NuCana Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Business Update
NuCana (NASDAQ: NCNA) has reported its Q4 and full-year 2024 financial results, highlighting progress in its anti-cancer drug development programs. The company's lead program, NUC-7738, showed promising results in combination with pembrolizumab, achieving disease control in 75% of patients with PD-1 inhibitor-resistant melanoma.
Financial highlights include cash position of £6.7 million as of December 31, 2024, with runway extended into Q3 2025. The company reported a reduced net loss of £19.0 million for 2024, compared to £27.6 million in 2023. Loss per share improved to £0.26 for 2024 from £0.53 in 2023.
Key 2025 milestones include initiating an expansion study of NUC-7738 with pembrolizumab for melanoma patients and seeking FDA guidance on pivotal study design. The company will also continue development of NUC-3373, which has shown positive results in combination studies.
NuCana (NASDAQ: NCNA) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nei suoi programmi di sviluppo di farmaci anti-cancro. Il programma principale dell'azienda, NUC-7738, ha mostrato risultati promettenti in combinazione con pembrolizumab, raggiungendo il controllo della malattia nel 75% dei pazienti con melanoma resistente agli inibitori PD-1.
I punti salienti finanziari includono una posizione di cassa di £6,7 milioni al 31 dicembre 2024, con una disponibilità estesa fino al terzo trimestre del 2025. L'azienda ha riportato una perdita netta ridotta di £19,0 milioni per il 2024, rispetto ai £27,6 milioni del 2023. La perdita per azione è migliorata a £0,26 per il 2024, rispetto a £0,53 nel 2023.
I principali traguardi per il 2025 includono l'avvio di uno studio di espansione di NUC-7738 con pembrolizumab per pazienti affetti da melanoma e la richiesta di orientamenti dalla FDA sul design dello studio pivotale. L'azienda continuerà anche lo sviluppo di NUC-3373, che ha mostrato risultati positivi negli studi combinati.
NuCana (NASDAQ: NCNA) ha informado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en sus programas de desarrollo de fármacos anticancerígenos. El programa principal de la compañía, NUC-7738, mostró resultados prometedores en combinación con pembrolizumab, logrando el control de la enfermedad en el 75% de los pacientes con melanoma resistente a los inhibidores de PD-1.
Los aspectos financieros destacados incluyen una posición de efectivo de £6,7 millones al 31 de diciembre de 2024, con un margen de financiación extendido hasta el tercer trimestre de 2025. La compañía reportó una pérdida neta reducida de £19,0 millones para 2024, en comparación con £27,6 millones en 2023. La pérdida por acción mejoró a £0,26 para 2024 desde £0,53 en 2023.
Los hitos clave para 2025 incluyen iniciar un estudio de expansión de NUC-7738 con pembrolizumab para pacientes con melanoma y buscar orientación de la FDA sobre el diseño del estudio pivotal. La compañía también continuará el desarrollo de NUC-3373, que ha mostrado resultados positivos en estudios combinados.
NuCana (NASDAQ: NCNA)는 2024년 4분기 및 연간 재무 결과를 발표하며 항암제 개발 프로그램의 진전을 강조했습니다. 회사의 주요 프로그램인 NUC-7738는 pembrolizumab과의 병용에서 유망한 결과를 보여주었으며, PD-1 억제제에 저항성인 흑색종 환자의 75%에서 질병 조절을 달성했습니다.
재무 하이라이트에는 2024년 12월 31일 기준 £6.7백만의 현금 보유액이 포함되며, 2025년 3분기까지 자금 지원이 연장되었습니다. 회사는 2024년 동안 £19.0백만의 감소된 순손실을 보고했으며, 이는 2023년의 £27.6백만과 비교됩니다. 주당 손실은 2024년 £0.26으로 개선되었고, 2023년에는 £0.53였습니다.
2025년의 주요 이정표에는 pembrolizumab과 함께 NUC-7738의 확장 연구를 시작하고 FDA에 중요한 연구 설계에 대한 지침을 요청하는 것이 포함됩니다. 회사는 또한 긍정적인 결과를 보인 NUC-3373의 개발을 계속할 것입니다.
NuCana (NASDAQ: NCNA) a publié ses résultats financiers pour le quatrième trimestre et l'année entière 2024, mettant en avant les progrès de ses programmes de développement de médicaments anticancéreux. Le programme phare de l'entreprise, NUC-7738, a montré des résultats prometteurs en combinaison avec le pembrolizumab, atteignant le contrôle de la maladie chez 75 % des patients atteints de mélanome résistant aux inhibiteurs de PD-1.
Les points saillants financiers incluent une position de trésorerie de £6,7 millions au 31 décembre 2024, avec une durée de financement prolongée jusqu'au troisième trimestre 2025. L'entreprise a signalé une perte nette réduite de £19,0 millions pour 2024, contre £27,6 millions en 2023. La perte par action s'est améliorée à £0,26 pour 2024 contre £0,53 en 2023.
Les principales étapes de 2025 comprennent le lancement d'une étude d'expansion de NUC-7738 avec le pembrolizumab pour les patients atteints de mélanome et la recherche de conseils de la FDA sur la conception d'études pivot. L'entreprise continuera également le développement de NUC-3373, qui a montré des résultats positifs dans les études combinées.
NuCana (NASDAQ: NCNA) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seinen Programmen zur Entwicklung von Krebsmedikamenten hervorgehoben. Das Hauptprogramm des Unternehmens, NUC-7738, zeigte vielversprechende Ergebnisse in Kombination mit Pembrolizumab und erreichte eine Krankheitskontrolle bei 75 % der Patienten mit PD-1-Inhibitor-resistentem Melanom.
Zu den finanziellen Höhepunkten gehören eine Bargeldposition von £6,7 Millionen zum 31. Dezember 2024, mit einer Laufzeit, die bis ins dritte Quartal 2025 verlängert wurde. Das Unternehmen berichtete von einem verringerten Nettoverlust von £19,0 Millionen für 2024, im Vergleich zu £27,6 Millionen im Jahr 2023. Der Verlust pro Aktie verbesserte sich auf £0,26 für 2024 von £0,53 im Jahr 2023.
Wichtige Meilensteine für 2025 umfassen den Start einer Erweiterungsstudie von NUC-7738 mit Pembrolizumab für Melanom-Patienten und die Einholung von FDA-Richtlinien zum Design von entscheidenden Studien. Das Unternehmen wird auch die Entwicklung von NUC-3373 fortsetzen, das in Kombinationsstudien positive Ergebnisse gezeigt hat.
- Strong clinical results with 75% disease control rate in melanoma patients
- Reduced net loss by 31% year-over-year
- New USPTO patent granted for NUC-7738
- Positive preliminary data from NUC-3373 combination therapy
- Cash position decreased from £17.2M to £6.7M year-over-year
- Continued reliance on ATM offerings for funding
- Unexpected negative outcome in NuTide:323 colorectal cancer study
- cash runway extending only into Q3 2025
Insights
NuCana's Q4/FY2024 results present a mixed picture with encouraging clinical progress balanced against financial constraints. The company reported a narrowed net loss of
The lead program NUC-7738 shows promising efficacy in combination with pembrolizumab for PD-1 inhibitor-resistant melanoma. Disease control in
For NUC-3373, results appear mixed. While some patients achieved partial responses, including complete reduction of target lesions in one urothelial cancer case, the company acknowledged disappointing results in colorectal cancer. This setback in a major potential indication reduces the near-term commercial prospects for this asset.
The recently granted composition of matter patent for NUC-7738 strengthens the IP portfolio and potential commercial exclusivity. With multiple data readouts expected in 2025, NuCana has potential catalysts ahead, but will likely need additional financing to fully capitalize on positive clinical results.
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
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
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.
- Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with 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.
- 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
NuCana continues to advance its various clinical programs and reported a net loss of
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
FAQ
What were the clinical results of NUC-7738 in melanoma patients for NCNA?
How much cash does NCNA have and what is their runway?
What are NCNA's key milestones for 2025?
How did NCNA's financial performance improve in 2024?
