Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (March 2024)
20 slides from Apnimed's investor presentation, March 2024
Slide 1: Drug Therapy for Obstructive Sleep Apnea
DRUG THERAPY FOR OBSTRUCTIVE SLEEP APNEA Mar 2024 August 2020 1
Slide 2: Apnimed executive summary: Unique opportunity for AD109 as the first OSA drug
Apnimed executive summary: Unique opportunity for AD109 as the first drug for the Obstructive Sleep Apnea (OSA) market Very large market Our oral drug An unusual AD109 Phase 3 Robust with no well- AD109 addresses opportunity trials in progress Pipeline tolerated therapy the neuromuscular A once-dail
Slide 3: Obstructive Sleep Apnea is a major clinical disorder with huge unmet need
Obstructive Sleep Apnea (OSA) is a major clinical disorder (~50M in the US) with huge unmet need OSA PREVALENCE ~50 MILLION (US) Untreated OSA 33% Diagnosed Brainstem Synapse Undiagnosed 67% OSA pathophysiology rests on a combination of narrowed upper airway and neuromuscular or ventilatory dysfunct
Slide 4: Patients with OSA are acutely symptomatic and at risk for major sequelae over time
Patients with OSA are acutely symptomatic and at risk for major sequelae over time Common acute CUMULATIVE INCIDENCE OF K-M CURVE DEMONSTRATING manifestations of OSA NON-FATAL CVS EVENTS (%) SURVIVAL PROBABILITY (%) • Daytime sleepiness • Fatigue • Cognitive impairment • Loud snoring • Dysphoria • M
Slide 5: CPAP therapy is relatively unchanged over nearly 40 years
CPAP therapy is relatively unchanged over nearly 40 years: A tight-fitting mask connected to a pump STANDARD OF CARE OTHER COMMERCIALLY AVAILABLE MEDICAL DEVICES FOR THERAPY POPULATIONS WITH STRICT ELIGIBLITY CRITERIA 1985 Strollo PJ et al. N Engl J Med 2014;370:139-49 Today Current treatments prese
Slide 6: AD109 targets OSA pathophysiology by improving upper airway muscle tone
AD109 targets OSA pathophysiology by improving sleep-related reductions in upper airway muscle tone Untreated OSA treated OSA with AD109 Brainstem Synapse Wake: Full upper airway Sleep: Low tone → Upper airway muscle muscle tone upper airway collapse firing improves, CNS drives upper airway muscle L
Slide 7: Our lead program, AD109 combines aroxybutynin with atomoxetine
Our lead program, AD109 combines our novel antimuscarinic aroxybutynin with atomoxetine AROXYBUTYNIN Novel anti-muscarinic NCE, further stabilizes the upper airway and sleep ATOMOXETINE Selective Norepinephrine reuptake inhibitor, promotes adrenergic tone leading to muscle Novel AD109 co-formulation
Slide 8: MARIPOSA: Highly successful Phase 2b trial in ~300 patients
MARIPOSA: Highly successful Phase 2b trial in ~300 pts, 1 month KEY TAKEAWAYS Robustly positive objective and Confirmed both drugs required subjective efficacy for AD109 at for efficacy and safety, Meets 1 month FDA “combination rule” STUDY RATIONALE • Primary Endpoint met: AHI improvement • Aroxybu
Slide 9: AD109 robustly positive for improved airway obstruction
AD109 robustly positive for improved airway obstruction % REDUCTION IN APNEA-HYPOPNEA APNEA-HYPOPNEA INDEX (AHI) INDEX (AHI) AFTER 4 WEEKS FOR BOTH AD109 DOSES AT RELATIVE TO PLACEBO BASELINE THROUGH 4 WEEKS *** *** AD109 vs placebo for AHI (p<0.001), with >40% ∫ ∫ reduction in AHI 47.1% Baseline 42
Slide 10: Most AD109 patients had robust reductions in AHI4
Most AD109 patients had robust reductions in AHI4 with 41% achieving a full clinical response Apnea-Hypopnea Index (AHI4) Responder Analysis PROPORTION OF PATIENTS REDUCTION IN AHI (%) 68.6 65.7 67.1 Placebo 59.7 AD109 2.5/75 mg 54.2 AD109 5/75 mg 41% of all patients on the AD109 52.2 2.5/75mg dose
Slide 11: AD109 improves OSA symptoms; PROMIS-Fatigue a good PRO for Phase 3
AD109 improves OSA symptoms; PROMIS-Fatigue a good Patient-reported Outcome (PRO) for Ph3 PROMIS – FATIGUE (T-SCORE) Measurement of OSA symptoms REDUCTION RELATIVE TO BASELINE important to patients • Fatigue can be a debilitating • AD109 demonstrated a * symptom of OSA statistically significant sign
Slide 12: AD109 path to NDA filing
AD109 path to NDA filing 2022 2023 2024 2025 2026 H2 H1 H2 H1 H2 H1 H2 H1 MARIPOSA study AD109 P3 studies with other approval-enabling studies completed Phase 3 results and NDA prep Planning, submission, conduct of EOP2 with FDA AD109 NDA End of Phase 2 submission meeting completed; First AD109 Phas
Slide 13: AD109 Phase 3 pivotal trials per FDA guidance
AD109 Phase 3 pivotal trials per FDA guidance • 640 participants in main cohort • 640 participants • Randomized 1:1 to placebo vs. AD109 • Randomized 1:1 to placebo vs. AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg) Study Design & Sample Size (aroxybutynin 2.5 mg/atomoxetine 75 mg) • 6-month dosing d
Slide 14: Significant commercial potential in large US and global market
Significant commercial potential in large US and global market • Clinician research indicates enthusiasm US patients with clinically for new modality meaningful OSA • Patient demand likely an important component 33% Diagnosed 67% Undiagnosed • Reasonable pricing could drive strong market access • Am
Slide 15: Apnimed pipeline
Apnimed pipeline Program Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 AD109 (aroxybutynin+ OSA atomoxetine) OSA with sleep disruption AD504 / AD817 (novel NRI combination) AD113 OSA with hypertension Shionogi-Apnimed Sleep Science Treatment-resistant AD981 Obesity Hypoventilation Syndrom
Slide 16: Newly formed JV Shionogi-Apnimed Sleep Science will accelerate new OSA therapeutics
Newly formed JV Shionogi-Apnimed Sleep Science will accelerate the development of new therapeutics for OSA A joint venture that combines expertise JOINT VENTURE SUMMARY • 50/50 JV ownership; both companies contribute certain IP • Apnimed to lead clinical development; • Deep knowledge of OSA • Highly
Slide 17: Powerful IP position in pharmacologic treatment of OSA
Powerful IP position in pharmacologic treatment of OSA KEY FILINGS FOR LEAD CANDIDATE AD109 Method of Combining NRI + Aroxybutynin + Atomoxetine for Novel Aroxybutynin Solid Antimuscarinic for OSA OSA Forms US Patent issued, Pat. No. 11,123,313 US Patent issued, Pat. No. 11,911,351 • Multiple patent
Slide 18: Apnimed has a strong history backed by experienced investors
Apnimed has a strong history backed by experienced investors KEY LEADERSHIP SELECTED BOARD INVESTORS MEMBERS Alpha Wave Larry Miller, MD Ventures Chair Joe Avellone, MD Columbia-Seligman Former EVP, Parexel Larry Miller, MD Dennis Molnar Michael Rogers Ron Farkas, MD, Morningside Isaac Cheng, MD Chi
Slide 19: Transformational opportunity for the first, once-daily oral drug for OSA
Transformational opportunity for the first, once-daily oral drug for OSA OSA is a serious, high-prevalence AD109 with Expect data Strong IP condition associated with reduced excellent readout 2025, position for efficacy/safety in NDA filing and AD109, extensive quality of life, cardiovascular multip
Slide 20: Apnimed
—Apnimed