EX-99.1 2 d94753dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

            For the Three Months Ended
June 30
     For the Six Months Ended
June 30,
 
     Notes      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

     3        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

     4        (0.19      (0.14      (0.31      (0.30

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
June 30,
     For the Six Months Ended
June 30,
 
     2020      2019      2020      2019  
     (in thousands)  
     £      £      £      £  

Loss for the period

     (6,061      (4,470      (10,027      (9,827

Other comprehensive income:

           

Items that may be reclassified subsequently to profit or loss:

           

Exchange differences on translation of foreign operations

     1        6        22        1  
  

 

 

    

 

 

    

 

 

    

 

 

 

Other comprehensive income for the period

     1        6        22        1  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total comprehensive loss for the period

     (6,060      (4,464      (10,005      (9,826
  

 

 

    

 

 

    

 

 

    

 

 

 

Attributable to:

           

Equity holders of the Company

     (6,060      (4,464      (10,005      (9,826
  

 

 

    

 

 

    

 

 

    

 

 

 

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

 

            June 30,
2020
    December 31,
2019
 
            (in thousands)  
     Notes      £     £  

Assets

       

Non-current assets

       

Intangible assets

     5        4,534       3,960  

Property, plant and equipment

        917       1,109  

Deferred tax asset

     3        40       46  
     

 

 

   

 

 

 
        5,491       5,115  
     

 

 

   

 

 

 

Current assets

       

Prepayments, accrued income and other receivables

        3,877       4,710  

Current income tax receivable

     3        6,932       8,481  

Cash and cash equivalents

     6        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

     8        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  
     

 

 

   

 

 

 

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

 

3


NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 

     For the Six Months Ended June 30,  
     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, 2019

     1,289        79,426       (339     17,564       1       42,466        (58,813     81,594  

Loss for the period

     —          —         —         —         —         —          (9,827     (9,827

Other comprehensive income for the period

     —          —         —         —         1       —          —         1  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —         —         —         1       —          (9,827     (9,826

Share-based payments

     —          —         —         1,166       —         —          —         1,166  

Exercise of share options

     1        85       —         (132     —         —          132       86  

Surrender of fully vested share options

     —          —         —         (38     —         —          38       —    
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2019

     1,290        79,511       (339     18,560       2       42,466        (68,470     73,020  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at January 1, 2020

     1,299        79,541       (339     20,620       (10     42,466        (80,055     63,522  

Loss for the period

     —          —         —         —         —         —          (10,027     (10,027

Other comprehensive income for the period

     —          —         —         —         22       —          —         22  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —         —         —         22       —          (10,027     (10,005

Share-based payments

     —          —         —         1,669       —         —          —         1,669  

Exercise of share options

     1        14       —         (68     —         —          68       15  

Issue of share capital

     18        2,015       —         —         —         —          —         2,033  

Share issue expenses

     —          (105     —         —         —         —          —         (105
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2020

     1,318        81,465       (339     22,221       12       42,466        (90,014     57,129  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

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 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  
  

 

 

   

 

 

 

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

The comparative figures for the year ended December 31, 2019 are not the Group’s statutory accounts for that financial year within the meaning of section 434 of the Companies Act 2006. Those accounts have been reported on by the Company’s auditor and delivered to the Registrar of Companies. The report of the auditor was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.

 

2.

Significant accounting policies

Basis of preparation

The unaudited condensed consolidated financial statements (the “financial statements”) for the three months and six months ended June 30, 2020 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, 2019. No new standards, amendments or interpretations have had an impact on the financial statements for the three months and six months ended June 30, 2020. The financial statements comprise the financial statements of the Group at June 30, 2020. 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, 2019.

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 and six months ended June 30, 2020 are not necessarily indicative of the results that can be expected for the Company’s fiscal year ending December 31, 2020.

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 £47.8 million at June 30, 2020 will be sufficient to fund its current operating plan for at least the next 12 months. Further, the directors have conducted a full assessment of the impact of COVID-19 on the going concern status of the Company and have concluded that it will not have a significant negative impact on the cash outflows of the Company over the period assessed for going concern purposes. During the second quarter of 2020, the Company temporarily paused and then subsequently re-commenced the enrollment of new patients in clinical trials as a result of COVID-19, resulting in the costs relating to these activities being deferred.

 

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. The Company currently has sufficient cash reserves to fund operations at least into the fourth quarter of 2021. There can be no assurances, however, that additional funding will be available on acceptable terms.

COVID-19

In December 2019, a novel strain of the coronavirus SARS-CoV-2, which causes COVID-19, surfaced in Wuhan, China. Since then, COVID-19 has spread to multiple countries, including the United Kingdom and the United States.

In response to the spread of COVID-19, all of the Company’s offices have been closed with employees continuing their work outside of the offices and the Company has restricted on-site staff access to only those required to execute their job responsibilities.

Also, in April 2020, in response to the COVID-19 pandemic, the Company announced that in order to ease the burden on clinical trial sites and enable healthcare professionals to focus their efforts on caring for patients with COVID-19, the enrollment of new patients in the Company’s ongoing clinical trials was temporarily paused. There was no interruption to the treatment of patients enrolled at that time. Subsequently, in May 2020, the Company announced that enrollment of new patients in the Company’s global Phase 3 clinical trial for patients with biliary tract cancer (NuTide:121) has re-commenced in certain geographies, including Australia, Canada, South Korea, Taiwan, Ukraine and the United Kingdom. Additionally, in May 2020, the Company announced the re-commencement of new patient enrollment in the Phase 1 and Phase 1b clinical trials of NUC-3373 and the Phase 1 clinical trial of NUC-7738. 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 overall impact is currently unknown and the Company is continuing to monitor the COVID-19 pandemic as it evolves.

There is 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, 2019.

 

3.

Income tax

 

     For the Three Months Ended
June 30,
     For the Six Months Ended
June 30,
 
     2020      2019      2020      2019  
     (in thousands)      (in thousands)  
     £      £      £      £  

Current tax:

           

In respect of current period U.K.

     1,289        1,116        2,604        2,123  

In respect of current period U.S.

     (1      (1      (1      (2
  

 

 

    

 

 

    

 

 

    

 

 

 
     1,288        1,115        2,603        2,121  

Deferred tax:

           

In respect of current period U.S.

     (5      (7      (9      (13

In respect of prior period U.S.

     —          —          (1      —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Income tax credit

     1,283        1,108        2,593        2,108  
  

 

 

    

 

 

    

 

 

    

 

 

 

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.

 

7


           June 30,      
2020
     December 31,
2019
 
     (in thousands)  
     £      £  

Current income tax receivable

     

U.K. tax

     6,928        8,477  

U.S. tax

     4        4  
  

 

 

    

 

 

 
     6,932        8,481  
  

 

 

    

 

 

 

Deferred tax asset

     

U.S. deferred tax asset

     40        46  
  

 

 

    

 

 

 

 

4.

Basic and diluted loss per share

 

     For the Three Months Ended
June 30,
     For the Six Months Ended
June 30,
 
     2020      2019      2020      2019  
     (in thousands, except per share data)  
     £      £      £      £  

Loss for the period

     (6,061      (4,470      (10,027      (9,827
  

 

 

    

 

 

    

 

 

    

 

 

 

Basic and diluted weighted average number of shares

     32,668        32,240        32,573        32,233  
     £      £      £      £  

Basic and diluted loss per share

     (0.19      (0.14      (0.31      (0.30
  

 

 

    

 

 

    

 

 

    

 

 

 

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 £4.3 million as of June 30, 2020 (as of December 31, 2019: £3.7 million) and computer software with a carrying value of £0.2 million as of June 30, 2020 (as of December 31, 2019: £0.3 million).

During the six months ended June 30, 2020, the Company acquired intangible assets with a cost of £0.8 million in relation to patents. There were no disposals of intangible assets in the six months ended June 30, 2020.

 

6.

Cash and cash equivalents

 

     June 30,
2020
     December 31,
2019
 
     (in thousands)  
     £      £  

Cash and cash equivalents

           47,800        51,962  
  

 

 

    

 

 

 

Cash and cash equivalents comprise cash at bank with maturities of three months or less and earn interest at fixed or variable rates based on the terms agreed for each account.

 

7.

Share-based payments

The Company has six share-based payment plans for employees, directors and consultants. The share options granted under these plans are settled in equity. The six share-based payment plans include three new plans approved by shareholders at the annual general meeting of the Company on June 25, 2020. No awards have been granted under these new plans during the six months ended June 30, 2020.

 

8


As detailed in the table below, during the six months ended June 30, 2020, 2,186,780 share options were granted under the Company’s U.K. share-based payment plans and U.S. share option sub-plan (six months ended June 30, 2019: 1,088,150 share options granted). Options granted under these plans 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. As the Company completed its initial public offering in October 2017, it is not possible to derive historical volatility from the Company’s ADSs prior to October 2017. The underlying expected volatility was therefore determined by using the historical volatility of similar listed entities as a proxy. The volatility percentage applied to each tranche is the average of the historical volatility of comparable companies to the Company.

The following weighted average principal assumptions were used in calculating the fair values of options granted:

 

     Options granted on
June 10, 2020
 

Vesting dates

     June 10, 2021  
     June 10, 2022  
     June 10, 2023  
     June 10, 2024  

Volatility

     76.59

Dividend yield

     0

Risk-free investment rate

     0.003

Fair value of option at grant date

   £ 2.76  

Fair value of share at grant date

   £ 4.78  

Exercise price at date of grant

   £ 4.78  

Lapse date

     June 10, 2030  

Expected option life (years)

     4.50  

Number of options granted

     2,186,780  

For the three months ended June 30, 2020, the Company has recognized £0.8 million of share-based payment expense in the statement of operations (three months ended June 30, 2019: £0.8 million). For the six months ended June 30, 2020, the Company has recognized £1.7 million of share-based payment expense in the statement of operations (six months ended June 30, 2019: £1.2 million).

 

8.

Share capital and share premium

 

     June 30,
2020
     December 31,
2019
 
     (in thousands)  
     £      £  

Share capital

     1,318        1,299  

Share premium

     81,465        79,541  
  

 

 

    

 

 

 
           82,783        80,840  
  

 

 

    

 

 

 
     June 30,
2020
     December 31,
2019
 
    

Number

(in thousands)

 
Issued share capital comprises:              

Ordinary shares of £0.04 each

     32,939        32,479  
  

 

 

    

 

 

 

 

9


     Number of
shares
     Share
capital
     Share
premium
 
     (in thousands)  
Fully paid shares:           £      £  

Balance at December 31, 2019

     32,479        1,299        79,541  

Issue of shares on exercise of options

     32        1        14  

Issue of shares

     428        18        1,910  
  

 

 

    

 

 

    

 

 

 

Balance at June 30, 2020

     32,939        1,318        81,465  
  

 

 

    

 

 

    

 

 

 

 

9.

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 (currently 13.8%). Based on the closing price of the Company’s ADSs on the Nasdaq Global Select Market on June 30, 2020, 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 £1.0 million (December 31, 2019: £1.3 million).

 

10.

Events after the reporting period

Proceeds from issue of share capital

Since the end of the reporting period the Company has issued 323,986 ADSs, representing 323,986 ordinary shares, raising gross proceeds of £1.5 million.

 

10