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ARS Update neffy Approval

Key Takeaway: ARS Pharma's neffy has been approved for the emergency treatment of Type I allergic reactions, including anaphylaxis, for patients weighing over 30 kg. The company plans to file a supplemental regulatory application for a lower dose suitable for pediatric patients in Q3 2024. While neffy offers a needle-free delivery system expected to improve patient compliance, there are concerns over potential safety issues and market acceptance. The product's commercial rollout will include post-marketing studies in alignment with FDA guidelines.

Market Sentiment Analysis

POSITIVE FACTORS

  • neffy has received approval for emergency treatment of allergic reactions
  • the device is designed to be easy to carry and administer
  • neffy offers a safer alternative compared to needle injections
  • clinical studies demonstrated efficacy and mild adverse events

CONCERNS & RISKS

  • risks related to maintaining regulatory approval
  • potential delays in coverage by payors
  • the efficacy of neffy in real-world settings remains uncertain
  • adverse reactions, such as nasal discomfort, could impact user acceptance

Full Press Release Details

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 regarding:
the design and potential benefits of neffy, including the likelihood allergy patients and caregivers will choose to carry and dose neffy compared to needle-bearing options; ARS Pharma's expected competitive position; the potential market,
demand and expansion opportunities for neffy; alignment with the FDA on post-marketing studies; plans to file a supplemental regulatory application for a neffy 1 mg dose for children 15 kg to <30 kg in Q3 2024; the timeline for potential
regulatory approval and commercialization of neffy in Europe; the timing for potential foreign regulatory filings in, for example, China, Japan, Australia and Canada; the timing of data from the Phase 2b randomized placebo-controlled urticaria trial
and initiation of a single pivotal study in urticaria; ARS Pharma's marketing and commercialization strategies, including potential partnerships in foreign jurisdictions; the expected composition and reach of ARS Pharma's commercial
force; the potential for the neffy Experience Program; the availability and functionality of neffyconnect; the anticipated pricing and co-pay buydown; the likelihood of neffy attaining favorable coverage; the expected timing for when neffy will be
commercially available; ARS Pharma's projected operating runway; the expected intellectual property protection for neffy; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are subject to the
safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking
statements. Words such as "anticipate," "demonstrate," "expect," "indicate," "plan," "potential," "target," "will" and similar expressions are intended
to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events
could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: the ability to maintain regulatory approval for neffy; results from clinical trials
and non-clinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labeling for neffy in any future indication or patient population; the scope, progress and
expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis- -vis intramuscular
injectable products; ARS Pharma's ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially
from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange
Commission ("SEC") on August 6, 2024. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma's website at ir.ars-pharma.com by clicking on the link "Financials & Filings" under the
"Investors & Media" tab. The forward-looking statements included in this presentation are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward- looking statements, except as
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
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% - 60% of 23%
- 35% fail to 7 Rx use as indicated (<20% carry two) 2 , 1,3 5, 6 4 patients delay administer dose correctly NO NEEDLE EASIER AND MORE SOLUTION: SMALL RELIABLE NO INJECTION CONSISTENT DOSING neffy Fits in your pocket; Rapid
administration Simple place and press 99.999% delivery of easy to carry the without a needle administration (no hold time) effective dose in reliability recommended 2 devices testing; not obstructed by No risk of
needle-related 100% of adults and children 2 any anaphylaxis symptoms; ~10% of cases require injuries; lacerations or are able to dose neffy no inhalation required repeat doses of cardiotoxic blood vessel successfully without any 1
epinephrine injections training 30-month shelf-life at room temperature, with Less hesitation to dose neffy stored at up to 3 months at high o temperatures (122 F) References: 1. Warren CM, et al. Ann Allergy Asthma Immunol. 2018. 2.
Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY). 3. Brooks C, et al. Ann Allergy Asthma Immunol. 2017. 4. El Turki A, et al. Emerg Med J. 4 2017. 5. Asthma and Allergy Foundation of American Patient Survey Report 2019. 6. Mehta
GD, et al. Expert Rev Clin Immunol. 2023. 7. ARS company estimates based on IQVIA data and references 1 through 6.
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:
Dosing and Administration: None One spray of neffy administered in one nostril Warnings and Precautions: Administer second dose in same nostril starting 5 Potential altered absorption with min after first dose in
absence of clinical underlying structural or anatomical nasal improvement or if symptoms worsen conditions Angina pectoris, ventricular arrhythmias, Advise patients when to seek emergency medical coexisting conditions assistance for
close monitoring of the anaphylactic episode and in the event further treatment is Adverse Reactions (incidence 2%): required Nasal discomfort (9.7%), headache (6%), Recommended patients are prescribed and have rhinorrhea
(3%), nausea (3%), dizziness (3%), throat irritation (2%), vomiting (2%) access to two neffy nasal sprays at all times with single doses Nasal use only 5
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
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 kg population) 5 primary registration studies conducted in adults and children Demonstrated PK/PD parameters within the range of approved products to reference efficacy and safety Bracketed pharmacokinetic (PK)
exposures Comparable pharmacodynamic (PD) response Five Primary Studies Patient Population EPI 15: HCP administration (single and twice dosing) Adult: healthy volunteers EPI 16: nasal-allergen challenge (single dosing) Adult: allergic
rhinitis patients EPI 17: self-administration Adult: type I allergy patients EPI 18: nasal-allergen challenge (repeat dosing) Adult: allergic rhinitis patients Pediatric: type I allergy patients: 30kg body weight (NDA) EPI 10: pediatric
Pediatric: type I allergy patients: 15 to < 30kg (sNDA planned) 7
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
comparable to approved products (SBP/HR approved Most common adverse events (>5%) with single does injection products) of neffy were mild nasal discomfort (9.7%) and mild headache (6%), with no correlation of nasal Rapid
and significant response on PD surrogates discomfort to pain or irritation for efficacy observed even 1 minute after dosing Mean VAS pain scores between 5 to 8 out of 100 PK bracketed by approved products (exposures No
irritation based on formal assessment IM/SC for efficacy, < EpiPen for safety) No serious adverse events in any clinical study Repeat doses (including during rhinitis) within No risk of needle-related injuries or
blood vessel range of approved injection products injections with neffy 8
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 Change from Baseline for
Systolic Blood Pressure (SBP) and Pulse Rate (PR) Following Two Doses of Epinephrine Administered 10 Minutes Apart in Right and Left Nares (R/L) or Right and Right Nares (R/R) in Subjects with Allergic Rhinitis with and without Nasal Allergen
Challenge (NAC) [Study 4] 9
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 announcement expected
later in 2024 China NDA filing expected in 2024 (partnered with Pediatrix) Australia MAA filing expected in 2024 (partnered with CSL Seqirus) Japan NDA filing expected in 2024 (partnered with Alfresa) Planning in progress for filing in other major
ex-US regions including Canada Expansion opportunities Data from Phase 2b randomized placebo-controlled trial in CSU patients on antihistamine therapy still experiencing acute exacerbations expected in 2025 Potential single pivotal
study in urticaria to initiate after Phase 2b study 10
Commercialization Strategy
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 over market growth
trend with ~20M diagnosed and under physician care 1 consumer promotion (2010 to 2015 ) 10 over the last 3 years 10 6.5M prescribed epinephrine Primarily managed by allergists & pediatricians ~13.5M Type I diagnosed but not 10 prescribed Rx
(past 3 years) ~3.3M don't fill regularly, ~3.2M fill ~5M 2-pack units haven't refilled or haven't filled Primarily managed by non-allergists of injectables annually, but - an additional ~5M 2- and non-pediatricians 11
~80-90% do not use as indicated 10 pack unit opportunity Diagnosing HCP not well-educated (1) do not carry (~50%), (2) do not inject (25-60%), Due to limitations of autoinjectors about treating anaphylaxis (3) wait (40-60%) or (4) dose incorrectly
(23-35%) including needle, size and portability References: 1. Based on IQVIA prescription data (~5.2 million two-packs sold in 2023). 2. Gupta RS, et al. Pediatrics. 2011. 3. Gupta RS, et al. Pediatrics 2018. 4. McGowan EC, et al. J Clin Allergy
Immunol. 2013. 5. Jackson KD, et al. NCHS 12 Data Brief. 2013. 6. Black LI, et al. CDC National Center for Health Statistics Data Brief. 2019. 7. Gupta RS, et al. JAMA Netw Open. 2019. 8. Verrill L, et al. Allergy Asthma Pro. 2015. 9. Bilo BM, et
al. Current Opin Allergy Clin Immunol. 2008. 10. IQVIA Claims Data, 2023. 11. Based on calculations from Warren CM, et al. Ann Allergy Asthma Immunol. 2018., Rooney E, et al. Poster Presentation at ACAAI 2022 (Louisville, KY). Brooks C, et al. Ann
Allergy Asthma Immunol. 2017., El Turki A, et al. Emerg Med J. 2017., Asthma and Allergy Foundation of American Patient Survey Report 2019, and Mehta GD, et al. Expert Rev Clin Immunol. 2023.
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 needs 9.3
% 55 More allergy patients and Patient Carry 5.1 caregivers are likely to N = 100 2 N = 917 carry neffy compared to 4.9 current needle-bearing 3 options 8.3 Patients are likely to dose % neffy more rapidly with a Caregiver 4.7 85 1 N
= 100 needle-free device Would Carry 3 N = 150 N = 200 Current Device neffy Market Research References: 1. Kaplan H, et al. Presentation at ACAAI 2022 (Louisville, Kentucky). 2. Warren CM, et al. Ann Allergy Asthma Immunol. 2018. 3. ARS market
research on file. 13
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 Rx? Anticipated %
of Patients that Don't Fill or Re-Fill 70% Injectables with an active neffy Rx at One Year References: 1. HCP Awareness, Trial, and Usage ("ATU") Market Research Study, May 2024 14
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 and caregivers to
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
all HCPs Reaching >80% of Prescriptions from Allergists and Pediatricians Education, awareness, and resources to drive adoption (neffy Experience) 16
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 challenge clinics)
Clinical Response Rate (%) Enable real-world experience with neffy neffy 100.0% (EPI-JP-03) Target allergist offices that conduct in- office food challenge testing HCPs will have the ability to gain first- 100% of patients
responded to a single dose of neffy in hand knowledge of neffy's effectiveness the first 15 minutes, and did not require a second dose of epinephrine per treatment guidelines Patients undergoing allergy challenge will also be exposed
to neffy 100% of patients experienced complete resolution of 2 the anaphylaxis symptoms with single dose of neffy 16 min median time to complete resolution of anaphylaxis following single dose of neffy References: 1. Ebisawa M, et al. Presentation
at AAAAI 2024 (Washington DC). 2. 100% of EPI-JP-03 patients dosed with neffy did not require a second dose in the first 15 minutes per guidelines because a response was not 17 being observed, and 100% of patients achieved complete resolution of
symptoms. 1 of the 15 subjects (6.7%) challenged with egg experienced a biphasic reaction 2h 45 min after being dosed with a single dose of neffy and achieving complete resolution of symptoms. This is consistent with the 12.8% frequency of biphasic
reactions reported in children with food-induced anaphylaxis.(Gupta RS, et al. J Allergy Clin Immunol Pract. 2021).
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)
Benefit investigation, prior authorization, and appeals support Home delivery or retail pick up Triage to Patient Assistance Program (PAP) 18
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 and peace of
mind by neffyconnect was developed to deliver on that commitment enabling patients to dose at first sign of allergic symptoms Cash price for two doses of neffy is $199 SUPPORT RAPID & BROAD UNRESTRICTED FORMULARY COVERAGE ARS is committed to the
SAR community of patients, anticipated given high degree of interest in neffy, positive caregivers, advocates, and physicians - co-pay buy-down to receptivity in early conversations, strong value proposition vs. $25 for commercial patients,
and patient assistant program competition, and programs to support formulary exceptions neffy Branded IM Injection Generic IM Injection 1 Patient Co-Pay - most insured $25 $35 Avg $40 1 Cash Price - uninsured $199 $150-$289 $111-$272 Product
expiration (up to) 30 months 18 months 18 months Average Patient Cost Per Month $0.83 / $6.63 $1.94 / $12.19 $2.22 / $10.63 (average) (Co-Pay or Cash Price/Shelf Life) References: 1. Cash price is available only through Aspen (Specialty Pharmacy)
and Walgreens, 2. List price (WAC) of two doses of neffy is $710 19
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

Frequently Asked Questions

What are forward-looking statements?

Forward-looking statements involve predictions and expectations about future events, including ARS Pharma's plans for neffy.

Who can use neffy?

Neffy is indicated for adults and children weighing 30 kg or more for allergic reactions.

What are neffy's administration requirements?

Neffy is administered as one spray in a nostril, with a possible second dose if symptoms persist.

What are common adverse reactions to neffy?

Common adverse reactions include nasal discomfort (9.7%) and headache (6%), usually mild.

Is there a pediatric dose for neffy?

Yes, a 1 mg dose of neffy is planned for children weighing 15 kg to less than 30 kg.

Last updated: Aug 12, 2024