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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 August 2023
(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 August 16, 2023, NuCana plc (the “Company”) issued a press release announcing its second quarter 2023 financial results. The Company’s unaudited condensed consolidated financial statements as of June 30, 2023 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 hereto as Exhibit 99.2, 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 333-258941) 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be amended from time to time, and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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

 

Exhibit

  

Description

99.1    Unaudited Condensed Consolidated Financial Statements as of June 30, 2023 and for the Three and Six Months Ended June 30, 2023 and 2022
99.2    Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Six Months Ended June 30, 2023 and 2022
99.3    Press Release Dated August 16, 2023
101.INS    XBRL Instance Document—the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH    INLINE XBRL Taxonomy Extension Schema Document
101.DEF    INLINE XBRL Taxonomy Extension Calculation Linkbase Document
101.CAL    INLINE XBRL Taxonomy Extension Definition Linkbase Document
101.LAB    INLINE XBRL Taxonomy Extension Label Linkbase Document
101.PRE    INLINE XBRL Taxonomy Extension Presentation Linkbase Document
104    Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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, thereto duly authorized.

 

NuCana plc
By:  

/s/ Donald Munoz

Name:   Donald Munoz
Title:   Chief Financial Officer

Date: August 16, 2023

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
    
2023
   
2022
   
2023
   
2022
 
                                 
           
(in thousands, except per share data)
 
           
£
   
£
   
£
   
£
 
Research and development expenses
        (3,959     (6,406     (10,764     (15,852
Administrative expenses
        (1,754     (1,889     (3,402     (4,040
Net foreign exchange (losses) gains
        (564     3,077       (1,259     4,208  
     
 
 
   
 
 
   
 
 
   
 
 
 
Operating loss
     
 
(6,277
 
 
(5,218
 
 
(15,425
 
 
(15,684
Finance income
        178       132       465       163  
     
 
 
   
 
 
   
 
 
   
 
 
 
Loss before tax
     
 
(6,099
 
 
(5,086
 
 
(14,960
 
 
(15,521
Income tax credit
     3        685       1,194       1,679       3,226  
     
 
 
   
 
 
   
 
 
   
 
 
 
Loss for the period
     
 
(5,414
 
 
(3,892
 
 
(13,281
 
 
(12,295
     
 
 
   
 
 
   
 
 
   
 
 
 
Basic and diluted loss per share
     4        (0.10     (0.07     (0.25     (0.24
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,
 
    
2023
   
2022
   
2023
   
2022
 
                          
    
(in thousands)
 
    
£
   
£
   
£
   
£
 
Loss for the period
  
 
(5,414
 
 
(3,892
 
 
(13,281
 
 
(12,295
Other comprehensive (expense) income:
        
Items that may be reclassified subsequently to profit or loss:
        
Exchange differences on translation of foreign operations
     (19     43       (38     56  
  
 
 
   
 
 
   
 
 
   
 
 
 
Other comprehensive (expense) income for the period
     (19     43       (38     56  
  
 
 
   
 
 
   
 
 
   
 
 
 
Total comprehensive loss for the period
  
 
(5,433
 
 
(3,849
 
 
(13,319
 
 
(12,239
  
 
 
   
 
 
   
 
 
   
 
 
 
Attributable to:
        
Equity holders of the Company
  
 
(5,433
 
 
(3,849
 
 
(13,319
 
 
(12,239
  
 
 
   
 
 
   
 
 
   
 
 
 
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
AS AT


 
  
 
 
  
     June 30,     

2023
 
 
December 31,
2022
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
  
(in thousands)
 
 
  
Notes
 
  
£
 
 
£
 
Assets
                         
Non-current
assets
                         
Intangible assets
     5        2,553       2,365  
Property, plant and equipment
              701       866  
Deferred tax asset
     3        113       103  
             
 
 
   
 
 
 
           
3,367
   
3,334
 
             
 
 
   
 
 
 
Current assets
                         
Prepayments, accrued income and other receivables
              2,617       3,957  
Current income tax receivable
     3        8,033       6,367  
Other assets
     6        2,596       2,684  
Cash and cash equivalents
     7        24,644       41,912  
             
 
 
   
 
 
 
           
37,890
   
54,920
 
             
 
 
   
 
 
 
Total assets
           
 
41,257
 
 
 
58,254
 
             
 
 
   
 
 
 
Equity and liabilities
                         
Capital and reserves
                         
Share capital and share premium
     9        143,213       143,203  
Other reserves
              77,709       75,872  
Accumulated deficit
              (193,540     (180,573
             
 
 
   
 
 
 
Total equity attributable to equity holders of the Company
           
 
27,382
 
 
 
38,502
 
             
 
 
   
 
 
 
Non-current
liabilities
                         
Provisions
     10        58       46  
Lease liabilities
              279       396  
             
 
 
   
 
 
 
           
337
   
442
 
             
 
 
   
 
 
 
Current liabilities
                         
Trade payables
              4,679       4,803  
Payroll taxes and social security
              189       162  
Accrued expenditure
              5,384       10,002  
Lease liabilities
              286       243  
Provisions
     10        3,000       4,100  
             
 
 
   
 
 
 
           
13,538
   
19,310
 
Total liabilities
           
 
13,875
 
 
 
19,752
 
             
 
 
   
 
 
 
Total equity and liabilities
           
 
41,257
 
 
 
58,254
 
             
 
 
   
 
 
 
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

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, 2022
  
 
2,087
 
  
 
141,050
 
 
 
(339
 
 
30,027
 
 
 
(17
 
 
42,466
 
  
 
(149,726
 
 
65,548
 
Loss for the period
     —          —         —         —         —         —          (12,295     (12,295
Other comprehensive income for the period
     —          —         —         —         56       —          —         56  
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
Total comprehensive loss for the period
     —          —         —         —         56       —          (12,295     (12,239
Share-based payments
     —          —         —         2,741       —         —          —         2,741  
Exercise of share options
     1        —         —         (118     —         —          102       (15
Lapse of share options
     —          —         —         (172     —         —          172       —    
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
Balance at June 30, 2022
  
 
2,088
 
  
 
141,050
 
 
 
(339
 
 
32,478
 
 
 
39
 
 
 
42,466
 
  
 
(161,747
 
 
56,035
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at January 1, 2023
  
 
2,095
 
  
 
141,108
 
 
 
(339
 
 
33,701
 
 
 
44
 
 
 
42,466
 
  
 
(180,573
 
 
38,502
 
Loss for the period
     —          —         —         —         —         —          (13,281     (13,281
Other comprehensive expense for the period
     —          —         —         —         (38     —          —         (38
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
Total comprehensive loss for the period
     —          —         —         —         (38     —          (13,281     (13,319
Share-based payments
     —          —         —         2,195       —         —          —         2,195  
Exercise of share options
     1        —         —         (90     —         —          84       (5
Lapse of share options
     —          —         —         (230     —         —          230       —    
Issue of share capital
     1        10       —         —         —         —          —         11  
Share issue expenses
     —          (2     —         —         —         —          —         (2
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
Balance at June 30, 2023
  
 
2,097
 
  
 
141,116
 
 
 
(339
 
 
35,576
 
 
 
6
 
 
 
42,466
 
  
 
(193,540
 
 
27,382
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
 
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
    
For the Six Months Ended
June 30,
 
    
2023
   
2022
 
              
    
(in thousands)
 
    
£
   
£
 
Cash flows from operating activities
    
Loss for the period
     (13,281     (12,295
Adjustments for:
    
Income tax credit
     (1,679     (3,226
Amortization and depreciation
     288       470  
Movement in provisions
     (1,109     —    
Finance income
     (465     (163
Interest expense on lease liabilities
     16       5  
Share-based payments
     2,195       2,741  
Net foreign exchange losses (gains)
     1,285       (4,283
  
 
 
   
 
 
 
     (12,750     (16,751
Movements in working capital:
    
Decrease in prepayments, accrued income and other receivables
     1,288       295  
(Decrease) increase in trade payables
     (124     312  
Decrease in payroll taxes, social security and accrued expenditure
     (4,598     (1,524
  
 
 
   
 
 
 
Movements in working capital
     (3,434     (917
  
 
 
   
 
 
 
Cash used in operations
  
 
(16,184
 
 
(17,668
  
 
 
   
 
 
 
Net income tax paid
     (2     —    
  
 
 
   
 
 
 
Net cash used in operating activities
  
 
(16,186
 
 
(17,668
  
 
 
   
 
 
 
Cash flows from investing activities
    
Interest received
     482       161  
Payments for property, plant and equipment
     (5     (10
Payments for intangible assets
     (291     (276
  
 
 
   
 
 
 
Net cash from (used in) investing activities
  
 
186
 
 
 
(125
  
 
 
   
 
 
 
Cash flows from financing activities
    
Payments for lease liabilities
     (84     (148
Proceeds from issue of share capital – exercise of share options
     1       1  
Proceeds from issue of share capital
     11       —    
Share issue expense
     (2     —    
  
 
 
   
 
 
 
Net cash used in financing activities
  
 
(74
 
 
(147
  
 
 
   
 
 
 
Net decrease in cash and cash equivalents
     (16,074     (17,940
Cash and cash equivalents at beginning of period
  
 
41,912
 
 
 
60,264
 
  
 
 
   
 
 
 
Effect of exchange rate changes on cash and cash equivalents
     (1,194     4,204  
  
 
 
   
 
 
 
Cash and cash equivalents at end of period
  
 
24,644
 
 
 
46,528
 
  
 
 
   
 
 
 
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.

NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. General information
NuCana plc (“NuCana” or the “Company”) is a clinical-stage biopharmaceutical company developing a portfolio of new medicines to treat patients with cancer. NuCana is harnessing the power of phosphoramidate chemistry to generate new medicines called ProTides. These compounds have the potential to improve cancer treatment by enhancing the efficacy and safety of several current standards of care.
The Company has had American Depository Shares (“ADSs”) registered with the US Securities and Exchange Commission (“SEC”) and has been listed on The Nasdaq Global Select Market (“Nasdaq”) since October 2, 2017. The Company is incorporated in England and Wales and domiciled in the United Kingdom. The Company’s registered office is located at 77/78 Cannon Street, London EC4N 6AF, United Kingdom and its principal place of business is located at 3 Lochside Way, Edinburgh, EH12 9DT, United Kingdom.
The Company has three wholly owned subsidiaries, NuCana, Inc., NuCana Limited and NuCana BioMed Trustee Company Limited (together referred to as the “Group”).
The financial information presented in these unaudited condensed consolidated financial statements does not constitute the Group’s statutory accounts within the meaning of section 434 of the U.K. Companies Act 2006.
The Group’s statutory accounts for the year ended December 31, 2022 have been reported on by the Company’s auditor, and delivered to the Registrar of Companies. The report of the auditor was (i) unqualified and (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report.
2. Significant accounting policies
Basis of preparation
The unaudited condensed consolidated financial statements (the “financial statements”) for the three months and six months ended June 30, 2023 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, 2022. No new standards, amendments or interpretations have had an impact on the financial statements for the three months and six months ended June 30, 2023. The financial statements comprise the financial statements of the Group at June 30, 2023. 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, 2022.
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, 2023 are not necessarily indicative of the results that can be expected for the Company’s fiscal year ending December 31, 2023.
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 for the 15 month period to September 30, 2024, 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 £24.6 million at June 30, 2023 will be sufficient to fund its current operating plan for at least the next 12 months.
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.

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, 2022.    
3. Income tax
 
    
For the Three Months Ended

June 30,
    
  For the Six Months Ended  

June 30,
 
    
2023
    
2022
    
2023
    
2022
 
                             
    
(in thousands)
 
    
£
    
£
    
£
    
£
 
Current tax:
                                   
In respect of current period U.K.
     882        1,188        1,870        3,215  
In respect of prior period U.K.
     (206      —          (206      —    
In respect of current period U.S.
     —          (1      (1      (1
    
 
 
    
 
 
    
 
 
    
 
 
 
       676        1,187        1,663        3,214  
Deferred tax:
                                   
In respect of current period U.S.
     9        7        17        12  
In respect of prior period U.S.
     —          —          (1      —    
    
 
 
    
 
 
    
 
 
    
 
 
 
Income tax credit
  
 
 
 
685
 
  
 
1,194
 
  
 
1,679
 
  
 
3,226
 
    
 
 
    
 
 
    
 
 
    
 
 
 
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 26.97% of expenditure related to eligible research and development projects incurred on or after April 1, 2023 (33.35% prior to April 1, 2023).


 
  
     June 30,     

2023
 
  
December 31,

2022
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
 
  
£
 
  
£
 
Current income tax receivable
                 
U.K. tax
     8,030        6,366  
U.S. tax
     3        1  
    
 
 
    
 
 
 
    
 
8,033
 
  
 
6,367
 
    
 
 
    
 
 
 
Deferred tax asset
                 
U.S. deferred tax asset
  
 
113
 
  
 
103
 
    
 
 
    
 
 
 
4. Basic and diluted loss per share
 
    
For the Three Months Ended
June 30,
    
For the Six Months Ended
June 30,
 
    
2023
    
2022
    
2023
    
2022
 
                             
    
(in thousands, except per share data)
 
    
£
    
£
    
£
    
£
 
Loss for the period
     (5,414      (3,892      (13,281      (12,295
    
 
 
    
 
 
    
 
 
    
 
 
 
Basic and diluted weighted average number of shares
     52,389        52,196        52,384        52,190  
         
Basic and diluted loss per share
     (0.10      (0.07      (0.25      (0.24
    
 
 
    
 
 
    
 
 
    
 
 
 
Basic loss per share is calculated by dividing the loss for the period attributable to the equity holders of the Company by the weighted average number of shares outstanding during the period.
The potential shares issued through equity settled transactions were considered to be anti-dilutive as they would have decreased the loss per share and were therefore excluded from the calculation of diluted loss per share.

5. Intangible assets
Intangible assets comprise patents with a carrying value of £2.6 million as of June 30, 2023 (as of December 31, 2022: £2.4 million).
During the six months ended June 30, 2023, the Company acquired intangible assets with a cost of £0.3 million in relation to patents.
6. Other assets

 
  
     June 30,     

2023
 
  
December 31,

2022
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
 
  
£
 
  
£
 
Other assets
     2,596        2,684  
    
 
 
    
 
 
 
In April 2021, the Company initiated legal proceedings against Gilead Sciences Ireland UC and Gilead Sciences GmbH in the German Regional Court of Dusseldorf (“RC Dusseldorf”) for patent infringement for the sale of Sovaldi as well as its combination products Harvoni, Vosevi and Epclusa in Germany. Later in 2021, the Company provided a security of €3.0 million by depositing funds with RC Dusseldorf to cover the legal costs of Gilead Sciences Ireland UC and Gilead Sciences GmbH in the event that the Company was unsuccessful in the final outcome of the patent infringement litigation in Germany.
In May 2023, the Company abandoned all proceedings in Germany and reached a settlement agreement with Gilead Sciences Ireland UC and Gilead Sciences GmbH, and as a result, the security deposit has been repaid in full in July 2023.
7. Cash and cash equivalents
 
 
  
     June 30,     

2023
 
  
December 31,

2022
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
 
  
£
 
  
£
 
Cash and cash equivalents
     24,644        41,912  
    
 
 
    
 
 
 
Cash and cash equivalents comprise cash at banks with deposit maturity terms of three months or less. Cash at banks earns interest at fixed or variable rates based on the terms agreed for each account.
8. Share-based payments
The Company has six share-based payment plans for employees, directors and consultants. The share options granted will be settled in equity. 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. Options granted under each of the six plans have a maximum life of 10 years.
As detailed in the table below, during the six months ended June 30, 2023, 2,695,639 share options were granted under the 2020 Long-Term Incentive Plan (six months ended June 30, 2022: 1,115,925 share options granted). Options granted under this plan will vest if the option holder remains under respective contract of employment or contract of service for the agreed vesting period. The share options granted in the period will vest over a period of up to four years.
The fair values of options granted were determined using the Black-Scholes model that takes into account factors specific to the share incentive plan such as the assumption that the options are exercised at a point in time of up to two years after vesting. This has been incorporated into the measurement by means of actuarial modelling. As NuCana plc was unlisted until October 2, 2017, it is not possible to derive historical volatility from the Company’s ADSs prior to October 2017. For options with an estimated life of greater than five years, the underlying expected volatility was determined by using the average of the historical volatility of similar listed entities as a proxy. Options granted with an estimated life of five years or less, have been valued using the Company’s own historical volatility rates.

    
Options granted on
 
       
    
January 11, 2023
   
January 11, 2023
   
January 11, 2023
 
Vesting dates
     January 11, 2024       January 11, 2024       January 11, 2024  
       January 11, 2025       January 11, 2025       January 11, 2025  
       January 11, 2026       January 11, 2026       January 11, 2026  
       January 11, 2027       January 11, 2027       January 11, 2027  
Volatility
     97.11     105.11     116.33
Dividend yield
     0     0     0
Risk-free investment rate
     3.31     3.34     3.38
Fair value of option at grant date
   £ 0.87     £ 1.19     £ 1.19  
Fair value of share at grant date
   £ 1.23     £ 1.23     £ 1.23  
Exercise price at date of grant
   £ 1.23     £ 0.04     £ 0.04  
Lapse date
     January 11, 2033       January 11, 2033       —    
Expected option life (years)
     4.5       3.5       2.5  
Number of options granted
     1,774,176       655,425       219,163  
       
    
June 16, 2023
   
June 16, 2023
   
                    
 
Vesting dates
     June 16, 2024       June 16, 2024  
Volatility
     121.58     124.98
Dividend yield
     0     0
Risk-free investment rate
     4.98     4.99
Fair value of option at grant date
   £ 0.56     £ 0.55  
Fair value of share at grant date
   £ 0.59     £ 0.59  
Exercise price at date of grant
   £ 0.04     £ 0.04  
Lapse date
     June 16, 2033       —    
Expected option life (years)
     2.0       1.0  
Number of options granted
     37,500       9,375  
For the three months ended June 30, 2023, the Company recognized £1.1 million of share-based payment expense in the statement of operations (three months ended June 30, 2022: £1.2 million). For the six months ended June 30, 2023, the Company has recognized £2.2 million of share-based payment expense in the statement of operations (six months ended June 30, 2022: £2.7 million).

9. Share capital and share premium
 
 
  
     June 30,     

2023
 
  
December 31,

2022
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
 
  
£
 
  
£
 
Share capital
     2,097        2,095  
Share premium
     141,116        141,108  
    
 
 
    
 
 
 
    
143,213
    
143,203
 
    
 
 
    
 
 
 
   
    
Number
(in thousands)
 
Issued share capital comprises:
                 
Ordinary shares of £0.04 each
     52,403        52,373  
    
 
 
    
 
 
 

 
  
Number of

shares
 
  
Share

   capital   
 
  
Share

 premium 
 
 
  
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
Fully paid shares:
  
 
 
  
£
 
  
£
 
Balance at December 31, 2022
     52,373        2,095        141,108  
Issue of shares on exercise of options
     14        1            
Issue of shares
     16        1        8  
    
 
 
    
 
 
    
 
 
 
Balance at June 30, 2023
  
 
52,403
 
  
 
2,097
 
  
 
141,116
 
    
 
 
    
 
 
    
 
 
 
10. Provisions

 
  
Legal
 proceedings 
 
  
Dilapidations
 
  
       Total       
 
 
  
 
 
  
 
 
  
 
 
 
  
(in thousands)
 
 
  
£
 
  
£
 
  
£
 
Balance at December 31, 2022
  
 
4,100
 
  
 
46
 
  
 
4,146
 
Additions
     —          21        21  
Reverse unused
     (46      —          (46
Utilized
     (801      (9      (810
Transfer from prepayments, accrued income and other receivables
     (247      —          (247
Effect of foreign currency exchange differences
     (6      —          (6
    
 
 
    
 
 
    
 
 
 
Balance at June 30, 2023
  
 
3,000
 
  
 
58
 
  
 
3,058
 
    
 
 
    
 
 
    
 
 
 
Classified as:
                          
Current
     3,000        —          3,000  
Non-current
     —          58        58  
    
 
 
    
 
 
    
 
 
 
    
 
3,000
 
  
 
58
 
  
 
3,058
 
    
 
 
    
 
 
    
 
 
 
All obligations arising from the patent infringement litigation in the U.K. and Germany, reflected within legal proceedings, have been confirmed as at June 30, 2023.
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 August 16, 2023. 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, 2022 filed with the SEC on April 4, 2023 (the “Annual Report”).

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 patients with cancer 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, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s pipeline includes NUC-3373 and NUC-7738. NUC-3373 is a new chemical entity derived from the nucleoside analog 5-fluorouracil, a widely used chemotherapy agent. NUC-3373 is currently in three ongoing clinical trials: a Phase 1b/2 clinical trial, in combination with other agents, for the treatment of patients with advanced colorectal cancer; a randomized Phase 2 trial, in combination with other agents, for the second-line treatment of patients with advanced colorectal cancer; and a Phase 1b/2 modular trial in combination with the PD-1 inhibitor pembrolizumab in patients with advanced solid tumors and in combination with docetaxel in patients with lung cancer. NUC-7738, is a transformation of 3’-deoxyadenosine, a novel anti-cancer nucleoside analog. NUC-7738 is in the Phase 2 part of a Phase 1/2 clinical trial in patients with advanced solid tumors which is evaluating NUC-7738 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.

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 component 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;

 

   

costs of maintaining and defending patents;

 

   

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. 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. Where appropriate, manufacturing and non-clinical research and development expenses are assigned or allocated to individual product candidates.

Administrative Expenses

Administrative expenses consist of personnel costs, depreciation, amortization 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 relates to cash held in U.S. dollars.

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, since our inception, we have generated losses 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 26.97% of eligible expenditures on qualifying research and development projects incurred on or after April 1, 2023 (33.35% prior to April 1, 2023). In the United States, we are able to offset the research and development credits against corporation tax payable. Our 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 17.53% from April 1, 2023 (21.68% prior to April 1, 2023). These rates are subject to the introduction of a territoriality restriction which may restrict our ability to claim relief in respect of research and development activity taking place outside the United Kingdom, which will apply to accounting periods beginning after April 1, 2024. 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. However, in that scenario, we may be able to claim tax credits under a large company scheme.


Results of Operations

Comparison of the Three Months Ended June 30, 2023 and June 30, 2022

The following table summarizes the results of our operations for the three months ended June 30, 2023 and 2022.

 

    

For the Three Months Ended

June 30,

 
     2023      2022  
               
     (unaudited)  
     (in thousands)  
     £      £  

Research and development expenses

     (3,959      (6,406

Administrative expenses

     (1,754      (1,889

Net foreign exchange (losses) gains

     (564      3,077  
  

 

 

    

 

 

 

Operating loss

     (6,277      (5,218

Finance income

     178        132  
  

 

 

    

 

 

 

Loss before tax

     (6,099      (5,086

Income tax credit

     685        1,194  
  

 

 

    

 

 

 

Loss for the period

     (5,414      (3,892

Other comprehensive (expense) income:

     

Items that may be reclassified subsequently to profit or loss:

     

Exchange differences on translation of foreign operations

     (19      43  
  

 

 

    

 

 

 

Total comprehensive loss for the period

     (5,433      (3,849
  

 

 

    

 

 

 

Research and Development Expenses

Research and development expenses were £4.0 million for the three months ended June 30, 2023 as compared to £6.4 million for the three months ended June 30, 2022, a decrease of £2.4 million. The decrease resulted primarily from lower expenses incurred in relation to clinical trials of £1.5 million in the three months ended June 30, 2023, compared with £2.9 million in the three months ended June 30, 2022, largely due to the discontinuation of the Phase 3 clinical trial of Acelarin in March 2022 and finalization of certain associated liabilities. Patent costs decreased by £0.6 million in the three months ended June 30, 2023 compared with the three months ended June 30, 2022 mainly due to lower patent defense activity. Other research and development costs decreased by £0.4 million in the three months ended June 30, 2023 compared with the three months ended June 30, 2022, primarily due to lower personnel costs, share-based payment expenses and manufacturing costs.

The following table gives a breakdown of the research and development costs incurred by product candidate for the three months ended June 30, 2023 and 2022:

 

    

For the Three Months Ended

June 30,

 
     2023      2022  
               
     (in thousands)  
     £      £  

NUC-3373

     3,572        2,435  

NUC-7738

     788        903  

Acelarin

     (803      2,852  

Other

     402        216  
  

 

 

    

 

 

 
     3,959      6,406  
  

 

 

    

 

 

 

Administrative Expenses

Administrative expenses were £1.8 million for the three months ended June 30, 2023 as compared to £1.9 million for the three months ended June 30, 2022. The decrease was principally related to lower insurance costs, amortization and professional fees partially offset by higher personnel costs and share-based payment expenses.


Net Foreign Exchange (Losses) Gains

For the three months ended June 30, 2023, we reported a net foreign exchange loss of £0.6 million as compared to a net foreign exchange gain of £3.1 million for the three months ended June 30, 2022. In the three months ended June 30, 2023, the loss arose from cash balances held in U.S. dollars and the U.S. dollar depreciating relative to the U.K. pound sterling. Conversely in the three months ended June 30, 2022, the gain arose from cash balances held in U.S. dollars and the U.S. dollar appreciating relative to the U.K. pound sterling.

Finance Income

Finance income represents bank interest and was £0.2 million for the three months ended June 30, 2023 and £0.1 million for the three months ended June 30, 2022. The increase in bank interest resulted from higher rates of interest being earned on cash deposits.

Income Tax Credit

The income tax credit for the three months ended June 30, 2023, which is largely comprised of U.K. research and development tax credits, amounted to £0.7 million as compared to £1.2 million for the three months ended June 30, 2022. The decrease in the income tax credit was primarily attributable to a decrease in our eligible research and development expenses, a decrease in the tax credit rate and an adjustment relating to prior periods of £0.2 million.

Results of Operations

Comparison of the Six Months Ended June 30, 2023 and June 30, 2022

The following table summarizes the results of our operations for the six months ended June 30, 2023 and 2022.

 

    

For the Six Months Ended

June 30,

 
     2023      2022  
               
     (unaudited)  
     (in thousands)  
     £      £  

Research and development expenses

     (10,764      (15,852

Administrative expenses

     (3,402      (4,040

Net foreign exchange (losses) gains

     (1,259      4,208  
  

 

 

    

 

 

 

Operating loss

     (15,425      (15,684

Finance income

     465        163  
  

 

 

    

 

 

 

Loss before tax

     (14,960      (15,521

Income tax credit

     1,679        3,226  
  

 

 

    

 

 

 

Loss for the period

     (13,281      (12,295

Other comprehensive (expense) income:

     

Items that may be reclassified subsequently to profit or loss:

     

Exchange differences on translation of foreign operations

     (38      56  
  

 

 

    

 

 

 

Total comprehensive loss for the period

     (13,319      (12,239
  

 

 

    

 

 

 

Research and Development Expenses

Research and development expenses were £10.8 million for the six months ended June 30, 2023 as compared to £15.9 million for the six months ended June 30, 2022, reflecting a decrease of £5.1 million. The decrease resulted primarily from lower expenses incurred in relation to clinical trials of £3.6 million in the six months ended June 30, 2023, compared with £7.8 million in the six months ended June 30, 2022, largely due to the discontinuation of the Phase 3 clinical trial of Acelarin in March 2022. Manufacturing costs were £0.2 million in the six months ended June 30, 2023 compared with £1.6 million for the six months ended June 30, 2022, a decrease of £1.4 million primarily due to phasing of NUC-3373 manufacturing activity. Patent costs increased by £1.1 million in the six months ended June 30, 2023 compared with the six months ended June 30, 2022 mainly due to higher patent defense activity in the first quarter of 2023. Other research and development costs decreased by £0.6 million in the six months ended June 30, 2023 compared with the six months ended June 30, 2022, principally due to lower personnel costs and share-based payment expenses.


The following table gives a breakdown of the research and development costs incurred by product candidate for the six months ended June 30, 2023 and 2022:

 

    

For the Six Months Ended

June 30,

 
     2023      2022  
               
     (in thousands)  
     £      £  

NUC-3373

     6,752        5,482  

NUC-7738

     1,625        1,979  

Acelarin

     1,643        7,778  

Other

     744        613  
  

 

 

    

 

 

 
     10,764        15,852  
  

 

 

    

 

 

 

Administrative Expenses

Administrative expenses were £3.4 million for the six months ended June 30, 2023 as compared to £4.0 million for the six months ended June 30, 2022, reflecting a decrease of £0.6 million. The decrease was primarily related to lower share-based payment expenses, insurance costs, amortization and professional fees.

Net Foreign Exchange (Losses) Gains

For the six months ended June 30, 2023, we reported a net foreign exchange loss of £1.3 million as compared to a net foreign exchange gain of £4.2 million for the six months ended June 30, 2022. In the six months ended June 30, 2023, the loss arose from cash balances held in U.S. dollars and the U.S. dollar depreciating relative to the U.K. pound sterling. Conversely in the six months ended June 30, 2022, the gain arose from cash balances held in U.S. dollars and the U.S. dollar appreciating relative to the U.K. pound sterling.

Finance Income

Finance income represents bank interest and was £0.5 million for the six months ended June 30, 2023 and £0.2 million for the six months ended June 30, 2022. The increase in bank interest resulted from higher rates of interest being earned on cash deposits.

Income Tax Credit

The income tax credit for the six months ended June 30, 2023, which is largely composed of U.K. research and development tax credits, amounted to £1.7 million as compared to £3.2 million for the six months ended June 30, 2022. The decrease in the income tax credit was primarily attributable to a decrease in our eligible research and development expenses, a decrease in the tax credit rate and an adjustment relating to prior periods of £0.2 million.

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. 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 June 30, 2023 and December 31, 2022, we had cash and cash equivalents of £24.6 million and £41.9 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 August 2021, we entered into an “at-the-market” (ATM) sales agreement with Jefferies LLC, or Jefferies, pursuant to which we may periodically sell ADSs having an aggregate offering price of up to $100.0 million through Jefferies 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 August 2021, 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 and six months ended June 30, 2023, we sold and issued 15,838 ADSs, representing 15,838 ordinary shares, under the ATM program, raising gross proceeds of £11,000.


Cash Flows

Comparison of the Six Months Ended June 30, 2023 and June 30, 2022

The following table summarizes the results of our cash flows for the six months ended June 30, 2023 and 2022.

 

    

For the Six Months Ended

June 30,

 
     2023      2022  
               
     (unaudited)  
     (in thousands)  
     £      £  

Net cash used in operating activities

     (16,186      (17,668

Net cash from (used in) investing activities

     186        (125

Net cash used in financing activities

     (74      (147
  

 

 

    

 

 

 

Net decrease in cash and cash equivalents

     (16,074      (17,940
  

 

 

    

 

 

 

Operating Activities

Net cash used in operating activities was £16.2 million for the six months ended June 30, 2023 as compared to £17.7 million for the six months ended June 30, 2022, a net decrease in cash outflows of £1.5 million. Operating loss cash outflows were lower by £4.0 million for the six months ended June 30, 2023, primarily reflecting lower research and development costs. Working capital outflows were £3.4 million in the six months ended June 30, 2023 as compared to working capital outflows of £0.9 million in the six months ended June 30, 2022. The working capital outflows in the six months ended June 30, 2023 included the payment of accruals for clinical trial expenses relating to the Phase 3 clinical trial of Acelarin.

Investing Activities

Net cash from investing activities was £0.2 million for the six months ended June 30, 2023 as compared with net cash used in investing activities of £0.1 million for the six months ended June 30, 2022. Interest received for the six months ended June 30, 2023 was £0.5 million compared with £0.2 million for the six months ended June 30, 2022.

Financing Activities

Net cash used in financing activities was £0.1 million for the six months ended June 30, 2023 as compared to £0.1 million for the six months ended June 30, 2022.

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 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. We carefully manage our capital resources and have sufficient controllable mitigating actions identified to manage our expenditure through the next 12 to 18 months, including management of third-party expenses, such as timing of clinical trial activities, and internal resource costs.

However, 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; and

 

   

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

Legal Proceedings

From time to time, we may be party to litigation that arises in the ordinary course of our business. Other than as discussed below, we do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our results of operations, financial condition or cash flows.

In 2018, we were granted a European patent from the European Patent Office, or EPO, EP 2955190, or EP 190, that covered the composition of matter of a genus of phosphoramidate nucleotide compounds that includes sofosbuvir, sold under the brand name Sovaldi, a leading drug for the treatment of hepatitis C sold by Gilead Sciences, Inc. Later in 2018, Gilead filed an Opposition to our patent at the EPO in an attempt to revoke it. In February 2021, the EPO Opposition Division disagreed with Gilead and upheld amended patent claims that cover sofosbuvir. However, Gilead appealed this decision and, on March 24, 2023, the EPO Technical Board of Appeal issued an oral decision revoking EP 190. This decision is final and has retroactive effect.

Subsequent to the decision of the EPO Opposition Division, but also in February 2021, Gilead Sciences, Inc. and Gilead Sciences Limited filed a lawsuit against us in the Patents Court of the High Court of Justice of England and Wales requesting revocation of the U.K. part of EP 190. In March 2021, we filed a counterclaim against Gilead Sciences, Inc. and Gilead Sciences Limited alleging infringement of our patent resulting from acts including the sale of Sovaldi, as well as its combination products Harvoni, Vosevi and Epclusa, in the U.K. In 2022, we were granted a further European patent from the EPO, EP 3904365, or EP 365, that covered the composition of matter of a smaller genus of phosphoramidate nucleotide compounds that includes sofosbuvir. Gilead Sciences, Inc. and Gilead Sciences Limited subsequently amended their claim to request revocation of the U.K. part of EP 365 and we counterclaimed for infringement. The U.K. Patents Court trial for this case took place between January 20, 2023 and February 3, 2023 and a judgment was handed down by the court on March 21, 2023. In its judgment, the High Court deemed that EP 190 and EP 365 were invalid in the U.K. As a result of this decision, we were liable to pay a proportion of Gilead’s legal fees for these legal proceedings in the U.K. As of June 6, 2023, all reimbursement obligations arising from the patent infringement litigation in the U.K. have been confirmed.

Additionally, in April 2021, we initiated legal proceedings against Gilead Sciences Ireland UC and Gilead Sciences GmbH in the German Regional Court of Dusseldorf for patent infringement for the sale of Sovaldi as well as its combination products Harvoni, Vosevi and Epclusa in Germany. However, as a result of the decision in March 2023 by the EPO Technical Board of Appeal, we abandoned all proceedings in Germany in May 2023 and, as a result, we were liable to pay a proportion of Gilead’s legal fees for these legal proceedings in Germany. As of May 11, 2023, all reimbursement obligations arising from the patent infringement litigation in Germany have been confirmed.

The litigation described above has, and any future litigation regarding our intellectual property could, subject us to significant legal expense. See “Risk Factors - Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.” in our Annual Report on Form 20-F for the year ended December 31, 2022.

The litigation described above does not affect the patent protection on any of our product candidates, which are covered by separate patents that were not involved in this litigation.

EX-99.3

Exhibit 99.3

NuCana Reports Second Quarter 2023 Financial Results and Provides Business Update

On Track to Present Data Updates from All Ongoing Clinical Studies in the Second Half of 2023

Well Capitalized with Anticipated Cash Runway into 2025

Edinburgh, United Kingdom, August 16, 2023 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced financial results for the second quarter ended June 30, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.

As of June 30, 2023, NuCana had cash and cash equivalents of £24.6 million compared to £31.0 million at March 31, 2023 and £41.9 million at December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £5.4 million for the quarter ended June 30, 2023, as compared to a net loss of £3.9 million for the quarter ended June 30, 2022. Basic and diluted loss per share was £0.10 for the quarter ended June 30, 2023, as compared to £0.07 per share for the comparable quarter ended June 30, 2022.

“During the first half of 2023, we focused on advancing our ProTides through clinical development and look forward to providing data updates from these studies in the second half of this year,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “We anticipate data updates from the three ongoing studies of NUC-3373, a ProTide that has the potential to replace 5-FU across multiple tumor types. These studies include: the Phase 2 part of the NuTide:302 study evaluating NUC-3373 combined with leucovorin and either irinotecan (NUFIRI) or oxaliplatin (NUFOX) plus bevacizumab in second-line patients with colorectal cancer; the randomized Phase 2 NuTide:323 study of NUFIRI plus bevacizumab compared to the standard of care FOLFIRI plus bevacizumab in patients with second-line colorectal cancer; and the Phase 1b/2 NuTide:303 modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.”

Mr. Griffith continued: “NUC-7738, our ProTide transformation of 3’-deoxyadenosine continues to progress well. We anticipate sharing data later this year from the Phase 2 part of the NuTide:701 study investigating NUC-7738 as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma.”

Mr. Griffith concluded, “With a cash runway expected to extend into 2025 and through many key milestones for both NUC-3373 and NUC-7738, we look forward to a busy and exciting rest of the year as we progress towards our goal of significantly improving treatment outcomes for patients with cancer.”


2023 Anticipated Milestones

 

 

NUC-3373 (a ProTide transformation of 5-FU)

In 2023, NuCana expects to:

 

   

Announce data from the Phase 2 (NuTide:302) study of NUC-3373 combined with irinotecan and bevacizumab (NUFIRI-bevacizumab) and in combination with oxaliplatin and bevacizumab (NUFOX-bevacizumab) in second-line patients with colorectal cancer;

 

   

Announce preliminary data from the randomized Phase 2 (NuTide:323) study of NUFIRI-bevacizumab versus the standard of care FOLFIRI-bevacizumab for the second-line treatment of patients with colorectal cancer; and

 

   

Announce data from the Phase 1b (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer to identify additional indications for development.

 

 

NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2023, NuCana expects to:

 

   

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and

 

   

Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma.

About NuCana

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer 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, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s pipeline includes NUC-3373 and NUC-7738. NUC-3373 is a new chemical entity derived from the nucleoside analog 5-fluorouracil, a widely used chemotherapy agent. NUC-3373 is currently being evaluated in three ongoing clinical studies: a Phase 1b/2 study (NuTide:302) in combination with leucovorin, irinotecan or oxaliplatin, and bevacizumab in patients with metastatic colorectal cancer; a randomized Phase 2 study (NuTide:323) in combination with leucovorin, irinotecan, and bevacizumab for the second-line treatment of patients with advanced colorectal cancer; and a Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with docetaxel for patients with lung cancer. NUC-7738 is a transformation of 3’-deoxyadenosine, a novel anti-cancer nucleoside analog. NUC-7738 is in the Phase 2 part of a Phase 1/2 study in patients with advanced solid tumors which is evaluating NUC-7738 as a monotherapy and in combination with pembrolizumab.


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 Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company’s goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; the utility of prior non-clinical and clinical data in determining future clinical results; and the sufficiency of the Company’s current cash, cash equivalents and marketable securities to fund its planned operations into 2025. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”) on April 4, 2023, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.


Unaudited Condensed Consolidated Statements of Operations

 

     For the Three Months Ended
June 30,
    For the Six Months Ended
June 30,
 
     2023     2022     2023     2022  
                          
     (in thousands, except per share data)  
     £     £     £     £  

Research and development expenses

     (3,959     (6,406     (10,764     (15,852

Administrative expenses

     (1,754     (1,889     (3,402     (4,040

Net foreign exchange (losses) gains

     (564     3,077       (1,259     4,208  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (6,277     (5,218     (15,425     (15,684

Finance income

     178       132       465       163  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before tax

     (6,099     (5,086     (14,960     (15,521

Income tax credit

     685       1,194       1,679       3,226  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

     (5,414     (3,892     (13,281     (12,295
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted loss per share

     (0.10     (0.07     (0.25     (0.24


Unaudited Condensed Consolidated Statements of Financial Position as at

 

          June 30, 2023          December 31, 2022  
              
     (in thousands)  
     £     £  

Assets

    

Non-current assets

    

Intangible assets

     2,553       2,365  

Property, plant and equipment

     701       866  

Deferred tax asset

     113       103  
  

 

 

   

 

 

 
     3,367       3,334  

Current assets

    

Prepayments, accrued income and other receivables

     2,617       3,957  

Current income tax receivable

     8,033       6,367  

Other assets

     2,596       2,684  

Cash and cash equivalents

     24,644       41,912  
  

 

 

   

 

 

 
     37,890       54,920  
  

 

 

   

 

 

 

Total assets

     41,257       58,254  
  

 

 

   

 

 

 

Equity and liabilities

    

Capital and reserves

    

Share capital and share premium

     143,213       143,203  

Other reserves

     77,709       75,872  

Accumulated deficit

     (193,540     (180,573
  

 

 

   

 

 

 

Total equity attributable to equity holders of the Company

     27,382       38,502  
  

 

 

   

 

 

 

Non-current liabilities

    

Provisions

     58       46  

Lease liabilities

     279       396  
  

 

 

   

 

 

 
     337       442  

Current liabilities

    

Trade payables

     4,679       4,803  

Payroll taxes and social security

     189       162  

Accrued expenditure

     5,384       10,002  

Lease liabilities

     286       243  

Provisions

     3,000       4,100  
  

 

 

   

 

 

 
     13,538       19,310  

Total liabilities

     13,875       19,752  
  

 

 

   

 

 

 

Total equity and liabilities

     41,257       58,254  
  

 

 

   

 

 

 


Unaudited Condensed Consolidated Statements of Cash Flows

 

    

For the Six Months Ended

June 30,

 
     2023     2022  
              
     (in thousands)  
     £     £  

Cash flows from operating activities

    

Loss for the period

     (13,281     (12,295

Adjustments for:

    

Income tax credit

     (1,679     (3,226

Amortization and depreciation

     288       470  

Movement in provisions

     (1,109     —    

Finance income

     (465     (163

Interest expense on lease liabilities

     16       5  

Share-based payments

     2,195       2,741  

Net foreign exchange losses (gains)

     1,285       (4,283
  

 

 

   

 

 

 
     (12,750     (16,751

Movements in working capital:

    

Decrease in prepayments, accrued income and other receivables

     1,288       295  

(Decrease) increase in trade payables

     (124     312  

Decrease in payroll taxes, social security and accrued expenditure

     (4,598     (1,524
  

 

 

   

 

 

 

Movements in working capital

     (3,434     (917
  

 

 

   

 

 

 

Cash used in operations

     (16,184     (17,668
  

 

 

   

 

 

 

Net income tax paid

     (2     —    
  

 

 

   

 

 

 

Net cash used in operating activities

     (16,186     (17,668
  

 

 

   

 

 

 

Cash flows from investing activities

    

Interest received

     482       161  

Payments for property, plant and equipment

     (5     (10

Payments for intangible assets

     (291     (276
  

 

 

   

 

 

 

Net cash from (used in) investing activities

     186       (125
  

 

 

   

 

 

 

Cash flows from financing activities

    

Payments for lease liabilities

     (84     (148

Proceeds from issue of share capital – exercise of share options

     1       1  

Proceeds from issue of share capital

     11       —    

Share issue expense

     (2     —    
  

 

 

   

 

 

 

Net cash used in financing activities

     (74     (147
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (16,074     (17,940

Cash and cash equivalents at beginning of period

     41,912       60,264  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     (1,194     4,204  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

     24,644       46,528  
  

 

 

   

 

 

 


For more information, please contact:

NuCana plc

Hugh S. Griffith

Chief Executive Officer

+44 131-357-1111

info@nucana.com

ICR Westwicke

Chris Brinzey

+1 339-970-2843

chris.brinzey@westwicke.com