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

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- 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.

ThirdQuarter 2020 Results and Financial Highlights:

  • Cash, cash equivalents and, investments, as of September 30, were $104.1 million.
     
  • Research and development expenses were $12.2 million and $9.9 million during the three months ended September 30, 2020 and 2019, respectively, an increase of $2.3 million, or 23%. The increase was due primarily to an increase of $1.1 million in personnel and facilities costs, an increase of $0.7 million in preclinical research, and an increase of $0.3 million in clinical manufacturing costs.
     
  • 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.
     
  • Net loss attributable to common stockholders for the three months ended September 30, 2020 was $16.0 million, or ($0.73) per basic and diluted share, compared with $12.7 million, or ($1.06) per basic and diluted share, for the prior year period.
     
  • 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.

 

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