false000167185800016718582026-05-152026-05-15

 

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

May 15, 2026

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 300

San Diego, California

 

92130

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (858) 771-9307

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.

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On May 15, 2026, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended March 31, 2026 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or subject to the liabilities of that, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 (the “Securities Act”), whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

Item 7.01 Regulation FD Disclosure.

On May 15, 2026, the Company updated its corporate presentation for use with investors, analysts and others. The revised presentation is available through the Company’s website, and a copy of the presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibit

Number

Description

99.1

 

Press Release dated May 15, 2026

99.2

 

Company Presentation dated May 15, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 


 

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: May 15, 2026

 

By:

/s/ Richard Lowenthal

 

 

 

Richard Lowenthal, M.S., MSEL

 

 

 

President and Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 


 

Exhibit 99.1

 

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ARS Pharmaceuticals Reports First Quarter 2026 Financial Results and Corporate Update

 

Q1 2026 total revenue of $22.7 million including neffy U.S. net product revenue of $17.5 million

 

CVS Caremark proposal in final stages of approval process; definitive update anticipated in early June

 

Sales force expansion to 148 representatives completed

 

Phase 2b CSU study interim population fully enrolled, and on track for Q4 2026 readout

 

Conference call to be held today, May 15, 2026, at 5:30 a.m. PT / 8:30 a.m. ET

 

SAN DIEGO, May 15, 2026 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients against allergic reactions that could lead to anaphylaxis, today announced financial results for the first quarter of 2026 and provided an update on the continued commercialization of neffy® (epinephrine nasal spray), the first and only FDA- and European Commission-approved needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis.

 

“Building on strong commercial momentum, neffy is redefining the landscape for emergency treatment of severe allergic reactions, including anaphylaxis, as the first and only needle-free epinephrine option,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “With expected prescription renewals beginning to layer on top of strong new patient demand in the second half of 2026, we are well-positioned to drive meaningful market share growth. We remain focused on expanding access, deepening prescriber adoption, ensuring affordability with a point-of-sale program at retail pharmacies that will convert non-covered claims to a price of $199 for patients, and advancing our intranasal epinephrine platform into chronic spontaneous urticaria.”

 

 


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First Quarter 2026 Financial Results

Revenue: Total revenue for the first quarter of 2026 was $22.7 million, comprised of $17.5 million in net product revenue from neffy sales in the U.S., $2.5 million in collaboration revenue from international partners, and $2.7 million in supply revenue from partners. The $2.5 million in collaboration revenue recognized during the quarter represents a portion of a $5.0 million milestone payment from our partner ALK-Abelló A/S (ALK), triggered by the approval of neffy 1 mg in the EU. Of the remaining $2.5 million balance, $2.4 million was recorded to financing liability and $0.1 million was recorded to contract liability on the balance sheet.
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $4.3 million, primarily associated with continued investment in development programs, clinical trials, and associated personnel costs.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2026 were $72.2 million, reflecting continued direct-to-consumer marketing investment and sales and marketing expenses associated with the U.S. commercialization of neffy. The expansion of the sales force in the first quarter from 106 to 148 representatives was funded through reallocation of existing resources.
Net Loss: Net loss for the first quarter of 2026 was $60.6 million, or ($0.61) per share basic and diluted.
Cash Runway: As of March 31, 2026, ARS Pharma had cash, cash equivalents, and short-term investments of $201.0 million, with 99,300,137 shares of common stock outstanding. ARS Pharma believes this cash position is sufficient to fund operations through cash-flow break-even.

 

neffy U.S. Commercial Update

Payor access progress: ARS Pharma submitted a proposal to CVS Caremark to add neffy to its commercial formulary without prior authorization, with a target July 1, 2026 effective date. The proposal is in the final stages of CVS’s approval process with economics within the range of ARS Pharma’s long-term gross-to-net retention target of approximately 50 percent. ARS Pharma anticipates being able to provide a more definitive update soon.
State Medicaid expansion: Florida added neffy to its unrestricted Medicaid formulary, bringing the total to nine state Medicaid plans covering neffy without prior authorization. Discussions with additional states are ongoing, and we anticipate a majority of Medicaid state plans adopting neffy to their unrestricted Medicaid formularies by early 2027.
Sales force expansion: ARS Pharma completed the previously announced expansion of its sales force from 106 to 148 representatives and area sales managers, increasing call frequency and depth of engagement among high-prescribing allergists and their support staff.
Removal of age criteria from 1 mg neffy: FDA approved removing the age criteria in late March 2026, so all children and adults who weigh 33 lbs or more can utilize neffy for the emergency treatment of Type I allergic reactions, including anaphylaxis.

 

 


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Additional commercial highlights include:

Increasing breadth and depth of healthcare provider adoption: More than 28,000 healthcare providers have prescribed neffy to date, with approximately half being repeat prescribers. Prescribing remains concentrated among the highest-decile accounts, which represent the majority of category volume.
School access expansion: More than 10,000 schools have opted into the neffyinSchools program, with each school receiving two cartons of neffy 2 mg or 1 mg at no cost for emergency use through the School Health Corp. SHConnect platform. More than 200 successful uses of neffy have been reported
New retail pharmacy program launched: This automated solution introduced in May operates at the point-of-sale to reduce claim abandonment when a claim is rejected. It converts a denied claim into our cash price of $199 for patients.

 

Continued Global Expansion of neffy and EURneffy

Health Canada approval of neffy: On April 15, 2026, Health Canada approved neffy as the first and only needle-free emergency treatment for allergic reactions, including anaphylaxis, in Canada. Commercial launch by ALK is expected later in 2026.
EURneffy® 1 mg approved in Europe: On March 31, 2026, the European Commission granted marketing authorization for EURneffy® 1 mg, extending the neffy franchise across the EU as the first and only needle-free adrenaline treatment for younger children at risk of anaphylaxis. The 1 mg dose is indicated for pediatric patients aged 4 years and older weighing between 15 kg and 30 kg. ARS Pharma's partner ALK is responsible for commercialization across the EU.

 

Clinical Advancement of Intranasal Epinephrine Program

Phase 2b trial in chronic spontaneous urticaria (CSU) on track: ARS Pharma’s Phase 2b trial (NCT06927999) evaluating its intranasal epinephrine technology as a treatment for acute flares of chronic spontaneous urticaria continues to enroll patients across the U.S. and Europe. The interim analysis population is fully enrolled, with interim data anticipated in the fourth quarter of 2026, followed by the potential initiation of a single Phase 3 pivotal efficacy study in mid-2027.

 

Conference Call and Webcast Information

 

ARS Pharma management will host a conference call and webcast at 5:30 a.m. PT / 8:30 a.m. ET today, May 15, 2026. To access the webcast and slides, please visit the Events & Presentations page in the Investors & Media section of the Company’s website. A replay of the webcast will be available for 30 days following the event. Dial-in information for conference participants may be obtained by registering for the event.

 

 


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EURneffy® is the trade name for neffy® (epinephrine nasal spray) in Europe.

 

About neffy®

 

neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater.

 

INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)

 

INDICATION

 

neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater.

 

IMPORTANT SAFETY INFORMATION

neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

 

Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.

 

Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.

 

Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson’s disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.

 

Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson’s disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.

 

neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.

 

 


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Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.

 

Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.

 

These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see the full Prescribing Information and Patient Information for neffy.

 

About Type I Allergic Reactions Including Anaphylaxis

Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.

 

About ARS Pharmaceuticals, Inc.

ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® (trade name EURneffy® in the EU and UK), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children aged 4 years and older who weigh 15 kg or greater. For more information, visit www.ars-pharma.com.

 

 


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Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the belief that ARS Pharma is well-positioned to drive meaningful market share growth; expectations regarding prescription renewals and demand generally; ARS Pharma’s plans to expand access to, deepen, adoption of, and ensure affordability of neffy; ARS Pharma’s projected cash runway and belief that it can fund operations through cash-flow break-even; expectations regarding the completion of the CVS Caremark formulary approval process and the expected gross-to-net economics thereof; the anticipated expansion of state Medicaid formulary coverage for neffy, including the timing thereof; the timing of commercial launch for neffy in Canada; ; the anticipated timing for an interim data readout from the Phase 2b CSU trial, and the anticipated timing for the potential initiation of a Phase 3 pivotal efficacy study; and other statements that are not historical fact. 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,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track,” “potential,” “plan,” “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: potential safety and other complications from neffy; the ability to maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy; the risk that personnel costs will be higher than anticipated; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy 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, regulations and policies. 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 Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”), and as updated by the ‘Risk Factors’ in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, to be filed with the SEC today. These documents can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.

 

The forward-looking statements included in this press release 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. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.

 


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Investor Contact:

Justin Chakma, ARS Pharma
justinc@ars-pharma.com

 

Media Contact:

Christy Curran, Sam Brown Inc.
christycurran@sambrown.com

615.414.8668

 


 

ARS Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and par value data)

 

 

March 31, 2026

 

 

December 31, 2025

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,321

 

 

$

41,317

 

Short-term investments

 

 

176,648

 

 

 

203,669

 

Accounts receivable, net

 

 

28,662

 

 

 

25,347

 

Inventories

 

 

8,817

 

 

 

8,369

 

Prepaid expenses and other current assets

 

 

6,788

 

 

 

6,194

 

Total current assets

 

 

245,236

 

 

 

284,896

 

Inventories, noncurrent

 

 

23,221

 

 

 

23,053

 

Property, plant and equipment, net

 

 

2,285

 

 

 

2,465

 

Intangible assets, net

 

 

14,176

 

 

 

14,452

 

Other assets

 

 

2,653

 

 

 

2,786

 

Total assets

 

$

287,571

 

 

$

327,652

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued liabilities (including related party amounts of $1,431 and $1,624, respectively)

 

$

48,263

 

 

$

37,948

 

Contract liability, current

 

 

757

 

 

 

609

 

Other current liabilities

 

 

592

 

 

 

588

 

Total current liabilities

 

 

49,612

 

 

 

39,145

 

Term loans, net (including related party amounts of $4,826 and $4,819, respectively)

 

 

96,522

 

 

 

96,374

 

Financing liability

 

 

74,673

 

 

 

72,140

 

Contract liability, net of current portion

 

 

978

 

 

 

1,130

 

Other accrued liabilities

 

 

4,478

 

 

 

4,605

 

Total liabilities

 

 

226,263

 

 

 

213,394

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized at March 31, 2026 and December 31, 2025; no shares issued and outstanding at March 31, 2026 and December 31, 2025

 

 

 

 

 

 

Common stock, $0.0001 par value per share; 200,000,000 shares authorized at March 31, 2026 and December 31, 2025; 99,300,137 and 99,290,926 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

 

 

10

 

 

 

10

 

Additional paid-in capital

 

 

416,615

 

 

 

408,726

 

Accumulated other comprehensive (loss) gain, net

 

 

(96

)

 

 

125

 

Accumulated deficit

 

 

(355,221

)

 

 

(294,603

)

Total stockholders’ equity

 

 

61,308

 

 

 

114,258

 

Total liabilities and stockholders’ equity

 

$

287,571

 

 

$

327,652

 

 

 


 

ARS Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Revenue:

 

 

 

 

 

 

Product revenue, net

 

$

17,452

 

 

$

7,763

 

Revenue under collaboration agreements

 

 

2,489

 

 

 

210

 

Revenue under supply agreements

 

 

2,740

 

 

 

 

Total revenue

 

 

22,681

 

 

 

7,973

 

Operating expenses:

 

 

 

 

 

 

Cost of goods sold (including related party amounts of $1,233 and $488, respectively)

 

 

6,286

 

 

 

1,094

 

Research and development (including related party amounts of $667 and $666, respectively)

 

 

4,336

 

 

 

2,952

 

Selling, general and administrative (including related party amounts of $135 and $124, respectively)

 

 

72,204

 

 

 

41,104

 

Total operating expenses

 

 

82,826

 

 

 

45,150

 

Loss from operations

 

 

(60,145

)

 

 

(37,177

)

Other income (expense), net:

 

 

 

 

 

 

Interest income

 

 

1,968

 

 

 

3,237

 

Interest expense (including related party amounts of $122 and $0, respectively)

 

 

(2,441

)

 

 

 

Total other (expense) income, net

 

 

(473

)

 

 

3,237

 

Net loss

 

 

(60,618

)

 

 

(33,940

)

Unrealized losses on available-for-sale securities

 

 

(221

)

 

 

(148

)

Comprehensive loss

 

$

(60,839

)

 

$

(34,088

)

Net loss per share, basic and diluted

 

$

(0.61

)

 

$

(0.35

)

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

 

 

99,296,408

 

 

 

98,060,636

 

 

 


Slide 1

May 2026 Corporate Presentation neffy – the transformative needle-free solution for severe allergic reactions Exhibit 99.2 NASDAQ: SPRY


Slide 2

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 potential market, demand and expansion opportunities for neffy; the belief that ARS Pharma is positioned to accelerate market share expansion; the anticipated gross-to-net percentage range; the expected intellectual property protection for neffy; guidance regarding ARS Pharma’s future performance and results of operations, including any cash or cash equivalent resource projections; the design and potential benefits of neffy, including its needle-free, compact, portable and easy to use design, reliability, temperature stability, and the likelihood allergy patients and caregivers will choose to carry and dose neffy compared to needle-bearing options; the belief that real-world outcomes data support the clinical interchangeability of neffy and epinephrine injection; the anticipated benefits of ARS Pharma’s ex-U.S. partnerships; the timeline for regulatory decisions and commercialization of neffy outside of the United States; evaluations, judgments, and expectations regarding ARS Pharma’s marketing and commercialization strategies; the likelihood of neffy attaining favorable coverage and the expected timing of coverage decisions; the potential market opportunity for chronic spontaneous urticaria, the potential for ARS Pharma’s intranasal epinephrine technology to expand into the urticaria indication and the estimated patient population for this indication, the demand for ARS-2, if approved; the anticipated timing for interim data from the urticaria trial, initiation of a Phase 3 clinical trial, and for the filing of a new drug application and FDA approval for ARS-2; ARS Pharma’s expected competitive position; the expected composition and reach of ARS Pharma’s commercial force and expected benefits from an expanded sales force; the expected benefits from the "Get neffy on Us" program, the impact of reduced prior authorizations on health care prescribers; 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 obtain and 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; the risk that ARS Pharma may not realize its expected return on investment from its DTC campaign; 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; ARS Pharma’s reliance on its licensing and co-promotion partners; the potential for payors and governments to delay, limit or deny coverage or reimbursements 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; net product sales may not be indicative of profitability or profitability at expected levels; reliance on survey results with small sample sizes; 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 Annual Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 15, 2026. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma’s website at ars-pharma.com by clicking on the link “Financial 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. ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


Slide 3

Transforming the Emergency Treatment of Type I Allergic Reactions neffy®: first and only FDA approved “no needle, no injection” solution for the emergency treatment of Type I allergic reactions Potential multi-billion US market opportunity ($3.5B Rx’ed, plus $7B expansion segment) driven by HCP and patient preference and adoption1 Phase 2b CSU interim population fully enrolled with topline results expected in Q4 2026 ($2B+ peak opportunity) Strong execution ($72.2M net US sales) in FY 2025, with seamless prescribing experience starting in mid-2026 to unlock significant growth Expanded sales force: Increase from 106 to 148 reps to increase call frequency and support conversion with target high-prescribers and office staff DTC: new optimized advertising campaign launched in January 2026, with $199 retail cash option available starting in May 2026 for commercial patients Prescribing breadth: 28,000+ HCPs have prescribed neffy, ~50% repeat GTN: ~50% target retention including future PBM additions and $0 co-pay NCE-like IP exclusivity potential with issued composition of matter and method of treatment patents until at least 2039 $201.0 million in cash, cash equivalents and short-term investments2 References: 1. Company estimates 2. As of 3/31/2026 ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Anaphylaxis is Accompanied by Many Frequent Symptoms References: 1. Shaker MS, et al. J Allergy Clin Immunol. 2020. 2. Pistiner M, et al. J Allergy Clin Immunol Pract. 2021. 3. Jalil M, et al. Abstract at AAAAI 2020 Virtual Meeting. 4. Gonzelez-Estrada A, et al. Ann Allergy Asthma Immunol. 2018. 5. Lee S, et al. J Allergy Clin Immunol. 2017. 6. Lee S, et al. J Allergy Clin Immunol Pract. 2014. 7. Manivannan V, et al. Am J Emerg Med. 2014. 8. Wood RA, et al. J Allergy Clin Immunol 2014. 9. Walsh KE, et al. Pharmacoepidemiol Drug Saf 2013. 10. Decker WW, et al. J Allergy Clin Immunol. 2008. 11. Ross MP, et al. J Allergy Clin Immunol. 2008. 12. Webb LM & Lieberman P. Ann Allergy Asthma Immunol. 2006. 13. Ditto AM, et al. Ann Allergy Asthma Immunol. 1996. 14. Rudders SA, et al. Pediatrics. 2010. Note that some publications do not specify angioedema symptom subtype. Angioedema subtype frequency aggregated when reported. urticaria (hives, erythema) or angioedema (swelling of the face, lips, tongue or larynx) >85% >55% gastrointestinal (eg, vomiting, nausea) Common Anaphylaxis Symptoms Include: difficult breathing >40% ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Type I Allergy Patients Face Significant Limitations with Other Treatment Options that neffy may help to address 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. 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. 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 Fits in your pocket; easy to carry the recommended 2 devices ~10% of cases require repeat doses of epinephrine1 EASIER AND MORE CONSISTENT DOSING Simple place and press administration (no hold time) 100% of adults and children dosed neffy successfully in human factors studies by reading the commercial instructions for use (IFU) RELIABLE 99.999% delivery of effective dose in reliability testing; not obstructed by any anaphylaxis symptoms; no inhalation required 30-month shelf-life at room temperature, with neffy stored at up to 3 months at high temperatures (122oF) Only 50% carry one1 (<20% carry two) ~25% - 60% do not administer, 1,3 5, 6 NO TREATMENT READILY AVAILABLE REFUSAL OF TREATMENT ~40% - 60% of patients delay2 DELAY IN TREATMENT 23% - 35% fail to dose correctly4 USER ERROR IN TREATMENT SOLUTION: neffy PROBLEM: ONLY 10% - 20% of patients with active Rx use as indicated7 SMALL ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Addressing the Significant Unmet Needs in US Severe Allergic Reaction Patient Population References: 1. Based on IQVIA prescription data through Sept 2025 (5.7M two-packs). 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 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. 12. Estimated based on 13.5M diagnosed, but not prescribed epinephrine Rx Promotional Responsiveness ~20M diagnosed and under physician care between 2021 - 202410 Epidemiology prevalence data estimates ~40M patients with type 1 allergic reactions2-9 ~50% increase over market growth trend with consumer promotion (2010 to 20151) Consistent Market Growth (Units) +6.5% CAGR since 2010, +12.7% YoY in 20231 ~50% fill ~5.5M 2-pack units of injectables annually, but ~80-90% do not use as indicated11 ~13.5M Type I diagnosed but not prescribed Rx (past 3 years)10 ~50% don’t fill regularly, haven’t refilled or haven’t filled – an additional ~5.5M 2-pack unit opportunity10 6.5M prescribed epinephrine10 Primarily managed by allergists & pediatricians Primarily managed by non-allergists and non-pediatricians $710 WAC/Rx ~50% GTN Yield ~11M+ two-packs ~$3.5B+ peak net sales potential in initial addressable segments alone = X X ~$7B+ potential in expansion segment12 + Not including increased units/patient as market research indicates ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Ex-US partners enable ARS to focus exclusively on the United States References: 1. 2023 IQVIA data based on estimated gross-to-net for generic and branded autoinjector products in the United States, 2. ALK Press Release (Nov 9, 2024) ALK licenses rights to neffy®, the first approved adrenaline nasal spray for emergency treatment of allergic reactions (anaphylaxis) | ALK US: 80%+ of WW sales1 ARS has received US, EU, UK, China, AUS, JP and CAN approvals; these regions represent 98% of global epinephrine autoinjector sales1 Strong ex-US licensing partnering strategy with $570M in upfront & milestones in addition to attractive royalty streams on net sales Projected ~$425M USD neffy annual peak sales in ALK region for anaphylaxis only (excluding US, China, Japan, AUS/NZ)2 ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Commercialization Progress ARS Pharmaceuticals, Inc. Investor Presentation – Ma y 2026


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HCPs support the belief that neffy will capture a lion’s share of the market with comparable market access as autoinjectors Anticipated share (%) of patients receiving neffy (Oct 2025 Survey) References: 1. October 2025 HCP ATU survey (n = 250) ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Structural barriers in autoinjector market structure mean fewer short-term opportunities to switch to neffy References: 1. IQVIA analysis (March 2026) based on Jan 2025 to Jan 2026 epinephrine pharmacy and claims (LRx) and medical and institutional claims (Dx), 2. IQVIA longitudinal epinephrine Rx claims analysis (2023) ARS Pharmaceuticals, Inc. Investor Presentation – May 2026 Epinephrine Autoinjector Market Flow ~55%1 Electronic virtual visits ~45%1 in-person visits High 30% overall EAI re-fill rate2 When EAI Expires (Later in 2026/2027) However, due to low EAI refill rates, over a 1-2 year period, there is significant patient turnover that results in more in-person HCP discussion opportunities EAI Rx Today (2025-2026) Short-term EAI market skewed to virtual electronic refills, where there is no HCP discussion, therefore limited opportunity to switch to neffy. ~45% new patient in-person visits ~40% electronic virtual refills New Patients ~15% new patient virtual visit High 30% overall EAI re-fill rate ~15% electronic virtual refills of 2025 cohort by 2027


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New Patients Underlying demand for neffy growing despite coverage challenges, but market structure obscures near-term uptake ARS Pharmaceuticals, Inc. Investor Presentation – May 2026 Epinephrine Autoinjector Market Flow When EAI Expires (Later in 2026/2027) EAI Rx Today (2025-2026) ~40% electronic virtual refills 2x higher than overall market share for neffy where in-person HCP discussions are occurring 90%+ intent to refill by actual neffy patients2 Organically more HCP neffy discussions over 1-2 years due to low EAI refill rates 50%+ future market share with improved market access when HCP discussion occurs about neffy Faster neffy market share growth due to installed base of neffy patients refilling virtually without HCP discussion ~55%1 Electronic virtual visits ~45%1 in-person visits ~45% new patient in-person visits ~15% new patient virtual visit References: 1. IQVIA analysis (March 2026) based on Jan 2025 to Jan 2026 epinephrine pharmacy and claims (LRx) and medical and institutional claims (Dx), 2. September 2025 consumer ATU survey (neffy users only, n = 70)


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neffy users indicating a higher intention to refill vs. EAIs, contributing to market expansion % of users likely to refill neffy1 (12 to 24 month expiry from product receipt) Actual EAI refill rates2 (12 to 24 months after initial Rx) 87% of neffy users report a positive impact on daily and social life1 References: 1. September 2025 consumer ATU survey (neffy users only, n = 70), 2. IQVIA longitudinal prescription data (2023) High rates of neffy patient satisfaction and intent to refill ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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neffy is already expanding the epinephrine market into new patient segments beyond those who already fill autoinjector Rx Source of neffy patients by segment (September 2025)1 Active EAI: ~$2B net sales2 (~3.3 million patients) Addressable US Segment Size (Patients) References: 1. September 2025 survey of neffy users (n = 70), 2. Segment net sales estimated by IQVIA epinephrine prescription data and neffy’s net price per two-pack unit. 26% of neffy patients are from market expansion segments that represent a significant addressable market in the US Lapsed/Non-Filler: (~3.3 million patients) Never Rx: (~13.5 million patients) ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Real world evidence from neffy experience supports the clinical interchangeability of neffy and injection References: 1. Casale TB, Spergel JM, Bernstein DI, Tanimoto S. Real world data on the effectiveness of neffy in clinical practice. Annals of Allergy, Asthma and Immunology (November 2025). ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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80% of patients are very likely or extremely likely to ask their HCP about neffy after learning about it2 89% of HCPs prescribe neffy when asked by a patient3 20% May 2025 2.9x increase 58% Dec 2025 DTC impact on aided consumer awareness of neffy (%)1 References: 1. September 2025 DTC Tracker (n = 400 type I allergy patients), 2. September 2025 consumer ATU survey (n = 400 type I allergy patients), 3. September 2025 HCP ATU survey (n = 250 HCPs) neffy investment in DTC is significantly increasing consumer awareness with early ROI measures on track to benchmarks ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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72% of patients are interested in a virtual prescriber option1 $0 co-pay for commercially eligible patients $0 visit fee <5 to 10 min appointment at the patient's convenience References: 1. August 2025 consumer ATU survey (n = 400 type I allergy patients) “Get neffy on Us” virtual prescriber with a $0 co-pay launched in November 2025 to reduce patient burden ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Chronic spontaneous urticaria (CSU) is a blockbuster opportunity for ARS-2 as the first-ever treatment for acute flares ~1.5M diagnosed and treated chronic urticaria patients based on US claims database analysis prevalence of 0.57%1 900K US chronic urticaria patients reported to be uncontrolled with Rx medication1 ~8-9 HCP visits per year1 plus ~4-5 ER visits per year1,2 $900+ WAC/Rx3 ~50% GTN Yield $2B+ peak CSU net sales potential4 X X = References: 1. Riedl MA et al. Clinical burden, treatment and disease control in patients with chronic spontaneous urticaria. Annals of Allergy, Asthma and Immunology (2025), 2. Barniol C, et al. Annals of Emergency Medicine (2018),, 3. Anticipated WAC of neffy at the time of CSU launch in 2028, 4. Assuming one episode per month that requires treatment with neffy No treatments available for acute CSU flares today ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Intranasal epinephrine (ARS-2) shows significant and rapid reduction of acute flares in treatment-resistant CSU patients in-clinic who exhibit flares nearly all the time References: 1. Bernstein J, et al. Frequency of angioedema in chronic spontaneous urticaria: Report from the Urticaria Voices study. American Academy of Asthma and Immunology Annual Meeting (February 2024) ARS Pharmaceuticals, Inc. Investor Presentation – May 2026 Randomized, placebo-controlled, blinded Phase 2b study in the clinic


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Phase 2b trial with low-dose ARS-2 (0.5 mg, 1 mg) in CSU patients with episodic flares to read out interim result (n=21) in Q4 2026 n = 42 CSU patients, 18 to 65 years old, with a history of moderate to severe acute exacerbations or flares (UAS Score ≥ 2) Patients are on chronic therapy of antihistamines or biologics, experiencing at least 1-2 acute flares/month or every other month EPI-U02 CSU Trial enrollment criteria ARS-2 (0.5 mg) ARS-2 (1.0 mg) Placebo Event 1 ARS-2 (0.5 mg) ARS-2 (1.0 mg) Placebo ARS-2 (0.5 mg) ARS-2 (1.0 mg) Placebo Event 2 Event 3 X X CSU patients randomized to 6 possible sequences to receive 0.5 mg, 1.0 mg, placebo to treat outpatient events Clinical outcomes Q4 2026 interim (n = 21) read-out Mid-2027 Phase 3 (n = ~100) 2028 NDA filing/FDA approval Self-assessment via smartphone app taken at multiple timepoints in first 180 min, and 6 hours and 8 hours post-dose Primary endpoints: Change in itch score (UAS) Change in hives scores (UAS) Patients can use a second dose if symptoms recur within 24 hours after initial dose ARS Pharmaceuticals, Inc. Investor Presentation – May 2026 Interim population (n = 21) is fully enrolled as of May 2026


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CSU experts intend to prescribe ARS-2, if approved, as an adjunctive therapy to a majority of CSU patients of all CSU patients would be prescribed ARS-2 (regardless of background therapy - antihistamines, biologics and combo) “I would be very excited to have this option to provide to our patients… even at the first appointment when talking about what we're going to do… up dosing anti histamines, potential for starting a biologic and I'm also going to give you this prescription for breakthrough symptom…” 64% Survey of allergists who manage ~3,000 CSU patients “None of our therapies that we use right now are directed at resolving CSU. They're all band aids that we're giving our patients to treat the symptoms... so you're going to have periods of time when there's going to be breakthrough because the condition hasn't gone away, and it's going to flare up. This provides a safe and effective option to treat those blips that keep happening.” “There's always going to be patients that have a breakthrough at each stage […] And the question arises, like how frequent enough is this happening or how severe is this enough to justify the next step. […] We don't necessarily need to jump up. [If] We have something that can help with those breakthrough events[…] It'd be a nice alternate pathway to treat a lot of these patients.” ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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Strong financial position to invest into the growth of neffy $201.0M in cash, cash equivalents and short-term investments as of March 31, 2026 ~50% target gross-to-net retention guidance Q1 2026 Highlights $22.7M total revenue $82.8M total operating expenses (cash and non-cash) $60.6M net loss ARS Pharmaceuticals, Inc. Investor Presentation – May 2026


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A Clear Path for Continuing to Accelerate neffy Growth in 2026, and Maintain Potential Blockbuster Sales Trajectory Multi-blockbuster peak sales potential driven by initial $3.5B segment, ~$7B expansion segment and ~$2B+ CSU indication 900+ documented cases of real-world anaphylaxis treated using neffy with a response rate to a single dose that is the same as injection 58% consumer aided awareness of neffy as of Dec 2025, with a similar or greater DTC spend investment in 2026 to further drive patient action 28,000+ HCPs Significant population of HCPs prescribing neffy to date, with prescribing anticipated to further accelerate once prior authorization formwork is unlocked as a workflow barrier $201M Strong cash balance provides funding to cash-flow break, with GTN on track for steady-state ~50% target retention including PBM additions and $0 co-pay ARS Pharmaceuticals, Inc. Investor Presentation – May 2026