0001558370-24-014646 | 10-Q | XBRL Viewer

Stock-Based Awards

9 Months Ended

Sep. 30, 2024

7. Stock-Based Awards

2015 Equity Incentive Plan

In September 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and the Company’s stockholders approved the 2015 Plan. The 2015 Plan became effective in connection with the Company’s initial public offering in October 2015. Beginning at the time the 2015 Plan became effective, no further grants may be made under the Company’s 2012 Equity Compensation Plan, as amended and restated (the “2012 Plan”). The 2015 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit (“RSU”) awards, performance stock awards, cash-based awards, and other stock-based awards. The number of shares initially reserved for issuance under the 2015 Plan was 1,643,872 shares of common stock. The number of shares of common stock that may be issued under the 2015 Plan will automatically increase on January 1 of each year ending on January 1, 2025, in an amount equal to the lesser of (i) 4.0% of the shares of the Company’s common stock outstanding on December 31st of the preceding calendar year or (ii) an amount determined by the Company’s board of directors. The shares of common stock underlying any awards that expire, are otherwise terminated, settled in cash, or repurchased by the Company under the 2015 Plan and the 2012 Plan will be added back to the shares of

common stock available for issuance under the 2015 Plan. As of January 1, 2024, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 2,835,795 shares. As of September 30, 2024, 4,440,792 shares remained available for grant under the 2015 Plan. The Company had 5,778,988 stock options and 3,071,776 RSUs outstanding as of September 30, 2024 under the 2015 Plan.

2017 Inducement Plan

In July 2017, the Company’s board of directors adopted the 2017 Inducement Plan (the “2017 Inducement Plan”). The 2017 Inducement Plan is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The Company had 329,000 stock options outstanding as of September 30, 2024 under the 2017 Inducement Plan. All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired.

2012 Equity Compensation Plan

In August 2012, the Company’s board of directors adopted the 2012 Plan and the Company’s stockholders approved the 2012 Plan. Upon the 2015 Plan becoming effective, no further grants can be made under the 2012 Plan. The Company had 337,244 stock options outstanding as of September 30, 2024 under the 2012 Plan.

Stock Option Valuation

The weighted average assumptions the Company used to estimate the fair value of stock options granted during the nine months ended September 30, 2024 and 2023 were as follows:


	Nine Months Ended
	September 30,
	2024		2023
Risk-free interest rate	3.85	%	3.53	%
Expected term (in years)	6.0		6.2
Expected volatility	81.95	%	77.73	%
Expected dividend yield	0	%	0	%

The Company recognizes compensation expense for awards over their vesting period. Compensation expense for awards includes the impact of forfeitures in the period when they occur.

Stock Options

The following table summarizes stock option activity for the nine months ended September 30, 2024:


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number	Exercise		Contractual	Intrinsic
(In thousands, except share and per share data and years)	of Shares	Price		Term	Value
				(in years)
Outstanding as of December 31, 2023	6,419,455	$	15.94	7.1	$	14
Granted	1,982,700		1.19
Exercised	(43,548)		0.72			19
Forfeited and cancelled	(1,913,375)		14.82
Outstanding as of September 30, 2024	6,445,232	$	11.85	6.9	$	13
Options vested and expected to vest as of September 30, 2024	6,445,232	$	11.85	6.9	$	13
Options exercisable as of September 30, 2024	3,512,137	$	15.40	5.4	$	3

The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2024 was $0.86 per share.

Restricted Stock Units

The following table summarizes RSU activity for the nine months ended September 30, 2024:


		Weighted
		Average
		Grant Date		Aggregate
	Number	Fair Value		Intrinsic
(In thousands, except share and per share data)	of Shares	Per Share		Value
Outstanding as of December 31, 2023	1,521,940	$	15.72
Granted	2,648,642		1.20
Vested	(542,846)		12.43	$	647
Forfeited and cancelled	(555,960)		12.54
Outstanding as of September 30, 2024	3,071,776	$	4.37

Stock-Based Compensation

Stock-based compensation expense included in total costs and expenses on the condensed consolidated statement of operations included the following:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2024		2023		2024		2023
Cost of revenue	$	232	$	347	$	707	$	1,119
Research and development		1,124		3,072		2,192		9,168
General and administrative		1,648		2,529		5,097		8,989
Total stock-based compensation expense	$	3,004	$	5,948	$	7,996	$	19,276

As of September 30, 2024, the Company had unrecognized stock-based compensation expense for stock options and RSUs of $11.5 million and $9.3 million, respectively, which is expected to be recognized over weighted average periods of 2.1 years and 1.9 years, respectively.

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Gain (Loss)	Accumulated Deficit	Total
Balance at beginning of period at Dec. 31, 2022	$ 1	$ 880,832	$ (897)	$ (682,315)	$ 197,621
Balance at beginning of period (in shares) at Dec. 31, 2022	66,688,647
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units (in shares)	517,378
Unrealized gain (loss) on marketable securities			543		543
Stock-based compensation expense		6,806			6,806
Net loss				(28,160)	(28,160)
Balance at end of period at Mar. 31, 2023	$ 1	887,638	(354)	(710,475)	176,810
Balance at end of period (in shares) at Mar. 31, 2023	67,206,025
Balance at beginning of period at Dec. 31, 2022	$ 1	880,832	(897)	(682,315)	197,621
Balance at beginning of period (in shares) at Dec. 31, 2022	66,688,647
Increase (Decrease) in Stockholders' Equity
Net loss					(86,990)
Balance at end of period at Sep. 30, 2023	$ 1	926,766	(1,129)	(769,305)	156,333
Balance at end of period (in shares) at Sep. 30, 2023	70,818,954
Balance at beginning of period at Mar. 31, 2023	$ 1	887,638	(354)	(710,475)	176,810
Balance at beginning of period (in shares) at Mar. 31, 2023	67,206,025
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units		30			30
Issuance of common stock in connection with vesting of restricted stock units (in shares)	163,677
Issuance of common stock under at-the-market sales agreement, net of offering costs of $826		26,714			26,714
Issuance of common stock under at-the-market sales agreement, net of offering costs of $826 (In shares)	3,400,000
Unrealized gain (loss) on marketable securities			(757)		(757)
Stock-based compensation expense		6,522			6,522
Net loss				(29,569)	(29,569)
Balance at end of period at Jun. 30, 2023	$ 1	920,904	(1,111)	(740,044)	179,750
Balance at end of period (in shares) at Jun. 30, 2023	70,769,702
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units		(86)			(86)
Issuance of common stock in connection with vesting of restricted stock units (in shares)	49,252
Unrealized gain (loss) on marketable securities			(18)		(18)
Stock-based compensation expense		5,948			5,948
Net loss				(29,261)	(29,261)
Balance at end of period at Sep. 30, 2023	$ 1	926,766	(1,129)	(769,305)	156,333
Balance at end of period (in shares) at Sep. 30, 2023	70,818,954
Balance at beginning of period at Dec. 31, 2023	$ 1	928,080	(106)	(770,796)	$ 157,179
Balance at beginning of period (in shares) at Dec. 31, 2023	70,894,889				70,894,889
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units		(55)			$ (55)
Issuance of common stock in connection with vesting of restricted stock units (in shares)	353,128
Unrealized gain (loss) on marketable securities			(258)		(258)
Stock-based compensation expense		2,089			2,089
Net loss				(16,941)	(16,941)
Balance at end of period at Mar. 31, 2024	$ 1	930,114	(364)	(787,737)	142,014
Balance at end of period (in shares) at Mar. 31, 2024	71,248,017
Balance at beginning of period at Dec. 31, 2023	$ 1	928,080	(106)	(770,796)	$ 157,179
Balance at beginning of period (in shares) at Dec. 31, 2023	70,894,889				70,894,889
Increase (Decrease) in Stockholders' Equity
Net loss					$ (35,513)
Balance at end of period at Sep. 30, 2024	$ 1	936,032	427	(806,309)	$ 130,151
Balance at end of period (in shares) at Sep. 30, 2024	71,417,513				71,417,513
Balance at beginning of period at Mar. 31, 2024	$ 1	930,114	(364)	(787,737)	$ 142,014
Balance at beginning of period (in shares) at Mar. 31, 2024	71,248,017
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units		(10)			(10)
Issuance of common stock in connection with vesting of restricted stock units (in shares)	84,808
Unrealized gain (loss) on marketable securities			(99)		(99)
Stock-based compensation expense		2,903			2,903
Net loss				(10,986)	(10,986)
Balance at end of period at Jun. 30, 2024	$ 1	933,007	(463)	(798,723)	133,822
Balance at end of period (in shares) at Jun. 30, 2024	71,332,825
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with vesting of restricted stock units		21			21
Issuance of common stock in connection with vesting of restricted stock units (in shares)	84,688
Unrealized gain (loss) on marketable securities			890		890
Stock-based compensation expense		3,004			3,004
Net loss				(7,586)	(7,586)
Balance at end of period at Sep. 30, 2024	$ 1	$ 936,032	$ 427	$ (806,309)	$ 130,151
Balance at end of period (in shares) at Sep. 30, 2024	71,417,513				71,417,513

Restructuring Charges	9 Months Ended
Sep. 30, 2024
Restructuring Charges
Restructuring Charges	13. Restructuring Charges In December 2023, the Company’s board of directors approved a reduction of the Company’s workforce by approximately 46%, which was substantially completed as of June 30, 2024. This action was taken in order to streamline operations, reduce costs and preserve capital. As a result, the Company terminated certain employees (“terminated employees”) and gave notice to additional employees (“noticed employees”) who were asked to provide transition services through termination dates ranging between one to thirteen months from the date notice was given. The terminated employees were entitled to receive cash severance payments and other benefits. The noticed employees are entitled to receive cash severance payments and other benefits, which are contingent upon providing additional services to the Company. During the three and nine months ended September 30, 2024, the Company recognized severance expense of $26 thousand and $2.6 million, respectively. During the nine months ended September 30, 2024, the Company made cash severance payments of $5.2 million to impacted employees.

Restructuring Charges

9 Months Ended

Sep. 30, 2024

Restructuring Charges

Restructuring Charges

13. Restructuring Charges

In December 2023, the Company’s board of directors approved a reduction of the Company’s workforce by approximately 46%, which was substantially completed as of June 30, 2024. This action was taken in order to streamline operations, reduce costs and preserve capital. As a result, the Company terminated certain employees (“terminated employees”) and gave notice to additional employees (“noticed employees”) who were asked to provide transition services through termination dates ranging between one to thirteen months from the date notice was given. The terminated employees were entitled to receive cash severance payments and other benefits. The noticed employees are entitled to receive cash severance payments and other benefits, which are contingent upon providing additional services to the Company.

During the three and nine months ended September 30, 2024, the Company recognized severance expense of $26 thousand and $2.6 million, respectively. During the nine months ended September 30, 2024, the Company made cash severance payments of $5.2 million to impacted employees.

Summary of Significant Accounting Policies (Details) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Discontinued Operations
Other current liabilities	$ 2.2	$ 2.2
Minimum
Contingent Consideration
Probability of success assumptions	17.00%
Discount range	6.60%
Maximum
Contingent Consideration
Probability of success assumptions	40.00%
Discount range	7.90%

Agreements Related to Intellectual Property

9 Months Ended

Sep. 30, 2024

10. Agreements Related to Intellectual Property

License Agreement – Sun Pharmaceutical Industries, Inc.

In December 2023, the Company entered into an exclusive patent license agreement with Sun Pharmaceutical Industries, Inc. (“Sun Pharma”). Under the license agreement, the Company granted Sun Pharma exclusive rights under certain patents that the Company exclusively licenses from a third party. The patents relate to the use of deuruxolitinib, Sun Pharma’s Janus kinase (“JAK”) inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata or androgenetic alopecia. Under the license agreement, Sun Pharma has paid the Company an upfront payment, and has agreed to pay the Company regulatory and commercial milestone payments upon the achievement of specified milestones set forth in the agreement, and a mid single-digit tiered royalty calculated as a percentage of Sun Pharma’s net sales. The Company has separate contractual obligations under which the Company has agreed to pay to third parties a portion of the consideration it may receive under the license agreement.

Upon execution of the agreement, the Company received an upfront payment of $15.0 million from Sun Pharma, a portion of which was payable to third parties. We recognized $3.0 million of licensing revenue during each of the three and nine months ended September 30, 2024.

License Agreement – Pediatrix Therapeutics, Inc.

In November 2022, the Company entered into a license agreement with Pediatrix Therapeutics, Inc. (“Pediatrix”), under which the Company granted Pediatrix the exclusive rights to develop, manufacture and commercialize lepzacitinib in Greater China. Pediatrix has paid the Company an upfront payment, and has agreed to pay the Company development, regulatory and commercial milestone payments upon the achievement of specified milestones set forth in the agreement, and a tiered royalty ranging from a low-to-high single digit percentage of net sales of lepzacitinib by Pediatrix in Greater China. A portion of consideration received from Pediatrix is payable to the former Confluence equity holders as described below under the caption “Agreement and Plan of Merger - Confluence.”

License Agreement – Eli Lilly and Company

In August 2022, the Company entered into a non-exclusive patent license agreement with Eli Lilly and Company (“Lilly”). Under the license agreement, the Company granted Lilly non-exclusive rights under certain patents and patent applications that the Company exclusively licenses from a third party. The patents and patent applications relate to the use of baricitinib, Lilly’s JAK inhibitor, to treat alopecia areata. Under the license agreement, Lilly has paid the Company an upfront payment, and regulatory and certain commercial milestone payments, and agreed to pay the Company anniversary payments and other commercial milestone payments upon the achievement of specified milestones as set forth in the agreement, and a low single-digit royalty calculated as a percentage of Lilly’s net sales of baricitinib for the treatment of alopecia areata. The Company has separate contractual obligations under which the Company has agreed to pay to third parties an amount equal to any regulatory and commercial milestone payments it receives under the Lilly license agreement, as well as a portion of the upfront consideration and a portion of the royalties it may receive under the license agreement. In July 2024, the Company entered into a royalty purchase agreement with OCM IP Healthcare Portfolio LP, an investment vehicle for Ontario Municipal Employees Retirement System (“OMERS”), pursuant to which the Company sold to OMERS a portion of the Company’s future royalty payments and the remaining anniversary milestones associated with the license to Lilly (see Note 11).

The Company recognized $0.7 million and $8.3 million of licensing revenue during the three months ended September 30, 2024 and 2023, respectively, and $4.6 million and $10.7 million during the nine months ended September 30, 2024 and 2023, respectively. The Company recognized $0.9 million of non-cash royalty income during each of the three and nine months ended September 30, 2024.

Asset Purchase Agreement – EPI Health, LLC

In October 2019, the Company sold RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) to EPI Health, LLC (“EPI Health”) pursuant to an asset purchase agreement. In July 2023, EPI Health filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code. Through the bankruptcy process, EPI Health and its parent company, Novan, Inc., sold the RHOFADE assets to a third party, which excluded the Company’s asset

purchase agreement with EPI Health and the outstanding amounts due. The sale was approved by the bankruptcy court in September 2023. As a result of the bankruptcy proceedings, all amounts that are due and outstanding by EPI Health have been fully reserved.

Agreement and Plan of Merger – Confluence

In August 2017, the Company entered into an Agreement and Plan of Merger, pursuant to which it acquired Confluence (the “Confluence Agreement”). Under the Confluence Agreement, the Company has agreed to pay the former Confluence equity holders aggregate remaining contingent consideration of up to $75.0 million based upon the achievement of specified regulatory and commercial milestones set forth in the Confluence Agreement. In addition, the Company has agreed to pay the former Confluence equity holders future royalty payments calculated as a low single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. In addition to the payments described above, if the Company sells, licenses or transfers any of the intellectual property acquired from Confluence pursuant to the Confluence Agreement to a third party, the Company will be obligated to pay the former Confluence equity holders a portion of any consideration received from such sale, license or transfer in specified circumstances.

As of September 30, 2024 and December 31, 2023, the balance of the Company’s contingent consideration liability was $10.0 million and $6.2 million, respectively (see Note 3).

Stock-Based Awards (Details) - shares		9 Months Ended
Stock-Based Awards (Details) - shares	Jan. 01, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Sep. 30, 2015
Stock-based awards
Options outstanding		6,445,232		6,419,455
Stock Option Valuation
Risk-free interest rate (as a percent)		3.85%	3.53%
Expected term (in years)		6 years	6 years 2 months 12 days
Expected volatility (as a percent)		81.95%	77.73%
Expected dividend yield (as a percent)		0.00%	0.00%
2017 Inducement Plan
Stock-based awards
Options outstanding		329,000
2015 Equity Incentive Plan
Stock-based awards
Number of shares authorized					1,643,872
Number of shares available for grant		4,440,792
Percentage increase to shares available for grant from common outstanding as of preceding December 31 (as a percent)		4.00%
Additional shares available	2,835,795
Options outstanding		5,778,988
2015 Equity Incentive Plan \| Restricted stock unit awards
Stock-based awards
Number of shares outstanding		3,071,776
2012 Equity Compensation Plan
Stock-based awards
Number of shares available for grant		0
Options outstanding		337,244

Stockholders' Equity

9 Months Ended

Sep. 30, 2024

Stockholders' Equity

Stockholders' Equity

6. Stockholders’ Equity

Preferred Stock

As of September 30, 2024 and December 31, 2023, the Company’s amended and restated certificate of incorporation (the “Charter”) authorized the Company to issue 10,000,000 shares of undesignated preferred stock. There were no shares of preferred stock outstanding as of September 30, 2024 or December 31, 2023.

Common Stock

As of September 30, 2024 and December 31, 2023, the Company’s Charter authorized the Company to issue 200,000,000 shares of $0.00001 par value common stock. There were 71,417,513 and 70,894,889 shares of common stock issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to any preferential dividend rights of any series of preferred stock that may be outstanding. No dividends have been declared through September 30, 2024.

Sales of Common Stock Pursuant to At-The-Market Facility

In April 2023, the Company sold 3.4 million shares of its common stock for aggregate gross proceeds of $27.5 million, pursuant to a sales agreement with SVB Securities LLC and Cantor Fitzgerald & Co., as sales agents, dated February 23, 2023. The Company paid selling commissions of $0.8 million in connection with the sale.

- Definition

The entire disclosure for equity.

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+ Details

Net Loss per Share (Tables)

9 Months Ended

Sep. 30, 2024

Net Loss per Share

Summary of basic and diluted net loss per share


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands, except for share and per share data)	2024		2023		2024		2023
Numerator:
Net loss	$	(7,586)	$	(29,261)	$	(35,513)	$	(86,990)
Denominator:
Weighted average shares of common stock outstanding, basic and diluted		71,381,731		70,807,934		71,249,813		69,452,495
Net loss per share, basic and diluted	$	(0.11)	$	(0.41)	$	(0.50)	$	(1.25)

Summary of potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders



	September 30,
	2024	2023
Options to purchase common stock	6,445,232	7,122,455
Restricted stock unit awards	3,071,776	1,707,190
Total potential shares of common stock	9,517,008	8,829,645

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2024

Property and Equipment, Net

Schedule of property and equipment, net


		September 30,		December 31,
(In thousands)	2024		2023
Computer equipment	$	1,198	$	1,253
Lab equipment		3,137		3,154
Furniture and fixtures		661		558
Leasehold improvements		817		817
Property and equipment, gross		5,813		5,782
Accumulated depreciation		(4,680)		(4,162)
Property and equipment, net	$	1,133	$	1,620

Organization and Nature of Business

9 Months Ended

Sep. 30, 2024

Organization and Nature of Business

Organization and Nature of Business

1. Organization and Nature of Business

Overview

Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012. Aclaris Therapeutics, Inc. and its wholly owned subsidiaries are referred to collectively as the “Company.”

The Company is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases. The Company’s proprietary KINect drug discovery platform combined with its preclinical development capabilities allows the Company to identify and advance potential drug candidates that it may develop independently or in collaboration with third parties. In addition to identifying and developing its novel drug candidates, the Company is pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its novel drug candidates. The Company also provides contract research services to third parties enabled by its early-stage research and development expertise.

Liquidity

The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. As of September 30, 2024, the Company had cash, cash equivalents and marketable securities of $173.4 million and an accumulated deficit of $806.3 million. Since inception, the Company has incurred net losses and negative cash flows from its operations. There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, including clinical and preclinical testing of the Company’s drug candidates, will require significant additional financing. The future viability of the Company is dependent on its ability to successfully develop its drug candidates and to generate revenue from identifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize its development assets or to raise additional capital to finance its operations. The Company will require additional capital to develop its drug candidates and to support its discovery efforts.

Additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy. The Company's ability to raise additional capital may be adversely impacted by potentially worsening global economic conditions caused by a variety of factors including geopolitical tensions and inflationary pressures. If the Company is unable to raise sufficient additional capital or generate revenue from transactions with potential third-party partners for the development and/or commercialization of its drug candidates, it may need to substantially curtail planned operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

In accordance with Accounting Standards Codification (“ASC”) Subtopic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its condensed consolidated financial statements are issued. As of the report date, the Company does not believe that substantial doubt exists about its ability to continue as a going concern. The Company believes its existing cash, cash equivalents and marketable securities are sufficient to fund its operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of these condensed consolidated financial statements.

Stock-Based Awards - Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock-based compensation expense
Total stock-based compensation expense	$ 3,004	$ 5,948	$ 7,996	$ 19,276
Unrecognized stock-based compensation expense, options	11,500		11,500
Unrecognized stock-based compensation expense, RSUs	9,300		9,300
Cost of revenue
Stock-based compensation expense
Total stock-based compensation expense	232	347	707	1,119
Research and development
Stock-based compensation expense
Total stock-based compensation expense	1,124	3,072	2,192	9,168
General and administrative
Stock-based compensation expense
Total stock-based compensation expense	$ 1,648	$ 2,529	$ 5,097	$ 8,989
Options to purchase common stock
Stock-based compensation expense
Weighted average recognition period unrecognized stock-based compensation cost (in years)			2 years 1 month 6 days
Restricted stock unit awards
Stock-based compensation expense
Weighted average recognition period unrecognized stock-based compensation cost (in years)			1 year 10 months 24 days

Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Assets:
Marketable securities	$ 125,785		$ 125,785		$ 141,999
Liabilities:
Transfers into or out of Level 3	0	$ 0	0	$ 0
Increase in value of contingent consideration	800	$ 1,700	3,800	$ (600)
Confluence
Liabilities:
Increase in value of contingent consideration			3,800
Recurring
Assets:
Cash equivalents	45,450		45,450		32,177
Marketable securities	125,785		125,785		141,999
Total assets	171,235		171,235		174,176
Liabilities:
Contingent consideration	10,000		10,000		6,200
Total liabilities	10,000		10,000		6,200
Recurring \| Level 1
Assets:
Cash equivalents	45,450		45,450		32,177
Total assets	45,450		45,450		32,177
Recurring \| Level 2
Assets:
Marketable securities	125,785		125,785		141,999
Total assets	125,785		125,785		141,999
Recurring \| Level 3
Liabilities:
Contingent consideration	10,000		10,000		6,200
Total liabilities	$ 10,000		$ 10,000		$ 6,200

Stock-Based Awards - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Options, Number of Shares
Number of Shares, beginning balance	6,419,455
Number of Shares, Granted	1,982,700
Number of Shares, Exercised	(43,548)
Number of Shares, Forfeited and cancelled	(1,913,375)
Number of Shares, ending balance	6,445,232	6,419,455
Number of Shares, Options vested and expected to vest	6,445,232
Number of Shares, Options exercisable	3,512,137
Options, Weighted Average Exercise Price
Weighted Average Exercise Price, beginning balance (in dollars per share)	$ 15.94
Weighted Average Exercise Price, Granted (in dollars per share)	1.19
Weighted Average Exercise Price, Exercised (in dollars per share)	0.72
Weighted Average Exercise Price, Forfeited and cancelled (in dollars per share)	14.82
Weighted Average Exercise Price, ending balance (in dollars per share)	11.85	$ 15.94
Weighted Average Exercise Price, Options vested and expected to vest (in dollars per share)	11.85
Weighted Average Exercise Price, Options exercisable (in dollars per share)	$ 15.40
Options, Weighted Average Remaining Contractual Term
Weighted Average Remaining Contractual Term (in years)	6 years 10 months 24 days	7 years 1 month 6 days
Weighted Average Remaining Contractual Term, Options vested and expected to vest (in years)	6 years 10 months 24 days
Weighted Average Remaining Contractual Term, Options exercisable (in years)	5 years 4 months 24 days
Aggregate Intrinsic Value
Aggregate Intrinsic Value	$ 13	$ 14
Aggregate Intrinsic Value, Exercised	19
Aggregate Intrinsic Value, Options vested and expected to vest	13
Aggregate Intrinsic Value, Options exercisable	$ 3
Weighted average grant-date fair value of stock options granted (in dollars per share)	$ 0.86

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Schedule of accrued expenses


	September 30,		December 31,
(In thousands)	2024		2023
Employee compensation expenses	$	2,603	$	3,910
Research and development expenses		124		6,661
Licensing expenses		1,084		5,478
Restructuring expenses (Note 13)		502		3,112
Other expenses		409		285
Total accrued expenses	$	4,722	$	19,446

Property and Equipment, Net

9 Months Ended

Sep. 30, 2024

Property and Equipment, Net

Property and Equipment, Net

4. Property and Equipment, Net

Property and equipment, net consisted of the following:


		September 30,		December 31,
(In thousands)	2024		2023
Computer equipment	$	1,198	$	1,253
Lab equipment		3,137		3,154
Furniture and fixtures		661		558
Leasehold improvements		817		817
Property and equipment, gross		5,813		5,782
Accumulated depreciation		(4,680)		(4,162)
Property and equipment, net	$	1,133	$	1,620

Depreciation expense was $0.2 million for each of the three months ended September 30, 2024 and 2023, and $0.6 million for each of the nine months ended September 30, 2024 and 2023.

Leases (Tables)

9 Months Ended

Sep. 30, 2024

Leases

Summary of supplemental balance sheet information related to operating leases


	September 30,		December 31,
(In thousands)	2024		2023
Operating Leases:
Gross cost	$	4,530	$	5,094
Accumulated amortization		(1,556)		(1,235)
Other assets	$	2,974	$	3,859

Current portion of lease liabilities	$	465	$	426
Other liabilities		2,245		3,074
Total operating lease liabilities	$	2,710	$	3,500

Agreements Related to Intellectual Property (Details) - USD ($) $ in Thousands	1 Months Ended			3 Months Ended		9 Months Ended
	Jul. 31, 2024	Oct. 31, 2019	Aug. 31, 2017	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Agreements Related to Intellectual Property
Revenue				$ 4,346	$ 9,282	$ 9,509	$ 13,679
Non-cash royalty income				894		894
Contingent consideration				10,000		10,000		$ 6,200
License and Service
Agreements Related to Intellectual Property
Revenue				3,701	8,577	7,583	11,210
License Agreement \| Sun Pharmaceutical Industries, Inc
Agreements Related to Intellectual Property
Upfront payment receivable								$ 15,000
License Agreement \| Sun Pharmaceutical Industries, Inc \| License and Service
Agreements Related to Intellectual Property
Revenue				3,000		3,000
Non-Exclusive Patent License Agreement \| Eli Lilly and Company \| OMERS
Agreements Related to Intellectual Property
Percentage of Remaining Anniversary Milestone Payments Payable Acquired	100.00%
Non-Exclusive Patent License Agreement \| Eli Lilly and Company \| License and Service
Agreements Related to Intellectual Property
Revenue				700	$ 8,300	4,600	$ 10,700
Asset Purchase Agreement
Agreements Related to Intellectual Property
Percentage of Sale of EPI Health Cream		1.00%
Agreement and Plan of Merger - Confluence
Agreements Related to Intellectual Property
Additional contingent consideration based on milestones, maximum, per Agreement			$ 75,000
Term of agreement			10 years
Royalty purchase agreement \| OMERS
Agreements Related to Intellectual Property
Non-cash royalty income				$ 900		$ 900
Proceeds From Upfront Payment	$ 26,500
Additional Amount Receivable On Achievement of Sales Milestones	$ 5,000

Segment Information

9 Months Ended

Sep. 30, 2024

Segment Information

Segment Information

14. Segment Information

The Company has two reportable segments, therapeutics and contract research. The therapeutics segment is focused on identifying and developing innovative therapies to address significant unmet needs for immuno-inflammatory diseases and earns revenue through licensing of the Company’s intellectual property. The contract research segment earns revenue from the provision of laboratory services. All intersegment revenue has been eliminated in the Company’s consolidated statement of operations. All customers and revenue pertaining to the Company’s segments are based in the United States. Corporate and other includes general and administrative expenses as well as eliminations of intercompany transactions. The Company does not report balance sheet information by segment since it is not reviewed by the chief operating decision maker, and all of the Company’s tangible assets are held in the United States.

The Company’s results of operations by segment for the three and nine months ended September 30, 2024 and 2023 are summarized in the tables below:


(In thousands)			Contract		Corporate		Total
Three Months Ended September 30, 2024	Therapeutics		Research		and Other		Company
Revenue from external customers	$	3,701	$	645	$	—	$	4,346
Intercompany revenue		—		3,035		(3,035)		—
Cost of revenue		—		3,485		(2,831)		654
Research and development		6,129		—		(205)		5,924
General and administrative		—		905		4,748		5,653
Licensing		1,754		—		—		1,754
Revaluation of contingent consideration		800		—		—		800
Restructuring expense		32		—		—		32
Loss from operations	$	(5,014)	$	(710)	$	(4,747)	$	(10,471)

(In thousands)			Contract		Corporate		Total
Three Months Ended September 30, 2023	Therapeutics		Research		and Other		Company
Revenue from external customers	$	8,577	$	705	$	—	$	9,282
Intercompany revenue		—		4,112		(4,112)		—
Cost of revenue		—		4,726		(3,878)		848
Research and development		24,110		—		(234)		23,876
General and administrative		—		1,174		5,917		7,091
Licensing		7,344		—		—		7,344
Revaluation of contingent consideration		1,700		—		—		1,700
Loss from operations	$	(24,577)	$	(1,083)	$	(5,917)	$	(31,577)

(In thousands)			Contract		Corporate		Total
Nine Months Ended September 30, 2024	Therapeutics		Research		and Other		Company
Revenue from external customers	$	7,583	$	1,926	$	—	$	9,509
Intercompany revenue		—		10,122		(10,122)		—
Cost of revenue		—		11,346		(9,476)		1,870
Research and development		23,555		—		(645)		22,910
General and administrative		—		3,033		13,184		16,217
Licensing		4,070		—		—		4,070
Revaluation of contingent consideration		3,800		—		—		3,800
Restructuring expense		1,650		217		1,032		2,899
Loss from operations	$	(25,492)	$	(2,548)	$	(14,217)	$	(42,257)

(In thousands)			Contract		Corporate		Total
Nine Months Ended September 30, 2023	Therapeutics		Research		and Other		Company
Revenue from external customers	$	11,210	$	2,469	$	—	$	13,679
Intercompany revenue		—		12,122		(12,122)		—
Cost of revenue		—		14,068		(11,370)		2,698
Research and development		72,490		—		(752)		71,738
General and administrative		—		3,490		20,708		24,198
Licensing		8,955		—		—		8,955
Revaluation of contingent consideration		(600)		—		—		(600)
Loss from operations	$	(69,635)	$	(2,967)	$	(20,708)	$	(93,310)

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-22

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-15

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 31
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-31

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 42
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-42

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 40
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-40

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//280/tableOfContent

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 26
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-26

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 34
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-34

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-41

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-21

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-21

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

+ Details

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
CONDENSED CONSOLIDATED BALANCE SHEETS
Preferred stock, par value (in dollars per share)	$ 0.00001	$ 0.00001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.00001	$ 0.00001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	71,417,513	70,894,889
Common stock, shares outstanding (in shares)	71,417,513	70,894,889

Restructuring Charges (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended	9 Months Ended
Restructuring Charges (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Sep. 30, 2024	Sep. 30, 2024
Restructuring Charges
Percentage of approved reduction in workforce	46.00%
Cash severance payments		$ 26	$ 2,600
Cash payments			$ 5,200
Minimum
Restructuring Charges
Period for which transition services is provided by noticed employees	1 month
Maximum
Restructuring Charges
Period for which transition services is provided by noticed employees	13 months

- Definition

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

+ References + Details

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues:
Total revenue	$ 4,346	$ 9,282	$ 9,509	$ 13,679
Costs and expenses:
Cost of revenue	654	848	2,087	2,698
Research and development	5,956	23,876	24,560	71,738
General and administrative	5,653	7,091	17,249	24,198
Licensing	1,754	7,344	4,070	8,955
Revaluation of contingent consideration	800	1,700	3,800	(600)
Total costs and expenses	14,817	40,859	51,766	106,989
Loss from operations	(10,471)	(31,577)	(42,257)	(93,310)
Other income:
Interest income	1,991	2,316	5,850	6,320
Non-cash royalty income	894		894
Total other income	2,885	2,316	6,744	6,320
Net loss	$ (7,586)	$ (29,261)	$ (35,513)	$ (86,990)
Net loss per share, basic	$ (0.11)	$ (0.41)	$ (0.50)	$ (1.25)
Net loss per share, diluted	$ (0.11)	$ (0.41)	$ (0.50)	$ (1.25)
Weighted average common shares outstanding, basic	71,381,731	70,807,934	71,249,813	69,452,495
Weighted average common shares outstanding, diluted	71,381,731	70,807,934	71,249,813	69,452,495
Other comprehensive loss:
Unrealized gain (loss) on marketable securities, net of tax of $0	$ 890	$ (18)	$ 533	$ (232)
Total other comprehensive gain (loss)	890	(18)	533	(232)
Comprehensive loss	(6,696)	(29,279)	(34,980)	(87,222)
Contract research
Revenues:
Total revenue	645	705	1,926	2,469
Licensing
Revenues:
Total revenue	$ 3,701	$ 8,577	$ 7,583	$ 11,210

Leases (Details) $ in Thousands	3 Months Ended		9 Months Ended
Leases (Details) $ in Thousands	Sep. 30, 2024 USD ($) ft²	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) ft²	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)	May 31, 2023 ft²	Jan. 31, 2023 ft²	Feb. 28, 2019 ft²
Leases
Area leased, sublease agreement \| ft²	33,019		33,019			11,564	6,261	20,433
Amortization expense	$ 100	$ 200	$ 400	$ 700
Operating Leases:
Current portion of lease liabilities	465		465		$ 426
Other liabilities	$ 2,245		$ 2,245		$ 3,074
Financial position	Other liabilities		Other liabilities		Other liabilities
Total operating lease liabilities	$ 2,710		$ 2,710		$ 3,500
Operating Leases
Operating Leases:
Gross cost	4,530		4,530		5,094
Accumulated amortization	(1,556)		(1,556)		(1,235)
Other assets	$ 2,974		$ 2,974		$ 3,859

Segment Information (Tables)

9 Months Ended

Sep. 30, 2024

Segment Information

Summary of results of operations by segment


(In thousands)			Contract		Corporate		Total
Three Months Ended September 30, 2024	Therapeutics		Research		and Other		Company
Revenue from external customers	$	3,701	$	645	$	—	$	4,346
Intercompany revenue		—		3,035		(3,035)		—
Cost of revenue		—		3,485		(2,831)		654
Research and development		6,129		—		(205)		5,924
General and administrative		—		905		4,748		5,653
Licensing		1,754		—		—		1,754
Revaluation of contingent consideration		800		—		—		800
Restructuring expense		32		—		—		32
Loss from operations	$	(5,014)	$	(710)	$	(4,747)	$	(10,471)

(In thousands)			Contract		Corporate		Total
Three Months Ended September 30, 2023	Therapeutics		Research		and Other		Company
Revenue from external customers	$	8,577	$	705	$	—	$	9,282
Intercompany revenue		—		4,112		(4,112)		—
Cost of revenue		—		4,726		(3,878)		848
Research and development		24,110		—		(234)		23,876
General and administrative		—		1,174		5,917		7,091
Licensing		7,344		—		—		7,344
Revaluation of contingent consideration		1,700		—		—		1,700
Loss from operations	$	(24,577)	$	(1,083)	$	(5,917)	$	(31,577)

(In thousands)			Contract		Corporate		Total
Nine Months Ended September 30, 2024	Therapeutics		Research		and Other		Company
Revenue from external customers	$	7,583	$	1,926	$	—	$	9,509
Intercompany revenue		—		10,122		(10,122)		—
Cost of revenue		—		11,346		(9,476)		1,870
Research and development		23,555		—		(645)		22,910
General and administrative		—		3,033		13,184		16,217
Licensing		4,070		—		—		4,070
Revaluation of contingent consideration		3,800		—		—		3,800
Restructuring expense		1,650		217		1,032		2,899
Loss from operations	$	(25,492)	$	(2,548)	$	(14,217)	$	(42,257)

(In thousands)			Contract		Corporate		Total
Nine Months Ended September 30, 2023	Therapeutics		Research		and Other		Company
Revenue from external customers	$	11,210	$	2,469	$	—	$	13,679
Intercompany revenue		—		12,122		(12,122)		—
Cost of revenue		—		14,068		(11,370)		2,698
Research and development		72,490		—		(752)		71,738
General and administrative		—		3,490		20,708		24,198
Licensing		8,955		—		—		8,955
Revaluation of contingent consideration		(600)		—		—		(600)
Loss from operations	$	(69,635)	$	(2,967)	$	(20,708)	$	(93,310)

Property and Equipment, Net (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Property and Equipment, Net
Property and equipment, gross	$ 5,813		$ 5,813		$ 5,782
Accumulated depreciation	(4,680)		(4,680)		(4,162)
Property and equipment, net	1,133		1,133		1,620
Depreciation expense	200	$ 200	600	$ 600
Computer equipment
Property and Equipment, Net
Property and equipment, gross	1,198		1,198		1,253
Lab equipment
Property and Equipment, Net
Property and equipment, gross	3,137		3,137		3,154
Furniture and fixtures
Property and Equipment, Net
Property and equipment, gross	661		661		558
Leasehold improvements
Property and Equipment, Net
Property and equipment, gross	$ 817		$ 817		$ 817

Income Taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Taxes
Federal income tax benefit	$ 0	$ 0	$ 0	$ 0
State income tax benefit	$ 0	$ 0	$ 0	$ 0

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Oct. 31, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-37581
Entity Registrant Name	Aclaris Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-0571712
Entity Address, Address Line One	701 Lee Road, Suite 103
Entity Address, City or Town	Wayne
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19087
City Area Code	484
Local Phone Number	324-7933
Title of 12(b) Security	Common Stock, $0.00001 par value
Trading Symbol	ACRS
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		71,430,942
Entity Central Index Key	0001557746
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Taxes

Income Taxes

12. Income Taxes

The Company did not record a federal or state income tax benefit for losses incurred during the three and nine months ended September 30, 2024 and 2023. The Company concluded that it is more likely than not that its deferred tax assets will not be realized which resulted in recording a full valuation allowance during those periods.

- 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
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
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-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

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-Subparagraph (b)
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-SubTopic 10
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-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

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-Topic 740
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-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Net Loss per Share

9 Months Ended

Sep. 30, 2024

Net Loss per Share

Net Loss per Share

8. Net Loss per Share

Basic and diluted net loss per share is summarized in the following table:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands, except for share and per share data)	2024		2023		2024		2023
Numerator:
Net loss	$	(7,586)	$	(29,261)	$	(35,513)	$	(86,990)
Denominator:
Weighted average shares of common stock outstanding, basic and diluted		71,381,731		70,807,934		71,249,813		69,452,495
Net loss per share, basic and diluted	$	(0.11)	$	(0.41)	$	(0.50)	$	(1.25)

The Company’s potentially dilutive securities, which included stock options and RSUs, have been excluded from the computation of diluted net loss per share since the effect would be to reduce the net loss per share. Therefore, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following table presents potential shares of common stock excluded from the calculation of diluted net loss per share for the nine months ended September 30, 2024 and 2023. All share amounts presented in the table below represent the total number outstanding as of September 30, 2024 and 2023.



	September 30,
	2024	2023
Options to purchase common stock	6,445,232	7,122,455
Restricted stock unit awards	3,071,776	1,707,190
Total potential shares of common stock	9,517,008	8,829,645

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (7,586)	$ (10,986)	$ (16,941)	$ (29,261)	$ (29,569)	$ (28,160)	$ (35,513)	$ (86,990)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

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+ Details

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands	3 Months Ended
	Jun. 30, 2023 USD ($)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
Offering costs netted against proceeds	$ 826

Sale of Future Royalties (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended	9 Months Ended
Sale of Future Royalties (Details) - USD ($) $ in Thousands	Jul. 31, 2024	Sep. 30, 2024	Sep. 30, 2024	Jun. 30, 2024	Dec. 31, 2023
Agreements Related to Intellectual Property
Accounts receivable, net		$ 343	$ 343		$ 298
Non-cash royalty income		894	894
Deferred income		3,765	3,765
Deferred income, net of current portion		21,182	21,182
Non-cash royalty
Agreements Related to Intellectual Property
Accounts receivable, net				$ 700
Deferred income related to the sale of future royalties				$ 25,800
Deferred income		3,800	3,800
Deferred income, net of current portion		21,200	21,200
OMERS \| Royalty purchase agreement
Agreements Related to Intellectual Property
Proceeds from upfront payment	$ 26,500
Additional amount receivable on achievement of sales milestones	$ 5,000
Non-cash royalty income		$ 900	$ 900
Eli Lilly and Company \| Patent License Agreement \| OMERS
Agreements Related to Intellectual Property
Percentage of remaining anniversary milestone payments payable acquired	100.00%

Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Numerator:
Net loss	$ (7,586)	$ (10,986)	$ (16,941)	$ (29,261)	$ (29,569)	$ (28,160)	$ (35,513)	$ (86,990)
Denominator:
Weighted average shares of common stock outstanding, basic	71,381,731			70,807,934			71,249,813	69,452,495
Weighted average shares of common stock outstanding, diluted	71,381,731			70,807,934			71,249,813	69,452,495
Net loss per share, basic	$ (0.11)			$ (0.41)			$ (0.50)	$ (1.25)
Net loss per share, diluted	$ (0.11)			$ (0.41)			$ (0.50)	$ (1.25)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
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-URI https://asc.fasb.org//1943274/2147483443/250-10-50-3

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+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

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+ Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Fair Value of Financial Assets and Liabilities - By Type of Security (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Marketable securities:
Book Value	$ 125,357	$ 142,108
Gross Unrealized Gain	509	160
Gross Unrealized Loss	(81)	(269)
Fair Value	125,785	141,999
Corporate debt securities
Marketable securities:
Book Value	73,258	52,362
Gross Unrealized Gain	414	65
Gross Unrealized Loss	(36)	(142)
Fair Value	73,636	52,285
Debt securities, maturity dates between one and five years	$ 40,500	$ 28,000
Corporate debt securities \| Minimum
Marketable securities:
Marketable securities maturity period	1 year	1 year
Corporate debt securities \| Maximum
Marketable securities:
Marketable securities maturity period	2 years	2 years
Commercial paper
Marketable securities:
Book Value		$ 12,345
Gross Unrealized Gain		2
Gross Unrealized Loss		(1)
Fair Value		12,346
Asset-backed debt securities
Marketable securities:
Book Value	$ 4,981	10,953
Gross Unrealized Gain		42
Gross Unrealized Loss	(3)	(30)
Fair Value	4,978	10,965
Debt securities, maturity dates between one and five years		$ 6,200
Asset-backed debt securities \| Minimum
Marketable securities:
Marketable securities maturity period		1 year
Asset-backed debt securities \| Maximum
Marketable securities:
Marketable securities maturity period		3 years
Foreign government agency debt securities
Marketable securities:
Book Value	4,872	$ 4,698
Gross Unrealized Gain	32	43
Fair Value	4,904	4,741
Debt securities, maturity dates between one and five years		$ 4,700
Foreign government agency debt securities \| Minimum
Marketable securities:
Marketable securities maturity period		1 year
Foreign government agency debt securities \| Maximum
Marketable securities:
Marketable securities maturity period		2 years
U.S. government and government agency debt securities
Marketable securities:
Book Value	42,246	$ 61,750
Gross Unrealized Gain	63	8
Gross Unrealized Loss	(42)	(96)
Fair Value	42,267	61,662
Debt securities, maturity dates between one and five years	$ 5,100	$ 23,900
U.S. government and government agency debt securities \| Minimum
Marketable securities:
Marketable securities maturity period	1 year	1 year
U.S. government and government agency debt securities \| Maximum
Marketable securities:
Marketable securities maturity period	2 years	2 years

Organization and Nature of Business (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Organization and Nature of Business
Cash, cash equivalents and marketable securities	$ 173,400
Accumulated deficit	$ 806,309	$ 770,796

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 47,651	$ 39,878
Short-term marketable securities	80,071	79,228
Accounts receivable, net	343	298
Prepaid expenses and other current assets	4,265	9,452
Total current assets	132,330	128,856
Marketable securities	45,714	62,771
Property and equipment, net	1,133	1,620
Other assets	3,217	4,158
Total assets	182,394	197,405
Current liabilities:
Accounts payable	7,662	8,878
Accrued expenses	4,722	19,446
Deferred income	3,765
Other current liabilities	2,667	2,628
Total current liabilities	18,816	30,952
Other liabilities	2,245	3,074
Deferred income, net of current portion	21,182
Contingent consideration	10,000	6,200
Total liabilities	52,243	40,226
Stockholders' Equity:
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at September 30, 2024 and December 31, 2023
Common stock, $0.00001 par value; 200,000,000 shares authorized at September 30, 2024 and December 31, 2023; 71,417,513 and 70,894,889 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	1	1
Additional paid-in capital	936,032	928,080
Accumulated other comprehensive income (loss)	427	(106)
Accumulated deficit	(806,309)	(770,796)
Total stockholders' equity	130,151	157,179
Total liabilities and stockholders' equity	$ 182,394	$ 197,405

Stock-Based Awards - RSUs (Details) - Restricted stock unit awards $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares
RSU, Number of Units
Units outstanding, beginning of the year \| shares	1,521,940
Granted \| shares	2,648,642
Vested \| shares	(542,846)
Forfeited and cancelled \| shares	(555,960)
Units outstanding, end of the year \| shares	3,071,776
RSU, Weighted Average Grant Date Fair Value Per Unit
Weighted average grant date fair value, beginning balance (in dollars per share) \| $ / shares	$ 15.72
Weighted average grant date fair value, granted (in dollars per share) \| $ / shares	1.20
Weighted average grant date fair value, vested (in dollars per share) \| $ / shares	12.43
Weighted average grant date fair value, forfeited and cancelled (in dollars per share) \| $ / shares	12.54
Weighted average grant date fair value, ending balance (in dollars per share) \| $ / shares	$ 4.37
Aggregate intrinsic value of awards that vested during the period \| $	$ 647

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses
Employee compensation expenses	$ 2,603	$ 3,910
Research and development expenses	124	6,661
Licensing expenses	1,084	5,478
Restructuring expenses (Note 13)	502	3,112
Other expenses	409	285
Total accrued expenses	$ 4,722	$ 19,446

Net Loss per Share - Anti-dilution (Details) - shares	9 Months Ended
Net Loss per Share - Anti-dilution (Details) - shares	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders	9,517,008	8,829,645
Options to purchase common stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders	6,445,232	7,122,455
Restricted stock unit awards
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders	3,071,776	1,707,190

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Accrued Expenses

5. Accrued Expenses

Accrued expenses consisted of the following:


	September 30,		December 31,
(In thousands)	2024		2023
Employee compensation expenses	$	2,603	$	3,910
Research and development expenses		124		6,661
Licensing expenses		1,084		5,478
Restructuring expenses (Note 13)		502		3,112
Other expenses		409		285
Total accrued expenses	$	4,722	$	19,446

Segment Information (Details) $ in Thousands	3 Months Ended		9 Months Ended
Segment Information (Details) $ in Thousands	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) segment	Sep. 30, 2023 USD ($)
Segment Information
Number of reportable segments \| segment			2
Total revenue	$ 4,346	$ 9,282	$ 9,509	$ 13,679
Cost of revenue	654	848	1,870	2,698
Research and development	5,924	23,876	22,910	71,738
General and administrative	5,653	7,091	16,217	24,198
Licensing	1,754	7,344	4,070	8,955
Revaluation of contingent consideration	800	1,700	3,800	(600)
Restructuring expense	32		2,899
Loss from operations	(10,471)	(31,577)	(42,257)	(93,310)
Therapeutics Segment
Segment Information
Total revenue	3,701	8,577	7,583	11,210
Contract Research Segment
Segment Information
Total revenue	645	705	1,926	2,469
Operating Segments \| Therapeutics Segment
Segment Information
Research and development	6,129	24,110	23,555	72,490
Licensing	1,754	7,344	4,070	8,955
Revaluation of contingent consideration	800	1,700	3,800	(600)
Restructuring expense	32		1,650
Loss from operations	(5,014)	(24,577)	(25,492)	(69,635)
Operating Segments \| Contract Research Segment
Segment Information
Total revenue	3,035	4,112	10,122	12,122
Cost of revenue	3,485	4,726	11,346	14,068
General and administrative	905	1,174	3,033	3,490
Restructuring expense			217
Loss from operations	(710)	(1,083)	(2,548)	(2,967)
Corporate and Other
Segment Information
Total revenue	(3,035)	(4,112)	(10,122)	(12,122)
Cost of revenue	(2,831)	(3,878)	(9,476)	(11,370)
Research and development	(205)	(234)	(645)	(752)
General and administrative	4,748	5,917	13,184	20,708
Restructuring expense			1,032
Loss from operations	$ (4,747)	$ (5,917)	$ (14,217)	$ (20,708)

Fair Value of Financial Assets and Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Assets and Liabilities

Schedule of assets and liabilities measured at fair value on a recurring and non-recurring basis


	September 30, 2024
(In thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents	$	45,450	$	—	$	—	$	45,450
Marketable securities		—		125,785		—		125,785
Total assets	$	45,450	$	125,785	$	—	$	171,235


Liabilities:
Contingent consideration	$	—	$	—	$	10,000	$	10,000
Total liabilities	$	—	$	—	$	10,000	$	10,000


	December 31, 2023
(In thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents	$	32,177	$	—	$	—	$	32,177
Marketable securities		—		141,999		—		141,999
Total assets	$	32,177	$	141,999	$	—	$	174,176


Liabilities:
Contingent consideration	$	—	$	—	$	6,200	$	6,200
Total liabilities	$	—	$	—	$	6,200	$	6,200

Schedule of the fair value of available for sale marketable securities


	September 30, 2024
			Gross		Gross
	Book		Unrealized		Unrealized		Fair
(In thousands)	Value		Gain		Loss		Value
Marketable securities:
Corporate debt securities⁽¹⁾	$	73,258	$	414	$	(36)	$	73,636
Asset-backed debt securities		4,981		—		(3)		4,978
Foreign government agency debt securities		4,872		32		—		4,904
U.S. government and government agency debt securities⁽²⁾		42,246		63		(42)		42,267
Total marketable securities	$	125,357	$	509	$	(81)	$	125,785
⁽¹⁾ Included in Corporate debt securities is $40.5 million with maturity dates between one and two years.
⁽²⁾ Included in U.S. government and government agency debt securities is $5.1 million with maturity dates between one and two years.


	December 31, 2023
			Gross		Gross
	Book		Unrealized		Unrealized		Fair
(In thousands)	Value		Gain		Loss		Value
Marketable securities:
Corporate debt securities⁽¹⁾	$	52,362	$	65	$	(142)	$	52,285
Commercial paper		12,345		2		(1)		12,346
Asset-backed debt securities⁽²⁾		10,953		42		(30)		10,965
Foreign government agency debt securities⁽³⁾		4,698		43		—		4,741
U.S. government and government agency debt securities⁽⁴⁾		61,750		8		(96)		61,662
Total marketable securities	$	142,108	$	160	$	(269)	$	141,999
⁽¹⁾ Included in Corporate debt securities is $28.0 million with maturity dates between one and two years.
⁽²⁾ Included in Asset-backed debt securities is $6.2 million with maturity dates between one and three years.
⁽³⁾ Included in Foreign government agency debt securities is $4.7 million with a maturity date between one and two years.
⁽⁴⁾ Included in U.S. government and government agency debt securities is $23.9 million with maturity dates between one and two years.

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-9

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

Reference 12: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

+ Details

Stockholders' Equity (Details) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($) Vote $ / shares shares	Dec. 31, 2023 $ / shares shares
Stockholders' Equity
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, par value (in dollars per share) \| $ / shares	$ 0.00001	$ 0.00001
Common stock, shares issued (in shares)	71,417,513	70,894,889
Common stock, shares outstanding (in shares)	71,417,513	70,894,889
Number of votes per share \| Vote	1
Dividends declared \| $	$ 0

Stockholders' Equity - Other Offerings and ATM Facility (Details) - At The Market Offering - Silicon Valley Bank Securities LLC and Cantor Fitzgerald & Co. shares in Millions, $ in Millions	1 Months Ended
	Apr. 30, 2023 USD ($) shares
Subsidiary, Sale of Stock [Line Items]
Common stock, sold \| shares	3.4
Aggregate gross proceeds	$ 27.5
Payments of stock offering costs	$ 0.8

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (35,513)	$ (86,990)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	664	635
Stock-based compensation expense	7,996	19,276
Revaluation of contingent consideration	3,800	(600)
Changes in operating assets and liabilities:
Accounts receivable	(45)	138
Prepaid expenses and other assets	3,744	(9,293)
Accounts payable	(1,216)	(1,079)
Accrued expenses and other liabilities	(15,514)	6,349
Deferred income	24,947
Net cash used in operating activities	(11,137)	(71,564)
Cash flows from investing activities:
Purchases of property and equipment, net	(121)	(868)
Purchases of marketable securities	(49,555)	(135,675)
Proceeds from sales and maturities of marketable securities	68,630	175,213
Net cash provided by investing activities	18,954	38,670
Cash flows from financing activities:
Proceeds from issuance of common stock under the at-the-market sales agreement, net of issuance costs		26,714
Payments of employee withholding taxes related to restricted stock unit award vesting	(76)	(102)
Proceeds from exercise of employee stock options and the issuance of stock	32	45
Net cash (used in) provided by financing activities	(44)	26,657
Net increase (decrease) in cash and cash equivalents	7,773	(6,237)
Cash and cash equivalents at beginning of period	39,878	45,277
Cash and cash equivalents at end of period	$ 47,651	39,040
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable		$ 376

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Summary of Significant Accounting Policies
Unaudited Interim Financial Information	Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated statement of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 27, 2024 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, its changes in stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. The condensed consolidated balance sheet data as of December 31, 2023 was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States (“GAAP”). The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are unaudited. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024.
Basis of Presentation	Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. The condensed consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Based upon the nature and size of the Company’s revenue, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the condensed consolidated statement of operations.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require an update to its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from the Company’s estimates.
Reclassifications	Reclassifications Certain prior year amounts have been reclassified to conform to the current year’s financial statement presentation.
Significant Accounting Policies	Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024. There have been no changes to the Company’s existing significant accounting policies from those disclosed in the annual report.
Contingent Consideration	Contingent Consideration The Company records a contingent consideration liability related to future potential payments resulting from the acquisition of Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) based upon significant unobservable inputs including the achievement of regulatory and commercial milestones, as well as estimated future sales levels and the discount rates applied to calculate the present value of the potential payments. Significant judgement is involved in determining the appropriateness of these assumptions. These assumptions are considered Level 3 inputs. Revaluation of the contingent consideration liability can result from changes to one or more of these assumptions. The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, recorded as income or expense in the condensed consolidated statement of operations. The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in the Company’s estimates include the probability of achieving regulatory milestones and commencing commercialization, which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success assumptions ranged between 17% and 40% at September 30, 2024. Additionally, estimated future sales levels and the risk-adjusted discount rate applied to the potential payments are also significant assumptions used in calculating the fair value. The discount rate ranged between 6.6% and 7.9% depending on the year of each potential payment.
Revenue Recognition	Revenue Recognition The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable. Contract Research Revenue The Company earns contract research revenue from the provision of laboratory services. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered. Revenue related to these contracts is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, the Company elected to apply the “right to invoice” practical expedient when recognizing contract research revenue and as such, recognizes revenue in the amount which it has the right to invoice. ASC Topic 606 also provides an optional exemption, which the Company has elected to apply, from disclosing remaining performance obligations when revenue is recognized from the satisfaction of the performance obligation in accordance with the “right to invoice” practical expedient. Licensing Revenue Licenses of Intellectual Property – The Company recognizes revenue received from non-refundable, upfront fees related to the licensing of intellectual property when the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the license has been transferred to the customer, and the customer is able to use and benefit from the license. Milestone and Royalty Payments – The Company considers any future potential milestones and sales-based royalties to be variable consideration. The Company recognizes revenue from development, regulatory and anniversary milestone payments as they are achieved. The Company recognizes revenue from commercial milestones and royalty payments as the sales occur.
Deferred Income Related to the Sale of Future Royalties	Deferred Income Related to the Sale of Future Royalties The Company amortizes its deferred income liability related to the sale of future OLUMIANT® (baricitinib) royalties under the units-of-revenue method by computing a ratio of the proceeds received to the total expected payments over the term of the royalty purchase agreement and then applying that ratio to the period’s estimated cash payment (see Note 11). The amortization is based on the Company’s current estimate of future royalty payments.
Discontinued Operations	Discontinued Operations As of September 30, 2024 and December 31, 2023, the Company had $2.2 million in discontinued operations reported as other current liabilities in the Company’s consolidated balance sheet, related to discontinued commercial products.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the impact of this ASU and upon adoption expects that any impact would be limited to additional segment expense disclosures in the footnotes to the Company’s consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective January 1, 2025. The Company is currently assessing the impact of this ASU.

Sale of Future Royalties

9 Months Ended

Sep. 30, 2024

Sale of Future Royalties

Sale of Future Royalties

11. Sale of Future Royalties

In July 2024, the Company entered into a royalty purchase agreement with OMERS. Under the royalty purchase agreement, the Company sold to OMERS a portion of the Company’s future royalty payments and the remaining anniversary milestones associated with the Company’s existing license to Lilly relating to OLUMIANT® (baricitinib) for the treatment of alopecia areata.

Under the terms of the royalty purchase agreement, the Company received an upfront payment of $26.5 million and is eligible to receive up to an additional $5.0 million based on the achievement of certain sales milestones for OLUMIANT in 2024. In exchange for these payments, OMERS acquired a portion of the royalty payable by Lilly to the Company for worldwide net sales of OLUMIANT for the treatment of alopecia areata from April 1, 2024 through the remainder of the royalty term under the Company’s license agreement with Lilly, and 100% of the remaining anniversary milestone payments payable by Lilly to the Company under the license agreement.

The Company evaluated the arrangement and concluded that the proceeds from the sale of future royalties should be recorded as deferred income on the condensed consolidated balance sheet, as the criteria for debt classification were not met in accordance with ASC Topic 470. In particular, the Company does not have significant continuing involvement in the generation of the cash flows due to OMERS and there are no guaranteed rates of return to OMERS. The Company recognizes non-cash royalty income under the “units-of-revenue” method in the condensed consolidated statements of operations and comprehensive loss. The Company initially recorded $0.7 million as a receivable for royalties earned in the second quarter of 2024 and recorded $25.8 million as deferred income related to the sale of future royalties. For each of the three and nine months ended September 30, 2024, the Company recognized $0.9 million of non-cash royalty income. As of September 30, 2024, the current and non-current portions of the remaining deferred income recognized under the units-of-revenue method were $3.8 million and $21.2 million, respectively.

Stock-Based Awards (Tables)

9 Months Ended

Sep. 30, 2024

Stock-Based Awards

Summary of assumptions used to determine fair value of stock options granted


	Nine Months Ended
	September 30,
	2024		2023
Risk-free interest rate	3.85	%	3.53	%
Expected term (in years)	6.0		6.2
Expected volatility	81.95	%	77.73	%
Expected dividend yield	0	%	0	%

Summary of stock option activity


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number	Exercise		Contractual	Intrinsic
(In thousands, except share and per share data and years)	of Shares	Price		Term	Value
				(in years)
Outstanding as of December 31, 2023	6,419,455	$	15.94	7.1	$	14
Granted	1,982,700		1.19
Exercised	(43,548)		0.72			19
Forfeited and cancelled	(1,913,375)		14.82
Outstanding as of September 30, 2024	6,445,232	$	11.85	6.9	$	13
Options vested and expected to vest as of September 30, 2024	6,445,232	$	11.85	6.9	$	13
Options exercisable as of September 30, 2024	3,512,137	$	15.40	5.4	$	3

Summary of restricted stock units activity


		Weighted
		Average
		Grant Date		Aggregate
	Number	Fair Value		Intrinsic
(In thousands, except share and per share data)	of Shares	Per Share		Value
Outstanding as of December 31, 2023	1,521,940	$	15.72
Granted	2,648,642		1.20
Vested	(542,846)		12.43	$	647
Forfeited and cancelled	(555,960)		12.54
Outstanding as of September 30, 2024	3,071,776	$	4.37

Summary of stock-based compensation expense


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(In thousands)	2024		2023		2024		2023
Cost of revenue	$	232	$	347	$	707	$	1,119
Research and development		1,124		3,072		2,192		9,168
General and administrative		1,648		2,529		5,097		8,989
Total stock-based compensation expense	$	3,004	$	5,948	$	7,996	$	19,276

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Unrealized gain (loss) on marketable securities, tax	$ 0	$ 0	$ 0	$ 0

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated statement of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 27, 2024 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, its changes in stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. The condensed consolidated balance sheet data as of December 31, 2023 was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States (“GAAP”). The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are unaudited. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024.

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. The condensed consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Based upon the nature and size of the Company’s revenue, the Company believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the condensed consolidated statement of operations.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require an update to its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from the Company’s estimates.

Reclassifications

Certain prior year amounts have been reclassified to conform to the current year’s financial statement presentation.

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024. There have been no changes to the Company’s existing significant accounting policies from those disclosed in the annual report.

Contingent Consideration

The Company records a contingent consideration liability related to future potential payments resulting from the acquisition of Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) based upon significant unobservable inputs including the achievement of regulatory and commercial milestones, as well as estimated future sales levels and the discount rates applied to calculate the present value of the potential payments. Significant judgement is involved in determining the appropriateness of these assumptions. These assumptions are considered Level 3 inputs. Revaluation of the contingent consideration liability can result from changes to one or more of these assumptions. The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, recorded as income or expense in the condensed consolidated statement of operations.

The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in the Company’s estimates include the probability of achieving regulatory milestones and commencing commercialization, which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success assumptions ranged between 17% and 40% at September 30, 2024. Additionally, estimated future sales levels and the risk-adjusted discount rate applied to the potential payments are also significant assumptions used in calculating the fair value. The discount rate ranged between 6.6% and 7.9% depending on the year of each potential payment.

Revenue Recognition

The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.

To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable.

Contract Research Revenue

The Company earns contract research revenue from the provision of laboratory services. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered. Revenue related to these contracts is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, the Company elected to apply the “right to invoice” practical expedient when recognizing contract research revenue and as such, recognizes revenue in the amount which it has the right to invoice. ASC Topic 606 also provides an optional exemption, which the Company has elected to apply, from disclosing remaining performance obligations when revenue is

recognized from the satisfaction of the performance obligation in accordance with the “right to invoice” practical expedient.

Licensing Revenue

Licenses of Intellectual Property – The Company recognizes revenue received from non-refundable, upfront fees related to the licensing of intellectual property when the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the license has been transferred to the customer, and the customer is able to use and benefit from the license.

Milestone and Royalty Payments – The Company considers any future potential milestones and sales-based royalties to be variable consideration. The Company recognizes revenue from development, regulatory and anniversary milestone payments as they are achieved. The Company recognizes revenue from commercial milestones and royalty payments as the sales occur.

Deferred Income Related to the Sale of Future Royalties

The Company amortizes its deferred income liability related to the sale of future OLUMIANT® (baricitinib) royalties under the units-of-revenue method by computing a ratio of the proceeds received to the total expected payments over the term of the royalty purchase agreement and then applying that ratio to the period’s estimated cash payment (see Note 11). The amortization is based on the Company’s current estimate of future royalty payments.

Discontinued Operations

As of September 30, 2024 and December 31, 2023, the Company had $2.2 million in discontinued operations reported as other current liabilities in the Company’s consolidated balance sheet, related to discontinued commercial products.

Recently Issued Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the impact of this ASU and upon adoption expects that any impact would be limited to additional segment expense disclosures in the footnotes to the Company’s consolidated financial statements.

In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective January 1, 2025. The Company is currently assessing the impact of this ASU.

Leases

9 Months Ended

Sep. 30, 2024

Leases

Leases

9. Leases

Operating Leases

Agreements for Office and Laboratory Space

The Company had a sublease agreement pursuant to which it subleased 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania, which expired on October 31, 2023.

In May 2023, the Company entered into a new lease agreement pursuant to which it leases 11,564 square feet of office space for its headquarters in Wayne, Pennsylvania. The lease commenced on November 1, 2023 and has a term that runs through February 2029.

In February 2019, the Company entered into a sublease agreement for 20,433 square feet of office and laboratory space in St. Louis, Missouri. The lease commenced in June 2019 and has a term that runs through May 2029. In January 2023, the Company amended the sublease agreement to add an additional 6,261 square feet of office and laboratory space effective February 2023. The Company exercised its option to terminate the leasing of the additional space effective as of June 30, 2024.

Supplemental balance sheet information related to operating leases is as follows:


	September 30,		December 31,
(In thousands)	2024		2023
Operating Leases:
Gross cost	$	4,530	$	5,094
Accumulated amortization		(1,556)		(1,235)
Other assets	$	2,974	$	3,859

Current portion of lease liabilities	$	465	$	426
Other liabilities		2,245		3,074
Total operating lease liabilities	$	2,710	$	3,500

Amortization expense related to operating lease right-of-use assets and accretion of operating lease liabilities totaled $0.1 million and $0.2 million for the three months ended September 30, 2024 and 2023, respectively, and $0.4 million and $0.7 million for the nine months ended September 30, 2024 and 2023, respectively.

Fair Value of Financial Assets and Liabilities

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Assets and Liabilities

Fair Value of Financial Assets and Liabilities

3. Fair Value of Financial Assets and Liabilities

The following tables present information about the fair value measurements of the Company’s financial assets and liabilities which are measured at fair value on a recurring and non-recurring basis, and indicate the level of the fair value hierarchy utilized to determine such fair values:


	September 30, 2024
(In thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents	$	45,450	$	—	$	—	$	45,450
Marketable securities		—		125,785		—		125,785
Total assets	$	45,450	$	125,785	$	—	$	171,235


Liabilities:
Contingent consideration	$	—	$	—	$	10,000	$	10,000
Total liabilities	$	—	$	—	$	10,000	$	10,000


	December 31, 2023
(In thousands)	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents	$	32,177	$	—	$	—	$	32,177
Marketable securities		—		141,999		—		141,999
Total assets	$	32,177	$	141,999	$	—	$	174,176


Liabilities:
Contingent consideration	$	—	$	—	$	6,200	$	6,200
Total liabilities	$	—	$	—	$	6,200	$	6,200

As of September 30, 2024 and December 31, 2023, the Company’s cash equivalents consisted of money market funds, which were valued based upon Level 1 inputs. The Company’s marketable securities as of September 30, 2024 consisted of corporate debt, asset-backed debt, foreign government agency debt, and U.S. government and government agency debt securities, which were all valued based upon Level 2 inputs. The Company’s marketable securities as of December 31, 2023 consisted of commercial paper and corporate debt, asset-backed debt, foreign government agency debt, and U.S. government and government agency debt securities, which were all valued based upon Level 2 inputs.

In determining the fair value of its Level 2 investments, the Company relies on quoted prices for identical securities in markets that are not active. These quoted prices are obtained by the Company with the assistance of a third party pricing service based on available trade, bid and other observable market data for identical securities. During the three and nine months ended September 30, 2024 and 2023, there were no transfers into or out of Level 3.

The overall $3.8 million increase in the fair value of the contingent consideration liability during the nine months ended September 30, 2024 was primarily due to changes in estimated sales levels, changes to the probability of success for certain drug candidates, and the passage of time.

As of September 30, 2024 and December 31, 2023, the fair value of the Company’s available-for-sale marketable securities by type of security was as follows:


	September 30, 2024
			Gross		Gross
	Book		Unrealized		Unrealized		Fair
(In thousands)	Value		Gain		Loss		Value
Marketable securities:
Corporate debt securities⁽¹⁾	$	73,258	$	414	$	(36)	$	73,636
Asset-backed debt securities		4,981		—		(3)		4,978
Foreign government agency debt securities		4,872		32		—		4,904
U.S. government and government agency debt securities⁽²⁾		42,246		63		(42)		42,267
Total marketable securities	$	125,357	$	509	$	(81)	$	125,785
⁽¹⁾ Included in Corporate debt securities is $40.5 million with maturity dates between one and two years.
⁽²⁾ Included in U.S. government and government agency debt securities is $5.1 million with maturity dates between one and two years.


	December 31, 2023
			Gross		Gross
	Book		Unrealized		Unrealized		Fair
(In thousands)	Value		Gain		Loss		Value
Marketable securities:
Corporate debt securities⁽¹⁾	$	52,362	$	65	$	(142)	$	52,285
Commercial paper		12,345		2		(1)		12,346
Asset-backed debt securities⁽²⁾		10,953		42		(30)		10,965
Foreign government agency debt securities⁽³⁾		4,698		43		—		4,741
U.S. government and government agency debt securities⁽⁴⁾		61,750		8		(96)		61,662
Total marketable securities	$	142,108	$	160	$	(269)	$	141,999
⁽¹⁾ Included in Corporate debt securities is $28.0 million with maturity dates between one and two years.
⁽²⁾ Included in Asset-backed debt securities is $6.2 million with maturity dates between one and three years.
⁽³⁾ Included in Foreign government agency debt securities is $4.7 million with a maturity date between one and two years.
⁽⁴⁾ Included in U.S. government and government agency debt securities is $23.9 million with maturity dates between one and two years.

- 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.

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