Apogee Therapeutics, Inc. · NASDAQ:APGE
Apogee Therapeutics — Investor Presentation (August 2024)
48 slides from Apogee Therapeutics's investor presentation, Aug 12, 2024
Slide 1: Corporate Overview August 2024
CORPORATE OVERVIEW August 2024
Slide 2: Disclaimers and Forward-looking Statements
2 © Apogee Therapeutics, Inc. 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 - lookin
Slide 3: Apogee plans to reshape the current standard of care for I&I diseases
3 © Apogee Therapeutics, Inc. Apogee plans to reshape the current standard of care for I&I diseases with its potential therapies Best - in - class monotherapy in atopic dermatitis • Less frequent dosing with potential for increased efficacy through higher exposures Best - in - class combination ther
Slide 4: Apogee's approach is to achieve differentiated efficacy and dosing
4 © Apogee Therapeutics, Inc. Apogee’s approach is to achieve differentiated efficacy and dosing in the markets it is pursuing Strategy Program Discovery Preclinical Phase 1 Phase 2 Phase 3 Potential best - in - class monotherapy in AD APG777 IL - 13 APG808 IL - 4R α APG990 OX40L APG333 TSLP APG777
Slide 5: Apogee mAbs are engineered for best-in-class properties, including half-life extension
5 © Apogee Therapeutics, Inc. Apogee mAbs are engineered for best - in - class properties, including half - life extension Potential for PK that: • Optimizes exposures • Decreases variability • Increases half - life • Designed to maximize antibody recycling • Drug exists at higher levels for longer
Slide 6: AD, asthma and COPD are the largest and least penetrated markets
6 © Apogee Therapeutics, Inc. • AD, asthma and COPD are the largest and least penetrated markets • Mature I&I markets have consistently achieved high biologics penetration (~30 - 70% after 15 - 20 years), suggesting potential for significant growth in AD (8%), asthma (~20%) and COPD (0%) Apogee is p
Slide 7: Potential best-in-class monotherapy in atopic dermatitis
Potential best - in - class monotherapy in atopic dermatitis
Slide 8: In psoriasis, Skyrizi has taken the lead with quarterly dosing
8 © Apogee Therapeutics, Inc. 0 2 4 6 8 10 12 14 16 18 20 22 24 50 40 60 0 70 100 80 90 Dosing Interval (weeks) Efficacy (PASI - 75, %) In psoriasis, an analog to AD, Skyrizi has taken the lead with quarterly dosing NOTE: Year denotes US launch year for adults with moderate to severe plaque psoriasi
Slide 9: Significant whitespace in the landscape of biologics for AD
9 © Apogee Therapeutics, Inc. There is significant whitespace in the landscape of approved and in - development biologics for AD NOTE: Only DUPIXENT and ADBRY are approved in th e US . SOURCE: 1. Lebrikizumab 250mg Q2W Ph3 avg. Silverberg JI et al. AAD 2022 2. Dupilumab 300 mg Q2W mono Ph3 avg. DUPI
Slide 10: Apogee is pursuing potentially best-in-class monotherapy and first-in-class combination in AD
10 © Apogee Therapeutics, Inc. 0 2 4 6 8 10 12 14 16 18 20 22 24 65 55 70 50 75 45 80 60 85 40 90 35 95 30 100 0 Amlitelimab Rocatinlimab Dupilumab Nemolizumab CBP - 201 Tralokinumab Lebrikizumab Dosing Interval (weeks) Apogee is pursuing potentially best - in - class monotherapy and first - in - cl
Slide 11: APG777 leverages lebrikizumab's mechanism
11 © Apogee Therapeutics, Inc. APG777 leverages lebrikizumab's mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 0.6 1.4 0.5 0.6 STAT6 TARC 13.4 IC 90 (nM) APG777 Lebri DUPIXENT Overlapping region Human IL - 13 APG777's epitope on IL - 13 overlaps with lebrik
Slide 12: APG777 Clinical Data
APG777 Clinical Data
Slide 13: APG777 exhibited a potentially best-in-class PK profile with half-life of ~75 days
13 © Apogee Therapeutics, Inc. APG777 exhibited a potentially best - in - class PK profile with a half - life of ~75 days • Slow clearance, resulting in half - life of ~75 days • Dose - proportional increases in both Cmax and AUC PK demonstrated dose - proportionality and half - life of ~75 days (ap
Slide 14: pSTAT6 and TARC are biomarkers of IL-13 target engagement
14 © Apogee Therapeutics, Inc. pSTAT6 and TARC are biomarkers of IL - 13 target engagement and AD severity 1. pSTAT6 is a proximal and sensitive marker of IL - 13 receptor activation APG777 Phase 1 biomarkers Taken together, APG777’s reduction of these biomarkers confirms inhibition of IL - 13 signa
Slide 15: Single dose APG777 showed near complete pSTAT6 inhibition for ~3 months
15 © Apogee Therapeutics, Inc. Single dose APG777 showed near complete pSTAT6 inhibition for ~3 months (limit of available follow - up) 0 1 2 3 4 5 6 7 8 9 10 11 12 50 100 0 % pSTAT6 Weeks Placebo (N=4) 300 mg (N=1) 600 mg (N=6) 1200 mg (N=6) Sustained APG777 pSTAT6 inhibition supports ability to su
Slide 16: Single dose of APG777 led to deep and sustained TARC inhibition
16 © Apogee Therapeutics, Inc. Single dose of APG777 led to deep and sustained TARC inhibition for ~3 months (limit of available follow - up) APG777 showed similar maximal inhibition of TARC compared to DUPIXENT but improved durability -30 -25 -20 -15 -10 -5 0 0 4 8 12 Weeks % TARC APG777 300 mg NOT
Slide 17: APG777 Phase 2 in AD
APG777 Phase 2 in AD
Slide 18: APG777 Phase 2 regimen is designed to achieve two goals
18 © Apogee Therapeutics, Inc. APG777 Phase 2 regimen is designed to achieve two goals Induction Goal: Exceed lebrikizumab exposures Maintenance Goal: Equal lebrikizumab exposures Lebrikizumab data suggests an exposure - response for efficacy in induction There was no exposure - response observed in
Slide 19: Lebrikizumab Ph3 subgroup with higher exposures had better efficacy
19 © Apogee Therapeutics, Inc. Lebrikizumab Ph3 subgroup with higher exposures had consistently better efficacy across key endpoints Efficacy of biologics in AD (Week 16, placebo - adjusted) 34 26 28 38 25 26 49 38 38 Responders, % EASI - 75 EASI - 90 IGA 0/1 DUPIXENT Ph3 Lebrikizumab Ph3, all patie
Slide 20: Lebrikizumab has demonstrated superior maintenance compared to DUPIXENT
20 © Apogee Therapeutics, Inc. Lebrikizumab has demonstrated superior maintenance compared to DUPIXENT 72 54 82 77 Maintenance of response in AD (Week 52 ) Responders, % EASI - 75 IGA 0/1 • N o dose - response or exposure - response in maintenance was observed for lebrikizumab • Lebrikizumab has sho
Slide 21: APG777 Phase 2 exposures designed to exceed lebrikizumab in induction and equal in maintenance
21 © Apogee Therapeutics, Inc. APG777 Phase 2 exposures are designed to exceed lebrikizumab in induction and equal in maintenance 2 - 4 vs 13 - 26 injections for lebrikizumab/DUPIXENT Modeled concentration of APG777 in induction and maintenance (Q3M) vs lebrikizumab APG777 Median 95% PI Lebrikizumab
Slide 22: Phase 2 design is >90% powered in both Part A / B
22 © Apogee Therapeutics, Inc. Phase 2 design is >90% powered in both Part A / B and has potential for significant acceleration Ongoing integrated Phase 2 trial expected to have 16 - week Part A topline data in 2H’25 Part A: Proof - of - concept (N ~110) Induction Maintenance Screening 2:1 Every 3 m
Slide 23: Phase 2 16-week Part A induction data planned for 2H 2025
23 © Apogee Therapeutics, Inc. Phase 2 16 - week Part A induction data in atopic dermatitis is planned to readout in 2H 2025 Safety Efficacy primary endpoint Efficacy key secondary endpoints Confirm well tolerated safety profile as seen in Phase 1 HV study and in line with other agents in class (e.g
Slide 24: Strong historical correlation between Ph2 and Ph3 data
24 © Apogee Therapeutics, Inc. Strong historical correlation between Ph2 and Ph3 data makes APG777 16 - week induction data a key catalyst SOURCE: Ph3 data for DUPIXENT, RINVOQ, and CIBINQO is from USPI. 1) Guttman - Yassky E et al J All Clin Immunol. 2020. 2) Gooderham MJ et al JAMA Dermatol . 2019
Slide 25: Potential first-in-class combination therapy in atopic dermatitis
Potential first - in - class combination therapy in atopic dermatitis
Slide 26: AD is heterogeneous
26 © Apogee Therapeutics, Inc. AD is heterogenous – Type 2 is the core pathway with varying involvement of Type 1 and Type 3 Severity Age Ethnicity Moderate Severe Type 2 Type 3 Type 1 Pediatric Adult Type 2 Type 3 Type 1 Asian European Type 2 Type 3 Type 1 SOURCE: Adapted from Fania et al. Int. J.
Slide 27: OX40L / OX40 interaction drives Type 1, 2, and 3 inflammation in AD
27 © Apogee Therapeutics, Inc. OX40L / OX40 interaction drives Type 1, 2, and 3 inflammation in atopic dermatitis NOTE: Amlitelimab biomarker changes presented are average values across dose cohorts based on approximate data points from di git ized charts. APC = antigen presenting cell SOURCE: Sanof
Slide 28: OX40L inhibition is clinically validated in AD
28 © Apogee Therapeutics, Inc. OX40L inhibition is clinically validated in AD and has demonstrated broad cytokine suppression Upcoming amlitelimab (OX40L) POC readouts Atopic dermatitis PoC achieved Asthma Ph2b data in H2 2024 Hidradenitis suppurativa (0.4M eligible patient pop.) Ph2 data in 2025 Al
Slide 29: APG990 leverages amlitelimab's mechanism
29 © Apogee Therapeutics, Inc. APG990 leverages amlitelimab’s mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 4.5 6.5 7.8 4.7 OX40 signaling OX40 binding IC 90 (nM) APG990 epitope overlaps with amlitelimab to leverage proven MoA APG990 is as potent as amlit
Slide 30: Potential first-in-class APG777+APG990 combo targets all inflammatory types
30 © Apogee Therapeutics, Inc. Potential first - in - class APG777+APG990 combo targets all inflammatory types, including full Type 2 inhibition NOTE: Amlitelimab biomarker changes presented are average values across dose cohorts based on approximate data points from di git ized charts. APC = antige
Slide 31: IL-13 and OX40L are the two orthogonal mechanisms with greatest efficacy in AD
31 © Apogee Therapeutics, Inc. IL - 13 and OX40L are the two orthogonal mechanisms with greatest efficacy in AD Target IL - 13 1,2 IL - 4R α 3 OX40L 4 IL - 22R 5 IL - 31R 6 TSLP 7 IL - 22 8 Agent Lebrikizumab (high - exposure) Lebrikizumab Amlitelimab LEO138559 Nemolizumab Fezakinumab Inflammation t
Slide 32: Targeting all inflammatory types may provide greater efficacy
32 © Apogee Therapeutics, Inc. Targeting all inflammatory types may provide greater efficacy Efficacy of advanced systemics in AD (Week 16, placebo - adjusted) 29 34 38 49 EASI - 75 Responders, % Amlitelimab, Ph2b (250mg Q4W +LD) DUPIXENT Ph3 Lebrikizumab Ph3, all patients (N = 851) Lebrikizumab Ph3
Slide 33: Potential best-in-class combination therapies in asthma and COPD
Potential best - in - class combination therapies in asthma and COPD
Slide 34: Apogee is pursuing potentially best-in-class combinations in respiratory diseases
34 © Apogee Therapeutics, Inc. 0 10 20 30 40 50 60 70 80 90 100 0 2 4 6 8 10 12 Dosing Interval (weeks) Tezepelumab asthma ITT Mepolizumab asthma ≥150 Benralizumab asthma ≥300 Apogee is pursuing potentially best - in - class combinations in respiratory diseases Reduction in asthma exacerbations Pote
Slide 35: Combo inhibition can lead to additive efficacy in respiratory indications
35 © Apogee Therapeutics, Inc. - 40 - 30 - 20 - 10 - 50 Phase 2a 1 QUEST 2 Placebo - adjusted FeNO change (ppb) PATHWAY 4 NAVIGATOR 5 SOURCE 6 MILLY 7 LUTE/VERSE 8 MESOS 9 Phase 1b 10 VENTURE 3 Respiratory Recent data has suggested combo inhibition can lead to additive efficacy in respiratory indica
Slide 36: Apogee's portfolio uniquely enables multiple respiratory combos
36 © Apogee Therapeutics, Inc. Apogee’s portfolio uniquely enables multiple combos with best - in - class potential in respiratory indications Only known portfolio with IL - 13, IL - 4R ⍺ , OX40L, and TSLP inhibitors to enable optimal respiratory combination approaches Potential to bring Q3M+ dosing
Slide 37: Apogee's TSLP combinations have potential to exceed monotherapy efficacy
37 © Apogee Therapeutics, Inc. Apogee’s TSLP combinations have potential to exceed monotherapy efficacy in a broader population Differentiators APG777 in asthma APG808 in COPD APG777+APG333 in asthma Best - in - class combo in COPD Potential patient population (% eligible) High EOS Potential for bro
Slide 38: APG808 leverages DUPIXENT's mechanism
38 © Apogee Therapeutics, Inc. APG808 leverages DUPIXENT's mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 1.1 1.3 1.9 1.7 STAT6 TARC IC 90 (nM) APG808 Concentration Time 26 vs 12 days Human IL - 4R α APG808's epitope on IL - 4R α overlaps with DUPIXENT’s a
Slide 39: APG808 Phase 1a clinical trial objectives
39 © Apogee Therapeutics, Inc. APG808 Phase 1a clinical trial objectives Confirm tolerable safety profile Establish optimized PK profile with a half - life of at least 42 days Determine dosing regimens to sustain exposures similar to DUPIXENT OBJECTIVES APG808 Dosing Goal: every 6 - or 8 - weeks (vs
Slide 40: Expansion indications
Expansion indications
Slide 41: Our programs have broad potential to disrupt the I&I space
41 © Apogee Therapeutics, Inc. Dermatology AD AA PN BP HS Pulmonology / Immunology Asthma 1 COPD 1 CRSwNP CSU AR 2 ColdU CPUO Food allergy SS Gastroenterology EoE Celiac Disease EGID UC 1 Planned Apogee Ph2 based on well - established mechanism 3 rd party clinical data supporting one or more Apogee
Slide 42: We are pursuing the largest markets in I&I
42 © Apogee Therapeutics, Inc. We are pursuing the largest markets in I&I with a total addressable population over 300M WW addressable patient population across indications (in millions) Indication NOTE: AD = Atopic Dermatitis, COPD = Chronic Obstructive Pulmonary Disease, CSU = Chronic Spontaneous
Slide 43: Corporate & Commercial
Corporate & Commercial
Slide 44: Experienced team with proven history of clinical development and commercial execution
44 © Apogee Therapeutics, Inc. Michael Henderson, MD Chief Executive Officer, Director Carl Dambkowski, MD Chief Medical Officer Jane Pritchett Henderson Chief Financial Officer Rebecca Dabora, PhD Chief Development Officer Matt Batters, JD Chief Legal Officer Wendy Aspden - Curran SVP of Clinical O
Slide 45: Board of Directors with industry-leading expertise
45 © Apogee Therapeutics, Inc. Michael Henderson, MD CEO, Apogee Therapeutics Mark McKenna Chairman & CEO, Mirador Therapeutics Jennifer Fox CFO & CBO, Zenas BioPharma Andrew Gottesdiener, MD Venrock Corporate Board of Directors with industry - leading development, regulatory, commercial and managem
Slide 46: APG777 could command #1 market share in the potentially $50B+ AD market
46 © Apogee Therapeutics, Inc. Analog Differentiation Peak Market Share Corresponding Peak Sales in the potentially $50B AD Market Apogee’s Path Potential for APG777 to be the first No known analogs have best - in - class dosing and efficacy ~$17B+ APG777 has the potential to “win the day” with anti
Slide 47: Multiple anticipated milestones through 2025 with $790M in cash
47 © Apogee Therapeutics, Inc. Corporate Multiple anticipated milestones through 2025 with $790M in cash providing expected runway into 2028 Potential best - in - class monotherapy in AD APG777 IL - 13 ✓ Positive Phase 1 PK & safety in HVs ✓ 1H: Phase 2 initiated in AD • 2H: Phase 2 16 - week induct
Slide 48: Apogee definition
Apogee /ˈ apəjē / noun The highest point in the development of something; a climax or culmination
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