ARS Pharmaceuticals, Inc 10-Q for FY2023 Q3

ARS Pharmaceuticals, Inc. (SPRY)

10-Q 2023-11-09 For: 2023-09-30

Added on April 11, 2026

About this 10-Q

ARS Pharmaceuticals, Inc filed this 10-Q on November 9, 2023, covering the quarter ended September 30, 2023 (FY2023 Q3).

Headline figures

Quarter ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $0; compared with $189K a year earlier
Net loss: $14.87M; compared with a net loss of $6.58M a year earlier
Diluted EPS: -$0.16; compared with -$0.21 a year earlier

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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)



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


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

Emerging growth company	☒



		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


	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


	•		any statements regarding future economic conditions or performance;


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


	•		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;


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


	•		the likelihood of neffy attaining favorable coverage;


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


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


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


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


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


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


	•		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.