Slide 1: ARS Update: neffy Approval
Exhibit 99.1 ARS Update neffy® Approval August 12, 2024
Slide 2: Forward-looking statements
Forward-looking statements Statements in this presentation that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include, without limitation, statements reg
Slide 3: neffy (epinephrine nasal spray) Now Approved
® neffy (epinephrine nasal spray) NOW APPROVED! INDICATION neffy is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adults and children who weigh ≥30kg 3
Slide 4: Type I Allergy Patients Face Significant Limitations with Current Treatment Options
Type I Allergy Patients Face Significant Limitations with Current Treatment Options that neffy may help to address REFUSAL OF DELAY IN NO TREATMENT USER ERROR IN PROBLEM: TREATMENT TREATMENT READILY AVAILABLE TREATMENT ONLY 10% - 20% of patients with active 1 Only 50% carry one ~25% - 60% do not ~40
Slide 5: U.S. prescribing information for neffy
U.S. prescribing information for neffy Indication Statement: Available Dose Strengths: • 2 mg nasal spray device • neffy is indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis, in Contraindications: adults and children who weigh ≥ 30kg • None Boxed Warning: Dosi
Slide 6: Alignment with FDA on post-marketing studies
Alignment with FDA on post-marketing studies File completed EPI-10 study for pediatric patients 15 to 30 kg in body weight (1 mg dose) Registry to collect clinical data from allergy challenge clinics (PMC) Nominal cost and no material impact on operating runway anticipated $ 6
Slide 7: Rigorous registration program conducted in adults and children
Rigorous registration program conducted in adults and children • Goal was to develop a low-dose, small, easy to use, and well-tolerated epinephrine nasal spray • > 1,200 administrations of neffy in > 700 subjects • 5 pilot and exploratory studies • 5 supportive studies with 1 mg dose (for 15 to 30 k
Slide 8: Registrational studies demonstrate comparability on PD surrogates and PK
Registrational studies demonstrate comparability on both PD surrogates for efficacy and PK with neffy PD and PK Data Safety Data • 2 mg neffy met all clinical endpoints • Adverse events generally mild in nature with no meaningful nasal irritation or pain up to 4 mg dose • PD surrogates for efficacy
Slide 9: Robust response on PD surrogate markers for efficacy
U.S. prescribing information for neffy: robust response on PD surrogate markers for efficacy Pulse Rate Systolic Blood Pressure Figure 1: Median Pulse Rate (PR) and Systolic Blood Pressure (SBP) Change from Baseline Following One Dose of Epinephrine in Healthy Subjects [Study 1] Figure 2: Median Cha
Slide 10: US launch is first step to making neffy available worldwide
US launch is first step to making neffy available to more patients worldwide FDA sNDA for 1 mg dose (15 to 30kg children) expected to be filed with FDA in Q3 2024 Positive marketing authorization application (CHMP opinion) by EMA in June 2024 EMA Product availability and Europe partnership announcem
Slide 11: Commercialization Strategy
Commercialization Strategy
Slide 12: Significant Opportunity to Address Unmet Needs in US Severe Allergic Reaction Market
Significant Opportunity to Address Unmet Needs in Current US Severe Allergic Reaction Market Consistent Market Growth (Units) Epidemiology prevalence data estimates 1 +6.5% CAGR since 2010, +12.7% YoY in 2023 2-9 ~40M patients with type 1 allergic reactions Promotional Responsiveness ~50% increase o
Slide 13: Innovative Treatment to Overcome Known Challenges with Needle-Injectors
neffy: Innovative Treatment to Overcome Known Challenges with Needle-Injectors for SAR Patients 45% REDUCTION IN TIME TO USE % of Time Carrying Average Time (minutes) at least One 1 from Symptom Start to Device Use 2,3 Epinephrine Device Benefits of needle-free 8.8 alternative to address major unmet
Slide 14: HCPs Indicate Substantial Opportunity to Convert and Grow Market
HCPs Indicate Substantial Opportunity to Convert and Grow Market May 2024 ATU, Sample = 202 HCPs How Likely Would You Be to Prescribe neffy Upon Availability?* 87% *Would Prescribe to Definitely Prescribe What % of the Time Would You Offer neffy to 66% Your Patients that Currently Fill an Injectable
Slide 15: neffy Strategic Objectives for Commercialization
neffy Strategic Objectives for Commercialization EDUCATE PRESCRIBERS Drive adoption within specialty and high decile prescribers on the compelling value-proposition of neffy FACILITATE ACCESS neffy access, affordability and support services ACTIVATE PATIENTS Create awareness and motivate patients an
Slide 16: Drive adoption within specialty and high decile prescribers
Drive adoption within specialty and high decile prescribers EDUCATE Healthcare Provider Launch Objectives • Commercial force of 110 Sales and Virtual Representatives and Area Sales Managers • Calling on 12,500 Allergy Specialists and High Decile Prescribers • Reaching 40-45% of Prescriptions from al
Slide 17: neffy shows rapid resolution of oral food challenge anaphylaxis symptoms
neffy shows robust and rapid clinical resolution of oral food challenge anaphylaxis symptoms (preview of neffy Experience in US) EDUCATE Efficacy Study of neffy in Oral Food Challenge neffy Experience Program 1 Induced Anaphylaxis (EPI-JP-03, n = 15 pediatric subjects) (rescue therapy at allergy cha
Slide 18: Committed to ensuring neffy access for all patients
Committed to ensuring neffy access for all patients FACILITATE Virtual pharmacy (BLINKRx) available to Healthcare Providers via EMR systems which centralizes all services for neffy fulfillment • Patient education and training resources • Inclusive insurance support and co-pay buydown (down to $25) •
Slide 19: neffy profile supports strong value proposition and potential savings
neffy profile supports strong value-proposition, and offers potential savings to patients and payers FACILITATE INNOVATION ACCESS & AFFORDABILITY ARS is proud to bring an innovative treatment option to the ARS believes that affordability should never prevent access: marketplace that provides freedom
Slide 20: Create awareness & motivate to seek neffy
Create awareness & motivate to seek neffy ACTIVATE Consumer Launch Objectives • Drive awareness & motivate patients to request neffy by name • Enable patients and caregivers to feel fully empowered to act during a potential crisis moment • Activate patients and caregivers to share their neffy story
Slide 21: neffy: The only needle-free way to administer epinephrine
neffy: The only needle-free way to administer epinephrine Rapid, reliable delivery Small and easy to carry Place and Press administration Well-tolerated in extensive trials Expected availability in 8 weeks 21
Slide 22: Closing Thoughts
Closing Thoughts *Post-Marketing Requirements/Post-Marketing Commitments
Slide 23: ARS in 2024 and beyond
ARS in 2024 and beyond ® neffy in type I allergies Global opportunity and pipeline Solid company fundamentals 1 • Q3 2024: 2 mg availability with • Q3 2024: Anticipated approval in Europe • Strong balance sheet of $218.7M commercial field force deployed in • 2024: Filings by partners in Australia, •
Slide 24: We appreciate your unwavering support and commitment to neffy
We appreciate your unwavering support and commitment to neffy! Patients Parents and Caregivers ARS Employees Advocates THANK YOU! Advisors and Directors ARS Stakeholders and Investors Healthcare Professional and Study Investigators 24
Slide 25: neffy (epinephrine nasal spray) Now Approved
® neffy (epinephrine nasal spray) NOW APPROVED! INDICATION neffy is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adults and children who weigh ≥30kg 25
Slide 26: Appendix
Appendix AiR?
Slide 27: neffy Designed for Ease of Use and Easy Carry
neffy Designed for Ease of Use and Easy Carry and to Minimize Risk of Side Effects Relative Size of neffy two pack Compared to iPhone 15 and EpiPen 6” Proprietary Intravail technology allows consistent intranasal absorption 5.8” High bioavailability at low 2 mg dose minimizes risk of side effects 3.
Slide 28: Differentiated FDA label for neffy compared to injection
Differentiated FDA label for neffy compared to injection may reduce hesitancy to dose and lead to broader adoption 1 2 Label differentiation Injection neffy 1. Emergency medical assistance “Advise patients when to seek emergency “In conjunction with the administration of after dosing not automatic,
Slide 29: neffy can address the unmet need aligned with what patients and parents want
neffy can address the unmet need and is aligned with what 1 patients and parents want OF PATIENTS LIKELY TO VERY LIKELY TO ASK THEIR 88% 1 PHYSICIAN ABOUT neffy Rx n = 392 Current Users OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR 89% 1 PHYSICIAN ABOUT neffy RX n = 88 Non-fillers 72% 81% OF T
Slide 30: neffy profile including 30-month shelf-life may increase market opportunity
neffy profile including 30-month shelf-life may increase market opportunity within current active Rx patient segment neffy needle-injectors Shelf-life (up to) 30 months ~18 months 1 2 Time between refills 18 months (patient market research) 15 months (IQVIA longitudinal data) 1 Preference share ~15