Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (November 2023)
25 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: Disclaimers
Disclaimers This presentation has been prepared by Cue Biopharma, Inc. (“we,” “us,” “our,” “Cue” or the “Company”) and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities in an
Slide 3: 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 4: CUE-101
CUE-101
Slide 5: 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 REGIMEN CUE-101 CUE-101 + KEYTRUDA Neoadjuvant Adjuvant STATUS Phase IA/IB Phase IA/IB IST IST Note: mOS = Median Overall Survival Fully Enrolled Ful
Slide 6: 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 7: CUE-101 Monotherapy: Potential Best-in-Class 2L+ Regimen for HPV+ R/M Head and Neck Cancer
CUE-101 Monotherapy: Potential Best-in-Class 2L+ Regimen for Patients with HPV+ R/M Head and Neck Cancer 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 comp
Slide 8: 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 REGIMEN CUE-101 CUE-101 + KEYTRUDA Neoadjuvant Adjuvant STATUS Phase IA/IB Phase IA/IB IST IST Note: mOS = Median Overall Survival Fully Enrolled Ful
Slide 9: 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 10: 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 11: 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 12: 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 13: CUE-102
CUE-102
Slide 14: 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 15: 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 16: 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 17: 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 18: 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 18
Slide 19: 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 19
Slide 20: Broad Opportunities for CUE-100 Series in Cancer Immunotherapy
BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy Clinical Proof of Concept (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 M
Slide 21: Competitive Positioning & Upcoming Milestones
Competitive Positioning & Upcoming Milestones
Slide 22: 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 23: 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 24: 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 25: Thank You
Thank You Immune Responses, On Cue™
Cue Biopharma — Investor Presentation (November 2023) on 6ix