SPRY 8-K
ARS Pharmaceuticals, Inc. (SPRY)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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:
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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 August 13, 2025, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2025 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 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 August 13, 2025, 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 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 |
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Description |
99.1 |
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99.2 |
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104 |
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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.
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ARS PHARMACEUTICALS, INC. |
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Date: August 13, 2025 |
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By: |
/s/ Richard Lowenthal, M.S., MSEL |
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Richard Lowenthal, M.S., MSEL |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
Exhibit 99.1
ARS Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Accelerating Growth for neffy® (epinephrine nasal spray)
$15.7 million in revenue, including $12.8 million in neffy U.S. net product revenue in second quarter of 2025
Growth for neffy in the U.S. driven by increased payor access with additional near-term growth anticipated from national direct-to-consumer (DTC) campaign and pediatric co-promote partnership
93% commercial coverage achieved with streamlined prior authorization process with approval rates at the pharmacy benefit manager (PBM) comparable to overall epinephrine market
EURneffy® approved in the United Kingdom and launched in Germany, now representing a global footprint with this first and only needle-free epinephrine treatment
Conference call to be held today, August 13, 2025, at 5:30 a.m. PT / 8:30 a.m. ET
SAN DIEGO, August 13, 2025 – ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced financial results for the second quarter of 2025, and provided an update on the commercial launch of neffy® (epinephrine nasal spray), the first and only FDA-approved and European Commission-approved needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis.
“The second quarter marks a pivotal inflection point for neffy, highlighted by robust growth in prescriptions driven by expanding payor access and strong sales execution,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “As we move through the peak back-to-school prescribing season and with our most recent DTC investment and co-promote partnership, neffy is rapidly establishing itself as a preferred epinephrine option for patients, caregivers and schools. With continued commercial momentum in the U.S. and an expanded global presence marked by EURneffy’s approval in the U.K. and launch in Germany, we are advancing our vision to redefine the standard of care for allergic emergencies while creating lasting value for patients, providers and shareholders alike.”
Second Quarter 2025 Financial Results
neffy Commercial Launch Progress in the United States
Additional highlights from the neffy U.S. commercial launch include:
“A key factor driving our growth and momentum has been achieving a critical milestone in payor access, which has significantly reduced administrative barriers for providers,” said Eric Karas, Chief Commercial Officer of ARS Pharma. “As the volume of neffy continues to increase, we anticipate that the economic factors for the remaining PBMs will continue to reduce prior authorization requirements. Additionally, the combination of our sales force execution and DTC advertising further positions us for market share growth. This, along with a more seamless physician prescribing experience and enhanced consumer awareness, creates a strong foundation for continued commercial expansion.”
Global Expansion for neffy and EURneffy
Clinical Expansion of Intranasal Epinephrine Program
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, August 13, 2025. 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.
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 aged 4 years and older 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 aged 4 years and older 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.
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), 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 4 years of age and older 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 who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.
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: ARS Pharma’s guidance that its financial position is expected to support its operating plans for at least the next three years; the expectation for further neffy script momentum in the second half of 2025 and beyond; the projection that gross-to-net retention is now at steady-state levels at approximately 50% and that this will provide greater predictability for revenue modeling; the expectation that PBMs will continue to reduce prior authorization requirements; the belief that ARS Pharma is positioned for market share growth and continued commercial expansion; the belief that the commercial launch in Germany is indicative of global demand for ARS Pharma’s intranasal epinephrine product; the anticipated timing for topline data from the urticaria trial and the potential for ARS Pharma’s intranasal epinephrine technology to expand into the urticaria indication, and the estimated patient population for this indication; the anticipated timing of regulatory decisions for neffy and the expected timing of commercial launches in Canada, China, Japan and Australia; the anticipated timing of the EMA’s regulatory decisions for neffy; the expected timing of commercial launch in the U.K.; 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,” “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 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on May 14, 2025 and in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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.
Investor Contact:
Justin Chakma, ARS Pharma
[email protected]
Media Contact:
Christy Curran, Sam Brown Inc.
[email protected]
615.414.8668
ARS Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and par value data)
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June 30, 2025 |
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December 31, 2024 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
51,540 |
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$ |
50,817 |
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Short-term investments |
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188,590 |
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263,205 |
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Accounts receivable, net |
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25,126 |
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8,175 |
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Inventories |
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8,738 |
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5,212 |
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Prepaid expenses and other current assets |
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7,442 |
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6,886 |
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Total current assets |
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281,436 |
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334,295 |
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Long-term inventories |
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13,374 |
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5,307 |
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Right-of-use asset |
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1,564 |
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37 |
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Fixed assets, net |
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1,075 |
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1,029 |
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Intangible assets, net |
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12,972 |
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7,371 |
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Other assets |
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3,051 |
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3,114 |
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Total assets |
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$ |
313,472 |
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$ |
351,153 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable and accrued liabilities (including related party amounts of $1,091 and $656, respectively) |
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$ |
44,264 |
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$ |
22,841 |
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Contract liability, current |
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746 |
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557 |
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Lease liability, current |
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589 |
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42 |
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Total current liabilities |
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45,599 |
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23,440 |
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Financing liability |
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71,959 |
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69,383 |
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Contract liability, net of current portion |
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1,103 |
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1,532 |
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Total liabilities |
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121,151 |
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94,355 |
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Commitments and contingencies |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized at June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 |
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— |
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— |
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Common stock, $0.0001 par value per share; 200,000,000 shares authorized at June 30, 2025 and December 31, 2024; 98,697,658 and 97,954,172 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively |
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10 |
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10 |
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Additional paid-in capital |
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394,485 |
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379,873 |
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Accumulated other comprehensive (loss) gain, net |
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(46 |
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220 |
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Accumulated deficit |
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(202,128 |
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(123,305 |
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Total stockholders’ equity |
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192,321 |
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256,798 |
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Total liabilities and stockholders’ equity |
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$ |
313,472 |
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$ |
351,153 |
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ARS Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue: |
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Product revenue, net |
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$ |
12,800 |
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$ |
— |
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$ |
20,563 |
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$ |
— |
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Revenue under collaboration agreements |
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2,594 |
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500 |
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2,804 |
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500 |
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Revenue under supply agreements |
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323 |
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— |
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323 |
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— |
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Total revenue |
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15,717 |
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500 |
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23,690 |
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500 |
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Operating expenses: |
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Cost of goods sold (including related party amounts of $866, $0, $1,354, and $0, respectively) |
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4,984 |
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— |
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6,078 |
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— |
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Research and development (including related party amounts of $582, $518, $1,245, and $1,245, respectively) |
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4,035 |
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6,896 |
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6,987 |
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12,130 |
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Selling, general and administrative (including related party amounts of $107, $114, $231, and $208, respectively) |
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54,312 |
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8,944 |
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95,416 |
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16,902 |
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Total operating expenses |
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63,331 |
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15,840 |
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108,481 |
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29,032 |
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Loss from operations |
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(47,614 |
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(15,340 |
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(84,791 |
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(28,532 |
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Other income, net |
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2,731 |
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2,824 |
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5,968 |
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5,724 |
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Net loss |
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$ |
(44,883 |
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$ |
(12,516 |
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$ |
(78,823 |
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$ |
(22,808 |
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Change in unrealized gains and losses on available-for-sale securities |
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(118 |
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(21 |
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(266 |
) |
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(194 |
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Comprehensive loss |
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$ |
(45,001 |
) |
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$ |
(12,537 |
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$ |
(79,089 |
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$ |
(23,002 |
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Net loss per share, basic and diluted |
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$ |
(0.46 |
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$ |
(0.13 |
) |
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$ |
(0.80 |
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$ |
(0.24 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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98,361,771 |
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96,827,687 |
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98,212,035 |
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96,656,690 |
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August 2025 neffy – the transformative needle-free solution for severe allergic reactions Exhibit 99.2 NASDAQ: SPRY
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 expectation for neffy sales and prescriptions in the second half of 2025 and beyond; 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 the likelihood allergy patients and caregivers will choose to carry and dose neffy compared to needle-bearing options; the anticipated benefits of ARS Pharma’s ex-U.S. partnerships and co-promotion agreement; the anticipated sales of neffy and gross-to-net percentage range; the timeline for regulatory decisions and commercialization of neffy outside of the United States; ARS Pharma’s marketing and commercialization strategies; the likelihood of neffy attaining favorable coverage and the expected timing of coverage decisions; the timing and expected percentage of commercial coverage with unrestricted access; the anticipated timing for topline data from the urticaria trial and the potential for ARS Pharma’s intranasal epinephrine technology to expand into the urticaria indication, and the estimated patient population for this indication; ARS Pharma’s expected competitive position; the expected composition and reach of ARS Pharma’s commercial force; the potential for the neffy Experience Program; 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; 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 June 30, 2025, filed with the SEC on August 13, 2025. 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 – August 2025
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 for those 4 years and older who weigh 33 lbs or more (2 mg and 1 mg now available) Strong execution ($12.8M net US sales) in Q2 2025 (the third full quarter of neffy sales since US launch) sets foundation for significant neffy US sales starting in Q3 2025 Prescribing breadth: 9,700 HCPs have prescribed neffy (+73% q/q) Secured 93% commercial payer coverage; 50%+ overall GTN retention Since DTC launch in late May, consumer awareness has increased 145% ~180% increase in weekly neffy two-pack volume from end of Q1 to end of Q2 Potential multi-billion US market opportunity ($3B Rx’ed, and up to $7B expansion segments) driven by HCP and patient preference and adoption1 NCE-like IP exclusivity potential with issued composition of matter and method of treatment patents until at least 2039 Launch supported by team members that launched NARCAN nasal spray and $240.1 million in cash, cash equivalents and short-term investments2 ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 References: 1. Company estimates 2. As of 6/30/2025
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. Symptoms (>2%) reported during US anaphylaxis events 2-14 Mucosal Respiratory Cardiac GI 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 – August 2025
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 – August 2025
Addressing the Significant Unmet Needs in US Severe Allergic Reaction Patient Population References: 1. Based on IQVIA prescription data available through 2023 (~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 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 ~3.2M fill ~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 ~3.3M don’t fill regularly, haven’t refilled or haven’t filled – an additional ~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 ~10M two-packs ~$3B+ peak net sales potential in initial addressable segments alone = X X ~$7B+ potential in expansion segment12 + ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 Not including increased units/patient as market research indicates
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 ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 US: 80%+ of WW sales1 ARS has received FDA/EC/MHRA approval, and filed in Canada, China, and AUS/NZ within 6 months of FDA approval; 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
Commercialization Progress ARS Pharmaceuticals, Inc. Investor Presentation – August 2025
ACTIVATE PATIENTS DTC campaign launched in two phases – first connected TV and streaming platforms (mid-May) then broadcast and linear TV (early July) to increase awareness and motivate patients and caregivers to seek neffy REACH MORE PRESCRIBERS Pediatrics co-promote with ALK increased US sales force direct reach to ~55% of epinephrine Rx in late June FACILITATE ACCESS 93% commercial coverage to date with +50% overall GTN retention EDUCATE PRESCRIBERS Drive adoption within specialty and high prescribers that have a long history of using injection neffy Strategic Objectives for Commercialization ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 Launch of 2 mg neffy (Sept 23, 2024) Ongoing 2025 Mid to late 2025 Launch of 1 mg neffy (May 7, 2025)
EDUCATE Enable real-world experience with neffy Target allergist offices that conduct in-office food challenge testing HCPs will have the ability to gain first-hand knowledge of neffy’s effectiveness Patients undergoing allergy challenge will also be exposed to neffy >2,800 HCPs have enrolled in the neffy Experience Program (rescue therapy at allergy challenge clinics) Strong demand to learn about neffy among HCPs targeted to date by ARS efforts ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 >9,700 HCPs have prescribed neffy to date, with 70% of prescriptions submitted by the priority highest decile allergists ARS sales organization of 118 sales reps, virtual reps, area sales managers and national sales directors More than ~15,000 HCPs have been engaged by the ARS sales force to date Partnership with ALK US sales targeting 9,000 pediatricians rolled out by end of June 2025 with neffy in primary position (41% awareness among pediatricians in March 2025) Combined ARS + ALK direct sales force (n = ~70) reach of ~20,000 HCPs representing ~55% of epinephrine Rx from all HCPs
Healthcare Providers Indicate Significant Uptake in 2025 References: 1. HCP Market Research Study, December 2024 ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 HCPs would proactively offer neffy to their patients today ~2 of 3 Top 3 neffy barriers to becoming the treatment of choice for healthcare providers (HCPs) (December 2024 HCP research, n = 150) Cost & Coverage (~37%) 93% commercial coverage today Competitive co-pay versus generic EAIs ($25 vs. $40) Clinical Experience (~33%) Expected to be addressed by time in market and accelerated by neffy Experience, conferences, speaker programs, CME and publications neffy experience in line with injection None (~13%) Results of March 2025 HCP research, n = 250 51% Anticipated neffy share one year from now (2026) among patients with an active epinephrine Rx (HCPs with clinical exposure, e.g. neffy experience) HCPs prescribe neffy when asked by a patient ~9 of 10
On track to ensuring broad neffy access for patients FACILITATE ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 Commercial coverage on track for peak summer epinephrine prescribing season 93% commercial coverage of neffy today 57% without prior authorization (PA) Remaining with PA, with an overall approval rate of ~60%, and 80+% for portion of Zinc payers requiring PA >50% overall GTN retention List price for two doses of neffy is $710 Co-pay buydown to $25 for commercial patients References: 1. IQVIA Epinephrine Formulary Coverage Tracker as of July 2025 Payers recognize the value of neffy Dispensing by major PBM for neffy is consistent with the total epinephrine market, due to neffy Rx approval rates being similar to generic EAIs despite PAs (May-June 2025)1 neffy dispenses total epinephrine dispenses
Consumer awareness is the key to neffy uptake and creates the opportunity for significant growth over the summer ACTIVATE ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 Only 20% of patients with an active epinephrine Rx reported aided awareness of neffy as of Q1 2025 81% of caregivers are likely to ask their HCP about neffy after learning about it ~9 out of 10 of HCPs prescribe neffy when asked by a patient Results of the March/April 2025 Consumer Market Research Study (n = 400 patients) Before Direct-to-Consumer Campaign Launch (May 15, 2025)
‘Hello neffy, Goodbye Needles’ DTC campaign and jingle launched in May 2025 prior to peak back to school season ACTIVATE ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 ‘Hello, neffy! Hello, neffy! No needles Goodbye!’ CTV/OLV & Linear TV Social Display Print POC Multi-Channel Activation: Expansive consumer marketing campaign: ~$50 million in 2025 DTC spend
Robust increase in consumer awareness in only the first two months of the DTC campaign ACTIVATE ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 ~5M Views in YouTube via Google Ads ~1 billion Impressions of neffy across integrated multimedia channels ~17M unique people reached on Social Media LTD Website Traffic LTD of ~1M References: 1. Metrics as of end of July 2025, 2. IQVIA and Klick Health Analysis 20% Mid-May 2025 Historic time to effect on prescriptions from start of a DTC campaign is about 12-16 weeks2 - Connected TV (targeted DTC) started mid-May - Linear TV (broad DTC) started early July Impact on aided consumer awareness of neffy (%) 145% increase 49% Late-July 2025
Multiple tailwinds going into “back to school” peak season (Q3 2025) set up neffy for an important sales inflection point “Back to school” seasonality trends 3. 93% commercial coverage achieved to date 2. Broad direct to consumer campaign launched in May 2025 (~$50M in spend in FY2025) 1. Availability of 1 mg dose in May 2025 covers children down to 4 years of age who weigh ≥15 kg 4. Expanded US sales force via partner ALK to directly target an additional 9,000 pediatricians started in June 2025 neffy “Back to school” tailwinds Jun-Sept represents ~45% of all EAI 2-packs sold each year Driven primarily by pediatric patients who represent ~43% of EAI 2-pack units sold each year # of dispensed EAI 2-packs References: 1. 2024 IQVIA Community Use Epinephrine Monthly Dispensed 2-Packs by Strength/Weight Range, 2. 2024 IQVIA Formulary Analyzer ARS Pharmaceuticals, Inc. Investor Presentation – August 2025
Treatment of acute flares in chronic spontaneous urticaria patients on antihistamines represents blockbuster opportunity ~2M diagnosed chronic urticaria patients based on 12 month US prevalence of 0.78%1 ~1M US chronic urticaria patients reported to be treated with Rx medication1 ~8-9 HCP visits per year1 plus ~4-5 ER visits per year1,2 neffy may provide episodic relief of acute flares in CSU patients who are stable on chronic antihistamines (Phase 2b clinical study to read out in H1 2026) Potential to improve quality of life without escalating to chronic use of costly systemic biologics with potentially more side effects or having to visit ER/hospital References: 1. Patil D, et al. Prevalence and clinical profile of patients with chronic spontaneous urticaria in the USA. American Academy of Dermatology Associate Annual Meeting (May 2022), 2. Barniol C, et al. Annals of Emergency Medicine (2018). 3. 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) , 4. Assuming one episode per month that requires treatment with neffy $710 WAC/Rx ~50% GTN Yield $2-3B+ peak net sales potential4 X X = ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 neffy Shows Robust and Rapid Clinical Responses in Treatment-Resistant Chronic Spontaneous Urticaria (CSU)
A Path to Blockbuster Potential for neffy Q4 2024 2025 2026 Multi-blockbuster peak sales potential driven by initial $3B segment, ~$7B expansion segment and ~$2-3B+ CSU indication 93% commercial coverage to date as of August 2025 Accelerated activation of consumer awareness with targeted DTC launched in late May, followed by broad DTC (linear TV) in July Expand breadth and depth of Rx’ing, and targeting HCPs, incl. up to an additional 9,000 pediatricians via ALK co-promote Continued investment into consumer demand and seamless patient acquisition experience Steady-state total GTN in the ~50% range Potential initiation of pivotal trial for treatment of acute flares in CSU patients on antihistamines Sales force targeting higher decile priority HCPs neffy experience and patient success stories creating positive feedback loop Payers recognizing value of neffy (e.g. Express Scripts) A Strong Foundation Accelerated Impact Intensifying Growth ARS Pharmaceuticals, Inc. Investor Presentation – August 2025 2 mg launch (30 kg+) 1 mg launch in May 2025 (15 to <30 kg)