Form 8-K - Current report

false 0001671858 0001671858 2024-08-09 2024-08-09

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

August 9, 2024

Date of Report (Date of earliest event reported)

 

 

ARS Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-39756		81-1489190
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

11682 El Camino Real, Suite 120 San Diego, California		92130
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: [phone]

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		SPRY		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

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Item 7.01

Regulation FD Disclosure.

Furnished as Exhibit 99.1 to this report is a Company presentation, which is being presented by the Company beginning at 8:00 a.m. Eastern Time on August 12, 2024.

The information in Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01

Other Events.

FDA Approval of neffy^® (epinephrine nasal spray)

On August 9, 2024, ARS Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adults and children who weigh ≥30 kg.

The approval of neffy is based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous pilot and supportive studies. neffy met all defined clinical endpoints and its pharmacokinetic and pharmacodynamic data were within the range of approved epinephrine injection products. These data included single- and twice-dosed studies in healthy adults, with self-administration and caregiver administration in Type I allergy patients, in pediatric patients ≥30 kg (66 lbs.) as well as in those with allergic rhinitis (congestion and runny nose). Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain, and no serious adverse events were reported in any clinical study.

neffy is expected to be available in the United States within eight weeks of FDA approval for patients who weigh greater than 30 kg (66 lbs.). The Company plans to file a supplemental NDA application with the FDA for neffy for children who weigh 15 to <30 kg by the end of the third quarter of 2024.

The European Committee for Medicinal Products for Human Use (the “CHMP”) adopted a positive opinion on June 27, 2024, recommending the granting of a marketing authorization for neffy (tradename EURneffy, in the European Union). The European Medicines Agency (“EMA”) decision is normally issued 67 days from the adoption of the CHMP opinion, and, if favorable, is followed by a grant of marketing authorization by the European Commission. Following the anticipated grant of marketing authorization by the European Commission expected in the third quarter of 2024, the Company anticipates that EURneffy will be made available to patients in Europe in the fourth quarter of 2024 by a pharmaceutical company with an already established commercial footprint in Europe.

Forward-Looking Statements

This report contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the timeline for neffy’s commercial availability; the Company’s plan to file a supplemental regulatory application for a neffy 1 mg product for children 15 kg to <30 kg; the timeline for potential regulatory approval and commercialization of EURneffy in Europe; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ

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materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “expected,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’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 may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; neffy may fail to achieve the degree of market acceptance by allergists, pediatricians and other physicians, patients, caregivers, third-party payors and others in the medical community necessary for commercial success; if we are unable to fully develop our sales, marketing and distribution capability, we may not be successful in commercializing neffy in the United States; 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-à-vis intramuscular injectable products; the CHMP positive opinion should not be relied on as an indication that EURneffy will ultimately be approved by the EMA; the EMA is not bound by the CHMP’s opinion or any of its recommendations; the labelling for EURneffy, if approved; the scope, progress and expansion of developing and commercializing EURneffy, if approved, including the ability to enter into distribution and/or partnering arrangements and obtain favorable reimbursement; the Company’s ability to protect its intellectual property position; and the impact of government laws, prescription drug price controls 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 the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 6, 2024.

 

Item 9.01

Financial Statements and Exhibits.

(d)

 

Exhibit Number		Description
99.1		Company Presentation, dated August 12, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

				ARS PHARMACEUTICALS, INC.
Date: August 12, 2024				By:		/s/ Richard Lowenthal
						Richard Lowenthal, M.S., MBA
						President and Chief Executive Officer

Exhibit 99.1 ARS Update neffy® Approval August 12, 2024

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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-à-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 required by law. 2

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® 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

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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.

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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

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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

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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

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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

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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

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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

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Commercialization Strategy

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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.

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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

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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

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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 seek neffy 15

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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

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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).

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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

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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

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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 to encourage peer uptake 20

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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

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Closing Thoughts *Post-Marketing Requirements/Post-Marketing Commitments

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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, • Expected operating runway of at least parallel China and Japan; filings in Canada and 3 years to support US commercialization • Q3 2024: Anticipated sNDA for 1 mg others • Robust composition of matter and dose to be filed with FDA • 2025: Phase 2b trial results expected for method of treatment IP protection • Mid-2025: Targeted at least 80% treating acute urticaria exacerbations in through at least 2038 unrestricted access in US CSU patients on antihistamine therapy 1. Cash, cash equivalents and investments as of June 30, 2024 23

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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

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® 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

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Appendix

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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 3.1” No meaningful pain or irritation Issued composition of matter and method of treatment patent exclusivity until at least 2038 Case holds two neffy 2mg devices

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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, medical assistance for close monitoring of epinephrine, the patient should seek immediate consistent with new AAAAI the anaphylactic episode, and in the event medical or hospital care.” treatment guidelines further treatment is required.” • Accidental IV injection may result in cerebral hemorrhage • Accidental injection into digits, hands or feet may result in loss of blood flow to the 2. Removes all injection-related affected area, and immediate visit to No injection-related warnings or warnings and precautions, which may emergency room precautions reduce anxiety and hesitation to dose • Needle-related injury due to lacerations, bent needle and embedded needles • Serious injection site infections including necrotizing fasciitis and myonecrosis 3. Wider temperature stability, which o o o o may facilitate carriage and Excursions permitted from 59 F to 86 F Excursions permitted from 5 F to 122 F continuous readiness 28 References: 1. EpiPen FDA Label – Prescribing Information (2/2023), 2. neffy FDA Label – Prescribing Information (8/2024)

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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 THE TIME, OF PEOPLE WOULD USE neffy PEOPLE WHO USE AN OTC WOULD SOONER THAN CURRENT 2 3 USE neffy FIRST NEEDLE INJECTORS References: 1. ARS patient market research on file. 2. Lowenthal R, et al. Presentation at AAAAI 2023 (San Antonio, Texas). 3. Kaplan H, et al. Presentation at ACAAI 2022 (Louisville, Kentucky). 29

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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 absolute % point increase in patient preference share vs. 18-month shelf-life 1 2 Cartons* per refill cycle Greater than 2 cartons/cycle 1.2 to 1.4 cartons/cycle 3 72% would use neffy instead of OTC antihistamine prior to autoinjector Likelihood to use device 4 45% reduction in time to use vs. autoinjector *One carton contains two devices Anticipate strong volume growth among today’s active Rx patient segment, in addition to lapsed/non-filler and untreated patient segments References: 1. ARS patient market research on file, 2. IQVIA longitudinal patient data, 3. Lowenthal R, et al. Presentation at AAAAI 2023 (San Antonio, Texas), 4. Kaplan H, et al. Presentation at ACAAI 2022 (Louisville, Kentucky). 30

Document and Entity Information	Aug. 09, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001671858
Document Type	8-K
Document Period End Date	Aug. 09, 2024
Entity Registrant Name	ARS Pharmaceuticals, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-39756
Entity Tax Identification Number	81-1489190
Entity Address, Address Line One	11682 El Camino Real
Entity Address, Address Line Two	Suite 120
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	(858)
Local Phone Number	771-9307
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	SPRY
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

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