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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 March 31, 2021

OR

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

For the transition period from                      to                     

Commission file number: 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 710

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 April 29, 2021, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 31,349,740.

 

 

 

 


 

CATALYST BIOSCIENCES, INC.

TABLE OF CONTENTS

 

 

 

 

 

Page No.

 

 

 

 

 

PART I. FINANCIAL INFORMATION

 

3

 

 

 

 

 

Item 1.

 

Financial Statements:

 

3

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of March 31, 2021 (unaudited) and December 31, 2020

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020 (unaudited)

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2021 and 2020 (unaudited)

 

5

 

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2021 and 2020 (unaudited)

 

6

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020 (unaudited)

 

7

 

 

 

 

 

 

 

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

 

8

 

 

 

 

 

Item 2.

 

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

 

16

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

24

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

25

 

 

 

 

 

PART II. OTHER INFORMATION

 

26

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

26

 

 

 

 

 

Item 1A.

 

Risk Factors

 

26

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

27

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

27

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

27

 

 

 

 

 

Item 5.

 

Other Information

 

27

 

 

 

 

 

Item 6.

 

Exhibits

 

27

 

 

 

 

 

Exhibit Index

 

28

 

 

 

 

 

Signatures

 

29

 

 

 

 


 

 

PART I. FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

Catalyst Biosciences, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

 

March 31, 2021

 

 

December 31, 2020

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

83,044

 

 

$

30,360

 

Short-term investments

 

 

23,956

 

 

 

48,994

 

Accounts receivable

 

 

1,006

 

 

 

3,313

 

Prepaid and other current assets

 

 

8,514

 

 

 

6,843

 

Total current assets

 

 

116,520

 

 

 

89,510

 

Long-term investments

 

 

 

 

 

2,543

 

Other assets, noncurrent

 

 

528

 

 

 

528

 

Right-of-use assets

 

 

1,646

 

 

 

1,832

 

Property and equipment, net

 

 

382

 

 

 

433

 

Total assets

 

$

119,076

 

 

$

94,846

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,956

 

 

$

5,931

 

Accrued compensation

 

 

2,232

 

 

 

2,476

 

Deferred revenue

 

 

1,332

 

 

 

1,983

 

Other accrued liabilities

 

 

6,983

 

 

 

6,743

 

Operating lease liability

 

 

678

 

 

 

663

 

Total current liabilities

 

 

14,181

 

 

 

17,796

 

Operating lease liability, noncurrent

 

 

806

 

 

 

981

 

Total liabilities

 

 

14,987

 

 

 

18,777

 

Commitments and Contingencies (Note 10)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   and outstanding

 

 

 

 

Common stock, $0.001 par value, 100,000,000 shares authorized; 31,331,027 and

   22,097,820 shares issued and outstanding at March 31, 2021 and

   December 31, 2020, respectively

 

 

31

 

 

 

22

 

Additional paid-in capital

 

 

441,252

 

 

 

390,803

 

Accumulated other comprehensive income

 

 

5

 

 

 

5

 

Accumulated deficit

 

 

(337,199

)

 

 

(314,761

)

Total stockholders’ equity

 

 

104,089

 

 

 

76,069

 

Total liabilities and stockholders’ equity

 

$

119,076

 

 

$

94,846

 

 

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

 

 

3


 

 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

License

 

$

 

 

$

15,045

 

Collaboration

 

 

1,467

 

 

 

1,321

 

License and collaboration revenue

 

 

1,467

 

 

 

16,366

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Cost of license

 

 

 

 

 

3,047

 

Cost of collaboration

 

 

1,480

 

 

 

1,432

 

Research and development

 

 

17,013

 

 

 

13,264

 

General and administrative

 

 

5,412

 

 

 

3,691

 

Total operating expenses

 

 

23,905

 

 

 

21,434

 

Loss from operations

 

 

(22,438

)

 

 

(5,068

)

Interest and other income (expense), net

 

 

-

 

 

 

1,015

 

Net loss

 

$

(22,438

)

 

$

(4,053

)

Net loss per share attributable to common

   stockholders, basic and diluted

 

$

(0.79

)

 

$

(0.28

)

Shares used to compute net loss per share attributable to

   common stockholders, basic and diluted

 

 

28,385,432

 

 

 

14,592,451

 

 

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

 

 

4


 

 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Net loss

 

$

(22,438

)

 

$

(4,053

)

Other comprehensive income:

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

106

 

Total comprehensive loss

 

$

(22,438

)

 

$

(3,947

)

 

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

 

 

5


 

 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

 

 

 

Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

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 for public offering, net

   of issuance costs of $3,563

 

 

 

 

 

 

 

 

9,185,000

 

 

 

9

 

 

 

49,241

 

 

 

 

 

 

 

 

 

49,250

 

Issuance of common stock from stock grants

 

 

 

 

 

 

 

 

38,058

 

 

 

 

 

 

182

 

 

 

 

 

 

 

 

 

182

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,438

)

 

 

(22,438

)

Balance at March 31, 2021

 

 

 

 

$

 

 

 

31,331,027

 

 

$

31

 

 

$

441,252

 

 

$

5

 

 

$

(337,199

)

 

$

104,089

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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, 2019

 

 

 

 

$

 

 

 

12,040,835

 

 

$

12

 

 

$

326,810

 

 

$

34

 

 

$

(258,520

)

 

$

68,336

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

7,817

 

 

 

 

 

 

805

 

 

 

 

 

 

 

 

 

805

 

Issuance of common stock from stock

   grants and option exercises

 

 

 

 

 

 

 

 

62,969

 

 

 

 

 

 

339

 

 

 

 

 

 

 

 

 

339

 

Issuance of common stock for public offering, net

   of issuance costs of $2,514

 

 

 

 

 

 

 

 

 

 

5,307,692

 

 

 

5

 

 

 

31,981

 

 

 

 

 

 

 

 

 

31,986

 

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

106

 

 

 

 

 

 

 

106

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,053

)

 

 

(4,053

)

Balance at March 31, 2020

 

 

 

 

$

 

 

 

17,419,313

 

 

$

17

 

 

$

359,935

 

 

$

140

 

 

$

(262,573

)

 

$

97,519

 

 

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

 

6


 

 

Catalyst Biosciences, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Operating Activities

 

 

 

 

 

 

 

 

Net loss

 

$

(22,438

)

 

$

(4,053

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,026

 

 

 

805

 

Depreciation and amortization

 

 

45

 

 

 

25

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

2,307

 

 

 

13,634

 

Prepaid and other current assets

 

 

(1,671

)

 

 

1,880

 

Accounts payable

 

 

(2,969

)

 

 

(2,963

)

Accrued compensation and other accrued liabilities

 

 

(31

)

 

 

866

 

Operating lease liability and right-of-use asset

 

 

26

 

 

 

16

 

Deferred revenue

 

 

(651

)

 

 

(15,000

)

Net cash flows used in operating activities

 

 

(24,356

)

 

 

(4,790

)

 

 

 

 

 

 

 

 

 

Investing Activities

 

 

 

 

 

 

 

 

Proceeds from maturities of short-term investments

 

 

27,581

 

 

 

33,457

 

Purchase of short-term investments

 

 

 

 

 

(6,019

)

Purchases of property and equipment

 

 

 

 

 

(17

)

Net cash flows provided by investing activities

 

 

27,581

 

 

 

27,421

 

 

 

 

 

 

 

 

 

 

Financing Activities

 

 

 

 

 

 

 

 

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

 

 

49,277

 

 

 

32,025

 

Issuance of common stock from stock grants and option exercises

 

 

182

 

 

 

339

 

Net cash flow provided by financing activities

 

 

49,459

 

 

 

32,364

 

Net increase in cash and cash equivalents

 

 

52,684

 

 

 

54,995

 

Cash and cash equivalents at beginning of the period

 

 

30,360

 

 

 

15,369

 

Cash and cash equivalents at end of the period

 

$

83,044

 

 

$

70,364

 

 

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

 

 

7


 

 

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”) is a fully integrated research and clinical development biopharmaceutical company with expertise in protease engineering, discovery, translational research, clinical development, and manufacturing. The Company is focused on advancing its protease product candidates in the fields of hemostasis and complement regulation. The Company is located in South San Francisco, California and operates in one segment.

The Company had a net loss of $22.4 million for the three months ended March 31, 2021 and an accumulated deficit of $337.2 million as of March 31, 2021. The Company expects to continue to incur losses for the next several years. As of March 31, 2021, the Company had $107.0 million of cash, cash equivalents and short-term investments. Its primary uses of cash are to fund operating expenses, including research and development expenditures and general and administrative expenditures. Based on the current status of its research and development plans, the Company believes that its existing cash, cash equivalents and short-term investments as of March 31, 2021 will be sufficient to fund its cash requirements for at least the next 12 months from the date of the filing of this quarterly report. If, at any time, the Company’s prospects for financing its research and development programs decline, the Company may decide to reduce research and development expenses by delaying, discontinuing or reducing its funding of one or more of its research or development programs. Alternatively, the Company might raise funds through strategic collaborations, public or private financings or other arrangements. Such funding, if needed, may not be available on favorable terms, or at all.  

 

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, 2021, 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, 2020 (“Annual Report”).

Accounting Pronouncements Recently Adopted

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in ASU 2019-12 are intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-12 as of January 1, 2021, on a prospective transition basis. The adoption of ASU 2019-12 did not have a material impact on the Company’s condensed consolidated financial statements.

New Accounting Pronouncements Recently Issued But Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). 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. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, for the purpose of clarifying certain aspects of ASU 2016-13. In May 2019, the FASB issued ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief, to provide entities with more flexibility in applying the fair value option on adoption of the credit impairment standard. ASU 2018-19 and ASU 2019-05 have the same effective date and transition requirements as ASU 2016-13. ASU 2016-13 will be effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, using a modified retrospective approach. Early adoption is permitted. The Company plans to adopt ASU 2016-13 and related updates as of January 1, 2023. The Company will assess the impact of adoption of this standard on its consolidated financial statements.

8


 

Research and Development Expenses

Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services used in research and development are initially deferred and capitalized in prepaid and other current assets. 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 costs consist of payroll and other personnel-related expenses, laboratory supplies and reagents, contract research and development services, materials, and consulting costs, as well as allocations of facilities and other overhead costs. Under the Company’s collaboration agreement with Biogen, certain specific expenditures are reimbursed by third parties. During the three months ended March 31, 2021 and 2020, $1.4 million and $1.3 million, respectively, of research and development expense was recorded as cost of collaboration revenue related to the collaboration agreement with Biogen signed in December 2019.

Stock-Based Compensation

The Company measures the cost of employee, non-employee and director services received in exchange for an award of equity instruments based on the fair value of the award on the date of grant and recognizes the related expense over the period during which the employee, non-employee or director is required to provide service in exchange for the award on a straight-line basis. The estimated fair value of equity awards that contain performance conditions is expensed over the term of the award once the Company has determined that it is probable that performance conditions will be satisfied.

The Company uses the Black-Scholes option-pricing valuation model to estimate the grant-date fair value of stock-based awards. The determination of fair value for stock-based awards on the date of grant using an option-pricing model requires management to make certain assumptions regarding a number of variables. The Company elected to account for forfeitures when they occur. As such, the Company recognizes stock-based compensation expense, over their requisite service period, based on the vesting provisions of the individual grants.

 

3.

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 3 – Summary of Significant Accounting Policies” in the Company’s Annual Report. There were no significant changes in these methodologies during the three months ended March 31, 2021.

There were no transfers in or out of Level 1 or 2 during the periods presented. The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2021 and December 31, 2020 (in thousands):

 

 

 

March 31, 2021

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

83,044

 

 

$

 

 

$

 

 

$

83,044

 

U.S. government agency securities(2)

 

 

16,807

 

 

 

 

 

 

 

 

 

16,807

 

Federal agency securities(2)

 

 

 

 

 

7,149

 

 

 

 

 

 

7,149

 

Total financial assets

 

$

99,851

 

 

$

7,149

 

 

$

 

 

$

107,000

 

 

 

 

December 31, 2020

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Financial assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds(1)

 

$

30,360

 

 

$

 

 

$

 

 

$

30,360

 

U.S. government agency securities(2)

 

 

37,837

 

 

 

 

 

 

 

 

 

37,837

 

Federal agency securities(2)

 

 

 

 

 

13,700

 

 

 

 

 

 

13,700

 

Total financial assets

 

$

68,197

 

 

$

13,700

 

 

$

 

 

$

81,897

 

 

(1)

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

(2

9


 

)

Included in short-term investments on the accompanying condensed consolidated balance sheets and classified as available-for-sale debt securities. $2.5 million of U.S. government agency securities as of December 31, 2020 are included in long-term investments on the accompanying condensed consolidated balance sheets due to the maturity being more than 12 months.

4.

Financial Instruments

Cash equivalents, short-term investments (debt securities) which are classified as available-for-sale debt securities, and long-term investments, consisted of the following (in thousands):

 

March 31, 2021

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Estimated

Fair

Value

 

Money market funds (cash equivalents)

 

$

83,044

 

 

$

 

 

$

 

 

$

83,044

 

U.S. government agency securities

 

 

16,804

 

 

 

3

 

 

 

 

 

 

16,807

 

Federal agency securities

 

 

7,147

 

 

 

2

 

 

 

 

 

 

7,149

 

Total financial assets

 

$

106,995

 

 

$

5

 

 

$

 

 

$

107,000

 

Classified as:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

$

83,044

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

23,956

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

107,000

 

 

December 31, 2020

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Estimated

Fair

Value

 

Money market funds (cash equivalents)

 

$

30,360

 

 

$

 

 

$

 

 

$

30,360

 

U.S. government agency securities

 

 

37,835

 

 

 

2

 

 

 

 

 

 

37,837

 

Federal agency securities

 

 

13,697

 

 

 

3

 

 

 

 

 

 

13,700

 

Total financial assets

 

$

81,892

 

 

$

5

 

 

$

 

 

$

81,897

 

Classified as:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

$

30,360

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

48,994

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,543

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

81,897

 

 

There have been no material realized gains or losses on available-for-sale debt securities for the periods presented. As of March 31, 2021, the remaining contractual maturities of $24.0 million of available-for-sale debt securities was less than one year.

 

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

5.

Lease

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. 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.

For the three months ended March 31, 2021 and 2020, the Company’s operating lease expense was $0.2 million and $0.2 million, respectively. The present value assumptions used in calculating the present value of the lease payments were as follows:

 

 

 

 

March 31, 2021

 

 

December 31, 2020

 

Weighted-average remaining lease term

 

 

2.08 years

 

 

2.33 years

 

Weighted-average discount rate

 

 

 

5.7

%

 

 

5.7

%

 

10


 

 

The maturity of the Company’s operating lease liabilities as of March 31, 2021 were as follows (in thousands):

 

Undiscounted lease payments

Operating Leases

 

Remaining in 2021

$

557

 

2022

 

762

 

2023

 

259

 

Total undiscounted lease payments

 

1,578

 

Less imputed interest

 

(94

)

Total operating lease liability

$

1,484

 

 

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

 

 

 

 

Three Months Ended March 31,

 

 

 

 

2021

 

 

2020

 

Cash paid for leases that were included in operating

   cash outflows

 

 

$

182

 

 

$

142

 

 

6.

Stock 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.

Performance-Based Stock Option Grants

In February 2021, the Committee approved the issuance of option grants to purchase 647,000 shares of common stock for executive officers pursuant to the 2018 Plan, which will vest upon (a) the achievement of specified performance goals and (b) the grantees’ continued employment during the service period specified in each grant.

The following table summarizes stock option activity under the Company’s equity incentive plans and related information:

 

 

 

Number of Shares

Underlying

Outstanding

Options

 

 

Weighted-

Average Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual Term

(Years)

 

Outstanding — December 31, 2020

 

 

2,355,615

 

 

$

8.59

 

 

 

7.96

 

Options granted

 

 

939,613

 

 

$

6.21

 

 

 

 

 

Options exercised

 

 

 

 

$

 

 

 

 

 

Options forfeited

 

 

(87,083

)

 

$

7.62

 

 

 

 

 

Options expired

 

 

 

 

$

 

 

 

 

 

Outstanding — March 31, 2021

 

 

3,208,145

 

 

$

7.92

 

 

 

8.37

 

Exercisable — March 31, 2021

 

 

1,213,061

 

 

$

10.18

 

 

 

 

 

 

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 history as a public company and limited number of sales of its common stock, 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 operating 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


 

The fair value of employee stock options was estimated using the following weighted-average assumptions for the three months ended March 31, 2021 and 2020:

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Employee Stock Options:

 

 

 

 

 

 

 

 

Risk-free interest rate

 

 

0.69

%

 

 

1.57

%

Expected term (in years)

 

 

6.05

 

 

 

5.53

 

Dividend yield

 

 

 

 

 

 

Volatility

 

 

93.83

%

 

 

110.00

%

Weighted-average fair value of stock options granted

 

$

4.70

 

 

$

5.58

 

 

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

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Research and development

 

$

369

 

 

$

344

 

General and administrative(1)

 

 

657

 

 

 

461

 

Total stock-based compensation

 

$

1,026

 

 

$

805

 

 

 

(1)

Included in general and administrative stock-based compensation for the three months ended March 31, 2021 is expense related to 10,149 shares of common stock issued to certain board members in lieu of their cash compensation.

As of March 31, 2021, 391,477 shares of common stock were available for future grant and 3,208,145 options to purchase shares of common stock were outstanding. As of March 31, 2021, the Company had unrecognized employee stock-based compensation expense of $8.2 million, related to unvested stock awards, which is expected to be recognized over an estimated weighted-average period of 2.9 years.

 

7.

Collaborations

Pfizer

Pursuant to the termination agreement entered into on December 8, 2016, in connection with the termination of a prior license and development agreement, Pfizer granted the Company an exclusive license to Pfizer’s proprietary rights for manufacturing materials and processes that apply to Factor VIIa variants, CB 813a and marzeptacog alfa (activated) - MarzAA. Pfizer also transferred to the Company the IND application and documentation related to the development, manufacturing and testing of the Factor VIIa products as well as the orphan drug designation. The Company agreed to make contingent cash payments to Pfizer in an aggregate amount up to $17.5 million, payable upon the achievement of certain clinical, regulatory and commercial milestones. Following commercialization of any covered product, Pfizer will also receive a single-digit royalty on net product sales on a country-by-country basis for a predefined royalty term. In February 2018, the Company paid Pfizer a $1.0 million milestone payment based on the dosing of the first patient in its Phase 2 study; the amount was recorded as a research and development expense. No payments were made to Pfizer in the three months ended March 31, 2021 and 2020.

Mosaic

In October 2017, the Company entered into a strategic research collaboration with 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 entered into two amendments to the Mosaic research collaboration agreements in December 2019 and May 2020. See Note 11.

ISU Abxis

In December 2018, the Company entered into an amended and restated license agreement with ISU Abxis (the “A&R ISU Abxis Agreement”), which amended and restated its previous license and collaboration agreement with ISU Abxis previously entered into in September 2013, as subsequently amended in October 2014 and December 2016 (the “Original 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 eliminates the profit-sharing arrangement in the Original

12


 

ISU Abxis Agreement and 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 March 31, 2021, no milestones have been met.

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 age-related macular degeneration (“AMD”) and other disorders. Pursuant to the Biogen Agreement, the Company will perform certain pre-clinical and manufacturing activities (“Research Services”), and Biogen will be solely responsible for funding the pre-clinical and manufacturing activities and performing IND-enabling activities, worldwide clinical development, and commercialization. The Company will provide the Research Services over a term of thirty months with Biogen having the option to extend the term for two additional twelve-month periods.

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 is eligible to receive development milestones and sales milestones of up to $340.0 million. In addition, the Company is 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 will also receive 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.

The Biogen Agreement will continue on a product-by-product and country-by-country basis until the tenth anniversary of the first commercial sale of the first product in a country, unless terminated earlier by either party as specified under the agreement.

For the three months ended March 31, 2021 and 2020, respectively, the Company recognized $0.0 million and $15.0 million in license revenue upon the transfer of the Exclusive License and the related know-how, and $0.0 million and less than $0.1 million in license revenue for reimbursable out-of-pocket costs incurred.

For the three months ended March 31, 2021 and 2020, respectively, the Company recognized $1.5 million and $1.3 million in collaboration revenue for reimbursable out-of-pocket and personnel costs incurred related to research services.

For the three months ended March 31, 2021, the Company recognized $0.8 million of revenue from the beginning of period deferred revenue balance.

8.

Net Loss per Share Attributable to Common Stockholders

The following table sets forth the computation of the basic and diluted net loss per common share during the three months ended March 31, 2021 and 2020 (in thousands, except share and per share data):

 

 

 

Three Months Ended March 31,