Exhibit |
Description | |
| 99.1 | Unaudited Condensed Consolidated Financial Statements as of June 30, 2024 and for the Three and Six Months Ended June 30, 2024 and 2023 | |
| 99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Six Months Ended June 30, 2024 and 2023 | |
| 99.3 | Press Release dated August 15, 2024 | |
| 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) | |
NuCana plc | ||
| By: | /s/ Donald Munoz | |
| Name: | Donald Munoz | |
| Title: | Chief Financial Officer | |
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||||||
Notes |
2024 |
2023 |
2024 |
2023 |
||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||||||
£ |
£ |
£ |
£ |
|||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Net foreign exchange (losses) gains |
( |
) | ( |
) | ( |
) | ||||||||||||||
Operating loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Finance income |
||||||||||||||||||||
Loss before tax |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Income tax credit |
3 | |||||||||||||||||||
Loss for the period |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Basic and diluted loss per ordinary share |
4 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(in thousands) |
||||||||||||||||
£ |
£ |
£ |
£ |
|||||||||||||
| Loss for the period |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Other comprehensive (expense) income: |
||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: |
||||||||||||||||
| Exchange differences on translation of foreign operations |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Other comprehensive (expense) income for the period |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total comprehensive loss for the period |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Attributable to: |
||||||||||||||||
| Equity holders of the Company |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
June 30, 2024 |
December 31, 2023 |
|||||||||||
(in thousands) |
||||||||||||
Notes |
£ |
£ |
||||||||||
Assets |
||||||||||||
Non-current assets |
||||||||||||
Intangible assets |
5 | |||||||||||
Property, plant and equipment |
||||||||||||
Deferred tax asset |
3 | |||||||||||
Current assets |
||||||||||||
Prepayments, accrued income and other receivables |
||||||||||||
Current income tax receivable |
3 | |||||||||||
Cash and cash equivalents |
6 | |||||||||||
| Total assets |
||||||||||||
Equity and liabilities |
||||||||||||
Capital and reserves |
||||||||||||
Share capital and share premium |
8 | |||||||||||
Other reserves |
||||||||||||
Accumulated deficit |
( |
) | ( |
) | ||||||||
Total equity attributable to equity holders of the Company |
||||||||||||
Non-current liabilities |
||||||||||||
Provisions |
||||||||||||
Lease liabilities |
||||||||||||
Current liabilities |
||||||||||||
Trade payables |
||||||||||||
Payroll taxes and social security |
||||||||||||
Accrued expenditure |
||||||||||||
Lease liabilities |
||||||||||||
Total liabilities |
||||||||||||
Total equity and liabilities |
||||||||||||
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, 2023 |
( |
) |
( |
) |
||||||||||||||||||||||||||||
Loss for the period |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
Other comprehensive expense for the period |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Total comprehensive loss for the period |
— | — | — | — | ( |
) | — | ( |
) | ( |
) | |||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Exercise of share options |
— | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||||
Lapse of share options |
— | — | — | ( |
) | — | — | — | ||||||||||||||||||||||||
Issue of share capital |
— | — | — | — | — | |||||||||||||||||||||||||||
Share issue expenses |
— | ( |
) | — | — | — | — | — | ( |
) | ||||||||||||||||||||||
Balance at June 30, 2023 |
( |
) |
( |
) |
||||||||||||||||||||||||||||
Balance at January 1, 2024 |
( |
) |
( |
) |
||||||||||||||||||||||||||||
Loss for the period |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
Other comprehensive income for the period |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Total comprehensive loss for the period |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Exercise of share options |
— | ( |
) | — | — | — | ||||||||||||||||||||||||||
Lapse of share options |
— | — | — | ( |
) | — | — | — | ||||||||||||||||||||||||
Issue of share capital |
— | — | — | — | — | |||||||||||||||||||||||||||
Share issue expenses |
— | ( |
) | — | — | — | — | — | ( |
) | ||||||||||||||||||||||
Balance at June 30, 2024 |
( |
) |
( |
) |
||||||||||||||||||||||||||||
For the Six Months Ended June 30, |
||||||||
2024 |
2023 |
|||||||
(in thousands) |
||||||||
£ |
£ |
|||||||
Cash flows from operating activities |
||||||||
Loss for the period |
( |
) | ( |
) | ||||
Adjustments for: |
||||||||
Income tax credit |
( |
) | ( |
) | ||||
Amortization and depreciation |
||||||||
Movement in provisions |
( |
) | ||||||
Finance income |
( |
) | ( |
) | ||||
Interest expense on lease liabilities |
||||||||
Share-based payments |
||||||||
Net foreign exchange (gains) losses |
( |
) | ||||||
| ( |
) | ( |
) | |||||
Movements in working capital: |
||||||||
Decrease in prepayments, accrued income and other receivables |
||||||||
Increase (decrease) in trade payables |
( |
) | ||||||
Increase (decrease) in payroll taxes, social security and accrued expenditure |
( |
) | ||||||
Movements in working capital |
( |
) | ||||||
Cash used in operations |
( |
) |
( |
) | ||||
Net income tax received (paid) |
( |
) | ||||||
Net cash used in operating activities |
( |
) |
( |
) | ||||
Cash flows from investing activities |
||||||||
Interest received |
||||||||
Payments for property, plant and equipment |
( |
) | ( |
) | ||||
Payments for intangible assets |
( |
) | ( |
) | ||||
Net cash from investing activities |
||||||||
Cash flows from financing activities |
||||||||
Payments for lease liabilities |
( |
) | ( |
) | ||||
Proceeds from issue of share capital – exercise of share options |
||||||||
Proceeds from issue of share capital |
||||||||
Share issue expenses |
( |
) | ( |
) | ||||
Net cash from (used in) financing activities |
( |
) | ||||||
Net decrease in cash and cash equivalents |
( |
) | ( |
) | ||||
Cash and cash equivalents at beginning of period |
||||||||
Effect of exchange rate changes on cash and cash equivalents |
( |
) | ||||||
Cash and cash equivalents at end of period |
||||||||
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(in thousands) |
(in thousands) |
|||||||||||||||
£ |
£ |
£ |
£ |
|||||||||||||
| Current tax: |
||||||||||||||||
| In respect of current period U.K. |
||||||||||||||||
| In respect of prior period U.K. |
— | ( |
) | ( |
) | |||||||||||
| In respect of current period U.S. |
— | — | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Deferred tax: |
||||||||||||||||
| In respect of current period U.S. |
||||||||||||||||
| In respect of prior period U.S. |
— | — | — | ( |
) | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Income tax credit |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(in thousands) |
||||||||
£ |
£ |
|||||||
| Current income tax receivable |
||||||||
| U.K. tax |
||||||||
| U.S. tax |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| Deferred tax asset |
||||||||
| U.S. deferred tax asset |
||||||||
| |
|
|
|
|||||
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(in thousands, except per share data) |
||||||||||||||||
£ |
£ |
£ |
£ |
|||||||||||||
Loss for the period |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Basic and diluted weighted average number of ordinary shares |
||||||||||||||||
Basic and diluted loss per ordinary share |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(in thousands) |
||||||||
£ |
£ |
|||||||
Cash and cash equivalents |
||||||||
Grant date |
Mar-13-2024 |
Mar-14-2024 |
Mar-13-2024 |
Mar-13-2024 |
||||||||||||
Vesting dates |
||||||||||||||||
| — | ||||||||||||||||
| — | ||||||||||||||||
| — | ||||||||||||||||
Volatility 1 |
% | % | % | % | ||||||||||||
Dividend yield |
% | % | % | % | ||||||||||||
Risk-free investment rate 1 |
% | % | % | % | ||||||||||||
Fair value of option at grant date 1 |
£ | £ | £ | £ | ||||||||||||
Fair value of share at grant date |
£ | £ | £ | £ | ||||||||||||
Exercise price at date of grant |
£ | £ | £ | £ | ||||||||||||
Lapse date |
||||||||||||||||
Expected option life (years) 1 |
||||||||||||||||
Number of options granted |
||||||||||||||||
Grant date |
Mar-13-2024 |
Mar-13-2024 |
Mar-13-2024 |
|||||||||
Vesting dates |
||||||||||||
| — | — | |||||||||||
| — | — | |||||||||||
| — | — | |||||||||||
Volatility 1 |
% | % | % | |||||||||
Dividend yield |
% | % | % | |||||||||
Risk-free investment rate 1 |
% | % | % | |||||||||
Fair value of option at grant date 1 |
£ | £ | £ | |||||||||
Fair value of share at grant date |
£ | £ | £ | |||||||||
Exercise price at date of grant |
£ | £ | £ | |||||||||
Lapse date |
— | — | ||||||||||
Expected option life (years) 1 |
||||||||||||
Number of options granted |
||||||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(in thousands) |
||||||||
£ |
£ |
|||||||
Share capital |
||||||||
Share premium |
||||||||
Number (in thousands) |
||||||||
Issued share capital comprises: |
||||||||
Ordinary shares of £ |
||||||||
Number of shares |
Share capital |
Share premium |
||||||||||
(in thousands) |
||||||||||||
Fully paid ordinary shares: |
£ |
£ |
||||||||||
Balance at December 31, 2023 |
||||||||||||
Exercise of share options |
||||||||||||
Issue of share capital |
||||||||||||
Balance at June 30, 2024 |
||||||||||||
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 15, 2024. 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, 2023 filed with the SEC on March 20, 2024 (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 being evaluated in three ongoing clinical trials: a Phase 1b/2 clinical trial (NuTide:302) in combination with leucovorin, irinotecan or oxaliplatin, and bevacizumab in patients with metastatic colorectal cancer; a randomized Phase 2 trial (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 trial (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 clinical trial in patients with advanced solid tumors which is evaluating NUC-7738 as a monotherapy and in combination with pembrolizumab.
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 Nasdaq, 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 relate 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, we have generated losses in the United Kingdom since our inception. 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 credits, 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). A large proportion of costs relating to our research and development, clinical trials and manufacturing activities are currently 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 file under a large company scheme.
Results of Operations
Comparison of the Three Months Ended June 30, 2024 and June 30, 2023
The following table summarizes the results of our operations for the three months ended June 30, 2024 and 2023.
| For the Three Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| Research and development expenses |
(6,769 | ) | (3,959 | ) | ||||
| Administrative expenses |
(1,509 | ) | (1,754 | ) | ||||
| Net foreign exchange losses |
(74 | ) | (564 | ) | ||||
|
|
|
|
|
|||||
| Operating loss |
(8,352 | ) | (6,277 | ) | ||||
| Finance income |
85 | 178 | ||||||
|
|
|
|
|
|||||
| Loss before tax |
(8,267 | ) | (6,099 | ) | ||||
| Income tax credit |
1,272 | 685 | ||||||
|
|
|
|
|
|||||
| Loss for the period |
(6,995 | ) | (5,414 | ) | ||||
| Other comprehensive expense: |
||||||||
| Items that may be reclassified subsequently to profit or loss: |
||||||||
| Exchange differences on translation of foreign operations |
— | (19 | ) | |||||
|
|
|
|
|
|||||
| Total comprehensive loss for the period |
(6,995 | ) | (5,433 | ) | ||||
|
|
|
|
|
|||||
Research and Development Expenses
Research and development expenses were £6.8 million for the three months ended June 30, 2024 as compared to £4.0 million for the three months ended June 30, 2023. Clinical trial expenses increased by £3.2 million in the three months ended June 30, 2024, compared with the three months ended June 30, 2023, primarily due to increased expenditure on NuTide:323. Other research and development costs decreased by £0.4 million in the three months ended June 30, 2024 compared with the three months ended June 30, 2023, primarily due to lower share-based payment expenses.
The following table gives a breakdown of the research and development costs incurred by product candidate for the three months ended June 30, 2024 and 2023:
| For the Three Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| NUC-3373 |
5,584 | 3,572 | ||||||
| NUC-7738 |
779 | 788 | ||||||
| Acelarin |
102 | (803 | ) | |||||
| Other |
304 | 402 | ||||||
|
|
|
|
|
|||||
| 6,769 | 3,959 | |||||||
|
|
|
|
|
|||||
Administrative Expenses
Administrative expenses were £1.5 million for the three months ended June 30, 2024 as compared to £1.8 million for the three months ended June 30, 2023, primarily due to lower share-based payment expenses and insurance costs.
Net Foreign Exchange Losses
For the three months ended June 30, 2024, we reported a net foreign exchange loss of £0.1 million as compared to a net foreign exchange loss of £0.6 million for the three months ended June 30, 2023. In the three months ended June 30, 2024, the US dollar depreciated less, relative to the UK pound sterling, and on a lower US dollar cash balance compared with the three months ended June 30, 2023.
Finance Income
Finance income represents bank interest and was £0.1 million for the three months ended June 30, 2024 and £0.2 million for the three months ended June 30, 2023. The decrease in bank interest resulted from lower cash deposits.
Income Tax Credit
The income tax credit for the three months ended June 30, 2024, which is largely comprised of U.K. research and development tax credits, amounted to £1.3 million as compared to £0.7 million for the three months ended June 30, 2023. 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 Six Months Ended June 30, 2024 and June 30, 2023
The following table summarizes the results of our operations for the six months ended June 30, 2024 and 2023.
| For the Six Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| Research and development expenses |
(13,552 | ) | (10,764 | ) | ||||
| Administrative expenses |
(3,090 | ) | (3,402 | ) | ||||
| Net foreign exchange gains (losses) |
21 | (1,259 | ) | |||||
|
|
|
|
|
|||||
| Operating loss |
(16,621 | ) | (15,425 | ) | ||||
| Finance income |
211 | 465 | ||||||
|
|
|
|
|
|||||
| Loss before tax |
(16,410 | ) | (14,960 | ) | ||||
| Income tax credit |
2,577 | 1,679 | ||||||
|
|
|
|
|
|||||
| Loss for the period |
(13,833 | ) | (13,281 | ) | ||||
| Other comprehensive income (expense): |
||||||||
| Items that may be reclassified subsequently to profit or loss: |
||||||||
| Exchange differences on translation of foreign operations |
7 | (38 | ) | |||||
|
|
|
|
|
|||||
| Total comprehensive loss for the period |
(13,826 | ) | (13,319 | ) | ||||
|
|
|
|
|
|||||
Research and Development Expenses
Research and development expenses were £13.6 million for the six months ended June 30, 2024 as compared to £10.8 million for the six months ended June 30, 2023, reflecting an increase of £2.8 million. The increase resulted primarily from higher expenses incurred in relation to clinical trials of £9.3 million in the six months ended June 30, 2024, compared with £3.6 million in the six months ended June 30, 2023, primarily due to increased expenditure on NuTide:323. Patent costs decreased by £2.1 million in the six months ended June 30, 2024 compared with the six months ended June 30, 2023 mainly due to higher patent defense activity in the first quarter of 2023. Other research and development costs decreased by £0.8 million in the six months ended June 30, 2024 compared with the six months ended June 30, 2023, principally due to lower 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, 2024 and 2023:
| For the Six Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| NUC-3373 |
11,005 | 6,752 | ||||||
| NUC-7738 |
1,686 | 1,625 | ||||||
| Acelarin |
278 | 1,643 | ||||||
| Other |
583 | 744 | ||||||
|
|
|
|
|
|||||
| 13,552 | 10,764 | |||||||
|
|
|
|
|
|||||
Administrative Expenses
Administrative expenses were £3.1 million for the six months ended June 30, 2024 as compared to £3.4 million for the six months ended June 30, 2023, reflecting a decrease of £0.3 million. The decrease was primarily related to lower share-based payment expenses and insurance costs, partly offset by higher professional fees.
Net Foreign Exchange Gains (Losses)
For the six months ended June 30, 2024, we reported a net foreign exchange gain of £21,000 as compared to a net foreign exchange loss of £1.3 million for the six months ended June 30, 2023. In the six months ended June 30, 2024, the gain arose from cash balances held in U.S. dollars and the U.S. dollar appreciating relative to the U.K. pound sterling. Conversely 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.
Finance Income
Finance income represents bank interest and was £0.2 million for the six months ended June 30, 2024 and £0.5 million for the six months ended June 30, 2023. The decrease in bank interest resulted from lower cash deposits.
Income Tax Credit
The income tax credit for the six months ended June 30, 2024, which is largely composed of U.K. research and development tax credits, amounted to £2.6 million as compared to £1.7 million for the six months ended June 30, 2023. The increase in the income tax credit was primarily attributable to an increase in our eligible research and development expenses, partly offset by a lower tax credit rate.
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, 2024 and December 31, 2023, we had cash and cash equivalents of £11.6 million and £17.2 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 six months ending June 30, 2024 we sold and issued 3,740,320 ADSs (equivalent to 149,612 ADSs from April 16, 2024 following completion of our ADS ratio change), representing 3,740,320 ordinary shares, under the ATM program, raising gross proceeds of £1.5 million.
Cash Flows
Comparison of the Six Months Ended June 30, 2024 and June 30, 2023
The following table summarizes the results of our cash flows for the six months ended June, 2024 and 2023.
| For the Six Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| Net cash used in operating activities |
(7,060 | ) | (16,186 | ) | ||||
| Net cash from investing activities |
39 | 186 | ||||||
| Net cash from (used in) financing activities |
1,323 | (74 | ) | |||||
|
|
|
|
|
|||||
| Net decrease in cash and cash equivalents |
(5,698 | ) | (16,074 | ) | ||||
|
|
|
|
|
|||||
Operating Activities
Net cash used in operating activities was £7.1 million for the six months ended June 30, 2024 as compared to £16.2 million for the six months ended June 30, 2023, a net decrease in cash outflows of £9.1 million. Operating loss cash outflows were higher by £2.4 million for the six months ended June 30, 2024. Working capital inflows were £4.1 million in the six months ended June 30, 2024 as compared to working capital outflows of £3.4 million in the six months ended June 30, 2023. A tax refund of £4.0 million was received in the six months ended June 30, 2024 with no similar cash inflow received in the six months ended June 30, 2023.
Investing Activities
Net cash from investing activities was £39,000 for the six months ended June 30, 2024 as compared to £0.2 million for the six months ended June 30, 2023. Interest received for the six months ended June 30, 2024 was £0.2 million compared with £0.5 million for the six months ended June 30, 2023. In the six months ended June 30, 2024, cash used to acquire intangible assets was lower by £0.1 million than in the six months ended June 30, 2023.
Financing Activities
Net cash from financing activities was £1.3 million for the six months ended June 30, 2024 as compared with net cash used in financing activities of £0.1 million for the six months ended June 30, 2023 reflecting an increase in the proceeds from the issue of share capital.
Operating and Capital Expenditure Requirements
We have not achieved profitability on an annual basis since our inception, and we expect to continue to incur net losses in the future.
In assessing the requirements necessary to continue progressing our research and development activities as currently anticipated there will also be a requirement to seek additional capital to fund operations. If we are unable to obtain additional capital, we may be required to delay or reduce our research and development programs, which could adversely affect our future business prospects and our ability to continue as a going concern. We believe, based upon our current operating plan, that our cash and cash equivalents on hand will not be sufficient to fund our anticipated operations for the next twelve months.
As a result of these matters, there is uncertainty related to our ability to raise sufficient additional capital within the going concern period, prior to our cash balances being exhausted. These events or conditions raise substantial doubt on our ability to continue as a going concern and, therefore, that we may be unable to realize our assets and discharge our liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
However, we carefully manage our capital resources and, as considered in our going concern assessment, we expect our cash spend run-rate to decrease over the year ended December 31, 2024 when compared to the year ended December 31, 2023, as our cash outflows in 2023 were impacted by the settlement of obligations arising from the patent infringement litigation in the U.K. and Germany.
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 taking place in the near term, 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 timing of receipt of our U.K. research and development tax credit cash rebates; |
| • | 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. |
Exhibit 99.3
NuCana Reports Second Quarter 2024 Financial Results and Provides Business Update
Key Data Readouts on Track for All Programs in 2024
Anticipated Cash Runway into Q1 2025
Edinburgh, United Kingdom, August 15, 2024 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced financial results for the second quarter ended June 30, 2024 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.
As of June 30, 2024, NuCana had cash and cash equivalents of £11.6 million compared to £12.9 million as of March 31, 2024 and £17.2 million at December 31, 2023. NuCana continues to advance its numerous clinical programs and reported a net loss of £7.0 million for the quarter ended June 30, 2024, as compared to a net loss of £5.4 million for the quarter ended June 30, 2023. Basic and diluted loss per ordinary share was £0.12 for the quarter ended June 30, 2024, as compared to £0.10 per ordinary share for the comparable quarter ended June 30, 2023.
“During the first half of the year, we remained focused on the execution of our clinical programs, all of which are on track for data updates this year,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “NUC-3373, a ProTide transformation of 5-FU, is currently being evaluated in three clinical studies: NuTide:323, a randomized, 182-patient Phase 2 study for the second-line treatment of patients with metastatic colorectal cancer; NuTide:302, a Phase 1/2 study in patients with metastatic colorectal cancer; and NuTide:303, a Phase 1b/2 study in patients with solid tumors and lung cancer. We are pleased to report that all three studies are progressing as planned, and we look forward to sharing data updates in the second half of 2024.”
Mr. Griffith continued: “In addition, NUC-7738, a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine, is being assessed in the Phase 2 part of the ongoing Phase 1/2 NuTide:701 study in PD-1 inhibitor-resistant melanoma patients. Following a positive data update at the American Association for Cancer Research (AACR) Annual Meeting earlier this year, we plan to announce additional data at the upcoming European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17 in Barcelona, Spain.”
Mr. Griffith concluded, “Our commitment to improving treatment outcomes for patients with cancer is what drives us to advance our development programs. We expect to announce numerous important data readouts in the second half of this year and look forward to providing updates on our progress.”
2024 Anticipated Milestones
| • | NUC-3373 (a ProTide transformation of 5-FU) |
In 2024, NuCana expects to:
| • | Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bevacizumab compared to the standard of care FOLFIRI + bevacizumab for the second-line treatment of patients with metastatic colorectal cancer; |
| • | Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bevacizumab and NUFOX + bevacizumab for the second-line treatment of patients with metastatic colorectal cancer; and |
| • | Announce data from 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. |
| • | NUC-7738 (a ProTide transformation of 3’-deoxyadenosine) |
In 2024, NuCana expects to:
| • | Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 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 metastatic 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 which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma.
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 Q1 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, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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, |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| £ | £ | £ | £ | |||||||||||||
| Research and development expenses |
(6,769 | ) | (3,959 | ) | (13,552 | ) | (10,764 | ) | ||||||||
| Administrative expenses |
(1,509 | ) | (1,754 | ) | (3,090 | ) | (3,402 | ) | ||||||||
| Net foreign exchange (losses) gains |
(74 | ) | (564 | ) | 21 | (1,259 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Operating loss |
(8,352 | ) | (6,277 | ) | (16,621 | ) | (15,425 | ) | ||||||||
| Finance income |
85 | 178 | 211 | 465 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before tax |
(8,267 | ) | (6,099 | ) | (16,410 | ) | (14,960 | ) | ||||||||
| Income tax credit |
1,272 | 685 | 2,577 | 1,679 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss for the period |
(6,995 | ) | (5,414 | ) | (13,833 | ) | (13,281 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic and diluted loss per ordinary share |
(0.12 | ) | (0.10 | ) | (0.25 | ) | (0.25 | ) | ||||||||
Unaudited Condensed Consolidated Statements of Financial Position As At
| June 30, 2024 |
December 31, 2023 |
|||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| Assets |
||||||||
| Non-current assets |
||||||||
| Intangible assets |
2,214 | 2,128 | ||||||
| Property, plant and equipment |
343 | 521 | ||||||
| Deferred tax asset |
168 | 143 | ||||||
|
|
|
|
|
|||||
| 2,725 | 2,792 | |||||||
| Current assets |
||||||||
| Prepayments, accrued income and other receivables |
2,044 | 2,671 | ||||||
| Current income tax receivable |
3,662 | 5,123 | ||||||
| Cash and cash equivalents |
11,639 | 17,225 | ||||||
|
|
|
|
|
|||||
| 17,345 | 25,019 | |||||||
|
|
|
|
|
|||||
| Total assets |
20,070 | 27,811 | ||||||
|
|
|
|
|
|||||
| Equity and liabilities |
||||||||
| Capital and reserves |
||||||||
| Share capital and share premium |
144,870 | 143,420 | ||||||
| Other reserves |
78,373 | 79,173 | ||||||
| Accumulated deficit |
(219,443 | ) | (207,706 | ) | ||||
|
|
|
|
|
|||||
| Total equity attributable to equity holders of the Company |
3,800 | 14,887 | ||||||
|
|
|
|
|
|||||
| Non-current liabilities |
||||||||
| Provisions |
58 | 58 | ||||||
| Lease liabilities |
154 | 190 | ||||||
|
|
|
|
|
|||||
| 212 | 248 | |||||||
| Current liabilities |
||||||||
| Trade payables |
6,108 | 3,375 | ||||||
| Payroll taxes and social security |
164 | 155 | ||||||
| Accrued expenditure |
9,659 | 8,940 | ||||||
| Lease liabilities |
127 | 206 | ||||||
|
|
|
|
|
|||||
| 16,058 | 12,676 | |||||||
| Total liabilities |
16,270 | 12,924 | ||||||
|
|
|
|
|
|||||
| Total equity and liabilities |
20,070 | 27,811 | ||||||
|
|
|
|
|
|||||
Unaudited Condensed Consolidated Statements of Cash Flows
| For the Six Months Ended June 30, |
||||||||
| 2024 | 2023 | |||||||
| (in thousands) | ||||||||
| £ | £ | |||||||
| Cash flows from operating activities |
||||||||
| Loss for the period |
(13,833 | ) | (13,281 | ) | ||||
| Adjustments for: |
||||||||
| Income tax credit |
(2,577 | ) | (1,679 | ) | ||||
| Amortization and depreciation |
272 | 288 | ||||||
| Movement in provisions |
— | (1,109 | ) | |||||
| Finance income |
(211 | ) | (465 | ) | ||||
| Interest expense on lease liabilities |
10 | 16 | ||||||
| Share-based payments |
1,292 | 2,195 | ||||||
| Net foreign exchange (gains) losses |
(112 | ) | 1,285 | |||||
|
|
|
|
|
|||||
| (15,159 | ) | (12,750 | ) | |||||
| Movements in working capital: |
||||||||
| Decrease in prepayments, accrued income and other receivables |
625 | 1,288 | ||||||
| Increase (decrease) in trade payables |
2,734 | (124 | ) | |||||
| Increase (decrease) in payroll taxes, social security and accrued expenditure |
725 | (4,598 | ) | |||||
|
|
|
|
|
|||||
| Movements in working capital |
4,084 | (3,434 | ) | |||||
|
|
|
|
|
|||||
| Cash used in operations |
(11,075 | ) | (16,184 | ) | ||||
|
|
|
|
|
|||||
| Net income tax received (paid) |
4,015 | (2 | ) | |||||
|
|
|
|
|
|||||
| Net cash used in operating activities |
(7,060 | ) | (16,186 | ) | ||||
|
|
|
|
|
|||||
| Cash flows from investing activities |
||||||||
| Interest received |
218 | 482 | ||||||
| Payments for property, plant and equipment |
(3 | ) | (5 | ) | ||||
| Payments for intangible assets |
(176 | ) | (291 | ) | ||||
|
|
|
|
|
|||||
| Net cash from investing activities |
39 | 186 | ||||||
|
|
|
|
|
|||||
| Cash flows from financing activities |
||||||||
| Payments for lease liabilities |
(127 | ) | (84 | ) | ||||
| Proceeds from issue of share capital – exercise of share options |
3 | 1 | ||||||
| Proceeds from issue of share capital |
1,492 | 11 | ||||||
| Share issue expenses |
(45 | ) | (2 | ) | ||||
|
|
|
|
|
|||||
| Net cash from (used in) financing activities |
1,323 | (74 | ) | |||||
|
|
|
|
|
|||||
| Net decrease in cash and cash equivalents |
(5,698 | ) | (16,074 | ) | ||||
| Cash and cash equivalents at beginning of period |
17,225 | 41,912 | ||||||
|
|
|
|
|
|||||
| Effect of exchange rate changes on cash and cash equivalents |
112 | (1,194 | ) | |||||
|
|
|
|
|
|||||
| Cash and cash equivalents at end of period |
11,639 | 24,644 | ||||||
|
|
|
|
|
|||||
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