Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (December 2024)
24 slides from Apnimed's investor presentation, Dec 2, 2024
Slide 1: Developing Novel Oral Medicines to Expand the Reach of Treatment for Sleep Apnea
DEVELOPING NOVEL ORAL MEDICINES TO EXPAND THE REACH OF TREATMENT FOR SLEEP APNEA
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: Our Manifesto
OUR MANIFESTO Declaration of beliefs, intention, and motivation Discovering, developing, and commercializing novel, oral therapies that address the neurobiology of Apnimed stands boldly for people living with obstructive sleep-related breathing diseases sleep apnea (OSA) and other sleep-related brea
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 Chief Operating MD, PhD Benamar Montemurro, Chief Business Goodrich MD, MPH MD Chief Executive Officer Chief Medical Chief Financial MD Officer Chief SVP, Medical SVP, Clin
Slide 5: Current Product Pipeline
CURRENT PRODUCT PIPELINE PROGRAM INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 AD109 Aroxybutynin OSA Atomoxetine Other Sleep and JV Programs Shionogi-Apnimed Breathing Disorders Sleep Science UPCOMING MILESTONES Phase 3 SynAIRgy/LunAIRo Topline data for LunAIRo and NDA Submission to FDA
Slide 6: Apnimed Is Poised to Transform the Treatment of OSA
APNIMED IS POISED TO TRANSFORM THE TREATMENT OF OSA and other sleep-related breathing diseases with novel, oral medicines INNOVATIVE PRODUCT UNTAPPED MARKET EXPERIENCED & RESOURCED TEAM Our lead candidate, OSA is very large market Well-positioned to succeed AD109 offers new hope for with a massive u
Slide 7: OSA Market Overview
OSA MARKET OVERVIEW
Slide 8: 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 intermittent oxygen deprivation OSA PATHOPHYSIOLOGY1,3 CAUSED BY TWO OVERLAPPING MECHANISMS1,3-5 Hard palate Soft palate Blocked airway Tongue Tongue Neuromuscular Predisposing anatomic d
Slide 9: Oxygen Deprivation Due to OSA
OXYGEN OSA CHRONIC MANIFESTATIONS1-4 OSA ACUTE MANIFESTATIONS5 DEPRIVATION • Hypertension • Daytime sleepiness DUE TO OSA • Cardiovascular Disease • Fatigue • Stroke • Cognitive impairment Increases the risk • Memory loss • Loud snoring of long-term health consequences and acute • Type 2 Diabetes •
Slide 10: OSA Market in the US: Very Large Prevalence and Low Rates of Diagnosis and Treatment
Significant latent demand OSA MARKET IN THE US IS CHARACTERIZED BY VERY LARGE PREVALENCE AND LOW RATES OF DIAGNOSIS AND TREATMENT US MEDICAL CLAIMS ANALYSIS (2019-2023)a Total estimated US prevalence of OSAb ~80M Total unique, diagnosed KEY INSIGHTS OSA patients in the US • ~23M unique diagnosis cla
Slide 11: Current Treatment Landscape
CURRENT TREATMENT LANDSCAPE
Slide 12: No Pharmacological Agent Exists to Address the Underlying Neuromuscular Dysfunction in OSA
Current treatment landscape NO PHARMACOLOGICAL AGENT EXISTS TO ADDRESS THE UNDERLYING NEUROMUSCULAR DYSFUNCTION IN OSA LEGACY STANDARD OF CARE PAP/CPAP/BIPAP • Highly effective when used compliantly and persistently1,2 • Long-term compliance is less than 50%3 • ~34% of patients continue to use CPAP
Slide 13: Majority Refuse, Abandon or Underutilize CPAP After Diagnosis
CPAP Initiation and persistence EVEN AFTER BEING DIAGNOSED, THE MAJORITY OF PEOPLE EITHER REFUSE, ABANDON OR UNDERUTILIZE CPAP TREATMENT COMMON CHALLENGES TO CPAP INITIATION & PERSISTENCE1,a CPAP INITIATION & PERSISTENCE2,3 Among Diagnosed Population • Long Lead Times: Between prescription and initi
Slide 14: GLP1/GIP Trial: Positive Effect in Subset of OSA With Obesity; Huge Unmet Need Remains
LILLY SURMOUNT–OSA trial synopsis GLP1/GIP TRIAL DEMONSTRATED POSITIVE EFFECT IN SUBSET OF OSA WITH OBESITY; YET, HUGE UNMET NEED REMAINS STUDY SCOPE AND RESULTS1 REAL-WORLD CONTEXT AND IMPLICATIONS • Two Phase 3 trials of adults with moderate to severe OSA • Study population reflects ~33% of total
Slide 15: The Majority of People Living With OSA Are Not Obese
Obesity is an important risk factor for OSA; however, THE MAJORITY OF PEOPLE LIVING WITH OSA ARE NOT OBESE PREVALENCE OF OBESITY WITH OSA TOTAL OSA POPULATION1 BY OSA SEVERITY1,2 Mild, Moderate & Severe Mild Moderate Severe 33% 100% obese Obesity-related OSA 80% (BMI>30) MODERATE 60% • 20% of OSA •
Slide 16: Three Profiles of People Living With OSA
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 17: AD109 Overview
AD109 OVERVIEW
Slide 18: AD109 May Reduce Airway Obstruction, Improve Oxygen Levels and Reduce Fatigue
Phase 3 program aims to deliver the following aspirational value proposition AD109 MAY REDUCE AIRWAY OBSTRUCTION, IMPROVE OXYGEN LEVELS AND REDUCE FATIGUE WITH A SAFE, TOLERABLE, ONCE-NIGHTLY PILL REDUCED AIRWAY IMPROVED REDUCED LEVEL OBSTRUCTION OXYGENATION OF FATIGUE • May improve upper airway mus
Slide 19: Targeting the Underlying Neuromuscular Dysfunction of OSA, AD109 May Improve Oxygen Levels
BY TARGETING THE UNDERLYING AROXYBUTYNIN NEUROMUSCULAR DYSFUNCTION OF OSA, OH O AD109 MAY IMPROVE OXYGEN LEVELS 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 UNTREA
Slide 20: Phase 2 MARIPOSA Results: AHI Responders
ADDITIONAL ANALYSIS Phase 2 Results APNEA-HYPOPNEA INDEX (AHI1) RESPONDERS Proportion of patients’ reduction in AHI (%) MARIPOSA: ONE-MONTH, DOUBLE-BLIND, PLACEBO-CONTROLLED 65.7 52% with >40% PROSPECTIVE TRIAL OF AD109 59.7 reduction in AHI 52.2 PRIMARY ENDPOINT 43.2 24% with >70% 38 41% of all pat
Slide 21: AD109 Shows Potential to Improve Symptoms
AD109 SHOWS POTENTIAL TO IMPROVE SYMPTOMS PROMIS-FATIGUE patient-reported outcome (PRO) FATIGUE CAN BE A DEBILITATING PROMIS–FATIGUE (T-SCORE) SYMPTOM OF OSA1 REDUCTION RELATIVE TO BASELINE3 * PROMIS-FATIGUE is a validated scale that assesses…2 8.50 • Experience of fatigue • Interference of fatigue
Slide 22: Ongoing AD109 Phase 3 Pivotal Trials
ONGOING AD109 PHASE 3 PIVOTAL TRIALS 1 2 Topline Data Mid-year 2025 Mid-year 2025 • 660 participants • 646 participants in main cohort 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 mg/a
Slide 23: Dawn of a New Era in OSA
DAWN OF LATENT DEMAND Bolus of patients waiting who refuse, A NEW ERA abandon or under-utilize CPAP IN OSA 1 NEW ALTERNATIVES IMPROVED SCREENING Numerous TO CPAP 5 2 Explosion in wearable OSA GLP-1 data challenging screening tech tailwinds support treatment convention in the prospect of obesity-rela
Slide 24: End
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