SPRY

EX-99.1

2 spry-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARS Pharmaceuticals Outlines Strategic Priorities, including a Focused Commercial Strategy, and Reports Second Quarter 2026 Financial Results

$26.2 million in U.S. neffy® net product revenue in Q2 2026; total U.S. epinephrine market share for Type 1 allergies of 5% and 8% share within field-targeted accounts

Commercial investment realigned toward targeted provider engagement, significantly reducing total operating expenses for 2H 2026 and supporting an expected path to cash flow breakeven by the end of 2027

Commercial operations strengthened with appointment of Meg Smith as Chief Commercial Officer and completed expansion of field sales organization

Interim data from Phase 2b trial in chronic spontaneous urticaria (CSU) expected in Q1 2027; no FDA-approved on-demand treatment currently exists for acute CSU flares

Conference call to be held today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET

SAN DIEGO, August 13, 2026 – ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect against allergic reactions that could lead to anaphylaxis, today outlined the strategic priorities and operating framework that will guide the Company going forward, its refined commercial strategy for neffy® (epinephrine nasal spray), and its financial results for the second quarter ended June 30, 2026.

“It is a privilege to lead ARS Pharma at this pivotal time, and my conviction in the opportunity ahead has only grown since stepping into this role. As the first and only needle-free epinephrine option, neffy is well positioned to become the standard of care for patients and caregivers in this multi-billion-dollar market,” said Donn Casale, President and CEO of ARS Pharma. “Today, we are announcing a shift in focus to provider adoption, with a more efficient commercial strategy intended to drive market share growth without sacrificing revenue. We believe that provider awareness and recommendation will be the cornerstone to growing the neffy brand. Our confidence in continued revenue growth, along with a more efficient commercial model, is expected to provide the foundation for long-term value creation. Beyond neffy, advancing our intranasal epinephrine platform into CSU unlocks a potential major growth opportunity in an area of high unmet need built on top of our existing commercial infrastructure.”

Updated Strategic Priorities

Following a comprehensive assessment of ARS Pharma’s commercial, clinical, and business operations, the Company has established a core set of strategic priorities intended to drive continued value creation from neffy and the intranasal epinephrine platform:

1. Targeted commercial execution. ARS Pharma is shifting its focus from broad consumer-directed marketing to targeted engagement with high-volume prescribers, a strategy that has already demonstrated to grow field-targeted market share.

2. Financial discipline aligned with neffy adoption rate. ARS Pharma has implemented a rigorous cost optimization framework, significantly reducing its SG&A expense, that focuses on building a profitable neffy franchise to drive shareholder value and provide financial support for platform expansion.

3. Advance CSU clinical program. ARS Pharma is extending its intranasal epinephrine platform into CSU. With no FDA-approved, on-demand options currently available to manage acute flares, the Company’s intranasal epinephrine platform may address a critical unmet need in CSU and offer a compelling market expansion opportunity.

Commercial Leadership and a Fully Deployed Field Organization

ARS Pharma today announced the appointment of Meg Smith as Chief Commercial Officer, effective August 17, 2026. Ms. Smith is a commercial executive with more than 25 years of progressive leadership experience. Most recently, she led the commercial organization at Dynavax Technologies that successfully launched HEPLISAV-B®.

“neffy is well positioned to become the new standard of care in a large, underserved market,” said Ms. Smith. “There is a solid foundation in place, growing prescriber momentum, and a talented field organization. I am excited to join the commercial leadership team at ARS where we will be relentlessly focused on provider-centered execution to convert that foundation into durable market share growth.”

ARS Pharma also announced that the expansion of its field sales organization is now complete. Sales force efforts will focus primarily on the highest-value prescribers, which represent 44% of the total U.S. market opportunity.

Mr. Casale added, “Executing our enhanced commercial strategy requires having the right leadership and footprint, and I am incredibly pleased to welcome Meg to the team. I am confident that she has the right capabilities and experience to drive this next chapter of the neffy launch, having seen her ability to inspire teams and drive operational ri

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

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.”

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.

Additional commercial highlights include:

• Increasing

8-K

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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 9, 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 11682 El Camino Real, Suite 120 San Diego, California 92130 (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 March 9, 2026, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 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 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 March 9, 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 March 9, 2026

99.2

Company Presentation dated March 9, 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: March 9, 2026

By:

/s/ Richard Lowenthal

Richard Lowenthal, M.S., MSEL

President and Chief Executive Officer

(Principal Executive Officer)