Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (January 2025)
31 slides from Elicio Therapeutics's investor presentation, Jan 23, 2025
Slide 1: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX January 2025
Slide 2: Disclaimers: No Representation or Warranty
Disclaimers No Representation or Warranty We do not make and hereby expressly disclaim any representation or warranty, express or implied, as to the reasonableness of the assumptions made in the Presentation or the accuracy or completeness or the information contained in or incorporated by reference
Slide 3: Disclaimers: Forward-Looking Statements
Disclaimers 3 Forward-Looking Statements This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, k
Slide 4: Amphiphile (AMP) Technology and ELI-002 Overview
4 Amphiphile (“AMP”) Technology • AMP delivers payloads to lymph nodes eliciting immune responses with increased magnitude, function, and durability • Designed to use the lymph nodes to educate, activate and amplify differentiated T cell responses to eliminate tumor cells • AMP technology offers pot
Slide 5: H2 2024 Execution
• $33M in new capital raised – expected to fund the Company into Q2 2025 beyond the anticipated Phase 2 interim analysis • ELI-002 7P updated Phase 1a data presented at AACR-Special Conference-Pancreatic Cancer • ELI-002 7P updated Phase 1a data presented at SITC • ELI-002 Phase 3 trial study design
Slide 6: Lymph Nodes Essential for Eliciting Robust T Cell Responses
6 • Expansion • Phenotype • Effector Function • Anti-tumor Activity Response Coordination The Immune “School House” Numerous Immune Cells APC : T Cell Interaction T Cell Response Lymph Node Targeting Lymph Nodes Essential for Eliciting Robust T Cell Responses Immune biology in the Lymph Nodes direct
Slide 7: AMP Technology Targets Vaccine Delivery to Lymph Nodes
7Pant, et al. Nature Medicine 2024; Liu, et al. Nature 2014; Moynihan, et al. Nature Medicine 2016; Ma, et al. Science 2019 ➢ APC Activation ➢ T Cell Expansion and Activation Immune Response 5 Subcutaneous injection 1 Lymph Node Lymph node targeting 3 Antigen Presenting Cell Delivery to immune cells
Slide 8: ELI-002 Is a Lymph Node Targeted mKRAS Vaccine
8 ELI-002 G12X G13X Peptide Composition 2P D R 7P D R V C S A D ELI-002 Albumin Binding Lipid for Lymph Node Targeting CpG DNA: TLR-9 Agonist X X Albumin Binding Lipid for Lymph Node Targeting mKRAS PeptidePEG Linker • 2 or 7 AMP-peptides • CD8 and CD4 epitopes • Potent TLR-9 immune activator AMP-mK
Slide 9: mKRAS Opportunity and Addressable Incidence
9 Incidence for the 7 Major Markets (MM): US, France, Germany, Italy, Spain, UK, and Japan Sources for tumor incidence obtained from GLOBOCAN (2020). PDAC: 90% of pancreatic cancers (O’Reilly, 2021), NSCLC 84.3% of lung cancers (SEER, 2021), BTC: 15% of liver cancers + gallbladder Sources for KRAS m
Slide 10: Lymph Node Targeted Vaccine vs Small Molecules and Neoantigen Vaccines
10 Promising P1 data in PDAC and CRC Targeting 7 mKRAS driver mutations Lymph Node Targeting MOA Off-the-shelf simplicity, COGs Robust T cell Response (CD4 + CD8) Monotherapy activity Potential durable clinical benefit Potential broad application for ~25% of human solid cancers expressing mKRAS Sign
Slide 11: Phase 1 Clinical Data Summary
• MRD+ PDAC (n=33) and CRC (n=6) patients treated after local surgery and chemotherapy (adjuvant setting) • Phase 1 trials included dose-ranging for both peptide and adjuvant components of ELI-002 • Data from both trials have shown: • ELI-002 was well tolerated at all dose levels, with no DLTs or SA
Slide 12: ELI-002 2P: Phase 1a Trial of 2-Peptide Formulation
ELI-002 2P: Phase 1a Trial of ELI-002 2-Peptide Formulation First-in-human Study: mKRAS G12D or G12R-expressing, Adjuvant treatment of MRD+ PDAC and CRC
Slide 13: ELI-002 2P Phase 1a Trial Design
13 20-Months Follow-up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) E L I - 0 0 2 M O N O T H E R A P Y : N C T 0 4 8 5 3 0 1 7 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=20 n=5 ✓ mKRAS G12D / R – aligned to 2 peptide
Slide 14: ELI-002 2P Tumor Biomarker Responses
14 • Waterfall displays best response of ctDNA or serum tumor biomarker • Most patients (84%, 21/25) showed decline from baseline in ctDNA or CEA/CA19-9 levels • 24% of patients (6/25) showed complete clearance of ctDNA • Responses observed in PDAC and CRC, mKRAS G12D and G12R • Responses observed d
Slide 15: ELI-002 Elicits Robust Immune Responses
Baseline Max Response 0 5 10 20 30 40 50 450 F o ld C h a n g e f ro m B a s e li n e 2 15 • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 84% of patients showed T cell responses; 100% at the RP2D (10 mg) • 58x average fold-change in T cell
Slide 16: T Cell Response Magnitude Correlates with Tumor Biomarker Response
Clearance Reduction Non-Responder ≥Median <Median -100 0 100 200 300 T Cell Response (Fold change f rom baseline) B e s t O v e ra ll B io m a rk e r R e s p o n s e (% o f B a s e li n e ) ✱✱ 16 • Strength of T cell response to ELI-002 is strongly correlated to tumor biomarker response • 100% of th
Slide 17: ESMO-IO Update: RFS in Full Cohort vs PDAC Subgroup
17 Phase 1AELI-002 2PESMO-IO UPDATE: RFS in Full Cohort vs PDAC Subgroup Median follow up has increased to 19.7 months vs 8.5 months in Pant et al., 2024 Nature Med Median RFS times similar for the full cohort and PDAC subgroup: Data cut-off Sept 24, 2024 Full Cohort (n=25)Relapse-free Survival: R e
Slide 18: Strong Correlation between RFS and T Cell Response
18 Phase 1AELI-002 2P2024 ESMO-IO Update Shows Strong Correlation between RFS and T Cell Response RFS Prolonged - no relapse or death in 10/13 (77%) of above median T cell group Data cut-off (DCO): September 24, 2024 • 10/13 in the above median T cell group have not relapsed or died • Favorable RFS
Slide 19: ELI-002 2P Relapse-free and Overall Survival
19 Phase 1AELI-002 2P2024 ESMO-IO Update Shows Early Encouraging Patient Survival Full Cohort (n=25) Overall Survival; mOS 28.94 mo is longer than historical for PDAC, CRC not yet estimable DCO September 24, 2024 Overall Survival: O ve ra ll Su rv iv al Months No. at Risk 25 25 23 23 22 20 13 6 2 2
Slide 20: ELI-002 7P: Phase 1a Trial of 7-Peptide Formulation
ELI-002 7P: Phase 1a Trial of ELI-002 7-Peptide Formulation First-in-human Study: mKRAS G12x or G13D-expressing, Adjuvant treatment of MRD+ PDAC and CRC
Slide 21: ELI-002 7P Phase 1a Trial Design
21 32-Months Follow-up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) E L I - 0 0 2 M O N O T H E R A P Y : N C T 0 5 7 2 6 8 6 4 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=13 n=1 ✓ Includes: mKRAS G12D/R/V/C/A/S/G13D ✓
Slide 22: ELI-002 7P Elicits Immune Responses in all Phase 1a Patients
0 5 10 15 20 25 30 100 200 300 F o ld -c h a n g e f ro m b a s e li n e 22 • 100% of patients showed T cell responses • 4.9 mg dose group selected for Phase 2 • Median fold change = 113.3x • 85.7% with CD4 and CD8 T cells • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry
Slide 23: ELI-002 2P vs ELI-002 7P 4.9 mg
23 ELI-002 2P (Nat Med) ELI-002 7P (All) ELI-002 7P (4.9 mg) Response Rate 84% 100% 100% Median Fold Change 12.8 18.5 113.3 CD4 + CD8 T cells 59% 75.0% 85.7% Response to 7 mKRAS Antigens 52.4% 50.0% 71.4% Response to Tumor Antigen 81% 83.3% 100% • ELI-002 7P data based on n=12 Patients (1.4 mg, n=5;
Slide 24: ELI-002 Stimulates Antigen Spreading
24 • ELI-002 7P vaccination led to expansion of T cell responses targeting passenger mutations alongside mKRAS driver mutations in a majority of evaluable patients • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 70% of evaluated patients (7
Slide 25: ELI-002 7P Tumor Biomarker Responses
25 • 71% (5/7) of patients in the 4.9 mg dose had biomarker decline • 40% (2/5) of patients in the 1.4 mg dose had biomarker decline • 14% (1/7) PDAC patients at 4.9 mg dose had complete clearance • Response may deepen over time (some patients not yet finished boosters) Amph-Peptides-7P Dose 1.4 mg
Slide 26: T Cell Response Drives Tumor Biomarker Response
> Median < Median -100 0 100 200 T Cell Response (Fold change f rom baseline) B e s t O v e ra ll B io m a rk e r R e s p o n s e (% o f B a s e li n e ) ✱ Clearance Reduction Non-Responder 26 • Strength of T cell response to ELI-002 is correlated to tumor biomarker response • 100% (6/6) of the abov
Slide 27: ELI-002 7P: DFS Strongly Correlates with T Cell Response
0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D is e a s e -f re e S u rv iv a l (% ) 27 Phase 1AELI-002 7P Supervised by Median T cell Fold Change 6 mo 12 mo Median DFS: not reached Median DFS: not reached ≥ Median T Cell Response (n = 6) < Median T Cell Response (n = 6) No. at Risk 6 6 5 3 1 0 6
Slide 28: ELI-002 7P Safety / Tolerability
28 • No DLT observed, No CRS or T cell Toxicities • Most common TRAE (>20%) were Fatigue (28.6%; all Gr1) and Malaise (21.4%; all Gr1) • One (1) pt had SAE (107-002) 1.4 mg dose non- treatment related intestinal obstruction resulted in hospitalization and w/d from treatment • No dose modification •
Slide 29: Phase 2 Trial Design and Phase 3 Alignment
Design aligned in FDA meeting: Randomized, blinded trial; primary endpoint investigator assessed DFS using modified RECIST (new lesions confirmed by biopsy/imaging) Phase 3 ✓ mKRAS: Expanded Antigen Coverage G12D / R / V / C / A / S / G13D 29 C L I N I C A L S T U D Y O V E R V I E W : N C T 0 5 7 2
Slide 30: Key Milestones Achieved and Growth Initiatives for 2025-2026
30 ✓ Preliminary Phase 1 T Cell and biomarker response (ASCO) ✓ T cell and Antigen Spreading (SITC) ✓ Complete Phase 2 enrollment with 144 patients enrolled (4Q 2024) ✓ FDA Type B Meeting (4Q 2024) ❑ Phase 2 DFS Interim Analysis (expected H1 2025) ❑ End of Phase 2 FDA Meeting (expected H2 2025) ❑ In
Slide 31: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX January 2025
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