0001558370-22-016278 | 10-Q | XBRL Viewer

Net loss per share

9 Months Ended

Sep. 30, 2022

12. Net loss per share

Basic 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 employee stock purchase plan shares (using the “treasury stock” method), and the 2018 Notes (using the “if-converted” method), unless their effect on net loss per share is anti-dilutive.

The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:


	Three months ended September 30,		Nine months ended September 30,
	2022	2021	2022	2021
Outstanding stock options	13,654,175	12,947,009	13,654,175	12,947,009
Outstanding restricted stock units	2,483,652	1,749,979	2,483,652	1,749,979
2018 Notes	41,873	41,873	41,873	41,873
Employee stock purchase plan	77,700	29,328	77,700	29,328
Total potentially dilutive securities	16,257,400	14,768,189	16,257,400	14,768,189

Fair value of financial instruments

9 Months Ended

Sep. 30, 2022

Fair value of financial instruments

Fair value of financial instruments

4. 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):




	September 30, 2022
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	77,187	$	54,314	$	22,873	$	—
Short-term investments		25,810		—		25,810		—
Total financial assets	$	102,997	$	54,314	$	48,683	$	—




	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 Company’s cash equivalents and short-term investments consist of U.S. Government money market funds, corporate bonds, agency bonds and commercial paper of publicly traded companies. 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 September 30, 2022 and December 31, 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 September 30, 2022, which equals the carrying value of the 2018 Notes as of September 30, 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 condensed consolidated balance sheet date. The carrying value of the Company’s long-term debt as of September 30, 2022, was approximately $24.4 million. The Company estimates that the fair value of its long-term debt was approximately $25.6 million as of September 30, 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.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Income taxes	9 Months Ended
Sep. 30, 2022
Income taxes
Income taxes	14. Income taxes The Company did not record a federal or state income tax provision or benefit for the three and nine months ended September 30, 2022 and 2021, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2022 and 2021, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.

Income taxes

9 Months Ended

Sep. 30, 2022

Income taxes

Income taxes

14. Income taxes

The Company did not record a federal or state income tax provision or benefit for the three and nine months ended September 30, 2022 and 2021, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2022 and 2021, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.

- Definition

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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Commitments and contingencies (Details) $ in Millions	Sep. 30, 2022 USD ($)
Commitments and contingencies
Other commitments	$ 0.0

Debt (Tables)

9 Months Ended

Sep. 30, 2022

Debt

Schedule of carrying value of debt


	September 30, 2022		December 31, 2021
Principal loan balance	$	25,000	$	—
Final Payment Fee		149		—
Debt issuance costs, net of accretion		(750)		—
Long-term debt, net of discount	$	24,399	$	—

Schedule of future principal payments under the Loan Agreement

Nature of business (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Nature of business
Cash, cash equivalents, and investments	$ 104,000
Accumulated deficit	$ 720,715	$ 663,711

Document and Entity Information	9 Months Ended
Document and Entity Information	Sep. 30, 2022 shares
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Entity File Number	001-35403
Entity Registrant Name	Verastem, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	27-3269467
Entity Address, Address Line One	117 Kendrick Street, Suite 500
Entity Address, City or Town	Needham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02494
City Area Code	781
Local Phone Number	292-4200
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	VSTM
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding	210,090,850
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001526119
Amendment Flag	false

Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021	Sep. 30, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Cash and cash equivalents	$ 78,166	$ 21,252
Restricted cash	241	241
Restricted cash	1,214
Total cash, cash equivalents and restricted cash	79,380	21,493	$ 24,555	$ 68,023
Grant [Member]
Property, Plant and Equipment [Line Items]
Restricted cash	1,000
Letter of credit \| Office and Laboratory Space in Needham, Massachusetts
Property, Plant and Equipment [Line Items]
Restricted cash		$ 200
Restricted cash	$ 200

Nature of business

9 Months Ended

Sep. 30, 2022

Nature of business

Nature of business

1. Nature of business

Verastem, Inc. (the “Company”) is a late stage development biopharmaceutical company, with an ongoing registration directed trial, committed to advancing new medicines for patients battling cancer. The Company’s pipeline is focused on novel anticancer agents that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, particularly rapidly accelerated fibrosarcoma (“RAF”)/ mitogen-activated protein kinase kinase (“MEK”) inhibition and focal adhesion kinase (“FAK”) inhibition.

The Company’s most advanced product candidates, avutometinib (VS-6766) and defactinib, are being investigated in both preclinical and clinical studies for the treatment of various solid tumors, including, low-grade serous ovarian cancer (“LGSOC”), non-small cell lung cancer (“NSCLC”), colorectal cancer (“CRC”), pancreatic cancer, uveal melanoma, and endometrial cancer. The Company believes that avutometinib (VS-6766) may be beneficial as a therapeutic as a single agent or when used together in combination with defactinib, other agents, other pathway inhibitors or other current and emerging standard of care treatments in cancers that do not adequately respond to currently available therapies.

On September 24, 2018, the Company’s first commercial product, COPIKTRA® (duvelisib), was approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of adult patients with certain hematologic cancers including relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma after at least two prior therapies and relapsed or refractory follicular lymphoma after at least two prior systemic therapies. On August 10, 2020, the Company and Secura Bio, Inc. (“Secura”) entered into an asset purchase agreement (“Secura APA”). Pursuant to the Secura APA, the Company sold to Secura its exclusive worldwide license, including certain related assets for the research, development, commercialization, and manufacture in oncology indications of products containing COPIKTRA (duvelisib). The transaction closed on September 30, 2020. Refer to Note 13. License, collaboration, and commercial agreements for a detailed discussion of the Secura APA.

The condensed consolidated financial statements include the accounts of Verastem Securities Company and Verastem Europe GmbH, wholly-owned subsidiaries of the Company. All financial information presented has been consolidated and includes the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

The Company is subject to the risks associated with other life science companies, including, but not limited to, possible failure of preclinical testing or clinical trials, competitors developing new technological innovations, inability to obtain marketing approval of the Company’s product candidates, avutometinib (VS-6766) and defactinib, market acceptance and commercial success of the Company’s product candidates, avutometinib (VS-6766) and defactinib, following receipt of regulatory approval, and, protection of proprietary technology and the continued ability to obtain adequate financing to fund the Company’s future operations. If the Company does not obtain marketing approval and successfully commercialize its product candidates, avutometinib (VS-6766) and defactinib, following regulatory approval, it will be unable to generate product revenue or achieve profitability and may need to raise additional capital.

The Company has historical losses from operations and anticipates that it may continue to incur operating losses as it continues the research and development of its product candidates. As of September 30, 2022 the Company had cash, cash equivalents, and investments of $104.0 million, and an accumulated deficit of $720.7 million. The Company expects its existing cash resources will be sufficient to fund its planned operations through at least 12 months from the date of issuance of these condensed consolidated financial statements.

The Company expects to finance the future development costs of its clinical product portfolio with its existing cash, cash equivalents, and investments, through future milestones and royalties received pursuant to the Secura APA, through our loan and security agreement with Oxford Finance LLC (“Oxford”), or through other strategic financing

opportunities that could include, but are not limited to collaboration agreements, future offerings of its equity, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities.

Stock-based compensation

9 Months Ended

Sep. 30, 2022

Stock-based compensation

Stock-based compensation

11. Stock-based compensation

Stock options

A summary of the Company’s stock option activity and related information for the nine months ended September 30, 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	940,375		1.26
Exercised	(98,176)		1.20
Forfeited/cancelled	(3,452,122)		5.55
Outstanding at September 30, 2022	13,654,175	$	2.92	7.2	$	—
Vested at September 30, 2022	7,792,304	$	3.45	6.0	$	—

The fair value of each stock option granted during the nine months ended September 30, 2022 and 2021 was estimated on the grant date using the Black-Scholes option-pricing model using the following weighted-average assumptions:


	September 30,
	2022		2021
Risk-free interest rate	2.83	%	0.76	%
Volatility	87	%	95	%
Dividend yield	—		—
Expected term (years)	5.7		5.9

Restricted stock units

A summary of the Company’s restricted stock unit activity and related information for the nine months ended September 30, 2022 is as follows:


	Shares	Weighted-average grant date fair value per share
Outstanding at December 31, 2021	2,805,004	$	2.44
Granted	322,113	$	1.36
Vested	(419,745)	$	2.94
Forfeited/cancelled	(223,720)	$	2.28
Outstanding at September 30, 2022	2,483,652	$	2.23

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 on (a) the date the option is granted, which is the first day of the purchase period, and (b) 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 following weighted-average assumptions:


	Nine months ended September 30,
	2022		2021
Risk-free interest rate	1.56	%	0.07	%
Volatility	77	%	68	%
Dividend yield	—		—
Expected term (years)	0.5		0.5

For the nine months ended September 30, 2022 and 2021, the Company recognized $0.1 million in each period of stock-based compensation expense under the Amended and Restated 2018 ESPP. During the nine months ended September 30, 2022, the Company issued 122,332 shares of common stock for proceeds of $0.2 million under the Amended and Restated 2018 ESPP.

License, collaboration and commercial agreements - Secura (Details) $ in Thousands	1 Months Ended	3 Months Ended			9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2022 USD ($)	Mar. 31, 2022 USD ($) Milestone	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($) Milestone	Sep. 30, 2021 USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized				$ 2	$ 2,596	$ 1,508
Sale of COPIKTRA license and related assets
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized					2,596	902
Transition Services Revenue
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized				2		606
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%
Term of agreement	1 year
Future potential royalties expected to be received		$ 100			100
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		800	2,500	800
Future potential royalties expected to be received				100		100
Revenue recognized		$ 0		0	2,600	900
Proceeds related to royalties					$ 100
Number of regulatory milestone achieved \| Milestone					1
License and Collaboration Agreement \| Secura \| Transition Services Revenue
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Revenue recognized				$ 0		$ 600
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 \| Sanofi
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Number of regulatory milestone achieved \| Milestone			1

Income taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Income taxes (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income taxes
Income Tax Expense (Benefit)	$ 0	$ 0	$ 0	$ 0

- Definition

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

+ References + Details

Accrued expenses (Tables)

9 Months Ended

Sep. 30, 2022

Accrued expenses

Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):


	September 30, 2022		December 31, 2021
Research and development expenses	$	8,163	$	9,311
Compensation and related benefits		3,393		3,892
Professional fees		678		785
Consulting fees		956		544
Interest		198		3
Commercialization costs		479		187
Other		921		899
Total accrued expenses	$	14,788	$	15,621

Investments

9 Months Ended

Sep. 30, 2022

Investments

Investments

5. Investments

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


	September 30, 2022
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	56,508	$	—	$	—	$	56,508
Corporate bonds, agency bonds and commercial paper (due within 90 days)		22,865		8		(1)		22,872
Total cash, cash equivalents & restricted cash:	$	79,373	$	8	$	(1)	$	79,380
Investments:
Corporate bonds, agency bonds and commercial paper (due within 1 year)	$	25,856	$	15	$	(61)	$	25,810
Total investments	$	25,856	$	15	$	(61)	$	25,810
Total cash, cash equivalents, restricted cash and investments	$	105,229	$	23	$	(62)	$	105,190


	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

There were no realized gains or losses on investments for the three and nine months ended September 30, 2022 or 2021. There was one debt security in an unrealized loss position for more than 12 months as of September 30, 2022, with a fair value of $5.0 million, and unrealized loss of less than $0.1 million. There were no investments in an unrealized loss position for more than 12 months as of December 31, 2021. There were six debt securities in an unrealized loss position for less than 12 months as of September 30, 2022, with a fair value of $16.4 million and

unrealized loss of less than $0.1 million. There were three debt securities in an unrealized loss position for less than 12 months as of December 31, 2021, with a fair value of $15.8 million and unrealized loss of less than $0.1 million. 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 September 30, 2022 and December 31, 2021, respectively.

Debt - Components of carrying value of debt (Details) $ in Thousands	Sep. 30, 2022 USD ($)
Debt
Principal loan balance	$ 25,000
Final Payment Fee	149
Debt issuance costs, net of accretion	(750)
Long-term debt, net of discount	$ 24,399

- Definition

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

+ References + Details

Accrued expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Accrued expenses
Research and development expenses	$ 8,163	$ 9,311
Compensation and related benefits	3,393	3,892
Professional fees	678	785
Consulting fees	956	544
Interest	198	3
Commercialization costs	479	187
Other	921	899
Total accrued expenses	$ 14,788	$ 15,621

Net loss per share - Potentially dilutive securities were excluded from the calculation of diluted net loss per share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	16,257,400	14,768,189	16,257,400	14,768,189
Outstanding stock options
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	13,654,175	12,947,009	13,654,175	12,947,009
Restricted stock units
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	2,483,652	1,749,979	2,483,652	1,749,979
2018 Notes.
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	41,873
Employee Stock Purchase Plan
Net loss per share
Potentially dilutive securities were excluded from the calculation of diluted net loss per share (in shares)	77,700	29,328	77,700	29,328

Summary of significant accounting policies

9 Months Ended

Sep. 30, 2022

Summary of significant accounting policies

Summary of significant accounting policies

2. Summary of significant accounting policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01 under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, or any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2022. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”) on March 28, 2022.

Significant Accounting Policies

The significant accounting policies are described in Note 2. Significant accounting policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. During the nine months ended September 30, 2022, the Company did not adopt any additional significant accounting policies.

Recently Issued Accounting Standards Updates

In June 2016, the FASB issued 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 condensed 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 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 condensed consolidated financial statements and related disclosures.

Concentrations of credit risk and off-balance sheet risk

Cash, 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 September 30, 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 September 30, 2022, there was one customer, Secura, that made up more than 60% of the Company’s accounts receivable balance. The Company assesses the creditworthiness of all its customers and sets and reassesses customer credit limits to ensure collectability of any accounts receivable balances are assured.

For the nine months ended September 30, 2022, there was one customer, Secura, who individually accounted for all of the Company’s revenue. Refer to Note 13. License, collaboration, and commercial agreements for a detailed discussion of the Secura APA.

Proceeds from Grants

During the nine months ended September 30, 2022, the Company was awarded the “Therapeutic Accelerator Award” grant from Pancreatic Cancer Network (“PanCAN”) for up to $3.8 million (the “PanCAN Grant”). The grant is expected to support a Phase 1b/2 clinical trial of avutometinib (VS-6766) in combination with defactinib entitled RAMP 205. The trial will evaluate whether blockade of KRAS signaling which is mutated in more than 90% of pancreatic tumors, along with chemotherapy and reduction of stromal density will improve outcomes for patients with pancreatic cancer. In August 2022, PanCAN agreed to provide the Company with an additional $0.5 million for the collection and analysis of patient samples. The Company received $1.0 million of cash proceeds in July 2022 which was initially recorded as deferred liabilities on the condensed balance sheet. The Company recorded less than $0.1 million of the proceeds as a reduction of research and development expense during the three months ended September 30, 2022. As of September 30, 2022, the Company recorded $1.0 million as deferred liabilities in the condensed consolidated balance sheet related to the PanCAN Grant.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Common stock	Additional paid-in capital	Accumulated other comprehensive income/ (loss)	Accumulated deficit	Total
Balance at Dec. 31, 2020	$ 17	$ 707,715	$ 53	$ (592,511)	$ 115,274
Balance (in shares) at Dec. 31, 2020	170,456,179
Increase (Decrease) in Stockholders' Equity
Net loss				(15,031)	(15,031)
Unrealized (loss) on available-for-sale marketable securities			(19)		(19)
Issuance of common stock resulting from exercise of stock options		381			381
Issuance of common stock resulting from exercise of stock options (in shares)	173,890
Issuance of common stock resulting from vesting of restricted stock units		(52)			(52)
Issuance of common stock resulting from vesting of restricted stock units (in shares)	1,047,271
Stock-based compensation expense		1,980			1,980
Issuance of common stock under Employee Stock Purchase Plan		76			76
Issuance of common stock under Employee Stock Purchase Plan (in shares)	53,372
Balance at Mar. 31, 2021	$ 17	710,100	34	(607,542)	102,609
Balance (in shares) at Mar. 31, 2021	171,730,712
Balance at Dec. 31, 2020	$ 17	707,715	53	(592,511)	115,274
Balance (in shares) at Dec. 31, 2020	170,456,179
Increase (Decrease) in Stockholders' Equity
Net loss					(54,719)
Unrealized (loss) on available-for-sale marketable securities					(26)
Balance at Sep. 30, 2021	$ 18	742,840	27	(647,230)	95,655
Balance (in shares) at Sep. 30, 2021	182,155,258
Balance at Mar. 31, 2021	$ 17	710,100	34	(607,542)	102,609
Balance (in shares) at Mar. 31, 2021	171,730,712
Increase (Decrease) in Stockholders' Equity
Net loss				(16,902)	(16,902)
Unrealized (loss) on available-for-sale marketable securities			5		5
Issuance of common stock resulting from exercise of stock options		361			361
Issuance of common stock resulting from exercise of stock options (in shares)	330,758
Issuance of common stock resulting from vesting of restricted stock units		(38)			(38)
Issuance of common stock resulting from vesting of restricted stock units (in shares)	15,896
Stock-based compensation expense		2,170			2,170
Balance at Jun. 30, 2021	$ 17	712,593	39	(624,444)	88,205
Balance (in shares) at Jun. 30, 2021	172,077,366
Increase (Decrease) in Stockholders' Equity
Net loss				(22,786)	(22,786)
Unrealized (loss) on available-for-sale marketable securities			(12)		(12)
Issuance of common stock resulting from exercise of stock options		155			155
Issuance of common stock resulting from exercise of stock options (in shares)	78,375
Issuance of common stock resulting from vesting of restricted stock units (in shares)	1,327,445
Stock-based compensation expense		1,987			1,987
Issuance of common stock under Employee Stock Purchase Plan		106			106
Issuance of common stock under Employee Stock Purchase Plan (in shares)	56,688
Conversion of Notes into common stock	$ 1	27,999			28,000
Conversion of Notes into common stock (in shares)	8,615,384
Balance at Sep. 30, 2021	$ 18	742,840	27	(647,230)	95,655
Balance (in shares) at Sep. 30, 2021	182,155,258
Balance at Dec. 31, 2021	$ 19	751,217	34	(663,711)	$ 87,559
Balance (in shares) at Dec. 31, 2021	185,286,480				185,286,000
Increase (Decrease) in Stockholders' Equity
Net loss				(16,962)	$ (16,962)
Unrealized (loss) on available-for-sale marketable securities			(147)		(147)
Issuance of common stock resulting from at-the-market transactions, net		575			575
Issuance of common stock resulting from at-the-market transactions, net (in shares)	285,900
Issuance of common stock resulting from vesting of restricted stock units (in shares)	699,635
Stock-based compensation expense		1,646			1,646
Issuance of common stock under Employee Stock Purchase Plan		100			100
Issuance of common stock under Employee Stock Purchase Plan (in shares)	57,636
Balance at Mar. 31, 2022	$ 19	753,538	(113)	(680,673)	72,771
Balance (in shares) at Mar. 31, 2022	186,329,651
Balance at Dec. 31, 2021	$ 19	751,217	34	(663,711)	$ 87,559
Balance (in shares) at Dec. 31, 2021	185,286,480				185,286,000
Increase (Decrease) in Stockholders' Equity
Net loss					$ (57,004)
Unrealized (loss) on available-for-sale marketable securities					(73)
Balance at Sep. 30, 2022	$ 21	783,606	(39)	(720,715)	$ 62,873
Balance (in shares) at Sep. 30, 2022	210,083,824				210,084,000
Balance at Mar. 31, 2022	$ 19	753,538	(113)	(680,673)	$ 72,771
Balance (in shares) at Mar. 31, 2022	186,329,651
Increase (Decrease) in Stockholders' Equity
Net loss				(21,952)	(21,952)
Unrealized (loss) on available-for-sale marketable securities			(17)		(17)
Issuance of common stock resulting from at-the-market transactions, net		1,240			1,240
Issuance of common stock resulting from at-the-market transactions, net (in shares)	1,006,444
Issuance of common stock resulting from exercise of stock options		92			92
Issuance of common stock resulting from exercise of stock options (in shares)	76,539
Issuance of common stock resulting from vesting of restricted stock units (in shares)	200,813
Stock-based compensation expense		1,758			1,758
Balance at Jun. 30, 2022	$ 19	756,628	(130)	(702,625)	53,892
Balance (in shares) at Jun. 30, 2022	187,613,447
Increase (Decrease) in Stockholders' Equity
Net loss				(18,090)	(18,090)
Unrealized (loss) on available-for-sale marketable securities			91		91
Issuance of common stock resulting from at-the-market transactions, net	$ 2	25,532			25,534
Issuance of common stock resulting from at-the-market transactions, net (in shares)	22,281,059
Issuance of common stock resulting from exercise of stock options		26			26
Issuance of common stock resulting from exercise of stock options (in shares)	21,637
Issuance of common stock resulting from vesting of restricted stock units (in shares)	102,985
Stock-based compensation expense		1,356			1,356
Issuance of common stock under Employee Stock Purchase Plan		64			64
Issuance of common stock under Employee Stock Purchase Plan (in shares)	64,696
Balance at Sep. 30, 2022	$ 21	$ 783,606	$ (39)	$ (720,715)	$ 62,873
Balance (in shares) at Sep. 30, 2022	210,083,824				210,084,000

Summary of significant accounting policies - Concentrations of credit risk and off-balance sheet risk (Details) $ in Thousands	1 Months Ended		3 Months Ended	9 Months Ended
	Aug. 31, 2022 USD ($)	Jul. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2022 USD ($) Institution customer
Concentrations of credit risk and off-balance sheet risk
Off-balance sheet concentrations of credit risk description				As of September 30, 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
Cash proceeds	$ 500	$ 1,000
Reduction of research and development expense			$ 100
Deferred liabilities				$ 965
Maximum
Concentrations of credit risk and off-balance sheet risk
Grant awarded, amount				$ 3,800
Trade accounts receivable \| Credit Concentration Risk \| Secura
Concentrations of credit risk and off-balance sheet risk
Number of customer \| customer				1
Trade accounts receivable \| Credit Concentration Risk \| Secura \| Minimum
Concentrations of credit risk and off-balance sheet risk
Percentage				60.00%
Revenue \| Customer Concentration Risk \| Secura
Concentrations of credit risk and off-balance sheet risk
Number of customer \| customer				1

Fair value of financial instruments (Tables)

9 Months Ended

Sep. 30, 2022

Fair value of financial instruments

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):




	September 30, 2022
Description	Total		Level 1		Level 2		Level 3
Financial assets
Cash equivalents	$	77,187	$	54,314	$	22,873	$	—
Short-term investments		25,810		—		25,810		—
Total financial assets	$	102,997	$	54,314	$	48,683	$	—




	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	$	—

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Operating activities
Net loss	$ (57,004)	$ (54,719)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	89	176
Amortization of right-of-use asset and lease liability	(113)	(98)
Stock-based compensation expense	4,760	6,137
Amortization of deferred financing costs, debt discounts and premiums and discounts on available-for-sale marketable securities	231	9,287
Changes in operating assets and liabilities:
Accounts receivable, net	442	134
Prepaid expenses, other current assets and other assets	1,349	(1,834)
Accounts payable	3,057	(1,038)
Accrued expenses and other liabilities	(833)	(1,614)
Deferred liabilities	965
Net cash used in operating activities	(47,057)	(43,569)
Investing activities
Purchases of property and equipment		(196)
Purchases of investments	(15,340)	(53,258)
Maturities of investments	68,500	53,475
Net cash provided by (used in) investing activities	53,160	21
Financing activities
Proceeds from long-term debt, net	24,148
Proceeds from the exercise of stock options and employee stock purchase program	282	1,079
Settlement of restricted stock for tax withholdings		(926)
Proceeds from the issuance of common stock, net	27,354
Net cash provided by (used in) financing activities	51,784	80
Payment of deferred offering costs		(73)
Increase (decrease) in cash, cash equivalents and restricted cash	57,887	(43,468)
Cash, cash equivalents and restricted cash at beginning of period	21,493	68,023
Cash, cash equivalents and restricted cash at end of period	$ 79,380	24,555
Supplemental disclosure of non-cash investing and financing activities
Deferred offering costs included in accounts payable and accrued expenses		46
Conversion of notes into common stock		$ 28,000

Debt (Details) $ in Millions	Mar. 25, 2022 USD ($)
Loan Agreement
Long-term debt
Financial covenants	$ 0.0
Accrued interest rate	5.00%
Term loan
Long-term debt
Aggregate principal amount	$ 150.0
Issuance of debt	25.0
Current borrowing capacity	$ 125.0
Percentage of final prepayment fee	5.00%
Additional interest rate in an event of default	0.50%
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	$ 15.0
Regulatory milestone payments	35.0
Minimum unrestricted cash proceeds from sale or issuance of equity securities	$ 50.0
Debt instrument period to draw loan, Minimum	60 days
Term C Loan
Long-term debt
Aggregate principal amount	$ 25.0
Debt instrument period to draw loan, Minimum	60 days
Term D Loan
Long-term debt
Aggregate principal amount	$ 35.0
Debt instrument period to draw loan, Minimum	30 days
Gross product revenue to be achieved	$ 50.0
Term E Loan
Long-term debt
Aggregate principal amount	$ 50.0

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

Stock-based compensation - Stock Options (Details) - Stock options - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Shares
Outstanding at the beginning of the period (in shares)	16,264,098
Granted (in shares)	940,375
Exercised (in shares)	(98,176)
Forfeited/cancelled (in shares)	(3,452,122)
Outstanding at the end of the period (in shares)	13,654,175		16,264,098
Vested at the end of the period (in shares)	7,792,304
Weighted-average exercise price per share
Outstanding at the beginning of the period (in dollars per share)	$ 3.56
Granted (in dollars per share)	1.26
Exercised (in dollars per share)	1.20
Forfeited/cancelled (in dollars per share)	5.55
Outstanding at the end of the period (in dollars per share)	2.92		$ 3.56
Vested at the end of the period (in dollars per share)	$ 3.45
Weighted-average remaining contractual term
Outstanding at the end of the period	7 years 2 months 12 days		6 years 8 months 12 days
Vested at the end of the period	6 years
Aggregate intrinsic value
Outstanding at the beginning of the period (in dollars)	$ 2,601
Outstanding at the end of the period (in dollars)			$ 2,601
Assumptions used to estimate fair value of each stock-based award on the grant date
Risk-free interest rate (as a percent)	2.83%	0.76%
Volatility (as a percent)	87.00%	95.00%
Dividend yield (as a percent)	0.00%	0.00%
Expected term (years)	5 years 8 months 12 days	5 years 10 months 24 days

License, collaboration and commercial agreements - Secura - Contract asset (Details) - License and Collaboration Agreement $ in Thousands	9 Months Ended
	Sep. 30, 2022 USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Balance at the beginning of period	$ 170
Additions	96
Reclassification to receivable	(141)
Balance at the end of period	125
Secura
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Balance at the beginning of period	170
Additions	96
Reclassification to receivable	(141)
Balance at the end of period	$ 125

Cash, cash equivalents and restricted cash (Tables)

9 Months Ended

Sep. 30, 2022

Cash, cash equivalents and restricted cash

Schedule of reconciliation of cash, cash equivalents and restricted cash

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


	September 30, 2022		December 31, 2021
Cash and cash equivalents	$	78,166	$	21,252
Restricted cash		1,214		241
Total cash, cash equivalents and restricted cash	$	79,380	$	21,493

Fair value of financial instruments - Financial Instruments Measured on a Recurring Basis (Details) - Recurring basis - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Financial assets
Cash equivalents	$ 77,187	$ 19,302
Short-term investments	25,810	79,004
Total financial assets	102,997	98,306
Level 1
Financial assets
Cash equivalents	54,314	19,302
Total financial assets	54,314	19,302
Level 2
Financial assets
Cash equivalents	22,873
Short-term investments	25,810	79,004
Total financial assets	$ 48,683	$ 79,004

Leases

9 Months Ended

Sep. 30, 2022

Leases

Leases

8. 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. 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 condensed 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.

As of September 30, 2022, a right-of-use asset of $1.9 million and lease liability of $2.4 million are reflected on the condensed consolidated balance sheets. The elements of lease expense were as follows (dollar amounts in thousands):


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Lease Expense
Operating lease expense	$	221	$	221	$	664	$	664
Total Lease Expense	$	221	$	221	$	664	$	664
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$	262	$	257	$	777	$	761


		September 30, 2022
Other Balance Sheet Information - Operating Leases
Weighted average remaining lease term (in years)		2.8
Weighted average discount rate		14.6%
Maturity Analysis
2022		262
2023		1,060
2024		1,081
2025		546
Total	$	2,949
Less: Present value discount		(506)
Lease Liability	$	2,443

Debt

9 Months Ended

Sep. 30, 2022

Debt

Debt

7. Debt

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 (VS-6766) 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 (VS-6766) 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 September 30, 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 September 30, 2022 and December 31, 2021 are detailed below (in thousands):


	September 30, 2022		December 31, 2021
Principal loan balance	$	25,000	$	—
Final Payment Fee		149		—
Debt issuance costs, net of accretion		(750)		—
Long-term debt, net of discount	$	24,399	$	—

As of September 30, 2022, future principal payments due are as follows (in thousands):


2022	$	—
2023		—
2024		6,250
2025		8,333
2026		8,333
2027		2,084
Total principal payments	$	25,000

- Definition

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.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1E
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495348-112611

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

Convertible Senior Notes (Details) $ / shares in Units, $ in Thousands				3 Months Ended		9 Months Ended
	Jul. 16, 2021 USD ($) shares	Nov. 06, 2020 USD ($) D	Oct. 17, 2018 USD ($) D $ / shares	Sep. 30, 2022 USD ($) $ / shares	Dec. 31, 2019 USD ($)	Sep. 30, 2022 USD ($) $ / shares	Dec. 31, 2021 $ / shares	Jul. 01, 2021 USD ($)	Mar. 31, 2020 USD ($)
Convertible Notes
Common stock, par value (in dollars per share) \| $ / shares				$ 0.0001		$ 0.0001	$ 0.0001
Other Nonoperating Income (Expenses)				$ 20		$ 54
Notes outstanding				24,399		24,399
Debt, carrying value				$ 25,000		$ 25,000
2018 Notes
Convertible Notes
Aggregate principal amount			$ 150,000
Interest rate (as a percent)			5.00%	5.00%		5.00%
Net proceeds			$ 145,300
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
Percentage of stock price trigger for conversion			130.00%
Trading days \| D			20
Consecutive trading days \| D			30
2019 Notes
Convertible Notes
Debt Conversion, Original Debt, Amount					$ 121,700
Debt Conversion, Converted Instrument, Amount					66,900
Repayments of Convertible Debt					$ 12,100
Interest rate (as a percent)					5.00%
Debt, carrying value									$ 0
2020 Notes
Convertible Notes
Aggregate principal amount		$ 28,000						$ 28,000
Debt Conversion, Converted Instrument, Amount	$ 28,000	$ 28,000
Interest rate (as a percent)		5.00%
Percentage of stock price trigger for conversion		123.08%
Trading days \| D		20
Consecutive trading days \| D		30
Debt Conversion, Converted Instrument, Shares Issued \| shares	8,615,384

Stock-based compensation - Employee Stock Purchase Plan (Details) $ in Thousands		9 Months Ended
	Jun. 21, 2019 item shares	Sep. 30, 2022 USD ($) shares	Sep. 30, 2021 USD ($)
Assumptions used to estimate fair value of each stock-based award on the grant date
Proceeds from the issuance of common stock, net		$ 27,354
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
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%
Volatility (as a percent)		77.00%	68.00%
Dividend yield (as a percent)		0.00%	0.00%
Expected term (years)		6 months	6 months
Issuance of common stock under ESPP \| shares		122,332
Proceeds from the issuance of common stock, net		$ 200
Employee Stock purchase plan \| Maximum
Assumptions used to estimate fair value of each stock-based award on the grant date
Stock-based compensation expense		$ 100	$ 100

Fair value of financial instruments (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021	Oct. 17, 2018
Financial liabilities
Long-term debt	$ 24,399
Debt, carrying value	$ 25,000
2018 Notes
Financial liabilities
Interest rate (as a percent)	5.00%		5.00%
Level 3 \| 2018 Notes
Financial liabilities
Debt, fair value	$ 300
Debt, carrying value		$ 200
Level 3 \| Term loan
Financial liabilities
Debt, fair value	25,600
Debt, carrying value	$ 24,400	$ 0

- Definition

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

+ References + Details

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands	Sep. 30, 2022	Dec. 31, 2021
CONDENSED CONSOLIDATED BALANCE SHEETS
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	5,000	5,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	300,000	300,000
Common stock, shares issued	210,084	185,286
Common stock, shares outstanding	210,084	185,286

Summary of significant accounting policies (Policies)	9 Months Ended
Summary of significant accounting policies (Policies)	Sep. 30, 2022
Summary of significant accounting policies
Basis of presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01 under the assumption that the Company will continue as a going concern for the next twelve months. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, or any adjustments that might result from the uncertainty related to the Company’s ability to continue as a going concern. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2022. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”) on March 28, 2022.
Significant Accounting Policies	Significant Accounting Policies The significant accounting policies are described in Note 2. Significant accounting policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. During the nine months ended September 30, 2022, the Company did not adopt any additional significant accounting policies.
Recently Issued Accounting Standards Updates	Recently Issued Accounting Standards Updates In June 2016, the FASB issued 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 condensed 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 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 condensed consolidated financial statements and related disclosures.
Concentrations of credit risk and off-balance sheet risk	Concentrations of credit risk and off-balance sheet risk Cash, 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 September 30, 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 September 30, 2022, there was one customer, Secura, that made up more than 60% of the Company’s accounts receivable balance. The Company assesses the creditworthiness of all its customers and sets and reassesses customer credit limits to ensure collectability of any accounts receivable balances are assured. For the nine months ended September 30, 2022, there was one customer, Secura, who individually accounted for all of the Company’s revenue. Refer to Note 13. License, collaboration, and commercial agreements for a detailed discussion of the Secura APA.

Common stock (Details) - At-the-market equity offering program - 2021 ATM Program - USD ($) $ in Millions	1 Months Ended	3 Months Ended	9 Months Ended
	Aug. 31, 2021	Sep. 30, 2022	Sep. 30, 2022
Subsidiary, Sale of Stock [Line Items]
Shares issued (in shares)		22,281,059	23,573,403
Net proceeds from issuance of stock		$ 25.5	$ 27.4
Common stock
Subsidiary, Sale of Stock [Line Items]
Maximum value of common stock allowed to be sold	$ 100.0

Cash, cash equivalents and restricted cash

9 Months Ended

Sep. 30, 2022

Cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash

3. Cash, cash equivalents and restricted cash


	September 30, 2022		December 31, 2021
Cash and cash equivalents	$	78,166	$	21,252
Restricted cash		1,214		241
Total cash, cash equivalents and restricted cash	$	79,380	$	21,493

Amounts included in restricted cash as of September 30, 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 $1.0 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 condensed consolidated balance sheet as of September 30, 2022. The letters of credit are included in non-current restricted cash on the condensed consolidated balance sheets as of September 30, 2022 and December 31, 2021.

Debt - Future principal payments (Details) $ in Thousands	Sep. 30, 2022 USD ($)
Future principal payments
2024	$ 6,250
2025	8,333
2026	8,333
2027	2,084
Total principal payments	$ 25,000

Investments (Tables)

9 Months Ended

Sep. 30, 2022

Investments

Schedule of cash, cash equivalents and investments

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


	September 30, 2022
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Cash, cash equivalents & restricted cash:
Cash and money market accounts	$	56,508	$	—	$	—	$	56,508
Corporate bonds, agency bonds and commercial paper (due within 90 days)		22,865		8		(1)		22,872
Total cash, cash equivalents & restricted cash:	$	79,373	$	8	$	(1)	$	79,380
Investments:
Corporate bonds, agency bonds and commercial paper (due within 1 year)	$	25,856	$	15	$	(61)	$	25,810
Total investments	$	25,856	$	15	$	(61)	$	25,810
Total cash, cash equivalents, restricted cash and investments	$	105,229	$	23	$	(62)	$	105,190


	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

Commitments and contingencies

9 Months Ended

Sep. 30, 2022

Commitments and contingencies

Commitments and contingencies

15. Commitments and contingencies

The Company has no other commitments other than minimum lease payments as disclosed in Note 8. Leases.

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 78,166	$ 21,252
Short-term investments	25,810	79,004
Accounts receivable, net	74	516
Prepaid expenses and other current assets	4,709	4,968
Total current assets	108,759	105,740
Property and equipment, net	121	210
Right-of-use asset, net	1,927	2,302
Restricted cash	241	241
Other assets	47	169
Total assets	111,095	108,662
Current liabilities:
Accounts payable	5,359	2,302
Accrued expenses	14,788	15,621
Deferred liabilities	965
Lease liability, short-term	761	667
Total current liabilities	21,873	18,590
Non-current liabilities:
Convertible senior notes	268	249
Long-term debt	24,399
Lease liability, long-term	1,682	2,264
Total liabilities	48,222	21,103
Stockholders' equity:
Preferred stock, $0.0001 par value; 5,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively
Common stock, $0.0001 par value; 300,000 shares authorized, 210,084 and 185,286 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	21	19
Additional paid-in capital	783,606	751,217
Accumulated other comprehensive income/(loss)	(39)	34
Accumulated deficit	(720,715)	(663,711)
Total stockholders' equity	62,873	87,559
Total liabilities and stockholders' equity	$ 111,095	$ 108,662

License, collaboration and commercial agreements (Tables)

9 Months Ended

Sep. 30, 2022

License, collaboration and commercial agreements

Schedule of contract assets

The following table presents changes in the Company’s contract asset for the nine months ended September 30, 2022 (in thousands):


Contract Asset:	December 31, 2021		Additions		Reclassification to receivable		September 30, 2022
Contract asset - Secura	$	170	$	96	$	(141)	$	125
Total	$	170	$	96	$	(141)	$	125

Convertible Senior Notes

9 Months Ended

Sep. 30, 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 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 “2018 Notes 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. Upon conversion, converting noteholders will be entitled to receive accrued interest on their converted 2018 Notes.

The Company has the right, exercisable at its option, to cause all 2018 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 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 condensed 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 September 30, 2022.

2019 Notes

In the fourth quarter of 2019, the Company entered into privately negotiated agreements to exchange approximately $121.7 million aggregate principal amount of the 2018 Notes for (i) approximately $66.9 million aggregate principal amount of 5.00% Convertible Senior Second Lien Notes due 2048 (the “2019 Notes”), (ii) an aggregate of approximately $12.1 million in 2018 Notes principal repayment and (iii) accrued interest on the 2018 Notes through the exchange date. As of March 31, 2020, all 2019 Notes have converted into shares of common stock and are no longer outstanding.

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”). 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”).

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, all 2020 Notes have converted into shares of common stock and are no longer outstanding.

Stock-based compensation (Tables)

9 Months Ended

Sep. 30, 2022

Stock-based compensation

Summary of stock option activity and related information

A summary of the Company’s stock option activity and related information for the nine months ended September 30, 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	940,375		1.26
Exercised	(98,176)		1.20
Forfeited/cancelled	(3,452,122)		5.55
Outstanding at September 30, 2022	13,654,175	$	2.92	7.2	$	—
Vested at September 30, 2022	7,792,304	$	3.45	6.0	$	—

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


	September 30,
	2022		2021
Risk-free interest rate	2.83	%	0.76	%
Volatility	87	%	95	%
Dividend yield	—		—
Expected term (years)	5.7		5.9

Schedule of restricted stock units

A summary of the Company’s restricted stock unit activity and related information for the nine months ended September 30, 2022 is as follows:


	Shares	Weighted-average grant date fair value per share
Outstanding at December 31, 2021	2,805,004	$	2.44
Granted	322,113	$	1.36
Vested	(419,745)	$	2.94
Forfeited/cancelled	(223,720)	$	2.28
Outstanding at September 30, 2022	2,483,652	$	2.23

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


	Nine months ended September 30,
	2022		2021
Risk-free interest rate	1.56	%	0.07	%
Volatility	77	%	68	%
Dividend yield	—		—
Expected term (years)	0.5		0.5

Common stock

9 Months Ended

Sep. 30, 2022

Common stock.

Common stock

10. Common stock

At-the-market equity offering programs

In August 2021, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“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 three and nine months ended September 30, 2022, the Company sold 22,281,059 shares and 23,573,403 shares, respectively, under the August 2021 ATM for net proceeds of approximately $25.5 million and $27.4 million, respectively, (after deducting commissions and other offering expenses).

- Definition

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.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 16
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 40
-Section 50
-Paragraph 6
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

License, collaboration and commercial agreements

9 Months Ended

Sep. 30, 2022

License, collaboration and commercial agreements

License, collaboration and commercial agreements

13. License, collaboration and commercial agreements

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.

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 PTCL 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 PTCL, (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 has 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 September 30, 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 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 September 30, 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 royalties. Portions of the contract asset are reclassified to accounts receivable when the right to consideration becomes unconditional. As of September 30, 2022 and December 31, 2021, the contract asset has been recorded within prepaid and other current assets on the condensed consolidated balance sheets.

The following table presents changes in the Company’s contract asset for the nine months ended September 30, 2022 (in thousands):


Contract Asset:	December 31, 2021		Additions		Reclassification to receivable		September 30, 2022
Contract asset - Secura	$	170	$	96	$	(141)	$	125
Total	$	170	$	96	$	(141)	$	125

During the first quarter of 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 September 30, 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 three and nine months ended September 30, 2022, the Company recognized $0.0 million and $2.6 million, respectively, 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 nine months ended September 30, 2022 primarily 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 nine months ended September 30, 2022, and future royalties expected to be received pursuant to the Secura APA that were not constrained.

During the three and nine months ended September 30, 2021, the Company recognized $0.0 million and $0.9 million, respectively, 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 nine months ended September 30, 2021 primarily related to one regulatory milestone for $0.8 million achieved by Secura’s sublicensee and $0.1 million related to future royalties expected to be received pursuant to the Secura APA. During the three and nine months ended September 30, 2021, the Company also recognized $0.0 million and $0.6 million, respectively, in transition services revenue within the statements of operations and comprehensive loss.

Leases - Balance sheet and other information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Leases
Right-of use asset	$ 1,927		$ 1,927		$ 2,302
Lease liability	2,443		2,443
Lease Expense
Operating lease expense	221	$ 221	664	$ 664
Total Lease Expense	221	221	664	664
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$ 262	$ 257	$ 777	$ 761
Weighted average remaining lease term (in years)	2 years 9 months 18 days		2 years 9 months 18 days
Weighted average discount rate	14.60%		14.60%
Maturity Analysis
2022	$ 262		$ 262
2023	1,060		1,060
2024	1,081		1,081
2025	546		546
Total	2,949		2,949
Less: Present value discount	(506)		(506)
Lease Liability	$ 2,443		$ 2,443

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue:
Total revenue		$ 2	$ 2,596	$ 1,508
Operating expenses:
Research and development	$ 11,288	9,325	39,818	27,951
Selling, general and administrative	6,421	5,523	18,869	18,455
Total operating expenses	17,709	14,848	58,687	46,406
Loss from operations	(17,709)	(14,846)	(56,091)	(44,898)
Other income	20		54
Interest income	316	40	446	141
Interest expense	(717)	(7,980)	(1,413)	(9,962)
Net loss	$ (18,090)	$ (22,786)	$ (57,004)	$ (54,719)
Net loss per share-basic	$ (0.09)	$ (0.13)	$ (0.30)	$ (0.31)
Net loss per share-diluted	$ (0.09)	$ (0.13)	$ (0.30)	$ (0.31)
Weighted average common shares outstanding used in computing net loss per share - basic	197,151	179,861	189,999	174,524
Weighted average common shares outstanding used in computing net loss per share - diluted	197,151	179,861	189,999	174,524
Net loss	$ (18,090)	$ (22,786)	$ (57,004)	$ (54,719)
Unrealized gain (loss) on available-for-sale securities	91	(12)	(73)	(26)
Comprehensive loss	$ (17,999)	(22,798)	(57,077)	(54,745)
Sale of COPIKTRA license and related assets
Revenue:
Total revenue			$ 2,596	902
Transition Services Revenue
Revenue:
Total revenue		$ 2		$ 606

Stock-based compensation - Restricted Stock (Details) - Restricted stock units	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Shares
Outstanding at the beginning of the period (in shares) \| shares	2,805,004
Granted (in shares) \| shares	322,113
Vested (in shares) \| shares	(419,745)
Forfeited/cancelled (in shares) \| shares	(223,720)
Outstanding at the end of the period (in shares) \| shares	2,483,652
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	1.36
Vested (in dollars per share) \| $ / shares	2.94
Forfeited/cancelled (in dollars per share) \| $ / shares	2.28
Outstanding at the end of the period (in dollars per share) \| $ / shares	$ 2.23

Investments (Details) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
Investments (Details) $ in Thousands	Sep. 30, 2022 USD ($) item	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($) item	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($) item
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Amortized Cost	$ 78,166		$ 78,166		$ 21,252
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Gains	23		23		48
Total cash, cash equivalents, restricted cash and investments, Gross Unrealized Losses	(62)		(62)		$ (14)
Total cash, cash equivalents, restricted cash and investments, Fair Value	104,000		104,000
Realized gains or losses on investments	$ 0	$ 0	$ 0	$ 0
Number of investments in unrealized loss position for more than 12 months \| item	1		1		0
Number of investments in unrealized loss position for less than 12 months \| item	6		6		3
Unrealized loss on fair value	$ 100		$ 100
Unrealized loss less than 12 months	100		100		$ 100
Fair value less than 12 months	16,400		16,400		15,800
Fair value more than 12 months	5,000		5,000
Amortized Cost
Schedule of Investments [Line Items]
Total cash, cash equivalents, restricted cash and investments, Amortized Cost	105,229		105,229		100,463
Total
Schedule of Investments [Line Items]
Total cash, cash equivalents, restricted cash and investments, Fair Value	105,190		$ 105,190		$ 100,497
Corporate bonds, agency bonds and commercial paper (due within 90 days)
Schedule of Investments [Line Items]
Original maturity period, cash and cash equivalents			90 days
Gross Unrealized Gains	8		$ 8
Gross Unrealized Losses	(1)		(1)
Corporate bonds, agency bonds and commercial paper (due within 90 days) \| Amortized Cost
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Amortized Cost	22,865		22,865
Corporate bonds, agency bonds and commercial paper (due within 90 days) \| Total
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Fair Value	22,872		$ 22,872
Corporate bonds, agency bonds and commercial paper (due within 1 year)
Schedule of Investments [Line Items]
Maturity period, investments			1 year		1 year
Gross Unrealized Gains	15		$ 15		$ 48
Gross Unrealized Losses	(61)		(61)		(14)
Corporate bonds, agency bonds and commercial paper (due within 1 year) \| Amortized Cost
Schedule of Investments [Line Items]
Due within 1 year, Amortized Cost	25,856		25,856		78,970
Corporate bonds, agency bonds and commercial paper (due within 1 year) \| Total
Schedule of Investments [Line Items]
Due within 1 year, Fair Value	25,810		25,810		79,004
Investments.
Schedule of Investments [Line Items]
Gross Unrealized Gains	15		15		48
Gross Unrealized Losses	(61)		(61)		(14)
Investments. \| Amortized Cost
Schedule of Investments [Line Items]
Investments, Amortized Cost	25,856		25,856		78,970
Investments. \| Total
Schedule of Investments [Line Items]
Investments, Fair Value	25,810		25,810		79,004
Cash and money market accounts. \| Amortized Cost
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Amortized Cost	56,508		56,508		21,493
Cash and money market accounts. \| Total
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Fair Value	56,508		56,508		21,493
Cash, cash equivalents & restricted cash
Schedule of Investments [Line Items]
Gross Unrealized Gains	8		8
Gross Unrealized Losses	(1)		(1)
Cash, cash equivalents & restricted cash \| Amortized Cost
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Amortized Cost	79,373		79,373		21,493
Cash, cash equivalents & restricted cash \| Total
Schedule of Investments [Line Items]
Cash, cash equivalents & restricted cash, Fair Value	$ 79,380		$ 79,380		$ 21,493

Net loss per share (Tables)

9 Months Ended

Sep. 30, 2022

Net loss per share

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

The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:


	Three months ended September 30,		Nine months ended September 30,
	2022	2021	2022	2021
Outstanding stock options	13,654,175	12,947,009	13,654,175	12,947,009
Outstanding restricted stock units	2,483,652	1,749,979	2,483,652	1,749,979
2018 Notes	41,873	41,873	41,873	41,873
Employee stock purchase plan	77,700	29,328	77,700	29,328
Total potentially dilutive securities	16,257,400	14,768,189	16,257,400	14,768,189

Subsequent events

9 Months Ended

Sep. 30, 2022

Subsequent events.

Subsequent events

16. Subsequent events

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

Accrued expenses

9 Months Ended

Sep. 30, 2022

Accrued expenses

Accrued expenses

6. Accrued expenses

Accrued expenses consist of the following (in thousands):


	September 30, 2022		December 31, 2021
Research and development expenses	$	8,163	$	9,311
Compensation and related benefits		3,393		3,892
Professional fees		678		785
Consulting fees		956		544
Interest		198		3
Commercialization costs		479		187
Other		921		899
Total accrued expenses	$	14,788	$	15,621

Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases

Summary of elements of lease expenses


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Lease Expense
Operating lease expense	$	221	$	221	$	664	$	664
Total Lease Expense	$	221	$	221	$	664	$	664
Other Information - Operating Leases
Operating cash flows paid for amounts included in measurement of lease liabilities	$	262	$	257	$	777	$	761


		September 30, 2022
Other Balance Sheet Information - Operating Leases
Weighted average remaining lease term (in years)		2.8
Weighted average discount rate		14.6%
Maturity Analysis
2022		262
2023		1,060
2024		1,081
2025		546
Total	$	2,949
Less: Present value discount		(506)
Lease Liability	$	2,443