Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (April 2025)
29 slides from Apnimed's investor presentation, April 2025
Slide 1: Investor Presentation
Investor Presentation April 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 Disorders
APNIMED IS DEDICATED TO SLEEP-RELATED BREATHING DISORDERS Lead Product Candidate (AD109) - Completed Phase 3 Enrollment Key upcoming Events • First-in-class, once-daily oral therapy combining a novel anti- • Topline results from two muscarinic and a selective norepinephrine reuptake inhibitor Phase
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 SASS-001 Sivopixant Sleep Apnea with a Central Component combination 8
Slide 9: AD109 Overview
AD109 OVERVIEW
Slide 10: Phase 2b Clinical Trial Design: Key Takeaways
Key Takeaways: PHASE 2B: Clinical Trial Design 1 Robust efficacy of AD109 • Primary Endpoint met: AHI improvement • Improvement of OSA symptoms (PROMIS-FATIGUE) Study Design • ~300 participants. & Sample Size • 4-week dosing duration 2 Confirmed both drugs required for efficacy and safety; meets FDA
Slide 11: Primary Endpoint: Reduction in Apnea-Hypopnea Index (AHI)
REDUCTION IN APNEA-HYPOPNEA INDEX (AHI1) From Median at Baseline PRIMARY ENDPOINT: 47% placebo adjusted reduction in AHI 20.5 (p<0.0001) • Apnea-hypopnea index (AHI4) was reduced from a median of 20.5 (12.3-27.2) to 10.8 (5.6-18.5) 41% of all patients on the AD109 2.5/75mg dose 10.8 saw their AHI1 r
Slide 12: AD109 AHI Responder Analysis
AD109 AHI1 RESPONDER ANALYSIS Proportion of participants reduction in AHI (%) 65.7 52% with >40% reduction in AHI 59.7 52.2 43.2 24% with >70% reduction in AHI 31.5 Proportion of patients 23.8 14.9 8.9 >20% >30% >40% >50% >60% >70% >80% >90% Magnitude of AHI reduction response. AD109 2.5/75 mg 12 Sc
Slide 13: 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 assesses2: 8.50 • Experience of fatigue • Interference of fatigue
Slide 14: AD109 Safety & Tolerability
AD109 SAFETY & TOLERABILTY Common Adverse Events % (≥3 patients) AD109* Placebo n [42] [63] • No Serious Adverse Events (SAEs); no Dry mouth 24% 5% new or unexpected AEs Insomnia (any) 26% 3% Insomnia (“mild”) 16% • AD109 well tolerated by most patients Insomnia (“moderate”) 10% - Most common AEs ra
Slide 15: Ongoing AD109 Phase 3 Pivotal Trials
ONGOING AD109 PHASE 3 PIVOTAL TRIALS 1 2 Topline Data Q3 2025 Q2 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 mg/atomoxetine 75 mg) • 12-mont
Slide 16: OSA Market Overview
OSA MARKET OVERVIEW
Slide 17: 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 18: 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 19: Three Profiles of People Living with OSA Highlight Need for New Treatments
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 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
Slide 23: Appendix
Appendix
Slide 24: AD109's Simple Administration and First-Night Effect Hold a Unique Position
AD109’S SIMPLE ADMINISTRATION AND THERAPEUTIC EFFECT ON THE FIRST NIGHT HOLDS A UNIQUE POSITION IT IN THE MARKET AD109 ADMINISTRATION & Weekly sub-cutaneous Positive airway pressure Once-nightly pill EASE OF USE injection machine / mask PATIENT Mild, Moderate & Severe, Moderate & Severe living Mild,
Slide 25: 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 26: Unmet Need Among PAP-Intolerant Market Offers Large Immediate Opportunity
UNMET NEED AMONG THE PAP-INTOLERANT MARKET OFFERS A LARGE IMMEDIATE OPPORTUNITY FOR AD109 Diagnosed (23.6M1) Undiagnosed (57M) LAUNCH PAP- ▪ ~50% of this segment does not have obesity as comorbidity Intolerant ▪ HCPs show intent to prescribe AD109 for people with & FOCUS 7.7M2 (37%) without obesity
Slide 27: Zepbound Expands Treatment Options in OSA, Yet Most Patients Fall Outside Indication
Impact of tirzepatide in OSA ZEPBOUND (tirzepatide) expands treatment options in OSA, yet more than 80% of OSA diagnosed patients fall outside the indication KEY TAKEAWAYS: 23.6M - Diagnosed with OSA (US) 9 1 • New Zepbound indication is relevant to <20% of the total OSA population. x • Key assumpti
Slide 28: The OSA Market Is Rapidly Evolving Supporting Rapid Adoption for AD109
THE OSA MARKET IS RAPIDLY EVOLVING IN A MANNER THAT SUPPORTS THE PROSPECT OF RAPID ADOPTION FOR AD109 CURRENT MARKET DYNAMICS EXPECTATIONS AT AD109 LAUNCH + PENT-UP DEMAND: Bolus of patients who + GROWTH IN DIAGNOSIS: Driven by new Education refuse, abandon or under-utilize CPAP screening, testing a
Slide 29: Commercialization Strategy
COMMERCIALIZATION STRATEGY Market Expansion Launch Opportunity Potential rapid penetration of AD109 Pre-Launch as first choice or combination therapy Establishing readiness • Expand sales and promotional • Leverage first-in-class profile reach targeting broader pool to capture low-hanging fruit: of