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Catalyst Biosciences Reports Fourth Quarter and Full-Year 2017 Operating & Financial Results and Provides Corporate Update

Cash Balance in excess of $135 million after our February 2018 follow-on financing allows for independent development of lead programs

Positive Phase 1/2 Subcutaneous data for CB 2679d presented at EAHAD 2018, Phase 2b to initiate in Q3 2018

Marzeptacog alfa (activated) Phase 2 study enrolling, interim data to be presented in July 2018

SOUTH SAN FRANCISCO, Calif., March 01, 2018 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO), today announced operating and financial results for the fourth quarter and full-year ended December 31, 2017 and provided a corporate update.

Recent Milestones:

  • Achieved key milestones with CB 2679d/ISU304, the Company’s next-generation coagulation Factor IX, including:
    • Announced top-line multi-dose results from the subcutaneous Factor IX CB 2679d Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B; and
    • Signed a commercial-scale manufacturing agreement with AGC Biologics for subcutaneous Factor IX CB 2679d.
  • Advanced the development of marzeptacog alfa (activated), the Company’s next-generation Factor VIIa, including the following accomplishments:
    • Initiated the Factor VIIa marzeptacog alfa (activated) Phase 2 part of a Phase 2/3 subcutaneous efficacy clinical trial in individuals with hemophilia A or B with an inhibitor.
  • Successfully raised ~$125 million through two underwritten public equity offerings.  During December 2017 raised $10.5 million and during February raised $115 million, including the full exercise of the underwriters’ over-allotment option to purchase additional shares.

“2017 was a pivotal year for us as we continued to make significant progress in the clinical development of both of our subcutaneously administered next-generation subcutaneously dosed, FIX and FVIIa, coagulation factors,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “With our recent equity offering, our balance sheet provides the resources to further accelerate the clinical development programs of our Factor IX and VIIa candidates through multiple key milestones in 2018 and 2019.”

Upcoming Milestones

  • Announce interim data from an open-label Phase 2 part of the Phase 2/3 program of marzeptacog alfa (activated), subcutaneous efficacy trial in individuals with hemophilia A or B with inhibitors to evaluate the ability of MarzAA to minimize, spontaneous bleeding episodes in July 2018.
  • Announce additional data from the Factor IX CB2679d Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B in the second quarter of 2018. Initiate a Phase 2b trial of CB 2679d in individuals with severe hemophilia B in the third quarter of 2018.

Fourth Quarter and Full-year 2017 Results and Financial Highlights

  • Cash, cash equivalents and short-term investments, as of Mar. 1, 2018 were in excess of $135 million, due primarily to the $115 million in gross financing in February 2018 and the proceeds from the exercise of warrants. Cash, cash equivalents and short-term investments, as of Dec. 31, 2017 and 2016 were $32.4 and $17.1 million, respectively. 
  • In the fourth quarter the Company completed a follow-on financing of $10.5 million in gross proceeds.
  • Research and development expense for the three months ended Dec. 31, 2017 was $3.6 million, compared with $3.1 million for the prior year period. The increase was due primarily to manufacturing expenses for marzeptacog alfa (activated). Research and development expense for the year ended Dec. 31, 2017 was $12.8 million, compared with $11.6 million for the prior year respectively, an increase of $1.3 million, due primarily to manufacturing expenses for marzeptacog alfa (activated).
  • General and administrative expense for the three months ended Dec. 31, 2017 was $2.6 million compared with $2.2 million for the prior year period.  The increase was due primarily to increased headcount. General and administrative expenses for the years ended Dec. 31, 2017 and 2016 were $10.0 million and $9.3 million, respectively, an increase of $0.7 million, due primarily to increased headcount and financing expenses.
  • Interest and other income for the three months ended Dec. 31, 2017 was $0.1 million, compared with $1.5 million for the prior year period.  The decrease was due primarily to the 2016 gain related to the sale of noncore NNR assets. Interest and other income for the years ended Dec. 31, 2017 and 2016, were $0.3 million and $3.5 million, respectively, a decrease of $3.2 million.
  • Net loss attributable to common stockholders for the year ended Dec. 31, 2017 was $25.5 million, or ($7.45) per basic and diluted share, compared with $16.9 million, or ($21.75) per basic and diluted share, for the prior year.  
  • On February 19, 2018, the last $5 million of redeemable convertible notes matured and were repaid in full with $5 million from the restricted cash indenture. The Company has no outstanding Notes or debt.
  • As of February 27, 2018, the Company had 10,968,644 shares of common stock outstanding.

About Catalyst Biosciences

Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia.
For more information, please visit www.catalystbiosciences.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d and marzeptacog alfa (activated) and development plans for these product candidates are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Catalyst’s clinical trial timelines, the anticipated announcement of top-line results from the subcutaneous CB 2679d Phase 1/2 proof-of-concept trial in the second quarter of 2018, the anticipated announcement of interim results from the marzeptacog alpha (activated) Phase 2 clinical trial in the secondquarter of 2018, the anticipated initiation of a Phase 2b trial of CB 2679d in individuals with severe hemophilia B in the third quarter of 2018, and the Company’s belief regarding sufficiency of its existing capital resources to meet its projected operating requirements for at least the next 12 months and accelerate the clinical development programs through key milestones in 2018 and 2019. 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 from the forward-looking statements that Catalyst makes, including, but not limited to, the risk that clinical trials and studies may be delayed and may not have satisfactory outcomes, that potential adverse effects may arise from the testing or use of Catalyst’s products, the risk that costs required to develop or manufacture Catalyst’s products will be higher than anticipated, competition and other factors that affect our ability to successfully develop and commercialize our product candidates, and other risks described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts:       
Investors:                                                                                                       
Fletcher Payne, CFO                                                              
Catalyst Biosciences, Inc.                                                       
1.650.871.0761                                                                      
investors@catbio.com

Media:
Josephine Belluardo, Ph.D.
LifeSci Public Relations
1.646.751.4361
jo@lifescipublicrelations.com

 
Catalyst Biosciences, Inc.
Consolidated Balance Sheets
(In thousands, except shares and per share amounts)
 
    December 31,
2017
    December 31,
2016
 
Assets                
Current assets:                
Cash and cash equivalents   $ 14,472     $ 10,264  
Short-term investments     17,971       6,800  
Restricted cash     5,333       19,468  
Prepaid and other current assets     1,309       958  
Accounts receivable     24       31  
Total current assets     39,109       37,521  
Restricted cash, noncurrent           125  
Deposits, noncurrent     128        
Property and equipment, net     276       444  
Total assets   $ 39,513     $ 38,090  
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable   $ 747     $ 837  
Accrued compensation     1,366       596  
Other accrued liabilities     1,322       805  
Deferred revenue, current portion     212       283  
Deferred rent, current portion     7       41  
Redeemable convertible notes     5,085       19,403  
Total current liabilities     8,739       21,965  
Deferred revenue, noncurrent portion           47  
Deferred rent, noncurrent portion           7  
Total liabilities     8,739       22,019  
Stockholders’ equity:                
Preferred stock, $0.001 par value, 5,000,000 shares authorized; 3,680 and 0 shares
  issued and outstanding at December 31, 2017 and 2016, respectively
           
Common stock, $0.001 par value, 100,000,000 shares authorized; 6,081,230 and
  801,756 shares issued and outstanding at December 31, 2017 and 2016,
  respectively
    6       1  
Additional paid-in capital     204,262       164,053  
Accumulated other comprehensive income (loss)           (1 )
Accumulated deficit     (173,494 )     (147,982 )
Total stockholders’ equity     30,774       16,071  
Total liabilities and stockholders’ equity   $ 39,513     $ 38,090  
                 


 
Catalyst Biosciences, Inc.
Consolidated Statements of Operations
(In thousands, except shares and per share amounts)
 
    Year Ended December 31,  
    2017     2016  
Contract revenue   $ 1,018     $ 399  
Operating expenses:                
Research and development     12,847       11,555  
General and administrative     9,993       9,262  
Total operating expenses     22,840       20,817  
Loss from operations     (21,822 )     (20,418 )
Interest and other income, net     261       3,473  
Net loss     (21,561 )     (16,945 )
Deemed dividend for convertible preferred stock beneficial conversion feature     (3,951 )      
Net loss attributable to common stockholders   $ (25,512 )   $ (16,945 )
Net loss per share attributable to common stockholders, basic and
  diluted
  $ (7.45 )   $ (21.75 )
Shares used to compute net loss per share attributable to common
  stockholders, basic and diluted
    3,423,901       779,166