance to PD-(L)1 therapy 2/2 patients enrolled with PD-(L)1 resistant Merkel Cell Carcinoma achieved responses, including 1 durable CR and 1 PR. Additionally, a PD-(L)1 resistant MSI-H CRC patient experien
Slide 29: Solnerstotug Continues to be Well Tolerated as Monotherapy and in Combination
Solnerstotug Continues to be Well Tolerated as Monotherapy and in Combination with Cemiplimab Phase 1 Dose Expansion Monotherapy Combination Solnerstotug 15 mg/kg n=10 (%) Solnerstotug 3 or 15 mg/kg* + cemi N=50* (%) At least 1 TEAE 9 (90) 37 (74) At least 1 SAE 3 (30) 12 (24) ≥Grade 3 TEAE 2 (20) 1
Slide 30: Most Frequently Occurring AEs Regardless of Causality
Preferred Term Monotherapy Solnerstotug 15 mg/kg n=10 Combination Solnerstotug 3 or 15 mg/kg + cemi n=50 Total n=60 Hypomagnesaemia 2 8 10 Constipation 2 6 8 Nausea 1 7 8 Fatigue 1 5 6 Infusion related reaction 2 4 6 Anaemia 1 5 6 Diarrhoea 1 4 5 Vomiting 0 5 5 Cytokine Release Syndrome 1 3 4 Dyspno
Slide 31: Pharmacokinetic Data Support Once Every Three Week Dosing
Pharmacokinetic Data Support Once Every Three Week (or Greater) Dosing Detectable in blood for thousands of hours (e.g., weeks) Supports Q3W dosing in humans Dose proportional exposure (0.3 to 15.0 mg/kg) consistent with lack of TMDD No apparent effect on PK with combination Some increase with repea
Slide 32: Approved Checkpoint Inhibitor Treatment Options Studies in PD-(L)1 Resistant Patients
Approved Checkpoint Inhibitor Treatment Options Studies Performed in PD-(L)1 Resistant Patients 1 VanderWalde, A. et al., Nat Med. 2023 (SWOG S1616) 2 Ascierto et al, J Clin Onc, 2023 (RELATIVITY-020) 3 Albrecht et al, Current Oncology Reports 2023 4 Kluger H, et al. J Immunother Cancer 2023 Checkpo
Slide 33: CD8+ TEM / TEMRA Change From Baseline by Dose
Visit C1D1 C1D8 C2D1 C2D8 C3D1 C3D8 C4D1 C5D1 50 40 30 20 10 0 -10 -20 -30 -40 -50 Visit % Change From C1D1 CD8+ TEM / TEMRA 3.0 mg/kg Solnerstotug TEM TEMRA C1D1 C1D8 C2D1 C2D8 C3D1 C3D8 C4D1 C5D1 C6D1 C7D1 C8D1 C9D1 C10D1 C11D1 C12D1 C13D1 C14D1 C15D1 C16D1 C17D1 C18D1 C19D1 -30 -20 -10 0 10 20 30
Slide 34: Exploratory Gene Expression Analysis Identifies Potential Biomarkers of Clinical Benefit
Compares baseline tumor RNA expression between a cohort of patients with observed clinical benefit (“response”) and a subset of non-responders with similar tumor types and demographics Exploratory Gene Expression Analysis Identifies Potential Biomarkers of Clinical Benefit Preliminary analysis that
Slide 35: Phase 2 Strategy
Phase 2 Strategy Solnerstotug 3 or 15 mg/kg* + Anti-PD-1 Phase 2 Study Objectives Primary Anti-tumor activity Secondary Safety, tolerability, PK Anti-PD-1 Randomized * Phase 2 dose dependent on FDA feedback and additional data from dose expansion; possibility that 2 dose levels will be required in P
Slide 36: Completed and Anticipated Solnerstotug Clinical Milestones
Completed and Anticipated Solnerstotug Clinical Milestones First patient dosed in combination with cemi Initial combination dose escalation PK & safety data Full Phase 1 dose expansion data First patient dosed with solnerstotug Initial monotherapy dose escalation PK & safety data Topline Phase 1 mon
Slide 37: Sensei Investment Highlights
Sensei Investment Highlights Unique, conditionally active MOA of lead VISTA targeted candidate solnerstotug designed to maximize anti-tumor activity and minimize negative side effects characteristic of other first generation, VISTA targeted approaches Expression of VISTA in multiple solid tumor type
Slide 38: Maryland 1405 Research Blvd Suite 125, Rockville MD 20850 Massachusetts 22 Boston Wharf Rd
Maryland 1405 Research Blvd Suite 125, Rockville MD 20850 Massachusetts 22 Boston Wharf Rd 7th floor Boston, MA 02210 senseibio.com
Slide 39: Evaluable Hot Tumor PD-(L)1 Refractory Patients on Combination Therapy
Evaluable “Hot” Tumor PD-(L)1 Refractory Patients on Combination Therapy Phase 1 Dose Expansion -30% solnerstotug (3 or 15 mg/kg) + cemiplimab All patients who received a prior PD-(L)1 Data as of March 17, 2025
Slide 40: NSCLC Patient (01-035) Durable Stable Disease
78 yo male with squamous cell carcinoma of the lung Diagnosed 26Oct 2021 PD-1/PD-L1 positive, PD-L1 80% GNAS (R201C), TP53(Y126N), CCDKN2A (E33), TB53 (c.920-2del), ARID1A(P697fs), TMB-17.72 mut/mb Prior Treatment/Radiation Nov 2021: Paclitaxel + Carboplatin + Pembrolizumab in the metastatic setting
Slide 41: Head and Neck Squamous Cell Carcinoma Patient (07-002) Durable Stable Disease
Head and Neck Squamous Cell Carcinoma Patient (07-002) Durable Stable Disease 3 mg/kg solnerstotug + cemiplimab 73 yo male with P16+ squamous cell carcinoma Diagnosed 20June 2020 Positive PD1/PDL1 screening MSS stable, ARID1A , TMB 7muts/mb Prior Treatment/Surgery: Jul20 to Aug 20: Carboplatin + Pac
Slide 42: Renal Cell Carcinoma Patient (04-024) Stable Disease
Renal Cell Carcinoma Patient (04-024) Stable Disease Accompanied by Tumor Regression 3 mg/kg solnerstotug + cemiplimab 59 yo male with renal cell carcinoma Diagnosed 26 November 2014 Prior Treatment/Surgery: 2014: Right nephrectomy Dec 2020 to Feb 2022: Pembrolizumab and Axitinib, best response PR,
Slide 43: Patient Demographics (MSS CRC Patients Only)
Patient Demographics (MSS CRC Patients Only) Phase 1 Dose Expansion Monotherapy Combination Solnerstotug 15 mg/kg n=10 (%) Solnerstotug 15 mg/kg + cemi n=10 (%) Gender, n (%) Male 7 (70) 7 (70) Female 3 (30) 3 (30) Age, years Median (min,max) 53 (41,68) 54.5 (42,72) Baseline ECOG, n (%) 0 3 (30) 4 (
Slide 44: Dose Expansion Patients with Cold Tumors Followed Trend Observed in Dose Escalation
Dose Expansion Patients with “Cold” Tumors Followed Trend Observed in Dose Escalation Study Phase 1 Dose Expansion Data as of March 17, 2025 -100% -30% Monotherapy Combination
Sensei Biotherapeutics — Investor Presentation (March 2025) on 6ix