Apogee Therapeutics, Inc. · NASDAQ:APGE

Apogee Therapeutics — Technical Presentation (March 2025)

26 slides from Apogee Therapeutics's technical presentation, Mar 3, 2025

  1. Slide 1: APG990 Phase 1 Interim Results

    APG990 Phase 1 Interim Title text 2 Results March 3rd 2025

  2. Slide 2: Disclaimers and Forward-looking statements

    Disclaimers and Forward-looking statements This presentation contains certain "forward-looking statements" within the meaning of applicable securities laws. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements ab

  3. Slide 3: Agenda

    Agenda Michael Henderson, MD Introduction Chief Executive Officer APG279 Scientific Rationale and Carl Dambkowski, MD APG990 Phase 1 Interim Results Chief Medical Officer Kristine Nograles, MD APG279 Development Program SVP, Clinical Development Michael Henderson, MD Building a Leading I&I Company C

  4. Slide 4: Introduction

    Introduction Michael Henderson, MD Chief Executive Officer

  5. Slide 5: Atopic dermatitis is a future $50B market with multiple shots on goal

    Atopic dermatitis is a future $50B market and Apogee has multiple shots to transform the treatment paradigm 100 Three opportunities to demonstrate best-in-class potential in AD with planned readouts before end of 2026 70 Maximize efficacy with potential APG279* 3 Ph1b vs Dupixent 2H 2026 first- / be

  6. Slide 6: APG279 combines APG777 and APG990 for potentially best-in-class efficacy and dosing

    APG 279 APG279 combines APG777 and APG990 – two antibodies targeting validated mechanisms for potentially best-in-class efficacy and dosing in AD OVERLAPPING OPTIMIZED PK AND BROAD & ROBUST EPITOPE FORMULATION INHIBITION HUMAN IL-13 Ex vivo human ALR assay1 77-day half-life APG777 3x lebrikizumab Ov

  7. Slide 7: APG279 Scientific Rationale

    APG279 Scientific Rationale Carl Dambkowski, MD Chief Medical Officer

  8. Slide 8: Targeting all inflammatory types may provide greater efficacy

    APG 279 Targeting all inflammatory types may provide greater efficacy Efficacy of advanced systemics in AD (Week 16, placebo-adjusted) Amlitelimab, Ph2b (250mg Q4W +LD) EBGLYSS Ph3, <60 kg subgroup (N = 180) • JAKs address AD heterogeneity by targeting DUPIXENT Ph3 RINVOQ Ph3, 30mg Type 1-3 inflamma

  9. Slide 9: Preclinical data demonstrate robust Type 1, 2, and 3 inhibition by APG279

    APG 279 Preclinical data demonstrate the robust Type 1, 2, and 3 inhibitory effect of APG279 Ex vivo human allogeneic lymphocyte reaction (ALR) assay1 1 Type 1 2 Type 2 3 Type 3 Untreated = 100% • APG777 targets IL-13 for deep Dosing IFNγ TARC IL-22 125+ inhibition of Type 2 inflammation 100 Lebriki

  10. Slide 10: Combination toxicology study of APG279 showed no toxicity, in contrast to JAK inhibitors

    APG 279 Combination toxicology study of APG279 in non-human primates showed no toxicity at any tested dose, in contrast to JAK inhibitors Clinical Preclinical Toxicology1 Black Box Cytopenia Decreased Spleen, Increased Tachycardia Hypotension Warning Thymus Weight Thymomas Potential infection Potent

  11. Slide 11: APG279 could be dosed as a single 2 mL injection two or four times per year

    APG 279 APG279 could be dosed as a single 2 mL injection two or four times per year in maintenance APG279 pre-filled syringe APG279 2-4 Injections per year Stable at high concentrations Stability (i.e., ≥180 mg/mL) Expected injection time Injectability comparable to DUPIXENT One 2 mL injection every

  12. Slide 12: APG990 Phase 1 Interim Results

    APG990 Phase 1 Interim Results Carl Dambkowski, MD Chief Medical Officer

  13. Slide 13: Interim APG990 Phase 1 data met or exceeded all trial objectives

    APG 990 PHASE 1 Interim APG990 Phase 1 data met or exceeded all trial objectives APG990 PHASE 1 INTERIM DATA SUMMARY GOAL GOAL GOAL Confirm tolerable safety Establish optimized PK Determine dosing regimens profile to enable future profile with a half-life of at to sustain exposures similar to combin

  14. Slide 14: APG990 Phase 1 trial in healthy volunteers is fully enrolled

    APG 990 PHASE 1 APG990 Phase 1 trial in healthy volunteers is fully enrolled with interim data from all cohorts Trial design elements Single ascending dose Double-blind, placebo-controlled, first-in-human trial 1,200 mg (SQ) Single ascending dose in healthy volunteers ×1 dose 600 mg (SQ) N = 40 ×1 d

  15. Slide 15: Baseline characteristics in the APG990 Phase 1 study were in line with expectations

    APG 990 PHASE 1 Baseline characteristics in the APG990 Phase 1 study were in line with our expectations Single dose Placebo Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 75 mg 150 mg 300 mg 600 mg 1,200 mg N=10 N=6 N=6 N=6 N=6 N=7 Age (yrs), mean 34.7 (13.3) 27.5 (7.9) 40.2 (13.8) 40.3 (15.5) 31.8 (1

  16. Slide 16: APG990 was well-tolerated and consistent with assets targeting OX40L

    APG 990 PHASE 1 APG990 was well-tolerated and exhibited a profile consistent with assets targeting OX40L Single dose Overall trial Placebo Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Placebo APG990 75 mg 150 mg 300 mg 600 mg 1,200 mg N=10 N=6 N=6 N=6 N=6 N=6 N=10 N=30 N (%) ≥1 TEAE 5 (50.0%) 4 (66.

  17. Slide 17: APG990 exhibited potentially best-in-class PK with a half-life of ~60 days

    APG 990 PHASE 1 APG990 exhibited potentially best-in-class PK with a half-life of ~60 days Single-dose concentration-time profile1 APG990 half-life was ~2.5-3x longer than amlitelimab 75 mg (N=6) 300 mg (N=6) 1200 mg (N=6) 150 mg (N=6) 600 mg (N=6) APG990 ~60 days ~2.5-3x Serum Concentration, µg/mL

  18. Slide 18: APG990 modeled exposures comparable to amlitelimab enable every 3- and 6-month dosing

    APG 990 PHASE 1 APG990 modeled exposures are comparable to amlitelimab and enable potential every 3- and 6-month dosing for APG279 Modeled concentration based on APG990 Phase 1 PK1 Concentration, μg/mL APG990 (50 mg) Median and 90% PI Every 3 months 20 Potential for APG279 10 Amlitelimab every 3- an

  19. Slide 19: APG279 Development Program

    APG279 Development Program Kristine Nograles, MD SVP, Clinical Development

  20. Slide 20: Phase 1b of APG279 against Dupixent planned to initiate this year

    APG 279 Phase 1b of APG279 against DUPIXENT planned to initiate this year Trial design elements Phase 1b trial in moderate-to-severe AD Randomized assessor-blinded, active comparator trial APG279 (APG777+APG990)1 N ~50-75 R Key inclusion criteria: biologic naïve, moderate- to-severe AD at screening

  21. Slide 21: APG279 Phase 1b clinical trial objectives

    APG 279 APG279 Phase 1b clinical trial objectives Objectives Safety PD biomarkers Efficacy Confirm tolerable safety Demonstrate broader Proportion of patients profile to enable additional pharmacodynamic effect on achieving key endpoints (e.g., combination trials biomarkers of Type 1, 2, and 3 EASI7

  22. Slide 22: Building a Leading I&I Company

    Building a Leading I&I Company Michael Henderson, MD Chief Executive Officer

  23. Slide 23: Our vision for building a next-gen biotech

    Our vision for building a next-gen biotech Best-in-class combinations APG777: • Rapidly advancing with Pipeline-in-a-product potential to break through the monotherapy efficacy ceiling APG777 in AD: • Path to leadership in Best-in-class 10+ potential expansion – APG279 (777+990): Ph1b indications st

  24. Slide 24: Over the next 2 years, 7 clinical trial readouts expected across our pipeline

    CO RPO RAT E Over the next 2 years, 7 clinical trial readouts expected across our pipeline $731M in cash with runway into Q1 2028 KEY READOUT 2025 2026 Potential APG777 • Mid-2025: AD Phase 2 16-week PoC readout • 1H: AD Phase 2 Part A 52-week readout best-in-class IL-13 (fully enrolled) • 2H: AD Ph

  25. Slide 25: Appendix

    Appendix

  26. Slide 26: APG990 was well-tolerated with a favorable safety profile (TEAEs ≥5%)

    APG 990 PHASE 1 APG990 was well-tolerated with a favorable safety profile (TEAEs ≥5% across all cohorts, all grades) Phase 1 Single Ascending Dose: By Cohort Overall Placebo Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Placebo APG990 75 mg 150 mg 300 mg 600 mg 1,200 mg N (%) N=10 N=6 N=6 N=6 N=6 N=6

Apogee Therapeutics — Technical Presentation (March 2025) on 6ix