EX-99.3 4 d94753dex993.htm EX-99.3 EX-99.3

Exhibit 99.3

NuCana Reports Second Quarter 2020 Financial Results and Provides Business Update

Edinburgh, United Kingdom, August 19, 2020 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced financial results for the second quarter ended June 30, 2020 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

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.”

Anticipated 2020 Milestones

 

   

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.

About NuCana plc

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.


Forward-Looking Statements

This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the amount and sufficiency of the Company’s current cash and cash equivalents to fund its planned operations at least into the fourth quarter of 2021; the Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the impact of COVID-19 on its preclinical studies, clinical studies, business, financial condition and results of operations; the Company’s goals with respect to the development and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2019 filed with the Securities and Exchange Commission (“SEC”) on March 10, 2020, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.


Unaudited Condensed Consolidated Statements of Operations

 

    

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


Unaudited Condensed Consolidated Statements of Financial Position

 

           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  
  

 

 

   

 

 

 


Unaudited Condensed Consolidated Statements of Cash Flows

 

     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:

NuCana plc

Hugh S. Griffith

Chief Executive Officer

T: +44 131 357 1111

E: info@nucana.com

Westwicke, an ICR Company

Chris Brinzey

T: +1 339-970-2843

E: chris.brinzey@westwicke.com

RooneyPartners

Marion Janic

T: +1 212-223-4017

E: mjanic@rooneyco.com