6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2020

(Commission File No. 001-38215)

 

 

NUCANA PLC

(Translation of registrant’s name into English)

 

 

3 Lochside Way

Edinburgh EH12 9DT

United Kingdom

(Address of registrant’s principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F  ☒             Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):  ☐

 

 

 


Other Events

On November 19, 2020, NuCana plc (the “Company”) issued a press release announcing its third quarter 2020 financial results. The Company’s unaudited condensed consolidated financial statements as of September 30, 2020 are attached as Exhibit 99.1 and are incorporated by reference herein. The Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations is attached as Exhibit 99.2 hereto and is incorporated by reference herein. The press release is attached as Exhibit 99.3 hereto and is incorporated by reference herein.

The information in the attached Exhibits 99.1 and 99.2 shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Number 333-227624) and Form S-8 (File Number 333-223476 and File Number 333-248135), and related prospectuses, as such registration statements and prospectuses may be amended from time to time, and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

The information in the attached Exhibit 99.3 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

Exhibits

 

99.1    Unaudited Condensed Consolidated Financial Statements as of September 30, 2020 and for the Three and Nine Months Ended September 30, 2020 and 2019
99.2    Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended September 30, 2020 and 2019
99.3    Press Release dated November 19, 2020
101    The following materials from this Report on Form 6-K are formatted in XBRL (eXtensible Business Reporting Language): (i) Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months ended September 30, 2020 and 2019, (ii) Unaudited Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months ended September 30, 2020 and 2019, (iii) Unaudited Condensed Consolidated Statements of Financial Position as at September 30, 2020 and December 31, 2019, (iv) Unaudited Condensed Consolidated Statements of Changes in Equity for the Nine Months ended September 30, 2020 and 2019, (v) Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2020 and 2019 and (vi) Notes to the Unaudited Condensed Consolidated Financial Statements.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

NuCana plc
By:   /s/ Donald Munoz
Name:   Donald Munoz
Title:   Chief Financial Officer

Date: November 19, 2020

EX-99.1

Exhibit 99.1

NUCANA PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

            For the Three Months Ended
September 30,
    For the Nine Months Ended
September 30,
 
     Notes      2020     2019     2020     2019  
            (in thousands, except per share data)  
            £     £     £     £  

Research and development expenses

        (6,117     (4,845     (17,918     (14,551

Administrative expenses

        (1,906     (1,423     (5,144     (4,231

Net foreign exchange (losses) gains

        (1,601     1,227       610       1,191  
     

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

        (9,624     (5,041     (22,452     (17,591

Finance income

        26       252       234       867  
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss before tax

        (9,598     (4,789     (22,218     (16,724

Income tax credit

     3        1,204       912       3,797       3,020  
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

        (8,394     (3,877     (18,421     (13,704
     

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted loss per share

     4        (0.24     (0.12     (0.55     (0.42

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
September 30,
    For the Nine Months Ended
September 30,
 
     2020     2019     2020     2019  
     (in thousands)  
     £     £     £     £  

Loss for the period

     (8,394     (3,877     (18,421     (13,704

Other comprehensive (expense) income:

        

Items that may be reclassified subsequently to profit or loss:

        

Exchange differences on translation of foreign operations

     (15     8       7       9  
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive (expense) income for the period

     (15     8       7       9  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

     (8,409     (3,869     (18,414     (13,695
  

 

 

   

 

 

   

 

 

   

 

 

 

Attributable to:

        

Equity holders of the Company

     (8,409     (3,869     (18,414     (13,695
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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

Assets

       

Non-current assets

       

Intangible assets

     5        4,686       3,960  

Property, plant and equipment

        1,281       1,109  

Deferred tax asset

     3        34       46  
     

 

 

   

 

 

 
        6,001       5,115  
     

 

 

   

 

 

 

Current assets

       

Prepayments, accrued income and other receivables

        5,065       4,710  

Current income tax receivable

     3        8,140       8,481  

Cash and cash equivalents

     6        100,678       51,962  
     

 

 

   

 

 

 
        113,883       65,153  
     

 

 

   

 

 

 

Total assets

        119,884       70,268  
     

 

 

   

 

 

 
       

Equity and liabilities

       

Capital and reserves

       

Share capital and share premium

     8        142,937       80,840  

Other reserves

        65,740       62,737  

Accumulated deficit

        (98,403     (80,055
     

 

 

   

 

 

 

Total equity attributable to equity holders of the Company

        110,274       63,522  
     

 

 

   

 

 

 
       

Non-current liabilities

       

Provisions

        46       26  

Lease liabilities

        441       538  
     

 

 

   

 

 

 
        487       564  
     

 

 

   

 

 

 

Current liabilities

       

Trade payables

        4,190       2,412  

Payroll taxes and social security

        138       160  

Lease liabilities

        278       268  

Accrued expenditure

        4,517       3,342  
     

 

 

   

 

 

 
        9,123       6,182  

Total liabilities

        9,610       6,746  
     

 

 

   

 

 

 

Total equity and liabilities

        119,884       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 Nine Months Ended September 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

     —          —         —         —         —         —          (13,704     (13,704

Other comprehensive income for the period

     —          —         —         —         9       —          —         9  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —         —         —         9       —          (13,704     (13,695

Share-based payments

     —          —         —         2,191       —         —          —         2,191  

Exercise of share options

     9        108       —         (132     —         —          132       117  

Surrender of fully vested share options

     —          —         —         (38     —         —          38       —    
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at September 30, 2019

     1,298        79,534       (339     19,585       10       42,466        (72,347     70,207  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 
                  

Balance at January 1, 2020

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

Loss for the period

     —          —         —         —         —         —          (18,421     (18,421

Other comprehensive income for the period

     —          —         —         —         7       —          —         7  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —         —         —         7       —          (18,421     (18,414

Share-based payments

     —          —         —         3,069       —         —          —         3,069  

Exercise of share options

     1        14       —         (68     —         —          68       15  

Lapse of share options

     —          —         —         (5     —         —          5       —    

Issue of share capital

     747        65,834       —         —         —         —          —         66,581  

Share issue expenses

     —          (4,499     —         —         —         —          —         (4,499
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at September 30, 2020

     2,047        140,890       (339     23,616       (3     42,466        (98,403     110,274  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

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 Nine Months Ended
September 30,
 
     2020     2019  
     (in thousands)  
     £     £  

Cash flows from operating activities

    

Loss for the period

     (18,421     (13,704

Adjustments for:

    

Income tax credit

     (3,797     (3,020

Amortization and depreciation

     667       522  

Finance income

     (234     (867

Interest expense on lease liabilities

     20       —    

Share-based payments

     3,069       2,191  

Net foreign exchange gains

     (619     (1,228
  

 

 

   

 

 

 
     (19,315     (16,106

Movements in working capital:

    

Increase in prepayments, accrued income and other receivables

     (408     (3,593

Increase (decrease) in trade payables

     1,778       (300

Increase in payroll taxes, social security and accrued expenditure

     1,153       8  
  

 

 

   

 

 

 

Movements in working capital

     2,523       (3,885
  

 

 

   

 

 

 

Cash used in operations

     (16,792     (19,991
  

 

 

   

 

 

 

Net income tax received

     4,152       20  
  

 

 

   

 

 

 

Net cash used in operating activities

     (12,640     (19,971
  

 

 

   

 

 

 

Cash flows from investing activities

    

Interest received

     300       915  

Payments for property, plant and equipment

     (350     (29

Payments for intangible assets

     (1,079     (988
  

 

 

   

 

 

 

Net cash used in investing activities

     (1,129     (102
  

 

 

   

 

 

 

Cash flows from financing activities

    

Payments of lease liabilities

     (223     (146

Proceeds from issue of share capital – exercise of share options

     15       117  

Proceeds from issue of share capital

     66,581       —    

Share issue expenses

     (4,499     —    
  

 

 

   

 

 

 

Net cash from (used in) financing activities

     61,874       (29
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     48,105       (20,102

Cash and cash equivalents at beginning of period

     51,962       76,972  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     611       1,221  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

     100,678       58,091  
  

 

 

   

 

 

 

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 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, 2019 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 U.K. Companies Act 2006.

2. Significant accounting policies

Basis of preparation

The unaudited condensed consolidated financial statements (the “financial statements”) for the three months and nine months ended September 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 nine months ended September 30, 2020. The financial statements comprise the financial statements of the Group at September 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 nine months ended September 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 £100.7 million at September 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.

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.

 

6


COVID-19

In response to the COVID-19 pandemic, 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.

In April 2020, 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. In May 2020, the Company announced that enrollment of new patients in the Company’s clinical trials, including the global Phase 3 clinical trial for patients with biliary tract cancer (NuTide:121), the Phase 1 and Phase 1b clinical trials of NUC-3373 and the Phase 1 clinical trial of NUC-7738, had re-commenced. 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 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, 2019.

3. Income tax

 

     For the Three Months Ended
September 30,
     For the Nine Months Ended
September 30,
 
     2020      2019      2020      2019  
     (in thousands)      (in thousands)  
     £      £      £      £  

Current tax:

           

In respect of current period U.K.

     1,230        1,006        3,834        3,129  

In respect of current period U.S.

     —          (1      (1      (3

In respect of prior period U.K.

     (22      (86      (22      (86
  

 

 

    

 

 

    

 

 

    

 

 

 
     1,208        919        3,811        3,040  

Deferred tax:

           

In respect of current period U.S.

     (4      (7      (13      (20

In respect of prior period U.S.

     —          —          (1      —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Income tax credit

     1,204        912        3,797        3,020  
  

 

 

    

 

 

    

 

 

    

 

 

 

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.

 

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

Current income tax receivable

     

U.K. tax

     8,136        8,477  

U.S. tax

     4        4  
  

 

 

    

 

 

 
     8,140        8,481  
  

 

 

    

 

 

 

Deferred tax asset

     

U.S. deferred tax asset

     34        46  
  

 

 

    

 

 

 

 

7


4. Basic and diluted loss per share

 

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

Loss for the period

     (8,394      (3,877      (18,421      (13,704
  

 

 

    

 

 

    

 

 

    

 

 

 
           

Basic and diluted weighted average number of shares

     35,093        32,372        33,419        32,280  
     £        £        £        £  

Basic and diluted loss per share

     (0.24      (0.12      (0.55      (0.42
  

 

 

    

 

 

    

 

 

    

 

 

 

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 £4.5 million as of September 30, 2020 (as of December 31, 2019: £3.7 million) and computer software with a carrying value of £0.2 million as of September 30, 2020 (as of December 31, 2019: £0.3 million).

During the nine months ended September 30, 2020, the Company acquired intangible assets with a cost of £1.1 million in relation to patents. There were no disposals of intangible assets in the nine months ended September 30, 2020.

6. Cash and cash equivalents

 

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

Cash and cash equivalents

     100,678        51,962  
  

 

 

    

 

 

 

Cash and cash equivalents comprise cash at bank with maturities of three months or less earning 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 six share-based payment plans include three new plans approved by shareholders at the annual general meeting of the Company on June 25, 2020. The share options granted under these plans are settled in equity. 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 nine months ended September 30, 2020, 2,585,639 share options were granted under the Company’s U.K. share-based payment plans and U.S. share option sub-plan (nine months ended September 30, 2019: 1,202,150 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. For options with an estimated life of greater than two years, the underlying expected volatility was 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. Options granted with an estimated life of two years or less, have been valued using the Company’s own historical volatility rates.

 

8


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

 

     Options granted on  
     June 10, 2020     Sept 9, 2020     Sept 9, 2020  

Vesting dates

     June 10, 2021       Sept 9, 2021       Sept 9, 2021  
     June 10, 2022       Sept 9, 2022       Sept 9, 2022  
     June 10, 2023       Sept 9, 2023       Sept 9, 2023  
     June 10, 2024       Sept 9, 2024       Sept 9, 2024  

Volatility

     76.59     82.98     87.21

Dividend yield

     0     0     0

Risk-free investment rate

     0.003     (0.08 )%      (0.08 )% 

Fair value of option at grant date

   £ 2.76     £ 4.24     £ 4.24  

Fair value of share at grant date

   £ 4.78     £ 4.28     £ 4.28  

Exercise price at date of grant

   £ 4.78     £ 0.04     £ 0.04  

Lapse date

     June 10, 2030       Sept 9, 2030       —    

Expected option life (years)

     4.50       3.50       2.50  

Number of options granted

     2,186,780       290,356       108,503  

For the three months ended September 30, 2020, the Company has recognized £1.4 million of share-based payment expense in the statement of operations (three months ended September 30, 2019: £1.0 million). For the nine months ended September 30, 2020, the Company has recognized £3.1 million of share-based payment expense in the statement of operations (nine months ended September 30, 2019: £2.2 million).

8. Share capital and share premium

 

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

Share capital

     2,047        1,299  

Share premium

     140,890        79,541  
  

 

 

    

 

 

 
     142,937        80,840  
  

 

 

    

 

 

 

 

     September 30,
2020
     December 31,
2019
 
    

Number

(in thousands)

 

Issued share capital comprises:

     

Ordinary shares of £0.04 each

     51,174        32,479  
  

 

 

    

 

 

 

 

     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

     18,663        747        61,335  
  

 

 

    

 

 

    

 

 

 

Balance at September 30, 2020

     51,174        2,047        140,890  
  

 

 

    

 

 

    

 

 

 

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 September 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 £0.9 million (December 31, 2019: £1.3 million).

 

 

9

EX-99.2

Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of financial condition and results of operations together with the unaudited condensed consolidated financial statements and the related notes to those statements included as Exhibit 99.1 to this Report on Form 6-K submitted to the Securities and Exchange Commission, or the SEC, on November 19, 2020. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, and the section entitled “Risk Factors”, each of which appear in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the SEC on March 10, 2020, or the Annual Report, as well as the Supplemental Risk Factor with respect to the COVID-19 pandemic which appears in our Form 6-K filed with the SEC on April 2, 2020.

We present our unaudited condensed consolidated financial statements in pounds sterling and in accordance with International Accounting Standard 34, “Interim Financial Reporting,” or IAS 34, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including generally accepted accounting principles in the United States, or U.S. GAAP.

Unless otherwise indicated or the context otherwise requires, all references to “NuCana,” the “Company,” “we,” “our,” “us” or similar terms refer to NuCana plc and its consolidated subsidiaries.

The statements in this discussion regarding industry outlook, our expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. 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 our Annual Report and any subsequent reports that we file with the SEC.

Company Overview

We are 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. Our most advanced ProTide candidates, 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 multiple clinical trials,

including a Phase 3 clinical trial for patients with biliary tract cancer, a Phase 1b clinical trial for patients with biliary tract cancer, a Phase 2 clinical trial for patients with platinum-resistant ovarian cancer, and a Phase 3 clinical trial for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase 1 clinical trial in patients with advanced solid tumors and a Phase 1b clinical trial in patients with advanced colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) that has never been successfully developed or approved as a chemotherapy but has shown potent anti-cancer activity in preclinical studies. We are evaluating NUC-7738 in a Phase 1 clinical trial for patients with advanced solid tumors. We have retained worldwide rights to these lead product candidates as well as our

preclinical product candidates, all of which we refer to as ProTides.

COVID-19

In April 2020, we 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 our ongoing clinical trials was temporarily paused. There was no interruption to the treatment of patients enrolled at that time. In May 2020, we announced that enrollment of new patients in our clinical trials, including the global Phase 3 clinical trial for patients with biliary tract cancer (NuTide:121), the Phase 1 and Phase 1b clinical trials of NUC-3373 and the Phase 1 clinical trial of NUC-7738, had re-commenced. While we continue to evaluate the impact of COVID-19 on our operations, we believe that this pandemic will inevitably cause some delays to the timing of initiation and completion of our clinical trials. The overall impact is currently unknown and we continue to monitor the impact of COVID-19.


Financial Operations Overview

Revenues

We do not have any approved products. Accordingly, we have not generated any revenue, and we do not expect to generate any revenue from the sale of any products unless and until we obtain regulatory approvals for, and commercialize any of, our product candidates. In the future, we will seek to generate revenue primarily from product sales and, potentially, regional or global collaborations with strategic partners.

Operating Expenses

We classify our operating expenses into two categories: research and development expenses and administrative expenses. Personnel costs, including salaries, benefits, bonuses and share-based payment expense, comprise a portion of each of these expense categories. We allocate expenses associated with personnel costs based on the function performed by the respective employees.

Research and Development Expenses

The largest component of our total operating expenses since our inception has been costs related to our research and development activities, including the preclinical and clinical development of our product candidates.

Research and development costs are expensed as incurred. Our research and development expense primarily consists of:

 

   

costs incurred under agreements with contract research organizations, or CROs, and investigative sites that conduct preclinical studies and clinical trials;

 

   

costs related to manufacturing active pharmaceutical ingredients and drug products for preclinical studies and clinical trials;

 

   

salaries and personnel-related costs, including bonuses, benefits and any share-based payment expense, for our personnel performing research and development activities or managing those activities that have been out-sourced;

 

   

fees paid to consultants and other third parties who support our product candidate development;

 

   

other costs incurred in seeking regulatory approval for our product candidates; and

 

   

payments under our license agreements.

The successful development of our ProTides is highly uncertain. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Accordingly, we expect research and development costs to increase significantly for the foreseeable future as programs progress. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates to offset these expenses. Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors including:

 

   

the scope, rate of progress, results and expenses of our ongoing and future clinical trials, preclinical studies and research and development activities;

 

   

the potential need for additional clinical trials or preclinical studies requested by regulatory agencies;

 

   

potential uncertainties in clinical trial enrollment rates or drop-out or discontinuation rates of patients;

 

   

competition with other drug development companies in, and the related expense of, identifying and enrolling patients in our clinical trials and contracting with third-party manufacturers for the production of the drug product needed for our clinical trials;

 

   

the achievement of milestones requiring payments under in-licensing agreements;

 

   

any significant changes in government regulation;

 

   

the terms and timing of any regulatory approvals;

 

   

the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; and

 

   

the ability to market, commercialize and achieve market acceptance for any of our product candidates, if approved.


We track research and development expenses on a program-by-program basis for both clinical-stage and preclinical product candidates. Manufacturing and non-clinical research and development expenses are assigned or allocated to individual product candidates, where appropriate.

Administrative Expenses

Administrative expenses consist of personnel costs, allocated expenses and other expenses for outside professional services, including legal, audit and accounting services. Personnel costs consist of salaries, bonuses, benefits and share-based payment expense. Other administrative expenses include office related costs, professional fees and costs of our information systems. We anticipate that our administrative expenses will continue to increase in the future as we increase our headcount to support our continued research and development and potential commercialization of our product candidates. We also incur expenses as a public company, including expenses related to compliance with the rules and regulations of the SEC and The Nasdaq Global Select Market, additional insurance expenses, and expenses related to investor relations and other administrative and professional services.

Net Foreign Exchange Gains (Losses)

Net foreign exchange gains (losses) primarily includes gains or losses on cash held in U.S. dollars and on U.S. dollar-denominated advances paid to suppliers.

Finance Income

Finance income relates to interest earned on our cash and cash equivalents.

Income Tax Credit

We are subject to corporate taxation in the United Kingdom and our wholly owned U.S. subsidiary, NuCana, Inc., is subject to corporate taxation in the United States. Due to the nature of our business, we have generated losses since inception in the United Kingdom. Our income tax credit recognized represents the sum of the research and development tax credits recoverable in the United Kingdom and in the United States, and income tax payable in the United States.

As a company that carries out extensive research and development activities, we benefit from the U.K. and U.S. research and development tax credit regimes. In the United Kingdom, we are able to surrender some of our losses for a cash rebate of up to 33.35% of eligible expenditures on qualifying research and development projects. In the United States, we are able to offset the research and development credits against corporation tax payable. Qualifying expenditures in the United Kingdom largely comprise clinical trial and manufacturing costs, employment costs for relevant staff and consumables incurred as part of research and development projects. In the United Kingdom, where we receive the larger proportion of the research and development credit, certain subcontracted qualifying research and development expenditures are eligible for a cash rebate of up to 21.68%. A large portion of costs relating to our research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims.

We may not be able to continue to claim research and development tax credits in the United Kingdom in the future under the current research and development tax credit scheme because we may no longer qualify as a small or medium-sized company, or SME. However, we may be able to file under a large company scheme.


Results of Operations

Comparison of the Three Months Ended September 30, 2020 and September 30, 2019

The following table summarizes the results of our operations for the three months ended September 30, 2020 and 2019.

 

     For the Three Months Ended
September 30,
 
     2020      2019  
     (unaudited)  
     (in thousands)  
     £      £  

Research and development expenses

     (6,117      (4,845

Administrative expenses

     (1,906      (1,423

Net foreign exchange (losses) gains

     (1,601      1,227  
  

 

 

    

 

 

 

Operating loss

     (9,624      (5,041

Finance income

     26        252  
  

 

 

    

 

 

 

Loss before tax

     (9,598      (4,789

Income tax credit

     1,204        912  
  

 

 

    

 

 

 

Loss for the period

     (8,394      (3,877

Other comprehensive (expense) income:

     

Items that may be reclassified subsequently to profit or loss:

     

Exchange differences on translation of foreign operations

     (15      8  
  

 

 

    

 

 

 

Total comprehensive loss for the period

     (8,409      (3,869
  

 

 

    

 

 

 

Research and Development Expenses

Research and development expenses were £6.1 million for the three months ended September 30, 2020 as compared to £4.8 million for the three months ended September 30, 2019, reflecting an increase of £1.3 million. The increase resulted primarily from higher expenses incurred related to clinical trials of £3.2 million in the three months ended September 30, 2020, compared with £2.3 million in the three months ended September 30, 2019. Non-clinical and manufacturing costs increased by £0.3 million for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019. Share-based payment expenses were £0.8 million for the three months ended September 30, 2020 compared with £0.6 million for the three months ended September 30, 2019. The total increase in research and development expenses was partially offset by a reduction of £0.1 million in travel costs in the three months ended September 30, 2020.

The following table gives a breakdown of the research and development costs incurred by product candidate for the three months ended September 30, 2020 and 2019:

 

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

Acelarin

     3,304        2,726  

NUC-3373

     1,405        1,231  

NUC-7738

     888        440  

Other

     520        448  
  

 

 

    

 

 

 
     6,117      4,845  
  

 

 

    

 

 

 

Administrative Expenses

Administrative expenses were £1.9 million for the three months ended September 30, 2020 as compared to £1.4 million for the three months ended September 30, 2019, reflecting an increase of £0.5 million. The increase was primarily related to higher insurance, professional fees and share-based payment expenses.

Net Foreign Exchange (Losses) Gains

For the three months ended September 30, 2020, we reported a net foreign exchange loss of £1.6 million as compared to a net foreign exchange gain of £1.2 million for the three months ended September 30, 2019. In the three months ended September 30, 2020, the loss reflected the appreciation of the U.K. pound sterling relative to the U.S. dollar. In the three months ended September 30, 2019, the gain was generated by the appreciation of the U.S. dollar relative to the U.K. pound sterling.


Finance Income

Finance income represents bank interest and was £26,000 for the three months ended September 30, 2020 and £0.3 million for the three months ended September 30, 2019. The decrease in bank interest resulted from lower average cash balances held on term deposits and lower rates of interest being earned on those deposits.

Income Tax Credit

The income tax credit for the three months ended September 30, 2020, which is largely composed of U.K. research and development tax credits, amounted to £1.2 million as compared to £0.9 million for the three months ended September 30, 2019. The increase in the income tax credit was primarily attributable to an increase in our eligible research and development expenses.

Results of Operations

Comparison of the Nine Months Ended September 30, 2020 and September 30, 2019

The following table summarizes the results of our operations for the nine months ended September 30, 2020 and 2019.

 

     For the Nine Months Ended
September 30,
 
     2020      2019  
     (unaudited)  
     (in thousands)  
     £      £  

Research and development expenses

     (17,918      (14,551

Administrative expenses

     (5,144      (4,231

Net foreign exchange gains

     610        1,191  
  

 

 

    

 

 

 

Operating loss

     (22,452      (17,591

Finance income

     234        867  
  

 

 

    

 

 

 

Loss before tax

     (22,218      (16,724

Income tax credit

     3,797        3,020  
  

 

 

    

 

 

 

Loss for the period

     (18,421      (13,704

Other comprehensive income:

     

Items that may be reclassified subsequently to profit or loss:

     

Exchange differences on translation of foreign operations

     7        9  
  

 

 

    

 

 

 

Total comprehensive loss for the period

     (18,414      (13,695
  

 

 

    

 

 

 

Research and Development Expenses

Research and development expenses were £17.9 million for the nine months ended September 30, 2020 as compared to £14.6 million for the nine months ended September 30, 2019, reflecting an increase of £3.3 million. The increase resulted primarily from higher expenses incurred related to clinical trials of £8.4 million in the nine months ended September 30, 2020, compared with £6.4 million in the nine months ended September 30, 2019. Manufacturing costs were £2.2 million in the nine months ended September 30, 2020 compared with £1.4 million for the nine months ended September 30, 2019, representing an increase of £0.8 million. Personnel costs and share-based payment expenses were higher for the nine months ended September 30, 2020 by £0.9 million as compared with the nine months ended September 30, 2019. A decrease in non-clinical and travel costs of £0.4 million for the nine months ended September 30, 2020 partially offset the increase in other research and development expenses.


The following table gives a breakdown of the research and development costs incurred by product candidate for the nine months ended September 30, 2020 and 2019:

 

     For the Nine Months Ended
September 30,
 
     2020      2019  
     (in thousands)  
     £      £  

Acelarin

     9,637        7,714  

NUC-3373

     4,191        3,753  

NUC-7738

     2,710        1,214  

Other

     1,380        1,870  
  

 

 

    

 

 

 
     17,918      14,551  
  

 

 

    

 

 

 

Administrative Expenses

Administrative expenses were £5.1 million for the nine months ended September 30, 2020 as compared to £4.2 million for the nine months ended September 30, 2019, reflecting an increase of £0.9 million. The increase was primarily related to higher personnel, insurance and share-based payment expenses, partially offset by lower professional fees and travel costs.

Net Foreign Exchange Gains

For the nine months ended September 30, 2020, we reported a net foreign exchange gain of £0.6 million as compared to a net foreign exchange gain of £1.2 million for the nine months ended September 30, 2019. For both periods, the gains reflected an appreciation of the U.S. dollar relative to the U.K. pound sterling.

Finance Income

Finance income represents bank interest and was £0.2 million for the nine months ended September 30, 2020 and £0.9 million for the nine months ended September 30, 2019. The decrease in bank interest resulted from lower average cash balances held on term deposits and lower rates of interest being earned on those deposits.

Income Tax Credit

The income tax credit for the nine months ended September 30, 2020, which is largely composed of U.K. research and development tax credits, amounted to £3.8 million as compared to £3.0 million for the nine months ended September 30, 2019. The increase in the income tax credit was primarily attributable to an increase in our eligible research and development expenses.

Liquidity and Capital Resources

Overview

Since our inception, we have incurred significant operating losses and negative cash flows. We anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and administrative expenses will increase in connection with conducting clinical trials and seeking marketing approval for our product candidates, as well as costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity financings, debt financings, research funding, collaborations, contract and grant revenue or other sources.

As of September 30, 2020 and December 31, 2019, we had cash and cash equivalents of £100.7 million and £52.0 million, respectively. We do not currently have any approved products and have never generated any revenue from product sales. To date we have financed our operations primarily through the issuances of our equity securities. In October 2017, we completed our initial public offering, or IPO, and in September 2020 we completed a follow-on public offering in which we sold 17,888,889 American Depositary Shares, or ADSs, including 2,333,333 ADSs sold upon full exercise of the underwriters’ option to purchase additional ADSs. The follow-on ADSs were sold at a public offering price of $4.50 per ADS for total gross proceeds of $80.5 million.

In October 2018, we entered into an “at-the-market” (ATM) sales agreement with Cowen and Company, LLC, or Cowen, pursuant to which we may sell from time to time, ADSs having an aggregate offering price of up to $100.0 million through Cowen, acting as our agent. Sales of our ADSs pursuant to this ATM program are subject to certain conditions specified in the sales agreement. Sales under the ATM program are registered on a shelf registration statement on Form F-3 that we filed with the SEC in October 2018, and which permits the offering, issuance and sale by us of up to a maximum aggregate offering price of $400.0 million of our securities, inclusive of our ADSs sold under the ATM program. During the three months ended September 30, 2020, we sold and issued 346,206 ADSs, representing 346,206 ordinary shares, under the ATM program, raising gross proceeds of £1.6 million. During the nine months ended September 30, 2020, we sold and issued 774,511 ADSs, representing 774,511 ordinary shares, under the ATM program, raising gross proceeds of £3.7 million.


Cash Flows

Comparison of the Nine Months Ended September 30, 2020 and September 30, 2019

The following table summarizes the results of our cash flows for the nine months ended September 30, 2020 and 2019.

 

     For the Nine Months Ended
September 30,
 
     2020      2019  
     (in thousands)  
     £      £  

Net cash used in operating activities

     (12,640      (19,971

Net cash used in investing activities

     (1,129      (102

Net cash from (used in) financing activities

     61,874        (29
  

 

 

    

 

 

 

Net increase (decrease) in cash and cash equivalents

     48,105        (20,102
  

 

 

    

 

 

 

Operating Activities

The net cash used in operating activities was £12.6 million for the nine months ended September 30, 2020 as compared to £20.0 million for the nine months ended September 30, 2019, a net decrease in cash outflows of £7.4 million. A tax refund of £4.2 million was received in the nine months ended September 30, 2020, whereas no similar cash inflow was recorded in the nine months ended September 30, 2019. In addition, operating loss cash flows were higher by £3.2 million, reflecting primarily higher research and development costs. The increase in operating loss cash flows was offset by working capital inflows of £2.5 million in the nine months ended September 30, 2020 as compared to working capital outflows of £3.9 million in the nine months ended September 30, 2019.

Investing Activities

The net cash used in investing activities was £1.1 million for the nine months ended September 30, 2020 as compared to £0.1 million for the nine months ended September 30, 2019. Interest received for the nine months ended September 30, 2020 was £0.3 million compared with £0.9 million for the nine months ended September 30, 2019, a decrease of £0.6 million. In the nine months ended September 30, 2020, cash used to acquire property, plant and equipment was higher by £0.3 million than in the nine months ended September 30, 2019 and cash used to acquire intangible assets was £0.1 million higher.

Financing Activities

The net cash from financing activities was £61.9 million for the nine months ended September 30, 2020 as compared to £29,000 cash used in financing activities for the nine months ended September 30, 2019. For the nine months ended September 30, 2020, the Company generated net proceeds from the issue of share capital of £62.1 million, as compared to £0.1 million for the nine months ended September 30, 2019.

Operating and Capital Expenditure Requirements

We have not achieved profitability on an annual basis since our inception, and we expect to incur net losses in the future. We expect that our operating expenses will increase as we continue to invest in our research and development programs, exploit our ProTide pipeline and build out our organization with additional employees.

We believe that our existing capital resources will be sufficient to fund our operations, including currently anticipated research and development activities and planned capital spending, for at least the next 12 months.

Our future funding requirements will depend on many factors, including but not limited to:

 

   

the scope, rate of progress and cost of our clinical trials, preclinical programs and other related activities;

 

   

the extent of success in our early preclinical and clinical stage research programs, which will determine the amount of funding required to further the development of our product candidates;

 

   

the progress that we make in developing new product candidates based on our proprietary ProTide technology;

 

   

the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop;


   

the costs involved in filing and prosecuting patent applications and enforcing and defending potential patent claims;

 

   

the outcome, timing and cost of regulatory approvals of our ProTide product candidates;

 

   

the cost and timing of establishing sales, marketing and distribution capabilities;

 

   

the costs of hiring additional skilled employees to support our continued growth and the related costs of leasing additional office space; and

 

   

developments related to COVID-19 and its impact on the costs and timing associated with the conduct of our clinical trials, preclinical programs and other related activities.

EX-99.3

Exhibit 99.3

NuCana Reports Third Quarter 2020 Financial Results and Provides Business Update

Completed Successful $80 million Public Offering

Presented Encouraging Data for NUC-3373 and NUC-7738 at the ESMO Virtual Congress 2020

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

As of September 30, 2020, NuCana had cash and cash equivalents of £100.7 million compared to £47.8 million at June 30, 2020 and £52.0 million at December 31, 2019. This cash balance includes the net proceeds from NuCana’s public offering in September 2020. NuCana continues to advance its various clinical programs and reported a net loss of £8.4 million for the quarter ended September 30, 2020, as compared to £3.9 million for the quarter ended September 30, 2019. Basic and diluted loss per share was £0.24 for the quarter as compared to £0.12 per share for the prior-year quarter.

“We are very pleased with our achievements during the third quarter,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “We significantly augmented our financial position with the successful completion of this public offering, supporting our progress towards several important milestones. These milestones include filing a New Drug Application (“NDA”) for Acelarin in biliary tract cancer, filing an NDA for NUC-3373 in colorectal cancer, and completing a Phase II clinical study for NUC-7738, in each case subject to regulatory feedback and clinical outcomes.”

Mr. Griffith continued: “We also presented encouraging data at the ESMO Virtual Congress 2020, including a poster highlighting interim 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) and a poster detailing the first-ever clinical data from the ongoing Phase I study of NUC-7738 in patients with advanced solid tumors (NuTide:701). We believe the data from the NuTide:302 study support the potential of NUC-3373 to improve progression-free survival in patients who had relapsed or were refractory to prior 5-FU-containing regimens. We also believe these data show NUC-3373’s potential to offer enhanced efficacy, an improved safety profile and a more convenient dosing regimen as compared to 5-FU. With respect to NUC-7738, we believe the interim data from the NuTide:701 study demonstrate that NUC-7738 has a favorable pharmacokinetic and tolerability profile and is showing encouraging anti-cancer activity.”

Mr. Griffith concluded, “We continue to drive recruitment in all of our ongoing studies and remain focused on our mission of developing safer and more effective medicines for patients with cancer.”


Anticipated 2021 Milestones

 

   

Acelarin is a ProTide transformation of gemcitabine. In 2021, NuCana expects to:

 

   

Complete recruitment to enable the first interim analysis of 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 2021, NuCana expects to:

 

   

Report data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer.

 

   

Initiate and report data from a Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer.

 

   

Initiate a Phase 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 2021, NuCana expects to:

 

   

Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors.

 

   

Initiate a Phase II study of NUC-7738 in patients with 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 sufficiency of the Company’s current cash and cash equivalents; 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 fact that the Company’s expectations as to the sufficiency of the Company’s current cash and cash equivalents to fund its planned operations excludes any potential costs related to pre-commercial activities or, if approved, commercialization costs, as well as 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
September 30,
   

For the nine months ended

September 30,

 
     2020     2019     2020     2019  
     (in thousands, except per share data)  
     £     £     £     £  

Research and development expenses

     (6,117     (4,845     (17,918     (14,551

Administrative expenses

     (1,906     (1,423     (5,144     (4,231

Net foreign exchange (losses) gains

     (1,601     1,227       610       1,191  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (9,624     (5,041     (22,452     (17,591

Finance income

     26       252       234       867  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before tax

     (9,598     (4,789     (22,218     (16,724

Income tax credit

     1,204       912       3,797       3,020  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

     (8,394     (3,877     (18,421     (13,704
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted loss per share

     (0.24     (0.12     (0.55     (0.42


Unaudited Condensed Consolidated Statements of Financial Position

 

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

Assets

    

Non-current assets

    

Intangible assets

     4,686       3,960  

Property, plant and equipment

     1,281       1,109  

Deferred tax asset

     34       46  
  

 

 

   

 

 

 
     6,001       5,115  
  

 

 

   

 

 

 

Current assets

    

Prepayments, accrued income and other receivables

     5,065       4,710  

Current income tax receivable

     8,140       8,481  

Cash and cash equivalents

     100,678       51,962  
  

 

 

   

 

 

 
     113,883       65,153  
  

 

 

   

 

 

 

Total assets

     119,884       70,268  
  

 

 

   

 

 

 
    

Equity and liabilities

    

Capital and reserves

    

Share capital and share premium

     142,937       80,840  

Other reserves

     65,740       62,737  

Accumulated deficit

     (98,403     (80,055
  

 

 

   

 

 

 

Total equity attributable to equity holders of the Company

     110,274       63,522  
  

 

 

   

 

 

 
    

Non-current liabilities

    

Provisions

     46       26  

Lease liabilities

     441       538  
  

 

 

   

 

 

 
     487       564  
  

 

 

   

 

 

 

Current liabilities

    

Trade payables

     4,190       2,412  

Payroll taxes and social security

     138       160  

Lease liabilities

     278       268  

Accrued expenditure

     4,517       3,342  
  

 

 

   

 

 

 
     9,123       6,182  

Total liabilities

     9,610       6,746  
  

 

 

   

 

 

 

Total equity and liabilities

     119,884       70,268  
  

 

 

   

 

 

 


Unaudited Condensed Consolidated Statements of Cash Flows

 

     For the nine months ended
September 30,
 
     2020     2019  
     (in thousands)  
     £     £  

Cash flows from operating activities

    

Loss for the period

     (18,421     (13,704

Adjustments for:

    

Income tax credit

     (3,797     (3,020

Amortization and depreciation

     667       522  

Finance income

     (234     (867

Interest expense on lease liabilities

     20       —    

Share-based payments

     3,069       2,191  

Net foreign exchange gains

     (619     (1,228
  

 

 

   

 

 

 
     (19,315     (16,106

Movements in working capital:

    

Increase in prepayments, accrued income and other receivables

     (408     (3,593

Increase (decrease) in trade payables

     1,778       (300

Increase in payroll taxes, social security and accrued expenditure

     1,153       8  
  

 

 

   

 

 

 

Movements in working capital

     2,523       (3,885
  

 

 

   

 

 

 

Cash used in operations

     (16,792     (19,991
  

 

 

   

 

 

 

Net income tax received

     4,152       20  
  

 

 

   

 

 

 

Net cash used in operating activities

     (12,640     (19,971
  

 

 

   

 

 

 

Cash flows from investing activities

    

Interest received

     300       915  

Payments for property, plant and equipment

     (350     (29

Payments for intangible assets

     (1,079     (988
  

 

 

   

 

 

 

Net cash used in investing activities

     (1,129     (102
  

 

 

   

 

 

 

Cash flows from financing activities

    

Payments of lease liabilities

     (223     (146

Proceeds from issue of share capital – exercise of share options

     15       117  

Proceeds from issue of share capital

     66,581       —    

Share issue expenses

     (4,499     —    
  

 

 

   

 

 

 

Net cash from (used in) financing activities

     61,874       (29
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     48,105       (20,102

Cash and cash equivalents at beginning of period

     51,962       76,972  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     611       1,221  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

     100,678       58,091  
  

 

 

   

 

 

 


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