Table of Contents

7

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10‑Q10-Q


(Mark one)

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

For the quarterly period ended September 30, 2017March 31, 2021

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.)

101 Lindenwood Drive,640 Lee Road, Suite 400200
Malvern,
Wayne, PA
(Address of principal executive offices)

1935519087
(Zip Code)

Registrant’s telephone number, including area code: (484) 324‑7933324-7933

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S‑TS-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non‑acceleratednon-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‑212b-2 of the Securities Exchange Act of 1934:

Large accelerated filer  

Accelerated filer  

Non-accelerated filer  

Smaller reporting company  

(Do not check if a 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 November 6, 2017April 30, 2021 was 30,834,67952,107,355.


Table of Contents

ACLARIS THERAPEUTICS, INC.

INDEX TO FORM 10-Q

PAGE

PAGE

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

2

Unaudited Condensed Consolidated Balance Sheets as of September 30, 2017March 31, 2021 and December 31, 20162020

2

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2017March 31, 2021 and 20162020

3

Unaudited Condensed Consolidated StatementStatements of Stockholders’ Equity for the ninethree months ended September 30, 2017March 31, 2021and 2020

4

Unaudited Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30, 2017March 31, 2021 and 20162020

5

Notes to Unaudited Condensed Consolidated Financial Statements

6

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

22

20

Item 3. Quantitative and Qualitative Disclosures about Market Risk

38

34

Item 4. Controls and Procedures

38

34

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

40

35

Item 1A. Risk Factors

40

36

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

41

36

Item 6. Exhibits

42

36

Signatures

44

38


Table of Contents

Part I. FINANCIAL INFORMATION

Item 1. Financial Statements

ACLARIS THERAPEUTICS, INC.INC.

CONDENSED CONSOLIDATED BALANCE SHEETSSHEETS

(UNAUDITED)(Unaudited)

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

    

September 30, 

 

December 31, 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

60,055

 

$

30,171

 

Marketable securities

 

 

167,793

 

 

107,051

 

Accounts receivable, net

 

 

658

 

 

 —

 

Prepaid expenses and other current assets

 

 

5,616

 

 

1,334

 

Total current assets

 

 

234,122

 

 

138,556

 

Marketable securities

 

 

 —

 

 

36,912

 

Property and equipment, net

 

 

1,203

 

 

481

 

Intangible assets

 

 

7,367

 

 

 —

 

Goodwill

 

 

18,504

 

 

 —

 

Other assets

 

 

195

 

 

136

 

Total assets

 

$

261,391

 

$

176,085

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

6,483

 

$

2,845

 

Accrued expenses

 

 

3,510

 

 

3,378

 

Total current liabilities

 

 

9,993

 

 

6,223

 

Contingent consideration

 

 

4,378

 

 

 —

 

Other liabilities

 

 

375

 

 

372

 

Deferred tax liability

 

 

2,386

 

 

 —

 

Total liabilities

 

 

17,132

 

 

6,595

 

Stockholders’ Equity:

 

 

 

 

 

 

 

Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at September 30, 2017 and December 31, 2016

 

 

 —

 

 

 —

 

Common stock, $0.00001 par value; 100,000,000 shares authorized at September 30, 2017 and December 31, 2016; 30,834,679 and 26,059,181 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

 

 

 —

 

 

 —

 

Additional paid‑in capital

 

 

380,873

 

 

260,671

 

Accumulated other comprehensive loss

 

 

(113)

 

 

(269)

 

Accumulated deficit

 

 

(136,501)

 

 

(90,912)

 

Total stockholders’ equity

 

 

244,259

 

 

169,490

 

Total liabilities and stockholders’ equity

 

$

261,391

 

$

176,085

 

    

March 31, 

December 31, 

 

    

2021

    

2020

 

 

Assets

Current assets:

Cash and cash equivalents

$

35,267

$

22,063

Short-term marketable securities

 

93,028

 

32,068

Accounts receivable, net

817

772

Prepaid expenses and other current assets

 

5,389

 

2,590

Total current assets

 

134,501

 

57,493

Marketable securities

 

14,362

 

Property and equipment, net

 

1,424

 

1,654

Intangible assets

7,105

7,123

Other assets

 

4,007

 

4,514

Total assets

$

161,399

$

70,784

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

7,292

$

5,254

Accrued expenses

 

3,599

 

5,906

Current portion of lease liabilities

625

603

Discontinued operations - current liabilities

2,989

3,111

Total current liabilities

 

14,505

 

14,874

Other liabilities

3,041

 

3,179

Long-term debt, net

10,692

10,653

Contingent consideration

20,500

4,061

Deferred tax liability

 

367

 

367

Total liabilities

 

49,105

 

33,134

Commitments and contingencies (Note 17)

Stockholders’ Equity:

Preferred stock, $0.00001 par value; 10,000,000 shares authorized and 0 shares issued or outstanding at March 31, 2021 and December 31, 2020

Common stock, $0.00001 par value; 100,000,000 shares authorized at March 31, 2021 and December 31, 2020; 52,081,729 and 45,109,314 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

 

 

Additional paid‑in capital

 

645,730

 

542,286

Accumulated other comprehensive loss

 

(140)

 

(94)

Accumulated deficit

 

(533,296)

 

(504,542)

Total stockholders’ equity

 

112,294

 

37,650

Total liabilities and stockholders’ equity

$

161,399

$

70,784

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

2


Table of Contents

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

(Unaudited)

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

    

2017

    

2016

    

2017

    

2016

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

    

$

684

    

$

 —

    

$

684

    

$

 —

 

Cost of revenue

 

 

453

 

 

 —

 

 

453

 

 

 —

 

Gross profit

 

 

231

 

 

 —

 

 

231

 

 

 —

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

10,864

 

 

7,162

 

 

26,601

 

 

26,533

 

General and administrative

 

 

8,123

 

 

3,650

 

 

20,611

 

 

10,407

 

Total operating expenses

 

 

18,987

 

 

10,812

 

 

47,212

 

 

36,940

 

Loss from operations

 

 

(18,756)

 

 

(10,812)

 

 

(46,981)

 

 

(36,940)

 

Other income, net

 

 

564

 

 

118

 

 

1,392

 

 

336

 

Net loss

 

$

(18,192)

 

$

(10,694)

 

$

(45,589)

 

$

(36,604)

 

Net loss per share, basic and diluted

 

$

(0.63)

 

$

(0.50)

 

$

(1.68)

 

$

(1.76)

 

Weighted average common shares outstanding, basic and diluted

 

 

28,834,808

 

 

21,415,871

 

 

27,180,244

 

 

20,752,590

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities, net of tax of $0

 

$

63

 

$

(12)

 

$

 7

 

$

144

 

Foreign currency translation adjustments

 

 

(10)

 

 

(43)

 

 

149

 

 

(49)

 

Total other comprehensive income (loss)

 

 

53

 

 

(55)

 

 

156

 

 

95

 

Comprehensive loss

 

$

(18,139)

 

$

(10,749)

 

$

(45,433)

 

$

(36,509)

 

Three Months Ended

March 31, 

    

2021

    

2020

Revenues:

Contract research

$

1,535

$

1,189

Other revenue

242

218

Total revenue

1,777

1,407

Costs and expenses:

Cost of revenue

1,202

1,269

Research and development

 

 

7,838

 

7,677

General and administrative

 

 

4,827

 

6,200

Revaluation of contingent consideration

16,439

1,767

Total costs and expenses

 

 

30,306

 

16,913

Loss from operations

 

 

(28,529)

 

(15,506)

Other income (expense), net

 

 

(225)

 

178

Loss from continuing operations

(28,754)

(15,328)

Loss from discontinued operations

(258)

Net loss

$

(28,754)

$

(15,586)

Net loss per share, basic and diluted

$

(0.57)

$

(0.37)

Weighted average common shares outstanding, basic and diluted

 

50,337,807

 

41,618,429

Other comprehensive income (loss):

Unrealized gain (loss) on marketable securities, net of tax of $0

$

(35)

$

60

Foreign currency translation adjustment

(11)

53

Total other comprehensive income (loss)

 

(46)

 

113

Comprehensive loss

$

(28,800)

$

(15,473)

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

3


Table of Contents

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF

STOCKHOLDERS’ EQUITY

(UNAUDITED)(Unaudited)

(In thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Common Stock

 

Additional

 

Other

 

 

 

Total

 

 

 

 

 

Par

 

Paid‑in

 

Comprehensive

 

Accumulated

 

Stockholders’

 

 

  

  Shares 

  

Value

  

Capital

  

Loss

  

Deficit

  

Equity

 

Balance at December 31, 2016

 

26,059,181

 

$

 —

 

$

260,671

 

$

(269)

 

$

(90,912)

 

$

169,490

 

Issuance of common stock under the at-the-market sales agreement, net of offering costs of $691

 

635,000

 

 

 —

 

 

19,311

 

 

 —

 

 

 —

 

 

19,311

 

Issuance of common stock in connection with public offering, net of underwriting discounts and commissions and offering costs of $5,352

 

3,747,602

 

 

 —

 

 

80,918

 

 

 —

 

 

 —

 

 

80,918

 

Issuance of common stock in connection with the acquisition of Confluence

 

349,527

 

 

 

 

 

9,675

 

 

 —

 

 

 —

 

 

9,675

 

Exercise of stock options and vesting of restricted stock units

 

43,369

 

 

 —

 

 

168

 

 

 —

 

 

 —

 

 

168

 

Unrealized loss on marketable securities

 

 —

 

 

 —

 

 

 —

 

 

 7

 

 

 —

 

 

 7

 

Foreign currency translation adjustment

 

 —

 

 

 —

 

 

 —

 

 

149

 

 

 —

 

 

149

 

Stock-based compensation expense

 

 —

 

 

 —

 

 

10,130

 

 

 —

 

 

 —

 

 

10,130

 

Net loss 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(45,589)

 

 

(45,589)

 

Balance at September 30, 2017

 

30,834,679

 

$

 —

 

$

380,873

 

$

(113)

 

$

(136,501)

 

$

244,259

 

Accumulated

 

Common Stock

Additional

Other

Total

 

Par

Paidin

Comprehensive

Accumulated

Stockholders’

 

  

  Shares 

  

Value

  

Capital

  

Loss

  

Deficit

  

Equity

 

Balance at December 31, 2020

45,109,314

$

$

542,286

$

(94)

$

(504,542)

$

37,650

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

666,144

(2,579)

(2,579)

Issuance of common stock in connection with public offering, net of offering costs of $7,011

6,306,271

103,348

103,348

Unrealized loss on marketable securities

(35)

(35)

Foreign currency translation adjustment

(11)

(11)

Stock-based compensation expense

2,675

2,675

Net loss

(28,754)

(28,754)

Balance at March 31, 2021

52,081,729

$

$

645,730

$

(140)

$

(533,296)

$

112,294

Accumulated

Common Stock

Additional

Other

Total

Par

Paidin

Comprehensive

Accumulated

Stockholders’

  

  Shares 

  

Value

  

Capital

  

Income (Loss)

  

Deficit

  

Equity

Balance at December 31, 2019

41,485,638

$

$

523,505

$

(66)

$

(453,527)

$

69,912

Vesting of restricted stock units

346,582

(95)

(95)

Fair value of warrants issued

378

378

Unrealized gain on marketable securities

60

60

Foreign currency translation adjustment

53

53

Stock-based compensation expense

3,453

3,453

Net loss

(15,586)

(15,586)

Balance at March 31, 2020

41,832,220

$

$

527,241

$

47

$

(469,113)

$

58,175

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

4


Table of Contents

ACLARIS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)(Unaudited)

(In thousands)

 

 

 

 

 

 

 

 

 

 

Nine Months Ended

 

 

 

September 30, 

 

 

    

2017

    

2016

 

Cash flows from operating activities:

    

 

    

    

 

    

 

Net loss

 

$

(45,589)

 

$

(36,604)

 

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

 

 

 

 

 

 

 

Depreciation and amortization

 

 

221

 

 

80

 

Stock-based compensation expense

 

 

10,130

 

 

4,194

 

Non-cash charges related to Vixen acquisition

 

 

 —

 

 

2,784

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(4,331)

 

 

110

 

Accounts payable

 

 

3,130

 

 

915

 

Accrued expenses

 

 

(14)

 

 

1,990

 

Net cash used in operating activities

 

 

(36,453)

 

 

(26,531)

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(658)

 

 

(170)

 

Acquisition of Confluence, net of cash acquired

 

 

(9,647)

 

 

 —

 

Purchases of marketable securities

 

 

(120,496)

 

 

(33,747)

 

Proceeds from sales and maturities of marketable securities

 

 

96,674

 

 

49,832

 

Net cash (used in), provided by investing activities

 

 

(34,127)

 

 

15,915

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from issuance of common stock in connection with private placement, net of issuance costs

 

 

 —

 

 

18,547

 

Proceeds from issuance of common stock under the at-the-market sales agreement, net of issuance costs

 

 

19,311

 

 

 —

 

Proceeds from issuance of common stock in connection with public offering, net of issuance costs

 

 

80,918

 

 

 —

 

Proceeds from the exercise of employee stock options

 

 

235

 

 

14

 

Net cash provided by financing activities

 

 

100,464

 

 

18,561

 

Net increase in cash and cash equivalents

 

 

29,884

 

 

7,945

 

Cash and cash equivalents at beginning of period

 

 

30,171

 

 

9,851

 

Cash and cash equivalents at end of period

 

$

60,055

 

$

17,796

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

Additions to property and equipment included in accounts payable

 

$

20

 

$

13

 

Fair value of stock issued in connection with Confluence acquisition

 

$

9,675

 

$

 —

 

Fair value of stock issued in connection with Vixen acquisition

 

$

 —

 

$

2,355

 

Offering costs included in accounts payable

 

$

107

 

$

 —

 

Three Months Ended

 

March 31, 

    

2021

    

2020

 

Cash flows from operating activities:

    

    

    

    

Net loss

$

(28,754)

$

(15,586)

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

Depreciation and amortization

 

288

 

576

Stock-based compensation expense

 

2,675

 

3,453

Revaluation of contingent consideration

16,439

1,767

Changes in operating assets and liabilities:

Accounts receivable

(45)

4,737

Prepaid expenses and other assets

 

(2,250)

 

338

Accounts payable

 

1,842

 

(4,317)

Accrued expenses

 

(2,427)

 

2,227

Net cash used in operating activities

 

(12,232)

 

(6,805)

Cash flows from investing activities:

Purchases of property and equipment

 

 

(124)

Purchases of marketable securities

 

(85,814)

 

(8,869)

Proceeds from sales and maturities of marketable securities

 

10,500

 

22,935

Net cash provided by (used in) investing activities

 

(75,314)

 

13,942

Cash flows from financing activities:

Proceeds from issuance of common stock in connection with public offering, net of issuance costs

103,348

Proceeds from debt financing (including warrants), net of issuance costs

10,950

Restricted stock unit employee tax withholdings

(3,014)

Finance lease payments

(57)

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

416

25

Net cash provided by financing activities

 

100,750

 

10,918

Net increase in cash, cash equivalents and restricted cash

 

13,204

 

18,055

Cash, cash equivalents and restricted cash at beginning of period

 

22,063

 

35,937

Cash, cash equivalents and restricted cash at end of period

$

35,267

$

53,992

Supplemental disclosure of non-cash investing and financing activities:

Additions to property and equipment included in accounts payable

$

$

16

Fair value of warrants issued in connection with debt financing

$

$

263

Offering costs included in accounts payable

$

$

30

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

5


Table of Contents

ACLARIS THERAPEUTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Amounts in thousands, except share and per share data)

1. Organization and Nature of Business

Overview

Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012.  OnIn July 17, 2015, Aclaris Therapeutics International Limited (“ATIL”) was established under the laws of the United Kingdom as a wholly-owned subsidiary of Aclaris Therapeutics, Inc.  On March 24, 2016, Vixen Pharmaceuticals, Inc. (“Vixen”) became a wholly-owned subsidiary of Aclaris Therapeutics, Inc. (see Note 12).  OnIn August 3, 2017, Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly-owned subsidiary thereof (see Note 3).thereof.  Aclaris Therapeutics, Inc., ATIL Vixen and Confluence are referred to collectively as the “Company”.“Company.”  The Company is a dermatologist-ledclinical-stage biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapiesnovel drug candidates for immuno-inflammatory diseases.  In addition to address significant unmet needs in medical and aesthetic dermatology. The Company’s leaddeveloping its novel drug candidate, A-101 40% Topical Solution, is a proprietary high‑concentration formulation of hydrogen peroxide topical solution thatcandidates, the Company is developing as a prescription treatmentpursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for seborrheic keratosis (“SK”), a common non‑malignant skin tumor. The Company has completed three Phase 3 clinical trials of A-101 40% Topical Solution in patients with SK, and in February 2017 submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”).  The NDA was accepted by the FDA in May 2017 and the Prescription Drug User Fee Act (“PDUFA”) target action date for the completion of the FDA’s review of the NDA is December 24, 2017.and/or commercialize its novel drug candidates.  

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.  At September 30, 2017,As of March 31, 2021, the Company had cash, cash equivalents and marketable securities of $227,848$142.7 million and an accumulated deficit of $136,501.$533.3 million.  Since inception, the Company has incurred net losses and negative cash flows from its operations.  Prior to the acquisition of Confluence in August 2017, the Company had never generated any revenue.  There iscan 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 and commercialization of the Company’s productsdrug 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 cashrevenue from operating activitiesidentifying 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 complete the clinical development of ATI-450 and ATI-1777, to develop its preclinical compounds, 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 potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic.  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 Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), 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

Table of Contents

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).  The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiaries, ATIL, Confluence and Vixen.  All material intercompany transactions have been eliminated. 

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, research and development expenses, contingent consideration and the valuation of stock-based awards.  Estimates are periodically

6


reviewed in light of changes in circumstances, facts and experience.  Actual results could differ from the Company’s estimates. 

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of September 30, 2017,March 31, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2017March 31, 2021 and 2016,2020, the condensed consolidated statement of stockholders’ equity for the ninethree months ended September 30, 2017,March 31, 2021 and 2020, and the condensed consolidated statements of cash flows for the ninethree months ended September 30, 2017March 31, 2021 and 20162020 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 March 15, 2017February 25, 2021 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Company’s financial position as of September 30, 2017,March 31, 2021, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2017March 31, 2021 and 20162020, its changes in stockholders’ equity for the three months ended March 31, 2021 and 2020 and its cash flows for the ninethree months ended September 30, 2017March 31, 2021 and 2016.2020.  The condensed consolidated balance sheet data as of December 31, 20162020 was derived from audited financial statements but does not include all disclosures required by GAAP.generally accepted accounting principles in the United States (“GAAP”).  The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2017March 31, 2021 and 20162020 are unaudited. The results for the three and nine months ended September 30, 2017March 31, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2017,2021, 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, 20162020 included in the Company’s annual report on Form 10-K filed with the SEC on March 15, 2017.February 25, 2021.  

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, ATIL and Confluence.  All intercompany transactions have been eliminated.  Based upon 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, research and development expenses, contingent consideration and the valuation of stock-based awards.  Estimates are periodically reviewed in light of changes in circumstances, facts and experience.  The COVID-19 pandemic has resulted in a global slowdown in economic activity.  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 financial statement presentation.

7

Table of Contents

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 20162020 included in the Company’s annual report on Form 10-K filed with the SEC on March 15, 2017.  Since the date of such financial statements,February 25, 2021.  Except as set forth below, there have been no changes to the Company’s significant accounting policies other thanfrom those noted below. 

In February 2017, the Company paid a $2.0 million PDUFA fee to the FDA in conjunction with the filing of its NDA for A-101 40% Topical Solution.  The Company has requested a waiver and refund of this PDUFA fee from the FDA, and the amount has been recorded in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet. 

Revenue Recognition

The Company recognizes revenue when the earnings process is complete, which under SEC Staff Accounting

Bulletin No. 104, Topic No. 13, “Revenue Recognition,” is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or services has occurred, the sales price is fixed or determinable, and collectability is reasonably assured. 

The Company earns revenue from the provision of laboratory services to clients through Confluence, its wholly-owned subsidiary.  Laboratory service 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 specifieddisclosed in the contracts. annual report.

7


The Company also receives revenue from grants under the Small Business Innovation Research program of the National Institutes of Health (“NIH”).  The Company, through its Confluence subsidiary, currently has two active grants from NIH which are related to early-stage research.  The Company recognizes revenue related to these grants as amounts become reimbursable under each grant, which is generally when research is performed and the related costs are incurred. 

Intangible Assets

Intangible assets include both finite lived and indefinite lived assets.  Finite lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used.  Indefinite lived intangible assets are not amortized. In-process research and development (“IPR&D”) assets acquired in a business combination are considered indefinite lived until the completion or abandonment of the associated research and development efforts.  The Company tests intangible assets for impairment at least annually, or if indicators of impairment are present.  The Company recognizes impairment losses when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. 

Contingent Consideration

The Company initially recorded thea contingent consideration liability at fair value on the date of acquisition related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, resulting from the acquisition of Confluence at its estimated fair value onbased upon significant unobservable inputs including the date of acquisition.  Changes in fair value reflect new information about the likelihoodachievement of the paymentdevelopment, 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 was involved in determining the appropriateness of these assumptions.  These assumptions are considered Level 3 inputs.  Revaluation of the contingent consideration and the passageliability can result from changes to one or more of time.  Future changes inthese assumptions.  The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, will be recorded as income or expense in the Company’scondensed 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 4% and 40%.  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 5.9% and 8.1% depending on the year of each potential payment.

Recently Issued Accounting Pronouncements

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2017-01, Business Combinations-Clarifying the Definition of a Business (Topic 805).  The amendments in this ASU provide a screen to determine when a set of acquired assets and/or activities is not a business.  The screen requires that when substantially all of the fair value of the gross assets acquired, or disposed of, is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business.  The amendments in this ASU will reduce the number of transactions that meet the definition of a business.  ASU 2017-01 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within those years, and early adoption will be permitted.  The Company is assessing the potential impact of ASU 2017-01 on its consolidated financial statements. None.

In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other-Simplifying the Test for Goodwill Impairment (Topic 350).  Under the amendments in this ASU, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount.  An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit.  The amendments in this ASU eliminate Step 2 from the goodwill impairment test.  ASU 2017-04 is effective for fiscal years beginning after December 15, 2019, and early adoption is permitted.  The Company is assessing the potential impact of ASU 2017-04 on its consolidated financial statements. 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers(Topic 606).  Under this ASU, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided.  ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017.  The Company is assessing the potential impact of ASU 2014-09 on its consolidated financial statements.

8


3. Acquisition of Confluence

On August 3, 2017, the Company entered into an Agreement and Plan of Merger with Confluence, Aclaris Life Sciences, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (the “Merger Sub”), and Fortis Advisors LLC, as representative of the holders of Confluence equity (the “Agreement and Plan of Merger”).  Pursuant to the terms of the Agreement and Plan of Merger, the Merger Sub merged with and into Confluence, with Confluence surviving as a wholly-owned subsidiary of the Company, resulting in the Company’s acquisition of 100% of the outstanding shares of Confluence.  Pursuant to the terms of the Agreement and Plan of Merger, the Company gave aggregate consideration with a fair value of $24,322 to the equity holders of Confluence, subject to a customary post-closing working capital adjustment. Confluence was a privately held biotechnology company focused on the discovery and development of kinase inhibitors to treat inflammatory and immunological disorders and cancer.  Confluence also provides laboratory services under contract research arrangements to pharmaceutical and biotech companies looking to supplement their research and development efforts with difficult-to-execute specialty skills and programs.  The acquisition of Confluence will add small molecule drug discovery and preclinical development capabilities, which the Company expects will allow it to bring early-stage research and development activities in-house that the Company currently outsources to third parties. 

The Company has also agreed to pay the Confluence equity holders contingent consideration of up to $80,000, based upon the achievement of certain development, regulatory and commercial milestones set forth in the Agreement and Plan of Merger.  Of the contingent consideration, $2,500 may be paid in shares of the Company’s common stock upon the achievement of a specified development milestone.  In addition, the Company has agreed to pay the Confluence equity holders specified 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, if the Company sells, licenses or transfers any of the intellectual property acquired from Confluence pursuant to the Agreement and Plan of Merger to a third party, the Company will be obligated to pay the Confluence equity holders a portion of any incremental consideration (in excess of the development and milestone payments described above) that the Company receives from such sales, licenses or transfers in specified circumstances. 

The following table summarizes the fair value of total consideration given to the Confluence equity holders pursuant to the Agreement and Plan of Merger: 

 

 

 

 

Cash consideration paid

 

$

10,269

Aclaris common stock issued

 

 

9,675

Contingent consideration

 

 

4,378

Total fair value of consideration to Confluence equity holders

 

$

24,322

The Company funded the acquisition and transaction expenses with cash on hand. 

The Company accounted for this transaction as a business combination using the acquisition method of accounting.  Under the acquisition method of accounting, the assets acquired and liabilities assumed in this transaction were recorded at their respective fair values on the date of acquisition using assumptions that are subject to change. The Company expects to finalize its allocation of the purchase price upon the finalization of valuations for the identified intangible assets, final resolution of the post-closing working capital adjustment and certain tax accounts that are based on the best estimates of management. The completion and filing of federal and state tax returns for the acquired entity may result in adjustments to the carrying value of assets and liabilities. 

9


The following table summarizes the preliminary fair value of assets acquired and liabilities assumed in the acquisition of Confluence as of the acquisition date: 

 

 

 

 

Cash and cash equivalents

 

$

622

Accounts receivable, net

 

 

574

Other current assets

 

 

89

Property and equipment

 

 

268

Other intangible assets

 

 

751

IPR&D

 

 

6,629

Goodwill

 

 

18,504

Total assets acquired

 

 

27,437

 

 

 

 

Accounts payable and accrued expenses

 

 

656

Deferred tax liability

 

 

2,386

Other liabilities

 

 

73

Total liabilities assumed

 

 

3,115

 

 

 

 

Total net assets acquired

 

$

24,322

The estimated fair value of the IPR&D, and other identified intangibles, acquired was determined using a replacement cost method which estimates the cost that would be required to rebuild the intangible assets identified in the acquisition of Confluence.  The acquisition of Confluence resulted in the recognition of goodwill in the amount $18,504 which represents the value of new products and technologies to be developed in the future as well as the value of the employee workforce acquired. 

The following supplemental unaudited pro forma information presents the Company’s financial results, for the periods presented, as if the acquisition of Confluence had occurred on January 1, 2016.  This supplemental unaudited pro forma financial information has been prepared for comparative purposes only, and is not necessarily indicative of what actual results would have been had the acquisition of Confluence occurred on January 1, 2016, nor is this information indicative of future results. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

    

2017

    

2016

    

2017

    

2016

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

    

$

1,063

    

$

937

    

$

3,366

    

$

2,617

 

Gross profit

 

 

384

 

 

452

 

 

1,102

 

 

1,184

 

Total operating expenses

 

 

18,822

 

 

11,464

 

 

48,122

 

 

39,273

 

Net loss

 

 

(17,875)

 

 

(10,891)

 

 

(45,627)

 

 

(37,769)

 

The supplemental unaudited pro forma financial results for the three and nine months ended September 30, 2017 include adjustments to exclude $997 and $1,351, respectively, of acquisition-related expenses, as well as $217 and $888, respectively, to exclude revenue billed to the Company by Confluence.  The supplemental unaudited pro forma financial results for the three and nine months ended September 30, 2017 includes an adjustment for amortization expense related to the other intangible assets acquired. 

There were no acquisition-related expenses incurred, or revenue billed to the Company by Confluence, for the three and nine months ended September 30, 2016, and accordingly, no adjustments are necessary for these items in the supplemental pro forma financial results for those time periods.  The supplemental unaudited pro forma financial results

10


for the three and nine months ended September 30, 2016 includes an adjustment for amortization expense related to the other intangible assets acquired. 

4. 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, 2021

 

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

 

Assets:

   

    

    

    

    

    

    

    

Cash equivalents

$

29,132

$

$

$

29,132

Marketable securities

 

107,390

107,390

Total assets

$

29,132

$

107,390

$

$

136,522

Liabilities:

Contingent consideration

$

$

$

20,500

$

20,500

Total liabilities

$

$

$

20,500

$

20,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30, 2017

 

 

    

Level 1

    

Level 2

    

Level 3

    

Total

 

Assets:

    

 

    

    

 

    

    

 

    

    

 

    

 

Cash equivalents

 

$

44,670

 

$

13,983

 

$

 —

 

$

58,653

 

Marketable securities

 

 

 —

 

 

167,793

 

 

 —

 

 

167,793

 

Total Assets

 

$

44,670

 

$

181,776

 

$

 —

 

$

226,446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

$

 —

 

$

 —

 

$

4,378

 

$

4,378

 

Total liabilities

 

$

 —

 

$

 —

 

$

4,378

 

$

4,378

 

8

Table of Contents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2016

 

    

Level 1

    

Level 2

    

Level 3

    

Total

 

December 31, 2020

 

(In thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

 

Assets:

    

 

    

    

 

    

    

 

    

    

 

    

 

    

    

    

    

    

    

    

    

Cash equivalents

 

$

11,522

 

$

12,691

 

$

 —

 

$

24,213

 

$

14,955

$

1,500

$

$

16,455

Marketable securities

 

 

 —

 

 

143,963

 

 

 —

 

 

143,963

 

 

32,068

32,068

Total

 

$

11,522

 

$

156,654

 

$

 —

 

$

168,176

 

Total assets

$

14,955

$

33,568

$

$

48,523

Liabilities:

Contingent consideration

$

$

$

4,061

$

4,061

Total liabilities

$

$

$

4,061

$

4,061

As of September 30, 2017March 31, 2021 and December 31, 2016,2020, the Company’s cash equivalents consisted of investments with maturities of less than three months and included a money market fund, which was valued based upon Level 1 inputs,inputs.  The Company’s cash equivalents as of December 31, 2020 also included commercial paper, which was valued based upon Level 2 inputs.  The Company’s marketable securities as of March 31, 2021 and December 31, 2020 consisted of commercial paper and asset-backed and U.S. government agency debt securities, which were valued based upon Level 2 inputs.  The Company’s marketable securities as of March 31, 2021 also included corporate debt securities, which were valued based upon Level 2 inputs.

In determining the fair value of its Level 2 investments, the Company relied on quoted prices for identical securities in markets that are not active. These quoted prices were 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.  On a quarterly basis,Quarterly, the Company compares the quoted prices obtained from the third-party pricing service to other available independent pricing information to validate the reasonableness of thosethe quoted prices.prices provided.  The Company evaluates whether adjustments to third-party pricing isare necessary and, historically, the Company has not made adjustments to the quoted prices obtained from the third-party pricing service.  During the ninethree months ended September 30, 2017March 31, 2021 and the year ended December 31, 2016,2020, there were no transfers between Level 1, Level 2 and Level 3.

11


TableThe increase in contingent consideration of Contents$16.4 million during the three months ended March 31, 2021 resulted from updates to the Company’s probability of achieving regulatory milestones and commencing commercialization and estimated future sales level assumptions as a result of the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis and the inclusion of estimated future sales related to hidradenitis suppurativa and psoriatic arthritis which are additional planned indications for ATI-450.

As of September 30, 2017March 31, 2021 and December 31, 2016,2020, the fair value of the Company’s available for sale marketable securities by type of security was as follows:

March 31, 2021

 

Gross

Gross

 

Amortized

Unrealized

Unrealized

Fair

 

(In thousands)

Cost

Gain

Loss

Value

 

Marketable securities:

Corporate debt securities

$

21,556

$

$

(31)

$

21,525

Commercial paper

54,045

54,045

Asset-backed debt securities

14,062

1

(6)

14,057

U.S. government agency debt securities

17,760

3

17,763

Total marketable securities

$

107,423

$

4

$

(37)

$

107,390

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30, 2017

 

 

 

 

 

 

Gross

 

Gross

 

 

 

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

 

 

Cost

 

Gain

 

Loss

 

Value

 

 

    

 

    

    

 

    

    

 

    

    

 

    

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

39,432

 

$

 —

 

$

(9)

 

$

39,423

 

Commercial paper

 

 

76,130

 

 

 —

 

 

 —

 

 

76,130

 

Asset-backed securities

 

 

20,752

 

 

 —

 

 

(3)

 

 

20,749

 

U.S. government agency debt securities

 

 

31,521

 

 

 —

 

 

(30)

 

 

31,491

 

Total marketable securities

 

$

167,835

 

$

 —

 

$

(42)

 

$

167,793

 

9

Table of Contents

December 31, 2020

 

Gross

Gross

 

Amortized

Unrealized

Unrealized

Fair

 

(In thousands)

Cost

Gain

Loss

Value

 

Marketable securities:

Commercial paper

$

20,483

$

$

$

20,483

Asset-backed debt securities

4,036

1

4,037

U.S. government agency debt securities

7,547

1

7,548

Total marketable securities

$

32,066

$

2

$

$

32,068

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

 

 

 

Gross

 

Gross

 

 

 

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

 

 

Cost

 

Gain

 

Loss

 

Value

 

Marketable securities:

    

 

    

    

 

    

    

 

    

    

 

    

 

Corporate debt securities

 

$

51,352

 

$

 —

 

$

(59)

 

$

51,293

 

Commercial paper

 

 

20,463

 

 

 —

 

 

 —

 

 

20,463

 

Asset-backed securities

 

 

28,692

 

 

 6

 

 

(1)

 

 

28,697

 

U.S. government agency debt securities

 

 

43,505

 

 

 8

 

 

(3)

 

 

43,510

 

Total marketable securities

 

$

144,012

 

$

14

 

$

(63)

 

$

143,963

 

5.4. Property and Equipment, Net

Property and equipment, net consisted of the following:

 

 

 

 

 

 

 

 

 

September 30, 

 

 

December 31, 

 

 

2017

 

2016

 

March 31, 

December 31, 

(In thousands)

2021

2020

 

Computer equipment

    

$

593

    

$

310

 

    

$

1,197

    

$

1,197

Manufacturing equipment

 

 

518

 

 

149

 

Lab equipment

 

 

265

 

 

 —

 

1,340

1,340

Furniture and fixtures

 

 

125

 

 

115

 

617

617

Leasehold improvements

 

 

33

 

 

33

 

1,123

1,123

Property and equipment, gross

 

 

1,534

 

 

607

 

 

4,277

 

4,277

Accumulated depreciation

 

 

(331)

 

 

(126)

 

 

(2,853)

 

(2,623)

Property and equipment, net

 

$

1,203

 

$

481

 

$

1,424

$

1,654

Depreciation expense was $103$0.2 million and $32$0.3 million for the three months ended September 30, 2017March 31, 2021 and 2016, respectively, and $208 and $80 for2020, respectively.

5. Intangible Assets

Intangible assets consisted of the nine months ended September 30, 2017 and 2016, respectively. following:

Gross Cost

Accumulated Amortization

Remaining

March 31, 

December 31, 

March 31, 

December 31, 

(In thousands, except years)

    

Life (years)

    

2021

    

2020

    

2021

    

2020

Other intangible assets

6.3

$

751

$

751

$

275

$

257

In-process research and development

na

6,629

6,629

Total intangible assets

$

7,380

$

7,380

$

275

$

257

As of March 31, 2021, estimated future amortization expense is as follows:

Year Ending

(In thousands)

    

December 31,

2021

$

56

2022

 

75

2023

 

75

2024

75

2025

75

Thereafter

120

Total

$

476

1210


6. Accrued Expenses

Accrued expenses consisted of the following:

 

 

 

 

 

 

 

 

 

September 30, 

 

 

December 31, 

 

 

2017

 

2016

 

March 31, 

December 31, 

(In thousands)

2021

2020

 

Employee compensation expenses

$

1,357

$

3,971

Research and development expenses

    

$

866

    

$

1,166

 

1,086

761

Employee compensation expenses

 

 

1,899

 

 

1,732

 

Commercial expenses

 

 

322

 

 

 —

 

Vixen contract payable

 

 

100

 

 

100

 

Other

 

 

323

 

 

380

 

 

1,156

 

1,174

Total accrued expenses

 

$

3,510

 

$

3,378

 

$

3,599

$

5,906

7. Stockholders’ EquityDebt

Preferred StockLoan and Security Agreement – Silicon Valley Bank

In March 2020, the Company entered into a Loan and Security Agreement with Silicon Valley Bank (“SVB”).  The Loan and Security Agreement provides for $11.0 million in term loans, of which the Company borrowed the entire amount on March 30, 2020.  The Loan and Security Agreement is secured by substantially all of the assets of the Company other than intellectual property.  In connection with the Loan and Security Agreement, the Company issued to SVB a warrant to purchase up to 460,251 shares of common stock (the “Warrant”) (see Note 8).  The proceeds of the Loan and Security Agreement were allocated to the term loan and Warrant using a relative fair value approach.  

The term loan repayment schedule provides for interest only payments beginning April 1, 2020 and continuing through March 1, 2022, followed by 24 consecutive equal monthly installments of principal, plus monthly payments of accrued interest, starting on April 1, 2022 and continuing through the maturity date of March 1, 2024. All outstanding principal and accrued and unpaid interest will be due and payable on the maturity date.  The Loan and Security Agreement provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 2% and (ii) 6.75%.  

The Loan and Security Agreement includes a final payment fee equal to 5% of the original principal amount borrowed.  The Company has the option to prepay the outstanding balance of the term loans in full, subject to a prepayment premium of (i) 3% of the original principal amount borrowed for any prepayment on or prior to the first anniversary of March 30, 2020, (ii) 2% of the original principal amount borrowed for any prepayment after the first anniversary and on or before the second anniversary of March 30, 2020 or (iii) 1% of the original principal amount borrowed for any prepayment after the second anniversary of March 30, 2020 but before March 1, 2024.

As of September 30, 2017March 31, 2021 and December 31, 2016,2020 the outstanding principal balance on the SVB Loan and Security Agreement was $11.0 million.

8. Stockholders’ Equity

Preferred Stock

As of March 31, 2021 and December 31, 2020, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock.  NoThere were 0 shares of preferred stock were outstanding as of September 30, 2017March 31, 2021 or December 31, 2016.2020.

Common Stock

As of September 30, 2017March 31, 2021 and December 31, 2016,2020, the Company’s amended and restated certificate of incorporation authorized the Company to issue 100,000,000 shares of $0.00001 par value common stock.

11

Table of Contents

Each share of common stock entitles the holder to one1 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. NoNaN dividends have been declared through September 30, 2017.March 31, 2021.  

At-The-Market Warrants

The Warrant issued to SVB in March 2020 had an initial exercise price of $0.956 per share, subject to adjustment as provided in the Warrant. The Warrant became immediately exercisable in full upon the funding of the term loan facility.  The Company assigned a fair value of $0.4 million to the Warrant using a Black-Scholes valuation methodology, and also concluded that the Warrant was indexed to its own stock and therefore classified the Warrant as an equity instrument.  In January 2021, SVB net exercised the Warrant in full, and the Company issued to SVB 388,119 shares of common stock.  

Equity OfferingPurchase Agreement with Lincoln Park Capital Fund, LLC  

On November 2, 2016,In August 2020, the Company entered into an at-the-market salesequity purchase agreement (the “Purchase Agreement”) with CowenLincoln Park Capital Fund, LLC (“Lincoln Park”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company LLCcould sell to sellLincoln Park, at its discretion, up to $15.0 million of shares of its common stock over the 36-month term of the Purchase Agreement. Upon execution of the Purchase Agreement, the Company issued 121,584 shares of its common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Purchase Agreement. The commitment shares were valued using the closing price of the Company’s securitiescommon stock on the effective date of the Purchase Agreement resulting in an aggregate fair value of $0.3 million.  Through December 31, 2020, the Company sold 2,111,170 shares of its common stock to Lincoln Park under a shelf registration statement filedthe Purchase Agreement for net proceeds of $7.7 million.  The Company terminated the Purchase Agreement in November 2016. DuringJanuary 2021 in connection with the three months ended September 30, 2017, thepublic offering of common stock described below.  The Company did not issuesell any additional shares prior to terminating the Purchase Agreement.

January 2021 Public Offering

In January 2021, the Company closed a public offering in which it sold 6,306,271 shares of common stock under the at-the-market sales agreement.  As of September 30, 2017, the Company had issued and sold an aggregate of 635,000 shares of common stock under the at-the-market sales agreement at a weighted average price to the public of $17.50 per share, of $31.50, for aggregate gross proceeds of $20,003.  The Company incurred expenses of $691 in connection with the shares issued under the at-the-market sales agreement.

Public Offering of Common Stock

On August 10, 2017, the Company entered into an underwriting agreement pursuant to which the Company issued and sold 3,747,602 shares of common stock under a registration statement on Form S-3 (the “Public Offering”), including the underwriters’ partial exercise of their option to purchase additional shares.  The shares of common stock were sold to the public at a price of $23.02 per share, for gross proceeds of $86,270. 

$110.4 million. The Company paid underwriting discounts and commissions of $5,176 to the underwriters$6.6 million, and also incurred expenses of $0.4 million in connection with the Public Offering.  In addition,offering.  As a result, the Company incurred expenses of $176 in connection with the Public Offering.  The

13


net offering proceeds received by the Company, after deducting underwriting discounts, and commissions and offering expenses, were $80,918. $103.3 million.

8. Stock‑Based

9. Stock-Based Awards

2017 Inducement Plan

On July 31, 2017, the Company’s board of directors adopted the 2017 Inducement Plan (the “2017 Inducement Plan”).  The 2017 Inducement Plan is a non-shareholder 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 2017 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 2017 Inducement Plan upon adoption, the Company may grant up to 1,000,000 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 2017 Inducement Plan will be added back to the shares of common stock available for issuance under the 2017 Inducement Plan.  As of September 30, 2017, 622,452 shares of common stock were available for grant under the 2017 Inducement Plan. 

2015 Equity Incentive Plan

OnIn September 15, 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and on September 16, 2015, 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, RSUrestricted 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 beginning on January 1, 2016 and 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 3131st 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, 2017,2021, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 1,042,3671,804,372 shares.  As of September 30, 2017, 1,368,904March 31, 2021,

12

Table of Contents

2,937,121 shares remained available for grant under the 2015 Plan.  The Company had 2,725,405 stock options and 2,385,853 RSUs outstanding as of March 31, 2021 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 439,500 stock options and 25,758 RSUs outstanding as of March 31, 2021 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

Upon the 2015 Plan becoming effective, no0 further grants can be made under the 2012 Plan. The Company granted stock options to purchase a total of 1,140,524 shares under the 2012 Plan, of which 1,003,647 and 1,049,667549,561 were outstanding as of September 30, 2017 and DecemberMarch 31, 2016, respectively.2021.  Stock options granted under the 2012 Plan vest over four years and expire after ten years.  As required, the exercise price for the stock options granted under the 2012 Plan was not less than the fair value of common shares as determined by the Company as of the date of grant. 

14


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, 2021 and 2020 were as follows:

 

 

 

 

 

 

 

    

Nine Months Ended

 

 

 

September 30, 

 

 

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

    

Three Months Ended

March 31, 

2021

2020

Risk-free interest rate

 

1.89

%

 

1.41

%

 

 

0.90

%

0.97

%

Expected term (in years)

 

6.2

 

 

6.5

 

 

 

6.3

6.2

Expected volatility

 

93.84

%

 

96.60

%

 

 

76.60

%

85.28

%

Expected dividend yield

 

 0

%

 

 0

%

 

 

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 from January 1, 2017 through September 30, 2017:for the three months ended March 31, 2021:

    

    

    

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, 2020

 

2,871,498

$

15.16

 

6.8

$

4,890

Granted

 

880,600

24.06

Exercised

 

(27,632)

15.06

224

Forfeited and cancelled

 

(10,000)

21.93

Outstanding as of March 31, 2021

 

3,714,466

$

17.25

 

7.3

$

31,732

Options vested and expected to vest as of March 31, 2021

 

3,714,466

$

17.25

 

7.3

$

31,732

Options exercisable as of March 31, 2021

 

2,083,539

$

17.56

 

5.9

$

18,085

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

 

    

Weighted

    

 

 

 

 

 

 

 

Weighted

 

Average

 

 

 

 

 

 

 

 

Average

 

Remaining

 

Aggregate

 

 

 

Number

 

Exercise

 

Contractual

 

Intrinsic

 

 

 

of Shares

 

Price

 

Term

 

Value

 

 

 

 

 

 

 

 

(in years)

 

 

 

 

Outstanding as of December 31, 2016

 

2,702,350

 

$

18.94

 

9.05

 

$

24,434

 

Granted

 

617,500

 

 

26.47

 

 

 

 

 

 

Exercised

 

(36,738)

 

 

6.40

 

 

 

 

 

 

Forfeited and cancelled

 

(40,281)

 

 

21.09

 

 

 

 

 

 

Outstanding as of September 30, 2017

 

3,242,831

 

$

20.49

 

8.60

 

$

21,704

 

Options vested and expected to vest as of September 30, 2017

 

3,242,831

 

$

20.49

 

8.60

 

$

21,704

 

Options exercisable as of September 30, 2017

 

828,823

(1)

$

10.95

 

7.73

 

$

12,666

 


(1)

All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of September 30, 2017.

The weighted average grant date fair value of stock options granted during the ninethree months ended September 30, 2017March 31, 2021 was $20.41$16.15 per share.

The intrinsic value of a stock option is calculated as the difference between the exercise price of the stock option and the fair value of the underlying common stock, and cannot be less than zero. 

1513


Restricted Stock Units

The following table summarizes RSU activity from January 1, 2017 through September 30, 2017:for the three months ended March 31, 2021:

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Average

 

 

 

 

 

Grant Date

 

 

 

Number

 

Fair Value

 

 

 

of Shares

 

Per Share

 

Outstanding as of December 31, 2016

 

219,614

 

$

27.43

 

Granted

 

88,547

 

 

26.59

 

Vested

 

(9,299)

 

 

20.32

 

Forfeited and cancelled

 

(4,531)

 

 

27.05

 

Outstanding as of September 30, 2017

 

294,331

 

$

27.41

 

Stock‑Based

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, 2020

2,244,157

$

3.83

Granted

565,600

24.06

Vested

(377,371)

5.94

$

8,892

Forfeited and cancelled

(20,775)

2.85

Outstanding as of March 31, 2021

2,411,611

$

8.25

Stock-Based Compensation

The following table summarizes stock‑basedStock-based compensation expense recorded byincluded in total costs and expenses on the Company:condensed consolidated statement of operations included the following:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30, 

 

September 30, 

 

     

2017

     

2016

     

2017

     

2016

 

Three Months Ended

 

March 31, 

 

(In thousands)

    

2021

    

2020

 

Cost of revenue

    

$

130

    

$

 —

  

$

130

    

$

 —

 

  

$

247

    

$

260

Research and development

 

 

1,332

 

 

623

 

 

3,853

 

 

1,577

 

876

816

General and administrative

 

 

2,211

 

 

995

 

 

6,147

 

 

2,617

 

 

1,552

 

2,377

Total stock-based compensation expense

 

$

3,673

 

$

1,618

 

$

10,130

 

$

4,194

 

$

2,675

$

3,453

As of September 30, 2017,March 31, 2021, the Company had unrecognized stock‑basedstock-based compensation expense for stock options and RSUs of $37,674$17.1 million and $6,090,$17.8 million, respectively, each of which is expected to be recognized over a weighted average periodsperiod of 3.06 years and 2.93 years, respectively.3.4 years.  

9.

10. Net Loss per Share

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30, 

 

September 30, 

 

 

2017

 

2016

    

2017

    

2016

 

Three Months Ended

 

March 31, 

 

(In thousands, except for share and per share data)

    

2021

    

2020

Numerator:

    

 

    

    

 

    

 

 

    

    

 

    

 

    

    

    

Net loss

 

$

(18,192)

 

$

(10,694)

 

$

(45,589)

 

$

(36,604)

 

$

(28,754)

$

(15,586)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares of common stock outstanding

 

 

28,834,808

 

 

21,415,871

 

 

27,180,244

 

 

20,752,590

 

Weighted average shares of common stock outstanding, basic and diluted

 

50,337,807

 

41,618,429

Net loss per share, basic and diluted

 

$

(0.63)

 

$

(0.50)

 

$

(1.68)

 

$

(1.76)

 

$

(0.57)

$

(0.37)

The Company’s potentially dilutive securities, which included stock options, RSUs and RSUs,warrants, 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 sharesstock outstanding used to calculate both basic and diluted net loss per share is the same.  The following table presents potential shares of common sharesstock excluded from the calculation

14

of diluted net loss per

16


share for both the three and nine months ended September 30, 2017March 31, 2021 and 2016.2020.  All share amounts presented in the table below represent the total number outstanding as of September 30, 2017March 31, 2021 and 2016.2020.

 

 

 

 

 

 

 

 

 

September 30, 

 

 

2017

 

2016

 

 

 

 

 

 

March 31, 

2021

2020

Options to purchase common stock

 

3,242,831

 

1,913,419

    

3,714,466

3,429,933

Restricted stock unit awards

 

294,331

 

85,000

 

2,411,611

3,870,059

Total potential common shares

 

3,537,162

 

1,998,419

 

Warrants

460,251

Total potential shares of common stock

6,126,077

7,760,243

10. Commitments and Contingencies

11. Leases

Operating Leases

Agreements for Office Space

The Company has a sublease agreement with Auxilium Pharmaceuticals, LLC (the “Sublandlord”) pursuant to which it subleases 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania. The sublease has a term that runs through October 2023. If for any reason the lease between Chesterbrook Partners, LP (“Landlord”) and Sublandlord is terminated or expires prior to October 2023, the Company’s sublease will automatically terminate. In December 2020, the Company entered into a sub-sublease agreement under which it sub-subleased 8,115 square feet.  The sub-sublease term runs concurrently with the original sublease agreement.

In August 2013,February 2019, the Company entered into a sublease agreement with a related party (see Note 11) for office space which is its corporate headquarters.  The sublease was subsequently amended and restated in March 2014, for its office space with a term ending on November 30, 2016.  The Company further amended the terms of this sublease agreement in December 2014, August 2015, February 2016, October 2016 and July 2017 to increase the square footage of the space being subleased and/or agree to new sublease terms.  The August 2015 amendment extended the term of the lease to November 2019. 

In November 2016, the Company entered into a lease agreement with a third party for additional office space in the same building as its headquarters with a term beginning in February 2017 and ending in November 2019. 

Confluence occupies20,433 square feet of office and laboratory space in St. Louis, Missouri under the termsMissouri. The lease commenced in June 2019 and has a term that runs through June 2029.

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

March 31, 

December 31, 

(In thousands)

2021

2020

Operating Leases:

Gross cost

$

5,240

$

5,240

Accumulated amortization

(1,279)

(1,111)

Other assets

$

3,961

$

4,129

Current portion of lease liabilities

$

625

$

603

Other liabilities

2,730

2,894

Total operating lease liabilities

$

3,355

$

3,497

Amortization expense related to operating lease right-of-use assets and accretion of an agreement which it entered into in March 2017 and which expires in December 2017. 

Rent expense was $110 and $66operating lease liabilities totaled $0.3 million for each of the three months ended September 30,March 31, 2021 and 2020.

Finance Leases

Laboratory Equipment

The Company leased laboratory equipment which it used in its laboratory space in St. Louis, Missouri under 2 finance lease financing arrangements which the Company entered into in August 2017 and 2016, respectively,October 2017, with terms ended in October 2020 and $284 and $178 for the nine months ended September 30, 2017 and 2016,December 2020, respectively. The Company recognizes rent expense on a straight-line basis over the term of the lease and has accrued for rent expense incurred but not yet paid. 

As of September 30, 2017, future minimum lease payments under these agreements were as follows:

 

 

 

 

 

Year Ending December 31, 

    

    

 

 

2017

 

$

114

 

2018

 

 

394

 

2019

 

 

368

 

2020

 

 

 —

 

2021

 

 

 —

 

Thereafter

 

 

 —

 

Total

 

$

876

 

1715


11.12. Related Party Transactions

Mallinckrodt plc

In August 2013,April 2018, Bryan Reasons was appointed to the Company’s board of directors. Subsequently, in March 2019, Mr. Reasons became the Chief Financial Officer of Mallinckrodt plc.  Prior to Mr. Reasons joining Mallinckrodt plc, the Company entered into a subleasemaster services agreement with NeXeption, Inc. ("NeXeption"), which was subsequently amended and restated in March 2014 and further amended in December 2014.  In August 2015,a subsidiary of Mallinckrodt plc, pursuant to an Assignment and Assumption Agreement, NeXeption, Inc. assigned all interests, rights, duties and obligations underwhich Confluence provides laboratory services to the sublease to NST Consulting, LLC, a wholly-owned subsidiary (“Mallinckrodt”) in the ordinary course of NST, LLC.  Followingbusiness. Mr. Reasons was not involved in the Assignment and Assumption Agreement, the sublease was further amended in August 2015, February 2016, October 2016 and July 2017.  Mr. Stephen Tullman, the chairmannegotiation or execution of the Company’s board of directors, wasagreement, but may be deemed to have an interest in the ongoing transactions based on his employment as an executive officer of NeXeption and is also the manager of NST Consulting, LLC and NST, LLC. Total payments made under the sublease duringMallinckrodt plc.  During the three months ended September 30, 2017March 31, 2021 and 2016 were $1062020, the Company invoiced Mallinckrodt for $20 thousand and $64,$0.2 million, respectively, under the master services agreement.  As of March 31, 2021 and December 31, 2020, the Company had $20 thousand and $24 thousand, respectively, of outstanding accounts receivable balances from Mallinckrodt.  Mr. Reasons had no financial interest in these transactions.  

13.Agreements Related to Intellectual Property

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.  EPI Health agreed to pay the Company a high single-digit royalty calculated as a percentage of net sales on a country-by-country basis until the date that the patent rights related to RHOFADE have expired or, if later, ten years from the date of the first commercial sale of RHOFADE in such country.  The Company recorded royalty income under the asset purchase agreement of $0.2 million during each of the ninethree months ended September 30, 2017March 31, 2021 and 2016 were $231 and $179, respectively. 

In February 2014, the Company entered into a services agreement with NST, LLC (the “NST Services Agreement”), pursuant to which NST, LLC provided certain pharmaceutical development, management and other administrative services to the Company. Under the same agreement, the Company also provided services to another company under common control with the Company and NST, LLC and was reimbursed by NST, LLC for those services. In addition to Mr. Tullman’s role as manager of NST, LLC, several of the Company’s executive officers are members of NST, LLC. 

The NST Services Agreement was amended in December 2014 pursuant to which NST, LLC assigned all interests, rights, duties and obligations under the NST Services Agreement to NST Consulting, LLC. Under the NST Services Agreement, as amended, NST Consulting, LLC provides services to the Company and the Company provides services to another company under common control with the Company and NST Consulting, LLC. The NST Services Agreement was further amended in August 2015, November 2015, January 2016, December 2016 and May 2017 to reduce the amount of services the Company2020.  Royalty income is obligated to provide to NST Consulting, LLC and the amount of services NST Consulting, LLC is obligated to provide to the Company. The Company may offset any payments owed by the Company to NST Consulting, LLC against payments that are owed by NST Consulting, LLC to the Company for the provision of personnel, including consultants, to the Company. 

18


During the three and nine months ended September 30, 2017 and 2016, amounts included in other revenue on the condensed consolidated statementstatements of operations and comprehensive loss forloss.  EPI Health has also agreed to pay the NST Services Agreement are summarizedCompany potential sales milestone payments of up to $20.0 million in the following table:aggregate upon the achievement of specified levels of net sales of products covered by the asset purchase agreement, and 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health in connection with any license or sublicense of the assets transferred in the disposition in any territory outside of the United States, subject to specified exceptions.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

    

2017

    

2016

    

2017

    

2016

 

Services provided by NST Consulting, LLC

 

$

49

 

$

79

 

$

161

 

$

237

 

Services provided to NST Consulting, LLC

 

 

 —

 

 

(15)

 

 

(18)

 

 

(45)

 

General and administrative expense, net

 

$

49

 

$

64

 

$

143

 

$

192

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Services provided by NST Consulting, LLC

 

$

 —

 

$

60

 

$

 —

 

$

181

 

Services provided to NST Consulting, LLC

 

 

 —

 

 

(21)

 

 

 —

 

 

(63)

 

Research and development expense, net

 

$

 —

 

$

39

 

$

 —

 

$

118

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Services provided by NST Consulting, LLC

 

$

49

 

$

139

 

$

161

 

$

418

 

Services provided to NST Consulting, LLC

 

 

 —

 

 

(36)

 

 

(18)

 

 

(108)

 

Total, net

 

$

49

 

$

103

 

$

143

 

$

310

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net payments made to NST

 

$

35

 

$

88

 

$

218

 

$

263

 

The Company had $17 and $91 payable to NST Consulting, LLC under the NST Services Agreement as of September 30, 2017 and December 31, 2016, respectively. 

12.Agreements Related to Intellectual Property

Assignment Agreement and Finder’s Services AgreementPlan of Merger – Confluence

In August 2012,2017, the Company entered into an assignment agreement withAgreement and Plan of Merger, pursuant to which it acquired Confluence (the “Confluence Agreement”).  In November 2018, a development milestone specified in the EstateConfluence Agreement was achieved, as a result of Mickey Miller, or the Miller Estate, under which the Company acquired somepaid the former Confluence equity holders $2.5 million in cash and issued 253,208 shares of its common stock with a fair value of $2.2 million.  Under the intellectual property rights covering A-101. In connection with obtaining the assignment of the intellectual property from the Miller Estate,Confluence Agreement, the Company also entered into a separate finder’s services agreement with KPT Consulting, LLC. In February 2016, underagreed to pay the termsformer Confluence equity holders aggregate remaining contingent consideration of the assignment agreement and the finder’s services agreement, the Company made a milestone payment of $300 upon the dosing of the first human subject with A-101 40% Topical Solution in the Company’s Phase 3 clinical trial. In April 2017, the Company made an additional milestone payment of $1,000up to $75.0 million based upon the achievement of specified regulatory milestones. The payments were recorded as general and administrative expensescommercial milestones set forth in the Company’s consolidated statement of operations.

Under the finder’s services agreement,Confluence Agreement.  In addition, the Company is obligated to make additional milestone payments of up to $4,500 upon the achievement of specified commercial milestones. Under each of the assignment agreement and the finder’s services agreement, the Company is also obligatedagreed to pay royalties on sales of A-101 or related products, atthe former Confluence equity holders future royalty payments calculated as a low single-digit percentagespercentage of net sales, subject to reduction in specified circumstances. The Company has not made any royalty payments to date under either agreement. Both agreements will terminate upon the expiration of the last pending, viable patent claim of the patents acquired under the assignment agreement, but no sooner than 15 years from the effective date of the agreements.

19


Stock Purchase Agreement with Vixen Pharmaceuticals, Inc. and License Agreement with Columbia University

On March 24, 2016, the Company entered into a stock purchase agreement (the “Vixen Agreement”) with Vixen, JAK1, LLC, JAK2, LLC and JAK3, LLC (together with JAK1, LLC and JAK2, LLC, the “Selling Stockholders”) and Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the representative of the Selling Stockholders.  Pursuant to the Vixen Agreement, the Company acquired all shares of Vixen’s capital stock from the Selling Stockholders (the “Vixen Acquisition”). Following the Vixen Acquisition, Vixen became a wholly-owned subsidiary of the Company. Pursuant to the Vixen Agreement, the Company paid $600 upfront and issued an aggregate of 159,420 shares of the Company’s common stock to the Selling Stockholders. The Company is obligated to make annual payments of $100 on March 24th of each year, through March 24, 2022, with such amounts being creditable against specified future payments that may be paid under the Vixen Agreement.

The Company is obligated to make aggregate payments of up to $18,000 to the Selling Stockholders upon the achievement of specified pre-commercialization milestones for three products in the United States, the European Union and Japan, and aggregate payments of up to $22,500 upon the achievement of specified commercial milestones. With respect to any commercialized products covered by the Vixen Agreement, the Company is obligated to pay low single-digit royalties on 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.  IfIn addition to the payments described above, if the Company sublicensessells, licenses or transfers any of Vixen’s patent rights and know-howthe intellectual property acquired from Confluence pursuant to the VixenConfluence Agreement to a third party, the Company will be obligated to pay a portion of any consideration the Company receives from such sublicenses in specified circumstances.

As a result of the transaction with Vixen, the Company became party to the Exclusive License Agreement, by and between Vixen and the Trustees of Columbia University in the City of New York (“Columbia”), dated as of December 31, 2015 (the “License Agreement”). Under the License Agreement, the Company is obligated to pay Columbia an annual license fee of $10, subject to specified adjustments for patent expenses incurred by Columbia and creditable against any royalties that may be paid under the License Agreement. The Company is also obligated to pay up to an aggregate of $11,600 upon the achievement of specified commercial milestones, including specified levels of net sales of products covered by Columbia patent rights and/or know-how, and royalties at a sub-single-digit percentage of annual net sales of products covered by Columbia patent rights and/or know-how, subject to specified adjustments. If the Company sublicenses any of Columbia’s patent rights and know-how acquired pursuant to the License Agreement, it will be obligated to pay Columbiaformer Confluence equity holders a portion of any consideration received from such sublicensessale, license or transfer in specified circumstances.  The royalties, as determined on a country-by-country and product-by-product basis, are payable until the date that all of the patent rights for that product have expired, the expiration of any market exclusivity period granted by a regulatory body or, in specified circumstances, ten years from the first commercial sale of such product.  The License Agreement terminates on the date of expiration of all royalty obligations thereunder unless earlier terminated by either party for a material breach, subject to a specified cure period. The Company may also terminate the License Agreement without cause at any time upon advance written notice to Columbia.

The Company accounted for the transaction with Vixen as an asset acquisition as the arrangement did not meet the definition of a business pursuant to the guidance prescribed in Accounting Standards Codification Topic 805, Business Combinations. The Company concluded the transaction with Vixen did not meet the definition of a business because the transaction principally resulted in the acquisition of the License Agreement. The Company did not acquire tangible assets, processes, protocols or operating systems. In addition, at the time of the transaction, there were no activities being conducted related to the licensed patents. The Company expensed the acquired intellectual property as of the acquisition date on the basis that the cost of intangible assets purchased from others for use in research and development activities, and that have no alternative future uses, are expensed at the time the costs are incurred.  Accordingly, the Company recorded the $600 upfront payment, the fair value of the shares of common stock issued of $2,355, and the present value of the six non-contingent annual payments as research and development expense in the nine months ended September 30, 2016.  Additionally, the Company will record as expense any contingent milestone payments or royalties in the period in which such liabilities are incurred.

2016


13.14. Income Taxes

The Company did not record a federal or state income tax benefit for losses incurred during each of the three and nine months ended September 30, 2017March 31, 2021 and 2016 due2020.  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.

15. Discontinued Operations

The following table presents information related to liabilities reported as discontinued operations in the Company’s conclusioncondensed consolidated balance sheet:  

March 31, 

December 31,

(In thousands)

    

2021

    

2020

Accounts payable

$

971

$

1,175

Accrued expenses

  

2,018

1,936

Discontinued operations - current liabilities

$

2,989

$

3,111

16. Segment Information

The Company has 2 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.  The contract research segment earns 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.  Corporate and other includes general and administrative expenses as well as eliminations of intercompany transactions.  The Company does not report balance sheet information by segment since it is not reviewed by the chief operating decision maker, and all of the Company’s tangible assets are held in the United States.  

The Company’s results of operations by segment for the three months ended March 31, 2021 and 2020 are summarized in the tables below:

(In thousands)

Contract

Corporate

Total

Three Months Ended March 31, 2021

Therapeutics

Research

and Other

Company

Total revenue

$

242

$

3,200

$

(1,665)

$

1,777

Cost of revenue

2,769

(1,567)

1,202

Research and development

7,936

(98)

7,838

General and administrative

629

4,198

4,827

Revaluation of contingent consideration

16,439

16,439

Loss from operations

$

(24,133)

$

(198)

$

(4,198)

$

(28,529)

(In thousands)

Contract

Corporate

Total

Three Months Ended March 31, 2020

Therapeutics

Research

and Other

Company

Total revenue

$

218

$

3,407

$

(2,218)

$

1,407

Cost of revenue

3,386

(2,117)

1,269

Research and development

7,778

(101)

7,677

General and administrative

753

5,447

6,200

Revaluation of contingent consideration

1,767

1,767

Loss from operations

$

(9,327)

$

(732)

$

(5,447)

$

(15,506)

Loss from discontinued operations

$

(257)

$

$

(1)

$

(258)

17

Intersegment Revenue

Revenue for the contract research segment included $1.7 million and $2.2 million for services performed on behalf of the therapeutics segment for the three months ended March 31, 2021 and 2020, respectively.  All intersegment revenue has been eliminated in the Company’s condensed consolidated statement of operations.  

17. Legal Proceedings

Securities Class Action

On July 30, 2019, plaintiff Linda Rosi (“Rosi”) filed a putative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York against the Company and certain of its executive officers.  The complaint alleges that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product.  The complaint seeks unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired the Company’s securities between May 8, 2018 and June 20, 2019. 

On September 5, 2019, an additional plaintiff, Robert Fulcher (“Fulcher”), filed a valuation allowance is required.substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al. in the same court against the same defendants.

14. Subsequent Events

On November 6, 2019, the court consolidated the Rosi and Fulcher actions (together, the “Consolidated Securities Action”) and appointed Fulcher “lead plaintiff” for the putative class. 

On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming 2017,additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness. The defendants filed a motion to dismiss the consolidated amended complaint on April 17, 2020. Following briefing and oral argument on February 25, 2021, the motion was granted in part and denied in part on March 29, 2021, and the issues in dispute significantly narrowed. The defendants filed an answer to the remaining aspects of the consolidated amended complaint on April 19, 2021.

The Company and the other defendants dispute plaintiffs’ claims in the Consolidated Securities Action.  At this time, the Company entered intocannot reasonably predict the outcome or potential loss, if any, that could result from this matter.

Stockholder Derivative Action

On November 15, 2019, plaintiff Keith Allred (“Allred”) filed a Sublease Agreementderivative stockholder complaint captioned Allred v. Walker et al. in the U.S. District Court for the Southern District of New York against certain of the Company’s directors and executive officers.  The complaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action.  The complaint seeks, among other things, unspecified compensatory damages on behalf of the Company.  

On November 25, 2019, an additional plaintiff, Bruce Brown (“Brown”), filed a substantially identical complaint captioned Brown v. Walker et al. in the same court against the same defendants.

On December 12, 2019, the court consolidated the Allred and Brown actions under the caption In re Aclaris Therapeutics, Inc. Derivative Litigation (the “Sublease”“Consolidated Derivative Action”) with Auxilium Pharmaceuticals, LLC, a Delaware limited liability company (the “Sublandlord”), under whichand directed that future derivative cases filed in or transferred to the court arising out of substantially the same transactions or events be similarly consolidated.  Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the Consolidated Derivative Action pending resolution of the defendants’ anticipated motion to dismiss the Consolidated Securities Action. The stay expired on April 27, 2021, but may be reinstated pending further developments in the

18

Consolidated Securities Action. No further proceedings have yet occurred or been scheduled in the Consolidated Derivative Action.

At this time, the Company will lease 33,019 square feetcannot reasonably predict the outcome or potential loss, if any, that could result from this matter.

Product Liability Lawsuit

On December 18, 2020, plaintiff Daurie Mancini filed an amended complaint under the caption Daurie Mancini v. Aclaris Therapeutics, Inc. et al in the Superior Court of space for its corporate headquarters.  The termNew Jersey Ocean County against the Company and certain third parties alleging injuries as a result of the Sublease will beginplaintiff’s alleged treatment with ESKATA in 2019. The amended complaint seeks unspecified compensatory and punitive damages. The Company filed a motion to dismiss the amended complaint on December 1, 2017March 15, 2021. Briefing on the Company’s motion to dismiss has not been completed.

The Company disputes plaintiff’s claims and expire on October 31, 2023.  Underintends to defend the Sublease, base rent for the period from December 1, 2017 through February 28, 2018 shall be abated, after whichmatter vigorously. At this time, the Company will pay an initial base rent of $47 per month through February 28, 2019.  Beginning March 1, 2019,cannot reasonably predict the monthly base rent will increase annually as specified in the Sublease. In addition, the Company will pay its pro rata share of the annual operating expenses associated with the premises, calculated as set forth in the Sublease. outcome or potential loss, if any, that could result from this matter.

2119


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

Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would“may,” “might,” “can,” “will,” “to be,” “will allow,“could,“intends to,“would,“will likely result,“should,“are expected to,“expect,“will continue,“intend,“is anticipated,“plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “likely,” “continue,” “ongoing” or similar expressions, or the negative of such words, or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to a number of factors, including risks related to:

·

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

·

the success and timing of our preclinical studies and clinical trials and regulatory approval of protocols for future clinical trials;

·

the difficulties in obtaining and maintaining regulatory approval of our drug candidates, and the labeling under any approval we may obtain;

·

our plans and ability to develop, manufacture and commercialize our drug candidates;

·

the expected benefits of our acquisition of Confluence Life Sciences, Inc.;

·

our ability to recruit or retain key scientific or management personnel or to retain our executive officers;

·

the size and growth of the potential markets for our drug candidates and our ability to serve those markets;

·

regulatory developments in the United States and foreign countries;

·

the rate and degree of market acceptance of any of our drug candidates;

·

our ability to obtain and maintain intellectual property protection for our drug candidates and our proprietary technology;

·

the successful development of our commercialization capabilities, including sales and marketing capabilities;

·

the impact of recently enacted and future legislation and regulation regarding the healthcare system;

·

the success of competing therapies and products that are or become available; and

·

the performance of third parties, including contract research organizations and third-party manufacturers.

These and other factorsstatements. Factors that could cause or contribute to these differences are describedinclude those below in this Quarterly Report on Form 10-Q and those in Part II – Item 1A,our Annual Report on Form 10-K, in each case under the caption “Risk Factors,” and under similar captions in our other filings with the Securities and Exchange Commission.Commission, or SEC. Statements made herein are as of the date of the filing of this Form 10-Q with the

22


Securities and Exchange Commission SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2016,2020, which are included in our 2016 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC on March 15, 2017.February 25, 2021.

Overview

We are a dermatologist-ledclinical-stage biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapiesnovel drug candidates for immuno-inflammatory diseases.  In addition to address significant unmet needs in medical and aesthetic dermatology. Our leaddeveloping our novel drug candidate, A-101 40% Topical Solution, is a proprietary formulation of high-concentration hydrogen peroxide topical solution thatcandidates, we are developing as a prescription treatmentpursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for seborrheic keratosis, and/or SK, a common non-malignant skin tumor.  In the first quarter of 2016, we initiated two multi-center, randomized, double blinded, vehicle-controlled Phase 3 clinical trials and one open-label Phase 3 clinical trial of A-101 40% Topical Solution in patients with SK. In November 2016, we announced positive top-line results from the two pivotal Phase 3 clinical trials, which are summarized below.  Based on these results, wecommercialize our novel drug candidates.

ATI-450, an Investigational Oral MK2 Inhibitor

We submitted aan Investigational New Drug Application, or NDA,IND, in April 2019 for A-101 40% Topical SolutionATI-450, an investigational oral, novel, small molecule selective mitogen-activated protein kinase-activated protein kinase 2, or MK2, inhibitor compound, for the treatment of SK torheumatoid arthritis, which was allowed by the U.S. Food and Drug Administration, or FDA, in February 2017,May 2019.  MK2 is a key regulator of pro-inflammatory mediators including TNFα, IL1β, IL6, IL8 and other essential pathogenic signals in chronic immuno-inflammatory diseases, as well as in oncology.  As an oral drug candidate, we are developing ATI-450 as a potential alternative to injectable anti-TNF/IL1/IL6 biologics and JAK inhibitors for treating certain immuno-inflammatory diseases.

We initiated a Phase 1 single (at 10mg, 30mg, 50mg and 100mg doses) and multiple ascending (at 10mg, 30mg and 50mg doses) dose clinical trial evaluating ATI-450 in 77 healthy subjects in August 2019 (ATI-450-PKPD-101). Final data from this trial demonstrated that ATI-450 resulted in marked inhibition of TNFα, IL1β, IL8 and IL6. We also observed that ATI-450 had dose-proportional pharmacokinetics with a terminal half-life of 9-12 hours in the NDAmultiple ascending dose cohort, and had no meaningful food effect or drug-drug interaction with methotrexate.  ATI-450 was accepted for filinggenerally well-tolerated at all doses tested in the trial.  The most common adverse events (reported by 2 or more subjects who received ATI-450) were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain and nausea. 

ATI-450 was also evaluated at 80mg and 120mg doses twice daily in a second Phase 1 clinical trial in healthy subjects (ATI-450-PKPD-102). Preliminary topline data from this trial showed that no dose-limiting toxicity was observed. Ex vivo analysis of blood samples from this Phase 1 trial showed that increased cytokine inhibition was achieved with these higher doses of ATI-450 relative to doses tested in the FDAfirst Phase 1 trial. No serious adverse events were reported and all adverse events were mild to moderate. The most common adverse events (reported by 2 or more subjects who received ATI-450) were headache, dizziness, nausea, parasthesia and, in May 2017.  The Prescription Drug User Fee Act, or PDUFA, target action date forthe post-dosing follow-up period of the trial, dry skin. These adverse events were all mild in severity. A final analysis of this trial is underway.

20

Moderate to Severe Rheumatoid Arthritis

Following the completion of the FDA’s reviewfirst Phase 1 clinical trial, in March 2020 we initiated a 12-week, Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis (ATI-450-RA-201). In the trial, which consisted of a 12-week treatment period and a 4-week follow-up period, 19 subjects were randomized in a 3:1 ratio and received either ATI-450 at 50 mg twice daily or placebo, in combination with methotrexate, for 12 weeks.

The final per-protocol analysis, which consisted of the NDA is December 24, 2017.  We also submitted a Marketing Authorization Application, or MAA,17 subjects who completed the treatment period (15 in the European Uniontreatment arm and two in July 2017.  We are also developing A-101 45% Topical Solutionthe placebo arm), confirmed that ATI-450 demonstrated durable clinical activity, as defined by a prescription treatment for common warts, also known as verruca vulgaris.  Additionally,marked and sustained reduction in 2015, we in-licensed exclusive, worldwide rights to certain inhibitorsDAS28-CRP and improvement of the Janus kinase, or JAK, family of enzymes, for specified dermatological conditions, including alopecia areata, or AA, vitiligo and androgenetic alopecia, or AGA.  In 2016, we acquired additional intellectual property rights for the development and commercialization of certain JAK inhibitors for specified dermatological conditions.  We intend to continue to in-license or acquire additional drug candidates and technologies to build a fully integrated dermatology company.

In November 2016, we completed two pivotal Phase 3 clinical trials of A-101 40% Topical Solution in a combined 937 patients who each had a total of four target SK lesions located on the face, trunk and extremities.  Each trial met all primary and secondary endpoints for that trial, achieving clinically and statistically significant clearance of SK lesions. Additionally, we completed an open-label safety trial of A-101 40% Topical Solution in November 2016, in which we enrolled 147 patients.  Across all three clinical trials, there were no treatment-related seriousACR20/50/70 responses over 12 weeks. ATI-450 was generally well tolerated. All adverse events among patients treated with A-101 40% Topical Solution, and thewere mild to moderate. The most common adverse events (each reported in 2 subjects) were nasopharyngitisurinary tract infection, or UTI, and sinusitisventricular extrasystoles, all of which were determined to be unrelated to A-101 40% Topical Solution.  treatment except for one UTI. Two subjects withdrew from the trial during the treatment period, one in the treatment arm and one in the placebo arm. The subject in the treatment arm withdrew due to palpitations, which were unrelated to the trial medication, and an elevated creatine phosphokinase, or CPK, which was determined by the site investigator to be treatment-related. The subject in the placebo arm withdrew as a result of prohibited medication needed to treat muscle strain. There was also one non-treatment-related serious adverse event (COVID-19) reported in the 4-week follow-up period of the trial in a subject who was no longer receiving treatment. The subject withdrew during the 4-week follow-up period of the trial.

A final analysis, which consisted of the 17 subjects, of ex vivo stimulated cytokines from blood samples taken from the treatment arm showed a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 over the 12-week treatment period. Similarly, analysis of endogenous inflammation biomarkers also demonstrated a marked and sustained inhibition of median concentrations of hsCRP, TNFα, IL6, IL8 and MIP1β in the treatment arm over the 12-week period.

We plan to submit for publication a full analysis of the Phase 2a data in a peer-reviewed scientific journal which will include data from other secondary and exploratory endpoints evaluated in the trial, including the 4-week follow-up data and a full analysis of MRI, pharmacodynamic and pharmacokinetic data.

Based on thesethe results observed in the Phase 2a trial, we intend to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.

Hidradenitis Suppurativa and Psoriatic Arthritis

As part of the planned expansion of our Phase 2 immuno-inflammatory clinical development programs, we also plan to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis.


ATI-1777, an Investigational Topical “Soft” JAK 1/3 Inhibitor

In June 2020, we submitted an NDAIND for A-101 40% Topical SolutionATI-1777, an investigational topical “soft” JAK 1/3 inhibitor compound, for the treatment of SKmoderate to the FDA in February 2017,severe atopic dermatitis. “Soft” JAK inhibitors are designed to be topically applied and the NDA was accepted by the FDA in May 2017.  We also submitted an MAAactive in the European Unionskin, but rapidly metabolized and inactivated when they enter the bloodstream, which may result in July 2017.  The PDUFA target action date for the completion of the FDA’s review of the NDA is December 24, 2017.  If approved, A-101 40% Topical Solution would become the first FDA-approved medication for the treatment of SK. low systemic exposure.

23


We are also developing A-101 45% Topical Solution for the treatment of common warts.  Although common warts are generally not harmful and in most cases eventually clear without medical treatment, they may be painful and aesthetically unattractive and are contagious.  On an annual basis, 1.9 million people are diagnosed with common warts. Common warts can be removed with slow-acting, over-the-counter products containing salicylic acid. As with SK, cryosurgery is the most frequently used in-office treatment for common warts. No prescription drugs have been approved by the FDA for the treatment of common warts.  We completedIn October 2020, we initiated a Phase 22a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in August 2016 evaluating 40% and 45% concentrations of A-101 for the treatment of common warts.  In this Phase 2 clinical trial, in which 90 patients completed an eight-week treatment period, we observed statistically significant improvements in the mean change in the Physician’s Wart Assessment, or PWA, score and in complete clearance of common warts in patients treated50 subjects with the 45% concentration of A-101 comparedmoderate to placebo.  In June 2017, we commenced two additional Phase 2 clinical trials of A-101 45% Topical Solution to assess the dose frequency in adult and pediatric patients with common warts.severe atopic dermatitis (ATI-1777-AD-201). We have completed enrollment in these trials, with a total of 316 patients enrolled at 34 investigational centers in the United States.  WeMarch 2021 and expect to report data from these additional Phase 2 clinical trials in the first half of 2018. 

In addition, we are developing the JAK inhibitors, ATI-50001 and ATI-50002, which we in-licensed from Rigel Pharmaceuticals, Inc., or Rigel, as potential treatments for AA. AA is an autoimmune dermatologic condition typically characterized by patchy non-scarring hair loss on the scalp and body.  More severe forms of AA include total scalp hair loss, known as alopecia totalis, and total hair loss on the scalp and body, known as alopecia universalis. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence) - with two-thirds of affected individuals being 30 years old or younger at the time of disease onset. Treatment options for the less severe, patchy forms of AA include corticosteroids, either topically applied or injected directly into the scalp where the bare patches are located, or the induction of an allergic reaction at the site of hair loss using a topical contact sensitizing agent, an approach known as topical immunotherapy.  The same treatment options are utilized for the more severe forms of AA, although utilization of these treatment options for the more severe forms of AA is limited due to limited efficacy, certain side effects, and their impracticality for extensive surface areas.

We are developing ATI-50001 as an oral treatment for AA and ATI-50002 as a topical treatment for AA and vitiligo, a disorder in which white patches of skin appear on different parts of the body.  We submitted an Investigational New Drug application, or IND, to the FDA for ATI-50001 in October 2016, and we completed a Phase 1 clinical trial to evaluate the pharmacokinetic and pharmacodynamic properties of this drug candidate in the first quarter of 2017.  We plan to initiate a Phase 2 dose-ranging clinical trial of ATI-50001 for the treatment of AA in the first half of 2018.  We submitted an IND to the FDA for ATI-50002 for the treatment of AA in July 2017.  We have initiated two Phase 2 clinical trials of ATI-50002 for the treatment of AA in which we expect to enroll a total of up to 36 patients, with data expected to be available in the first half of 2018.  We expect to initiate one additional Phase 2 dose-ranging clinical trial of ATI-50002 for the treatment of AA in November 2017 in which we plan to enroll approximately 120 patients at 20 investigational centers in the United States.  We expect data for this additional Phase 2 clinical trial to be available in the second halfquarter of 2018.  We also plan to initiate a Phase 2 clinical trial2021.

21

ATI-2138, an Investigational ITJ Inhibitor

We are also developing another series of JAK inhibitorsATI-2138, an investigational oral ITK/TXK/JAK3, or ITJ, inhibitor compound, as a potential treatment for the treatment of AGA. 

In August 2017, we acquired Confluence Life Sciences, Inc. psoriasis and/or Confluence.inflammatory bowel disease, which are both T-cell mediated autoimmune diseases.  The acquisition of Confluence adds small molecule drug discovery and preclinical development capabilities which, we expect, will allow us to bring early-stage research and development activities in-house that we currently outsource to third parties.  Through the acquisition of Confluence, we also acquired several preclinical product candidates, including additional JAK inhibitors known as “soft” JAK inhibitors, as well as inhibitors of the MK-2 signaling pathway and inhibitors of interleukin-2-inducibleITJ compound interrupts T cell kinase, or ITK.signaling through the combined inhibition of ITK/TXK/JAK3 pathways in lymphocytes. We paid $10.3 millionexpect to file an IND for ATI-2138 in cash and issued 349,527 sharesthe second half of 2021.

Our Other Drug Candidates

We continue to seek third-party partners for our common stock with a value of $9.7 million, to the former equity holders of Confluence.  We are obligated to pay up to $80.0 million to the former Confluence equityholders upon the achievement of specified development, regulatory and commercial milestones, as well as low single-digit royalties upon net sales of covered products and a portion of any amounts we may receive from the further sale, out-license or transfer of the acquired intellectual property to third parties. 

24


Since our inception in July 2012, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developingdermatology investigational drug candidate A-101 40%45% Topical Solution as a potential treatment for the treatment of SK, building our intellectual property portfolio, developing our supply chain and engaging in other discovery and clinical activities in dermatology. Through the date of this report, we have financed our operations with sales of our convertible preferred stock, as well as net proceeds from our initial public offering, or IPO, in October 2015, a private placement of our common stock in June 2016, public offerings of our common stock in November 2016 and August 2017, and an at-the-market facility with Cowen and Company LLC, or Cowen that we entered into in November 2016. We do not expect to generate significant revenue unless and until we obtain marketing approval for and commercialize A-101 40% Topical Solution for the treatment of SK or one of our other current or future drug candidates.warts (verruca vulgaris).

Financial Overview

Since our inception, we have incurred significant operating losses.  Our net loss was $48.1$28.8 million for the three months ended March 31, 2021 and $51.0 million for the year ended December 31, 2016 and $45.6 million for the nine months ended September 30, 2017.2020.  As of September 30, 2017,March 31, 2021, we had an accumulated deficit of $136.5$533.3 million.  We expect to incur significant expenses and operating losses for the foreseeable future as we advance our drug candidates from discovery through preclinical development and clinical trials, seek marketing approval and pursue commercialization of any approved drug candidate.development.  In addition, our drug candidates, even if wethey are approved by regulatory agencies for marketing, may not achieve commercial success.  We may also not be successful in pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for any ofand/or commercialize our drug candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. In addition, we may incur expenses in connection with the in-license or acquisition of additional drug candidates.  Furthermore, we have incurred and expect to continue to incur significant costs associated with operating as a public company, including legal, accounting, investor relations and other expenses.  We also expect to add additional personnel to support our expanding and advancing development pipeline. As a result, we will need substantial additional funding to support our continuing operations.

We have historically financed our operations primarily with sales of equity securities and pursue our growth strategy.  Until such time as we can generate significant revenueincurring indebtedness in the form of loans from product sales, if ever,commercial lenders.  In the near term, we expect to finance our operations through the sale of equity, debt financings orthese and other capital sources, including potential collaborationspartnerships with other companies or other strategic transactions.  We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on commercially acceptable terms, or at all.  If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our drug candidates.

Impact of COVID-19 on Our Business

The impacts of the global COVID-19 pandemic continue to evolve. We have implemented a virtual operations strategy, including teleworking and other alternative work arrangements for our employees, intended to protect the health and safety of our employees while enabling us to continue to develop our drug candidates and provide contract research services to our clients. We are focused on ensuring the continuity of our operations. However, COVID-19 has caused disruptions to our business. For example, due to the COVID-19 pandemic subject enrollment in our Phase 2a trial of ATI-450 in subjects with cryopyrin-associated periodic syndrome was paused as a result of which, among other reasons, we decided to focus our efforts and resources on other immuno-inflammatory diseases.

If COVID-19 continues to spread, we may experience additional disruptions that could severely impact our business, results of operations and prospects, including the timing of our development programs and our clinical trials, including our trials of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis and ATI-1777 as a potential treatment for moderate to severe atopic dermatitis and the supply of active pharmaceutical ingredients and drug product for our clinical trials. The extent to which the COVID-19 pandemic impacts our business, our preclinical and clinical development and our regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted, such as the geographic spread of the disease, the duration of the pandemic, travel restrictions, quarantines, stay-at-home orders, social distancing requirements, business closures and supply chain and other disruptions in the United States and other countries, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease, including the administration of vaccines.  Accordingly, we do not yet know the full extent of the potential impacts on our business, our preclinical and clinical development and regulatory activities.

22

Acquisition and License Agreements

Agreement and Plan of Merger with Confluence

In August 2017, we entered into an Agreement and Plan of Merger, or delaythe Confluence Agreement, with Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.), or Confluence, Aclaris Life Sciences, Inc., our pursuitwholly-owned subsidiary, or Merger Sub, and Fortis Advisors LLC, as representative of potential in-licensesthe equity holders of Confluence.  Pursuant to the terms of the Confluence Agreement, the Merger Sub merged with and into Confluence, with Confluence surviving as our wholly-owned subsidiary. We paid closing consideration of $10.3 million in cash and issued 349,527 shares of our common stock with a fair value of $9.7 million to the former Confluence equity holders. 

In November 2018, a development milestone specified in the Confluence Agreement was achieved, as a result of which we paid the former Confluence equity holders $2.5 million in cash and issued 253,208 shares of our common stock with a fair value of $2.2 million.  Under the Confluence Agreement, we also 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, we have 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, acquisitions.in specified circumstances, ten years from the first commercial sale of such product.  In addition to the payments described above, if we sell, license or transfer any of the intellectual property acquired from Confluence pursuant to the Confluence Agreement to a third party, we 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.  


Asset Purchase Agreement with EPI Health

In October 2019, we entered into an asset purchase agreement with EPI Health, LLC, or EPI Health, pursuant to which we sold the worldwide rights to RHOFADE (oxymetazoline hydrochloride) cream, 1%, or RHOFADE, which included the assignment of certain licenses for related intellectual property assets, or the Disposition.  

 

Pursuant to the asset purchase agreement, EPI Health paid us an upfront payment of $35.0 million, $1.75 million of which was placed in escrow, and $0.2 million for inventory.  In addition, EPI Health has agreed to pay us (i) potential sales milestone payments of up to $20.0 million in the aggregate upon the achievement of specified levels of net sales of products covered by the agreement, (ii) a specified high single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, until the date that the patent rights related to a particular product, such as RHOFADE, have expired, provided, that with respect to sales of RHOFADE in any territory outside of the United States, such royalty shall be paid on a country-by-country basis until the date that the RHOFADE patent rights in the particular country have expired or, if later, 10 years from the date of the first commercial sale of RHOFADE in such country and (iii) 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health in connection with any license or sublicense of the assets transferred in the Disposition in any territory outside of the United States, subject to specified exceptions.  In addition, EPI Health has agreed to assume our obligation to pay specified royalties and milestone payments under certain agreements with third parties.

Components of Our Results of Operations

Revenue

We recognize revenue when the earnings process is complete, which under SEC Staff AccountingContract Research

Bulletin No. 104, Topic No. 13, “Revenue Recognition,” is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or services has occurred, the sales price is fixed or determinable, and collectability is reasonably assured. 

We earn revenue from the provision of laboratory services to clients through Confluence, our wholly-owned subsidiary.  Laboratory serviceservices.  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. 

We also receive revenue from grants under the Small Business Innovation Research program of the National Institutes of Health, or NIH.  Through our Confluence subsidiary, we currently have two active grants from NIH which are related to early-stage research.  We recognize revenue related to these grants as amounts become reimbursable under each grant, which is generally when research is performed and the related costs are incurred. 

2523


Other Revenue

Other revenue consists of royalties earned on net sales of RHOFADE pursuant to the asset purchase agreement with EPI Health described above.

Cost of Revenue

Cost of revenue consists of the costs incurred in connection with the provision of laboratory services to our clients through Confluence.contract research services.  Cost of revenue primarily includes:

·

employee-related expenses, which include salaries, benefits and stock-based compensation;

·

outsourced professional scientific services;

·

depreciation of laboratory equipment;

·

facility-related costs; and

·

laboratory materials and supplies used to support the services provided.

Research and Development Expenses

Research and development expenses consist of expenses incurred in connection with the discovery and development of our drug candidates.  These expenses primarily include:

·

expenses incurred under agreements with contract research organizations, or CROs, as well as investigativeclinical trial sites and consultants that conduct our clinical trials and preclinical studies;

studies, and investigator-initiated trials;

·

manufacturing scale-up expenses and the cost of acquiring and manufacturing active pharmaceutical ingredients and preclinical and clinical trial materials and commercial materials, including manufacturing validation batches;

materials;

·

outsourced professional scientific development services;

·

medical affairs expenses related to our drug candidates;

employee-related expenses, which include salaries, benefits and stock-based compensation;

·

depreciation of manufacturing equipment;

·

payments made under agreements with third parties under which we have acquired or licensed intellectual property;

·

expenses relating to regulatory activities, including filing fees paid to regulatory agencies; and

·

laboratory materials and supplies used to support our research activities.

We expense research and development costs as incurred.  Our direct research and development expenses primarily consist of external costs including fees paid to CROs, consultants, investigator sites, regulatory agencies and third parties that manufacture our preclinical and clinical trial materials, and are tracked on a program-by-program basis. We do not allocate personnel costs, facilities or other indirect expenses, which are included within “Personnel and other costs” in the table below, to specific research and development programs. 

The following table summarizes our research and development expenses for the periods presented:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30, 

 

September 30, 

 

 

2017

    

2016

 

2017

    

2016

 

 

(In thousands)

A-101 Topical Solution (40% and 45%)

    

$

3,750

    

$

3,326

  

$

7,031

    

$

13,029

JAK inhibitors

 

 

2,753

 

 

1,893

 

 

7,639

 

 

4,901

Vixen acquisition

 

 

 —

 

 

 —

 

 

 —

 

 

3,385

Other research expenses

 

 

407

 

 

50

 

 

508

 

 

140

Total project-related expenses

 

 

6,910

 

 

5,269

 

 

15,178

 

 

21,455

Personnel and other costs

 

 

2,622

 

 

1,270

 

 

7,570

 

 

3,501

Stock-based compensation

 

 

1,332

 

 

623

 

 

3,853

 

 

1,577

Total research and development expenses

 

$

10,864

 

$

7,162

 

$

26,601

 

$

26,533

26


Research and development activities are central to our business model.  Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect ourto continue to incur research and development expenses to increase significantly overin the next several yearsnear term as we increasecontinue the clinical development of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis and other immuno-inflammatory diseases and ATI-1777 as a potential treatment for moderate to severe atopic dermatitis, continue the development of our preclinical compounds, and continue to discover and develop additional drug candidates.  We expense research and development costs as incurred.  Our direct research and development expenses primarily consist of external costs including fees paid to CROs, consultants, clinical trial sites, regulatory agencies and third parties that manufacture our preclinical and clinical trial materials, and are tracked on a program-by-program basis.  We do not allocate personnel costs, including stock-based compensation, continuefacilities or other indirect expenses, to conduct pre-commercial activities related to A-101 40% Topical Solution for the treatment of SK,specific research and conduct clinical trials and prepare regulatory filings for our other drug candidates.development programs.  

The successful development of our drug candidates is highly uncertain. At this time, weWe cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from any of our drug candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:

·

the number of clinical sites included in the trials;

24

·

the length of time required to enroll suitable patients;

subjects;

·

the number of patientssubjects that ultimately participate in the trials;

·

the number of doses patientssubjects receive;

·

the impact on the recruitment, enrollment, conduct and timing of our clinical trials due to the COVID-19 pandemic;

the duration of patientsubject follow-up; and

·

the results of our clinical trials.

Our expenditures are subject to additional uncertainties, including the terms and timingpreparation of marketing approvals,regulatory filings for our drug candidates, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights.  We may never succeed in achieving marketing approval for any of our drug candidates. We may obtain unexpected results from our clinical trials.trials or other development activities.  We may elect to discontinue, delay or modify the development, including clinical trials, of some drug candidates or focus on others.  A change in the outcome of any of these variables with respect to the development of a drug candidate could mean a significant change in the costs and timing associated with the development of that drug candidate.  For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Drug commercialization will take several years and millions of dollars in development costs.

General and Administrative Expenses

General and administrative expenses consist principally of salaries and related costs, including stock-based compensation, for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel expenses and recruiting expenses. Other generalfunctions.  General and administrative expenses also include facility-related costs, patent filing and prosecution costs, professional fees for marketing, legal, auditing and tax services, insurance costs, as well as payments made under our related party services agreement and milestone payments under our finder’s services agreement. 

We anticipate that our general and administrative expenses will increase as a result of increased personnel costs, including stock-based compensation, expanded infrastructure and higher consulting, legal and tax-related services associated with maintaining compliance with NASDAQ and SEC requirements, accounting and investor relations costs, insurance costs and director and officer insurance premiums associated with being a public company. Additionally, if and when we believe a marketing approvaltravel expenses.

Revaluation of a drug candidate appears likely, we anticipate an increaseContingent Consideration

Revaluation of contingent consideration consists of changes in payroll and other expenses as a resultthe fair value of our preparation for commercial operations, especially as it relates to the sales and marketing of that drug candidate.contingent consideration liability between reporting dates.

27


Other Income (Expense), Net

Other income (expense), net primarily consists of interest earned on our cash, cash equivalents and marketable securities, interest expense related to our debt obligations, and gains and losses on transactions denominated in foreign currencies.

Critical Accounting Policies and Significant Judgments and Estimates

This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP.generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, contingent consideration and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  ActualWe evaluate our estimates and judgments on an ongoing basis.  Our actual results may differ from these estimates under different assumptions or conditions.  We believeExcept as described below, there have been no material changes to our criticalsignificant accounting policies and use of estimates as disclosed in the footnotes to our audited consolidated financial statements for the year ended December 31, 20162020 included in our 2016 Annual Report on Form 10-K filed with the SEC on March 15, 2017.February 25, 2021.  

Intangible Assets

Intangible assets include both finite lived and indefinite lived assets.  Finite lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used.  Indefinite lived intangible assets are not amortized. In-process research and development assets acquired in a business combination are considered indefinite lived until the completion or abandonment of the associated research and development efforts.  We test intangible assets for impairment at least annually, or if indicators of impairment are present.  We recognize impairment losses when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. 

Contingent Consideration

We initially recorded thea contingent consideration liability at fair value on the date of acquisition related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, resulting from the acquisition of Confluence at its estimated fair value onbased upon significant unobservable inputs including the date

25

achievement of the paymentdevelopment, 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 was involved in determining the appropriateness of these assumptions.  These assumptions are considered Level 3 inputs.  Revaluation of our contingent consideration and the passageliability can result from changes to one or more of time.  Future changes inthese assumptions.  We evaluate the fair value estimate of theour contingent consideration liability on a quarterly basis with changes, if any, will be recorded as income or expense in our condensed consolidated statement of operations. operations and which could have a material impact on our financial results.

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 our 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 4% and 40%. 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 5.9% and 8.1% depending on the year of each potential payment.

During the three months ended March 31, 2021, we updated assumptions for probability of success and estimated future sales levels as a result of the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.  We also included estimated future sales related to hidradenitis suppurativa and psoriatic arthritis which are additional planned indications for ATI-450.  These updates resulted in a charge of $16.4 million.

Recently Issued Accounting Pronouncements

In January 2017, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2017-01, Business Combinations-Clarifying the Definition of a Business (Topic 805).  The amendments in this ASU provide a screen to determine when a set of acquired assets and/or activities is not a business.  The screen requires that when substantially all of the fair value of the gross assets acquired, or disposed of, is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business.  The amendments in this ASU will reduce the number of transactions that meet the definition of a business.  ASU 2017-01 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within those years, and early adoption will be permitted.  We are assessing the potential impact of ASU 2017-01 on our consolidated financial statements. None.

2826


In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other-Simplifying the Test for Goodwill Impairment (Topic 350).  Under the amendments in this ASU, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount.  An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit.  The amendments in this ASU eliminate Step 2 from the goodwill impairment test.  ASU 2017-04 is effective for fiscal years beginning after December 15, 2019, and early adoption is permitted.  We are assessing the potential impact of ASU 2017-04 on our consolidated financial statements. 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers(Topic 606).  Under this ASU, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided.  ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017.  We are assessing the potential impact of ASU 2014-09 on our consolidated financial statements. 

Results of Operations

Comparison of Three Months Ended September 30, 2017March 31, 2021 and 20162020

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

 

 

 

 

    

2017

    

2016

    

Change

 

 

 

(In thousands)

 

Revenue

 

$

684

 

$

 —

 

$

684

 

Cost of revenue

 

 

453

 

 

 —

 

 

453

 

Gross profit

 

 

231

 

 

 —

 

 

231

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

10,864

 

 

7,162

 

 

3,702

 

General and administrative

 

 

8,123

 

 

3,650

 

 

4,473

 

Total operating expenses

 

 

18,987

 

 

10,812

 

 

8,175

 

Loss from operations

 

 

(18,756)

 

 

(10,812)

 

 

(7,944)

 

Other income, net

 

 

564

 

 

118

 

 

446

 

Net loss

 

$

(18,192)

 

$

(10,694)

 

$

(7,498)

 

Three Months Ended March 31, 

 

(In thousands)

    

2021

    

2020

    

Change

 

Revenues:

Contract research

$

1,535

$

1,189

$

346

Other revenue

242

218

24

Total revenue

1,777

1,407

370

Costs and expenses:

Cost of revenue

1,202

1,269

(67)

Research and development

 

7,838

 

7,677

 

161

General and administrative

 

4,827

 

6,200

 

(1,373)

Revaluation of contingent consideration

16,439

1,767

14,672

Total costs and expenses

 

30,306

 

16,913

 

13,393

Loss from operations

 

(28,529)

 

(15,506)

 

(13,023)

Other income (expense), net

 

(225)

 

178

 

(403)

Loss from continuing operations

(28,754)

(15,328)

(13,426)

Loss from discontinued operations

(258)

258

Net loss

$

(28,754)

$

(15,586)

$

(13,168)

29


Revenue

Revenue

RevenueContract research revenue was $ 0.7$1.5 million and $1.2 million for the three months ended September 30, 2017,March 31, 2021 and 2020, respectively, and was comprised primarily of fees earned from the provision of laboratory services to clients through Confluence, which we acquired in August 2017.  We did not generate anyservices.  The $0.3 million increase was primarily driven by higher average billing rates.  Other revenue infor each of the three months ended September 30, 2016. March 31, 2021 and 2020 consisted of $0.2 million of royalties earned on net sales of RHOFADE.

Cost of Revenue

Cost of revenue was $ 0.5$1.2 million and $1.3 million for the three months ended September 30, 2017,March 31, 2021 and was comprised entirely of costs incurred2020, respectively, and related to provideproviding laboratory services to our clients through Confluence, which we acquired in August 2017.  We did not incur any costclients.

Research and Development Expenses

The following table summarizes our research and development expenses:

Three Months Ended

March 31, 

(In thousands)

2021

    

2020

Change

ATI-450

    

$

2,073

    

$

1,976

  

$

97

ATI-1777

946

757

189

ATI-2138

1,383

301

1,082

Discovery

692

627

65

Other research and development

416

1,194

(778)

Personnel

1,452

2,006

(554)

Stock-based compensation

876

816

60

Total research and development expenses

$

7,838

$

7,677

$

161

27

ATI-450

Expenses for ATI-450 during the three months ended September 30, 2016. 

ResearchMarch 31, 2021 primarily consisted of costs associated with multiple clinical trials, including a Phase 2a trial in subjects with moderate to severe rheumatoid arthritis, drug product manufacturing expenses, and Development Expenses

Research andother development expenses.  ATI-450 expenses were $10.9 million forduring the three months ended September 30, 2017, comparedMarch 31, 2020 primarily consisted of preclinical development activities and activities related to $7.2 milliona Phase 1 clinical trial that was completed in January 2020.

ATI-1777

Expenses for ATI-1777 were higher during the three months ended September 30, 2016. The increase of $3.7 million wasMarch 31, 2021 compared to March 31, 2020 primarily driven by an increase of $1.2 million of expenses relateddue to ourcosts associated with a Phase 2 clinical trials of A-101 45% Topical Solution, an increase of $0.9 million in preclinical and2a clinical trial in subjects with moderate to severe atopic dermatitis which commenced in late 2020, partially offset by lower preclinical development expenses related to the JAK inhibitor technology, an increase of $0.3 million in expenses related to the scale-up of commercial manufacturingactivities.

ATI-2138

Expenses for A-101 40% Topical Solution, an increase of $0.6 million in payroll-related expenses due toATI-2138 were higher headcount, an increase of $0.7 million in stock-based compensation expense, and a $0.6 million increase in expenses related to medical affairs activities.  We also incurred $0.3 million of expenses related to drug discovery research performed by Confluence, which we acquired in August 2017; and therefore did not incur similar expenses induring the three months ended September 30, 2016.  The increases noted aboveMarch 31, 2021 compared to March 31, 2020 primarily due to preclinical development activities and IND-enabling studies.

Discovery and other research and development

Expenses related to discovery increased during the three months ended March 31, 2021 compared to March 31, 2020 due to increased investment in our discovery-stage programs.  Other research and development expenses, which primarily include expenses for our legacy dermatology assets and medical affairs activities, were partially offset bylower during the three months ended March 31, 2021 compared to March 31, 2020 due to a $1.2 million decrease in costs associated withfor our legacy dermatology assets following the developmentdecision to discontinue investment in those programs.  Additionally, travel expenses were lower during the three months ended March 31, 2021 compared to March 31, 2020 due to the COVID-19 pandemic.

Personnel and stock-based compensation

Personnel expenses and stock-based compensation decreased during the three months ended March 31, 2021 compared to March 31, 2020 due to lower headcount.  

General and Administrative Expenses

The following table summarizes our general and administrative expenses:

Three Months Ended

March 31, 

(In thousands)

2021

    

2020

Change

Personnel

    

$

959

    

$

1,597

  

$

(638)

Professional and legal fees

1,355

1,117

238

Facility and support services

 

398

 

510

 

(112)

Other general and administrative

563

599

(36)

Stock-based compensation

1,552

2,377

(825)

Total general and administrative expenses

$

4,827

$

6,200

$

(1,373)

Personnel and stock-based compensation expenses decreased during the three months ended March 31, 2021 compared to March 31, 2020 primarily due to lower headcount.  Professional and legal fees included accounting, legal, investor relations and corporate communication costs, as well as legal fees related to patents and current lawsuits described in this report and were higher during the three months ended March 31, 2021 compared to March 31, 2020 primarily as a result of A-101 40% Topical Solutiona non-cash write-off of previously capitalized expenses related to an equity line of credit which was terminated in January 2021.  Facility and support services included general office expenses, information technology costs and other expenses, and decreased during the three months ended March 31, 2021 compared to March 31, 2020 primarily due to lower information technology costs resulting from lower headcount.  Other general and administrative expenses were

28

lower during the three months ended March 31, 2021 compared to March 31, 2020 primarily due to reduced travel-related activities in light of the COVID-19 pandemic.

Revaluation of Contingent Consideration

The increase in revaluation of contingent consideration during the three months ended March 31, 2021 compared to March 31, 2020 primarily resulted from updates to the probability of success and estimated future sales level assumptions as a result of the completion of oura Phase 32a clinical trialstrial of ATI-450 in November 2016. subjects with moderate to severe rheumatoid arthritis and the inclusion of estimated future sales related to hidradenitis suppurativa and psoriatic arthritis which are additional planned indications for ATI-450.

General and Administrative ExpensesOther Income (Expense), net

General and administrative expenses were $8.1The $0.4 million fordecrease in other income (expense), net during the three months ended September 30, 2017,March 31, 2021 compared to $3.7 million for the three months ended September 30, 2016. The increase of $4.5 million was primarily attributable to an increase of $0.7 million in payroll-related expenses due to increased headcount, $1.2 million in higher stock-based compensation expense.  In addition, we had a $1.4 million increase in market research expenses and a $0.2 million increase in sales operations expenses, both related to pre-commercial activities for A-101 40% Topical Solution.  We also incurred $0.4 million of professional fees in conjunction with our acquisition of Confluence, for which there were no similar amounts in the prior year period. 

Other Income, Net

The $0.4 million increase in other income, netMarch 31, 2020 was primarily due to higher invested balances of marketable securities as a result of funds received from our financing transactions in 2016interest expense and 2017. 

30


Comparison of Nine Months Ended September 30, 2017 and 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 

 

 

 

 

 

    

2017

    

2016

    

Change

 

 

 

(In thousands)

 

Revenue

 

$

684

 

$

 —

 

$

684

 

Cost of revenue

 

 

453

 

 

 —

 

 

453

 

Gross profit

 

 

231

 

 

 —

 

 

231

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

26,601

 

 

26,533

 

 

68

 

General and administrative

 

 

20,611

 

 

10,407

 

 

10,204

 

Total operating expenses

 

 

47,212

 

 

36,940

 

 

10,272

 

Loss from operations

 

 

(46,981)

 

 

(36,940)

 

 

(10,041)

 

Other income, net

 

 

1,392

 

 

336

 

 

1,056

 

Net loss

 

$

(45,589)

 

$

(36,604)

 

$

(8,985)

 

Revenue

Revenue was $ 0.7 million for the nine months ended September 30, 2017, and was comprised primarily of fees earned from the provision of laboratory services to clients through Confluence, which we acquired in August 2017.  We did not generate any revenue in the nine months ended September 30, 2016. 

Cost of Revenue

Cost of revenue was $ 0.5 million for the nine months ended September 30, 2017, and was comprised entirely of costs incurred to provide laboratory services to our clients through Confluence, which we acquired in August 2017.  We did not incur any cost of revenue in the nine months ended September 30, 2016. 

Research and Development Expenses

Research and development expenses were $26.6 million for the nine months ended September 30, 2017 and $26.5 million for the nine months ended September 30, 2016.  Although there was a minimal change in total research and development expenses, we had decreases of $7.6 million in the costs associated with the development of A-101 40% Topical Solution as a result of the completion of our Phase 3 clinical trials in November 2016outstanding debt balances and $3.4 million in expenseslower interest income associated with the acquisition of Vixen Pharmaceuticals, Inc., or Vixen, in the nine months ended September 30, 2016, for which there was no similar transaction in the current year period.   These decreases were offset primarily by an increase of $2.7 million in preclinical and clinical development expenses related to the JAK inhibitor technology, an increase of $1.1 million of expenses related to our Phase 2 clinical trials of A-101 45% Topical Solution an increase of $1.8 million in payroll-related expenses due to higher headcount, a $2.3 million increase in stock-based compensation expense, a $2.0 million increase in expenses related to medical affairs activities, and $0.5 million of regulatory expenses associated with the NDA filing for A-101 40% Topical Solution incurred during the nine months ended September 30, 2017.  We also incurred $0.3 million of expenses related to drug discovery research performed by Confluence, which we acquired in August 2017; therefore we did not incur similar expenses in the nine months ended September 30, 2016.marketable securities.

31


General and Administrative Expenses

General and administrative expenses were $20.6 million for the nine months ended September 30, 2017, compared to $10.4 million for the nine months ended September 30, 2016. The increase of $10.2 million was primarily attributable to increases of $2.5 million in market research expenses and $0.3 million in sales operations expenses, both related to pre-commercial activities for A-101 40% Topical Solution, an increase of $1.6 million in payroll-related expenses due to increased headcount, $3.5 million in higher stock-based compensation expense and $0.5 million in higher facilities-related costs including rent expense.  In addition, milestone payments pursuant to the finder’s services agreement related to A-101 40% Topical Solution increased $0.7 million over the prior year period.  We also incurred $0.6 million of professional fees in conjunction with our acquisition of Confluence, for which there were no similar amounts in the prior year period. 

Other Income, Net

The $1.1 million increase in other income, net was primarily due to higher invested balances of marketable securities as a result of funds received from our financing transactions 2016 and 2017. 

Liquidity and Capital Resources

Overview

Since our inception, we have incurred net losses and negative cash flows from our operations.  Prior to our acquisition of Confluence in August 2017, we had never generateddid not generate any revenue.  We have financed our operations since inceptionover the last several years primarily through sales of our convertible preferred stock, as well as net proceedsequity securities and incurring indebtedness in the form of loans from commercial lenders.  We may engage in additional debt and equity financing transactions in order to raise funds.  In addition, to the extent we are able to consummate transactions with potential third-party partners to further develop, obtain marketing approval for and/or commercialize our IPO in October 2015,drug candidates, we may receive upfront payments, milestone payments or royalties from such arrangements that would increase our private placement in June 2016, our public offerings in November 2016 and August 2017 and our at-the-market facility with Cowen.liquidity.

As of September 30, 2017,March 31, 2021, we had cash, cash equivalents and marketable securities of $227.8$142.7 million.  Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view towards liquidity and capital preservation.

We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity, over the next five years, other than our subleaseterm loan facility, lease obligations, and contingent obligations under acquisitionthe Confluence Agreement, which is summarized above under “Overview—Acquisition and intellectual property licensing agreements, which are summarized below under “Contractual Obligations and Commitments.License Agreements.  

InitialEquity Financing

January 2021 Public Offering

On October 13, 2015,In January 2021, we closed our IPOa public offering in which we sold 5,750,0006,306,271 shares of common stock at a price to the public of $11.00$17.50 per share, for aggregate gross proceeds of $63.3$110.4 million. We paid underwriting discounts and commissions of $4.4$6.6 million, and we also incurred expenses of $2.3 million in connection with the IPO.  As a result, the net offering proceeds to us, after deducting underwriting discounts and commissions and expenses, were $56.6 million. 

Private Placement

On June 2, 2016, we closed a private placement in which we sold an aggregate of 1,081,082 shares of common stock at a price of $18.50 per share, for gross proceeds of $20.0 million.  We incurred placement agent fees of $1.3 million, and expenses of $0.2 million in connection with the private placement.  As a result, the net offering proceeds to us, after deducting placement agent fees and transaction expenses, were $18.5 million. 

32


November 2016 Public Offering

On November 23, 2016, we closed our follow-on public offering in which we sold 4,600,000 shares of common stock at a price to the public of $22.75 per share, for aggregate gross proceeds of $104.7 million. We paid underwriting discounts and commissions of $6.3 million, and we also incurred expenses of $0.2$0.4 million in connection with the offering.  As a result, the net offering proceeds received by us, after deducting underwriting discounts, commissions and offering expenses, were $98.2$103.3 million.

At-The-Market FacilityEquity Purchase Agreement with Lincoln Park Capital Fund, LLC  

On April 21, 2017,In August 2020, we sold 635,000entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provided that, upon the terms and subject to the conditions and limitations set forth therein, we could sell to Lincoln Park, at our discretion, up to $15.0 million of shares of our common stock at a weighted average price per shareover the 36-month term of $31.50, for aggregate gross proceedsthe Purchase Agreement. Upon execution of approximately $20.0 million.  We paid underwriting discounts and commissions of $0.6 million, andthe Purchase Agreement, we also incurred expenses of $0.1 million in connection with this sale.  The shares were sold through Cowen pursuant to a sales agreement with them dated November 2, 2016.  Following these sales, we may offer and sell additionalissued 121,584 shares of our common stock havingto Lincoln Park as commitment shares in accordance with the closing conditions contained within the

29

Purchase Agreement. The commitment shares were valued using the closing price of our common stock on the effective date of the Purchase Agreement resulting in an aggregate offering pricefair value of up to approximately $55.0 million from time to time through Cowen pursuant to the sales agreement.

August 2017 Public Offering

On August 16, 2017, we closed our follow-on public offering in which$0.3 million. Through December 31, 2020, we sold 3,747,6022,111,170 shares of our common stock at a price to Lincoln Park under the public of $23.02 per share,Purchase Agreement for aggregate grossnet proceeds of $86.3$7.7 million.  We paid underwriting discounts and commissions of $5.2 million, and we also incurred expenses of $0.2 millionterminated the Purchase Agreement in January 2021 in connection with the offering.  Aspublic offering of common stock described above. We did not sell any additional shares during the three months ended March 31, 2021 prior to terminating the Purchase Agreement.

Debt Financing

Loan and Security Agreement with Silicon Valley Bank  

In March 2020, we entered into a Loan and Security Agreement with Silicon Valley Bank, or SVB.  The Loan and Security Agreement provides for $11.0 million in term loans, of which we borrowed the entire amount on March 30, 2020.  The Loan and Security Agreement is secured by substantially all of our assets other than intellectual property.  

The term loan repayment schedule provides for interest only payments beginning April 1, 2020 and continuing through March 1, 2022, followed by 24 consecutive equal monthly installments of principal, plus monthly payments of accrued interest, starting on April 1, 2022 and continuing through the maturity date of March 1, 2024. All outstanding principal and accrued and unpaid interest will be due and payable on the maturity date.  The Loan and Security Agreement provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 2% and (ii) 6.75%.  

The Loan and Security Agreement includes a final payment fee equal to 5% of the original principal amount borrowed.  We have the option to prepay the outstanding balance of the term loans in full, subject to a prepayment premium of (i) 3% of the original principal amount borrowed for any prepayment on or prior to the first anniversary of March 30, 2020, (ii) 2% of the original principal amount borrowed for any prepayment after the first anniversary and on or before the second anniversary of March 30, 2020 or (iii) 1% of the original principal amount borrowed for any prepayment after the second anniversary of March 30, 2020 but before March 1, 2024.

The Loan and Security Agreement contains a customary covenant that limits our ability, subject to specified exceptions, to incur additional indebtedness without the prior written consent of SVB.

Liquidity and Cash Flows

Cash and cash equivalents were $35.3 million as of March 31, 2021 compared to $22.1 million as of December 31, 2020.  We also had $107.4 million in short- and long-term marketable securities as of March 31, 2021 compared to $32.1 million as of December 31, 2020.

The sources and uses of cash that contributed to the change in cash and cash equivalents were:

Three Months Ended March 31,

(In thousands)

    

2021

    

2020

Cash and cash equivalents beginning balance

$

22,063

$

35,937

Net cash used in operating activities

 

(12,232)

 

(6,805)

Net cash provided by (used in) investing activities

 

(75,314)

 

13,942

Net cash provided by financing activities

100,750

10,918

Cash and cash equivalents ending balance

$

35,267

$

53,992

30

Operating Activities

Operating activities use of cash was the result of:

Three Months Ended March 31,

(In thousands)

    

2021

    

2020

Net loss

$

(28,754)

$

(15,586)

Non-cash adjustments to reconcile net loss to net cash used in operating activities

 

19,402

 

5,796

Change in accounts payable and accrued expenses

(585)

(2,090)

Change in accounts receivable

(45)

4,737

Change in prepaid expenses and other assets

 

(2,250)

 

338

Net cash used in operating activities

$

(12,232)

$

(6,805)

Net cash used in operating activities increased for the three months ended March 31, 2021 compared to March 31, 2020 primarily as a result of larger charges related to revaluation of contingent consideration during the net offering proceeds received by us, after deducting underwriting discounts, commissions and offering expenses, were $80.9 million. 

Cash Flows

The following table summarizes our cash flows for the ninethree months ended September 30, 2017March 31, 2021.  The revaluation of contingent consideration was due to updates to assumptions including the probability of success and 2016:

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 

 

 

    

2017

    

2016

    

 

 

(In thousands)

 

Net cash used in operating activities

 

$

(36,453)

 

$

(26,531)

 

Net cash (used in) provided by investing activities

 

 

(34,127)

 

 

15,915

 

Net cash provided by financing activities

 

 

100,464

 

 

18,561

 

Net increase in cash and cash equivalents

 

$

29,884

 

$

7,945

 

Operating Activities

Duringestimated future sales level assumptions as a result of the nine months ended September 30, 2017, operating activities used $36.5 millioncompletion of cash, primarily resulting from our net lossa Phase 2a clinical trial of $45.6 millionATI-450 in subjects with moderate to severe rheumatoid arthritis and changes in our operating assetsthe inclusion of estimated future sales related to hidradenitis suppurativa and liabilities of $1.2 million,psoriatic arthritis which are additional planned indications for ATI-450.  The increase was partially offset by non-cash adjustments of $10.4 million.  Net cash used by changes in our operating assetslower stock-based compensation and liabilitiesdepreciation and amortization expenses during the ninethree months ended September 30, 2017 consisted of a $4.3 million increaseMarch 31, 2021 compared to March 31, 2020.

The change in prepaid expenses and other current assets partially offset by a $3.1 million increase in accounts payable and accrued expenses.  The increase in prepaid expenses and other current assets was primarily due to a $2.0 million PDUFA fee paid to the FDA in conjunction with the filing of the NDA for A-101 40% Topical Solution, as well as deposits made for clinical supplies and development activities which are expected to be incurred during the fourth quarter of 2017.  The increasechanges in accounts payable and accrued expenses was primarily due todriven by expenses incurred, but not yet paid, as of March 31, 2021 compared to March 31, 2020.  The change in connection with our Phase 2 clinical trials for A-101 45% Topical Solution, ATI-50001 and ATI-50002, as well aschanges in accounts receivable was primarily the timing of vendor invoicing and payments.  Non-cash expenses of $10.4 million were primarily composed of stock-based compensation expense. 

33


During the nine months ended September 30, 2016, operating activities used $26.5 millionresult of cash primarily resultingreceived during the quarter ended March 31, 2020 from our net lossAllergan Sales, LLC related to sales of $36.6 million partially offset by cash provided byRHOFADE that occurred after the date we sold RHOFADE to EPI Health.  The change in changes in our operatingprepaid expenses and other assets and liabilities of $3.0 million and by non-cash adjustments of $7.1 million. Net cash provided by changes in our operating assets and liabilities during the nine months ended September 30, 2016 consisted primarily of a $2.9 million increase in accounts payable and accrued expenses. The increase in accounts payable and accrued expenses was primarily due to expenses incurred, but not yet paid,prepaid balances for drug product manufacturing agreements and other preclinical development contracts.

Investing Activities

Cash flow from investing activities was the result of:

Three Months Ended March 31,

(In thousands)

    

2021

    

2020

Purchases of property and equipment

$

$

(124)

Purchases of marketable securities

 

(85,814)

 

(8,869)

Proceeds from sales and maturities of marketable securities

10,500

22,935

Net cash provided by (used in) investing activities

$

(75,314)

$

13,942

Net cash used in connection with our Phase 3 clinical trialsinvesting activities for A-101 and the timing of vendor invoicing and payments.  Non-cash expenses of $7.1 million were primarily composed of $4.2 million of stock-based compensation expense and $2.8 million associated with the acquisition of Vixen. 

Investing Activities

During the ninethree months ended September 30, 2017,March 31, 2021 resulted from purchases of marketable securities following our January 2021 public offering compared to net cash provided by investing activities used $34.1 million of cash, consisting of proceedsfor the three months ended March 31, 2020 which resulted from sales and maturities of marketable securities used primarily to fund operations.

31

Financing Activities

Financing activities use of cash was the result of:

Three Months Ended March 31,

(In thousands)

    

2021

    

2020

Proceeds from issuance of common stock in connection with public offering, net of issuance costs

$

103,348

$

Proceeds from debt financing (including warrants), net of issuance costs

 

 

10,950

Restricted stock unit employee tax withholdings

(3,014)

Finance lease payments

(57)

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

 

416

 

25

Net cash provided by financing activities

$

100,750

$

10,918

Cash provided by financing activities increased for the three months ended March 31, 2021 compared to March 31, 2020 primarily due to our January 2021 public offering.  The increase was partially offset by purchasesan increase in cash used for tax withholdings in connection with the vesting of marketable securities of $120.5 million, $9.6 million for the acquisition of Confluence and purchases of equipment of $0.7 million.restricted stock units.

During the nine months ended September 30, 2016, investing activities provided $15.9 million of cash, consisting of proceeds from sales and maturities of marketable securities of $49.8 million, partially offset by purchases of marketable securities of $33.7 million and purchases of equipment of $0.2 million.

Financing Activities

During the nine months ended September 30, 2017, financing activities provided $100.5 million including $19.3 million in April 2017 under our sales agreement with Cowen, and $80.9 million of net proceeds from our August 2017  public offering, as well as $0.2 million of cash received from the exercise of employee stock options. 

During the nine months ended September 30, 2016, financing activities provided $18.6 million of cash primarily from the private placement of our common stock in June 2016. 

Funding Requirements

We plan to focus in the near term on the development, marketing approval and potential commercialization of A-101 40% Topical Solution for the treatment of SK. We anticipate we will incur net losses forin the next several yearsnear term as we continue ourthe clinical development of A-101 40% Topical SolutionATI-450 as a potential treatment for moderate to severe rheumatoid arthritis and other immuno-inflammatory diseases and ATI-1777 as a potential treatment for moderate to severe atopic dermatitis, continue the treatmentdevelopment of SKour preclinical compounds, and continue researchto discover and development of A-101 45% Topical Solution for the treatment of common warts and ATI-50001 and ATI-50002 for the treatment of AA, and potentially for other dermatological conditions, as well as for development of other JAK inhibitor compounds. In addition, we plan to continue to invest in discovery efforts to exploredevelop additional drug candidates, build commercial capabilities and expand our corporate infrastructure.candidates.  We may not be able to complete the development and initiate commercialization ofgenerate revenue from these programs if, among other things, our clinical trials are not successful, or if the FDA does not approve A-101 40% Topical Solution or our other drug candidates currently in clinical trials when we expect, or at all.all, or we are not able to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our drug candidates.  

Our primary uses of capital are, and we expect will continue in the near term to be, compensation and related expenses, clinical trial costs, external research and development services, laboratory and related supplies, legal and other regulatory expenses, and administrative and overhead costs.  Our future funding requirements will be heavily determined by the resources needed to support the development and commercialization of our drug candidates.  

As a publicly traded company, we have incurredincur and will continue to incur significant legal, accounting and other expenses that we were not required to incur as a private company.similar expenses.  In addition, the Sarbanes-Oxley Act of 2002, as well as rules adopted by the SEC and the NASDAQNasdaq Stock Market LLC, requires public companies to implement specified corporate governance practices that were not applicable to us prior to our IPO. We expect ongoing compliance with these

34


rules and regulations willcould increase our legal and financial compliance costs and will make some activities more time-consuming and costly.costs.  

We believe our existing cash, cash equivalents and marketable securities are sufficient to fund our operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of our unaudited condensed consolidated financial statements that appear in Item 1 of this Quarterly Report on Form 10-Q based on our current operating assumptions including the completion of our Phase 2 clinical trials for A-101 45% Topical Solution for the treatment of common warts and the continued development of ATI-50001 and ATI-50002 as potential treatments for AA and vitiligo. These assumptions may prove to be wrong, and we could utilize our available capital resources sooner than we expect.assumptions.  We expect that we will require additional capital to commercialize A-101 40% Topical Solution, if we receive marketing approval,complete the clinical development of ATI-450 and ATI-1777, to develop our preclinical compounds, and to pursue in-licenses or acquisitions of other drug candidates.  If we receive marketing approval for A-101 40% Topical Solution, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize that drug candidate.support our 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 us to continue to implement our long-term business strategy. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If we are unable to raise sufficient additional capital or generate revenue from transactions with potential third-party partners for the development and/or commercialization of our drug candidates, we may need to substantially curtail our planned operations and the pursuit of our growth strategy.operations.  

We may raise additional capital through the sale of equity or convertible debt securities. In such an event, yourour stockholders’ ownership will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a holder of our common stock.

32

Because of the numerous risks and uncertainties associated with research development and commercializationdevelopment of pharmaceutical drugs, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements in the near term will depend on many factors, including:

·

the number and characteristicsdevelopment requirements of the drug candidates that we may pursue;

·

the scope, progress, results and costs of researchingpreclinical development, laboratory testing and developingconducting preclinical and clinical trials for our drug candidates;

the costs, timing and outcome of regulatory review of our drug candidates;
the extent to which we in-license or acquire additional drug candidates and technologies;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
the impact on the timing of our preclinical studies, the recruitment, enrollment, conduct and timing of our clinical trials and our business due to the COVID-19 pandemic;
our ability to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our drug candidates, and conducting preclinical studiesearn revenue from such arrangements; and clinical trials;

·

the timingrevenue earned from our commercial products as a result of and the costs involved in, obtaining marketing approvals for our drug candidates;

·

the cost of manufacturing our drug candidates and any drugs we successfully commercialize;

·

our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;

·

the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and

·

the timing, receipt and amount of sales of, or milestone payments relatedlicenses to, or royalties on, our current or future drug candidates, if any.

partnerships with, third parties.

Contractual Obligations and Commitments

We occupy office space for our headquarters in Malvern,Wayne, Pennsylvania under two operating lease agreements both ofa sublease agreement which have termshas a term through November 2019, that require future aggregate rental payments of $0.1 million duringOctober 2023.  In December 2020, we entered into a sub-sublease agreement under which we sub-subleased 8,115 square feet.  The sub-sublease term runs concurrently with the three months ending December 31, 2017, $0.4 million during the year ending December 31, 2018, and $0.4 million during the year ending December 31, 2019.

Confluence occupiesoriginal sublease agreement.  We occupy office and laboratory space in St. Louis, Missouri under an operating leasea sublease agreement which has a term through December 2017, which requires future rental payments of $0.1June 2029.

In March 2020, we borrowed $11.0 million during the three months ending December 31, 2017. 

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Under the assignment agreement pursuant to which we acquired intellectual property, we have agreed to pay royalties on sales of A-101 40% Topical Solution or related products at rates ranging in low single-digit percentages of net sales, as defined in the agreement. Under the related finder’s services agreement, we have agreed to make aggregate payments of up to $4.5 million upon the achievement of specified commercial milestones. In addition, we have agreed to pay royalties on sales of A-101 40% Topical Solution or related products at a low single-digit percentage of net sales, as defined in the agreement.

Under a commercial supply agreement with a third party, we have agreed to pay a termination fee of up to $0.4 million in the event we terminate the agreement without cause or the third party terminates the agreement for cause.

Under a license agreement with Rigel that we entered into in August 2015, we have agreed to make aggregate payments of up to $80.0 million upon the achievement of specified pre-commercialization milestones, such as clinical trials and regulatory approvals. Further, we have agreed to pay up to an additional $10.0 million to Rigel upon the achievement of a second set of development milestones. With respect to any products we commercialize under the agreement, we will pay Rigel quarterly tiered royalties on our annual net sales of each product developed usingLoan and Security Agreement with SVB.  Amounts borrowed under the licensed JAK inhibitors at a high single-digit percentage of annual net sales,Loan and Security Agreement are subject to specified reductions.

Under a stock purchase agreement with the selling stockholders of Vixen, we are obligated to make aggregate payments of up to $18.0 million upon the achievement of specified pre-commercialization milestones for three products covered by the Vixen patent rights in the United States, the European Union and Japan, and aggregate payments of up to $22.5 million upon the achievement of specified commercial milestones for products covered by the Vixen patent rights.  We are also obligated to make a payment of $0.1 million on March 24th of each year,interest only through March 24, 2022, after which amounts are creditable against any specified future payments that may be paid under the stock purchase agreement.  With respect to any covered products that we commercialize, we are obligated to pay 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.  If we sublicense any of the patent rights and know-how acquired pursuant to the stock purchase agreement, we will be obligated to pay a portion of any consideration we receive from such sublicenses in specified circumstances. 

Under a license agreement with The Trustees of Columbia University in the City of New York, or Columbia, we are obligated to pay an annual license fee of $10,000, subject to specified adjustments for patent expenses incurred by Columbia and creditable against any royalties that may be paid under the license agreement.  We are also obligated to pay up to an aggregate of $11.6 million upon the achievement of specified commercial milestones, including specified levels of net sales of products covered by Columbia patent rights and/or know-how, and royalties at a sub-single-digit percentage of annual net sales of products covered by Columbia patent rights and/or know-how, subject to specified adjustments.  If we sublicense any of Columbia’s patent rights and know-how acquired pursuant to the license agreement, we will be obligated to pay Columbia a portion of any consideration received from such sublicenses in specified circumstances. 

Under an acquisition agreement with Confluence  we are obligatedrequired to make aggregateprincipal and interest payments through the maturity date of up to $80.0 million upon the achievement of specified development, regulatory and commercialization milestones.  With respect to any covered products we commercialize, we are obligated to pay 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.  If we sublicense any of the patent rights and know-how acquired pursuant to the merger agreement, we will be obligated to pay a portion of any consideration we receive from such sublicenses in specified circumstances. March 2024. 

We enter into contracts in the normal course of business with CROs and contract manufacturing organizations for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts generally

36


provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.

Segment Information

We have 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.  The contract research segment earns revenue from the provision of laboratory services.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.  

Emerging Growth Company Status

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies. 

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

We are exposed to market risk related to changes in interest rates. Our cash equivalents and marketable securities consist of money market funds, asset-backed debt securities, commercial paper, corporate debt securities and U.S. government agency debt.debt securities. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.  Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase.  However, due to the short-term nature and risklow-risk profile of our investment portfolio, we do not expect that an immediate 10% change in market interest rates would have a material effect on the fair market value of our investment portfolio.  We have the ability to hold our marketable securities until maturity, and therefore we dowould not expect our operating results or cash flows to be affected significantlyto any significant degree by the effect of a change in market interest rates on our investments.

The Loan and Security Agreement with SVB provides for an annual interest rate equal to the greater of (i) the prime rate then in effect as reported in The Wall Street Journal plus 2% and (ii) 6.75%.  To the extent that any present or future credit facilities that we enter into are based on a floating interest rate, we will be subject to risks relating to changes in market interest rates.  In periods of rising interest rates when we have such debt outstanding, our interest expense would increase.  Based upon our debt outstanding of $11.0 million as of March 31, 2021, a 100 basis-point increase in the interest rate on our loan with SVB would result in $0.1 million of additional interest expense on an annualized basis.

The uncertainty that exists with respect to the economic impact of the global COVID-19 pandemic has introduced significant volatility in the financial markets during and subsequent to our quarter ended March 31, 2021.

Item 4. Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.  

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2017,March 31, 2021, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of such date at the reasonable assurance level.  

Management’s assessment of disclosure controls and procedures excluded consideration of Confluence’s internal control over financial reporting, which was acquired during the third quarter of 2017.  This exclusion is consistent with guidance provided by the staff of the SEC that an assessment of a recently acquired business may be omitted from management’s report on internal control over financial reporting for up to one year from the date of acquisition, subject to specified conditions.  Confluence’s total assets were $1.3 million as of September 30, 2017 and Confluence’s total revenues were $0.7 million during the three months ended September 30, 2017.

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(b)Changes in Internal ControlsControl Over Financial Reporting

There have not been any changes in our internal controlscontrol over financial reporting during our fiscal quarter ended September 30, 2017March 31, 2021 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.  As a result of our acquisition of Confluence, we are in the process of designing and implementing controls over intangible assets. 

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time we may beare subject to litigation and claims arising in the ordinary course of business. Webusiness including intellectual property and product liability litigation, but, except as stated below, we are not currently a party to any material legal proceedings and we are not aware of any other pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.

Securities Class Action

On July 30, 2019, plaintiff Linda Rosi, or Rosi, filed a putative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York against us and certain of our executive officers.  The complaint alleges that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA (hydrogen peroxide) topical solution, 40% (w/w), or ESKATA, our non-marketed FDA-approved product, and find that the materials minimized the risks or overstated the efficacy of the product.  The complaint seeks unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired our securities between May 8, 2018 and June 20, 2019.

On September 5, 2019, an additional plaintiff, Robert Fulcher, or Fulcher, filed a substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al. in the same court against the same defendants.

On November 6, 2019, the court consolidated the Rosi and Fulcher actions, or together, the Consolidated Securities Action, and appointed Fulcher “lead plaintiff” for the putative class.

On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming two additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness. The defendants filed a motion to dismiss the consolidated amended complaint on April 17, 2020. Following briefing and oral argument on February 25, 2021, the motion was granted in part and denied in part on March 29, 2021, and the issues in dispute significantly narrowed. The defendants filed an answer to the remaining aspects of the consolidated amended complaint on April 19, 2021.

We and the other defendants dispute plaintiffs’ claims in the Consolidated Securities Action.

Stockholder Derivative Action

On November 15, 2019, plaintiff Keith Allred, or Allred, filed a derivative stockholder complaint captioned Allred v. Walker et al. in the U.S. District Court for the Southern District of New York against certain of our directors and executive officers.  The complaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action.  The complaint seeks, among other things, unspecified compensatory damages on behalf of our company.

On November 25, 2019, an additional plaintiff, Bruce Brown, or Brown, filed a substantially identical complaint captioned Brown v. Walker et al. in the same court against the same defendants.

35

On December 12, 2019, the court consolidated the Allred and Brown actions under the caption In re Aclaris Therapeutics, Inc. Derivative Litigation, or the Consolidated Derivative Action, and directed that future derivative cases filed in or transferred to the court arising out of substantially the same transactions or events be similarly consolidated.  Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the Consolidated Derivative Action pending resolution of the defendants’ then-anticipated motion to dismiss the Consolidated Securities Action. The stay expired on April 27, 2021, but may be reinstated pending further developments in the Consolidated Securities Action. No further proceedings have yet occurred or been scheduled in the Consolidated Derivative Action.

Item 1A. Risk Factors

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities.  Except for the new risk factors set forth immediately below, ourOur risk factors have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2020, filed with the SEC on March 15, 2017. February 25, 2021.

We may not realize the anticipated benefits of our acquisition of Confluence.

In August 2017, we acquired Confluence Life Sciences, Inc., or Confluence, including several preclinical drug candidates and Confluence’s contract research services business. Acquisitions are inherently risky, and we may not realize the anticipated benefits of the acquisition of Confluence.  Specifically, we are subject to the risks that:

·

we fail to successfully develop or integrate Confluence’s preclinical drug candidates into our pipeline in order to achieve our strategic objectives;

·

we are unable to adequately integrate or continue operating Confluence’s contract research services business;

·

we receive inadequate or unfavorable data from preclinical studies or clinical trials evaluating the acquired preclinical drug candidates; and

·

our due diligence processes in connection with the acquisition fail to identify significant problems, liabilities or other shortcomings or challenges of Confluence, including problems, liabilities or other shortcomings or challenges with respect to intellectual property, product quality and safety and other known and unknown liabilities. 

If we are unable to successfully integrate Confluence’s business and employees, it could have an adverse effect on our future results and the market price of our common stock. 

The success of our acquisition of Confluence will depend, in large part, on our ability to realize operating synergies from combining our business with Confluence’s business. To realize these anticipated benefits, we must successfully integrate Confluence’s business and employees. This integration will be complex and time-consuming. 

The failure to successfully integrate and manage the challenges presented by the integration process may result in our failure to achieve some or all of the anticipated benefits of the merger. Potential difficulties that may be encountered in the integration process include the following:

40


·

complexities associated with managing the larger combined company with distant business locations;

·

integrating personnel from the two companies;

·

current and prospective employees may experience uncertainty regarding their future roles with our company, which might adversely affect our ability to retain, recruit and motivate key personnel;

·

lost sales and customers as a result of customers of Confluence’s contract research services business deciding not to do business with the combined company;

·

potential unknown liabilities and unforeseen expenses associated with the merger; and

·

performance shortfalls at one or both of the companies as a result of the diversion of management’s attention caused by completing the merger and integrating the companies’ operations.

If any of these events were to occur, the ability of the combined company to maintain relationships with customers, suppliers and employees or our ability to achieve the anticipated benefits of the merger could be adversely affected, or could reduce our future earnings or otherwise adversely affect our business and financial results and, as a result, adversely affect the market price of our common stock.

Charges to earnings resulting from the merger may cause our operating results to suffer.

Under accounting principles, we will allocate the total purchase price of the merger to Confluence’s net tangible assets and intangible assets based on their fair values as of the date of the merger, and we will record the excess of the purchase price over those fair values as goodwill. Our management’s estimates of fair value will be based upon assumptions that they believe to be reasonable but that are inherently uncertain. The following factors, among others, could result in material charges that would cause our financial results to be negatively impacted:

·

impairment of goodwill

·

charges for the amortization of identifiable intangible assets and for stock-based compensation; and

·

accrual of newly identified pre-merger contingent liabilities that are identified subsequent to the finalization of the purchase price allocation.

Additional costs may include costs of employee redeployment, relocation and retention, including salary increases or bonuses, taxes and termination of contracts that provide redundant or conflicting services. Some of these costs may have to be accounted for as expenses that would negatively impact our results of operations.

Our sublease could terminate if the master lease is terminated for any reason, thus terminating our rights to access our corporate headquarters.

We sublease space for our corporate headquarters.  While the term of the sublease extends until October 31, 2023, if for any reason the master lease is terminated or expires prior to October 31, 2023, our sublease will also automatically terminate.  In such an event, we would need to obtain a new direct lease with the master landlord or negotiate and enter into a new lease for office space at a different location, which may harm our business.

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

Issuances of Common Stock upon the Exercise of Warrants

On January 15, 2021, we issued 388,119 shares of our common stock to one warrantholder upon the net exercise of warrants. The issuance of these securities was exempt from registration under Section 3(a)(9) of the Securities Act.

None. 

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Item 6. Exhibits

Exhibit
No.

Document

Exhibit
No.

Document

2.1*+^

Agreement and Plan of Merger, dated as of August 3, 2017, by and among the Registrant, Aclaris Life Sciences, Inc., Confluence Life Sciences, Inc. and Fortis Advisors LLC

3.1

Amended and Restated Certificate of Incorporation of the Registrant (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37581), filed with the SEC on October 13, 2015).

3.2

Amended and Restated Bylaws of the Registrant (incorporated herein by reference to Exhibit 3.23.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37581), filed with the SEC on October 13, 2015)June 24, 2020).

10.1*

Fifth Amendment to Amended and Restated Sublease, by and between the Registrant and NST Consulting, LLC, dated as of July 17, 2017.

10.2

Aclaris Therapeutics, Inc. Inducement Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37581), filed with the SEC on August 1, 2017).

10.3

Form of Stock Option Grant Notice and Stock Option Agreement used in connection with the Aclaris Therapeutics, Inc. Inducement Plan (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37581), filed with the SEC on August 1, 2017).

10.4

Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement used in connection with Aclaris Therapeutics, Inc. Inducement Plan (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-37581), filed with the SEC on August 1, 2017).

31.1*

Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.

31.2*

Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.

32.1**

Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.

101.INS

XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

36

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document


104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

*

Filed herewith.

42


**

These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

+

Confidential treatment has been requested with respect to portions of this exhibit, indicated by asterisks, which has been filed separately with the SEC.

^

Pursuant to Item 601(b)(2) of Regulation S-K promulgated by the SEC, certain exhibits and schedules to this agreement have been omitted. The Registrant hereby agrees to furnish supplementally to the SEC, upon its request, any or all of such omitted exhibits or schedules

4337


SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.  

ACLARIS THERAPEUTICS, INC.

Date: NovemberMay 7, 20172021

By:

/s/ Neal Walker

Neal Walker

President and Chief Executive Officer

(On behalf of the Registrant)

Date: NovemberMay 7, 20172021

By:

/s/ Frank Ruffo

Frank Ruffo

Chief Financial Officer

(Principal Financial Officer)

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