UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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| Item 7.01. | Regulation FD Disclosure. |
On June 28, 2024, ARS Pharmaceuticals, Inc. (the “Company”) updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The information under this Item 7.01 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 otherwise 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.
| Item 8.01 | Other Events. |
On June 28, 2024, the Company announced the European Committee for Medicinal Products for Human Use (the “CHMP”) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product EURneffy, a 2 mg nasal spray solution intended 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. Treatment is indicated for adults and children with a body weight greater than or equal to 30 kg. The CHMP’s summary of positive opinion was published June 27, 2024 without prejudice to the European Commission decision, which will normally be issued 67 days from adoption of the CHMP’s opinion. The CHMP’s positive opinion is the scientific recommendation to the European Commission for marketing authorization in the Europe Union.
Forward-Looking Statements
Statements in this report 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 European Commission’s endorsement of the CHMP’s positive opinion and the anticipated timing of the European Commission’s decision. 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 “normally,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the CHMP positive opinion should not be relied on as an indication that EURneffy will ultimately be approved by the European Commission; the European Commission is not bound by the CHMP’s opinion or any of its recommendations; the labelling for EURneffy, if approved; the scope, progress and expansion of developing and commercializing EURneffy, if approved, including the ability to enter into distribution and/or partnering arrangements and obtain favorable reimbursement; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; the Company’s ability to protect its intellectual property position; the impact of government laws and regulations; and the Company’s ability to execute its plans and strategies. 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’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the Securities and Exchange Commission on May 9, 2024.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Company Presentation, dated June 28, 2024. | |
| 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: June 28, 2024 | By: | /s/ Richard Lowenthal | ||||
| Richard Lowenthal, M.S., MSEL | ||||||
| President and Chief Executive Officer | ||||||