0000950170-23-009485.txt : 20230323 0000950170-23-009485.hdr.sgml : 20230323 20230323160922 ACCESSION NUMBER: 0000950170-23-009485 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230323 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230323 DATE AS OF CHANGE: 20230323 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARS Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001671858 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 811489190 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39756 FILM NUMBER: 23756283 BUSINESS ADDRESS: STREET 1: 11682 EL CAMINO REAL, SUITE 120 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: 858-771-9307 MAIL ADDRESS: STREET 1: 11682 EL CAMINO REAL, SUITE 120 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: Silverback Therapeutics, Inc. DATE OF NAME CHANGE: 20160412 8-K 1 sbtx-20230323.htm 8-K 8-K
0001671858false00016718582023-03-232023-03-23

 

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 23, 2023

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 120

San Diego, California

 

92130

(Address of principal executive offices)

 

(Zip Code)

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:

☐

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 23, 2023, ARS Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2022 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)

 

 

 

 

Exhibit

Number

 

Description

 

 

99.1

 

Press Release dated March 23, 2023

 

 

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.

 

 

 

 

 

Date: March 23, 2023

ARS Pharmaceuticals, Inc.

 

 

 

 

 

 

By:

/s/ Richard Lowenthal, M.S., MSEL

 

 

Name:

Richard Lowenthal, M.S., MSEL

 

 

Title:

President and Chief Executive Officer

 

 

 

 EX-99 2 sbtx-ex99_1.htm EX-99.1 EX-99

ARS Pharmaceuticals Highlights Progress and Reports Fourth Quarter and Full Year 2022 Financial Results

 

New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023

Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years

SAN DIEGO – March 23, 2023 - 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 highlighted recent progress and reported fourth quarter and full year 2022 financial results.

 

“This is an incredibly exciting time for ARS, with potential regulatory approvals for neffy® around the corner and a resulting transition to a commercial-stage company. Our goal with neffy is to provide patients with the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in an easy to use and rapidly administered needle-free nasal spray. We believe we are well on our way to achieving this goal,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “Both our NDA and MAA for neffy are currently under review by the regulators in the U.S. and E.U. and we are on-track with our commercial preparedness activities for a potential U.S. launch later this year, if approved. We also recently reacquired European rights to neffy which enhance our optionality to evaluate potential partnerships or strategic transactions. The team has done a remarkable job executing the development of neffy, and we look forward to engaging with the regulatory agencies in an effort to impact the lives of millions of people with serious allergic reactions.”

 

neffy Progress

•
neffy NDA and MAA for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis, Under Review with FDA and EMA: The Compatny’s new drug application (NDA) and marketing authorization application (MAA) for neffy for the emergency treatment of allergic reactions (Type I), including anaphylaxis in adults and children ≥30 kg (66 lbs), were accepted for review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions (Type I), including anaphylaxis.

 

The regulatory submissions to the FDA and EMA were based on data from four primary registrational studies showing that 2.0 mg intranasal dose of neffy met all clinical endpoints recommended by regulators and that its pharmacokinetics were within the range of approved epinephrine injection products. These data, which were presented at the 2022 American College of Allergy Asthma and Immunology Annual Scientific Meeting (ACAAI) and the 2023 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting, included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 600 individuals receiving at least one dose, and many with repeat administration. Adverse events in the clinical trials were generally mild in nature without any meaningful nasal irritation or pain.

 

•
Presented Data Supporting Use of neffy During the 2023 AAAAI Meeting: ARS presented positive data supporting neffy during the 2023 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting. Presentations highlighted clinical trial data demonstrating that neffy delivered consistent epinephrine levels to attain a pharmacokinetic (PK) and pharmacodynamic (PD) profile within the range of approved intramuscular (IM) injection products with a dose proportional exposure between once and twice dosing.

 

ARS also presented findings from surveys of 300 patients identifying that the needle is the principal reason why patients do not fill their epinephrine prescription today, and why they delay epinephrine use and use OTC products first despite treatment guidelines recommending immediate use of epinephrine.

 

Fourth Quarter and Full Year 2022 Financial Results

•
Cash Position: Cash, cash equivalents and short-term investments were $274.4 million as of December 31, 2022. ARS believes its existing cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan for at least three years.
•
R&D Expenses: Research and development (R&D) expenses were $4.7 million for the quarter ended December 31, 2022, and $18.4 million for the year ended December 31, 2022.
•
G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the quarter ended December 31, 2022, and $18.5 million for the year ended December 31, 2022. G&A expenses for the fourth quarter increased over the prior three quarters mainly due to costs related to the merger with Silverback Therapeutics, Inc. and beginning preparations for the potential commercialization of neffy.
•
Net Loss: Net loss was $14.4 million for the quarter ended December 31, 2022, and $34.7 million for the year ended December 31, 2022.

 

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 25 to 40 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently 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 ARS Pharmaceuticals, Inc.

ARS 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’s projected cash runway; the anticipated timing for regulatory review decisions on neffy and the potential approval of neffy; ARS’s commercial readiness for the potential US launch of neffy, if approved, and the timing thereof; ARS’s strategy of pursuing potential partnerships or strategic transactions for neffy in Europe; the estimated addressable patient population for neffy; 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,” “believe,” “plan,” “expect,” “goal,” “look forward to,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS’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; 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’s ability to protect its intellectual property position; the impact of government laws and regulations; ARS’s ability to execute its plans and strategies; and uncertainties related to ARS’s capital requirements. 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—Risks Related to ARS Pharma” in the company’s definitive merger proxy statement filed with the Securities and Exchange Commission (“SEC”) on October 6, 2022, and under the caption “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022, being filed with the SEC later today. These documents can also be accessed on ARS’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 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 Pharmaceuticals, Inc.

Consolidated Balance Sheets

(In thousands, except par value and share amounts)

 

 

 

 

December 31,

 

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

$

210,518

 

 

$

60,063

 

Short-term investments

 

 

 

63,863

 

 

 

—

 

Prepaid expenses and other current assets

 

 

 

3,319

 

 

 

667

 

Total current assets

 

 

 

277,700

 

 

 

60,730

 

Right-of-use asset

 

 

 

445

 

 

 

621

 

Fixed assets, net

 

 

 

329

 

 

 

72

 

Other assets

 

 

 

2,961

 

 

 

23

 

Total assets

 

 

$

281,435

 

 

$

61,446

 

Liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable and accrued liabilities (including related party amounts of $16 in 2022 and $159 in 2021)

 

 

$

4,931

 

 

$

3,107

 

Lease liability, current

 

 

 

230

 

 

 

144

 

Contract liability, current

 

 

 

283

 

 

 

1,457

 

Note payable, current

 

 

 

—

 

 

 

3,479

 

Total current liabilities

 

 

 

5,444

 

 

 

8,187

 

Lease liability, net of current portion

 

 

 

251

 

 

 

480

 

Contract liability, net of current portion

 

 

 

2,854

 

 

 

2,996

 

Note payable, net of current portion

 

 

 

—

 

 

 

4,930

 

Preferred stock warrant liability

 

 

 

—

 

 

 

83

 

Total liabilities

 

 

 

8,549

 

 

 

16,676

 

Commitments and contingencies

 

 

 

 

 

 

 

Convertible preferred stock and stockholders’ equity (deficit):

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2022 and 2021; no shares issued and outstanding at December 31, 2022 and 2021

 

 

 

—

 

 

 

—

 

Series A convertible preferred stock, $0.01 par value; no shares and 4,764,000 shares authorized at December 31, 2022 and 2021, respectively; no shares and 4,764,000 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

 

—

 

 

 

365

 

Series B convertible preferred stock, $0.01 par value; no shares and 606,060 shares authorized at December 31, 2022 and 2021, respectively; no shares and 606,060 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

 

—

 

 

 

1,000

 

Series C convertible preferred stock, $0.01 par value; no shares and 7,749,999 shares authorized at December 31, 2022 and 2021, respectively; no shares and 7,692,309 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

 

—

 

 

 

19,868

 

Series D convertible preferred stock, $0.01 par value; no shares and 9,337,066 shares authorized at December 31, 2022 and 2021, respectively; no shares and 9,337,066 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

 

—

 

 

 

54,806

 

Stockholders’ equity (deficit)

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 and 56,000,000 shares authorized at December 31, 2022 and 2021, respectively; 93,943,316 and 30,369,413 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

 

9

 

 

 

3

 

Additional paid-in capital

 

 

 

349,408

 

 

 

10,984

 

Accumulated other comprehensive gain

 

 

 

407

 

 

 

—

 

Accumulated deficit

 

 

 

(76,938

)

 

 

(42,256

)

Total stockholders’ equity (deficit)

 

 

 

272,886

 

 

 

(31,269

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

 

$

281,435

 

 

$

61,446

 

 

 

 

ARS Pharmaceuticals, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share information)

 

 

 

Years Ended December 31,

 

 

 

2022

 

 

2021

 

Revenue under collaboration agreements

 

$

1,316

 

 

$

5,506

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

Research and development (including related party amounts of $2,144 in 2022 and $1,072 in 2021)

 

 

18,376

 

 

 

20,273

 

General and administrative (including related party amounts of $603 in 2022 and $476 in 2021)

 

 

18,456

 

 

 

4,687

 

Total operating expenses

 

 

36,832

 

 

 

24,960

 

Loss from operations

 

 

(35,516

)

 

 

(19,454

)

Other income (expense):

 

 

 

 

 

 

Other income (expense), net

 

 

974

 

 

 

(789

)

Change in fair value of financial instruments

 

 

(140

)

 

 

—

 

Total other income (expense):

 

 

834

 

 

 

(789

)

Net loss

 

$

(34,682

)

 

$

(20,243

)

Unrealized gain on available-for-sale securities

 

 

407

 

 

 

—

 

Comprehensive loss attributable to common stockholders

 

$

(34,275

)

 

$

(20,243

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.87

)

 

$

(0.70

)

Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

39,956,043

 

 

 

28,872,242

 

 

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