Slide 1: ARS Corporate Presentation Q4 2023
ARS Corporate Presentation Q4 2023 Exhibit 99.1
Slide 2: Forward looking statements
Forward looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding: ARS’s ability to complete the newly required trial and provide the additional information requested by the FDA in the CRL on the timing anticipated, or at all
Slide 3: Potential to Transform the Treatment of Type I Allergic Reactions
Potential to Transform the Treatment of Type I Allergic Reactions neffy®: first potential “no needle, no injection” solution for Type I allergic reactions to address an unmet market need Registration program demonstrates comparable PK and PD, without risk of needle-related safety concerns, fear and
Slide 4: Rapid administration without a needle
Rapid administration without a needle No risk of needle-related injuries; lacerations2 or cardiotoxic blood vessel injections Less hesitation to dose NO NEEDLE NO INJECTION SMALL Fits in your pocket; can carry more than 1 ~10% of cases require multiple doses of epinephrine1 EASIER AND MORE CONSISTEN
Slide 5: neffy Designed for Needle-free, Easier Carriage
neffy Designed for Needle-free, Easier Carriage
Slide 6: Registrational studies demonstrate comparability on both PD surrogates and PK with neffy
Registrational studies demonstrate comparability on both PD surrogates for efficacy and PK with neffy Safety Data 2 mg neffy met all clinical endpoints PD surrogates for efficacy comparable to approved products (SBP/HR approved injection products) Rapid and significant response on PD surrogates for
Slide 7: Robust response on PD surrogate markers for efficacy
Robust response on PD surrogate markers for efficacy Mean Change HR (BPM) Time (Minutes) Heart Rate Response Mean Change SBP (mmHg) Time (Minutes) Systolic Blood Pressure Response First PD 1 minute First PD 1 minute neffy 2 mg IM 0.3 mg neffy 2 mg IM 0.3 mg ** Significance level: ** p <0.01, *** p <
Slide 8: neffy shows enhanced absorption during critical period following nasal allergen challenge
neffy shows enhanced absorption during critical period of clinical response following nasal allergen-challenge (NAC) Time to observe clinical response, and re-dose per guidelines (within 5 to 15 min) * * * * * * neffy 2.0 mg neffy 2.0 mg rhinitis IM 0.3 mg Mean Epinephrine Concentration (pg/mL) Nasa
Slide 9: FDA Complete Response Letter requests nasal allergen challenge study with repeat doses
FDA Complete Response Letter requests nasal allergen challenge (NAC) study with repeat doses of neffy Mean Plasma Concentration (pg/mL) Time (mins) Repeat-dosing (10 min apart) results in healthy subjects neffy with repeat dosing is dose-proportional, whereas the approved injection products are not,
Slide 10: neffy market exclusivity potential until at least 2038
neffy market exclusivity potential until at least 2038 Issued composition of matter patent (US10,576,156) on Intravail® + epinephrine provides foundational exclusivity blocking any generic products. Method of treatment patents (US11,173,209; US11,191,838) block other alkyl glycosides. Issued method
Slide 11: Commercialization Strategy
Commercialization Strategy
Slide 12: Significant opportunity to address unmet needs in current US severe allergic reaction market
Significant opportunity to address unmet needs in current US severe allergic reaction market (~$1B1) 1. Based on IQVIA data (~5 million two-packs sold per year) and weighted average generic/branded epinephrine auto-injector net pricing, 2. Gupta RS et al. Pediatrics (2011), Gupta RS et al. Pediatric
Slide 13: neffy addresses the unmet need and is aligned with what providers, patients and parents want
neffy has the ability to address the unmet need and is aligned with what healthcare providers, patients and parents want1 72% OF THE TIME, PEOPLE WHO USE AN OTC WOULD USE neffy FIRST2 81% OF PEOPLE WOULD USE neffy SOONER THAN CURRENT AUTOINJECTOR3 OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR
Slide 14: Physicians supportive of adopting neffy into practice
Physicians supportive of adopting neffy into practice Would prescribe neffy if their patients asked for it 100% 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL 8.5 out of 10 rating1 viewed as a major advance in therapy n = 75 Physicians No difference in uptake of neffy by physician specialty1 1. ARS
Slide 15: neffy: innovative treatment to overcome known challenges with injectables
neffy: innovative treatment to overcome known challenges with injectables for SAR patients 1. Kaplan et al. ACAAI 2022 (Poster P008). 2. Warren et al. Ann Allergy Asthma Immunol 2018. 3. ARS patient survey data on file Carry 55% N = 9172 Would Carry 85% N = 1503 % of Time Carrying at least One Epine
Slide 16: neffy strategic objectives
neffy strategic objectives ACTIVATE PATIENTS Create awareness and motivate patients and caregivers to seek neffy FACILITATE ACCESS neffy access, affordability and support services EDUCATE PRESCRIBERS Drive adoption within specialty and high decile prescribers on the compelling value-proposition of n
Slide 17: neffy: the first needle-free way to administer epinephrine
neffy: the first 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