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BioCanCell Reports Second Quarter 2018 Financial and Operational Results

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CAMBRIDGE, Mass., Aug. 22, 2018 (GLOBE NEWSWIRE) -- BioCanCell Ltd. (TASE: ANCN), a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, today announced operating and financial results for the quarter ending June 30, 2018 and provided a corporate update.

"We continue to make progress in our plans to initiate our pivotal study of inodiftagene vixteplasmid as a treatment for non-muscle invasive bladder cancer and look forward to initiating the trial in the second half of this year," stated Frank Haluska, M.D., Ph.D., President and Chief Executive Officer of BioCanCell. "Our balance sheet is strong after closing a private equity offering of $22.9M in the last quarter, and we are well positioned to advance our pipeline."

2018 Second Quarter Results and Financial Highlights (*)

  • Cash Position: Cash and cash equivalents were $19.5 million as of June 30, 2018, compared to cash and cash equivalents of $4.8 million as of June 30, 2017. Net cash used in operating activities for the three months ended June 30, 2018 was $1.9 million, compared to $4.1 million for the same period in 2017. BioCanCell anticipates that its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2019.
  • Operating Expenses: Total operating expenses for the three months ended June 30, 2018 were $4 million, which consisted of $1.8 million of research and development (R&D) expenses and $2.2 million of general and administrative (G&A) expenses.
  • Net Loss: The Company's net loss for the three months ended June 30, 2018 was $5.2 million, or $0.52 per share, compared to $3.6 million for the three months ended June 30, 2017, or $0.38 per share.

(*) The reported NIS figures as of June 30, 2018, have been presented in dollars, translated at the representative rate of exchange as of June 30, 2018 (NIS 3.65 = US$ 1.00).

Upcoming Milestones:

  • Initiating enrollment of patients into the first of two registrational clinical trials of inodiftagene vixteplasmid in early-stage bladder cancer in the second half of 2018.

About BioCanCell
BioCanCell is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, with offices in Cambridge, MA, and Jerusalem, Israel. The Company's most advanced product candidate, inodiftagene vixteplasmid (BC-819), is in development as a treatment for early stage NMIBC. For additional information please go to www.biocancell.com.

Forward Looking Statements

This press release contains "forward-looking statements" that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of clinical trials, the anticipated effects of receiving Fast Track designation, the anticipated timeframe for conducting additional clinical trials and making regulatory submissions, and other strategic and business plans and objectives. These forward-looking statements are based on information BioCanCell has when those statements are made or its management's good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to: the success of the approach to discover and develop prospective therapeutic products, which is new and may never lead to marketable products; a lack of history of commercial sales; a dependence on the success of inodiftagene vixteplasmid, the development of which will require significant additional clinical testing before regulatory approval can be sought and commercial sales launched; a need to raise substantial additional funds to complete R&D activities; an ability to overcome scientific or technological difficulties that may be encountered and that may impede R&D activities; and an ability to obtain and maintain intellectual property protection for product candidates, including pursuant to licensed patents.

Company Contact:
Frank Haluska, M.D., Ph.D.
President and Chief Executive Officer
857-259-4622
info@biocancell.com

Investor Contact:
Ashley R. Robinson
Managing Director
LifeSci Advisors, LLC
617-535-7752
arr@lifesciadvisors.com


Condensed Consolidated Interim Statements of Position as of


    June 30, 2018   June 30, 2017   December 31, 2017    
    (Unaudited)   (Unaudited)   (Audited)    
    NIS thousands   NIS thousands   NIS thousands    
Current assets                
Cash and cash equivalents   71,293   17,580   5,040    
Receivables and other debit balances   4,985   1,340   1,388    
                 
Total current assets   76,278   18,920   6,428    
                 
Long-term prepaid expenses   546   21   37    
Long-term pledged deposits   212   -   -    
Asset in respect of employee benefits, net   11   11   11    
Property, plant and equipment, net   992   746   760    
                 
Total non-current assets   1,761   778   808    
                 
Total assets   78,039   19,698   7,236    
                 
Current liabilities          
Trade payables   10,887   720   559    
Other payables and credit balances   12,308   8,095   8,254    
Short-term employee benefits   1,616   745   536    
Derivative instruments   19,921   -   -    
                 
Total current liabilities   44,732   9,560   9,349    
                 
Non-current liabilities          
Derivative instruments   23,838   -   -    
                 
Total non-current liabilities   23,838   -   -    
                 
Total liabilities   68,570   9,560   9,349    
               
Shareholders' equity          
Share capital   -   -   -    
Share premium   266,921   228,840   228,893    
Capital reserve for translation differences   38   (31 ) (133 )  
Capital reserve for share-based payments   11,695   5,699   7,183    
Accumulated deficit   (269,185 ) (224,370 ) (238,056 )  
               
Total shareholders' equity   9,469   10,138   (2,113 )  
                 
 Total liabilities and shareholders' equity   78,039   19,698   7,236    
                 


 
BioCancell Ltd.
Condensed Consolidated Interim Statements of Income
           
  For the 6-month period ended
  For the 3-month period ended 
  Year ended  
  June 30,   June 30,   June 30,   June 30,   December 31,  
  2018   2017   2018   2017   2017  
  (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited)   (Audited)  
  NIS thousands   NIS thousands   NIS thousands   NIS thousands   NIS thousands  
                     
Research and development expenses 15,194   14,813   6,588   10,175   22,340  
General and administrative expenses 11,392   5,530   8,187   2,632   11,374  
                     
Operating loss 26,586   20,343   14,775   12,807   33,714  
                     
Finance income (1 ) (84 ) (1 ) (83 ) (5 )
Finance expense 3,146   730   2,884   3   365  
                     
Finance expense (income), net 3,145   646   2,883   (80 ) 360  
                     
Loss before taxes on income 29,731   20,989   17,658   12,727   34,074  
           
Taxes on income 1,398   556   1,183   346   1,157  
                     
Loss for the period attributable to          
 the shareholders of the Company 31,129   21,545   18,841   13,073   35,231  
                     
Ordinary loss per share (in NIS):          
           
Basic and diluted loss 3.2   2.6   1.9   1.4   3.9  
                     
Number of shares used to compute  basic and diluted  loss per share          
(thousands of shares) 9,646   8,421   9,679   9,443   9,025  
                     

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