Apnimed, Inc. · NASDAQ:APMD
Apnimed — Investor Presentation (January 2023)
18 slides from Apnimed's investor presentation, January 2023
Slide 1: Drug Therapy for Obstructive Sleep Apnea
DRUG THERAPY FOR OBSTRUCTIVE SLEEP APNEA January 2023 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 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 Airway muscle firing tone collapse improves, reducing CNS drives airway muscles while Low CNS d
Slide 7: Our lead program, AD109 combines atomoxetine and 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, further stabilizes the upper airway and sleep Novel AD109 co-formulat
Slide 8: 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 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 10: 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 PLACEBOc BASELINE THROUGH 4 WEEKS *** *** AD109 vs placebo for AHI (p<0.001), with >40% ∫ ∫ reduction in AHI 47.1% Baseline 4
Slide 11: 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 75/2.5 mg 41% of all patients on the 52.2 54.2 AD109 75/5 mg AD109 75/2.5 mg dose
Slide 12: 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 13: AD109 safety and tolerability in MARIPOSA
AD109 safety and tolerability in MARIPOSA COMMON ADVERSE EVENTS % (≥3 PATIENTS) 75/5 mg 75/2.5 mg 75 mg ato 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 Low
Slide 14: 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 15: 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 ~35MM US patients with US sleep clinicians clinically meaningful OSA • Reasonable pricing could drive strong market access 30% Diagnosed: 70% Undiagnosed: 10.5MM patients 24.5MM patients • Clini
Slide 16: Apnimed has a strong financing history backed by experienced investors
Apnimed has a strong financing history backed by experienced investors $142.25mm round Completed Series C Led by Sectoral Asset Management and Alpha Wave Ventures 2022 Also participating: existing investors (Morningside Ventures, Seligman Investments, and Tao Capital Partners) and several other new
Slide 17: 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 18: Apnimed
—Apnimed