Key Data Readouts on Track for All Programs in 2024
Randomized Phase 2 Study of 182 Second-Line Colorectal Cancer Patients Fully Enrolled
NUC-7738 plus Pembrolizumab Demonstrated Encouraging Anti-Cancer Activity in Several Patients who were Resistant to PD-1 Inhibitors
Anticipated Cash Runway into Q1 2025
As of
“Our focus remains on advancing our innovative ProTide pipeline to develop more efficacious and safer medicines for patients with cancer,” said
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 + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with metastatic colorectal cancer;
- Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev 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.
- 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
Unaudited Condensed Consolidated Statements of Operations
For the Three Months Ended | |||||
2024 | 2023 | ||||
(in thousands, except per share data) | |||||
£ | £ | ||||
Research and development expenses | (6,783) | (6,805) | |||
Administrative expenses | (1,581) | (1,648) | |||
Net foreign exchange gains (losses) | 95 | (695) | |||
Operating loss | (8,269) | (9,148) | |||
Finance income | 126 | 287 | |||
Loss before tax | (8,143) | (8,861) | |||
Income tax credit | 1,305 | 994 | |||
Loss for the period | (6,838) | (7,867) | |||
Basic and diluted loss per share | (0.13) | (0.15) | |||
Unaudited Condensed Consolidated Statements of Financial Position As At
2024 | 2023 | ||||
(in thousands) | |||||
£ | £ | ||||
Assets | |||||
Non-current assets | |||||
Intangible assets | 2,165 | 2,128 | |||
Property, plant and equipment | 430 | 521 | |||
Deferred tax asset | 156 | 143 | |||
2,751 | 2,792 | ||||
Current assets | |||||
Prepayments, accrued income and other receivables | 2,766 | 2,671 | |||
Current income tax receivable | 6,416 | 5,123 | |||
Cash and cash equivalents | 12,868 | 17,225 | |||
22,050 | 25,019 | ||||
Total assets | 24,801 | 27,811 | |||
Equity and liabilities | |||||
Capital and reserves | |||||
Share capital and share premium | 144,870 | 143,420 | |||
Other reserves | 79,633 | 79,173 | |||
Accumulated deficit | (214,374) | (207,706) | |||
Total equity attributable to equity holders of the Company | 10,129 | 14,887 | |||
Non-current liabilities | |||||
Provisions | 58 | 58 | |||
Lease liabilities | 172 | 190 | |||
230 | 248 | ||||
Current liabilities | |||||
Trade payables | 5,764 | 3,375 | |||
Payroll taxes and social security | 214 | 155 | |||
Accrued expenditure | 8,297 | 8,940 | |||
Lease liabilities | 167 | 206 | |||
14,442 | 12,676 | ||||
Total liabilities | 14,672 | 12,924 | |||
Total equity and liabilities | 24,801 | 27,811 | |||
Unaudited Condensed Consolidated Statements of Cash Flows
For the Three Months Ended | ||||
2024 | 2023 | |||
(in thousands) | ||||
£ | £ | |||
Cash flows from operating activities | ||||
Loss for the period | (6,838) | (7,867) | ||
Adjustments for: | ||||
Income tax credit | (1,305) | (994) | ||
Amortization and depreciation | 136 | 143 | ||
Movement in provisions | - | (55) | ||
Finance income | (126) | (287) | ||
Interest expense on lease liabilities | 5 | 8 | ||
Share-based payments | 626 | 1,141 | ||
Net foreign exchange (gains) losses | (98) | 726 | ||
(7,600) | (7,185) | |||
Movements in working capital: | ||||
Increase in prepayments, accrued income and other receivables | (87) | (463) | ||
Increase in trade payables | 2,390 | 888 | ||
Decrease in payroll taxes, social security and accrued expenditure | (586) | (3,575) | ||
Movements in working capital | 1,717 | (3,150) | ||
Cash used in operations | (5,883) | (10,335) | ||
Net income tax received | - | - | ||
Net cash used in operating activities | (5,883) | (10,335) | ||
Cash flows from investing activities | ||||
Interest received | 124 | 322 | ||
Payments for intangible assets | (81) | (159) | ||
Net cash from investing activities | 43 | 163 | ||
Cash flows from financing activities | ||||
Payments for lease liabilities | (64) | (42) | ||
Proceeds from issue of share capital – exercise of share options | 3 | 1 | ||
Proceeds from issue of share capital | 1,492 | - | ||
Share issue expenses | (45) | - | ||
Net cash from (used in) financing activities | 1,386 | (41) | ||
Net decrease in cash and cash equivalents | (4,454) | (10,213) | ||
Cash and cash equivalents at beginning of period | 17,225 | 41,912 | ||
Effect of exchange rate changes on cash and cash equivalents | 97 | (698) | ||
Cash and cash equivalents at end of period | 12,868 | 31,001 | ||
For more information, please contact:
Chief Executive Officer
+44 131-357-1111
info@nucana.com
ICR Westwicke
+1 339-970-2843
chris.brinzey@westwicke.com
Source:
2024 GlobeNewswire, Inc., source