10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-39756

ARS Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its Charter)

 

 

 

Delaware

81-1489190

(State or other jurisdiction of

incorporation or organization)

(I.R.S. 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

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, par value $0.0001 per share

SPRY

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of November 6, 2023 there were 95,997,252 shares of registrant’s common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

 

 

 

Page

PART I

FINANCIAL INFORMATION

Item 1.

Financial Statements

6

 

Condensed Consolidated Balance Sheets

6

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

7

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

8

 

Condensed Consolidated Statements of Cash Flows

9

 

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

26

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

Item 4.

Controls and Procedures

37

 

 

 

PART II

OTHER INFORMATION

 

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

38

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

93

Item 5.

Other Information

93

Item 6.

Exhibits

94

2


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

 

any statements regarding future economic conditions or performance;

research and development plans, including planned clinical trials, for neffy, including for additional indications;

the expected timing for reporting data;

 

the design and potential benefits of neffy;

our plans to complete a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of epinephrine injection product under allergen-induced rhinitis conditions to support approval of our New Drug Application (“NDA”) resubmission for neffy with the U.S. Food and Drug Administration (“FDA”) for the treatment of allergic reactions (Type 1), including anaphylaxis for adults and children ≥30 kg;

the timing for the FDA’s review of, and the potential outcome from, our Formal Dispute Resolution Request, if any, to appeal the FDA’s Complete Response Letter (“CRL”) regarding our initial NDA for neffy;

our expectations regarding the timing for resubmitting an NDA for neffy with the FDA for the treatment of allergic reactions (Type 1), including anaphylaxis for adults and children ≥30 kg, the FDA’s review of our NDA for neffy, including the classification of our NDA submission as Class 2 and the anticipated Prescription Drug User Fee Act (“PDUFA”) target action date;

our belief that additional testing for nitrosamine impurities based on new draft guidance issued after our NDA submission will not be a rate-limiting step for the resubmission to the FDA;

Our plans to submit a supplemental NDA to the FDA and a post approval variation to the European Medicines Agency (“EMA”) for 1.0 mg neffy and the timing thereof;

our plans to submit regulatory filings for neffy in Japan and China in collaboration with our partners and the timing thereof;

the expected timing for regulatory review decisions for neffy;

the timing of the commercial launch of neffy, if approved;

the commercial potential of and commercialization strategy for neffy;

the size of the markets for neffy and any other product candidates, the projected growth thereof, and our ability to capture and grow those markets;

the rate and degree of market acceptance of neffy and any other product candidates;

our expected competitive position;

our expectations regarding our ability to achieve gross profit margins similar to small molecule drugs;

our potential to become the standard in treatment and transform the treatment of allergic reactions;

the likelihood of neffy attaining favorable coverage;

the expected intellectual property protection for neffy;

legislative and regulatory developments in the United States and foreign countries;

estimates regarding anticipated operating losses, capital requirements and needs for additional funds;

our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection for neffy or any future product candidate;

our expected use of the remaining net proceeds of our initial public offering; and

 

3


 

statements of belief and any statement of assumptions underlying any of the foregoing.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A, “Risk Factors” of this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

Unless the context otherwise indicates, references in this Quarterly Report to the terms “ARS”, “the Company”, “we”, “our” and “us” refer to ARS Pharmaceuticals, Inc. and its consolidated subsidiaries, and references to our “common stock” refers to our voting common stock.

4


 

SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

An investment in shares of our common stock involves a high degree of risk. Below is a list of the more significant risks associated with our business. This summary does not address all of the risks that we face. Additional discussion of the risks listed in this summary, as well as other risks that we face, are set forth under Part II, Item 1A, “Risk Factors” in this Quarterly Report. Some of the material risks associated with our business include the following:

We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future. We have never generated revenue from product sales and may never be profitable.

We have a limited operating history and only one current product candidate, neffy, which is in the clinical stage of development and has no commercial sales, which may make it difficult to evaluate the prospects for our future viability. We may need additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or commercialization efforts. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate.

We currently depend on the success of neffy, which is our only current product candidate. If we are unable to obtain regulatory approval for, and successfully commercialize, neffy, or experience significant delays in doing so, our business will be materially harmed.

If the FDA does not conclude that neffy or any future product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidates under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.

If we fail to develop and commercialize neffy for additional indications or fail to discover, develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.

Competitive products may reduce or eliminate the commercial opportunity for neffy for its current or future indications. If our competitors develop technologies or product candidates more rapidly than us, or their technologies or product candidates are more effective or safer than ours, our ability to develop and successfully commercialize neffy may be adversely affected.

We are dependent on international third-party licensees and assignees for the development and commercialization of neffy in several countries outside the United States. The failure of these third parties to meet their contractual, regulatory or other obligations could adversely affect our business.

We may seek to enter into additional collaborations, licenses and other similar arrangements for neffy or any future product candidate and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.

We currently have limited marketing, sales or distribution infrastructure. If we are unable to fully develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we may not be successful in commercializing our product candidates.

The market for neffy and any future product candidates we may develop may be smaller than we expect.

Any of our current and future product candidates for which we, or any current or future licensing and collaboration partners, obtain regulatory approval in the future will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. If approved, neffy and any future product candidates could be subject to post-marketing restrictions or withdrawal from the market and we, or any current or future licensing and collaboration partners, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval.

Even if neffy or any future product candidate of ours receives regulatory approval, it may fail to achieve the degree of market acceptance by allergists, pediatricians and other physicians, patients, caregivers, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for our product candidates and other proprietary technologies.

Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.

 

5


 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

ARS Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and par value data)

 

 

 

September 30, 2023

 

 

December 31, 2022

 

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

$

60,532

 

 

$

210,518

 

Short-term investments

 

 

 

181,370

 

 

 

63,863

 

Prepaid expenses and other current assets

 

 

 

2,564

 

 

 

3,319

 

Total current assets

 

 

 

244,466

 

 

 

277,700

 

Right-of-use asset

 

 

 

300

 

 

 

445

 

Fixed assets, net

 

 

 

617

 

 

 

329

 

Other assets

 

 

 

3,173

 

 

 

2,961

 

Total assets

 

 

$

248,556

 

 

$

281,435

 

Liabilities, convertible preferred stock and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable and accrued liabilities (including related party amounts of $208 and $16, respectively)

 

 

$

10,945

 

 

$

4,931

 

Lease liability, current

 

 

 

235

 

 

 

230

 

Contract liability, current

 

 

 

 

 

 

283

 

Total current liabilities

 

 

 

11,180

 

 

 

5,444

 

Lease liability, net of current portion

 

 

 

92

 

 

 

251

 

Contract liability, net of current portion

 

 

 

 

 

 

2,854

 

Total liabilities

 

 

 

11,272

 

 

 

8,549

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022

 

 

 

 

 

 

 

Common stock, $0.0001 par value per share; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 95,796,254 and 93,943,316 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

9

 

 

 

9

 

Additional paid-in capital

 

 

 

361,571

 

 

 

349,408

 

Accumulated other comprehensive (loss) gain, net

 

 

 

(161

)

 

 

407

 

Accumulated deficit

 

 

 

(124,135

)

 

 

(76,938

)

Total stockholders’ equity

 

 

 

237,284

 

 

 

272,886

 

Total liabilities, convertible preferred stock and stockholders’ equity

 

 

$

248,556

 

 

$

281,435

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6


 

ARS Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue under collaboration agreements

 

$

 

 

$

189

 

 

$

30

 

 

$

1,316

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (including related party amounts of $307, $776, $1,382 and $1,888, respectively)

 

 

3,002

 

 

 

3,893

 

 

 

16,862

 

 

 

13,666

 

General and administrative (including related party amounts of $322, $73, $840 and $344, respectively)

 

 

14,976

 

 

 

2,926

 

 

 

40,462

 

 

 

7,723

 

Total operating expenses

 

 

17,978

 

 

 

6,819

 

 

 

57,324

 

 

 

21,389

 

Loss from operations

 

 

(17,978

)

 

 

(6,630

)

 

 

(57,294

)

 

 

(20,073

)

Other income (expense), net

 

 

3,112

 

 

 

47

 

 

 

10,097

 

 

 

(180

)

Net loss

 

$

(14,866

)

 

$

(6,583

)

 

$

(47,197

)

 

$

(20,253

)

Change in unrealized gains and losses on available-for-sale securities

 

 

19

 

 

 

 

 

 

(568

)

 

 

 

Comprehensive loss

 

$

(14,847

)

 

$

(6,583

)

 

$

(47,765

)

 

$

(20,253

)

Net loss per share, basic and diluted

 

$

(0.16

)

 

$

(0.21

)

 

$

(0.50

)

 

$

(0.66

)

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

 

 

95,576,627

 

 

 

30,755,123

 

 

 

94,910,012

 

 

 

30,578,516

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

7


 

ARS Pharmaceuticals, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share data)

(unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Additional Paid-in Capital

 

Accumulated Other Comprehensive (Loss) Gain, Net

 

Accumulated Deficit

 

Total Stockholders’ Equity

 

Balance at December 31, 2022

 

 

93,943,316

 

$

9

 

$

349,408

 

$

407

 

$

(76,938

)

$

272,886

 

Exercise of common stock options

 

 

502,687

 

 

 

 

1,319

 

 

 

 

 

 

1,319

 

Restricted stock units released

 

 

2,025

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

2,250

 

 

 

 

 

 

2,250

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

(339

)

 

(14,961

)

 

(15,300

)

Balance at March 31, 2023

 

 

94,448,028

 

$

9

 

$

352,977

 

$

68

 

$

(91,899

)

$

261,155

 

Exercise of common stock options

 

 

851,001

 

 

 

 

2,739

 

 

 

 

 

 

2,739

 

Restricted stock units released

 

 

2,025

 

 

 

 

 

 

 

 

 

 

 

Shares issued under the employee stock purchase plan

 

 

21,899

 

 

 

 

115

 

 

 

 

 

 

115

 

Stock-based compensation

 

 

 

 

 

 

2,161

 

 

 

 

 

 

2,161

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

(248

)

 

(17,370

)

 

(17,618

)

Balance at June 30, 2023

 

 

95,322,953

 

$

9

 

$

357,992

 

$

(180

)

$

(109,269

)

$

248,552

 

Exercise of common stock options

 

 

473,301

 

 

 

 

922

 

 

 

 

 

 

922

 

Stock-based compensation

 

 

 

 

 

 

2,657

 

 

 

 

 

 

2,657

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

19

 

 

(14,866

)

 

(14,847

)

Balance at September 30, 2023

 

 

95,796,254

 

$

9

 

$

361,571

 

$

(161

)

$

(124,135

)

$

237,284

 

 

 

 

Series A
Convertible
Preferred Stock

 

 

Series B
Convertible
Preferred Stock

 

 

Series C
Convertible
Preferred Stock

 

 

Series D
Convertible
Preferred Stock

 

 

Common Stock

 

Additional
Paid-in

 

Accumulated

 

Total
Stockholders’
Equity

 

 

Shares

 

Amount

 

 

Shares

 

Amount

 

 

Shares

 

Amount

 

 

Shares

 

Amount

 

 

Shares

 

Amount

 

Capital

 

Deficit

 

(Deficit)

 

Balance at December 31, 2021

 

4,764,000

 

$

365

 

 

 

606,060

 

$

1,000

 

 

 

7,692,309

 

$

19,868

 

 

 

9,337,066

 

$

54,806

 

 

 

30,369,413

 

$

3

 

$

10,984

 

$

(42,256

)

$

(31,269

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

264

 

 

 

 

264

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,250

)

 

(7,250

)

Balance at March 31, 2022

 

4,764,000

 

$

365

 

 

 

606,060

 

$

1,000

 

 

 

7,692,309

 

$

19,868

 

 

 

9,337,066

 

$

54,806

 

 

 

30,369,413

 

$

3

 

$

11,248

 

$

(49,506

)

$

(38,255

)

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

385,710

 

 

 

 

287

 

 

 

 

287

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

356

 

 

 

 

356

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,420

)

 

(6,420

)

Balance at June 30, 2022

 

4,764,000

 

$

365

 

 

 

606,060

 

$

1,000

 

 

 

7,692,309

 

$

19,868

 

 

 

9,337,066

 

$

54,806

 

 

 

30,755,123

 

$

3

 

$

11,891

 

$

(55,926

)

$

(44,032

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

460

 

 

 

 

460

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,583

)

 

(6,583

)

Balance at September 30, 2022

 

4,764,000

 

$

365

 

 

 

606,060

 

$

1,000

 

 

 

7,692,309

 

$

19,868

 

 

 

9,337,066

 

$

54,806

 

 

 

30,755,123

 

$

3

 

$

12,351

 

$

(62,509

)

$

(50,155

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

8


 

ARS Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(47,197

)

 

$

(20,253

)

Non-cash adjustments to reconcile net loss to net cash provided by (used) in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

6,957

 

 

 

1,080

 

Non-cash interest expense

 

 

 

 

 

125

 

Depreciation

 

 

61

 

 

 

20

 

Amortization and accretion of short-term investments, net

 

 

(5,121

)

 

 

 

Change in fair value of warrant liability

 

 

 

 

 

(3

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Other receivables

 

 

 

 

 

(328

)

Prepaid and other assets

 

 

481

 

 

 

6

 

Accounts payable and accrued liabilities (including related party amounts of $192 and $220, respectively)

 

 

6,104

 

 

 

1,138

 

Operating right-of-use assets and lease liabilities, net

 

 

(9

)

 

 

(50

)

Contract liability

 

 

(3,137

)

 

 

(1,316

)

Net cash used in operating activities

 

 

(41,861

)

 

 

(19,581

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of short-term investments, available-for-sale

 

 

(237,953

)

 

 

 

Maturities of short-term investments, available-for-sale

 

 

125,000

 

 

 

 

Purchase of property and equipment

 

 

(266

)

 

 

(73

)

Net cash used in investing activities

 

 

(113,219

)

 

 

(73

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from exercise of common stock options and employee stock purchase plan

 

 

5,094

 

 

 

287

 

Cash paid for transaction costs

 

 

 

 

 

(647

)

Repayment of bank note payable

 

 

 

 

 

(2,727

)

Net cash provided by (used in) financing activities

 

 

5,094

 

 

 

(3,087

)

Net change in cash and cash equivalents

 

 

(149,986

)

 

 

(22,741

)

Cash and cash equivalents at beginning of period

 

 

210,518

 

 

 

60,063

 

Cash and cash equivalents at end of period

 

$

60,532

 

 

$

37,322

 

Supplemental cash flow information:

 

 

 

 

 

 

Purchases of property and equipment included in accounts payable

 

$

91

 

 

$

 

Purchases of property and equipment reclassed from prepaid expenses and other current assets

 

$

174

 

 

$

 

Unpaid transaction costs included in accounts payable and accrued expenses

 

$

 

 

$

137