Apnimed, Inc. · NASDAQ:APMD
Apnimed — JPMorgan Healthcare Conference 2022
21 slides from Apnimed's conference presentation, January 2022
Slide 1: Drug Therapy for Obstructive Sleep Apnea
DRUG THERAPY FOR OBSTRUCTIVE SLEEP APNEA Jan 2022 • JPMorgan Healthcare Conference • apnimed.com August 2020
Slide 2: Obstructive Sleep Apnea is a major clinical disorder with huge unmet need
Obstructive Sleep Apnea (OSA) is a major clinical disorder (>25M in the US) with huge unmet need Normal Control OSA Patient OSA prevalence Millions (US) 50 45 Top estimate of prevalence 40 range 35 30 25 Diagnosed 20 15 10 Undiagnosed 5 0 Richard Schwab, Clinics in Chest Medicine, 1998 National Heal
Slide 3: Patients with OSA are at significant risk for cardiovascular events
Patients with OSA are at significant risk for cardiovascular events Cumulative incidence of Cumulative incidence of fatal CVS events (%) non-fatal CVS events (%) Incidence of Events (%) Incidence of Events (%) Months Months Over a 12-year follow-up, patients with OSA, especially severe OSA, have a m
Slide 4: 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 1985 Today 4 Jan 2022
Slide 5: More recent treatments for OSA include oral appliances and implantable neurostimulators
More recent treatments for OSA include oral appliances and implantable neurostimulators Strollo PJ et al. N Engl J Med 2014;370:139-49 Oral appliances, usually Mandibular advancement Implanted hypoglossal neurostimulators cause the tongue devices, move the lower jaw forward to enlarge the muscle to
Slide 6: Apnimed's success is a dramatic break from decades of unsuccessful drug treatments for OSA
Apnimed’s success is a dramatic break from decades of unsuccessful drug treatments for OSA Noradrenergic Atomoxetine, 2 studies, n=24 Desipramine, 1 study, n=14 Protryptiline, 3 studies, n=24 Z-drugs Zolpidem (10 mg), 2 studies, n=54 Eszopiclone, 2 studies, n=38 Zopiclone, 2 studies, n=26 Carbonic a
Slide 7: Apnimed development pipeline
Apnimed development pipeline Lead asset: AD109, Atomoxetine + Aroxybutynin Indication/ Pre- Exploratory Program P1 P2 P3 Formulation clinical Clinical OSA AD109 (ato+aroxybutynin) Snoring AD504 OSA w/ disturbed sleep (ato+trazodone) Novel release profile Monotherapy or Other combination alternatives
Slide 8: Our lead program, AD109 combines atomoxetine and a novel antimuscarinic, aroxybutynin
Our lead program, AD109 combines atomoxetine and a novel antimuscarinic, aroxybutynin Atomoxetine Norepinephrine reuptake inhibitor, promotes adrenergic tone leading to muscle activation Aroxybutynin Anti-muscarinic, (R)enantiomer of oxybutynin, likely NCE, active Novel AD109 co-formulation of atomo
Slide 9: AD109 mechanism of action: Pharmacologic stimulation of the pharyngeal muscles
AD109 mechanism of action: Pharmacologic stimulation of the pharyngeal muscles OSA treated with AD109 Reduced muscle firing→ airway obstruction Airway muscle firing improves, limited obstruction Reduced phasic contraction of airway AD109 stimulates increased firing of airway muscles muscles leads to
Slide 10: AD109: Positive dose-response in mild/moderate OSA
AD109: Positive dose-response in mild/moderate OSA Protocol APC-004: randomized, controlled, 1 night, double-blind, crossover trial with 31 patients with mild-moderate OSA (AHI 5-20, PGI-S ≥1). Study conducted at 3 US sites. Hypoxic Burden (HB) Apnea-Hypopnea Index (AHI) Better O2 Better * p<0.05 vs
Slide 11: AD109: Durable objective efficacy over weeks in mild to severe OSA
AD109: Durable objective efficacy over 4 weeks in mild to severe OSA Protocol APC-003-OLE: 4-week, open-label extension study of patients from protocol APC-003 with 37 patients with mild-severe OSA (AHI 10-45 or > 45 with airway collapsibility conditions met). Study conducted at 7 US sites. Apnea-Hy
Slide 12: Responder analysis shows majority of patients have substantial response
Responder analysis shows majority of patients have substantial response, large proportion near “cure” HB% responders in patients with AHI % responders in patients with baseline AHI<45 baseline AHI<45 in APC003 reduction from HB Patients (subset studies with AHI<45)+APC004 APC-003 and APC-004 AHIPati
Slide 13: AD109: Consistent efficacy across trials
AD109: Consistent efficacy across trials Dosing Duration % reduction in Significance vs. Drug Protocol And Sample Size median AHI1 / HB Placebo AD036 10 nights; (ato/oxy) APN-002 n=140 parallel-arm 61% / 54%2 p=0.009 • >300 patients treated AD036 1 night; APN-006 56% / 52% p<0.0001 (ato/oxy) n=62 cr
Slide 14: AD109: Well tolerated over multiple studies
AD109: Well tolerated over multiple studies • AE’s consistent with approved labeling of atomoxetine and oxybutynin Ato 75/Aroxy 2.5 Ato 75 Aroxy 2.5 Placebo Protocol Category n (%) (N = 56) (N = 54) (N = 54) (N = 57) APC-003 single night crossover GERD 2 (3.6) 2 (3.7) 0 0 Ato 75/Aroxy 2.5 Ato 37.5/A
Slide 15: AD109: Durable symptom improvement over 4 weeks
AD109: Durable symptom improvement over 4 weeks Protocol APC-003-OLE: 4-week, open-label extension study of patients from protocol APC-003 with 37 patients with mild-severe OSA (AHI 10-45 or > 45 with airway collapsibility conditions met). Study conducted at 7 US sites. OSA-specific Quality of Life
Slide 16: MARIPOSA: a Phase-3 enabling study for AD109 and key 2022 milestone
MARIPOSA: a Phase-3 enabling study for AD109 and key 2022 milestone AD109 • FDA-required additional dose-finding for AD109 with 2.5mg aroxy – Also advances atomoxetine & trazodone AD109 combination (AD504) with 5mg aroxy AD504 • Atomoxetine alone, placebo, as control arms Ato+Traz 50mg 30 day AHI 10
Slide 17: Path to NDA submission and approval
Path to NDA submission and approval Ongoing Initiate first Initiate second Phase 3 MARIPOSA AD109 Phase AD109 Phase readout and study 3 trial 3 trial NDA prep 1H 2022 2H 2022 1H 2023 2H 2023 1H 2024 2H 2024 Planning, submission, conduct of EOP2 with FDA AD109 NDA Planning, prep AD109 approval Advanc
Slide 18: Apnimed is building a strong IP estate with composition of matter and method-of-use filings
Apnimed is building a strong IP estate with composition of matter and method-of-use filings • 20+ filings in 19 “families”, additional filings in progress • Key patent filings: – US Patent 11,123,313 granted on core filing and expansion, based on exclusive worldwide license from Mass General Brigham
Slide 19: Extraordinary market and financial opportunity
Extraordinary market and financial opportunity >30M+ in US with OSA, >500M globally Pricing below Pricing above specialty tier specialty tier About 1/3 are Potential market access at different price points1 diagnosed About 2/3 are undiagnosed • Fewer than 4M diagnosed patients use • US market resear
Slide 20: Apnimed: breakthrough opportunity for a drug for sleep apnea
Apnimed: breakthrough opportunity for a drug for sleep apnea • OSA is a serious condition associated with reduced quality of life, cardiovascular disease, and early mortality • Current device therapies are poorly tolerated or address niche populations; no drug therapy is available • AD109 has shown
Slide 21: Thank You
Thank You 21 Jan 2022