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6-K 1 d266089d6k.htm 6-K 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2025

(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 March 20, 2025, NuCana plc (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2024 and providing an update on its clinical programs. The press release is attached as Exhibit 99.1 and is incorporated by reference herein.

The information in the attached Exhibit 99.1 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 shall be expressly set forth by specific reference in such a filing.

Exhibits

 

Exhibit

  

Description

99.1    Press Release Dated March 20, 2025


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/ Hugh S. Griffith

Name:

 

Hugh S. Griffith

Title:

 

Chief Executive Officer

Date: March 20, 2025

EX-99.1 2 d266089dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

NuCana Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Business Update

Remains on Track to Initiate an Expansion Study of NUC-7738 in Combination with Pembrolizumab for Patients with PD-1 Inhibitor-Resistant Melanoma in 2025

Data from the Expansion Study to Support Interaction with FDA and Define Regulatory Strategy for NUC-7738

Data from the Ongoing Phase 1b/2 Study of NUC-3373 in Combination with Pembrolizumab

Anticipated Cash Runway Extended into Q3 2025

Edinburgh, United Kingdom, March 20, 2025 (GLOBE NEWSWIRE) - NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2024 and provided an update on its clinical development program with its two lead anti-cancer medicines.

“Throughout 2024, we shared multiple data updates from our two lead anti-cancer medicines, NUC-7738 and NUC-3373,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “Our lead program, NUC-7738, is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. Over the past year, we presented data highlighting NUC-7738’s potential, when used in combination with pembrolizumab, to reduce tumor volume and prolong progression free survival in PD-1 inhibitor refractory and resistant patients with metastatic melanoma in the NuTide:701 study. Notably, disease control was observed in 75% (9/12) of the patients, five of whom had tumor reductions, with two patients achieving Partial Responses. Seven of the 12 patients had a progression free survival time of greater than five months, which is highly atypical in this patient population. Equally important, the combination has shown a favorable safety profile.”

Mr. Griffith added, “Encouraged by these findings, we are excited to further evaluate NUC-7738’s potential in an expansion of the NuTide:701 study for patients with PD-1 inhibitor-resistant melanoma. We plan to initiate this expansion study and provide data updates later this year. In addition, we plan to meet with the U.S. Food and Drug Administration to seek guidance on the optimal registration strategy for NUC-7738 as we look to advance it towards approval.”

Mr. Griffith continued, “Turning to NUC-3373, our second anti-cancer program is a targeted thymidylate synthase inhibitor with immune modulating properties. It is currently being evaluated in a Phase 1b/2 study known as NuTide:303, which has two separate modules. One module is studying NUC-3373 in combination with pembrolizumab for patients with advanced solid tumors and the second module is studying NUC-3373 with docetaxel for patients with lung cancer. We are excited with the data we have seen from the NuTide:303 study and are particularly encouraged by the significant tumor volume reductions and prolonged progression free survival observed. Two patients achieved Partial Responses, including a patient with urothelial bladder cancer who achieved 100% reduction in their target lesions. While we were disappointed with the surprising and unexpected outcome of the NuTide:323 study of NUC-3373 in combination with leucovorin, irinotecan, and bevacizumab in patients with advanced colorectal cancer, we are continuing to evaluate further potential pathways for NUC-3373 in this challenging indication. We look forward to generating further data from this program as we work towards our mission of improving treatment outcomes for patients with cancer which drives our relentless pursuit of the development of new anti-cancer agents.”


Mr. Griffith concluded, “In addition to the clinical advancements we have made, we have also strengthened our intellectual property portfolio with the addition of a new granted patent by the United States Patent and Trademark Office covering NUC-7738’s composition of matter. Looking ahead in 2025, we are on track to advance both NUC-7738 and NUC-3373 and are excited to provide updates on our success with these programs throughout the year.”

2025 Anticipated Milestones

 

   

NUC-7738

 

   

Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma;

 

   

Announce data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab; and

 

   

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma.

 

   

NUC-3373

 

   

Announce data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.

Fourth Quarter and Year-End 2024 Financial Highlights and Cash Position

As of December 31, 2024, NuCana had cash and cash equivalents of £6.7 million compared to £11.4 million as of September 30, 2024 and £17.2 million as of December 31, 2023. The reduction in cash and cash equivalents during the fourth quarter was primarily the result of cash used in operating activities, partially offset by £2.2 million in net proceeds raised through its at-the-market (ATM) offering. Subsequent to December 31, 2024, NuCana has raised an additional £0.5 million in net proceeds through its ATM offering. NuCana expects that its cash and cash equivalents as of December 31, 2024, together with amounts raised through its ATM offering subsequent to that date, will be sufficient to fund its planned operations into Q3 2025.

NuCana continues to advance its various clinical programs and reported a net loss of £0.7 million for the quarter ended December 31, 2024, as compared to a net loss of £7.7 million for the quarter ended December 31, 2023. Net loss for the year ended December 31, 2024 was £19.0 million, compared to a net loss of £27.6 million for the year ended December 31, 2023. Basic and diluted loss per ordinary share was £0.01 for the quarter and £0.26 for the year ended December 31, 2024, as compared to £0.14 per ordinary share for the comparable quarter and £0.53 for the year ended December 31, 2023.


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 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 novel anti-cancer agent that disrupts RNA polyadenylation, profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. 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 and cash equivalents to fund its planned operations into Q3 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, our ability to raise additional capital sufficient to fund our planned operations and 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, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, 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.


Condensed Consolidated Statements of Operations

 

     For the Three Months Ended
December 31,
    For the Year Ended
December 31,
 
        2024           2023           2024           2023     
    

(in thousands, except per share data)

 
     (unaudited)              
     £     £     £     £  

Research and development expenses

     (729     (6,859     (18,017     (25,062

Administrative expenses

     (540     (1,286     (4,988     (6,063

Impairment of intangible assets

     (33     (503     (33     (503

Net foreign exchange gains (losses)

     437       (459     229       (1,156
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (865     (9,107     (22,809     (32,784

Finance income

     75       137       358       754  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before tax

     (790     (8,970     (22,451     (32,030

Income tax credit

     137       1,315       3,454       4,398  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

     (653     (7,655     (18,997     (27,632
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted loss per ordinary share

     (0.01     (0.14     (0.26     (0.53


Condensed Consolidated Statements of Financial Position As At

 

     December 31,
2024
    December 31,
2023
 
     (in thousands)  
     £     £  

Assets

    

Non-current assets

    

Intangible assets

     2,199       2,128  

Property, plant and equipment

     197       521  

Deferred tax asset

     113       143  
  

 

 

   

 

 

 
     2,509       2,792  

Current assets

    

Prepayments, accrued income and other receivables

     922       2,671  

Current income tax receivable

     4,594       5,123  

Cash and cash equivalents

     6,749       17,225  
  

 

 

   

 

 

 
     12,265       25,019  
  

 

 

   

 

 

 

Total assets

     14,774       27,811  
  

 

 

   

 

 

 

Equity and liabilities

    

Capital and reserves

    

Share capital and share premium

     151,827       143,420  

Other reserves

     78,421       79,173  

Accumulated deficit

     (224,294     (207,706
  

 

 

   

 

 

 

Total equity attributable to equity holders of the Company

     5,954       14,887  
  

 

 

   

 

 

 

Non-current liabilities

    

Provisions

     37       58  

Lease liabilities

     117       190  
  

 

 

   

 

 

 
     154       248  

Current liabilities

    

Trade payables

     2,705       3,375  

Payroll taxes and social security

     134       155  

Accrued expenditure

     5,714       8,940  

Lease liabilities

     73       206  

Provisions

     40       —   
  

 

 

   

 

 

 
     8,666       12,676  

Total liabilities

     8,820       12,924  
  

 

 

   

 

 

 

Total equity and liabilities

     14,774       27,811  
  

 

 

   

 

 

 


Condensed Consolidated Statements of Cash Flows

 

     For the Year Ended December 31,  
     2024     2023  
     (in thousands)  
     £     £  

Cash flows from operating activities

    

Loss for the period

     (18,997     (27,632

Adjustments for:

    

Income tax credit

     (3,454     (4,398

Amortization and depreciation

     522       575  

Impairment of intangible assets

     33       503  

Movement in provisions

     10       (4,109

Finance income

     (358     (754

Interest expense on lease liabilities

     17       29  

Share-based payments

     1,646       3,857  

Net foreign exchange (gains) losses

     (369     1,176  
  

 

 

   

 

 

 
     (20,950     (30,753

Movements in working capital:

    

Decrease in prepayments, accrued income and other receivables

     1,737       1,234  

Decrease in trade payables

     (670     (1,428

Decrease in payroll taxes, social security and accrued expenditure

     (3,250     (1,087
  

 

 

   

 

 

 

Movements in working capital

     (2,183     (1,281
  

 

 

   

 

 

 

Cash used in operations

     (23,133     (32,034
  

 

 

   

 

 

 

Net income tax received

     4,015       5,595  
  

 

 

   

 

 

 

Net cash used in operating activities

     (19,118     (26,439
  

 

 

   

 

 

 

Cash flows from investing activities

    

Interest received

     372       770  

Payments for property, plant and equipment

     (4     (4

Payments for intangible assets

     (289     (474

Repayment of other assets

     —        2,596  
  

 

 

   

 

 

 

Net cash from investing activities

     79       2,888  
  

 

 

   

 

 

 

Cash flows from financing activities

    

Payments of lease liabilities

     (223     (270

Proceeds from issue of share capital – exercise of share options

     7       4  

Proceeds from issue of share capital

     8,729       249  

Share issue expenses

     (329     (36
  

 

 

   

 

 

 

Net cash from (used in) financing activities

     8,184       (53
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (10,855     (23,604

Cash and cash equivalents at beginning of year

     17,225       41,912  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     379       (1,083
  

 

 

   

 

 

 

Cash and cash equivalents at end of year

     6,749       17,225  
  

 

 

   

 

 

 


For more information, please contact:

NuCana plc

Hugh S. Griffith

Chief Executive Officer

+44 131-357-1111

info@nucana.com

ICR Healthcare

Chris Brinzey

+1 339-970-2843

Chris.Brinzey@ICRHealthcare.com