0001193125-26-449778 | 10-Q | XBRL Viewer

Nature of Business

1. Nature of Business

Description of Business

ARS Pharmaceuticals, Inc. (“ARS”, “ARS Pharma” or the “Company”) is a biopharmaceutical company focused on the commercialization and development of neffy (currently identified in the European Union and United Kingdom by the trade name EURneffy and in China by the trade name 优敏速) for needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis in adults and children who weigh 15 kg or greater. neffy is the first and only FDA and European Commission-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than 35 years.

The Company incorporated in Delaware in January 2016 and is located in San Diego, California. The Company has a wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., incorporated in Delaware in August 2015, through which it conducts substantially all its operations. ARS Pharmaceuticals Operations, Inc. has a wholly owned subsidiary in Ireland, ARS Pharmaceuticals IRL, Limited, to facilitate the filing of regulatory approval for neffy in European countries.

Liquidity and Capital Resources

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net operating losses in most years since its inception and had an accumulated deficit of $453.1 million as of September 30, 2026. The Company had cash, cash equivalents, and short-term investments of $138.4 million as of September 30, 2026 and has not generated positive cash flows from operations in most years. To date, the Company has funded its operations primarily with proceeds from the merger with Silverback Therapeutics, Inc. (“Silverback”) in November 2022 (the “Merger”), the private placement of convertible preferred stock, the issuance of common stock, licensing, supply and distribution agreements, debt, and net product sales. The Company’s currently available cash, cash equivalents, and short-term investments as of September 30, 2026 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date these financial statements are issued.

From August 5, 2015 (inception) through September 30, 2026, the Company has devoted substantially all of its efforts to developing intellectual property, conducting product development and clinical trials, organizing and staffing the Company, business planning, raising capital, building infrastructure, pre-commercial and commercial activities, and providing general and administrative support for these operations. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. There can be no assurance that the Company will achieve profitability in the future, or if achieved, that it will be sustained on a continuing basis.

Insider Trading Arrangements

3 Months Ended

Sep. 30, 2026

Material Terms of Trading Arrangement

Rule 10b5-1 Trading Arrangements

During the three months ended September 30, 2026, our officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated trading plans for the orderly disposition of the Company’s securities as set forth in the table below.

         
        Adoption /

        Type of Trading Arrangement

        Total Shares of

         
        Termination

        Rule

        Non-Rule

        Common Stock

        Name and Position

        Action

        Date

        10b5-1(1)

        10b5-1(2)

        to be Sold

        Expiration Date

Richard Lowenthal, on behalf of Richard E. Lowenthal Charitable Remainder UniTrust Dated January 7, 2020*
Former Chief Executive Officer

Termination(3)

August 28, 2026

X

1,050,000

May 14, 2027

Richard Lowenthal, on behalf of Lowenthal-Tanimoto Family Trust U/A DTD 4/3/2006*
Former Chief Executive Officer

Termination(3)

August 28, 2026

X

1,050,000

May 14, 2027

Sarina Tanimoto, on behalf of Sarina Tanimoto Charitable Remainder UniTrust Dated January 7, 2020*
Former Chief Medical Officer

Termination(3)

August 28, 2026

X

1,050,000

May 14, 2027

Sarina Tanimoto, on behalf of Lowenthal-Tanimoto Family Trust U/A DTD 4/3/2006*
Former Chief Medical Officer

Termination(3)

August 28, 2026

X

1,050,000

May 14, 2027

Eric Karas
Former Chief Commercial Officer

Termination(4)

August 18, 2026

X

100,000

January 29, 2027

Alexander Fitzpatrick
Chief Legal Officer

Termination(5)

August 30, 2026

X

103,355

December 31, 2026

Alexander Fitzpatrick
Chief Legal Officer

Adoption

September 4, 2026

X

454,652

September 1, 2028

_____________

(1)

Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

(2)

“Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.

(3)

Represents the termination, as described in Rule 10b5-1(c) under the Exchange Act, of a trading plan adopted on May 21, 2025, that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

(4)

Represents the termination, as described in Rule 10b5-1(c) under the Exchange Act, of a trading plan adopted on December 11, 2025, that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

(5)

Represents the termination, as described in Rule 10b5-1(c) under the Exchange Act, of a trading plan adopted on December 5, 2025, that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

* This plan, together with the other three plans marked with an asterisk in this table, are treated as a single “plan” because the individual constituent contracts with each broker-dealer, when taken together as a whole, meet all of the applicable conditions of Rule 10b5-1(c) under the Exchange Act and remain collectively subject to the provisions of such rule, including that a modification of any individual contract acts as modification of the whole contract.

Eric Karas [Member]

Eric Karas

Former Chief Commercial Officer

false

false

true

Plan One [Member] | Richard Lowenthal [Member]

false

August 18, 2026

January 29, 2027

164 days

100,000

Richard Lowenthal

Former Chief Executive Officer

false

false

true

Plan One [Member] | Sarina Tanimoto [Member]

false

August 28, 2026

May 14, 2027

259 days

1,050,000

Sarina Tanimoto

Former Chief Medical Officer

false

false

true

Plan One [Member] | Alexander Fitzpatrick [Member]

false

August 28, 2026

May 14, 2027

259 days

1,050,000

Alexander Fitzpatrick

Chief Legal Officer

false

false

true

Plan Two [Member] | Richard Lowenthal [Member]

false

August 30, 2026

December 31, 2026

123 days

103,355

Richard Lowenthal

Former Chief Executive Officer

false

false

true

Plan Two [Member] | Sarina Tanimoto [Member]

false

August 28, 2026

May 14, 2027

259 days

1,050,000

Sarina Tanimoto

Former Chief Medical Officer

false

false

true

Plan Two [Member] | Alexander Fitzpatrick [Member]

false

August 28, 2026

May 14, 2027

259 days

1,050,000

Alexander Fitzpatrick

Chief Legal Officer

true

false

Adoption Date

September 4, 2026

false

Collaborative Arrangement [Abstract]

false

Expiration Date

September 1, 2028

Arrangement Duration

728 days

Aggregate Available

454,652

Balance Sheet Details - Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands	Sep. 30, 2026	Dec. 31, 2025
Accounts Payable and Accrued Liabilities [Abstract]
Accounts payable	$ 5,418	$ 5,725
Accrued gross-to-net liabilities	25,540	14,162
Accrued marketing related expenses	15,245	6,880
Accrued compensation	7,202	1,276
Accrued cost of goods sold	3,757	3,165
Other	6,631	6,740
Total	$ 63,793	$ 37,948

Fair Value Measurements

9 Months Ended

Sep. 30, 2026

Fair Value Disclosures [Abstract]

Fair Value Measurements

6. Fair Value Measurements

The Company categorizes its assets and liabilities measured at fair value in accordance with the authoritative accounting guidance that establishes a consistent framework for measuring fair value and expands disclosures for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:


Level 1	–	Quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2	–	Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and
Level 3	–	Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.

The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands):


					Gross		Gross			Estimated
			Amortized		Unrealized		Unrealized			Fair
	Level		Cost		Gains		Losses			Value
September 30, 2026
Cash and cash equivalents - Money market mutual funds		1	$	25,321	$	—	$	—		$	25,321
Short-term investments - U.S. Treasury securities		2		112,837		—		(104	)		112,733
Total			$	138,158	$	—	$	(104	)	$	138,054
December 31, 2025
Cash and cash equivalents - Money market mutual funds		1	$	41,030	$	—	$	—		$	41,030
Short-term investments - U.S. Treasury securities		2		203,544		134		(9	)		203,669
Total			$	244,574	$	134	$	(9	)	$	244,699

There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the periods presented. During the three and nine months ended September 30, 2026, the Company purchased $33.1 million and $67.7 million in short-term investments, respectively, and $56.5 million and $160.5 million in short-term investments matured or were sold, respectively. During the three and nine months ended September 30, 2025, the Company purchased $127.4 million and $193.1 million in short-term investments, respectively, and $88.5 million and $232.0 million in short-term investments matured, respectively.

The Company’s short-term investments portfolio contains investments in U.S. Treasury securities that have an effective maturity date that is less than one year from the respective balance sheet date. The Company’s money market mutual fund holdings are highly liquid and invest primarily in cash and U.S. Treasury securities.

For the three and nine months ended September 30, 2026, net unrealized gains on available-for-sale securities were less than $0.1 million and net unrealized losses were $0.2 million, respectively. For the three and nine months ended September 30, 2025, net unrealized gains were less than $0.1 million and net unrealized losses on available-for-sale securities were $0.2 million, respectively. Management determined that the gross unrealized losses on the Company’s available-for-sale securities as of September 30, 2026 were primarily attributable to current economic and market conditions and not credit risk. As of September 30, 2026 and December 31, 2025, no allowance for credit losses was recorded for available-for-sale securities. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell any investments prior to recovery of its amortized cost basis, which is expected to be at maturity.

Accrued interest receivable on the Company’s available-for-sale securities was $0.5 million and $1.0 million at September 30, 2026 and December 31, 2025, respectively, and was included in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets.

The Company’s Term Loans (as defined in Note 8 – Term Loans) are carried at historical cost, adjusted for the debt discount and debt issuance costs, and are not required to be carried at fair value. The carrying value of the Term Loans approximates fair value due to the use of current market rates that are repriced frequently.

As of September 30, 2026 and December 31, 2025, the Company did not have any liabilities that were measured at fair value on a recurring basis.

Collaboration, Out-Licensing and Related Agreements (Table)

9 Months Ended

Sep. 30, 2026

Schedule of Reconciliation of Contract and Financing Liability from ALK Collaboration Agreement

A reconciliation of the contract liability from the ALK Collaboration Agreement is as follows (in thousands):


Balance at December 31, 2025	$	1,739
Regulatory milestone allocated to development and regulatory performance obligations		69
Revenue recognized related to development and regulatory performance obligations		(250	)
Balance at September 30, 2026	$	1,558

A reconciliation of the Financing Liability from the ALK Collaboration Agreement is as follows (in thousands):


Balance at December 31, 2025	$	72,140
Regulatory milestone allocated to the EEA License		2,393
Sales-based royalties earned under the EEA License		675
Balance at September 30, 2026	$	75,208

Term Loans (Tables)

9 Months Ended

Sep. 30, 2026

Debt Disclosure [Abstract]

Schedule of Composition of the Term Loan

The following table summarizes the composition of the Term Loans as reflected on the accompanying condensed consolidated balance sheet (in thousands):


	September 30, 2026			December 31, 2025
Gross proceeds	$	125,000		$	100,000
Unamortized debt discount and debt issuance costs		(3,193	)		(3,626	)
Total	$	121,807		$	96,374

Intangible Assets - Schedule of Finite-Lived Intangible Assets (Detail) - USD ($)
$ in Thousands

Sep. 30, 2026

Dec. 31, 2025

Intangible Asset, Goodwill and Other [Abstract]

Less accumulated amortization

^[1]

$ 15,360

(1,736)

(908)

Total

$ 13,624

$ 14,452

[1]	(1) As described in Note 3 – Collaboration, Out-Licensing and Related Agreements and Note 10 – In-Licensing and Supply, capitalized milestone payments were recognized from the Recordati Termination Agreement and Aegis License Agreement, respectively.

Summary of Significant Accounting Policies (Additional Information) (Detail)	3 Months Ended		9 Months Ended
	Sep. 30, 2026 USD ($)	Sep. 30, 2025 USD ($)	Sep. 30, 2026 USD ($) Segment	Sep. 30, 2025 USD ($)	Dec. 31, 2025 USD ($)
Summary of Significant Accounting Policies [Line Items]
Allowance for credit losses	$ 0		$ 0		$ 0
Advertising expense	$ 3,900,000	$ 40,900,000	$ 71,200,000	$ 72,800,000
Number of operating segments \| Segment			1
Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Lease renewal term	12 months		12 months
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	100.00%	100.00%	100.00%	100.00%
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member] \| Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	25.00%		30.00%
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member] \| Maximum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	75.00%		70.00%
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	100.00%		100.00%
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member] \| Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	25.00%		30.00%
Revenue under collaboration agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member] \| Maximum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	75.00%		70.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	93.00%	100.00%	96.00%	98.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member] \| Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	12.00%	19.00%	11.00%	15.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer One [Member] \| Maximum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	66.00%	81.00%	47.00%	83.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	93.00%	100.00%	96.00%	98.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member] \| Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	12.00%	19.00%	11.00%	15.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Two [Member] \| Maximum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	66.00%	81.00%	47.00%	83.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Three [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	93.00%		96.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Three [Member] \| Minimum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	12.00%		11.00%
Revenue under supply agreements [Member] \| Customer Concentration Risk [Member] \| Customer Three [Member] \| Maximum [Member]
Summary of Significant Accounting Policies [Line Items]
Percentage of credit risk	66.00%		47.00%

Collaboration, Out-Licensing and Related Agreements - Schedule of Reconciliation of Contract and Financing Liability from ALK Collaboration Agreement (Detail) $ in Thousands	9 Months Ended
	Sep. 30, 2026 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Financing Liability, Balance at December 31, 2025	$ 72,140
Financing Liability, Balance at September 30, 2026	75,208
ALK Collaboration Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contract Liability, Balance at December 31, 2025	1,739
Regulatory Milestone Allocated to Development and Regulatory Performance Obligations	69
Revenue recognized related to development and regulatory performance obligations	(250)
Contract Liability, Balance at September 30, 2026	1,558
ALK Collaboration Agreement [Member] \| ALK Financing Liability [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Financing Liability, Balance at December 31, 2025	72,140
Regulatory milestone allocated to the EEA License	2,393
Sales-based royalties earned under the EEA License	675
Financing Liability, Balance at September 30, 2026	$ 75,208

Summary of Significant Accounting Policies - Summary of Antidilutive Securities Excluded from Computation of Earnings Per Share Amount (Detail) - shares	9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	19,933,201	17,196,685
Warrants To Purchase Common Stock [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	45,456	45,456
Common Stock Options [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	19,817,214	17,106,592
Estimated Shares to be Purchased under the Employee Stock Purchase Plan [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	70,531	43,255
Restricted Stock Units Outstanding [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	0	1,382

Summary of Significant Accounting Policies - Schedule of Concentration Credit Risk (Detail) - Customer Concentration Risk [Member]	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025	Dec. 31, 2025
Account Receivable [Member] \| Customer A [Member]
Product Information [Line Items]
Percentage of credit risk			30.00%		18.00%
Account Receivable [Member] \| Customer B [Member]
Product Information [Line Items]
Percentage of credit risk			30.00%		15.00%
Account Receivable [Member] \| Customer C [Member]
Product Information [Line Items]
Percentage of credit risk			25.00%		21.00%
Account Receivable [Member] \| Customer D [Member]
Product Information [Line Items]
Percentage of credit risk					12.00%
Account Receivable [Member] \| Customer E [Member]
Product Information [Line Items]
Percentage of credit risk					16.00%
Gross Product Revenue [Member] \| Customer A [Member]
Product Information [Line Items]
Percentage of credit risk	27.00%	25.00%	25.00%	22.00%
Gross Product Revenue [Member] \| Customer B [Member]
Product Information [Line Items]
Percentage of credit risk	24.00%	23.00%	25.00%	24.00%
Gross Product Revenue [Member] \| Customer C [Member]
Product Information [Line Items]
Percentage of credit risk	22.00%	21.00%	20.00%	21.00%
Gross Product Revenue [Member] \| Customer D [Member]
Product Information [Line Items]
Percentage of credit risk		14.00%		13.00%

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2026

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”), and Accounting Standards Update (“ASU”), of the Financial Accounting Standards Board (“FASB”). The Company’s financial statements are presented on a condensed consolidated basis, which include the accounts of ARS Pharmaceuticals, Inc., ARS Pharmaceuticals Operations, Inc. and ARS Pharmaceuticals IRL, Limited. All intercompany accounts and transactions have been eliminated in consolidation. The Company’s functional and reporting currency is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income in the accompanying condensed consolidated statements of operations and comprehensive loss. All adjustments considered necessary for a fair presentation have been included.

Unaudited Interim Condensed Consolidated Financial Statements

The accompanying condensed consolidated balance sheet as of September 30, 2026, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2026 and 2025, the condensed consolidated statements of stockholders’ (deficit) equity for the three and nine months ended September 30, 2026 and 2025, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2026 and 2025, are unaudited. The balance sheet as of December 31, 2025 was derived from the audited financial statements as of and for the year ended December 31, 2025. The unaudited interim condensed consolidated financial statements have been prepared on a basis consistent with the audited annual financial statements as of and for the year ended December 31, 2025, and, in the opinion of management, reflect all adjustments, consisting solely of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2026, the condensed consolidated results of its operations for the three and nine months ended September 30, 2026 and 2025, and its cash flows for the nine months ended September 30, 2026 and 2025. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2026 and 2025 are also unaudited. The condensed consolidated results of operations for the three and nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the full year ending December 31, 2026 or any other period.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s condensed consolidated financial statements are revenue recognized under collaboration agreements and accruals for variable consideration of product revenue. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Fair Value of Financial Instruments

Cash, cash equivalents, and short-term investments are carried at fair value. The carrying amounts of all accounts receivable, prepaid expenses and other current assets, and accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments.

Cash and Cash Equivalents

Cash and cash equivalents include cash readily available in checking, money market mutual funds, and short-term investments with remaining maturities when purchased of 90 days or less, if any. The Company considers all highly liquid investments with remaining maturities when purchased of 90 days or less to be cash equivalents.

Investments

The Company invests excess cash in investment grade fixed income securities. These investments are included in short-term investments on the condensed consolidated balance sheets, classified as available-for-sale, and reported at fair value with unrealized gains and losses included in accumulated other comprehensive (loss) gain, net. Realized gains and losses on the sale of securities are recognized in other (expense) income, net.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable includes trade accounts receivable from product sales to customers, partner receivables for reimbursable research and development costs, royalties, license fees, and milestone payments due under the Company’s collaboration agreements and for supply of neffy under the Company’s supply agreements. Trade accounts receivables are recorded at wholesale acquisition cost (“WAC”), less purchase price discounts, prompt pay discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company determines the allowance for credit losses for accounts receivable based on each customer’s or partner’s accounts receivable balance and age, their financial condition, and the general economic environment.

When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. The allowance for credit losses was not material at both September 30, 2026 and December 31, 2025.

Concentrations of Credit Risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to cash risk by placing its cash with high credit quality financial institutions.

The Company reviews its financial instruments portfolio on a quarterly basis to determine if any unrealized losses have resulted from a credit loss or other factors. As part of the review, management considers factors such as historical experience, market data, issuer-specific factors, and current economic conditions. This review is subjective, as it requires management to evaluate whether an event or change in circumstances has occurred in that period that may be related to credit issues.

The Company is also subject to credit risk related to its accounts receivable from product sales and revenue under collaboration and supply agreements. neffy is distributed primarily through wholesale distributors and pharmacies. These entities are not obligated to purchase any set number of units, and they distribute neffy on demand as orders are received. The Company enters into collaboration and supply agreements with pharmaceutical companies that have operations outside the U.S. under which the Company is entitled to receive payments for royalties, license fees, milestone achievements, reimbursable costs for research and development services, and supply of neffy. The Company extends credit to its customers and partners in the normal course of business after evaluating their overall financial condition.

Prior to August 2025, the Company operated under a title model agreement under which the title agent retained all credit and collection risk on product sales to the Company’s wholesale distributors and pharmacy customers. As of August 2025, the Company ceased operating under a title model agreement and now retains all credit and collection risk on product sales.

The following table presents customers whose accounts receivable balances represented 10% or more of total accounts receivable as of the dates presented:


	% of Accounts Receivable
	September 30,			December 31,
	2026			2025
Customer A		30	%		18	%
Customer B		30	%		15	%
Customer C		25	%		21	%
Customer D	*				12	%
Customer E	*				16	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

The following table presents customers that accounted for 10% or more of total gross product revenue during the periods presented:


	% of Total Gross Product Revenue
	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025
Customer A		27	%		25	%		25	%		22	%
Customer B		24	%		23	%		25	%		24	%
Customer C		22	%		21	%		20	%		21	%
Customer D	*				14	%	*				13	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

For each of the three and nine months ended September 30, 2026, two customers accounted for 100% of revenue under collaboration agreements, with each customer representing 25% and 75% and 30% and 70% of revenue under collaboration agreements, respectively. For the three and nine months ended September 30, 2026, three customers accounted for 93% and 96% of revenue under supply agreements, with each individual customer representing between 12% and 66% and 11% and 47% of revenue under supply agreements, respectively. For each of the three and nine months ended September 30, 2025, one customer accounted for 100% of revenue under collaboration agreements. For the three and nine months ended September 30, 2025, two customers accounted for 100% and 98% of revenue under supply agreements, with each customer representing 19% and 81% and 15% and 83% of revenue under supply agreements, respectively. To date, the Company has not experienced any credit losses from its trade and partner accounts receivable.

Inventories

Inventories consist of finished goods held for sale and distribution, raw materials and work in process, and include labor and overhead. Inventories are stated at the lower of cost or net realizable value, and are determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company periodically reviews its inventory to identify obsolete, slow-moving, or otherwise unsalable inventories, and establishes allowances for situations in which the cost of the inventory is not expected to be recovered. Such impairment charges, if any, are recorded in cost of goods sold on the accompanying condensed consolidated statements of operations.

The Company capitalizes inventory costs after regulatory approval, when future commercialization is considered probable, and a future economic benefit is expected to be realized. Prior to regulatory approval, the Company records inventory costs as research and development expenses. As such, when regulatory approval is received, this may result in zero-cost inventory that does not have a carrying value. This inventory is available to the Company to utilize for commercial operations as well as ongoing research and development activities.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally five years. Repair and maintenance costs are charged to expense as incurred.

Intangible Assets

Intangible assets are measured at fair value as of the acquisition date or, in the case of capitalized milestone payments, the date they become due. The evaluation of intangible assets includes assessing the amortization period for which the asset is expected to contribute to the future cash flows of the Company. Intangible assets with finite useful lives are amortized over their estimated useful lives, primarily on a straight-line basis when the Company is unable to reliably estimate the pattern of cash flow.

Leases

The Company determines the initial classification and measurement of its right-of-use (“ROU”) asset and lease liabilities at the lease commencement date and thereafter, if modified. The Company recognizes a ROU asset for its operating leases with lease terms greater than 12 months. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The lease liability is calculated by using the present value of all lease payments, discounted at the incremental borrowing rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments in a similar economic environment, determined with reference to peer companies. Variable charges for common area maintenance and other variable costs are recognized as expense as incurred. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in research and development and general and administrative expenses in the accompanying condensed consolidated statements of operations and comprehensive loss.

Impairment of Long-Lived Assets

Long-lived assets consist primarily of property and equipment, the ROU asset, and intangible assets. The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the asset or asset group are expected to generate, including its eventual residual value. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds its fair value. The Company has not recognized any impairment losses from inception through September 30, 2026.

Revenue Recognition

The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The provisions of ASC 606 require the following steps to determine revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Product revenue, net

The Company’s product, neffy, was approved by the FDA in August 2024, and the Company began generating product revenue from sales of neffy in September 2024. The Company sells its product to its wholesale distributor and pharmacy customers in the United States. These customers subsequently resell the products to pharmacies and health care providers or dispense products directly to patients. In accordance with ASC 606, the Company recognizes revenue at a point in time when the customers obtain control of the Company’s products, typically upon delivery. The Company also enters into consignment agreements with certain pharmacies, under which revenue is recognized when the product is sold to a patient and control transfers from the Company to the patient.

Product revenue is recorded at the net transaction price, which includes estimates for variable consideration such as distribution service fees, prompt pay discounts, product returns, chargebacks, rebates, co-payment assistance, and other incentives for certain indirect customers. The Company establishes reserves for these estimates based on amounts earned or expected to be claimed on related sales.

The Company uses the expected value method to determine the appropriate amount of variable consideration, considering factors such as contractual and statutory requirements, known market events, industry trends and data, forecasted customer buying and payment patterns, and historical actual data. Estimates are reassessed each reporting period, and adjustments are recorded on a cumulative catch-up basis, which would affect product revenue and net loss in the period of adjustment. Variable consideration is included in net product revenue only to the extent it is probable that a significant revenue reversal will not occur in a future period.

Rebates. The Company provides commercial rebates to pharmacy benefit managers and managed care organizations and is subject to mandatory discount obligations under the Medicare, Medicaid, and Tricare programs. The rebate amounts for these programs are determined by contractual arrangements or statutory requirements. Rebates are owed after the product has been dispensed to a patient and the Company has been invoiced. The Company estimates the amount of rebates based on the expected number of claims and the related costs associated with the revenue recognized for product that remains in the distribution channel and any rebate amounts for product that has been dispensed to a patient but not invoiced to the Company at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the accompanying condensed consolidated balance sheets.

Commercial Pharmacy Discounts. The Company provides discounts to its pharmacy customers. These discounts are a contractually fixed percentage of WAC and are a direct reduction from the WAC price they are charged. They are calculated at the time of sale based on the amount purchased. These discounts are recorded as contra trade accounts receivable on the accompanying condensed consolidated balance sheets.

Co-payment Programs. The Company offers co-payment assistance programs to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. The Company estimates the amount of co-payment assistance based on the expected volume and the average buy down rate associated with the revenue recognized for products that remain in the distribution channel and any co-payment assistance amounts not invoiced to the Company at the end of each reporting period. Co-payment program estimates are recorded as other current liabilities on the accompanying condensed consolidated balance sheets.

Product Returns. Customers have the right to return damaged product, product that is within six months or less of the labeled expiration date, or product that is past the expiration date by no more than twelve months. neffy was commercially launched in September 2024 and due to the limited returns data, the Company uses professional judgment and industry data to estimate returns. As time passes and additional historical sales and returns data becomes available, the Company will update the estimated returns as needed. A reserve for potential product returns is recorded as other current liabilities on the accompanying condensed consolidated balance sheets.

Chargebacks. Certain government entities and covered entities (e.g. Veterans Administration, 340B, covered entities) can purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and WAC will be charged back to the Company. The Company estimates the amount of chargebacks based on the expected number of claims and the related costs associated with the revenue recognized for product that remains in the distribution channel and any chargeback amounts not invoiced to the Company at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the accompanying condensed consolidated balance sheets.

Distribution Service Fees. The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchased amount. These fees are recorded as other current liabilities on the accompanying condensed consolidated balance sheets.

Prompt Pay Discounts. The Company incentivizes on time invoice payments through prompt pay discounts. Prompt pay discounts are typically taken by customers, so an estimate of the discount is recorded at the time of sale based on the purchased amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the accompanying condensed consolidated balance sheets.

Revenue under collaboration and supply agreements

The Company licenses certain rights to neffy to third parties under collaboration agreements and supplies neffy to third parties for commercial sale under supply agreements. At contract inception, the Company evaluates its arrangements to determine whether they involve joint operating activities in which the parties are active participants and share significant risks and rewards in accordance with ASC Topic 808, Collaborative Agreements (“ASC 808”). Arrangements that meet these criteria are accounted for as collaborative arrangements under ASC 808. This assessment is updated over the life of the arrangement as roles and responsibilities change.

For collaboration agreements within the scope of ASC 808 that include multiple components, the Company determines which components are accounted for under ASC 808 and which components represent vendor-customer relationships accounted for under ASC 606. For components accounted for under ASC 808, the Company applies a consistent recognition approach based on applicable accounting guidance or a reasonable policy election. Amounts due from or payable to collaboration partners are presented in the income statement based on the nature of the underlying activity. When the Company is the principal in sales to third parties, revenues, cost of goods sold, and operating expenses are recorded on a gross basis. When the Company is not the principal, its share of results is recorded on a net basis as collaboration revenue or expense.

If the Company concludes that some or all components of the agreement are distinct and represent a transaction with a customer, the Company accounts for those elements of the arrangement in accordance with ASC 606 by applying the five-step model described above.

The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; clinical, regulatory, and/or commercial milestone payments; payment for clinical and commercial supply; and royalties on the net sales of licensed products.

Commercial Supply. Arrangements that include a promise for the future supply of drug product for commercial sale at the licensee’s discretion are generally considered customer options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. Revenue from product sales to the Company’s collaboration partners is recognized at the point-in-time that the collaboration partner obtains control, which is typically based upon the terms of delivery of the product. Revenue related to commercial supply arrangements, including transfer price revenue, is recorded to revenue under supply agreements on the condensed consolidated statements of operations.

Licenses of Intellectual Property. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, revenue is recognized from non-refundable, upfront payments allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. If the license is subject to repurchase by the Company, at its option, control of the license is not considered transferred to the customer, and in such case, the Company would account for the proceeds allocated to such license as either a financing obligation or a lease in accordance with ASC 606. Future amounts received related to the license which is subject to the Company’s repurchase, such as royalties or milestone payments, would be accounted for as additional financing proceeds and would increase the financing obligation in the accompanying condensed consolidated balance sheet. The Company would record such financing obligation as revenue when the right to repurchase has lapsed or was exercised. Revenue related to the licensing of intellectual property is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

If the license is not a distinct performance obligation, the Company evaluates the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone Payments. At the inception of each arrangement that includes clinical, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. In making the assessment of the constraint, the Company considers several factors, such as the stage of product development, the risks associated with the remaining activities required to achieve the milestones, as well as whether the achievement of the milestone is outside the control of the Company. Milestone payments that are not within the Company’s control, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized when the underlying performance obligation has been met. Revenue related to clinical, regulatory, or commercial milestone payments is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

Transaction Price Allocation. At the inception of each arrangement, the Company identifies its distinct performance obligations and allocates the transaction price to the performance obligations based upon their relative standalone selling prices. Standalone selling price is the price at which an entity would sell a promised good or service separately to a customer. The best evidence of standalone selling price is an observable price of a good or service when sold separately by an entity in similar circumstances to similar customers. Since the Company typically does not have such evidence, the Company estimates standalone selling price so that the amount that is allocated to each performance obligation equals the amount that the Company expects to receive for transferring the promised goods or services. The methods that the Company uses to make such estimates include (1) the adjusted market assessment approach, under which the Company forecasts product sales in the appropriate market, considers probability of commercialization success, and estimates discount rates; and (2) the expected cost of satisfying the performance obligations inclusive of a reasonable margin, also known as the expected cost plus margin approach. Revenue related to transaction price allocation is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

Research and Development Revenues. For arrangements that contain research and development commitments, any arrangement consideration allocated to the research and development work is recognized as the underlying services are performed over the research and development term, if the criteria for over time recognition are met. If the over time recognition criteria are not met, research and development performance obligations are recognized at a point-in-time, when the research and development work is completed. Revenue related to research and development commitments is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

Clinical Supply. Arrangements that include a promise for the future supply of drug product for clinical development at the licensee’s discretion are generally considered customer options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. Revenue from product sales to the Company’s collaboration partners is recognized at the point-in-time that the collaboration partner obtains control, which is typically based upon the terms of delivery of the product. Revenue related to clinical supply arrangements is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

Royalty Revenues. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Revenue related to royalties is recorded to revenue under collaboration agreements on the condensed consolidated statements of operations.

Cost of Goods Sold

Cost of goods sold primarily consists of direct and indirect costs related to the manufacture of neffy for commercial sale, including salaries and related expenses for personnel, stock-based compensation, third-party manufacturing costs, raw material and component costs, packaging services, freight, storage costs, distribution fees, amortization of capitalized in-licensed costs, supply agreement fees, and royalties on product sales. Prior to the FDA approval of neffy in August 2024, costs incurred for the manufacture of neffy were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of goods sold related to neffy initially reflects a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers.

Research and Development Costs

Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, stock-based compensation expense, external research and development costs incurred under agreements with contract research organizations, investigative sites and consultants to conduct clinical studies, costs related to compliance with regulatory requirements, costs related to in-licensing technology, costs related to manufacturing the Company’s product candidates (including neffy prior to FDA approval in August 2024) for clinical trials, and other allocated expenses.

Payments for research and development activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying condensed consolidated balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. The Company uses judgments and estimates to determine the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.

Selling, General and Administrative Costs

Selling, general and administrative costs are expensed in the period incurred. Selling, general and administrative costs primarily consist of marketing-related expenses, salaries and related expenses for personnel, including meals and travel-related expenses incurred by the sales team, stock-based compensation, legal fees incurred relating to corporate and patent matters, professional fees incurred for accounting, auditing, tax, and other consulting services, and insurance costs.

Advertising

Costs for producing advertising are expensed when incurred. Costs for communicating advertising, such as search engine marketing, banner advertisements, social media advertisements, and print advertisements, are recorded as prepaid expenses and then expensed the first time the advertising takes place. Advertising costs for the three and nine months ended September 30, 2026, were $3.9 million and $71.2 million, respectively. For the three and nine months ended September 30, 2025, advertising costs were $40.9 million and $72.8 million, respectively.

Patent Costs

Costs related to filing and pursuing patent applications are recorded as general and administrative expenses in the statements of operations and expensed as incurred since recoverability of such expenditures is uncertain.

License Fees

Costs incurred to acquire technology licenses and milestone payments made under existing agreements are expensed prior to FDA approval and capitalized after FDA approval when technological feasibility has been achieved, based on management’s assessment of the ultimate recoverability and the potential for alternative future use.

Stock-Based Compensation

Stock-based compensation expense represents the cost of the grant date fair value of stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company recognizes expense for awards subject to performance-based milestones over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions at each reporting date. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and recognizes forfeitures as they occur. In the event that stock-based awards are granted in contemplation of or shortly before a planned release of material non-public information, and such information is expected to result in a material increase in the share price of the Company’s common stock, the Company may consider whether an adjustment to the observable market price is required when estimating the grant date fair value.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive loss typically consists of the change in unrealized gains and losses on available-for-sale securities.

Segment Reporting

Operating segments are components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker for purposes of making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. For purposes of this calculation, stock options, warrants, and unvested restricted stock units, are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive.

The following securities are excluded from the calculation of weighted-average dilutive common shares because their inclusion would have been anti-dilutive:


	September 30,
	2026		2025
Warrants to purchase common stock		45,456		45,456
Common stock options outstanding		19,817,214		17,106,592
Estimated shares to be purchased under the employee stock purchase plan		70,531		43,255
Restricted stock units outstanding		—		1,382
Total		19,933,201		17,196,685

Recently Issued Accounting Pronouncements — Not Yet Adopted

From time to time, new accounting pronouncements are issued by the FASB or other standards setting bodies that are adopted as of the specified effective date. The Company believes the impact of recently issued standards, other than those noted below, and any issued but not yet effective standards will not have a material impact on the Company’s financial statements upon adoption.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any and all prior periods presented in the financial statements. The impact of adoption of this ASU on the Company’s disclosures is currently being evaluated.

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2026

Share-Based Payment Arrangement [Abstract]

Summary of Share-based Compensation Expense

Stock-based compensation expense recognized for all equity awards has been reported in the accompanying condensed consolidated statements of operations and comprehensive loss as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
Research and development expense(1)	$	2,089	$	664	$	3,941	$	1,991
Selling, general and administrative expense(2)		6,033		5,025		23,999		14,367
Total	$	8,122	$	5,689	$	27,940	$	16,358

_____________

(1) Stock-based compensation expense for the three and nine months ended September 30, 2026 included $1.7 million related to the accelerated vesting of previously unvested equity awards upon the termination of a former executive officer.

(2) Stock-based compensation expense for the three and nine months ended September 30, 2026 included $1.5 million and $6.8 million, respectively, related to the accelerated vesting of previously unvested equity awards upon the termination of former executive officers.

Summary of Activity Related to Stock Option

A summary of the Company’s stock option activity for the nine months ended September 30, 2026 is as follows:


						Weighted-
	Shares			Weighted-		Average		Aggregate
	Subject to			Average		Remaining		Intrinsic
	Options			Exercise		Contractual		Value
	Outstanding			Price		Life (Years)		(in thousands)
Outstanding at December 31, 2025		16,744,639		$	7.66
Granted		6,291,834		$	9.79
Exercised		(858,577	)	$	3.19
Forfeited		(2,360,682	)	$	10.70
Outstanding at September 30, 2026		19,817,214		$	8.17		5.6	$	10,644
Exercisable at September 30, 2026		13,282,346		$	7.54		4.1	$	10,644

Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model

The fair value of stock options granted was estimated using a Black-Scholes option-pricing model (“Black-Scholes”) with the following assumptions:


	Nine Months Ended September 30,
	2026	2025
Expected term (in years)	5.5 – 6.1	5.5 – 6.1
Expected volatility	81.5% – 85.2%	84.1% – 87.3%
Risk-free interest rate	3.7% – 4.6%	3.9% – 4.4%
Expected dividend yield	0%	0%

Inventories - Schedule of Inventory (Detail) - USD ($) $ in Thousands	Sep. 30, 2026	Dec. 31, 2025
Inventory Disclosure [Abstract]
Raw materials	$ 26,997	$ 26,815
Work in process	918	288
Finished goods	5,516	4,319
Total inventories	33,431	31,422
Inventories	11,711	8,369
Inventories, noncurrent	$ 21,720	$ 23,053

Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2026	Dec. 31, 2025
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and Cash Equivalents, at Carrying Value	$ 25,621	$ 41,317
Level 1 [Member] \| Fair Value, Recurring [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and Cash Equivalents, at Carrying Value	25,321	41,030
Cash And Cash Equivalents Gross Unrealized Gains	0	0
Cash and Cash Equivalents Gross Unrealized Losses	0	0
Estimated Fair Value	25,321	41,030
Level 2 [Member] \| Fair Value, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
U.S. Treasury securities, Gross unrealized gains	0	134
Gross unrealized losses	(104)	(9)
Level 2 [Member] \| Fair Value, Recurring [Member] \| U.S. Treasury Securities [Member] \| Short-Term Investments [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
U.S. Treasury securities, Amortized Cost	112,837	203,544
U.S. Treasury securities, Gross unrealized gains	0	134
Gross unrealized losses	(104)	(9)
U.S. Treasury securities, Fair Value	112,733	203,669
Level 1 And Level 2 [Member] \| Fair Value, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total Amortized Cost	138,158	244,574
Total Fair Value	$ 138,054	$ 244,699

Balance Sheet Details (Tables)

9 Months Ended

Sep. 30, 2026

Balance Sheet Related Disclosures [Abstract]

Schedule of Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consisted of the following (in thousands):


	September 30, 2026		December 31, 2025
Accounts payable	$	5,418	$	5,725
Accrued gross-to-net liabilities		25,540		14,162
Accrued marketing related expenses		15,245		6,880
Accrued compensation		7,202		1,276
Accrued cost of goods sold		3,757		3,165
Other		6,631		6,740
Total	$	63,793	$	37,948

Segment Information - Schedule of Revenue by Geographic Area Based on Customers Location (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025
Disaggregation of Revenue [Line Items]
Total revenue	$ 37,710	$ 32,501	$ 94,049	$ 56,191
United States [Member]
Disaggregation of Revenue [Line Items]
Total revenue	33,414	31,300	77,076	51,863
Denmark [Member]
Disaggregation of Revenue [Line Items]
Total revenue			7,786	4,079
Japan [Member]
Disaggregation of Revenue [Line Items]
Total revenue			5,995
Rest of World [Member]
Disaggregation of Revenue [Line Items]
Total revenue	$ 4,296	$ 1,201	$ 3,192	$ 249

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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-Paragraph 91
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479777/606-10-55-91

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2026

Schedule of Concentration Credit Risk

The following table presents customers whose accounts receivable balances represented 10% or more of total accounts receivable as of the dates presented:


	% of Accounts Receivable
	September 30,			December 31,
	2026			2025
Customer A		30	%		18	%
Customer B		30	%		15	%
Customer C		25	%		21	%
Customer D	*				12	%
Customer E	*				16	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

The following table presents customers that accounted for 10% or more of total gross product revenue during the periods presented:


	% of Total Gross Product Revenue
	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025
Customer A		27	%		25	%		25	%		22	%
Customer B		24	%		23	%		25	%		24	%
Customer C		22	%		21	%		20	%		21	%
Customer D	*				14	%	*				13	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

Summary of Antidilutive Securities Excluded from Computation of Earnings Per Share Amount

The following securities are excluded from the calculation of weighted-average dilutive common shares because their inclusion would have been anti-dilutive:


	September 30,
	2026		2025
Warrants to purchase common stock		45,456		45,456
Common stock options outstanding		19,817,214		17,106,592
Estimated shares to be purchased under the employee stock purchase plan		70,531		43,255
Restricted stock units outstanding		—		1,382
Total		19,933,201		17,196,685

Collaboration, Out-Licensing and Related Agreements - Additional Information (Detail 1)	Sep. 30, 2026
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2026-07-01
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Expected timing of satisfaction	2028

Term Loans - Schedule of Composition of the Term Loan (Detail) - USD ($) $ in Thousands	Sep. 30, 2026	Dec. 31, 2025
Debt Disclosure [Abstract]
Gross proceeds	$ 125,000	$ 100,000
Unamortized debt discount and debt issuance costs	(3,193)	(3,626)
Total	$ 121,807	$ 96,374

Amount of unamortized debt discount (premium) and debt issuance costs.

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

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Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

9 Months Ended

Sep. 30, 2026

Commitments and Contingencies

9. Commitments and Contingencies

Contingencies

From time to time, the Company may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business.

On July 24, 2023, Aera A/S, an IP consultancy firm in Denmark representing an unidentified opponent, filed a notice of opposition with the European Patent Office (the “EPO”) in respect of EP 3678649 (the “EP ‘649 Patent”), which is a patent directed to a nasal spray formulation of epinephrine, and uses thereof. Following oral proceedings on October 7, 2025, the EPO Opposition Division upheld the validity of all claims of the EP ‘649 Patent. The opponent appealed the decision of the Opposition Division, and the Company filed its response to the grounds of appeal on July 3, 2026. Oral proceedings before the Board of Appeal are scheduled for July 1, 2027. The Company intends to continue to vigorously defend the EP ’649 Patent, although the Board of Appeal may reverse the decision of the Opposition Division in whole or in part.

On March 25, 2025, AptarGroup, Inc. (“AptarGroup”) and Aptar France SAS (collectively, “Aptar”) filed a suit against ARS Pharmaceuticals, Inc. and ARS Pharmaceuticals Operations, Inc. in the United States District Court for the Southern District of New York. Aptar alleges the Company violated the Defend Trade Secrets Act (18 USC § 1836), misappropriated trade secrets under New York state law, and committed various breaches of contract. The complaint was served to the Company, and the Company filed a motion to dismiss on June 12, 2025. Aptar subsequently filed an opposition to the motion to dismiss on July 28, 2025, and the Company filed a reply brief on August 27, 2025. On March 30, 2026, the Court granted in part and denied in part the motion to dismiss, dismissing the trade secret misappropriation claim under New York state law and allowing the other claims to proceed. On April 29, 2026, Aptar filed a motion for leave to file an amended complaint to replead the previously dismissed claim, which the Company opposed. The Court granted the motion for leave to file an amended complaint on June 17, 2026, and the Company filed its answer to the amended complaint on July 6, 2026. Aptar moved to further amend the complaint on October 14, 2026, seeking to add Silgan Dispensing Systems Corp. as an additional defendant. The Company intends to vigorously defend itself in this matter. On September 29, 2025, the Company filed a lawsuit against AptarGroup in the U.S. District Court for the Southern District of California, alleging that AptarGroup violated federal antitrust law in connection with its sale of certain constituent parts of neffy. On December 16, 2025, Aptar moved to dismiss or in the alternative transfer ARS’s lawsuit to the Southern District of New York. On January 27, 2026, ARS filed an opposition to Aptar’s motion to dismiss, and Aptar filed a reply brief on February 27, 2026. On July 17, 2026, the Court declined to address Aptar’s motion to dismiss arguments and instead transferred the Company’s lawsuit to the Southern District of New York. On August 7, 2026, Aptar again moved to dismiss the complaint. The Company filed an opposition on August 21, 2026, and Aptar filed a reply brief on August 28, 2026. The Company intends to diligently pursue this claim and seek all available relief.

On August 29, 2025, the Company filed a lawsuit against Lupin, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Lupin prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Lupin on August 13, 2025, advising the Company that Lupin submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 2 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above.

On February 26, 2026, the Company filed a lawsuit against Lupin, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Lupin prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Lupin on February 6, 2026, advising the Company that Lupin submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 1 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above. On October 1, 2026, the Company and Lupin entered into a stipulation whereby Lupin, while maintaining its challenges to validity, agreed that its proposed generic 1mg and 2mg epinephrine nasal spray products meet all of the limitations of the asserted claims of U.S. Patents Nos. 10,682,414, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838.

On April 10, 2026, the Company filed a lawsuit against Cipla Ltd. and Cipla USA, Inc. (collectively, “Cipla”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Cipla prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Cipla on March 25, 2026, advising the Company that Cipla submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 1 mg and 2 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above.

On July 10, 2026, Jonico, Inc. d/b/a Berlin Pharmacy filed a putative class action lawsuit against the Company, and its wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., in the U.S. District Court for the Western District of Pennsylvania, Civil Action No. 3:26-cv-01339. The complaint alleges that the Company sent, or caused to be sent, facsimile advertisements promoting neffy to pharmacies, without the prior express invitation or permission of the recipients and without the requisite opt-out notices, in violation of the Telephone Consumer Protection Act, 47 U.S.C. § 227 (the “TCPA”). The TCPA provides for statutory damages of $500 per violation, which may be trebled up to $1,500 per violation for willful or knowing violations; the complaint also seeks injunctive relief. On September 28, 2026, the Company moved to dismiss the complaint for failure to state a claim, arguing that the alleged facsimile does not qualify as an “advertisement” under the TCPA. On October 19, 2026, before the Company’s motion to dismiss was fully briefed and decided, the plaintiff filed an amended complaint (the “First Amended Complaint”). The First Amended Complaint asserts the same TCPA claim as the original complaint. The Company disputes these allegations and intends to vigorously defend itself.

On August 5, 2026, a purported stockholder of the Company filed a securities class action complaint in the U.S. District Court for the Southern District of California against the Company and certain of its current and former officers. The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the Company’s expected timeline for expanded insurance coverage for neffy. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. The Company intends to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable or estimable.

Regardless of the outcome, involvement in legal proceedings may have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. The Company cannot predict the outcome of these suits, and failure by the Company to obtain favorable resolutions could have a material adverse effect on its business, results of operations, and financial condition. The Company’s chances of success on the merits of these suits are still uncertain and any possible loss or range of loss cannot be reasonably estimated and as such the Company has not recorded a liability as of September 30, 2026.

Except as described above, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or other body pending or, to the knowledge of the Company’s executive officers, threatened against or affecting the Company, the Company’s common stock, any of its subsidiaries or its subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

Unconditional Purchase Obligations and Commitments

Unconditional purchase obligations and commitments are defined as agreements to purchase goods or services that are enforceable and legally binding (non-cancelable, or cancelable only in certain circumstances). In the normal course of business, the Company enters into arrangements with suppliers, manufacturers, and various other companies that supply goods or services. These arrangements can include unconditional purchase obligations and commitments.

The total remaining unconditional purchase obligations related to the supply of raw materials is $55.6 million as of September 30, 2026. Purchase obligations by year are as follows: 2026 ($9.4 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035. During the three and nine months ended September 30, 2026, the Company made zero and $1.6 million in payments under these agreements, respectively. During the three and nine months ended September 30, 2025, the Company made $0.7 million and $8.0 million in payments under these agreements, respectively.

Subsequent to period end, the Company entered into an amendment to certain arrangements related to the supply of raw materials, reducing the remaining unconditional purchase obligations by $23.9 million.

The total amount of commitments related to the ALK Co-Promotion Agreement is $18.2 million as of September 30, 2026. Commitments by year are as follows: 2026 ($4.4 million), 2027 ($10.7 million), 2028 ($1.8 million), and 2029 ($1.3 million). No payments were made under this agreement during the three and nine months ended September 30, 2026 and 2025.

The amounts above do not represent the entire anticipated expenditure in the future but represent only those items for which the Company is contractually obligated. For this reason, these amounts do not provide an indication of the Company’s expected future cash outflows related to purchases and commitments.

Intangible Assets - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025
Intangible Asset, Finite-Lived [Line Items]
Amortization expense	$ 0.3	$ 0.2	$ 0.8	$ 0.5
Weighted-average amortization period			12 years 3 months 18 days

Amount of amortization expense for finite-lived intangible asset. Excludes goodwill and capitalized cost for software to be sold, leased, or marketed.

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Related-Party Transactions - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025	Sep. 29, 2025
OrbiMed
Related Party Transaction [Line Items]
Royalty expense payable	$ 1.7	$ 2.0	$ 4.8	$ 3.4
RA Capital Management, L.P [Member]
Related Party Transaction [Line Items]
Equity method investment, ownership percentage					10.00%
Pacific-Link Consulting, LLC
Related Party Transaction [Line Items]
Consulting expenses	$ 0.6	$ 0.6	$ 2.0	$ 1.9

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

Common Stock and Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares	Sep. 30, 2026	Dec. 31, 2025
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	32,306,298	27,599,226
Common Stock Options Granted and Outstanding [Member]
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	19,817,214	16,744,639
Common Stock Reserved For Future Awards or Option Grants [Member]
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	9,118,580	8,085,186
Common Stock Reserved For Future Employee Stock Purchase Plan Issuances [Member]
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	3,325,048	2,722,563
Warrants To Purchase Common Stock [Member]
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	45,456	45,456
Restricted Stock Units Granted and Outstanding [Member]
Class of Stock [Line Items]
Common stock reserved for future awards or option grants	0	1,382

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Stock-Based Compensation - Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model (Detail)	9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected volatility, Minimum	81.50%	84.10%
Expected volatility, Maximum	85.20%	87.30%
Risk-free interest rate, Minimum	3.70%	3.90%
Risk-free interest rate, Maximum	4.60%	4.40%
Expected dividend yield	0.00%	0.00%
Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 6 days	6 years 1 month 6 days
Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	5 years 6 months	5 years 6 months

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In-Licensing and Supply - Additional Information (Detail) - USD ($)
$ in Thousands

1 Months Ended

3 Months Ended

9 Months Ended

Dec. 31, 2018

Sep. 30, 2025

Sep. 30, 2026

Sep. 30, 2025

Sep. 30, 2026

Sep. 30, 2025

Dec. 31, 2025

Sep. 30, 2024

Aug. 31, 2024

Upfront License Fees

$ 12,500

Future development, regulatory and commercial milestone payments

^[1]

15,360

$ 15,360

60,000

Aegis Therapeutics Agreement

Aggregate milestone payments upon achievement of certain sales milestones

Upfront License Fees

$ 50,000

20,000

Milestone payment due

$ 9,000

Milestone payment recognized

$ 2,000

Notice Period Description

$ 2,500

The Company may terminate the Aegis Agreement with 30 days’ written notice or either party may terminate the Aegis Agreement for certain breaches of the Aegis Agreement. Unless terminated earlier by either or both parties, the term of the Aegis Agreement will continue until the final expiration of all royalty obligations under the Aegis Agreement.

Legal Patent Fees

$ 500

$ 0

$ 1,500

$ 0

Aegis Therapeutics Agreement | First Commercial Sale Of Neffy

Aegis Therapeutics Agreement | Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense

$ 5,000

Regulatory milestone

$ 1,500

Renaissance Agreement

Contract Termination Claims, Description

Either party may elect not to renew the U.S. Renewal Term and/or the EU Renewal Term by providing the requisite prior notice to the other party, with the initial terms automatically renewing for successive two-year terms, unless either party gives notice pursuant to the Renaissance Agreement. Either party may terminate the Renaissance Agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before a specified date, (b) the authorization and approval representing more than a certain number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (c) the Company decided in its sole discretion to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws.

[1]	(1) As described in Note 3 – Collaboration, Out-Licensing and Related Agreements and Note 10 – In-Licensing and Supply, capitalized milestone payments were recognized from the Recordati Termination Agreement and Aegis License Agreement, respectively.

Term Loans

9 Months Ended

Sep. 30, 2026

Debt Disclosure [Abstract]

Term Loans

8. Term Loans

On September 29, 2025 (the “Closing Date”), the Company and certain direct and indirect subsidiaries of the Company who may become a party thereto from time to time, as guarantors (the “Guarantors”), and ARS Pharmaceuticals Operations, Inc., as the borrower (the “Borrower” and, collectively with the Guarantors, the “Credit Parties”), entered into a credit agreement (the “Credit Agreement”), which was amended in July 2026, with RA Capital Agency Services, LLC (as the “Administrative Agent” and as the “Collateral Agent”), and affiliates of OMERS Administration Corporation and RA Capital Management, L.P., as lenders, and such other lenders who may become a party thereto from time to time (the “Lenders”), providing for an aggregate principal amount of up to $250.0 million of term loans from the Lenders to the Borrower (the “Term Loans”). The Term Loans will mature on September 29, 2030.

Pursuant to the terms of the Credit Agreement, the Term Loans may be advanced in four tranches. The first tranche (the “Term A Loan”) was funded in the principal amount of $100.0 million on the Closing Date. The second tranche (the “Term B Loan”) was subsequently funded in the principal amount of $25.0 million on September 25, 2026. The third tranche (the “Term C Loan”), in a principal amount of $25.0 million, may be advanced at the Borrower’s election during the period commencing on and including the Closing Date and ending no later than the two-year anniversary of the Closing Date, subject to the Company achieving trailing 12-month (“TTM”) net revenues for neffy of at least $100.0 million and customary conditions. The fourth tranche (the “Term D Loan”) of up to $100.0 million is uncommitted and may be advanced at the Borrower’s election, subject to the consent of all of the Term D Lenders and customary conditions. All outstanding principal is due at maturity on September 29, 2030. The Term Loans require interest-only payments and do not require scheduled principal payments prior to maturity. The Borrower may prepay principal on the Term Loans, in whole or in part, subject to a prepayment premium and an exit fee.

The Company received $100.0 million in gross cash proceeds from the Term A Loan on the Closing Date, less the upfront fees taken in the form of an original issue discount and third-party fees totaling $3.8 million. The Company also received $25.0 million in gross cash proceeds from the Term B Loan on September 25, 2026, less third-party fees totaling less than $0.1 million. The debt discount and the debt issuance costs associated with each of the Term A Loan and Term B Loan are recorded net of the respective loan balance and are amortized to interest expense over the term of each loan using the effective interest rate method.

The Term Loans will initially bear interest at a per annum rate of 5.50% plus the greater of (i) the three-month forward-looking term SOFR or (ii) 3.00%, which interest rate may be reduced by 25 to 50 basis points based on achieving certain TTM net revenue milestones. The Credit Agreement provides for interest-only payments on a quarterly basis until maturity. At Borrower’s election and subject to certain conditions, 100% of accrued interest in the first two years, and 50% of accrued interest in the last three years, may be paid-in-kind, in which case the applicable interest rate for the Term Loans shall increase by 1.00% per annum for the portion of such Term Loans that is paid-in-kind.

The obligations of the Borrower under the Credit Agreement are guaranteed on a full and unconditional basis by the Company and the Guarantors and are secured by substantially all of the respective Credit Parties’ tangible and intangible assets and property, including intellectual property, subject to certain exceptions.

The Credit Agreement contains customary representations and warranties, covenants and events of default, including a requirement for the Borrower to maintain at all times, a minimum specified amount of unrestricted cash in deposit accounts. The Credit Agreement also includes customary events of default, including, among others, payment defaults, material misrepresentations, breaches of covenants following any applicable cure period, cross defaults with certain other indebtedness or material agreements, bankruptcy and insolvency events, judgment defaults, the occurrence of certain events that could reasonably be expected to have a “material adverse effect,” and the occurrence of a change in control (as defined in the Credit Agreement). The occurrence of an event of default could result in the acceleration of the Company’s obligations under the Credit Agreement and the exercise by the Administrative Agent of other rights and remedies provided for under the Credit Agreement.

The Administrative Agent and Collateral Agent, as well as a Lender, are affiliates of RA Capital Management, L.P. (“RA Capital”). Affiliates of RA Capital collectively hold in excess of 10% of the Company’s outstanding common stock and are currently the Company’s largest stockholder. One of the Company’s board members is a controlling person of RA Capital’s general partner. The Lender affiliated with RA Capital holds a portion of Term Loans in the principal amount of $5.0 million.

The following table summarizes the composition of the Term Loans as reflected on the accompanying condensed consolidated balance sheet (in thousands):


	September 30, 2026			December 31, 2025
Gross proceeds	$	125,000		$	100,000
Unamortized debt discount and debt issuance costs		(3,193	)		(3,626	)
Total	$	121,807		$	96,374

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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Stockholders' Equity Note [Abstract]

Cover Page - shares	9 Months Ended
Cover Page - shares	Sep. 30, 2026	Nov. 03, 2026
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Entity Registrant Name	ARS Pharmaceuticals, Inc.
Entity Central Index Key	0001671858
Document Period End Date	Sep. 30, 2026
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2026
Document Fiscal Period Focus	Q3
Document Quarterly Report	true
Document Transition Report	false
Entity Interactive Data Current	Yes
Entity Current Reporting Status	Yes
Title of 12(b) Security	Common Stock
Trading Symbol	SPRY
Security Exchange Name	NASDAQ
Securities Act File Number	001-39756
Entity Tax Identification Number	81-1489190
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	11682 El Camino Real
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	858
Local Phone Number	771-9307
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		100,528,400

Term Loans - Additional Information (Detail) $ in Thousands		9 Months Ended
Term Loans - Additional Information (Detail) $ in Thousands	Sep. 29, 2025 USD ($) Tranche	Sep. 30, 2026 USD ($)	Sep. 30, 2025 USD ($)	Dec. 31, 2025 USD ($)
Debt Instrument [Line Items]
Debt instrument, face amount		$ 125,000		$ 100,000
Proceeds at closing of the credit agreement		24,973	$ 96,989
Debt issue discount and third-party fees		$ 3,193		$ 3,626
Maximum [Member]
Debt Instrument [Line Items]
Basis spread on variable rate	50.00%
Minimum [Member]
Debt Instrument [Line Items]
Basis spread on variable rate	25.00%
RA Capital Management, L.P [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	$ 5,000
Equity method investment, ownership percentage	10.00%
Term Loans [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	$ 250,000
Maturity date	Sep. 29, 2030
Number of tranches \| Tranche	4
Interest rate	3.00%
Accrued interest in the first two years	100.00%
Accrued interest in the last three years	50.00%
Percentage of increase in debt instrument	1.00%
Term Loans [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Interest rate	5.50%
Term Loans [Member] \| Credit Agreement [Member] \| Minimum [Member]
Debt Instrument [Line Items]
(TTM) net revenues	$ 100,000
Term A Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	100,000
Proceeds at closing of the credit agreement	100,000
Debt issue discount and third-party fees	3,800
Term B Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	25,000
Proceeds at closing of the credit agreement	25,000
Term B Loan [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Debt issue discount and third-party fees	100
Term C Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	25,000
Term D Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	$ 100,000

Common Stock and Stockholders' Equity

9 Months Ended

Sep. 30, 2026

Common Stock and Stockholders' Equity

11. Common Stock and Stockholders’ Equity

Authorized Shares

The Company’s current Amended and Restated Certificate of Incorporation authorizes 200,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock Reserved for Future Issuance

Common stock reserved for future issuance consisted of the following:


	September 30, 2026		December 31, 2025
Common stock options granted and outstanding		19,817,214		16,744,639
Common stock reserved for future awards or option grants		9,118,580		8,085,186
Common stock reserved for future employee stock purchase plan issuances		3,325,048		2,722,563
Warrants to purchase common stock		45,456		45,456
Restricted stock units granted and outstanding		—		1,382
Total		32,306,298		27,599,226

Equity Offerings

In January 2025, the Company filed an automatic shelf registration statement on Form S-3ASR with the Securities and Exchange Commission which became effective upon filing (the “Shelf Registration Statement”). The Shelf Registration Statement allows the Company, from time to time, to offer and sell any combination of shares of the Company’s common stock and preferred stock, various series of debt securities, and/or warrants to purchase any of such securities, either individually or in combination with other securities, in one or more offerings. The Company simultaneously entered into a Controlled Equity OfferingSM sales agreement (the “Equity Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to offer, sell and issue shares of the Company’s common stock from time to time through Cantor acting as sales agent and up to a maximum aggregate offering price of $200.0 million. As of September 30, 2026, no securities have been sold pursuant to the Shelf Registration Statement or Equity Sales Agreement.

The entire disclosure for equity.

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 29: http://www.xbrl.org/2003/role/disclosureRef
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Reference 34: http://www.xbrl.org/2003/role/disclosureRef
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
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Commitments and Contingencies - Additional Information (Detail) - USD ($)		3 Months Ended		9 Months Ended
	Jul. 10, 2026	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025	Oct. 01, 2026
Unrecorded Unconditional Purchase Obligation [Line Items]
Litigation expense	$ 500
Litigation trebled up	$ 1,500
ALK Co-Promotion Agreement [Member]
Unrecorded Unconditional Purchase Obligation [Line Items]
Commitments		$ 18,200,000		$ 18,200,000
Commitments, 2026		4,400,000		4,400,000
Commitments, 2027		10,700,000		10,700,000
Commitments, 2028		1,800,000		1,800,000
Commitments, 2029		1,300,000		1,300,000
Purchase obligations amount made		0	$ 0	0	$ 0
Inventories [Member]
Unrecorded Unconditional Purchase Obligation [Line Items]
Unconditional purchase obligations		55,600,000		55,600,000
Unconditional purchase obligations, 2026		9,400,000		9,400,000
Unconditional purchase obligations, 2027		11,800,000		11,800,000
Unconditional purchase obligations, 2028		13,800,000		13,800,000
Thereafter through 2035		2,900,000		2,900,000
Purchase obligations amount made		$ 0	$ 700,000	$ 1,600,000	$ 8,000,000
Inventories [Member] \| Subsequent Event [Member]
Unrecorded Unconditional Purchase Obligation [Line Items]
Unconditional purchase obligations						$ 23,900,000

Summary of Significant Accounting Policies (Polices)

9 Months Ended

Sep. 30, 2026

Basis of Presentation and Principles of Consolidation

Unaudited Interim Condensed Consolidated Financial Statements

Use of Estimates

Fair Value of Financial Instruments

Cash and Cash Equivalents

Investments

Accounts Receivable and Allowance for Credit Losses

Concentrations of Credit Risk

The following table presents customers whose accounts receivable balances represented 10% or more of total accounts receivable as of the dates presented:


	% of Accounts Receivable
	September 30,			December 31,
	2026			2025
Customer A		30	%		18	%
Customer B		30	%		15	%
Customer C		25	%		21	%
Customer D	*				12	%
Customer E	*				16	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

The following table presents customers that accounted for 10% or more of total gross product revenue during the periods presented:


	% of Total Gross Product Revenue
	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025
Customer A		27	%		25	%		25	%		22	%
Customer B		24	%		23	%		25	%		24	%
Customer C		22	%		21	%		20	%		21	%
Customer D	*				14	%	*				13	%

_____________

* Amounts related to respective customer represented less than 10% for the period presented.

Inventories

Property and Equipment

Intangible Assets

Leases

Impairment of Long-Lived Assets

Revenue Recognition

Product revenue, net

Revenue under collaboration and supply agreements

Cost of Goods Sold

Research and Development Costs

Selling, General and Administrative Costs

Advertising

Patent Costs

License Fees

Stock-Based Compensation

Comprehensive Loss

Segment Reporting

Net Loss Per Share

The following securities are excluded from the calculation of weighted-average dilutive common shares because their inclusion would have been anti-dilutive:


	September 30,
	2026		2025
Warrants to purchase common stock		45,456		45,456
Common stock options outstanding		19,817,214		17,106,592
Estimated shares to be purchased under the employee stock purchase plan		70,531		43,255
Restricted stock units outstanding		—		1,382
Total		19,933,201		17,196,685

Recently Issued Accounting Pronouncements - Not Yet Adopted

Recently Issued Accounting Pronouncements — Not Yet Adopted

Inventories - Additional Information (Detail) - USD ($) $ in Millions	Sep. 30, 2026	Dec. 31, 2025
Inventory Disclosure [Abstract]
Zero cost inventory	$ 0.0	$ 6.7

Intangible Assets - Schedule of Estimated Future Amortization Expense (Detail) $ in Thousands	Sep. 30, 2026 USD ($)
Intangible Asset, Goodwill and Other [Abstract]
2026 (remaining three months)	$ 276
2027	1,105
2028	1,105
2029	1,105
2030	1,105
2031 and thereafter	8,928
Total	$ 13,624

Stock-Based Compensation

9 Months Ended

Sep. 30, 2026

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

12. Stock-Based Compensation


	Three Months Ended September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
Research and development expense(1)	$	2,089	$	664	$	3,941	$	1,991
Selling, general and administrative expense(2)		6,033		5,025		23,999		14,367
Total	$	8,122	$	5,689	$	27,940	$	16,358

_____________

Stock-based compensation expense capitalized into inventory for the three and nine months ended September 30, 2026 was $0.4 million and $1.2 million, respectively. For the three and nine months ended September 30, 2025, stock-based compensation expense capitalized into inventory was $0.3 million and $0.8 million, respectively.

As of September 30, 2026, the total unrecognized stock-based compensation expense related to outstanding employee options was $43.3 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.8 years.

As of September 30, 2026 and December 31, 2025, there were zero and 1,382 restricted stock units outstanding, respectively.

Equity Incentive Plans

The Company maintains the 2016, 2018 and 2020 Equity Incentive Plans and the Employee Stock Purchase Plan (“ESPP”). Shares of common stock purchased under the ESPP for the nine months ended September 30, 2026 and 2025 were 97,515 shares and 111,918 shares, respectively.

As of September 30, 2026, 30,701,662 shares were authorized under the 2016 and 2020 Equity Incentive Plans, of which 8,821,235 shares were available for future grant, and 16,380,208 shares were outstanding. As of September 30, 2026, 6,634,333 shares were authorized under the 2018 Equity Incentive Plan, of which 297,345 shares were available for future grant, and 3,437,006 shares were outstanding.

Stock Options

Stock options granted under the Company’s equity incentive plans expire no later than 10 years from the date of grant and generally vest over a one- to four-year period. The Company issues new shares of common stock upon the exercise of stock options.

A summary of the Company’s stock option activity for the nine months ended September 30, 2026 is as follows:


						Weighted-
	Shares			Weighted-		Average		Aggregate
	Subject to			Average		Remaining		Intrinsic
	Options			Exercise		Contractual		Value
	Outstanding			Price		Life (Years)		(in thousands)
Outstanding at December 31, 2025		16,744,639		$	7.66
Granted		6,291,834		$	9.79
Exercised		(858,577	)	$	3.19
Forfeited		(2,360,682	)	$	10.70
Outstanding at September 30, 2026		19,817,214		$	8.17		5.6	$	10,644
Exercisable at September 30, 2026		13,282,346		$	7.54		4.1	$	10,644

The exercisable shares subject to options outstanding at September 30, 2026 in the table above include vested and early exercisable awards. The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the Company’s common stock for all options that were in-the-money at September 30, 2026. The aggregate intrinsic value of options exercised during the nine months ended September 30, 2026 and 2025 was $2.1 million and $8.0 million, respectively.

The weighted-average grant date fair value per share of option grants for the nine months ended September 30, 2026 and 2025 was $7.15 and $8.69, respectively. The total fair value of shares vested during the nine months ended September 30, 2026 and 2025 was $29.5 million and $19.4 million, respectively.

The fair value of stock options granted was estimated using a Black-Scholes option-pricing model (“Black-Scholes”) with the following assumptions:


	Nine Months Ended September 30,
	2026	2025
Expected term (in years)	5.5 – 6.1	5.5 – 6.1
Expected volatility	81.5% – 85.2%	84.1% – 87.3%
Risk-free interest rate	3.7% – 4.6%	3.9% – 4.4%
Expected dividend yield	0%	0%

The fair value of stock options was determined using the Black-Scholes assumptions described below.

Fair Value of Common Stock. The fair market value of the Company’s common stock is based on its closing price as reported on the date of grant on the primary stock exchange on which the Company’s common stock is traded.

Expected Term. The expected term represents the period that the options granted are expected to be outstanding. The expected term of stock options issued is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as the Company has concluded that its stock option exercise history does not provide a reasonable basis upon which to estimate expected term.

Expected Volatility. Given the Company’s limited historical stock price volatility data, the Company derived the expected volatility from the average historical volatilities over a period approximately equal to the expected term of comparable publicly traded companies within its peer group that were deemed to be representative of future stock price trends as the Company has limited trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.

Risk-free Interest Rate. The risk-free interest rate is based on the U.S. Treasury rate, with maturities similar to the expected term of the stock options.

Expected Dividend Yield. The Company has never paid dividends on its common stock and does not anticipate paying any dividends in the foreseeable future. Therefore, the Company uses an expected dividend yield of zero.

Common Stock and Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2026

Stockholders' Equity Note [Abstract]

Summary of Common Shares Reserved for Future Issuance

Common stock reserved for future issuance consisted of the following:


	September 30, 2026		December 31, 2025
Common stock options granted and outstanding		19,817,214		16,744,639
Common stock reserved for future awards or option grants		9,118,580		8,085,186
Common stock reserved for future employee stock purchase plan issuances		3,325,048		2,722,563
Warrants to purchase common stock		45,456		45,456
Restricted stock units granted and outstanding		—		1,382
Total		32,306,298		27,599,226

Inventories

9 Months Ended

Sep. 30, 2026

Inventory Disclosure [Abstract]

Inventories

4. Inventories

Inventories consisted of the following (in thousands):


	September 30, 2026		December 31, 2025
Raw materials	$	26,997	$	26,815
Work in process		918		288
Finished goods		5,516		4,319
Total inventories	$	33,431	$	31,422
Reported as:
Inventories	$	11,711	$	8,369
Inventories, noncurrent		21,720		23,053
Total inventories	$	33,431	$	31,422

Prior to FDA approval in August 2024, costs incurred for the manufacturing of neffy were recorded as research and development expenses, which upon approval resulted in zero-cost inventory. The Company held no zero-cost inventory as of September 30, 2026. The Company held $6.7 million in zero-cost inventory as of December 31, 2025, none of which was determined to be obsolete.

Common Stock and Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	9 Months Ended
	Jan. 31, 2025	Sep. 30, 2026	Dec. 31, 2025
Class of Stock [Line Items]
Common stock, shares authorized		200,000,000	200,000,000
Common stock, par value		$ 0.0001	$ 0.0001
Preferred stock , shares authorized		10,000,000	10,000,000
Preferred stock, par value		$ 0.0001	$ 0.0001
Equity Offerings [Member] \| Equity Sales Agreement [Member]
Class of Stock [Line Items]
Securities sold		0
Equity Offerings [Member] \| Maximum [Member] \| Equity Sales Agreement [Member]
Class of Stock [Line Items]
Maximum aggregate offering price of securities	$ 200.0

Stock-Based Compensation - Summary of Share-based Compensation Expense (Detail) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 30, 2026

Sep. 30, 2025

Sep. 30, 2026

Sep. 30, 2025

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Stock-based compensation expense

$ 8,122

$ 5,689

$ 27,940

$ 16,358

Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Stock-based compensation expense

^[1]

2,089

664

3,941

1,991

Location, Statement of Income, Balance [Axis]: us-gaap:SellingGeneralAndAdministrativeExpense

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]

Stock-based compensation expense

^[2]

$ 6,033

$ 5,025

$ 23,999

$ 14,367

[1]	Stock-based compensation expense for the three and nine months ended September 30, 2026 included $1.7 million related to the accelerated vesting of previously unvested equity awards upon the termination of a former executive officer.
[2]	Stock-based compensation expense for the three and nine months ended September 30, 2026 included $1.5 million and $6.8 million, respectively, related to the accelerated vesting of previously unvested equity awards upon the termination of former executive officers.

Stock-Based Compensation - Summary of Share-based Compensation Expense (Parenthetical) (Detail) - USD ($) $ in Millions	3 Months Ended	9 Months Ended
	Sep. 30, 2026	Sep. 30, 2026
Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense of unvested equity awards	$ 1.7	$ 1.7
Location, Statement of Income, Balance [Axis]: us-gaap:SellingGeneralAndAdministrativeExpense
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense of unvested equity awards	$ 1.5	$ 6.8

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2026	Dec. 31, 2025
Current assets:
Cash and cash equivalents	$ 25,621	$ 41,317
Short-term investments	112,733	203,669
Accounts receivable, net	52,757	25,347
Inventories	11,711	8,369
Prepaid expenses and other current assets	8,206	6,194
Total current assets	211,028	284,896
Inventories, noncurrent	21,720	23,053
Property, plant and equipment, net	1,927	2,465
Intangible assets, net	13,624	14,452
Other assets	3,185	2,786
Total assets	251,484	327,652
Current liabilities:
Accounts payable and accrued liabilities (including related party amounts of $2,436 and $1,624, respectively)	63,793	37,948
Contract liability, current	511	609
Other current liabilities	599	588
Total current liabilities	64,903	39,145
Term loans, net (including related party amounts of $4,842 and $4,819, respectively)	121,807	96,374
Financing liability	75,208	72,140
Contract liability, net of current portion	1,047	1,130
Other accrued liabilities	474	4,605
Total liabilities	263,439	213,394
Commitments and contingencies (Note 9)
Stockholders' (deficit) equity
Preferred Stock, $0.0001 par value per share; 10,000,000 shares authorized at September 30, 2026 and December 31, 2025; no shares issued and outstanding at September 30, 2026 and December 31, 2025	0	0
Common stock, $0.0001 par value per share; 200,000,000 shares authorized at September 30, 2026 and December 31, 2025; 100,248,400 and 99,290,926 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively	10	10
Additional paid-in capital	441,286	408,726
Accumulated other comprehensive (loss) gain, net	(104)	125
Accumulated deficit	(453,147)	(294,603)
Total stockholders' (deficit) equity	(11,955)	114,258
Total liabilities and stockholders' (deficit) equity	$ 251,484	$ 327,652

Stock Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025	Dec. 31, 2025
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock compensation expense capitalized to inventory	$ 0.4	$ 0.3	$ 1.2	$ 0.8
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount	$ 43.3		$ 43.3
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition			2 years 9 months 18 days
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number	19,817,214		19,817,214		16,744,639
Restricted common stock, vesting in equal monthly installments			10 years
Aggregate Intrinsic Value, Exercised			$ 2.1	8.0
Fair Value of Shares Vested			$ 29.5	$ 19.4
Common stock reserved for future awards or option grants	32,306,298		32,306,298		27,599,226
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value			$ 7.15	$ 8.69
Restricted Stock Units [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number	0		0		1,382
Equity Incentive Plan 2016 and 2020 [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	30,701,662		30,701,662
Equity Incentive Plan 2018 [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	6,634,333		6,634,333
Common Stock [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share purchased under employee stock purchase plan			97,515	111,918
Equity Incentive Plans [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Description			The Company maintains the 2016, 2018 and 2020 Equity Incentive Plans and the Employee Stock Purchase Plan (“ESPP”). Shares of common stock purchased under the ESPP for the nine months ended September 30, 2026 and 2025 were 97,515 shares and 111,918 shares, respectively.
Equity Incentive Plans [Member] \| Equity Incentive Plan 2016 and 2020 [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number	16,380,208		16,380,208
Common stock reserved for future awards or option grants	8,821,235		8,821,235
Equity Incentive Plans [Member] \| Equity Incentive Plan 2018 [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number	3,437,006		3,437,006
Common stock reserved for future awards or option grants	297,345		297,345

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025
Revenue:
Total revenue	$ 37,710	$ 32,501	$ 94,049	$ 56,191
Operating expenses:
Cost of goods sold (including related party amounts of $1,711, $2,046, $4,795, and $3,400, respectively)	10,098	8,191	29,230	14,269
Research and development (including related party amounts of $551, $559, $1,830, and $1,804, respectively)	18,263	2,751	27,297	9,738
Selling, general and administrative (including related party amounts of $101, $123, $362, and $354, respectively)	43,520	74,751	193,303	170,167
Total operating expenses	71,881	85,693	249,830	194,174
Loss from operations	(34,171)	(53,192)	(155,781)	(137,983)
Interest income	1,136	2,097	4,709	8,065
Interest expense (including related party amounts of $127, $3, $373, and $3, respectively)	(2,552)	(56)	(7,472)	(56)
Total other (expense) income, net	(1,416)	2,041	(2,763)	8,009
Net loss	(35,587)	(51,151)	(158,544)	(129,974)
Unrealized gains (losses) on available-for-sale securities	36	39	(229)	(227)
Comprehensive loss	$ (35,551)	$ (51,112)	$ (158,773)	$ (130,201)
Net loss per share, Basic	$ (0.36)	$ (0.52)	$ (1.59)	$ (1.32)
Net loss per share, Diluted	$ (0.36)	$ (0.52)	$ (1.59)	$ (1.32)
Weighted-average shares outstanding used in computing net loss per share, basic	99,685,424	98,807,600	99,432,878	98,412,739
Weighted-average shares outstanding used in computing net loss per share, Diluted	99,685,424	98,807,600	99,432,878	98,412,739
Product revenue, net
Revenue:
Total revenue	$ 33,414	$ 31,300	$ 77,076	$ 51,863
Revenue under collaboration agreements
Revenue:
Total revenue	1,661	55	4,207	2,859
Revenue under supply agreements
Revenue:
Total revenue	$ 2,635	$ 1,146	$ 12,766	$ 1,469

Balance Sheet Details

9 Months Ended

Sep. 30, 2026

Balance Sheet Related Disclosures [Abstract]

Balance Sheet Details

7. Balance Sheet Details

Accounts payable and accrued liabilities consisted of the following (in thousands):


	September 30, 2026		December 31, 2025
Accounts payable	$	5,418	$	5,725
Accrued gross-to-net liabilities		25,540		14,162
Accrued marketing related expenses		15,245		6,880
Accrued compensation		7,202		1,276
Accrued cost of goods sold		3,757		3,165
Other		6,631		6,740
Total	$	63,793	$	37,948

Intangible Assets

9 Months Ended

Sep. 30, 2026

Intangible Asset, Goodwill and Other [Abstract]

Intangible Assets

5. Intangible Assets

Intangible assets, net, all of which are finite-lived, consisted of the following (in thousands):


	September 30, 2026			December 31, 2025
Capitalized milestone payments(1)	$	15,360		$	15,360
Less accumulated amortization		(1,736	)		(908	)
Total	$	13,624		$	14,452

______________

(1) As described in Note 3 – Collaboration, Out-Licensing and Related Agreements and Note 10 – In-Licensing and Supply, capitalized milestone payments were recognized from the Recordati Termination Agreement and Aegis License Agreement, respectively.

Amortization expense for the three and nine months ended September 30, 2026 was $0.3 million and $0.8 million, respectively, and was recorded in cost of goods sold in the accompanying condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, amortization expense was $0.2 million and $0.5 million, respectively.

The weighted-average amortization period of intangible assets is 12.3 years. As of September 30, 2026, estimated future amortization expense for capitalized intangible assets is expected to be as follows (in thousands):


Year Ended December 31,	Amount
2026 (remaining three months)	$	276
2027		1,105
2028		1,105
2029		1,105
2030		1,105
2031 and thereafter		8,928
Total	$	13,624

Segment Information

9 Months Ended

Sep. 30, 2026

Segment Reporting [Abstract]

Segment Information

14. Segment Information

The Company reports segment information using the management approach and views its operations and manages its business as a single operating segment. The Company’s Chief Operating Decision Maker (“CODM”), who is the Chief Executive Officer, allocates resources and evaluates the performance of the operating segment based on historical and projected product sales, segment operating expenses, and consolidated net loss, as reflected in the accompanying condensed consolidated statements of operations and comprehensive loss, which is the segment measure of loss.

The segment reports that are provided to the CODM are tracked against the Company’s internally budgeted expenses. The segment operating expense categories consist primarily of the Company’s functional departments: clinical, development, medical affairs, sales and marketing, and general and administrative. The CODM does not review assets when evaluating the operating segment’s performance; therefore, this information is not presented.

Certain prior period segment expenses have been recast to conform to the manner in which our Chief Operating Decision Maker reviews the information during the current period. The recast did not impact the Company’s previously reported consolidated results of operations.

Segment reporting for the three and nine months ended September 30, 2026 and 2025 (in thousands) is as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025
Total revenue	$	37,710		$	32,501		$	94,049		$	56,191
Less segment operating expenses:
Cost of goods sold		10,098			8,191			29,230			14,269
Clinical		1,991			1,457			5,725			3,911
Development		14,306			690			17,918			3,942
Medical affairs		811			1,086			3,363			3,104
Sales and marketing		27,649			63,211			140,072			135,259
General and administrative		8,861			5,002			25,369			16,473
Stock-based compensation		8,122			5,689			27,940			16,358
Other segment operating expenses		43			367			213			858
Other segment (income) expense:
Interest income		(1,136	)		(2,097	)		(4,709	)		(8,065	)
Interest expense		2,552			56			7,472			56
Segment net loss	$	(35,587	)	$	(51,151	)	$	(158,544	)	$	(129,974	)

The following table summarizes revenue by geographic area based on the customers’ location (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
United States	$	33,414	$	31,300	$	77,076	$	51,863
Denmark	*		*			7,786		4,079
Japan	*		*			5,995	*
Rest of world		4,296		1,201		3,192		249
Total revenue	$	37,710	$	32,501	$	94,049	$	56,191

_____________

* Revenue from this country was not individually material for the indicated period and is included within “Rest of world.”

The entire disclosure for segment reporting.

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Segment Information - Schedule of Segment Reporting Provided to the CODM (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025
Revenue:
Total revenue	$ 37,710	$ 32,501	$ 94,049	$ 56,191
Other segment (income) expense:
Interest income	(1,136)	(2,097)	(4,709)	(8,065)
Interest expense	2,552	56	7,472	56
Net loss	(35,587)	(51,151)	(158,544)	(129,974)
Single Reportable Segment [Member]
Revenue:
Total revenue	37,710	32,501	94,049	56,191
Other segment (income) expense:
Interest income	1,136	2,097	4,709	8,065
Interest expense	2,552	56	7,472	56
Net loss	(35,587)	(51,151)	(158,544)	(129,974)
Single Reportable Segment [Member] \| Cost of Goods Sold [Member]
Less segment operating expenses:
Total segment operating expenses	10,098	8,191	29,230	14,269
Single Reportable Segment [Member] \| Clinical [Member]
Less segment operating expenses:
Total segment operating expenses	1,991	1,457	5,725	3,911
Single Reportable Segment [Member] \| Development [Member]
Less segment operating expenses:
Total segment operating expenses	14,306	690	17,918	3,942
Single Reportable Segment [Member] \| Medical Affairs [Member]
Less segment operating expenses:
Total segment operating expenses	811	1,086	3,363	3,104
Single Reportable Segment [Member] \| Sales and Marketing [Member]
Less segment operating expenses:
Total segment operating expenses	27,649	63,211	140,072	135,259
Single Reportable Segment [Member] \| General and Administrative [Member]
Less segment operating expenses:
Total segment operating expenses	8,861	5,002	25,369	16,473
Single Reportable Segment [Member] \| Stock-Based Compensation [Member]
Less segment operating expenses:
Total segment operating expenses	8,122	5,689	27,940	16,358
Single Reportable Segment [Member] \| Other Segment Operating Expenses [Member]
Less segment operating expenses:
Total segment operating expenses	$ 43	$ 367	$ 213	$ 858

Collaboration, Out-Licensing and Related Agreements - Additional Information (Detail) $ in Thousands, € in Millions		1 Months Ended													3 Months Ended			6 Months Ended	9 Months Ended		10 Months Ended	12 Months Ended
	Nov. 09, 2024	Jun. 30, 2025 EUR (€)	Jun. 30, 2025 USD ($)	May 31, 2025 Doctor	Nov. 30, 2024 USD ($)	Jun. 30, 2024 EUR (€)	Jun. 30, 2024 USD ($)	Mar. 31, 2024 USD ($)	Feb. 28, 2023 EUR (€)	Feb. 28, 2023 USD ($)	Mar. 31, 2021 USD ($)	Sep. 30, 2020 EUR (€)	Apr. 30, 2020 USD ($)	Mar. 31, 2020 USD ($)	Sep. 30, 2026 USD ($)	Mar. 31, 2026 USD ($)	Sep. 30, 2025 USD ($)	Jun. 30, 2026 USD ($)	Sep. 30, 2026 USD ($)	Sep. 30, 2025 USD ($)	Dec. 31, 2025 USD ($)	Dec. 31, 2020 USD ($)	Sep. 30, 2026 EUR (€)	Sep. 30, 2026 USD ($)	Dec. 31, 2023 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Other accrued liabilities																					$ 4,605			$ 474
Selling, general and administrative expenses related party amount															$ 43,520		$ 74,751		$ 193,303	$ 170,167
Financing liability																					72,140			75,208
Revenue under collaboration agreements															37,710		32,501		94,049	56,191
Japan [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenue under collaboration agreements																			5,995
EEA License [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Performance obligation, transaction price					$ 69,400
ROW License [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Performance obligation, transaction price					73,100
Development and Regulatory Services [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Performance obligation, transaction price					2,600
Alfresa Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Initial Transaction Price													$ 7,000
Revenue under collaboration agreements															0		0		0	0
Alfresa Agreement [Member] \| License Agreement [Member] \| Japan [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment													$ 2,000	$ 2,000					15,000
License Agreement Expiration Term													10 years
Regulatory milestone payment													$ 5,000
Recordati Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Royalty expense payable															300		100		500	200
Recordati Agreement [Member] \| Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone Payments						€ 2.0	$ 2,100
Recordati Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment																						$ 11,800
Regulatory milestone payment																						$ 6,000
Recordati Agreement [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment									€ 3.0	$ 3,300
Aggregate milestone payments		€ 5.0	$ 5,900
Estimated Life of Finite Lived Intangible Assets		13 years 6 months	13 years 6 months
Revenue recognized under the ALK Collaboration Agreement																					0
Recordati Agreement [Member] \| Termination Agreement [Member] \| Location, Statement of Income, Balance [Axis]: us-gaap:ResearchAndDevelopmentExpense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment \| €												€ 3.0
Recordati Agreement [Member] \| In Process Research and Development [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contract with Customer, Liability																									$ 3,100
Recordati Agreement [Member] \| European Medicines Agency [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone Payments \| €									2.0
Recordati Agreement [Member] \| First commercial sale of Recordati Licensed Product [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone Payments \| €									5.0
Recordati Agreement [Member] \| Aggregate sale of Recordati Licensed Product [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Royalty payments									€ 5.0														€ 4.1	4,700
Pediatrix Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License Agreement Expiration Term											10 years
Initial Transaction Price											$ 3,000
Upfront payment and achievement of regulatory and commercial milestones																								7,000
Revenue under collaboration agreements															0		0		0	0
Pediatrix Agreement [Member] \| License Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales-Based Milestones																			80,000
Seqirus Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License Agreement Expiration Term								15 years
Initial Transaction Price								$ 500
Upfront payment and achievement of regulatory and commercial milestones																								3,900
Commercial milestone payment															1,300				$ 1,300
Revenue under collaboration agreements																	0			0
Seqirus Agreement [Member] \| License Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Regulatory and commercial milestones payments																		$ 1,000
ALK Collaboration Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contract with Customer, Liability																					$ 1,739			1,558
Upfront payment and achievement of regulatory and commercial milestones																								155,000
ALK Collaboration Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment					$ 145,000
License Agreement Expiration Term					15 years														15 years
Regulatory milestone payment																$ 5,000
Regulatory and Commercial Sales Milestones					$ 20,000
Revenue under collaboration agreements																$ 2,500
Purchase Commitment Period	5 years
ALK Collaboration Agreement [Member] \| License Agreement [Member] \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Regulatory milestone payment					10,000														$ 10,000
Sales-Based Milestones					300,000														300,000
ALK Collaboration Agreement [Member] \| EEA License [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Financing liability																								74,200
ALK Collaboration Agreement [Member] \| Development and Regulatory Services [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contract with Customer, Liability																								$ 2,500
Revenue under collaboration agreements															100		100		300	300
ALK Collaboration Agreement [Member] \| First Commercial Sale Of Neffy [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment and achievement of regulatory and commercial milestones					$ 10,000
ALK Co-Promotion Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of pediatricians \| Doctor				10,000
Performance based bonus payments percentage				30.00%
Transaction under agreement with A.L.K U.S				Payments to ALK U.S. for the services performed during the first year of the arrangement will be deferred and paid in the second year of the arrangement. In addition to the base fee, ALK U.S. will be eligible to receive performance-based bonus payments from the Company starting in the second year of the arrangement equal to 30% of the portion of neffy net sales generated from the ALK U.S.-targeted prescribers in excess of a specified initial market share threshold in year two or a 50% market share threshold during years three and four of the arrangement.
Threshold percentage				50.00%
Selling, general and administrative expenses related party amount																	$ 2,400			$ 3,800
Co-promotion agreement expense															$ 1,500				$ 6,800

Nature of Business - Additional Information (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2026	Dec. 31, 2025
Cash and Cash Equivalents [Line Items]
Accumulated deficit	$ 453,147	$ 294,603
Minimum [Member]
Cash and Cash Equivalents [Line Items]
Period for first new delivery method of epinephrine	35 years
Liquidity and Capital Resources [Member]
Cash and Cash Equivalents [Line Items]
Accumulated deficit	$ 453,100
Cash, cash equivalents and short-term investments	$ 138,400

Amount of accumulated undistributed earnings (deficit).

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S45
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480100/505-10-S45-4

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477657/942-210-S45-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478478/942-210-S50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(21))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(30)(a)(3))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(30)(b))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/exampleRef
-Topic 852
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481372/852-10-55-10

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(2)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480016/944-40-65-2

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (h)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480016/944-40-65-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-11

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03(a)(23)(a)(4))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478777/944-210-S99-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-04(17))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479170/946-210-S99-1

Segment Information - Additional Information (Detail)	9 Months Ended
Segment Information - Additional Information (Detail)	Sep. 30, 2026 Segment
Disaggregation of Revenue [Line Items]
Number of operating segments	1
Number of reportable segments	1
Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration]	srt:ChiefExecutiveOfficerMember
Segment Reporting, CODM, Profit (Loss) Measure, How Used, Description	The Company’s Chief Operating Decision Maker (“CODM”), who is the Chief Executive Officer, allocates resources and evaluates the performance of the operating segment based on historical and projected product sales, segment operating expenses, and consolidated net loss, as reflected in the accompanying condensed consolidated statements of operations and comprehensive loss, which is the segment measure of loss.

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Collaboration, Out-Licensing and Related Agreements

9 Months Ended

Sep. 30, 2026

Collaboration, Out-Licensing and Related Agreements

3. Collaboration, Out-Licensing and Related Agreements

Alfresa Agreement

In March 2020, the Company signed a Letter of Intent (“LOI”) with Alfresa Pharma Corporation (“Alfresa”) for the right to negotiate a definitive agreement for the exclusive license and sublicensable right to develop, register, import, manufacture and commercialize neffy in Japan in exchange for an upfront payment of $2.0 million. In April 2020, the Company entered into a collaboration and license agreement (the “Alfresa Agreement”) for the rights pursuant to the LOI. Under the Alfresa Agreement, the Company delivered a license to neffy technology, completed a required clinical study, and remains obligated to use commercially reasonable efforts to develop and commercialize neffy in Japan. The parties agreed to share the cost of any additional clinical studies required for approval of neffy in Japan. Alfresa is solely responsible for regulatory and commercialization activities and may elect to assume responsibility for manufacturing and supplying drug product for commercial use in Japan. Either party may terminate the agreement for certain breaches of the Alfresa Agreement. Unless terminated earlier by either or both parties, the term of the agreement will continue until the later of (i) expiration of the last-to-expire patent in Japan; or (ii) 10 years after the first commercial sale of neffy in Japan.

In December 2025, in connection with the Alfresa Agreement, the Company also entered into a commercial supply agreement (the “Alfresa Supply Agreement”) with Alfresa, under which ARS will supply Alfresa’s requirements (and Alfresa will purchase from ARS its requirements) for a transfer price in the low-double-digit percentage on net sales of neffy in Japan. The Alfresa Supply Agreement is coterminous with the Alfresa Agreement. Either the Company or Alfresa may terminate the Alfresa Supply Agreement in the event of an uncured material breach of the other party. Pursuant to the Alfresa Agreement, at any time, Alfresa may elect to manufacture its own supply of drug product. In the event Alfresa elects to do so, Alfresa is obligated to pay the Company a royalty payment on the net sales of drug product in the Alfresa Territory in an amount equal to monetary value the Company would receive by supplying drug product to Alfresa at the transfer price. The promises under the Alfresa Supply Agreement did not meet the definition of a performance obligation nor did these promises convey a material right to Alfresa.

At inception of the Alfresa Agreement, the Company identified the following performance obligations: (i) the license for neffy; and (ii) research and development services, both of which have been satisfied. The initial transaction price was $7.0 million, which included the upfront payment of $2.0 million and a regulatory milestone of $5.0 million that was deemed not probable of significant reversal at the inception of the Alfresa Agreement. Variable consideration related to future milestone payments was fully constrained at inception and excluded from the transaction price until a significant revenue reversal is no longer probable. The transaction price was allocated to performance obligations based on their estimated stand-alone selling prices.

As of September 30, 2026, the Company has earned an aggregate of $15.0 million for the upfront payment and achievement of regulatory and commercial milestones, and there are no remaining regulatory or commercial milestone payments under the Alfresa Agreement. The Company is also entitled to receive a transfer price in the low double-digit percentage on future net sales of neffy in Japan.

No revenue under collaboration agreements was recognized under the Alfresa Agreement for the three and nine months ended September 30, 2026 and 2025.

Recordati Agreement

In September 2020, the Company entered into a License and Supply Agreement (the “Recordati Agreement”) with Recordati Ireland, Ltd. (“Recordati”) for the exclusive license and sublicensable right to develop, import, manufacture or have manufactured commercial product, file and hold regulatory approvals and commercialize neffy in Europe and certain European Free Trade Association, Russia/the Commonwealth of Independent States, Middle East and African countries (the “Recordati Territory”). Under the Recordati Agreement, the Company received an upfront payment of $11.8 million and a regulatory milestone payment of $6.0 million in 2020.

In February 2023, the Company and Recordati entered into a termination agreement (the “Recordati Termination Agreement”), pursuant to which, among other things, the Company and Recordati agreed to terminate the Recordati Agreement. Pursuant to the Recordati Termination Agreement, the Company reacquired all of the Recordati Rights, paid Recordati a one-time upfront payment of €3.0 million ($3.3 million in U.S. dollars), and agreed to pay additional payments upon achievement of certain milestones including: (i) a European Medicines Agency (“EMA”) regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of neffy in the Recordati Territory, and (iii) royalty payments of up to €5.0 million in the aggregate from sales of neffy in the Recordati Territory (collectively, the “Recordati Rights”). As of September 30, 2026, potential royalty payments of up to €4.1 million (approximately $4.7 million in U.S. dollars) remain.

The Company determined that the Recordati Rights at the time of entering into the Recordati Termination Agreement had no alternative future use and therefore recorded the €3.0 million upfront payment to Recordati as an in-process research and development (“IPR&D”) expense presented within research and development expense. The Recordati Termination Agreement ended the Company’s performance obligations pursuant to the Recordati Agreement and consequently the existing contract liability of $3.1 million previously received from Recordati was recorded against IPR&D expense presented within research and development expense in the consolidated statements of operations for the year ended December 31, 2023. Accordingly, no revenue has been recognized subsequent to the Recordati Termination Agreement.

In June 2024, the EMA regulatory milestone was met and a €2.0 million ($2.1 million in U.S. dollars) expense was recorded in research and development expense in the consolidated statements of operations and comprehensive loss during the year ended December 31, 2024. In June 2025, the first commercial sale milestone was met for the first commercial sale of neffy in the Recordati Territory. As a result, the Company capitalized the €5.0 million ($5.9 million in U.S. dollars) milestone for the first commercial sale of neffy in the Recordati Territory to intangible assets in the accompanying condensed consolidated balance sheets. The intangible assets will be amortized through cost of goods sold in the accompanying condensed consolidated statements of operations and comprehensive loss on a straight-line basis over the estimated life of the intellectual property of 13.5 years.

Royalty expense from the sale of neffy in the Recordati Territory for the three and nine months ended September 30, 2026 was $0.3 million and $0.5 million, respectively, and was recorded in cost of goods sold in the accompanying condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, royalty expense was $0.1 million and $0.2 million, respectively.

Pediatrix Agreement

In March 2021, the Company entered into a collaboration and distribution agreement (the “Pediatrix Agreement”) with Pediatrix Therapeutics, Inc. (“Pediatrix”) for the exclusive license and sublicensable right to develop, import, manufacture or have manufactured commercial product, file and hold regulatory approvals and commercialize neffy in the People’s Republic of China, Taiwan, Macau, and Hong Kong (the “Pediatrix Territory”). Under the Pediatrix Agreement, Pediatrix is responsible, at its sole cost and expense, for all ongoing development work that is necessary for or otherwise supports regulatory approval in the Pediatrix Territory, including all clinical trials, and activities related to post-approval commitments and commercialization tests. In addition, Pediatrix is responsible for commercialization activities and may elect to assume responsibility for manufacturing and supplying drug product for commercial use. The Company is responsible for the manufacturing of product for clinical studies as well as commercial supply, all at a negotiated transfer price. Either party may terminate the Pediatrix Agreement for certain breaches of the agreement. Unless terminated earlier by either or both parties, the term of the agreement will continue until the later of (i) expiration of the last-to-expire patent in the Pediatrix Territory, (ii) the expiration of all regulatory exclusivities that cover neffy in the Pediatrix Territory, or (iii) 10 years after the first commercial sale of neffy in the Pediatrix Territory.

In January 2026, in connection with the Pediatrix Agreement, the Company also entered into a commercial supply agreement (the “Pediatrix Supply Agreement”) with Pediatrix, under which ARS will supply Pediatrix’s requirements (and Pediatrix will purchase from ARS its requirements) for a specified price. The Pediatrix Supply Agreement is coterminous with the Pediatrix Agreement. Either the Company or Pediatrix may terminate the Pediatrix Supply Agreement in the event of an uncured material breach of the other party. The promises under the Pediatrix Supply Agreement do not meet the definition of a performance obligation, nor did these promises convey a material right to Pediatrix.

At inception of the Pediatrix Agreement, the Company identified the performance obligations as the delivery of the license for neffy in the Pediatrix Territory, which has been satisfied. The initial transaction price was $3.0 million, which includes the upfront payment received at the inception of the Pediatrix Agreement. Variable consideration related to future milestone payments was fully constrained at inception and excluded from the transaction price until a significant revenue reversal is no longer probable. The transaction price was wholly allocated to the performance obligation, and variable consideration is reassessed each reporting period.

As of September 30, 2026, the Company has earned an aggregate of $7.0 million for the upfront payment and achievement of regulatory and commercial milestones and is eligible to receive up to $80.0 million in sales-based milestone payments. There are no regulatory or commercial milestones remaining under the Pediatrix Agreement. Since receiving regulatory approval in the Pediatrix Territory, the Company is also entitled to tiered royalties in the low double-digits on future net sales in the Pediatrix Territory and will receive a per unit supply price for commercial supply sold to Pediatrix under the Pediatrix Supply Agreement.

No revenue under collaboration agreements was recognized under the Pediatrix Agreement for the three and nine months ended September 30, 2026 and 2025.

Seqirus Agreement

In March 2024, the Company entered into a license and distribution agreement (the “Seqirus Agreement”) with Seqirus Pty Ltd. (“Seqirus”), which was amended in December 2025, for the exclusive license to commercialize neffy in Australia and New Zealand (the “Seqirus Territory”). Under the Seqirus Agreement, the Company is responsible for the transfer of know-how, which includes regulatory materials, regulatory data, and commercialization data, and also for the manufacturing of product for commercial supply which is available to Seqirus at a negotiated price. Seqirus is solely responsible for all regulatory and commercialization activities in the Seqirus Territory. Either party may terminate the Seqirus Agreement for certain breaches. Unless terminated earlier by either or both parties, the initial term of the Seqirus Agreement is 15 years from the first commercial sale of neffy in the Seqirus Territory. The Seqirus Agreement will automatically renew for two-year periods unless either party gives a notice to terminate at least 12 months prior to the end of the initial or any renewal term.

At inception of the Seqirus Agreement, the Company identified a single performance obligation: the delivery of the license for neffy in the Seqirus Territory in combination with the transfer of know-how, which has been satisfied. The license and know-how were considered distinct from potential supply obligations, which are effectively options for Seqirus to purchase commercial supply and do not represent a material right. The initial transaction price was $0.5 million, which includes the upfront payment received at the inception of the Seqirus Agreement. Variable consideration related to future milestone payments was fully constrained at inception and excluded from the transaction price until a significant revenue reversal is no longer probable. The transaction price was wholly allocated to the performance obligation, and variable consideration is reassessed each reporting period.

As of September 30, 2026, the Company has earned an aggregate of $3.9 million for the upfront payment and achievement of regulatory and commercial milestones and is eligible to receive up to $1.0 million in remaining regulatory and commercial milestones. Since receiving approval in the Seqirus Territory, the Company is also entitled to receive a per unit supply price for commercial supply sold to Seqirus.

During the three and nine months ended September 30, 2026, the Company earned a commercial milestone payment of $1.3 million, which was recorded to collaboration revenue. No revenue under collaboration agreements was recognized under the Seqirus Agreement for the three and nine months ended September 30, 2025.

ALK Collaboration Agreement

In November 2024, the Company entered into a collaboration, license and distribution agreement (the “ALK Collaboration Agreement”) with ALK-Abelló A/S (“ALK”). Pursuant to the ALK Collaboration Agreement, the Company granted to ALK a worldwide (other than the United States, Japan, mainland China, Hong Kong, Taiwan, Macau, Australia and New Zealand) (“ALK Territory”), exclusive license under certain of the Company’s patents and know-how to develop, manufacture and commercialize products containing epinephrine administered intranasally, including EURneffy (the trade name for neffy in the European Union) (epinephrine nasal spray) (“Products”), for all human uses, including the immediate or emergency treatment of allergic reactions (including Type I) and anaphylaxis and urticaria, and other future indications as agreed by the parties. If the Company develops any new intranasally administered product that contains epinephrine and files a new drug application in the United States for such product (“New Product”), upon ALK’s request such New Product will be included as a Product under the ALK Collaboration Agreement, subject to ALK bearing the costs of development of such New Product for its licensed territory.

Under the ALK Collaboration Agreement, the Company is obligated to transfer to ALK the existing marketing authorizations for the Products in the ALK Territory. The Company is also required to conduct certain development and regulatory activities for Products in support of obtaining further regulatory approval of Products in the ALK Territory, and will transfer such regulatory approvals to ALK. ALK is obligated to use commercially reasonable efforts to obtain and maintain regulatory approval for Products through the European Commission and within specified countries within the ALK Territory. Following such approval for a Product in each indication within specified countries within the ALK Territory, ALK is obligated to use commercially reasonable efforts to commercialize such Product in such indication in such countries and to achieve the first commercial sale of a Product in certain countries in accordance with a timeline specified in the ALK Collaboration Agreement.

Under the ALK Collaboration Agreement, ALK made a $145.0 million upfront payment to the Company, and the Company earned $10.0 million for the achievement of regulatory and commercial milestones. The Company is eligible to receive remaining regulatory milestone payment of $10.0 million and sales-based milestone payments of up to $300.0 million. The Company is entitled to receive tiered royalty payments on net sales in the mid- to high-teens, subject to certain standard reductions and offsets. Royalties will be payable, on a Product-by-Product and country-by-country basis, until the latest of the expiration of the licensed patents covering such Product in such country, 15 years from first commercial sale of such Product in such country, or expiration of regulatory exclusivity for such Product in such country.

The contract will expire upon the expiration of the last to expire royalty term for all Products in the ALK Territory, unless terminated earlier. Either the Company or ALK may terminate the ALK Collaboration Agreement in the case of the other party’s insolvency or in the event of an uncured material breach of the other party, except that the Company may not terminate the ALK Collaboration Agreement for ALK’s material breach of its commercial diligence obligations. ALK may terminate the ALK Collaboration Agreement for convenience upon 12 months’ prior written notice or for a safety or regulatory concern. The Company may terminate the ALK Collaboration Agreement in the event ALK makes certain challenges to certain of the Company’s patents. Prior to a change of control and outside of a set period of time after which the Company commences change of control negotiations, the Company may terminate the ALK Collaboration Agreement with respect to all countries in the European Economic Area (“EEA”) upon prior written notice to ALK and payment of a termination fee that is the higher of an agreed mid-nine digit amount and the fair market value of the Products business in the EEA at the time of such termination (the “Repurchase Option”). The Company may also terminate the ALK Collaboration Agreement if ALK commercializes a non-injectable epinephrine product or manufactures such a product in the United States.

In connection with the ALK Collaboration Agreement, the Company and ALK also entered into a commercial supply agreement (the “ALK Supply Agreement”) in November 2024, which was amended in March 2026, under which the Company will supply ALK’s requirements (and ALK will purchase from the Company its requirements) of Products for five years for a specified supply price, after which ALK may elect to transition to itself or its contract manufacturer the manufacture and supply of Products. The contract term for the ALK Supply Agreement is coterminous with the ALK Collaboration Agreement. Either the Company or ALK may terminate the ALK Supply Agreement in the event of an uncured material breach of the other party.

Accounting Assessment

The Company concluded that the ALK Collaboration Agreement and the ALK Supply Agreement qualify as a contract with a customer under ASC 606 as one combined arrangement. The Company identified the following performance obligations: (i) exclusive commercialization license in the European Economic Area (the “EEA License”); (ii) exclusive commercialization license in the rest of the ALK Territory (the “ROW License”); and (iii) five separate development and regulatory services performance obligations. The Company also evaluated the (i) promise to add a New Product and new indications to the ALK Collaboration Agreement, and (ii) the promises under the ALK Supply Agreement, and concluded that these promises did not meet the definition of a performance obligation nor did these promises convey a material right to ALK.

The Company determined that the non-refundable upfront payment of $145.0 million is the estimated transaction price at contract inception. The regulatory and commercial milestone payments (totaling $20.0 million) were fully constrained at contract inception due to the uncertainty of whether any of the milestones will be achieved. In making the assessment of the constraint utilizing the most likely amount method, the Company considered the stage of development, and the risks associated with the remaining development required to achieve the milestones, as well as whether the achievement of the milestone is outside the control of the Company or ALK. The Company determined that the regulatory and commercial milestones, sales-based milestones, and royalties will be recognized on the later of when the related sales occur or when control of the associated license has been transferred, as the Company determined that such sales-based consideration relates predominantly to the licenses granted to ALK. The Company reevaluates the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur and will include regulatory milestones in the transaction price if it is probable that a significant revenue reversal will not occur in future periods.

At contract inception, the Company determined the estimated standalone selling prices for each performance obligation in order to allocate the transaction price among the performance obligations. The standalone selling price for the licenses was estimated using the adjusted market assessment approach. Under this method, the Company forecasted future cash flows expected in the ALK Territory, the probability of commercialization success, and a market discount rate. To estimate the standalone selling prices of the development and regulatory services, the Company forecasted its expected costs of satisfying each performance obligation inclusive of an appropriate margin for that service.

The Company allocated the total transaction price to each performance obligation on a relative standalone selling price basis and determined whether revenue should be recognized at a point in time or over time. The Company allocated $69.4 million to the EEA License performance obligation; $73.1 million to the ROW License performance obligation; and $2.6 million to the development and regulatory services performance obligations.

As of September 30, 2026, the Company has earned an aggregate of $155.0 million in milestone payments for the upfront payment and achievement of regulatory and commercial milestones, of which $74.2 million has been allocated to the EEA License and is accounted for as a financing liability. The Company is eligible to receive remaining regulatory milestone payments of up to $10.0 million and sales-based milestone payments of up to $300.0 million as well as tiered royalties on net sales in the mid- to high-teens, subject to customary reductions and offsets. Royalties are payable on a Product-by-Product and country-by-country basis until the latest of: (i) the expiration of the licensed patents covering such Product in such country; (ii) 15 years from the first commercial sale of such Product in such country; or (iii) expiration of regulatory exclusivity for such Product in such country. The Company is also eligible to receive a per unit supply price for commercial supply sold to ALK under the ALK Supply Agreement.

The Company earned the $5.0 million regulatory milestone during the three months ended March 31, 2026, of which $2.5 million was recognized as revenue under collaboration agreements in the accompanying condensed consolidated statements of operations and comprehensive loss. The remaining $2.5 million was allocated to the development and regulatory performance obligations and EEA license and recognized as increases to the contract liability and financing liability, respectively. Revenue recognized for the performance of development and regulatory services under the ALK Collaboration Agreement for the three and nine months ended September 30, 2026 was $0.1 million and $0.3 million, respectively, and was recorded in revenue under collaboration agreements in the accompanying condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, revenue recognized for the performance of development and regulatory services was less than $0.1 million and $0.3 million, respectively.

Contract Liability

The development and regulatory services performance obligations under the ALK Collaboration Agreement each represent a separate performance obligation. The development and regulatory services, which are transferred to the customer over time, were provided to ALK beginning at the inception of the ALK Collaboration Agreement and are expected to continue through 2028. Development and regulatory service performance obligations were initially recorded as contract liabilities, and revenue earned under these performance obligations is recognized as services are performed based on the costs incurred through the end of each reporting period as a percentage of the estimated total costs to be incurred for these performance obligations.

A reconciliation of the contract liability from the ALK Collaboration Agreement is as follows (in thousands):


Balance at December 31, 2025	$	1,739
Regulatory milestone allocated to development and regulatory performance obligations		69
Revenue recognized related to development and regulatory performance obligations		(250	)
Balance at September 30, 2026	$	1,558

Financing Liability

As discussed above, the Company retains a substantive Repurchase Option for the EEA License, which prevents control from transferring to ALK under ASC 606. As a result, the consideration allocated to the EEA License is accounted for as a financing liability because the repurchase price exceeds the original selling price and will remain outstanding until the Repurchase Option lapses or is exercised. Commercial and sales-based milestones allocated to the EEA License are recognized as increases to the financing liability when earned.

A reconciliation of the Financing Liability from the ALK Collaboration Agreement is as follows (in thousands):


Balance at December 31, 2025	$	72,140
Regulatory milestone allocated to the EEA License		2,393
Sales-based royalties earned under the EEA License		675
Balance at September 30, 2026	$	75,208

ALK Co-Promotion Agreement

In May 2025, the Company and ALK-Abelló, Inc. (“ALK U.S.”, an affiliate of ALK) entered into a co-promotion agreement, which was subsequently amended in October 2025 and March 2026, and the parties entered into a related side letter in August 2026 (the “ALK Co-Promotion Agreement”), to co-promote neffy to over 10,000 specified pediatricians and other prescribers in the U.S. Accordingly, the Company granted ALK U.S. a non-exclusive, royalty-free license to use the neffy trademarks and copyrights and the ARS house marks in the U.S. solely in connection with promoting neffy pursuant to the terms of the ALK Co-Promotion Agreement.

Under the ALK Co-Promotion Agreement, ALK U.S. commenced its promotion activities in May 2025 and is obligated to meet specified ramp-up milestones and minimum detail requirements using sales representatives that meet specific qualifications. In addition, during the term of the ALK Co-Promotion Agreement and for 180 days thereafter, ALK U.S. will not market, sell or manufacture any injection product containing epinephrine in the U.S.

The Company is the principal of all sales transactions of neffy in the U.S. and, subject to the terms of the ALK Co-Promotion Agreement, continues to have sole responsibility for all U.S. commercialization activities, including marketing, medical affairs, market access, production, distribution, pharmacovigilance, quality and safety.

The Company will pay ALK U.S. a base fee to compensate ALK U.S. for its promotion activities. Payments to ALK U.S. for the services performed during the first year of the arrangement will be deferred and paid in the second year of the arrangement. In addition to the base fee, ALK U.S. will be eligible to receive performance-based bonus payments from the Company starting in the second year of the arrangement equal to 30% of the portion of neffy net sales generated from the ALK U.S.-targeted prescribers in excess of a specified initial market share threshold in year two or a 50% market share threshold during years three and four of the arrangement.

The ALK Co-Promotion Agreement expires on the fourth anniversary of the commencement of promotion activities thereunder. Either party may terminate the ALK Co-Promotion Agreement in the event of an uncured material breach of the other party or for either party’s change of control. The Company may terminate the ALK Co-Promotion Agreement in the case of ALK U.S.’s insolvency, if ALK U.S. fails to meet specified ramp-up timelines, or if ALK U.S. markets, sells or commercializes any non-injection product containing epinephrine in the U.S. After the first six months, the Company may terminate the ALK Co-Promotion Agreement if minimum detail requirements are not met for a consecutive three-month period. After the first year, the Company may terminate the ALK Co-Promotion Agreement for any reason or no reason for a fee (as described below). After the first year, ALK U.S. may terminate the ALK Co-Promotion Agreement for any reason or no reason, and the Company may terminate the agreement in the event ALK U.S. restructures its sales force.

Upon termination of the ALK Co-Promotion Agreement by the Company for convenience, so long as ALK U.S. has met specified performance thresholds during the term, the Company is obligated to pay ALK U.S. a specified mid-to-low double-digit percentage of the portion of neffy net sales generated from the ALK U.S.-targeted prescribers in excess of a specified mid-quartile market share threshold that increases over time up to 50% for a specified period after termination, which period decreases in duration the later that the termination occurs. Upon termination of the ALK Co-Promotion Agreement by the Company in connection with a change of control of the Company, the Company is obligated to pay ALK U.S. a one-time mid-seven digit to low eight-digit termination fee in an amount that increases the later that the termination occurs.

The Company evaluated the terms of the ALK Co-Promotion Agreement and concluded that it represents a vendor arrangement with ALK U.S. Expense under the ALK Co-Promotion Agreement for the three and nine months ended September 30, 2026 was $1.5 million and $6.8 million, respectively, and was recorded in selling, general and administrative expense in the accompanying condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, selling, general and administrative expense under the ALK Co-Promotion Agreement was $2.4 million and $3.8 million, respectively. The corresponding liability was recorded in accounts payable and accrued liabilities in the accompanying condensed consolidated balance sheet as of September 30, 2026.

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025
Cash flows from operating activities:
Net loss	$ (158,544)	$ (129,974)
Non-cash adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	27,940	16,358
Depreciation and amortization expense	1,228	950
Accretion on investments, net of amortization	(2,070)	(4,520)
Other non-cash items	2,503	2,434
Changes in operating assets and liabilities:
Accounts receivable	(27,363)	(28,382)
Inventories	(2,564)	(12,269)
Prepaid expenses and other assets	(2,599)	372
Accounts payable and accrued liabilities	22,064	27,945
Contract liability	(181)	(295)
Net cash and cash equivalents used in operating activities	(139,586)	(127,381)
Cash flows from investing activities:
Purchases of short-term investments, available-for-sale	(67,681)	(193,147)
Proceeds from maturities and sales of short-term investments, available-for-sale	160,458	232,000
Payments of milestone obligations under license agreements	0	(5,860)
Purchases of property and equipment	0	(339)
Net cash and cash equivalents provided by investing activities	92,777	32,654
Cash flows from financing activities:
Proceeds from term loan, net of issuance costs	24,973	96,989
Proceeds from milestone obligations met and royalties earned under license agreements recognized as an increase to the financing liability	2,735	2,577
Proceeds from exercise of common stock options and issuance of common stock under the employee stock purchase plan	3,405	3,901
Net cash and cash equivalents provided by financing activities	31,113	103,467
Net (decrease) increase in cash and cash equivalents	(15,696)	8,740
Cash and cash equivalents at beginning of period	41,317	50,817
Cash and cash equivalents at end of period	25,621	59,557
Supplemental cash flow information:
Cash paid for interest	7,011	0
Non-cash investing and financing activities:
Intangible assets included in accounts payable and accrued liabilities	$ 0	$ 2,000

Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Other Comprehensive Gain (Loss), Net [Member]	Accumulated Deficit [Member]
Beginning balance at Dec. 31, 2024	$ 256,798	$ 10	$ 379,873	$ 220	$ (123,305)
Beginning balance, shares at Dec. 31, 2024		97,954,172
Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units	725		725
Exercise of common stock options and release of restricted stock units		175,632
Stock-based compensation	5,539		5,539
Net loss and comprehensive loss	(34,088)			(148)	(33,940)
Ending balance at Mar. 31, 2025	228,974	$ 10	386,137	72	(157,245)
Ending balance, shares at Mar. 31, 2025		98,129,804
Beginning balance at Dec. 31, 2024	256,798	$ 10	379,873	220	(123,305)
Beginning balance, shares at Dec. 31, 2024		97,954,172
Net loss and comprehensive loss	(130,201)
Ending balance at Sep. 30, 2025	147,655	$ 10	400,931	(7)	(253,279)
Ending balance, shares at Sep. 30, 2025		98,844,178
Beginning balance at Mar. 31, 2025	228,974	$ 10	386,137	72	(157,245)
Beginning balance, shares at Mar. 31, 2025		98,129,804
Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units	2,697		2,697
Exercise of common stock options and shares issued under the employee stock purchase plan, Shares		567,854
Stock-based compensation	5,651		5,651
Net loss and comprehensive loss	(45,001)			(118)	(44,883)
Ending balance at Jun. 30, 2025	192,321	$ 10	394,485	(46)	(202,128)
Ending balance, shares at Jun. 30, 2025		98,697,658
Exercise of common stock options, Shares		146,520
Exercise of common stock options, Value	479		479
Stock-based compensation	5,967		5,967
Net loss and comprehensive loss	(51,112)			39	(51,151)
Ending balance at Sep. 30, 2025	147,655	$ 10	400,931	(7)	(253,279)
Ending balance, shares at Sep. 30, 2025		98,844,178
Beginning balance at Dec. 31, 2025	$ 114,258	$ 10	408,726	125	(294,603)
Beginning balance, shares at Dec. 31, 2025	99,290,926	99,290,926
Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units	$ 62		62
Exercise of common stock options and release of restricted stock units		9,211
Stock-based compensation	7,827		7,827
Net loss and comprehensive loss	(60,839)			(221)	(60,618)
Ending balance at Mar. 31, 2026	61,308	$ 10	416,615	(96)	(355,221)
Ending balance, shares at Mar. 31, 2026		99,300,137
Beginning balance at Dec. 31, 2025	$ 114,258	$ 10	408,726	125	(294,603)
Beginning balance, shares at Dec. 31, 2025	99,290,926	99,290,926
Exercise of common stock options, Shares	858,577
Net loss and comprehensive loss	$ (158,773)
Ending balance at Sep. 30, 2026	$ (11,955)	$ 10	441,286	(104)	(453,147)
Ending balance, shares at Sep. 30, 2026	100,248,400	100,248,400
Beginning balance at Mar. 31, 2026	$ 61,308	$ 10	416,615	(96)	(355,221)
Beginning balance, shares at Mar. 31, 2026		99,300,137
Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units	786		786
Exercise of common stock options and shares issued under the employee stock purchase plan, Shares		137,728
Stock-based compensation	12,801		12,801
Net loss and comprehensive loss	(62,383)			(44)	(62,339)
Ending balance at Jun. 30, 2026	12,512	$ 10	430,202	(140)	(417,560)
Ending balance, shares at Jun. 30, 2026		99,437,865
Exercise of common stock options, Shares		810,535
Exercise of common stock options, Value	2,557		2,557
Stock-based compensation	8,527		8,527
Net loss and comprehensive loss	(35,551)			36	(35,587)
Ending balance at Sep. 30, 2026	$ (11,955)	$ 10	$ 441,286	$ (104)	$ (453,147)
Ending balance, shares at Sep. 30, 2026	100,248,400	100,248,400

Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation.

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Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.

Number of share options (or share units) exercised during the current period.

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Value, after forfeiture, of shares issued under share-based payment arrangement. Excludes employee stock ownership plan (ESOP).

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Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2026	Dec. 31, 2025
Accounts payable and accrued liabilities	$ 63,793	$ 37,948
Term loan, related party amount	$ 4,842	$ 4,819
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock , shares authorized	10,000,000	10,000,000
Preferred stock, shares, issued	0	0
Preferred stock, shares, outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares, issued	100,248,400	99,290,926
Common stock, shares, outstanding	100,248,400	99,290,926
Related Party [Member]
Accounts payable and accrued liabilities	$ 2,436	$ 1,624

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2026

Fair Value Disclosures [Abstract]

The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands):


					Gross		Gross			Estimated
			Amortized		Unrealized		Unrealized			Fair
	Level		Cost		Gains		Losses			Value
September 30, 2026
Cash and cash equivalents - Money market mutual funds		1	$	25,321	$	—	$	—		$	25,321
Short-term investments - U.S. Treasury securities		2		112,837		—		(104	)		112,733
Total			$	138,158	$	—	$	(104	)	$	138,054
December 31, 2025
Cash and cash equivalents - Money market mutual funds		1	$	41,030	$	—	$	—		$	41,030
Short-term investments - U.S. Treasury securities		2		203,544		134		(9	)		203,669
Total			$	244,574	$	134	$	(9	)	$	244,699

Inventories (Tables)

9 Months Ended

Sep. 30, 2026

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventories consisted of the following (in thousands):


	September 30, 2026		December 31, 2025
Raw materials	$	26,997	$	26,815
Work in process		918		288
Finished goods		5,516		4,319
Total inventories	$	33,431	$	31,422
Reported as:
Inventories	$	11,711	$	8,369
Inventories, noncurrent		21,720		23,053
Total inventories	$	33,431	$	31,422

In-Licensing and Supply

9 Months Ended

Sep. 30, 2026

In-LicensingAndSupply [Abstract]

In-Licensing and Supply

10. In-Licensing and Supply

License Agreement with Aegis

In June 2018, the Company entered into a license agreement (the “Aegis Agreement”) with Aegis Therapeutics, LLC (“Aegis”). Under the Aegis Agreement, the Company licensed the exclusive, worldwide, royalty-bearing, sublicensable, rights to certain proprietary Aegis technology, patent rights and know-how to develop and commercialize epinephrine products. The Company utilizes this technology in its sole commercial product, neffy. As consideration for the license, the Company paid an upfront license fee of $50,000, which was recorded in research and development expenses in the consolidated statements of operations for the year ended December 31, 2018.

The Company is required to make aggregate milestone payments of up to $20.0 million upon achievement of certain regulatory and commercial milestones. Regulatory milestone payments under the Aegis Agreement are recorded upon completion of the required events, as the triggering events are not considered to be probable until they are achieved. Prior to the FDA approval of neffy in August 2024, the Company made regulatory milestone payments totaling $1.5 million to Aegis, which were recorded as research and development expenses in the consolidated statements of operations.

Since the FDA approval of neffy in August 2024, regulatory and commercial milestone payments have been capitalized as intangible assets in the consolidated balance sheets upon achievement. Amortization expense for capitalized milestone payments has been recognized as cost of goods sold in the accompanying condensed consolidated statements of operations and comprehensive loss on a straight-line basis over the estimated life of the intellectual property. In August and September 2024, milestone payments of $2.5 million and $5.0 million were recognized for achieving FDA approval of neffy and the first commercial sale of neffy, respectively. In September 2025, a milestone payment of $2.0 million was recognized for achieving certain annual net product sales of neffy. As of September 30, 2026, the Company’s remaining milestone payment obligation is $9.0 million upon the achievement of certain annual net sales.

The Company also pays royalties based on a mid-single-digit percentage of net product sales on its or its sublicensees’ net sales of the Licensed Products (as defined in the Aegis Agreement) on a product-by-product basis. Royalties are recorded to cost of goods sold in the period the related product revenue is recognized.

In November 2024, OrbiMed Advisors LLC (“OrbiMed”) entered into an agreement with Aegis, to purchase the rights, royalty interests, and related sales milestone payments on net product sales of neffy. The Company will make all future payments under the Aegis Agreement to an affiliate of OrbiMed. As described in Note 13 – Related Party Transactions, a member of the Company’s Board of Directors is a General Partner at OrbiMed.

The Company and Aegis jointly bear certain patent costs incurred in connection with the prosecution and maintenance of patent rights specific to epinephrine and epinephrine products. Legal patent expense under the Aegis Agreement was $0.5 million and $1.5 million for the three and nine months ended September 30, 2026, respectively. No legal patent expense was incurred under the Aegis Agreement for the three and nine months ended September 30, 2025.

In conjunction with the Aegis Agreement, the Company also entered into a supply agreement (the “Aegis Supply Agreement”) with Aegis that allows the Company to purchase materials for preclinical, development and commercial use at predetermined prices. The Company may elect to have Aegis supply minimum quantities but there are no minimum or maximum purchase obligations under the Aegis Supply Agreement unless this election is made. The parties may terminate the Aegis Supply Agreement at any time by mutual agreement. In addition, the parties may terminate the Aegis Supply Agreement in the event of certain breaches of the Aegis Supply Agreement or upon the earlier of the expiration or termination of the Aegis Agreement or June 2028. The Aegis Supply Agreement term may be extended by mutual written agreement.

Manufacturing Agreement with Renaissance

In September 2020, the Company entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023, September 2024, and July 2025 (the “Renaissance Agreement”). Pursuant to the Renaissance Agreement, Renaissance agreed to manufacture for, and provide to the Company, neffy nasal unit dose sprays (“Renaissance Products”). The Company is obligated to provide Renaissance with certain supplies to manufacture the Renaissance Products and to purchase from Renaissance a mid-double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the EU, and a high double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the U.S. The Renaissance Agreement contains conventional commercial pharmaceutical manufacturing provisions including certain minimum purchase amounts to be determined in the future based on forecast needs and minimum batch size projections. The Company may also request Renaissance to perform certain services related to the Renaissance Product, for which the Company will pay reasonable compensation to Renaissance.

Pursuant to the amendment in September 2024, the amended initial term of the Renaissance Agreement commenced on September 17, 2024, and will terminate on (a) December 31, 2029 for Renaissance Product designated for commercial sale in the U.S. (“U.S. Initial Term”), and (b) December 31, 2030 for Renaissance Product designated for commercial sale in the EU (“EU Initial Term”), in each case unless earlier terminated by one of the parties. The U.S. Initial Term and EU Initial Term automatically renew for successive two-year terms (“Renewal Term”). Either party may elect not to renew the U.S. Renewal Term and/or the EU Renewal Term by providing the requisite prior notice to the other party, with the initial terms automatically renewing for successive two-year terms, unless either party gives notice pursuant to the Renaissance Agreement. Either party may terminate the Renaissance Agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before a specified date, (b) the authorization and approval representing more than a certain number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (c) the Company decided in its sole discretion to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws.

License Agreement

On July 1, 2026, the Company entered into a license agreement (the “License Agreement”) with a strategic partner, pursuant to which the Company received exclusive worldwide rights to certain intellectual property related to epinephrine products. The Company paid an upfront license fee of $12.5 million, which was recognized as research and development expense in each of the three and nine months ended September 30, 2026. The License Agreement also includes future development, regulatory and commercial milestone payments of up to $60.0 million in the aggregate, as well as sales-based royalty payments on products incorporating the licensed intellectual property.

Intangible Assets (Tables)

9 Months Ended

Sep. 30, 2026

Intangible Asset, Goodwill and Other [Abstract]

Schedule of Finite-Lived Intangible Assets

Intangible assets, net, all of which are finite-lived, consisted of the following (in thousands):


	September 30, 2026			December 31, 2025
Capitalized milestone payments(1)	$	15,360		$	15,360
Less accumulated amortization		(1,736	)		(908	)
Total	$	13,624		$	14,452

______________

Schedule of Estimated Future Amortization Expense

As of September 30, 2026, estimated future amortization expense for capitalized intangible assets is expected to be as follows (in thousands):


Year Ended December 31,	Amount
2026 (remaining three months)	$	276
2027		1,105
2028		1,105
2029		1,105
2030		1,105
2031 and thereafter		8,928
Total	$	13,624

Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2026	Sep. 30, 2025	Sep. 30, 2026	Sep. 30, 2025
Research and development expenses related party amount	$ 18,263	$ 2,751	$ 27,297	$ 9,738
Selling, general and administrative expenses related party amount	43,520	74,751	193,303	170,167
Interest expense related party amount	2,552	56	7,472	56
Other income (expense), net	(1,416)	2,041	(2,763)	8,009
Related Party [Member]
Cost of goods sold expenses related party amount	1,711	2,046	4,795	3,400
Research and development expenses related party amount	551	559	1,830	1,804
Selling, general and administrative expenses related party amount	101	123	362	354
Interest expense related party amount	$ 127	$ 3	$ 373	$ 3

The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.

The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc.

Schedule of Segment Reporting Provided to the CODM

Segment Information (Tables)

9 Months Ended

Sep. 30, 2026

Segment Reporting [Abstract]

Segment reporting for the three and nine months ended September 30, 2026 and 2025 (in thousands) is as follows:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025
Total revenue	$	37,710		$	32,501		$	94,049		$	56,191
Less segment operating expenses:
Cost of goods sold		10,098			8,191			29,230			14,269
Clinical		1,991			1,457			5,725			3,911
Development		14,306			690			17,918			3,942
Medical affairs		811			1,086			3,363			3,104
Sales and marketing		27,649			63,211			140,072			135,259
General and administrative		8,861			5,002			25,369			16,473
Stock-based compensation		8,122			5,689			27,940			16,358
Other segment operating expenses		43			367			213			858
Other segment (income) expense:
Interest income		(1,136	)		(2,097	)		(4,709	)		(8,065	)
Interest expense		2,552			56			7,472			56
Segment net loss	$	(35,587	)	$	(51,151	)	$	(158,544	)	$	(129,974	)

Schedule of Revenue by Geographic Area Based on Customers Location

The following table summarizes revenue by geographic area based on the customers’ location (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
United States	$	33,414	$	31,300	$	77,076	$	51,863
Denmark	*		*			7,786		4,079
Japan	*		*			5,995	*
Rest of world		4,296		1,201		3,192		249
Total revenue	$	37,710	$	32,501	$	94,049	$	56,191

_____________

* Revenue from this country was not individually material for the indicated period and is included within “Rest of world.”

Tabular disclosure of segment reporting. Includes, but is not limited to, reconciliation of reportable segment amount to corresponding consolidated total.

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/1943274/2147482810/280-10-50-31

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 6: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 7: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 9: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 10: http://www.xbrl.org/2009/role/commonPracticeRef
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Related-Party Transactions

Stock-Based Compensation - Summary of Activity Related to Stock Option (Detail) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2026
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Subject to Options Outstanding, Beginning balance	16,744,639
Shares Subject to Options Outstanding, Granted	6,291,834
Shares Subject to Options Outstanding, Exercised	(858,577)
Shares Subject to Options Outstanding, Forfeited	(2,360,682)
Shares Subject to Options Outstanding, Ending balance	19,817,214
Shares Subject to Options Exercisable, Ending Balance	13,282,346
Weighted- Average Exercise Price, Beginning balance	$ 7.66
Weighted- Average Exercise Price, Granted	9.79
Weighted- Average Exercise Price, Exercised	3.19
Weighted Average Exercise Price, Forfeited	10.7
Weighted- Average Exercise Price, Ending balance	8.17
Weighted- Average Exercise Price Exercisable , Ending balance	$ 7.54
Weighted- Average Remaining Contractual Life (Years)	5 years 7 months 6 days
Weighted- Average Remaining Contractual Life (Years), Exercisable	4 years 1 month 6 days
Aggregate Intrinsic Value, Ending balance	$ 10,644
Aggregate Intrinsic Value, Exercisable Ending balance	$ 10,644

Related-Party Transactions

9 Months Ended

Sep. 30, 2026

13. Related Party Transactions

In September 2015, the Company entered into a consulting agreement, superseded in July 2022, for regulatory and development services with Pacific-Link Regulatory Consulting, Inc., an entity owned by the Company’s former President/Chief Executive Officer/director and his spouse, the former Chief Medical Officer of the Company. Consulting expense under this agreement for the three and nine months ended September 30, 2026 was $0.6 million and $2.0 million, respectively. For the three and nine months ended September 30, 2025, consulting expense under this agreement was $0.6 million and $1.9 million, respectively.

As described in Note 8 – Term Loans, in September 2025, the Company entered into the Credit Agreement with the Administrative Agent and a Lender, who are affiliates of RA Capital. The general partner of RA Capital is RA Capital Management GP, LLC, of which a member of the Board of Directors of the Company is a controlling person. RA Capital Healthcare Fund, L.P. and RA Capital Nexus Fund II, L.P. collectively hold in excess of 10% of the Company’s outstanding common stock and are currently the Company’s largest stockholder. RA Capital serves as the investment adviser for each of RA Capital Healthcare Fund, L.P. and RA Capital Nexus Fund II, L.P.

As described in Note 10 – In-Licensing and Supply, OrbiMed acquired from the Aegis, the rights to certain royalty interests and milestones related to neffy under the Aegis agreement. As a result, certain milestone and royalty payments due under the Aegis Agreement are payable to an affiliate of OrbiMed. A member of the Company’s Board of Directors is a General Partner at OrbiMed. Royalty expense payable to an affiliate of OrbiMed for the three and nine months ended September 30, 2026 was $1.7 million and $4.8 million, respectively, and was recorded in cost of goods sold in the accompanying condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, royalty expense was $2.0 million and $3.4 million, respectively.

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.