Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (September 2023)
17 slides from Apnimed's investor presentation, September 2023
Slide 1: Drug Therapy for Obstructive Sleep Apnea
DRUG THERAPY FOR OBSTRUCTIVE SLEEP APNEA Sept 2023 August 2020 1
Slide 2: Apnimed executive summary: Unique opportunity in OSA market without therapeutics
Apnimed executive summary: Unique opportunity in Obstructive Sleep Apnea (OSA) market without therapeutics Very large market Our drug AD109 An unusual AD109 Phase 2 Potential path with no well- addresses the opportunity trials concluded to approval in tolerated therapy neuromuscular A once-daily ora
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 MILLIONS (US) 25% Diagnosed Untreated Undiagnosed OSA 75% Brainstem Synapse OSA pathophysiology involves sleep-related obstruction due to factors like small upper airway caliber, minim
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 • A
Slide 5: CPAP therapy is relatively unchanged over nearly 40 years
CPAP therapy is relatively unchanged over nearly 40 years: A tightly-fitted mask connected to a pump STANDARD OF CARE OTHER COMMERCIALLY AVAILABLE TREATMENTS FOR THERAPY POPULATIONS WITH STRICT ELIGIBLITY CRITERIA 1985 Strollo PJ et al. N Engl J Med 2014;370:139-49 Today All 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 airway muscle Sleep: Low tone → Airway muscle firing tone airway collapse improves, reducing CNS drives airway muscles while Low CNS d
Slide 7: Our lead program, AD109 combines aroxybutynin with atomoxetine
Our lead program, AD109 combines our novel antimuscarinic aroxybutynin with atomoxetine ATOMOXETINE Selective Norepinephrine reuptake inhibitor, promotes adrenergic tone leading to muscle activation AROXYBUTYNIN Novel anti-muscarinic NCE, further stabilizes the upper airway and sleep Novel AD109 co-
Slide 8: MARIPOSA trial: Highly successful trial in ~300 patients, 1 month
MARIPOSA trial: Highly successful trial in ~300 patients, 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 • Atomo
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 52.2 AD109 2.5/75mg dose
Slide 11: AD109 improves OSA symptoms; PROMIS-Fatigue a good choice for Ph3
AD109 improves OSA symptoms; PROMIS-Fatigue a good choice 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 Placebo symptom of OSA statistically significant signal with AD109 2.
Slide 12: AD109 path to NDA filing
AD109 path to NDA filing 2022 2023 2024 2025 H1 H2 H1 H2 H1 H2 H1 H2 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 Phase 3 t
Slide 13: AD109 phase 3 pivotal studies
AD109 phase 3 pivotal studies 640 participants 640 participants Study Design & Sample Size Randomized 1:1 to placebo vs. AD109 Randomized 1:1 to placebo vs. AD109 12-month dosing duration 6-month dosing duration Primary: reduction in AHI Primary: reduction in AHI Key Endpoints Key secondary: improve
Slide 14: Significant commercial potential in large US and global market
Significant commercial potential in large US and global market • Initial marketing efforts focus on 6,000 US patients with clinically US sleep clinicians meaningful OSA • Reasonable pricing could drive strong market access 25% Diagnosed 75% Undiagnosed • Clinician research indicates enthusiasm for n
Slide 15: Apnimed has a strong financing history backed by experienced investors
Apnimed has a strong financing history backed by experienced investors Overall Equity Raised 208mm raised Since inception | June 2018 Investors Strong Syndicate Sectoral Asset Management, Alpha Wave Ventures, Morningside Ventures, Seligman Investments, Tao Capital Partners and others Sept 2023 15
Slide 16: 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 has Phase 3 trials Experienced condition associated with reduced shown excellent will initiate 2H management efficacy and 2023 with likely team and quality of life, cardiovascular safety
Slide 17: Apnimed
—Apnimed