0000950170-23-021997 | 10-Q | XBRL Viewer

Summary of Common Shares Reserved for Future Issuance

Common stock reserved for future issuance consisted of the following:


	March 31, 2023		December 31, 2022
Common stock options granted and outstanding		15,584,419		12,063,560
Restricted stock units granted and outstanding		7,107		10,651
Common stock reserved for future awards or option grants		4,048,939		3,373,801
Total		19,640,465		15,448,012

Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
Research and development expenses related party amount	$ 591	$ 540
General and administrative expenses related party amount	$ 337	$ 165

Commitments and Contingencies - Additional Information (Detail)		1 Months Ended		3 Months Ended
	Nov. 07, 2022 USD ($)	Nov. 30, 2022 $ / shares shares	Sep. 30, 2019 USD ($) $ / shares shares	Mar. 31, 2023 USD ($) $ / shares	Mar. 31, 2022 USD ($)	Dec. 31, 2022 $ / shares	Oct. 31, 2021 ft²
Loss Contingencies [Line Items]
Estimated fair value of the warrants adjusted				$ 0	$ (1,000)
Common stock, value per share \| $ / shares				$ 0.0001		$ 0.0001
Noncancelable lease agreement description				In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease, and the Company is subject to additional charges for common area maintenance and other costs.
Option to Extend				there is no option to extend the lease
Operating Lease Weighted Average Discount Rate				8.00%
Operating Lease Weighted Average Remaining Lease Term				23 months
Silicon Valley Bank [Member] \| Note Payable [Member]
Loss Contingencies [Line Items]
Debt issuance costs			$ 47,000,000
Warrants converted to warrants to purchase \| shares		45,456
Common stock, value per share \| $ / shares		$ 2.20
Repayments of debt including principal and interest	$ 5,400,000
Silicon Valley Bank [Member] \| Note Payable [Member] \| Warrant [Member]
Loss Contingencies [Line Items]
Estimated fair value of the warrants adjusted			$ 86,000,000
Silicon Valley Bank [Member] \| Note Payable [Member] \| Series C Convertible Preferred Stock [Member] \| Warrant [Member]
Loss Contingencies [Line Items]
Class of warrant, warrants to purchase \| shares			38,460
Warrants exercise price \| $ / shares			$ 2.60
Silicon Valley Bank [Member] \| Loan and Security Agreement [Member] \| Note Payable [Member]
Loss Contingencies [Line Items]
Debt instrument aggregate principal amount			$ 10,000,000.0
Final balloon payment at maturity			$ 300,000
San Diego California [Member]
Loss Contingencies [Line Items]
Leased properties, square feet \| ft²							4,047
Noncancelable lease term of contract							38 months
Operating lease expense				$ 100,000	100,000
Cash paid for amounts included in measurement of lease liabilities				$ 100,000	$ 100,000

Summary of Significant Accounting Policies (Polices)

3 Months Ended

Mar. 31, 2023

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 (expense) in the condensed consolidated statements of operations and comprehensive loss. All adjustments considered necessary for a fair presentation have been included.

Since ARS Pharma was determined to be the accounting acquirer in connection with the Merger, for periods prior to the Merger the condensed consolidated financial statements were prepared on a stand-alone basis for ARS Pharma and did not include the combined entities activity or financial position. For periods subsequent to the Merger, the condensed consolidated financial statements include Silverback’s activity and Silverback’s assets and liabilities at their acquisition date fair value. Historical share and per share figures of ARS Pharma have been retroactively restated based on the exchange ratio in the Merger of 1.1819.

Unaudited Interim Condensed Consolidated Financial Statements

The accompanying condensed consolidated balance sheet as of March 31, 2023, the condensed consolidated statements of operations and comprehensive loss and condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three months ended March 31, 2023 and 2022, and the condensed consolidated statements of cash flows for the three months ended March 31, 2023 and 2022, are unaudited. The balance sheet as of December 31, 2022 was derived from the audited financial statements as of and for the year ended December 31, 2022. 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, 2022, 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 March 31, 2023, the condensed consolidated results of its operations for the three months ended March 31, 2023 and 2022, and its cash flows for the three months ended March 31, 2023 and 2022. The financial data and other information disclosed in these notes related to the three months ended March 31, 2023 and 2022 are also unaudited. The condensed consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year ending December 31, 2023 or any other period.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements requires it 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 relate to revenue recognized for its collaboration agreements, accruals for research and development expenses and valuation of equity awards. 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.

Cash and Cash Equivalents

Cash and cash equivalents include cash readily available in checking and money market mutual funds. 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 intermediate-term fixed income securities. These investments are included in short-term investments on the balance sheets, classified as available-for-sale, and reported at fair value with unrealized gains and losses included in accumulated other comprehensive loss. Realized gains and losses on the sale of these securities are recognized in net loss.

Fair Value of Financial Instruments

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

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.

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.

Impairment of Long-Lived Assets

Long-lived assets consist primarily of property and equipment. 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. 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 March 31, 2023.

Leases

Effective January 1, 2021, the Company early adopted ASC No. 2016-02, Leases (Topic 842) (“ASC 842”), which supersedes the current accounting for leases, using the modified retrospective transition method. The Company has elected to apply the practical expedients allowed by the standard for existing leases. The new standard, while retaining two distinct types of leases, finance and operating, (i) requires lessees to record a right-of-use (“ROU”) asset and a related liability for the rights and obligations associated with a lease, regardless of lease classification, and recognize lease expense in a manner similar to current accounting, (ii) eliminates current real estate specific lease provisions, (iii) modifies the lease classification criteria and (iv) aligns many of the underlying lessor model principles with those in the new revenue standard. The Company determines the initial classification and measurement of its 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, with the present value determined by using the incremental borrowing rate for operating leases determined by using 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 as well as a review of 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 condensed consolidated statements of operations and comprehensive loss.

Revenue Recognition

Our revenues generally consist of licenses and research services under license and collaboration agreements. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Research and Development Costs

Research and development 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 our clinical studies, costs related to compliance with regulatory requirements, costs related to manufacturing the Company’s product candidates 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.

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 on existing agreements are charged to research and development expense or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use.

Acquired in-process research and development expense

Acquired in-process research and development expense (“IPR&D”), is expensed on the acquisition date if there is no alternative future use. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration becomes payable. Milestone payments made to third parties subsequent to regulatory approval will be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product.

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.

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 gain/loss 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 Common 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, convertible preferred stock, stock options, and preferred stock warrants 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. Historical share figures have been retroactively restated based on the exchange ratio of 1.1819.


	Three Months Ended March 31,
	2023		2022
Convertible preferred stock		—		26,473,899
Warrants to purchase convertible preferred stock		—		45,456
Warrants to purchase common stock		45,456		—
Common stock options granted and outstanding		15,584,419		5,375,291
Total		15,629,875		31,894,646

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which changes the accounting for recognizing impairments of financial assets. Under the new guidance, credit losses for certain types of financial instruments will be estimated based on expected losses. The new guidance also modifies the impairment models for available-for-sale debt securities and for purchased financial assets with credit deterioration since their origination. This standard was effective for the Company beginning January 1, 2023. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements.

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2023

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


	Three Months Ended March 31,
	2023		2022
Convertible preferred stock		—		26,473,899
Warrants to purchase convertible preferred stock		—		45,456
Warrants to purchase common stock		45,456		—
Common stock options granted and outstanding		15,584,419		5,375,291
Total		15,629,875		31,894,646

Net Loss Per Share Attributable to Common Stockholders (Tables)

3 Months Ended

Mar. 31, 2023

Earnings Per Share [Abstract]

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


	Three Months Ended March 31,
	2023		2022
Convertible preferred stock		—		26,473,899
Warrants to purchase convertible preferred stock		—		45,456
Warrants to purchase common stock		45,456		—
Common stock options granted and outstanding		15,584,419		5,375,291
Total		15,629,875		31,894,646

Merger and Related Transactions - Additional Information (Detail) - ARS Pharma [Member] $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Business Acquisition [Line Items]
Prepaid expense and other assets	$ 4,400
Accrued liabilities and other liabilities	12,000
Acquired in-process research and development	1,100
Cash, cash Equivalents, and short-term investments	262,300
Business combination, Intangible assets recognized	0
Business combination, Goodwill recognized	0
Additional Paid-in Capital [Member]
Business Acquisition [Line Items]
Business Combination Acquisition Related Costs	$ 2,100

Summary of Significant Accounting Policies - Summary of Antidilutive Securities Excluded from Computation of Earnings Per Share Amount (Detail) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	15,629,875	31,894,646
Convertible Preferred Stock [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	0	26,473,899
Warrants To Purchase Convertible Preferred Stock [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	0	45,456
Warrants To Purchase Common Stock [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	45,456	0
Common Stock [Member]
Earnings Per Share Basic Line Items
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	15,584,419	5,375,291

Collaboration and Out-Licensing (Table)

3 Months Ended

Mar. 31, 2023

Collaborative Arrangement [Abstract]

Schedule Of Reconciliation Of Contract Liability From Collaboration Agreements

A reconciliation of contract liability from collaboration agreements was as follows (in thousands):


Balance at December 31, 2022	$	3,137
IPR&D expense related to the Termination Agreement		(3,107	)
Revenue recognized		(20	)
Balance at March 31, 2023	$	10

In-Licensing and Supply - Additional Information (Detail) - USD ($)	1 Months Ended	3 Months Ended			12 Months Ended
	Jun. 30, 2018	Mar. 31, 2023	Sep. 30, 2022	Mar. 31, 2022	Dec. 31, 2019
Aegis Therapeutics Agreement
Defined Benefit Plan Disclosure [Line Items]
Upfront License Fees	$ 50,000,000
Aggregate milestone payments upon achievement of certain sales milestones		$ 20,000,000.0
Notice Period Description		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		$ 0		$ 0
Supply Agreement Expense		$ 100,000		0
Aegis Therapeutics Agreement \| New Drug Application
Defined Benefit Plan Disclosure [Line Items]
Aggregate Milestone Payments			$ 1,000,000.0		$ 500,000
Renaissance Agreement
Defined Benefit Plan Disclosure [Line Items]
Contract Termination Claims, Description		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 Company has not submitted a regulatory filing for any Renaissance Product in the U.S. on or before June 30, 2022, (b) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before the target U.S. launch date, (c) the authorization and approval representing more than a targeted number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (d) 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 Expense Recognized		$ 900,000		$ 400,000

Stock-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2023

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 condensed consolidated statements of operations and comprehensive loss as follows (in thousands):


	Three Months Ended March 31,
	2023		2022
Research and development expense	$	608	$	54
General and administrative expense		1,642		210
Total stock-based compensation expense	$	2,250	$	264

Summary of Activity Related to Stock Option Grants

A summary of the Company’s stock option activity for the three months ended March 31, 2023 is as follows:


	Shares Subject to Options Outstanding			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (Years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2022		12,063,560		$	6.07
Granted		4,099,600		$	8.26
Exercised		(502,687	)	$	2.62
Forfeited		(76,054	)	$	21.32
Outstanding at March 31, 2023		15,584,419		$	6.69		6.67	$	39,388,194
Exercisable at March 31, 2023		11,470,122		$	6.12		5.56	$	39,361,532

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 weighted-average assumptions:


	Three Months Ended March 31,
	2023			2022
Expected term (in years)		6.1			6.1
Expected volatility		95.3	%		90.3	%
Risk-free interest rate		3.9	%		1.6	%
Expected dividend yield		—			—

Collaboration and Out-Licensing - Additional Information (Details) $ in Thousands, € in Millions		1 Months Ended						3 Months Ended		12 Months Ended
	Feb. 22, 2023 EUR (€)	Mar. 31, 2021 USD ($)	Nov. 30, 2020 USD ($)	Sep. 30, 2020 EUR (€)	Sep. 30, 2020 USD ($)	Jul. 31, 2020 USD ($)	Mar. 31, 2020 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 EUR (€)	Dec. 31, 2020 USD ($)	Dec. 31, 2022 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contract with Customer, Liability, Revenue Recognized								$ (20)
Contract with Customer, Liability								10					$ 3,137
Alfresa Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment.							$ 2,000
Milestone Payments							13,000
Initial Transaction Price							7,000
Contract with Customer, Liability, Revenue Recognized								100	$ 100
Contract with Customer, Liability								100
Alfresa Agreement [Member] \| License Agreement [Member] \| JAPAN
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment.							$ 2,000
License Agreement Expiration Term							10 years
Milestone Payments						$ 5,000
Recordati Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment.												$ 11,800
Initial Transaction Price					$ 11,800
Regulatory Milestone Payment			$ 6,000									$ 6,000
Regulatory and Commercial Sales Milestones \| €											€ 90.0
Recordati Agreement [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment. \| €	€ 3.0
Contract with Customer, Liability, Revenue Recognized								$ 0	$ 600
Recordati Agreement [Member] \| Research and Development Expense [Member] \| Termination Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment. \| €				€ 3.0
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
Pediatrix Agreement [Member] \| License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront Payment.		$ 3,000
License Agreement Expiration Term		10 years
Initial Transaction Price		$ 3,000
Contract with Customer, Liability, Revenue Recognized										$ 3,000
Regulatory and Commercial Sales Milestones		$ 84,000

Balance Sheet Details - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Balance Sheet Related Disclosures [Abstract]
Prepaid insurance	$ 1,229	$ 1,539
Prepaid expenses	1,050	771
Interest receivable	442	796
Other receivables	80	213
Total	$ 2,801	$ 3,319

Stock-Based Compensation

3 Months Ended

Mar. 31, 2023

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

10. Stock-Based Compensation

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


	Three Months Ended March 31,
	2023		2022
Research and development expense	$	608	$	54
General and administrative expense		1,642		210
Total stock-based compensation expense	$	2,250	$	264

As of March 31, 2023, the total unrecognized stock-based compensation expense was $29.1 million, which is expected to be recognized over a remaining weighted-average period of approximately 3.18 years.

In November 2022, in connection with the Merger, the Company assumed restricted stock units granted by Silverback, of which 10,651 were outstanding as of December 31, 2022 and 7,107 are outstanding as of March 31, 2023.

Equity Incentive Plans

In September 2018, ARS Pharma adopted the 2018 Equity Incentive Plan. As a result of the Merger, on November 8, 2022 ARS Pharma, as the accounting acquirer, is deemed to have assumed Silverback’s 2016 and 2020 Equity Incentive Plans, and Employee Stock Purchase Plan (“ESPP”). For the three months ended March 31, 2023, ESPP activity is not material to the condensed consolidated financial statements.

As of March 31, 2023, the 2016 and 2020 Equity Incentive Plans authorized a total of 16,018,660 shares, of which 3,754,826 shares are available for future grant, and 9,956,626 shares are outstanding. As of March 31, 2023, the 2018 Equity Incentive Plan authorized a total of 6,634,333 shares, of which 294,113 shares are available for future grant, and 5,634,900 shares are outstanding. The Company does not intend to grant future stock options or other equity awards under the 2018 Equity Incentive Plan.

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 four-year period, with vesting either occurring at a rate of 25% at the end of the first year and thereafter in 36 equal monthly installments or on a monthly basis. In the case of awards granted to our non-employee board members, vesting generally occurs on a monthly basis over three years or in full on an annual basis. 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 three months ended March 31, 2023 is as follows:


	Shares Subject to Options Outstanding			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (Years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2022		12,063,560		$	6.07
Granted		4,099,600		$	8.26
Exercised		(502,687	)	$	2.62
Forfeited		(76,054	)	$	21.32
Outstanding at March 31, 2023		15,584,419		$	6.69		6.67	$	39,388,194
Exercisable at March 31, 2023		11,470,122		$	6.12		5.56	$	39,361,532

The exercisable shares subject to options outstanding at March 31, 2023 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 March 31, 2023. The aggregate intrinsic value of options exercised during the three months ended March 31, 2023 was $2.4 million. No options were exercised during the three months ended March 31, 2022.

The weighted-average grant date fair value per share of option grants for the three months ended March 31, 2023 and 2022 was $6.50 and $1.57, respectively. The total fair value of shares vested during the three months ended March 31, 2023 and 2022 was $0.7 million and $0.1 million, respectively.

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


	Three Months Ended March 31,
	2023			2022
Expected term (in years)		6.1			6.1
Expected volatility		95.3	%		90.3	%
Risk-free interest rate		3.9	%		1.6	%
Expected dividend yield		—			—

The fair value of stock options was determined using the Black-Scholes assumptions below. Each of these inputs is subjective and generally requires significant judgement.


			Fair Value of Common Stock. Prior to the Merger on November 8, 2022, grant date fair market value of the shares of common stock underlying stock options was determined by ARS Pharma’s Board of Directors. Prior to the Merger, there was no public market for the ARS Pharma’s common stock, therefore the ARS Pharma Board of Directors determined the fair value of common stock at the time of grant of the option by considering a number of objective and subjective factors including independent third-party valuations of the ARS Pharma common stock, sales of convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock and general and industry specific economic outlook, amongst other factors. Following the Merger, 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.

Related-Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Related Party Transaction [Line Items]
Stock-based compensation expense	$ 2,250	$ 264
Board of directors
Related Party Transaction [Line Items]
Stock options vested	590,950
Stock-based compensation expense	$ 100	100
Pacific-Link Consulting, LLC
Related Party Transaction [Line Items]
Consulting expense	600	500
Marlinspike Group, LLC
Related Party Transaction [Line Items]
Consulting expense	100	100
Red Team Associates, LLC
Related Party Transaction [Line Items]
Consulting expense	$ 200	$ 100

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 87,862	$ 210,518
Short term investments	176,687	63,863
Prepaid expenses and other current assets	2,801	3,319
Total current assets	267,350	277,700
Right-of-use asset	398	445
Fixed assets, net	584	329
Other Assets	2,860	2,961
Total assets	271,192	281,435
Current liabilities:
Accounts payable and accrued liabilities (including related party amounts of $307 and $16, respectively)	9,596	4,931
Lease liability, current	232	230
Contract liability, current	10	283
Total current liabilities	9,838	5,444
Lease liability, net of current portion	199	251
Contract liability, net of current portion	0	2,854
Total liabilities	10,037	8,549
Commitments and contingencies (Note 7)
Stockholders' equity:
Preferred Stock, $0.0001 par value per share; 10,000,000 shares authorized at March 31, 2023 and December 31, 2022; no shares issued and outstanding at March 31, 2023 and December 31, 2022	0	0
Common stock, $0.0001 par value per share; 200,000,000 shares authorized at March 31, 2023 and December 31, 2022; 94,448,028 and 93,943,316 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively	9	9
Additional paid-in capital	352,977	349,408
Accumulated other comprehensive gain	68	407
Accumulated deficit	(91,899)	(76,938)
Total stockholders' equity	261,155	272,886
Total liabilities, convertible preferred stock and stockholders' equity	$ 271,192	$ 281,435

Convertable Preferred Stock and Common Stock and Stockholders'Equity (Deficit) (Tables)

3 Months Ended

Mar. 31, 2023

Summary of Common Shares Reserved for Future Issuance

Common stock reserved for future issuance consisted of the following:


	March 31, 2023		December 31, 2022
Common stock options granted and outstanding		15,584,419		12,063,560
Restricted stock units granted and outstanding		7,107		10,651
Common stock reserved for future awards or option grants		4,048,939		3,373,801
Total		19,640,465		15,448,012

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Accumulated Deficit [Member]	Series A Convertible Preferred Stock [Member]	Series B Convertible Preferred Stock [Member]	Series C Convertible Preferred Stock [Member]	Series D Convertible Preferred Stock [Member]
Temporary equity, Beginning balance at Dec. 31, 2021						$ 365	$ 1,000	$ 19,868	$ 54,806
Temporary equity, Beginning balance, shares at Dec. 31, 2021						4,764,000	606,060	7,692,309	9,337,066
Beginning balance at Dec. 31, 2021	$ (31,269)	$ 3	$ 10,984		$ (42,256)
Beginning balance, shares at Dec. 31, 2021		30,369,413
Stock-based compensation	264		264
Net loss and comprehensive loss	(7,250)				(7,250)
Temporary Equity, Ending balance at Mar. 31, 2022						$ 365	$ 1,000	$ 19,868	$ 54,806
Temporary Equity, Ending balance, shares at Mar. 31, 2022						4,764,000	606,060	7,692,309	9,337,066
Ending balance at Mar. 31, 2022	(38,255)	$ 3	11,248		(49,506)
Ending balance, shares at Mar. 31, 2022		30,369,413
Beginning balance at Dec. 31, 2022	$ 272,886	$ 9	349,408	$ 407	(76,938)
Beginning balance, shares at Dec. 31, 2022	93,943,316	93,943,316
Exercise of common stock options	$ 1,319		1,319
Exercise of common stock options, Shares	502,687	502,687
Restricted stock units released, Shares		2,025
Stock-based compensation	$ 2,250		2,250
Net loss and comprehensive loss	(15,300)			(339)	(14,961)
Ending balance at Mar. 31, 2023	$ 261,155	$ 9	$ 352,977	$ 68	$ (91,899)
Ending balance, shares at Mar. 31, 2023	94,448,028	94,448,028

Amount after tax and reclassification adjustments of other comprehensive income (loss).

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+ References + Details

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2023

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

Unaudited Interim Condensed Consolidated Financial Statements

Use of Estimates

Cash and Cash Equivalents

Investments

Fair Value of Financial Instruments

Concentrations of Credit Risk

Property and Equipment

Impairment of Long-Lived Assets

Leases

Revenue Recognition

Research and Development Costs

Patent Costs

License Fees

Acquired in-process research and development expense

Stock-Based Compensation

Comprehensive Loss

Segment Reporting

Net Loss Per Common Share


	Three Months Ended March 31,
	2023		2022
Convertible preferred stock		—		26,473,899
Warrants to purchase convertible preferred stock		—		45,456
Warrants to purchase common stock		45,456		—
Common stock options granted and outstanding		15,584,419		5,375,291
Total		15,629,875		31,894,646

Recently Adopted Accounting Pronouncements

Net Loss Per Share Attributable to Common Stockholders - Summary of Antidilutive Securities Excluded from Computation of Earnings Per Share Amount (Detail) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive shares	15,629,875	31,894,646

Stock Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions		3 Months Ended
	Sep. 30, 2018	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount		$ 29.1
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition		3 years 2 months 4 days
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number		15,584,419		12,063,560
Restricted common stock, vesting in equal monthly installments		10 years
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage		25.00%
Aggregate Intrinsic Value, Exercised		$ 2.4
Fair Value of Shares Vested		$ 0.7	$ 0.1
Common stock reserved for future awards or option grants		19,640,465		15,448,012
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value		$ 6.50	$ 1.57
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		7,107		10,651
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		16,018,660
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
Equity Incentive Plans [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Description	In September 2018, ARS Pharma adopted the 2018 Equity Incentive Plan. As a result of the Merger, on November 8, 2022 ARS Pharma, as the accounting acquirer, is deemed to have assumed Silverback’s 2016 and 2020 Equity Incentive Plans, and Employee Stock Purchase Plan (“ESPP”). For the three months ended March 31, 2023, ESPP activity is not material to the condensed consolidated financial statements.
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		9,956,626
Common stock reserved for future awards or option grants		3,754,826
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		5,634,900
Common stock reserved for future awards or option grants		294,113

Balance Sheet Details - Schedule of Property and equipment (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Property, Plant and Equipment, Net [Abstract]
Equipment	$ 652	$ 377
Less accumulated depreciation	(68)	(48)
Total	$ 584	$ 329

Cover Page - shares	3 Months Ended
Cover Page - shares	Mar. 31, 2023	May 10, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Entity Registrant Name	ARS Pharmaceuticals, Inc.
Entity Central Index Key	0001671858
Document Period End Date	Mar. 31, 2023
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
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
Entity 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 120
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	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		94,774,232

Convertable Preferred Stock and Common Stock and Stockholders'Equity (Deficit) - Additional Information (Details) - $ / shares	1 Months Ended	3 Months Ended
	Nov. 30, 2022	Mar. 31, 2023	Dec. 31, 2022
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
Common Stock [Member]
Class of Stock [Line Items]
Conversion of preferred stock, common shares issued	26,473,899
Common Stock [Member] \| Silverback [Member]
Class of Stock [Line Items]
Number of shares issued		36,535,541
Preferred Stock [Member]
Class of Stock [Line Items]
Conversion of preferred stock, common shares issued	22,399,435

In-Licensing and Supply

3 Months Ended

Mar. 31, 2023

In-LicensingAndSupply [Abstract]

In-Licensing and Supply

8. 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 for the development of its lead product candidate, 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 condensed consolidated statement of operations.

The Company is required to make aggregate milestone payments of up to $20.0 million upon achievement of certain regulatory and commercial milestones. The regulatory milestone payments under the Aegis Agreement will be recognized as research and development expense upon completion of the required events, as the triggering events are not considered to be probable until they are achieved. The Company made a $0.5 million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019, and a $1.0 million payment to Aegis upon the FDA’s acceptance of the Company’s New Drug Application (“NDA”) submission for neffy, which occurred in the third quarter of 2022. The Company may be required to pay royalties based on annual net product sales in the low to mid-single digits on its or its sublicensees’ net sales of the Licensed Products (as defined in the Aegis Agreement) on a country-by-country and product-by-product basis.

The Company is responsible for reimbursing Aegis for patent costs incurred in connection with prosecuting and maintaining patent rights that are specific to epinephrine or epinephrine products. There were no expenses recognized in connection with legal patent fees for the three months ended March 31, 2023 and 2022.

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.

In conjunction with the Aegis Agreement, the Company also entered into a Supply Agreement (the “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 Supply Agreement unless this election is made. The parties may terminate the Supply Agreement at any time by mutual agreement. In addition, the parties may terminate the Supply Agreement in the event of certain breaches of the Supply Agreement or upon the earlier of the expiration or termination of the Aegis Agreement or June 2028. The Supply Agreement term may be extended by mutual written agreement. Expense recognized under the Supply Agreement was $0.1 million and zero for the three months ended March 31, 2023 and 2022, respectively.

Manufacturing Agreement with Renaissance

In September 2020, the Company entered into a manufacturing agreement (the “Renaissance Agreement”) with Renaissance Lakewood, LLC (“Renaissance”). 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 E.U., 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.

The initial term of the Renaissance Agreement commenced on September 9, 2020 and continues (a) for Renaissance Product designated for commercial sale in the U.S. until the earlier of the fifth anniversary of the (i) target U.S. launch date and (ii) the initial U.S. launch date (“U.S. Initial Term”), and (b) for Renaissance Product designated for commercial sale in the E.U. and other countries, the earlier of the fifth anniversary of (i) the target E.U. launch date and (ii) the initial E.U. launch date (“E.U. Initial Term”), in each case unless earlier terminated by one of the parties. The U.S. Initial Term and E.U. 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 E.U. Renewal Term by providing the requisite prior notice to the other party. 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 Company has not submitted a regulatory filing for any Renaissance Product in the U.S. on or before June 30, 2022, (b) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before the target U.S. launch date, (c) the authorization and approval representing more than a targeted number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (d) 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. Expense recognized under the Renaissance Agreement was $0.9 million and $0.4 million for the three months ended March 31, 2023 and 2022, respectively.

Convertable Preferred Stock and Common Stock and Stockholders'Equity (Deficit) (Deficit)

3 Months Ended

Mar. 31, 2023

Stockholders' Equity (Deficit)

9. Convertible Preferred Stock and Common Stock and Stockholders’ Equity (Deficit)

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.

Convertible Preferred Stock

In November 2022, ARS Pharma completed the Merger with Silverback in accordance with the Merger Agreement. Under the terms of the Merger Agreement, immediately prior to the effective time of the Merger, 22,399,435 shares of ARS Pharma’s convertible preferred stock were converted into 26,473,899 shares of ARS Pharma’s common stock.

Common Stock

In November 2022, upon completion of the Merger and as the accounting acquirer, ARS Pharma is deemed to have issued 36,535,541 shares of its common stock to Silverback stockholders.

Common stock reserved for future issuance consisted of the following:


	March 31, 2023		December 31, 2022
Common stock options granted and outstanding		15,584,419		12,063,560
Restricted stock units granted and outstanding		7,107		10,651
Common stock reserved for future awards or option grants		4,048,939		3,373,801
Total		19,640,465		15,448,012

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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Commitments and Contingencies Disclosure [Abstract]

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Due from Related Parties, Current	$ 307	$ 16
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	94,448,028	93,943,316
Common stock, shares, outstanding	94,448,028	93,943,316

Fair Value Measurements

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

Fair Value Measurements

4. 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, the 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):


March 31, 2023	Level		Amortized Cost		Gross unrealized gains		Gross unrealized losses			Estimated Fair Value
Cash and cash equivalents - Money market mutual funds		1	$	71,867	$	—	$	—		$	71,867
Cash and cash equivalents - U.S. Treasury securities		2		14,966		3		—			14,969
Short-term investments - U.S. Treasury securities		2		176,622		73		(8	)		176,687
Total			$	263,455	$	76	$	(8	)	$	263,523
December 31, 2022
Cash and cash equivalents - Money market mutual funds		1	$	209,273	$	—	$	—		$	209,273
Short-term investments - U.S. Treasury securities		2		63,456		407		—			63,863
Total			$	272,729	$	407	$	—		$	273,136

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 months ended March 31, 2023, the Company purchased $131.4 million in short-term investments.

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 cash and cash equivalents consists of U.S. Treasury securities and money market mutual funds that have remaining maturities when purchased of 90 days or less.

During the three months ended March 31, 2023, the Company recorded $0.1 million in net unrealized holding gains to accumulated other comprehensive gain, and reclassified $0.3 million from accumulated other comprehensive gain to other income. Management determined that the gross unrealized losses on the Company’s available-for-sale securities as of March 31, 2023 were primarily attributable to current economic and market conditions and not credit risk. As of March 31, 2023 and December 31, 2022, no allowance for credit losses was recorded. 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 their amortized cost basis.

As of March 31, 2023 and December 31, 2022, the Company did not have any liabilities that were measured at fair value on a recurring basis.

Commitments and Contingencies

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies

7. Commitments and Contingencies

Note Payable

In September 2019, the Company entered into a Loan and Security Agreement (“Loan Agreement”) with Silicon Valley Bank for working capital in the principal amount, as amended, of $10.0 million (the “Note”). The Note required interest only payments through June 30, 2021 and had a maturity date of March 1, 2024. In addition, there was a final payment (“Balloon Payment”) of $0.3 million at maturity.

In connection with the Note, the lender received warrants to purchase 38,460 shares of Series C convertible preferred stock at $2.60 per share. The warrants were immediately exercisable and will expire on September 30, 2029. The estimated fair value of the warrants at issuance was $86,000, which was recorded as a debt discount. In addition, the Company recorded debt issuance costs totaling $47,000. The debt discount, debt issuance costs and Balloon Payment were amortized to interest expense using the effective interest rate method over the loan term. In November 2022, as a result of the Merger, the warrants converted to warrants to purchase 45,456 shares of the Company’s common stock at $2.20 per share.

On November 7, 2022, the Company paid off the remaining balance of $5.4 million on its loans with Silicon Valley Bank, including all principal and interest and the Balloon Payment. The warrants issued to Silicon Valley Bank in connection with the loans continue to be outstanding.

Leases

In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease, and the Company is subject to additional charges for common area maintenance and other costs. Monthly rental payments due under the lease commenced on December 6, 2021 and escalate through the lease term. The Company prepaid the first month’s rent upon execution of the lease, and the lease agreement provided full rent abatement for the second and third months of the rental term. As of March 31, 2023, the remaining lease term of the Company’s operating lease was 23 months, and the discount rate on the Company’s operating lease was 8%. As there was not an implicit rate within the lease, the discount rate was determined by using a set of peer companies incremental borrowing rates. The Company's operating lease expense was $0.1 million for each of the three months ended March 31, 2023 and 2022. The Company's variable lease expense was immaterial for each of the three months ended March 31, 2023 and 2022. Cash paid for amounts included in the measurement of lease liabilities was $0.1 million and immaterial for the three months ended March 31, 2023 and 2022, respectively.

As of March 31, 2023, future minimum noncancelable operating lease payments are as follows (in thousands):


Year ended December 31,	Amount
2023	$	179
2024		245
2025		42
Total lease payments		466
Less imputed interest		(35	)
Lease liability		431
Less current portion of lease liability		(232	)
Lease liability, net of current portion	$	199

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 August 12, 2021, Amphastar Pharmaceuticals, Inc. (“Amphastar”) filed a Petition for Inter Partes Review (“IPR”) with the United States Patent and Trademark Office (“USPTO”), seeking to invalidate claims 1-20 of United States Patent No. 10,682,414 (the “‘414 patent”). The ‘414 patent issued on June 16, 2020 and is entitled “Intranasal Epinephrine Formulations and Methods for the Treatment of Disease.” The claims of the ‘414 patent are directed to methods of treating a type-1 hypersensitivity reaction, including anaphylaxis, using an aqueous nasal spray pharmaceutical formulation containing epinephrine or a salt thereof, including the Company’s neffy product candidate, in a single dose. On February 9, 2023, the USPTO issued a Final Written Decision finding claims 3-6 and 18-20, which encompass the Company’s neffy product candidate, patentable, and claims 1-2 and 7-17 unpatentable. On April 12, 2023, Amphastar filed a notice of appeal with the United States Court of Appeals for the Federal Circuit. Although the results of any notice of appeal are inherently unpredictable and uncertain, and could result in the Federal Circuit finding some or all of claims 1-20 of the ‘414 patent to be invalid or unenforceable, the Company does not believe that an adverse outcome will have a material adverse effect on its business, operating results, cash flows or financial condition.

On November 5, 2021, a securities class action complaint was filed against Silverback and certain of Silverback’s former officers and directors in the U.S. District for the Western District of Washington, captioned Dresner v. Silverback Therapeutics, Inc., et al., Case No. 2:21-cv-01499 (the “Dresner Case”). The court has appointed lead plaintiff and lead plaintiff's counsel, and plaintiff's counsel then filed the amended complaint on April 11, 2022. The amended complaint alleges that between December 3, 2020 and March 31, 2022, Silverback and certain of its officers and directors violated (1) Sections 11 and 15 of the Securities Act of 1933, as amended (the “Securities Act”); and (2) Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Securities and Exchange Commission (“SEC”) Rule 10b-5 promulgated thereunder, by making allegedly false and misleading statements in various SEC filings and press releases regarding the clinical and commercial prospects of its product candidate, SBT6050, which is now discontinued. The complaint seeks unspecified damages and interest, as well as attorneys’ fees and other costs. Silverback and the other defendants filed a motion to dismiss on May 26, 2022 and lead plaintiff filed an opposition brief on July 11, 2022. On August 10, 2022, Silverback and the other defendants filed a reply brief. The court held a hearing on October 28, 2022 and issued an order granting defendants’ motion to dismiss without prejudice on November 4, 2022. Plaintiffs were given leave to amend and filed a Second Amended Complaint (“SAC”) on December 5, 2022, which asserted Section 11 claims only with respect to Silverback’s December 3, 2020 IPO and Section 10(b) claims during a shorter class period of March 29, 2021 through March 31, 2022. Defendants filed a motion to dismiss the SAC on January 2, 2023. Lead plaintiff filed an opposition brief on January 23, 2023, and defendants filed a reply brief January 27, 2023. On April 12, 2023, the court issued an order granting Defendants’ motion and a judgment dismissing all claims with prejudice. Plaintiffs had 30 days from the date of the order to file a notice of appeal (if any).

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 either 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 March 31, 2023.

Except as described above, the Company is not currently involved in any legal proceeding that it believes could have a materially adverse effect on its financial condition or results of operations. 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.

Commitments and Contingencies - Summary of Future Minimum Noncancelable Operating Lease Payments (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Lessee, Operating Lease, Liability, to be Paid [Abstract]
2023	$ 179
2024	245
2025	42
Total lease payments	466
Less imputed interest	(35)
Lease liability	431
Less current portion of lease liability	(232)	$ (230)
Lease liability, net of current portion	$ 199	$ 251

Stockholders' Equity (Deficit) - Summary of Common Shares Reserved for Future Issuance (Detail) - shares	Mar. 31, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Total	19,640,465	15,448,012

Fair Value Measurements - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Purchase of short-term investments	$ 131,353,000	$ 0
Allowance for credit losses	0		$ 0
Net unrealized holding gains	100,000
U.S. Treasury Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Reclassified from accumulated other comprehensive income	300,000
Short-Term Investments [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Purchase of short-term investments	131,400,000
Fair Value, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, assets transfers from Level 1 to Level 2	0
Fair Value Assets Level 2 To Level 1 Transfers Amount	0
Fair Value Liabilities Level 1 To Level 2 Transfers Amount	0
Fair value, liabilities transfers from Level 2 to Level 1	0
Fair value, assets transfers into (out of) level 3	$ 0

Employee Benefit Plans (Additional Information) (Details) - USD ($) $ in Millions	1 Months Ended	3 Months Ended
	Jun. 30, 2022	Mar. 31, 2023
Retirement Benefits [Abstract]
Defined Contribution Plan, Employer Matching Contribution, Percent of Match	5.00%
Contribution totaled		$ 0.1

Condensed Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
Condensed Statements of Cash Flows - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
Cash flows from operating activities:
Net loss	$ (14,961)	$ (7,250)
Non-cash adjustments to reconcile net loss to net cash provided by (used) in operating activities:
Stock-based compensation	2,250	264
Change in fair value of warrant liability	0	(1)
Depreciation and amortization	20	50
Amortization and accretion of short-term investments, net	(1,809)	0
Changes in operating assets and liabilities:
Prepaid and other assets	445	92
Accounts payable and accrued liabilities (including related party amounts of $291 and $55, respectively)	4,756	546
Operating right-of-use assets and lease liabilities, net	(3)	37
Contract liability	(3,127)	(663)
Net cash used in operating activities	(12,429)	(6,925)
Cash flows from investing activities:
Purchases of short-term investments, available-for-sale	(131,353)	0
Maturities of short-term investments, available-for-sale	20,000	0
Purchase of property and equipment	(193)	(21)
Net cash used in investing activities	(111,546)	(21)
Cash flows from financing activities:
Proceeds from exercise of common stock options	1,319	0
Repayment of bank note payable	0	(908)
Net cash provided by (used in) financing activities	1,319	(908)
Net change in cash and cash equivalents	(122,656)	(7,854)
Cash, cash equivalents, and restricted cash at beginning of period	210,518	60,063
Cash, cash equivalents, and restricted cash at end of period	87,862	52,209
Supplemental disclosure of cash flow information:
Purchases of property and equipment included in accounts payable	91	21
Purchases of property and equipment reclassed from prepaid expenses and other current assets	174	0
Interest paid	$ 0	$ 114

Balance Sheet Details - Schedule of Accounts payable and accrued liabilities (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Accounts Payable and Accrued Liabilities [Abstract]
Accounts payable	$ 2,580	$ 1,659
Accrued legal and professional fees	491	908
Accrued clinical expenses	1,121	609
Accrued compensation	994	447
Accrued tax expenses	187	174
Accrued development expenses	2,328	133
Other	1,895	1,001
Total	$ 9,596	$ 4,931

Collaboration and Out-Licensing

3 Months Ended

Mar. 31, 2023

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Collaboration and Out-Licensing

6. Collaboration and Out-Licensing

The Company has entered into collaboration and licensing agreements to license certain rights to neffy to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; clinical, regulatory, and/or commercial milestone payments; payment for clinical and commercial supply and royalties or a transfer price on the net sales of licensed products.

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, up-front 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 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, up-front 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. 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 transferred to the customer.

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.

Clinical and Commercial Supply. Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company has not earned revenues for clinical or commercial supply sales as of March 31, 2023.

Royalty/Transfer Price Revenues. For arrangements that include sales-based royalties or transfer price, 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). The Company has not received any royalty or transfer price revenues as of March 31, 2023.

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 for the rights pursuant to the LOI. Under the agreement, the Company delivered a license to the neffy technology and is responsible for completion of a certain clinical study and for the manufacturing of development and commercial drug supply. 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 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 commercial sale of neffy in Japan.

In addition to the $2.0 million received under the LOI, the Company is eligible to receive up to $13.0 million of milestone payments upon achievement of certain clinical and regulatory milestones. Further, the Company is eligible to receive a negotiable transfer price expected to be in the low double-digit percentage on net sales subject to the regulatory approval to commercialize neffy in Japan. In July 2020, the Company earned a $5.0 million milestone payment upon the completion of a clinical milestone in Japan.

At the commencement of this collaboration, the Company identified the following performance obligations: the license for neffy and research and development services. The Company determined the initial transaction price to be $7.0 million, which includes a clinical milestone as it was deemed not probable of significant reversal at the inception of the agreement. Due to the uncertainty in the achievement of the regulatory and commercial milestones, the variable consideration associated with these future milestone payments has been fully constrained and is excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. The transaction price was allocated to the performance obligations based on the estimated stand-alone selling price of each performance obligation. The Company recognized less than $0.1 million in revenue for each of the three months ended March 31, 2023 and 2022, and had a contract liability of less than $0.1 million as of March 31, 2023.

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 is responsible for completion of any clinical studies for neffy required by the European Medicines Agency (“EMA”) before granting European Union Marketing Authorization, and by the Medicines and Healthcare products Regulatory Agency (“MHRA”) prior to granting United Kingdom Marketing Authorization. The Company filed the initial regulatory submissions with the EMA in the fourth quarter of 2022 and will file the initial regulatory submissions with the MHRA for neffy and is responsible for the manufacturing of commercial supply. Recordati is solely responsible for all regulatory activities in the region after the Company’s initial regulatory submissions to the EMA and MHRA, for any post-approval clinical studies and commercialization activities. Either party may terminate the Recordati Agreement for certain breaches. Unless terminated earlier by either or both parties, the term of the Recordati Agreement will continue as long as Recordati has commercial sales of neffy in the region.

Under the terms of the Recordati Agreement, the Company received an upfront payment of $11.8 million and a regulatory milestone payment of $6.0 million during 2020. In addition, the Company is eligible to receive up to 90.0 million euros of milestone payments upon achievement of certain regulatory and commercial sales milestones. Subject to regulatory approval, the Company will earn tiered royalties in the low double-digits on annual net sales in the region and will receive a per unit supply price for the sale of commercial supply to Recordati. The per unit commercial supply costs are subject to a cap. The combined tiered royalty and supply price have a low double-digit cap.

At the commencement of this collaboration, the Company identified the following performance obligations: the license for neffy in the defined territory and the research and development services. The Company determined the initial transaction price to be the $11.8 million. Due to the uncertainty in the achievement of all the developmental and commercial milestones, at inception of the contract, the variable consideration associated with future milestone payments was fully constrained and excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. The transaction price was allocated to the performance obligations based on the estimated stand-alone selling price of each performance obligation. In November 2020, the Company earned a regulatory milestone of $6.0 million.

On February 22, 2023, the Company and Recordati entered into a termination agreement (the “Termination Agreement”), pursuant to which, among other things, the Company and Recordati agreed to terminate the Recordati Agreement. Pursuant to the Termination Agreement, the Company reacquired all of the Recordati Rights, paid Recordati a one-time upfront payment of €3.0 million, and has agreed to pay additional payments upon achievement of certain milestones including: (i) an EMA regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Recordati Licensed Product in the Recordati Territory, and (iii) royalty payments of up to €5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory.

The Company determined that the Recordati Rights had no alternative future use and therefore recorded the €3.0 million upfront payment to Recordati as an IPR&D expense presented within research and development in the Company's condensed consolidated statements of operations and comprehensive loss. The 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 in the Company’s condensed consolidated statements of operations and comprehensive loss. Accordingly, no revenue was recognized in the three months ended March 31, 2023. The Company recognized revenue of $0.6 million for the three months ended March 31, 2022.

Pediatrix Agreement

In March 2021, the Company entered into a Collaboration and Distribution 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. Under the 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 defined 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 agreement for certain breaches of the agreement. Unless terminated earlier by either or both parties, the term of the agreement will continue as long as Pediatrix has commercial sales of neffy in the region, or 10 years after the first commercial sale.

Under the terms of the agreement, the Company received an upfront payment of $3.0 million. In addition, the Company is eligible to receive up to $84.0 million of milestone payments upon achievement of certain regulatory and commercial sales milestones. Subject to regulatory approval, the Company will earn tiered royalties in the low double-digits on annual net sales in the region and will receive a per unit supply price for the sale of commercial supply to Pediatrix.

At the commencement of this collaboration, the Company identified performance obligations related to the delivery of the license for neffy in the defined territory and manufacturing of product for clinical studies and commercial supply. The Company concluded that the license was distinct from potential supply obligation. The supply provisions are effectively options granted to Pediatrix to purchase future goods and would only constitute a performance obligation if they contain a material right. The Company determined the option to purchase the clinical and commercial supply was not at a significantly discounted price and does not represent a material right, therefore does not constitute a performance obligation. The Company determined the initial transaction price to be the $3.0 million. Due to the uncertainty in the achievement of all the developmental and commercial milestones, the variable consideration associated with these future milestone payments has been fully constrained and is excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. The Company recognized revenue of the full $3.0 million during the year ended December 31, 2021.

A reconciliation of contract liability from collaboration agreements was as follows (in thousands):


Balance at December 31, 2022	$	3,137
IPR&D expense related to the Termination Agreement		(3,107	)
Revenue recognized		(20	)
Balance at March 31, 2023	$	10

Stock-Based Compensation - Summary of Share-based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 2,250	$ 264
Research and development expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	608	54
General and administrative expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,642	$ 210

Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies Disclosure [Abstract]

Summary of Future Minimum Noncancelable Operating Lease Payments

As of March 31, 2023, future minimum noncancelable operating lease payments are as follows (in thousands):


Year ended December 31,	Amount
2023	$	179
2024		245
2025		42
Total lease payments		466
Less imputed interest		(35	)
Lease liability		431
Less current portion of lease liability		(232	)
Lease liability, net of current portion	$	199

Accrued Expenses - Summary of Accrued Expenses (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Professional services and other	$ 491	$ 908

Balance Sheet Details - Schedule of Other Assets (Detail) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Other Assets [Abstract]
Prepaid insurance	$ 2,839	$ 2,940
Security deposit	21	21
Total	$ 2,860	$ 2,961

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
Revenue under collaboration agreements	$ 20	$ 663
Operating expenses:
Research and development	6,552	5,423
General and administrative	12,181	2,339
Total operating expenses	18,733	7,762
Loss from operations	(18,713)	(7,099)
Other income (expense), net	3,752	(151)
Net loss	(14,961)	(7,250)
Change in unrealized loss on available-for-sale securities	(339)	0
Comprehensive loss	$ (15,300)	$ (7,250)
Earnings Per Share, Basic	$ (0.16)	$ (0.24)
Earnings Per Share, Diluted	$ (0.16)	$ (0.24)
Weighted Average Number of Shares Outstanding, Basic	94,227,313	30,369,413
Weighted Average Number of Shares Outstanding, Diluted	94,227,313	30,369,413

Stock-Based Compensation - Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model (Detail)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Share-Based Payment Arrangement [Abstract]
Expected term (in years)	6 years 1 month 6 days	6 years 1 month 6 days
Expected volatility	95.30%	90.30%
Risk-free interest rate	3.90%	1.60%
Expected dividend yield	0.00%	0.00%

Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

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

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


March 31, 2023	Level		Amortized Cost		Gross unrealized gains		Gross unrealized losses			Estimated Fair Value
Cash and cash equivalents - Money market mutual funds		1	$	71,867	$	—	$	—		$	71,867
Cash and cash equivalents - U.S. Treasury securities		2		14,966		3		—			14,969
Short-term investments - U.S. Treasury securities		2		176,622		73		(8	)		176,687
Total			$	263,455	$	76	$	(8	)	$	263,523
December 31, 2022
Cash and cash equivalents - Money market mutual funds		1	$	209,273	$	—	$	—		$	209,273
Short-term investments - U.S. Treasury securities		2		63,456		407		—			63,863
Total			$	272,729	$	407	$	—		$	273,136

Leases - Additional Information (Detail)	3 Months Ended
Leases - Additional Information (Detail)	Mar. 31, 2023
Lessee, Lease, Description [Line Items]
Operating Lease Weighted Average Remaining Lease Term	23 months
Operating Lease Weighted Average Discount Rate	8.00%
Sublease agreement description	In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease, and the Company is subject to additional charges for common area maintenance and other costs.

Merger and Related Transactions

3 Months Ended

Mar. 31, 2023

Business Combinations [Abstract]

Merger and Related Transactions

3. Merger and Related Transactions

As described in Note 1- Nature of Business, ARS Pharma merged with Silverback on November 8, 2022. The Merger was accounted for as a reverse recapitalization under U.S. GAAP. ARS Pharma was considered the accounting acquirer for financial reporting purposes. This determination was based on the facts that, immediately following the Merger: (i) ARS Pharma stockholders own a substantial majority of the voting rights of the combined organization; (ii) ARS Pharma has designated a majority (eight of eleven) of the initial members of the board of directors of the combined organization; and (iii) ARS Pharma’s senior management holds all key positions in senior management of the combined organization. The transaction was accounted for as a reverse recapitalization because on the effective date of the Merger, the pre-combination assets of Silverback were primarily cash and other non-operating assets. Additionally, the Company concluded that the in-process research and development (“IPR&D”) assets that remained as of the combination were not significant when compared to the cash and investments obtained through the transaction.

Under reverse recapitalization accounting, the assets and liabilities of Silverback were recorded at their fair value, which approximated book value due to the short-term nature of the instruments. No goodwill or intangible assets were recognized.

Under the terms of the Merger Agreement, immediately prior to the effective time of the Merger, each share of ARS Pharma’s preferred stock was converted into one share of ARS Pharma’s common stock.

As the accounting acquirer, ARS Pharma is deemed to have assumed all of Silverback’s outstanding and unexercised stock options. The assumed options continue to be governed by the terms of the 2016 and 2020 Equity Incentive Plans of Silverback (as discussed more in Note 10- Stock-Based Compensation) under which the options were originally granted.

As part of the reverse recapitalization, ARS Pharma obtained $262.3 million in cash, cash equivalents and short-term investments, net of transaction costs. ARS Pharma also obtained prepaids and other current assets of approximately $4.4 million and assumed payables and accruals of approximately $12.0 million. ARS Pharma also obtained $1.1 million in IPR&D assets that have no alternative future use. The fair value attributable to these assets was recorded as research and development expense in the Company’s consolidated statement of operations and comprehensive loss for the year ended December 31, 2022. ARS Pharma also incurred transaction costs of approximately $2.1 million and this amount was recorded as a reduction to additional paid-in capital in the consolidated statement of convertible preferred stock and stockholders’ equity (deficit) for the year ended December 31, 2022 filed with the SEC on March 23, 2023 in the Company’s Annual Report on Form 10-K.

Employee Benefit Plans

3 Months Ended

Mar. 31, 2023

Defined Benefit Plans and Other Postretirement Benefit Plans Disclosures [Abstract]

Employee Benefit Plans

11. Employee Benefit Plans

In June 2022, the Company adopted a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code of 1986, as amended, for the Company’s U.S. employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the Internal Revenue Service (the “IRS”) annual limits. The Company matches up to 5% of an employee’s contributions, subject to IRS limitations. Expenses associated with the Company’s matching contribution totaled $0.1 million for the three months ended March 31, 2023.

Balance Sheet Details

3 Months Ended

Mar. 31, 2023

Balance Sheet Related Disclosures [Abstract]

Balance Sheet Details

5. Balance Sheet Details

Prepaid expenses and other current assets consisted of the following (in thousands):


	March 31, 2023		December 31, 2022
Prepaid insurance	$	1,229	$	1,539
Prepaid expenses		1,050		771
Interest receivable		442		796
Other receivables		80		213
Total	$	2,801	$	3,319

Property and equipment consisted of the following (in thousands):


	March 31, 2023			December 31, 2022
Equipment	$	652		$	377
Less accumulated depreciation		(68	)		(48	)
Total	$	584		$	329

Depreciation expense was immaterial for the three months ended March 31, 2023 and 2022.

Other assets consisted of the following (in thousands):


	March 31, 2023		December 31, 2022
Prepaid insurance	$	2,839	$	2,940
Security deposit		21		21
Total	$	2,860	$	2,961

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


	March 31, 2023		December 31, 2022
Accounts payable	$	2,580	$	1,659
Accrued legal and professional fees		491		908
Accrued clinical expenses		1,121		609
Accrued compensation		994		447
Accrued tax expenses		187		174
Accrued development expenses		2,328		133
Other		1,895		1,001
Total	$	9,596	$	4,931

Summary of Significant Accounting Policies (Additional Information) (Details)	3 Months Ended
	Mar. 31, 2023
Accounting Policies [Abstract]
Stock holders equity note stock split exchange ratio	1.1819

Condensed Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Statement of Cash Flows [Abstract]
Accounts payable and accrued liabilities including related party amounts	$ 291	$ 55

Nature of Business - Additional Information (Detail) $ in Thousands	3 Months Ended
	Mar. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
Accumulated deficit	$ (91,899)	$ (76,938)
ARS Pharma [Member]
Ownership Percentage	62.00%
Silverback [Member]
Common stock equal to the exchange ratio	1.1819
Ownership Percentage	38.00%
Liquidity and Capital Resources [Member]
Accumulated deficit	$ 91,900
Cash, cash Equivalents, and short-term investments	$ 264,500

Related-Party Transactions

3 Months Ended

Mar. 31, 2023

Related-Party Transactions

12. 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 Consulting, LLC, an entity owned by the President/Chief Executive Officer/director and the Chief Medical Officer of the Company. The Company incurred consulting expenses related to this agreement totaling $0.6 million and $0.5 million during the three months ended March 31, 2023 and 2022, respectively.

In September 2018, the Company entered into a consulting agreement with Marlinspike Group, LLC (“Marlinspike Group”) to provide management, business consulting services and business development support. The managing member of Marlinspike Group is the Chair of the Board of Directors of the Company and one of its stockholders. The Company incurred expenses related to this agreement totaling $0.1 million for each of the three months ended March 31, 2023 and 2022.

In November 2018, the Company entered into a consulting agreement for commercial and marketing consulting services with Red Team Associates, LLC (“Red Team”), an entity controlled by the Executive Vice President of Commercial Strategy of the Company. The Company incurred consulting expenses related to this agreement totaling $0.2 million and $0.1 million during the three months ended March 31, 2023 and 2022, respectively.

In April 2021, the Company entered into a consulting agreement, as amended in April 2022, with a member of the Board of Directors of the Company for general advice and assistance with the development of its current and future product candidates. As compensation for the consulting services the Company granted the member of the Board of Directors 590,950 stock options that vest over a four-year period. The Company incurred stock-based compensation expense related to this agreement totaling less than $0.1 million for each of the three months ended March 31, 2023 and 2022.

Nature of Business

3 Months Ended

Mar. 31, 2023

Organization and Nature of Business

1. Nature of Business

Description of Business

ARS Pharmaceuticals, Inc. (“ARS” or the “Company”) is focused on the development of ARS-1 (brand name neffy®), a proprietary product candidate for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions including anaphylaxis. 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.

Merger Transaction

On November 8, 2022 (the “Closing Date”), Silverback Therapeutics, Inc., a Delaware corporation (“Silverback”), now known as ARS Pharmaceuticals, Inc., completed its reverse merger (the “Merger”) with privately-held ARS Pharmaceuticals, Inc. (“ARS Pharma”), in accordance with the terms of the agreement and plan of merger and reorganization, dated July 21, 2022, as amended on August 11, 2022 and October 25, 2022 (the “Merger Agreement”), whereby Sabre Merger Sub, Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of Silverback, merged into ARS Pharma, with ARS Pharma surviving as Silverback’s wholly-owned subsidiary. ARS Pharma was renamed ARS Subsidiary, Inc., and then subsequently renamed ARS Pharmaceuticals Operations, Inc.

At the effective time of the Merger (the “Effective Time”), each share of ARS Pharma common stock outstanding immediately prior to the Effective Time, after giving effect to the automatic conversion of all shares of preferred stock of ARS Pharma into shares of ARS Pharma common stock immediately prior to the Effective Time (excluding shares held as treasury stock by ARS Pharma or held or owned by Silverback, Merger Sub or any subsidiary of Silverback or ARS Pharma and dissenting shares), was automatically converted into the right to receive shares of Silverback common stock equal to the exchange ratio of 1.1819. At the completion of the Merger, the prior ARS Pharma equityholders owned 62% and the prior Silverback equityholders owned 38% of the combined company, in each case on a fully diluted basis using the treasury stock method and excluding out-of-money options of Silverback.

The Merger was accounted for as a reverse recapitalization, with ARS Pharma being treated as the acquirer for accounting purposes. Pursuant to the Merger Agreement, Silverback changed its name to ARS Pharmaceuticals, Inc., and changed its corporate ticker symbol on the Nasdaq Global Market to “SPRY”. See discussions of the transactions in connection with the Merger at Note 3- Merger and Related Transactions.

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 since its inception and had an accumulated deficit of $91.9 million as of March 31, 2023. The Company had cash, cash equivalents, and short-term investments of $264.5 million as of March 31, 2023 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily with proceeds from the Merger, the issuance of convertible preferred stock, payments earned under collaboration agreements and bank debt. The Company’s currently available cash, cash equivalents, and short-term investments as of March 31, 2023 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date the financial statements are issued.

From August 5, 2015 (inception) through March 31, 2023, the Company has devoted substantially all of its efforts to developing intellectual property and conducting product development and clinical trials, raising capital, and building infrastructure. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. If the Company does not successfully commercialize any product candidates for which it receives regulatory approval, it will be unable to generate recurring product revenue or achieve profitability. Management expects operating expenses to increase for the foreseeable future and there can be no assurance that the Company will ever achieve profitability, or if achieved, that it will be sustained on a continuing basis.

The novel coronavirus-2019 (“COVID-19”) epidemic and geopolitical events have resulted in a significant disruption of global financial markets. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States, including recent bank failures, and worldwide resulting from a resurgence of COVID-19, future health epidemics or pandemics, geopolitical actions or other macroeconomic factors. If such further disruption occurs, the Company could experience an inability to access additional capital. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects.

Stock-Based Compensation - Summary of Activity Related to Stock Option (Detail) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2023 USD ($) $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Subject to Options Outstanding, Beginning balance \| shares	12,063,560
Shares Subject to Options Outstanding, Granted \| shares	4,099,600
Shares Subject to Options Outstanding, Exercised \| shares	(502,687)
Stock Issued During Period Shares Stock Options Forfeited \| shares	(76,054)
Shares Subject to Options Outstanding, Ending balance \| shares	15,584,419
Shares Subject to Options Exercisable, Ending Balance \| shares	11,470,122
Weighted- Average Exercise Price, Beginning balance \| $ / shares	$ 6.07
Weighted- Average Exercise Price, Granted \| $ / shares	8.26
Weighted Average Exercise Price Forfeited \| $ / shares	21.32
Weighted- Average Exercise Price, Exercised \| $ / shares	2.62
Weighted- Average Exercise Price, Ending balance \| $ / shares	6.69
Weighted- Average Exercise Price Exercisable , Ending balance \| $ / shares	$ 6.12
Weighted- Average Remaining Contractual Life (Years)	6 years 8 months 1 day
Weighted- Average Remaining Contractual Life (Years), Exercisable	5 years 6 months 21 days
Aggregate Intrinsic Value, Ending balance \| $	$ 39,388,194
Aggregate Intrinsic Value, Exercisable Ending balance \| $	$ 39,361,532

Convertable Preferred Stock and Common Stock and Stockholders'Equity (Deficit) - Summary of common stock reserved for Future Issuance (Detail) - shares	Mar. 31, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Common stock options granted and outstanding	15,584,419	12,063,560
Restricted stock units granted and outstanding	7,107	10,651
Common stock reserved for future awards or option grants	4,048,939	3,373,801
Total	19,640,465	15,448,012

Stockholders' Equity (Deficit)

3 Months Ended

Mar. 31, 2023

Stockholders' Equity (Deficit)

9. Convertible Preferred Stock and Common Stock and Stockholders’ Equity (Deficit)

Authorized Shares

Convertible Preferred Stock

Common Stock

In November 2022, upon completion of the Merger and as the accounting acquirer, ARS Pharma is deemed to have issued 36,535,541 shares of its common stock to Silverback stockholders.

Common stock reserved for future issuance consisted of the following:


	March 31, 2023		December 31, 2022
Common stock options granted and outstanding		15,584,419		12,063,560
Restricted stock units granted and outstanding		7,107		10,651
Common stock reserved for future awards or option grants		4,048,939		3,373,801
Total		19,640,465		15,448,012