Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Q1 2021 Earnings Presentation
20 slides from Cue Biopharma's earnings presentation, May 17, 2021
Slide 1: Q1-FY 2021 Investor Update Call
Q1-FY 2021 Investor Update Call Immune Responses, On Cue™ Nasdaq: CUE | May 17, 2021
Slide 2: Forward-Looking Statements Disclaimer
Forward-Looking Statements Disclaimer 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 and 1Q-FY 21 Highlights Dan Passeri, CEO • Pipeline and Platform Progress Dr. Anish Suri, President and CSO • CUE-101 Clinical Update Dr. Ken Pienta, Acting CMO Dr. Matteo Levisetti, SVP, Clinical Development • 1Q-FY 21 Financial Results & Guidance Kerri-Ann Millar, CFO • Concl
Slide 4: Rationally Engineered Biologics to Restore Immune Balance
Rationally Engineered Biologics to Restore Immune Balance by Harnessing Nature’s “Cues” for Selective and Specific Immune Modulation
Slide 5: Restoring Immune Balance
Restoring Immune Balance 5 © 2021 CUE BIOPHARMA
Slide 6: CUE-101: Foundational to the CUE-100 Series and Derivatives
CUE-101: Foundational to the CUE-100 Series and Derivatives PRE-CLINICAL PHASE 1 PROTEIN DESIGN TARGET SELECTION PHASE II IND-ENABLING (A)/(B) Immuno- oncology CUE-101 CUE-102 Pipeline HPV Asia Rights: KRAS WT1 CUE-101 CUE-102 G12V IL-2 CUE-103 (TBD) Empty Variant Viral T cell epitope Immuno-STATs N
Slide 7: IL-2-based CUE-100 Series: CUE-101 Clinical Data Supports Broad Utility
IL-2-based CUE-100 Series: CUE-101 Clinical Data Supports Broad Utility of CUE-100 Series Immuno-STATs in Oncology CUE-100 Series “Signal 1” TCR engagement of Tumor-specific T cells Top View Tumor-Peptide Loaded HLA “Signal 2” rationally engineered IL-2: • Abrogate binding to IL-2R⍺: Minimize Treg a
Slide 8: CUE-101 Experience Enables Broad Opportunities in IO and AI
CUE-101 Experience Enables Broad Opportunities in IO and AI Immuno-STAT Pipeline Im Bi-specific RDI-STATs Pipeline m un gy (addresses tumor-escape mechanisms) o-o ol o nc - onc olo no WT1 gy m u Im Viral T cell epitope KRASG12V AI HPV & Infl Tumor-targeting scFv l ogy am nco ma - o tion uno CUE-401:
Slide 9: Approaches to Modulate Autoimmunity
Approaches to Modulate Autoimmunity T Cell Mediated Autoimmune Diseases Antigen-Specific Approach Pathway-Specific Approach AIM: Deploy class I/II Immuno-STATs to AIM: Engineered key signals to restore modulate autoreactive T cells and/or immune balance through generation of generate antigen-specifi
Slide 10: CUE-101: Phase 1 Clinical Development Network
CUE-101: Phase 1 Clinical Development Network Cue Biopharma has engaged a network of nationally recognized clinical investigators and 14 Phase 1 sites are now open • Emory Winship Cancer Institute | Nabil Saba • Karmanos Cancer Institute | Elizabeth Heath and Ammar Sukari • MD Anderson Cancer Center
Slide 11: CUE-101: Ongoing Monotherapy First-In-Human Phase 1 Trial
CUE-101: Ongoing Monotherapy First-In-Human Phase 1 Trial Indication: HPV+ Recurrent or metastatic head and neck cancer with confirmed progressive disease Heavily pretreated: Refractory or resistant to 1st line platinum-based chemotherapy and/or CPIs Part A: Monotherapy Dose Escalation Part B: Monot
Slide 12: CUE-101-01: Patient Characteristics
CUE-101-01: Patient Characteristics Age Mean (range) 63.5 (48-82) Sex Male 35 (97.2%) Female 1 (2.8%) ECOG 0 14 (38.9%) 1 22 (61.1%) Prior Therapies Median (range) 3 (1-7) Prior Platinum Treatment/Regimens Total 34 (94.4%) Multiple Platinum Regimens 18 (50%) Regimens Single Agent 19 (52.8%) Paclitax
Slide 13: CUE-101: Investigator-Assessed AEs by Subject Count
CUE-101: Investigator-Assessed AEs by Subject Count Treatment-Related All Adverse Events Adverse Events* ≥ Grade 3 Any Grade ≥ Grade 3 Any Grade Fatigue 2 (6%) 12 (35%) 2 (6%) 16 (47%) Anaemia 1 (3%) 2 (6%) 2 (6%) 12 (35%) Lymphocyte count decreased 3 (9%) 3 (9%) 6 (18%) 10 (29%) Dyspnoea 0 (0%) 1 (
Slide 14: CUE-101-01: Sustained Exposure Observed with Repeat Dosing
CUE-101-01: Sustained Exposure Observed with Repeat Dosing 105 8.0 mg/kg 4.0 mg/kg [CUE-101] (ng/mL) 104 2.0 mg/kg 1.0 mg/kg 0.54 mg/kg 103 0.18 mg/kg 0.06 mg/kg 102 101 0 72 4 6 8 0 2 4 14 21 28 36 43 50 Hours Post Start of Infusion CUE-101 exposures are dose-proportional and comparable upon repeat
Slide 15: CUE-101: Cohort 4 Case Study – Necrosis and a T Cell Infiltrate
CUE-101: Cohort 4 Case Study – Necrosis and a T Cell Infiltrate Cohort 4 (1 mg/kg) patient was on therapy for over 18 weeks Hematoxylin and eosin stain Immunostaining (cell nuclei = blue; extracellular matrix and cytoplasm = (cell nuclei = blue; CD8+ T cells = rose; pink) PD-LI = brown) 15 © 2021 CU
Slide 16: CUE-101: Objective Response Observed in Patient with Increased E7-specific CD8+ T cells
CUE-101: Objective Response Observed in Patient with Increased E7- specific CD8+ T cells Two target lesions at baseline: Pharmacodynamics: Pharmacodynamics: Sustained increase in NK cells Increased numbers of E7-specific Cohort 6, 4 mg/kg with a transient increase in Tregs CD8+ T cells in the blood
Slide 17: Increase in Tumor Infiltrating T cells Observed Following CUE-101 Administration
Increase in Tumor Infiltrating T cells (TILs) Observed Following CUE-101 Administration Pre-dose Cycle 3 Day 1 1500 CD3+GZMB+ cells 1000 500 20x 0 CD3 GZMB Cytokeratin CD3 GZMB Cytokeratin PRE C3D1 17 © 2021 CUE BIOPHARMA
Slide 18: Cue Biopharma, Inc: Q1 2021 Financial Highlights
Cue Biopharma, Inc: Q1 2021 Financial Highlights 18 © 2021 CUE BIOPHARMA
Slide 19: Key Anticipated Milestones: Risk Reduction and Value Creation
Key Anticipated Milestones: Risk Reduction and Value Creation 2021 2022 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q CUE-101 Mid-2021 1H 2022 Monotherapy Select recommended Ph. 2 dose Complete Ph. 1 trial CUE-101 2H 2021 2H 2022 + Pembrolizumab Report initial Ph. 1 results Report Ph. 1 data CUE-101 2H 2021 2H 2022 Neoad
Slide 20: Thank you
Thank you Immune Responses, On Cue™ Nasdaq: CUE