Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (July 2025)
21 slides from Apnimed's investor presentation, July 2025
Slide 1: Investor Presentation July 2025
Investor Presentation July 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 2 of 2 Phase III trials Key upcoming Events • First-in-class, once-daily oral therapy combining a novel anti- • AD109 NDA submission muscarinic and a selective norepinephrine reuptake inhibitor 1Q26 L
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 PRE- PROGRAM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL* AD109 Aroxybutynin OSA Atomoxetine Partnered Programs Shionogi-Apnimed Sleep Science Sulthiame OSA SASS-001 Sleep Apnea Sivopixant with a Central combination Component 8 *NDA package under construction. Has no
Slide 9: AD109 Overview
AD109 OVERVIEW
Slide 10: AD109 Phase 3 Program Overview
AD109 Phase 3 Program overview 1 2 Topline Data Announced July 23, 2025 Announced May 19, 2025 • Randomized (1:1) double-blind, placebo- • Randomized (1:1) double-blind, placebo- Study Design controlled, parallel-arm Phase 3 clinical trial controlled, parallel-arm Phase 3 clinical trial & Sample Siz
Slide 11: Phase 3 Study Designs
Phase 3 Study Designs Screening Run-in Full treatment dose End of study 4 weeks 1dose week 25 weeks 2 weeks AD109 2.5 mg / AD109 37.5 mg 2.5 mg aroxy/75 mg ato Adults with Off- drug AHI4≥ 5 Placebo Placebo Randomization PSG PSG Primary and secondary 1:1 26 weeks endpoint analysis Screening Run-in do
Slide 12: Primary Endpoint Achieved in Each Phase 3 Trial
Primary Endpoint Achieved in each Phase 3 trial PERCENT REDUCTION IN PERCENT REDUCTION IN APNEA-HYPOPNEA INDEX (AHI1) APNEA-HYPOPNEA INDEX (AHI1) % Change From Baseline % Change From Baseline *** *** 55.6 46.8 19.1 6.8 BETTER BETTER Placebo Week 26 AD109 Week 26 Placebo Week 26 AD109 Week 26 Modifie
Slide 13: Topline Results – Overall Summary
Topline Results – Overall Summary • Primary endpoint met in both trials – AD109 lead to a clinically meaningful and statistically significant reduction in Apnea-Hypopnea Index (AHI) compared to placebo (p<0.001) • Secondary endpoints met in both trials – AD109 lead to a clinically meaningful and sta
Slide 14: OSA Market Overview
OSA MARKET OVERVIEW
Slide 15: OSA Market in the US: 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 16: 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 17: 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 18: HCPs See Broad Utility for AD109 Across 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 19: Intellectual Property Position
INTELLECTUAL PROPERTY POSITION AROXYBUTYNIN O OH O • Method of treatment 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
Slide 20: 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 21: 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