Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 05, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38560 | |
Entity Registrant Name | AADI BIOSCIENCE, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 61-1547850 | |
Entity Address, Address Line One | 17383 Sunset Boulevard | |
Entity Address, Address Line Two | Suite A250 | |
Entity Address, City or Town | Pacific Palisades | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 90272 | |
City Area Code | 424 | |
Local Phone Number | 744-8055 | |
Title of 12(b) Security | Common stock, $0.0001 par value per share | |
Trading Symbol | AADI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,436,990 | |
Entity Central Index Key | 0001422142 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 34,046 | $ 39,019 |
Short-term investments | 117,128 | 133,541 |
Accounts receivable, net | 5,565 | 1,862 |
Inventory | 3,803 | 1,861 |
Prepaid expenses and other current assets | 4,388 | 3,746 |
Total current assets | 164,930 | 180,029 |
Property and equipment, net | 2,225 | 508 |
Operating lease right-of-use assets | 1,437 | 1,522 |
Other assets | 2,062 | 2,178 |
Total assets | 170,654 | 184,237 |
Current liabilities: | ||
Accounts payable | 6,510 | 3,519 |
Accrued liabilities | 10,833 | 14,922 |
Operating lease liabilities, current portion | 404 | 394 |
Total current liabilities | 17,747 | 18,835 |
Operating lease liabilities, net of current portion | 1,164 | 1,267 |
Due to licensor | 5,757 | 5,757 |
Total liabilities | 24,668 | 25,859 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 300,000,000 shares authorized; 24,436,990 and 24,435,007 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 2 | 2 |
Additional paid-in capital | 364,437 | 361,689 |
Accumulated other comprehensive loss | (32) | (115) |
Accumulated deficit | (218,421) | (203,198) |
Total stockholders’ equity | 145,986 | 158,378 |
Total liabilities and stockholders’ equity | $ 170,654 | $ 184,237 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 24,436,990 | 24,435,007 |
Common stock, shares outstanding (in shares) | 24,436,990 | 24,435,007 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total revenue | $ 5,867 | $ 2,307 |
Operating expenses | ||
Selling, general and administrative | 11,207 | 9,148 |
Research and development | 10,956 | 6,794 |
Cost of goods sold | 529 | 179 |
Total operating expenses | 22,692 | 16,121 |
Loss from operations | (16,825) | (13,814) |
Other income (expense) | ||
Interest income | 1,660 | 15 |
Interest expense | (58) | (58) |
Total other income (expense), net | 1,602 | (43) |
Net loss | (15,223) | (13,857) |
Other comprehensive loss: | ||
Change in unrealized loss on short-term investments | 83 | 0 |
Comprehensive loss | $ (15,140) | $ (13,857) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.57) | $ (0.66) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.57) | $ (0.66) |
Weighted average number of common shares outstanding used in computing net loss per share attributable to common stockholders, basic (in shares) | 26,862,646 | 20,914,842 |
Weighted-average common shares outstanding, diluted (in shares) | 26,862,646 | 20,914,842 |
Product sales, net | ||
Total revenue | $ 5,867 | $ 2,307 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (15,223) | $ (13,857) |
Change in unrealized loss on short-term investments | 83 | 0 |
Comprehensive Income (Loss), Net of Tax, Attributable to Parent | $ (15,140) | $ (13,857) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2021 | 20,895,000 | ||||
Balance at Dec. 31, 2021 | $ 136,406 | $ 2 | $ 279,089 | $ 0 | $ (142,685) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation expense | 1,781 | 1,781 | |||
Issuance of common stock upon exercise of warrants (in shares) | 7,000 | ||||
Issuance of common stock upon exercise of warrants | 54 | 54 | |||
Issuance of common stock upon exercise of stock options (in shares) | 40,000 | ||||
Issuance of common stock upon exercise of stock options | 244 | 244 | |||
Net loss | (13,857) | (13,857) | |||
Balance (in shares) at Mar. 31, 2022 | 20,942,000 | ||||
Balance at Mar. 31, 2022 | 124,628 | $ 2 | 281,168 | 0 | (156,542) |
Balance (in shares) at Dec. 31, 2022 | 24,435,000 | ||||
Balance at Dec. 31, 2022 | 158,378 | $ 2 | 361,689 | (115) | (203,198) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation expense | $ 2,740 | 2,740 | |||
Issuance of common stock upon exercise of warrants (in shares) | 2,000 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 1,983 | ||||
Issuance of common stock upon exercise of stock options | $ 8 | 8 | |||
Other comprehensive income | 83 | 83 | |||
Net loss | (15,223) | (15,223) | |||
Balance (in shares) at Mar. 31, 2023 | 24,437,000 | ||||
Balance at Mar. 31, 2023 | $ 145,986 | $ 2 | $ 364,437 | $ (32) | $ (218,421) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (15,223) | $ (13,857) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 2,740 | 1,781 |
Discount amortization on short-term investments | (1,200) | 0 |
Non-cash interest expense | 58 | 58 |
Non-cash lease expense | 116 | 66 |
Depreciation and amortization expense | 38 | 74 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,703) | (2,708) |
Inventory | (1,942) | (202) |
Prepaid expenses and other current assets | (642) | (579) |
Other non-current assets | 116 | 125 |
Operating lease liabilities | (124) | (44) |
Accounts payable and accrued liabilities | (1,544) | (4,129) |
Net cash used in operating activities | (21,310) | (19,415) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,369) | (23) |
Purchase of short-term investments | (23,052) | 0 |
Maturity of short-term investments | 40,750 | 0 |
Net cash provided by (used in) investing activities | 16,329 | (23) |
Cash flows from financing activities: | ||
Issuance of common stock upon exercise of stock options | 8 | 244 |
Issuance of common stock upon exercise of warrants | 0 | 54 |
Net cash provided by financing activities | 8 | 298 |
Net decrease in cash, cash equivalents and restricted cash | (4,973) | (19,140) |
Cash, cash equivalents and restricted cash at beginning of year | 39,083 | 148,989 |
Cash, cash equivalents and restricted cash, end of period | 34,110 | 129,849 |
Supplemental disclosure of cash flow information: | ||
Interest paid during the period | 58 | 58 |
Supplemental disclosure of non-cash activities: | ||
Deferred transaction costs included in accounts payable and accrued liabilities | 0 | 249 |
Accrued property and equipment | $ 387 | $ 27 |
Nature of Organization and Oper
Nature of Organization and Operations | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Organization and Operations | Nature of Organization and Operations Aadi Bioscience, Inc. (together with its subsidiaries, the “Company” or “Aadi”) is a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes. Aadi’s lead drug product, FYARRO ® , is a form of sirolimus bound to albumin. Sirolimus is a potent inhibitor of the mTOR biological pathway, the activation of which pathway can promote tumor growth, and inhibits downstream signaling from mTOR. In November 2021, the U.S. Food and Drug Administration (the “FDA”) approved FYARRO sirolimus protein-bound particles for injectable suspension (albumin-bound) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor ( “ PEComa ” ). On February 22, 2022, Aadi launched FYARRO in the United States for treatment of advanced malignant PEComa. FYARRO is licensed to Aadi by Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol Myers Squibb Company (“BMS”). The Company’s historical operations have consisted principally of performing research and development activities and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved. Liquidity Since inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations and has only recently begun to realize revenues from its planned principal operations commencing with the commercial sale of FYARRO. The Company has experienced net losses since its inception and expects to continue to incur net losses into the foreseeable future. The Company had an accumulated deficit of $218.4 million as of March 31, 2023 and a net loss of $15.2 million and $13.9 million for the three months ended March 31, 2023 and 2022, respectively. To date, these operating losses have been funded primarily from outside sources of invested capital through the issuance of convertible promissory notes, grant funding, the sale of securities, and proceeds from license agreements. The Company had cash, cash equivalents and short-term investments of $151.2 million at March 31, 2023. Management believes the Company’s current cash, cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report. If the Company is unable to achieve and maintain profitability, it will need additional financing to support its continuing operations and pursue its strategic objectives. Additional financing may be achieved through a combination of equity offerings, and debt financings. The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all. On March 17, 2022, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may offer and sell, from time to time at the Company’s sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million through Cowen as its sales agent for an at-the-marketing-offering. As of March 31, 2023 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements, and the related disclosures, have been prepared in accordance with GAAP and SEC regulations and, in the opinion of management include all adjustments necessary for a fair presentation of the results of operations, financial position, changes in stockholders’ equity and cash flows for each period presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). All adjustments are of a normal recurring nature. The Company’s condensed consolidated financial statements are stated in U.S. dollars. Certain prior year amounts have been reclassified to conform to the current year presentation. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2023. 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, including unrealized gains and losses on short-term investments. Comprehensive loss has been reflected in the condensed consolidated statements of operations and comprehensive loss for all periods presented. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company has identified its Chief Executive Officer as the chief operating decision maker and the Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing proprietary therapeutics. All the assets and operations of the Company’s sole operating and reportable segment are located in the United States. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. In the opinion of management, all adjustments that are considered necessary for fair presentation have been included. The most significant estimates in the Company’s condensed consolidated financial statements relate to fair value of the intangible asset, fair value of the convertible promissory notes, gross-to-net accruals, share-based compensation expense and accrued research and development costs. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions. Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents and investments in money market funds, United States government treasury bills, commercial paper, corporate bonds, and government agency debt securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. While the Company has not experienced any losses in such deposits, the recent failure of Silicon Valley Bank, at which the Company holds cash and cash equivalents in multiple accounts, exposed the Company to credit risk prior to the resolution by the Federal Deposit Insurance Corporation in a manner that fully protected all depositors. The Company has not experienced any losses on deposits since inception. The Company’s accounts receivable is derived from customers located in the United States. The Company performs ongoing credit evaluations of its customers and maintains allowances for potential credit losses on customers’ accounts when deemed necessary. The Company does not typically require collateral from its customers. Credit losses historically have not been material. The Company continuously monitors customer payments and maintains an allowance for credit losses based on its assessment of various factors including historical experience, age of the receivable balances, and other current economic conditions or other factors that may affect customers’ ability to pay. Customer Concentration The majority of the Company's revenue for the three months ended March 31, 2023 were from two customers at 51% and 48% of the Company’s revenue, respectively. Additionally, two customers accounted for 62% and 37% of net accounts receivable as of March 31, 2023. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid marketable securities purchased with original maturities of three months or less at the time of purchase date to be cash equivalents. As of March 31, 2023 and December 31, 2022, cash and cash equivalents including money market investments totaled $23.7 million and $32.0 million, respectively. Restricted cash consists of a letter of credit secured by restricted cash in connection with one of the Company's office leases described in Note 7, and is included in other assets on the condensed consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Cash and cash equivalents $ 34,046 $ 39,019 Restricted cash, non-current 64 64 Total cash, cash equivalents and restricted cash $ 34,110 $ 39,083 Fair Value of Financial Instruments The accounting guidance defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an 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 accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs, such as quoted prices in active markets Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions which reflect those that a market participant would use Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels. In determining the fair value of its financial instruments, the Company considers the source of observable market data inputs, liquidity of the instrument, the credit risk of the counterparty to the contract, and its risk of nonperformance. In the case fair value is not observable, for the items subject to fair value measurements, the Company applies valuation techniques deemed the most appropriate under the GAAP guidance based on the nature of the assets and liabilities being measured. The carrying amounts of cash equivalents, accounts receivable, prepaid expenses and other current assets, and accounts payable are reasonable estimates of their fair value because of the short maturity of these items. Short-Term Investments The Company invests in various types of securities, including United States government treasury bills, commercial paper, corporate debt securities, and government agency bonds. The Company classifies its investments as available-for-sale and records them at fair value based upon market prices at period end. Unrealized gains and losses that are deemed temporary in nature are recorded in accumulated other comprehensive loss as a separate component of stockholders' equity. Dividend and interest income are recognized when earned. The Company recognizes purchase premiums and discounts as interest income using the interest method over the terms of the securities. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. The Company classifies short-term investments with remaining maturities greater than one year as current assets because such short-term investments are available to fund the Company’s current operations. At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the decline in fair value below amortized cost is a result of credit losses or other factors, whether the Company expects to recover the amortized cost of the security, the Company's intent to sell and if it is more likely than not that the Company will be required to sell the securities before the recovery of amortized cost. The Company records changes in allowance for expected credit loss in other income (expense). There have been no allowance for expected credit losses recorded during any of the periods presented. See Note 4 for further information. Accounts Receivable, Net Accounts receivable are recorded net of customer allowances for chargebacks and allowance for credit losses. Allowance for chargebacks is based on contractual terms. The Company estimates the allowance for credit losses based on existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances and credit loss. Receivables are recorded to an allowance for credit loss when it is probable that amounts will not be collected based on terms of the customer contracts. As of March 31, 2023 and December 31, 2022, recorded customer allowances for charge backs were $0.8 million and $0.1 million, respectively. There were no allowances for credit losses and no receivables were written off for the periods ended March 31, 2023 and December 31, 2022, respectively. Inventory Inventory is stated at the lower of cost or estimated net realizable value. The Company uses actual costing methodology determined on a first-in, first-out method. The Company capitalizes inventory costs associated with its products based upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Details of inventory are presented as follows (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 2,911 $ 944 Work in process — — Finished goods 892 917 Total $ 3,803 $ 1,861 Property and Equipment, Net Property and equipment, consisting of computers, furniture and fixtures, office equipment, construction in process and leasehold improvements are stated at cost, less accumulated depreciation. Property and equipment is depreciated using the straight-line method over the estimated useful lives of the assets, generally three Details of property and equipment are presented as follows (in thousands): March 31, 2023 December 31, 2022 Computers and Software $ 366 $ 338 Construction in process 1,805 77 Furniture and fixtures 65 65 Leasehold improvements 129 129 Total $ 2,365 $ 609 Accumulated depreciation (140) (101) Property and equipment, net $ 2,225 $ 508 Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, the Company records the associated lease liability and corresponding right-of-use asset upon commencement of the lease using the implicit rate or a discount rate based on a credit-adjusted secured borrowing rate commensurate with the term of the lease. The Company does not recognize assets or liabilities for leases with lease terms of less than 12 months. The Company additionally evaluates leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: (i) the lease has a purchase option that is reasonably certain of being exercised, (ii) the present value of the future cash flows is substantially all of the fair market value of the underlying asset, (iii) the lease term is for a significant portion of the remaining economic life of the underlying asset, (iv) the title to the underlying asset transfers at the end of the lease term, or (v) if the underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease. Operating lease assets represent a right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. Operating lease liabilities with a term greater than one year and their corresponding right-of-use assets are recognized at the commencement date of the lease based on the present value of lease payments over the expected lease term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. As the Company’s leases do not typically provide an implicit rate, the Company utilizes the appropriate incremental borrowing rate, determined as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and in a similar economic environment. For finance leases, depreciation expense is recognized for the leased asset acquired and interest expense is recognized related to the portion of the financing in the condensed consolidated statements of operations and comprehensive loss . For operating leases, lease cost is recognized on a straight-line basis over the lease term and variable lease payments are recognized as operating expense in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company. The Company has elected the practical expedient to not separate between lease and non-lease components. Commitments and Contingencies The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range. The Company has not recorded any such liabilities as of March 31, 2023 and December 31, 2022 . Revenue Recognition and Related Allowances The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 606, Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Net Sales FYARRO was approved by the FDA in November 2021. On February 22, 2022, the Company launched sales of FYARRO to specialty distributors (“SDs”) and a specialty pharmacy (“SP”). The Company recognizes product sales when the SDs and SP obtain control of the product. Product sales are recorded at the net sales price, which includes provisions for the following allowances which are reflected either as a reduction to the related account receivable or as an accrued liability, depending on how the allowance is settled: Distribution Fees : Distribution fees include distribution service fees paid to the SDs and SP based on a contractually fixed percentage of the wholesale acquisition cost (“WAC”). Distribution fees are recorded as an offset to product sales based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowance for rebates includes mandated discounts under the Medicaid Drug Rebate Program and TRICARE program. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements. The allowance for rebates is based on contracted or statutory discount rates and expected utilization by benefit plan participants. The Company’s estimates for expected utilization of rebates are based on utilization data received from the SDs and SP since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment. Chargebacks: Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs and SP at a discounted price. The SDs and SP charge back to the Company the difference between the price initially paid by the SDs and SP and the discounted price paid to the SDs and SP by these entities. If actual future chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment. Co-Payment Assistance: The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirement. Co-payment assistance is accrued at the time of product sale to SDs and SP based on estimated patient participation and average co-pay benefit to be paid per a claim. The Company estimated amounts are compared to actual program participation and co-pay amounts paid using data provided by third-party administrators. If actual amounts differ from the original estimates the assumptions being applied are updated and adjustment for prior period accruals will be adjusted in the current period. Product Returns: Consistent with industry practice, the Company offers the SDs and SP limited product return rights for damages, shipment errors, and expiring product, provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SDs and SP and has the ability to control the amount of product that is sold to the SDs and SP the Company’s estimate of future potential product returns is based on the on-hand channel inventory data and sell-through data obtained from the SDs and SP. In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. The total amount deducted from gross product sales for the allowances described above for the three months ended March 31, 2023, and 2022, was $1.0 million and $0.4 million, respectively. The following table sets forth the changes in the accrued revenue allowances (in thousands): Balance at Beginning of Year Provision for Current Period Sales Payments Balance at March 31, 2023 For the Three Months Ended March 31, 2023 $ 1,434 $ 1,035 $ (553) $ 1,916 Balance at Beginning of Year Provision for Current Period Sales Payments Balance at March 31, 2022 For the Three Months Ended March 31, 2022 $ — $ 407 $ — $ 407 Revenue Under License Agreement The Company generates revenues from payments received under a license agreement. Under such license agreement, the Company recognizes revenue when it transfers promised goods or services to partners in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with partners, the Company performs the following five steps: (i) identifies the promised goods or services in the contract; (ii) identifies the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determines the transaction price, including the constraint on variable consideration; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the Company satisfies the performance obligations. For revenue from such license agreement, the Company generally collects an upfront license payment from the license partner and is also entitled to receive event-based payments subject to the license partner’s achievement of specified development, regulatory and sales-based milestones. In addition, the Company is generally entitled to royalties if products under the license agreement are commercialized. Transaction price for a contract represents the amount to which the Company is entitled in exchange for providing goods and services to the partner. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment, all other fees the Company may earn under such license agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining regulatory approvals and successful completion of clinical trials. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. The Company does not include any amounts subject to uncertainties in the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Because such agreements generally only have one type of performance obligation, a license, which is generally all transferred at the same time as agreement inception, allocation of the transaction price among multiple performance obligations is not required. Upfront amounts allocated to licenses are recognized as revenue when the licenses are transferred to the partners. Development milestones and other fees are recognized in revenue when their occurrence becomes probable. Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical expenses, share-based compensation expense, contract services, and other external development expenses. The Company records research and development activities conducted by third-party service providers, which include work related to preclinical studies, clinical trials, and contract manufacturing activities, to research and development expense as incurred. The Company is required to estimate the amount of services provided but not yet invoiced and include these expenses in accrued expenses on the condensed consolidated balance sheets and within research and development expenses in the condensed consolidated statements of operations and comprehensive loss. These expenses are a significant component of the Company’s research and development expenses and require significant estimates and judgments. The Company accrues for these expenses based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. As actual expenses become known, the Company adjusts its accrued expenses. Share-Based Compensation The Company recognizes all share-based payments to employees, including grants of employee stock options in the condensed consolidated statements of operations and comprehensive loss based on their fair values. All of the Company’s share-based awards, to employees, non-employees, officers, and directors, are subject only to service-based vesting conditions. The Company estimates the fair value of its share-based awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (i) the expected stock price volatility, (ii) the calculation of expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Options granted during the year have a maximum contractual term of ten years. Forfeitures are recognized and accounted for as they occur. Due to the historical lack of a public market for the trading of the Company’s securities and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted to employees, officers, and directors using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees, and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term. Employee Stock Purchase Plan Stock-based compensation expense for employee stock purchases under the Company’s 2021 Employee Stock Purchase Plan (the “2021 ESPP”) is recorded at the estimated fair value of the purchase as of the plan enrollment date and is recognized as expense on a straight-line basis over the applicable six-month ESPP offering period. Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties related to uncertain tax positions, if any exist, in income tax expense. Net Loss per Share Attributable to Common Stockholders Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Basic and diluted weighted average shares of common stock outstanding for the three months ended March 31, 2023, includes the weighted average effect of 2,426,493 Pre-Funded Warrants (as defined below), which were issued in September 2022, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $0.0001 per share. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company’s potentially dilutive securities, which include outstanding stock options and warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive. The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive (in thousands): Three Months Ended March 31, 2023 2022 Options to purchase common stock 3,846 2,028 Warrants to purchase common stock 29 29 Recent Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options” (Subtopic 470-20) and “Derivatives and H |
Fair Value Measurement
Fair Value Measurement | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement The following table sets forth the recurring fair value of the Company’s financial assets and liabilities, allocated into the Level 1, Level 2 and Level 3 hierarchy that were measured at fair value on a recurring basis (in thousands): Fair Value Measurements as of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 23,654 $ — $ — $ 23,654 U.S. government treasury bills 50,076 — — 50,076 Commercial paper — 47,233 — 47,233 Corporate bonds — 4,260 — 4,260 Government agency — 15,559 — 15,559 Total financial assets $ 73,730 $ 67,052 $ — $ 140,782 Fair Value Measurements as of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 32,035 $ — $ — $ 32,035 U.S. government treasury bills 70,708 — — 70,708 Commercial paper — 53,296 — 53,296 Corporate bonds — 4,250 — 4,250 Government agency — 5,287 — 5,287 Total financial assets $ 102,743 $ 62,833 $ — $ 165,576 (1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheets. As of March 31, 2023, net unrealized loss on investments was $32,000. All marketable securities had a contractual maturity of less than one year as of March 31, 2023. |
Short-Term Investments and Cash
Short-Term Investments and Cash Equivalents | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-Term Investments and Cash Equivalents | Short-Term Investments and Cash Equivalents The following table summarizes the Company's short-term investments (in thousands): As of March 31, 2023 Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Money market funds $ 23,654 $ — $ — $ 23,654 U.S. government treasury bills Less than 1 50,101 — (26) 50,075 Commercial paper Less than 1 47,233 — — 47,233 Corporate bonds Less than 1 4,280 — (20) 4,260 Government agency Less than 1 15,545 14 — 15,559 Total $ 140,813 $ 14 $ (46) $ 140,781 As of December 31, 2022 Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Money market funds $ 32,035 $ — $ — $ 32,035 U.S. government treasury bills Less than 1 70,812 4 (108) 70,708 Commercial paper Less than 1 53,296 — — 53,296 Corporate bonds Less than 1 4,276 — (26) 4,250 Government agency Less than 1 5,272 15 — 5,287 Total $ 165,691 $ 19 $ (134) $ 165,576 |
Intangible Asset
Intangible Asset | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Asset | Intangible AssetOn August 26, 2021, the Company closed its reverse merger pursuant to which the Company’s wholly-owned subsidiary merged with and into Aadi Subsidiary, Inc. (formerly Aadi Bioscience, Inc.) (“Private Aadi”), with Private Aadi surviving as a wholly owned subsidiary of the Company (the “Merger”). The Company recorded a long-lived contract intangible asset as a result of the Merger, related to the license agreement, dated June 24, 2018, with Gossamer Bio, Inc. (“Gossamer”), as amended (the “Gossamer License Agreement”), which was assumed in the Merger. In accordance with GAAP, for asset acquisitions, the excess purchase price over the fair value of the acquired assets and liabilities was ascribed to the acquired contract intangible asset. Due to the significant excess purchase price being allocated over the fair value of the acquired contract intangible asset, the Company determined that an indicator of impairment was present. The contract intangible asset was assessed for recoverability using an undiscounted cash flow model, which resulted in undiscounted cash flows below the carrying amount. At the effective time of the Merger, the Company recognized an impairment of $74.2 million to bring the carrying amount of the contract intangible asset down to its estimated fair value of $3.9 million. The fair value estimate of the intangible asset relates to contingent cash flows expected from the out-licensing arrangement, of which 90% of any future net cash proceeds will be remitted to each holder of common stock of the Company’s predecessor, Aerpio, as of immediately prior to the closing of the Merger and paid through the contingent value rights (“CVRs”) pursuant to a Contingent Value Rights Agreement, dated as of August 26, 2021 (the “CVR Agreement”). The useful life of the intangible asset was estimated to be approximately 14.3 years. On April 25, 2022, the Company received a formal notice of termination from Gossamer for the Gossamer License Agreement, relating to Gossamer’s GB004 product candidate, a legacy product candidate of the Company's predecessor, Aerpio, after Gossamer announced that its Phase 2 SHIFT-UC clinical trial studying GB004 in patients with mild-to-moderate active ulcerative colitis did not meet the primary or secondary endpoints at week 12 and the study was being terminated for lack of treatment benefit. The Gossamer License Agreement terminated effective July 24, 2022. Based on the termination of the Gossamer License Agreement, the Company fully impaired the intangible asset, $3.7 million, of which the Gossamer License Agreement is the underlying asset, during the year ended December 31, 2022. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Details of accrued liabilities are presented as follows (in thousands): March 31, December 31, Accrued professional fees $ 3,066 $ 1,814 Accrued salaries and payroll 2,306 1,299 Accrued bonus 1,496 5,463 Accrued clinical 1,333 2,399 Accrued contract manufacturing 898 405 Advanced customer payments — 1,571 Accrued other - sales related 1,150 1,435 Accrued other 584 536 Total accrued liabilities $ 10,833 $ 14,922 |
Operating Lease
Operating Lease | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Operating Lease | Operating Lease In April 2019, the Company entered into a twenty-eight month facility lease agreement for office space in Pacific Palisades, California (the “Pacific Palisades Lease”). The Pacific Palisades Lease commenced on May 1, 2019, included four months of rent abatement and a rent escalation clause and was set to expire on August 31, 2021. In August 2021, the Company exercised its option to extend the term of the Pacific Palisades Lease for an additional three-year period and entered into an amendment to the lease agreement (the “Pacific Palisades Lease Amendment”). Pursuant to the Pacific Palisades Lease Amendment, the Company and the landlord agreed to extend the term for an additional period of three (3) years and six (6) months, until February 28, 2025, with an option to renew for an additional three (3) years in accordance with the terms of the Pacific Palisades Lease. Included in the Pacific Palisades Lease Amendment were nine months of rent abatement and a rent escalation clause. In April 2022, the Company entered into a lease agreement for office space in Morristown, New Jersey (the “Morristown Lease”). The Morristown Lease has a term of seventy-three months, unless terminated sooner, and includes rent abatement for the first three months and the forty-seventh and forty-eighth calendar months after lease commencement. Included in the Morristown Lease are fixed rent escalations of approximately 2% on each anniversary year of the lease term. The following table summarizes information related to the Company’s lease (in thousands): March 31, 2023 December 31, 2022 Assets: Operating lease right-of-use assets $ 1,437 $ 1,522 Liabilities: Operating lease liabilities, current $ 404 $ 394 Operating lease liabilities, non-current 1,164 1,267 Total operating lease liabilities $ 1,568 $ 1,661 Rent expense for the three months ended March 31, 2023 and 2022 is presented on the following table (in thousands): Three Months Ended March 31, 2023 2022 Operating leases rent expense $ 116 $ 50 Cash paid for leases and included in operating cash flows for the three months ended March 31, 2023 and 2022 is presented on the following table (in thousands): Three Months Ended March 31, 2023 2022 Cash paid included in operating cash flows $ 124 $ 28 The future minimum lease payments required under the operating lease as of March 31, 2023, are summarized below (in thousands): Future Minimum Lease Payments: 2023 $ 377 2024 512 2025 320 2026 231 2027 280 Thereafter 110 Total minimum lease payments $ 1,830 Less: amount representing interest (262) Present value of operating lease liabilities $ 1,568 Less: operating lease liabilities, current (404) Operating lease liabilities, non-current $ 1,164 Remaining lease term (in years) 4.33 Incremental borrowing rate 7.48 % |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
License Agreements | License Agreements Bristol Myers Squibb Company License Agreement On April 9, 2014, the Company entered into a license agreement (as amended the “BMS License Agreement”) with BMS for exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to FYARRO. The BMS License Agreement will remain in effect from the effective date of April 9, 2014 until expiration of all milestone and royalty payment obligations under the agreement, unless terminated by either of the parties upon giving an advance notice as specified in the BMS License Agreement. Under the terms of the BMS License Agreement, BMS agreed to supply the Company with licensed products of FYARRO necessary for clinical or non-clinical development. Under the terms of the BMS License Agreement, BMS is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees. During the three months ended March 31, 2023 and 2022, royalties on net product sales were $0.4 million and $0.2 million, respectively. No payments related to milestones were paid during the three months ended March 31, 2023 or 2022. On August 30, 2021, the Company and BMS entered into Amendment No. 1 (the “Amendment”) to the BMS License Agreement related to certain intellectual property rights of BMS pertaining to the compound known as FYARRO. Under the terms of the Amendment, the Company paid BMS $5.8 million representing 50% of the previously outstanding payment obligation under the terms of the BMS License Agreement, following the effective time of the 2021 private investment in public equity financing (the “2021 PIPE Financing”). Pursuant to the terms of the Amendment, the remaining previously outstanding payment obligation of $5.8 million, is due on the third anniversary of the effective time of the 2021 PIPE Financing, or August 26, 2024 plus any accrued and unpaid interest due thereon (the “Balloon Payment”). The Balloon Payment shall accrue interest, beginning August 26, 2021 until paid in full, at a rate equal to 4.00% per annum based on the weighted average amount outstanding during the applicable calendar quarter, and interest is payable quarterly in arrears. In addition, the parties agreed to amend the royalty rates payable to BMS based on net sales of products subject to the BMS License Agreement. EOC License Agreement On December 8, 2020, the Company entered into a license agreement (“EOC License Agreement”) with EOC Pharma (Hong Kong) Limited (“EOC”) under which the Company received $14.0 million in January 2021 in non-refundable upfront consideration as partial payment for the rights and licenses granted to EOC by the Company for the further development and commercialization of FYARRO in the People’s Republic of China, Hong Kong Special Administration Region, Macao Special Administrative Region and Taiwan (the “Licensed Territory”). In accordance with the BMS License Agreement, the Company is required to pay 20% of all sublicense fees to BMS. On June 27, 2022, the Company received written notice from EOC that EOC elected to terminate the EOC License Agreement, effective immediately, due to alleged material breaches by the Company under such agreement. The Company disagrees with, and continues to dispute, EOC’s allegations of material breach and does not believe that EOC had a right to terminate the EOC License Agreement for material breach, and accordingly believes that the termination of the EOC License Agreement is a termination for convenience. EOC had the right to terminate the agreement for convenience upon 120 days advance written notice. The Company waived such notice period in connection with EOC's termination notice and, as a result, the EOC License Agreement was terminated effective June 27, 2022. Either party had the right to terminate the EOC License Agreement in the event that the other party breaches the agreement and fails to cure the breach, becomes insolvent or challenges certain of the intellectual property rights licensed under the agreement. The Company assessed the EOC License Agreement and concluded that EOC is a customer and identified the license of ABI-009 provided to EOC as the sole performance obligation. The $14.0 million upfront payment received from EOC is non-refundable and non-creditable and is considered fixed consideration. The Company recognized revenue of $14.0 million in December 2020 when the EOC License Agreement was signed, and the $14.0 million upfront payment was received in January 2021. The potential milestone payments and royalty payments under the EOC License Agreement were considered variable consideration and were constrained with respect to revenue recognition notification from EOC that the milestone and royalty payments had been achieved. The Company was eligible to receive an additional $257.0 million in the aggregate upon achievement of certain development, regulatory, and sales milestones, as well as tiered royalties on net sales in the Licensed Territory. Under the terms of the EOC License Agreement, EOC was obligated to fund all research, development, regulatory, marketing and commercialization activities in the defined Licensed Territory. The Company earned $1.0 million in milestone revenue upon achievement of the FDA approval milestone on November 22, 2021. EOC paid the $1.0 million milestone payment in December 2021. In accordance with the BMS License Agreement, 20% of the $1.0 million payment, or $0.2 million was accrued at December 21, 2021, and paid in January 2022. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Preferred Stock As of March 31, 2023 and December 31, 2022 , under the Company’s certificate of incorporation, as amended and restated, the Company has 10,000,000 shares of preferred stock, par value $0.0001 per share, in authorized capital with no shares outstanding. Common Stock and Pre-Funded Warrants As of March 31, 2023 and December 31, 2022, the Company had 300,000,000 shares of authorized common stock, par value of $0.0001 per share under the Company's certificate of incorporation, as amended and restated. As of March 31, 2023 and December 31, 2022, the shares of common stock outstanding were 24,436,990 and 24,435,007, respectively. In March 2022, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company LLC (“Cowen”) , with respect to an “at the market offering” program pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of common stock having aggregate gross proceeds of up to $75.0 million through Cowen as its sales agent . The Company will pay Cowen 3.0% of the aggregate gross proceeds from each sale of shares of common stock under the Sales Agreement. As of March 31, 2023 , no shares of common stock had been sold pursuant to the Sales Agreement. On September 22, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for a private investment in public equity financing (the “2022 PIPE Financing”) with certain investors (the “2022 PIPE Investors”) for the sale by the Company of (i) 3,373,526 shares of the Company’s common stock for a price of $12.50 per share and (ii) pre-funded warrants to purchase an aggregate of 2,426,493 shares of the Company's common stock (the "Pre-Funded Warrants") at a purchase price of $12.4999 per Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at an exercise price of $0.0001 and will be exercisable until exercised in full. The 2022 PIPE Financing closed on September 26, 2022. Aggregated net proceeds, after deducting certain expenses incurred of $0.3 million related to the issuance of the shares were $72.2 million. On September 22, 2022, the Company and the 2022 PIPE Investors entered into a Registration Rights Agreement (the “2022 PIPE Registration Rights Agreement”) providing for the registration for resale of the securities sold under the Purchase Agreement, including the shares issuable upon the exercise of the Pre-Funded Warrants, that are not then registered on an effective registration statement, pursuant to a registration statement filed with the SEC. The Pre-Funded Warrants meet the criteria to be classified within stockholders’ equity. As of March 31, 2023, all Pre-Funded Warrants are still outstanding. Dividends The holders of common stock are entitled to receive cash dividends, if and when declared by the board of directors of the Company (the “board of directors”). Since the Company’s inception, no cash dividends have been declared or paid to the holders of common stock. Liquidation In the event of any voluntary or involuntary liquidation, dissolution, or winding-up of the Company, the holders of common stock are entitled to share ratably in the Company’s assets. Voting The holders of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders and written actions in lieu of meetings. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation 2014 Plan (as amended and restated in February 2017, the “Private Aadi Plan”) In connection with the Merger, the Company assumed the Private Aadi Plan, which was amended and restated in February 2017, and the issued and outstanding stock options under the Private Aadi Plan (the Private Aadi common stock underlying the awards was adjusted for shares of the Company’s common stock pursuant to the Merger Agreement). The Private Aadi Plan allowed for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock unit awards and other stock awards. In connection with the closing of the Merger and the adoption of the 2021 Plan (as defined below), no further awards will be issued under the Private Aadi Plan. The options that are granted from the Private Aadi Plan are exercisable at various dates as determined upon grant and will expire no more than ten years from their date of grant. The Private Aadi Plan stock options generally vest over a four-year term. 2011 Plan and 2017 Plan In connection with the closing of the Merger, the Company assumed the Aerpio 2011 Equity Incentive Plan (the “2011 Plan”) and the Aerpio 2017 Stock Option and Incentive Plan (the “2017 Plan,” and together with the 2011 Plan, the “Prior Plans”). No new awards will be granted under the Prior Plans effective as of the closing of the Merger and adoption of the 2021 Plan (as defined below). 2021 Plan At the closing of the Merger, the Company adopted the Aadi Bioscience, Inc. 2021 Equity Incentive Plan (the “2021 Plan”), which permits the award of stock options, stock appreciation rights, restricted stock, restricted stock units, performance units and performance grants to employees, members of the board of directors, and outside consultants. Subject to the adjustment provisions contained in the 2021 Plan and the evergreen provision described below, a total of 2,070,784 shares of common stock were initially reserved for issuance pursuant to the 2021 Plan. In addition, the shares reserved for issuance under the 2021 Plan include any shares of common stock (i) subject to awards of stock options or other awards granted under the Prior Plans that expire or otherwise terminate without having been exercised in full and shares of common stock granted under the Prior Plans that are forfeited or repurchased by the Company, and (ii) any shares of common stock subject to stock options or similar awards granted under the Private Aadi Plan that were assumed in the Merger (provided that the maximum number of shares that may be added to the 2021 Plan pursuant to this sentence is 764,154 shares). The number of shares available for issuance under the 2021 Plan also will include an annual increase, or the evergreen feature, on the first day of each of the Company’s fiscal years, beginning with the Company’s fiscal year 2022, equal to the least of: • 2,070,784 shares of common stock; • a number of shares equal to 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year; or • such number of shares as the board of directors or its designated committee may determine. As a result of the evergreen increase, a total of 977,400 shares were added to the 2021 Plan on January 1, 2023. Shares issuable under the 2021 Plan are authorized, but unissued, or reacquired shares of common stock. If an award expires or becomes unexercisable without having been exercised in full, is surrendered pursuant to an exchange program, or, with respect to restricted stock, restricted stock units, performance units or performance shares, is forfeited to or repurchased by the combined company due to failure to vest, the unpurchased shares (or for awards other than stock options or stock appreciation rights, the forfeited or repurchased shares) will become available for future grant or sale under the 2021 Plan (unless the 2021 Plan has terminated). As of March 31, 2023, 296,343, 99,025 and 3,450,997 shares were outstanding under the Private Aadi Plan, 2017 Plan and 2021 Plan, respectively. As of March 31, 2023, no shares were outstanding under the 2011 Plan. The following table summarizes the stock option activity during the three months ended March 31, 2023: Stock Weighted Average Weighted Average Aggregate Outstanding, January 1, 2023 2,990,423 $ 19.28 8.59 $ 2,849 Granted 1,261,506 9.60 Exercised (1,983) 4.45 Expired/cancelled (403,581) 20.20 Outstanding as of March 31, 2023 3,846,365 $ 16.51 8.73 $ 1,259 Options exercisable as of March 31, 2023 851,373 $ 18.56 6.81 $ 1,127 Vested and expected to vest as of March 31, 2023 3,846,365 $ 16.51 8.73 $ 1,259 As of March 31, 2023, the aggregate intrinsic value of options outstanding was $1.3 million. For the three months ended March 31, 2023, and 2022, the weighted-average grant-date fair value of options granted was $8.57 and $14.80 per share, respectively. As of March 31, 2023, there was $30.9 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.83 years. The total intrinsic value of the options exercised during the three months ended March 31, 2023, and 2022, was $16,000 and $0.1 million, respectively As of March 31, 2023, and December 31, 2022, 568,368 and 853,760 shares were reserved for issuance under the 2021 Plan, respectively. Compensation Expense Summary The Company recognized the following compensation cost related to employee and non-employee share-based compensation activity for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Selling, general and administrative $ 1,640 $ 1,101 Research and development 1,100 680 Total $ 2,740 $ 1,781 The Company uses the Black-Scholes option pricing model to determine the estimated fair value for share-based awards. Option pricing and models require the input of various assumptions, including the option’s expected life, expected dividend yield, price volatility and risk-free interest rate of the underlying stock. The calculation was based on the following assumptions: Three Months Ended March 31, 2023 2022 Weighted average grant date fair value (per share) $8.57 $14.80 Risk-free interest rate 3.42% - 4.17% 1.46% - 1.76% Expected volatility 89.94% - 95.72% 85.99% - 86.25% Expected term (in years) 5.8 - 6.1 6.1 Expected dividend yield — — Merger Warrants to Purchase Common Stock The Company had warrants outstanding for the purchase of 29,167 shares of the Company’s common stock at both March 31, 2023, and December 31, 2022. These warrants were assumed in the Merger and were issued by Aerpio in October 2019, for the purchase of 40,000 shares (after taking into account the reverse stock split of the Company’s common stock at a ratio of 15:1 effected on August 26, 2021 immediately prior to the closing of the Merger, (the "Reverse Stock Split")) of the Company’s common stock at an exercise price of $7.29 per share (after taking into account the Reverse Stock Split). These warrants were fully vested as of the date of the Merger and expire on October 24, 2024. No warrants were exercised during the three months ended March 31, 2023. At the grant date, the fair value of these awards was determined using a Black-Scholes option pricing model. The number of shares and the exercise price shall be adjusted for standard anti-dilution events such as stock splits, combinations, reorganizations, or issue shares as part of a stock dividend. The warrants meet the criteria to be classified within stockholders’ equity. |
Employee Stock Purchase Plan
Employee Stock Purchase Plan | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Employee Stock Purchase Plan | Employee Stock Purchase Plan On August 17, 2021, a special meeting of the Company’s stockholders was held to approve the Merger and related matters, at which the Company's stockholders considered and approved the Company’s 2021 ESPP which permits participants to contribute up to 15% of their eligible compensation during defined rolling six-month offering periods to purchase the Company's common stock. The purchase price of the shares will be 85% of the lower of the fair market value of the Company's common stock on the first day of trading of the offering period or on the applicable purchase date. Upon approval of the 2021 ESPP by the stockholders, Aerpio’s Amended and Restated 2017 Employee Stock Purchase Plan terminated. An aggregate of 519,563 shares of common stock were initially reserved for issuance under the 2021 ESPP. The number of shares of common stock available for issuance under the 2021 ESPP will be increased on the first day of each fiscal year beginning with the 2022 fiscal year in an amount equal to the least of (i) 310,617 shares of common stock, (ii) one percent (1%) of the outstanding shares of all classes of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount to be determined by the board of directors or its designated committee no later than the last day of the immediately preceding fiscal year. On January 1, 2023, 244,350 share of common stock were added to the 2021 ESPP. Shares of common stock issuable under the 2021 ESPP will be authorized, but unissued, or reacquired shares of common stock. If the Company’s capital structure changes because of a stock dividend, stock split or similar event, the number of shares that can be issued under the 2021 ESPP will be appropriately adjusted. The Company opened enrollment into the ESPP in May 2022. The Company uses the Black-Scholes model to determine the estimated fair value for purchases under the 2021 ESPP. Black-Scholes models require the input of various assumptions, including the expected life, expected dividend yield, price volatility and risk-free interest rate of the underlying stock. The calculation was based on the following assumptions: Three Months Ended March 31, 2023 Strike price (per share) $11.40 - $11.66 Risk-free interest rate 1.54% - 4.40% Expected volatility 92.59% - 105.68% Expected term (in years) 0.5 Expected dividend yield — As of March 31, 2023, and December 31, 2022, 736,711 and 492,361 shares of common stock were available for issuance under the 2021 ESPP, respectively. The Company had an outstanding liability of $0.3 million and $0.1 million as of March 31, 2023, and December 31, 2022 , respectively, which will be recognized over six months. No shares were issued under the 2021 ESPP during the three months ended March 31, 2023, and 2022 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company recorded income tax expense of zero for the three months ended |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Litigation From time to time, the Company could be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. Regardless of the outcome, legal proceedings can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. On June 27, 2022, EOC filed a Request for Arbitration with the International Chamber of Commerce’s International Court of Arbitration against the Company. In the Request for Arbitration, EOC claims that the Company breached certain provisions of the EOC License Agreement, including failing to provide certain manufacturing information to EOC. As a result, EOC is seeking monetary damages. The arbitration process is ongoing. The Company intends to defend itself vigorously in this matter and pursue all relief to which the Company is entitled. The Company is unable to estimate the possible loss or range of loss, therefore no amounts have been accrued as of March 31, 2023. See Note 8 for more information about the EOC License Agreement and its termination. Purchase Commitments The Company has ongoing contracts with vendors for clinical trials and contract manufacturing. These contracts are generally cancellable, with notice, at the Company’s option. The Company recorded accrued expenses of $2.2 million and $2.8 million for expenditures incurred by clinical and contract manufacturing vendors as of March 31, 2023, and December 31, 2022, respectively. At March 31, 2023, the Company had one significant contract with Fresenius Kabi that contains specific activities including non-cancellable commitments, minimum purchase commitments, and binding annual forecasts. As of March 31, 2023, there were non-cancellable purchase commitments related to the purchase of inventory for $1.5 million to be paid in 2023. Mirati Collaboration In October 2022, the Company entered into a collaboration and supply agreement with Mirati Therapeutics, Inc. (“Mirati”) to evaluate the combination of Mirati’s adagrasib, a KRAS G12C selective inhibitor, and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors. Under the terms of the agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study and the Company will supply study drug and jointly share the cost of the study. The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial is to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and FYARRO in patients with KRAS G12C mutant solid tumors. In addition, the study will investigate the safety, tolerability and efficacy of adagrasib and FYARRO in combination in patients both with and without prior exposure to a KRAS G12C inhibitor. The trial will build on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and FYARRO relative to either agent alone. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements, and the related disclosures, have been prepared in accordance with GAAP and SEC regulations and, in the opinion of management include all adjustments necessary for a fair presentation of the results of operations, financial position, changes in stockholders’ equity and cash flows for each period presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). All adjustments are of a normal recurring nature. The Company’s condensed consolidated financial statements are stated in U.S. dollars. Certain prior year amounts have been reclassified to conform to the current year presentation. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited interim financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2023. |
Other Comprehensive Income | 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, including unrealized gains and losses on short-term investments. Comprehensive loss has been reflected in the condensed consolidated statements of operations and comprehensive loss for all periods presented. |
Segment Information | Segment InformationOperating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company has identified its Chief Executive Officer as the chief operating decision maker and the Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing proprietary therapeutics. All the assets and operations of the Company’s sole operating and reportable segment are located in the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. In the opinion of management, all adjustments that are considered necessary for fair presentation have been included. The most significant estimates in the Company’s condensed consolidated financial statements relate to fair value of the intangible asset, fair value of the convertible promissory notes, gross-to-net accruals, share-based compensation expense and accrued research and development costs. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents and investments in money market funds, United States government treasury bills, commercial paper, corporate bonds, and government agency debt securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. While the Company has not experienced any losses in such deposits, the recent failure of Silicon Valley Bank, at which the Company holds cash and cash equivalents in multiple accounts, exposed the Company to credit risk prior to the resolution by the Federal Deposit Insurance Corporation in a manner that fully protected all depositors. The Company has not experienced any losses on deposits since inception. The Company’s accounts receivable is derived from customers located in the United States. The Company performs ongoing credit evaluations of its customers and maintains allowances for potential credit losses on customers’ accounts when deemed necessary. The Company does not typically require collateral from its customers. Credit losses historically have not been material. The Company continuously monitors customer payments and maintains an allowance for credit losses based on its assessment of various factors including historical experience, age of the receivable balances, and other current economic conditions or other factors that may affect customers’ ability to pay. |
Cash and Cash Equivalents | Cash, Cash Equivalents and Restricted CashThe Company considers all highly liquid marketable securities purchased with original maturities of three months or less at the time of purchase date to be cash equivalents. |
Restricted Cash | Restricted cash consists of a letter of credit secured by restricted cash in connection with one of the Company's office leases described in Note 7, and is included in other assets on the condensed consolidated balance sheets. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The accounting guidance defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an 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 accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs, such as quoted prices in active markets Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions which reflect those that a market participant would use Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels. In determining the fair value of its financial instruments, the Company considers the source of observable market data inputs, liquidity of the instrument, the credit risk of the counterparty to the contract, and its risk of nonperformance. In the case fair value is not observable, for the items subject to fair value measurements, the Company applies valuation techniques deemed the most appropriate under the GAAP guidance based on the nature of the assets and liabilities being measured. The carrying amounts of cash equivalents, accounts receivable, prepaid expenses and other current assets, and accounts payable are reasonable estimates of their fair value because of the short maturity of these items. |
Short-Term Investments | Short-Term Investments The Company invests in various types of securities, including United States government treasury bills, commercial paper, corporate debt securities, and government agency bonds. The Company classifies its investments as available-for-sale and records them at fair value based upon market prices at period end. Unrealized gains and losses that are deemed temporary in nature are recorded in accumulated other comprehensive loss as a separate component of stockholders' equity. Dividend and interest income are recognized when earned. The Company recognizes purchase premiums and discounts as interest income using the interest method over the terms of the securities. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold. The Company classifies short-term investments with remaining maturities greater than one year as current assets because such short-term investments are available to fund the Company’s current operations. At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the decline in fair value below amortized cost is a result of credit losses or other factors, whether the Company expects to recover the amortized cost of the security, the Company's intent to sell and if it is more likely than not that the Company will be required to sell the securities before the recovery of amortized cost. The Company records changes in allowance for expected credit loss in other income (expense). There have been no allowance for expected credit losses recorded during any of the periods presented. See Note 4 for further information. |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable are recorded net of customer allowances for chargebacks and allowance for credit losses. Allowance for chargebacks is based on contractual terms. The Company estimates the allowance for credit losses based on existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances and credit loss. Receivables are recorded to an allowance for credit loss when it is probable that amounts will not be collected based on |
Inventory | InventoryInventory is stated at the lower of cost or estimated net realizable value. The Company uses actual costing methodology determined on a first-in, first-out method. The Company capitalizes inventory costs associated with its products based upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, consisting of computers, furniture and fixtures, office equipment, construction in process and leasehold improvements are stated at cost, less accumulated depreciation. Property and equipment is depreciated using the straight-line method over the estimated useful lives of the assets, generally three |
Leases | Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, the Company records the associated lease liability and corresponding right-of-use asset upon commencement of the lease using the implicit rate or a discount rate based on a credit-adjusted secured borrowing rate commensurate with the term of the lease. The Company does not recognize assets or liabilities for leases with lease terms of less than 12 months. The Company additionally evaluates leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: (i) the lease has a purchase option that is reasonably certain of being exercised, (ii) the present value of the future cash flows is substantially all of the fair market value of the underlying asset, (iii) the lease term is for a significant portion of the remaining economic life of the underlying asset, (iv) the title to the underlying asset transfers at the end of the lease term, or (v) if the underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease. Operating lease assets represent a right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. Operating lease liabilities with a term greater than one year and their corresponding right-of-use assets are recognized at the commencement date of the lease based on the present value of lease payments over the expected lease term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. As the Company’s leases do not typically provide an implicit rate, the Company utilizes the appropriate incremental borrowing rate, determined as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and in a similar economic environment. For finance leases, depreciation expense is recognized for the leased asset acquired and interest expense is recognized related to the portion of the financing in the condensed consolidated statements of operations and comprehensive loss . For operating leases, lease cost is recognized on a straight-line basis over the lease term and variable lease payments are recognized as operating expense in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company. The Company has elected the practical expedient to not separate between lease and non-lease components. |
Commitments and Contingencies | Commitments and Contingencies The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range. The Company has not recorded any such liabilities as of March 31, 2023 and December 31, 2022 . |
Revenue Recognition | Revenue Recognition and Related Allowances The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 606, Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Net Sales FYARRO was approved by the FDA in November 2021. On February 22, 2022, the Company launched sales of FYARRO to specialty distributors (“SDs”) and a specialty pharmacy (“SP”). The Company recognizes product sales when the SDs and SP obtain control of the product. Product sales are recorded at the net sales price, which includes provisions for the following allowances which are reflected either as a reduction to the related account receivable or as an accrued liability, depending on how the allowance is settled: Distribution Fees : Distribution fees include distribution service fees paid to the SDs and SP based on a contractually fixed percentage of the wholesale acquisition cost (“WAC”). Distribution fees are recorded as an offset to product sales based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowance for rebates includes mandated discounts under the Medicaid Drug Rebate Program and TRICARE program. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements. The allowance for rebates is based on contracted or statutory discount rates and expected utilization by benefit plan participants. The Company’s estimates for expected utilization of rebates are based on utilization data received from the SDs and SP since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment. Chargebacks: Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs and SP at a discounted price. The SDs and SP charge back to the Company the difference between the price initially paid by the SDs and SP and the discounted price paid to the SDs and SP by these entities. If actual future chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment. Co-Payment Assistance: The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirement. Co-payment assistance is accrued at the time of product sale to SDs and SP based on estimated patient participation and average co-pay benefit to be paid per a claim. The Company estimated amounts are compared to actual program participation and co-pay amounts paid using data provided by third-party administrators. If actual amounts differ from the original estimates the assumptions being applied are updated and adjustment for prior period accruals will be adjusted in the current period. Product Returns: Consistent with industry practice, the Company offers the SDs and SP limited product return rights for damages, shipment errors, and expiring product, provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SDs and SP and has the ability to control the amount of product that is sold to the SDs and SP the Company’s estimate of future potential product returns is based on the on-hand channel inventory data and sell-through data obtained from the SDs and SP. In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. Revenue Under License Agreement The Company generates revenues from payments received under a license agreement. Under such license agreement, the Company recognizes revenue when it transfers promised goods or services to partners in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with partners, the Company performs the following five steps: (i) identifies the promised goods or services in the contract; (ii) identifies the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determines the transaction price, including the constraint on variable consideration; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the Company satisfies the performance obligations. For revenue from such license agreement, the Company generally collects an upfront license payment from the license partner and is also entitled to receive event-based payments subject to the license partner’s achievement of specified development, regulatory and sales-based milestones. In addition, the Company is generally entitled to royalties if products under the license agreement are commercialized. Transaction price for a contract represents the amount to which the Company is entitled in exchange for providing goods and services to the partner. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment, all other fees the Company may earn under such license agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining regulatory approvals and successful completion of clinical trials. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. The Company does not include any amounts subject to uncertainties in the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Because such agreements generally only have one type of performance obligation, a license, which is generally all transferred at the same time as agreement inception, allocation of the transaction price among multiple performance obligations is not required. Upfront amounts allocated to licenses are recognized as revenue when the licenses are transferred to the partners. Development milestones and other fees are recognized in revenue when their occurrence becomes probable. |
Research and Development | Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical expenses, share-based compensation expense, contract services, and other external development expenses. The Company records research and development activities conducted by third-party service providers, which include work related to preclinical studies, clinical trials, and contract manufacturing activities, to research and development expense as incurred. The Company is required to estimate the amount of services provided but not yet invoiced and include these expenses in accrued expenses on the condensed consolidated balance sheets and within research and development expenses in the condensed consolidated statements of operations and comprehensive loss. These expenses are a significant component of the Company’s research and development expenses and require significant estimates and judgments. The Company accrues for these expenses based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. As actual expenses become known, the Company adjusts its accrued expenses. |
Share-Based Compensation and Employee Stock Purchase Plan | Share-Based Compensation The Company recognizes all share-based payments to employees, including grants of employee stock options in the condensed consolidated statements of operations and comprehensive loss based on their fair values. All of the Company’s share-based awards, to employees, non-employees, officers, and directors, are subject only to service-based vesting conditions. The Company estimates the fair value of its share-based awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (i) the expected stock price volatility, (ii) the calculation of expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Options granted during the year have a maximum contractual term of ten years. Forfeitures are recognized and accounted for as they occur. Due to the historical lack of a public market for the trading of the Company’s securities and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted to employees, officers, and directors using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees, and utilizes the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term. Employee Stock Purchase Plan |
Income Taxes | Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Basic and diluted weighted average shares of common stock outstanding for the three months ended March 31, 2023, includes the weighted average effect of 2,426,493 Pre-Funded Warrants (as defined below), which were issued in September 2022, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $0.0001 per share. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options” (Subtopic 470-20) and “Derivatives and Hedging – Contracts in Entity’s Own Equity” (Subtopic 815-40). This new guidance is intended to reduce the complexity of accounting for convertible instruments. The guidance also addresses how convertible instruments are accounted for in the diluted earnings per share calculation and requires enhanced disclosures about the terms of convertible instruments. Entities may adopt ASU 2020-06 using either a partial retrospective or fully retrospective method of transition. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years for smaller reporting companies. The Company is currently evaluating the impact the adoption of ASU 2020-06 will have on the Company’s consolidated financial statements. In 2016, the FASB issued ASU 2016-13 “ Financial Instruments - Credit Losses” which (i) significantly changes the impairment model for most financial assets that are measured at amortized cost and certain other instruments from an incurred loss model to an expected loss model which will be based on an estimate of current expected credit loss; and (ii) provides for recording credit losses on available-for-sale debt securities through an allowance account. The standard also requires certain incremental disclosures. Subsequently, the FASB issued several ASUs to clarify, improve, or defer the adoption of ASU 2016-13. The Company adopted ASU 2016-13 beginning in January 2023. The Company determined that the adoption of this standard did not result in a material impact to the condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Restricted Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Cash and cash equivalents $ 34,046 $ 39,019 Restricted cash, non-current 64 64 Total cash, cash equivalents and restricted cash $ 34,110 $ 39,083 |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Cash and cash equivalents $ 34,046 $ 39,019 Restricted cash, non-current 64 64 Total cash, cash equivalents and restricted cash $ 34,110 $ 39,083 |
Schedule of Inventory | Details of inventory are presented as follows (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 2,911 $ 944 Work in process — — Finished goods 892 917 Total $ 3,803 $ 1,861 |
Property, Plant and Equipment | Details of property and equipment are presented as follows (in thousands): March 31, 2023 December 31, 2022 Computers and Software $ 366 $ 338 Construction in process 1,805 77 Furniture and fixtures 65 65 Leasehold improvements 129 129 Total $ 2,365 $ 609 Accumulated depreciation (140) (101) Property and equipment, net $ 2,225 $ 508 |
Schedule Of Gross-To-Net Sales Adjustments | The following table sets forth the changes in the accrued revenue allowances (in thousands): Balance at Beginning of Year Provision for Current Period Sales Payments Balance at March 31, 2023 For the Three Months Ended March 31, 2023 $ 1,434 $ 1,035 $ (553) $ 1,916 Balance at Beginning of Year Provision for Current Period Sales Payments Balance at March 31, 2022 For the Three Months Ended March 31, 2022 $ — $ 407 $ — $ 407 |
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive (in thousands): Three Months Ended March 31, 2023 2022 Options to purchase common stock 3,846 2,028 Warrants to purchase common stock 29 29 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Assets and Liabilities Measured on Recurring Basis | The following table sets forth the recurring fair value of the Company’s financial assets and liabilities, allocated into the Level 1, Level 2 and Level 3 hierarchy that were measured at fair value on a recurring basis (in thousands): Fair Value Measurements as of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 23,654 $ — $ — $ 23,654 U.S. government treasury bills 50,076 — — 50,076 Commercial paper — 47,233 — 47,233 Corporate bonds — 4,260 — 4,260 Government agency — 15,559 — 15,559 Total financial assets $ 73,730 $ 67,052 $ — $ 140,782 Fair Value Measurements as of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 32,035 $ — $ — $ 32,035 U.S. government treasury bills 70,708 — — 70,708 Commercial paper — 53,296 — 53,296 Corporate bonds — 4,250 — 4,250 Government agency — 5,287 — 5,287 Total financial assets $ 102,743 $ 62,833 $ — $ 165,576 (1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheets. |
Short-Term Investments and Ca_2
Short-Term Investments and Cash Equivalents (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Short-Term Investments | The following table summarizes the Company's short-term investments (in thousands): As of March 31, 2023 Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Money market funds $ 23,654 $ — $ — $ 23,654 U.S. government treasury bills Less than 1 50,101 — (26) 50,075 Commercial paper Less than 1 47,233 — — 47,233 Corporate bonds Less than 1 4,280 — (20) 4,260 Government agency Less than 1 15,545 14 — 15,559 Total $ 140,813 $ 14 $ (46) $ 140,781 As of December 31, 2022 Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Money market funds $ 32,035 $ — $ — $ 32,035 U.S. government treasury bills Less than 1 70,812 4 (108) 70,708 Commercial paper Less than 1 53,296 — — 53,296 Corporate bonds Less than 1 4,276 — (26) 4,250 Government agency Less than 1 5,272 15 — 5,287 Total $ 165,691 $ 19 $ (134) $ 165,576 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Details of accrued liabilities are presented as follows (in thousands): March 31, December 31, Accrued professional fees $ 3,066 $ 1,814 Accrued salaries and payroll 2,306 1,299 Accrued bonus 1,496 5,463 Accrued clinical 1,333 2,399 Accrued contract manufacturing 898 405 Advanced customer payments — 1,571 Accrued other - sales related 1,150 1,435 Accrued other 584 536 Total accrued liabilities $ 10,833 $ 14,922 |
Operating Lease (Tables)
Operating Lease (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Summary of Information Related to Lease | The following table summarizes information related to the Company’s lease (in thousands): March 31, 2023 December 31, 2022 Assets: Operating lease right-of-use assets $ 1,437 $ 1,522 Liabilities: Operating lease liabilities, current $ 404 $ 394 Operating lease liabilities, non-current 1,164 1,267 Total operating lease liabilities $ 1,568 $ 1,661 |
Summary of Rent Expense Related to Lease | Rent expense for the three months ended March 31, 2023 and 2022 is presented on the following table (in thousands): Three Months Ended March 31, 2023 2022 Operating leases rent expense $ 116 $ 50 Cash paid for leases and included in operating cash flows for the three months ended March 31, 2023 and 2022 is presented on the following table (in thousands): Three Months Ended March 31, 2023 2022 Cash paid included in operating cash flows $ 124 $ 28 |
Summary of Future Minimum Lease Payments Required under Operating Lease | The future minimum lease payments required under the operating lease as of March 31, 2023, are summarized below (in thousands): Future Minimum Lease Payments: 2023 $ 377 2024 512 2025 320 2026 231 2027 280 Thereafter 110 Total minimum lease payments $ 1,830 Less: amount representing interest (262) Present value of operating lease liabilities $ 1,568 Less: operating lease liabilities, current (404) Operating lease liabilities, non-current $ 1,164 Remaining lease term (in years) 4.33 Incremental borrowing rate 7.48 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes the stock option activity during the three months ended March 31, 2023: Stock Weighted Average Weighted Average Aggregate Outstanding, January 1, 2023 2,990,423 $ 19.28 8.59 $ 2,849 Granted 1,261,506 9.60 Exercised (1,983) 4.45 Expired/cancelled (403,581) 20.20 Outstanding as of March 31, 2023 3,846,365 $ 16.51 8.73 $ 1,259 Options exercisable as of March 31, 2023 851,373 $ 18.56 6.81 $ 1,127 Vested and expected to vest as of March 31, 2023 3,846,365 $ 16.51 8.73 $ 1,259 |
Summary of Recognized Compensation Cost Related to Employee and Non-employee Stock-Based Compensation Activity | The Company recognized the following compensation cost related to employee and non-employee share-based compensation activity for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Selling, general and administrative $ 1,640 $ 1,101 Research and development 1,100 680 Total $ 2,740 $ 1,781 |
Stock Options Valuation Assumptions | The calculation was based on the following assumptions: Three Months Ended March 31, 2023 2022 Weighted average grant date fair value (per share) $8.57 $14.80 Risk-free interest rate 3.42% - 4.17% 1.46% - 1.76% Expected volatility 89.94% - 95.72% 85.99% - 86.25% Expected term (in years) 5.8 - 6.1 6.1 Expected dividend yield — — |
Compensation Related Costs, Sha
Compensation Related Costs, Share Based Payments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-Based Payment Award, Employee Stock Purchase Plan, Valuation Assumptions | The calculation was based on the following assumptions: Three Months Ended March 31, 2023 Strike price (per share) $11.40 - $11.66 Risk-free interest rate 1.54% - 4.40% Expected volatility 92.59% - 105.68% Expected term (in years) 0.5 Expected dividend yield — |
Nature of Organization and Op_2
Nature of Organization and Operations - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Accumulated deficit | $ (218,421) | $ (203,198) | |
Net loss | (15,223) | $ (13,857) | |
Cash, cash equivalents, and short-term investments | $ 151,200 | ||
Sales Agreement | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Issuance of common stock (in shares) | 0 | ||
Cowen and Company LLC | Common Stock | Sales Agreement | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Maximum aggregate offering prices | $ 75,000 | ||
Issuance of common stock (in shares) | 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 USD ($) segment $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Sep. 26, 2022 $ / shares shares | Oct. 31, 2019 $ / shares shares | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Common stock, shares outstanding (in shares) | shares | 24,436,990 | 24,435,007 | |||
Common stock, shares authorized (in shares) | shares | 300,000,000 | 300,000,000 | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Number of operating segments | segment | 1 | ||||
Cash and cash equivalents | $ 34,046,000 | $ 39,019,000 | |||
Allowance for doubtful accounts | 800,000 | 100,000 | |||
Allowance for credit losses | 0 | 0 | |||
Receivables written off | $ 0 | 0 | |||
Stock plan offering period | 6 months | ||||
Number of warrants issued to purchase common stock (in shares) | shares | 40,000 | ||||
Warrants exercise price (in dollars per share) | $ / shares | $ 7.29 | ||||
Private Placement Financing | Purchase Agreement | Pre-Funded Warrant | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Number of warrants issued to purchase common stock (in shares) | shares | 2,426,493 | 2,426,493 | |||
Warrants exercise price (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Product Sales Allowance | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Deduction from gross product sales for allowances | $ 1,035,000 | $ 407,000 | |||
Minimum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property and equipment estimated useful lives | 3 years | ||||
Maximum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property and equipment estimated useful lives | 5 years | ||||
Term of options granted | 10 years | ||||
Money Market Investments | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Cash and cash equivalents | $ 23,700,000 | $ 32,000,000 | |||
Company One | Revenue Benchmark | Customer Concentration Risk | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 51% | ||||
Company Two | Revenue Benchmark | Customer Concentration Risk | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 48% | ||||
Customer One | Accounts Receivable | Customer Concentration Risk | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 62% | ||||
Customer Two | Accounts Receivable | Customer Concentration Risk | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 37% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 34,046 | $ 39,019 | ||
Restricted cash, non-current | 64 | 64 | ||
Total cash, cash equivalents and restricted cash | $ 34,110 | $ 39,083 | $ 129,849 | $ 148,989 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Raw materials | $ 2,911 | $ 944 |
Work in process | 0 | 0 |
Finished goods | 892 | 917 |
Total | $ 3,803 | $ 1,861 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,365 | $ 609 |
Accumulated depreciation | (140) | (101) |
Property and equipment, net | 2,225 | 508 |
Computers and Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 366 | 338 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,805 | 77 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 65 | 65 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 129 | $ 129 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Gross-to-Net Sales Adjustments (Details) - Product Sales Allowance - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at Beginning of Year | $ 1,434 | $ 0 |
Provision for Current Period Sales | 1,035 | 407 |
Payments | (553) | 0 |
Balance at March 31, 2023 | $ 1,916 | $ 407 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Outstanding Potentially Dilutive Securities Excluded in Calculation of Diluted Net Loss per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total amount of anti-dilutive securities excluded from computation of earnings per share (in shares) | 3,846 | 2,028 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total amount of anti-dilutive securities excluded from computation of earnings per share (in shares) | 29 | 29 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | $ 140,781 | $ 165,576 |
Unrealized losses for cash equivalents and investments | 46 | 134 |
Net unrealized loss on investments | 32 | |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 23,654 | 32,035 |
Unrealized losses for cash equivalents and investments | 0 | 0 |
U.S. government treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 50,075 | 70,708 |
Unrealized losses for cash equivalents and investments | 26 | 108 |
Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 47,233 | 53,296 |
Unrealized losses for cash equivalents and investments | 0 | 0 |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 4,260 | 4,250 |
Unrealized losses for cash equivalents and investments | 20 | 26 |
Government agency | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 15,559 | 5,287 |
Unrealized losses for cash equivalents and investments | 0 | 0 |
Fair Value, Measurements, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 140,782 | 165,576 |
Fair Value, Measurements, Recurring | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 23,654 | 32,035 |
Fair Value, Measurements, Recurring | U.S. government treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 50,076 | 70,708 |
Fair Value, Measurements, Recurring | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 47,233 | 53,296 |
Fair Value, Measurements, Recurring | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 4,260 | 4,250 |
Fair Value, Measurements, Recurring | Government agency | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 15,559 | 5,287 |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 73,730 | 102,743 |
Fair Value, Measurements, Recurring | Level 1 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 23,654 | 32,035 |
Fair Value, Measurements, Recurring | Level 1 | U.S. government treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 50,076 | 70,708 |
Fair Value, Measurements, Recurring | Level 1 | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 1 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 1 | Government agency | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 67,052 | 62,833 |
Fair Value, Measurements, Recurring | Level 2 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 2 | U.S. government treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 2 | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 47,233 | 53,296 |
Fair Value, Measurements, Recurring | Level 2 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 4,260 | 4,250 |
Fair Value, Measurements, Recurring | Level 2 | Government agency | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 15,559 | 5,287 |
Fair Value, Measurements, Recurring | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | U.S. government treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | Government agency | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | $ 0 | $ 0 |
Short-Term Investments and Ca_3
Short-Term Investments and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 140,813 | $ 165,691 |
Unrealized Gains | 14 | 19 |
Unrealized Losses | (46) | (134) |
Fair Value | 140,781 | 165,576 |
Money market funds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 23,654 | 32,035 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | 23,654 | 32,035 |
U.S. government treasury bills | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 50,101 | 70,812 |
Unrealized Gains | 0 | 4 |
Unrealized Losses | (26) | (108) |
Fair Value | 50,075 | 70,708 |
Commercial paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 47,233 | 53,296 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | 47,233 | 53,296 |
Corporate bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 4,280 | 4,276 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (20) | (26) |
Fair Value | 4,260 | 4,250 |
Government agency | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 15,545 | 5,272 |
Unrealized Gains | 14 | 15 |
Unrealized Losses | 0 | 0 |
Fair Value | $ 15,559 | $ 5,287 |
Short-Term Investments and Ca_4
Short-Term Investments and Cash Equivalents - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Unrealized losses for cash equivalents and investments | $ 46 | $ 134 |
Unrealized Gains | $ 14 | $ 19 |
Intangible Asset - Additional I
Intangible Asset - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Aug. 26, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Impairment of acquired contract intangible asset | $ 74,200,000 | $ 3,700,000 | |
Contract intangible asset estimated fair value | $ 3,900,000 | ||
Percentage of future net cash proceeds will be remitted to CVR Holders | 90% | ||
Estimated useful life of intangible assets | 14 years 3 months 18 days | ||
Amortization expense | $ 0 | $ 100,000 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued professional fees | $ 3,066 | $ 1,814 |
Accrued salaries and payroll | 2,306 | 1,299 |
Accrued bonus | 1,496 | 5,463 |
Accrued clinical | 1,333 | 2,399 |
Accrued contract manufacturing | 898 | 405 |
Advanced customer payments | 0 | 1,571 |
Accrued other - sales related | 1,150 | 1,435 |
Accrued other | 584 | 536 |
Total accrued liabilities | $ 10,833 | $ 14,922 |
Operating Lease - Additional In
Operating Lease - Additional Information (Detail) | 1 Months Ended | ||
Apr. 30, 2022 | Aug. 31, 2021 | Apr. 30, 2019 | |
Los Angeles, California | |||
Lessee Lease Description [Line Items] | |||
Operating lease, agreement term | 28 months | ||
Operating lease, rent abatement period | 9 months | 4 months | |
Operating lease, lease amendment term | 3 years | ||
Operating lease, extend the term for an additional period | 3 years 6 months | ||
Morristown, New Jersey | |||
Lessee Lease Description [Line Items] | |||
Operating lease, agreement term | 73 months | ||
Operating lease, rent abatement period | 3 months | ||
Operating lease, rent escalation percentage | 2% |
Operating Lease - Summary of In
Operating Lease - Summary of Information Related to Lease (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Operating lease right-of-use assets | $ 1,437 | $ 1,522 |
Liabilities: | ||
Operating lease liabilities, current | 404 | 394 |
Operating lease liabilities, non-current | 1,164 | 1,267 |
Total operating lease liabilities | $ 1,568 | $ 1,661 |
Operating Lease - Summary of Re
Operating Lease - Summary of Rent Expense and Cash Paid for Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||
Operating leases rent expense | $ 116 | $ 50 |
Cash paid included in operating cash flows | $ 124 | $ 28 |
Operating Lease - Summary of Fu
Operating Lease - Summary of Future Minimum Lease Payments Required under Operating Lease (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Future Minimum Lease Payments: | ||
2023 | $ 377 | |
2024 | 512 | |
2025 | 320 | |
2026 | 231 | |
2027 | 280 | |
Thereafter | 110 | |
Total minimum lease payments | 1,830 | |
Less: amount representing interest | (262) | |
Total operating lease liabilities | 1,568 | $ 1,661 |
Less: operating lease liabilities, current | (404) | (394) |
Operating lease liabilities, non-current | $ 1,164 | $ 1,267 |
Remaining lease term (in years) | 4 years 3 months 29 days | |
Incremental borrowing rate | 7.48% |
License Agreements - Additional
License Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Nov. 22, 2021 | Aug. 30, 2021 | Dec. 31, 2021 | Jan. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 21, 2021 | |
Capitalized Contract Cost [Line Items] | ||||||||||
Royalties accrued on product sales | $ 400,000 | $ 200,000 | ||||||||
Due to licensor | $ 5,757,000 | $ 5,757,000 | ||||||||
Right to terminate the agreement | 120 days | |||||||||
Upfront payment | $ 14,000,000 | $ 14,000,000 | ||||||||
Total revenue | $ 14,000,000 | 5,867,000 | 2,307,000 | |||||||
Amount of certain development, regulatory, and sales milestones payments eligible to receive under license agreement | 257,000,000 | |||||||||
Celgene License Agreement | ||||||||||
Capitalized Contract Cost [Line Items] | ||||||||||
Payment of license fees | $ 5,800,000 | |||||||||
Related party transaction, balloon payment interest rate per annum | 4% | |||||||||
Celgene License Agreement | EOC Pharma (Hong Kong) Limited | ||||||||||
Capitalized Contract Cost [Line Items] | ||||||||||
Payment received from license agreement | $ 14,000,000 | |||||||||
Celgene License Agreement | ||||||||||
Capitalized Contract Cost [Line Items] | ||||||||||
Payments related to milestone | $ 0 | $ 0 | ||||||||
License fees, percentage of previously outstanding payment obligation | 50% | |||||||||
Due to licensor | $ 5,800,000 | |||||||||
Celgene License Agreement | EOC Pharma (Hong Kong) Limited | ||||||||||
Capitalized Contract Cost [Line Items] | ||||||||||
Payments related to milestone | $ 1,000,000 | |||||||||
Due to licensor | $ 200,000 | |||||||||
Sublicense fees, percentage | 20% | 20% | ||||||||
Total revenue | $ 1,000,000 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | |||
Sep. 26, 2022 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) vote $ / shares shares | Dec. 31, 2022 $ / shares shares | Oct. 31, 2019 $ / shares shares | |
Class Of Stock [Line Items] | |||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Common stock, shares outstanding (in shares) | 24,436,990 | 24,435,007 | |||
Number of warrants issued to purchase common stock (in shares) | 40,000 | ||||
Warrants exercise price (in dollars per share) | $ / shares | $ 7.29 | ||||
Dividends common stock declared or paid | $ | $ 0 | ||||
Common stock, votes per share | vote | 1 | ||||
Sales Agreement | |||||
Class Of Stock [Line Items] | |||||
ATM offering price | $ | $ 75,000,000 | ||||
ATM gross proceeds paid percentage | 3% | ||||
Issuance of common stock (in shares) | 0 | ||||
Purchase Agreement | Private Placement Financing | |||||
Class Of Stock [Line Items] | |||||
Issuance of common stock (in shares) | 3,373,526 | ||||
Sale of stock (in dollars per share) | $ / shares | $ 12.50 | ||||
Deferred offering costs paid for financing | $ | $ 300,000 | ||||
Issuance of common stock to PIPE Investors | $ | $ 72,200,000 | ||||
Purchase Agreement | Private Placement Financing | Pre-Funded Warrant | |||||
Class Of Stock [Line Items] | |||||
Sale of stock (in dollars per share) | $ / shares | $ 12.4999 | ||||
Number of warrants issued to purchase common stock (in shares) | 2,426,493 | 2,426,493 | |||
Warrants exercise price (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Aug. 26, 2021 shares | Feb. 28, 2017 | Mar. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) $ / shares | Jan. 01, 2023 shares | Dec. 31, 2022 USD ($) shares | Oct. 31, 2019 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares outstanding (in shares) | 3,846,365 | 2,990,423 | |||||
Aggregate intrinsic value of options outstanding | $ | $ 1,259 | $ 2,849 | |||||
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 8.57 | $ 14.80 | |||||
Intrinsic value of options exercised | $ | $ 16 | $ 100 | |||||
Warrants outstanding (in shares) | 29,167 | 29,167 | |||||
Number of warrants issued to purchase common stock (in shares) | 40,000 | ||||||
Reverse stock split ratio | 0.0667 | ||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 7.29 | ||||||
Number of warrants exercised (in shares) | 0 | ||||||
Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Term of options granted | 10 years | ||||||
Private Aadi Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock shares available for issuance (in shares) | 0 | ||||||
Vesting period | 4 years | ||||||
Shares outstanding (in shares) | 296,343 | ||||||
Private Aadi Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Term of options granted | 10 years | ||||||
2011 Plan and 2017 Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock options or similar awards granted, assumed through merger (in shares) | 0 | ||||||
2021 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock shares available for issuance (in shares) | 2,070,784 | 568,368 | 977,400 | 853,760 | |||
Percentage applied to the outstanding shares as annual increase in number of shares authorized for issuance | 4% | ||||||
Shares outstanding (in shares) | 3,450,997 | ||||||
Aggregate intrinsic value of options outstanding | $ | $ 1,300 | ||||||
Unrecognized compensation cost related to stock options | $ | $ 30,900 | ||||||
Weighted average period expected to be recognized | 2 years 9 months 29 days | ||||||
2021 Equity Incentive Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock options or similar awards granted, assumed through merger (in shares) | 764,154 | ||||||
Aerpio 2011 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares outstanding (in shares) | 0 | ||||||
Aerpio 2017 Stock Option and Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares outstanding (in shares) | 99,025 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Stock Option Shares | ||
Shares, Outstanding at beginning balance (in shares) | 2,990,423 | |
Shares, Granted (in shares) | 1,261,506 | |
Shares, Exercised (in shares) | (1,983) | |
Shares, Expired/cancelled (in shares) | (403,581) | |
Shares, Outstanding at ending balance (in shares) | 3,846,365 | 2,990,423 |
Shares, Options exercisable (in shares) | 851,373 | |
Shares, Vested and expected (in shares) | 3,846,365 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Outstanding at beginning balance (in dollars per share) | $ 19.28 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 9.60 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 4.45 | |
Weighted Average Exercise Price, Expired/cancelled (in dollars per share) | 20.20 | |
Weighted Average Exercise Price, Outstanding at ending balance (in dollars per share) | 16.51 | $ 19.28 |
Weighted Average Exercise Price, Options exercisable (in dollars per share) | 18.56 | |
Weighted Average Exercise Price, Vested and expected to vest (in dollars per share) | $ 16.51 | |
Weighted Average Remaining Contractual Term, Outstanding | 8 years 8 months 23 days | 8 years 7 months 2 days |
Weighted Average Remaining Contractual Term, Options exercisable | 6 years 9 months 21 days | |
Weighted Average Remaining Contractual Term, Vested and expected to vest | 8 years 8 months 23 days | |
Aggregate Intrinsic Value, Outstanding | $ 1,259 | $ 2,849 |
Aggregate Intrinsic Value, Options exercisable | 1,127 | |
Aggregate Intrinsic Value, Vested and expected to vest | $ 1,259 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Recognized Compensation Cost Related to Employee and Non-employee Stock-Based Compensation Activity (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation expense | $ 2,740 | $ 1,781 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation expense | 1,640 | 1,101 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Share-based compensation expense | $ 1,100 | $ 680 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Valuation Assumptions (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted-average grant date fair value (in dollars per share) | $ 8.57 | $ 14.80 |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.42% | 1.46% |
Expected volatility | 89.94% | 85.99% |
Expected term (in years) | 5 years 9 months 18 days | 6 years 1 month 6 days |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 4.17% | 1.76% |
Expected volatility | 95.72% | 86.25% |
Expected term (in years) | 6 years 1 month 6 days |
Employee Stock Purchase Plan -
Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | ||||
Aug. 17, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Jan. 01, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock plan offering period | 6 months | ||||
Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Maximum employee contribution | 15% | ||||
Offering period | 6 months | ||||
Purchase price percent of shares | 85% | ||||
Common stock shares available for issuance (in shares) | 519,563 | 244,350 | |||
Maximum number of shares provided for issuance (in shares) | 310,617 | ||||
Percentage of annual increase in number of shares reserved for issuance | 1% | ||||
Common stock available from issuance (in shares) | 736,711 | 492,361 | |||
Employee stock purchase plan liability | $ 0.3 | $ 0.1 | |||
Issuance of shares under the employee stock purchase plan (in shares) | 0 | 0 |
Employee Stock Purchase Plan _2
Employee Stock Purchase Plan - Calculation Assumptions (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 9 months 18 days | 6 years 1 month 6 days |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 1.54% | |
Risk-free interest rate, Maximum | 4.40% | |
Expected volatility, Minimum | 92.59% | |
Expected volatility, Maximum | 105.68% | |
Expected term (in years) | 6 months | |
Expected dividend yield | 0% | |
Employee Stock Purchase Plan | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Strike price (per share) | $ 11.40 | |
Employee Stock Purchase Plan | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Strike price (per share) | $ 11.66 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Accrued clinical and contract manufacturing expense | $ 2.2 | $ 2.8 |
Purchase commitments to be paid | 1.5 | |
Incurred collaboration and supply agreement expense | $ 0.4 |