Cue Biopharma, Inc. · NASDAQ:CUE

Cue Biopharma — Q4 2020 Earnings Presentation

27 slides from Cue Biopharma's earnings presentation, Mar 16, 2021

  1. Slide 1: Q4-FY 2020 Investor Update Call

    Q4-FY 2020 Investor Update Call Immune Responses, On Cue™ Nasdaq: CUE | March 16, 2021

  2. 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

  3. Slide 3: Agenda

    Agenda • Introduction and 4Q-FY 20 Highlights Dan Passeri, CEO • CUE-101 Clinical Update Dr. Ken Pienta, Acting CMO Dr. Matteo Levisetti, Senior VP, Clinical Development • Pipeline and Platform Progress Dr. Anish Suri, President and CSO • 4Q-FY 20 Financial Results & Guidance Kerri-Ann Millar, CFO •

  4. Slide 4: Restoring Immune Balance

    Restoring Immune Balance 4 © 2021 CUE BIOPHARMA

  5. Slide 5: CUE-101, CUE-100 Series and Derivatives

    CUE-101, 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 Neo-STATs Clinical de

  6. Slide 6: 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

  7. Slide 7: 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

  8. Slide 8: CUE-101: Induced Changes in NK Cells and Tregs in Cohorts 1-7

    CUE-101: Induced Changes in NK Cells and Tregs in Cohorts 1 - 7 Cohorts 1 and 2 Cohort 3 Cohort 4 80 80 80 Cohorts 1 and 2 Cohort 3 Cohort 4 NK cells and Tregs NK cells and Tregs NK cells and Tregs [% of CD45+ cells] [% of CD45+ cells] [% of CD45+ cells] 60 60 60 40 40 40 20 20 20 0 0 0 C1D1 C1D8 C1

  9. Slide 9: CUE-101: Cohort 4 Case Study – 3rd line Systemic Treatment

    CUE-101: Cohort 4 Case Study – 3rd line Systemic Treatment Treatment Timeline Outcome Robotic transoral resection First 1 Curative intent tongue base intervention 2 Adjuvant RT 1 mo Curative intent Carboplatin + fluorouracil + Duration: 6.0 weeks 3 cetuximab for advanced, 1 yr, 1 mo Best Response =

  10. Slide 10: Cohort 4 Case Study – PK, PD, Response

    CUE-101: Cohort 4 Case Study – PK, PD, Response Pharmacokinetics: Pharmacodynamics: One target lesion at baseline: Dose proportional Increase in peripheral Diameter: 58 mm blood E7-specific T cells No change for 20 wks 104 Cohort 1 >7-fold increase 0.25 Cohort 2 [CUE-101] (ng/mL) [% of total CD8+ T

  11. Slide 11: 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) 11 © 2021 CU

  12. Slide 12: CUE-101: Cohort 5 Case Study – 3rd Line Systemic Treatment

    CUE-101: Cohort 5 Case Study – 3rd Line Systemic Treatment Treatment Timeline Notes Tolerability 1 RT tongue and neck 0 Curative intent ECOG status: 1 at Duration: 6.0 weeks screening; Unchanged 2 Cisplatin for maintenance 0 Best Response = CR while on CUE-101 Carboplatin + fluorouracil + therapy Du

  13. Slide 13: Cohort 5 Case Study – PK, Response

    CUE-101: Cohort 5 Case Study – PK, Response Pharmacokinetics: Three target lesions at baseline: Dose proportional 1) Tumor mass: 11 mm Sum of Diameters 2) Lymph node No.1: 15 mm (SOD) = 50 mm 105 5 10 2.0 mg/kg1 Cohort 3) Lymph node No. 2: 24 mm 1.0 mg/kg2 Cohort [CUE-101] (ng/mL) 104 4 [CUE-101] (n

  14. Slide 14: Ongoing Pembrolizumab Combination Study

    CUE-101: Ongoing Pembrolizumab Combination Study ClinicalTrials.gov: Part C: Pembrolizumab Combination Dose Escalation Part D: Combination NCT03978689 Expansion at RP2D Eligibility: Initiated February 2021 Dose • HPV+ Head and neck cancer Pembrolizumab • Recurrent or metastatic (R/M) Cohort 3 CUE-10

  15. Slide 15: Preclinical Studies Support Pembrolizumab Combination

    CUE-101: Preclinical Studies Support Pembrolizumab Combination Tumor growth inhibition by mCUE-101 is greatly enhanced Expansion of functional HPV E7 antigen-specific CD8+ T cells in the tumor and in combination with αPD1 blockade periphery by mCUE-101 is greatly enhanced in combination with αPD1 bl

  16. Slide 16: CUE-101 Experience: Potential for Broad Opportunities in IO and AI

    CUE-101 Experience: Potential for 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 C

  17. Slide 17: CUE-100 Neo-STAT: Rationale and Vision

    CUE-100 Neo-STAT: Rationale and Vision To generate a universal immuno-STAT (IST) scaffold via a singular CMC cell line creation (e.g., Goal: MCB) enabling more competitive development metrics (time and cost savings). 25 Note empty % of CMV-specific CD8+ Top View MHC clefts CMV CUE-100 Series IST T c

  18. Slide 18: RDI-STATs: Novel Bi-specifics Re-directing Viral-Specific T Cells to Tumor Cells

    RDI-STATs: Novel Bi-specifics Re-directing Viral-Specific T Cells to Tumor Cells Bi-specific RDI-STAT Viral T Cell Epitope TIL (e.g., CMV) Anti- viral Tcell HLA-A02 IL-2v KILLING IgG Fc TAA • Harnesses a pre-existing and robust viral T cell repertoire present in high frequency • Superior specificity

  19. Slide 19: Approaches to Modulate Autoreactive T Cell Responses

    Approaches to Modulate Autoreactive T Cell Responses 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 generat

  20. Slide 20: Immune Balance: Restoration via Induced Tregs (iTregs)

    Immune Balance: Restoration via Induced Tregs (iTregs) Advantages for iTregs vs. nTregs CUE-401 • Numbers: nTregs are limited in numbers vs iTregs, which can be generated from the broader CD4+ T cell repertoire IL-2 Variant • Diversity: TCR specificity of nTregs is pre-determined and (same as CUE-10

  21. Slide 21: CUE-401: Induction of FoxP3+ iTregs

    CUE-401: Induction of FoxP3+ iTregs Healthy donors Foxp3 CD4 T cells] All80assays performed in 80 [% of Foxp3+ CD4+ T cells] presence of TCR donor 1 iTreg induction + recombinant donor 2 60 iTreg induction activation via CD3/CD28 + 60 + CUE-401 [% of Foxp3 CD4+ T cells] 80 cytokines donor 3 stimulat

  22. Slide 22: CUE-401: Suppression of T Cell Responses by iTregs Induced by CUE-401

    CUE-401: Suppression of T Cell Responses by iTregs Induced by CUE-401 iTreg suppression of polyclonal T cell proliferation 100 % Suppression 80 60 PSM-induced iTregs CUE-401-induced iTregs 40 non-iTreg ctrl CD4+ T cells 20 0 3:1 1:1 1:2 iTreg: Tresponder Ratio Average of 3 donors % suppression compa

  23. Slide 23: CUE-101 Experience: Potential for Broad Opportunities in IO and AI

    CUE-101 Experience: Potential for 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 C

  24. Slide 24: Cue Biopharma, Inc: 2020 Financial Highlights

    Cue Biopharma, Inc: 2020 Financial Highlights 24 © 2021 CUE BIOPHARMA

  25. Slide 25: Cue Biopharma Drug Product Candidate Pipeline

    Cue Biopharma Drug Product Candidate Pipeline TARGET SELECTION PRE-CLINICAL PHASE 1 LATE CLINICAL PARTNER CUE-101 Monotherapy 2L+ (HPV) CUE-101 + Keytruda 1L (HPV) Cancer: CUE-101 Neoadjuvant (HPV) Asia Rights: CUE-100 series CUE-101 and derivatives CUE-102 (WT1) CUE-102 IL-2 CUE-103 CUE-103* KRAS G

  26. Slide 26: Key 2021 Anticipated Milestones: Risk Reduction and Value Creation

    Key 2021 Anticipated Milestones: Risk Reduction and Value Creation 1 2 3 4 Select CUE-101 Report initial results Initiate CUE-101 Continue CUE-102 monotherapy of CUE-101 + neoadjuvant study IND-enabling recommended pembrolizumab to enable studies with IND Phase 2 dose Phase 1 intratumor PD filing in

  27. Slide 27: Thank you

    Thank you Immune Responses, On Cue™ Nasdaq: CUE | March 16, 2021

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