EX-99.1 2 d347363dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

            For the Three Months Ended
March 31,
 
     Notes      2022     2021  
       
            (in thousands, except per share data)  
            £     £  

Research and development expenses

        (9,446     (8,706

Administrative expenses

        (2,152     (2,104

Net foreign exchange gains (losses)

        1,131       (677
     

 

 

   

 

 

 

Operating loss

        (10,467     (11,487

Finance income

        31       24  
     

 

 

   

 

 

 

Loss before tax

        (10,436     (11,463

Income tax credit

     3        2,033       1,702  
     

 

 

   

 

 

 

Loss for the period

        (8,403     (9,761
     

 

 

   

 

 

 

Basic and diluted loss per share

     4        (0.16     (0.19

The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.


NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

     For the Three Months Ended
March 31,
 
     2022     2021  
    
     (in thousands)  
     £     £  

Loss for the period

     (8,403     (9,761

Other comprehensive income (expense):

    

Items that may be reclassified subsequently to profit or loss:

    

Exchange differences on translation of foreign operations

     13       (3
  

 

 

   

 

 

 

Other comprehensive income (expense) for the period

     13       (3
  

 

 

   

 

 

 

Total comprehensive loss for the period

     (8,390     (9,764
  

 

 

   

 

 

 

Attributable to:

    

Equity holders of the Company

     (8,390     (9,764
  

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

 

2


NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AS AT

 

               March 31,   
2022
    December 31,
2021
 
       
            (in thousands)  
     Notes      £     £  

Assets

       

Non-current assets

       

Intangible assets

     5        2,505       2,410  

Property, plant and equipment

        727       851  

Deferred tax asset

     3        68       60  

Other non-current assets

     6        2,556       2,540  
     

 

 

   

 

 

 
        5,856       5,861  
     

 

 

   

 

 

 

Current assets

       

Prepayments, accrued income and other receivables

        3,790       4,161  

Current income tax receivable

     3        9,215       7,188  

Cash and cash equivalents

     7        52,561       60,264  
     

 

 

   

 

 

 
        65,566       71,613  
     

 

 

   

 

 

 

Total assets

        71,422       77,474  
     

 

 

   

 

 

 

Equity and liabilities

       

Capital and reserves

       

Share capital and share premium

     9        143,138       143,137  

Other reserves

        73,481       72,137  

Accumulated deficit

        (157,901     (149,726
     

 

 

   

 

 

 

Total equity attributable to equity holders of the Company

        58,718       65,548  
     

 

 

   

 

 

 

Non-current liabilities

       

Provisions

        46       46  

Lease liabilities

        141       164  
     

 

 

   

 

 

 
        187       210  
     

 

 

   

 

 

 

Current liabilities

       

Trade payables

        2,699       1,829  

Payroll taxes and social security

        714       170  

Accrued expenditure

        8,945       9,510  

Lease liabilities

        159       207  
     

 

 

   

 

 

 
        12,517       11,716  

Total liabilities

        12,704       11,926  
     

 

 

   

 

 

 

Total equity and liabilities

        71,422       77,474  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

 

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NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 

     For the Three Months Ended March 31,  
     Share
capital
     Share
premium
     Own
share
reserve
    Share
option
reserve
    Foreign
currency
translation
reserve
    Capital
reserve
     Accumulated
deficit
    Total
equity
attributable
to equity
holders
 
                   
     (in thousands)  
     £      £      £     £     £     £      £     £  

Balance at January 1, 2021

     2,047        140,890        (339     24,782       (22     42,466        (110,594     99,230  

Loss for the period

     —          —          —         —         —         —          (9,761     (9,761

Other comprehensive expense for the period

     —          —          —         —         (3     —          —         (3
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —          —         —         (3     —          (9,761     (9,764

Share-based payments

     —          —          —         1,795       —         —          —         1,795  

Exercise of share options

     39        159        —         (1,088     —         —          1,088       198  

Lapse of share options

     —          —          —         (121     —         —          121       —    
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at March 31, 2021

     2,086        141,049        (339     25,368       (25     42,466        (119,146     91,459  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at January 1, 2022

     2,087        141,050        (339     30,027       (17     42,466        (149,726     65,548  

Loss for the period

     —          —          —         —         —         —          (8,403     (8,403

Other comprehensive income for the period

     —          —          —         —         13       —          —         13  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —          —         —         13       —          (8,403     (8,390

Share-based payments

     —          —          —         1,575       —         —          —         1,575  

Exercise of share options

     1        —          —         (118     —         —          102       (15

Lapse of share options

     —          —          —         (126     —         —          126       —    
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at March 31, 2022

     2,088        141,050        (339     31,358       (4     42,466        (157,901     58,718  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

 

4


NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    

For the Three Months Ended

March 31,

 
     2022     2021  
    
     (in thousands)  
     £     £  

Cash flows from operating activities

    

Loss for the period

     (8,403     (9,761

Adjustments for:

    

Income tax credit

     (2,033     (1,702

Amortization and depreciation

     197       222  

Finance income

     (32     (24

Interest expense on lease liabilities

     3       6  

Share-based payments

     1,575       1,795  

Net foreign exchange (gains) losses

     (1,149     664  
  

 

 

   

 

 

 
     (9,842     (8,800

Movements in working capital:

    

Decrease (increase) in prepayments, accrued income and other receivables

     390       (191

Increase in trade payables

     870       1,285  

Decrease in payroll taxes, social security and accrued expenditure

     (38     (368
  

 

 

   

 

 

 

Movements in working capital

     1,222       726  
  

 

 

   

 

 

 

Cash used in operations

     (8,620     (8,074
  

 

 

   

 

 

 

Net income tax received

     —         —    
  

 

 

   

 

 

 

Net cash used in operating activities

     (8,620     (8,074
  

 

 

   

 

 

 

Cash flows from investing activities

    

Interest received

     31       24  

Payments for property, plant and equipment

     —         (4

Payments for intangible assets

     (166     (138
  

 

 

   

 

 

 

Net cash used in investing activities

     (135     (118
  

 

 

   

 

 

 

Cash flows from financing activities

    

Payments for lease liabilities

     (75     (74

Proceeds from issue of share capital

     1       198  
  

 

 

   

 

 

 

Net cash (used in) from financing activities

     (74     124  
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (8,829     (8,068

Cash and cash equivalents at beginning of period

     60,264       87,356  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     1,126       (663
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

     52,561       78,625  
  

 

 

   

 

 

 

The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

 

5


NUCANA PLC

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. General information

NuCana plc (“NuCana” or the “Company”) is a clinical-stage biopharmaceutical company developing a portfolio of new medicines to treat patients with cancer. NuCana is harnessing the power of phosphoramidate chemistry to generate new medicines called ProTides. These compounds have the potential to improve cancer treatment by enhancing the efficacy and safety of several current standards of care.

The Company has ordinary shares in the form of American Depositary Shares (“ADSs”) registered with the US Securities and Exchange Commission (the “SEC”) and has been listed on The Nasdaq Global Select Market (“Nasdaq”) since October 2, 2017. The Company is incorporated in England and Wales and domiciled in the United Kingdom. The Company’s registered office is located at 77/78 Cannon Street, London EC4N 6AF, United Kingdom and its principal place of business is located at 3 Lochside Way, Edinburgh, EH12 9DT, United Kingdom.

The Company has three wholly owned subsidiaries, NuCana, Inc., NuCana Limited and NuCana BioMed Trustee Company Limited (together referred to as the “Group”).

The financial information presented in these unaudited condensed consolidated financial statements does not constitute the Group’s statutory accounts within the meaning of section 434 of the U.K. Companies Act 2006.

The Group’s statutory accounts for the year ended December 31, 2021 have been reported on by the Company’s auditor, but not yet delivered to the Registrar of Companies. The report of the auditor was (i) unqualified and (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report.

2. Significant accounting policies

Basis of preparation

The unaudited condensed consolidated financial statements (the “financial statements”) for the three months ended March 31, 2022 have been prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting” (“IAS 34”). The significant accounting policies and methods of computation applied in the preparation of the financial statements are consistent with those applied in the Company’s annual financial statements for the year ended December 31, 2021. No new standards, amendments or interpretations have had an impact on the financial statements for the three months ended March 31, 2022. The financial statements comprise the financial statements of the Group at March 31, 2022. The financial statements are presented in pounds sterling, which is also the Company’s functional currency. All values are rounded to the nearest thousand, except where otherwise indicated.

The financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company’s annual financial statements for the year ended December 31, 2021.

In the opinion of management, these unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of the results of operations, financial position and cash flows. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results that can be expected for the Company’s fiscal year ending December 31, 2022.

Going concern

In common with many companies in the biopharmaceutical sector, the Company incurs significant expenditure in its early years as it researches and develops its potential products for market.

The Company’s board of directors, having reviewed the operating budgets and development plans, considers that the Company has adequate resources to continue in operation for the foreseeable future. The board of directors is therefore satisfied that it is appropriate to adopt the going concern basis of accounting in preparing the financial statements. The Company believes that its cash and cash equivalents of £52.6 million at March 31, 2022 will be sufficient to fund its current operating plan for at least the next 12 months. Further, following the announcement on March 2, 2022 that the Company’s Phase 3 clinical trial of Acelarin for patients with advanced biliary tract cancer was being discontinued, the directors have conducted an assessment on the going concern status of the Company and have concluded that it will have a positive impact on the cash outflows of the Company over the period assessed for going concern purposes.

 

6


As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. The Company may never achieve profitability, and unless and until it does, it will continue to need to raise additional capital. There can be no assurances, however, that additional funding will be available on acceptable terms.

COVID-19

In response to the COVID-19 pandemic, the majority of the Company’s employees continue to work from home with limited attendance at the Company’s offices.

While the Company continues to evaluate the impact of COVID-19 on its operations, the Company believes that this pandemic will inevitably cause some delays to the timing of initiation and completion of its clinical trials. The Company is continuing to monitor the impact of COVID-19.

COVID-19 has had no impact on the judgements and estimates used in the preparation of these financial statements.

Judgements and estimates

The accounting estimates and judgements made by management in applying the Group’s accounting policies that have the most significant effect on the amounts included within these financial statements were the same as those that applied to the annual financial statements for the year ended December 31, 2021.

3. Income tax

 

     For the Three Months Ended
March 31,
 
     2022      2021  
     
     (in thousands)  
     £      £  

Current tax:

     

In respect of current period U.K.

     2,027        1,706  

In respect of current period U.S.

     —          —    
  

 

 

    

 

 

 
     2,027        1,706  

Deferred tax:

     

In respect of current period U.S.

     6        (4

In respect of prior period U.S.

     —          —    
  

 

 

    

 

 

 

Income tax credit

     2,033        1,702  
  

 

 

    

 

 

 

The income tax credit recognized primarily represents the U.K. research and development tax credit. In the United Kingdom, the Company is able to surrender some of its losses for a cash rebate of up to 33.35% of expenditure related to eligible research and development projects.

 

        March 31,   
   2022   
     December 31,
2021
 
     
     (in thousands)  
     £      £  

Current income tax receivable

     

U.K. tax

     9,212        7,185  

U.S. tax

     3        3  
  

 

 

    

 

 

 
     9,215        7,188  
  

 

 

    

 

 

 

Deferred tax asset

     

U.S. deferred tax asset

     68        60  
  

 

 

    

 

 

 

 

7


4. Basic and diluted loss per share

 

     For the Three Months Ended
March 31,
 
         2022          2021  
     
     (in thousands, except per
share data)
 
     £      £  

Loss for the period

     (8,403      (9,761
  

 

 

    

 

 

 

Basic and diluted weighted average number of shares

     52,183        51,649  

Basic and diluted loss per share

     (0.16      (0.19
  

 

 

    

 

 

 

Basic loss per share is calculated by dividing the loss for the period attributable to the equity holders of the Company by the weighted average number of shares outstanding during the period.

The potential shares issued through equity settled transactions were considered to be anti-dilutive as they would have decreased the loss per share and were therefore excluded from the calculation of diluted loss per share.

5. Intangible assets

Intangible assets comprise patents with a carrying value of £2.4 million as of March 31, 2022 (as of December 31, 2021: £2.3 million) and computer software with a carrying value of £0.1 million as of March 31, 2022 (as of December 31, 2021: £0.1 million).

During the three months ended March 31, 2022, the Company acquired intangible assets with a cost of £0.2 million in relation to patents.

6. Other non-current assets

 

        March 31,   
   2022   
     December 31,
2021
 
     
     (in thousands)  
     £      £  

Other non-current assets

     2,556        2,540  
  

 

 

    

 

 

 

During 2021, the Company initiated legal proceedings against Gilead Sciences Ireland UC and Gilead Sciences GmbH for patent infringement in Germany. The Company was requested by the court to provide the defendants with a security of €3.0 million (£2.6 million) to cover the legal costs of the defendants in the event that the Company is unsuccessful in the final outcome of the legal proceedings. Subsequently, the Company provided the security in accordance with the court order by depositing €3.0 million with the court.

The extent to which the sum deposited will be reimbursed to the Company is dependent on a range of potential outcomes, and the timing of those outcomes, with respect to the patent infringement litigation in Germany, which is currently indeterminable.

7. Cash and cash equivalents

 

        March 31,   
   2022   
     December 31,
2021
 
     
     (in thousands)  
     £      £  

Cash and cash equivalents

     52,561        60,264  
  

 

 

    

 

 

 

Cash and cash equivalents comprise cash at banks with deposit maturity terms of three months or less, which is subject to insignificant risk of changes in value. Cash at banks earns interest at fixed or variable rates based on the terms agreed for each account.

 

8


8. Share-based payments

The Company has six share-based payment plans for employees, directors and consultants. The share options granted will be settled in equity. Options granted under each of the six plans have a maximum life of 10 years. If the Company determines, and at its discretion, an arrangement may be made under the 2020 Long-Term Incentive Plan to substitute the right to acquire shares with a cash alternative of equivalent value.

As detailed in the table below, during the three months ended March 31, 2022, 1,115,925 share options were granted under the 2020 Long-Term Incentive Plan (three months ended March 31, 2021: 1,501,663 share options granted). Options granted under this plan will vest if the option holder remains under respective contract of employment or contract of service for the agreed vesting period. The share options granted in the period will vest over a period of up to four years.

The fair values of options granted were determined using the Black-Scholes model that takes into account factors specific to the share incentive plan such as the assumption that the options are exercised at a point in time of up to two years after vesting. This has been incorporated into the measurement by means of actuarial modelling. As NuCana plc was unlisted until October 2, 2017, it is not possible to derive historical volatility from the Company’s ADSs prior to October 2017. For options with an estimated life of greater than four years, the underlying expected volatility was determined by using the average of the historical volatility of similar listed entities as a proxy. Options granted with an estimated life of four years or less, have been valued using the Company’s own historical volatility rates.

 

     Options granted on  
     March 9, 2022     March 9, 2022  

Vesting dates

     March 9, 2023       March 9, 2023  
     March 9, 2024       March 9, 2024  
     March 9, 2025       March 9, 2025  
     March 9, 2026       March 9, 2026  

Volatility

     89.32     95.70

Dividend yield

     0     0

Risk-free investment rate

     1.36     1.37

Fair value of option at grant date

   £ 0.37     £ 0.53  

Fair value of share at grant date

   £ 0.56     £ 0.56  

Exercise price at date of grant

   £ 0.56     £ 0.04  

Lapse date

     March 9, 2032       March 9, 2032  

Expected option life (years)

     4.50       3.50  

Number of options granted

     1,020,925       95,000  

For the three months ended March 31, 2022, the Company recognized £1.6 million of share-based payment expense in the statement of operations (three months ended March 31, 2021: £1.8 million).

9. Share capital and share premium

 

     March 31,
2022
     December 31,
2021
 
     
     (in thousands)  
     £      £  

Share capital

     2,088        2,087  

Share premium

     141,050        141,050  
  

 

 

    

 

 

 
     143,138        143,137  
  

 

 

    

 

 

 
        March 31,   
   2022   
     December 31,
2021
 
     
    

Number

(in thousands)

 

Issued share capital comprises:

     

Ordinary shares of £0.04 each

     52,196        52,180  
  

 

 

    

 

 

 

 

9


     Number of
shares
     Share
capital
     Share
premium
 
        
     (in thousands)  
            £      £  

Fully paid shares:

        

Balance at December 31, 2021

     52,180        2,087        141,050  

Issue of shares on exercise of options

     16        1        —    
  

 

 

    

 

 

    

 

 

 

Balance at March 31, 2022

     52,196        2,088        141,050  
  

 

 

    

 

 

    

 

 

 

10. Contingent liabilities

Under its U.K. share-based payment plan, the Company granted unapproved share options that have fully vested. If and when these share options are exercised, the Company will be liable for the Employer Class 1 National Insurance payable to HMRC in the United Kingdom. This contingent liability will be determined based on the market value of the shares on exercise less the exercise price paid by the option holders, at the prevailing rate of Employer National Insurance (13.8% at March 31, 2022). Based on the closing price of the Company’s ADSs on the Nasdaq Global Select Market on March 31, 2022, the last trading day of the period to which these financial statements relate, and assuming full exercise of all outstanding and vested unapproved share options on that date, the Employer National Insurance contingent liability would have been £0.2 million (December 31, 2021: £0.4 million).

As referenced in Note 6, during 2021 the Company provided a security of €3.0 million to cover the legal costs of Gilead Sciences Ireland UC and Gilead Sciences GmbH in the event that the Company is unsuccessful in the final outcome of the patent infringement litigation in Germany. Any cost reimbursement by the Company to the defendants is dependent on a range of potential outcomes, and the timing of those outcomes, with respect to the litigation, which are currently indeterminable. Therefore, no provision has been recognized with respect to these legal costs as the Company does not consider it probable that the litigation will be unsuccessful.

 

 

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