Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (November 2023)
24 slides from Cue Biopharma's investor presentation, November 2023
Slide 1: Cue Biopharma, Inc. Immune Responses, On Cue
Cue Biopharma, Inc. Immune Responses, On Cue™ Nasdaq: CUE November 2023
Slide 2: Immuno-STATs: A Breakthrough Platform for Immunotherapy
Immuno-STATs: A Breakthrough Platform for Immunotherapy • CUE-100 series: Generation of a therapeutic index for IL-2 – Tolerability and lack of serious IL-2 toxicities • Clinical efficacy in advanced/metastatic cancers – Mono Tx (3L+): prolonged survival – CPI Combo Tx (1L): significant increase in
Slide 3: CUE-101
CUE-101
Slide 4: CUE-101: Lead Clinical Program for HPV Associated Cancers
CUE-101: Lead Clinical Program for HPV Associated Cancers and N eck Cancer Expansion in Head Patient HPV16 E7 IL-2v 2L+ R/M 1L R/M Locally Advanced Fc Note: mOS = Median Overall Survival REGIMEN CUE-101 CUE-101 + KEYTRUDA Neoadjuvant Adjuvant SOC = Standard of Care ORR = Overall Response Rate IIT =
Slide 5: CUE-101 Monotherapy: Patterns of Clinical Efficacy in 2L+ R/M HNSCC Patients
CUE-101 Monotherapy: Patterns of Clinical Efficacy in 2L+ R/M HNSCC Patients Patient A Patient B Percent Change from Baseline (CFB) in Percent Change from Baseline Sum of Diamieters of Target Lesion(s) HPV cfDNA Sum of Target Lesions 60 20 PD 40 0 20 PD -20 0 PR -40 -20 PR -60 -40 -80 -60 -100 -80 B
Slide 6: CUE-101 Monotherapy: Potential Best-in-Class 2L+ Regimen
CUE-101 Monotherapy: Potential Best-in-Class 2L+ Regimen for Patients with HPV+ R/M Head and Neck Median Overall Survival (mOS) 20.8* MONTHS *As of SITC cutoff date; Kaplan Meier estimate 7.5 8.4 1 OPDIVO KEYTRUDA 2 CUE-101 3 2L 2L 3L+ Prolonged survival observed with CUE-101 monotherapy compared to
Slide 7: CUE-101: Lead Clinical Program for HPV Associated Cancers
CUE-101: Lead Clinical Program for HPV Associated Cancers and N eck Cancer Expansion in Head Patient HPV16 E7 IL-2v 2L+ R/M 1L R/M Locally Advanced Fc Note: mOS = Median Overall Survival REGIMEN CUE-101 CUE-101 + KEYTRUDA Neoadjuvant Adjuvant SOC = Standard of Care ORR = Overall Response Rate IIT =
Slide 8: CUE-101 + KEYTRUDA: Potential Best-in-Class 1L Regimen
CUE-101 + KEYTRUDA: Potential Best-in-Class 1L Regimen for Patients with HPV+ R/M Head and Neck Cancer Extends CPI 56% monotherapy efficacy in low- 47% responder patients Overall Response Rate (i.e., CPS 1-19) 38% (RECIST 1.1) Represents ~50% of all 1L patients eligible for KEYTRUDA 23% 19% monother
Slide 9: Survival in Combination Patients at the RP2D
Survival in Combination Patients at the RP2D Current mPFS 5.8 months and maturing mPFS for 1L Pembro ~ 3.2 months* Overall survival (months from 1st dose) in patients treated with 4 mg/kg CUE-101 and pembrolizumab (N=22) at 27-Sep-2023. Durable stable disease (SD) requires RECIST 1.1 SD on ≥ 2 conse
Slide 10: CUE-101: Market Opportunities in HPV Associated Cancers
CUE-101: Market Opportunities in HPV Associated Cancers Clinical Development and Market Opportunities CUE-101 Up to $500M Cervical, CUE-101 US & EU Head and Neck Genitoanal R/M Opportunity1 HPV16 E7 Overview of IL-2v CUE-101 Phase 1 Up to $750M Recurrent/ Locally >$1B CUE-101 US & EU CUE-101 US & EU
Slide 11: CUE-101: Clinical Validation and Platform De-risking
CUE-101: Clinical Validation and Platform De-risking ü Demonstrated single-agent anti-tumor activity • RECIST-based PR and durable stable disease (DSD) in 3L+ R/M HNSCC patients • Prolonged survival observed (Kaplan-Meier estimate of mOS >20 months) ü Enhancement of clinical efficacy in combination
Slide 12: CUE-102
CUE-102
Slide 13: Wilms' Tumor 1: Well Characterized Cancer Target with Broad Applicability
Wilms’ Tumor 1: Well Characterized Cancer Target with Broad Applicability CUE-102 Molecular Design Wilms Tumor 1 (WT1)1 • Ranked as #1 cancer antigen by National Cancer Institute 1 WT137-45 IL-2 Variant • Intracellular oncofetal antigen, favorable clinical track (Same as record with low potential fo
Slide 14: CUE-102: Phase 1 U.S. Trial Population and Market Opportunities
CUE-102: Phase 1 U.S. Trial Population and Market Opportunities U.S. Patients Addressable by CUE-102 (HLA-A:02+, WT1+) 50,000 Up to $5.0B/Year Number of Patents 40,000 Market Opportunity Up to $4.5B/Year Up to $3.4B/Year Market Opportunity 30,000 Market Opportunity 20,000 10,000 0 Ongoing Phase I Po
Slide 15: CUE-102: Ongoing Phase 1 Study
CUE-102: Ongoing Phase 1 Study CUE-102 Patient Screening Indicates Substantial CUE-102 Monotherapy Trial Design1 WT1 Expression Across Target Indications2 Part A: Dose Escalation (CUE-102 Q3W IV, 3 + 3 Design) Cohort 4 8 mg/kg Cohort 3 100% 4 mg/kg Cohort 2 RP2D 60% 53% 60% 2 mg/kg Cohort 1 1 mg/kg
Slide 16: CUE-102: Dose Escalation Patient Status by Cohort
CUE-102: Dose Escalation Patient Status by Cohort Cohort Treated Evaluable SD DCR Status C1 (1 mg/kg) 3 3 1 33% 0/3 on treatment C2 (2 mg/kg) 6 5 4 80% 3/6 on treatment C3 (4 mg/kg) 5 4 3 75% 4/5 on treatment C4 (8 mg/kg) 4 2 1 50% 2/4 on treatment Fourteen of 18 patients had at least 1 post-dose sc
Slide 17: CUE-102: Tumor Reduction Observed in Heavily Pre-treated Gastric Cancer Patient
CUE-102: Tumor Reduction Observed in Heavily Pre-treated Gastric Cancer Patient (2mg/kg dose) Sources: CUE-102 SITC Poster Nov 2023 © 2023 CUE BIOPHARMA 17
Slide 18: CUE-102: Tumor Reduction Observed in Heavily Pre-treated Ovarian Cancer Patient
CUE-102: Tumor Reduction Observed in Heavily Pre-treated Ovarian Cancer Patient (2mg/kg dose) Sources: CUE-102 SITC Poster Nov 2023 © 2023 CUE BIOPHARMA 18
Slide 19: BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy
BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy Clinical PoC with CUE-101 Provides a Springboard for Platform Expansion into Broad Indications Clinical-stage Assets “Empty” HLA KRASG12D receptive to chemical HPV WT1 KRASG12V conjugation of tumor epitope PRAME IL-2 MAGE-A4 COL6A3 HLA C
Slide 20: Competitive Positioning & Upcoming Milestones
Competitive Positioning & Upcoming Milestones
Slide 21: Immuno-STATs: Best-in-class T cell Engagers
Immuno-STATs: Best-in-class T cell Engagers Immuno-STATs T Cells Cancer Costimulatory Signal Stabilized pHLA (TCR Binder) Selective Antigen-specific Activation & Tumor Cell Killing Expansion via Fc T Cell Receptor Backbone Key Points of Differentiation as demonstrated with first clinical candidate:
Slide 22: Current State of Immunotherapy: Significant Unmet Need Remains
Current State of Immunotherapy: Significant Unmet Need Remains Despite Recent Breakthroughs with Checkpoint Inhibitors Reported Overall Response Rate with PD-1/PD-L1 Monotherapy1 100% 80% CUE-101+CPI CUE-102 60% 47% Demonstrated enhancement Opportunity to enhance historically low responses with CPI
Slide 23: Immuno-STAT Platform: Positioned for Near-term Value Inflection
Immuno-STAT Platform: Positioned for Near-term Value Inflection Milestones CUE-101 Monotherapy 1Q 2024: Define Registration Path Immuno-STATs 1H 2024: Provide Topline Readout CUE-101 + Pembrolizumab 2H 2024: Define Registration Path CUE-101 Neoadjuvant (IST) 1H 2024: Complete Enrollment for Neoadjuv
Slide 24: Thank You
Thank You Immune Responses, On Cue™
Cue Biopharma — Investor Presentation (November 2023) on 6ix