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Catalyst Biosciences Reports Third Quarter 2020 Operating & Financial Results and Provides a Corporate Update

SOUTH SAN FRANCISCO, Calif. – Nov. 5, 2020 – Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and financial results for the third quarter ended September 30, 2020 and provided a corporate update.

“In the third quarter we focused on preparing to initiate two clinical trials for MarzAA and building our complement programs. We plan to enroll patients in a pivotal Phase 3 study of MarzAA for the treatment of bleeding in hemophilia A or B patients with inhibitors and initiate a Phase 1/2 trial of MarzAA for the treatment of bleeding in Factor VII Deficiency, Glanzmann thrombasthenia, and Hemlibra patients by the end of the year”, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst Biosciences. “In addition, we are on track to deliver on other important program milestones including disclosing a development candidate for our systemic complement program this year.”

Recent Milestones:

  • Complement intellectual property:  The United States Patent and Trademark Offices issued a patent covering Catalyst’s portfolio of engineered proteases that selectively cleave and degrade complement factor 3 (C3), including the lead candidate CB 2782-PEG, a potential best-in-class treatment for dry AMD currently under development under a license and collaboration agreement with Biogen. These modified proteases inhibit complement activation and have the potential to treat multiple diseases in which complement activation plays a role. The newly issued patent provides protection until at least 2038.

Expected Milestones:

  • Marzeptacog alfa (activated) – MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa):
    • Enroll the first patient in a Phase 3 open-label trial before the end of the year, evaluating the efficacy of SQ MarzAA to treat episodic bleeding in individuals with hemophilia A or B with inhibitors, and
    • Initiate a Phase 1/2 trial in FVII Deficiency, Glanzmann Thrombasthenia, and Hemlibra patients before year-end.

  • Systemic complement:  Announce a development candidate in December 2020.

Third Quarter 2020 Results and Financial Highlights:

  • Cash, cash equivalents and, investments, as of September 30, were $104.1 million.

  • General and administrative expenses were $3.8 million and $3.3 million during the three months ended September 30, 2020 and 2019, respectively, an increase of $0.5 million, or 17%. The increase was due primarily to an increase of $0.4 million in professional services and an increase of $0.4 million in payroll and payroll related costs, partially offset by a decrease of $0.2 million in indirect employee and facilities costs.

  • Interest and other income, net was $0.1 million and $0.5 million during the three months ended September 30, 2020 and 2019, respectively, a decrease of $0.4 million. The decrease was primarily due to a decrease in interest income on investments.

  • As of September 30, 2020, the Company had 22,082,924 shares of common stock outstanding.

About Catalyst Biosciences

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare hematologic and complement-mediated disorders. Our protease engineering platform generated two late-stage clinical programs in hemophilia; a research program on engineering of subcutaneous (SQ) complement inhibitors; a discovery stage Factor IX gene therapy construct - CB 2679d-GT - for Hemophilia B, and a partnered preclinical development program with Biogen for dry age-related macular degeneration (AMD). The product candidates generated by our protease engineering platform have improved functionality and potency that allow for: SQ administration of recombinant coagulation factors and complement inhibitors; low-dose, high activity gene therapy constructs; and less frequently dosed intravitreal therapeutics.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about Catalyst’s plans to enroll the first patient in a Phase 3 open-label trial of MarzAA and initiate a Phase 1/2 trial of MarzAA in FVII Deficiency, Glanzmann Thrombasthenia, and Hemlibra patients before year-end, the potential for MarzAA to effectively and therapeutically treat hemophilia subcutaneously, the superiority of CB 2679d-GT over other gene therapy candidates and the Company’s collaboration with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed as a result of COVID-19 and other factors, that trials may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of MarzAA, including the generation of neutralizing antibodies,  the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, including as a result of delays in development and manufacturing resulting from COVID-19 and other factors, the risk that Biogen will terminate Catalyst’s agreement, competition and other risks described in the “Risk Factors” section of the Company’s quarterly report filed with the Securities and Exchange Commission on November 5, 2020, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

Contact:

Ana Kapor
Catalyst Biosciences, Inc.

investors@catbio.com

Catalyst Biosciences, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

September 30, 2020

 

 

December 31, 2019

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,923

 

 

$

15,369

 

Short-term investments

 

 

77,959

 

 

 

61,496

 

Accounts receivable

 

 

1,555

 

 

 

15,000

 

Prepaid and other current assets

 

 

3,535

 

 

 

4,201

 

Total current assets

 

 

107,972

 

 

 

96,066

 

Long-term investments

 

 

1,171

 

 

 

 

Other assets, noncurrent

 

 

698

 

 

 

257

 

Right-of-use assets

 

 

1,524

 

 

 

1,927

 

Property and equipment, net

 

 

439

 

 

 

304

 

Total assets

 

$

111,804

 

 

$

98,554

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,244

 

 

$

4,279

 

Accrued compensation

 

 

2,543

 

 

 

2,106

 

Deferred revenue

 

 

764

 

 

 

15,000

 

Other accrued liabilities

 

 

8,750

 

 

 

7,031

 

Operating lease liability

 

 

519

 

 

 

483

 

Total current liabilities

 

 

16,820

 

 

 

28,899

 

Operating lease liability, noncurrent

 

 

925

 

 

 

1,319

 

Total liabilities

 

 

17,745

 

 

 

30,218

 

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; 22,082,924 and

   12,040,835 shares issued and outstanding at September 30, 2020 and

   December 31, 2019, respectively

 

 

22

 

 

 

12

 

Additional paid-in capital

 

 

389,883

 

 

 

326,810

 

Accumulated other comprehensive income

 

 

8

 

 

 

34

 

Accumulated deficit

 

 

(295,854

)

 

 

(258,520

)

Total stockholders’ equity

 

 

94,059

 

 

 

68,336

 

Total liabilities and stockholders’ equity

 

$

111,804

 

 

$

98,554

 

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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

License

 

$

32

 

 

$

 

 

$

15,100

 

 

$

 

Collaboration

 

 

861

 

 

 

 

 

 

3,817

 

 

 

 

License and collaboration revenue

 

 

893

 

 

 

 

 

 

18,917

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of license

 

 

32

 

 

 

 

 

 

3,102

 

 

 

 

Cost of collaboration

 

 

879

 

 

 

 

 

 

4,030

 

 

 

 

Research and development

 

 

12,249

 

 

 

9,927

 

 

 

38,419

 

 

 

33,066

 

General and administrative

 

 

3,833

 

 

 

3,268

 

 

 

11,895

 

 

 

10,224

 

Total operating expenses

 

 

16,993

 

 

 

13,195

 

 

 

57,446

 

 

 

43,290

 

Loss from operations

 

 

(16,100

)

 

 

(13,195

)

 

 

(38,529

)

 

 

(43,290

)

Interest and other income, net

 

 

67

 

 

 

489

 

 

 

1,195

 

 

 

1,722

 

Net loss

 

$

(16,033

)

 

$

(12,706

)

 

$

(37,334

)

 

$

(41,568

)

Net loss per share attributable to common

   stockholders, basic and diluted

 

$

(0.73

)

 

$

(1.06

)

 

$

(2.05

)

 

$

(3.47

)

Shares used to compute net loss per share attributable to

   common stockholders, basic and diluted

 

 

22,072,243

 

 

 

12,022,620

 

 

 

18,199,575

 

 

 

11,992,240

 

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