10-Q 1 acrs-20240630x10q.htm 10-Q
http://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrent0001557746--12-312024Q2false7089488971332825708948897133282500P1YP1YP1YP1YP1MP1YP1YP1Y0001557746us-gaap:CommonStockMember2024-04-012024-06-300001557746us-gaap:CommonStockMember2024-01-012024-03-310001557746us-gaap:CommonStockMember2023-04-012023-06-300001557746us-gaap:CommonStockMember2023-01-012023-03-310001557746us-gaap:RetainedEarningsMember2024-06-300001557746us-gaap:AdditionalPaidInCapitalMember2024-06-300001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-300001557746us-gaap:RetainedEarningsMember2024-03-310001557746us-gaap:AdditionalPaidInCapitalMember2024-03-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-03-3100015577462024-03-310001557746us-gaap:RetainedEarningsMember2023-12-310001557746us-gaap:AdditionalPaidInCapitalMember2023-12-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-310001557746us-gaap:RetainedEarningsMember2023-06-300001557746us-gaap:AdditionalPaidInCapitalMember2023-06-300001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-300001557746us-gaap:RetainedEarningsMember2023-03-310001557746us-gaap:AdditionalPaidInCapitalMember2023-03-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-3100015577462023-03-310001557746us-gaap:RetainedEarningsMember2022-12-310001557746us-gaap:AdditionalPaidInCapitalMember2022-12-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001557746acrs:SiliconValleyBankSecuritiesLlcAndCantorFitzgeraldAndCo.Memberacrs:AtMarketOfferingMember2023-04-3000015577462023-01-012023-12-310001557746acrs:EquityCompensation2017InducementPlanMember2024-06-300001557746acrs:EquityCompensationPlan2012Member2024-06-300001557746acrs:EquityIncentivePlan2015Member2015-09-300001557746acrs:EquityIncentivePlan2015Member2024-01-012024-01-010001557746us-gaap:RestrictedStockUnitsRSUMember2024-06-300001557746us-gaap:RestrictedStockUnitsRSUMember2023-12-310001557746us-gaap:RestrictedStockUnitsRSUMemberacrs:EquityIncentivePlan2015Member2024-06-300001557746acrs:EliLillyAndCompanyMemberus-gaap:LicenseAndServiceMemberacrs:PatentLicenseAgreementMember2024-04-012024-06-300001557746us-gaap:LicenseAndServiceMember2024-04-012024-06-300001557746acrs:LaboratoryResearchRevenueMember2024-04-012024-06-300001557746acrs:DermatologyTherapeuticsSegmentMember2024-04-012024-06-300001557746acrs:ContractResearchSegmentMember2024-04-012024-06-300001557746acrs:EliLillyAndCompanyMemberus-gaap:LicenseAndServiceMemberacrs:PatentLicenseAgreementMember2024-01-012024-06-300001557746us-gaap:LicenseAndServiceMember2024-01-012024-06-300001557746acrs:LaboratoryResearchRevenueMember2024-01-012024-06-300001557746acrs:DermatologyTherapeuticsSegmentMember2024-01-012024-06-300001557746acrs:ContractResearchSegmentMember2024-01-012024-06-300001557746acrs:EliLillyAndCompanyMemberus-gaap:LicenseAndServiceMemberacrs:PatentLicenseAgreementMember2023-04-012023-06-300001557746us-gaap:LicenseAndServiceMember2023-04-012023-06-300001557746acrs:LaboratoryResearchRevenueMember2023-04-012023-06-300001557746acrs:DermatologyTherapeuticsSegmentMember2023-04-012023-06-300001557746acrs:ContractResearchSegmentMember2023-04-012023-06-300001557746acrs:EliLillyAndCompanyMemberus-gaap:LicenseAndServiceMemberacrs:PatentLicenseAgreementMember2023-01-012023-06-300001557746us-gaap:LicenseAndServiceMember2023-01-012023-06-300001557746acrs:LaboratoryResearchRevenueMember2023-01-012023-06-300001557746acrs:DermatologyTherapeuticsSegmentMember2023-01-012023-06-300001557746acrs:ContractResearchSegmentMember2023-01-012023-06-3000015577462023-12-012023-12-310001557746us-gaap:LeaseholdImprovementsMember2024-06-300001557746us-gaap:FurnitureAndFixturesMember2024-06-300001557746us-gaap:ComputerEquipmentMember2024-06-300001557746acrs:LaboratoryEquipmentMember2024-06-300001557746us-gaap:LeaseholdImprovementsMember2023-12-310001557746us-gaap:FurnitureAndFixturesMember2023-12-310001557746us-gaap:ComputerEquipmentMember2023-12-310001557746acrs:LaboratoryEquipmentMember2023-12-3100015577462023-05-3100015577462023-01-3100015577462019-02-280001557746us-gaap:RetainedEarningsMember2024-04-012024-06-300001557746us-gaap:RetainedEarningsMember2024-01-012024-03-310001557746us-gaap:RetainedEarningsMember2023-04-012023-06-300001557746us-gaap:RetainedEarningsMember2023-01-012023-03-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-04-012024-06-300001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-03-310001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-04-012023-06-300001557746us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001557746acrs:OperatingLeasesMember2024-06-300001557746acrs:OperatingLeasesMember2023-12-310001557746us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-06-300001557746acrs:EmployeeConsultantsAndDirectorsStockOptionsMember2024-01-012024-06-300001557746us-gaap:CommonStockMember2024-06-300001557746us-gaap:CommonStockMember2024-03-310001557746us-gaap:CommonStockMember2023-12-310001557746us-gaap:CommonStockMember2023-06-300001557746us-gaap:CommonStockMember2023-03-310001557746us-gaap:CommonStockMember2022-12-310001557746us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001557746us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-3100015577462023-06-3000015577462022-12-310001557746acrs:ConfluenceMember2024-01-012024-06-300001557746us-gaap:USGovernmentAgenciesDebtSecuritiesMember2024-06-300001557746us-gaap:FixedIncomeSecuritiesMember2023-12-310001557746us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001557746us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001557746us-gaap:FairValueMeasurementsRecurringMember2024-06-300001557746us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001557746us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001557746us-gaap:FairValueMeasurementsRecurringMember2023-12-310001557746us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-06-300001557746acrs:EmployeeConsultantsAndDirectorsStockOptionsMember2024-01-012024-06-300001557746us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-06-300001557746acrs:EmployeeConsultantsAndDirectorsStockOptionsMember2023-01-012023-06-300001557746us-gaap:ResearchAndDevelopmentExpenseMember2024-04-012024-06-300001557746us-gaap:GeneralAndAdministrativeExpenseMember2024-04-012024-06-300001557746us-gaap:CostOfSalesMember2024-04-012024-06-300001557746us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-06-300001557746us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-06-300001557746us-gaap:CostOfSalesMember2024-01-012024-06-300001557746us-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001557746us-gaap:GeneralAndAdministrativeExpenseMember2023-04-012023-06-300001557746us-gaap:CostOfSalesMember2023-04-012023-06-300001557746us-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-300001557746us-gaap:GeneralAndAdministrativeExpenseMember2023-01-012023-06-300001557746us-gaap:CostOfSalesMember2023-01-012023-06-300001557746us-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-300001557746us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-3100015577462024-01-012024-03-310001557746us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-300001557746us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-3100015577462023-01-012023-03-3100015577462024-07-310001557746acrs:EquityIncentivePlan2015Member2024-06-300001557746srt:MinimumMember2023-12-012023-12-310001557746srt:MaximumMember2023-12-012023-12-310001557746acrs:OntarioMunicipalEmployeesRetirementSystemMemberus-gaap:SubsequentEventMemberacrs:RoyaltyPurchaseAgreementMember2024-07-012024-07-310001557746acrs:SiliconValleyBankSecuritiesLlcAndCantorFitzgeraldAndCo.Memberacrs:AtMarketOfferingMember2023-04-012023-04-300001557746acrs:AssetPurchaseAgreementEncompassingWorldwideRightsToOxymetazolineHydrochlorideCreamPlusIntellectualPropertyMember2019-10-012019-10-310001557746acrs:OntarioMunicipalEmployeesRetirementSystemMemberacrs:EliLillyAndCompanyMemberus-gaap:SubsequentEventMemberacrs:PatentLicenseAgreementMember2024-07-310001557746srt:MinimumMember2024-01-012024-06-300001557746srt:MaximumMember2024-01-012024-06-300001557746srt:MinimumMemberus-gaap:CorporateDebtSecuritiesMember2024-01-012024-06-300001557746srt:MinimumMemberus-gaap:AssetBackedSecuritiesMember2024-01-012024-06-300001557746srt:MinimumMemberacrs:ForeignGovernmentAgenciesDebtSecuritiesMember2024-01-012024-06-300001557746srt:MaximumMemberus-gaap:CorporateDebtSecuritiesMember2024-01-012024-06-300001557746srt:MaximumMemberus-gaap:AssetBackedSecuritiesMember2024-01-012024-06-300001557746srt:MaximumMemberacrs:ForeignGovernmentAgenciesDebtSecuritiesMember2024-01-012024-06-300001557746srt:MinimumMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-01-012023-12-310001557746srt:MinimumMemberus-gaap:CorporateDebtSecuritiesMember2023-01-012023-12-310001557746srt:MinimumMemberus-gaap:AssetBackedSecuritiesMember2023-01-012023-12-310001557746srt:MinimumMemberacrs:ForeignGovernmentAgenciesDebtSecuritiesMember2023-01-012023-12-310001557746srt:MaximumMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-01-012023-12-310001557746srt:MaximumMemberus-gaap:CorporateDebtSecuritiesMember2023-01-012023-12-310001557746srt:MaximumMemberus-gaap:AssetBackedSecuritiesMember2023-01-012023-12-310001557746srt:MaximumMemberacrs:ForeignGovernmentAgenciesDebtSecuritiesMember2023-01-012023-12-310001557746us-gaap:OperatingSegmentsMemberacrs:DermatologyTherapeuticsSegmentMember2024-04-012024-06-300001557746us-gaap:OperatingSegmentsMemberacrs:DermatologyTherapeuticsSegmentMember2024-01-012024-06-300001557746us-gaap:OperatingSegmentsMemberacrs:DermatologyTherapeuticsSegmentMember2023-04-012023-06-300001557746us-gaap:OperatingSegmentsMemberacrs:DermatologyTherapeuticsSegmentMember2023-01-012023-06-300001557746us-gaap:CorporateDebtSecuritiesMember2024-06-300001557746us-gaap:AssetBackedSecuritiesMember2024-06-300001557746acrs:ForeignGovernmentAgenciesDebtSecuritiesMember2024-06-300001557746us-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-12-310001557746us-gaap:CorporateDebtSecuritiesMember2023-12-310001557746us-gaap:AssetBackedSecuritiesMember2023-12-310001557746acrs:ForeignGovernmentAgenciesDebtSecuritiesMember2023-12-310001557746us-gaap:OperatingSegmentsMemberacrs:ContractResearchSegmentMember2024-04-012024-06-300001557746us-gaap:CorporateNonSegmentMember2024-04-012024-06-3000015577462024-04-012024-06-300001557746us-gaap:OperatingSegmentsMemberacrs:ContractResearchSegmentMember2024-01-012024-06-300001557746us-gaap:CorporateNonSegmentMember2024-01-012024-06-300001557746us-gaap:OperatingSegmentsMemberacrs:ContractResearchSegmentMember2023-04-012023-06-300001557746us-gaap:CorporateNonSegmentMember2023-04-012023-06-3000015577462023-04-012023-06-300001557746us-gaap:OperatingSegmentsMemberacrs:ContractResearchSegmentMember2023-01-012023-06-300001557746us-gaap:CorporateNonSegmentMember2023-01-012023-06-3000015577462023-01-012023-06-300001557746acrs:AgreementAndPlanOfMergerMember2017-08-310001557746acrs:SunPharmaceuticalIndustriesIncMemberus-gaap:NoncollaborativeArrangementTransactionsMember2023-12-310001557746acrs:AgreementAndPlanOfMergerMember2017-08-012017-08-310001557746acrs:OntarioMunicipalEmployeesRetirementSystemMemberus-gaap:SubsequentEventMemberacrs:RoyaltyPurchaseAgreementMember2024-07-3100015577462024-06-3000015577462023-12-3100015577462024-01-012024-06-30iso4217:USDacrs:Votexbrli:purexbrli:sharesiso4217:USDxbrli:sharesutr:sqftacrs:segment

7

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark one)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                      

Commission File Number 001-37581

Aclaris Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware
(State or Other Jurisdiction of
Incorporation or Organization)

46-0571712
(I.R.S. Employer
Identification No.)

701 Lee Road, Suite 103
Wayne, PA
(Address of principal executive offices)

19087
(Zip Code)

Registrant’s telephone number, including area code: (484324-7933

N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:

 

Trading Symbol(s)

Name of Each Exchange on which Registered

Common Stock, $0.00001 par value

 

ACRS

The Nasdaq Stock Market, LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934:

Large accelerated filer  

Accelerated filer  

Non-accelerated filer  

Smaller reporting company  

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes  No 

The number of outstanding shares of the registrant’s common stock, par value $0.00001 per share, as of the close of business on July 31, 2024 was 71,344,557.

ACLARIS THERAPEUTICS, INC.

INDEX TO FORM 10-Q

    

PAGE

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

2

Unaudited Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023

2

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023

3

Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023

4

Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023

5

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3. Quantitative and Qualitative Disclosures about Market Risk

34

Item 4. Controls and Procedures

35

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

36

Item 1A. Risk Factors

36

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

36

Item 5. Other Information

36

Item 6. Exhibits

36

Signatures

38

Part I. FINANCIAL INFORMATION

Item 1. Financial Statements

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share data)

    

June 30, 

December 31, 

    

2024

    

2023

Assets

Current assets:

Cash and cash equivalents

$

22,834

$

39,878

Short-term marketable securities

 

88,259

 

79,228

Accounts receivable, net

325

298

Prepaid expenses and other current assets

 

6,217

 

9,452

Total current assets

 

117,635

 

128,856

Marketable securities

 

38,778

 

62,771

Property and equipment, net

 

1,293

 

1,620

Other assets

 

3,365

 

4,158

Total assets

$

161,071

$

197,405

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

7,269

$

8,878

Accrued expenses

 

5,762

 

19,446

Other current liabilities

2,651

2,628

Total current liabilities

 

15,682

 

30,952

Other liabilities

2,367

 

3,074

Contingent consideration

9,200

6,200

Total liabilities

 

27,249

 

40,226

Stockholders’ Equity:

Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at June 30, 2024 and December 31, 2023

Common stock, $0.00001 par value; 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; 71,332,825 and 70,894,889 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively

 

1

 

1

Additional paid‑in capital

 

933,007

 

928,080

Accumulated other comprehensive loss

 

(463)

 

(106)

Accumulated deficit

 

(798,723)

 

(770,796)

Total stockholders’ equity

 

133,822

 

157,179

Total liabilities and stockholders’ equity

$

161,071

$

197,405

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except share and per share data)

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2024

    

2023

    

2024

    

2023

Revenues:

Contract research

$

625

$

875

$

1,281

$

1,764

Licensing

2,141

994

3,882

2,633

Total revenue

2,766

1,869

5,163

4,397

Costs and expenses:

Cost of revenue

624

1,042

1,433

1,850

Research and development

 

8,759

25,275

 

18,604

 

47,862

General and administrative

 

4,752

8,317

 

11,596

 

17,107

Licensing

1,285

550

2,316

1,611

Revaluation of contingent consideration

200

(1,500)

3,000

(2,300)

Total costs and expenses

 

15,620

 

33,684

 

36,949

 

66,130

Loss from operations

 

(12,854)

 

(31,815)

 

(31,786)

 

(61,733)

Other income, net

 

1,868

 

2,246

 

3,859

 

4,004

Net loss

$

(10,986)

$

(29,569)

$

(27,927)

$

(57,729)

Net loss per share, basic and diluted

$

(0.15)

$

(0.42)

$

(0.39)

$

(0.84)

Weighted average common shares outstanding, basic and diluted

 

71,291,400

 

70,633,528

 

71,183,129

 

68,763,542

Other comprehensive loss:

Unrealized loss on marketable securities, net of tax of $0

$

(99)

$

(757)

$

(357)

$

(214)

Total other comprehensive loss

 

(99)

 

(757)

 

(357)

 

(214)

Comprehensive loss

$

(11,085)

$

(30,326)

$

(28,284)

$

(57,943)

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF

STOCKHOLDERS’ EQUITY

(Unaudited)

(In thousands, except share data)

Accumulated

 

Common Stock

Additional

Other

Total

 

Par

Paidin

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

Issuance of common stock in connection with vesting of restricted stock units

84,808

(10)

(10)

Unrealized loss on marketable securities

(99)

(99)

Stock-based compensation expense

2,903

2,903

Net loss

(10,986)

(10,986)

Balance at June 30, 2024

71,332,825

$

1

$

933,007

$

(463)

$

(798,723)

$

133,822

Accumulated

Common Stock

Additional

Other

Total

Par

Paidin

Comprehensive

Accumulated

Stockholders’

  Shares 

  

Value

  

Capital

  

Loss

  

Deficit

  

Equity

Balance at December 31, 2022

66,688,647

$

1

$

880,832

$

(897)

$

(682,315)

$

197,621

Issuance of common stock in connection with vesting of restricted stock units

517,378

Unrealized gain on marketable securities

543

543

Stock-based compensation expense

6,806

6,806

Net loss

(28,160)

(28,160)

Balance at March 31, 2023

67,206,025

$

1

$

887,638

$

(354)

$

(710,475)

$

176,810

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

163,677

30

30

Issuance of common stock under at-the-market sales agreement, net of offering costs of $826

3,400,000

26,714

26,714

Unrealized loss on marketable securities

(757)

(757)

Stock-based compensation expense

6,522

6,522

Net loss

(29,569)

(29,569)

Balance at June 30, 2023

70,769,702

$

1

$

920,904

$

(1,111)

$

(740,044)

$

179,750

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

Six Months Ended

June 30, 

    

2024

    

2023

Cash flows from operating activities:

    

    

    

    

Net loss

$

(27,927)

$

(57,729)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

 

485

 

416

Stock-based compensation expense

 

4,992

 

13,328

Revaluation of contingent consideration

3,000

(2,300)

Changes in operating assets and liabilities:

Accounts receivable

(27)

53

Prepaid expenses and other assets

 

2,317

 

(1,605)

Accounts payable

 

(1,609)

 

1,074

Accrued expenses

 

(14,368)

 

(244)

Net cash used in operating activities

 

(33,137)

 

(47,007)

Cash flows from investing activities:

Purchases of property and equipment, net

 

(121)

 

(784)

Purchases of marketable securities

 

(35,218)

 

(118,513)

Proceeds from sales and maturities of marketable securities

 

51,498

 

125,433

Net cash provided by investing activities

 

16,159

 

6,136

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

(66)

Proceeds from exercise of employee stock options and the issuance of stock

30

Net cash (used in) provided by financing activities

 

(66)

 

26,744

Net decrease in cash and cash equivalents

 

(17,044)

 

(14,127)

Cash and cash equivalents at beginning of period

 

39,878

 

45,277

Cash and cash equivalents at end of period

$

22,834

$

31,150

Supplemental disclosure of non-cash investing and financing activities:

Additions to property and equipment included in accounts payable

$

$

394

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

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 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 June 30, 2024, the Company had cash, cash equivalents and marketable securities of $149.9 million and an accumulated deficit of $798.7 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, heightened interest rates, 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.

6

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of June 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, the condensed consolidated statement of stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the six months ended June 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 June 30, 2024, the results of its operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, its changes in stockholders’ equity for the three and six months ended June 30, 2024 and 2023 and its cash flows for the six months ended June 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 six months ended June 30, 2024 and 2023 are unaudited. The results for the three and six months ended June 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.

7

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 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 June 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 7.0% and 8.2% 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.

8

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.

Discontinued Operations

As of June 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.

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:

June 30, 2024

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets:

    

    

    

    

    

    

    

    

Cash equivalents

$

20,332

$

$

$

20,332

Marketable securities

 

127,037

127,037

Total assets

$

20,332

$

127,037

$

$

147,369

Liabilities:

Contingent consideration

$

$

$

9,200

$

9,200

Total liabilities

$

$

$

9,200

$

9,200

9

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 June 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 June 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 six months ended June 30, 2024 and 2023, there were no transfers into or out of Level 3.

The overall $3.0 million increase in the fair value of the contingent consideration liability during the six months ended June 30, 2024 was primarily due to changes in estimated sales levels and changes to the probability of success for certain drug candidates.

As of June 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:

June 30, 2024

Gross

Gross

Book

Unrealized

Unrealized

Fair

(In thousands)

Value

Gain

Loss

Value

Marketable securities:

Corporate debt securities(1)

$

68,307

$

6

$

(210)

$

68,103

Asset-backed debt securities(2)

5,023

(22)

5,001

Foreign government agency debt securities

4,804

1

4,805

U.S. government and government agency debt securities(3)

49,375

(247)

49,128

Total marketable securities

$

127,509

$

7

$

(479)

$

127,037

(1) Included in Corporate debt securities is $33.7 million with maturity dates between one and two years.

(2) Included in Asset-backed debt securities is $0.1 million with maturity dates between one and two years.

(3) Included in U.S. government and government agency debt securities is $5.0 million with maturity dates between one and two years.

10

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.

4. Property and Equipment, Net

Property and equipment, net consisted of the following:

June 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

 

(4,520)

 

(4,162)

Property and equipment, net

$

1,293

$

1,620

Depreciation expense was $0.2 million for each of the three months ended June 30, 2024 and 2023, and $0.4 million for each of the six months ended June 30, 2024 and 2023.

5. Accrued Expenses

Accrued expenses consisted of the following:

June 30, 

December 31, 

(In thousands)

    

2024

    

2023

Employee compensation expenses

$

2,138

$

3,910

Research and development expenses

1,092

6,661

Licensing expenses

1,219

5,478

Restructuring expenses (Note 12)

1,140

3,112

Other expenses

 

173

 

285

Total accrued expenses

$

5,762

$

19,446

6. Stockholders’ Equity

Preferred Stock

As of June 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 June 30, 2024 or December 31, 2023.

11

Common Stock

As of June 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 71,332,825 and 70,894,889 shares of common stock issued and outstanding as of June 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 June 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.

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 June 30, 2024, 4,351,008 shares remained available for grant under the 2015 Plan. The Company had 5,867,413 stock options and 3,110,751 RSUs outstanding as of June 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 333,000 stock options outstanding as of June 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 380,792 stock options outstanding as of June 30, 2024 under the 2012 Plan.

12

Stock Option Valuation

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

    

Six Months Ended

June 30, 

2024

2023

Risk-free interest rate

 

3.85

%

3.48

%

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 six months ended June 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

Forfeited and cancelled

 

(1,820,950)

14.74

Outstanding as of June 30, 2024

 

6,581,205

$

11.85

7.0

$

23

Options vested and expected to vest as of June 30, 2024

 

6,581,205

$

11.85

7.0

$

23

Options exercisable as of June 30, 2024

 

3,525,088

$

15.74

 

5.3

$

16

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

Restricted Stock Units

The following table summarizes RSU activity for the six months ended June 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

2,638,025

1.20

Vested

(493,254)

13.37

$

587

Forfeited and cancelled

(555,960)

12.54

Outstanding as of June 30, 2024

3,110,751

$

4.35

13

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

Six Months Ended

 

June 30, 

June 30, 

 

(In thousands)

    

2024

    

2023

    

2024

    

2023

 

Cost of revenue

    

$

223

    

$

473

  

$

475

    

$

772

Research and development

1,097

3,494

1,068

6,096

General and administrative

 

1,583

 

2,555

 

3,449

 

6,460

Total stock-based compensation expense

$

2,903

$

6,522

$

4,992