Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (February 2026)
23 slides from Cue Biopharma's investor presentation, February 2026
Slide 1: Transforming Patients' Lives Through Precision Immunoengineering in Autoimmune Disease
Transforming Patients’ Lives Through Precision Immunoengineering in Autoimmune Disease February 2026 ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D O NO T D I ST R I B U T E 1
Slide 2: Cautionary Note Regarding Forward Looking Statements
Cautionary Note Regarding Forward Looking Statements This presentation has been prepared by Cue Biopharma, Inc. (“we,” “us,” “our,” “Cue” or the “Company”) limited operating history, limited cash and a history of losses; our ability to achieve profitability; potential and is made for informational p
Slide 3: The Problem: Immune Imbalance Underlies Autoimmunity
The Problem: Immune Imbalance Underlies Autoimmunity Regulation is Dominated and Suppressed by Inflammatory Players Deficient Regulatory Cells Dominant Pro-Inflammatory Cells ↓ IL-2 ↑ Autoreactive Teffs ↓ Treg frequency ↑ B cells/Autoantibodies ↓ Treg function ↑ Proinflammatory innate immune cells ↓
Slide 4: CUE-401: A 'Master Switch' of Immune Balance
CUE 401: A ‘Master Switch’ of Immune Balance Restoring Long-Term Tolerance by Re-Establishing Balance via T regulatory cells Expansion of nTregs and Reduction and inhibition iTregs to enhance & IL-2 TGF-β of pro-inflammatory variant variant mechanisms maintain self-tolerance CUE-401 nTregs iTregs Gr
Slide 5: CUE-401: First-in-Class, Bifunctional Tolerogenic Mechanism
CUE-401: First-in-Class, Bifunctional Tolerogenic Mechanism Transformative first-in-class molecule incorporating attenuated components of TGF-β and IL-2 • Unique next generation mechanism tolerizes multiple cell types involved in autoimmunity Pipeline in a Fc Backbone Allows for simultaneous deliver
Slide 6: Nobel Prize Confirms the Role of IL-2 and TGF-β in Treg Induction
Nobel Prize Confirms the Role of IL-2 and TGF-β in Treg Induction Critical Signaling Agents to Produce Induced T-regulatory Cells via FOXP3 Gene Upregulation TGF-β provides the “GO" signal to turn on the FOXP3 gene • Primary cytokine that activates the SMAD pathway and directs FoxP3 transcription, p
Slide 7: Optimizing Biological Activity via Protein Engineering
Optimizing Biological Activity via Protein Engineering Attenuating Cytokine Affinities Retains Key Biologic Functions and Reduces Potential for Effects on Non-Immune Cells IL-2 Induced Reporter TGF-β-Induced Signaling Mask Luminescence (RLU) mean ± SD A450nm, mean ± SD >10,000 fold attenuation >10,0
Slide 8: CUE-401 Induced FOXP3+ Suppressive iTregs From Naïve Murine CD4+ T Cells
CUE-401 Induced FOXP3+ Suppressive iTregs From Naïve Murine CD4+ T Cells IL-2 and TGF-β are Both Critically Required Cytokines to Produce Sufficient iTregs ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D O NO T D I ST R I B U T E Source: Sponsored Research Collaboration with 8 Dr. Richard DiPao
Slide 9: CUE-401 Harnesses Multiple Signals to Induce iTregs
CUE-401 Harnesses Multiple Signals to Induce iTregs Provides Both IL-2 and TGF-β Activating Signals that are Necessary for iTreg Differentiation Control IL-2 alone TGF-β alone CUE-401 FOXP3 CFSE* Conventional T cells ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D O NO Tsuccinimidyl *carboxyflu
Slide 10: CUE-401: Durable Efficacy in Preclinical Model of Autoimmune Gastritis
CUE-401: Durable Efficacy in Preclinical Model of Autoimmune Gastritis Normalizes Histopathologic Gastritis Scores While Markedly Reducing Pathologic Autoimmune Effector T Cells in Tissue Prevention of Autoimmune Gastritis Frequency of Self-Reactive Effector T Cells in In vivo gastritis histology sc
Slide 11: CUE-401: Durable Benefit in Model of Acute GVHD
CUE-401: Durable Benefit in Model of Acute GVHD Increased Tissue Tregs and Maintenance of Graft 9+ Weeks Post-Treatment after 3 Doses Delayed GVHD & Increased Overall Survival Increased Treg Persistence of Human Numbers in GVHD T Cell Graft Provides Target Tissue Evidence of Tolerance P<0.0001 CUE-4
Slide 12: CUE-401: Differentiated Benefit in GVHD Models vs IL-2 Mutein
CUE-401: Differentiated Benefit in GVHD Models vs IL-2 Mutein CUE-401 Increased Survival 9+ Weeks Post-Treatment while IL-2 Mutein Alone Accelerated Disease CUE-401 IL-2 (wild type or a mutein) Significantly delayed development of GVHD Accelerated progression of GVHD & reduced overall & increased ov
Slide 13: CUE-401 Suppresses Effector T Cell Production of Proinflammatory Cytokines
CUE-401 Suppresses Effector T Cell Production of Proinflammatory Cytokines Girgis N et al., 2025,CUE-401: A Novel TGF-beta/IL-2 Fusion Protein for the Induction Expansion of FOXP3+ Regulatory T Cells. Cytokines Conference , Seattle. Washington USA ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D
Slide 14: CUE-401: Suppression of Inflammation in Diverse Models of Disease
CUE-401: Suppression of Inflammation in Diverse Models of Disease Functional Suppression of Inflammation in Multiple Disease Models Supports Broad Applicability in the Clinic EAE Model of Multiple Sclerosis Delayed Type Hypersensitivity – T Cell Mediated Significant inhibition and delay of disease o
Slide 15: NHP Data Indicates Significant Fold Increase in Tregs After Single Dose of CUE-401
NHP Data Indicates Significant Fold Increase in Tregs After Single Dose of CUE-401 CUE-401 - Fold change in % of Tregs CUE-401 - Fold change in number of Tregs/ul ©2025 ©2024 Cue Nektar-358 NHP data suggests 15-fold increase in NHP setting – Dixit et al 2021, ACR 2017 Cue Biopharma C ON FI D E NT I
Slide 16: Highly Differentiated Approach to Immune Balance
Highly Differentiated Approach to Immune Balance Treg Expanders Treg Cell Tolerizing Cytokine CUE-401 (E.g. IL-2 muteins) Therapies Vaccines Blockers TGFβ–mediated suppression of inflammatory cell types YES NO NO NO NO Expansion of nTregs YES YES YES NO NO Generation of iTregs YES NO YES / NO NO NO
Slide 17: Differentiated Efficacy and Safety
Differentiated Efficacy and Safety Unique Biology Compared with Isolated Regulatory T cell Approaches Efficacy Profile Safety Profile Increased quantity of Tregs Attenuation of both TGF- and IL-2 Proliferation of existing Tregs while inducing new self- prevents or limits off target signaling antige
Slide 18: CUE-401: IND Enabling Studies are Ongoing
CUE-401: IND Enabling Studies are Ongoing IND Submission Planned Q2 2026 • Highly manufacturable and stable CMC • Processes and assays established to support release of material for GLP toxicology and clinical studies IND-Enabling • Existing datasets informed GLP study design that will define clinic
Slide 19: Efficient Path to Characterization of CUE-401
Efficient Path to Characterization of CUE-401 Phase 1 Single and Multiple Ascending Dose Study PART 1 PART 2 Single Ascending Dose (SAD) in Multiple Ascending Dose (MAD) in Healthy Volunteers Healthy Volunteers Phase 1 (Part 1) Study Design: Phase 1 (Part 2) Study Design: • Blinded, randomized, plac
Slide 20: CUE-401: Leading Disease Indication Options for Phase 2/3
CUE-401: Leading Disease Indication Options for Phase 2 / 3 Phase 1 PoM May Provide Support for Multiple Opportunities Rheumatoid Inflammatory Graft vs Host Systemic Lupus Primary Biliary Atopic Dermatitis Arthritis Bowel Disease Disease Erythematosus Cirrhosis Decreased Treg Local Treg Decreased Tr
Slide 21: CUE-401: Redefining the Management of Autoimmune Disease
CUE-401: Redefining the Management of Autoimmune Disease With the Potential to Address Disease Control, Maintenance and Restoration* Classic Autoimmune Progression Specific Asymptomatic Non-disease Full blown symptoms, At risk stage with specific autoimmune uncertain autoimmunity symptoms disease di
Slide 22: Thank You
Thank You ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D O NO T D I ST R I B U T E 22
Slide 23: Nektar ACR 2017
Nektar 385 ACR 2017 ©2025 ©2024 Cue Cue Biopharma C ON FI D E NT I A L D O NO T D I ST R I B U T E 23
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