0001558370-23-003738 | 10-K | XBRL Viewer

Summary of significant accounting policies

2. Significant accounting policies

Basis of presentation

The accompanying financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern.

Use of estimates

The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including estimates related to revenue recognition, including returns, rebates, and other pricing adjustments, accrued and prepaid clinical trial expense and other general accruals and stock-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable. Actual results could differ from such estimates.

Segment and geographic information

Operating segments are defined as components of an enterprise about which separate discrete information is available and regularly reviewed by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing drugs for the treatment of cancer. All material long-lived assets of the Company reside in the United States.

Proceeds from grants

During the year ended December 31, 2022, the Company was awarded the “Therapeutic Accelerator Award” grant from Pancreatic Cancer Network (“PanCAN”) for up to $3.8 million (the “PanCAN Grant”). In August 2022, PanCAN agreed to provide the Company with an additional $0.5 million for the collection and analysis of patient samples. The grant is expected to support a Phase 1b/2 clinical trial of GEMZAR (gemcitabine) and ABRAXANE (Nab-paclitaxel) in combination with avutometinib and defactinib entitled RAMP 205. The RAMP 205 trial will evaluate whether combining avutometinib (to target mutant KRAS which is mutated in more than 90% of pancreatic tumors) and defactinib (to reduce stromal density and adaptive resistance to avutometinib) to the standard GEMZAR/ABRAXANE regimen improves outcomes for patients with pancreatic cancer. The Company received $1.0 million of cash proceeds in July 2022 which was initially recorded as deferred liabilities on the balance sheet. The Company recognizes grants as contra research and development expense in the consolidated statement of operations and comprehensive loss on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate. The Company recorded $0.3 million of the proceeds as a reduction of research and development expense during the year ended December 31, 2022. As of December 31, 2022, the Company recorded $0.7 million as deferred liabilities in the consolidated balance sheet related to the PanCAN Grant.

Cash, cash equivalents and restricted cash

The Company considers all highly liquid investments with an original or remaining maturity of three months or less at the date of purchase to be cash equivalents. Cash equivalents consist of a U.S. Government money market funds and corporate bonds and commercial paper of publicly traded companies. Cash equivalents are reported at fair value.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands):


	December 31, 2022		December 31, 2021
Cash and cash equivalents	$	74,933	$	21,252
Restricted cash		856		241
Total cash, cash equivalents and restricted cash	$	75,789	$	21,493

Amounts included in restricted cash as of December 31, 2022 represent (i) cash received pursuant to the PanCAN Grant restricted for future expenditures for specific research and development activities and (ii) cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amounts of $0.6 million and $0.2 million, respectively. Amounts included in restricted cash as of December 31, 2021 represent cash held to collateralize outstanding letters of credit provided as a security deposit for the Company’s office space located in Needham, Massachusetts in the amount of $0.2 million. Cash received pursuant to the PanCAN Grant is included in prepaid expenses and other current assets on the consolidated balance sheet as of December 31, 2022. The letters of credit are included in non-current restricted cash on the consolidated balance sheets as of December 31, 2022 and December 31, 2021.

Fair value of financial instruments

The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:


Level 1 inputs		Quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date.
Level 2 inputs		Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3 inputs		Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

Items Measured at Fair Value on a Recurring Basis

The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands)


	December 31, 2022
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	73,613	$	72,617	$	996	$	—
Short-term investments		12,961		—		12,961		—
Total financial assets	$	86,574	$	72,617	$	13,957	$	—


	December 31, 2021
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	19,302	$	19,302	$	—	$	—
Short-term investments		79,004		—		79,004		—
Total financial assets	$	98,306	$	19,302	$	79,004	$	—

The investments and cash equivalents have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of December 31, 2022 and 2021.

Fair Value of Financial Instruments

The fair value of the Company’s 2018 issued 5.00% Convertible Senior Notes due 2048 (the “2018 Notes”) was approximately $0.3 million as of December 31, 2022, which equals the carrying value of the 2018 Notes as of December 31, 2022. The fair value of the 2018 Notes was approximately $0.3 million as of December 31, 2021, which differed from the carrying value of the 2018 Notes of $0.2 million as of December 31, 2021. The fair value of the 2018 Notes is influenced by the Company’s stock price, stock price volatility, and current market yields and was determined using Level 3 inputs.

The fair value of the Company’s long-term debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments as of the consolidated balance sheet date. The carrying value of the Company’s long-term debt as of December 31, 2022, was approximately $24.5 million. The Company estimates that the fair value of its long-term debt was approximately $24.9 million as of December 31, 2022. There was no long-term debt outstanding as of December 31, 2021. The fair value of the Company’s long-term debt was determined using Level 3 inputs.

Investments

Investments and cash equivalents consist of investments in a U.S. Government money market funds, overnight repurchase agreements collateralized by government agency securities or U.S. Treasury securities, corporate bonds and commercial paper of publicly traded companies that are classified as available-for-sale pursuant to Accounting Standards Codification (ASC) Topic 320, Investments—Debt and Equity Securities. The Company classifies investments available to fund current operations as current assets on its consolidated balance sheets. Debt securities are carried at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity, until such gains and losses are realized. The fair value of these securities is based on quoted prices for identical or similar assets. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is transferred from other comprehensive loss to the consolidated statements of operations and comprehensive loss.

The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers the intent to sell, or whether it is more likely than not that the Company will be required to sell, the investment before recovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to year end. Realized gains and losses are determined using the specific identification method and are included in interest income in the consolidated statements of operations and comprehensive loss.

There were no realized gains or losses on investments for the years ended December 31, 2022, 2021 or 2020. There were two debt securities and three debt securities in an unrealized loss position as of December 31, 2022 and December 31, 2021, respectively. None of these investments had been in an unrealized loss position for more than 12 months as of December 31, 2022, or December 31, 2021. The fair value of these securities as of December 31, 2022, and December 31, 2021, was $6.0 million and $15.8 million, respectively, and the aggregate unrealized loss was immaterial. The Company considered the decline in the market value for these securities to be primarily attributable to current economic conditions. As it was not more likely than not that the Company would be

required to sell these securities before the recovery of their amortized cost basis, which may be at maturity, the Company did not consider these investments to be other-than-temporarily impaired as of December 31, 2022, and December 31, 2021, respectively.

Cash, cash equivalents, restricted cash and investments consist of the following (in thousands):


	December 31, 2022
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	74,794	$	—	$	—	$	74,794
Corporate bonds, agency bonds and commercial paper (due within 90 days)		995		—		—		995
Total cash, cash equivalents & restricted cash:	$	75,789	$	—	$	—	$	75,789
Investments:
Corporate bonds, agency bonds and commercial paper (due within 1 year)	$	12,961	$	2	$	(2)	$	12,961
Total investments	$	12,961	$	2	$	(2)	$	12,961
Total cash, cash equivalents, restricted cash and investments	$	88,750	$	2	$	(2)	$	88,750


	December 31, 2021
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	21,493	$	—	$	—	$	21,493
Total cash, cash equivalents & restricted cash:	$	21,493	$	—	$	—	$	21,493
Investments:
Corporate bonds and commercial paper (due within 1 year)	$	78,970	$	48	$	(14)	$	79,004
Total investments	$	78,970	$	48	$	(14)	$	79,004
Total cash, cash equivalents, restricted cash and investments	$	100,463	$	48	$	(14)	$	100,497

Concentrations of credit risk and off-balance sheet risk

Cash and cash equivalents, investments, and trade accounts receivable are financial instruments that potentially subject the Company to concentrations of credit risk. The Company mitigates this risk by maintaining its cash and cash equivalents and investments with high quality, accredited financial institutions. The management of the Company’s investments is not discretionary on the part of these financial institutions. As of December 31, 2022, the Company’s cash, cash equivalents and investments were deposited at three financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.

As of December 31, 2022, and 2021, there was one customer, Secura, that made up more than 60% of the Company’s trade accounts receivable balance. The Company assesses the creditworthiness of all its customers and sets and reassesses customer credit limits to ensure collectability of any trade accounts receivable balances are assured.

For the year ended December 31, 2022 and 2021, one customer, Secura, individually accounted for all of the Company’s total revenue. Refer to Note 13. License, collaboration, and commercial agreements for a detailed discussion of the Secura APA.

Property and equipment

Property and equipment consist of laboratory equipment, office furniture, computer equipment and leasehold improvements. Expenditures for repairs and maintenance are recorded to expense as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation and amortization are calculated using the straight-line method over the following estimated useful lives of the assets:


Laboratory equipment		5 years
Furniture		5 years
Computer equipment		3 years
Leasehold improvements		Lesser of useful life or life of lease

Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized.

The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying value of assets may not be recoverable. Recoverability is measured by comparison of the asset’s book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses have been recorded through December 31, 2022.

Research and development costs

The Company expenses research and development costs to operations as incurred. Research and development expenses consist of:

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employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;

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external research and development expenses incurred under arrangements with third parties, such as clinical research organizations (“CROs”), clinical trial sites, manufacturing organizations and consultants, including the scientific advisory board;

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license fees;

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facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, and laboratory supplies; and

Costs for certain development activities, such as clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to the Company by its vendor on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid expenses and other current assets or accrued expenses.

Stock-based compensation

For service-based equity awards, the Company recognizes stock-based compensation expense for stock options, and restricted stock units (“RSUs”) issued to employees, directors, and consultants based on the grant date fair value of the awards on a straight-line basis over the requisite service period, which typically is the vest period. The Company recognized stock-based compensation for shares issued to employees under the Company’s employee stock purchase plan (“ESPP”) plan.

The Company has granted performance-based RSUs and stock options with terms that allow the recipients to vest in a specific number of shares based upon the achievement of performance-based milestones as specified in the grants. Stock-based compensation expense associated with these performance-based RSUs and stock options is recognized if the performance condition is considered probable of achievement using the Company’s best estimates of the time to vesting for the achievement of the performance-based milestones. Awards subject to performance-

based vesting requirements are expensed utilizing an accelerated attribution model if achievement of the performance criteria is determined to be probable.

The grant date fair value of stock options is estimated using the Black-Scholes option pricing model that takes into account the fair value of its common stock, the exercise price, the expected life of the option, the expected volatility of its common stock, expected dividends on its common stock, and the risk-free interest rate over the expected life of the option. The Company applies the simplified method described in the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin (“SAB”) Topic 14.D.2 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. 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 population. The Company has not paid and do not anticipate paying cash dividends on the Company’s shares of common stock; therefore, the expected dividend yield is assumed to be zero. The computation of expected volatility is based on the historical volatility of the Company’s common stock. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The Company accounts for forfeitures as they occur.

The Company issues shares under the Company’s ESPP to employees. Stock-based compensation expense for discounted purchases under the ESPP is measured using the Black-Scholes model to compute the fair value of the lookback provision plus the purchase discount and is recognized as compensation expense over the offering period.

Leases

Leases are accounted for in accordance with ASC Topic 842, Leases (“ASC 842”). This standard requires lessees to recognize in the statement of financial position a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term for both finance and operating leases.

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances within the arrangement. A lease is identified where an arrangement conveys the right to control the use of identified property, plant, and equipment for a period of time in exchange for consideration. Leases which are identified within the scope of ASC 842 and which have a term greater than one year are recognized on the Company’s consolidated balance sheets as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize leases with terms of one year or less on its consolidated balance sheets. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates to calculate the present value of lease payments. Incremental borrowing rates are the rates the Company incurs to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

In accordance with ASC 842, components of a lease are split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, maintenance, consumables, etc.), and non-components (e.g., property taxes, insurance, etc.). The fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain practical expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating right-of-use asset being recorded on the consolidated balance sheets and amortized on a straight-line basis as lease expense.

Revenue recognition

The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services in accordance with ASC Topic 606 Revenue from Contracts with Customers (ASC 606). To determine revenue recognition for contracts with its customers, the Company performs the following five step assessment: (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 entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception and once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines which goods and services 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 revenue, net

Product Revenue, Net – The Company sold COPIKTRA to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resold COPIKTRA either directly to patients or to community hospitals or oncology clinics with in-office dispensaries who in turn distribute COPIKTRA to patients. In addition to distribution agreements with customers, the Company also entered into arrangements with (1) certain government agencies and various private organizations (Third-Party Payers), which may provide for chargebacks or discounts with respect to the purchase of COPIKTRA, and (2) Medicare and Medicaid, which may provide for certain rebates with respect to the purchase of COPIKTRA.

The Company recognized revenue on sales of COPIKTRA when a customer obtains control of the product, which occurs at a point in time (typically upon delivery). Product revenues are recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration include trade discounts and allowances, Third-Party Payer chargebacks and discounts, government rebates, other incentives, such as voluntary co-pay assistance, product returns, and other allowances that are offered within contracts between the Company and customers, payors, and other indirect customers relating to the Company’s sale of COPIKTRA. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability. These estimates take into consideration a range of possible outcomes based upon relevant factors such as customer contract terms, information received from third parties regarding the anticipated payor mix for COPIKTRA, known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled with respect to sales made.

The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under contracts will not occur in a future period. The Company’s analyses contemplate the application of the constraint in accordance with ASC 606. For the year ended December 31, 2020, the Company determined a material reversal of revenue would not occur in a future period for the estimates detailed below and, therefore, the transaction price was not reduced further. There was not any product revenue, net recorded for the year ended December 31, 2021 and 2022. Actual amounts of consideration ultimately received may differ from the Company’s estimates. However, as of December 31, 2022, there are not any reserve balances associated with product revenue, net.

Trade Discounts and Allowances: The Company generally provided customers with invoice discounts on sales of COPIKTRA for prompt payment, which are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensated its specialty distributor customers for sales order management, data, and distribution services. The Company has determined such services are not distinct from the Company’s sale of COPIKTRA to the specialty distributor customers and, therefore, these payments have also been recorded as a reduction of revenue within the

consolidated statements of operations and comprehensive loss for the year ended December 31, 2020. There were no amounts recorded for the years ended December 31, 2022 and 2021.

Third-Party Payer Chargebacks, Discounts and Fees: The Company executed contracts with Third-Party Payers which allowed for eligible purchases of COPIKTRA at prices lower than the wholesale acquisition cost charged to customers who directly purchase the product from the Company. In some cases, customers charged the Company for the difference between what they paid for COPIKTRA and the ultimate selling price to the Third-Party Payers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net. Chargeback amounts are generally determined at the time of resale to the qualified Third-Party Payer by customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at the end of each reporting period that the Company expects will be sold to Third-Party Payers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit. In addition, the Company compensated certain Third-Party Payers for administrative services, such as account management and data reporting. These administrative service fees have also been recorded as a reduction of product revenue within the consolidated statements of operations and comprehensive loss for the year ended December 31, 2020. There were no amounts recorded for the years ended December 31, 2022 and 2021.

Government Rebates: The Company was subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.

Other Incentives: Other incentives which the Company offered include voluntary co-pay assistance programs, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive for product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses on the consolidated balance sheets.

Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel.

Subject to certain limitations, the Company’s return policy allows for eligible returns of COPIKTRA for credit under the following circumstances:

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Receipt of damaged product;

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Shipment errors that were a result of an error by the Company;

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Expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date;

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Product subject to a recall; and

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Product that the Company, at its sole discretion, has specified can be returned for credit.

If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from product revenue. The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less.

Licenses and sales of intellectual property

Licenses of Intellectual Property - The Company may enter into collaboration and licensing arrangements for research and development, manufacturing, and commercialization activities with collaboration partners for the development and commercialization of its product candidates, which have components within the scope of ASC 606. The arrangements generally contain multiple elements or deliverables, which may include (i) licenses, or options to obtain licenses, to the Company’s intellectual property or sale of the Company’s license, (ii) research and development activities performed for the collaboration partner, (iii) participation on joint steering committees, and (iv) the manufacturing of commercial, clinical or preclinical material. Payments pursuant to these arrangements typically include non-refundable, upfront payments, milestone payments upon the achievement of significant development events, research and development reimbursements, sales milestones, and royalties on product sales. The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in a future period. The contracts into which the Company enters generally do not include significant financing components.

In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its collaboration and license agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract within the scope of ASC 606; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above; and d) the measure of progress in step (v) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties on license arrangements, should be included in the transaction price as described further below.

If a license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. In assessing whether a promise or performance obligation is distinct from the other elements, the Company considers factors such as the research, development, manufacturing and commercialization capabilities of the collaboration partner and the availability of its associated expertise in the general marketplace. In addition, the Company considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining elements, whether the value of the promise is dependent on the unsatisfied promise, whether there are other vendors that could provide the remaining promise, and whether it is separately identifiable from the remaining promise. For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure as of progress of each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The measure of progress, and thereby periods over which revenue should be recognized, is subject to estimates by management and may change over the course of the arrangement. Such a change could have a material impact on the amount of revenue the Company records in future periods.

Customer Options: If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services such as research and development services or manufacturing services, the goods and services underlying the customer options are not considered to be performance obligations at the inception of the arrangement; rather, such goods and services are contingent on exercise of the option, and the associated option fees are not included in the transaction price. The Company evaluates customer options for material rights or options

to acquire additional goods or services for free or at a discount. If a customer option is determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the estimated probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.

Milestone Payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the respective milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

Royalties: For license arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.

For sales of license and intellectual property, that include sale-based royalties, including milestone payments based on a level of sales, the Company evaluates whether the royalties and sales-based milestones are considered probable of being achieved and estimates the amount of royalties to include over the contractual term using the expected value method and estimates the sales-based milestones using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated royalty and milestone value is included in the transaction price. Royalties and sales-based milestones for territories for which there is not regulatory approval are not considered probable until such regulatory approval is achieved. The Company evaluates factors such as whether consideration is outside of the Company’s control, timeline for when the uncertainty will be resolved and historical sales of COPIKTRA if applicable. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and amount of royalty revenue to be received and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

Collaborative arrangements

Collaborative Arrangements: Contracts are considered to be collaborative arrangements when they satisfy the following criteria defined in ASC Topic 808, Collaborative Arrangements (ASC 808): (i) the parties to the contract must actively participate in the joint operating activity and (ii) the joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful. Payments received from or made to a partner that are the result of a collaborative relationship with a partner, instead of a customer relationship, such as co-development activities, are recorded as a reduction or increase to research and development expense, respectively.

Accounts receivable, net

Accounts receivable, net consists of amounts due from customers, net of applicable revenue reserves. Accounts receivable have standard payments that generally require payment within 30 to 90 days. The Company analyzes accounts that are past due for collectability and provides an allowance for receivables when collection

becomes doubtful. Given the nature and credit profile of the Company’s limited number of customers, an allowance for doubtful accounts is not deemed necessary at December 31, 2022.

Income taxes

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if current evidence indicates that it is considered more likely than not that these benefits will not be realized.

The Company recognizes the tax effects of an uncertain tax position only if it is more likely than not that it will be sustained based solely on its technical merits as of the reporting date and only in an amount more likely than not that it will be sustained upon review by the tax authorities. The Company evaluates uncertain tax positions on a quarterly basis and adjust the liability for changes in facts and circumstances, such as new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, significant amendment to an existing tax law, or resolution of an examination. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences will impact the income tax provision in the period in which such determination is made. The resolution of its uncertain income tax positions is dependent on uncontrollable factors such as law changes, new case law, and the willingness of the income tax authorities to settle, including the timing thereof and other factors. Although the Company does not anticipate significant changes to its uncertain income tax positions in the next twelve months, items outside of its control could cause its uncertain income tax positions to change in the future, which would be recorded in its statements of operations. Interest and/or penalties related to income tax matters are recognized as a component of income tax expense.

Net operating loss (“NOL”) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years.

The Company experienced a greater than 50% change in ownership as defined under Section 382 and 383 of the Internal Revenue Code as well as similar state provisions during the year ended December 31, 2020. For more details please refer to Note 11. Income Taxes.

Net loss per share

Basic net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is calculated by increasing the denominator by the weighted-average number of additional shares that could have been outstanding from securities convertible into common stock, such as stock options, restricted stock units and warrants (using the “treasury stock” method), Notes and Series A Preferred Stock (using the “if-converted” method), unless their effect on net loss per share is antidilutive. The effect of computing diluted net loss per common share was antidilutive for any potentially issuable shares of common stock from the conversion of stock options, restricted stock units and warrants and, as such, have been excluded from the calculation. However, under the “if-converted” method, convertible instruments that are-in-the-money, are assumed to have been converted as of the beginning of the period or when issued, if later. Additionally, the effects of any interest expense and changes in fair value of bifurcated derivatives shall be added back to the numerator of the diluted net loss per share calculation. Refer to Note 10. Net Loss per share for further details related to the calculation of net loss per share.

Recently issued accounting standards updates

In June 2016, the FASB issued Accounting Standard Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will replace the incurred loss impairment methodology under current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. In November 2019, the FASB issued ASU 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives (Topic 815), and Leases (Topic 842). This ASU delayed the required adoption for SEC filers that are smaller reporting companies as of their determination on November 15, 2019, until annual and interim periods beginning after December 15, 2022, with early adoption permitted. The Company has determined that as of November 15, 2019, it is a smaller reporting company and has not elected to early adopt this standard. The Company is currently evaluating the impact the adoption of the standard will have on its consolidated financial statements and related disclosures.

In August 2020, the FASB issued No. 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) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The ASU also simplifies the diluted earnings per share (“EPS”) calculation in certain areas. For smaller reporting companies, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The Company is currently evaluating the impact ASU 2020-06 will have on its consolidated financial statements and related disclosures.

Property and equipment, net

12 Months Ended

Dec. 31, 2022

Property and equipment, net

Property and equipment, net

3. Property and equipment, net

Property and equipment and related accumulated depreciation are as follows (in thousands):


	December 31,		December 31,
	2022		2021
Leasehold improvements	$	146	$	146
Furniture and fixtures		811		1,074
Computer equipment		665		665
		1,622		1,885
Less: accumulated depreciation		(1,530)		(1,675)
Total property and equipment, net	$	92	$	210

The Company recorded approximately $0.1 million, $0.2 million, and $0.5 million in depreciation expense for the years ended December 31, 2022, 2021, and 2020, respectively.

Accrued expenses

12 Months Ended

Dec. 31, 2022

Accrued expenses

Accrued expenses

4. Accrued expenses

Accrued expenses consist of the following (in thousands):


	December 31, 2022		December 31, 2021
Research and development expenses	$	8,535	$	9,311
Compensation and related benefits		3,844		3,892
Professional fees		469		785
Consulting fees		902		544
Interest		192		3
Commercialization costs		148		187
Other		893		899
Total accrued expenses	$	14,983	$	15,621

Long-term debt

12 Months Ended

Dec. 31, 2022

Long-term debt

Debt

5. Long-term debt

Oxford

On March 25, 2022 (the “Closing Date”), the Company entered into a loan and security agreement (the “Loan Agreement”) with Oxford, as collateral agent and a lender, and Oxford Finance Credit Fund III LP, as a lender (“OFCF III” and together with Oxford, the “Lenders”), pursuant to which the Lenders have agreed to lend the Company up to an aggregate principal amount of $150.0 million in a series of term loans (the “Term Loans”).

Pursuant to the Loan Agreement, the Company received an initial Term Loan of $25.0 million on the Closing Date and may borrow an additional $125.0 million of Term Loans at its option upon the satisfaction of certain conditions as follows:

$15.0 million (the “Term B Loan”), when the Company has either (a) received the Regulatory Milestone Payment (as defined in the Secura APA) from Secura of $35.0 million which is due upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma (“PTCL”) or (b) received at least $50.0 million in unrestricted cash proceeds from the sale or issuance of equity securities after the Closing Date (the “Term B Milestones”). The Company may draw the Term B Loan within 60 days after the occurrence of one of the Term B Milestones, but no later than March 31, 2023.

ii.

$25.0 million (the “Term C Loan”), when the Company has received accelerated or full approval from the FDA of avutometinib for the treatment of LGSOC (the “Term C Milestone”). The Company may draw the Term C Loan within 60 days after the occurrence the Term C Milestone, but no later than March 31, 2024.

iii.

$35.0 million (the “Term D Loan”), when the Company has achieved at least $50.0 million in gross product revenue calculated on a trailing six-month basis (the “Term D Milestone”). The Company may draw the Term D Loan within 30 days after the occurrence of the Term D Milestone, but no later than March 31, 2025.

iv.

$50.0 million (the “Term E Loan”), at the sole discretion of the Lenders.

The Term Loans bear interest at a floating rate equal to (a) the greater of (i) the one-month CME Secured Overnight Financing Rate and (ii) 0.13% plus (b) 7.37%, which is subject to an overall floor and cap. Interest is payable monthly in arrears on the first calendar day of each calendar month. Beginning (i) April 1, 2024, if the Term B Loan is not made, (ii) April 1, 2025, if the Term B Loan is made, or (iii) April 1, 2026, if the Term B Loan is made and either (A) avutometinib has received FDA approval for the treatment of LGSOC or (B) COPIKTRA has received FDA approval for the treatment of PTCL, the Company shall repay the Term Loans in consecutive equal monthly payments of principal, together with applicable interest, in arrears. All unpaid principal and accrued and unpaid interest with respect to each Term Loan is due and payable in full on March 1, 2027.

The Company is required to make a final payment of 5.0% of the original principal amount of the Term Loans that are drawn, payable at maturity or upon any earlier acceleration or prepayment of the Term Loans (the “Final Payment Fee”). The Company may prepay all, but not less than all, of the Term Loans, subject to a prepayment fee equal to (i) 3.0% of the principal amount of the applicable Term Loan if prepaid on or before the first anniversary date of the funding date of such Term Loan, (ii) 2.0% of the principal amount of the applicable Term Loan if prepaid after the first anniversary and on or before the second anniversary of the funding date of such Term Loan, and (iii) 1.0% of the principal amount of the applicable Term Loan if prepaid after the second anniversary of the applicable funding date of such Term Loan. All Term Loans are subject to a facility fee of 0.5% of the principal amount.

The Loan Agreement contains no financial covenants. The Loan Agreement includes customary events of default, including, among others, payment defaults, breach of representations and warrants, covenant defaults, judgment defaults, insolvency and bankruptcy defaults, and a material adverse change. The occurrence of an event of default could result in the acceleration of the obligations under the Loan Agreement, termination of the Term Loan commitments and the right to foreclose on the collateral securing the obligations. During the existence of an event of default, the Term Loans will accrue interest at a rate per annum equal to 5.0% above the otherwise applicable interest rate.

In connection with the Loan Agreement, the Company granted Oxford a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property (but including the right to payments and proceeds of intellectual property), and a negative pledge on intellectual property.

The Company assessed all terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the Loan Agreement, including put and call features. The Company determined that all features of the Loan Agreement were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. There have been no changes to the Company’s assessment through December 31, 2022.

The debt issuance costs and the Final Payment Fee have been recorded as a debt discount which are being accreted to interest expense through the maturity date of the Term Loan using the effective interest method. The components of the carrying value of the debt as of December 31, 2022 (in thousands):


	December 31, 2022
Principal loan balance	$	25,000
Final Payment Fee		225
Debt issuance costs, net of accretion		(699)
Long-term debt, net of discount	$	24,526

As of December 31, 2022, future principal payments due are as follows (in thousands):


2023		—
2024		6,250
2025		8,333
2026		8,333
2027		2,084
Total principal payments	$	25,000

Hercules

On March 21, 2017, the Company entered into a term loan facility of up to $25.0 million with Hercules Capital, Inc. (“Hercules”). The term loan facility was governed by a loan and security agreement, dated March 21, 2017 (the “Original Loan Agreement”). The Original Loan Agreement was amended on January 4, 2018, March 6, 2018, October 11, 2018, April 23, 2019, and November 14, 2019 (the “Amended Loan Agreement”) to increase the total borrowing limit under the Original Loan Agreement from $25.0 million to up to $75.0 million, pursuant to certain conditions of funding. The Amended Term Loan was scheduled to mature on December 1, 2022.

On November 9, 2020, the Company repaid in full all principal, accrued and unpaid interest, fees, and expenses under the Amended Loan Agreement with Hercules in an aggregate amount of $37.4 million (the “Payoff Amount”). The Payoff Amount included the principal balance of $35.0 million, final payment fee of $1.8 million, prepayment penalty fee of $0.5 million, and accrued and unpaid interest of $0.1 million. On November 9, 2020 the Amended Loan Agreement was terminated along with Hercules’ commitment to provide funding under any future term loans. All liens on substantially all of the Company’s assets to secure the loans under the Amended Loan Agreement have been terminated and released. The Payoff Amount, excluding accrued interest, exceeded the carrying amount of the Hercules debt on November 9, 2020 by $1.6 million. As a result, the Company recorded a loss on debt extinguishment of $1.6 million included in the statements of operations and comprehensive loss for the year ended December 31, 2020.

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

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Leases

12 Months Ended

Dec. 31, 2022

Leases

Leases

6. Leases

On April 15, 2014, the Company entered into a lease agreement for approximately 15,197 square feet of office and laboratory space in Needham, Massachusetts. The lease term commenced on April 15, 2014 and it was scheduled to expire on September 30, 2019. Effective February 15, 2018, the Company amended its lease agreement to relocate within the facility to another location consisting of 27,810 square feet of office space (the Amended Lease Agreement). The Amended Lease Agreement extends the expiration date of the lease from September 2019 through June 2025. Pursuant to the Amended Lease Agreement, the initial annual base rent amount is approximately $0.7 million, which increases during the lease term to $1.1 million for the last twelve-month period.

The Company has accounted for its Needham, Massachusetts office space as an operating lease. The Company’s lease contains an option to renew and extend the lease terms and an option to terminate the lease prior to the expiration date. The Company has not included the lease extension or the termination options within the right-of-use asset and lease liability on the consolidated balance sheets as neither option is reasonably certain to be exercised. The Company’s lease includes variable non-lease components (e.g., common area maintenance, maintenance, consumables, etc.) that are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. The Company does not have any other operating or finance leases.

In calculating the present value of future lease payments, the Company has elected to utilize its incremental borrowing rate based on the remaining lease term at the date of adoption of ASC 842. The Company has elected to account for lease components and associated non-lease components as a single lease component and has allocated all of the contract consideration to the lease components only. This will potentially result in the initial and subsequent measurement of the balances of the right-of-use asset and lease liability for leases being greater than if the policy election was not applied.

As of December 31, 2022, a right-of-use asset of $1.8 million and lease liability of $2.3 million are reflected on the consolidated balance sheets. The elements of lease expense were as follows (dollar amounts in thousands):


	Year ended December 31,
	2022		2021
Lease Expense
Operating lease expense	$	885	$	885
Total Lease Expense	$	885	$	885
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$	1,039	$	1,019


		December 31, 2022
Other Balance Sheet Information - Operating Leases
Weighted average remaining lease term (in years)		2.5
Weighted average discount rate		14.6%
Maturity Analysis
2023		1,060
2024		1,081
2025		546
Total	$	2,687
Less: Present value discount		(423)
Lease Liability	$	2,264

Common stock

12 Months Ended

Dec. 31, 2022

Common stock.

Common stock

7. Common stock

As of December 31, 2022 and 2021, the Company had reserved the following shares of common stock for the issuance of common stock for vested restricted stock units, the exercise of stock options, employee stock purchase plan, 2018 Notes and Series A Preferred Stock conversions to shares of common stock (in thousands):


	December 31,
	2022	2021
Shares reserved under equity compensation plans	34,739	36,234
Shares reserved for inducement grants	3,928	3,991
Shares reserved for 2018 Notes	42	42
Shares reserved for ESPP	1,068	1,190
Shares reserved for Series A Preferred Stock	10,000	—
Total shares reserved	49,777	41,457

Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors.

Series A Preferred Stock

Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by the stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding.

On November 4, 2022, the Company entered into an exchange agreement (the “Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS

LP and MSI BVF SPV, LLC (collectively referred to as “BVF”), pursuant to which BVF exchanged 10,000,000 shares of the Company’s common stock for 1,000,000 shares of newly designated Series A convertible preferred stock, par value $0.0001 per share (the “Series A Preferred Stock”) (the “Exchange”).

Each share of the Series A Preferred Stock is convertible into 10 shares of common stock at the option of the holder at any time, subject to certain limitations, including that the holder will be prohibited from converting Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above a conversion blocker, which is initially set at 9.99% (the “Conversion Blocker”) of the total common stock then issued and outstanding immediately following the conversion of such shares of Preferred Stock. Holders of the Series A Preferred Stock are permitted to increase the Conversion Blocker to an amount not to exceed 19.99% upon 60 days’ notice.

Shares of Series A Preferred Stock will generally have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Preferred Stock will participate pari passu with any distribution of proceeds to holders of common stock. Holders of Series A Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the common stock, an equivalent dividend, calculated on an as-converted basis. Shares of Series A Preferred Stock are otherwise not entitled to dividends.

The Series A Preferred Stock ranks (i) senior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms junior to the Series A Preferred Stock; (ii) on parity with the common stock and any class or series of capital stock of the Company created specifically ranking by its terms on parity with the Series A Preferred Stock; and (iii) junior to any class or series of capital stock of the Company created specifically ranking by its terms senior to any Series A Preferred Stock, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily.

The Company evaluated the Series A Preferred Stock for liability or equity classification under ASC 480, Distinguishing Liabilities from Equity, and determined that equity treatment was appropriate because the Series A Preferred Stock did not meet the definition of the liability under ASC 480. Additionally, the Series A Preferred Stock is not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, or (iii) upon the occurrence of an event that is not solely within control of the Company. As such, the Company recorded the Series A Preferred Stock as permanent equity.

At-the-market equity offering programs

On March 30, 2017, the Company established an at-the-market equity offering program pursuant to which it was able to offer and sell up to $35.0 million of its common stock at then-current market prices from time to time through Cantor Fitzgerald & Co. (“Cantor”), as sales agent. On August 28, 2017, the Company amended its sales agreement with Cantor to increase the maximum aggregate offering price of shares of common stock that can be sold under the at-the-market equity offering program to $75.0 million. The Company did not make any sales under this program during the year ended December 31, 2021. During the year ended December 31, 2020, the Company sold 6,769,559 shares under this program for net proceeds of approximately $12.2 million (after deducting commissions and other offering expenses).

In August 2021, the Company entered into a sales agreement with Cantor pursuant to which the Company can offer and sell up to $100.0 million of its common stock at the current market prices from time to time through Cantor as sales agent (the “August 2021 ATM”). During the year-ended December 31, 2022 and 2021, the Company sold 23,573,403 shares and 2,930,585 shares, respectively, under the August 2021 ATM for net proceeds of approximately $27.4 million and $6.8 million, respectively, (after deducting commissions and other offering expenses).

Private Investment in Public Equity (PIPE)

On February 27, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors in which the Company agreed to sell 46,511,628 shares of common stock at a purchase price of $2.15 per share, which represents 12.6% premium to the last reported sale price of the Company’s common stock of $1.91 per share on February 27, 2020. On March 3, 2020, the closing occurred. The aggregate proceeds net of underwriting discounts and offering costs, were approximately $93.8 million.

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

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Topic 505
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Stock-based compensation

12 Months Ended

Dec. 31, 2022

Stock-based compensation

Stock-based compensation

8. Stock-based compensation

Stock-based compensation expense as reflected in the Company’s consolidated statements of operations and comprehensive loss was as follows (in thousands):


	Year ended December 31,
	2022		2021		2020
Research and development	$	1,766	$	2,099	$	1,935
Selling, general and administrative		4,281		5,612		6,183
Total stock-based compensation expense	$	6,047	$	7,711	$	8,118

All of the $6.0 million, $7.7 million, and $8.1 million of stock-based compensation expense recorded during the years ended December 31, 2022, 2021, and 2020, respectively, was recorded to additional paid-in capital.

The Company has awards outstanding under two equity compensation plans, the 2021 Equity Incentive Plan (the “2021 Plan”), and the Amended and Restated 2012 Incentive Plan (the “2012 Plan”), as well as the inducement award program. As of December 31, 2022 and 2021, there were no awards outstanding under the 2010 Equity Incentive Plan (the “2010 Plan”). Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the individual plans.

2021 Plan

During 2021, the Company’s stockholders approved the 2021 Plan. Upon effectiveness of the 2021 Plan, the Company ceased making awards under the 2012 Plan. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs and other stock-based awards. The number of shares of common stock initially reserved for issuance under the 2021 Plan is (i) 23,900,000 which is the sum of 13,250,124 shares plus the number of shares available for issuance under the 2012 Plan as of the date the Company’s Board of Directors approved the 2021 Plan (10,649,876 shares) plus (ii) the number of shares of the Company’s common stock underlying awards under the 2012 Plan and the 2010 Plan that expire, terminate or are surrendered without delivery of shares, are forfeited to or repurchased by the Company, or otherwise become available again for grant under the terms of the 2012 Plan or the 2010 Plan, as applicable.

As of December 31, 2022, under the 2021 Plan, the Company has granted stock options for 4,685,445 shares of common stock, of which 404,850 have been forfeited and 0 have been exercised, and granted RSUs for 2,032,397 shares of common stock, of which 213,400 have been forfeited and 541,012 have vested. As of December 31, 2022, 20,996,662 shares remain available for future issuance. The exercise price of each option has been equal to the closing price of a share of the Company’s common stock on the grant date.

2012 Plan

The 2012 Plan became effective immediately upon the closing of the Company’s IPO in February 2012. Upon effectiveness of the 2012 Plan, the Company ceased making awards under the 2010 Plan. The 2012 Plan initially allowed the Company to grant awards for up to 3,428,571 shares of common stock, plus the number of shares of common stock available for grant under the 2010 Plan as of the effectiveness of the 2012 Plan (which was an additional 30,101 shares), plus that number of shares of common stock related to awards outstanding under the 2010 Plan which terminate by expiration, forfeiture, cancellation or otherwise. The 2012 Plan included an “evergreen provision” that allowed for an annual increase in the number of shares of common stock available for

issuance under the 2012 Plan. The annual increase was added on the first day of each year from 2013 through 2018 and was equal to the lesser of 1,285,714 shares of common stock and 4.0% of the number of shares of common stock outstanding, or a lesser amount as determined by the board of directors. On each of January 1, 2018, January 1, 2017 and January 1, 2016, the number of shares available for issuance under the 2012 Plan increased by 1,285,714 under this provision. On December 18, 2018, the shareholders of the Company approved the Amended and Restated 2012 Incentive Plan which increased the maximum number of shares available for issuance under the 2012 Plan to 16,628,425 and eliminated the evergreen provision. On May 19, 2020, the shareholders of the Company approved the Amended and Restated 2012 Incentive Plan which increased the maximum number of shares available for issuance by 13,000,000 shares.

Awards under the 2012 Plan may include the following award types: incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, RSUs, other stock-based or cash-based awards and any combination of the foregoing. As of December 31, 2022, under the 2012 Plan, the Company has granted stock options for 22,098,207 shares of common stock, of which 11,915,465 have been forfeited and 2,296,645 have been exercised, and granted RSUs for 6,678,621 shares of common stock, of which 1,049,068 have been forfeited and 5,302,060 have vested. The exercise price of each option has been equal to the closing price of a share of the Company’s common stock on the grant date. Upon adoption of the 2021 Plan, the Company ceased issuing awards from the 2012 Plan.

Inducement Award Program

In December 2014, the Company established an inducement award program (in accordance with Nasdaq Listing Rule 5635(c)(4)) under which it may grant non-statutory stock options to purchase, and RSUs in respect of up to an aggregate of 750,000 shares of common stock to new or prospective employees as inducement to enter into employment with the Company. In December 2016, the Board of Directors authorized and reserved 580,000 additional shares of common stock under this program. In December 2017, the Board of Directors authorized and reserved 2,500,000 additional shares of common stock under this program. In June and December 2018, the Board of Directors authorized and reserved 1,700,000 and 1,250,000 additional shares of common stock under this program, respectively. In February 2020, the Board of Directors authorized the reduction of 2,033,367 shares available for issuance under this program. The program is governed by the terms of the 2021 Plan, but shares issued pursuant to the program are not issued under the 2021 Plan. As of December 31, 2022, the Company had granted options for 7,875,009 shares of common stock under the program, of which 5,439,075 have been forfeited and 584,016 have been exercised, and granted RSUs for 873,063 shares, of which 243,294 have been forfeited and 160,280 have vested. As of December 31, 2022, 1,605,930 shares remain available for future issuance.

Stock Options

Most options granted by the Company vest twenty-five percent (25%) one year from vesting start date and six and a quarter percent (6.25%) for each successive three-month period, thereafter (subject to acceleration of vesting in the event of certain change of control transactions) subject to the employee’s continued employment with, or service to, the Company on such vesting date and are exercisable for a period of ten years from the date of grant.

A summary of the Company’s stock option activity and related information for the year ended December 31, 2022, is as follows:


	Shares	Weighted-average exercise price per share		Weighted-average remaining contractual term (years)	Aggregate intrinsic value (in thousands)
Outstanding at December 31, 2021	16,264,098	$	3.56	6.7	$	2,601
Granted	1,547,998		0.95
Exercised	(98,176)		1.20
Forfeited/cancelled	(3,695,310)		5.41
Outstanding at December 31, 2022	14,018,610	$	2.80	7.1	$	18
Vested at December 31, 2022	8,686,694	$	3.28	6.1	$	2

The fair value of each stock option was estimated using a Black-Scholes option-pricing model with the following weighted-average assumptions:


	Year ended December 31,
	2022		2021		2020
Risk-free interest rate	3.13	%	1.15	%	0.60	%
Volatility	88	%	89	%	96	%
Dividend yield	—		—		—
Expected term (years)	5.8		6.0		6.0

The Company recorded stock-based compensation expense associated with employee and non-employee stock options of $4.2 million, $4.1 million, and $4.3 million, for the years ended December 31, 2022, 2021, and 2020, respectively. The weighted-average grant date fair value of options granted in the years ended December 31, 2022, 2021, and 2020 was $0.69, $1.82, and $1.62 per share, respectively. The fair value of options that vested during the years ended December 31, 2022, 2021, and 2020 was $4.4 million, $3.8 million, and $7.4 million, respectively. The aggregate intrinsic value of options exercised (i.e., the difference between the market price at exercise and the price paid by employees to exercise the option) during the years ended December 31, 2022 and 2021 was less than $0.1 million and $0.8 million, respectively.

At December 31, 2022 there was $6.6 million of total unrecognized compensation cost related to unvested stock options and the Company expects to recognize this cost over a remaining weighted-average period of 2.6 years.

Restricted Stock Units (“RSUs”)

Each RSU entitles the holder to receive one share of the Company’s common stock when the RSU vests. The RSUs generally vest (i) twenty-five percent (25%) one year from vesting start date and six and a quarter percent (6.25%) for each successive three-month period, thereafter, (ii) two tranches for 50% of the award with the second and final vesting date on the one year anniversary of the vesting commencement date and (iii) 100 percent within two years of the vesting commencement date. The RSUs are subject to acceleration of vesting in the event of certain change of control transactions and subject to the employee’s continued employment with, or service to, the Company on such vesting date. Compensation expense is recognized on a straight-line basis.

A summary of RSU activity during the year ended December 31, 2022, is as follows:


	Shares	Weighted-average grant date fair value per share
Outstanding at December 31, 2021	2,805,004	$	2.44
Granted	398,413	$	0.92
Vested	(876,829)	$	2.63
Forfeited/cancelled	(251,621)	$	2.29
Outstanding at December 31, 2022	2,074,967	$	2.09

The Company recorded stock-based compensation expense associated with employee and non-employee RSUs of $1.8 million, $3.5 million, and $3.7 million, for the years ended December 31, 2022, 2021, and 2020, respectively. The total fair value of restricted stock units vested during the years ended December 31, 2022, 2021, and 2020 was approximately $2.3 million, $3.7 million, and $3.8 million, respectively.

At December 31, 2022, there was $4.3 million of total unrecognized compensation cost related to unvested RSUs and the Company expects to recognize this cost over a remaining weighted-average period of 2.8 years.

On March 27, 2020, the Company amended all outstanding stock options and RSUs awards held by employees (including executive officers), other than certain performance-based awards, to provide that, in the event of a change of control, such equity awards currently held by employees that are outstanding and unvested immediately prior to a change of control of the Company will become fully vested and, if applicable, exercisable immediately prior to, and subject to the consummation of, such change of control. The amendment was implemented to provide assurance to the Company’s existing employees and not in response to any change of control offer for the Company. The modification affected 93 employees and resulted in incremental stock compensation expense of $0.2 million that was recognized over the remaining requisite service period for each award. The modification resulted in incremental stock compensation expense of $0.0 million, $0.1 million, and $0.1 million recognized in the years ended December 31, 2022, 2021 and 2020, respectively.

The Company modified all unvested equity awards held by 41 employees included in the August 2020 Restructuring discussed in Note 14. Restructurings. On September 30, 2020, the Company accelerated all unvested awards held by employees included in the August 2020 Restructuring to be fully vested on September 30, 2020. As a result of the modification, the Company recognized incremental stock compensation cost of approximately $0.5 million during year ended December 31, 2020 within selling, general and administrative expense in the consolidated statements of operations and comprehensive loss.

Employee stock purchase plan

At the Special Meeting of Stockholders, held on December 18, 2018, the stockholders approved the 2018 Employee Stock Purchase Plan (“2018 ESPP”). On June 21, 2019, the board of directors of the Company amended and restated the 2018 ESPP, to account for certain non-material changes to the plan’s administration (the “Amended and Restated 2018 ESPP”). The Amended and Restated 2018 ESPP provides eligible employees with the opportunity, through regular payroll deductions, to purchase shares of the Company’s common stock at 85% of the lesser of the fair market value of the common stock (a) on the date the option is granted, which is the first day of the purchase period, and (b) on the exercise date, which is the last business day of the purchase period. The Amended and Restated 2018 ESPP generally allows for two six-month purchase periods per year beginning in January and July, or such other periods as determined by the compensation committee of the Company’s board of directors. The Company has reserved 2,000,000 shares of common stock for the administration of the Amended and Restated 2018 ESPP. The fair value of shares expected to be purchased under the Amended and Restated 2018 ESPP was calculated using the Black-Scholes model with the following weighted-average assumptions:


	Year ended December 31,
	2022		2021		2020
Risk-free interest rate	1.56	%	0.07	%	1.04	%
Volatility	77	%	68	%	109	%
Dividend yield	—		—		—
Expected term (years)	0.5		0.5		0.5

The Company has recognized $0.1 million of stock-based compensation expense under the Amended and Restated 2018 ESPP, for each of the years ended December 31, 2022, 2021, and 2020. During the year ended December 31, 2022, 2021, and 2020, the Company issued 122,332 shares, 110,060 shares and 358,193 shares, respectively, of common stock for proceeds of $0.2 million, $0.2 million and $0.4 million, respectively under the Amended and Restated 2018 ESPP.

Convertible senior notes

12 Months Ended

Dec. 31, 2022

Convertible Senior Notes

Convertible Senior Notes

9. Convertible Senior Notes

2018 Notes

On October 17, 2018, the Company closed a registered direct public offering of $150.0 million aggregate principal amount of the Company’s 2018 Notes for net proceeds of approximately $145.3 million. The 2018 Notes are governed by the terms of a base indenture for senior debt securities (the “2018 Base Indenture”), as supplemented by the first supplemental indenture thereto (the “Supplemental Indenture” and together with the “2018 Base Indenture”, the “2018 Indenture”), each dated October 17, 2018, by and between the Company and Wilmington Trust, National Association, (“Wilmington”) as trustee. The 2018 Notes are senior unsecured obligations of the Company and bear interest at a rate of 5.00% per annum, payable semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2019. The 2018 Notes will mature on November 1, 2048, unless earlier repurchased, redeemed or converted in accordance with their terms.

The 2018 Notes are convertible into shares of the Company’s common stock, par value $0.0001 per share, together, if applicable, with cash in lieu of any fractional share, at an initial conversion rate of 139.5771 shares of common stock per $1,000 principal amount of the 2018 Notes, which corresponds to an initial conversion price of approximately $7.16 per share of common stock and represents a conversion premium of approximately 15.0% above the last reported sale price of the common stock of $6.23 per share on October 11, 2018. Upon conversion, converting noteholders will be entitled to receive accrued interest on their converted 2018 Notes. To the extent the Company has insufficient authorized but unissued shares to settle conversions in shares of common stock, the Company would be required to settle the deficiency in cash.

The Company will have the right, exercisable at its option, to cause all Notes then outstanding to be converted automatically if the “Daily VWAP” (as defined in the 2018 Indenture) per share of the Company’s common stock equals or exceeds 130% of the conversion price on each of at least 20 VWAP Trading Days (as defined in the 2018 Indenture), whether or not consecutive, during any 30 consecutive VWAP Trading Day period commencing on or after the date the Company first issued the 2018 Notes.

The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends, but will not be adjusted for any accrued and unpaid interest.

Prior to November 1, 2022, the Company will not have the right to redeem the 2018 Notes. On or after November 1, 2022, the Company may elect to redeem the 2018 Notes, in whole or in part, at a cash redemption price equal to the principal amount of the 2018 Notes to be redeemed, plus accrued and unpaid interest, if any.

Unless the Company has previously called all outstanding 2018 Notes for redemption, the 2018 Notes will be subject to repurchase by the Company at the holders’ option on each of November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043 (or, if any such date is not a business day, on the next business day) at a cash repurchase price equal to the principal amount of the 2018 Notes to be repurchased, plus accrued and unpaid interest, if any.

If a “Fundamental Change” (as defined in the 2018 Indenture) occurs at any time, subject to certain conditions, holders may require the Company to purchase all or any portion of their 2018 Notes at a purchase price equal to 100% of the principal amount of the 2018 Notes to be purchased, plus accrued and unpaid interest. If a “Fundamental Change” occurs on or before November 1, 2022 and a holder elects to convert its Notes in connection with such change, such holder may be entitled to an increase in the conversion rate in certain circumstances as set forth in the Indenture.

The 2018 Indenture includes customary covenants and set forth certain events of default after which the 2018 Notes may be declared immediately due and payable and set forth certain types of bankruptcy or insolvency events of default involving the Company or certain of its subsidiaries after which the 2018 Notes become automatically due and payable.

The Company assessed all terms and features of the 2018 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2018 Notes, including the conversion, put and call features. The conversion feature was initially bifurcated as an embedded derivative but subsequently qualified for a scope exception to derivative accounting upon the Company’s stockholders approving an increase in the number of authorized shares of Common Stock in December 2018. The Company determined that all other features of the 2018 Notes were clearly and closely associated with the debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company’s consolidated financial statements. The Company reassesses the features on a quarterly basis to determine if they require separate accounting. There have been no changes to the Company’s original assessment through December 31, 2022.

2019 Notes

On November 14, 2019 and December 23, 2019, the Company entered into privately negotiated agreements to exchange approximately $114.3 million and $7.4 million, respectively, aggregate principal amount of the 2018 Notes for (i) approximately $62.9 million and $4.0 million, respectively, aggregate principal amount of newly issued 5.00% Convertible Senior Second Lien Notes due 2048 (the “2019 Notes”), (ii) an aggregate of $11.4 million and $0.7 million, respectively, in 2018 Notes principal repayment and (iii) accrued interest on the 2018 Notes through November 14, 2019 and December 23, 2019, respectively. The 2019 Notes are governed by the terms of an indenture (the “2019 Indenture”). The 2019 Notes are senior secured obligations of the Company and bear interest at 5.00% per annum, payable semi-annually in arrears on May 1 and November 1 of each year. The 2019 Notes will mature on November 1, 2048, unless earlier repurchased, redeemed or converted in accordance with the terms.

The Company determined 2019 Notes exchange met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties and the lenders granted a concession. The future undiscounted cash flows of the 2019 Notes after the exchange exceeded the carrying value of the converted 2018 Notes prior to the exchange. As such no gain was recognized as a result of the exchange. The Company reduced the carrying value of the 2019 Notes by the cash given and the change in fair value of the conversion option driven by the reduction in conversion price. The change in fair value of the conversion option was determined to be $13.6 million.

The 2019 Notes were convertible into shares of the Company’s common stock, par value $0.0001 per share, together, if applicable, with cash in lieu of any fractional share, at an initial conversion rate of 606.0606 shares of common stock per $1,000 principal amount of the 2019 Notes, which corresponds to an initial conversion price of approximately $1.65 per share of common stock. In addition, if the holders converted the 2019 Notes with a conversion date that is on or prior to November 1, 2020, then the consideration due upon any such conversion will also include a cash interest make-whole payment for all future scheduled interest payments on the converted 2019 Notes through November 1, 2020 (“2019 Notes Interest Make-Whole Provision”).

The Company assessed all terms and features of the 2019 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2019 Notes, including the conversion, put and call features. In consideration of the 2019 Notes Interest Make-Whole Provision, the Company concluded the provision required bifurcation as a derivative. The fair

value of the 2019 Interest Make-Whole Provision was determined using a Monte Carlo model. It was determined that the fair value of the derivative upon the November 14, 2019 and December 23, 2019 issuance of the 2019 Notes was $0.2 million in aggregate; and recorded this amount as a derivative liability and the offsetting amount as a debt discount as a reduction to the carrying value of the 2019 Notes on the closing dates. During the period November 14, 2019 to December 31, 2019, 2019 Note holders converted $9.5 million aggregate principal of 2019 Notes in exchange for 5,767,872 shares of common stock, $0.4 million of cash for 2019 Interest Make-Whole Provision payments, and accrued interest.

During the first quarter of 2020, 2019 Note holders converted $57.4 million aggregate principal of 2019 Notes in exchange for 34,796,350 shares of common stock, $1.8 million of cash for the 2019 Note Interest Make-Whole Provision, and accrued interest. The Company recorded $1.3 million for the year ended December 31, 2020, as other expense for the change in fair value of the 2019 Notes Interest Make-Whole Provision in the consolidated statements of operations and comprehensive loss. The Company determined that all other features of the 2019 Notes were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's consolidated financial statements. As of March 31, 2020, all 2019 Notes have converted into shares of common stock.

2020 Notes

On November 6, 2020, the Company entered into a privately negotiated agreement with an investor who was a holder of the Company’s 2018 Notes to exchange approximately $28.0 million aggregate principal amount of 2018 Notes for approximately $28.0 million aggregate principal amount of newly issued 5.00% Convertible Senior Notes due 2048 (the “2020 Notes” and together with the 2018 Notes and 2019 Notes referred to as the “Notes”). The issuance of the 2020 Notes closed on November 13, 2020. The 2020 Notes were governed pursuant to the Base Indenture between the Company and Wilmington, as trustee and collateral agent, dated as of October 17, 2018 as supplemented by the second supplemental indenture thereto dated as of November 13, 2020 (the “2020 Notes Supplemental Indenture” and together with the Base Indenture, the “2020 Indenture”).

The Company had the right, exercisable at its option, to cause all 2020 Notes then outstanding to be converted automatically if the “Daily VWAP” (as defined in the 2020 Indenture) per share of the Company’s common stock equaled or exceeded 123.08% of the conversion price on each of at least 20 “VWAP Trading Days” (as defined in the 2020 Indenture), whether or not consecutive, during any 30 consecutive VWAP Trading Day period commencing on or after the date the Company first issued the 2020 Notes (the “2020 Notes Mandatory Conversion Option”).

The initial conversion rate for the 2020 Notes was 307.6923 shares of the Company’s common stock per $1,000 principal amount of the 2020 Notes, which is equivalent to an initial conversion price of approximately $3.25 per share. The conversion rate was subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends, but was not subject to adjustment for any accrued and unpaid interest.

Prior to November 1, 2023, the Company did not have the right to redeem the 2020 Notes. On or after November 1, 2023, the Company had the option to redeem the 2020 Notes, in whole or in part, at a cash redemption price equal to the principal amount of the 2020 Notes to be redeemed, plus accrued and unpaid interest, if any.

Unless the Company had previously called all outstanding 2020 Notes for redemption, the 2020 Notes were subject to repurchase by the Company at the holders’ option on each of November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043 (or, if any such date is not a business day, on the next business day) at a cash repurchase price equal to the principal amount of the 2020 Notes to be repurchased, plus accrued and unpaid interest, if any.

The Company determined the 2020 Notes exchange met the definition of a debt modification under ASC 470-50, Modifications and Extinguishments. The Company reduced the carrying value of the 2020 Notes by the change in fair value of the conversion option driven by the reduction in conversion price. The change in fair value of the conversion option was determined to be $2.3 million.

The Company determined that all features of the 2020 Notes were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's consolidated financial statements.

On July 1, 2021, the Company exercised the Company’s 2020 Notes Mandatory Conversion Option for the aggregate principal amount of $28.0 million of the Company’s 2020 Notes. On July 16, 2021, the aggregate principal of $28.0 million of 2020 Notes was converted into 8,615,384 shares of common stock. As a result, as of September 30, 2021, all 2020 Notes have converted into shares of common stock. Upon conversion of the 2020 Notes, holders received a cash payment equal to the accrued and unpaid interest on the converted 2020 Notes. Pursuant to ASC 815-15-40-1, upon conversion, the Company recorded the remaining discount on the 2020 Notes of $7.8 million as interest expense in the statements of operations and comprehensive loss during the year ended December 31, 2021.

All Notes

The Company determined that the expected life of the 2018 Notes, 2019 Notes, and 2020 Notes was equal to the period through November 1, 2023, as this represents the point at which the 2018 Notes, 2019 Notes, and 2020 Notes were initially subject to repurchase by the Company at the option of the holders. Accordingly, for the 2018 Notes, the total debt discount, inclusive of the fair value of the embedded conversion feature derivative at issuance is being amortized using the effective interest method through November 1, 2023. For the 2019 Notes and 2020 Notes, the total debt discount, inclusive of the fair value of the embedded conversion feature derivative at issuance and change in fair value of conversion option upon exchange, was being amortized using the effective interest method through November 1, 2023. Pursuant to ASC 815-15-40-1, upon conversion of the 2019 Notes and 2020 Notes into common stock, the remaining debt discount on the conversion date was recorded to interest expense in the statements of operations and comprehensive loss. For the year ended December 31, 2022, the Company recognized less than $0.1 million of interest expense related to the 2018 Notes.

Net loss per share

12 Months Ended

Dec. 31, 2022

Net loss per share

Net loss per share

10. Net Loss per Share

ASC Topic 260, Earnings Per Share, requires the Company to calculate its net loss per share based on basic and diluted net loss per share, as defined. Basic EPS excludes dilution and is computed by dividing net loss by the weighted average number of shares outstanding for the period. For the years ended December 31, 2022, 2021, and 2020 net loss, basic and diluted EPS are the same as the assumed exercise of stock options, restricted stock units, and the Notes are anti-dilutive.

The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:


	Year Ended December 31,
	2022	2021	2020
Outstanding stock options	14,018,610	16,264,098	12,690,745
Outstanding restricted stock units	2,074,967	2,805,004	2,649,317
2018 Notes	41,873	41,873	41,873
2020 Notes	—	—	8,615,384
Employee stock purchase plan	82,496	57,636	53,372
Series A Preferred Stock	10,000,000	—	—
Total potentially dilutive securities	26,217,946	19,168,611	24,050,691

Income taxes

12 Months Ended

Dec. 31, 2022

Income taxes

Income taxes

11. Income Taxes

As of December 31, 2022, the Company had federal and state NOL carryforwards of approximately $436.6 million and $203.3 million, respectively, which are available to reduce future taxable income. The Company also had federal and state tax credits of $5.6 million and $1.9 million, respectively, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards will expire at various dates through 2042, except for $240.9 million of federal NOL carryforwards which may be carried forward indefinitely.

During the year ended December 31, 2020, the Company recorded income tax expense of $0.2 million, which primarily related to state income tax as a result of the sale of COPIKTRA license and related assets to Secura. Refer to Note 13. License, collaboration and commercial agreements for further discussion of the sale to Secura.

For the years ended December 31, 2022, 2021, and 2020 income tax expense consisted of the following (in thousands):


	Year ended December 31,
	2022		2021		2020
Current tax expense:
Federal	$	—	$	—	$	—
State		—		—		194
Current income tax expense		—		—		194
Deferred
Federal		—		—		—
State		—		—		—
Deferred income tax expense		—		—		—
Total income tax expense	$	—	$	—	$	194

A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations follows:



	December 31,
	2022		2021
Income tax benefit using U.S. federal statutory rate	21.00	%	21.00	%
State tax benefit, net of federal benefit	2.15	%	3.01	%
Research and development tax credits	2.81	%	2.71	%
Stock-based compensation	(2.17)	%	—	%
Permanent items	(0.08)	%	(0.44)	%
Change in the valuation allowance	(21.41)	%	(21.23)	%
NOL and tax credit expiration under Section 382	(2.26)	%	(4.34)	%
Other	(0.04)	%	(0.71)	%
	—	%	—	%

The principal components of the Company’s deferred tax assets and liabilities are as follows (in thousands):


	December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	103,243	$	98,777
Capitalized research and development		11,621		1,276
Research and development credits		7,107		4,516
Stock-based compensation		3,450		4,200
Installment sale		7,768		8,819
Lease liability		538		730
Other deferred tax assets		587		411
Total deferred tax assets		134,314		118,729
Deferred tax liabilities:
Right-of-use asset		(425)		(574)
Debt discount		(4)		(11)
Other deferred tax liability		(29)		(91)
Total deferred tax liabilities		(458)		(676)
Net deferred tax asset prior to valuation allowance		133,856		118,053
Valuation allowance		(133,856)		(118,053)
Net deferred tax asset	$	—	$	—

The Tax Cuts and Jobs Act (“TCJA”) requires taxpayers to capitalize and amortize research and development (“R&D”) expenditures under section 174 for tax years beginning after December 31, 2021. This rule became effective for the Company during 2022 and resulted in capitalized R&D costs of $44.5 million as of December 31, 2022. The Company will amortize these costs for tax purposes over 5 years for R&D performed in the U.S. and over 15 years for R&D performed outside the U.S.

The Company has recorded a valuation allowance against its deferred tax assets at December 31, 2022 and 2021 because the Company’s management believes that it is more likely than not that these assets will not be fully realized. The increase in the valuation allowance of approximately $15.8 million in the year ended December 31, 2022, primarily relates to the capitalization of research and development expenses, the generation of NOLs and R&D credits.

Section 382 of the Internal Revenue Code and similar provisions under state law limit the utilization of U.S. NOL carryforwards, state NOL carryforwards, R&D credits, and Orphan Drug (“OD”) credits following certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%. Based on the Company’s analysis under Section 382, the Company believes that its federal NOL carryforwards, its state NOL carryforwards, R&D credits, and OD credits are limited by Section 382 and similar provisions under state law as of December 31, 2022. The portion of federal NOL carryforwards, state NOL carryforwards, R&D credits, and OD credits that were determined to be limited have been written off as of December 31, 2022. The remaining unused carryforwards and credits remain available for future periods. Due the Company’s full valuation allowance the write off of NOL carryforwards and R&D and OD credits did not have any impact to the statements of operation and comprehensive loss.

The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. From inception and through December 31, 2022, the Company had no unrecognized tax benefits or related interest and penalties accrued. The Company has not conducted a study of R&D credit carryforwards. This study may result in an adjustment to the Company’s R&D credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s R&D credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheet or statement of operations if an adjustment were required. The Company would recognize both accrued interest and penalties related to unrecognized benefits in income tax expense. The Company’s uncertain tax positions are related to years that remain

subject to examination by relevant tax authorities. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Commitments and contingencies

Commitments and contingencies

12 Months Ended

Dec. 31, 2022

Commitments and contingencies

12. Commitments and contingencies

The Company has entered into a lease agreement for approximately 27,810 square feet of office space in Needham, Massachusetts. Please refer to Note 6. Leases for further details regarding the minimum aggregate future lease commitments as of December 31, 2022. In conjunction with the execution of the Amended Lease Agreement, the Company has provided a security deposit in the form of a letter of credit in the amount of $0.2 million as of December 31, 2022, and 2021. The amount is included in non-current restricted cash on the consolidated balance sheets as of December 31, 2022, and 2021.

Pursuant to the terms of various agreements, the Company may be required to pay various development, regulatory and commercial milestones. In addition, if any products related to these agreements are approved for sale, the Company may be required to pay significant royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurring.

License, collaboration and commercial agreements

12 Months Ended

Dec. 31, 2022

License, collaboration and commercial agreements

License, collaboration and commercial agreements

13. License, collaboration and commercial agreements

Secura Bio, Inc. (“Secura”)

On August 10, 2020, the Company and Secura signed the Secura APA and on September 30, 2020, the transaction closed.

Pursuant to the Secura APA, the Company sold to Secura its exclusive worldwide license, including related assets, for the research, development, commercialization, and manufacture in oncology indications of products containing duvelisib. The sale included certain intellectual property related to duvelisib in oncology indications, certain existing duvelisib inventory, claims and rights under certain contracts pertaining to duvelisib. Pursuant to the Secura APA, Secura assumed all operational and financial responsibility for activities that were part of the Company’s duvelisib oncology program, including all commercialization efforts related to duvelisib in the United States and Europe, as well as the Company’s ongoing duvelisib clinical trials. Further, Secura assumed all obligations with existing collaboration partners developing and commercializing duvelisib, which include Yakult Honsha Co., Ltd. (“Yakult”), CSPC Pharmaceutical Group Limited (“CSPC”), and Sanofi. Additionally, Secura assumed all royalty payment obligations due under the amended and restated license agreement with Infinity Pharmaceuticals, Inc. (“Infinity”) (“Infinity License Agreement”).

Pursuant to the terms of the Secura APA, Secura has paid the Company an up-front payment of $70.0 million in September 2020 and has agreed to pay the Company (i) regulatory milestone payments up to $45.0 million, consisting of a payment of $35.0 million upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma and a payment of $10.0 million upon receipt of the first regulatory approval for the commercial sale of COPIKTRA in the European Union for the treatment of peripheral T-cell lymphoma, (ii) sales milestone payments of up to $50.0 million, consisting of $10.0 million when total worldwide net sales of COPIKTRA exceed $100.0 million, $15.0 million when total worldwide net sales of COPIKTRA exceed $200.0 million and $25.0 million when total worldwide net sales of COPIKTRA exceed $300.0 million, (iii) low double-digit royalties on the annual aggregate net sales above $100.0 million in the United States, European Union, and the United Kingdom of Great Britain and Northern Ireland and (iv) 50% of all royalty, milestone and sublicense revenue payments payable to Secura under the Company’s existing license agreements with Sanofi, Yakult, and CSPC, and 50% of all royalty and milestone payments payable to Secura under any license or sublicense agreement entered into by Secura in certain jurisdictions.

In connection with the Secura APA, the Company and Secura entered into a transition services agreement (“Secura TSA”). Under the terms of the Secura TSA, the Company provided certain support functions at Secura’s direction for a term of less than one year from the date of execution (“Secura TSA Services”). Services performed were paid at a mutually agreed upon rate.

The Company evaluated the Secura APA and Secura TSA in accordance with ASC 606 as the Company concluded that the counterparty, Secura, is a customer. The Company identified the following performance obligations under the Secura APA and Secura TSA:

●

a bundled performance obligation consisting of delivery of the duvelisib global license and intellectual property, certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approvals, and certain regulatory documentation and books and records (the “Bundled Secura Performance Obligation”); and

●

Secura TSA Services.

The Company concluded that the duvelisib global license and intellectual property were not distinct within the context of the contract (i.e. separately identifiable) because the other assets including certain existing duvelisib inventory, certain duvelisib contracts and clinical trials, certain regulatory approval, and certain regulatory documentation and books and records do not have stand-alone value from other duvelisib global license and intellectual property and Secura could not benefit from them without the duvelisib global license and intellectual property. Consistent with the guidance under ASC 606-10-25-16A, the Company disregarded immaterial promised goods and services when determining performance obligations.

The Company has determined that the upfront payment of $70.0 million, future potential milestone payments and royalties including from Secura’s sublicensees should be allocated to the delivery of the Bundled Secura Performance Obligation. The Company has the right to consideration for TSA services in an amount that corresponds directly with the value to Secura of the Company’s performance to date. Consideration allocated to the Secura TSA Services will be recognized as such services are provided over the performance period using an output method based on the amount to which the Company has a right to invoice.

The Company determined $0.1 million of future potential royalties the Company expects to receive pursuant to the Secura APA were not constrained as of December 31, 2022. When estimating the amount of royalties to be received that were not constrained, the Company used the expected value method as there are a range of possible outcomes. When estimating royalties expected to be received, the Company used a combination of internal projections and forecasts and data from external sources. The Company determined that all other future potential royalties were constrained under the guidance as of December 31, 2022. As part of the Company’s evaluation of the constraint on future royalties, the Company considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in royalty payments. Those factors include: the likelihood and magnitude of revenue reversals related to future royalties, the amount of variable consideration is highly susceptible to factors outside of the Company’s influence, the amount of time to resolve the uncertainty, and lack of significant history of selling COPIKTRA outside of the United States.

As the consideration for future royalties is conditional, the Company recorded a corresponding contract asset for the expected future royalties. Portions of the contract asset are reclassified to accounts receivable when the right to consideration becomes unconditional. As of December 31, 2022, the $0.1 million contract asset has been recorded within prepaid and other current assets on the consolidated balance sheet.

The following table presents changes in the Company’s contract asset for the year ended December 31, 2022 (in thousands):


Contract Asset:	December 31, 2021		Additions		Reclassification to receivable		December 31, 2022
Contract asset - Secura	$	170	$	96	$	(170)	$	96
Total	$	170	$	96	$	(170)	$	96

During the year ended December 31, 2022, one regulatory milestone was achieved by Secura’s sublicensee, CSPC, of which 50% of the milestone or $2.5 million was paid to the Company pursuant to the Secura APA. The Company determined all other future potential milestones were excluded from the transaction price, as all other milestone amounts were fully constrained under the guidance as of December 31, 2022. As part of the Company’s

evaluation of the constraint, the Company considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors included: the likelihood and magnitude of revenue reversals related to future milestones, the amount of variable consideration that is highly susceptible to factors outside of the Company’s influence and the uncertainty about the consideration is not expected to be resolved for a long period of time. All other future potential milestone payments were fully constrained as the risk of significant revenue reversal related to these amounts has not yet been resolved.

During the year ended December 31, 2022, the Company recognized $2.6 million of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss. The sale of COPIKTRA license and related assets revenue for the year ended December 31, 2022 related to one regulatory milestone for $2.5 million achieved by Secura’s sublicensee, CSPC, and $0.1 million related to royalties on COPIKTRA sales in the year ended December 31, 2022, and future royalties expected to be received pursuant to the Secura APA that were not constrained.

During the year ended December 31, 2021, the Company recognized $1.4 million of sale of COPIKTRA license and related assets revenue within the statements of operations and comprehensive loss. The sale of COPIKTRA license and related assets revenue for the year ended December 31, 2021 primarily related to two regulatory milestone for $1.3 million achieved by Secura’s sublicensee and $0.2 million related to royalties received and expected to be received pursuant to the Secura APA. During the year ended December 31, 2021, the Company also recognized $0.6 million in transition services revenue within the statements of operations and comprehensive loss.

During the year ended December 31, 2020, the Company recognized $70.0 million as sale of COPIKTRA license and related assets revenue related to delivery of the Bundled Secura Performance Obligation and $0.4 million in transition services revenue within the statements of operations and comprehensive loss. The Company recognized approximately $31.2 million of cost of sales – sale of COPIKTRA license and related assets within the statements of operations and comprehensive loss which consisted of $19.2 million, $6.0 million, $5.8 million and $0.2 million for the intangible asset, certain duvelisib inventory, net duvelisib contract prepaid balances and manufacturing equipment, respectively, which were delivered to Secura as part of the sale.

Chugai Pharmaceutical Co., Ltd (Chugai)

On January 7, 2020, the Company entered into a license agreement with Chugai (the “Chugai Agreement”) whereby Chugai granted the Company an exclusive worldwide license for the development, commercialization and manufacture of products containing avutometinib, a dual RAF/MEK inhibitor.

Under the terms of the Chugai Agreement, the Company received an exclusive right to develop and commercialize products containing avutometinib at the Company’s own cost and expense. The Company is required to pay Chugai a non-refundable payment of $3.0 million which was paid in February 2020. The Company is further obligated to pay Chugai double-digit royalties on net sales of products containing avutometinib, subject to reduction in certain circumstances. Chugai also obtained opt back rights to develop and commercialize avutometinib (a) in the European Union, which option may be exercised through the date the Company submits a NDA to the FDA for a product which contains avutometinib as the sole active pharmaceutical ingredient and (b) in Japan and Taiwan, which option may be exercised through the date the Company receives marketing authorization from the FDA for a product which contains avutometinib as the sole active pharmaceutical ingredient. As consideration for executing either option, Chugai would have to make a payment to the Company calculated on the Company’s development costs to date. Chugai has communicated their intention not to exercise their opt back rights for Japan, Taiwan, or the European Union. Chugai and the Company have made customary representations and warranties and have agreed to certain customary covenants, including confidentiality and indemnification.

Unless earlier terminated, the Chugai Agreement will expire upon the fulfillment of the Company’s royalty obligations to Chugai for the sale of any products containing avutometinib, which royalty obligations expire on a product-by-product and country-by-country basis, upon the last to occur, in each specific country, of (a) expiration of valid patent claims covering such product or (b) 12 years from the first commercial sale of such product in such country.

The Company may terminate the Chugai Agreement upon 180 days’ written notice. Subject to certain limitations, Chugai may terminate the Chugai Agreement upon written notice if the Company challenges any patent licensed by Chugai to the Company under the Chugai Agreement. Either party may terminate the license agreement in its entirety with 120 days’ written notice for the other party’s material breach if such party fails to cure the breach. Either party may also terminate the Chugai Agreement in its entirety upon certain insolvency events involving the other party.

The Company evaluated the license agreement with Chugai under ASC Topic 805, Business Combinations (“ASC 805”) and concluded that as the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar assets, the transaction did not meet the requirements to be accounted for as a business combination and therefore was accounted for as an asset acquisition. The Company recorded the up-front payment of $3.0 million as research and development expense within the consolidated statement of operations and comprehensive loss for the year ended December 31, 2020.

Infinity Pharmaceuticals, Inc. (“Infinity”)

In November 2016, the Company entered into the Infinity License Agreement with Infinity under which the Company acquired an exclusive worldwide license for the research, development, commercialization, and manufacture of products in oncology indications containing duvelisib.

Pursuant to the terms of the Infinity License Agreement, the Company was obligated to pay Infinity royalties on worldwide net sales of any products in an oncology indication containing duvelisib ranging from the mid-single digits to the high single-digits. In addition to the foregoing, the Company was obligated to pay Infinity an additional royalty of 4% on worldwide net sales of any products in an oncology indication containing duvelisib to cover the reimbursement of research and development costs owed by Infinity to Mundipharma International Corporation Limited and Purdue Pharmaceutical Products L.P.

During the year ended December 31, 2022, 2021, and 2020, the Company recorded royalty expense of $0.0 million, $0.0 million, and $1.3 million, respectively related to the Infinity License Agreement, which are included in costs of sales - product within the consolidated statements of operation and comprehensive loss.

As discussed above under heading Secura Bio, Inc. (“Secura”) as of September 30, 2020, Secura has assumed from the Company all responsibilities and obligations under the Infinity License Agreement. All royalties due pursuant to the Infinity License Agreement are the sole responsibility of Secura.

Sanofi

On July 25, 2019, the Company entered into a license and collaboration agreement with Sanofi (the “Sanofi Agreement”), under which the Company granted exclusive rights to Sanofi to develop and commercialize products containing duvelisib in Russia, the Commonwealth of Independent States (“CIS”), Turkey, the Middle East and Africa (collectively the “Sanofi Territory”) for the treatment, prevention, palliation or diagnosis of any oncology indication in humans or animals.

Sanofi paid the Company an upfront, non-refundable payment of $5.0 million in August 2019. The Company is also entitled to receive aggregate payments of up to $42.0 million if certain regulatory and commercial milestones are successfully achieved. Sanofi is obligated to pay the Company double-digit royalties on net sales of products containing duvelisib in the Sanofi Territory, subject to reduction in certain circumstances.

The Company satisfied the performance obligation upon delivery of the license and initial technology transfer and recognized the upfront payment of $5.0 million as license and collaboration revenue during the year ended December 31, 2019. For the year ended December 31, 2020, the Company recognized $2.5 million of license revenue upon achievement of two development milestones which were paid in the year ended December 31, 2020.

As discussed above under heading Secura Bio, Inc. (“Secura”) as of September 30, 2020, Secura has assumed from the Company all responsibilities and obligations under the Sanofi Agreement. After September 30, 2020, the Company is entitled to 50% of future milestone payments and royalties pursuant to the Secura APA

discussed under heading Secura Bio, Inc. (“Secura”) above. Future milestone and royalty payments pursuant to the Sanofi Agreement will be paid by Sanofi to Secura. The Company’s portion of such milestone and royalty payments will be subsequently remitted to the Company by Secura.

Yakult Honsha Co., Ltd. (Yakult)

On June 5, 2018, the Company entered into a license and collaboration agreement (the Yakult Agreement) with Yakult, under which the Company granted exclusive rights to Yakult to develop and commercialize products containing duvelisib in Japan for the treatment, prevention, palliation or diagnosis of all oncology indications in humans or animals.

Yakult paid the Company an upfront, non-refundable payment of $10.0 million in June 2018. The Company is also entitled to receive aggregate payments of up to $90.0 million if certain development, regulatory and commercial milestones are successfully achieved. Yakult is obligated to pay the Company a double-digit royalty on net sales of products containing duvelisib in Japan, subject to reduction in certain circumstances, and to fund certain global development costs related to worldwide clinical trials conducted by the Company in which Yakult has opted to participate (Global Clinical Trials) on a pro-rata basis.

As discussed above under heading Secura Bio, Inc. (“Secura”) as of September 30, 2020, Secura has assumed from the Company all responsibilities and obligations under the Yakult Agreement. After September 30, 2020, the Company is entitled to 50% of future milestone payments and royalties pursuant to the Secura APA discussed under heading Secura Bio, Inc. (“Secura”) above. Payments pursuant to the Yakult Agreement will be paid by Yakult to Secura. The Company’s portion of such milestone and royalty payments will be subsequently remitted to the Company by Secura.

CSPC Pharmaceutical Group Limited (CSPC)

On September 25, 2018, the Company entered into a license and collaboration agreement with CSPC (the CSPC Agreement), under which the Company granted exclusive rights to CSPC to develop and commercialize products containing duvelisib in the People’s Republic of China (China), Hong Kong, Macau and Taiwan (collectively, the “CSPC Territory”) for the treatment, prevention, palliation or diagnosis of all oncology indications in humans.

CSPC paid the Company an aggregate upfront, non-refundable payment of $15.0 million, less the previously paid $5.0 million Exclusivity Fee. The Company is also entitled to receive aggregate payments of up to $160.0 million if certain development, regulatory and commercial milestones are successfully achieved. CSPC is obligated to pay the Company a double-digit royalty on net sales of products containing duvelisib in the CSPC Territory, subject to reduction in certain circumstances, and to fund certain global development costs related to worldwide clinical trials conducted by the Company in which CSPC has opted to participate (“Global Clinical Trials”) on a pro-rata basis.

As discussed above under heading Secura Bio, Inc. (“Secura”) as of September 30, 2020 Secura has assumed from the Company all responsibilities and obligations under the CSPC Agreement. After September 30, 2020, the Company is entitled to 50% of future milestone payments and royalties pursuant to the Secura APA discussed under heading Secura Bio, Inc. (“Secura”) above. Payments pursuant to the CSPC Agreement will be paid by CSPC to Secura. The Company’s portion of such milestone and royalty payments will be subsequently remitted to the Company by Secura.

Restructurings

12 Months Ended

Dec. 31, 2022

Restructurings

Restructurings

14. Restructurings

On February 27, 2020, following further analysis of the Company’s strategy, the Company committed to an operational plan to reduce overall operating expenses, including the elimination of approximately 31 positions across the Company and other cost-saving measures (the “February 2020 Restructuring”). The February 2020 Restructuring is designed to streamline operations, speed execution of the Company’s clinical development of avutometinib and defactinib, and reflect a focused, account-based approach in the field.

In August 2020, in connection with the duvelisib sale to Secura pursuant to the Secura APA, the Company committed to a strategic restructuring (the “August 2020 Restructuring”). The restructuring included a workforce reduction of approximately 41 positions primarily in the Company’s commercial operations department.

During the year-ended December 31, 2020, the Company recorded an aggregate expense of $4.6 million for the February 2020 Restructuring and August 2020 Restructuring for one-time termination benefits for employee severance, benefits, and related costs. This expense is reflected in the consolidated statements of operation and comprehensive loss as selling general, and administrative expense for $4.1 million, and research and development expense for $0.5 million. There were no restructuring expenses for the years ended December 31, 2022 and 2021.

Employee benefit plan

12 Months Ended

Dec. 31, 2022

Employee benefit plan

Employee benefit plan

15. Employee benefit plan

In June 2011, the Company adopted a 401(k) retirement and savings plan (the 401(k) Plan) covering all employees. The 401(k) Plan allows employees to make pre-tax or post-tax contributions up to the maximum allowable amount set by the Internal Revenue Service. Under the 401(k) Plan, the Company may make discretionary contributions as approved by the board of directors. The Company made contributions to the 401(k) Plan of approximately $0.8 million, $0.8 million, and $0.9 million for the years ended December 31, 2022, 2021, and 2020, respectively.

The entire disclosure for retirement benefits.

Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Subsequent events

12 Months Ended

Dec. 31, 2022

Subsequent events.

Subsequent events

16. Subsequent events

The Company reviews all activity subsequent to year end but prior to the issuance of the consolidated financial statements for events that could require disclosure or that could impact the carrying value of assets or liabilities as of the consolidated balance sheet date. The Company is not aware of any material subsequent events other than the following:

Securities Purchase Agreement

On January 24, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with BVF, pursuant to which the Company agreed to sell and issue to BVF in a private placement (the “Private Placement”) up to 2,144,160 shares of its Series B convertible preferred stock, par value $0.0001 per share (the “Series B Preferred Stock”), in two tranches. The Series B Preferred Shares will be convertible into the Company’s common stock at the option of the holders at any time, subject to certain limitations, at a conversion rate equal to $0.5901 per share.

The Company agreed to sell and issue in the first tranche of the Private Placement 1,200,000 shares of Preferred Stock at a purchase price of $25.00 per share of Preferred Stock (equivalent to $0.5901 per share of common stock). The first tranche of the Private Placement closed on January 27, 2023 and the Company received gross proceeds from the first tranche of the Private Placement of approximately $30.0 million, before deducting fees to the placement agent and other offering expenses.

In addition, the Company agreed to sell and issue in the second tranche of the Private Placement 944,160 shares of Series B Preferred Stock at a purchase price of $31.77 per share of Preferred Stock (equivalent to $0.75 per share of common stock) if at any time within 18 months following the closing of the first tranche the 10-day volume weighted average price of the Company’s Common Stock (as quoted on Nasdaq and as calculated by Bloomberg) should reach at least $1.125 per share (adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as needed) with aggregate trading volume during the same 10-

day period of at least $25 million within 18 months from the closing date of the initial tranche. The second tranche of the Private Placement is expected to close within seven trading days of meeting the second tranche conditions and will be subject to additional, customary closing conditions. If the second tranche conditions are satisfied, the Company anticipates receiving gross proceeds from the second tranche of the Private Placement of approximately $30.0 million, before deducting fees to the placement agent and other offering expenses payable by the Company.

Silicon Valley Bank

On March 10, 2023, Silicon Valley Bank (“SVB”), based in Santa Clara, California, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. On March 12, 2023, the Department of the Treasury, the Federal Reserve, and the FDIC announced that all depositors of SVB will be fully protected and have access to all their money starting March 13, 2023. As of March 13, 2023, the Company’s deposit balance at SVB was approximately $2 million. The Company is continually monitoring developments related to the recovery of its uninsured funds at SVB.

Summary of significant accounting policies (Policies)

12 Months Ended

Dec. 31, 2022

Segment and geographic information

Basis of presentation

Basis of presentation

Use of estimates

Use of estimates

Segment and geographic information

Cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash


	December 31, 2022		December 31, 2021
Cash and cash equivalents	$	74,933	$	21,252
Restricted cash		856		241
Total cash, cash equivalents and restricted cash	$	75,789	$	21,493

Fair value of financial instruments

Fair value of financial instruments


Level 1 inputs		Quoted prices in active markets for identical assets or liabilities that the Company can access at the measurement date.
Level 2 inputs		Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3 inputs		Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

Items Measured at Fair Value on a Recurring Basis

The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands)


	December 31, 2022
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	73,613	$	72,617	$	996	$	—
Short-term investments		12,961		—		12,961		—
Total financial assets	$	86,574	$	72,617	$	13,957	$	—


	December 31, 2021
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	19,302	$	19,302	$	—	$	—
Short-term investments		79,004		—		79,004		—
Total financial assets	$	98,306	$	19,302	$	79,004	$	—

Fair Value of Financial Instruments

Investments

Investments

Cash, cash equivalents, restricted cash and investments consist of the following (in thousands):


	December 31, 2022
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	74,794	$	—	$	—	$	74,794
Corporate bonds, agency bonds and commercial paper (due within 90 days)		995		—		—		995
Total cash, cash equivalents & restricted cash:	$	75,789	$	—	$	—	$	75,789
Investments:
Corporate bonds, agency bonds and commercial paper (due within 1 year)	$	12,961	$	2	$	(2)	$	12,961
Total investments	$	12,961	$	2	$	(2)	$	12,961
Total cash, cash equivalents, restricted cash and investments	$	88,750	$	2	$	(2)	$	88,750


	December 31, 2021
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	21,493	$	—	$	—	$	21,493
Total cash, cash equivalents & restricted cash:	$	21,493	$	—	$	—	$	21,493
Investments:
Corporate bonds and commercial paper (due within 1 year)	$	78,970	$	48	$	(14)	$	79,004
Total investments	$	78,970	$	48	$	(14)	$	79,004
Total cash, cash equivalents, restricted cash and investments	$	100,463	$	48	$	(14)	$	100,497

Concentrations of credit risk and off-balance sheet risk

Concentrations of credit risk and off-balance sheet risk

Property and equipment

Property and equipment


Laboratory equipment		5 years
Furniture		5 years
Computer equipment		3 years
Leasehold improvements		Lesser of useful life or life of lease

Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized.

Research and development costs

Research and development costs

The Company expenses research and development costs to operations as incurred. Research and development expenses consist of:

●

employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;

●

license fees;

●

facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, and laboratory supplies; and

Stock-based compensation

Stock-based compensation

based vesting requirements are expensed utilizing an accelerated attribution model if achievement of the performance criteria is determined to be probable.

Leases

Leases

Revenue recognition

Product revenue, net

consolidated statements of operations and comprehensive loss for the year ended December 31, 2020. There were no amounts recorded for the years ended December 31, 2022 and 2021.

Subject to certain limitations, the Company’s return policy allows for eligible returns of COPIKTRA for credit under the following circumstances:

●

Receipt of damaged product;

●

Shipment errors that were a result of an error by the Company;

●

Expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date;

●

Product subject to a recall; and

●

Product that the Company, at its sole discretion, has specified can be returned for credit.

Licenses and sales of intellectual property

Revenue Recognition

Collaborative Arrangements

Collaborative arrangements

Accounts Receivable, Net

Accounts receivable, net

becomes doubtful. Given the nature and credit profile of the Company’s limited number of customers, an allowance for doubtful accounts is not deemed necessary at December 31, 2022.

Income taxes

Income taxes

Net loss per share

Net loss per share

Recently Issued Accounting Standards Updates

Recently issued accounting standards updates

Summary of significant accounting policies (Tables)

12 Months Ended

Dec. 31, 2022

Schedule of reconciliation of cash, cash equivalents and restricted cash


	December 31, 2022		December 31, 2021
Cash and cash equivalents	$	74,933	$	21,252
Restricted cash		856		241
Total cash, cash equivalents and restricted cash	$	75,789	$	21,493

Schedule of financial instruments measured at fair value on a recurring basis

The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis (in thousands)


	December 31, 2022
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	73,613	$	72,617	$	996	$	—
Short-term investments		12,961		—		12,961		—
Total financial assets	$	86,574	$	72,617	$	13,957	$	—


	December 31, 2021
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	19,302	$	19,302	$	—	$	—
Short-term investments		79,004		—		79,004		—
Total financial assets	$	98,306	$	19,302	$	79,004	$	—

Schedule of cash, cash equivalents and investments

Cash, cash equivalents, restricted cash and investments consist of the following (in thousands):


	December 31, 2022
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	74,794	$	—	$	—	$	74,794
Corporate bonds, agency bonds and commercial paper (due within 90 days)		995		—		—		995
Total cash, cash equivalents & restricted cash:	$	75,789	$	—	$	—	$	75,789
Investments:
Corporate bonds, agency bonds and commercial paper (due within 1 year)	$	12,961	$	2	$	(2)	$	12,961
Total investments	$	12,961	$	2	$	(2)	$	12,961
Total cash, cash equivalents, restricted cash and investments	$	88,750	$	2	$	(2)	$	88,750


	December 31, 2021
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	21,493	$	—	$	—	$	21,493
Total cash, cash equivalents & restricted cash:	$	21,493	$	—	$	—	$	21,493
Investments:
Corporate bonds and commercial paper (due within 1 year)	$	78,970	$	48	$	(14)	$	79,004
Total investments	$	78,970	$	48	$	(14)	$	79,004
Total cash, cash equivalents, restricted cash and investments	$	100,463	$	48	$	(14)	$	100,497

Schedule of estimated useful lives of the assets


Laboratory equipment		5 years
Furniture		5 years
Computer equipment		3 years
Leasehold improvements		Lesser of useful life or life of lease

Property and equipment, net (Tables)

12 Months Ended

Dec. 31, 2022

Property and equipment, net

Schedule of property equipment and related accumulated depreciation

Property and equipment and related accumulated depreciation are as follows (in thousands):


	December 31,		December 31,
	2022		2021
Leasehold improvements	$	146	$	146
Furniture and fixtures		811		1,074
Computer equipment		665		665
		1,622		1,885
Less: accumulated depreciation		(1,530)		(1,675)
Total property and equipment, net	$	92	$	210

Accrued expenses (Tables)

12 Months Ended

Dec. 31, 2022

Accrued expenses

Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):


	December 31, 2022		December 31, 2021
Research and development expenses	$	8,535	$	9,311
Compensation and related benefits		3,844		3,892
Professional fees		469		785
Consulting fees		902		544
Interest		192		3
Commercialization costs		148		187
Other		893		899
Total accrued expenses	$	14,983	$	15,621

Long-term debt (Tables)

12 Months Ended

Dec. 31, 2022

Long-term debt

Schedule of carrying value of debt


	December 31, 2022
Principal loan balance	$	25,000
Final Payment Fee		225
Debt issuance costs, net of accretion		(699)
Long-term debt, net of discount	$	24,526

Schedule of future principal payments under the Loan Agreement


2023		—
2024		6,250
2025		8,333
2026		8,333
2027		2,084
Total principal payments	$	25,000

Leases (Tables)

12 Months Ended

Dec. 31, 2022

Leases

Summary of elements of lease expenses


	Year ended December 31,
	2022		2021
Lease Expense
Operating lease expense	$	885	$	885
Total Lease Expense	$	885	$	885
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$	1,039	$	1,019


		December 31, 2022
Other Balance Sheet Information - Operating Leases
Weighted average remaining lease term (in years)		2.5
Weighted average discount rate		14.6%
Maturity Analysis
2023		1,060
2024		1,081
2025		546
Total	$	2,687
Less: Present value discount		(423)
Lease Liability	$	2,264

Common stock (Tables)

12 Months Ended

Dec. 31, 2022

Common stock.

Schedule of shares of common stock reserved for the issuance of common stock for vested restricted stock units and the exercise of stock options


	December 31,
	2022	2021
Shares reserved under equity compensation plans	34,739	36,234
Shares reserved for inducement grants	3,928	3,991
Shares reserved for 2018 Notes	42	42
Shares reserved for ESPP	1,068	1,190
Shares reserved for Series A Preferred Stock	10,000	—
Total shares reserved	49,777	41,457

Stock-based compensation (Tables)

12 Months Ended

Dec. 31, 2022

Stock-based compensation

Schedule of stock-based compensation expense as reflected in the Company's consolidated statements of operations and comprehensive loss

Stock-based compensation expense as reflected in the Company’s consolidated statements of operations and comprehensive loss was as follows (in thousands):


	Year ended December 31,
	2022		2021		2020
Research and development	$	1,766	$	2,099	$	1,935
Selling, general and administrative		4,281		5,612		6,183
Total stock-based compensation expense	$	6,047	$	7,711	$	8,118

Summary of stock option activity and related information


	Shares	Weighted-average exercise price per share		Weighted-average remaining contractual term (years)	Aggregate intrinsic value (in thousands)
Outstanding at December 31, 2021	16,264,098	$	3.56	6.7	$	2,601
Granted	1,547,998		0.95
Exercised	(98,176)		1.20
Forfeited/cancelled	(3,695,310)		5.41
Outstanding at December 31, 2022	14,018,610	$	2.80	7.1	$	18
Vested at December 31, 2022	8,686,694	$	3.28	6.1	$	2

Schedule of assumptions used to estimate fair value of each stock option on grant date


	Year ended December 31,
	2022		2021		2020
Risk-free interest rate	3.13	%	1.15	%	0.60	%
Volatility	88	%	89	%	96	%
Dividend yield	—		—		—
Expected term (years)	5.8		6.0		6.0

Schedule of restricted stock units


	Shares	Weighted-average grant date fair value per share
Outstanding at December 31, 2021	2,805,004	$	2.44
Granted	398,413	$	0.92
Vested	(876,829)	$	2.63
Forfeited/cancelled	(251,621)	$	2.29
Outstanding at December 31, 2022	2,074,967	$	2.09

Schedule of assumptions used to estimate fair value of each employee stock purchase plan on grant date


	Year ended December 31,
	2022		2021		2020
Risk-free interest rate	1.56	%	0.07	%	1.04	%
Volatility	77	%	68	%	109	%
Dividend yield	—		—		—
Expected term (years)	0.5		0.5		0.5

Net loss per share (Tables)

12 Months Ended

Dec. 31, 2022

Net loss per share

Schedule of potentially dilutive securities were excluded from the calculation of diluted net loss per share


	Year Ended December 31,
	2022	2021	2020
Outstanding stock options	14,018,610	16,264,098	12,690,745
Outstanding restricted stock units	2,074,967	2,805,004	2,649,317
2018 Notes	41,873	41,873	41,873
2020 Notes	—	—	8,615,384
Employee stock purchase plan	82,496	57,636	53,372
Series A Preferred Stock	10,000,000	—	—
Total potentially dilutive securities	26,217,946	19,168,611	24,050,691

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income taxes

Schedule of components of Income tax expense

For the years ended December 31, 2022, 2021, and 2020 income tax expense consisted of the following (in thousands):


	Year ended December 31,
	2022		2021		2020
Current tax expense:
Federal	$	—	$	—	$	—
State		—		—		194
Current income tax expense		—		—		194
Deferred
Federal		—		—		—
State		—		—		—
Deferred income tax expense		—		—		—
Total income tax expense	$	—	$	—	$	194

Schedule of reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations



	December 31,
	2022		2021
Income tax benefit using U.S. federal statutory rate	21.00	%	21.00	%
State tax benefit, net of federal benefit	2.15	%	3.01	%
Research and development tax credits	2.81	%	2.71	%
Stock-based compensation	(2.17)	%	—	%
Permanent items	(0.08)	%	(0.44)	%
Change in the valuation allowance	(21.41)	%	(21.23)	%
NOL and tax credit expiration under Section 382	(2.26)	%	(4.34)	%
Other	(0.04)	%	(0.71)	%
	—	%	—	%

Schedule of principal components of deferred tax assets and liabilities

The principal components of the Company’s deferred tax assets and liabilities are as follows (in thousands):


	December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	103,243	$	98,777
Capitalized research and development		11,621		1,276
Research and development credits		7,107		4,516
Stock-based compensation		3,450		4,200
Installment sale		7,768		8,819
Lease liability		538		730
Other deferred tax assets		587		411
Total deferred tax assets		134,314		118,729
Deferred tax liabilities:
Right-of-use asset		(425)		(574)
Debt discount		(4)		(11)
Other deferred tax liability		(29)		(91)
Total deferred tax liabilities		(458)		(676)
Net deferred tax asset prior to valuation allowance		133,856		118,053
Valuation allowance		(133,856)		(118,053)
Net deferred tax asset	$	—	$	—

License, collaboration and commercial agreements (Tables)

12 Months Ended

Dec. 31, 2022

License, collaboration and commercial agreements

Schedule of contract assets

The following table presents changes in the Company’s contract asset for the year ended December 31, 2022 (in thousands):


Contract Asset:	December 31, 2021		Additions		Reclassification to receivable		December 31, 2022
Contract asset - Secura	$	170	$	96	$	(170)	$	96
Total	$	170	$	96	$	(170)	$	96

Nature of business (Details) - USD ($) $ in Thousands			12 Months Ended
Nature of business (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 25, 2022	Dec. 31, 2022	Dec. 31, 2021
Nature of business
Cash, cash equivalents, and investments			$ 87,900
Accumulated deficit			737,523	$ 663,711
Term loan
Nature of business
Issuance of debt		$ 25,000
Series B Convertible Preferred Stock
Nature of business
Proceeds from Issuance of Convertible Preferred Stock			$ 30,000
Subsequent events \| Term loan
Nature of business
Issuance of debt	$ 15,000

Summary of significant accounting policies - Segment and geographic information (Details)	12 Months Ended
	Dec. 31, 2022 item
Segment and geographic information
Number of operating segments	1

Summary of significant accounting policies - Proceeds from grants (Details) - USD ($)
$ in Thousands

1 Months Ended

12 Months Ended

Aug. 31, 2022

Jul. 31, 2022

Dec. 31, 2022

Reduction of research and development expense

Grant awarded, amount

$ 3,800

Cash proceeds

$ 500

$ 1,000

$ 300

Research and development costs

Research and development costs

The Company expenses research and development costs to operations as incurred. Research and development expenses consist of:

●

employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;

●

license fees;

●

facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, and laboratory supplies; and

Deferred liabilities

$ 710

Summary of significant accounting policies - Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Property, Plant and Equipment [Line Items]
Cash and cash equivalents	$ 74,933	$ 21,252
Restricted cash	241	241
Restricted cash	856
Total cash, cash equivalents and restricted cash	75,789	$ 21,493	$ 68,023	$ 79,262
Grant [Member]
Property, Plant and Equipment [Line Items]
Restricted cash	600
Letter of credit \| Office and Laboratory Space in Needham, Massachusetts.
Property, Plant and Equipment [Line Items]
Restricted cash	200
Restricted cash	$ 200

Summary of significant accounting policies - Fair Value Financial Instruments, Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Financial liabilities
Debt, carrying value	$ 25,000
Level 3 \| Term loan
Financial liabilities
Debt, carrying value	24,500
Debt, fair value	24,900
Level 3 \| 2018 Notes
Financial liabilities
Debt, carrying value		$ 200
Debt, fair value	$ 300	$ 300

Summary of significant accounting policies - Fair Value Financial Instruments, Measured at Fair Value (Details) - Recurring basis - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Financial assets
Cash equivalents	$ 73,613	$ 19,302
Short-term investments	12,961	79,004
Total financial assets	86,574	98,306
Level 1
Financial assets
Cash equivalents	72,617	19,302
Total financial assets	72,617	19,302
Level 2
Financial assets
Cash equivalents	996
Short-term investments	12,961	79,004
Total financial assets	$ 13,957	$ 79,004

Summary of significant accounting policies - Fair Value Financial Instruments, Derivative Liability (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Nov. 06, 2020	Oct. 17, 2018
Derivative liability
Debt, carrying value	$ 25,000
2018 Notes
Derivative liability
Interest rate (as a percent)	5.00%			5.00%
2018 Notes \| Level 3
Derivative liability
Debt, fair value	$ 300	$ 300
Debt, carrying value		$ 200
5.00% Convertible Senior Third Lien Notes due 2048
Derivative liability
Interest rate (as a percent)			5.00%

Summary of significant accounting policies - Investments (Details)	12 Months Ended
	Dec. 31, 2022 USD ($) item	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Investments
Cash, cash equivalents & restricted cash	$ 74,933,000	$ 21,252,000
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Gains	2,000	48,000
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Losses	(2,000)	(14,000)
Total cash, cash equivalents, restricted cash and investments, Fair Value	87,900,000
Realized gains or losses on investments	$ 0	$ 0	$ 0
Number of investments in unrealized loss position	2	3
Number of investments in unrealized loss position for more than 12 months	0	0
Unrealized loss on fair value	$ 6,000,000.0	$ 15,800,000
Amortized Cost
Investments
Total cash, cash equivalents, restricted cash and investments, Amortized Cost	88,750,000	100,463,000
Total
Investments
Total cash, cash equivalents, restricted cash and investments, Fair Value	88,750,000	100,497,000
Cash, cash equivalents & restricted cash \| Amortized Cost
Investments
Cash, cash equivalents & restricted cash	75,789,000	21,493,000
Cash, cash equivalents & restricted cash \| Total
Investments
Cash, cash equivalents & restricted cash, Fair Value	75,789,000	21,493,000
Cash and money market accounts. \| Amortized Cost
Investments
Cash, cash equivalents & restricted cash	74,794,000	21,493,000
Cash and money market accounts. \| Total
Investments
Cash, cash equivalents & restricted cash, Fair Value	74,794,000	$ 21,493,000
Corporate bonds and commercial paper
Investments
Maturity period, investments		1 year
Investments.
Investments
Gross Unrealized Gains	2,000	$ 48,000
Gross Unrealized Losses	(2,000)	(14,000)
Investments. \| Amortized Cost
Investments
Investments, Amortize Cost	12,961,000	78,970,000
Investments. \| Total
Investments
Investments, Fair Value	$ 12,961,000	79,004,000
Corporate bonds, agency bonds and commercial paper
Investments
Original maturity period, cash and cash equivalents	90 days
Corporate bonds, agency bonds and commercial paper (due within 1 year)
Investments
Maturity period, investments	1 year
Gross Unrealized Gains	$ 2,000	48,000
Gross Unrealized Losses	(2,000)	(14,000)
Corporate bonds, agency bonds and commercial paper (due within 1 year) \| Amortized Cost
Investments
Due within 1 year	12,961,000	78,970,000
Corporate bonds, agency bonds and commercial paper (due within 1 year) \| Total
Investments
Due within 1 year		$ 79,004,000
Due within 1 year, Fair Value	12,961,000
Corporate bonds, agency bonds and commercial paper (due within 90 days) \| Amortized Cost
Investments
Cash, cash equivalents & restricted cash	995,000
Corporate bonds, agency bonds and commercial paper (due within 90 days) \| Total
Investments
Cash, cash equivalents & restricted cash, Fair Value	$ 995,000

Summary of significant accounting policies - Concentrations of credit risk and off-balance sheet risk (Details) $ in Thousands	1 Months Ended		12 Months Ended		24 Months Ended
	Aug. 31, 2022 USD ($)	Jul. 31, 2022 USD ($)	Dec. 31, 2022 USD ($) customer Institution	Dec. 31, 2021 customer	Dec. 31, 2022 customer
Concentrations of credit risk and off-balance sheet risk
Off-balance sheet concentrations of credit risk description			As of December 31, 2022, the Company’s cash, cash equivalents and investments were deposited at three financial institutions and it has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
Number of financial institutions in which cash, cash equivalents and investments were deposited \| Institution			3
Grant awarded, amount			$ 3,800
Cash proceeds	$ 500	$ 1,000
Reduction of research and development expense			300
Deferred liabilities			$ 710
Trade accounts receivable \| Credit Concentration Risk
Concentrations of credit risk and off-balance sheet risk
Number of customer \| customer					1
Trade accounts receivable \| Credit Concentration Risk \| Minimum
Concentrations of credit risk and off-balance sheet risk
Percentage			60.00%	60.00%
Revenue \| Customer Concentration Risk
Concentrations of credit risk and off-balance sheet risk
Number of customer \| customer			1	1

Summary of significant accounting policies - Property and Equipment (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Property and equipment, net
Impairment losses on long-lived assets	$ 0
Laboratory equipment
Property and equipment, net
Estimated useful lives	5 years
Furniture
Property and equipment, net
Estimated useful lives	5 years
Computer equipment
Property and equipment, net
Estimated useful lives	3 years

Summary of significant accounting policies - Revenue Recognition and Accounts Receivable, Net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Revenue recognition
Total revenue	$ 2,596	$ 2,053	$ 88,516
Cost Of Sale, License And Related Assets			31,187
Trade discounts and allowances
Revenue recognition
Product revenue reserves and allowances	0
Government rebates and other incentives
Revenue recognition
Product revenue reserves and allowances	0
Sale of COPIKTRA license and related assets
Revenue recognition
Total revenue	2,596	$ 1,447	$ 70,000
Product revenue reserves and allowances	$ 0
Minimum
Accounts Receivable
Threshold accounts receivable typically due	30 days
Maximum
Accounts Receivable
Threshold accounts receivable typically due	90 days
Prior to product's expiration
Revenue recognition
Period for eligible returns of expired product	3 months
After product's expiration date
Revenue recognition
Period for eligible returns of expired product	6 months

Property and equipment, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Property and equipment
Property and equipment, gross	$ 1,622	$ 1,885
Less: accumulated depreciation	(1,530)	(1,675)
Property and equipment, net	92	210
Depreciation expenses	118	206	$ 531
Leasehold improvements
Property and equipment
Property and equipment, gross	146	146
Furniture
Property and equipment
Property and equipment, gross	811	1,074
Computer equipment
Property and equipment
Property and equipment, gross	$ 665	$ 665

Accrued expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Accrued expenses
Research and development expenses	$ 8,535	$ 9,311
Compensation and related benefits	3,844	3,892
Professional fees	469	785
Consulting fees	902	544
Interest	192	3
Commercialization costs	148	187
Other	893	899
Total accrued expenses	$ 14,983	$ 15,621

Long-term debt (Details) - USD ($) $ in Thousands				12 Months Ended
Long-term debt (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 25, 2022	Nov. 09, 2020	Dec. 31, 2020	Nov. 14, 2019	Mar. 21, 2017
Long-term debt
Loss on debt extinguishment				$ (1,580)
Loan Agreement
Long-term debt
Financial covenants		$ 0
Accrued interest rate		5.00%
Amended Term Loan Agreement
Long-term debt
Repayment of term loan			$ 37,400
Repayment of principal			35,000
Repayment of final payment			1,800
Prepayment penalty fee			500
Accrued and unpaid interest			100
Loss on debt extinguishment				$ 1,600
Carrying amount of the debt excluding accrued interest			$ 1,600
Term loan
Long-term debt
Aggregate principal amount		$ 150,000
Issuance of debt		25,000
Current borrowing capacity		$ 125,000
Percentage of final prepayment fee		5.00%
Additional interest rate in an event of default		0.50%
Term loan \| Subsequent events
Long-term debt
Issuance of debt	$ 15,000
Term loan \| Secured Overnight Financing Rate
Long-term debt
Interest rate		7.37%
Basis spread		0.13%
Term loan \| If prepaid on or before the first anniversary
Long-term debt
Percentage of final prepayment fee		3.00%
Term loan \| If prepaid after the first anniversary and on or before the second anniversary
Long-term debt
Percentage of final prepayment fee		2.00%
Term loan \| If prepaid after the second anniversary
Long-term debt
Percentage of final prepayment fee		1.00%
Term B Loan
Long-term debt
Aggregate principal amount		$ 15,000
Regulatory milestone payments		35,000
Minimum unrestricted cash proceeds from sale or issuance of equity securities		$ 50,000
Debt instrument period to draw loan, Minimum		60 days
Term C Loan
Long-term debt
Aggregate principal amount		$ 25,000
Debt instrument period to draw loan, Minimum		60 days
Term D Loan
Long-term debt
Aggregate principal amount		$ 35,000
Debt instrument period to draw loan, Minimum		30 days
Gross product revenue to be achieved		$ 50,000
Term F Loan
Long-term debt
Aggregate principal amount		$ 50,000
Medium-term Notes [Member] \| Loan Agreement
Long-term debt
Maximum borrowing capacity						$ 25,000
Medium-term Notes [Member] \| Amended Term Loan Agreement
Long-term debt
Maximum borrowing capacity					$ 75,000

Long-term debt - Components of carrying value of debt (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Long-term debt
Principal loan balance	$ 25,000
Final Payment Fee	225
Debt issuance costs, net of accretion	(699)
Long-term debt, net of discount	$ 24,526

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

+ References + Details

Long-term debt - Future principal payments (Details) $ in Thousands	Dec. 31, 2022 USD ($)
Future principal payments
2024	$ 6,250
2025	8,333
2026	8,333
2027	2,084
Total principal payments	$ 25,000

Leases (Details) $ in Millions	Feb. 15, 2018 USD ($) ft²	Apr. 15, 2014 ft²
Office and Laboratory Space in Needham, Massachusetts.
Leases
Area of space \| ft²	27,810	15,197
Office and Laboratory Space in Needham, Massachusetts. \| Minimum
Leases
Operating lease expense \| $	$ 0.7
Office and Laboratory Space in Needham, Massachusetts. \| Maximum
Leases
Operating lease expense \| $	$ 1.1
Office and Laboratory Space in Needham, Massachusetts
Leases
Area of space \| ft²	27,810

Leases - Balance sheet and other information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Leases
Right-of use asset	$ 1,789	$ 2,302
Lease liability	2,264
Lease Expense
Operating lease expense	885	885
Total Lease Expense	885	885
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$ 1,039	$ 1,019
Weighted average remaining lease term (in years)	2 years 6 months
Weighted average discount rate	14.60%
Maturity Analysis
2024	$ 1,060
2025	1,081
2026	546
Total	2,687
Less: Present value discount	(423)
Lease Liability	$ 2,264

Common stock (Details) $ / shares in Units, $ in Thousands						1 Months Ended	12 Months Ended
Common stock (Details) $ / shares in Units, $ in Thousands	Nov. 04, 2022 $ / shares shares	Mar. 03, 2020 USD ($)	Feb. 27, 2020 $ / shares shares	Aug. 28, 2017 USD ($)	Mar. 30, 2017 USD ($)	Aug. 31, 2021 USD ($)	Dec. 31, 2022 USD ($) Vote $ / shares shares	Dec. 31, 2021 USD ($) $ / shares shares	Dec. 31, 2020 USD ($) shares	Dec. 18, 2018 shares
Common stock
Shares reserved for issuance							49,777,000	41,457,000
Number of votes entitled for each share of common stock \| Vote							1
Common stock
Proceeds from Issuance of Common Stock \| $							$ 27,354	$ 6,723	$ 106,059
Preferred Stock, Shares Authorized							5,000,000	5,000,000
Preferred stock, par value (in dollars per share) \| $ / shares							$ 0.0001	$ 0.0001
Private Investment in Public Equity (PIPE)
Common stock
Shares issued			46,511,628
Proceeds from Issuance of Common Stock \| $		$ 93,800
Share price (in dollars per share) \| $ / shares			$ 2.15
Share price premium (as percentage)			12.60%
Share price, prior to premium price (in dollars per share) \| $ / shares			$ 1.91
Common stock
Common stock
Shares issued									46,511,628
Common stock \| Biotechnology Value Fund [Member]
Common stock
Conversion of stock, shares converted	10,000,000
Common stock \| At-the-market equity offering program
Common stock
Shares issued							0		6,769,559
Proceeds from Issuance of Common Stock \| $									$ 12,200
SeriesA Convertible Preferred Stock [Member]
Common stock
Convertible preferred stock, shares issued upon conversion	10
Conversion of preferred stock, conversion blocker, percent	9.99%
Conversion of Preferred Stock, Conversion Blocker, Notice Period	60 days
SeriesA Convertible Preferred Stock [Member] \| Maximum
Common stock
Conversion of Preferred Stock, Conversion Blocker, Percent, Upon Giving Notice	19.99%
SeriesA Convertible Preferred Stock [Member] \| Biotechnology Value Fund [Member]
Common stock
Shares issued on conversion	1,000,000
Preferred stock, par value (in dollars per share) \| $ / shares	$ 0.0001
2017 ATM Program \| Common stock \| At-the-market equity offering program
Common stock
Maximum value of common stock allowed to be sold \| $				$ 75,000	$ 35,000
Inducement Award Program
Common stock
Shares reserved for issuance							3,928,000	3,991,000
2021 ATM Program \| At-the-market equity offering program
Common stock
Shares issued							23,573,403	2,930,585
Net proceeds from issuance of stock \| $							$ 27,400	$ 6,800
2021 ATM Program \| Common stock \| At-the-market equity offering program
Common stock
Maximum value of common stock allowed to be sold \| $						$ 100,000
Convertible Common Stock [Member] \| 2018 Notes
Common stock
Shares reserved for issuance							42,000	42,000
Equity compensation plans
Common stock
Shares reserved for issuance							34,739,000	36,234,000
Employee Stock purchase plan
Common stock
Shares reserved for issuance							1,068,000	1,190,000		2,000,000
Common stock
Proceeds from Issuance of Common Stock \| $							$ 200	$ 200	$ 400
Series A Preferred Stock
Common stock
Shares reserved for issuance							10,000,000

Stock-based compensation - Stock-Based Compensation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Stock-based compensation
Total stock-based compensation expense	$ 6,047	$ 7,711	$ 8,118
Research and development
Stock-based compensation
Total stock-based compensation expense	1,766	2,099	1,935
Selling, General And Administrative Expense [Member]
Stock-based compensation
Total stock-based compensation expense	$ 4,281	$ 5,612	$ 6,183

Stock-based compensation - Equity Plans and Activity (Details)				1 Months Ended						12 Months Ended	72 Months Ended
	Jan. 01, 2018 shares	Jan. 01, 2017 shares	Jan. 01, 2016 shares	Feb. 29, 2020 shares	Dec. 31, 2018 shares	Jun. 30, 2018 shares	Dec. 31, 2017 shares	Dec. 31, 2016 shares	Feb. 29, 2012 shares	Dec. 31, 2022 item shares	Dec. 31, 2018 shares	Dec. 31, 2021 shares	May 19, 2020 shares	Dec. 18, 2018 shares	Dec. 31, 2014 shares
Stock-based compensation
Number of Equity Compensation Plans \| item										2
Stock options
Stock-based compensation
Granted (in shares)										1,547,998
Exercised (in shares)										98,176
Restricted stock units
Stock-based compensation
Granted (in shares)										398,413
Forfeited (in shares)										251,621
Vested (in shares)										876,829
Inducement Award Program
Stock-based compensation
Number of shares reserved															750,000
Additional number of shares authorized for issuance					1,250,000	1,700,000	2,500,000	580,000
Shares available for future grants										1,605,930
Reduction of shares available for issuance				2,033,367
Inducement Award Program \| Stock options
Stock-based compensation
Granted (in shares)										7,875,009
Forfeited (in shares)										5,439,075
Exercised (in shares)										584,016
Inducement Award Program \| Restricted stock units
Stock-based compensation
Granted (in shares)										873,063
Forfeited (in shares)										243,294
Vested (in shares)										160,280
Equity Incentive Plan 2021 [Member]
Stock-based compensation
Number of shares reserved												23,900,000
Shares available for future grants										20,996,662
Equity Incentive Plan 2021 [Member] \| Stock options
Stock-based compensation
Granted (in shares)										4,685,445
Forfeited (in shares)										404,850
Exercised (in shares)										0
Equity Incentive Plan 2021 [Member] \| Restricted stock units
Stock-based compensation
Granted (in shares)										2,032,397
Forfeited (in shares)										213,400
Vested (in shares)										541,012
2012 Plan
Stock-based compensation
Number of shares reserved									3,428,571			10,649,876	13,000,000	16,628,425
Additional number of shares authorized for issuance	1,285,714	1,285,714	1,285,714						30,101
Percentage of outstanding shares of common stock used to compute annual increase in number of shares reserved											4.00%
2012 Plan \| Maximum
Stock-based compensation
Annual increase in number of shares reserved											1,285,714
2012 Plan \| Stock options
Stock-based compensation
Granted (in shares)										22,098,207
Forfeited (in shares)										11,915,465
Exercised (in shares)										2,296,645
2012 Plan \| Restricted stock units
Stock-based compensation
Granted (in shares)										6,678,621
Forfeited (in shares)										1,049,068
Vested (in shares)										5,302,060
Incentive Plan 2021 New Shares [Member]
Stock-based compensation
Number of shares reserved												13,250,124

Stock-based compensation - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Additional disclosures
Stock-based compensation expense	$ 6,047	$ 7,711	$ 8,118
Stock options
Stock-based compensation
Expiration term	10 years
Shares
Outstanding at the beginning of the period (in shares)	16,264,098
Granted (in shares)	1,547,998
Exercised (in shares)	(98,176)
Forfeited/cancelled (in shares)	(3,695,310)
Outstanding at the end of the period (in shares)	14,018,610	16,264,098
Vested at the end of the period (in shares)	8,686,694
Weighted-average exercise price per share
Outstanding at the beginning of the period (in dollars per share)	$ 3.56
Granted (in dollars per share)	0.95
Exercised (in dollars per share)	1.20
Forfeited/cancelled (in dollars per share)	5.41
Outstanding at the end of the period (in dollars per share)	2.80	$ 3.56
Vested at the end of the period (in dollars per share)	$ 3.28
Weighted-average remaining contractual term
Outstanding at the end of the period	7 years 1 month 6 days	6 years 8 months 12 days
Vested at the end of the period	6 years 1 month 6 days
Aggregate intrinsic value
Outstanding at the beginning of the period (in dollars)	$ 2,601
Outstanding at the end of the period (in dollars)	18	$ 2,601
Vested at the end of the period (in dollars)	$ 2
Assumptions used to estimate fair value of each stock-based award on the grant date
Risk-free interest rate (as a percent)	3.13%	1.15%	0.60%
Volatility (as a percent)	88.00%	89.00%	96.00%
Dividend yield (as a percent)	0.00%	0.00%	0.00%
Expected term (years)	5 years 9 months 18 days	6 years	6 years
Additional disclosures
Stock-based compensation expense	$ 4,200	$ 4,100	$ 4,300
Weighted-average grant date fair value (in dollars per share)	$ 0.69	$ 1.82	$ 1.62
Fair value of vested stock options	$ 4,400	$ 3,800	$ 7,400
Aggregate intrinsic value of options exercised (in dollars)	100	$ 800
Total unrecognized stock-based compensation expense (in dollars)	$ 6,600
Weighted-average recognition period	2 years 7 months 6 days
Stock options \| One Year From Vesting
Stock-based compensation
Vesting percentage	25.00%
Vesting period	1 year
Stock options \| Successive Three-Month Periods After One Year From Vesting
Stock-based compensation
Vesting percentage	6.25%
Vesting period	3 months

Stock-based compensation - Restricted Stock (Details) $ / shares in Units, $ in Thousands	1 Months Ended		12 Months Ended
	Aug. 31, 2020 position	Aug. 31, 2020 employee	Dec. 31, 2022 USD ($) tranche item $ / shares shares	Dec. 31, 2021 USD ($) $ / shares shares	Dec. 31, 2020 USD ($) employee
Additional disclosures
Stock-based compensation expense			$ 6,047	$ 7,711	$ 8,118
One-time Termination Benefits \| August 2020 Restructuring
Additional disclosures
Number of eliminated positions	41	41
Restricted stock units
Stock-based compensation
Number of shares holder to receive when RSU vests \| shares			1
Shares
Outstanding at the beginning of the period (in shares) \| shares			2,805,004
Granted (in shares) \| shares			398,413
Vested (in shares) \| shares			(876,829)
Forfeited/cancelled (in shares) \| shares			(251,621)
Outstanding at the end of the period (in shares) \| shares			2,074,967	2,805,004
Weighted-average grant date fair value
Outstanding at the beginning of the period (in dollars per share) \| $ / shares			$ 2.44
Granted (in dollars per share) \| $ / shares			0.92
Vested (in dollars per share) \| $ / shares			2.63
Forfeited/cancelled (in dollars per share) \| $ / shares			2.29
Outstanding at the end of the period (in dollars per share) \| $ / shares			$ 2.09	$ 2.44
Additional disclosures
Stock-based compensation expense			$ 1,800	$ 3,500	3,700
Fair value of shares vested			2,300	3,700	$ 3,800
Unrecognized stock-based compensation expense			$ 4,300
Weighted-average recognition period			2 years 9 months 18 days
Number of affected employees \| employee					93
Incremental stock compensation expense to be recognized over the remaining requisite service period					$ 200
Incremental stock compensation expense			$ 0	$ 100	100
Restricted stock units \| Selling, general and administrative expenses
Additional disclosures
Stock-based compensation expense					$ 500
Restricted stock units \| One Year From Vesting
Stock-based compensation
Number of anniversaries \| item			1
Vesting percentage			25.00%
Vesting period			1 year
Restricted stock units \| Successive Three-Month Periods After One Year From Vesting
Stock-based compensation
Vesting percentage			6.25%
Vesting period			3 months
Restricted stock units \| One Year Anniversary
Stock-based compensation
Number of installments \| tranche			2
Vesting percentage			50.00%
Vesting period			1 year
Restricted stock units \| Within Two Years of Vesting Commencement
Stock-based compensation
Vesting percentage			100.00%
Vesting period			2 years

Stock-based compensation - Employee Stock Purchase Plan (Details) $ in Thousands		12 Months Ended
	Dec. 18, 2018 item shares	Dec. 31, 2022 USD ($) shares	Dec. 31, 2021 USD ($) shares	Dec. 31, 2020 USD ($) shares
Stock-based compensation
Shares reserved for issuance \| shares		49,777,000	41,457,000
Assumptions used to estimate fair value of each stock-based award on the grant date
Stock-based compensation expense		$ 6,047	$ 7,711	$ 8,118
Proceeds from the issuance of common stock, net		$ 27,354	$ 6,723	$ 106,059
Employee Stock purchase plan
Stock-based compensation
Percent of common stock at market price to be purchased	85.00%
Number of vesting periods \| item	2
Vesting period	6 months
Shares reserved for issuance \| shares	2,000,000	1,068,000	1,190,000
Assumptions used to estimate fair value of each stock-based award on the grant date
Risk-free interest rate (as a percent)		1.56%	0.07%	1.04%
Volatility (as a percent)		77.00%	68.00%	109.00%
Expected term (years)		6 months	6 months	6 months
Stock-based compensation expense		$ 100
Issuance of common stock under ESPP \| shares		122,332	110,060	358,193
Proceeds from the issuance of common stock, net		$ 200	$ 200	$ 400

Convertible Senior Notes (Details)						1 Months Ended	2 Months Ended	3 Months Ended	12 Months Ended
Convertible Senior Notes (Details)	Jul. 16, 2021 USD ($) shares	Nov. 06, 2020 USD ($) D $ / shares	Dec. 23, 2019 USD ($) $ / shares	Nov. 14, 2019 USD ($) $ / shares	Oct. 17, 2018 USD ($) D item $ / shares	Dec. 31, 2019 USD ($)	Dec. 31, 2019 USD ($) shares	Mar. 31, 2020 USD ($) shares	Dec. 31, 2022 USD ($) $ / shares	Dec. 31, 2021 USD ($) $ / shares	Dec. 31, 2020 USD ($)	Jul. 01, 2021 USD ($)	Oct. 11, 2018 $ / shares
Convertible Notes
Common stock, par value (in dollars per share) \| $ / shares									$ 0.0001	$ 0.0001
Change in fair value of conversion option of Notes on exchange											$ 2,331,000
Other Nonoperating Income (Expenses)									$ 47,000		(1,313,000)
Change in fair value of conversion feature											(1,313,000)
Interest make-whole payments on the 2019 Notes											1,763,000
Notes outstanding									24,526,000
Debt, carrying value									25,000,000
2019 Notes
Convertible Notes
Aggregate principal amount									1,000
Debt Conversion, Original Debt, Amount							$ 9,500,000
Debt Conversion, Converted Instrument, Amount			$ 4,000,000.0	$ 62,900,000				$ 57,400,000
Interest rate (as a percent)			5.00%	5.00%
Gains (Losses) on Restructuring of Debt									0
Common stock, par value (in dollars per share) \| $ / shares			$ 0.0001	$ 0.0001
Initial conversion rate			606.0606	606.0606
Initial conversion price of Common Stock \| $ / shares			$ 1.65	$ 1.65
Debt discount			$ 200,000
Derivative liability			200,000
Change in fair value of conversion option of Notes on exchange				$ 13,600,000
Other Nonoperating Income (Expenses)											$ 1,300,000
Interest expense									100,000
Debt conversion, Converted Instrument, Cash								$ 1,800,000
Debt Conversion, Converted Instrument, Shares Issued \| shares							5,767,872	34,796,350
Interest make-whole payments on the 2019 Notes				400,000		$ 400,000
2018 Notes
Convertible Notes
Aggregate principal amount		$ 28,000,000.0			$ 150,000,000.0				$ 1,000			$ 28,000,000.0
Debt Conversion, Original Debt, Amount			7,400,000	114,300,000
Debt Conversion, Converted Instrument, Amount	$ 28,000,000.0
Repayments of Convertible Debt			$ 700,000	$ 11,400,000
Interest rate (as a percent)					5.00%				5.00%
Net proceeds					$ 145,300,000
Common stock, par value (in dollars per share) \| $ / shares					$ 0.0001
Initial conversion rate					139.5771
Initial conversion price of Common Stock \| $ / shares					$ 7.16
Conversion premium above the last reported sales price of the Common Stock (as a percent)					15.00%
Sale price of the Common Stock \| $ / shares													$ 6.23
Percentage of stock price trigger for conversion					130.00%
Trading days \| item					20
Consecutive trading days \| D					30
Percentage price of principal amount to be purchased plus accrued and unpaid interest					100.00%
Debt Conversion, Converted Instrument, Shares Issued \| shares	8,615,384
5.00% Convertible Senior Third Lien Notes due 2048
Convertible Notes
Aggregate principal amount		$ 28,000,000.0							$ 1,000
Interest rate (as a percent)		5.00%
Initial conversion rate		307.6923
Initial conversion price of Common Stock \| $ / shares		$ 3.25
Percentage of stock price trigger for conversion		123.08%
Trading days \| D		20
Consecutive trading days \| D		30
Change in fair value of conversion option of Notes on exchange		$ 2,300,000
Interest expense										$ 7,800,000

Net loss per share - Potentially dilutive securities were excluded from the calculation of diluted net loss per share (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	26,217,946	19,168,611	24,050,691
Stock options
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	14,018,610	16,264,098	12,690,745
Restricted stock units
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	2,074,967	2,805,004	2,649,317
Employee Stock purchase plan
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	82,496	57,636	53,372
Series A Preferred Stock
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	10,000,000
2018 Notes \| Convertible Common Stock [Member]
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	41,873	41,873	41,873
2020 Notes \| Convertible Common Stock [Member]
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)			8,615,384

Income Taxes - Operating Loss Carryforwards (Details) $ in Millions	Dec. 31, 2022 USD ($)
Federal
Operating loss carryforwards
NOL carryforwards	$ 436.6
Operating loss carryforwards, indefinite period	240.9
State
Operating loss carryforwards
NOL carryforwards	$ 203.3

Income Taxes - Tax Credits (Details) $ in Millions	Dec. 31, 2022 USD ($)
Federal
Tax credit carryforwards
Tax credits	$ 5.6
State
Tax credit carryforwards
Tax credits	$ 1.9

Income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
Income taxes (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income taxes
Income tax expense	$ 0	$ 0	$ 194

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes - Income Tax Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Current tax expense:
Federal	$ 0	$ 0	$ 0
State	0	0	194
Current income tax expense	0	0	194
Deferred
Federal	0	0	0
State	0	0	0
Deferred income tax expense	0	0	0
Total income tax expense	$ 0	$ 0	$ 194

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes - Reconciliation of Income Taxes and Deferred Tax Assets (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Reconciliation of income taxes computed using the U.S. federal statutory rate
Income tax benefit using U.S. federal statutory rate (as a percent)	21.00%	21.00%
State tax benefit, net of federal benefit (as a percent)	2.15%	3.01%
Research and development tax credits (as a percent)	2.81%	2.71%
Stock-based compensation	(2.17%)
Permanent items (as a percent)	(0.08%)	(0.44%)
Change in the valuation allowance (as a percent)	(21.41%)	(21.23%)
NOL and tax credit expiration under Section 382 (as a percent)	(2.26%)	(4.34%)
Other (as a percent)	(0.04%)	(0.71%)
Deferred tax assets:
Net operating loss carryforwards	$ 103,243	$ 98,777
Capitalized research and development	11,621	1,276
Research and development credits	7,107	4,516
Stock-based compensation	3,450	4,200
Installment sale	7,768	8,819
Lease liability	538	730
Other deferred tax assets	587	411
Total deferred tax assets	134,314	118,729
Deferred tax liabilities:
Right-of-use asset	(425)	(574)
Debt Discount	(4)	(11)
Other deferred tax liability	(29)	(91)
Total deferred tax liabilities	(458)	(676)
Net deferred tax asset prior to valuation allowance	133,856	118,053
Valuation allowance	(133,856)	(118,053)
Net deferred tax asset		$ 0
Additional disclosures
Total capitalized R&D to be amortized	44,500
Increase (decrease) in valuation allowance	15,800
Unrecognized tax benefits	0
Interest and penalties accrued related to unrecognized tax benefits	0
Liability for uncertain tax positions	$ 0
Federal
Additional disclosures
Capitalized Research and Development Expenses, Amortization Period	5 years
Foreign
Additional disclosures
Capitalized Research and Development Expenses, Amortization Period	15 years

Commitments and contingencies (Details) - USD ($) $ in Millions	Dec. 31, 2022	Dec. 31, 2021
Office and Laboratory Space in Needham, Massachusetts \| Letter of credit \| Restricted Cash and Cash Equivalents, Noncurrent [Member]
Property, Plant and Equipment [Line Items]
Security deposit	$ 0.2	$ 0.2

License, collaboration and commercial agreements - Secura (Details) $ in Thousands		1 Months Ended	12 Months Ended
	Jul. 25, 2019 USD ($)	Sep. 30, 2020 USD ($)	Dec. 31, 2022 USD ($) item	Dec. 31, 2021 USD ($) item	Dec. 31, 2020 USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Term of agreement		1 year
Revenue recognized			$ 2,596	$ 2,053	$ 88,516
Cost of sales - Sale of COPIKTRA license and related assets					31,187
Sanofi
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Number of regulatory milestone achieved \| item			1
Sale of COPIKTRA license and related assets
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized			$ 2,596	1,447	70,000
Transition Services Revenue
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized				606	372
License and Collaboration Agreement \| Secura
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Upfront payment		$ 70,000
Regulatory milestone payments			2,500
Milestone payments receivable upon approval of COPIKTRA		35,000
Milestone payments receivable upon approval for commercial sale		10,000
Threshold sales to trigger royalty payments		$ 100,000
Percentage of all royalty, milestone and sublicense revenue payments payable		50.00%
Percentage of all royalty and milestone payments payable under certain jurisdictions		50.00%
Future potential royalties expected to be received			$ 100	200
Cost of sales - Sale of COPIKTRA license and related assets					31,200
Percentage of share on regulatory milestone achieved			50.00%
License and Collaboration Agreement \| Secura \| Sale of COPIKTRA license and related assets
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Regulatory milestone payments			$ 2,500	1,300
Revenue recognized			$ 2,600	$ 1,400	70,000
Number of regulatory milestone achieved \| item			1	2
License and Collaboration Agreement \| Secura \| Transition Services Revenue
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized				$ 600	400
License and Collaboration Agreement \| Secura \| Sales Exceeds $100 Million
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Sales milestone receivable		$ 10,000
Threshold sales to trigger milestone payments		100,000
License and Collaboration Agreement \| Secura \| Sales Exceeds $200 Million
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Sales milestone receivable		15,000
Threshold sales to trigger milestone payments		200,000
License and Collaboration Agreement \| Secura \| Sales Exceeds $300 Million
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Sales milestone receivable		25,000
Threshold sales to trigger milestone payments		300,000
License and Collaboration Agreement \| Secura \| Maximum
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Regulatory milestone payments		45,000
Sales milestone receivable		$ 50,000
License and Collaboration Agreement \| Secura \| Intangible asset
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cost of sales - Sale of COPIKTRA license and related assets					19,200
License and Collaboration Agreement \| Secura \| Duvelisib inventory
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cost of sales - Sale of COPIKTRA license and related assets					6,000
License and Collaboration Agreement \| Secura \| Manufacturing equipment
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cost of sales - Sale of COPIKTRA license and related assets					200
License and Collaboration Agreement \| Secura \| Duvelisib contract prepaid balances
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cost of sales - Sale of COPIKTRA license and related assets					$ 5,800
License and Collaboration Agreement \| Sanofi
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Maximum aggregate payments entitled to receive if all milestones successfully achieved	$ 42,000

License, collaboration and commercial agreements - Secura - Contract asset (Details) - License and Collaboration Agreement $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Balance at the beginning of period	$ 170
Additions	96
Reclassification to receivable	(170)
Balance at the end of period	96
Secura
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Balance at the beginning of period	170
Additions	96
Reclassification to receivable	(170)
Balance at the end of period	96
Prepaid Expenses and Other Current Assets \| Secura
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Balance at the end of period	$ 100

License, collaboration and commercial agreements - Chugai Pharmaceutical Co., Ltd (Chugai) (Details) - Chugai Pharmaceutical Co., Ltd. - License and Collaboration Agreement - USD ($) $ in Millions		12 Months Ended
	Jan. 07, 2020	Dec. 31, 2020
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
One-time cash payment	$ 3.0
Agreement obligations expire from first commercial sale of product (in years)	12 years
Number of days written prior notice required for other party to terminate agreement	180 days
Number of days written notice required to terminate agreement if fails to cure breach	120 days
Research and development
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
One-time cash payment		$ 3.0

License, collaboration and commercial agreements - Infinity (Details) - Exclusive license agreement - Infinity - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Nov. 30, 2016	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
License and collaboration agreements
Percentage of additional royalty on worldwide net sales	4.00%
Royalty payments		$ 0.0	$ 0.0	$ 1.3

License, collaboration and commercial agreements - Sanofi (Details) $ in Thousands		1 Months Ended	12 Months Ended
	Jul. 25, 2019 USD ($)	Aug. 31, 2019 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($) Milestone
License and collaboration agreements
Total revenue			$ 2,596	$ 2,053	$ 88,516
License and collaboration revenue
License and collaboration agreements
Total revenue					$ 2,912
License and Collaboration Agreement \| Sanofi
License and collaboration agreements
Proceeds received		$ 5,000
Maximum aggregate payments entitled to receive if all milestones successfully achieved	$ 42,000
Number of additional milestones achieved \| Milestone					2
License revenue					$ 2,500
Percentage of future milestone payments and royalties entitled			50.00%
License and Collaboration Agreement \| Sanofi \| License and collaboration revenue
License and collaboration agreements
Total revenue					$ 5,000

License, collaboration and commercial agreements - Yakult (Details) - USD ($) $ in Thousands		1 Months Ended	12 Months Ended
	Jun. 05, 2018	Jun. 30, 2018	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
License and collaboration agreements
Total revenue			$ 2,596	$ 2,053	$ 88,516
License and Collaboration Agreement \| Yakult
License and collaboration agreements
Proceeds received		$ 10,000
Maximum aggregate payments entitled to receive if all milestones successfully achieved	$ 90,000
Percentage of future milestone payments and royalties entitled			50.00%

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

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License, collaboration and commercial agreements - CSPC (Details) - USD ($) $ in Thousands		1 Months Ended	12 Months Ended
	Sep. 25, 2018	Aug. 31, 2018	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
License and collaboration agreements
Total revenue			$ 2,596	$ 2,053	$ 88,516
License and Collaboration Agreement \| CSPC
License and collaboration agreements
Upfront, non-refundable payment obligation to be received prior to initial Exclusivity Fee	$ 15,000
Maximum aggregate payments entitled to receive if all milestones successfully achieved	$ 160,000
Percentage of future milestone payments and royalties entitled			50.00%
Exclusivity Agreement [Member] \| CSPC
License and collaboration agreements
Proceeds received		$ 5,000