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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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 21, 2024, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2023 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: March 21, 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 Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Preparing to submit response to the FDA’s CRL for neffy®(epinephrine nasal spray) in Type 1 allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen challenge study and nitrosamine assessments, with expected up to six-month review period
In Phase 2 urticaria clinical trial, neffy met primary endpoints and showed rapid symptom control; planning to initiate outpatient study later in 2024, potentially followed by initiation of a single pivotal efficacy study
Ended fourth quarter with $228.4 million in cash, cash equivalents and short-term investments with an expected operating runway of at least three years; well-capitalized to support anticipated H2 2024 launch of neffy in the U.S.
SAN DIEGO -- March 21, 2024 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023.
“We started the year by turning the page and quickly addressing the two deficiencies identified in the FDA’s CRL for neffy late last year and are now working to finalize our response to the CRL, which we expect to submit in early Q2 2024. We want to deliver this needle-free, safe, effective, and easy to carry epinephrine solution to patients in need as quickly as possible. To do so, we remain well capitalized with anticipated cash and equivalents greater than $200 million at the time of the anticipated FDA approval of neffy, expected in the second half of 2024,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. Mr. Lowenthal further stated, “At the recent American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in February 2024, six posters and oral presentations on neffy were presented, including efficacy data showing a 100% response rate with a single dose of neffy in the 15 enrolled pediatric subjects experiencing anaphylaxis symptoms following oral food challenge, further increasing our confidence in neffy’s commercial ramp and potential. At AAAAI, we also presented positive topline data from our Phase 2 inpatient, randomized, controlled study of neffy in patients with refractory chronic spontaneous urticaria. neffy met all primary endpoints and showed rapid symptom control, supporting advancement to an outpatient study in chronic spontaneous urticaria patients who experience acute exacerbations of symptoms, which we plan to initiate later in 2024, followed by a potential pivotal study in 2025.”
U.S. Regulatory Status of neffy (epinephrine nasal spray) for Type I Allergic Reactions
Clinical Status of neffy for Urticaria
Additional Business Updates and Anticipated Milestones
Fourth Quarter and Full Year 2023 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 US, 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, among chronic urticaria cases. 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. neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients. 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 ARS Pharma’s: plan to submit its response to the FDA’s CRL early in the second quarter of 2024, with an anticipated FDA action date and launch of neffy, if approved, in the second half of 2024; plans to initiate an outpatient urticaria study later in 2024, potentially followed by initiation of a single pivotal efficacy study; projected operating runway; belief that it is well capitalized to support the launch of neffy in the U.S., if approved; expected competitive position; belief that patients using neffy, as opposed to autoinjectors, will be more likely to fill their prescriptions, carry their devices, and ultimately use their devices; the timing of the EMA’s decision and submissions to other foreign regulatory authorities; expectation that recent chronic urticaria data and oral food challenge induced anaphylaxis efficacy data will support post-marketing promotion of neffy; belief that neffy may provide episodic symptomatic relief and improve the quality of life of urticaria patients; 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,” “believes,” “expects,” “plans,” “potential,” “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; 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 successful and sufficient to support approval; the PDUFA target action date may be further delayed due to various factors outside ARS Pharma’s control; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labelling for neffy, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the Securities and Exchange Commission (SEC) on November 9, 2023, and in ARS Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, being filed with the SEC later today. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma’s website at ir.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.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Laura O’Neill
Finn Partners
Laura.oneill@finnpartners.com
ARS Pharmaceuticals, Inc.
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
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December 31, 2023 |
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December 31, 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
70,971 |
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$ |
210,518 |
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Short-term investments |
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157,389 |
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63,863 |
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Prepaid expenses and other current assets |
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3,366 |
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3,319 |
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Total current assets |
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231,726 |
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277,700 |
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Right-of-use asset |
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250 |
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445 |
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Fixed assets, net |
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574 |
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329 |
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Other assets |
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638 |
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2,961 |
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Total assets |
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$ |
233,188 |
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$ |
281,435 |
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Liabilities, convertible preferred stock and stockholders’ equity |
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Current liabilities: |
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Accounts payable and accrued liabilities (including related party amounts of $178 and $16, respectively) |
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$ |
2,154 |
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$ |
4,931 |
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Lease liability, current |
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237 |
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230 |
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Contract liability, current |
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— |
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283 |
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Total current liabilities |
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2,391 |
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5,444 |
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Lease liability, net of current portion |
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37 |
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251 |
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Contract liability, net of current portion |
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— |
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2,854 |
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Total liabilities |
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2,428 |
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8,549 |
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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 December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022 |
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— |
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— |
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Common stock, $0.0001 par value per share; 200,000,000 shares authorized at December 31, 2023 and 2022; 96,414,963 and 93,943,316 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively |
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10 |
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9 |
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Additional paid-in capital |
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362,004 |
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349,408 |
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Accumulated other comprehensive gain, net |
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49 |
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407 |
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Accumulated deficit |
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(131,303 |
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(76,938 |
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Total stockholders’ equity |
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230,760 |
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272,886 |
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Total liabilities, convertible preferred stock and stockholders’ equity |
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$ |
233,188 |
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$ |
281,435 |
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ARS Pharmaceuticals, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share information)
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Year Ended December 31, |
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2023 |
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2022 |
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Revenue under collaboration agreements |
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$ |
30 |
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$ |
1,316 |
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Operating expenses: |
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Research and development (including related party amounts of $1,796 and $2,144, respectively) |
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20,266 |
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18,376 |
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General and administrative (including related party amounts of $940 and $603, respectively) |
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47,284 |
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18,456 |
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Total operating expenses |
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67,550 |
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36,832 |
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Loss from operations |
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(67,520 |
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(35,516 |
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Other income, net |
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13,155 |
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974 |
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Change in fair value of financial instruments |
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— |
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(140 |
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Net loss |
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$ |
(54,365 |
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$ |
(34,682 |
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Change in unrealized gains and losses on available-for-sale securities |
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(358 |
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407 |
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Comprehensive loss |
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$ |
(54,723 |
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$ |
(34,275 |
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Net loss per share, basic and diluted |
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$ |
(0.57 |
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$ |
(0.87 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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95,215,322 |
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39,956,043 |
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