Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (May 2025)
22 slides from Apnimed's investor presentation, May 2025
Slide 1: Investor Presentation
Investor Presentation May 2025
Slide 2: Disclaimer
DISCLAIMER Forward-Looking Statements This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbour provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than statements of histor
Slide 3: Apnimed is dedicated to sleep-related breathing diseases
APNIMED IS DEDICATED TO SLEEP-RELATED BREATHING DISEASES Lead Product Candidate (AD109) - Completed 1 of 2 Phase III trials Key upcoming Events • First-in-class, once-daily oral therapy combining a novel anti- • Topline results from second muscarinic and a selective norepinephrine reuptake inhibitor
Slide 4: Apnimed Leadership Team, Board Members, Selected Investors
APNIMED LEADERSHIP TEAM Larry Miller, Dennis Molnar Ron Farkas, Ramzi Luigi Taranto Barry Wohl Graham John Yee, John Cronin, MD MD, PhD Benamar Montemurro, Goodrich MD, MPH MD Chief Executive Chief Operating Chief Medical Chief Financial MD Chief Business Chief SVP, Medical SVP, Clinical Officer Off
Slide 5: OSA is a serious chronic sleep-related breathing disease
OSA IS A SERIOUS CHRONIC SLEEP-RELATED BREATHING DISEASE1,2 where the upper airway repeatedly collapses, causing airway obstruction OSA PATHOPHYSIOLOGY1,3 CAUSED BY TWO OVERLAPPING MECHANISMS1,3-5 Hard palate Soft palate Blocked airway Tongue Tongue Neuromuscular Narrowed upper airway dysfunction an
Slide 6: OSA can significantly impact patients' health and quality of life
OSA CAN SIGNIFICANTLY IMPACT PATIENTS’ HEALTH AND QUALITY OF LIFE CHRONIC ACUTE PSYCHOSOCIAL MANIFESTATIONS1-4 MANIFESTATIONS5 MANIFESTATIONS9 • Cardiovascular Disease • Fatigue • Ability to achieve career goals • Metabolic Disease • Daytime sleepiness • Be present for loved ones • Memory loss • Cog
Slide 7: AD109 improves upper airway obstruction
AROXYBUTYNIN AD109 IMPROVES UPPER AIRWAY OBSTRUCTION O OH O (R) N AWAKE Novel anti-muscarinic (new chemical SLEEP Full upper airway entity) is designed to stabilize the Lower tone Upper airway collapse muscle tone upper airway and sleep4,5 UNTREATED OSA TREATED OSA WITH AD109 Single Novel Tablet Co-
Slide 8: Pipeline
PIPELINE PROGRAM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 AD109 Aroxybutynin OSA Atomoxetine Partnered Programs Shionogi-Apnimed Sleep Science Sulthiame OSA SASS-001 Sivopixant Sleep Apnea with a Central Component combination 8
Slide 9: AD109 Overview
AD109 OVERVIEW
Slide 10: AD109 Phase 3 Program overview
AD109 Phase 3 Program overview 1 2 Topline Data Q3 2025 Q2 2025 – topline data announced May 19, 2025 • 660 participants • 646 participants Study Design • Randomized 1:1 to placebo vs. AD109 • Randomized 1:1 to placebo vs. AD109 & Sample Size (aroxybutynin 2.5 mg/atomoxetine 75 mg) (aroxybutynin 2.5
Slide 11: Phase 3 Study Objectives and Design
Phase 3 Study Objectives and Design Study Objective Trial Design Evaluate efficacy and safety of AD109 vs placebo in • Design: Randomized, double-blind, placebo- adult participants with mild to severe OSA across a controlled, parallel-arm Phase 3 clinical trial wide range of weight classes, who are
Slide 12: Participant Demographics
Participant Demographics Characteristic SynAIRgy (N=646) Characteristic SynAIRgy (N=646) Age (yrs), mean (SD) [range] 57.1 (11) [19-87] AHI4, mean (SD) [range] 22 (11) [5-102] BMI (kg/m2), mean (SD) [range] 32.3 (5.0) [18.5-42] AHI4 severity, n (%) Mild, AHI4 5–<15 222 (34.4) BMI, n (%) Moderate, AH
Slide 13: Topline Results - Summary
Topline Results - Summary • Primary endpoint met - Clinically meaningful and statistically significant reduction in Apnea-Hypopnea Index (AHI) (p = 0.001 in ITT). • Secondary endpoint met - Clinically meaningful and statistically significant improvement in Oxygen Desaturation Index ≥3% (p = 0.001 in
Slide 14: Primary Endpoint: Percent Reduction in Apnea-Hypopnea Index
PERCENT REDUCTION IN APNEA-HYPOPNEA INDEX (AHI1) Percent Change From Baseline mean reduction in AHI PRIMARY ENDPOINT: 56% at 26 weeks compared *** (p=0.001) to baseline • Apnea-hypopnea index (AHI4) was reduced by 55.6 56% for AD109 compared to 19% for placebo 51% of participants treated with AD109
Slide 15: OSA Market Overview
OSA MARKET OVERVIEW
Slide 16: OSA market in the US: very large prevalence and low rates of diagnosis and treatment
Significant pent-up demand OSA MARKET IN THE US IS CHARACTERIZED BY VERY LARGE PREVALENCE AND LOW RATES OF DIAGNOSIS AND TREATMENT US MEDICAL CLAIMS ANALYSIS (2019-2024)1 Total estimated US prevalence of OSA2 ~80M KEY INSIGHTS Total unique, diagnosed OSA patients in the US • ~23M unique diagnosis cl
Slide 17: Competitive Landscape
COMPETITIVE LANDSCAPE CPAP IS THE LEGACY STANDARD OF CARE • Majority of diagnosed patients refuse, abandon or under utilize CPAP 1-2 OTHER INTERVENTIONS Surgical Hypoglossal Oral OSA Options3 Neurostimulator3-5 Devices3 FOR NICHE POPULATIONS TREATMENTS WITH STRICT • Highly invasive • Moderate-to-sev
Slide 18: Three profiles of people living with OSA highlight need for new treatment options
THREE PROFILES OF PEOPLE LIVING WITH OSA HIGHLIGHT THE NEED FOR NEW TREATMENT OPTIONS PROFILES OF PEOPLE LIVING WITH OSA CPAP FRUSTRATED WEIGHT LOSS AVOIDING DIAGNOSIS AND INTOLERANT IS NOT ENOUGH DUE TO TREATMENT “I ditched mine after “I thought if I just lost “I think I have it but 2 months of sle
Slide 19: HCPs see broad utility for AD109 across a wide range of patient types
US Market Research HCPS SEE BROAD UTILITY FOR AD109 ACROSS A WIDE RANGE OF PATIENT TYPES, INCLUDING OBESE PATIENTS ON GLP-1s INTENDED UTILIZATION OF AD109 (among all physicians surveyed) DEMAND & UTILIZATION STUDY – August 2024 • 67% state intent to use AD109 within first 6 mos of launch 3001 HCPs P
Slide 20: Intellectual Property Position
INTELLECTUAL PROPERTY POSITION AROXYBUTYNIN O OH O • Method of use patent granted in US and (R) N other geographies for the combination of NRI + Antimuscarinic for OSA (expires 2038) Novel anti-muscarinic (New chemical entity) is designed to stabilize the upper airway and sleep1,2 • Method of use pa
Slide 21: Shionogi-Apnimed Sleep Science: a JV accelerating new therapeutics
Shionogi-Apnimed Sleep Science: a JV accelerating new therapeutics for sleep and breathing diseases JOINT VENTURE SUMMARY • 50/50 JV ownership; both companies contribute certain IP SASS: a joint venture that combines expertises • Apnimed to lead clinical development; Shionogi to lead discovery effor
Slide 22: Obstructive Sleep Apnea
OBSTRUCTIVE OSA is a serious chronic sleep-related breathing disease where the upper airway SLEEP APNEA repeatedly collapses during sleep, causing intermittent oxygen deprivation. In the U.S., over ~23M2 unique diagnosis OSA spans age, sex, and PREVALENCE claims in US between 2019- ~80 million1, bod