Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (November 2022)
20 slides from Apnimed's investor presentation, November 2022
Slide 1: Drug Therapy for Obstructive Sleep Apnea
DRUG THERAPY FOR OBSTRUCTIVE SLEEP APNEA November 2022 August 2020 1
Slide 2: Apnimed executive summary: Unique opportunity in market without therapeutics
Apnimed executive summary: Unique opportunity in 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 oral with demonstrated ~ 3 years
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 NORMAL CONTROL OSA PATIENT OSA prevalence 50+ Millions (US) 15-20+ Top estimate of prevalence range 10.5 Diagnosed 42% Undiagnosed 20 Richard Schwab, Clinics in Chest Medicine, 1998 National Healthy Slee
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 CUMULATIVE INCIDENCE OF manifestations of OSA NON-FATAL CVS EVENTS (%) FATAL CVS EVENTS (%) • Daytime sleepiness • Fatigue • Cognitive impairment • Loud snoring • Dysphoria • Auto
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 The recent development of hy
Slide 6: AD109 targets OSA pathophysiology by improving sleep-related reductions in 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 Airway muscle firing tone collapse improves, reducing CNS drives airway muscles while Low CNS d
Slide 7: Our lead program, AD109 combines atomoxetine and a novel antimuscarinic, aroxybutynin
Our lead program, AD109 combines atomoxetine and a novel antimuscarinic, aroxybutynin ATOMOXETINE Selective Norepinephrine reuptake inhibitor, promotes adrenergic tone leading to muscle activation AROXYBUTYNIN Anti-muscarinic NCE, active primarily in REM sleep Novel AD109 co-formulation of atomoxeti
Slide 8: Lead program AD109 has shown consistent efficacy on obstruction and oxygen levels in prior Ph2 trials
Lead program AD109 has shown consistent efficacy on obstruction and oxygen levels in prior Ph2 trials • Three prior Phase 2 trials of atomoxetine SAMPLE DOSING SIGNIFICANCE 75mg/aroxybutynin 2.5mg ranging from 1 PROTOCOL SIZE DURATION VS PLACEBO night to 28 nights n=60 APC-003 1 night p=0.001 crosso
Slide 9: MARIPOSA: A Phase 3-enabling study for AD109
MARIPOSA: A Phase 3-enabling study for AD109 Study designed to answer key questions and FDA suggestions from Type C meeting • Additional dose-finding for AD109 PARALLEL-ARM | 1 MONTH DOSING • Evaluation of multiple subjective endpoints for BASELINE AHI 10–45 | N=294 P3 incl. PROMIS (key secondary en
Slide 10: MARIPOSA trial: Overall outcome & takeaways
MARIPOSA trial: Overall outcome & takeaways ONE TWO THREE FOUR Robustly positive Confirmed both drugs AD109 generally safe Informative dose- objective and required for efficacy and well tolerated response and subjective efficacy and safety, Meets FDA • No SAEs, deaths, exploratory program for AD109
Slide 11: 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 12: Most AD109 patients had robust reductions in AHI4 with 41% achieving a full clinical response
Most AD109 patients had robust reductions in AHI4 with 41% achieving a full clinical response Apnea-Hypopnea Index (AHI4) AHI4 Response by Clinical Severity Responder Analysis for the AD109 75/2.5 dose PROPORTION OF PATIENTS REDUCTION IN AHI (%) 68.6 65.7 67.1 Placebo PATIENTS WHO ACHIEVED AD109 75/
Slide 13: 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 75
Slide 14: AD109 safety and tolerability in MARIPOSA
AD109 safety and tolerability in MARIPOSA COMMON ADVERSE EVENTS % (≥3 PATIENTS) 75/5 75/2.5 75ato Pbo No Serious Adverse n [41] [42] [63] [63] Events (SAEs); no dry mouth 59 24 27 5 new or unexpected urinary impairment (any) 22 7 22 0 AEs insomnia (any) 22 26 37 3 constipation 12 0 3 3 Lower dose AD
Slide 15: MARIPOSA sets the stage for an AD109 Phase 3
MARIPOSA sets the stage for an AD109 Phase 3 Statistically significant and clinically meaningful efficacy at one month, supporting success in Phase 3 • MARIPOSA incorporated extensive feedback from FDA meetings regarding dose finding and symptom endpoints End of Ph2 FDA meeting AD109 dose of 75/2.5
Slide 16: 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 study conduct, along with other AD109 NDA completed approval-enabling studies submission Phase 3 results and NDA prep Planning, submission, conduct of EOP2 with FDA First AD109 Phase 3 trial – First Patient
Slide 17: 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 ~30MM US patients with US sleep clinicians clinically meaningful OSA • Reasonable pricing could drive strong market access 30% Diagnosed: 70% Undiagnosed: 9MM patients 21MM patients • Clinician
Slide 18: Apnimed has a strong financing history backed by experienced investors
Apnimed has a strong financing history backed by experienced investors $62.5mm round Completed Series C Led by Sectoral Asset Management. April 2022 Also participating: Alpha Wave Ventures, NexPoint, other new investors, and all existing investors (Morningside Ventures, Seligman Investments, and Tao
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, AD109 has shown Phase 3 trials will Experienced high-prevalence excellent efficacy initiate early 2023 management team and condition associated and safety in multiple with likely NDA filing investor syndicate
Slide 20: Thank You
—Apnimed THANK YOU