Item 1. Financial Statements
Item 1. Financial Statements
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET S
(Unaudited)
(In thousands, except share and per share data)
March 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
30,357
$
24,570
Short-term marketable securities
74,957
89,024
Accounts receivable, net
250
318
Prepaid expenses and other current assets
3,226
12,039
Total current assets
108,790
125,951
Marketable securities
85,211
90,302
Property and equipment, net
942
1,008
Other assets
3,151
3,066
Total assets
$
198,094
$
220,327
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
6,354
$
4,690
Accrued expenses
8,572
20,333
Deferred income
3,888
3,890
Other current liabilities
2,700
2,683
Total current liabilities
21,514
31,596
Other liabilities
4,308
4,439
Deferred income, net of current portion
19,206
20,038
Contingent consideration
9,000
8,700
Total liabilities
54,028
64,773
Stockholders’ Equity:
Preferred stock, $ 0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at March 31, 2025 and December 31, 2024
—
—
Common stock, $ 0.00001 par value; 200,000,000 shares authorized at March 31, 2025 and December 31, 2024; 108,265,529 and 107,850,124 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively
1
1
Additional paid‑in capital
1,061,577
1,058,317
Accumulated other comprehensive income
434
97
Accumulated deficit
( 917,946 )
( 902,861 )
Total stockholders’ equity
144,066
155,554
Total liabilities and stockholders’ equity
$
198,094
$
220,327
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended
March 31,
2025
2024
Revenues:
Contract research
$
445
$
657
Licensing
1,010
1,741
Total revenue
1,455
2,398
Costs and expenses:
Cost of revenue
506
809
Research and development
11,584
9,845
General and administrative
6,139
6,844
Licensing
1,010
1,031
Revaluation of contingent consideration
300
2,800
Total costs and expenses
19,539
21,329
Loss from operations
( 18,084 )
( 18,931 )
Other income:
Interest income
2,166
1,990
Non-cash royalty income
833
—
Total other income
2,999
1,990
Net loss
$
( 15,085 )
$
( 16,941 )
Net loss per share, basic and diluted
$
( 0.12 )
$
( 0.24 )
Weighted average common shares outstanding, basic and diluted
122,390,303
71,074,858
Other comprehensive income:
Unrealized gain (loss) on marketable securities, net of tax of $ 0
$
337
$
( 258 )
Total other comprehensive income (loss)
337
( 258 )
Comprehensive loss
$
( 14,748 )
$
( 17,199 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share data)
Accumulated
Common Stock
Additional
Other
Total
Par
Paid ‑ in
Comprehensive
Accumulated
Stockholders’
Shares
Value
Capital
Income
Deficit
Equity
Balance at December 31, 2024
107,850,124
$
1
$
1,058,317
97
( 902,861 )
$
155,554
Issuance of common stock in connection with vesting of restricted stock units
415,405
—
( 275 )
—
—
( 275 )
Unrealized gain on marketable securities
—
—
—
337
—
337
Stock-based compensation expense
—
—
3,535
—
—
3,535
Net loss
—
—
—
—
( 15,085 )
( 15,085 )
Balance at March 31, 2025
108,265,529
$
1
$
1,061,577
$
434
$
( 917,946 )
$
144,066
Accumulated
Common Stock
Additional
Other
Total
Par
Paid ‑ in
Comprehensive
Accumulated
Stockholders’
Shares
Value
Capital
Loss
Deficit
Equity
Balance at December 31, 2023
70,894,889
$
1
$
928,080
$
( 106 )
$
( 770,796 )
$
157,179
Issuance of common stock in connection with vesting of restricted stock units
353,128
—
( 55 )
—
—
( 55 )
Unrealized loss on marketable securities
—
—
—
( 258 )
—
( 258 )
Stock-based compensation expense
—
—
2,089
—
—
2,089
Net loss
—
—
—
—
( 16,941 )
( 16,941 )
Balance at March 31, 2024
71,248,017
$
1
$
930,114
$
( 364 )
$
( 787,737 )
$
142,014
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Three Months Ended
March 31,
2025
2024
Cash flows from operating activities :
Net loss
$
( 15,085 )
$
( 16,941 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
128
243
Stock-based compensation expense
3,535
2,089
Revaluation of contingent consideration
300
2,800
Changes in operating assets and liabilities:
Accounts receivable
68
( 75 )
Prepaid expenses and other assets
8,208
2,044
Accounts payable
1,664
1,932
Accrued expenses and other liabilities
( 11,042 )
( 12,907 )
Deferred income
( 833 )
—
Net cash used in operating activities
( 13,057 )
( 20,815 )
Cash flows from investing activities:
Purchases of property and equipment
( 43 )
( 135 )
Purchases of marketable securities
( 9,996 )
—
Proceeds from sales and maturities of marketable securities
29,991
16,968
Payment of deferred transaction consideration for in-licensed assets
( 833 )
—
Net cash provided by investing activities
19,119
16,833
Cash flows from financing activities:
Payments of employee withholding taxes related to restricted stock unit award vesting
( 275 )
( 55 )
Net cash used in financing activities
( 275 )
( 55 )
Net increase (decrease) in cash and cash equivalents
5,787
( 4,037 )
Cash and cash equivalents at beginning of period
24,570
39,878
Cash and cash equivalents at end of period
$
30,357
$
35,841
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 small and large molecule product 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 product candidates that it may develop independently or in collaboration with third parties. In addition to identifying and developing its novel product 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 product 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 March 31, 2025, the Company had cash, cash equivalents and marketable securities of $ 190.5 million and an accumulated deficit of $ 917.9 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 product candidates, will require significant additional financing. The future viability of the Company is dependent on its ability to successfully develop its product 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 product 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, inflationary pressures and tariff policies. 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 product 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.
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2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information
The accompanying condensed consolidated balance sheet as of March 31, 2025, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, the condensed consolidated statement of stockholders’ equity for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 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, 2025 (“Annual Report”) 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 March 31, 2025, the results of its operations and comprehensive loss for the three months ended March 31, 2025 and 2024, its changes in stockholders’ equity for the three months ended March 31, 2025 and 2024 and its cash flows for the three months ended March 31, 2025 and 2024. The condensed consolidated balance sheet data as of December 31, 2024 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 months ended March 31, 2025 and 2024 are unaudited. The results for the three months ended March 31, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, 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, 2024 included in the Company’s Annual Report.
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 and comprehensive loss.
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 revision to 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.
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Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2024 included in the Company’s Annual Report. 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 and comprehensive loss.
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 March 31, 2025. 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 7.3 % and 8.8 % 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.
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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 March 31, 2025 and December 31, 2024, the Company had $ 2.2 million in discontinued operations reported as other current liabilities in the Company’s condensed consolidated balance sheet, related to discontinued commercial products.
Recently Issued Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses.” This standard requires disclosure of additional information about specific expense categories in the notes to financial statements on an annual and interim basis. This ASU becomes effective for annual periods beginning after December 15, 2026 and interim periods within annual reporting periods beginning after December 15, 2027. The Company is currently assessing the impact of this ASU.
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 for annual periods beginning after December 15, 2024. The Company is currently assessing the impact of this ASU.
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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:
March 31, 2025
(In thousands)
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$
27,447
$
—
$
—
$
27,447
Marketable securities
—
160,168
—
160,168
Total assets
$
27,447
$
160,168
$
—
$
187,615
Liabilities:
Contingent consideration
$
—
$
—
$
9,000
$
9,000
Total liabilities
$
—
$
—
$
9,000
$
9,000
December 31, 2024
(In thousands)
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$
22,245
$
—
$
—
$
22,245
Marketable securities
—
179,326
—
179,326
Total assets
$
22,245
$
179,326
$
—
$
201,571
Liabilities:
Contingent consideration
$
—
$
—
$
8,700
$
8,700
Total liabilities
$
—
$
—
$
8,700
$
8,700
As of March 31, 2025 and December 31, 2024, 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 March 31, 2025 and December 31, 2024 consisted of commercial paper and corporate 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 months ended March 31, 2025 and 2024, there were no transfers into or out of Level 3.
The overall $ 0.3 million increase in the fair value of the contingent consideration liability during the three months ended March 31, 2025 was primarily due to the passage of time.
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As of March 31, 2025 and December 31, 2024, the fair value of the Company’s available-for-sale marketable securities by type of security was as follows:
March 31, 2025
Gross
Gross
Book
Unrealized
Unrealized
Fair
(In thousands)
Value
Gain
Loss
Value
Marketable securities:
Corporate debt securities (1)
$
100,332
$
298
$
( 56 )
$
100,574
Commercial paper
4,774
1
—
4,775
Foreign government agency debt securities
4,977
8
—
4,985
U.S. government and government agency debt securities (2)
49,651
188
( 5 )
49,834
Total marketable securities
$
159,734
$
495
$
( 61 )
$
160,168
(1) Included in Corporate debt securities is $ 49.6 million with maturity dates between one and three years .
(2) Included in U.S. government and government agency debt securities is $ 35.6 million with maturity dates between one and three years .
December 31, 2024
Gross
Gross
Book
Unrealized
Unrealized
Fair
(In thousands)
Value
Gain
Loss
Value
Marketable securities:
Corporate debt securities (1)
$
105,154
$
192
$
( 156 )
$
105,190
Commercial paper
4,720
—
( 1 )
4,719
Foreign government agency debt securities
4,911
16
—
4,927
U.S. government and government agency debt securities (2)
64,454
47
( 11 )
64,490
Total marketable securities
$
179,239
$
255
$
( 168 )
$
179,326
(1) Included in Corporate debt securities is $ 59.8 million with maturity dates between one and three years .
(2) Included in U.S. government and government agency debt securities is $ 30.5 million with maturity dates between one and three years .
4. Property and Equipment, Net
Property and equipment, net consisted of the following:
March 31,
December 31,
(In thousands)
2025
2024
Computer equipment
$
1,241
$
1,198
Lab equipment
3,137
3,137
Furniture and fixtures
661
661
Leasehold improvements
817
817
Property and equipment, gross
5,856
5,813
Accumulated depreciation
( 4,914 )
( 4,805 )
Property and equipment, net
$
942
$
1,008
Depreciation expense was $ 0.1 million and $ 0.2 million for the three months ended March 31, 2025 and 2024, respectively.
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5. Accrued Expenses
Accrued expenses consisted of the following:
March 31,
December 31,
(In thousands)
2025
2024
Employee compensation expenses
$
1,733
$
4,979
Research and development expenses
2,276
2,173
Deferred transaction consideration
3,094
3,927
Licensing expenses
900
8,645
Restructuring expenses (Note 13)
—
163
Other expenses
569
446
Total accrued expenses
$
8,572
$
20,333
6. Stockholders’ Equity
Preferred Stock
As of March 31, 2025 and December 31, 2024, 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 March 31, 2025 or December 31, 2024.
Common Stock
As of March 31, 2025 and December 31, 2024, the Company’s Charter authorized the Company to issue 200,000,000 shares of $ 0.00001 par value common stock. There were 108,265,529 and 107,850,124 shares of common stock issued and outstanding as of March 31, 2025 and December 31, 2024, 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 March 31, 2025.
Warrants
In November 2024, the Company issued warrants to Biosion, Inc. (“Biosion”) and Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (“CTTQ”) to purchase, in the aggregate, 14,281,985 shares of the Company’s common stock (the “Warrants”). The Warrants have an initial exercise price of $ 0.00001 per share, subject to adjustment as provided in the Warrants. The Warrants are immediately exercisable, subject to any applicable overseas direct investment filing that may be required for the holders. The Warrants will terminate when exercised in full. The Company classified the Warrants within equity because they are indexed to the Company’s own stock. The Company assigned an estimated fair value of $ 44.8 million to the Warrants, which was based on the fair value of the Company’s common stock on the date of issuance less the nominal exercise price of $ 0.00001 per share.
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7. Stock-Based Awards
2024 Inducement Plan
In November 2024, the Company’s board of directors adopted the 2024 Inducement Plan (the “2024 Inducement Plan”). The 2024 Inducement Plan is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The only employees eligible to receive grants of awards under the 2024 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq rules, generally including individuals who were not previously an employee or director of the Company. Under the terms of the 2024 Inducement Plan, the Company may grant up to 2,000,000 shares of common stock pursuant to nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit (“RSU”) awards, and other stock awards. The shares of common stock underlying any awards that expire, or are otherwise terminated, settled in cash or repurchased by the Company under the 2024 Inducement Plan will be added back to the shares of common stock available for issuance under the 2024 Inducement Plan. As of March 31, 2025, 939,000 shares remained available for grant under the 2024 Inducement Plan. The Company had 825,000 stock options and 236,000 RSUs outstanding as of March 31, 2025 under the 2024 Inducement Plan.
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, 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 automatically increased on January 1 of each year which ended 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. On January 1, 2025, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 4,314,004 shares. As of March 31, 2025, 4,010,941 shares remained available for grant under the 2015 Plan. The Company had 9,163,298 stock options and 3,174,857 RSUs outstanding as of March 31, 2025 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 343,500 stock options outstanding as of March 31, 2025 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 218,404 stock options outstanding as of March 31, 2025 under the 2012 Plan.
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Stock Option Valuation
The weighted average assumptions the Company used to estimate the fair value of stock options granted during the three months ended March 31, 2025 and 2024 were as follows:
Three Months Ended
March 31,
2025
2024
Risk-free interest rate
4.40
%
3.81
%
Expected term (in years)
6.3
6.0
Expected volatility
83.25
%
81.81
%
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 three months ended March 31, 2025:
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, 2024
6,721,967
$
11.12
6.8
$
2,968
Granted
3,858,735
2.40
Forfeited and cancelled
( 30,500 )
9.68
Outstanding as of March 31, 2025
10,550,202
$
8.00
7.9
$
742
Options vested and expected to vest as of March 31, 2025
10,550,202
$
8.00
7.9
$
742
Options exercisable as of March 31, 2025
4,405,247
$
14.02
5.8
$
372
The weighted average grant date fair value of stock options granted during the three months ended March 31, 2025 was $ 1.78 per share.
Restricted Stock Units
The following table summarizes RSU activity for the three months ended March 31, 2025:
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, 2024
2,276,151
$
5.12
Granted
1,669,609
2.41
Vested
( 525,753 )
8.89
$
1,230
Forfeited and cancelled
( 9,150 )
9.42
Outstanding as of March 31, 2025
3,410,857
$
3.20
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Stock-Based Compensation
Stock-based compensation expense included in total costs and expenses on the condensed consolidated statement of operations and comprehensive loss included the following:
Three Months Ended
March 31,
(In thousands)
2025
2024
Cost of revenue
$
219
$
252
Research and development
1,185
( 29 )
General and administrative
2,131
1,866
Total stock-based compensation expense
$
3,535
$
2,089
As of March 31, 2025, the Company had unrecognized stock-based compensation expense for stock options and RSUs of $ 14.9 million and $ 9.7 million, respectively, which is expected to be recognized over weighted average periods of 2.9 years and 2.5 years, respectively.
8. Net Loss per Share
Basic and diluted net loss per share is summarized in the following table:
Three Months Ended
March 31,
(In thousands, except for share and per share data)
2025
2024
Numerator:
Net loss
$
( 15,085 )
$
( 16,941 )
Denominator:
Weighted average shares of common stock outstanding, basic and diluted
122,390,303
71,074,858
Net loss per share, basic and diluted
$
( 0.12 )
$
( 0.24 )
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. For the three months ended March 31, 2025, the basic and diluted weighted-average shares outstanding included the Warrants, as there were no outstanding contingencies associated with the vesting or exercisability of the Warrants.
The following table presents potential shares of common stock excluded from the calculation of diluted net loss per share for the three months ended March 31, 2025 and 2024. All share amounts presented in the table below represent the total number outstanding as of March 31, 2025 and 2024.
Three Months Ended
March 31,
2025
2024
Options to purchase common stock
10,550,202
6,966,980
Restricted stock units
3,410,857
3,139,539
Total potential shares of common stock
13,961,059
10,106,519
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9. Leases
Operating Leases
Agreements for Office and Laboratory Space
In May 2023, the Company entered into a lease agreement pursuant to which it leases 11,564 square feet of office space for its headquarters in Wayne, Pennsylvania. The lease commenced in November 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:
March 31,
December 31,
(In thousands)
2025
2024
Operating Leases:
Gross cost
$
4,530
$
4,530
Accumulated amortization
( 1,823 )
( 1,688 )
Other assets
$
2,707
$
2,842
Current portion of lease liabilities
$
498
$
481
Other liabilities
1,986
2,117
Total operating lease liabilities
$
2,484
$
2,598
Amortization expense related to operating lease right-of-use assets and accretion of operating lease liabilities totaled $ 0.1 million for each of the three months ended March 31, 2025 and 2024.
10. Agreements Related to Intellectual Property
Exclusive License Agreement – Biosion, Inc.
In November 2024, the Company entered into an exclusive license agreement (the “Biosion Agreement”) with Biosion, pursuant to which it received the exclusive rights to develop, manufacture and commercialize bosakitug (ATI-045) and ATI-052 worldwide, excluding Mainland China, Macau, Hong Kong and Taiwan (“Greater China”). In connection with the Biosion Agreement, the Company also entered into a collaboration agreement (the “CTTQ Agreement”) with Biosion and CTTQ, a licensee of bosakitug in Greater China.
As partial consideration for the rights and licenses under the Biosion Agreement and CTTQ Agreement, the Company, agreed to, in the aggregate, (i) pay $ 30.0 million in upfront cash consideration, plus $ 4.5 million for the reimbursement of certain development costs, (ii) issue the Warrants, and (iii) pay $ 6.2 million for the reimbursement of certain development costs and drug product material as set forth in the Biosion Agreement.
In addition, the Company agreed to pay, in the aggregate, (i) up to $ 125 million upon the achievement of specified regulatory milestones commencing with product approval, (ii) up to $ 795 million upon the achievement of specified sales milestones, (iii) a tiered low-to-mid single digit royalty based upon a percentage of annual net sales, subject to specified reductions as set forth in the Biosion Agreement, and (iv) a portion of any sublicense consideration received from the grant of any sublicense or similar rights under any of the rights or licenses granted to the Company under the Biosion Agreement.
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The Company will expense these payments in the period when either they are determined to be probable of occurring or when the payment is triggered.
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 upfront and regulatory payments, and has agreed to pay the Company other 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.
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 the 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 upfront, anniversary, regulatory and commercial milestone payments. In addition, Lilly has agreed to pay the Company other commercial milestone payments upon the achievement of specified milestones and additional anniversary payments as set forth in the agreement, as well as 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 payments associated with the license to Lilly (see Note 11).
The Company recognized $ 1.0 million of licensing revenue during the three months ended March 31, 2025, all of which was payable to third parties. The Company recognized $ 1.7 million of licensing revenue during the three months ended March 31, 2024, a portion of which was payable to third parties.
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
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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 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 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 March 31, 2025 and December 31, 2024, the balance of the Company’s contingent consideration liability was $ 9.0 million and $ 8.7 million, respectively (see Note 3).
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 payments 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. In exchange, 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. For the three months ended March 31, 2025, the Company recognized $ 0.8 million of non-cash royalty income. As of March 31, 2025, the current and non-current portions of the remaining deferred income recognized under the units-of revenue method were $ 3.9 million and $ 19.2 million, respectively. As of December 31, 2024, the current and non-current portions of the remaining deferred income recognized under the units-of revenue method were $ 3.9 million and $ 20.0 million, respectively.
12. Income Taxes
The Company did no t record a federal or state income tax benefit for losses incurred during the three months ended March 31, 2025 and 2024. 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.
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 completed as of December 31, 2024. During the three months ended March 31, 2025, the
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Company made cash severance payments of $ 0.2 million to impacted employees. During the three months ended March 31, 2024, the Company recognized severance expense of $ 2.5 million and made cash severance payments of $ 3.0 million to impacted employees.
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 condensed consolidated statement of operations and comprehensive loss. All customers and revenue pertaining to the Company’s segments are based in the United States and all assets are held in the United States. The Company does not report asset information by segment because it is not regularly provided to the Company’s chief executive officer, who is the Company’s chief operating decision maker (“CODM”).
Since inception, the Company has incurred net losses and has an accumulated deficit of $ 917.9 million as of March 31, 2025. As such, the CODM uses segment loss from operations for each segment in assessing segment performance by comparing the results of each segment to forecast. All intercompany activity is eliminated in the intersegment elimination column in the tables below.
A reconciliation of operating loss to total consolidated loss before income taxes for the three months ended March 31, 2025 and 2024 is as follows:
(In thousands)
Contract
Intersegment
Three Months Ended March 31, 2025
Therapeutics
Research
Elimination
Total
Revenue from external customers
$
1,010
$
445
$
—
$
1,455
Intercompany revenue
—
3,435
( 3,435 )
—
Cost of revenue
—
3,717
( 3,211 )
506
Research and development:
Bosakitug
3,384
—
—
3,384
ATI-2138
1,808
—
—
1,808
ATI-052
619
—
—
619
Zunsemetinib
111
—
—
111
Discovery
1,346
—
—
1,346
Total Research and development project spend
7,268
—
—
7,268
Personnel
2,927
—
—
2,927
Other research and development expense (1)
1,613
—
—
1,613
Total research and development
11,808
—
( 224 )
11,584
General and administrative
—
900
—
900
Licensing
1,010
—
—
1,010
Revaluation of contingent consideration
300
—
—
300
Segment operating loss
$
( 12,108 )
$
( 737 )
$
—
$
( 12,845 )
Non-segment general and administrative
5,239
Other income
2,999
Loss before income taxes
$
( 15,085 )
(1) Other segment items for the Therapeutics segment consist primarily of the following research and development expenses: stock-based compensation, depreciation and amortization, and regulatory.
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(In thousands)
Contract
Intersegment
Three Months Ended March 31, 2024
Therapeutics
Research
Elimination
Total
Revenue from external customers
$
1,741
$
657
$
—
$
2,398
Intercompany revenue
—
3,665
( 3,665 )
—
Cost of revenue
—
4,241
( 3,432 )
809
Research and development:
ATI-2138
63
—
—
63
Lepzacitinib
1,073
—
—
1,073
Zunsemetinib
2,023
—
—
2,023
Discovery
1,540
—
—
1,540
Total Research and development project spend
4,699
—
—
4,699
Personnel
4,702
—
—
4,702
Other research and development expense (1)
677
—
—
677
Total research and development
10,078
—
( 233 )
9,845
General and administrative
—
1,108
—
1,108
Licensing
1,031
—
—
1,031
Revaluation of contingent consideration
2,800
—
—
2,800
Segment operating loss
$
( 12,168 )
$
( 1,027 )
$
—
$
( 13,195 )
Non-segment general and administrative
5,736
Other income
1,990
Loss before income taxes
$
( 16,941 )
(1) Other segment items for the Therapeutics segment consist primarily of the following research and development expenses: stock-based compensation, depreciation and amortization, and regulatory.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.