ARS Pharmaceuticals, Inc 10-K for FY2023

ARS Pharmaceuticals, Inc. (SPRY)

10-K 2024-03-21 For: 2023-12-31

Added on April 11, 2026

About this 10-K

ARS Pharmaceuticals, Inc filed this 10-K on March 21, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $30K; down 97.7% from $1.32M a year earlier
Net loss: $54.37M; compared with a net loss of $34.68M a year earlier
Diluted EPS: -$0.57; compared with -$0.87 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)


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒



		Page
PART I
Item 1.	Business	6
Item 1A.	Risk Factors	46
Item 1B.	Unresolved Staff Comments	101
Item 1C.	Cybersecurity	101
Item 2.	Properties	102
Item 3.	Legal Proceedings	102
Item 4.	Mine Safety Disclosures	102

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	103
Item 6.	[Reserved]	104
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	104
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	114
Item 8.	Financial Statements and Supplementary Data	115
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	139
Item 9A.	Controls and Procedures	139
Item 9B.	Other Information	140
Item 9C.	Disclosure regarding Foreign Jurisdictions that Prevent Inspections	140

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	141
Item 11.	Executive Compensation	141
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	141
Item 13.	Certain Relationships and Related Transactions, and Director Independence	141
Item 14.	Principal Accountant Fees and Services	141

PART IV
Item 15.	Exhibits, Financial Statement Schedules	142
Item 16.	Form 10-K Summary	144

SIGNATURES



Body System		Common Symptoms of Type I Allergic Reactions
Respiratory		Chest tightness, wheezing, difficulty breathing ~50%+ frequency Upper airway or laryngeal Angioedema including swelling of throat ~20+% frequency

Cardiovascular		Hypotension, presyncope (feeling faint), loss of consciousness ~20% frequency

Dermatological		Urticaria (hives) and pruritus (itching) ~50%+ frequency Angioedema including swelling of lips, tongue and mouth ~ 50%+ frequency

Gastrointestinal		Abdominal pain and vomiting ~20% frequency



Clinical Feature		Supporting Clinical Data
Comparable PKs to epinephrine		Cmax, tmax and AUCs were within the range of approved intra-muscular injection products with a low intranasal dose of 2.0 mg neffy (people >30 kg in weight) and 1.0 mg neffy (people 15 – 30 kg weight). Exposures with repeat doses of neffy were greater than IM to ensure efficacy, and comparable to EpiPen to ensure safety.

Low dose of epinephrine avoids side-effects that can be confused with anaphylaxis symptoms		Minimal to no gastrointestinal side effects with 1.0 or 2.0 mg neffy such as vomiting, diarrhea or abdominal pain that can occur if excess non-absorbed epinephrine is swallowed, confounding clinical monitoring since those same gastrointestinal side effects are symptoms of anaphylaxis during approximately 20% of events.

Robust PDs within a range comparable to injection products with no risk of accidental blood vessel injections		PD responses including systolic blood pressure and heart rate were within normal physiologic changes and comparable to auto-injector products, with maximum changes less than EpiPen. neffy has no potential for the accidental blood vessel injections observed with injection products such as EpiPen, which can lead to rapid and high epinephrine exposures that cause rapid increases in systolic blood pressure and can lead to cerebral hemorrhage or other cardiovascular side effects.

No meaningful pain or irritation after administration		Visual analogue scale scores were an average of 5 to 8 on a 100 mm scale, and show no meaningful pain (or burning or stinging sensation) after administration, attributable to neffy being an aqueous formulation. There is also no irritation observed based on formal scoring. Needle containing intra-muscular injection products are known to be painful and cause reluctance to dose.

Easy to use		No critical dosing errors during self-administration with 2.0 mg neffy by type I allergy adult subjects (EPI-17). Zero percent error rate in human factor validation studies with intended commercial instructions for use and quick reference guide, when used by untrained adults or untrained children. Ability to dose neffy is not affected by any of the frequently observed anaphylaxis-related symptoms such as angioedema or swelling of the face, lips, tongue or larynx (~50% frequency), gastrointestinal symptoms such as vomiting or dysphagia (~20% frequency), or upper airway or breathing difficulty (~50% frequency).

Easy to carry		neffy is comparable in size to a wireless earbud case, and multiple neffy devices can fit in a patient or parent’s pocket to satisfy guideline recommendations.

High reliability		neffy’s sprayer device is designed to deliver the effective dose more than 99.999% of the time, with no recalls or warnings among the millions of the same nasal sprayer devices sold to date.

No breathing or inhalation required		neffy is designed to be absorbed passively through the nasal mucosa without any inhalation, sniffing or breathing required, with its particles too large to enter the lungs.

Injection-like absorption even with nasal congestion		neffy reaches exposures comparable to approved injectable products even after induction of moderate to severe nasal rhinitis and/or edema (e.g., nasal congestion)


	•		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 (“PK”)/pharmacodynamic (“PD”) study assessing repeat doses of neffy compared to repeat doses of an 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 I), including anaphylaxis for adults and children ≥30 kg;


	•		our expectations regarding the timing for resubmitting an NDA for neffy with the FDA for the treatment of allergic reactions (Type I), 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;


	•		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;


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


	•		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;


	•		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 from the Silverback Therapeutics, Inc. 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.