NuCana Reports Second Quarter 2020 Financial Results and Provides Business Update

NuCana Reports Second Quarter 2020 Financial Results and Provides Business Update

  • August 30, 2020
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As of June 30, 2020, NuCana had cash and cash equivalents of £47.8 million compared to £47.6 million as of March 31, 2020 and £52.0 million as of December 31, 2019. NuCana continues to advance its various clinical programs and reported a net loss of £6.1 million for the quarter ended June 30, 2020, as compared to £4.5 million for the quarter ended June 30, 2019. Basic and diluted loss per share was £0.19 for the quarter as compared to £0.14 per share for the prior-year quarter.

“We had a very productive second quarter despite the COVID-19 pandemic. While we placed a brief pause on the recruitment of new patients in April, we have since lifted that pause and our operations have experienced minimal disruption to date”, said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “We are driving recruitment in the ongoing global Phase III study of Acelarin plus cisplatin in patients with biliary tract cancer. We are also making good progress in the Phase Ib combination and Phase I monotherapy studies of NUC-3373 as well as the Phase I study of NUC-7738.”

Mr. Griffith continued: “We are also excited to have three posters accepted for presentation at the ESMO Virtual Congress 2020 to be held September 19-21, 2020. We look forward to presenting additional interim clinical data from the ongoing Phase Ib study of NUC-3373 in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer (NuTide:302). Additionally, we will present the first-ever clinical data from the ongoing Phase I study of NUC-7738 in patients with advanced solid tumors (NuTide:701). Finally, we will present a poster related to the ongoing NuTide:121 study of Acelarin plus cisplatin in patients with advanced biliary tract cancer.”

The poster titles are as follows:

  • Poster 464P – Pharmacokinetic analysis of NUC-3373 with and without leucovorin in patients with previously treated metastatic colorectal cancer (NuTide:302 study)
     
  • Poster 600TiP – A first-in-human study of, NUC-7738, a 3′-dA phosphoramidate, in patients with advanced solid tumors (NuTide:701)
     
  • Poster 80TiP – Global Phase 3 study of NUC-1031 plus cisplatin vs gemcitabine plus cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

Mr. Griffith said: “We were also pleased to have presented data at the American Association for Cancer Research in June that suggested an additional immunomodulatory mode of action for Acelarin and NUC-3373.  These data showed our ProTides’ potential to alter tumor biology and enhance the activity of immune checkpoint inhibitors. They also revealed new and exciting modes of action and help explain why our ProTides appear to be such potent anti-cancer agents.”

Mr. Griffith concluded: “As we continue to advance our novel ProTide pipeline, we remain fortunate to be in a strong financial position with our cash runway still expected to extend at least into the fourth quarter of 2021.  We remain focused on advancing our novel ProTide pipeline to develop more effective and safer medicines for patients with cancer.”

  • Acelarin is a ProTide transformation of gemcitabine. In 2020, NuCana expects to:
     
    • Drive enrollment in the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.
       
  • NUC-3373 is a ProTide transformation of the active anti-cancer metabolite of 5-FU. In 2020, NuCana expects to:
     
    • Report data from the ongoing Phase Ib study (NuTide:302) of NUC-3373 in patients with advanced colorectal cancer and establish the recommended Phase II dose of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan.
    • Contingent on regulatory guidance and other factors, initiate a Phase II/III study of NUC-3373 in combination with other agents for patients with colorectal cancer.
    • Report data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
       
  • NUC-7738 is a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine. In 2020, NuCana expects to:
     
    • Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors.
  • NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s robust pipeline includes three ProTides in clinical development. Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is currently being evaluated in four clinical studies, including a Phase III study for patients with biliary tract cancer, a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with platinum-resistant ovarian cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) and is in a Phase I study for patients with advanced solid tumors.

        For the three months ended
    June 30,
      For the six months ended
    June 30,
        2020   2019     2020   2019  
        (in thousands, except per share data)
        £   £     £   £  
    Research and development expenses   (5,863 ) (5,356 )   (11,801 ) (9,706 )
    Administrative expenses   (1,629 ) (1,462 )   (3,238 ) (2,808 )
    Net foreign exchange gains (losses)   84   943     2,211   (37 )
    Operating loss   (7,408 ) (5,875 )   (12,828 ) (12,551 )
    Finance income   64   297     208   616  
    Loss before tax   (7,344 ) (5,578 )   (12,620 ) (11,935 )
    Income tax credit   1,283   1,108     2,593   2,108  
    Loss for the period   (6,061 ) (4,470 )   (10,027 ) (9,827 )
                 
                 
    Basic and diluted loss per share   (0.19 ) (0.14 )   (0.31 ) (0.30 )
                 
                 

        June 30,
     2020
      December 31,
    2019
     
        (in thousands)
        £   £  
    Assets      
    Non-current assets      
    Intangible assets   4,534   3,960  
    Property, plant and equipment   917   1,109  
    Deferred tax asset   40   46  
        5,491   5,115  
    Current assets      
    Prepayments, accrued income and other receivables   3,877   4,710  
    Current income tax receivable   6,932   8,481  
    Cash and cash equivalents   47,800   51,962  
        58,609   65,153  
    Total assets   64,100   70,268  
    Equity and liabilities      
    Capital and reserves      
    Share capital and share premium   82,783   80,840  
    Other reserves   64,360   62,737  
    Accumulated deficit   (90,014 ) (80,055 )
    Total equity attributable to equity holders of the Company   57,129   63,522  
           
    Non-current liabilities      
    Provisions   26   26  
    Lease liabilities   429   538  
        455   564  
           
    Current liabilities      
    Trade payables   1,928   2,412  
    Payroll taxes and social security   151   160  
    Lease liabilities   246   268  
    Accrued expenditure   4,191   3,342  
        6,516   6,182  
           
    Total liabilities   6,971   6,746  
           
    Total equity and liabilities   64,100   70,268  
               
               

      For the six months ended June 30,
     
      2020   2019  
      (in thousands)
      £   £  
    Cash flows from operating activities    
    Loss for the period (10,027 ) (9,827 )
    Adjustments for:    
    Income tax credit (2,593 ) (2,108 )
    Amortization and depreciation 440   336  
    Finance income (208 ) (616 )
    Interest expense on lease liabilities 14    
    Share-based payments 1,669   1,166  
    Net foreign exchange (gains) losses (2,252 ) 22  
      (12,957 ) (11,027 )
    Movements in working capital:    
    Decrease (increase) in prepayments, accrued income and other receivables 802   (1,518 )
    Decrease in trade payables (484 ) (164 )
    Increase in payroll taxes, social security and accrued expenditure 840   1,063  
    Movements in working capital 1,158   (619 )
    Cash used in operations (11,799 ) (11,646 )
    Net income tax received 4,152   11  
    Net cash used in operating activities (7,647 ) (11,635 )
    Cash flows from investing activities    
    Interest received 279   622  
    Payments for property, plant and equipment (14 ) (21 )
    Payments for intangible assets (804 ) (734 )
    Net cash used in investing activities (539 ) (133 )
    Cash flows from financing activities    
    Payments of lease liabilities (148 ) (95 )
    Proceeds from issue of share capital – exercise of share options 15   86  
    Proceeds from issue of share capital 2,033    
    Share issue expenses (105 )  
    Net cash from (used in) financing activities 1,795   (9 )
    Net decrease in cash and cash equivalents (6,391 ) (11,777 )
    Cash and cash equivalents at beginning of period 51,962   76,972  
    Effect of exchange rate changes on cash and cash equivalents 2,229   (21 )
    Cash and cash equivalents at end of period 47,800   65,174  
             
             

    For more information, please contact:

    [email protected]” data-reactid=”54″>NuCana plc
    Hugh S. Griffith
    Chief Executive Officer
    T: +44 131 357 1111
    E: [email protected]

    [email protected]” data-reactid=”55″>Westwicke, an ICR Company
    Chris Brinzey
    T: +1 339-970-2843
    E: [email protected]

    [email protected]” data-reactid=”56″>RooneyPartners
    Marion Janic
    T: +1 212-223-4017
    E: [email protected]

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