SPRY ARS Pharmaceuticals Inc

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

March 20, 2025

Date of Report (Date of earliest event reported)

ARS Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

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:

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

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 March 20, 2025, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2024 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, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, 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.

(d)

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 Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

$7.3 million in total neffy® (epinephrine nasal spray) U.S. net product revenue in 2024 since launch in late September 2024

neffy 1 mg approved by U.S. FDA for children aged four and older and weighing 15 kilograms to < 30 kilograms (33 lbs. to < 66 lbs.), expanding the reach of neffy to approximately 2 million younger, school-aged children at risk of a severe allergic reaction

$314.0 million in cash, cash equivalents, and short-term investments at year-end 2024, supporting an increased investment in commercialization in 2025 while maintaining an operating runway of at least three years

Company to host conference call today, March 20, 2025 at 5:30 a.m. PT / 8:30 a.m. ET

SAN DIEGO, March 20, 2025 – ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, today announced its financial results for the fourth quarter and full year ended December 31, 2024, and provided highlights on the U.S. commercial launch of neffy, the first and only needle-free epinephrine emergency treatment for Type I allergic reactions, including anaphylaxis, as well as recent business updates.

“Our strong execution throughout 2024 and into 2025 has positioned ARS Pharma for sustained growth and meaningful near-term value creation. The successful U.S. commercial launch of neffy, FDA approval of neffy 1 mg for younger children, and our expansion into new global markets mark key milestones in our effort to build a transformative franchise in severe allergy treatment,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Our momentum is highlighted by the steady increase in physician adoption, positive patient feedback, and growing payer coverage, which form a strong foundation for long-term success. With a solid financial position and a disciplined operational strategy, we are well-equipped to further accelerate adoption and drive significant impact for both our stakeholders and the millions of people who depend on life-saving epinephrine treatment.”

Fourth Quarter and Full Year 2024 Financial Results

Business Outlook

neffy U.S. Commercial Launch Highlights

ARS Pharma continues to execute the U.S. commercial launch of neffy. Key achievements to date include:

Global Regulatory Approvals and Activities for neffy and EURneffy

U.S. Allergy Challenge Clinic Registry Study: ARS Pharma plans to initiate a post-marketing registry-based study of neffy for the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics in April 2025.

Expansion of Intranasal Epinephrine into Urticaria

ARS Pharma plans to initiate a Phase 2b clinical trial in the second quarter of 2025 to evaluate its intranasal epinephrine technology as a treatment for acute flares in patients with chronic spontaneous urticaria, a prevalent skin disease affecting approximately 2 million people in the U.S. The trial is expected to enroll patients in the U.S. and Europe, with topline data anticipated in early 2026.

Conference Call and Webcast Information

ARS Pharma management will host a conference call and webcast at 8:30 a.m. ET today, March 20, 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.

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

It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.

neffy is for use in the nose only.

Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.

Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.

The presence of a sulfite in neffy should not deter use.

neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.

Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.

Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.

Most common adverse reactions are nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, throat irritation, nasal congestion, paresthesia, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.

These are not all the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing 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 Pharmaceuticals 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) (previously referred to as ARS-1), 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 15 kg 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: the belief that ARS Pharma is well positioned for sustained growth and meaningful value creation; ARS Pharma’s projected cash runway and belief that it is well capitalized and prepared to support the ongoing launch of neffy; the expectation that neffy 1 mg will be available in the U.S. by the end of May 2025; the planned studies of neffy, including for the treatment of urticaria, and the timing thereof; the anticipated timing of regulatory decisions for neffy in the U.K., Canada, China, Japan and; ARS Pharma’s belief that it remains on track to achieve its goals coverage goals of 60% and 80% by the end of the first quarter and third quarter of 2025, respectively; the expectation and timing for additional states to add neffy to their formularies; the expected timing of commercial launches in Germany and the U.K.; the expected timing of the milestones under the agreement with ALK; the needle-free profile of neffy increasing the likelihood that patients will both carry and administer adrenaline; the potential market and demand for neffy; the potential benefits to urticaria patients if our intranasal epinephrine technology is approved for this indication; financial projections; 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,” “expect,” “if,” “may,” “potential,” “plan,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ 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 Pharmaceuticals’ 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 Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, and in ARS Pharmaceuticals’ Annual Report on Form 10-K for the year ended December 31, 2024, being filed with the SEC on March 20, 2025. These documents can also be accessed on ARS Pharmaceuticals’ 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 Pharmaceuticals 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
justinc@ars-pharma.com

Media Contact:

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

615.414.8668

ARS Pharmaceuticals, Inc.

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ARS Pharmaceuticals, Inc.

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