Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Q1 2020 Earnings Presentation
16 slides from Cue Biopharma's earnings presentation, May 19, 2020
Slide 1: Q1-FY 2020 Update Call
Q1- FY 2020 Update Call Immune Responses, On Cue™ Nasdaq: CUE | Tuesday, May 19, 2020
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 s
Slide 3: Agenda
Agenda • Introduction and Q1 Highlights Dan Passeri, CEO • CUE-101 Clinical Update Dr. Ken Pienta, Acting CMO • Pipeline and Platform Progress Dr. Anish Suri, President and CSO • Financials Kerri-Ann Millar, VP Finance • Concluding Remarks Dan Passeri • Q&A All 3 © 2020 CUE BIOPHARMA
Slide 4: Overview of Progress in Q1
Overview of Progress in Q1 • Data from first four CUE-101 patient cohorts demonstrates favorable characteristics and drug properties, including safety, tolerability and dose proportional PK that aligns with projections Validate • Growing evidence supporting that the CUE-101 appears to be “clinically
Slide 5: CUE-101: Phase 1 Clinical Development Network
CUE-101: Phase 1 Clinical Development Network • Emory Winship Cancer Institute: Nabil Saba • Karmanos Cancer Institute: Elizabeth Heath and Ammar Sukari • MD Anderson Cancer Center: Bonnie Glisson • MGH/Harvard and Dana Farber Cancer Institute: Sara Pai and Lori Wirth • Moffitt Cancer Center: Christ
Slide 6: CUE-101: Ongoing First-In-Human Study
CUE-101: Ongoing First-In-Human Study • Eligibility Part A: Monotherapy Dose Escalation - Part A & B: HPV+ H&N Cancer, R/M 2L+ Cohort N • Design (CUE-101 Q3W) - Part A: Dose Escalation (3+3) Cohort 3 - Part A: Safety Expansion (Up to 9 Patients) RP2D:BED/MTD - Part B: Dose Expansion (10-20 Pts at RP
Slide 7: CUE-101: Phase 1 Dose Cohorts
CUE-101: Phase 1 Dose Cohorts Cohort CUE-101 Dose CUE-101 Dose relative to CUE-101 CUE-101 IL-2 content approved Proleukin dose IL-2 content relative to the approved (0.037 mg/kg) (nmol/kg) Proleukin dose (2.4 nmol/kg) Cohort 1 ✓ 0.06 mg/kg (starting ~ 1.6x 1.1 ~ 0.46x dose) Cohort 2 ✓ 0.18 mg/kg ~
Slide 8: CUE-101: Clinical Development Plan
CUE-101: Clinical Development Plan 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H&N R/M 2L+ CUE-101 Monotherapy Parts A & B Safety and Immunologic Effect H&N R/M 1L CUE-101 + anti-PD-1 Combotherapy H&N Neoadjuvant Other HPV-Driven Cancers TBD 8 © 2020 CUE BIOPHARMA
Slide 9: CUE-100 Series: Exploiting IL-2 via Rational Protein Design
CUE-100 Series: Exploiting IL-2 via Rational Protein Design CUE-100 Series Immune Signaling Components Optimized for desired biological activity through two single amino acid changes • Abrogates binding to IL-2R alpha Attenuated • Reduces binding affinity to IL-2R beta Side View IL-2 Maintains IL-2
Slide 10: CUE-100 Series: Mechanistic Differentiation Over Emerging "Not Alpha" IL-2 Landscape
CUE-100 Series: Mechanistic Differentiation Over Emerging “Not Alpha” IL-2 Landscape Wild Type IL-2 “Not Alpha” IL-2 CUE-100 IL-2 Series (e.g., Proleukin) (e.g., THOR-707) (e.g., CUE-101) IL-2R⍺ > = = = = << IL-2Rβ Non-tumor Anti-tumor Non-tumor Anti-tumor Non-tumor Anti-tumor Treg Treg Treg IL-2Rγ
Slide 11: Building Blocks of IO Growth Strategy
Building Blocks of IO Growth Strategy • Increase R&D efficiency via chemical attachment of antigens to HLA Scalability • Enables targeting of multiple tumor antigens, including post-translationally modified peptides and neo-antigens Neo- STATTM Antigen & • Address broader set of tumors (i.e., WT1, K
Slide 12: Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework
Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework CUE-100 Neo-STAT Top Therapeutic scaffold receptive for View Therapeutic scaffold chemical conjugation of peptides, that manufactured in bulk potentially: • Increases R&D efficiency and reduces cost of the generation of clinical grade materia
Slide 13: Primary Human T Cell Expansion: Neo-STAT = Immuno-STAT
Primary Human T Cell Expansion: Neo-STAT = Immuno-STAT CMV CUE-100 Series Immuno-STAT CMV CMV Neo-STAT Responsive MART-1 Neo-STAT Donors MART-1 CUE-100 Series Immuno-STAT MART-1 MART-1 Neo-STAT CMV Neo-STAT Responsive Donors 13 © 2020 CUE BIOPHARMA
Slide 14: Pipeline
Pipeline TARGET SELECTION PRE-CLINICAL PHASE 1 LATE CLINICAL PARTNER CUE-101 (HPV E7 / A02) CUE-100 CUE-102 (WT1 / A02) IL-2 Asia Rights to CUE-102 (WT1 / A24) CUE-101, CUE- 102, and CUE-103 CUE-103 (Undisclosed) CUE-200 KRAS / A11 CD80 & 4-1BBL CUE-201 (Undisclosed) CUE-300 CUE-301 (Proins / DR4) P
Slide 15: Balance Sheet and Statement of Operations Summary
Balance Sheet and Statement of Operations Summary (in thousands) As of March 31, 2020 As of December 31, 2019 Cash and Cash Equivalents $23,432 $44,290 Marketable Securities $25,298 $15,120 Total Current Assets $51,190 $61,025 Working Capital $39,100 $49,370 (in thousands) Q1 2020 Q1 2019 Collaborat
Slide 16: Key 2020 Milestones
Key 2020 Milestones 1 PK/PD results from the Phase 1 CUE-101 clinical trial in 2Q20 2 Clinical responses in Phase 1 CUE-101 via RECIST criteria in 2H20 3 Initiate CUE-101 combination trial with Keytruda in 1L SCCHN in 2H20 4 Initiate and extend IND-enabling activities for CUE-102 in 2H20 5 Select ta