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
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
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Registrant’s telephone number, including area code:
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) |
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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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Title of each class |
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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 May 9, 2024, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter ended March 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.
Item 9.01 |
Financial Statements and Exhibits. |
(d)
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Exhibit Number |
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Description |
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99.1 |
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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: May 9, 2024 |
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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 |
Exhibit 99.1
ARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results
neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024
Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP opinion expected in the second quarter of 2024
Preparing to initiate outpatient study of neffy for urticaria (hives) in second half of 2024
$223.6 million in cash and securities as of March 31, 2024, providing an expected operating runway of at least three years; well-capitalized to support anticipated U.S. launch of neffy in the second half of 2024
SAN DIEGO -- May 9, 2024 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the first quarter of 2024.
“With the completion of all requested neffy® (epinephrine nasal spray) studies and submission of our response to FDA, we believe we are very close to delivering the first needle-free, safe, effective, and easy to carry epinephrine solution to the millions of people living with Type I allergies including anaphylaxis. Our primary focus is ensuring we are well-positioned for a successful launch of neffy in the U.S. upon approval, which is expected within the next six months. Importantly, we are well-capitalized with a multi-year operating runway that supports our neffy commercialization activities in the U.S.,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “Our goal is to ensure that patients around the world have access to neffy in a timely manner. We’ve completed our submission to the EMA’s CHMP and expect an opinion on our MAA this quarter. We’re also delighted to partner with Australian pharmaceutical leader CSL Seqirus to support the approval and commercialization of neffy in Australia and New Zealand. These positive updates reflect our team’s strong execution and unwavering commitment to serving patients.”
U.S. Regulatory Status of neffy for Type 1 Allergic Reactions
Global Regulatory Status of neffy
Clinical Expansion of neffy for Urticaria
Additional Business Highlights
First Quarter 2024 Financial Results
About Type I Allergic Reactions including Anaphylaxis
Type I severe 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 autoinjectors 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 severe allergic reactions. Of those, only 3.2 million have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.
About Urticaria
Urticaria is a skin disorder that causes itchy hives and/or angioedema with an annualized incidence of 5 million in the United States, with about 40% becoming chronic urticaria; 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy. These non-responsive patients on stable therapy regimens can experience exacerbations or flares several times a year among acute cases, and even several times a week, including up to three or four emergency room visits per year. Angioedema is also a co-occurring symptom in about 33 to 67% of these patients. There are currently no approved community use treatments for acute flares experienced by urticaria patients on chronic regimens of antihistamines. ARS Pharma is investigating neffy for episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients. If neffy is approved for this indication, patients would have the option to quickly resolve exacerbations or flares at home without escalating to chronic use of systemic biologics that may have more serious side effects and benefit-risk considerations or visiting the emergency room for further treatment.
About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. 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 anticipated timing for regulatory review decisions on the neffy NDA and MAA; our belief that neffy will be approved for the treatment of Type I allergic reactions; the timing for the potential U.S. launch of neffy, if approved; the planned outpatient study of neffy for urticaria and the timing thereof; the potential initiation of a single pivotal efficacy study for neffy in urticaria and the timing thereof; ARS Pharma’s projected cash runway; ARS Pharma’s belief that it is well capitalized to support the launch of neffy in the U.S., if approved; planned submissions of neffy to other foreign regulatory authorities for approval and the timing thereof; the potential benefits to urticaria patients if neffy is approved in this indication; 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,” “plans,” “believes,” “expects,” “on track to,” “will,” “potential” 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 in any indication; even though the FDA has stated that completion of the repeat-dose study under allergen-induced allergic rhinitis conditions for neffy will sufficiently address the agency’s outstanding questions, there is no guarantee that new issues will not be identified which could delay or prevent the
approval of neffy; whether the FDA will view the results from ARS Pharma’s repeat dose study under allergen induced allergic rhinitis conditions for neffy as sufficient to support approval for Type I allergic reactions; the PDUFA target action date may be further delayed due to various factors outside ARS Pharma’s control; potential safety and other complications from neffy; the labelling for neffy in any indication, if approved; the scope, progress and expansion of developing and commercializing neffy; the size and growth of the market therefor 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; uncertainties related to capital requirements; 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-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024, and in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, being filed with the SEC today. These documents can also be accessed on ARS Pharma’s web page at ir.ars-pharma.com by clicking on the link “Financials & Filings.”
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.
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ARS Investor Contacts:
Justin Chakma, ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran, Sam Brown Inc.
christycurran@sambrown.com
ARS Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and par value data)
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March 31, 2024 |
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December 31, 2023 |
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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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$ |
56,006 |
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$ |
70,971 |
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Short-term investments |
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167,626 |
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157,389 |
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Prepaid expenses and other current assets |
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2,609 |
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3,366 |
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Total current assets |
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226,241 |
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231,726 |
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Right-of-use asset |
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198 |
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250 |
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Fixed assets, net |
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616 |
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574 |
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Other assets |
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528 |
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638 |
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Total assets |
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$ |
227,583 |
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$ |
233,188 |
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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 $280 and $178, respectively) |
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$ |
3,498 |
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$ |
2,154 |
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Lease liability, current |
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217 |
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237 |
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Total current liabilities |
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3,715 |
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2,391 |
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Lease liability, net of current portion |
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— |
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37 |
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Total liabilities |
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3,715 |
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2,428 |
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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 March 31, 2024 and December 31, 2023; no shares issued and outstanding at March 31, 2024 and December 31, 2023 |
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— |
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— |
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Common stock, $0.0001 par value per share; 200,000,000 shares authorized at March 31, 2024 and December 31, 2023; 96,574,049 and 96,414,963 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively |
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10 |
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10 |
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Additional paid-in capital |
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365,577 |
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362,004 |
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Accumulated other comprehensive (loss) gain, net |
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(124 |
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49 |
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Accumulated deficit |
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(141,595 |
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(131,303 |
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Total stockholders’ equity |
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223,868 |
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230,760 |
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Total liabilities and stockholders’ equity |
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$ |
227,583 |
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$ |
233,188 |
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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 March 31, |
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2024 |
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2023 |
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Revenue under collaboration agreements |
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$ |
— |
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$ |
20 |
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Operating expenses: |
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Research and development (including related party amounts of $726 and $591, respectively) |
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5,234 |
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6,552 |
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General and administrative (including related party amounts of $93 and $337, respectively) |
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7,958 |
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12,181 |
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Total operating expenses |
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13,192 |
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18,733 |
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Loss from operations |
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(13,192 |
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(18,713 |
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Other income, net |
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2,900 |
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3,752 |
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Net loss |
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$ |
(10,292 |
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$ |
(14,961 |
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Change in unrealized gains and losses on available-for-sale securities |
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(173 |
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(339 |
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Comprehensive loss |
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$ |
(10,465 |
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$ |
(15,300 |
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Net loss per share, basic and diluted |
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$ |
(0.11 |
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$ |
(0.16 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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96,486,480 |
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94,227,313 |
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