31

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2022March 31, 2023

OR

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

For the transition period from                     to                     

Commission file number: 000-51173

 

Catalyst Biosciences, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

56-2020050

(State or Other Jurisdiction of

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

 

611 Gateway Blvd., Suite 710120

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

(650) 871-0761

(Registrant’s Telephone Number, Including Area Code)

 

Securities registered or to be 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

 

CBIO

 

NASDAQ

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

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

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

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

Emerging growth company

 

 

 

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

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

As of July 29, 2022,May 8, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 31,477,053.37,759,825.

 

 

 

 


 

CATALYST BIOSCIENCES, INC.

TABLE OF CONTENTS

 

 

 

 

 

Page No.

 

 

 

 

 

PART I. FINANCIAL INFORMATION

 

3

 

 

 

 

 

Item 1.

 

Financial Statements:

 

3

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2022March 31, 2023 (unaudited) and December 31, 20212022

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30,March 31, 2023 and 2022 and 2021 (unaudited)

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss)Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and six months ended June 30,March 31, 2023 and 2022 and 2021 (unaudited)

 

5

 

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ EquityCash Flows for the three and six months ended June 30,March 31, 2023 and 2022 and 2021 (unaudited)

 

6

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021 (unaudited)

7

 

 

 

 

 

 

 

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

 

87

 

 

 

 

 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

17

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

2422

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

2523

 

 

 

 

 

PART II. OTHER INFORMATION

 

2624

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

2624

 

 

 

 

 

Item 1A.

 

Risk Factors

 

2624

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

2624

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

2624

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

2625

 

 

 

 

 

Item 5.

 

Other Information

 

2625

 

 

 

 

 

Item 6.

 

Exhibits

 

2625

 

 

 

 

 

Exhibit Index

 

2726

 

 

 

 

 

Signatures

 

28

 

 

 

 


 

 

PART I. FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

Catalyst Biosciences, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

June 30, 2022

 

 

December 31, 2021

 

 

March 31, 2023

 

 

December 31, 2022

 

 

(Unaudited)

 

 

 

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

75,394

 

 

$

44,347

 

 

$

8,099

 

 

$

21,666

 

Short-term investments

 

 

 

 

 

2,504

 

Accounts and other receivables, net

 

 

5,000

 

 

 

1,818

 

Accounts and other receivables

 

 

5,000

 

 

 

5,000

 

Prepaid and other current assets

 

 

914

 

 

 

2,807

 

 

 

915

 

 

 

1,540

 

Total current assets

 

 

81,308

 

 

 

51,476

 

 

 

14,014

 

 

 

28,206

 

Long-term receivable from GCBP

 

 

4,550

 

 

 

 

Other assets, noncurrent

 

 

168

 

 

 

472

 

 

 

168

 

 

 

168

 

Right-of-use assets

 

 

1,733

 

 

 

2,744

 

 

 

17

 

 

 

66

 

Property and equipment, net

 

 

164

 

 

 

970

 

 

 

1

 

 

 

4

 

Total assets

 

$

83,373

 

 

$

55,662

 

 

$

18,750

 

 

$

28,444

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Liabilities, redeemable convertible preferred stock and stockholders’ deficit

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,037

 

 

$

6,419

 

 

$

16

 

 

$

194

 

Accrued compensation

 

 

911

 

 

 

1,467

 

 

 

1,085

 

 

 

2,582

 

Deferred revenue

 

 

 

 

 

230

 

Other accrued liabilities

 

 

948

 

 

 

4,072

 

 

 

743

 

 

 

1,452

 

Dividends payable

 

 

 

 

 

7,558

 

CVR derivative liability

 

 

5,000

 

 

 

5,000

 

Operating lease liability

 

 

1,415

 

 

 

1,977

 

 

 

 

 

 

38

 

Total current liabilities

 

 

4,311

 

 

 

14,165

 

 

 

6,844

 

 

 

16,824

 

Operating lease liability, noncurrent

 

 

 

 

 

408

 

CVR derivative liability, noncurrent

 

 

4,550

 

 

 

 

Total liabilities

 

 

4,311

 

 

 

14,573

 

 

 

11,394

 

 

 

16,824

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 shares issued

and outstanding

 

 

 

 

 

Common stock, $0.001 par value, 100,000,000 shares authorized; 31,477,053 and

31,409,707 shares issued and outstanding at June 30, 2022 and

December 31, 2021, respectively

 

 

31

 

 

 

31

 

Commitments and Contingencies (Note 9)

 

 

 

 

 

 

 

 

Redeemable convertible preferred stock, $0.001 par value, 123,418 shares authorized;

12,340 shares issued and outstanding at March 31, 2023 and December 31, 2022

 

 

33,309

 

 

 

33,309

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Common stock, $0.001 par value, 100,000,000 shares authorized; 37,759,825 and

37,756,574 shares issued and outstanding at March 31, 2023 and December 31, 2022,

respectively

 

 

37

 

 

 

37

 

Additional paid-in capital

 

 

444,629

 

 

 

443,752

 

 

 

384,686

 

 

 

389,210

 

Accumulated deficit

 

 

(365,598

)

 

 

(402,694

)

 

 

(410,676

)

 

 

(410,936

)

Total stockholders’ equity

 

 

79,062

 

 

 

41,089

 

Total liabilities and stockholders’ equity

 

$

83,373

 

 

$

55,662

 

Total stockholders’ deficit

 

 

(25,953

)

 

 

(21,689

)

Total liabilities, redeemable convertible preferred stock and stockholders’ deficit

 

$

18,750

 

 

$

28,444

 

 

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

 

 


 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration

 

$

 

 

$

1,132

 

 

$

794

 

 

$

2,599

 

 

$

 

 

$

794

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses (income):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of collaboration

 

 

 

 

 

1,139

 

 

 

798

 

 

 

2,619

 

 

 

 

 

 

798

 

Research and development

 

 

1,871

 

 

 

15,389

 

 

 

11,574

 

 

 

32,402

 

 

 

588

 

 

 

9,703

 

General and administrative

 

 

3,844

 

 

 

4,518

 

 

 

8,838

 

 

 

9,930

 

 

 

3,970

 

 

 

4,994

 

Gain on disposal of assets, net

 

 

(57,245

)

 

 

 

 

(57,245

)

 

 

 

 

(4,736

)

 

 

 

Total operating expenses (income)

 

 

(51,530

)

 

 

21,046

 

 

 

(36,035

)

 

 

44,951

 

 

 

(178

)

 

 

15,495

 

Income (loss) from operations

 

 

51,530

 

 

 

(19,914

)

 

 

36,829

 

 

 

(42,352

)

 

 

178

 

 

 

(14,701

)

Interest and other income (expense), net

 

 

102

 

 

 

(14

)

 

 

267

 

 

 

(14

)

Interest and other income, net

 

 

96

 

 

 

165

 

Income (loss) before income taxes

 

 

274

 

 

 

(14,536

)

Income tax expenses

 

 

14

 

 

 

 

Net income (loss)

 

$

51,632

 

 

$

(19,928

)

 

$

37,096

 

 

$

(42,366

)

 

$

260

 

 

$

(14,536

)

Net income (loss) per share attributable to common

stockholders, basic

 

$

1.64

 

 

$

(0.64

)

 

$

1.18

 

 

$

(1.42

)

 

$

0.01

 

 

$

(0.46

)

Net income (loss) per share attributable to common

stockholders, diluted

 

$

1.64

 

 

$

(0.64

)

 

$

1.18

 

 

$

(1.42

)

 

$

0.01

 

 

$

(0.46

)

Shares used to compute net income (loss) per share attributable to

common stockholders, basic

 

 

31,477,053

 

 

 

31,348,602

 

 

 

31,466,630

 

 

 

29,875,202

 

 

 

37,758,416

 

 

 

31,456,090

 

Shares used to compute net income (loss) per share attributable to

common stockholders, diluted

 

 

31,482,925

 

 

 

31,348,602

 

 

 

31,469,566

 

 

 

29,875,202

 

 

 

37,984,324

 

 

 

31,456,090

 

 

 

 

 

 

 

 

 

Cash dividends paid per common share

 

$

0.24

 

 

$

 

CVR cash dividends paid per common share

 

$

0.01

 

 

$

 

 

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

 

 


Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net income (loss)

 

$

51,632

 

 

$

(19,928

)

 

$

37,096

 

 

$

(42,366

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale debt securities

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Total comprehensive income (loss)

 

$

51,632

 

 

$

(19,931

)

 

$

37,096

 

 

$

(42,369

)

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

 


 

Catalyst Biosciences, Inc.

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

(In thousands, except share amounts)

(Unaudited)

 

 

Redeemable Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders'

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2022

 

 

12,340

 

 

$

33,309

 

 

 

37,756,574

 

 

$

37

 

 

$

389,210

 

 

$

(410,936

)

 

$

(21,689

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

210

 

 

 

 

 

 

210

 

Issuance of common stock from stock grants

 

 

 

 

 

 

 

 

3,251

 

 

 

 

 

 

2

 

 

 

 

 

 

2

 

CVR cash dividends paid related to GCBP Agreement ($0.01 per share)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(206

)

 

 

 

 

 

(206

)

CVR derivative liability

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,530

)

 

 

 

 

 

(4,530

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

260

 

 

 

260

 

Balance at March 31, 2023

 

 

12,340

 

 

$

33,309

 

 

 

37,759,825

 

 

$

37

 

 

$

384,686

 

 

$

(410,676

)

 

$

(25,953

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

Redeemable Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders’

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

 

 

$

 

 

 

31,409,707

 

 

$

31

 

 

$

443,752

 

 

$

 

 

$

(402,694

)

 

$

41,089

 

 

 

 

 

$

 

 

 

31,409,707

 

 

$

31

 

 

$

443,752

 

 

$

(402,694

)

 

$

41,089

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

32,684

 

 

 

 

 

 

515

 

 

 

 

 

 

 

 

 

515

 

 

 

 

 

 

 

 

 

32,684

 

 

 

 

 

 

515

 

 

 

 

 

 

515

 

Issuance of common stock from stock

grants and option exercises

 

 

 

 

 

 

 

 

34,662

 

 

 

 

 

 

16

 

 

 

 

 

 

 

 

 

16

 

Issuance of common stock from stock grants

 

 

 

 

 

 

 

 

34,662

 

 

 

 

 

 

16

 

 

 

 

 

 

16

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,536

)

 

 

(14,536

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,536

)

 

 

(14,536

)

Balance at March 31, 2022

 

 

 

 

 

 

 

 

31,477,053

 

 

 

31

 

 

 

444,283

 

 

 

 

 

 

(417,230

)

 

 

27,084

 

 

 

 

 

$

 

 

 

31,477,053

 

 

$

31

 

 

$

444,283

 

 

$

(417,230

)

 

$

27,084

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

346

 

 

 

 

 

 

 

 

 

346

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

51,632

 

 

 

51,632

 

Balance at June 30, 2022

 

 

 

 

$

 

 

 

31,477,053

 

 

$

31

 

 

$

444,629

 

 

$

 

 

$

(365,598

)

 

$

79,062

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2020

 

 

 

 

$

 

 

 

22,097,820

 

 

$

22

 

 

$

390,803

 

 

$

5

 

 

$

(314,761

)

 

$

76,069

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

10,149

 

 

 

 

 

 

1,026

 

 

 

 

 

 

 

 

 

1,026

 

Issuance of common stock from stock

grants and option exercises

 

 

 

 

 

 

 

 

38,058

 

 

 

 

 

 

182

 

 

 

 

 

 

 

 

 

182

 

Issuance of common stock for public offering, net

of issuance costs of $3,563

 

 

 

 

 

 

 

 

9,185,000

 

 

 

9

 

 

 

49,241

 

 

 

 

 

 

 

 

 

49,250

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,438

)

 

 

(22,438

)

Balance at March 31, 2021

 

 

 

 

 

 

 

 

31,331,027

 

 

 

31

 

 

 

441,252

 

 

 

5

 

 

 

(337,199

)

 

 

104,089

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

13,713

 

 

 

 

 

 

983

 

 

 

 

 

 

 

 

 

983

 

Issuance of common stock from stock

grants and option exercises

 

 

 

 

 

 

 

 

5,000

 

 

 

 

 

 

23

 

 

 

 

 

 

 

 

 

23

 

Unrealized loss on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(19,928

)

 

 

(19,928

)

Balance at June 30, 2021

 

 

 

 

$

 

 

 

31,349,740

 

 

$

31

 

 

$

442,258

 

 

$

2

 

 

$

(357,127

)

 

$

85,164

 

 

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

 


 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Operating Activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

37,096

 

 

$

(42,366

)

 

$

260

 

 

$

(14,536

)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

861

 

 

 

2,009

 

 

 

210

 

 

 

515

 

Depreciation and amortization

 

 

180

 

 

 

90

 

 

 

3

 

 

 

113

 

Change in fair value of long-term receivables

 

 

(20

)

 

 

 

Change in fair value of derivative liabilities

 

 

20

 

 

 

 

Bad debt expense

 

 

200

 

 

 

 

 

 

 

 

200

 

Net gain on disposal of assets

 

 

(57,245

)

 

 

 

 

(4,736

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts and other receivables

 

 

1,618

 

 

 

1,342

 

 

 

 

 

 

1,054

 

Prepaid and other current assets

 

 

2,197

 

 

 

(2,338

)

 

 

625

 

 

 

1,485

 

Accounts payable

 

 

(5,382

)

 

 

(4,091

)

 

 

(178

)

 

 

(1,713

)

Accrued compensation and other accrued liabilities

 

 

(3,680

)

 

 

663

 

 

 

(2,411

)

 

 

1,036

 

Operating lease liability and right-of-use asset

 

 

41

 

 

 

157

 

 

 

11

 

 

 

26

 

Deferred revenue

 

 

(230

)

 

 

55

 

 

 

 

 

 

(230

)

Net cash flows used in operating activities

 

 

(24,344

)

 

 

(44,479

)

 

 

(6,216

)

 

 

(12,050

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investing Activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from maturities of short-term investments

 

 

2,504

 

 

 

38,632

 

 

 

 

 

 

2,504

 

Proceeds from the sale of property and equipment

 

 

447

 

 

 

 

Proceeds from the sale of complement portfolio to Vertex

 

 

55,000

 

 

 

Payment of transaction costs in connection with sale of complement portfolio to Vertex

 

 

(2,576

)

 

 

 

 

Purchases of property and equipment

 

 

 

 

 

(347

)

Proceeds from the sale of legacy rare bleeding disorder program to GCBP

 

 

1,000

 

 

 

 

Payment of transaction costs in connection with the sale of legacy rare bleeding disorder

program to GCBP

 

 

(589

)

 

 

 

Net cash flows provided by investing activities

 

 

55,375

 

 

 

38,285

 

 

 

411

 

 

 

2,504

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financing Activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for public offering, net of issuance costs

 

 

 

 

 

49,250

 

Issuance of common stock from stock grants and option exercises

 

 

16

 

 

 

205

 

Net cash flow provided by financing activities

 

 

16

 

 

 

49,455

 

Net increase in cash and cash equivalents

 

 

31,047

 

 

 

43,261

 

Payment of dividends

 

 

(7,764

)

 

 

 

Issuance of common stock from stock grants

 

 

2

 

 

 

16

 

Net cash flows (used in) provided by financing activities

 

 

(7,762

)

 

 

16

 

Net decrease in cash and cash equivalents

 

 

(13,567

)

 

 

(9,530

)

Cash and cash equivalents at beginning of the period

 

 

44,347

 

 

 

30,360

 

 

 

21,666

 

 

 

44,347

 

Cash and cash equivalents at end of the period

 

$

75,394

 

 

$

73,621

 

 

$

8,099

 

 

$

34,817

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosure of Non-Cash Investing and Financing Activities:

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for operating lease liabilities

 

$

 

 

$

1,850

 

Supplemental Disclosure on Non-Cash Investing and Financing Activities:

 

 

 

 

 

 

 

 

CVR derivative liability

 

$

4,530

 

 

$

 

Accrued transaction costs related to GCBP asset sale

 

$

205

 

 

$

 

 

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

 

 


 

Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1.

Nature of Operations and Liquidity

Catalyst Biosciences, Inc. and its subsidiary (the “Company” or “Catalyst”) iswas a biopharmaceutical company with expertise in protease engineering. Prior to ceasing research and development activities in March 2022, the Company had several protease assets that maywere designed to address unmet medical needs in disorders of the complement or coagulation systems. As discussed further below, the Company recently completed a purchase agreement to acquire a clinical-stage drug candidate for the treatment of NASH (nonalcoholic steatohepatitis, a severe form of nonalcoholic fatty liver disease). Concurrent with this purchase agreement, the Company entered into a separate business combination agreement to acquire an indirect controlling interest in a China-based pharmaceutical company. The Company is exploring several strategic alternativeswill continue to monetizeevaluate the Company’s remaining assetsimpact of the novel coronavirus disease (“COVID-19”) pandemic on its business, operations, and is focused on distributing its available cash after paying or reserving for its obligations and liabilities, to stockholders.requirements. The Company is located in South San Francisco, California and operates in 1one segment.

On May 19, 2022, Catalyst entered into and closed on an asset purchase agreement with Vertex Pharmaceuticals IncorporatedInc. (“Vertex”), pursuant to which Vertex acquired Catalyst’s complement portfolio, including CB 2782-PEG and CB 4332, as well as its complement-related intellectual property including the ProTUNEtmTM and ImmunoTUNEtmTM platforms (Seeplatforms. See Note 12). After the transaction of its complement portfolio,11, Restructuring.

On February 27, 2023, Catalyst entered into and closed on an asset purchase agreement with GC Biopharma Corp. (“GCBP”), pursuant to which GCBP acquired Catalyst’s product candidates consist oflegacy rare bleeding disorder program, including the coagulation related assets marzeptacog alfa (activated) (“MarzAA”), dalcinonacog alfa (“DalcA”), and CB 2679d-GT. MarzAACB-2679d-GT. See Note 11, Restructuring.

F351 Asset Acquisition

On December 26, 2022, the Company executed and closed an Asset Purchase Agreement, which was amended on March 29, 2023 (the “F351 Agreement”), with GNI Group Ltd. and GNI Hong Kong Limited (together “GNI”) to purchase all of the assets and intellectual property rights primarily related to the proprietary Hydronidone compound (collectively, the “F351 Assets”), other than such assets and intellectual property rights located in the People’s Republic of China. At the closing of the agreement on December 26, 2022, the Company paid $35.0 million in the form of 6,266,521 shares of Catalyst common stock and 12,340 shares of newly designated Series X redeemable convertible preferred stock (“Catalyst Convertible Preferred Stock”). Each share of Catalyst Convertible Preferred Stock is convertible into 10,000 shares of common stock, subject to stockholder approval under Nasdaq rules and subject to a SQ administered next generation engineered coagulation Factor VIIabeneficial ownership conversion blocker. For additional information, see Note 3, F351 Asset Acquisition.

Business Combination Agreement

Concurrent with the F351 Asset acquisition, the Company signed a definitive agreement, as amended on March 29, 2023, with GNI Group Ltd., GNI Hong Kong Limited, GNI USA, Inc., Continent Pharmaceuticals Inc. and Shanghai Genomics, Inc. (collectively, “GNI”) and other minority stockholders to acquire an indirect controlling interest in Beijing Continent Pharmaceutical Co Ltd. (“FVIIa”BC”), a commercial-stage pharmaceutical company based in China and majority-owned subsidiary of GNI, in exchange for newly issued shares of common stock (the “Business Combination Agreement”). The closing of the transactions under the Business Combination Agreement will be subject to stockholder approval at a stockholder meeting expected to be held in the third quarter of 2023 and certain customary closing conditions. For additional information, see Note 9, Commitments and Contingencies.

Contingent Value Rights Agreement

Pursuant to the Business Combination Agreement, on December 26, 2022, Catalyst and the Rights Agent (as defined therein) executed a contingent value rights agreement, as amended on March 29, 2023 (the “CVR Agreement”), pursuant to which each holder of Catalyst common stock as of January 5, 2023 (the “CVR Holders”), excluding GNI, received one contractual contingent value right (a “CVR”) issued by the Company for each share of Catalyst common stock held by such holder. Each CVR entitles the treatmentholder thereof to receive certain cash payments in the future. For additional information, see Note 9, Commitments and Contingencies.

Liquidity

On January 12, 2023, the Company paid a one-time cash dividend of episodic bleeding and prophylaxis in subjects with rare bleeding disorders. DalcA is a next-generation SQ administered FIX. CB 2679d-GT is an AAV-based gene therapy construct harboring$0.24 per share to the DalcA sequence. Both MarzAA and DalcA have shown sustained efficacy and safety in mid-stage clinical trials and are availableCompany’s common stockholders of record as of close of business on January 5, 2023, excluding GNI. The aggregate amount of the special dividend payment was approximately $7.6 million.


On March 8, 2023, the Company distributed the net cash proceeds received from the GCBP asset sale of $0.2 million, or $0.01 per share, to the CVR Holders, excluding GNI. See Note 11, Restructuring, for partnering. CB 2679d-GT has obtained preclinical proof-of-concept and is also available for partnering.additional information regarding this distribution.

The Company had a net income of $37.1$0.3 million for the sixthree months ended June 30, 2022 andMarch 31, 2023. As of March 31, 2023, the Company had an accumulated deficit of $365.6$410.7 million as of June 30, 2022. As of June 30, 2022, the Company had $75.4 million ofand cash and cash equivalents. equivalents of $8.1 million. Its primary uses of cash are to fund operating expenses and general and administrative expenditures. As part of the F351 Agreement, the Company issued 12,340 shares of Catalyst Convertible Preferred Stock, which upon stockholder approval, will be converted to 123,400,000 shares of common stock, subject to applicable beneficial ownership limitations. The terms of the Catalyst Convertible Preferred Stock include a cash settlement feature which provide that, if the Company’s stockholders fail to approve the conversion of the Catalyst Convertible Preferred Stock by September 30, 2023, the Company could be required to make cash payments to the holders of Catalyst Convertible Preferred Stock significantly in excess of its current liquidity. The Company believes that stockholders who are entitled to vote on the conversion proposal at the Company’s 2023 Annual Meeting of Stockholders, which is expected to be held in the third quarter of 2023, will vote to approve the proposal. However, as the vote of the Company’s common stockholders is outside of the control of the Company, there is substantial doubt about its existing cash and cash equivalentsability to continue as of June 30, 2022 will be sufficient to fund its cash requirementsa going concern for at least the next 12 months following the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated 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 relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the date of the filingoutcome of this report. The Company will continue to evaluate the impact of the novel coronavirus disease (“COVID-19”) pandemic on its business, operations, and cash requirements.uncertainty.

2.

Summary of Significant Accounting Policies

Basis of Presentation

The Company’s condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. These interim results and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2022,2023, or for any other future annual or interim period.

The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (“Annual2022 (the “Annual Report”).

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, allowance of doubtful accounts, long-term receivable, contingent value rights, operating lease right-of-use assets and liabilities, accrued expenses, income taxes and stock-based compensation. The Company bases its estimates on various assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Accounting Pronouncements Recently Adopted

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 is effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, using a modified retrospective approach. The Company adopted ASU 2016-13 and related updates as of January 1, 2023 and the adoption did not have a material impact on its condensed consolidated financial statements.

Long-Term Receivable

The Company determined that the hold-back from the GCBP asset sale in February 2023 qualified as a long-term receivable. The receivable is considered a loan held for investment since the Company has the intent and ability to hold to maturity. Catalyst has


elected to account for the receivable under the fair value option method of accounting and any changes in fair value are recorded in interest and other income, net on the condensed consolidated statement of operations. Refer to Note 4, Fair Value Measurements and Note 11, Restructuring, for additional information regarding the long-term receivable and GCBP asset sale.

Net Income (Loss) Perper Share Attributable to Common Stockholders

The Company calculates basic and diluted net income (loss) per share attributable to common stockholders in conformity with the two-class method required for participating securities. The Catalyst Convertible Preferred Stock contractually entitles the holders of such shares to participate in dividends but such participation is contingent upon the completion of the merger with GNI. As a result, the Catalyst Convertible Preferred Stock is excluded from the basic EPS calculation, as these shares are not participating securities until the merger with GNI closes. As such, net income for the periods presented was not allocated to these securities. During periods of loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company.

Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period. period, without consideration for potentially dilutive securities. Participating securities are excluded from the basic weighted average common shares outstanding.

Diluted net income (loss) per share attributable to common stockholders is based on the weighted average number of shares of common stockshares outstanding during the period, adjusted to include the assumed exerciseincluding potential dilutive common shares. For purposes of certainthis calculation, outstanding stock options and warrants using the treasury stock method.are considered potential dilutive common shares. The calculation assumes that any proceeds that could be obtainedof diluted EPS does not consider the effect of the Catalyst Convertible Preferred Stock since conversion is contingent upon exercisethe occurrence of options and warrants would be used to purchase common stock at the average market price during the period. Adjustments to the denominator are required to reflect the related dilutive shares.

8


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

Accounting Pronouncements Recently Adopted

In May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU 2021-04 provide guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this ASU 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, including interim periods within those fiscal years. The Company adopted ASU 2021-04 and related updates on January 1, 2022, and the adoption did not have a material impact on its condensed consolidated financial statements.specified future event.

3.

F351 Asset Acquisition

On December 26, 2022, the Company acquired the F351 Assets from GNI in accordance with the terms of the F351 Agreement as discussed in Note 1, Nature of Operations and Liquidity. Under the terms of the F351 Agreement, the Company issued 6,266,521 shares of common stock and 12,340 shares of Catalyst Convertible Preferred Stock.

The Company concluded that the F351 acquisition was not the acquisition of a business, as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, the intellectual property rights (outside of China) to a clinical stage drug candidate for the treatment of liver fibrosis, or the F351 Assets.

Subject to stockholder approval, each share of Catalyst Convertible Preferred Stock issued under the F351 Agreement is convertible into 10,000 shares of common stock. The Company is required to hold a stockholders’ meeting to request the approval of the conversion of the Catalyst Convertible Preferred Stock into shares of common stock in accordance with Nasdaq Listing Rule 5635(a) (the “Conversion Proposal”). The Company expects to hold its 2023 Annual Meeting of Stockholders in the third quarter of 2023 and will include the following matters as proposals to be voted on at the meeting: (i) the Conversion Proposal and (ii) if necessary or appropriate, the approval of an amendment to the Company’s certificate of incorporation to authorize sufficient shares of common stock for the conversion of the Catalyst Convertible Preferred Stock issued pursuant to the F351 Agreement.

In March 2023, the Company amended the F351 Agreement and the Catalyst Convertible Preferred Stock Certificate of Designation to extend the deadline for the cash settlement of the Catalyst Convertible Preferred Stock from June 26, 2023 to September 30, 2023. Under the amended terms, if the Company’s stockholders do not approve the conversion of the Catalyst Convertible Preferred Stock by September 30, 2023, then the Catalyst Convertible Preferred Stock would be redeemable at the option of the holders for cash equal to the closing price of the common stock on the last trading day prior to the holder’s redemption request. Using the closing price on May 8, 2023 of $0.21, if all the currently outstanding Catalyst Convertible Preferred Stock was redeemed for cash, the Company would be required to make a payment of approximately $25.9 million. The Company has insufficient liquidity to make such a payment, if required.


4.

Fair Value Measurements

For a description of the fair value hierarchy and the Company’s fair value methodology, see “Part II - Item 8 - Financial Statements and Supplementary Data - Note 3Summary of Significant Accounting Policies” in the Company’s Annual Report. There were no significant changes in these methodologies during the sixthree months ended June 30, 2022.March 31, 2023.

The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of June 30, 2022March 31, 2023 and December 31, 20212022 (in thousands):

 

 

June 30, 2022

 

 

March 31, 2023

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

75,394

 

 

$

 

 

$

 

 

$

75,394

 

 

$

8,099

 

 

$

 

 

$

 

 

$

8,099

 

Long-term receivable from GCBP

 

 

 

 

 

 

 

 

4,550

 

 

 

4,550

 

Total financial assets

 

$

75,394

 

 

$

 

 

$

 

 

$

75,394

 

 

$

8,099

 

 

$

 

 

$

4,550

 

 

$

12,649

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CVR derivative liability

 

$

 

 

$

 

 

$

5,000

 

 

$

5,000

 

CVR derivative liability, noncurrent

 

 

 

 

 

 

 

 

4,550

 

 

 

4,550

 

Total financial liabilities

 

$

 

 

$

 

 

$

9,550

 

 

$

9,550

 

 

 

December 31, 2021

 

 

December 31, 2022

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

44,347

 

 

$

 

 

$

 

 

$

44,347

 

 

$

21,666

 

 

$

 

 

$

 

 

$

21,666

 

U.S. government agency securities(2)

 

 

2,504

 

 

 

 

 

 

 

 

 

2,504

 

Total financial assets

 

$

46,851

 

 

$

 

 

$

 

 

$

46,851

 

 

$

21,666

 

 

$

 

 

$

 

 

$

21,666

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CVR derivative liability

 

$

 

 

$

 

 

$

5,000

 

 

$

5,000

 

Total financial liabilities

 

$

 

 

$

 

 

$

5,000

 

 

$

5,000

 

 

 

(1)

Included in cash and cash equivalents on the accompanying condensed consolidated balance sheets.

(2)sheets

Included in short-term investments on the accompanying condensed consolidated balance sheets and classified as available-for-sale debt securities..

The carrying amounts of cash and cash equivalents, accounts and other receivables, accounts payable, and accrued liabilities approximate their fair values due to the short-term maturity of these instruments.

Derivative Liabilities and Long-term Receivables

9


Catalyst Biosciences, Inc.

NotesThe CVR derivative liability relates to Condensed Consolidated Financial Statements (Unaudited)

4.

Financial Instruments

Cash equivalents and short-term investments (debt securities)the CVR Agreement executed in connection with the Business Combination Agreement. The fair value of this derivative liability is based on significant unobservable inputs, which are classified as available-for-sale securities, consistedrepresent Level 3 measurements within the fair value hierarchy. The estimated fair value of the CVR liability was determined based on the anticipated amount and timing of projected cash flows to be received from Vertex pursuant to the Vertex asset purchase agreement. As of March 31, 2023, the Company expects to receive a $5.0 million hold-back payment from Vertex in the second quarter of 2023, which will be distributed, net of expenses, to the holders of Catalyst common stock as of January 5, 2023 under the CVR Agreement. The CVR liability was initially recorded at $5.0 million at issuance on December 26, 2022 and there was no change in the estimated fair value as of March 31, 2023.

The long-term receivable and the corresponding CVR derivative liability, noncurrent relate to the asset purchase agreement with GCBP. The fair value of this long-term receivable and derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the long-term receivable and CVR derivative liability, noncurrent was determined based on the anticipated amount and timing of projected cash flows to be received from GCBP pursuant to the GCBP asset purchase agreement discounted to their present values using an estimated discount rate of 5.05%. As of March 31, 2023, the Company expects to receive a $5.0 million hold-back payment from GCBP in the first quarter of 2025, which will be distributed, net of expenses, to the holders of Catalyst common stock as of January 5, 2023 under the CVR Agreement.


The following table sets forth the changes in the estimated fair value of the Company’s Level 3 financial assets and liabilities (in thousands):

June 30, 2022

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Estimated

Fair

Value

 

Money market funds (cash equivalents)

 

$

75,394

 

 

$

 

 

$

 

 

$

75,394

 

Total financial assets

 

$

75,394

 

 

$

 

 

$

 

 

$

75,394

 

Classified as:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

$

75,394

 

Total financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

$

75,394

 

 

 

Long-term receivable

 

 

CVR derivative

 

 

 

from GCBP

 

 

liability, noncurrent

 

Balance at December 31, 2022

 

$

 

 

$

 

Additions in the period

 

 

4,530

 

 

 

4,530

 

Changes in fair value

 

 

20

 

 

 

20

 

Balance at March 31, 2023

 

$

4,550

 

 

$

4,550

 

 

December 31, 2021

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Estimated

Fair

Value

 

Money market funds (cash equivalents)

 

$

44,347

 

 

$

 

 

$

 

 

$

44,347

 

U.S. government agency securities

 

 

2,504

 

 

 

 

 

 

 

 

 

2,504

 

Total financial assets

 

$

46,851

 

 

$

 

 

$

 

 

$

46,851

 

Classified as:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

$

44,347

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,504

 

Total financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

$

46,851

 

There have been 0 material realized gains or losses on available-for-sale debt securities for the periods presented. As of June 30, 2022, the Company had 0 available-for-sale debt securities.

5.

Lease

Operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. In calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original lease term and not the remaining lease term. The lease includes non-lease components (e.g., common area maintenance) that are paid separately from rent based on actual costs incurred and, therefore, were not included in the right-of-use asset and lease liability but are reflected as an expense in the period incurred.

The Company leases office space for its corporate headquarters, located in South San Francisco, CA. The lease term is through April 30, 2023 and there are no stated renewal options. The Company currently has a month-to-month lease that will continue to be utilized following the expiration of the corporate headquarters lease.

In March 2022, the Company entered into a sublease agreement for one of its leased facilitiesfacility that commenced in April 2022. Under the terms of the sublease agreement, the Company will receive $0.2 million in base lease payments over the term of the sublease, which ends in April 2023.2023. For the three and six months ended June 30, 2022,March 31, 2023, the Company recognized sublease income of $38,000. The sublease agreement began in April 2022, so no sublease income was recognized during the three months ended March 31, 2022.

For the three and six months ended June 30,March 31, 2023 and 2022, the Company’s operating lease expense was $0.6$0.1 million and $1.1$0.5 million, respectively.For

The Company has historically prepaid one month’s worth of rent expense, therefore as of March 31, 2023, the three and six months ended June 30, 2021, the Company’s operatingCompany does not have any remaining lease expense was $0.4 million and $0.6 million, respectively.

payments under its current lease agreement. The present value assumptions used in calculating the present value of the lease payments were as follows:

 

June 30, 2022

 

 

December 31, 2021

 

 

March 31, 2023

 

 

December 31, 2022

 

Weighted-average remaining lease term

0.8 years

 

 

1.3 years

 

 

0 years

 

 

0.3 years

 

Weighted-average discount rate

 

4.8

%

 

 

4.8

%

 

 

0.0

%

 

 

4.3

%

 

10


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

The maturity of the Company’s operating lease liabilities as of June 30, 2022 were as follows (in thousands):

Year Ending December 31,

Amount

 

Remaining in 2022

$

1,029

 

2023

 

410

 

Total undiscounted lease payments

 

1,439

 

Less imputed interest

 

(24

)

Total operating lease liability

$

1,415

 

Supplemental cash flow information related to operating leases was as follows (in thousands):

 

 

Six Months Ended June 30,

 

 

2022

 

 

2021

 

Cash paid for amounts included in the measurement of lease liabilities

$

1,015

 

 

$

680

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Cash paid for amounts included in the measurement of lease liabilities

 

$

39

 

 

$

502

 

 

6.

Stock-BasedStock Based Compensation

2018 Omnibus Incentive Plan

In June 2018, stockholders of the Company approved the Company’s 2018 Omnibus Incentive Plan (the “2018 Plan”). The 2018 Plan had previously been approved by the Company’s Board of Directors (the “Board”) and the Compensation Committee (the “Committee”) of the Board, subject to stockholder approval. The 2018 Plan became effective on June 13, 2018. On June 9, 2021, the stockholders of the Company approved an amendment previously approved by the Board to increase the number of shares of common stock reserved for issuance under the 2018 Plan by 2,500,000 to a total of 5,300,000 shares. The amendment became effective immediately upon stockholder approval. After the option modification (as discussed below), the number of shares of common stock reserved for issuance under the 2018 Plan increased to a total of 31,456,403. As of March 31, 2023, there were 25,521,867 shares of common stock available for future grant.


Performance-Based Stock Option GrantGrants

In June 2022, the Committee approved the issuance of an option grant to purchase 400,000 shares (2,457,917 shares after the option modification discussed below) of common stock to the Chief Executive Officer pursuant to the 2018 Plan, which will vest upon (a) the achievement of a specified performance goal and (b) the grantees’grantee’s continued employment during the service period. ForDuring the sixthree months ended June 30, 2022,March 31, 2023, this award was cancelled. Prior to cancellation, no expense has been recognized related to this award.award and no options have vested.

Special Cash Dividend

On January 12, 2023, the Company paid a special, one-time cash dividend of $7.6 million (or $0.24 per share) to the Company’s common stockholders of record as of the close of business on January 5, 2023. The Company determined, in accordance with the adjustment provision of the 2018 Plan, that the special cash dividend was unusual and non-recurring and that appropriate adjustment to the stock options to purchase shares of the Company’s common stock outstanding under the 2018 Plan was required. The Company treated this adjustment as a modification to the original stock option grants because the terms of the agreements were modified in order to preserve the value of the option awards after a large non-recurring cash dividend. These options were amended to decrease the exercise price and increase the number of shares subject to the stock option on a proportionate basis. No incremental value was provided to the option holders as a result of the modification and no additional compensation cost was recorded by the Company.

The following table summarizes stock option activity under the Company’s 2018 Plan and related information:

 

 

 

Number of Shares

Underlying

Outstanding

Options

 

 

Weighted-

Average Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual Term

(Years)

 

Outstanding — December 31, 2021

 

 

2,603,630

 

 

$

7.70

 

 

 

7.46

 

Options granted

 

 

1,314,200

 

 

$

0.72

 

 

 

 

 

Options forfeited

 

 

(1,173,227

)

 

$

4.19

 

 

 

 

 

Options expired

 

 

(47,192

)

 

$

12.84

 

 

 

 

 

Outstanding — June 30, 2022

 

 

2,697,411

 

 

$

5.64

 

 

 

7.85

 

Exercisable — June 30, 2022

 

 

1,375,625

 

 

$

9.01

 

 

 

 

 

 

 

Number of Shares

Underlying

Outstanding

Options

 

 

Weighted-

Average Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual Term

(Years)

 

Outstanding — December 31, 2022

 

 

8,678,767

 

 

$

1.42

 

 

 

7.47

 

Options granted (1)

 

 

14,008,093

 

 

$

0.86

 

 

 

 

 

Options forfeited and cancelled (1)

 

 

(14,210,119

)

 

$

0.91

 

 

 

 

 

Options expired

 

 

(12,174

)

 

$

36.16

 

 

 

 

 

Outstanding — March 31, 2023

 

 

8,464,567

 

 

$

1.30

 

 

 

6.01

 

Exercisable — March 31, 2023

 

 

7,306,692

 

 

$

1.40

 

 

 

 

 

(1)

Includes options that were cancelled and re-granted as part of the option modification from the special cash dividend, as further discussed above.

Valuation Assumptions

The Company estimated the fair value of stock options granted using the Black-Scholes option-pricing formula and a single option award approach. Due to its limited relevant historical data, the Company estimated its volatility considering a number of factors including the use of the volatility of comparable public companies. The expected term of options granted under the Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited relevant history. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. This fair value is being amortized ratably over the requisite service periods of the awards, which is generally the vesting period.

11


Catalyst Biosciences, Inc.The only options granted during the quarter ended March 31, 2023 were as a result of the option modification. Since no new stock options were granted during the quarter ended March 31, 2023, all weighted-average assumptions for the period were not applicable.

Notes to Condensed Consolidated Financial Statements (Unaudited)

The fair value of employee stock options was estimated using the following weighted-average assumptions:

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Employee Stock Options:

 

 

 

 

 

 

 

 

Risk-free interest rate

 

 

 

 

 

1.87

%

Expected term (in years)

 

 

 

 

 

6.1

 

Dividend yield

 

 

 

 

 

 

Volatility

 

 

 

 

 

91.54

%

Weighted-average fair value of stock options granted

 

$

 

 

$

0.39

 


 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Employee Stock Options:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Risk-free rate

 

 

2.93

%

 

 

0.96

%

 

 

2.22

%

 

 

0.74

%

Expected term (in years)

 

 

6.0

 

 

 

5.7

 

 

 

6.0

 

 

 

6.0

 

Dividend yield

 

0

 

 

0

 

 

0

 

 

0

 

Volatility

 

 

91.82

%

 

 

92.79

%

 

 

91.63

%

 

 

93.64

%

Weighted-average fair value of stock options granted

 

$

0.87

 

 

$

3.37

 

 

$

0.55

 

 

$

4.45

 

Total stock-based compensation expense recognized was as follows (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Research and development

 

$

83

 

 

$

394

 

 

$

211

 

 

$

763

 

 

$

66

 

 

$

128

 

General and administrative(1)

 

 

263

 

 

 

589

 

 

 

650

 

 

 

1,246

 

 

 

144

 

 

 

387

 

Total stock-based compensation expense

 

$

346

 

 

$

983

 

 

$

861

 

 

$

2,009

 

 

$

210

 

 

$

515

 

 

 

(1)

Included in general and administrative stock-based compensation for the six months ended June 30, 2022 is stock-based compensation expense related to 32,684 shares of common stock issued to certain board members in lieu of their cash compensation. NaNNo shares of common stock were issued to board members for the three months ended June 30, 2022.March 31, 2023.

As of June 30, 2022, 3,013,716 shares of common stock were available for future grant.

7.

Collaborations

Mosaic

In October 2017, the Company entered into a strategic research collaboration with Mosaic Biosciences (“Mosaic”) to develop intravitreal anti-complement factor 3 (C3) products for the treatment of dry Age-related Macular Degeneration (AMD) and other retinal diseases. The Company subsequently amended this agreement in December 2018, December 2019 and May 2020.

Under the as amended Mosaic collaboration agreement, Mosaic is eligible to receive up to $4.0 million in potential future milestone payments related to regulatory and clinical development events for CB 2782-PEG and an additional anti-complement product candidate in lieu of the Company’s prior obligations to pay Mosaic a double-digit percentage of funds the Company receives from Biogen or any other amounts the Company receives related to sublicense fees, research and development payments, or any other research, regulatory, clinical or commercial milestones and royalties on any other development candidates.

As a result of the sale of the Company’s complement portfolio, including CB 2782-PEG and other assets, to Vertex in May 2022, the Mosaic collaboration agreement was transferred to Vertex (see Note 12).

ISU Abxis

In December 2018, the Company entered into an amended and restated license agreement with ISU Abxis (the “A&R ISU Abxis Agreement”). Under the A&R ISU Abxis Agreement, ISU Abxis will receive commercialization rights in South Korea to the Company’s engineered Factor IX dalcinonacog alfa - DalcA and the Company will receive clinical development and commercialization rights in the rest of world (excluding South Korea) and manufacturing development and manufacturing rights worldwide (including South Korea). The A&R ISU Abxis Agreement provides for a low single-digit royalty payment to ISU Abxis, on a country-by-country basis, for net product sales of DalcA by the Company or its affiliates in each country other than South Korea. Pursuant to the A&R ISU Abxis Agreement, the Company will also pay up to an aggregate of $19.5 million in milestone payments to ISU Abxis, including $2.5 million in regulatory and development milestone payments and up to $17.0 million in commercial milestone payments, if the applicable milestones are met. As of June 30, 2022, 0 milestones have been met.

12


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

Biogen

On December 18, 2019, the Company and Biogen International GmbH (“Biogen”) entered into a License and Collaboration Agreement (the “Biogen Agreement”), under which the Company granted Biogen a worldwide, royalty-bearing, exclusive, with the right to sublicense, license (“Exclusive License”) to develop and commercialize CB 2782-PEG and other anti-C3 proteases for potential treatment of dry AMD and other disorders. Pursuant to the Biogen Agreement, the Company performed certain pre-clinical and manufacturing activities (“Research Services”), and Biogen was solely responsible for funding the pre-clinical and manufacturing activities and performing IND-enabling activities, worldwide clinical development, and commercialization.

Under the terms of the Biogen Agreement, the Company received an up-front payment for the transfer of the Exclusive License (inclusive of certain know-how) of $15.0 million in January 2020. The Company was eligible to receive development milestones and sales milestones of up to $340.0 million. In addition, the Company was eligible to receive royalties in the range of single-digit to low double-digit percentage rates of annual net sales on a product-by-product and country-by-country basis. The Company also received reimbursements for costs associated with the performance of the Research Services.

The Company determined that the performance obligations under the Biogen Agreement were the Exclusive License and the Research Services. For the Exclusive License, the Company used the residual approach in determining the standalone selling price, or SSP, which includes the upfront payments, milestones and royalties. For the Research Services, the Company used the historical pricing approach for determining the SSP, which includes the reimbursement of personnel and out-of-pocket costs.

In March 2022, the Company received written notice from Biogen declaring intent to terminate the Biogen Agreement which was effective as of May 2022. As a result of the termination, Biogen no longer hassale of the Exclusive License to develop, manufacture and commercialize CB 2782-PEGCompany’s rare bleeding disorders programs, including DalcA and other anti-C3 proteases for potential treatmentassets, to GCBP in February 2023, the A&R ISU Abxis Agreement was transferred to GCBP. See Note 11, Restructuring. As of dry AMD and other disorders. In March 2022, Biogen returned full rights to CB 2782-PEG.

In June 2022, Biogen and the Company reached an agreement to resolve the outstanding obligations and monetary disputes between the parties. The Company agreed to forgive approximately $0.6 milliondate of accounts receivable, net due from Biogen and to pay Biogen $10,000 in cash. This resulted in the Company recognizing a $0.6 million settlement expense for the three months ended June 30, 2022, which is included in general and administrative operating expenses in the condensed consolidated statements of operations.

The Company recognized $0.7 million of research and development expense as cost of collaboration revenue for the six months ended June 30, 2022. The Company recognized $1.1 million and $2.6 million for the three and six months ended June 30, 2021, respectively, of research and development expense as cost of collaboration revenue related to the Biogen Agreement. Research and development expenses were reimbursed by Biogen in accordance with the agreement.

For the six months ended June 30, 2022, the Company recognized $0.2 million of revenue from the beginning of period deferred revenue balance.transfer, no milestones have been met.

8.

Net Income (Loss) Perper Share Attributable to Common Stockholders

ThePotentially dilutive effect of outstanding stock options and warrants is calculated using the treasury stock method. Stock options and warrantssecurities are anti-dilutive and excluded from the calculation of diluted net income (loss) per share calculationattributable to common stockholders if the exercise price exceeds the average market price of the common shares.

their inclusion is anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Options to purchase common stock

 

 

2,512,078

 

 

 

3,236,592

 

 

 

8,249,500

 

 

 

2,777,710

 

Common stock warrants

 

 

85

 

 

 

85

 

 

 

 

 

 

85

 

Total

 

 

2,512,163

 

 

 

3,236,677

 

 

 

8,249,500

 

 

 

2,777,795

 

13


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

The following table sets forthIn addition, the Catalyst Convertible Preferred Stock has also been excluded from the computation of diluted net income (loss) per share attributable to common stockholders because the contingency for conversion of these shares has not been met.


The following is a reconciliation of the numerator (net income or loss) and denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common share as followsstockholders (in thousands, except share and per share data):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net income (loss) attributable to common stockholders

 

$

51,632

 

 

$

(19,928

)

 

$

37,096

 

 

$

(42,366

)

Weighted-average number of shares used in

   computing net loss per share, basic

 

 

31,477,053

 

 

 

31,348,602

 

 

 

31,466,630

 

 

 

29,875,202

 

Effect of dilutive stock options

 

 

5,872

 

 

 

 

 

 

2,936

 

 

 

 

Weighted-average number of shares used in

   computing net loss per share, diluted

 

 

31,482,925

 

 

 

31,348,602

 

 

 

31,469,566

 

 

 

29,875,202

 

Net income (loss) per share, basic

 

$

1.64

 

 

$

(0.64

)

 

$

1.18

 

 

$

(1.42

)

Net income (loss) per share, diluted

 

$

1.64

 

 

$

(0.64

)

 

$

1.18

 

 

$

(1.42

)

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Numerator

 

 

 

 

 

 

 

 

Net income (loss)

 

$

260

 

 

$

(14,536

)

 

 

 

 

 

 

 

 

 

Denominator

 

 

 

 

 

 

 

 

Weighted-average number of shares used in computing net income

   (loss) per share available to common stockholders, basic

 

 

37,758,416

 

 

 

31,456,090

 

Effect of dilutive stock options

 

 

225,908

 

 

 

 

Weighted-average number of shares used in computing net income

   (loss) per share available to common stockholders, diluted

 

 

37,984,324

 

 

 

31,456,090

 

Net income (loss) per share available for common stockholders, basic

 

$

0.01

 

 

$

(0.46

)

Net income (loss) per share available for common stockholders, dilutive

 

$

0.01

 

 

$

(0.46

)

 

9.

Commitments and Contingencies

Manufacturing Agreements

The Company previously signed an agreement with AGC Biologics, Inc. (“AGC”) to perform certain manufacturing services related to the Company’s collaboration agreement with Biogen, which included firm work orders totaling $0.7 million. The payment obligations were fully paid off asAs of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and Vertex assumed responsibilitybelieves that it is not exposed to any significant credit risk in cash and cash equivalents.  However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

Business Combination Agreement

Concurrent with the F351 Asset acquisition, as amended on March 29, 2023, the Company entered into the Business Combination Agreement with GNI and other minority stockholders (“Sellers” and each a “Seller”) to acquire an indirect controlling interest in BC, a commercial-stage pharmaceutical company based in China and majority-owned subsidiary of GNI, in exchange for further complement-related manufacturingnewly issued shares of Catalyst common stock. The closing of the transactions under the Business Combination Agreement will be subject to stockholder approval at a stockholder meeting expected to be held in the third quarter of 2023 and certain customary closing conditions. If the transaction is approved by stockholders, the Company would issue at closing a total of up to 1,110,776,224 shares of Catalyst common stock for an indirect controlling interest in BC. Each Seller may elect to be issued Catalyst Convertible Preferred Stock in lieu of the Company’s common stock.

The Business Combination Agreement contains certain termination rights, including the right for Catalyst to terminate the Business Combination Agreement to enter into a definitive agreement for a superior proposal. Upon termination of the Business Combination Agreement under specified circumstances, the Company may be required to pay a termination fee of $2.0 million and either party, as the case may be, may be required to reimburse the other party for reasonable out-of-pocket fees and expenses incurred by such party in connection with the saleBusiness Combination Agreement, up to a maximum amount of $2.0 million.

Contingent Value Rights Agreement

Pursuant to the Business Combination Agreement, on December 26, 2022, Catalyst and the Rights Agent (as defined therein) executed the CVR Agreement, as amended on March 29, 2023, pursuant to which the CVR Holders received one contractual CVR issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Catalyst common stock held by such holder. Each CVR entitles the holder thereof to receive (i) certain cash payments from the net proceeds related to the disposition of the Company’s complement portfolio to Vertex (See Note 12). Duringlegacy assets (MarzAA, DalcA, and CB 2679d-GT), (ii) 100% of the quarter ended June 30, 2022,excess cash (net of all current or contingent liabilities, including transaction-related expenses) retained by the Company terminated its manufacturing agreement with AGC for Catalyst’s remaining programs and has 0 remaining obligationsin excess of $1.0 million as of the closing date of the transactions under the agreement asBusiness Combination Agreement, (iii) 100% of June 30, 2022.

In July 2021,the amount actually received by the Company, entered into annet of expenses, pursuant to the Vertex asset purchase agreement and (iv) 100% of the excess, by which the preapproved costs to manage, negotiate, settle and finalize certain third party claims exceed the costs actually incurred with respect to such claims. The CVRs are not transferable, except in certain limited circumstances as provided for in the Company’s screeningCVR Agreement, will not be certificated or evidenced by any instrument, and natural history of disease clinical studies related to CFI deficiency,will not be registered with total payments of up to $6.5 million. During the quarter ended June 30, 2022,SEC or listed for trading on any exchange.


In February 2023, the Company terminated this agreement and incurred $0.8recorded a $4.5 million for clinical trial services incurred prior to termination and reasonable wind-down expenses. Aslong-term CVR derivative liability as a result of June 30, 2022, the Company has 0 remaining obligations under this agreement.

On September 16, 2021, the Company signed a Manufacturing and Research and Development Studies Agreement to support the lyophilized drug product, CB 4332. The agreement covers analytical method qualification to support good manufacturing practices (“GMP”) manufacturing. The Company had firm work orders related to this agreement totaling $0.3 million. During the quarter ended June 30, 2022, the Company terminated this agreement and the payment obligations were fully paid off as of June 30, 2022.

Legal Proceedings

On June 15, 2022, certain Company stockholders who beneficially hold in the aggregate more than five percent (5%)disposition of the Company’s common stock filed a lawsuit in Delaware Chancery Court, captioned JDS1, LLC v. Catalyst Biosciences, Inc., alleging thatlegacy assets to GCBP. On March 8, 2023, the Company violated Section 271 ofdistributed the Delaware General Corporation Law and breach of fiduciary duty in connection withnet cash proceeds received from the Company’sGCBP asset sale to Vertex, as well as certain claims relatedof $0.2 million to the alleged failureCVR Holders. Refer to disclose information related to the Vertex transaction. See Item 1 in Part II of this Form 10-QNote 4, Fair Value Measurements andNote 11, Restructuring, for additional information. The Company believes these claims lack merit. However, shouldinformation regarding the Company not ultimately prevail, it is not possible to estimate the amount or range of potential loss, if any.CVR derivative liability and GCBP asset sale.

COVID-19

The current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting the Company’s employees and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national, and international markets. The COVID-19 pandemic may disrupt the Company’s ability to out-license anyconduct the clinical development and commercialization of its remaining assets.

14


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

Hydronidone in NASH fibrosis as planned.

10.

Income Taxes

During the three months ended March 31, 2023 and 2022, the Company recorded an income tax expense of $14,000 and zero, respectively. The Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States.

As of June 30, 2022,March 31, 2023, after consideration of certain limitations (see below), the Company had approximately $185.9$194.1 million federal and $3.4$3.6 million state net operating loss carryforwards ("NOL") available to reduce future taxable income which, if unused, the majority will carry forward indefinitely for federal and will begin to expire in 20332032 for state tax purposes. Contained in the federal NOL carryforward are $87.1 million that will not be immediately available to offset due to 382 limitations but will free up in varying amounts each year.

If the Company experiences a greater than 50 percentage pointpercent aggregate change in ownership over a three-year period (a Section 382 ownership change), utilization of its pre-change NOL carry forwardscarryforwards are subject to annual limitation under Section 382 of the Internal Revenue Code (California has similar provisions).  The annual limitation is determined by multiplying the value of the Company's stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. The Company determined that ownership changes occurred on December 21,31, 2007, August 20, 2015, April 13, 2017, February 15, 2018, and February 18, 2020.2020, and December 26, 2022. The ability of the Company to use its remaining NOL and tax credit carry forwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership.

11.

Interest and Other Income (Expense), Net

The following table shows the detail of interest and other income (expense), net as follows (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Interest income

 

$

85

 

 

$

11

 

 

$

87

 

 

$

28

 

Gain from extinguishment of liability

 

 

 

 

 

 

 

180

 

 

 

Other

 

 

17

 

 

 

(25

)

 

 

 

 

 

(42

)

Total interest and other income (expense), net

 

$

102

 

 

$

(14

)

 

$

267

 

 

$

(14

)

12.

Restructuring

Reduction-in-Force

In November 2021, the Board approved a restructuring of its business based on its decision to stop the clinical development of MarzAA and focus solely on its complement programs and protease medicines platform. The restructuring included a reduction-in-force whereby approximately 35% of employees were terminated. During the year ended December 31, 2021, the Company recorded charges of $0.4 million related to one-time severance costs and related expenses in connection with the workforce reduction, and charges of $3.8 million related to the write-off of prepaid manufacturing costs that will no longer be used for the clinical development of MarzAA. The remaining restructuring liability of $0.2 million was paid during the second quarter of 2022.

In March 2022, the Board approved a further reduction of its workforce as part of its restructuring plan whereby 22 full-time employees were terminated. Following this reduction, the Company had 5five full-time employees remaining. During the quarter ended March 31, 2022, the Company recorded additional charges of $1.0 million for severance and other costs related to the reduction-in-force, recognized as an operating expense within the condensed consolidated statements of operations, which the Company paid induring the second quarter of 2022.

Sale of Assets

During the quarter ended June 30, 2022, the Company entered into sales agreements with Dren Bio, Inc. and Copia Scientific, LLC, pursuant to which the Company sold various lab equipment, consumables, and furniture and fixtures for total consideration of $0.4 million. The Company recorded a loss on disposal of $0.2 million, which is included in gain on disposal of assets, net in the condensed consolidated statements of operations.

15


Catalyst Biosciences, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

In May 2022, the Company entered into an asset purchase agreement with Vertex, pursuant to which Vertex purchased the Company’s complement portfolio, including CB 2782-PEG and CB 4332, as well as its complement-related intellectual property including the ProTUNETM and ImmunoTUNETM platforms for $60.0 million in cash consideration. Cash of $55.0 million was received upfront in May 2022 and the remaining $5.0 million will be paid one year after the closing upon satisfaction of certain post-closing indemnification obligations. The hold-back amount is recorded within accounts and other receivables net on the condensed consolidated balance sheet. Once received, the net proceeds from the hold-back amount will be distributed to the CVR Holders pursuant to the CVR Agreement, see Note 9, Commitments and Contingencies. There were no carrying amounts associated with the intellectual property sold to Vertex, and, therefore, the Company recorded a gain of $57.4 million related to the disposal, net of $2.6 million of transaction costs during the second quarter of 2022.


In February 2023, Catalyst entered into an asset purchase agreement with GCBP, pursuant to which GCBP acquired the Company’s legacy rare bleeding disorders programs, including MarzAA, DalcA and CB-2679d-GT, for $6.0 million in cash consideration. Cash of $1.0 million was received upfront in February 2023 and the remaining $5.0 million will be paid two years after the closing upon satisfaction of certain post-closing indemnification obligations. The hold-back amount is recorded as a long-term receivable on the condensed consolidated balance sheet. In March 2023, the Company distributed the net cash proceeds received upfront of $0.2 million to the CVR Holders. Once received, the remaining net proceeds, net of expenses, from the hold-back amount will be distributed to the CVR Holders pursuant to the CVR Agreement, see Note 9, Commitments and Contingencies. There were no carrying amounts associated with the intellectual property sold to GCBP, and, therefore, Catalyst recorded a gain of $4.7 million related to the disposal, net of $0.8 million of transaction costs, which is included in gain on disposal of assets, net in the condensed consolidated statements of operations.operations for the three months ended March 31, 2023.

13.12.

Subsequent EventEvents

In August 2022,Cost Sharing Agreement

On April 13, 2023, the Company entered into ana Cost Sharing and Agency Agreement with GNI. Under this agreement, GNI will pay for certain costs related to the development of the F351 Assets in the U.S. incurred from December 26, 2022 until the Business Combination Agreement closes. After the Business Combination Agreement closes, the Company will be required to reimburse GNI for such costs. The Company has not incurred any expenses related to the development of the F351 Assets through March 31, 2023.

Manufacturing Agreements

On April 18, 2023, the Company entered into two separate agreements to support the F351 Assets acquired from GNI. One agreement will cover analytical method process familiarization and validation to support good manufacturing practices (“GMP”) manufacturing, and the other agreement will cover non-GMP manufacturing services and clinical supply batch GMP manufacturing of the F351 Assets, with total payments of up to $0.3 million and $0.2 million, respectively. The Company can terminate its license agreementthese agreements at any time upon 90 days written notice. Upon termination, the Company will be responsible to pay for the use of laboratory facilitiesservices incurred prior to termination and any non-cancellable obligations in South San Francisco, CAconnection with a termination date of August 14, 2022.

such services.


ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Unless otherwise indicated, in this Quarterly Report on Form 10-Q, references to “Catalyst,” “we,” “us,” “our” or the “Company” mean Catalyst Biosciences, Inc. and our subsidiary. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes that appear in this Quarterly Report on Form 10-Q (this “Report”) and with the audited consolidated financial statements and related notes that are included as part of our Annual Report on Form 10-K for the year ended December 31, 2021 (“Annual2022 (the “Annual Report”).

In addition to historical information, this Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”). Forward-looking statements are identified by words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. For example, forward-looking statements include any statements regarding the strategies, prospects, plans, expectations or objectives of management for future operations or the distribution of cash to Company stockholders, the benefits that may be derived from product candidates or the commercial or market opportunity in any target indication, our ability to protect intellectual property rights, our anticipated operations, financial position, revenues, costs or expenses, statements regarding future economic conditions or performance, statements of belief and any statement of assumptions underlying any of the foregoing. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part II, Item 1A — “Risk Factors,” elsewhere in this Report and in Part I - Item 1A – “Risk Factors” in the Annual Report. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this Report, speak only as of their date, and we undertakeCatalyst undertakes no obligation to update or revise these statements in light of future developments. We cautionCatalyst cautions investors that ourits business and financial performance are subject to substantial risks and uncertainties.

Overview

We are a biopharmaceutical company with expertise in protease engineering. PriorF351 Asset Acquisition

On December 26, 2022, Catalyst acquired the F351 Assets from GNI Group Ltd. and GNI Hong Kong Limited (the “Sellers”) pursuant to ceasing researchthat certain F351 Agreement, by and development activities in March of this year, we had engineered several protease assets that may address unmet medical needs in disordersamong Catalyst and the Sellers. The F351 Assets include 15 issued or pending patents and patent applications outside of the complement or coagulation systems. We intendPeople’s Republic of China, with the last acquired issued patent expected to distributeexpire in August 2037. Under the terms of the F351 Agreement and upon the effective time of the transactions contemplated by the F351 Agreement, Catalyst issued to the Sellers equity interests with an aggregate value of $35.0 million in the form of: 6,266,521 shares of the Company’s available cash,common stock and 12,340 shares of newly designated Series X convertible preferred stock (“Catalyst Convertible Preferred Stock”), which Catalyst Convertible Preferred Stock is convertible, upon the approval of the stockholders of Catalyst (as further described herein) into shares of common stock at a ratio of one (1) share of Catalyst Convertible Preferred Stock to 10,000 shares of common stock.

Subject to stockholder approval, each share of Catalyst Convertible Preferred Stock issued under the F351 Agreement is convertible into 10,000 shares of common stock. Pursuant to the F351 Agreement, Catalyst has agreed to hold a stockholders’ meeting, which is expected to be held in the third quarter of 2023, to submit the following matters to the Company’s stockholders for their consideration: (i) the approval of the conversion of the Catalyst Convertible Preferred Stock into shares of common stock in accordance with Nasdaq rules, or the Conversion Proposal, and (ii) if necessary or appropriate, the approval of an amendment to Catalyst’s certificate of incorporation to authorize sufficient shares of common stock for the conversion of the Catalyst Convertible Preferred Stock issued pursuant to the F351 Agreement. Following stockholder approval of the Conversion Proposal, each share of Catalyst Convertible Preferred Stock is convertible into shares of the Company’s common stock at any time at the option of the holder thereof, into 10,000 shares of its common stock, subject to certain limitations, including that a holder of Catalyst Convertible Preferred Stock is prohibited from converting shares of Catalyst Convertible Preferred Stock into shares of its common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be initially set at 9.99% and thereafter adjustable by the holder to a number between 4.99% and 19.99%) of the total number of shares of Catalyst’s common stock issued and outstanding immediately after paying or reservinggiving effect to such conversion.

Business Combination Agreement

On December 26, 2022, Catalyst, GNI USA, Inc., GNI Japan, GNI Hong Kong, Shanghai Genomics, Inc. (collectively the “Contributors”), the individuals (collectively the “Minority Holders”) listed on an annex to that certain Business Combination Agreement, as amended (the “Business Combination Agreement”) and Continent Pharmaceuticals Inc. (“CPI”) entered into the Business Combination Agreement. The Business Combination Agreement contains the terms and conditions of the proposed business combination pursuant to which Catalyst will acquire an indirect controlling interest in BC. The closing of the transactions under the Business


Combination Agreement will be subject to stockholder approval at a stockholder meeting expected to be held in the third quarter of 2023 and certain customary closing conditions. If the transaction is approved by stockholders, Catalyst would issue at closing a total of up to 1,110,776,224 shares of its common stock for our obligationsan indirect controlling interest in BC.

The Business Combination Agreement contains certain termination rights, including the right for it to terminate the Business Combination Agreement to enter into a definitive agreement for a superior proposal. Upon termination of the Business Combination Agreement under specified circumstances, Catalyst may be required to pay a termination fee of $2.0 million and liabilities, to stockholders as sooneither party, as the potential liabilitycase may be, may be required to reimburse the other party for reasonable out-of-pocket fees and expenses associatedincurred by such party in connection with the ongoing Delaware Court of Chancery stockholder litigation are understood. The timing andBusiness Combination Agreement, up to a maximum amount of anticipated$2.0 million.

Contingent Value Rights Agreement

Concurrent with the signing of the Business Combination Agreement, Catalyst entered into the CVR Agreement, pursuant to which each common stockholder, excluding GNI, received one CVR issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of common stock held by such holder at the CVR Record Date. Each CVR entitles the holder thereof to receive (i) certain cash distributions at this timepayments from the net proceeds, if any, related to (a) the disposition of its legacy assets within 90 calendar days after the remainder of the Holdback Amount (as defined in the CVR Agreement) is finally determined and received by Catalyst or (b) the resolution of certain legal claims; provided, however, such period will be automatically extended for any Claim (as defined in the CVR Agreement) for an additional one-year period to the extent any Claim is appealed during the initial term, (ii)100% of the excess cash (net of all current or contingent liabilities, including transaction-related expenses) retained by the Company in excess of $1.0 million as of the closing date of the transactions under the Business Combination Agreement, and (iii) 100% of the amount actually received (net of indemnity claims, if any) by Catalyst pursuant to the asset purchase agreement dated as of May 19, 2022, by and between Catalyst and Vertex. The contingent payments under the CVR Agreement, if they become payable, will become payable to the Rights Agent (as defined in the CVR Agreement) for subsequent distribution to the CVR Holders. In the event that no such proceeds are uncertain. Although we may potentially distribute upreceived, or the permitted deductions under the CVR Agreement are greater than any such proceeds, CVR Holders will not receive any payment pursuant to $65.0 million to stockholders in one or more distributions, therethe CVR Agreement. There can be no assurance that CVR Holders will receive any amounts. The CVRs are not transferable, except in certain limited circumstances as provided for in the CVR Agreement, will not be certificated or evidenced by any instrument, and will not be registered with the SEC or listed for trading on any exchange.

Prior to the timing or amountsF351 acquisition, Catalyst was engaged in the research and development of any distributions we make. The actual amount of any distributions will depend on many factors, including, without limitation, costs incurred by the Company in connection with ongoing litigation, the amount of any judgement that may be rendered against the Company in such litigation, if any, costs and expenses for ongoing operations, directors and officers liability insurance, tax obligations including resultingproduct candidates from the sale of assets to Vertex Pharmaceuticals Incorporated (“Vertex”), employee severance and other activities related to the winding down of company operations, the Company’s receipt of some or all of the $5.0 million hold-back from the Company’s sale of assets to Vertex, and potential proceeds from the sale, license or other disposition of any other Company assets.


The following table summarizes our remaining intellectual property with their latest stage of development.

Program Status

Catalyst’s protein engineering platform. In February 2022, weCatalyst announced that weit engaged Perella Weinberg Partners as a financial advisor to assist usCatalyst in exploring strategic alternatives to monetize ourits assets. In March 2022, Catalyst ceased research and development activities and in May 2022, weCatalyst entered into an asset purchase agreement with Vertex, pursuant to which Vertex purchased ourCatalyst’s complement portfolio, including CB 2782-PEG and CB 4332, as well as ourits complement-related intellectual property, including the ProTUNETMProTUNE™ and ImmunoTUNETMImmunoTUNE™ platforms, for $60.0 million in cash consideration. Cash of $55.0 million was received upfront and the remaining $5.0 million was retained by Vertex as a hold-back until one year after the closing date to satisfy certain post-closing indemnification obligations. Our clinical stage coagulation assets are Marzeptacog alfa (activated)Any amounts received from Vertex with respect to this hold-back, net of expenses, will be distributed to the CVR Holders. On February 27, 2023, Catalyst signed an asset purchase agreement with GC Biopharma Corp. (“GCBP”) pursuant to which GCBP acquired Catalyst’s legacy rare bleeding disorders programs including marzeptacog alpha activated (“MarzAA”), an SQ administered next-generation engineered coagulation Factor VIIa (“FVIIa”) for the treatment of episodic bleeding and prophylaxis in subjects with rare bleeding disorders, and dalcinonacog alfaalpha (“DalcA”), and CB-2679d-GT for a next-generation SQ FIX for prophylaxistotal of $6.0 million in hemophilia B. Both MarzAAcash consideration, $1.0 million payable on signing and DalcA have shown clinical efficacy and safety in mid-stage trials and are available for partnering.

Coagulation Programs

MarzAA

MarzAA is an engineered, subcutaneously administered, next-generation recombinant Factor VIIa. We commenced enrollment$5.0 million payable on February 28, 2025, subject to satisfaction of Crimson-1, a Phase 3 registrational trialpost-closing indemnification obligations. In March 2023, Catalyst distributed net proceeds of MarzAA for episodic treatment of spontaneous or traumatic bleeding episodes in adolescents and adults with congenital hemophilia A or hemophilia B with inhibitors in May 2021. We discontinued this trial based on a number of factors, including challenges in enrollment, competition from competing approved therapies,approximately $0.2 million to the capital requirements to complete the trial, and other operational factors. Patients enrolled in the study returned to their standard of care and completed all required safety assessments. We reported interim data collected prior to trial termination on July 11 at the 2022 International Society on Thrombosis and Haemostasis (“ISTH”) Congress in London. These data showed that MarzAA was well tolerated with no injection site reactions, drug-related adverse events, or thrombotic events. Efficacy data was collected on 14% (66/488) of planned, evaluable bleeds with SQ MarzAA having an 86.2% treatment success at 24 hours vs 86.5% treatment success for intravenous standard of care at 24 hours. We had initiated enrollment in a Phase 1/2 trial of MarzAA for treatment of bleeding in individuals with Factor VII Deficiency, Glanzmann Thrombasthenia, and hemophilia A with inhibitors on emicizumab prophylaxis. This trial was terminated in parallel with Crimson-1 in November 2021.

Despite having to discontinue these trials due to logistical, competitive and financial challenges, we believe a SQ recombinant Factor VIIa therapy, like MarzAA, has the potential to be an important treatment option for patients with various bleeding disorders and are exploring opportunities to license or sell MarzAA to another party for further development.


DalcA

DalcA is a next-generation SQ Factor IX product candidate for the prophylactic treatment of individuals with hemophilia B. An open-label, Phase 2b study was completed in 2020, demonstrating that FIX plasma activity levels were raised from severe to mild hemophilia B levels and maintained throughout the course of the study. We haveCVR Holders. Once received, guidanceany additional net proceeds from the FDA ontransaction will be distributed to the design ofCVR Holders. Catalyst is also pursuing certain legal claims against a third party related to payments under a 2016 asset purchase agreement, and any net recoveries related to these claims will be distributed to the registrational Phase 3 clinical trial, have the necessary data to support its initiation, and are exploring opportunities to license or sell DalcA to another party for further development.CVR Holders.

We haveFinancial Operations Overview

Catalyst has no drug products approved for commercial sale and havehas not generated any revenue from drug product sales.

With the exception of the three and six months ended March 31, 2023 and June 30, 2022, we haveCatalyst has never been profitable and havehas incurred significant operating losses in each year since inception. WeCatalyst had net income of $51.6$0.3 million and net losses of $19.9$14.5 million for the three months ended June 30,March 31, 2023 and 2022, and 2021, respectively, and net income of $37.1 million and net losses of $42.4 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, weMarch 31, 2023, Catalyst had an accumulated deficit of $365.6 million. As of June 30, 2022, our$410.7 million and cash and cash equivalents balance was $75.4of $8.1 million. Substantially all ourits operating losses were incurred in ourits research and development programs and in ourits general and administrative operations.


Financial Operations Overview

License and Collaboration Revenue

License and collaborationCollaboration revenue consists of revenue earned for performance obligations satisfied pursuant to our licensethe License and collaboration agreementCollaboration Agreement with Biogen which was entered into in December 2019 and terminated as ofin May 2022. In consideration for the grant of an exclusive license and related know-how, we received an up-front license payment of $15.0 million in January 2020, which was recorded in license revenue during the year ended December 31, 2020. We2022 (the “Biogen Agreement”). Catalyst recognized collaboration revenue for reimbursable third-party vendor, out-of-pocket and personnel costs pertaining to the Biogen Agreement of $0.8 million for the sixthree months ended June 30, 2022, and $1.1 million and $2.6 millionMarch 31, 2022. No collaboration revenue was recognized for the three and six months ended June 30, 2021, respectively.March 31, 2023.

We haveCatalyst has not generated any revenue from the sale of any drug products and we doCatalyst does not expect to generate any revenue from the sale of drug products until we obtainCatalyst obtains regulatory approval of and commercialize ourcommercializes its product candidates.

Cost of License and Collaboration Revenue

Cost of license and collaboration revenue consists of fees for research and development services payable to third-party vendors and personnel costs, corresponding to the recognition of license and collaboration revenue from Biogen. Cost of license and collaboration revenue does not include any allocated overhead costs. In connection with the license revenue recognized from Biogen as discussed above in 2020, we paid Mosaic a $3.0 million sublicense fee and recorded such payment as cost of license. WeCatalyst recognized third-party vendor, out-of-pocket and personnel costs, most of which were reimbursable, pertaining to the Biogen Agreement of $0.8 million for the sixthree months ended June 30,March 31, 2022, and $1.1 million and $2.6 million for the three and six months ended June 30, 2021, respectively, and recorded such costs as cost of collaboration revenue. No cost of collaboration revenue was recognized for the three months ended March 31, 2023.

Research and Development Expenses

As of March this year, we2022, Catalyst ceased the development of certain programs and during the quarter ended June 30, 2022, we haveCatalyst ceased all research and development activities. Research and development expenses represent costs incurred to conduct research, such as the discovery and development of ourits product candidates. We recognizeCatalyst recognizes all research and development costs as they are incurred. Nonrefundable advance payments for goods or services used in research and development are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered or services are performed, or until it is no longer expected that the goods or services will be delivered.

Research and development expenses have traditionally consisted primarily of the following:

 

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

 

laboratory and vendor expenses, including payments to consultants and third parties, related to the execution of preclinical, non-clinical and clinical studies;

 

the cost of acquiring and manufacturing preclinical and clinical materials and developing manufacturing processes;

 

clinical trial expenses, including costs of third-party clinical research organizations;

 

performing toxicity and other preclinical studies; and

 

facilities and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization expense and other supplies.


The table below details ourthe Company’s internal and external costs for research and development for the period presented (in thousands)thousands). See Overview and Program Status for further discussion of the current research and development programs.

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Hemophilia

 

$

29

 

 

$

4,444

 

 

$

2,081

 

 

$

11,814

 

Complement

 

 

756

 

 

 

5,875

 

 

 

4,139

 

 

 

10,525

 

Personnel and other

 

 

1,003

 

 

 

4,676

 

 

 

5,143

 

 

 

9,300

 

 

$

522

 

 

$

4,140

 

Stock-based compensation

 

 

83

 

 

 

394

 

 

 

211

 

 

 

763

 

 

 

66

 

 

 

128

 

Complement

 

 

 

 

 

3,383

 

Hemophilia

 

 

 

 

 

2,052

 

Total research and development expenses

 

$

1,871

 

 

$

15,389

 

 

$

11,574

 

 

$

32,402

 

 

$

588

 

 

$

9,703

 

The largest component of our total operating expenses hashad historically been ourCatalyst’s investment in research and development activities, including the clinical and manufacturing development of ourits product candidates. Costs listed for ourits hemophilia and complement programs above consist of clinical trial, manufacturing and research costs. OurIts internal resources, employees and infrastructure, identified above as personnel and other, are generally not directly tied to individual product candidates or development programs. As such, we doCatalyst does not maintain information regarding these costs incurred for these research and development programs on a project-specific basis.

Since we haveCatalyst has entered into a Cost Sharing and Agency Agreement with GNI USA, Inc. pursuant to which GNI USA, Inc. will be responsible for development expenses related to the F351 Assets until the closing of the transactions under the Business Combination Agreement. Accordingly, since Catalyst has ceased ourits other research and development activities, weit does not expect our aggregateto incur material research and development expenses will be minimal duringuntil the next year as we continue to explore strategic opportunities for the clinical and manufacturing development of our programs.

On May 20, 2016, we signed a development and manufacturing services agreement with AGC, pursuant to which AGC conducted manufacturing development of agreed upon product candidates. We will own all intellectual property developed in such manufacturing development activities that are specifically related to our product candidates and will have a royalty-free and perpetual license to use AGC’s intellectual property to the extent reasonably necessary to make these product candidates, including commercial manufacturing. As of June 30, 2022, six GMP batches have been manufactured at AGC in addition to an engineering batch.

The initial termclosing of the agreement is ten years or, if later, until all stages under outstanding statements of work have been completed. Either party may terminate the agreement in its entirety upon written notice of a material uncured breach or upon the other party’s bankruptcy, and we may terminate the agreement upon prior notice for any reason. In addition, each party may terminate the agreement in the event that the manufacturing development activities cannot be completed for technical or scientific reasons. We had firm work orders with AGC to manufacture MarzAA and DalcA to support clinical trials totaling $15.8 million, and the payment obligations were fully paid off as of December 31, 2021. We also had firm work orders with AGC to perform certain manufacturing services related to our collaboration agreement with Biogen totaling $0.7 million and the payment obligations were fully paid off as of March 31, 2022. In connection with the sale of our complement portfolio, Vertex assumed responsibility for further manufacturing of our complement-related programs. During the quarter ended June 30, 2022, we terminated our manufacturing agreement with AGC for Catalyst’s remaining programs and have no remaining obligationstransactions under the agreement as of June 30, 2022.

In July 2021, we entered into an agreement for our screening and natural history of disease clinical studies related to CFI deficiency, with total payments of up to $6.5 million. During the quarter ended June 30, 2022, we terminated this agreement and incurred $0.8 million for clinical trial services incurred prior to termination and reasonable wind-down expenses. As of June 30, 2022, we have no remaining obligations under this agreement.

On September 16, 2021, we signed a Manufacturing and Research and Development Studies Agreement to support the lyophilized drug product, CB 4332. The agreement covers analytical method qualification to support GMP manufacturing. We had firm work orders related to this agreement totaling $0.3 million. During the quarter ended June 30, 2022, we terminated this agreement and the payment obligations were fully paid off as of June 30, 2022.

We also have a long-term clinical supply services agreement with Catalent Indiana, LLC (“Catalent”). Catalent has facilities in the U.S. and Europe and conducts drug product development and manufacturing for MarzAA and DalcA. We successfully completed development work for a variety of vial sizes which supports flexible dosing.Business Combination Agreement.


General and Administrative Expenses

General and administrative expenses consist of personnel costs, allocated expenses, expenses for outside professional services, including legal, human resources, audit and accounting services, and other general expenses. Personnel costs consist of salaries, bonus,bonuses, benefits and stock-based compensation. We incurCatalyst incurs expenses associated with operating as a public company, including expenses related to compliance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and Nasdaq Stock Market LLC (“Nasdaq”), insurance expenses, audit expenses, investor relations activities, Sarbanes-Oxley compliance expenses and other administrative expenses and professional services. We expect such expenses

Gain on Disposal of Assets

Gain on disposal of assets resulted from the sale of Catalyst’s legacy rare bleeding disorder program, including MarzAA, DalcA and CB-2679d-GT to fluctuate as we continue to explore strategic opportunities for our programs.GCBP in February 2023. The gain is presented net of the direct costs incurred in connection with the transaction.

Results of Operations

The following table set forth ourthe Company’s results of operations data for the periods presented (in thousands):

 

 

Three Months Ended June 30,

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change ($)

 

 

Change (%)

 

 

2023

 

 

2022

 

 

Change ($)

 

 

Change (%)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration

 

$

 

 

$

1,132

 

 

$

(1,132

)

 

 

(100

)%

 

$

 

 

$

794

 

 

$

(794

)

 

 

(100

)%

Operating expenses (income):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of collaboration

 

 

 

 

 

1,139

 

 

 

(1,139

)

 

 

(100

)%

 

 

 

 

 

798

 

 

 

(798

)

 

 

(100

)%

Research and development

 

 

1,871

 

 

 

15,389

 

 

 

(13,518

)

 

 

(88

)%

 

 

588

 

 

 

9,703

 

 

 

(9,115

)

 

 

(94

)%

General and administrative

 

 

3,844

 

 

 

4,518

 

 

 

(674

)

 

 

(15

)%

 

 

3,970

 

 

 

4,994

 

 

 

(1,024

)

 

 

(21

)%

Gain on disposal of assets, net

 

 

(57,245

)

 

 

 

 

 

(57,245

)

 

 

100

%

 

 

(4,736

)

 

 

 

 

 

(4,736

)

 

 

100

%

Total operating expenses (income)

 

 

(51,530

)

 

 

21,046

 

 

 

(72,576

)

 

*

 

 

 

(178

)

 

 

15,495

 

 

 

(15,673

)

 

*

 

Income (loss) from operations

 

 

51,530

 

 

 

(19,914

)

 

 

71,444

 

 

*

 

 

 

178

 

 

 

(14,701

)

 

 

14,879

 

 

*

 

Interest and other income (expense), net

 

 

102

 

 

 

(14

)

 

 

116

 

 

*

 

Interest and other income, net

 

 

96

 

 

 

165

 

 

 

(69

)

 

 

(42

)%

Income (loss) before income taxes

 

 

274

 

 

 

(14,536

)

 

 

14,810

 

 

*

 

Income tax expenses

 

 

14

 

 

 

 

 

 

14

 

 

 

100

%

Net income (loss)

 

$

51,632

 

 

$

(19,928

)

 

$

71,560

 

 

*

 

 

$

260

 

 

$

(14,536

)

 

$

14,796

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*Not meaningful

 

 

Six Months Ended June 30,

 

 

 

 

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change ($)

 

 

Change (%)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration

 

$

794

 

 

$

2,599

 

 

$

(1,805

)

 

 

(69

)%

Operating expenses (income):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of collaboration

 

 

798

 

 

 

2,619

 

 

 

(1,821

)

 

 

(70

)%

Research and development

 

 

11,574

 

 

 

32,402

 

 

 

(20,828

)

 

 

(64

)%

General and administrative

 

 

8,838

 

 

 

9,930

 

 

 

(1,092

)

 

 

(11

)%

Gain on disposal of assets, net

 

 

(57,245

)

 

 

 

 

 

(57,245

)

 

 

100

%

Total operating expenses (income)

 

 

(36,035

)

 

 

44,951

 

 

 

(80,986

)

 

*

 

Income (loss) from operations

 

 

36,829

 

 

 

(42,352

)

 

 

79,181

 

 

*

 

Interest and other income (expense), net

 

 

267

 

 

 

(14

)

 

 

281

 

 

*

 

Net income (loss)

 

$

37,096

 

 

$

(42,366

)

 

$

79,462

 

 

*

 

License and Collaboration Revenue

No license and collaborationCollaboration revenue was recognized duringfor the three months ended June 30,March 31, 2022 due to the termination of our Biogen Agreement effective in May 2022, per Biogen’s written termination notice in March 2022. License and collaboration revenue for the six months ended June 30, 2022 and for the three and six months ended June 30, 2021 consisted of reimbursable collaboration expenses from ourthe Biogen Agreement.

Cost of License and Collaboration

No cost of license and collaboration revenue was recognized duringfor the three months ended June 30, 2022 due to the termination of our Biogen Agreement. March 31, 2023.

Cost of license andCollaboration

Cost of collaboration revenue for the sixthree months ended June 30,March 31, 2022 and for the three and six months ended June 30, 2021 primarily related to reimbursable third-party vendor and personnel costs we incurred pertaining to the Biogen Agreement. No cost of collaboration revenue was recognized for the three months ended March 31, 2023.


Research and Development Expenses

Research and development expenses were $1.9$0.6 million and $15.4$9.7 million during the three months ended June 30,March 31, 2023 and 2022, and 2021, respectively, a decrease of $13.5$9.1 million, or 88%. The decrease was primarily due to a decrease of $5.1 million in complement-related costs, a decrease of $4.4 million in hemophilia-related costs, a decrease of $3.7 million in personnel-related costs, and a $0.3 million decrease in stock-based compensation expense.

Research and development expenses were $11.6 million and $32.4 million during the six months ended June 30, 2022 and 2021, respectively, a decrease of $20.8 million, or 64%(94)%. The decrease was due primarily to a decrease of $9.7$3.6 million in hemophilia-relatedpersonnel-related costs, a decrease of $6.4$3.4 million in complement-related costs, and a decrease of $4.2$2.1 million in personnel-related costs, and a $0.5 million decrease in stock-based compensation expense.hemophilia-related costs. Research and development expenses for the sixthree months ended June 30,March 31, 2022 include approximately $0.6 million of severance and other costs related to ourits reduction-in-force.


General and Administrative Expenses

General and administrative expenses were $3.8$4.0 million and $4.5$5.0 million during the three months ended June 30,March 31, 2023 and 2022, and 2021, respectively, a decrease of $0.7$1.0 million, or 15%. This decrease was due primarily to a decrease of $1.1 million in personnel-related costs and a $0.2 million decrease in professional fees, partially offset by an increase of $0.4 million in facilities and other administrative costs and a net increase of $0.2 million related to settlements reached with Biogen and certain contract service vendors.

General and administrative expenses were $8.8 million and $9.9 million during the six months ended June 30, 2022 and 2021, respectively, a decrease of $1.1 million, or 11%(21)%. The decrease was due primarily to a decrease of $1.1 million in personnel-related costs and a decrease of $0.8$0.7 million in professional fees,services and a $0.4 million decrease in personnel-related costs, partially offset by an increase of $0.4$0.1 million in facilities and other administrative costs, an increase of $0.2 million related to our allowance for doubtful accounts, and a net increase of $0.2 million related to settlements reached with Biogen and certain contract service vendors.overhead costs. General and administrative expensesfor the sixthree months ended June 30,March 31, 2022 include approximately $0.4 million of severance and other costs related to ourits reduction-in-force.

Gain on Disposal of Assets, Net

Gain on disposal of assets, net was $57.2$4.7 million for the three and six months ended June 30, 2022,March 31, 2023, which primarily consisted of a $57.4 million gain related to the sale of our complement portfolioCatalyst’s legacy rare bleeding disorder program to VertexGCBP in May 2022.February 2023.

Interest and Other Income, (Expense), Net

The $0.1 million increasedecrease in interest and other income, (expense), net for the three months ended June 30, 2022March 31, 2023 compared to the three months ended June 30, 2021 was primarily due to an increase in interest income.

The $0.3 million increase in interest and other income (expense), net for the six months ended June 30,March 31, 2022 compared to the six months ended June 30, 2021 was primarily due to a gain on extinguishment of $0.2 million gain recognized uponin the extinguishmentfirst quarter of a liability and2022 where there was no comparable activity in the first quarter of 2023, partially offset by an increase in interest income.income of $0.1 million.

Recent Accounting Pronouncements

Refer to “Accounting Pronouncements Recently Adopted” included in Note 2, Summary of Significant Accounting Policies, in the “Notes to the Condensed Consolidated Financial Statements” in this Form 10-Q.Report.

Liquidity and Capital Resources

On January 12, 2023, Catalyst paid a one-time cash dividend of $0.24 per share, or approximately $7.6 million, to holders of the Company’s common stock, excluding GNI.

On March 8, 2023, the Company distributed the net cash proceeds received from the GCBP asset sale of $0.2 million, or $0.01 per share, to holders of the Company’s common stock, excluding GNI.

As of June 30, 2022, weMarch 31, 2023, Catalyst had $75.4$8.1 million of cash and cash equivalents. For the sixthree months ended June 30, 2022, weMarch 31, 2023, Catalyst had $37.1 million in net income of $0.3 million and $24.3$6.2 million cash used in operating activities. We haveCatalyst had an accumulated deficit of $365.6$410.7 million as of June 30, 2022. Our primary uses of cash are to fund operating and general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.


We believeMarch 31, 2023. Catalyst expects that ourits existing capital resources, including cash and cash equivalents will beare sufficient to meet our projectedsupport its operating requirements forexpenses through at least the next 12 months from the date of this filing. We havefiling, assuming the Company’s stockholders approve the Conversion Proposal. Catalyst’s estimate as to how long the Company expects its cash and cash equivalents to be able to fund its operations is based this estimate on assumptions that may prove to be wrong, and weit could utilize ouruse the Company’s available capital resources sooner than weit currently expect. We planexpects. Further, changing circumstances, some of which may be beyond Catalyst’s control, could cause it to consume capital significantly faster than currently anticipated, and the Company may need to seek additional funds sooner than planned.

In connection with the F351 Agreement, Catalyst issued Catalyst Convertible Preferred Stock to GNI. Catalyst is obligated to seek stockholder approval for the conversion of the Catalyst Convertible Preferred Stock into common stock. In the event that the Company fails to timely hold the stockholders’ meeting or fails to obtain stockholder approval of the Conversion Proposal, then the holders of the Catalyst Convertible Preferred Stock would be entitled to require Catalyst to redeem, in cash, the shares of common stock underlying its Catalyst Convertible Preferred Stock at a price per share equal to the fair value of the common stock. If Catalyst is forced to redeem a significant amount of shares underlying the Catalyst Convertible Preferred Stock, it could, among other things, materially affect the Company’s results of operations and cash usage forecasts, require Catalyst to raise additional capital and impact its ability to raise additional capital. Also, while Catalyst cannot predict the amount with any level of certainty, there is a level of cash settlement at which, if it is exceeded, could require Catalyst to make redemption payments in excess of its current liquidity. Catalyst believes that its stockholders who are entitled to vote on the Conversion Proposal at its 2023 Annual Meeting of Stockholders, which is expected to be held in the third quarter of 2023, will vote to approve the proposal. However, as the vote of the Company’s stockholders is outside of its control, there is substantial doubt about Catalyst’s ability to continue as a going concern within one year from the filing of this Report.

Catalyst expects to fund losses from operations and capital fundingfinance any future cash needs through our current cash balance, as well as potential additional asset sales,a combination of divestitures of its product candidates or other assets, equity offerings, debt financings, collaborations, strategic alliances and licensing transactions, collaborations or strategic partnerships with other companies. As of June 30, 2022, we had effective registration statements on Form S-3 that enable us to sell up to $150.0 million in securities subject to limitations under SEC rules. 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. Licensing transactions, collaborations or strategic partnerships may result in us relinquishing valuable rights. Wearrangements. There can providebe no assurance thatas to the timing, terms or consummation of any divestiture or financing, will be available inand the amounts we needterms of any such financing may adversely affect the Company’s stockholders’ rights. If Catalyst raises funds through collaborations, strategic alliances or licensing arrangements with third parties, it may have to relinquish valuable rights to its technologies, product candidates or to grant licenses on terms acceptablethat may not be favorable to us, if at all. If we are not able to secure adequate additional funding we may be forced to delay, 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.the Company.


The following table summarizes ourthe Company’s cash flows for the periods presented (in thousands):

 

 

Six Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

 

2023

 

 

2022

 

Cash used in operating activities

 

$

(24,344

)

 

$

(44,479

)

 

$

(6,216

)

 

$

(12,050

)

Cash provided by investing activities

 

 

55,375

 

 

 

38,285

 

 

 

411

 

 

 

2,504

 

Cash provided by financing activities

 

 

16

 

 

 

49,455

 

Net increase in cash and cash equivalents

 

$

31,047

 

 

$

43,261

 

Cash (used in) provided by financing activities

 

 

(7,762

)

 

 

16

 

Net decrease in cash and cash equivalents

 

$

(13,567

)

 

$

(9,530

)

Cash Flows from Operating Activities

Cash used in operating activities for the sixthree months ended June 30, 2022March 31, 2023 was $24.3$6.2 million. The most significant component of ourthe Company’s cash used was a net loss of $20.1$4.4 million excluding the net gain of $57.2$4.7 million from the sale of our complement portfolio and other assets.its legacy rare bleeding disorder program. The net loss included non-cash expense related to stock-based compensation of $0.9 million, bad debt expense of $0.2 million, and depreciation and amortization of $0.2 million. In addition, net cash outflow of $5.4$2.0 million was attributable to the change in ourits net operating assets and liabilities primarily as a result of a $5.4 million decrease in accounts payable, a $3.7$2.4 million decrease in accrued compensation and other accrued liabilities and a $0.2 million decrease in deferred revenue related to the Biogen Agreement,accounts payable, partially offset by a $2.2$0.6 million decrease in prepaid and other current assets.

Cash used in operating activities for the three months ended March 31, 2022 was $12.1 million. The most significant component of the Company’s cash used was a net loss of $14.5 million. This included non-cash expense related to stock-based compensation of $0.5 million, bad debt expense of $0.2 million and depreciation and amortization of $0.1 million. In addition, cash inflow of $1.7 million was attributable to the change in its net operating assets and liabilities primarily as a result of a $1.5 million decrease in prepaid and other current assets, and a $1.6$1.1 million decrease in accounts and other receivables.

Cash used in operating activities for the six months ended June 30, 2021 was $44.5 million, due primarily to a net loss of $42.4 million, and the change in our net operating assets and liabilities of $4.2 million. The change in our net operating assets and liabilities is due primarily to a $2.3 million increase in prepaid and other assetsreceivable, and a $4.1 million decrease in accounts payable, offset by a $0.1 million increase in deferred revenue related to the Biogen Agreement, a $1.3 million decrease in accounts and other receivables, a $0.7$1.0 million increase in accrued compensation and other accrued liabilities, partially offset by a $1.7 million decrease in accounts payable and a $0.1$0.2 million increasedecrease in changesdeferred revenue related to operating lease liabilities and right-of-use assets. Non-cash charges of $2.0 million were recorded for stock-based compensation.the Biogen Agreement.

Cash Flows from Investing Activities

Cash provided by investing activities for the sixthree months ended June 30, 2022March 31, 2023 was $55.4$0.4 million, due primarily to $55.0$1.0 million in cash proceeds from the sale of our complement portfoliothe Company’s legacy rare bleeding disorder program to Vertex, $2.5 million due to proceeds from maturities of investments, and $0.4 million in proceeds from the sale of property and equipment, partiallyGCBP, offset by $2.6$0.6 million in transaction costs related to the sale of our complement portfolioits legacy rare bleeding disorder program to Vertex.GCBP.

Cash provided by investing activities for the sixthree months ended June 30, 2021March 31, 2022 was $38.3$2.5 million, due primarily to $38.6 million in proceeds from maturities of investments, partially offset by $0.3 million used in purchases of property and equipment.investments.

Cash Flows from Financing Activities

Cash used in financing activities for the three months ended March 31, 2023 was $7.8 million, due primarily to the special dividend paid in January 2023 and the distribution of net proceeds related to the GCBP Agreement to the CVR Holders.

Cash provided by financing activities for the sixthree months ended June 30,March 31, 2022 was due to the issuance of stock grants and option exercises.grants.

Cash provided by financing activities for the six months ended June 30, 2021 was $49.5 million, due to $49.3 million in net proceeds from the issuance of common stock related to our public offering in the first quarter of 2021 and $0.2 million in stock grants and option exercises.


Critical Accounting Polices and Estimates

There have been no significant changes to ourCatalyst’s critical accounting policies since December 31, 2021.2022. For a description of critical accounting policies that affect ourits significant judgments and estimates used in the preparation of ourits unaudited condensed consolidated financial statements, refer to Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in ourthe Annual Report on Form 10-K.Report.

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

Not applicable.


ITEM 4.

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Management, with the participation of our Chief Executive Officer and our Interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2022.March 31, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensureprovide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to ourthe company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on thetheir evaluation of our disclosure controls and procedures as of June 30, 2022,March 31, 2023, our Chief Executive Officer and Interim Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were not effective due to an unremediated material weakness in our internal control over financial reporting.

As we continue to evaluate our internal control over financial reporting, we may determine that additional measures should be taken to addressat the identified control deficiency or other deficiencies, and/or that we should modify the remediation plan described below. Notwithstanding the identified material weakness in our internal control over financial reporting, we have concluded that the consolidated financial statements and other financial information included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial condition, results of operations and cash flows as of, and for, the periods presented.

Material Weakness in Internal Control Over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented or detected on a timely basis. In connection with management’s assessment of our internal control over financial reporting described above, management concluded that, as of June 30, 2022, a material weakness existed in our internal control over financial reporting.

Our material weakness related to the following control deficiency:

We did not design and maintain effective controls related to the review of certain contracts, including the proper application of U.S. GAAP. Specifically, we did not design and maintain controls to properly review the retention bonuses granted to our employees in November 2021 after our reduction in workforce to assess the appropriate accounting treatment under U.S. GAAP.

Remediation Plans

To address our material weakness, we have implemented internal control activity over our accounting policy for monitoring and reviewing personnel contracts so that contracts with a significant impact are reviewed and U.S. GAAP is properly applied. We have formalized our internal control documentation and strengthened supervisory reviews by our management. While these actions and planned actions are subject to ongoing management evaluation and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period to ensure proper seasoning and implementation, we are committed to continuous improvement and will continue to diligently review our internal control over financial reporting.assurance level.

Changes in Internal Control Over Financial Reporting

We are taking actions to remediate the material weakness relating to our internal control over financial reporting as described above. Except as described above, there wereThere has been no changeschange in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified during the quarter ended June 30, 2022March 31, 2023 that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.


PART II. OTHER INFORMATION

ITEM 1.

On June 15, 2022, certain Company stockholders who beneficially hold in the aggregate more than five percent (5%) of our common stock filedCatalyst is not a lawsuit in Delaware Chancery Court, captioned JDS1, LLC v. Catalyst Biosciences, Inc., et al., C.A. No. 2022-0515-KSJM (Del. Ch.), against the Company and its board of directors alleging, among other things, violations of Section 271 of the Delaware General Corporation Law and breach of fiduciary duty in connection with the Company’s asset saleparty to Vertex, as well as certain claims related to the alleged failure to disclose information related to the Vertex transaction. The plaintiffs sought an expedited hearing related to the disclosure claims, which the court denied. The Company has filed a motion to dismiss the disclosure claims, which is currently pending. Plaintiffs are seeking injunctive relief, declaratory relief, and unspecified damages. The Company believes these claims are without merit. There can be no assurance as to the time or expense that will be required to resolve theseany material legal proceedings.

ITEM 1A.

RISK FACTORS

The information set forth below and the risk factors disclosed in “Part I - Item 1A - Risk Factors” ofour Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission on March 31, 2022, disclose risk and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our common stock, and are incorporated herein by reference.

You should carefully consider the risks and uncertainties disclosed asfactors discussed in Part I, Item 1A., “Risk Factors” in our Annual Report for the fiscal year ended December 31, 2022, which could materially affect our business, financial position, or future results of operations. The risks described in our Annual Report for the fiscal year ended December 31, 2022, are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC. The risk factor set forth below supplements and updates the risk factors previously disclosed and should be read together with allthe risk factors described in our Annual Report for the fiscal year ended December 31, 2022 and with any risk factors we may include in subsequent periodic filings with the SEC.

Our common stock may be delisted from Nasdaq.

As previously reported, on November 2, 2022, Catalyst Biosciences, Inc., a Delaware corporation (the “Company” or “Catalyst”), received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, LLC (“Nasdaq”) informing the other information in this Report, includingCompany that, because the section titled “Part I - Financial Information - Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the condensed consolidated financial statements and related notes.

We may not be able to distribute as much cash to stockholders as we anticipate or as quickly as we anticipate.

The dividend or distribution of cash to our stockholders must come out of surplus as defined under Delaware law. To calculate our surplus, we must considerclosing bid price for the Company’s obligations and potential liabilities. In estimatingcommon stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the amount of cash that can be distributed,Company was not in compliance with the board has consideredminimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Company was granted 180 calendar days, or until May 1, 2023, to regain compliance with the Company’s anticipated and potential liabilities, including without limitation costs and expenses for ongoing operations, costs incurredMinimum Bid Price Requirement.

On May 2, 2023, the Company was notified by the Company in connection with ongoing litigation, the amountListing Qualifications Staff (the “Staff”) of any judgement that may be rendered against the Company in such litigation, if any, anticipated directors and officers liability insurance expense, tax obligations including resulting from the sale of assets to Vertex, employee severance and other activities related to the winding down of company operations.  If these expenses are higher than anticipated, the amountNasdaq that the Company can ultimately distribute to stockholders may be reduced.  In addition, ifdid not meet the Minimum Bid Price Requirement and was not eligible for a second 180-day period. As previously reported, on April 4, 2023, the Staff notified the Company does not receive some or allthat it failed to comply with Nasdaq’s $2,500,000 minimum stockholders’ equity requirement for continued listing as set forth in Listing Rule 5550(b)(1) (the “Equity Requirement”). The deficiency with regards to the Equity Requirement serves as an additional and separate basis for delisting. The Company timely submitted a hearing request to Nasdaq’s Hearings Department. The hearing request stays the suspension of the $5.0 million hold-back fromCompany’s common stock pending the Company’s salepanel’s conclusion of assetsthe hearing process. The Company believes that completion of the pending transactions under the Business Combination Agreement and reverse stock split as described in the preliminary proxy statement (the “Preliminary Proxy Statement”) filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 30, 2023 will enable the combined company following the transactions under the Business Combination Agreement to Vertex,meet the amount availableapplicable Nasdaq initial listing requirements, providing a basis for distribution to the Company’s stockholders may be reduced.suspension of delisting. There can be no assurance as tothat the timing or amount of distributions toCompany will succeed in its hearing and that the panel will grant the Company’s stockholders.request for a suspension of delisting or continued listing on The Nasdaq Capital Market, or that the combined company will meet Nasdaq’s initial listing requirements.

Delisting of our common stock from The Nasdaq Capital Market could materially adversely impact the liquidity and value of our common stock and could prevent the closing of the transactions contemplated by the Business Combination Agreement. Catalyst’s ability to publicly or privately sell equity securities and the liquidity of its common stock could be adversely affected if it is delisted from The Nasdaq Capital Market or if it is unable to transfer its listing to another stock market. If Catalyst’s common stock is delisted by Nasdaq, it could lead to a number of negative implications, including an adverse effect on the price of its common stock, increased volatility in its common stock, limited availability of market quotations for its common stock, reduced liquidity in its common stock, the loss of federal preemption of state securities laws and greater difficulty in issuing additional securities and obtaining financing. In addition, delisting of Catalyst’s common stock could deter broker-dealers from making a market in or otherwise seeking or generating interest in its common stock, could result in a loss of current or future coverage by certain sell-side analysts and might deter certain institutions and persons from investing in its securities at all. Delisting could also cause a loss of confidence of Catalyst’s customers, collaborators, vendors, suppliers and employees, which could harm its business and future prospects.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None.


ITEM 4.

MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5.

OTHER INFORMATION

None.

ITEM 6.

EXHIBITS

See Index to Exhibits at the end of this Report, which is incorporated by reference here. The Exhibits listed in the accompanying Index to Exhibits are filed as part of this Report.



EXHIBIT INDEX

 

Exhibit

Number

 

DescriptionExhibit Title

Form

File No.

Filing Date

Filed or Furnished herewith

2.1

Amendment to Business Combination Agreement, dated as of March 29, 2023, by and among Catalyst, GNI USA, GNI Group, GNI HK, Shanghai Genomics, the Minority Holders and CPI.

8-K

000-51173

March 30, 2023

2.2

Agreement and Amendment to Asset Purchase Agreement, dated as of March 29, 2023, by and among Catalyst, GNI Group and GNI HK.

8-K

000-51173

March 30, 2023

2.3

Contingent Value Rights Agreement, dated as of December 26, 2022, between Catalyst and American Stock Transfer & Trust Company, LLC

X

2.4

Amendment to Contingent Value Rights Agreement, dated as of March 29, 2023, executed by Catalyst.

8-K

000-51173

March 30, 2023

10.1§

Asset Purchase Agreement dated as of February 27, 2023 by and between Catalyst Biosciences, Inc. and GC Biopharma Corp.

8-K

000-51173

March 2, 2023

10.2**

Waiver Agreement between Catalyst Biosciences, Inc. and Dr. Nassim Usman, dated January 17, 2023.

X

10.3**

Waiver Agreement between Catalyst Biosciences, Inc. and Dr. Grant Blouse, dated January 14, 2023.

X

10.4**

Waiver Agreement between Catalyst Biosciences, Inc. and Ms. Seline Miller, dated January 17, 2023.

X

 

 

 

31.1

 

Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

31.2

 

Certification of the Interim Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

32.1

 

Certification of the Chief Executive Officer pursuant to Rule 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

32.2

 

Certification of the Interim Chief Financial Officer pursuant to Rule 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

 

 

 


101

 

The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022,March 31, 2023, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets as of June 30, 2022March 31, 2023 (unaudited) and December 31, 2021;2022; (ii) the Condensed Consolidated Statements of Operations for the three and six months ended June 30,March 31, 2023 and 2022 and 2021 (unaudited); (iii) the Condensed Consolidated StatementsStatement of Comprehensive Income (Loss) for the threeRedeemable Convertible Preferred Stock and six months ended June 30,Stockholders’ Equity (Deficit) as of March 31, 2023 and March 31, 2022 and 2021 (unaudited); (iv) the Condensed Consolidated Statement of Stockholders’ Equity as of June 30, 2022 and June 30, 2021 (unaudited); (v) the Condensed Consolidated Statements of Cash Flows for the sixthree months ended June 30,March 31, 2023 and 2022 and 2021 (unaudited); and (vi)(v) the Notes to Unaudited Interim Condensed Consolidated Financial Statements.

X

 

 

 

104

 

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

§Portions of this exhibit (indicated by “[***]”) have been redacted in accordance with Regulation S-K Item 601(b)(10)(iv).

**Denotes management contract, compensatory plan or arrangement.


 

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.

 

 

 

CATALYST BIOSCIENCES, INC.

 

 

 

Date: AugustMay 15, 20222023

 

/s/ Nassim Usman, Ph.D.

 

 

Nassim Usman, Ph.D.

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

Date: AugustMay 15, 20222023

 

/s/ Seline Miller

 

 

Seline Miller

 

 

Interim Chief Financial Officer

 

 

(Interim Financial and Principal Accounting Officer)

 

 

28