UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DCD.C. 20549

FORM 10-Q

(Mark One)

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

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30 2017,2023

ORor

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 001-36003

Commission file number: 001-36003

Histogen Inc.

CONATUS PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

Delaware

20-3183915

(State or Other Jurisdictionother jurisdiction of

Incorporationincorporation or Organization)organization)

(I.R.S.IRS Employer

Identification No.)

Address Not Applicable1

(Address of principal executive offices, including zip code)

(858)526-3100

(Registrant’s telephone number, including area code)

10655 Sorrento Valley Road, Suite 200,

San DiegoCA92121

(Former Name or Former Address, 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, $0.0001 par value

16745 W. Bernardo Dr., Suite 200HSTO

San Diego, CA

92127

(Address of Principal Executive Offices)

(Zip Code)OTC

(858) 376-2600

(Registrant’s Telephone Number, Including Area Code)

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

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

Large accelerated filer

Accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Non-accelerated filer

  (Do not check if a smaller reporting company)

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 Exchange Act). Yes No

As of October 30, 2017,November 9, 2023, the registrant had 30,005,4624,271,759 shares of common stock, ($0.0001$0.0001 par value)value, outstanding.

1Histogen Inc. (the “Company”) terminated its lease agreement for its headquarters and laboratory. Accordingly, the Company does not maintain a headquarters. For purposes of compliance with applicable requirements of the Securities Act of 1933, as amended, and Securities Exchange Act of 1934, as amended, any stockholder communication required to be sent to the Company’s principal executive offices may be directed to the Company’s agent for


CONATUS PHARMACEUTICALS INC.service of process at Corporation Service Company, 251 Little Falls Drive, Wilmington, New Castle County, Delaware 19808, or to the email address set forth in the Company’s proxy materials and/or identified on the Company’s investor relations website.


Histogen Inc.

FORM 10-Q

TABLE OF CONTENTS

PART I.I - FINANCIAL INFORMATION

ITEMItem 1.

FINANCIAL STATEMENTSCondensed Consolidated Financial Statements (unaudited)

34

Condensed Consolidated Balance Sheets

4

Condensed Balance SheetsConsolidated Statements of Operations

35

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)

6

Condensed Statements of Operations and Comprehensive Loss

4

CondensedConsolidated Statements of Cash Flows

57

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Notes to CondensedManagement’s Discussion and Analysis of Financial StatementsCondition and Results of Operations

627

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

ITEM 2.Item 4.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSControls and Procedures

1537

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

22

ITEM 4.

CONTROLS AND PROCEDURES

22

PART II.II - OTHER INFORMATION

ITEMItem 1.

LEGAL PROCEEDINGSLegal Proceedings

2338

Item 1A.

Risk Factors

38

ITEM 1A.Item 2.

RISK FACTORSUnregistered Sales of Equity Securities and Use of Proceeds

2344

Item 3.

Defaults Upon Senior Securities

44

ITEM 2.Item 4.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDSMine Safety Disclosures

2544

Item 5.

Other Information

44

ITEM 3.Item 6.

DEFAULTS UPON SENIOR SECURITIESExhibits

2545

ITEM 4.

MINE SAFETY DISCLOSURESSignatures

25

ITEM 5.

OTHER INFORMATION

25

ITEM 6.

EXHIBITS

25

EXHIBIT INDEX

26

SIGNATURES

27

47


3


PART I. FINANCIALI - FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

Conatus Pharmaceuticals Inc.Item 1. Financial Statements

Condensed Balance SheetsHISTOGEN INC. AND SUBSIDIARIES

(Unaudited)CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,360,452

 

 

$

58,083,409

 

Marketable securities

 

 

70,823,435

 

 

 

18,931,715

 

Other receivables

 

 

 

 

 

2,500,000

 

Prepaid and other current assets

 

 

1,339,208

 

 

 

937,436

 

Total current assets

 

 

86,523,095

 

 

 

80,452,560

 

Property and equipment, net

 

 

204,914

 

 

 

261,446

 

Other assets

 

 

2,538,211

 

 

 

1,609,834

 

Total assets

 

$

89,266,220

 

 

$

82,323,840

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

10,937,851

 

 

$

5,311,093

 

Accrued compensation

 

 

1,810,919

 

 

 

2,351,703

 

Current portion of deferred revenue

 

 

19,454,795

 

 

 

30,897,192

 

Note payable

 

 

 

 

 

1,000,000

 

Total current liabilities

 

 

32,203,565

 

 

 

39,559,988

 

Deferred revenue, less current portion

 

 

12,673,762

 

 

 

20,803,762

 

Convertible note payable

 

 

12,968,493

 

 

 

 

Deferred rent

 

 

139,392

 

 

 

171,544

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares

   issued and outstanding

��

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized; 30,005,462 shares

   issued and outstanding at September 30, 2017; 26,118,722 shares issued

   and outstanding at December 31, 2016

 

 

3,001

 

 

 

2,612

 

Additional paid-in capital

 

 

194,951,562

 

 

 

172,424,531

 

Accumulated other comprehensive loss

 

 

(23,093

)

 

 

(6,145

)

Accumulated deficit

 

 

(163,650,462

)

 

 

(150,632,452

)

Total stockholders’ equity

 

 

31,281,008

 

 

 

21,788,546

 

Total liabilities and stockholders’ equity

 

$

89,266,220

 

 

$

82,323,840

 

(In thousands, except share and per share amounts)

 

 

September 30,
2023

 

 

December 31,
2022

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,573

 

 

$

12,109

 

Restricted cash

 

 

300

 

 

 

400

 

Accounts receivable, net

 

 

 

 

 

99

 

Prepaid and other current assets

 

 

582

 

 

 

848

 

Total current assets

 

 

5,455

 

 

 

13,456

 

Property and equipment, net

 

 

 

 

 

436

 

Right-of-use asset

 

 

 

 

 

4,658

 

Other assets

 

 

362

 

 

 

523

 

Total assets

 

$

5,817

 

 

$

19,073

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

386

 

 

$

382

 

Accrued liabilities

 

 

943

 

 

 

595

 

Current portion of lease liabilities

 

 

 

 

 

238

 

Current portion of deferred revenue

 

 

19

 

 

 

19

 

Total current liabilities

 

 

1,348

 

 

 

1,234

 

Lease liabilities, non-current

 

 

 

 

 

4,379

 

Deferred revenue, non-current

 

 

65

 

 

 

79

 

Finance lease liability, non-current

 

 

 

 

 

5

 

Total liabilities

 

 

1,413

 

 

 

5,697

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 4,271,759 shares issued and outstanding at September 30, 2023 and December 31, 2022

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

103,117

 

 

 

102,673

 

Accumulated deficit

 

 

(97,686

)

 

 

(88,273

)

Total Histogen Inc. stockholders’ equity

 

 

5,436

 

 

 

14,405

 

Noncontrolling interest

 

 

(1,032

)

 

 

(1,029

)

Total equity

 

 

4,404

 

 

 

13,376

 

Total liabilities and stockholders’ equity

 

$

5,817

 

 

$

19,073

 

See accompanying notes to the unaudited condensed consolidated financial statements.

4



Conatus Pharmaceuticals Inc.HISTOGEN INC. AND SUBSIDIARIES

Condensed Statements of OperationsUNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and Comprehensive Lossper share amounts)

(Unaudited)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

License revenue

 

$

5

 

 

$

5

 

 

$

15

 

 

$

3,765

 

Total revenue

 

 

5

 

 

 

5

 

 

 

15

 

 

 

3,765

 

Operating expense

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

660

 

 

 

907

 

 

 

2,189

 

 

 

3,932

 

General and administrative

 

 

2,870

 

 

 

2,696

 

 

 

6,913

 

 

 

7,508

 

Total operating expense

 

 

3,530

 

 

 

3,603

 

 

 

9,102

 

 

 

11,440

 

Loss from operations

 

 

(3,525

)

 

 

(3,598

)

 

 

(9,087

)

 

 

(7,675

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

 

 

 

(1

)

 

 

(1

)

 

 

(2

)

Other income (expense)

 

 

(5

)

 

 

 

 

 

(5

)

 

 

 

Gain on sale of subsidiary

 

 

 

 

 

 

 

 

1

 

 

 

 

Loss on disposal of fixed assets

 

 

(324

)

 

 

 

 

 

(324

)

 

 

 

Net loss

 

 

(3,854

)

 

 

(3,599

)

 

 

(9,416

)

 

 

(7,677

)

Loss (gain) attributable to noncontrolling interest

 

 

3

 

 

 

3

 

 

 

3

 

 

 

20

 

Deemed dividend – accretion of discount and redemption feature of redeemable convertible preferred stock

 

 

 

 

 

 

 

 

 

 

 

(488

)

Net loss available to common stockholders

 

$

(3,851

)

 

$

(3,596

)

 

$

(9,413

)

 

$

(8,145

)

Net loss per share available to common stockholders, basic and diluted

 

$

(0.90

)

 

$

(1.01

)

 

$

(2.20

)

 

$

(2.85

)

Weighted-average number of common shares outstanding used to compute net loss per share, basic and diluted

 

 

4,271,759

 

 

 

3,554,623

 

 

 

4,271,759

 

 

 

2,853,713

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

9,565,890

 

 

$

 

 

$

26,572,397

 

 

$

 

Total revenues

 

 

9,565,890

 

 

 

 

 

 

26,572,397

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

11,165,150

 

 

 

4,825,421

 

 

 

32,308,786

 

 

 

13,770,371

 

General and administrative

 

 

2,449,382

 

 

 

2,069,447

 

 

 

7,406,591

 

 

 

6,883,708

 

Total operating expenses

 

 

13,614,532

 

 

 

6,894,868

 

 

 

39,715,377

 

 

 

20,654,079

 

Loss from operations

 

 

(4,048,642

)

 

 

(6,894,868

)

 

 

(13,142,980

)

 

 

(20,654,079

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

258,623

 

 

 

33,640

 

 

 

648,103

 

 

 

94,995

 

Interest expense

 

 

(189,041

)

 

 

(17,500

)

 

 

(473,354

)

 

 

(52,500

)

Other (expense) income

 

 

(21,318

)

 

 

11,818

 

 

 

(71,779

)

 

 

1,645

 

Total other income

 

 

48,264

 

 

 

27,958

 

 

 

102,970

 

 

 

44,140

 

Net loss

 

 

(4,000,378

)

 

 

(6,866,910

)

 

 

(13,040,010

)

 

 

(20,609,939

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized (losses) gains on marketable securities

 

 

(455

)

 

 

(9,999

)

 

 

(16,948

)

 

 

12,885

 

Comprehensive loss

 

$

(4,000,833

)

 

$

(6,876,909

)

 

$

(13,056,958

)

 

$

(20,597,054

)

Net loss per share, basic and diluted

 

$

(0.13

)

 

$

(0.31

)

 

$

(0.46

)

 

$

(0.96

)

Weighted average shares outstanding used in computing

   net loss per share, basic and diluted

 

 

30,004,037

 

 

 

22,410,702

 

 

 

28,104,199

 

 

 

21,527,993

 

See accompanying notes to the unaudited condensed consolidated financial statements.

5



Conatus Pharmaceuticals Inc.HISTOGEN INC. AND SUBSIDIARIES

Condensed Statements of Cash FlowsUNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE

(Unaudited)CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(13,040,010

)

 

$

(20,609,939

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

81,023

 

 

 

79,877

 

Stock-based compensation expense

 

 

3,049,181

 

 

 

2,456,196

 

Amortization of premiums and discounts on marketable securities, net

 

 

(13,260

)

 

 

6,323

 

Accrued interest included in convertible note payable

 

 

468,493

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Other receivables

 

 

2,500,000

 

 

 

 

Prepaid and other current assets

 

 

(458,038

)

 

 

844,647

 

Other assets

 

 

(872,111

)

 

 

 

Accounts payable and accrued expenses

 

 

5,617,193

 

 

 

(97,396

)

Accrued compensation

 

 

(540,784

)

 

 

175,197

 

Deferred revenue

 

 

(19,572,397

)

 

 

 

Deferred rent

 

 

(22,587

)

 

 

(13,313

)

Net cash used in operating activities

 

 

(22,803,297

)

 

 

(17,158,408

)

Investing activities

 

 

 

 

 

 

 

 

Maturities of marketable securities

 

 

57,257,000

 

 

 

30,847,000

 

Purchase of marketable securities

 

 

(109,152,408

)

 

 

(24,958,424

)

Capital expenditures

 

 

(24,491

)

 

 

(107,165

)

Net cash (used in) provided by investing activities

 

 

(51,919,899

)

 

 

5,781,411

 

Financing activities

 

 

 

 

 

 

 

 

Proceeds from issuance of convertible promissory note, net

 

 

12,500,000

 

 

 

 

Principal payment on promissory note

 

 

(1,000,000

)

 

 

 

Proceeds from issuance of common stock, net

 

 

30,609,789

 

 

 

11,781,626

 

Repurchase of common stock

 

 

(11,202,542

)

 

 

 

Proceeds from stock issuances related to exercise of stock options and

   employee stock purchase plan

 

 

92,992

 

 

 

32,898

 

Net cash provided by financing activities

 

 

31,000,239

 

 

 

11,814,524

 

Net (decrease) increase in cash and cash equivalents

 

 

(43,722,957

)

 

 

437,527

 

Cash and cash equivalents at beginning of period

 

 

58,083,409

 

 

 

13,876,090

 

Cash and cash equivalents at end of period

 

$

14,360,452

 

 

$

14,313,617

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

4,861

 

 

$

52,500

 

(In thousands, except share amounts)

 

 

Redeemable Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Total
Histogen Inc.
Stockholders’
Equity

 

 

Noncontrolling

 

 

Total
Equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

 

Interest

 

 

(Deficit)

 

Balance at December 31, 2022

 

 

 

 

$

 

 

 

 

4,271,759

 

 

$

5

 

 

$

102,673

 

 

$

(88,273

)

 

$

14,405

 

 

$

(1,029

)

 

$

13,376

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

419

 

 

 

 

 

 

419

 

 

 

 

 

 

419

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,470

)

 

 

(3,470

)

 

 

(3

)

 

 

(3,473

)

Balance at March 31, 2023

 

 

 

 

$

 

 

 

 

4,271,759

 

 

$

5

 

 

$

103,092

 

 

$

(91,743

)

 

$

11,354

 

 

$

(1,032

)

 

$

10,322

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

32

 

 

 

 

 

 

32

 

 

 

 

 

 

32

 

Net (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,092

)

 

 

(2,092

)

 

 

3

 

 

 

(2,089

)

Balance at June 30, 2023

 

 

 

 

$

 

 

 

 

4,271,759

 

 

$

5

 

 

$

103,124

 

 

$

(93,835

)

 

$

9,294

 

 

$

(1,029

)

 

$

8,265

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7

)

 

 

 

 

 

(7

)

 

 

 

 

 

(7

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,851

)

 

 

(3,851

)

 

 

(3

)

 

 

(3,854

)

Balance at September 30, 2023

 

 

 

 

$

 

 

 

 

4,271,759

 

 

$

5

 

 

$

103,117

 

 

$

(97,686

)

 

$

5,436

 

 

$

(1,032

)

 

$

4,404

 

 

 

Redeemable Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Total
Histogen Inc.
Stockholders’
Equity

 

 

Noncontrolling

 

 

Total
Equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

 

Interest

 

 

(Deficit)

 

Balance at December 31, 2021

 

 

 

 

$

 

 

 

 

2,497,450

 

 

$

5

 

 

$

98,839

 

 

$

(77,652

)

 

$

21,192

 

 

$

(1,006

)

 

$

20,186

 

Issuance of common stock,
   net of issuance costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9

)

 

 

 

 

 

(9

)

 

 

 

 

 

(9

)

Issuance of redeemable convertible preferred stock, net of issuance costs

 

 

5,000

 

 

 

4,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

165

 

 

 

 

 

 

165

 

 

 

 

 

 

165

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(673

)

 

 

(673

)

 

 

(11

)

 

 

(684

)

Balance at March 31, 2022

 

 

5,000

 

 

$

4,296

 

 

 

 

2,497,450

 

 

$

5

 

 

$

98,995

 

 

$

(78,325

)

 

$

20,675

 

 

$

(1,017

)

 

$

19,658

 

Issuance of redeemable convertible preferred stock, net of issuance costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(119

)

 

 

 

 

 

(119

)

 

 

 

 

 

(119

)

Accretion of issuance costs, discount and redemption feature of redeemable convertible preferred stock

 

 

 

 

 

954

 

 

 

 

 

 

 

 

 

 

(954

)

 

 

 

 

 

(954

)

 

 

 

 

 

(954

)

Redemption of redeemable convertible preferred stock

 

 

(5,000

)

 

 

(5,250

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

115

 

 

 

 

 

 

115

 

 

 

 

 

 

115

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,388

)

 

 

(3,388

)

 

 

(6

)

 

 

(3,394

)

Balance at June 30, 2022

 

 

 

 

$

 

 

 

 

2,497,450

 

 

$

5

 

 

$

98,037

 

 

$

(81,713

)

 

$

16,329

 

 

$

(1,023

)

 

$

15,306

 

Issuance of common stock, net of issuance costs

 

 

 

 

 

 

 

 

 

1,774,309

 

 

 

 

 

 

4,414

 

 

 

 

 

 

4,414

 

 

 

 

 

 

4,414

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

133

 

 

 

 

 

 

133

 

 

 

 

 

 

133

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,596

)

 

 

(3,596

)

 

 

(3

)

 

 

(3,599

)

Balance at September 30, 2022

 

 

 

 

$

 

 

 

 

4,271,759

 

 

$

5

 

 

$

102,584

 

 

$

(85,309

)

 

$

17,280

 

 

$

(1,026

)

 

$

16,254

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

6


HISTOGEN INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(9,416

)

 

$

(7,677

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

100

 

 

 

102

 

Stock-based compensation

 

 

444

 

 

 

413

 

Gain from sale of subsidiary

 

 

(1

)

 

 

 

Loss on disposal of fixed assets

 

 

324

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

99

 

 

 

91

 

Prepaid expenses and other current assets

 

 

266

 

 

 

655

 

Other assets

 

 

162

 

 

 

167

 

Accounts payable

 

 

4

 

 

 

(832

)

Accrued liabilities

 

 

357

 

 

 

(198

)

Right-of-use asset and lease liabilities, net

 

 

41

 

 

 

49

 

Deferred revenue

 

 

(15

)

 

 

(14

)

Net cash used in operating activities

 

 

(7,635

)

 

 

(7,244

)

Cash flows from investing activities

 

 

 

 

 

 

Cash proceeds from sale of subsidiary

 

 

1

 

 

 

 

Cash paid for property and equipment

 

 

 

 

 

(215

)

Cash proceeds from sale of property and equipment

 

 

12

 

 

 

 

Net cash provided by (used in) investing activities

 

 

13

 

 

 

(215

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from the issuance of common stock, net of issuance costs

 

 

 

 

 

4,414

 

Costs paid in connection with December 2021 financing

 

 

 

 

 

(9

)

Repayment of finance lease obligations

 

 

(14

)

 

 

(6

)

Issuance costs for redeemable convertible preferred stock

 

 

 

 

 

(585

)

Redemption payment for redeemable convertible preferred stock

 

 

 

 

 

(488

)

Net cash (used in) provided by financing activities

 

 

(14

)

 

 

3,326

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(7,636

)

 

 

(4,133

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

12,509

 

 

 

19,085

 

Cash, cash equivalents and restricted cash, end of period

 

$

4,873

 

 

$

14,952

 

Reconciliation of cash, cash equivalents and restricted cash to
   the condensed consolidated balance sheets

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,573

 

 

$

14,552

 

Restricted cash

 

 

300

 

 

 

400

 

Total cash, cash equivalents and restricted cash

 

$

4,873

 

 

$

14,952

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Cash paid for interest

 

$

1

 

 

$

1

 

Noncash investing and financing activities

 

 

 

 

 

 

Redemption payment of redeemable convertible preferred stock from escrow

 

$

 

 

$

(4,762

)

Issuance of redeemable convertible preferred stock, proceeds held in escrow

 

$

 

 

$

4,762

 

Fair value of warrants issued to Placement Agent

 

$

 

 

$

283

 

See accompanying notes to the unaudited condensed consolidated financial statements.

7


HISTOGEN INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS


Conatus Pharmaceuticals Inc.1. Description of Business and Basis of Presentation

Description of Business

Notes to Condensed Financial Statements

(Unaudited)

1.

Organization and Basis of Presentation

Histogen Inc. (the “Company,” “Histogen,” “we,” or the “combined company”), formerly known as Conatus Pharmaceuticals Inc. (the Company)(“Conatus”), was incorporated in the state of Delaware on July 13, 2005. TheUntil recently, the Company iswas a biotechnologyclinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the development and commercialization of novel medicinesbody’s natural process to treat liver disease.restore immune function.

As of September 30, 2017,On January 28, 2020, the Company, has devoted substantially allthen operating as Conatus, entered into an Agreement and Plan of its efforts to product developmentMerger and has not realized product sales revenues from its planned principal operations.

The Company hasReorganization, as amended (the “Merger Agreement”), with privately-held Histogen, Inc. (“Private Histogen”) and Chinook Merger Sub, Inc., a limited operating history, and the sales and income potentialwholly-owned subsidiary of the Company’s businessCompany (“Merger Sub”). Under the Merger Agreement, Merger Sub merged with and market are unproven.into Private Histogen, with Private Histogen surviving as a wholly-owned subsidiary of the Company (the “Merger”). On May 26, 2020, the Merger was completed. Conatus changed its name to Histogen Inc., and Private Histogen, which remains as a wholly-owned subsidiary of the Company, changed its name to Histogen Therapeutics Inc. On May 27, 2020, the combined company’s common stock began trading on The Nasdaq Capital Market (“Nasdaq”) under the ticker symbol “HSTO”.

On September 18, 2023, the Company has experienced net losses sinceannounced, after extensive consideration of potential strategic alternatives, that its inceptionBoard of Directors (the “Board”), had unanimously approved the dissolution and liquidation of Histogen (the “Dissolution”) pursuant to a plan of complete liquidation and dissolution (the “Plan of Dissolution”), subject to stockholder approval. In connection with the Plan of Dissolution, the Company discontinued all development programs and terminated all but two employees as of September 30, 2017,2023. The focus of the remaining two employees is to manage the wind-down of the Company's operations and matters related to managing the Dissolution, including obtaining the necessary stockholder approval of the Plan of Dissolution. Additionally, the Company is currently seeking to sell their caspase program assets and other remaining assets.

In light of the planned dissolution, on September 26, 2023, the Company received written notice from Nasdaq advising the Company that based upon Nasdaq’s review and pursuant to Listing Rule 5101, Nasdaq believed that the Company is a “public shell,” and that the continued listing of our securities was no longer warranted. As a result, the trading of the Company's common stock was suspended as of the opening of business on October 5, 2023, and on October 12, 2023, Nasdaq filed a Form 25-NSE with the Securities and Exchange Commission (“SEC”), which removed the Company's common stock from listing and registration on Nasdaq.

Recent Developments

On October 3, 2023, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Allergan Sales, LLC (“Allergan”), pursuant to which Histogen and its affiliates sold to Allergan certain assets, including certain patents and other intellectual property rights, related to Histogen’s hypoxia generated growth factor technology (the “Transaction”). In exchange, Allergan agreed to pay Histogen a purchase price of $2.1 million and agreed to assume certain liabilities as set forth in the Asset Purchase Agreement. The Asset Purchase Agreement contains customary provisions on, among other things, representation and warranties, and covenants related to the transfer of ownership of the acquired assets and other matters. In connection with the Transaction, on October 3, 2023, the Company and Allergan mutually elected to terminate the Allergan License Agreements, as amended from time to time.

In connection with the Transaction, on October 3, 2023, the Company also entered into a Mutual Termination of the Second Amended and Restated Strategic Relationship Success Fee Agreement (the “Lordship Agreement’) with Lordship Ventures LLC (“Lordship”), pursuant to which Histogen agreed to pay Lordship a mutually agreed to success and termination fee as required by the terms of the Lordship Agreement (refer to Note 10 for further information).

Reverse Stock Split

On June 2, 2022, the Company’s Board approved a one-for-twenty reverse stock split of its then outstanding common stock (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded down to the next whole share of common stock. The par value and the authorized shares of the common stock were not adjusted as a result of the Reverse Stock Split. All references to share and per share amounts for all periods presented in the condensed consolidated financial statements have been retrospectively restated to reflect this Reverse Stock Split. Additionally, all rights to receive shares of common stock under outstanding warrants, options, and restricted stock units (“RSUs”) were adjusted to give effect of the reverse stock split. Furthermore, remaining shares of common stock available for future issuance under stock-based payment award plans and employee stock purchase plans were adjusted to give effect to the Reverse Stock Split.

8


Liquidity and Going Concern

The Company has incurred operating losses and negative cash flows from operations and had an accumulated deficit of $163.7 million.$97.7 million as of September 30, 2023. The Company expects operating losses and negative cash flows from operations to continue for the foreseeable future, including through the execution of the Plan of Dissolution if approved by the Company’s stockholders.

In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to incur net lossescontinue as a going concern within one year after the date that these consolidated financial statements are issued on November 9, 2023. The Company has determined that its cash and cash equivalents as of September 30, 2023 of $4.6 million would be insufficient to fund its operations for a period of at least twelve months from the next several years. Successful transition to attaining profitable operations is dependent upon achieving a leveldate of revenues adequate to supportthese financial statements which raises substantial doubt regarding the Company’s cost structure. Ifability to continue as a going concern. The Company does not have plans to alleviate the substantial doubt about the Company’s ability to continue as a going concern.

On September 18, 2023, the Company is unableannounced that the Board unanimously approved the Plan of Dissolution. As the Plan of Dissolution has not yet been brought to generate revenues adequate to support its cost structure,a vote or approved by the Company’s stockholders, the Company may need to raise additional equity or debt financing.

Theconcluded that the liquidation basis of accounting should not be applied as of the balance sheet date. Accordingly, the accompanying unaudited interim condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of these uncertainties described above.

Basis of Presentation and Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries, including Histogen Therapeutics, Inc., and have been prepared in accordance with U.S.accounting principles generally accepted accounting principles (GAAP)in the United States (“GAAP”). All intercompany balances and transactions have been eliminated upon consolidation.

The Company acquired Centro De Investigacion de Medicina Regenerativa, S.A. de C.V. (“CIMRESA”), a company in Mexico, during 2018 to facilitate a potential clinical development program for HST-001, or hair stimulating complex (“HSC”). This was a wholly-owned subsidiary intended to pursue registration with the COFEPRIS (Mexico equivalent to Food and Drug Administration). Since the Company acquired CIMRESA in 2018, there have been no financial or operational activities. On January 17, 2023, the Company sold the wholly-owned subsidiary, CIMRESA, and deconsolidated the former subsidiary, resulting in a gain during the nine months ended September 30, 2023.

The Company holds a majority interest in Adaptive Biologix, Inc. (“AB”, formerly Histogen Oncology, LLC). AB was formed to develop and market applications for the treatment of cancer. The Company consolidates AB into its condensed consolidated financial statements (refer to Note 2 for further information).

Unaudited Interim Financial Information

The unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2023 and 2022 have been prepared in accordance with the rules and regulations of the SecuritiesSEC and Exchange Commission (SEC) related to a quarterly report on Form 10-Q. CertainGAAP. Accordingly, these condensed consolidated financial statements do not include all of the information and note disclosures normally included in annualfootnotes required by GAAP for complete financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. Thestatements. In the opinion of Management, these unaudited interim condensed consolidated financial statements reflectcontain all adjustments which, in the opinionnecessary, all of management, are necessary for a fair statement of the results for the periods presented. All such adjustmentswhich are of a normal and recurring nature. The operatingnature, to present fairly the Company’s financial position, results presented in these unaudited interim condensed financial statementsof operations, and cash flows. Interim results are not necessarily indicative of the results that may be expected for anya full year or future periods. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and therelated notes thereto for the year ended December 31, 20162022 included in the Company’s annual reportAnnual Report on Form 10-K that the Company filed with the SEC on March 16, 2017.9, 2023.

2. Summary of Significant Accounting Policies

2.

Summary of Significant Accounting Policies

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, and liabilities and the disclosure of contingent assets and liabilities and contingencies at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.periods presented. Management believes that these estimates and assumptions are reasonable, however, actual results may differ and could have a material effect on future results of operations and financial position. Though the impact of the COVID-19 pandemic to the business

9


and operating results presents additional uncertainty, the Company continues to use the best information available to them in their significant accounting estimates.

Significant estimates and assumptions include those related to the useful lives of property and equipment, discount rates used in recognizing contracts containing leases, unrecognized tax benefits, and volatility used for stock-based compensation option pricing. Actual results couldmay materially differ from those estimates.

Variable Interest Entities

Concentrations of Credit Risk

Financial instrumentsThe Company determined that potentially subjectAB is a variable interest entity (“VIE”) and that the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities.is its primary beneficiary. The Company maintains depositsholds greater than 50% of the shares and has the authority to manage the business and affairs of the VIE. AB’s other shareholder does not have a controlling interest.

A VIE is typically an entity for which the Company has less than a 100% equity interest but controls the decision making over the business and affairs of the entity, directs the decisions driving the economic performance of such entity and participates in federally insured financial institutions in excessthe profit and losses of federally insured limits.such an entity. The Company has not experienced any lossesweighed both quantitative and qualitative information about the different risks and reward characteristics of each entity and the significance of that entity to the consolidating group in such accountsthe aggregate.

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, the Chief Executive Officer, in making decisions regarding resource allocation and believes it is not exposed to significant risk onassessing performance. The Company views its cash. Additionally, the Company established guidelines regarding approved investmentsoperations and maturities of investments, which are designed to maintain safetymanages its business as one operating segment.

Cash, Cash Equivalents and liquidity.Restricted Cash

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity from the date of purchase of three monthsninety days or less to be cash equivalents. Cash and cash equivalents include cash in readily available checking, and money market accounts and brokerage accounts.

Marketable Securities

The Company classifies its marketable securitiesCompany’s current restricted cash consists of cash held as available-for-sale and records such assets at estimated fair value in the condensed balance sheets, with unrealized gains and losses, if any, reportedcollateral for a letter of credit issued as a componentsecurity deposit for the lease of other comprehensive income (loss) within the condensed statements of operations and comprehensive loss and as a separate component of stockholders’ equity. The Company classifies marketable securities with remaining maturities greater than one year as current assets because such marketable


securities are available to fund the Company’s current operations. Theheadquarters and is required to be held throughout the lease term.

Risks and Uncertainties

Credit Risk

At certain times throughout the year, the Company invests itsmay maintain deposits in federally insured financial institutions in excess cash balances primarily in corporate debt securitiesof federally insured limits.

Customer Risk

During the three and money market funds with strong credit ratings. Realized gains and losses are calculated on the specific identification method and recorded as interest income. There were no realized gains and losses for the nine-month periodsnine months ended September 30, 20172023 and 2016.2022, one customer accounted for 100% of total revenues.

Accounts Receivable

At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significanceAccounts receivable are generally due within 30 days and are recorded net of the decline in value comparedallowance for doubtful accounts, if any. Management considers all accounts receivable to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security’s relative performance versus its peers, sector or asset class, expected market volatilitybe recoverable, and the market and economy in general. When the Company determines that a decline in the fair value below its cost basis is other-than-temporary, the Company recognizes an impairment loss in the period in which the other-than-temporary decline occurred. There have beenaccordingly, no other-than-temporary declines in the value of marketable securities, as it is more likely than not the Company will hold the securities until maturity or a recovery of the cost basis.

Fair Value of Financial Instruments

The carrying amounts of prepaid and other current assets,provision for doubtful accounts payable and accrued expenses are reasonable estimates of their fair value because of the short maturity of these items.

Stock-Based Compensation

Stock-based compensation expense for stock option grants under the Company’s stock option plans iswas recorded at the estimated fair value of the awardDecember 31, 2022. No accounts receivable are recorded as of September 30, 2023 on the grant date and is recognized as expense on a straight-line basis over the requisite service period of the stock-based award. Stock-based compensation expense for employee stock purchases under the Company’s 2013 Employee Stock Purchase Plan (the ESPP) is recorded at the estimated fair value of the purchase as of the plan enrollment date and is recognized as expense on a straight-line basis over the applicable six-month ESPP offering period.  The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized.accompanying condensed consolidated balance sheets.

Property and Equipment

Property and equipment which consistsare reported net of accumulated depreciation and amortization and are comprised of office furniture and fixtures, computersequipment, lab and officemanufacturing equipment, and leasehold improvements,improvements. Ordinary maintenance and repairs are stated at costcharged to expense, while expenditures that extend the physical or economic life of the assets are capitalized. Furniture and all equipment are depreciated over thetheir estimated useful lives, ofor five years, using the assets (three to five years)straight-line method. Software is amortized over its estimated useful lives, or three years, using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives orand limited by the remaining term of the building lease, term.using the straight-line method. No property and equipment are recorded as of September 30, 2023 on the accompanying condensed consolidated balance sheets.

10


Valuation of Long-Lived Assets

The Company regularly reviews the carrying valueLong-lived assets to be held and estimated lives of all of its long-lived assets,used, including property and equipment, to determine whether indicators ofare reviewed for impairment may exist which warrant adjustments to carrying valueswhenever events or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flowchanges in future periods, as well as the strategic significance of the assets to the Company’s business objective. Should an impairment exist, the impairment loss would be measured based on the excess ofcircumstances indicate that the carrying amount of the asset’s fair value. The Company hasassets may not recognized any impairment losses throughbe recoverable. During the three months ended September 30, 2017.

Revenue Recognition

The2023, the Company recognizes revenue when eachdisposed of its remaining property and equipment and, as of September 30, 2023, other assets are the following four criteria is met: (i) persuasive evidence of an arrangement exists; (ii) products are delivered or as services are rendered; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably assured.

The Company recognizes revenue under its Option, Collaboration and License Agreement (the Collaboration Agreement) with Novartis Pharma AG (Novartis) basedremaining long-lived assets recorded on the relevant accounting literature.  Under this guidance, multiple elements or deliverables may include (i) grants of licenses, or options to obtain licenses, to intellectual property, (ii) research and development services, (iii) participation on joint research and/or joint development committees, and/or (iv) manufacturing or supply services. The payments entities may receive under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; amounts due upon the achievement of specified objectives; and/or royalties on future product sales.


Multiple-element arrangements require the separability of deliverables included in an arrangement into different units of accounting and the allocation of arrangement consideration to the units of accounting. The evaluation of multiple-element arrangements requires management to make judgments about (i) the identification of deliverables, (ii) whether such deliverables are separable from the other aspects of the contractual relationship, (iii) the estimated selling price of each deliverable, and (iv) the expected period of performance for each deliverable.

To determine the units of accounting under a multiple-element arrangement, management evaluates certain separation criteria, including whether the deliverables have stand-alone value, based on the relevant facts and circumstances for each arrangement. Management then estimates the selling price for each unit of accounting and allocates the arrangement consideration to each unit using the relative selling price method. The allocated consideration for each unit of accounting is recognized based on the method most appropriate for that unit of account and in accordance with the revenue recognition criteria detailed above.

If there are deliverables in an arrangement that are not separable from other aspects of the contractual relationship, they are treated as a combined unit of accounting, with the allocated revenue for the combined unit recognized in a manner consistent with the revenue recognition applicable to the final deliverable in the combined unit. Payments received prior to satisfying the relevant revenue recognition criteria are recorded as deferred revenue in the accompanying condensed consolidated balance sheets and recognized as revenue when the related revenue recognition criteria are met.

The Collaboration Agreement provides for non-refundable milestone payments. The Company recognizes revenue that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is considered substantive when the consideration payable(refer to the Company for such milestone (i) is consistent with the Company’s performance necessary to achieve the milestone or the increase in value to the collaboration resulting from the Company’s performance, (ii) relates solely to the Company’s past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this assessment, the Company considers all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the milestone consideration is related to future performance or deliverables.

The Company periodically reviews the estimated performance periods under the Collaboration Agreement, which provides for non-refundable upfront payments and fees. The Company will adjust the periods over which revenue should be recognized when appropriate to reflect changes in assumptions relating to the estimated performance periods. The Company could accelerate revenue recognition in the event of early termination of programs or if the Company’s expectations change. Alternatively, the Company could decelerate revenue recognition if programs are extended or delayed. While such changes to the Company’s estimates have no impact on the Company’s reported cash flows, the amount of revenue recorded in future periods could be materially impacted.

The Company records revenues related to the reimbursement of costs incurred under the Collaboration Agreement where the Company acts as a principal, controls the research and development activities and bears credit risk. Under the Collaboration Agreement, the Company is reimbursed for associated out-of-pocket costs and for a certain amount of the Company’s full-time equivalent (FTE) costs based on an agreed-upon FTE rate. The gross amount of these pass-through reimbursed costs is reported as revenue in the accompanying statements of operations and comprehensive loss, while the actual expenses for which the Company is reimbursed are reflected as research and development costs.

See Note 8 – Collaboration and License Agreements4 for further information.information).

Research and Development Expenses

All research and development costs are expensed as incurred.

Income Taxes

The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. As of December 31, 2016, there are no unrecognized tax benefits included in the condensed balance sheet that would, if recognized, affect the Company’s effective tax rate, and the Company has noted no material changes through September 30, 2017. The Company has not recognized interest and penalties in the condensed balance sheets or condensed statements of operations and comprehensive loss. The Company is subject to U.S. and California taxation. As of December 31, 2016, the Company’s tax years beginning 2005 to date are subject to examination by taxing authorities.


Comprehensive Loss

The Company is required to report all components of comprehensive loss, including net loss, in the accompanying condensed consolidated financial statements in the period in which they are recognized. Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from nonownernon-owner sources, including unrealized gains and losses on marketable securities. Comprehensive gains (losses) have been reflected in the condensed statements of operationsinvestments and foreign currency translation adjustments. Net loss and comprehensive loss were the same for all periods presented.

Revenue Recognition

Segment ReportingLicense Revenue

Operating segments are identified as componentsThe Company records revenue in accordance with ASC 606, Revenue from Contracts with Customers, whereby revenue is recognized when a customer obtains control of promised goods or services in an enterprise about which separate discrete financial informationamount that reflects the consideration expected to be received in exchange for those goods or services. A five-step model is used to achieve the core principle: (1) identify the customer contract, (2) identify the contract’s performance obligations, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations and (5) recognize revenue when or as a performance obligation is satisfied. The Company applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in making decisions regarding resource allocationexchange for the goods or services it transfers to the customer. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and assessing performance. To date,in similar circumstances (refer to Note 5 for further information).

Grant Awards

In September 2020, the Company has viewed its operations and managed its business as one segment operating primarilywas approved for a grant award from the U.S. Department of Defense (“DoD”) in the United States.amount of approximately $2.0 million to partially fund the Company’s Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee. The Company applies International Accounting Standard (“IAS”) 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy as there is no existing authoritative guidance under GAAP. Under the terms of the award, the DoD will reimburse the Company for certain allowable costs. The period of performance for the grant award substantially expires in September 2025 and is subject to annual and quarterly reporting requirements. As the DoD grant is a cost-type (reimbursement) grant, the Company must incur program expenses in accordance with the Statement of Work and approved budget in order to be reimbursed by the DoD. The Company will recognize funding received from the grant award as a reduction of research and development expenses in the period in which qualifying expenses have been incurred, as the Company is reasonably assured that the expenses will be reimbursed and the funding is collectible. For the three and nine months ended September 30, 2023, qualifying expenses totaling $0 and $0.1 million have been incurred with a corresponding reduction of research and development expenses related to the award, respectively. As of September 30, 2023 and December 31, 2022, $0 and $0.1 million was included in accounts receivable within the condensed consolidated balance sheets with respect to the award, respectively. The Company made the decision in December 2022 to terminate the study for futility regarding patient recruitment and redirect efforts and funding away from HST-003 to other product candidates. As of March 31, 2023, the Company had completed its HST-003 clinical study close-out activities and early terminated the grant award.

Research and Development Expenses

All research and development costs are charged to expense as incurred. Research and development expenses primarily include (i) payroll and related costs associated with research and development performed, (ii) costs related to clinical and preclinical testing of the Company’s technologies under development, and (iii) other research and development costs, net of reimbursable research and development costs incurred under the DoD grant.

General and Administrative Expenses

General and administrative expenses represent personnel costs for employees involved in general corporate functions, including finance, accounting, legal and human resources, among others. Additional costs included within general and administrative expenses consist of professional fees for legal (including patent costs), audit and other consulting services, travel and entertainment, recruiting, facility costs, general information technology costs, depreciation and amortization, and other general corporate overhead expenses.

11


Patent Costs

The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included as a component of general and administrative expenses in the accompanying consolidated statements of operations.

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between consolidated financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. No income tax expense or benefit was recorded for the three and nine months ended September 30, 2023 and 2022, due to the full valuation allowance on the Company’s net deferred tax assets. A valuation allowance is provided if it is more likely than not that some or all the deferred tax assets will not be realized.

The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition.

The Company’s policy is to recognize interest or penalties related to income tax matters in income tax expense. Interest and penalties related to income tax matters were not material for the periods presented.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is calculatedcomputed by dividing the net loss attributable to common stockholders by the weighted average number ofweighted-average common shares outstanding during the period.period, without consideration for potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted averageweighted-average number of common shares and common share equivalentspotentially dilutive securities outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company’s potentially dilutive securities have been excluded fromFor the computation ofthree and nine months ended September 30, 2023 and 2022, diluted net loss per share in the periods in which they would be anti-dilutive. For all periods presented, thereattributable to common stockholders is no difference in the number of shares usedequal to compute basic and diluted shares outstanding due to the Company’s net loss position.per share attributable to common stockholders as common stock equivalent shares from stock options and warrants were anti-dilutive.

The following table sets forth the outstanding potentially dilutive securitiesshares that have been excluded infrom the calculation of diluted net loss per share attributable to common stockholders because of their anti-dilutive effect (in common stock equivalents):

 

 

September 30, 2023

 

 

September 30, 2022

 

Common stock options issued and outstanding

 

 

218,919

 

 

 

129,006

 

Warrants to purchase common stock

 

 

4,876,571

 

 

 

4,876,639

 

Total anti-dilutive shares

 

 

5,095,490

 

 

 

5,005,645

 

Stock-Based Compensation

Service-Based Awards

The Company recognizes stock-based compensation expense for service-based stock options and restricted stock units (“RSUs”) over the requisite service period on a straight-line basis. Employee and director stock-based compensation for service-based stock options is measured based on estimated fair value as of the grant date using the Black-Scholes option pricing model. The Company estimates the fair value of RSUs based on the closing price of the Company’s common stock on the date of issuance. The Company uses the following assumptions for estimating fair value of service-based option grants:

Fair Value of Common Stock – The fair value of common stock underlying the option grant is determined based on observable market prices of the Company’s common stock.

Expected Volatility – Volatility is a measure of the amount by which the Company’s share price has historically fluctuated or is expected to do so would be anti-dilutive.fluctuate (i.e., expected volatility) during a period. Due to the lack of an adequate history of a public market for the trading of the Company’s common stock and a lack of adequate company-specific historical and implied volatility data, volatility has been estimated and based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, the Company has selected companies with comparable characteristics, including enterprise value, risk profiles, and position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards.

12

 

 

September 30,

 

 

 

2017

 

 

2016

 

Warrants to purchase common stock

 

 

149,704

 

 

 

149,704

 

Common stock options issued and outstanding

 

 

4,910,557

 

 

 

3,496,826

 

Shares issuable upon conversion of convertible note payable

 

 

2,297,138

 

 

 

 

Common stock subject to repurchase

 

 

 

 

 

6,316

 

ESPP shares pending issuance

 

 

7,514

 

 

 

7,415

 

Total

 

 

7,364,913

 

 

 

3,660,261

 


RecentExpected Term – This is the period of time during which the options are expected to remain unexercised. Options have a maximum contractual term of ten years. The Company estimates the expected term of stock options using the “simplified method”, whereby the expected term equals the average of the vesting term and the original contractual term of the underlying option.

Risk-Free Interest Rate – This is the observed yield on zero-coupon U.S. Treasury securities, as of the day each option is granted, with a term that most closely resembles the expected term of the option.

Expected Forfeiture Rate – Forfeitures are recognized as they occur.

Recently Issued Accounting Pronouncements Not Yet Adopted

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606). This guidance requires that an entity recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. For public companies, ASU No. 2014-09 is effective for annual reporting periods beginning after December 15, 2017 and interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after December 15, 2016. The Company is continuing to assess the impact of the new guidance on its accounting policies and procedures and is evaluating the new requirements as applied to existing revenue contracts. While this assessment is still in progress, the Company believes the most significant impact will relate to the timing of collaboration revenues, where the recognition of variable consideration such as milestone payments may be accelerated. In conjunction with its continuing assessment of the impact of the new guidance, the Company is also evaluating its method of adoption and reviewing and updating its internal controls over financial reporting to ensure that information required to implement the new standard is appropriately captured and recorded. The Company will implement any changes as required to facilitate adoption of the new guidance beginning in the first quarter of 2018.

In February 2016,March 2023, the FASB issued ASU No. 2016-02, 2023-01, Leases (Topic 842). : Common Control Arrangements (“ASU 2023-01”), amending certain provisions of ASC 842 that apply to arrangements between related parties under common control. This guidance requires organizations that lease assets with lease terms of more than 12 months to recognize onstandard amends the balance sheet the assets and liabilitiesaccounting for the rights and obligations created by those leases.leasehold improvements in common-control arrangements for all entities. The amendments in this ASU also requires disclosures to give financial statement users information on the amount, timing and uncertainty of cash flows arising from leases, including qualitative and quantitative information. Forare effective for public companies, ASU No. 2016-02 is effectivebusiness entities for fiscal years andbeginning after December 15, 2023, including interim periods within those fiscal years, beginning after December 15, 2018. Earlywith early adoption is permitted. The Company does not expect to early adopt this guidance and is currentlyin the process of evaluating the impact of the pending adoption of ASU No. 2016-02 on its financial statements and related disclosures.

In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This guidance changes the accounting for certain aspects of stock-based compensation, including income taxes, forfeitures, tax withholding and classification on the statement of cash flows. For public companies, ASU No. 2016-09 is effective for annual and interim periods beginning after


December 15, 2016. The Company adopted this guidance effective March 31, 2017, as required. The adoption of this guidance on the Company’s consolidated financial statements.

Recently Adopted Accounting Pronouncements

None.

3. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

 

 

September 30,
2023

 

 

December 31,
2022

 

Lab and manufacturing equipment

 

$

 

 

$

937

 

Office furniture and equipment

 

 

 

 

 

225

 

Software

 

 

 

 

 

48

 

Total

 

 

 

 

 

1,210

 

Less: accumulated depreciation and amortization

 

 

 

 

 

(774

)

Property and equipment, net

 

$

 

 

$

436

 

Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022, were $100 thousand and $102 thousand, respectively. During the three months ended September 30, 2023, the Company disposed of $1.2 million in property and equipment that had an immaterialaccumulated depreciation of $0.9 million, resulting in a loss of $0.3 million on the accompanying condensed consolidated statements of operations.

4. Balance Sheet Details

Prepaid and other current assets consisted of the following (in thousands):

 

 

September 30,
2023

 

 

December 31,
2022

 

Insurance

 

$

463

 

 

$

626

 

Prepaid rent

 

 

 

 

 

81

 

Pre-clinical and clinical related expenses

 

 

 

 

 

64

 

Prepaid corporate taxes

 

 

79

 

 

 

 

Other

 

 

40

 

 

 

77

 

Total

 

$

582

 

 

$

848

 

13


Other assets consisted of the following (in thousands):

 

 

September 30,
2023

 

 

December 31,
2022

 

Insurance

 

$

353

 

 

$

513

 

Other

 

 

9

 

 

 

10

 

Total

 

$

362

 

 

$

523

 

Accrued liabilities consisted of the following (in thousands):

 

 

September 30,
2023

 

 

December 31,
2022

 

Current portion of finance lease liabilities

 

$

 

 

$

9

 

Accrued compensation

 

 

787

 

 

 

160

 

Preclinical and clinical related expenses

 

 

 

 

 

150

 

Legal fees

 

 

134

 

 

 

44

 

Accrued franchise tax

 

 

 

 

 

162

 

Other

 

 

22

 

 

 

70

 

Total

 

$

943

 

 

$

595

 

5. Revenues

The following is a summary description of the material revenue arrangements, including arrangements that generated revenues during the three and nine months ended September 30, 2023 and 2022.

Allergan License Agreements

2017 Allergan Amendment

In 2017, the Company entered into a series of agreements (collectively, the “2017 Allergan Agreement”), which ultimately transferred Suneva Medical, Inc.’s license and supply rights of the Company’s cell conditioned medium (“CCM”) skin care ingredient in the medical aesthetics market to Allergan and granted Allergan an exclusive, royalty-free, perpetual, irrevocable, non-terminable and transferable license, including the right to sublicense to third parties, to use the Company’s CCM skin care ingredient in the medical aesthetics market. The 2017 Allergan Agreement also obligated the Company to deliver CCM to Allergan (the “Supply of CCM to Allergan”) in the future as well as share with Allergan any potential future improvements to the Company’s CCM skin care ingredients identified through the Company’s research and development efforts (“Potential Future Improvements”). In consideration for the execution of the agreements, the Company received a cash payment of $11.0 million and a potential additional payment of $5.5 million if Allergan’s net sales of products containing the Company’s CCM skin care ingredient exceeds $60.0 million in any calendar year through December 31, 2027.

2019 Allergan Amendment

In March 2019, the Company entered into a separate agreement with Allergan (the “2019 Allergan Amendment”) to amend the 2017 Allergan Agreement in exchange for a one-time payment of $7.5 million to the Company. The agreement broadened Allergan’s license rights, expanding Allergan’s access to certain sales channels where its products incorporating the CCM ingredient can be sold. Specifically, the license was broadened to provide Allergan the exclusive right to sell through the “Amazon Professional” website, or any website or digital platform owned or licensed by Allergan or under the Allergan brand name, and non-exclusive rights to sell on other websites and through brick-and-mortar medical spas and wellness centers (excluding websites and brick-and-mortar stores of luxury brands).

The Company evaluated the 2019 Allergan Amendment under ASC 606 and concluded that Allergan continues to be a customer and that the expanded license is distinct from the 2017 Allergan Agreement. The Company determined the expanded license under the 2019 Allergan Amendment to be functional intellectual property as Allergan has the right to utilize the Company’s CCM skin care ingredient, and that ingredient is functional to Allergan at the time the Company transferred the expanded license.

14


The standalone selling price of the expanded license was not readily observable since the Company has not yet established a price for this expanded license and the expanded license has not been sold on a standalone basis to any customer. The Company accounted for the 2019 Allergan Amendment as a modification to the 2017 Allergan Agreement. The contract modification was accounted for as if the 2017 Allergan Agreement had been terminated and the new contract included the expanded license as well as the remaining performance obligations that arose from the 2017 Allergan Agreement related to the Supply of CCM to Allergan and Potential Future Improvements.

The total transaction price for the new contract included the $7.5 million from the 2019 Allergan Amendment as well as the amounts deferred as of the 2019 Allergan Amendment execution date for each the Supply of CCM to Allergan and Potential Future Improvements.

The standalone selling price for the Supply of CCM to Allergan was determined based on comparable sales transactions. The standalone selling price of the Potential Future Improvements was estimated at the fully burdened rate of research and development employees cost plus a commercially reasonable markup. The amount of the total transaction price allocated to the expanded license was determined using the residual approach, as a result of not having a standalone selling price for the expanded license; that is, the total transaction price less the standalone selling prices of the Supply of CCM to Allergan and Potential Future Improvements.

Revenue related to the Supply of CCM to Allergan has been deferred and recognized at the point in time in which deliveries are completed while revenue related to the Potential Future Improvements has been deferred and amortized ratably over the remaining life of the patent into early 2028. The Supply of CCM to Allergan under the 2019 Allergan Amendment was entirely fulfilled during the year ended December 31, 2019. The $7.5 million residual amount of the total transaction price allocated to the expanded license was recognized as license revenue upon transfer of the license to Allergan in March 2019.

2020 Allergan Amendment

In January 2020, the Company further amended the 2019 Allergan Amendment in exchange for a one-time payment of $1.0 million to the Company (the “2020 Allergan Amendment”). The 2020 Allergan Amendment further broadened Allergan’s exclusive and non-exclusive license rights to include products used for or in connection with microdermabrasion. In addition, the Company agreed to provide Allergan with an additional 200 kilograms of CCM (the “Additional Supply of CCM to Allergan”).

The Company evaluated the 2020 Allergan Amendment under ASC 606 and concluded that Allergan continues to be a customer and that the expanded license is distinct from the 2019 Allergan Amendment. The Company determined the expanded license under the 2020 Allergan Amendment to be functional intellectual property as Allergan has the right to utilize the Company’s CCM skin care ingredient, and that ingredient is functional to Allergan at the time the Company transferred the expanded license.

The standalone selling price of the expanded license was not readily observable since the Company has not yet established a price for this expanded license and the expanded license has not been sold on a standalone basis to any customer. The Company accounted for the 2020 Allergan Amendment as a modification to the 2019 Allergan Amendment (which had modified the 2017 Allergan Agreement, as noted above). The contract modification was accounted for as if the 2019 Allergan Amendment had been terminated and the new contract included the expanded license and Additional Supply of CCM to Allergan, as well as the remaining performance obligation related to Potential Future Improvements.

The total transaction price for the new contract included the $1.0 million from the 2020 Allergan Amendment, the future payment for the Additional Supply of CCM to Allergan, as well as the amounts deferred as of the 2020 Allergan Amendment execution date for Potential Future Improvements.

The standalone selling price for the Additional Supply of CCM to Allergan was determined using the observable inputs of historical comparable sales transactions, including the margin from such sales. The Company also considered its reduced expected cost of satisfying this performance obligation based on the current efficiencies within its CCM manufacturing processes. Due to significant efficiencies in the Company’s CCM manufacturing processes, the forecasted cost of CCM production has decreased, while the applied margin was determined by comparison to similar sales transactions in prior years. The standalone selling price of the Potential Future Improvements was estimated at the fully burdened rate of research and development employees cost plus a commercially reasonable markup. The amount of the total transaction price allocated to the expanded license was determined using the residual approach, as a result of not having a standalone selling price for the expanded license; that is, the total transaction price less the standalone selling prices of the Additional Supply of CCM to Allergan and Potential Future Improvements.

15


Under the Amended and Restated License Agreement, as amended, Allergan will indemnify the Company for third party claims arising from Allergan’s breach of the agreement, negligence or willful misconduct, or the exploitation of products by Allergan or its sublicensees. The Company will indemnify Allergan for third party claims arising from the Company’s breach of the agreement, negligence or willful misconduct, or the exploitation of products by the Company prior to the effective date. Allergan may terminate the Agreement for convenience upon one business days’ notice to the Company.

Revenue related to the Additional Supply of CCM to Allergan was deferred and was recognized at the point in time in which deliveries were completed. All deliveries of Additional Supply of CCM to Allergan have been completed as of March 31, 2021. As such, there is no revenue for the three and nine months ended September 30, 2023 and 2022.

Revenue of $0.2 million related to the Potential Future Improvements has been deferred and amortized ratably over the remaining life of the patent into early 2028, for which $5 thousand and $15 thousand of previously deferred revenue was recognized in revenue during each of the three and nine months ended September 30, 2023 and 2022, respectively.

2022 Allergan Letter Agreement

Pursuant to the 2017 Allergan Amendment, the Company had the right to a potential milestone payment of $5.5 million if Allergan’s net sales of products containing the Company’s CCM skin care ingredient exceeds $60.0 million in any calendar year through December 31, 2027. In lieu of the potential milestone payment of $5.5 million, the Company entered into a letter agreement on March 18, 2022 (the “Letter Agreement”) with Allergan. In consideration for the execution of the Letter Agreement, the Company received a one-time payment equal to $3.8 million (the “Final Payment”) in March 2022. In exchange, among other things, the Company agreed that the Final Payment represents a full and final satisfaction of all money due to the Company pursuant to the License Agreement. The Company evaluated the 2022 Allergan Letter Agreement under ASC 606 and concluded that the performance obligation has been satisfied and therefore applied point in time recognition. The Company recognized the entire $3.8 million of license revenue related to the Letter Agreement during the year ended December 31, 2022. The Letter Agreement did not have an impact on the Company’s financial statements and related disclosures.

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. This guidance addresses the presentation and classification of certain cash flow items, including the classification of cash receipts and payments that have aspects of more than one class of cash flows,remaining performance obligation to reduce the existing diversity in practice. ASU 2016-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. Early adoption is permitted. The Company early adopted this guidance effective June 30, 2017. The adoption of this guidance had no impact onshare with Allergan any Potential Future Improvements to CCM identified through the Company’s financial statementsresearch and related disclosures.development efforts.

In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718). This guidance amends the scope of modification accounting for share-based payment arrangementsRemaining Performance Obligation and addresses the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting under Topic 718. For public companies, ASU No. 2017-09Deferred Revenue

The remaining performance obligation is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted. The Company early adopted this guidance effective June 30, 2017. The adoption of this guidance had no impact on the Company’s financial statementsobligation to share with Allergan any Potential Future Improvements to CCM identified through the Company’s research and related disclosures.

3.

Fair Value Measurements

The accounting guidance defines fair value, establishes a consistent frameworkdevelopment efforts. Deferred revenue recorded for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level 1:

Includes financial instruments for which quoted market prices for identical instruments are available in active markets.

Level 2:

Includes financial instruments for which there are inputs other than quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets with insufficient volume or infrequent transaction (less active markets) or model-driven valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.

Level 3:

Includes financial instruments for which fair value is derived from valuation techniques in which one or more significant inputs are unobservable, including management’s own assumptions.

Below is a summary of assets measured at fair valuePotential Future Improvements was $0.1 million as of both September 30, 20172023 and December 31, 2016.

 

 

 

 

 

 

Fair Value Measurements Using

 

 

 

September 30, 2017

 

 

Quoted Prices in

Active Markets

for Identical

Assets (Level 1)

 

 

Significant

Other

Observable

Inputs (Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,875,586

 

 

$

12,875,586

 

 

$

 

 

$

 

Corporate debt securities

 

 

70,823,435

 

 

 

 

 

 

70,823,435

 

 

 

 

Total

 

$

83,699,021

 

 

$

12,875,586

 

 

$

70,823,435

 

 

$

 

 

 

 

 

 

 

Fair Value Measurements Using

 

 

 

December 31, 2016

 

 

Quoted Prices in

Active Markets

for Identical

Assets (Level 1)

 

 

Significant

Other

Observable

Inputs (Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

45,523,208

 

 

$

45,523,208

 

 

$

 

 

$

 

Corporate debt securities

 

 

27,702,317

 

 

 

 

 

 

27,702,317

 

 

 

 

Total

 

$

73,225,525

 

 

$

45,523,208

 

 

$

27,702,317

 

 

$

 


The Company’s marketable securities, consisting principally2022. Deferred revenue is classified in current portion of debt securities, are classified as available-for-sale, are stated at fair value, and consist of Level 2 financial instruments in the fair value hierarchy. The Company determines the fair value of its debt security holdings based on pricing from a service provider. The service provider values the securities based on using market prices from a variety of industry-standard independent data providers. Such market prices may be quoted prices in active markets for identical assets (Level 1 inputs) or pricing determined using inputs other than quoted prices that are observable either directly or indirectly (Level 2 inputs), such as yield curve, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, broker and dealer quotes, as well as other relevant economic measures.

4.

Marketable Securities

The Company invests its excess cash in money market funds and debt instruments of financial institutions, corporations, government sponsored entities and municipalities. The following tables summarizedeferred revenue liabilities when the Company’s marketable securities:

As of September 30, 2017

 

Maturity

(in years)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Estimated

Fair Value

 

Corporate debt securities

 

1 or less

 

$

70,846,528

 

 

$

1,235

 

 

$

(24,328

)

 

$

70,823,435

 

Total

 

 

 

$

70,846,528

 

 

$

1,235

 

 

$

(24,328

)

 

$

70,823,435

 

As of December 31, 2016

 

Maturity

(in years)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Estimated

Fair Value

 

Corporate debt securities

 

1 or less

 

$

18,937,860

 

 

$

901

 

 

$

(7,046

)

 

$

18,931,715

 

Total

 

 

 

$

18,937,860

 

 

$

901

 

 

$

(7,046

)

 

$

18,931,715

 

5.

Property and Equipment

Property and equipment consistobligations to provide research for Potential Future Improvements are expected to be satisfied within twelve months of the following:balance sheet date. The deferred revenue is recognized on a straight-line basis over the remaining life of the licensing patents into early 2028.

6. Redeemable Convertible Preferred Stock

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Furniture and fixtures

 

$

333,670

 

 

$

333,670

 

Computer equipment and office equipment

 

 

142,045

 

 

 

119,354

 

Leasehold improvements

 

 

152,217

 

 

 

152,217

 

 

 

 

627,932

 

 

 

605,241

 

Less accumulated depreciation and amortization

 

 

(423,018

)

 

 

(343,795

)

Total

 

$

204,914

 

 

$

261,446

 

The redeemable convertible preferred stock instruments were contingently redeemable preferred stock. Each series contained redemption features, limited voting rights, dividends, and conversion terms. The convertible preferred stock was presented on the consolidated balance sheets as mezzanine equity as of March 31, 2022. All shares of redeemable convertible preferred stock were fully redeemed and were no longer outstanding as of June 30, 2022.

March 2022 Offering

6.

Note Payable

In July 2010,March 2022, the Company issued to Pfizer Inc. (Pfizer)completed a $1.0 million promissory noteprivate placement offering (the Pfizer Note). The Pfizer Note bore interest at a rate“March 2022 Offering”) of 7% per annum and was scheduled to mature on July 29, 2020. Interest was payable on a quarterly basis. In July 2013, the Pfizer Note was amended to become convertible into(i) 2,500 shares of the Company’s common stock following the completionSeries A Redeemable Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”), and (ii) 2,500 shares of the Company’s initial publicSeries B Redeemable Convertible Preferred Stock, par value $0.0001 per share (the “Series B Preferred Stock” and together with the Series A Preferred Stock, the “Preferred Stock”), in each case, at an offering (IPO),price of $952.38 per share, representing a 5% original issue discount to the stated value of $1,000 per share of Preferred Stock, for gross proceeds from the Offerings of approximately $4.76 million, before the deduction of the placement agent’s fee and other offering expenses. The shares of Series A Preferred Stock had a stated value of $1,000 per share and were convertible, at a conversion price of $20.00 per share, into 125,000 shares of common stock. The shares of Series B Preferred Stock had a stated value of $1,000 per share and were convertible, at a conversion price of $20.00 per share, into 125,000 shares of common stock. The closing occurred on March 25, 2022. The proceeds of $4.76 million were held in escrow and were only permitted to be disbursed to the Company upon conversion of the Series A and Series B Preferred Stock. Since the redeemable convertible preferred stock could have been redeemed at the option of the holder, but was not mandatorily redeemable, the redeemable preferred stock was classified as mezzanine equity and initially recognized at fair value of $4.76 million as mezzanine equity on the accompanying statement of redeemable convertible preferred stock and stockholders' equity.

16


The March 2022 Offering generated gross proceeds of $4.76 million and the Company incurred cash-based placement agent fees and other offering expenses of approximately $0.6 million. The proceeds were held in escrow and were only permitted to be disbursed to the Company upon conversion of the Series A and Series B Preferred Stock.

The Company’s placement agent was issued compensatory warrants to purchase up to 7.0% of the aggregate number of shares of Preferred Stock sold in the offering (on an as-converted to common stock basis), resulting in common stock warrants to purchase up to 17,501 shares of common stock, with an exercise price of 125% of the offering price, or $25.00 per share, which are exercisable 6 months after issuance on or after September 25, 2022, and expire five and a half (5.5) years following the date of issuance on September 25, 2027.

The placement agent warrants, which are recorded as a component of stockholders’ equity, were valued at an aggregate of $34 thousand dollars using the Black Scholes option pricing model based upon the following assumptions: expected volatility of 78.90%, risk-free interest rate of 2.40%, expected dividend yield of 0%, and an expected term of 5.5 years.

As of September 30, 2023, the Company had 17,501 shares of common stock reserved for issuance pursuant to the placement agent’s warrants issued by the Company in the March 2022 Offering at an exercise price of $25.00 per share.

Voting Rights

The shares of Preferred Stock had no voting rights, except that they only have the right to vote, with the holders of common stock, as a single class on a proposal to approve an amendment to the Company's certificate of incorporation to effect a reverse stock split of issued and outstanding common stock within a range, to be determined by the Board and set forth in such proposal.

Each share of Series A Preferred Stock outstanding on April 14, 2022 (the “Record Date”) had a number of votes equal to the number of shares of Common Stock issuable upon conversion of such share (whether or not such shares are then convertible). Accordingly, as of the Record Date, each share of Series A Preferred Stock had 3,776 votes, which is determined by dividing $1,000, the stated value of one share of Series A Preferred Stock, by $0.2648, the NASDAQ Minimum Price as of the closing on March 25, 2022. The holders of the Series A Preferred Stock agreed to not transfer their shares of Series A Preferred Stock until after the 2022 Annual Meeting and to vote all shares of Series A Preferred Stock in favor of the Reverse Stock Split Proposal.

Each share of Series B Preferred Stock outstanding on the Record Date entitled the holder thereof to cast 30,000 votes on the Reverse Stock Split Proposal. The holders of the Series B Preferred Stock agreed to not transfer their shares of Series B Preferred Stock until after the 2022 Annual Meeting and to vote all shares of Series B Preferred Stock in the same proportion as the aggregate shares of Common Stock and Series A Preferred Stock are voted on the Reverse Stock Split Proposal. As an example, if 70% of the aggregate votes cast by Common Stock and Series A Preferred Stock voting on the Reverse Stock Split Proposal were voted in favor thereof and 30% of the aggregate votes cast by Common Stock and Series A Preferred Stock voting on the Reverse Stock Split Proposal were voted against such Proposal, then 70% of the votes entitled to be cast by Series B Preferred Stock would have been cast in favor of the proposal and 30% of such votes would have been cast against the proposal.

Dividends

The holders of the redeemable convertible preferred stock were entitled to receive dividends on shares of Preferred Stock equal (on an as-if-converted-to-Common-Stock basis, disregarding for such purpose any conversion limitations hereunder) to and in the same form as dividends actually paid on shares of the Common Stock when, as and if such dividends are paid on shares of the Common Stock. No other dividends were payable on shares of Preferred Stock.

Conversion Rights

Each share of Preferred Stock was convertible, at any time and from time to time from and after the Reverse Stock Split Date at the option of the Holder thereof, into that number of shares of Common Stock determined by dividing the stated value per share of preferred stock by the conversion price. The shares of Series A Preferred Stock had a stated value of $1,000 per share and were convertible, at a conversion price of $20.00 per share, into 125,000 shares of common stock. The shares of Series B Preferred Stock had a stated value of $1,000 per share and were convertible, at a conversion price of $20.00 per share, into 125,000 shares of common stock.

Redemption Rights

Each share of Preferred Stock was redeemable after (i) the earlier of (1) the receipt of authorized stockholder approval for the reverse stock split and (2) the date that was 90 days following the Original Issue Date of March 25, 2022, and (ii) before the date that was 120 days after the Original Issue Date or July 23, 2022 (the “Redemption Period”), each stockholder had the right to cause the Company to

17


redeem all or part of such stockholder’s shares of Preferred Stock at a price per share equal to 105% of the fair marketstated value of $1,000 per share.

Between June 2, 2022, and June 29, 2022, at the request of the holders, the Company redeemed for cash proceeds totaling $5.25 million ($4.76 million payment from escrow and $0.5 million redemption payment by the Company), 2,500 outstanding shares of Series A Preferred Stock and 2,500 outstanding shares of Series B Preferred Stock based on the receipt of the Redemption Notices (the “Preferred Redemption”) at a price equal to 105% of the $1,000 stated value per share, which represented all outstanding shares of Preferred Stock. The approximately $1.1 million accretion of the Series A and Series B Preferred Stock to its redemption value was recorded as a reduction to additional paid-in capital. The Company recognized a portion of the accretion as a deemed dividend related to the accretion of the discount and redemption feature of approximately $0.5 million upon redemption of Preferred Stock on the consolidated statement of operations.

On June 30, 2022, the Company filed a Certificate of Elimination with respect to the Series A Preferred Stock and Series B Preferred Stock (the “Series A Certificate of Elimination and the Series B Certificate of Elimination”), which upon filing with the Secretary of State of the State of Delaware (“Delaware Secretary”), eliminated from all matters set forth in the Certificates of Designation of Series A and Series B Preferred Stock.

As of September 30, 2023 and December 31, 2022, all shares of the Series A Preferred Stock and Series B Preferred Stock are no longer outstanding and the Company’s only remaining class of outstanding stock is its common stock, onpar value $0.0001 per share.

7. Stockholders’ Equity

Common Stock

January 2021 Offering

In January 2021, the Company completed an S-1 offering (the “January 2021 Offering”) of an aggregate of 580,000 shares of common stock, pre-funded warrants to purchase up to 120,000 shares of its common stock, and common stock warrants to purchase up to an aggregate of 700,000 shares of common stock. To the extent that an investor determines, at their sole discretion, that they would beneficially own in excess of the Beneficial Ownership Limitations (or as such investor may otherwise choose), in lieu of purchasing shares of common stock and common stock warrants, such investor could have elected to purchase Pre-Funded Warrants and Common Warrants at the pre-funded purchase price in lieu of the shares of common stock and common stock warrants in such a manner to result in the same aggregate purchase price being paid by such investor to the Company. The combined purchase price of one share of common stock and the accompanying common stock warrant was $20.00, and the combined purchase price of one pre-funded warrant and accompanying common stock warrant was $19.998. The common stock warrants are exercisable for five (5) years at an exercise price of $20.00 per share. The pre-funded warrants were immediately exercisable at an exercise price of $0.002 per share and were exercisable at any time until all of the pre-funded warrants are exercised in full. Placement agent warrants were issued to purchase up to 35,000 shares of common stock, are immediately exercisable for an exercise price of $25.00 per share, and are exercisable for five (5) years following the date of conversion. On January 24, 2017,issuance. The Company received gross proceeds of $14.0 million and incurred placement agent’s fees and other offering expenses of approximately $1.9 million.

The common stock warrants and placement agent warrants were valued at $7.2 million and $0.3 million, respectively, using the Company voluntarily prepaidBlack-Scholes option pricing model based on the entire balancefollowing assumptions: expected volatility 80.08%, risk-free interest rate 0.38%, expected dividend yield 0%, and an expected term of the outstanding principal and accrued and unpaid interest5.0 years.

As of the Pfizer NoteSeptember 30, 2023, a total of 336,060 warrants issued in the amountJanuary 2021 Offering to purchase shares of $1,004,861.

Prior to the prepayment of the Pfizer Note, the Company recorded the Pfizer Note on the balance sheet at face value. Based on borrowing rates available to the Company for loans with similar terms, the Company believed that the fair value of the Pfizer Note approximated its carrying value. The fair value measurement was categorized within Level 3 of the fair value hierarchy.

On February 15, 2017,common stock have been exercised and the Company issued a convertible promissory note (the Novartis Note) in336,060 shares of its common stock. The Company received gross proceeds of approximately $6.8 million.

As of September 30, 2023, the principal amountCompany had 387,565 shares and 11,375 shares of $15.0 million,common stock reserved for issuance pursuant to the Investment Agreement entered into betweenwarrants and placement agent’s warrants, respectively, issued by the Company in the January 2021 Offering, at an exercise price of $20.00 per share and Novartis on December 19, 2016$25.00 per share, respectively.

June 2021 Offering

In June 2021, the Company completed a registered direct offering (the Investment Agreement). The Novartis Note bears interest on the unpaid principal balance“June 2021 Offering”) of an aggregate of 298,865 shares of common stock, together with accompanying warrants to purchase up to an aggregate of 239,093 shares of common stock, at a ratepublic offering price of 6%$22.00 per annum and has a scheduled maturity date of December 31, 2019.share. The Company may prepay or convert all or partaccompanying warrants permit the investor to purchase additional shares equal to 80% of the Novartis Note intonumber of shares of the Company’s common stock at its option, until December 31, 2019. Novartis haspurchased by the optioninvestor. The warrants have an exercise price of $20.00 per share, are immediately exercisable, and expire five and a half (5.5) years following the date of issuance. In addition, the Company’s placement

18


agent was issued compensatory warrants equal to convert all5.0%, or part14,946 shares, of the Novartis Note intoaggregate number of common stock sold in the offering, which are immediately exercisable for an exercise price of $27.50 and expire five (5) years following the date of issuance on June 7, 2026. The Company received gross proceeds of $6.6 million and incurred cash-based placement agent fees and other offering expenses of approximately $0.9 million.

The warrants and placement agent warrants were valued at $3.0 million and $0.2 million, respectively, using a Black-Scholes option pricing model with the following assumptions: expected volatility 81.44% and 80.15%, risk-free interest rate 0.88% and 0.77%, expected dividend yield 0% and 0%, and an expected term of 5.5 years or 5.0 years, respectively.

As of September 30, 2023, no warrants associated with the June 2021 Offering have been exercised.

As of September 30, 2023, the Company had 90,910 shares and 14,946 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by the Company in the June 2021 Offering, at an exercise price of $20.00 per share and $27.50 per share, respectively. In connection with the July 2022 Offering, the Company agreed to amend warrants, by reducing the exercise price and extending the expiration date, to purchase up to an aggregate of 148,183 shares of common stock of the Company that were originally issued to the investor in the June 2021 Offering. Refer to July 2022 Offering overview below for accounting treatment for the amended warrants.

December 2021 Offering

In December 2021, the Company completed a registered direct offering (the “December 2021 Offering”) of an aggregate of 411,764 shares of common stock and 411,766 warrants to purchase up to 411,766 shares of common stock, at a public offering price of $8.50 per share. The accompanying warrants permit the investor to purchase additional shares equal to approximately the same number of shares of the Company’s common stock uponpurchased by the investor. The warrants have an exercise price of $8.50 per share, may be exercised any time on or after 6 months and one (1) day after the issuance date, and expire five and a change in controlhalf (5.5) years following the date of the Company or termination of the Collaboration Agreement by Novartis pursuant to certain provisions. If converted, the principal and accrued interest under the Novartis Note will convert intoissuance. In addition, the Company’s common stock at a conversion priceplacement agent was issued compensatory warrants equal to 120%5.0%, or 20,590 shares, of the 20-day trailing average closing price per share of the common stock immediately prior to the conversion date. In the event the aggregate number of shares of common stock issued uponsold in the


conversion would exceed offering, which are immediately exercisable for an exercise price of $10.626 and expire five and a half (5.5) years following the lesserdate of 19.0%issuance on June 21, 2027. The Company received gross proceeds of $3.5 million and incurred cash-based placement agent fees and other offering expenses of approximately $0.5 million.

The placement agent warrants, which are recorded as a component of stockholders’ equity, were valued at an aggregate $0.1 million using the Company’s outstanding shares on a fully-diluted basis (i) at the inception of the Investment Agreement or (ii)Black-Scholes option pricing model based on the conversion date, then onlyfollowing assumptions: expected volatility of 79.81%, risk-free interest rate of 1.21%, expected dividend yield of 0% and an expected term of 5.5 years.

As of September 30, 2023, no warrants associated with the lesser amount shall convert intoDecember 2021 Offering have been exercised.

As of September 30, 2023, the Company had 164,707 shares and 20,590 shares of common stock reserved for issuance pursuant to the warrants and Novartis shall be repaid in cash for any remaining principal and unpaid interest after such conversion. Upon the occurrence of certain events of default, the Novartis Note requiresplacement agent’s warrants, respectively, issued by the Company in the December 2021 Offering, at an exercise price of $8.50 per share and $10.626 per share, respectively. In connection with the July 2022 Offering, the Company agreed to repayamend warrants, by reducing the principal balanceexercise price and extending the expiration date, to purchase up to an aggregate of 247,059 shares of common stock of the Novartis NoteCompany that were originally issued to the investor in the December 2021 Offering. Refer to July 2022 Offering overview below for accounting treatment for the amended warrants.

July 2022 Offering

On July 12, 2022, the Company entered into a Securities Purchase Agreement (the “July 2022 Purchase Agreement”) with a single healthcare-focused institutional investor for the sale by the Company of (i) a pre-funded warrant to purchase up to 1,774,309 shares of Common Stock (the “Pre-Funded Warrant”), (ii) a Series A warrant to purchase up to an aggregate of 1,774,309 shares of common stock (the “Series A Warrant”), and (iii) a Series B warrant to purchase up to an aggregate of 1,774,309 shares of common stock (the “Series B Warrant,” and together with the Pre-Funded Warrant and the Series A Warrant, the “Warrants”), in a private placement offering (the “Offering”). The combined purchase price of one Pre-Funded Warrant and accompanying Series A Warrant and accompanying Series B Warrant was $2.818.

Subject to certain ownership limitations, the Series A Warrant became exercisable immediately after the issuance date at an exercise price equal to $2.568 per share of common stock, subject to adjustments as provided under the terms of the Series A Warrant, and has a term of five and a half (5.5) years from the issuance date. Subject to certain ownership limitations, the Series B Warrant became exercisable immediately after the issuance date at an exercise price equal to $2.568 per share of common stock, subject to adjustments as provided under the terms of the Series B Warrant, and has a term of one and a half (1.5) years from the issuance date. Subject to certain ownership limitations described in the Pre-Funded Warrant, the Pre-Funded Warrant was immediately exercisable at an exercise

19


price of $0.0001 per share of common stock any time until all of the Pre-Funded Warrant is exercised in full. As of September 30, 2023, the Pre-Funded Warrant to purchase up to an aggregate of 1,774,309 shares of common stock had been fully exercised and the Company issued 1,774,309 shares of common stock.

The Company also agreed to amend certain warrants to purchase up to an aggregate of 447,800 shares of common stock of the Company that were issued to the investor in the private placement in November 2020, June 2021 and December 2021 with exercise prices ranging from $8.50 to $34.00 per share and expiration dates ranging from May 18, 2026 to June 21, 2027, so that such warrants have a reduced exercise price of $2.568 per share and expiration date of five and a half (5.5) years following the closing of the private placement, for an additional offering price of $0.0316 per amended warrant. The incremental fair value resulting from the modifications to the warrants was adjusted against the gross proceeds from the offering as an equity issuance cost.

The gross proceeds to the Company were approximately $5 million, before deducting the placement agent’s fees and other offering expenses, and excluding the proceeds, if any, from the exercise of the Series A Warrant, the Series B Warrant, and amended warrants.

The Series A warrants and placement agent warrants were valued at $3.8 million and $0.2 million, respectively, using the Black-Scholes option pricing model based on the following assumptions: expected volatility 79.28%, risk-free interest rate 3.06%, expected dividend yield 0%, and an expected term of 5.5 years.

The Series B warrants were valued at $2.3 million using the Black-Scholes option pricing model based on the following assumptions: expected volatility 74.25%, risk-free interest rate 3.16%, expected dividend yield 0%, and an expected term of 1.5 years.

The amended warrants were valued at $1.0 million using the Black-Scholes option pricing model based on the following assumptions: expected volatility 79.28%, risk-free interest rate 3.06%, expected dividend yield 0%, and an expected term of 5.5 years. The estimated fair value of the original warrants immediately prior to the warrant amendments was $0.5 million using Black-Scholes option pricing model based on the following assumptions: expected volatility ranging from 81.2183.34%, risk-free interest rates of 3.063.16%, expected dividend yield 0%, and an expected terms of 3.844.94 years. The warrant modifications resulted in an estimated value of $0.5 million, measured as the incremental fair value of the amended warrants, and was adjusted against the gross proceeds from the offering.

As of September 30, 2023, no warrants associated with the July 2022 Purchase Agreement have been exercised.

As of September 30, 2023, the Company had 3,996,418 shares and 124,202 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by the Company in the July 2022 Purchase Agreement, at an exercise price of $2.568 per share and $3.5225 per share, respectively.

Common Stock Warrants

As of September 30, 2023, warrants to purchase 68 shares of common stock with an exercise price of $1,486.00 per share that were issued by Conatus in connection with obtaining financing in 2016 expired unexercised on July 3, 2023.

See warrant discussion above in connection with the January 2021 Offering, the June 2021 Offering, the December 2021 Offering, and the July 2022 Offering.

Stock-Based Compensation

Equity Incentive Plans

On December 18, 2017, Private Histogen established the Histogen Inc. 2017 Stock Plan (the “2017 Plan”). Under the 2017 Plan, Private Histogen was authorized to issue a maximum aggregate of 41,861 shares of common stock with adjustments for unissued or forfeited shares under the predecessor plan (the Histogen Inc. 2007 Stock Plan). In April 2019, Private Histogen amended the 2017 Plan, which increased the number of common stock available for grants by 16,336 shares. The 2017 Plan permitted the issuance of incentive stock options (“ISOs”), non-statutory stock options (“NSOs”), and Stock Purchase Rights. NSOs could be granted to employees, directors, or consultants, while ISOs could be granted only to employees. Options granted vest over a maximum period of four years and expire ten years from the date of grant. In connection with the closing of the Merger, no further awards were made under the 2017 Plan and any unpaid accrued interest.cancelled, forfeited or expired options were not made available for granting. As of September 30, 2023, 4,662 fully vested options remain outstanding under the 2017 Plan.

20


In May 2020, in connection with the closing of the Merger, the Company’s stockholders approved the Company’s 2020 Incentive Award Plan (the “2020 Plan”). The ability to borrow and repay the debt at a discount usingmaximum number of shares of the Company’s common stock was deemed to be additional, foregone revenue attributable to the Collaboration Agreement, which the Company imputed and recorded as both a receivable from Novartis and a liability (deferred revenue) of $2.5 million at the inception of the Collaboration Agreement and the Investment Agreement. On February 15, 2017, the Company recorded the $15.0 million proceeds from theavailable for issuance of the Novartis Note as a convertible note payable in the amount of $12.5 million and a reduction of the outstanding receivable from Novartis of $2.5 million. The convertible note payable, along with the related accrued interest, totaled $13.0 million as of September 30, 2017.     

The Company elected to account for the Novartis Note under the fair value option. At September 30, 2017,2020 Plan equals the Company concluded that the fair valuesum of the Novartis Note remained at $13.0 million due to its conversion features. The fair value measurement is categorized within Level 3 of the fair value hierarchy.

7.

Stockholders’ Equity

Common Stock

In May 2017, the Company completed a public offering of 5,980,000 shares of its common stock at a public offering price of $5.50 per share. The shares were registered pursuant to a registration statement on Form S-3 filed on August 14, 2014. The Company received net proceeds of $30.6 million, after deducting underwriting discounts and commissions and offering-related transaction costs. Immediately following the offering, the Company used $11.2 million of the net proceeds to repurchase and retire 2,166,836 shares of its common stock from funds affiliated with Advent Private Equity (collectively Advent) at a price of $5.17 per share, which is equal to the net proceeds per share that the Company received from the offering, before expenses, pursuant to a stock purchase agreement the Company entered into with Advent in May 2017.

Warrants

In 2013, the Company issued warrants exercisable for 1,124,026 shares of Series B preferred stock, at an exercise price of $0.90 per share, to certain existing investors in conjunction with a private placement (the 2013 Warrants) and warrants exercisable for 111,112 shares of Series B preferred stock, at an exercise price of $0.90 per share, to Oxford Finance LLC and Silicon Valley Bank in conjunction with the Company’s entry into a loan and security agreement (the Lender Warrants). Upon completion of the IPO, the 2013 Warrants and the Lender Warrants became exercisable for 136,236 and 13,468(a) 42,500 shares; (b) any shares of common stock respectively,of the Company which are subject to awards under the Conatus 2013 Equity Incentive Plan (the “Conatus 2013 Plan”) as of the effective date of the 2020 Plan which become available for issuance under the 2020 Plan after such date in accordance with its terms; and (c) an annual increase on the first day of each calendar year beginning with the January 1 of the calendar year following the effectiveness of the 2020 Plan and ending with the last January 1 during the initial ten-year term of the 2020 Plan, equal to the lesser of (i) five percent of the number of shares of the Company’s common stock outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year, and (ii) such lesser number of shares of the Company’s common stock as determined by the Company’s Board.

On June 20, 2023, the Company held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”) at which time the stockholders approved an exercise priceamendment to the Company’s 2020 Plan to increase the number of $7.43 per share. The 2013 Warrants andshares authorized for issuance thereunder by 500,000 shares, as previously approved by the Lender Warrants will expire on May 30, 2018 and July 3, 2023, respectively.Board.

Stock Options

The following table summarizes activity related to the Company’s stock option activityoptions under all stock option plansthe 2017 Plan and the 2020 Plan for the nine months ended September 30, 2017:2023:

 

 

Options
Outstanding

 

 

Weighted-
average
Exercise
Price

 

 

Weighted-
average
Remaining
Contractual
Term
(in years)

 

 

Aggregate
Intrinsic
Value
(in
thousands)

 

Outstanding at December 31, 2022

 

 

113,279

 

 

$

21.30

 

 

 

8.09

 

 

$

 

Granted

 

 

472,454

 

 

 

0.94

 

 

 

 

 

 

 

Cancelled / Forfeited

 

 

(371,301

)

 

 

5.27

 

 

 

 

 

 

 

Outstanding at September 30, 2023

 

 

214,432

 

 

$

4.20

 

 

 

9.29

 

 

$

 

Vested and exercisable at September 30, 2023

 

 

22,912

 

 

$

30.56

 

 

 

7.16

 

 

$

 

Valuation of Stock Option Awards

 

 

Total

Options

 

 

Weighted-

Average

Exercise

Price

 

Balance at December 31, 2016

 

 

3,393,813

 

 

$

5.10

 

Granted

 

 

1,702,600

 

 

 

4.91

 

Exercised

 

 

(62,944

)

 

 

1.19

 

Cancelled

 

 

(122,912

)

 

 

4.67

 

Balance at September 30, 2017

 

 

4,910,557

 

 

$

5.10

 

The following weighted-average assumptions were used to calculate the fair value of awards granted to employees, non-employees and directors:

On August 31, 2017,

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Expected volatility

 

 

%

 

 

%

 

 

93.53

%

 

 

78.95

%

Risk-free interest rate

 

 

%

 

 

%

 

 

3.91

%

 

 

2.14

%

Expected option life (in years)

 

 

 

 

 

 

 

 

6.03

 

 

 

6.02

 

Expected dividend yield

 

 

%

 

 

%

 

 

%

 

 

%

Additionally, in connection with the appointmentclosing of its newthe Merger, no further awards will be made under the Conatus 2013 Plan. As of September 30, 2023, 4,487 fully vested options remain outstanding under the Conatus 2013 Plan with a weighted average exercise price of $740.10 per share.

Restricted Stock Units

On November 8, 2021, the Company granted 23,423 restricted stock units to the Company’s then Interim Chief Executive Vice President, Chief Operating Officer, and Chief Financial Officer, and Senior Vice President of Technical Operations. The fair value of the RSUs was $14.58 per share, which was the closing market price of the Company’s common stock on the date of grant. The RSUs vest in full upon the earlier of (1) 12 months following the grant date and (2) a change of control of the Company, grantedas defined in the Company’s 2020 Plan, subject to continued service to the Company. Prior to RSU vesting, on November 7, 2022, the Company and the RSU recipients mutually agreed to enter into RSU Cancellation Agreements such that the RSU awards are cancelled and no longer outstanding.

Forfeiture Stock Option Grants

On March 10, 2023, the Company approved stock optionsoption grants to purchase 525,000111,063 shares of the Company’s common stock outsideto certain officers and employees as part of itsan annual award grant. Because the Company did not have sufficient shares available under the 2020

21


Plan at the time of approval, these shares were subject to forfeiture in the event that the shares available pursuant to the plan were not increased prior to the one-year anniversary and vesting of the award by an amount required to be available for issuance for all outstanding stock awards containing the forfeiture condition (“Forfeiture Stock Option Grants”). The Company had a conditional obligation to increase the shares available for issuance under the stock option plans.plans before these Forfeiture Stock Option Grants can be granted at which time the Company would begin to recognize compensation costs from the inception date of the award through grant date. On June 20, 2023, the Company held its Annual Meeting at which the stockholders approved an amendment to the Company’s 2020 Plan to increase the number of shares authorized for issuance thereunder by 500,000 shares, which met the Company’s conditional obligation to increase the shares available for issuance. The Forfeiture Stock Options Grants were granted as of June 20, 2023.

As such, during the three and nine months ended September 30, 2023, the Company began recognizing compensation expense for the Forfeiture Stock Option Grants dating back to the March 10, 2023 inception date of the grant awards.

On September 18, 2023, the Company announced the Board approved a Plan of Dissolution and implemented a reduction in its workforce effective September 30, 2023. The reduction in workforce resulted in the forfeiture of 281,934 stock options granted under the 2020 Plan to certain officers and employees which did not meet certain vesting criteria.

Stock Option Cancellations

On March 10, 2023, the Company entered into Stock Option Cancellation Agreements with certain officers and employees (the “Option holders”), pursuant to which such individuals surrendered and cancelled 69,045 stock options with a weighted average price of $17.92 per share to purchase shares of the Company’s common stock (the “Cancelled Stock Options”). Pursuant to the terms of the Stock Option Cancellation Agreements, the Company agreed to pay each of the option holders a lump sum cash payment of $250 in exchange for the agreement to cancel the aforementioned stock options. The Company determined that because the Cancelled Stock Options were cancelled in exchange of cash consideration, the cash payments are considered partial settlements of the original awards and the cancellation should be accounted for as a repurchase of outstanding equity. The Company also determined that cash paid in exchange of cancellation was madeless than the fair value of the original awards and the stock options were probable of vesting pursuant to their original terms. Therefore, the Company recorded previously unrecognized compensation costs related to the Cancelled Stock Options of approximately $0 and $0.4 million during the three and nine months ended September 30, 2023, respectively, on the accompanying condensed consolidated statements of operations.

Inducement Grant

On February 23, 2023, the Company issued 106,793 stock options to its newly appointed Executive Vice President and Chief Scientific Officer as an inducement that was a material componentgrant outside of the executive’s compensation and acceptance of employmentCompany’s equity incentive plans in accordance with the Company and was granted as an employment inducement award pursuant to NASDAQNasdaq Listing Rule 5635(c)(4). While granted outside ofIn accordance with the Company’s stock option plans, the terms and conditions of this award are consistent with awards granted to the Company’s executive officers pursuant to the Company’s 2013 Incentive Award Plan. The stock options


will vest over a four-year period, with a quarteragreement, 25% of the options vestingvest on the first anniversary of the employee’s hire date, of granton February 1, 2024, and the remainder of the options vesting monthlythen ratably over the subsequent threeremaining 36 months. Based on the terms being similar to standard grants as awarded under the 2020 Plan, the Company applied ASC 718 accounting basis for the recognition of share-based compensation expense. The inducement grant was valued at $0.1 million using the Black-Scholes option pricing model based on the following assumptions: expected volatility 91.65%, risk-free interest rate 4.06%, expected dividend yield 0%, and an expected term of 6.08 years. On September 18, 2023, the Company announced the Board approved a Plan of Dissolution and implemented a reduction in its workforce effective September 30, 2023. The reduction in workforce also resulted in the forfeiture of 106,793 inducement grant stock options which did not meet certain vesting criteria. As of September 30, 2023, no inducement grant options were vested and none are outstanding.

Stock-BasedStock-based Compensation Expense

The Company recordedcompensation cost, including the inducement grant expense, that has been included in the accompanying condensed consolidated statements of operations for all stock-based compensation arrangements is detailed as follows (in thousands):

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

General and administrative

 

$

6

 

 

$

121

 

 

$

415

 

 

$

388

 

Research and development

 

 

(13

)

 

 

12

 

 

 

29

 

 

 

25

 

Total

 

$

(7

)

 

$

133

 

 

$

444

 

 

$

413

 

As of $1.0 million and $0.7 million for the three months ended September 30, 2017 and 2016, respectively, and $3.02023, total unrecognized compensation cost related to unvested options was approximately $0.1 million and $2.5 million for the nine months ended September 30, 2017 and 2016, respectively.which is expected to be recognized over a weighted-average period of 2.87 years.

22


Common Stock Reserved for Future Issuance

The following shares of commonCommon stock were reserved for future issuance is as follows:

 

 

As of September 30,

 

 

 

2023

 

 

2022

 

Common stock warrants

 

 

4,876,571

 

 

 

4,876,639

 

Common stock options issued and outstanding under stock plans

 

 

218,919

 

 

 

129,006

 

Common stock available for issuance under stock plans

 

 

708,768

 

 

 

94,524

 

Total

 

 

5,804,258

 

 

 

5,100,169

 

8. Commitments and Contingencies

Leases

In January 2020, the Company entered into a long-term operating lease with San Diego Sycamore, LLC (“Sycamore”) for its headquarters that includes office and laboratory space. The lease commenced on March 1, 2020 and was set to expire on August 31, 2031, with no options to renew or extend. The lease was accounted for as a modification of the Company’s existing lease with Sycamore as the lease agreement did not grant the Company an additional right-of-use asset.

The terms of the lease agreement include seven months of rent abatement at September 30, 2017:lease commencement and a tenant improvement allowance of up to $2.2 million. The tenant improvements are required to be permanently affixed to the leased office and laboratory space and do not constitute leasehold improvements of the Company. During the construction period of the tenant improvements, the lease agreement requires the Company to relocate its operations to a similar Sycamore property whereby monthly rent is substantially reduced for the duration of the construction period. The lease is subject to additional variable charges for common area maintenance, insurance, taxes and other operating costs. At lease commencement, the Company recognized a right-of-use asset and operating lease liability totaling $4.5 million. The Company used a discount rate based on its estimated incremental borrowing rate to determine the right-of-use asset and operating lease liability amounts to be recognized. The Company determined its incremental borrowing rate based on the term and lease payments of the new operating lease and what it would normally pay to borrow, on a collateralized basis, over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. The terms of the lease required the Company to provide the landlord a security deposit of $0.3 million as collateral for a letter of credit issued to be held throughout the lease term. This security deposit is shown as restricted cash on the accompanying consolidated balance sheets.

Warrants to purchase common stock

149,704

Common stock options issued and outstanding

4,910,557

Common stock authorized for future option grants

545,503

Common stock authorized for the ESPP

544,578

Shares issuable upon conversion of convertible note payable

2,297,138

Total

8,447,480

8.

Collaboration and License Agreements

In December 2016,June 2021, the Company entered into the CollaborationFirst Amendment to Lease (the “Amendment”). Pursuant to the Amendment, among other things, the Company and Sycamore agreed (i) to substitute the temporary premises, (ii) to delay the start of construction and the timing of the Company’s relocation to the replacement temporary premises, (iii) to increase the tenant improvement allowance from $2.2 million to $2.3 million, (iv) to increase the letter of credit amount from $0.3 million to $0.4 million upon commencement of the tenant improvements, and (v) to review potential subsequent reductions to the security deposit and related letter of credit requirement at certain time intervals along the lease term provided that the Company is not in default. As a result of the modification, the lease liability was remeasured using the incremental borrowing rate at the modification date and a corresponding reduction of $0.3 million was recorded to both the lease liability and right-of-use-asset.

During the year ended December 31, 2022, the Company completed construction of the building improvements. Due to construction delays, the tenant improvement construction period was extended by two months for which the Company was granted an incremental two-month extension of rent abatement and effectively shortened the lease term. Upon completion of the improvements, the building improvement costs in excess of the tenant improvement allowance that was funded by the Company were capitalized to the right-of-use-asset, to be amortized over the remaining lease term. As a result of the modification, the lease liability was remeasured and a corresponding increase of $0.4 million was recorded to both the lease liability and right-of-use-asset.

On August 7, 2023, the Company entered into a Lease Termination Agreement with Novartis,(the “Lease Termination Agreement”) for its headquarters and laboratory operating lease, pursuant to which the Company granted Novartis an exclusive optionand the landlord mutually agreed to collaborate withaccelerate the termination date to August 31, 2023, subject to a termination fee paid by the Company to develop products containing emricasan.  Pursuantof approximately $1.0 million. The Company entered into the Lease Termination Agreement primarily for the purpose of reducing the overall cash commitment and long-term liabilities related to the Collaboration Agreement, the Company received a non-refundable upfront payment of $50.0 million from Novartis.

In May 2017, Novartis exercised its option under the Collaboration Agreement. In July 2017, the Company received a $7.0 million option exercise payment, at which time the license under the Collaboration Agreement became effective (the License Effective Date). Under the Collaboration Agreement, the Company will be eligible to receive up to an aggregate of $650.0 million in milestone payments over the term of the Collaboration Agreement, contingent on the achievement of certain development, regulatory and commercial milestones,lease as well as royalties or profit and loss sharing on future product sales in the United States, if any.

Pursuant to the Collaboration Agreement, the Company is responsible for completing its four ongoing Phase 2b trials. Novartis will generally pay 50%part of the Company’s Phase 2b emricasan development costsefforts to pursue potential strategic alternatives at the time.

The lease termination eliminated the Company’s right-of-use assets and operating lease liabilities balance in its entirety and resulted in a credit of approximately $29 thousand, which was recognized as an adjustment against general and administrative expenses on the accompanying condensed consolidated statement of operations for the period ending September 30, 2023. The Company recognized a

23


loss of $1.0 million resulting primarily from the lease termination fee, partially offset by the credit adjustment to eliminate the Company's right-of-use assets and operating lease liabilities. The lease termination will also result in the cancellation of the letter of credit during the fourth quarter of 2023, which will reclass $0.3 million of restricted cash to cash and cash equivalents on the accompanying condensed consolidated balance sheets.

The Lease Termination Agreement was accounted for as a lease termination rather than a modification because the Company contemporaneously terminated the lease and its right-of-use of the facility. The tables below show the beginning balances of the operating right-of-use (“ROU”) assets and operating lease liabilities as of January 1, 2023 and the ending balances as of September 30, 2023, including the changes during the period (in thousands):

 

 

Operating
Lease ROU Assets

 

Operating lease ROU assets at January 1, 2023

 

$

4,658

 

Amortization of operating lease ROU assets

 

 

(223

)

Write off of ROU asset due to lease termination

 

 

(4,435

)

Operating lease ROU assets at September 30, 2023

 

$

 

 

 

Operating
Lease Liabilities

 

Operating lease liabilities at January 1, 2023

 

$

4,617

 

Principal payments on operating lease liabilities

 

 

(154

)

Write off of lease liability due to lease termination

 

 

(4,463

)

Operating lease liabilities at September 30, 2023

 

$

 

The Company leased certain office equipment that was classified as a finance lease. In parallel with terminating its operating lease, the Company early terminated its finance lease with payment of a termination fee of $14 thousand. As of September 30, 2023, the Company’s operating lease and finance lease were terminated and no future minimum payments of current or long-term lease liabilities remain on the accompanying condensed consolidated balance sheets.

Employment and Severance Agreements

On September 18, 2023, the Company announced that its Board had unanimously approved the dissolution and liquidation of Histogen pursuant to anthe Plan of Dissolution, subject to stockholder approval. In connection with the Plan of Dissolution, the Company discontinued all development programs and terminated all but two employees as of September 30, 2023. The focus of the remaining two employees is to manage the wind-down of the Company's operations and matters related to managing the Dissolution, including obtaining the necessary stockholder approval of the Plan of Dissolution. In connection with the employee terminations, the Company renegotiated severance obligations and entered into separation agreements that provide for severance payments in lieu of those set forth in the existing executive employment agreements. The Company also entered into amended and restated employment agreements with the two remaining employees tasked with managing the wind-down of operations, including a severance payment and provision for a retention payment for agreeing to oversee matters related to the Dissolution. As of September 30, 2023, the Company recorded severance payments obligations that represent a liability of $0.7 million on the accompanying condensed consolidated balance sheets. The Company has also agreed upon budget. Novartisto $0.6 million of severance and retention payments that will assume full responsibility for emricasan’s Phase 3 development and all combination product development.

Unless terminated earlier,be recognized ratably over the Collaboration Agreement will remain in effect on a product-by-product and country-by-country basis until Novartis’ royalty obligations expire. Novartis has certain termination rightscourse of the Dissolution beginning October 1, 2023 which remains subject to recoupment by the Company in the event of a mandated clinical trial holdvoluntary or for any product containing emricasan as its sole active ingredient. Additionally, Novartis has the rightcause termination prior to terminate the Collaboration Agreement without cause upon 180 days prior written notice to the Company.  In such event, the license granted to Novartis will be terminated and revert to the Company. In the event Novartis terminates the Collaboration Agreement due to the Company’s uncured material breach or insolvency, the license granted to Novartis pursuant to the Collaboration Agreement will become irrevocable, and Novartis will be required to continue to make all milestone and royalty payments otherwise due to the Company under the Collaboration Agreement, provided that if the Company materially breaches the Collaboration Agreement such that the rights licensed to Novartis or the commercial prospectsfinal adjournment of the emricasan products are seriously impaired, the milestone and royalty payments will be reduced by 50%.stockholders meeting.

Under the relevant accounting literature, the Collaboration Agreement meets the definition of a collaborative arrangement and a multiple-element arrangement. The Company concluded that there were two significant deliverables under the Collaboration Agreement – the option to obtain the license and the research and development services – but that the license does not have stand-alone value as Novartis cannot obtain value from the license without the research and development services, which the Company is uniquely able to perform. As such, the Company expects to recognize as collaboration revenue a portion of the upfront payment received of $50.0 million, the option exercise fee of $7.0 million, and the imputed income from the Investment Agreement as described below on a straight-line basis between the inception of the agreement (or with respect to the option exercise fee, upon exercise of the option) through mid-2019 – the estimated period over which the Company expects to perform the research and development services. Due to the inherently unpredictable nature of product development activities, the Company periodically reviews the performance period of the research and development services and will adjust the period over which revenue is recognized when appropriate. The Company could accelerate revenue recognition in the event of early termination of programs or if the Company’s expectations change. Alternatively, the Company could decelerate revenue recognition if programs are extended or delayed. While


such changes to the Company’s estimates have no impact on the Company’s reported cash flows, the amount of revenue recorded in future periods could be materially impacted. Expense reimbursements for the Company’s Phase 2b emricasan development costs will be recognized as collaboration revenue when the related expenses are incurred.Material Contracts

Under the Investment Agreement, the Company is able to borrow up to $15.0 million at a rate of 6% per annum, under one or two notes, which will mature on December 31, 2019.  The Company may elect at its sole discretion to convert all or part of the outstanding principal and accrued interest into fully paid shares of common stock, at 120% of the 20-day trailing average closing price per share of the common stock immediately prior to the conversion date. Novartis has the option to convert all or part of the note(s) into shares of the Company’s common stock upon a change in control of the Company or termination of the Collaboration Agreement by Novartis pursuant to certain provisions. Pfizer Inc.

In the event the conversion of the notes would exceed the lesser of 19.0% of the Company’s outstanding shares on a fully-diluted basis (i) at the inception of the Investment Agreement or (ii) on the conversion date, then only the lesser amount shall convert into shares of common stock and Novartis shall be repaid in cash for any remaining principal and unpaid interest after such conversion. This ability to borrow and repay the debt at a discount using shares of the Company’s common stock was deemed to be additional, foregone revenue attributable to the Collaboration Agreement, which the Company imputed and recorded as both a receivable from Novartis and a liability (deferred revenue) of $2.5 million at the inception of the Collaboration Agreement and the Investment Agreement. On February 15, 2017, the Company issued the Novartis Note in the principal amount of $15.0 million and recorded the $15.0 million proceeds as a convertible note payable in the amount of $12.5 million and a reduction of the outstanding receivable from Novartis of $2.5 million.

9.

Commitments

In February 2014, the CompanyJuly 2010, Conatus entered into a noncancelable operating lease agreement (the Lease) for certain office space with a lease term from July 2014 through December 2019 and a renewal option for an additional five years. In May 2015, the Company entered into a first amendment to the Lease (the First Lease Amendment) for additional office space starting in September 2015 through September 2020. The First Lease Amendment also extended the term of the Lease to September 2020. The monthly base rent under the Lease and the First Lease Amendment increases approximately 3% annually from $32,784 in 2015 to $39,268 in 2020. Future minimum payments under this noncancelable operating lease total $1.3 million at September 30, 2017.

Rent expense was $94,501 for each of the three-month periods ended September 30, 2017 and 2016 and $283,504 for each of the nine-month periods ended September 30, 2017 and 2016.

In July 2010, the Company entered into a stock purchase agreementStock Purchase Agreement with Pfizer, pursuant to which the Companyit acquired all of the outstanding capital stock of Idun Pharmaceuticals, Inc., which was subsequently spun off to the Company’sConatus stockholders in January 2013. Under the stock purchase agreement, the Company may be required to make payments to Pfizer totaling $18.0$18.0 million upon the achievement of specified regulatory milestones.

24


Prior to the termination of the Collaboration Agreement with Amerimmune on November 28, 2022, the obligations pursuant to the Stock Purchase Agreement were the responsibility of the Company's former collaboration partner, Amerimmune. In accordance with authoritative guidance, amounts for the milestone payments will be recognized when it is probable that the related contingent liability has been incurred and the amount owed is reasonably estimated. No amounts for the milestone payments have been recorded during the three and nine months ended September 30, 2023 and year ended December 31, 2022.

PUR Settlement


In April 2019, Private Histogen entered into a Settlement, Release and Termination Agreement (“PUR Settlement”) with PUR Biologics, LLC and its members which terminated the License, Supply and Operating Agreements between Private Histogen and PUR, eliminated Private Histogen’s membership interest in PUR and returned all in-process research and development assets to Private Histogen (the “Development Assets”). The agreement also provided indemnifications and complete releases by and among the parties. The acquisition of the Development Assets was accounted for as an asset acquisition in accordance with ASC 805-50-50, Acquisition of Assets Rather than a Business.

As consideration for the reacquisition of the Development Assets, Private Histogen compensated PUR with both equity and cash components, including 8,366 shares of Series D convertible preferred stock with a fair value of $1.75 million and a potential cash payout of up to $6.25 million (the “Cap Amount”). Private Histogen paid PUR $0.5 million in upfront cash, forgave approximately $22 thousand of accounts receivable owed by PUR to Private Histogen, and settled an outstanding payable of PUR of approximately $23 thousand owed to a third party. The Company is also obligated to make milestone and royalty payments, including (a) a $0.4 million payment upon the unconditional acceptance and approval of a New Drug Application or Pre-Market Approval Application by the FDA related to the Development Assets, (b) a $0.4 million commercialization milestone upon reaching gross sales (by the Company or licensee) of the $0.5 million of products incorporating the Development Assets, and (c) a five percent (5%) royalty on net revenues collected by the Company from commercial sales (by the Company or licensee) of products incorporating the Development Assets. The aforementioned cash payments, along with any future milestone and royalty payments, are all applied against the Cap Amount. In accordance with authoritative guidance, amounts for the milestone and royalty payments will be recognized when it is probable that the related contingent liability has been incurred and the amount owed is reasonably estimated. No amounts for the milestone and royalty payments have been recorded during the three and nine months ended September 30, 2023 and year ended December 31, 2022.

JHU License Agreement

On April 3, 2023, the Company entered into an Exclusive License Agreement (the “JHU License Agreement”) with Johns Hopkins University (“Johns Hopkins”), pursuant to which Johns Hopkins granted the Company an exclusive license to certain intellectual property associated with the use of emricasan for the treatment of disease in humans resulting from viral or bacterial infections (including but not limited to, MRSA, VRSA, and SARS-CoV-2). In exchange, the Company agreed to pay Johns Hopkins an upfront license fee, reimbursement of certain patent costs, payments upon meeting certain milestones of up to $2.1 million, and royalty payments, including minimum annual royalty payments that totals $0.3 million of future payables creditable to the then current year royalties on net sales through 2033. The Company recognized expenses of $6 thousand and $112 thousand for the three and nine months ended September 30, 2023, respectively, related to the upfront license fee and reimbursement of intellectual property prosecution costs. The JHU License Agreement contains customary provisions on, among other things, termination, indemnification and patent prosecution and maintenance of the licensed intellectual property portfolio. In accordance with authoritative guidance, amounts for the milestone and royalty payments will be recognized when it is probable that the related contingent liability has been incurred and the amount owed is reasonably estimated. No milestones that require milestone payments have been met and therefore no amounts for the milestone and royalty payments have been recorded during the three and nine months ended September 30, 2023.

Litigation and Legal Matters

The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s consolidated financial statements. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. As of September 30, 2023, no accruals have been made and no liability recognized related to such claims and legal proceedings.

Employee Litigation

On or about February 17, 2022, two former employees, each of whom separately resigned and terminated their employment with Histogen, filed a complaint in the Superior Court of California, County of San Diego against the Company, the Company’s Board, the Company’s former Chief Executive Officer, as well as three individuals, two of which are currently employed by the Company. Although the complaint lists the “Histogen Board, a business entity form unknown” as a defendant, the complaint does not specifically

25


list the names of the board members. The plaintiffs allege whistleblower status, retaliation, discrimination, unfair business practices, wrongful termination, violation of civil rights, and other California state law claims. The Company has tendered the complaint to its liability insurer and engaged outside litigation counsel, as approved by its carrier, to defend Histogen, the Board and the individuals in this matter. The Company objects to the naming of each of the defendants in this matter and denies each of the plaintiffs’ claims. The plaintiffs agreed to pre-arbitration mediation, which was conducted on May 4, 2022, as was required by the arbitration agreement executed by each of the plaintiffs. Considering that the parties did not resolve the matter through this mediation, the Company petitioned the San Diego Superior Court for an order that the matter be submitted to arbitration consistent with each of the plaintiff’s arbitration agreements. The hearing for the motion to compel arbitration was held on August 12, 2022 and the San Diego Superior Court issued a ruling to uphold the binding arbitration agreements signed by both plaintiffs. On July 10, 2023, plaintiff’s counsel filed a formal demand for arbitration for one of the plaintiffs. On August 3, 2023, a joint stipulation was filed dismissing the former Chief Executive Officer, as well as the three individuals, two of which are currently employed by the Company. The plaintiffs requested and the Company agreed to an additional pre-arbitration mediation, which was conducted on September 25, 2023. The Company and one of the plaintiffs reached a settlement agreement covered by the Company’s liability insurance, however, the matter remains unresolved between the Company and the second plaintiff. The matter is expected to proceed to arbitration but is the responsibility of the remaining plaintiff to follow through with the initiation of the arbitration proceeding. The Company believes that defense costs, settlement monies, damages or any other awards would be covered by their liability insurance; provided, however, insurance may not cover all claims or could exceed their insurance coverage. The Company believes that there are substantial defenses to this lawsuit, and intends to vigorously defend against each of these claims. While this litigation matter is in the early stages for the remaining plaintiff, the Company believes the action is without merit. Nonetheless, the ultimate outcome is unknown at this time.

ITEM 2.

9. Related Parties

Lordship

Lordship, with its predecessor entities along with its principal owner, Jonathan Jackson, have invested and been affiliated with Private Histogen since 2010. As of both September 30, 2023 and December 31, 2022, Lordship controlled approximately 2.8% of the Company’s outstanding voting shares, respectively, and currently holds two Board seats.

In November 2012, Private Histogen entered into a Strategic Relationship Success Fee Agreement with Lordship (the “Success Fee Agreement”). The Success Fee Agreement causes certain payments to be made from the Company to Lordship equal to 1% of certain product revenues and 10% of certain license and royalty revenues generated from their Human Multipotent Cell Conditioned Media, or CCM, and their Human Extracellular Matrix, or hECM, in connection with the Company’s biologics technology platform. The Success Fee Agreement also stipulates that if the Company engages in a merger or sale of all or substantially all (defined as 90% or more) of its assets or equity to a third party, then the Company has the option to terminate the agreement by paying Lordship the fair market value of future payments with the minimum payment being at least equal to the most recent annual payments Lordship has received. The Success Fee Agreement was amended in August 2016, but continues to carry the same rights to certain payments. The Company recognized $0 expense to Lordship for both the three months ended September 30, 2023 and 2022, and $0 and $375 thousand for the nine months ended September 30, 2023 and 2022, respectively, all of which is included in general and administrative expenses on the accompanying condensed consolidated statements of operations. As of September 30, 2023 and December 31, 2022, there was a balance of $9 thousand and $10 thousand, respectively, paid to Lordship included as a component of other assets on the accompanying consolidated balance sheets in connection with the deferral of revenue from the Allergan license transfer agreements. Refer to Note 10 for further information.

10. Subsequent Events

On October 3, 2023, the Company entered into an Asset Purchase Agreement with Allergan Sales, LLC (“Allergan”), pursuant to which Histogen and its affiliates sold to Allergan certain assets, including certain patents and other intellectual property rights, related to Histogen’s hypoxia generated growth factor technology. In exchange, Allergan agreed to pay Histogen a purchase price of $2.1 million and agreed to assume certain liabilities as set forth in the Asset Purchase Agreement.

The Asset Purchase Agreement contains customary provisions on, among other things, representation and warranties, and covenants related to the transfer of ownership of the acquired assets and other matters. In connection with the Transaction, on October 3, 2023, the Company and Allergan mutually elected to terminate the Allergan License Agreements, as amended from time to time.

In connection with the Transaction, on October 3, 2023, the Company also entered into a Mutual Termination of the Second Amended and Restated Strategic Relationship Success Fee Agreement (the “Lordship Agreement’) with Lordship, pursuant to which Histogen agreed to pay Lordship a mutually agreed to success and termination fee of $0.4 million as required by the terms of the Lordship Agreement.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

26


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and the unaudited interim condensed financial statements included in this quarterly report on Form 10-Qresults of operations should be read in conjunction with the(i) our unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q for the period ended September 30, 2023 (this “Quarterly Report”). This information should also be read in conjunction with our audited historical consolidated financial statements which are included in our Form 10-K for the fiscal year ended December 31, 20162022 (“Form 10-K”). References to the Company’s operating results prior to the Merger will refer to the operating results of Private Histogen. Except as otherwise indicated herein or as the context otherwise requires, references in this Quarterly Report on Form 10-Q to “Histogen” “the Company,” “we,” “us” and “our” refer to Histogen Inc.., a Delaware corporation, on a post-Merger basis, and the related Management’s Discussion and Analysisterm “Private Histogen” refers to the business of Financial Condition and Resultsprivately-held Histogen Inc. prior to completion of Operations, both of which are contained in our annual report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 16, 2017.Merger.

Cautionary Note Regarding Forward-Looking Statements

This quarterly reportQuarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act.(the “Exchange Act”). All statements other than statements of historical facts contained in this quarterly report,Quarterly Report are forward-looking statements, including statements regardingwith respect to the timing and success of the Dissolution pursuant to the Plan of Dissolution, our strategy, future resultsoperations, future financial position, future revenue, projected costs, prospects, plans and objectives of operationsmanagement and expected market growth, and are subject to inherent risks and uncertainties, including, among other things:

beliefs about the Company’s available options, strategic alternatives and financial position, business strategy, prospective products, product approvals, researchcondition;
the proposed Dissolution pursuant to the Plan of Dissolution;
our expectations related to the use of our cash;
the amount and development costs, timing and likelihood of success,distributions made to stockholders, if any, in connection with the Dissolution;
the plans and objectives of management for future operationsoperations;
the timing, implementation or success of our Plan of Dissolution;
the amounts that will need to be set aside by us;
the adequacy of contingency reserves to satisfy our obligations;
our ability to favorably resolve certain potential tax claims, litigation matters and other unresolved contingent liabilities;
the amount of proceeds that might be realized from the sale or other disposition of our assets;
the application of, and any changes in, applicable tax laws, regulations, administrative practices, principles and interpretations;
the incurrence by us of expenses relating to the Dissolution;
the ability of our Board to abandon, modify or delay implementation of the Plan of Dissolution, even after stockholder approval;
future resultseconomic conditions or performance; and
assumptions underlying any of anticipated products, are forward-looking statements. the foregoing.

These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, orand achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by termsterminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,“expects,“target,“intends,“project,“plans,“contemplate,“anticipates,“believe,“believes,“estimate,“estimates,“predict,“predicts,“potential” or “continue”“potential,” “continue,” or the negative of these terms or other similar expressions. Thecomparable terminology. These forward-looking statements in this quarterly report are only predictions. We have based these forward-looking statements

27


largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this quarterly reportQuarterly Report and are subject to a number of risks, uncertainties, and assumptions, including those described in Part II, Item 1A, “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

OverviewWe have common law trademark rights in the unregistered marks “Histogen Inc”, “Histogen”, “Histogen Therapeutics Inc.,” and the Histogen logos in certain jurisdictions. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.

We areOverview

Until recently, we were a biotechnologyclinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function.

On September 18, 2023, we announced, after extensive consideration of potential strategic alternatives, that our Board of Directors (the “Board”), had unanimously approved the dissolution and liquidation of Histogen (“Dissolution”) pursuant to a plan of complete liquidation and dissolution (the “Plan of Dissolution”), subject to stockholder approval. In connection with the Plan of Dissolution, we discontinued all development programs and commercializationterminated all but two employees as of novel medicinesSeptember 30, 2023. The focus of the two remaining employees is to treat liver disease. Wemanage the wind-down of our operations and matters related to managing the Dissolution, including obtaining the necessary stockholder approval of the Plan of Dissolution. Additionally, we are developing emricasan,currently seeking to sell our caspase program assets.

In light of our planned dissolution, on September 26, 2023, we received written notice from The Nasdaq Stock Market LLC, or Nasdaq, advising us that based upon Nasdaq’s review and pursuant to Listing Rule 5101, Nasdaq believed that we were a first-in-class,“public shell,” and that the continued listing of our securities was no longer warranted. As a result, the trading of our common stock was suspended as of the opening of business on October 5, 2023, and on October 12, 2023, Nasdaq filed a Form 25-NSE with the Securities and Exchange Commission, or the SEC, which removed our common stock from listing and registration on Nasdaq.

Our Clinical and Pre-clinical Assets

Emricasan is an orally activeavailable pan-caspase protease inhibitor for the treatment of patients with chronic liver disease. Emricasan is designed to reduce the activities of human caspases, which are enzymes that mediate inflammation and apoptosis. We believe that by reducing the activity of these enzymes, caspaseEmricasan has completed extensive toxicology testing including chronic toxicology and clean carcinogenicity testing. The drug candidate has previously been shown to be well tolerated in multiple clinical studies involving approximately 1,000 subjects employing multiple doses ranging from 1 mg to 500 mg orally with dosing for up to two years, including a Phase 1 study in mild symptomatic COVID-19 patients to assess safety, tolerability, and preliminary efficacy.

CTS-2090 is a selective caspase-1 inhibitors havetargeting inflammasome activation and has the potential to interrupt the progression oftreat a variety of inflammation mediated diseases.

We plan Inflammasomes are a collection of large multiprotein structures responsible for the activation of inflammatory responses. There are six known inflammasome subtypes - NLRP1, NLRP3, NLRC4, NLRP6, AIM2 and IFI 16 - that respond to continue advancing toward initial registrationdifferent stimuli. A primary function of emricasanthe inflammasomes is to generate active caspase-1 from procaspase 1 in response to various pathogens and other stimuli. The ultimate products produced by the activation of caspase 1 are highly pro-inflammatory cytokines, IL-1ß and IL-18. In addition, caspase 1 initiates pyroptosis, a highly inflammatory form of cell death, through the cleavage of gasdermin D. The selection of CTS-2090 as a lead compound is based on its preclinical profile, including high selectivity for patients with cirrhosis due to nonalcoholic steatohepatitis, or NASH, with parallel development toward registrationcaspase-1, and drug-like properties showing a high degree of emricasan for patients with NASH fibrosis. Our current clinical program for emricasan includes the following randomized, double-blind, placebo-controlled Phase 2b clinical trials:

Phase 2b ENCORE-PH (Portal Hypertension) Clinical Trial: In November 2016, we initiated a clinical trial to evaluate the effect of emricasan in approximately 240 compensated or early decompensated NASH cirrhosis patients with severe portal hypertension. Top-line results are expecteddrug exposure in the second halfintestinal track after oral administration.

Additionally, we have a proprietary portfolio of 2018.

Phase 2b ENCORE-LF (Liver Function) Clinical Trial: In May 2017, we initiatedorally active molecules that inhibit inflammasome pathways and thus the activation of the potent inflammatory cytokine interleukin-1β, or IL-1β. Inhibition of IL-1β is a clinical trialclinically validated approach to evaluate emricasan in approximately 210 patientstreating inflammatory diseases, with decompensated NASH cirrhosis. Top-line results are expectedinjectable biologic products using that mechanism of action already on the market. The NLRP3 inflammasome pathway, for example, is dependent upon caspase-1, which activates IL-1β. As such, caspase-1 occupies a uniquely central position in the second halfinflammasome pathway, and we have leveraged our scientific expertise in caspase research and development to design potent, selective and orally bioavailable inhibitors of 2019.caspase-1. Excess IL-1β has been linked to a variety

Phase 2b ENCORE-NF (NASH Fibrosis) Clinical Trial: In January 2016,28


of diseases including rare genetic inflammatory diseases, neurological diseases, cancer, liver and other gastrointestinal diseases, and cardiovascular diseases.

Proprietary Hypoxia Generated Growth Factor Technology included Human Multipotent Cell Conditioned Media, or CCM and Human Extracellular Matrix, or hECM. On October 3, 2023, we initiated a clinical trial to evaluate emricasan in approximately 330 patientsentered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with liver fibrosis resulting from NASH. Top-line results are expected in the first half of 2019.  

Phase 2b POLT-HCV-SVR Clinical Trial: In May 2014, we initiated a clinical trial in approximately 60 post-orthotopic liver transplant, or POLT, recipients with reestablished liver fibrosis post-transplant as a result of recurrent hepatitis C virus, or HCV, infection who have successfully achieved a sustained viral response, or SVR, following HCV antiviral therapy, or POLT-HCV-SVR, patients with residual fibrosis or cirrhosis, classified as Ishak Fibrosis Score 2-6. Top-line results are expected in the second quarter of 2018.


In addition, we plan to initiate a post-treatment observational studyAllergan Sales, LLC (“Allergan”), pursuant to which subjectsHistogen and its affiliates sold to Allergan certain assets, including certain patents and other intellectual property rights, related to Histogen’s hypoxia generated growth factor technology (the “Transaction”). In exchange, Allergan agreed to pay Histogen a purchase price of $2.1 million and agreed to assume certain liabilities as set forth in the Asset Purchase Agreement. The Asset Purchase Agreement contains customary provisions on, among other things, representation and warranties, and covenants related to the transfer of ownership of the acquired assets and other matters. In connection with the Transaction, on October 3, 2023, the Company and Allergan mutually elected to terminate the Allergan License Agreements, as amended from time to time.

Material Contracts

Pfizer Inc.

In July 2010, we entered into a Stock Purchase Agreement with Pfizer pursuant to which it acquired all of the four trials above will be followed for long-term three-year safety follow-up.outstanding capital stock of Idun Pharmaceuticals, Inc. (“Idun”), a wholly-owned subsidiary of Pfizer at the time. Pursuant to the Stock Purchase Agreement, we are required to make additional payments to Pfizer totaling $18.0 million upon the achievement of specified regulatory milestones relating to emricasan.

In May 2017, Novartis Pharma AG, or Novartis, exercised its option underPrior to the Option, Collaboration and License Agreement, ortermination of the Collaboration Agreement we entered into with Novartis in December 2016. PursuantAmerimmune on November 28, 2022, the obligations pursuant to such exercise, we granted Novartis an exclusive, worldwide license tothe Stock Purchase Agreement were the responsibility of our intellectual property rights relating to emricasan to collaborateformer collaboration partner, Amerimmune. In accordance with us and develop and commercialize emricasan products, containing emricasan either as a single active ingredient or in combination with other Novartis compounds for liver cirrhosis or liver fibrosis,authoritative guidance, amounts for the treatment, diagnosismilestone payments will be recognized when it is probable that the related contingent liability has been incurred and prevention of disease in all indications in humans. The license became effective upon our receipt of a $7.0 million option exercise payment in July 2017.

Pursuant to the Collaboration Agreement, we are responsibleamount owed is reasonably estimated. No amounts for completingthe milestone payments have been recorded during the three ENCORE trials and the POLT-HCV-SVR trial described above. We and Novartis will generally share the costs of these four Phase 2b trials and the planned observational study equally. Upon completion of the four Phase 2b trials, Novartis will assume 100% of the observational study costs. Novartis is responsible for 100% of certain expenses for required registration-supportive nonclinical activities. Novartis is also responsible for the development of emricasan beyond the four Phase 2b trials and planned observational study described above, including the Phase 3 development of emricasan single agent products and all development for emricasan combination products, and Novartis has agreed to use commercially reasonable efforts to develop and commercialize emricasan products. A joint steering committee comprised of representatives from our company and Novartis oversees the collaboration, development and commercialization of emricasan products.

Under the Collaboration Agreement, Novartis paid us an upfront payment of $50.0 million and an option exercise payment of $7.0 million.  In addition, we are eligible to receive up to an aggregate of $650.0 million in milestone payments, as well as royalties.

In June 2017, the U.S. Food and Drug Administration granted Orphan Drug Designation to our preclinical product candidate IDN-7314, a pan-caspase inhibitor, for the treatment of primary sclerosing cholangitis, or PSC, a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In October 2017, the European Medicines Agency granted orphan designation to IDN-7314 for the treatment of PSC. We believe these orphan designations provide an opportunity to address an important unmet medical need and expand our development pipeline beyond emricasan. Pursuant to the Collaboration Agreement, Novartis will have a right of first negotiation prior to any offer for IDN-7314 by us to a third party, and we may not develop IDN-7314 in any pivotal registration clinical trials or commercialize IDN-7314 in liver disease until the earlier of five years after the first commercial sale of an emricasan product in the United States or major European market or ten years from the execution date of the Collaboration Agreement. We will continue to evaluate the potential of IDN-7314 as a product candidate as a component of our pipeline expansion plans. We also plan to expand our development pipeline by developing new product candidates based on our expertise in caspase inhibition or purchasing or in-licensing product candidates. In addition to liver disease, we may pursue the development of product candidates in other disease areas.

Since our inception, our primary activities have been organizational activities, including recruiting personnel, conducting research and development, including clinical trials, and raising capital. We have no products approved for sale, and we have not generated any revenues from product sales to date. We have funded our operations since inception primarily through sales of equity securities and convertible promissory notes and payments made under the Collaboration Agreement, and we have incurred significant operating losses since our inception. We have never been profitable and have incurred net losses of $29.7 million and $24.1 million for the years ended December 31, 2016 and 2015, respectively, and $13.0 million for the nine months ended September 30, 2017. As2023 and 2022 or the year ended December 31, 2022.

Idun Distribution Agreement

In January 2013, the Company conducted a spin-off of its subsidiary Idun, which the Company had acquired from Pfizer in the transaction described above, to stockholders at that time. Immediately prior to the spin-off, all rights relating to emricasan were distributed to the Company pursuant to a distribution agreement.

JHU License Agreement

On April 3, 2023, the Company entered into an Exclusive License Agreement (the “JHU License Agreement”) with Johns Hopkins University (“Johns Hopkins”), pursuant to which Johns Hopkins granted the Company an exclusive license to certain intellectual property associated with the use of emricasan for the treatment of disease in humans resulting from viral or bacterial infections (including but not limited to, MRSA, VRSA, and SARS-CoV-2). In exchange, the Company agreed to pay Johns Hopkins an upfront license fee, reimbursement of certain patent costs, payments upon meeting certain milestones of up to $2.1 million, and royalty payments, including minimum annual royalty payments that totals $0.3 million of future payables creditable to the then current year royalties on net sales through 2033. The Company recognized expenses of $6 thousand and $112 thousand for the three and nine months ended September 30, 2017, we had an accumulated deficit2023, respectively, related to the upfront license fee and reimbursement of $163.7 million.

We expect to continue to incur significant operating losses and negative cash flows from operating activities for the foreseeable future as we continue the clinical development of emricasan and seek regulatory approval for and, if approved, pursue commercialization of emricasan. In May 2017, we completed a public offering of 5,980,000 shares of our common stock at a public offering price of $5.50 per share. We received net proceeds of $30.6 million, after deducting underwriting discounts and commissions and offering-related transactionintellectual property prosecution costs. Immediately following the offering, we used $11.2 million of the net proceeds to repurchase and retire 2,166,836 shares of our common stock from funds affiliated with Advent Private Equity, or Advent, at a price of $5.17 per share.

As of September 30, 2017, we had cash, cash equivalents and marketable securities of $85.2 million. Although it is difficult to predict future liquidity requirements, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next 12 months from the date of the filing of this Form 10-Q. We will need to raise additional capital to fund further operations, including the development of product candidates other than emricasan. We may obtain additional financing in the future through the issuance of our common stock in future public offerings, through other equity or debt financings or through collaborations or partnerships with other companies.


Successful transition to profitability is dependent upon achieving a level of revenues adequate to support our cost structure. We cannot assure you that we will ever be profitable or generate sustained positive cash flow from operating activities and, unless and until we do, we will need to raise substantial additional capital through equity or debt financings or through collaborations or partnerships with other companies. We may not be able to raise additional capitalThe JHU License Agreement contains customary provisions on, terms acceptable to us, or at all, and any failure to raise capital as and when needed could have a material adverse effect on our results of operations, financial condition and our ability to execute on our business plan.

JOBS Act

In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an “emerging growth company,” we are electing not to take advantagetermination, indemnification and patent prosecution and maintenance of the extended transition period afforded by the JOBS Actlicensed intellectual property portfolio. In accordance with authoritative guidance, amounts for the implementation of new or revised accounting standards,milestone and as a result, weroyalty payments will comply with new or revised accounting standards onbe recognized when it is probable that the relevant dates on which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision not to take advantage of the extended transition period is irrevocable. In addition, we are in the process of evaluating the benefits of relying on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if as an “emerging growth company” we choose to rely on such exemptions, we may not be required to, among other things, (i) provide an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the auditrelated contingent liability has been incurred and the financial statements (auditor discussionamount owed is reasonably estimated. No milestones that require milestone payments have been met and analysis)therefore no amounts for the milestone and (iv) disclose certain executive compensation-related items such asroyalty payments have been recorded during the correlation between executive compensationthree and performance and comparisonsnine months ended September 30, 2023.

Components of the Chief Executive Officer’s compensation to median employee compensation. These exemptions will apply for a periodResults of five years following the completion of our initial public offering, or IPO, or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier.Operations

Revenue

Financial Overview

Revenues

Our revenues to date have been generated primarily from the Collaboration Agreement with Novartis.  Undersale of license fees.

License Revenue

Our license revenue to date has been generated primarily from payments received under the terms of the Collaboration Agreement, we received an upfront payment of $50.0 million. In May 2017, Novartis exercised its option, and we received a $7.0 million option exercise payment in July 2017.  We are eligible to receive up to $650.0 million in additional payments for development, regulatory and commercial sales milestones, as well as royalties or profit and loss sharing on future product sales in the United States, if any.Allergan Agreements.

We currently have no products approved for sale, and we have not generated any revenues from product sales to date. We have not submitted any product candidate for regulatory approval. If we fail to achieve clinical success in the development of emricasan in a timely manner and/or obtain regulatory approval for this product candidate, or to successfully develop other product candidates, our ability to generate future revenues would be materially adversely affected.29


Operating Expenses

Research and Development Expenses

The majority of our operating expenses to date have been incurred in research and development activities. Starting in late 2011, research and development expenses have been focused on the development of emricasan. Since acquiring emricasan in 2010, we have incurred $98.5 million in the development of emricasan through September 30, 2017. Our business model is currently focused on the development of emricasan in various liver diseases and is dependent upon our continuing to conduct research and a significant amount of clinical development. Our researchResearch and development expenses consist primarily of:of costs incurred for the preclinical and clinical development of our product candidates, which include:

expenses incurred under agreements with third-party contract research organizations, or CROs, investigative clinical trial sites and consultants that conduct research and development activities on our clinical trialsbehalf, and our preclinical studies;

consultants;

employee-related expenses, which include costs related to develop and manufacture preclinical study and clinical trial material;

salaries and employee-related costs, including stock-based compensation and benefits;

costs incurred and reimbursed under our grant awarded by the costU.S. Department of finalizingDefense (“DoD”) to partially fund our chemistry, manufacturing and controls, or CMC, capabilities and providingPhase 1/2 clinical trial materials; and

of HST-003 for regeneration of cartilage in the knee;

costs associated withincurred for IND enabling activities for HST-004 for spinal disc repair;

costs incurred for completing the feasibility assessment of emricasan for the potential treatment of skin bacterial infections including those related to ABSSSI’s, as well as other research activitiesinfectious diseases; and regulatory approvals.

Research

laboratory and development costs are expensed as incurred.


At this time, duevendor expenses related to the inherently unpredictable natureexecution of preclinical and clinical development, we are unable to estimate with any certainty the costs we will incur in the continued development of emricasan. Clinical development timelines, the probability of successtrials.

We accrue all research and development costs can differ materially from expectations.

The costs of clinical trials may vary significantly over the life of a project owing to factors that include but are not limited to the following:

per patient trial costs;

the number of patients that participate in the clinical trials;

the number of sites included in the clinical trials;

the countries inperiod for which the clinical trialsthey are conducted;

the length of time required to enroll eligible patients;

the number of doses that patients receive;

the drop-out or discontinuation rates of patients;

potential additional safety monitoring or other studies requested by regulatory agencies;

the duration of patient follow-up; and

the efficacy and safety profileincurred. Costs for certain development activities are recognized based on an evaluation of the product candidate.progress to completion of specific tasks using information and data provided to us by our vendors, collaborators and third-party service providers. Advance payments for goods or services to be received in future periods for use in research and development activities are deferred and then expensed as the related goods are delivered and as services are performed.

We are currently focused on advancing emricasan in multiple indications, andexpect our future research and development expenses will depend on its clinical success. In addition,to decrease substantially for the foreseeable future as we cannot forecast with any degreehave discontinued our development programs while we pursue approval for the Plan of certaintyDissolution from our stockholders.

Our direct research and development expenses are tracked by product candidate and consist primarily of external costs, such as fees paid under third-party license agreements and to what extent Novartis will developoutside consultants, contract research organizations (“CROs”), contract manufacturing organizations and commercialize emricasan.

Researchresearch laboratories in connection with our preclinical development, process development, manufacturing and development expenditures will continue to be significant and will increase as we continue clinical development of emricasan over at least the next several years. We expect to incur significant development costs as we conduct our ongoing Phase 2b trials of emricasan and develop product candidates other than emricasan.

activities. We do not expect emricasanallocate employee costs and costs associated with our discovery efforts, laboratory supplies and facilities, including other indirect costs, to be commercially available, if at all,specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research as well as for at leastmanaging our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple programs and, therefore, we do not track our costs by product candidate unless such costs are includable as subaward costs. The following table shows our research and development expenses by type of activity (in thousands):

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Pre-clinical and clinical

 

$

21

 

 

$

312

 

 

$

347

 

 

$

952

 

Salaries and benefits

 

 

605

 

 

 

387

 

 

 

1,440

 

 

 

1,819

 

Facilities and other costs

 

 

34

 

 

 

208

 

 

 

402

 

 

 

1,161

 

Total research and development expenses

 

$

660

 

 

$

907

 

 

$

2,189

 

 

$

3,932

 

We have discontinued our development programs while we pursue approval for the next several years.Plan of Dissolution from our stockholders.

30


General and Administrative Expenses

General and administrative expenses consist principallyprimarily of personnel-related costs, insurance costs, facility costs and professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. Personnel-related costs consist of salaries, benefits, and related costs for personnel in executive, finance, business development and administrative functions. stock-based compensation.

Other general and administrative expenses include costs related to being a public company, as well as insurance, facilities, travel, patent filing and maintenance, legal and consulting expenses.Income (Expense)

If we exercise our option to co-commercialize emricasan pursuant to the Collaboration Agreement, we may incur expenses associated with activities related to commercializing emricasan. Some expenses may be incurred prior to receiving regulatory approval of emricasan. We do not expect to receive any such regulatory approval for at least the next several years.

Interest Income

Interest income consists primarily of interest income earned on our cash equivalents, which consist of money market funds. Our interest income has not been significant due to low interest earned on invested balances.

Loss on Disposal of Fixed Assets

Loss on disposal of fixed assets is the difference between the net book value of the assets disposed and cash received for sale of property and equipment.

Results of Operations

Comparison of three months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended September 30, 2023 and 2022 (in thousands):

 

 

Three Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

Change

 

Revenues

 

 

 

 

 

 

 

 

 

License revenue

 

$

5

 

 

$

5

 

 

$

 

Total revenues

 

 

5

 

 

 

5

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

Research and development

 

 

660

 

 

 

907

 

 

 

(247

)

General and administrative

 

 

2,870

 

 

 

2,696

 

 

 

174

 

Total operating expenses

 

 

3,530

 

 

 

3,603

 

 

 

(73

)

Loss from operations

 

 

(3,525

)

 

 

(3,598

)

 

 

73

 

Interest expense, net

 

 

 

 

 

(1

)

 

 

1

 

Other income (expense)

 

 

(5

)

 

 

 

 

 

(5

)

Loss on disposal of fixed assets

 

 

(324

)

 

 

 

 

 

(324

)

Net loss

 

$

(3,854

)

 

$

(3,599

)

 

$

(255

)

Revenues

For both the three months ended September 30, 2023 and 2022, we recognized license revenue of $5 thousand related to deferred revenue recognized on a straight-line basis over the remaining life of the licensing patents related to the Allergan License Agreement.

Total Operating Expenses

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2023 and 2022 were $0.7 million and $0.9 million, respectively. The decrease of $0.2 million was primarily due to decreases in consulting and outside services and a reduction of development costs related to clinical and preclinical candidates, partially offset by personnel related expenses.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2023 and 2022 were $2.9 million and $2.7 million, respectively. The increase of $0.2 million was primarily due to an approximately $1.0 million lease termination fee and increases in personnel related expenses, offset by decreases in legal fees, stock-based compensation costs, insurance, and outside services.

31


Results of Operations

Comparison of nine months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022 (in thousands):

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

Change

 

Revenues

 

 

 

 

 

 

 

 

 

License revenue

 

$

15

 

 

$

3,765

 

 

$

(3,750

)

Total revenues

 

 

15

 

 

 

3,765

 

 

 

(3,750

)

Operating expenses

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,189

 

 

 

3,932

 

 

 

(1,743

)

General and administrative

 

 

6,913

 

 

 

7,508

 

 

 

(595

)

Total operating expenses

 

 

9,102

 

 

 

11,440

 

 

 

(2,338

)

Loss from operations

 

 

(9,087

)

 

 

(7,675

)

 

 

(1,412

)

Interest expense, net

 

 

(1

)

 

 

(2

)

 

 

1

 

Other income (expense)

 

 

(5

)

 

 

 

 

 

(5

)

Gain on sale of subsidiary

 

 

1

 

 

 

 

 

 

1

 

Loss on disposal of fixed assets

 

 

(324

)

 

 

 

 

 

(324

)

Net loss

 

$

(9,416

)

 

$

(7,677

)

 

$

(1,739

)

Revenues

For the nine months ended September 30, 2023 and 2022, we recognized license revenue of $15 thousand and $3.8 million, respectively. The decrease in the current period is due to a one-time payment of $3.75 million received in March 2022 as consideration for execution of the 2022 Allergan Letter Agreement.

Total Operating Expenses

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2023 and 2022 were $2.2 million and $3.9 million, respectively. The decrease of $1.7 million was primarily due to decreases in personnel related expenses, outsourced manufacturing facility expenses, and a reduction of development expenses related to clinical and preclinical candidates.

General and Administrative Expenses

General and administrative expenses for the nine months ended September 30, 2023 and 2022 were $6.9 million and $7.5 million, respectively. The decrease of $0.6 million was primarily due to decreases in legal, royalty, and insurance expenses, partially offset by increases for the $1.0 million lease termination fee and certain personnel related expenses.

Liquidity and Capital Resources

From inception through September 30, 2023, we had an accumulated deficit of $97.7 million and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future, including through the execution of the Plan of Dissolution if approved by the Company’s shareholders.

In accordance with Accounting Standards Codification, or ASC, 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued on November 9, 2023. The Company has determined that its cash and cash equivalents as of September 30, 2023 of $4.6 million would be insufficient to fund its operations for a period of at least twelve months from the date of these financial statements which raises substantial doubt regarding the Company’s ability to continue as a going concern.

On September 18, 2023, we announced that the Company’s Board unanimously approved the Plan of Dissolution. As the Plan of Dissolution has not yet been brought to a vote or approved by the Company’s shareholders, the Company concluded that the liquidation basis of accounting should not be applied as of the balance sheet date. Accordingly, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and marketable securities.satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the

Interest Expense32


Interest expense consistsrecoverability and classification of accrued interestassets or the amounts and classification of liabilities that may result from the outcome of these uncertainties described above.

In light of our planned dissolution, on September 26, 2023, we received written notice from The Nasdaq Stock Market LLC, or Nasdaq, advising us that based upon Nasdaq’s review and pursuant to Listing Rule 5101, Nasdaq believed that we were a “public shell,” and that the continued listing of our $15.0 million convertible promissory note payablesecurities was no longer warranted. As a result, the trading of our common stock was suspended as of the opening of business on October 5, 2023, and on October 12, 2023, Nasdaq filed a Form 25-NSE with the Securities and Exchange Commission, or the SEC, which removed our common stock from listing and registration on Nasdaq.

Common Stock

January 2021 Offering of Common Stock

In January 2021, we completed an S-1 offering (the “January 2021 Offering”) of an aggregate of 580,000 shares of common stock, pre-funded warrants to Novartispurchase up to 120,000 shares of its common stock, and coupon interest on our $1.0 million promissory note payablecommon stock warrants to Pfizer Inc.

Other Income (Expense)

Other income (expense) includes non-operating transactionspurchase up to an aggregate of 700,000 shares of common stock. To the extent that an investor determines, at their sole discretion, that they would beneficially own in excess of the Beneficial Ownership Limitations (or as such as those causedinvestor may otherwise choose), in lieu of purchasing shares of common stock and common stock warrants, such investor could have elected to purchase pre-funded warrants and common stock warrants at the pre-funded purchase price in lieu of the shares of common stock and common stock warrants in such a manner to result in the same aggregate purchase price being paid by currency fluctuations between transaction dates and settlement datessuch investor to the Company. The combined purchase price of one share of common stock and the conversionaccompanying common stock warrant was $20.00, and the combined purchase price of account balances heldone pre-funded warrant and accompanying common stock warrant was $19.998. The common stock warrants are exercisable for five (5) years at an exercise price of $20.00 per share. The pre-funded warrants were immediately exercisable at an exercise price of $0.002 per share and were exercisable at any time until all of the pre-funded warrants are exercised in foreign currenciesfull. Placement agent warrants were issued to U.S. dollars.purchase up to 35,000 shares of common stock, are immediately exercisable for an exercise price of $25.00, and are exercisable for five (5) years following the date of issuance. We received gross proceeds of $14.0 million and incurred placement agent’s fees and other offering expenses of approximately $1.9 million.

As of September 30, 2023, a total of 336,060 warrants issued in the January 2021 Offering to purchase shares of common stock have been exercised and we issued 336,060 shares of its common stock. We received gross proceeds of approximately $6.8 million.

As of September 30, 2023, we had 387,565 shares and 11,375 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by us in the January 2021 Offering, at an exercise price of $20.00 per share and $25.00 per share, respectively.

June 2021 Offering of Common Stock

In June 2021, we completed a registered direct offering (the “June 2021 Offering”) of an aggregate of 298,865 shares of common stock, together with accompanying warrants to purchase up to an aggregate of 239,093 shares of common stock, at a public offering price of $22.00 per share. The accompanying warrants permit the investor to purchase additional shares equal to 80% of the number of shares of our common stock purchased by the investor. The warrants have an exercise price of $20.00 per share, are immediately exercisable, and expire five and a half (5.5) years following the date of issuance. In addition, our placement agent was issued compensatory warrants equal to 5.0%, or 14,946 shares, of the aggregate number of common stock sold in the offering, which are immediately exercisable for an exercise price of $27.50 and expire five (5) years following the date of issuance on June 7, 2026. We received gross proceeds of $6.6 million and incurred cash-based placement agent fees and other offering expenses of approximately $0.9 million.

As of September 30, 2023, no warrants associated with the June 2021 Offering have been exercised.

As of September 30, 2023, we had 90,910 shares and 14,946 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by us in the June 2021 Offering, at an exercise price of $20.00 per share and $27.50 per share, respectively. In connection with the July 2022 Offering, we agreed to amend warrants, by reducing the exercise price and extending the expiration date, to purchase up to an aggregate of 148,183 shares of our common stock that were originally issued to the investor in the June 2021 Offering.

December 2021 Offering of Common Stock

In December 2021, we completed a registered direct offering (the “December 2021 Offering”) of an aggregate of 411,764 shares of common stock and 411,766 warrants to purchase up to 411,766 shares of common stock, at a public offering price of $8.50 per share. The accompanying warrants permit the investor to purchase additional shares equal to approximately the same number of shares of our

33


common stock purchased by the investor. The warrants have an exercise price of $8.50 per share, may be exercised any time on or after 6 months and one (1) day after the issuance date, and expire five and a half (5.5) years following the date of issuance. In addition, the placement agent was issued compensatory warrants equal to 5.0%, or 20,590 shares, of the aggregate number of shares of common stock sold in the offering, which are immediately exercisable for an exercise price of $10.626 and expire five and a half (5.5) years following the date of issuance on June 21, 2027. We received gross proceeds of $3.5 million and incurred cash-based placement agent fees and other offering expenses of approximately $0.5 million.

As of September 30, 2023, no warrants associated with the December 2021 Offering have been exercised.

As of September 30, 2023, we had 164,707 shares and 20,590 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by us in the December 2021 Offering, at an exercise price of $8.50 per share and $10.626 per share, respectively. In connection with the July 2022 Offering, we agreed to amend warrants, by reducing the exercise price and extending the expiration date, to purchase up to an aggregate of 247,059 shares of our common stock that were originally issued to the investor in the December 2021 Offering.

July 2022 Offering of Common Stock

On July 12, 2022, we entered into a Securities Purchase Agreement (the “July 2022 Purchase Agreement”) with a single healthcare-focused institutional investor for the sale by us of (i) a pre-funded warrant to purchase up to 1,774,309 shares of Common Stock (the “Pre-Funded Warrant”), (ii) a Series A warrant to purchase up to an aggregate of 1,774,309 shares of common stock (the “Series A Warrant”), and (iii) a Series B warrant to purchase up to an aggregate of 1,774,309 shares of common stock (the “Series B Warrant,” and together with the Pre-Funded Warrant and the Series A Warrant, the “Warrants”), in a private placement offering (the “Offering”). The combined purchase price of one Pre-Funded Warrant and accompanying Series A Warrant and accompanying Series B Warrant was $2.818.

Subject to certain ownership limitations, the Series A Warrant is exercisable immediately after the issuance date at an exercise price equal to $2.568 per share of common stock, subject to adjustments as provided under the terms of the Series A Warrant, and has a term of five and a half (5.5) years from the issuance date. Subject to certain ownership limitations, the Series B Warrant is exercisable immediately after the issuance date at an exercise price equal to $2.568 per share of common stock, subject to adjustments as provided under the terms of the Series B Warrant, and has a term of one and a half (1.5) years from the issuance date. Subject to certain ownership limitations described in the Pre-Funded Warrant, the Pre-Funded Warrant was immediately exercisable and may be exercised at an exercise price of $0.0001 per share of common stock any time until all of the Pre-Funded Warrant is exercised in full. As of September 30, 2023, the Pre-Funded Warrant to purchase up to an aggregate of 1,774,309 shares of common stock had been fully exercised and the Company issued 1,774,309 shares of common stock.

We also agreed to amend certain warrants to purchase up to an aggregate of 447,800 shares of our common stock that were issued to the investor in the private placement in November 2020, June 2021 and December 2021 with exercise prices ranging from $8.50 to $34.00 per share and expiration dates ranging from May 18, 2026 to June 21, 2027, so that such warrants have a reduced exercise price of $2.568 per share and expiration date of five and a half (5.5) years following the closing of the private placement, for an additional offering price of $0.0316 per amended warrant. The incremental fair value resulting from the modifications to the warrants was adjusted against the gross proceeds from the offering as an equity issuance cost.

The gross proceeds to us were approximately $5 million, before deducting the placement agent’s fees and other offering expenses, and excluding the proceeds, if any, from the exercise of the Series A Warrant, the Series B Warrant, and amended warrants.

As of September 30, 2023, no warrants associated with the July 2022 Purchase Agreement have been exercised.

As of September 30, 2023, we had 3,996,418 shares and 124,202 shares of common stock reserved for issuance pursuant to the warrants and placement agent’s warrants, respectively, issued by us in the July 2022 Purchase Agreement, at an exercise price of $2.568 per share and $3.5225 per share, respectively.

Common Stock Warrants

As of September 30, 2023, warrants to purchase 68 shares of common stock with an exercise price of $1,486.00 per share that were issued by Conatus in connection with obtaining financing in 2016 expired unexercised on July 3, 2023.

See warrant discussion above in connection with the January 2021 Offering, the June 2021 Offering, the December 2021 Offering, and the July 2022 Offering.

34


Cash Flow Summary for the nine months ended September 30, 2023 and 2022

The following table shows a summary of our cash flows for the nine months ended September 30, 2023 and 2022 (in thousands):

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Net cash provided by (used in)

 

 

 

 

 

 

Operating activities

 

$

(7,635

)

 

$

(7,244

)

Investing activities

 

 

13

 

 

 

(215

)

Financing activities

 

 

(14

)

 

 

3,326

 

Net decrease in cash, cash equivalents and restricted cash

 

$

(7,636

)

 

$

(4,133

)

Operating activities

Net cash used in operating activities was $7.6 million for the nine months ended September 30, 2023, resulting from our net loss of $9.4 million, which included total non-cash charges of $0.9 million related primarily to stock-based compensation, and depreciation and amortization, coupled with a $0.9 million change in our operating assets and liabilities.

Net cash used in operating activities was $7.3 million for the nine months ended September 30, 2022, resulting from our net loss of $7.7 million, which included total non-cash charges of $0.5 million related to stock-based compensation, and depreciation and amortization, coupled with a $0.1 million change in our operating assets and liabilities.

Investing activities

Net cash provided by investing activities was $13 thousand for the nine months ended September 30, 2023, which was related to the sale of certain property and equipment and the sale of a wholly owned subsidiary.

Net cash used by investing activities was $0.2 million for the nine months ended September 30, 2022, which was related to the purchase of property and equipment.

Financing activities

Net cash used by financing activities was $14 thousand for the nine months ended September 30, 2023, related to repayment and early termination of finance lease obligations.

Net cash used by financing activities was $3.3 million for the nine months ended September 30, 2022, primarily related to $4.4 million net proceeds from a July 2022 private placement, offset by $0.6 million of issuance costs resulting from the issuance and sale of our redeemable convertible preferred stock in a March 2022 private placement offering coupled with $0.5 million related to the redemption premium paid to repurchase the redeemable convertible preferred stock.

Funding Requirements

We expect to continue to incur expenses and operating losses for the foreseeable future in order to operate as a public company and support the approval of the Plan of Dissolution by the Company’s stockholders. We are subject to a number of risks similar to other companies that have determined to focus primarily on the approval of the Plan of Dissolution, including, but not limited to, those which are described under Part II Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. We will incur substantial expenses as we:


pursue dissolution and liquidation of the Company (including legal, accounting and other professional fees);
reduce any personnel and associated costs;
defend or resolve unforeseen claims asserted against us, if any;
terminate any contracts associated with our business operations; and
seek to maintain and protect our intellectual property portfolio, as may be necessary in the pursuant of the sale of our remaining asset.

35


There can be no assurance that our stockholders will approve the Plan of Dissolution. Based on the current business plan to pursue the liquidation and dissolution according to the Plan of Dissolution, there is substantial doubt about our ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s 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 United States generally accepted accounting principles generally accepted in the United States.(“U.S. GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities atas of the date of the financial statements, as well asbalance sheet and the reported revenues andamounts of expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We baseperiod. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued research and development expenses and stock-based compensation. Our estimates are based on historical experiencetrends and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.

We consider our critical accounting policies and estimates to be related to stock-based compensation. While our significant accounting policies are described in more detail in our financial statements, we believe these accounting policies and estimates to be most critical to the judgments and estimates used in the preparation of our financial statements. There werehave been no significantmaterial changes to our critical accounting policies and estimates during the three and nine months ended September 30, 2017 to the critical accounting policies described2023 from those disclosed in “Item 7 –“Histogen’s Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies, and Significant Judgments and Estimates”” included in ourthe 2022 Annual Report on Form 10-K for10-K.

Off-Balance Sheet Arrangements

We did not have during the fiscal year ended December 31, 2016 filed withperiods presented, and we do not currently have, any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K under the SEC on March 16, 2017.Exchange Act.

Results of OperationsContractual Obligations and Commitments

Comparison of the Three Months Ended September 30, 2017 and 2016

Total Revenues

Total revenues were $9.6 million for the three months ended September 30, 2017, as compared to $0.0 million for the same period in 2016. For the three months ended September 30, 2017, total revenues consisted of collaboration revenue related to the Collaboration Agreement with Novartis, which was executed in December 2016.

We currently recognize collaboration revenue on the license portion of deferred revenue on a straight-line basis between the inception of the agreement (or with respect to the option exercise fee, upon exercise of the option) through mid 2019 – the estimated period over which we expect to perform the research and development services. Due to the inherently unpredictable nature of product development activities, we periodically review the performance period of the research and development services and will adjust the period over which revenue is recognized when appropriate. Changes in the performance period could materially impact the timing of future revenue recognition.

Research and Development Expenses

Research and development expenses were $11.2 million for the three months ended September 30, 2017, as compared to $4.8 million for the same period in 2016. The increase of $6.4 million was primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and Administrative Expenses

General and administrative expenses were $2.4 million for the three months ended September 30, 2017, as compared to $2.1 million for the same period in 2016. The increase of $0.3 million was primarily due to higher personnel costs and professional fees.

Changes in components of Other Income (Expense) were as follows:

Interest Income

Interest income was $259,000 for the three months ended September 30, 2017, as compared to $34,000 for the same period in 2016. Interest income consisted of interest earned on our cash, cash equivalents and marketable securities and fluctuates based onThere have been no material changes in investment balances and interest rates.

Interest Expense

Interest expense was $189,000 for the three months ended September 30, 2017, as compared to $18,000 for the same period in 2016. The increase was due to higher interest expense related to the $15.0 million convertible promissory note issued to Novartis in February 2017, partially offset by lower interest expense related to the $1.0 million promissory note payable to Pfizer Inc., which was voluntarily prepaid in January 2017.


Other (Expense) Income

Other expense was $21,000 for the three months ended September 30, 2017, as compared to other income of $12,000 for the same period in 2016. Other expense represents non-operating transactions such as those caused by currency fluctuations between transaction dates and settlement dates and the conversion of account balances held in foreign currencies to U.S. dollars.

Comparison of the Nine Months Ended September 30, 2017 and 2016

Total Revenues

Total revenues were $26.6 million forduring the nine months ended September 30, 2017, as compared to $0.0 million for the same period in 2016. For the nine months ended September 30, 2017, total revenues consisted of collaboration revenue related to the Collaboration Agreement with Novartis, which was executed in December 2016.

Research and Development Expenses

Research and development expenses were $32.3 million for the nine months ended September 30, 2017, as compared to $13.8 million for the same period in 2016. The increase of $18.5 million was primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and Administrative Expenses

General and administrative expenses were $7.4 million for the nine months ended September 30, 2017, as compared to $6.9 million for the same period in 2016. The increase of $0.5 million was primarily due to higher personnel costs and professional fees.

Changes in components of Other Income (Expense) were as follows:

Interest Income

Interest income was $648,000 for the nine months ended September 30, 2017, as compared to $95,000 for the same period in 2016. Interest income consisted of interest earned on our cash, cash equivalents and marketable securities and fluctuates based on changes in investment balances and interest rates.

Interest Expense

Interest expense was $473,000 for the nine months ended September 30, 2017, as compared to $53,000 for the same period in 2016. The increase was due to higher interest expense related to the $15.0 million convertible promissory note issued to Novartis in February 2017, partially offset by lower interest expense related to the $1.0 million promissory note payable to Pfizer Inc., which was voluntarily prepaid in January 2017.

Other (Expense) Income

Other expense was $72,000 for the nine months ended September 30, 2017, as compared to other income of $2,000 for the same period in 2016. Other expense represents non-operating transactions such as those caused by currency fluctuations between transaction dates and settlement dates and the conversion of account balances held in foreign currencies to U.S. dollars.

Liquidity and Capital Resources

We have incurred losses since inception and negative cash flows from operating activities through December 31, 2015. For the year ended December 31, 2016, we had positive net cash flows from operating activities due to the upfront payment related to the Collaboration Agreement with Novartis. As of September 30, 2017, we had an accumulated deficit of $163.7 million. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the development and potential commercialization of emricasan.

Prior2023 to our IPO in July 2013, we funded our operations primarily through private placements of equity and convertible debt securities. In July 2013, we completed our IPO of 6,000,000 shares of common stock at an offering price of $11.00 per share. We received net proceeds of $58.6 million, after deducting underwriting discounts and commissions and offering-related transaction costs.


In August 2014, we entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with MLV & Co. LLC, orMLV, pursuant to which we could sell from time to time, at our option, up to an aggregate of $50.0 million of shares of our common stock through MLV, as sales agent. We terminated the Sales Agreement in December 2016. We sold 6,305,526 shares of our common stock pursuant to the Sales Agreement at a weighted average price per share of $2.35 and received net proceeds of $14.2 million, after deducting offering-related transaction costs and commissions.

In April 2015, we completed a public offering of 4,025,000 shares of our common stock at a public offering price of $5.75 per share. We received net proceeds of $21.4 million, after deducting underwriting discounts and commissions and offering-related transaction costs. In May 2017, we completed a public offering of 5,980,000 shares of our common stock at a public offering price of $5.50 per share. We received net proceeds of $30.6 million, after deducting underwriting discounts and commissions and offering-related transaction costs. Immediately following the offering, we used $11.2 million of the net proceeds to repurchase and retire 2,166,836 shares of our common stock from Advent at a price of $5.17 per share, which is equal to the net proceeds per share we received from the offering, before expenses, pursuant to a stock purchase agreement we entered into with Advent in May 2017.

In December 2016, we entered into the Collaboration Agreement with Novartis pursuant to which we granted Novartis an exclusive option to collaborate with us for the global development and commercialization of emricasan. Under the Collaboration Agreement, Novartis paid us an upfront payment of $50.0 million. In May 2017, Novartis exercised its option, and we received a $7.0 million option exercise payment in July 2017. Concurrent with the entry into the Collaboration Agreement, we entered into an Investment Agreement with Novartis whereby we agreed to sell and Novartis agreed to purchase, convertible promissory notes, in one or two closings, for an aggregate principal amount of up to $15.0 million. In February 2017, we issued to Novartis a convertible promissory note, or the Novartis Note, in the principal amount of $15.0 million. The maturity date of the Novartis Note is December 31, 2019. The Novartis Note bears interest on the unpaid principal balance at a rate of 6% per annum. We may prepay or convert the Novartis Note into shares of our common stock, at our option, until December 31, 2019. Novartis may convert the Novartis Note into shares of our common stock upon a change of control of our company or termination of the Collaboration Agreement by Novartis pursuant to certain provisions. If converted, the principal and accrued interest under the Novartis Note will convert into shares of our common stock at a conversion price equal to 120% of the 20-day trailing average closing price per share of the common stock immediately prior to the conversion date. Upon the occurrence of certain events of default, the Novartis Note requires us to repay the principal balance and any unpaid accrued interest.

At September 30, 2017, we had cash, cash equivalents and marketable securities of $85.2 million. We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next 12 months from the date of the filing of this Form 10-Q. To fund further operations, we will need to raise additional capital. We plan to continue to fund losses from operations and capital funding needs through future equity and debt financing, as well as potential collaborations. The sale of additional equity or convertible debt could result in additional dilution to our stockholders. The incurrence of indebtedness would result in debt service obligations and could result in operating and financing covenants that would restrict our operations. No assurances can be provided that financing will be available in the amounts we need or on terms acceptable to us, if at all. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm our business, results of operations and future prospects.

The following table sets forth a summary of the net cash flow activity for each of the periods set forth below:

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Net cash used in operating activities

 

$

(22,803,297

)

 

$

(17,158,408

)

Net cash (used in) provided by investing activities

 

 

(51,919,899

)

 

 

5,781,411

 

Net cash provided by financing activities

 

 

31,000,239

 

 

 

11,814,524

 

Net (decrease) increase in cash and cash equivalents

 

$

(43,722,957

)

 

$

437,527

 

Net cash used in operating activities was $22.8 million and $17.2 million for the nine months ended September 30, 2017 and 2016, respectively. The primary use of cash was to fund our operations related to the development of emricasan.

Net cash used in investing activities was $51.9 million for the nine months ended September 30, 2017, which consisted primarily of cash used to purchase marketable securities, partially offset by proceeds from maturities of marketable securities. Net cash provided by investing activities was $5.8 million for the nine months ended September 30, 2016, which consisted primarily of proceeds from maturities of marketable securities, partially offset by cash used to purchase marketable securities.


Net cash provided by financing activities was $31.0 million for the nine months ended September 30, 2017, which consisted primarily of net proceeds from our public offering in May 2017 and proceeds from the issuance of the $15.0 million Novartis Note in February 2017, partially offset by the repurchase of shares from Advent in May 2017 and voluntary prepayment of the $1.0 million promissory note payable to Pfizer Inc. in January 2017. Net cash provided by financing activities was $11.8 million for the nine months ended September 30, 2016, which consisted primarily of net proceeds from sales of common stock pursuant to the Sales Agreement.

Contractual Obligations and Commitments

As of September 30, 2017, there have been no material changes outside the ordinary course of our business to the contractual obligations we reporteddisclosed in “Item 7 – Management’sour “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments”Operations” included in our annual reportthe 2022 Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 16, 2017.10-K.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements (as defined by applicable regulations of the SEC) that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.36


ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

We are a smaller reporting company as defined by Rule 12b-2 of September 30, 2017, there have been no material changes in our market risk from that described in “Item 7A. Quantitativethe Exchange Act and Qualitative Disclosures About Market Risk” in our annual report on Form 10-K forare not required to provide the year ended December 31, 2016 filed with the Securities and Exchange Commission on March 16, 2017.information required under this item.

ITEM 4.

CONTROLS AND PROCEDURES

Conclusion Regarding the EffectivenessITEM 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

OurWe maintain disclosure controls and procedures designed to provide reasonable assurance of achieving the objective that information in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified and pursuant to the requirements of the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by SEC Rule 13a-15(b), we carried out an evaluation, with the participation of our principal executive officerManagement, including our Chief Executive Officer and principal financial officer, has evaluatedChief Financial Officer, of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as ofSeptember 30, 2023, the end of the period covered by this quarterly report on Form 10-Q.report. Based on such evaluation,upon the foregoing, our principal executive officerChief Executive Officer and principal financial officer haveChief Financial Officer concluded that as of such date, our disclosure controls and procedures were effective.effective at a reasonable assurance level as of September 30, 2023.

Inherent Limitations of Disclosure Controls and Procedures andChanges in Internal Control Overover Financial Reporting

Our management, including our principal executive officer and our principal financial officer, does not expect that our disclosure controls and procedures orThere were no changes in our internal control over financial reporting will prevent all error and all fraud. Aduring our last fiscal quarter that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Management recognizes that a control system, no matter how well conceiveddesigned and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-makingdecision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.controls. 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. Overconditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Changes in Internal Control Over Financial Reporting37


There has been no change in our internal control over financial reporting during the quarter ended September 30, 2017, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


PART II.II — OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

Employee Litigation

On or about February 17, 2022, two former employees, each of whom separately resigned and terminated their employment with Histogen, filed a complaint in the Superior Court of California, County of San Diego against us, our Board, our former Chief Executive Officer, as well as three individuals, two of which are currently employed by the Company. Although the complaint lists the “Histogen Board, a business entity form unknown” as a defendant, the complaint does not specifically list the names of the board members. The plaintiffs allege whistleblower status, retaliation, discrimination, unfair business practices, wrongful termination, violation of civil rights, and other California state law claims. We have tendered the complaint to our liability insurer and engaged outside litigation counsel, as approved by our carrier, to defend Histogen, the Board and the individuals in this matter. We object to the naming of each of the defendants in this matter and deny each of the plaintiffs’ claims. The plaintiffs agreed to pre-arbitration mediation, which was conducted on May 4, 2022, as was required by the arbitration agreement executed by each of the plaintiffs. Considering that the parties did not resolve the matter through this mediation, the Company petitioned the San Diego Superior Court for an order that the matter be submitted to arbitration consistent with each of the plaintiff’s arbitration agreements. The hearing for the motion to compel arbitration was held on August 12, 2022 and the San Diego Superior Court issued a partyruling to uphold the binding arbitration agreements signed by both plaintiffs. On July 10, 2023, plaintiff’s counsel filed a formal demand for arbitration for one of the plaintiffs. On August 3, 2023, a joint stipulation was filed dismissing the former Chief Executive Officer, as well as the three individuals, two of which are currently employed by the Company. The plaintiffs requested and the Company agreed to an additional pre-arbitration mediation, which was conducted on September 25, 2023. The Company and one of the plaintiffs reached a settlement agreement covered by the Company’s liability insurance, however, the matter remains unresolved between the Company and the second plaintiff. The matter is expected to now proceed to arbitration but is the responsibility of the remaining plaintiff to follow through with the initiation of the arbitration proceeding. We believe that our defense costs, settlement monies, damages or any material legal proceedings.other awards would be covered by our liability insurance; provided, however, insurance may not cover all claims or could exceed our insurance coverage. We believe that there are substantial defenses to this lawsuit, and we intend to vigorously defend against each of these claims. While this litigation matter is in the early stages for the remaining plaintiff, we believe the action is without merit. Nonetheless, the ultimate outcome is unknown at this time.

ITEM 1A.

RISK FACTORS

There have been no material changes toItem 1A. Risk Factors

Summary of Risk Factors

We are providing the following summary of the risk factors includedcontained in “Item 1A. Risk Factors” in our annual reportthis Quarterly Report on Form 10-K for10-Q to enhance the year ended December 31, 2016 filedreadability and accessibility of our risk factor disclosures. This summary does not address all of the risks that we face. We encourage you to carefully review the full risk factors contained in this Quarterly Report on Form 10-Q and our other filings with the SecuritiesSEC, in their entirety.

Risks Related to the Dissolution

the availability, timing and Exchange Commission on March 16, 2017, other than the risk factors below.

We may not be able to obtain orphan drug exclusivity for emricasan or IDN-7314 for any indication.

In the United States, under the Orphan Drug Act, the U.S. Food and Drug Administration, or the FDA, may grant orphan designation to a drug or biological product intended to treat a rare disease or condition. Such diseases and conditions are those that affect fewer than 200,000 individuals in the United States, or if they affect more than 200,000 individuals in the United States, there is no reasonable expectation that the costamount of developing and making a drug product available in the United States for these types of diseases or conditions will be recovered from sales of the product. Orphan Drug Designation must be requested before submitting an NDA. If the FDA grants Orphan Drug Designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by that agency. Orphan Drug Designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, but it can lead to financial incentives, such as opportunities for grant funding toward clinical trial costs, tax advantages and user-fee waivers.

If a drug that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the drug is entitled to orphan drug marketing exclusivity for a period of seven years. Orphan drug marketing exclusivity generally prevents the FDA from approving another application, including a full NDA, to market the same drug or biological product for the same indication for seven years, except in limited circumstances, including if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care. For purposes of small molecule drugs, the FDA defines “same drug” as a drug that contains the same active chemical entity and is intended for the same use as the drug in question. A designated orphan drug may not receive orphan drug marketing exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Orphan drug marketing exclusivity rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

The criteria for designating an orphan medicinal product in the European Union, or the EU, are similar in principle to those in the United States. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication. The application for orphan designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The ten-year market exclusivity in the EU may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if:

the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;

liquidating distributions;

the applicant consentsamounts that will need to a second orphan medicinal product application; or

be set aside by us;

the applicant cannot supply enough orphan medicinal product.

adequacy of contingency reserves to satisfy our obligations;

We originally applied for Orphan Drug Designation for emricasan for the treatment of fibrosis in HCV-POLT patients in the United States and the EU. In late 2013, the FDA granted an Orphan Drug Designation for emricasan for the treatment of POLT patients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease. In the EU, we withdrew the application based on feedback from the applicable regulatory body that emricasan may have efficacy in fibrosis outside of the HCV-POLT patient population. In June 2017, the FDA granted Orphan Drug Designation for IDN-7314 for the treatment of primary sclerosing cholangitis, or PSC. In October 2017, the European Medicines Agency, or EMA, granted orphan designation to IDN-7314 for the treatment of PSC. We cannot assure you that we will be able to obtain orphan drug exclusivity for emricasan or IDN-7314 in any jurisdiction for the target indications in a timely manner or at all or that a competitor will not obtain orphan drug exclusivity that could block the regulatory approval of emricasan or IDN-7314 for several years. If we are unable to obtain Orphan Drug Designation in the United States or in the EU, we will not receive market exclusivity, which might affect

our ability to generate sufficient revenues.favorably resolve certain potential tax claims, litigation matters and other unresolved contingent liabilities;
the amount of proceeds that might be realized from the sale or other disposition of our assets;
the application of, and any changes in, applicable tax laws, regulations, administrative practices, principles and interpretations;
the incurrence by us of expenses relating to the Dissolution; and
the ability of our Board to abandon, modify or delay implementation of the Plan of Dissolution, even after stockholder approval.

RISK FACTORS

Investing in our securities involves a high degree of risk. You should carefully consider the following risks factors, together with all of the other information included or incorporated by reference in this Quarterly Report on Form 10-Q, including our condensed

38


consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The risks described below are material risks currently known, expected or reasonably foreseeable by us. However, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects, or financial condition. If a competitor is able to obtain orphan exclusivity that would block emricasan’s or IDN-7314’s regulatory approval, our ability to generate revenues could be significantly reduced, which could harmany of these risks actually materialize, our business, prospects, financial condition, and results of operations.operations could be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment.

Risks Related to the Dissolution

We cannot assure you as to the amount of distributions, if any, to be made to our stockholders.

If our stockholders approve the Dissolution, we estimate that we will have between approximately $1.29 to $1.76 million of cash that we will be able to distribute to our stockholders in connection with the Dissolution, which implies a per share distribution of between $0.30 and $0.41 based on 4,271,759 assumed shares outstanding as of October 16, 2023. This amount may be unablepaid in one or more distributions. We cannot predict the timing or amount of any such distributions, as uncertainties exist as to maintainthe value we may receive upon the sale of all or effectively utilize orphan drug exclusivitysubstantially all of our assets, the net value of any remaining assets after such sales are completed, the ultimate amount of our liabilities, the operating costs and amounts to be set aside for emricasanclaims, obligations and provisions during the liquidation and winding-up process, and the related timing to complete such transactions. These and other factors make it impossible to predict with certainty the actual net cash amount that will ultimately be available for distribution to stockholders or IDN-7314 forthe timing of any indication.such distributions. In addition, as discussed below under the heading “Risks Related to the Dissolution—The amount of cash available to distribute to our stockholders depends on our ability to dispose of certain of our non-cash assets,” there are many factors impacting our ability to successfully execute the sale or disposition of certain of our non-cash assets. As a result of these and other risks and uncertainties, we have provided a wide range of cash that we estimate may be available to distribute to our stockholders in connection with the Plan of Dissolution.

We received Orphan Drug DesignationWithout limiting its flexibility, our Board may, at its option, rely on the “safe harbor” procedures under Sections 280 and 281(a) of the DGCL to, among other things, obtain an order from the FDADelaware Court of Chancery establishing the amount and form of security for emricasancontested known, contingent and potential future claims that are likely to arise or become known within five years filing of the Certificate of Dissolution (or such longer period of time as the Delaware Court of Chancery may determine not to exceed ten years) (the “Court Order”), and pay or make reasonable provision for the treatment of POLT patients with reestablished fibrosis to delay the progression to cirrhosisour uncontested known claims and end-stage liver disease.  We also received Orphan Drug Designation from the FDAexpenses and orphan designation from the EMAestablish reserves for IDN-7314 for the treatment of PSC. We may be unable to obtain regulatory approval for emricasan or IDN-7314 for these orphan populations or any other orphan population, or we may be unable to successfully commercialize emricasan or IDN-7314 for such orphan populations due to risks that include:

the orphan patient populations may change in size;

there may be changes in the treatment options for patients that may provide alternative treatments to emricasan or IDN-7314;

the development costs may be greater than projected revenue of drug sales for the orphan indications;

the FDA may disagree with the design or implementation of our clinical trials;

there may be difficulties in enrolling patients for clinical trials;

emricasan or IDN-7314 may not prove to be efficacious in the orphan patient populations;

clinical trial results may not meet the level of statistical significanceclaims as required by the FDA orCourt Order and the EMA;DGCL. Should we obtain such a Court Order, we expect to distribute all of our remaining assets in excess of the amount to be used by us to pay claims and

emricasan or IDN-7314 fund the reserves required by the Court Order and pay our operating expenses through the completion of the dissolution and winding-up process to our stockholders. The Court Order, if we chose to obtain one, would reflect the Delaware Court of Chancery’s own determination as to the amount and form of security reasonably likely to be sufficient to provide compensation for all known, contingent and potential future claims against us. There can be no assurances that the Delaware Court of Chancery would not require us to withhold additional amounts in excess of the amounts that we believe are sufficient to satisfy our potential claims and liabilities. Accordingly, stockholders may not receive any distributions of our remaining assets for a substantial period of time.

In addition, there are numerous factors that could impact the amount of the reserves to be determined by any such Court Order, and consequently the amount of cash initially available for distribution, if any, to our stockholders following the effective time of the Dissolution, including without limitation:

whether any potential liabilities are resolved prior to the filing of the Certificate of Dissolution;
whether any claim is resolved or barred pursuant to Section 280 of the DGCL;
unanticipated costs relating to the defense, satisfaction or settlement of existing or future lawsuits or other claims threatened against us;
whether unforeseen claims are asserted against us, in which case we would have a favorable risk/benefit assessmentto defend or resolve such claims and/or be required to establish additional reserves to provide for such claims; and
whether any of the expenses incurred in the orphan indication.

winding-up process, including expenses of required personnel and other operating expenses (including legal, accounting and other professional fees) necessary to dissolve and liquidate the Company, are more or less than our estimates.

Further, the amount of any distributable proceeds and our ability to make distributions to our stockholders depends on our ability to sell or otherwise dispose of our remaining non-cash assets in order to attain the highest value for such non-cash assets and maximize value for our stockholders and creditors, which is subject to significant risks and uncertainties.

39


In addition, as we wind down, we will continue to incur expenses from operations, such as operating costs, salaries, rental payments, directors’ and officers’ insurance, payroll and local taxes; and other legal, accounting and financial advisory fees, which will reduce any amounts available for distribution to our stockholders.

As a result of these and other factors, we cannot assure you as to any amounts to be distributed to our stockholders if our Board proceeds with the Dissolution. If our stockholders do not approve the Plan of Dissolution, no liquidating distributions will be made.

Liquidating distributions to stockholders could be substantially reduced and/or delayed due to uncertainty regarding the resolution of certain potential tax claims, litigation matters and other unresolved contingent liabilities of the Company.

Without limiting its flexibility, our Board may, at its option, rely on the “safe harbor” procedures under Sections 280 and 281(a) of the DGCL to, among other things, obtain the Court Order establishing the amount and form of security for pending claims for which the Company is a party, contingent or unmatured contract claims for which the holder declined the Company’s offer of a security, and unknown claims that, based on facts known to the Company, are likely to arise or become known within five years filing of the Certificate of Dissolution (or such longer period of time, not to exceed ten years, as the Delaware Court of Chancery may determine), and pay or make reasonable provision for our uncontested known claims and expenses and establish reserves for other claims as required by the Court Order and the DGCL.

Whether any remaining assets or cash of the Company can be used to make liquidating distributions to stockholders would depend on whether claims for which we have set aside reserves are resolved or satisfied at amounts less than such reserves and whether a need has arisen to establish additional reserves. We cannot assure stockholders that our liabilities can be resolved for less than the amounts we have reserved, or that unknown liabilities that have not been accounted for will not arise. As a result, we may continue to hold back funds and delay additional liquidating distributions to stockholders. It is important for us to retain sufficient funds to pay the expenses and liabilities actually owed to our creditors, because under the DGCL, if the we fail to do so, each stockholder could be held liable for the repayment to creditors, out of the amounts previously distributed to such stockholder in the Dissolution from us or from any liquidating trust or trusts, of such stockholder’s pro rata share of such excess (up to the full amount actually received by such stockholder in Dissolution).

We cannot predict the timing of the distributions to stockholders.

Following the sale or other disposition of our remaining non-cash assets, or such earlier time as our Board determines in its sole discretion, we will file the Certificate of Dissolution as soon as practicable and in accordance with the DGCL.

We are currently targeting a filing of the Certificate of Dissolution as soon as practical following the approval of the Plan of Dissolution, if approved by our stockholders. Ultimately, the decision of whether or not to proceed with the Dissolution will be made by our Board in its sole discretion. If our stockholders approve the Plan of Dissolution, our Board has not set a deadline to make its decision to proceed with the effectiveness of the Dissolution. No further stockholder approval would be required to effect the Dissolution. However, if our Board determines that the Dissolution is not in the best interests of the Company and our stockholders, our Board may, in its sole discretion, abandon the Dissolution or may amend or modify the Plan of Dissolution to the extent permitted by Delaware law without the necessity of further stockholder approval. After the Certificate of Dissolution has been filed, revocation of the Dissolution would require stockholder approval under Delaware law.

Our Board will determine, in its sole discretion and in its own timing, the timing of any distributions to our stockholders in the Dissolution. We can provide no assurance as to if or when any such distribution will be made, and we cannot provide any assurance as to the amount to be paid to stockholder in any such distribution, if one is made. The Board intends to seek to distribute funds to our stockholders as quickly as possible, as permitted by the DGCL, and will take all reasonable actions to optimize the distributable value to our stockholders.

Under the DGCL, before a dissolved corporation may make any distribution to its stockholders, it must pay or make reasonable provision to pay all of its claims and obligations, including all contingent, conditional or unmatured contractual claims known to the corporation. The precise amount and timing of any distributions to our stockholders will depend on and could be delayed or diminished due to many factors, including without limitation:

whether a claim is resolved for more than the amount of reserve established for such claim pursuant to any Court Order;
whether we are unable to obtain regulatory approvalresolve claims with creditors or other third parties, or if such resolutions take longer than expected;
whether a creditor or other third party seeks an injunction against the making of additional distributions to stockholders on the basis that the amounts to be distributed are needed to satisfy our liabilities or other obligations to the extent not previously reserved for;

40


whether due to new facts and developments, a new claim, as our Board reasonably determines, requires additional funds to be reserved for emricasan or IDN-7314 for any orphan population orits satisfaction; and
whether the expenses we incur in the winding-up process, including expenses of personnel required and other operating expenses (including legal, accounting and other professional fees), necessary to dissolve and liquidate the Company are more than anticipated.

As a result of these and other factors, it might take significant time to resolve these matters, and as a result we are unable to successfully commercialize emricasanpredict the timing of distributions, if any are made, to our stockholders.

The Dissolution pursuant to the Plan of Dissolution may be disrupted and adversely impacted by the effects of natural disasters, political crises, public health crises, and other events outside of our control.

Natural disasters, such as adverse weather, fires, earthquakes, power shortages and outages, political crises, such as terrorism, war, political instability, or IDN-7314 forother conflict, criminal activities, public health crises, such orphan population, itas disease epidemics and pandemics, and other disruptions or events outside of our control could harmnegatively affect our business prospects, financial condition and resultsoperations. Any of operations.these events may cause a delay in our targeted timing to file the Certificate of Dissolution with the Delaware Secretary of State.

We entered intoThe amount of cash available to distribute to our stockholders depends on our ability to dispose of certain of our non-cash assets.

Our efforts to enhance stockholder value through the Collaboration Agreement with Novartis, and we may formsale or seek additional strategic alliances or collaborations in the future. Such alliances and collaborations may inhibit future opportunities, and weother disposition of our remaining non-cash assets may not realizebe successful, which would significantly reduce, or eliminate, the benefitscash or value of other non-cash assets available for distribution to our stockholders. We cannot assure you that our efforts to enhance stockholder value will succeed. There will be risks associated with any potential transactions, including whether offers for our remaining non-cash assets will be at valuations that we deem reasonable. Moreover, we are not able to predict how long it will take to consummate the sale or other disposition of our remaining non-cash assets, the delay of which may impact the timing of the Dissolution. We intend for any sale or other disposition of assets to occur prior to stockholder approval of the Plan of Dissolution. However, the timing and terms of such collaborationsa sale or alliances.

We entered into the Collaboration Agreement with Novartis for the developmentother disposition will depend on a variety of emricasan,factors, many of which are beyond our control. A delay in, or failure to complete, any such transaction could have an effect on our stock price and we may form or seek strategic alliances, joint ventures or collaborations or enter into licensing arrangements with other third parties that we believe will complement or augment our development and commercialization efforts with respect to future product candidates that we may develop. In connection with entering into the Collaboration Agreement, we incurred non-recurring and other charges and issued a convertible note in the amount of $15.0 million. any potential distributions to our stockholders.

In addition, for the period from the execution date of the Collaboration Agreement until the earlier of five years after the first commercialour ability to successfully complete such a sale of an emricasan productor other disposition could be negatively affected by adverse macroeconomic and geopolitical developments, both in the United States and elsewhere around the world. We are exploring and evaluating potential transactions, the success or major Europeantiming of which may be impacted by a general economic slowdown or recession. In order to successfully monetize our assets, we must identify and complete one or more transactions with third parties. Even if we are able to identify potential transactions in furtherance of the sale or other disposition of our remaining non-cash assets, such buyers may be operationally constrained or unable to locate financing on attractive terms or at all, which risk may be heightened due to the uncertainty of a potential general economic slowdown or recession. Additionally, if financing is unavailable to potential buyers of our assets, or if potential buyers are unwilling to engage in various transactions due to the uncertainty in the market or ten yearsrising interest rates, our ability to complete such acquisition would be significantly impaired.

Any negative impact on such third parties due to any of the foregoing events could cause costly delays and have a material adverse effect on our ability to return value to our stockholders, including our ability to realize full value from a sale or other disposition of certain of our non-cash assets as part of our monetization strategy. Any such negative impacts could also reduce the amount of cash or other property we are able to distribute to our stockholders.

Our Board may determine not to proceed with the Dissolution.

Even if the Plan of Dissolution is approved by our stockholders, our Board may determine, in the exercise of its fiduciary duties, not to proceed with the Dissolution. If our Board elects to pursue any alternative to the Plan of Dissolution, our stockholders may not receive any of the funds that might otherwise be available for distribution to our stockholders. Additionally, as discussed above under the heading “We cannot predict the timing of the distributions to stockholders”, the decision of whether or not to proceed with the Dissolution will be made by our Board in its sole discretion and our Board has not set a deadline to make its decision to proceed with or abandon the Dissolution after stockholder approval. After the Certificate of Dissolution has been filed, revocation of the Dissolution would require stockholder approval under Delaware law.

41


Our stockholders may be liable to our creditors for part or all of the amount received from us in our liquidating distributions if reserves are inadequate.

If the Dissolution becomes effective, we may establish a contingency reserve designed to satisfy any additional claims and obligations that may arise, including any claims from holders of the Company’s Common Stock, options to purchase Common Stock and/or warrants to purchase Common Stock or preferred stock of the Company. Any contingency reserve may not be adequate to cover all of our claims and obligations. Under the DGCL, if we fail to create an adequate contingency reserve for payment of our expenses, claims and obligations, each stockholder could be held liable for payment to our creditors for claims brought during the three-year period after we file the Certificate of Dissolution with the Delaware Secretary of State, up to the lesser of (i) such stockholder’s pro rata share of amounts owed to creditors in excess of the contingency reserve and (ii) the amounts previously received by such stockholder in dissolution from us and from any liquidating trust or trusts. Accordingly, in such event, a stockholder could be required to return part or all of the distributions previously made to such stockholder pursuant to the Dissolution, and a stockholder could receive nothing from us under the Plan of Dissolution. Moreover, if a stockholder has paid taxes on amounts previously received, a repayment of all or a portion of such amounts received could result in a situation in which such repayment does not result in a commensurate refund of such taxes paid.

Our directors and officers will continue to receive benefits from the executionCompany following the Dissolution.

Following the effective date of the Collaboration Agreement,Dissolution, we have agreed notwill continue to developindemnify each of our current and former directors and officers to the extent permitted under the DGCL and our certificate of incorporation, amended and restated bylaws and agreements as in any pivotal registration clinical trials or commercialize any pan-caspase inhibitors in liver disease.  Further, Novartis will have a righteffect at the time of first negotiation prior to any offer by us to any third party for future pan-caspase inhibitors that we may develop or acquire for the treatmentfiling of liver diseases or for certain retained pan-caspase inhibitors, provided that any license or collaboration that we enter into or propose to enter into must be on terms and conditions in the aggregate no more favorable to such third party than those last offered to Novartis. These provisions and similar provisions in agreements we may enter into in the future may inhibit our ability to develop and commercialize other pan-caspase inhibitors, including IDN-7314, or enter into future alliances or collaborations to develop or commercialize other pan-caspase inhibitors, including IDN-7314.


Future efforts for additional alliances or collaborations may also require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.Certificate of Dissolution. In addition, we face significant competitionintend to maintain directors’ and officers’ insurance coverage throughout the wind down period.

We will continue to incur the expenses of complying with public company reporting requirements.

We have an obligation to continue to comply with the applicable reporting requirements of the Exchange Act, even though compliance with such reporting requirements is economically burdensome. In order to curtail expenses, we currently intend, after the filing of the Certificate of Dissolution, to seek relief from the SEC from the reporting requirements under the Exchange Act.

However, the SEC may not grant any such relief, in which case we would be required to continue to bear the expense of being a public reporting company.

If stockholders vote against the Dissolution pursuant to the Plan and Dissolution, we may pursue other alternatives, but there can be no assurance that any of these alternatives would result in greater stockholder value than the proposed Dissolution, and any alternative we select may entail additional risks.

In July 2023, we announced that, in light of our financial condition and review of its business, including the status of programs, resources and capabilities, our Board had approved a plan to review strategic alternatives, including a sale or merger of the Company or one or more sales of our assets, and to significantly and immediately reduce our operations. After an extensive review of strategic alternatives, we have been unable to identify any meaningful financial alternatives, a merger partner or purchaser of our Company or substantially all of our assets. In September 2023, after extensive consideration of potential strategic alternatives, our Board approved and adopted the Plan of Dissolution that would include the distribution of remaining cash to stockholders following an orderly wind down of the company’s operations, including any proceeds from the potential sale of any pipeline assets. In order to reduce costs and in connection with the Plan of Dissolution, we discontinued all clinical development programs and reduced our workforce, including the termination of all employees except for two employees at the end of September.

If our stockholders do not approve the Plan of Dissolution, the Board will continue its corporate existence and continue to explore what, if any, alternatives are available for the future of the Company in light of its discontinued business activities; however, those alternatives are likely limited to seeking appropriate strategic partners,voluntary dissolution at a later time with potentially diminished assets, seeking bankruptcy protection (should our net assets decline to levels that would require such action) or investing our cash in another operating business.

There can be no assurance that any of these alternatives would result in greater stockholder value than the proposed Dissolution pursuant to the Plan of Dissolution. Moreover, any alternative we select may entail additional risks.

Our stockholders will not be able to buy or sell shares of our common stock after we close our stock transfer books on the Final Record Date.

If the Board determines to proceed with the Dissolution, we intend to close our stock transfer books and discontinue recording transfers of our common stock at the negotiationeffective time of the Dissolution as set forth in the Certificate of Dissolution. After we close our stock transfer books, we will not record any further transfers of our common stock on our books except by will, intestate succession or

42


operation of law. Therefore, shares of our common stock will not be freely transferable after the Final Record Date. As a result of the closing of the stock transfer books, all liquidating distributions from a liquidating trust, if any, or from us after the Final Record Date will be made pro rata to the same stockholders of record as the stockholders of record as of the Final Record Date.

We plan to initiate steps to exit from certain reporting requirements under the Exchange Act, which may substantially reduce publicly available information about us. If the exit process is time-consumingprotracted, we will continue to bear the expense of being a public reporting company despite having no source of revenue.

Our common stock is currently registered under the Exchange Act, which requires that we, and complex. Furthermore,our officers and directors with respect to Section 16 of the Exchange Act, comply with certain public reporting and proxy statement requirements thereunder. Compliance with these requirements is costly and time-consuming. We plan to initiate steps to exit from such reporting requirements in order to curtail expenses; however, such process may be protracted and we may be required to continue to file Current Reports on Form 8-K or other reports to disclose material events, including those related to the Dissolution. Accordingly, we will continue to incur expenses that will reduce the amount available for distribution, including expenses of complying with public company reporting requirements and paying its service providers, among others. If our reporting obligations cease, publicly available information about us will be substantially reduced.

Stockholders may not be able to realizerecognize a loss for U.S. federal income tax purposes until they receive a final distribution from us.

Distributions made pursuant to the Plan of Dissolution are intended to be treated as received by a stockholder in exchange for the stockholder’s shares of our common stock. Accordingly, the amount of any such distribution allocable to a block of shares of our common stock owned by a U.S. stockholder will reduce the stockholder’s tax basis in such shares, but not below zero. Any excess amount allocable to such shares will be taxable as capital gain. Such gain generally will be taxable as long-term capital gain if the shares have been held for more than one year. Any tax basis remaining in a share of our common stock following the final liquidating distribution by the Company will be treated as a capital loss. The deductibility of capital losses is subject to limitations. For a more detailed discussion, see “Certain Material U.S. Federal Income Tax Consequences” beginning on page 31 of this Proxy Statement. You should consult your tax advisor as to the particular tax consequences of the Dissolution to you, including the applicability of any U.S. federal, state, local and non-U.S. tax laws.

The tax treatment of any liquidating distribution may vary from stockholder to stockholder, and the discussions in this proxy statement regarding tax consequences are general in nature.

We have not requested a ruling from the IRS with respect to the anticipated tax consequences of the Dissolution, and we will not seek an opinion of counsel with respect to the anticipated tax consequences of any liquidating distributions. If any of the anticipated tax consequences described in this proxy statement prove to be incorrect, the result could be increased taxation at the corporate or stockholder level, thus reducing the benefit to our stockholders and us from the Dissolution. Tax considerations applicable to particular stockholders may vary with and be contingent on the stockholder’s individual circumstances. You should consult your own tax advisor for tax advice instead of such transactions ifrelying on the discussions of tax consequences in this proxy statement.

Further stockholder approval will not be required in connection with the implementation of the Plan of Dissolution, including the sale or disposition of all or substantially all of our assets following the effective time of the Dissolution pursuant to the Plan of Dissolution.

The approval of the Plan of Dissolution by the requisite vote of the stockholders will grant full and complete authority to our Board and officers, without further stockholder action, to proceed with the Dissolution pursuant to Plan of Dissolution in accordance with any applicable provision of Delaware law. Following the effective time of the Dissolution, we may sell, distribute or otherwise dispose of our remaining non-cash assets without further stockholder approval. As a result, stockholders will no longer have the opportunity to approve or reject a sale of all or substantially all of our assets after the Certificate of Dissolution has been filed and the Plan of Dissolution provides for ratification of any prior sales and disposition of our assets. Also, after the effective time, the Board may, in order to maximize value for our stockholders and creditors, authorize actions in implementing the Plan of Dissolution, including the specific terms and prices for the sales and dispositions of its remaining assets, with which stockholders may not agree. Although we are unable to successfully integrate them withcurrently targeting, if approved by our existing operations and company culture. stockholders, a filing of the Certificate of Dissolution as soon as practical following any approval by our stockholders of the Plan of Dissolution as discussed above under the heading “—We cannot predict the timing of the distributions to

43


stockholders”, ultimately, the decision of when and whether or not to proceed with the Dissolution will be certainmade by the Board in its sole discretion.

We can abandon or revoke the Dissolution and this may cause prior distributions made in liquidation to be treated as dividends.

By approving the Plan of Dissolution, stockholders will also be granting our Board the authority, notwithstanding stockholder approval of the Plan of Dissolution, to abandon the Dissolution prior to the filing of the Certificate of Dissolution without further stockholder action, if our Board determines that followingthe Dissolution is not in the best interests of us and our stockholders.

After the filing of the Certificate of Dissolution, our Board may revoke the Dissolution if holders of a strategic transactionmajority of the voting power of our common stock entitled to vote on the Plan of Dissolution approve a resolution adopted by our Board recommending such revocation. If the Plan of Dissolution is abandoned or license, we will achieverevoked, then all prior distributions made in liquidation to stockholders may be treated as dividends to the revenues or specific net income that justifies such transaction.extent of our current and accumulated earnings and profits. See “Certain Material U.S. Federal Income Tax Consequences” of our Proxy Statement filed October 18, 2023.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Item 2. Unregistered Sales of Equity Securities

None.

and Use of ProceedsProceeds.

None.Unregistered Sales of Equity Securities

None.

Issuer Purchases of Equity Securities

None.

Use of Proceeds

Not applicable.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None.Item 3. Defaults Upon Senior Securities.

None.

ITEM 4.

MINE SAFETY DISCLOSURES

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

During the quarterly period ended September 30, 2023, no director or officer adopted or terminated any Rule 10b5-1 trading arrangement, and/or any non-Rule 10b5-1 trading arrangement (as such terms are defined pursuant to Item 408(a) of Regulation S-K).

44


Item 6. Exhibits.

EXHIBIT INDEX

ITEM 5.Exhibit Number

OTHER INFORMATION

None.

ITEM 6.

EXHIBITS

A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this quarterly report on Form 10-Q and is incorporated herein by reference.


EXHIBIT INDEX

Exhibit

Number 

Description of Exhibit

    2.1

Plan of Dissolution of Registrant (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K with the Securities and exchange Commission on September 18, 2023).

    3.1(1)    3.1

Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2013).

    3.2

Certificate of Amendment (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 27, 2020).

    3.2(1)    3.3

Certificate of Amendment (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 27, 2020).

    3.4

Certificate of Amendment, filed June 1, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 2, 2022).

    3.5

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 27, 2020).

    3.6

Bylaw Amendment (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2022).

    4.1(2)    3.7

Certificate of Designation of Preferences, Rights and Limitations of Series A Redeemable Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2022).

    3.8

Certificate of Designation of Preferences, Rights and Limitations of Series B Redeemable Convertible Preferred Stock (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2022).

    3.9

Certificate of Elimination relating to the Certificate of Designations of Preferences, Rights and Limitations of Series A Redeemable Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 30, 2022).

    3.10

Certificate of Elimination relating to the Certificate of Designations of Preferences, Rights and Limitations of Series B Redeemable Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 30, 2022).

    4.1

Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form10-Q filed with the Securities and Exchange Commission on August 13, 2020).

    4.2

    4.2(3)

First AmendedForm of Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-4 (Registration No. 333-236332) filed with the Securities and Restated Investor Rights Agreement, datedExchange Commission on February 9, 20117, 2020).

    4.3

    4.3(3)

Form of Warrant issued(incorporated by reference to investors inExhibit 4.1 to the Registrant’s 2013 bridge financingCompany’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 12, 2020.)

    4.4

    4.4(2)

Form of Warrant issuedplacement agent’s warrant (incorporated by reference to lenders underExhibit 4.2 to the LoanCompany’s Current Report on Form 8-K filed with the Securities and Security Agreement, dated July 3, 2013, by and among the Registrant, Oxford Finance LLC, Silicon Valley Bank and the other lenders party theretoExchange Commission on November 12, 2020.)

    4.5

  10.1(4)

Employment Agreement, dated August 31, 2017,Form of Common Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1/A (File No. 333-251491) filed with the Securities and between Keith W. Marshall, Ph.D. and the RegistrantExchange Commission on December 29, 2020).

    4.6

  10.2(4)

Non-Qualified Inducement Stock Option Grant NoticeForm of Placement Agent Warrant (incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-1/A (File No. 333-251491) filed with the Securities and Stock Option Agreement, dated August 31, 2017, by and between Keith W. Marshall, Ph.D. and the RegistrantExchange Commission on December 29, 2020).

    4.7

  23.1

ConsentForm of Ernst & Young LLP, Independent Registered Public Accounting FirmPre-Funded Warrant (incorporated by reference to Exhibit 4.7 to the Company’s Registration Statement on Form S-1/A (File No. 333-251491) filed with the Securities and Exchange Commission on December 29, 2020).

    4.8

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on June 8, 2021).

  31.1    4.9

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 8, 2021).

45


    4.10

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 16, 2021).

    4.11

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 16, 2021).

    4.12

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2022).

    4.13

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2022).

    4.14

Form of Series A Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2022).

    4.15

Form of Series B Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2022).

    4.16

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 12, 2022).

   10.1+

Amended and Restated 2020 Incentive Award Plan, effective June 20, 2023 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2023).

   10.2

Lease Termination Agreement, dated August 7, 2023, between the Company and San Diego Sycamore, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2023).

   10.3*+^

Notice of Termination and Letter Agreement, dated September 18, 2023 by and between the Company and Steven J. Mento.

   10.4*+

Notice of Termination and Letter Agreement, dated September 18, 2023, by and between the Company and Alfred P. Spada.

   10.5*+^

Notice of Termination and Letter Agreement, dated September 18, 2023, by and between the Company and Joyce Reyes.

   10.6*+^

Amended and Restated Executive Employment Agreement, dated September 18, 2023, by and between the Company and Susan Knudson.

   31.1*

Certification of Principal Executive Officer pursuantPursuant to Rules 13a-1413a-14(a) and 15d-14 promulgated pursuant to15d-14(a) under the Securities Exchange Act of 1934, as amendedAdopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  31.2   32.1*

Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant to the Securities Exchange Act of 1934, as amended

  32.1*

Certification of Principal Executive Officer pursuantPursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 20022002.

  32.2*101.INS

Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Inline XBRL Instance Document.

101.INS101.SCH

XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema DocumentDocument.

101.CAL

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase DocumentDocument.

101.DEF

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase DocumentDocument.

101.LAB

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase DocumentDocument.

101.PRE

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase DocumentDocument.

104

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

(1)

Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed with the SEC on August 1, 2013.

(2)

Incorporated by reference to Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 (Registration No. 333-189305), filed with the SEC on July 8, 2013.

(3)

Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (Registration No. 333- 189305), filed with the SEC on June 14, 2013.

(4)

Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed with the SEC on September 1, 2017.

*

This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is 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.


SIGNATURES

* Filed herewith.

+ Indicates a management contract or compensatory plan, contract or arrangement.

^ Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

46


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.

CONATUS PHARMACEUTICALS INC.Histogen Inc.

Date: November 2, 20179, 2023

By:

/s/ Steven J. Mento, Ph.D. Susan A. Knudson

Steven J. Mento, Ph.D.

Susan A. Knudson

President, and Chief Executive Officer

(principal executive officer)

Date: November 2, 2017

/s/ Keith W. Marshall, Ph.D. 

Keith W. Marshall, Ph.D.

Executive Vice President, Chief Operating Officer, and Chief Financial Officer

(principal financial officer)

(Principal Executive Officer and Principal Financial Officer)

47

27