Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Q2 2022 Earnings Presentation
19 slides from Cue Biopharma's earnings presentation, Aug 23, 2022
Slide 1: Q2 Investor/Earnings Call
Q2 Investor/Earnings Call Immune Responses, On Cue™ Nasdaq: CUE August 23, 2022
Slide 2: Forward-Looking Statements Disclosure
Forward-Looking Statements Disclosure 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 sa
Slide 3: Agenda
Agenda • Introduction Dan Passeri, CEO • Immuno-STATS: TCR-selective Engagers Anish Suri, President and CSO • Clinical Update Dr. Ken Pienta, Acting CMO – CUE-101: Representative of IL2 based CUE-100 series Dr. Matteo Levisetti, SVP, Clinical Clinical Development • 2Q-FY22 Financial Results Kerri-An
Slide 4: Immuno-STATs (ISTs): TCR-selective Engagers of Tumor-specific T cells
Immuno-STATs (ISTs): TCR-selective Engagers of Tumor-specific T cells Immuno-STAT Protein Design CUE-100 Series ISTs Enable a Therapeutic Index for IL-2 ANTI-TUMOR IRRELEVANT T CELL T CELL +++ >> +/- IL-2R IL-2R TCR TCR XX IL-2 IL-2 p-HLA p-HLA Fc Fc CUE-100 series Immuno-STAT (IST) © 2022 CUE BIOPH
Slide 5: Key Takeaways
Key TAKEAWAYS Immuno-STAT is an innovative biologics platform for selective delivery of activating signals to tumor-specific T cells • Initial focus on selectively delivering IL-2 to tumor-specific T cells (CUE-100 series) • First clinical experience with CUE-101 in late-stage cancer patients reveal
Slide 6: Ongoing SD and Tumor Reduction in Patient Treated with CUE-101 (2 mg/kg)
Ongoing SD and Tumor Reduction in Patient Treated with CUE-101 (2 mg/kg) Case History Change from Baseline (CFB) in Sum of 80% Diameters of Target Lesion(s) • Prior therapy: 60% – 1L cisplatin, 5-FU, pembrolizumab 40% CUE-101 Monotherapy: 2 mg/kg – 2L Cetuximab/RT 20% • Durable SD > 14 months PD – 3
Slide 7: Ongoing Durable SD, Tumor Reduction and Undetectable cf HPV DNA in Patient Treated with CUE-101 (4 mg/kg)
Ongoing Durable SD, Tumor Reduction and Undetectable cf HPV DNA in Patient Treated with CUE-101 (4 mg/kg) Case History • Prior relapse therapy: – 1L pembrolizumab – 2L carboplatin/taxol CUE-101 Monotherapy: 4 mg/kg • Durable SD approaching 1 year • Progressive disease prior to enrollment • Treated i
Slide 8: CUE-101: Confirmed PR in Monotherapy with Supporting PD Metrics
CUE-101: Confirmed PR in Monotherapy with Supporting PD Metrics Change from Baseline (CFB) in Sum of Increase in HPV E7-specific CD8+ T cells with minimal Diameters of Target Lesion(s) change in total T cells Case History 9-Fold increase 10 10 CD4+ T cells • Prior therapy: 9 9 specific CD8+ T cells
Slide 9: Positive Trend in Overall Survival Observed at RP2D (n=20)
Positive Trend in Overall Survival Observed at RP2D (n=20) Historical 2L mOS ** Response symbols indicate patient experienced PR or Durable SD during the study. Onset and duration of the response is not indicated on the plot. Data Extract 26-July-2022 © 2022 CUE BIOPHARMA 9
Slide 10: Tumor Responses Observed in Dose-Escalation (Part C)
Tumor Responses Observed in Dose-Escalation (Part C) 1 mg/kg CUE-101 + pembrolizumab (N=3) • Durable SD: 1 patient (off treatment WK 18 withdrew consent) • PD: 2 patients (off treatment WK 12 PD) 2 mg/kg CUE-101 + pembrolizumab (N=3) • Confirmed PR: 1 patient (ongoing at WK 36) • Durable SD: 1 patie
Slide 11: CUE-101: Confirmed PR in Combo Cohort (2 mg/kg + pembrolizumab)
CUE-101: Confirmed PR in Combo Cohort 2 (2 mg/kg + pembrolizumab) Baseline Week 18 Longitudinal Target Lesion (TL) Measurements TL2 TL2 TL3 TL3 Change from Baseline in HPV cfDNA (copies/mL) t um or et e ctable Und od i n bl o DNA TL4 TL4 © 2022 CUE BIOPHARMA 11
Slide 12: CUE-101: Confirmed PR in Combo Cohort (4 mg/kg + pembrolizumab)
CUE-101: Confirmed PR in Combo Cohort 3 (4 mg/kg + pembrolizumab) Baseline Week 12 Longitudinal Target Lesion (TL) Measurements TL4 TL3 TL3 Change from Baseline in HPV cfDNA 20 (copies/mL) % Change From Baseline 0 -20 -40 -60 -80 TL4 TL3 TL4 -100 C2 C3 C4 C5 C6 © 2022 CUE BIOPHARMA 12
Slide 13: CUE-102 (WT1): Significant Opportunity in Multiple Solid and Heme Cancers
CUE-102 (WT1): Significant Opportunity in Multiple Solid and Heme Cancers • WT1 is an attractive onco-fetal tumor antigen with significant expression in numerous solid and heme cancers • Solid: CRC, Ovarian, Lung, Gastric, Pancreatic, Breast, GBM • Heme: AML, ALL, MM, MDS • CUE-102 targets a dominan
Slide 14: CUE-102: Monotherapy First-in-Human Phase 1 Trial
CUE-102: Monotherapy First-in-Human Phase 1 Trial CUE-102-01 is a Phase 1, FIH study to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of CUE-102 in subjects who are HLA A*0201-positive, have WT1-positive, recurrent/metastatic cancers, and have fail
Slide 15: BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy
BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy CUE-101 in r/m HNSCC: Rapid Expansion into Indications Across Clinical Proof of Concept & Additional Indications Multiple Alleles Platform De-risking HPV WT1 KRAS G12V/D/R ✓: Clinical Trial In Progress CUE-101 CUE-102 CUE-103 CUE-104, CU
Slide 16: Cue Biopharma, Inc: Q2 2022 Financial Highlights
Cue Biopharma, Inc: Q2 2022 Financial Highlights © 2022 CUE BIOPHARMA 16
Slide 17: Strategic Positioning and Core Strategic Metrics Going Forward
Strategic Positioning and Core Strategic Metrics Going Forward 1) CUE-101 (A02) has clearly demonstrated tolerability and single agent activity ü dose range from 0.06mg/kg – 8 mg/kg with no MTD ü clear evidence of PD effect on tumor-specific immune cells (T cells/ NK cells) ü clinical activity demon
Slide 18: Upcoming Key Milestones
Upcoming Key Milestones • In CUE-101 Monotherapy (mOS data EOY 2022- registration trial anticipated mid 2023) • CUE-101 + Pembrolizumab Combination (preliminary ORR 2Q 2023) • CUE-102 Monotherapy (data from dose escalation by mid 2023-significant market opportunities) • We believe, as substantiated
Slide 19: Thank You
Thank You Rationally Engineered Biologics to Restore Immune Balance by Harnessing “Nature’s Cues” for Selective and Specific Immune Modulation