Mar 10, 2020
First Patients Dosed in Global Phase III Biliary Tract Cancer Study (NuTide:121)
with Potential for Accelerated Approval Filing
Numerous Clinical Data Announcements Expected in 2020
Cash and Cash Equivalents to Fund Operations into the Second Half of 2021
As of
“It has been a productive year for NuCana in 2019 and we are making excellent progress advancing our pipeline of novel ProTides,” said
“For our third ProTide in the clinic, NUC-7738, a transformation of a novel nucleoside analog, 3’-deoxyadenosine, we announced in October non-clinical data detailing multiple potential anti-cancer modes of action resulting in cancer cell death. We look forward to announcing clinical data from the ongoing Phase I study of NUC-7738 in patients with advanced solid tumors (NuTide:701) in 2020.”
NuCana believes its current cash and cash equivalents will be sufficient to fund its planned operations into the second half of 2021. In addition to continuing or completing the ongoing clinical studies, NuCana expects its current cash and cash equivalents will enable the following:
Anticipated Milestones
About
NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients 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, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. Our most advanced ProTide candidates, Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is currently being evaluated in four clinical studies, including a Phase III study for patients with biliary tract cancer, a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with platinum-resistant ovarian cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with previously treated metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) and is in a Phase I study for patients with advanced solid tumors.
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
Condensed Consolidated Statements of Operations | |||||||||||||
For the three months ended |
For the year ended |
||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||
(in thousands, except per share data) | |||||||||||||
(unaudited) | |||||||||||||
£ | £ | £ | £ | ||||||||||
Research and development expenses | (5,177 | ) | (4,650 | ) | (19,728 | ) | (16,846 | ) | |||||
Administrative expenses | (1,722 | ) | (1,585 | ) | (5,953 | ) | (5,184 | ) | |||||
Net foreign exchange (losses) gains | (2,210 | ) | 1,137 | (1,019 | ) | 2,902 | |||||||
Operating loss | (9,109 | ) | (5,098 | ) | (26,700 | ) | (19,128 | ) | |||||
Finance income | 182 | 326 | 1,049 | 1,065 | |||||||||
Loss before tax | (8,927 | ) | (4,772 | ) | (25,651 | ) | (18,063 | ) | |||||
Income tax credit | 1,219 | 1,160 | 4,239 | 4,223 | |||||||||
Loss for the period | (7,708 | ) | (3,612 | ) | (21,412 | ) | (13,840 | ) | |||||
Basic and diluted loss per share | (0.24 | ) | (0.11 | ) | (0.66 | ) | (0.43 | ) | |||||
Condensed Consolidated Statements of Financial Position at |
|||||||
2019 | 2018 | ||||||
(in thousands) | |||||||
£ | £ | ||||||
Assets | |||||||
Non-current assets | |||||||
Intangible assets | 3,960 | 3,122 | |||||
Property, plant and equipment | 1,109 | 427 | |||||
Deferred tax asset | 46 | 47 | |||||
5,115 | 3,596 | ||||||
Current assets | |||||||
Prepayments, accrued income and other receivables | 4,710 | 2,354 | |||||
Current income tax receivable | 8,481 | 4,263 | |||||
Cash and cash equivalents | 51,962 | 76,972 | |||||
65,153 | 83,589 | ||||||
Total assets | 70,268 | 87,185 | |||||
Equity and liabilities | |||||||
Capital and reserves | |||||||
Share capital and share premium | 80,840 | 80,715 | |||||
Other reserves | 62,737 | 59,692 | |||||
Accumulated deficit | (80,055 | ) | (58,813 | ) | |||
Total equity attributable to equity holders of the Company | 63,522 | 81,594 | |||||
Non-current liabilities | |||||||
Provisions | 26 | 26 | |||||
Lease liabilities | 538 | - | |||||
564 | 26 | ||||||
Current liabilities | |||||||
Trade payables | 2,412 | 2,455 | |||||
Payroll taxes and social security | 160 | 127 | |||||
Accrued expenditure | 3,342 | 2,983 | |||||
Lease liabilities | 268 | - | |||||
6,182 | 5,565 | ||||||
Total liabilities | 6,746 | 5,591 | |||||
Total equity and liabilities | 70,268 | 87,185 | |||||
Condensed Consolidated Statements of Cash Flows for the year ended |
|||||
2019 | 2018 | ||||
(in thousands) | |||||
£ | £ | ||||
Cash flows from operating activities | |||||
Loss for the year | (21,412 | ) | (13,840 | ) | |
Adjustments for: | |||||
Income tax credit | (4,239 | ) | (4,223 | ) | |
Amortization and depreciation | 718 | 371 | |||
Finance income | (1,049 | ) | (1,065 | ) | |
Share-based payments | 3,226 | 1,795 | |||
Net foreign exchange losses (gains) | 1,006 | (2,959 | ) | ||
(21,750 | ) | (19,921 | ) | ||
Movements in working capital: | |||||
(Increase) decrease in prepayments, | |||||
accrued income and other receivables | (2,452 | ) | 817 | ||
(Decrease) increase in trade payables | (43 | ) | 1,335 | ||
Increase in payroll taxes, social security | |||||
and accrued expenditure | 393 | 1,321 | |||
Movements in working capital | (2,102 | ) | 3,473 | ||
Cash used in operations | (23,852 | ) | (16,448 | ) | |
Net income tax received | 19 | 4,224 | |||
Net cash used in operating activities | (23,833 | ) | (12,224 | ) | |
Cash flows from investing activities | |||||
Interest received | 1,116 | 973 | |||
Payments for property, plant and equipment | (46 | ) | (210 | ) | |
Payments for intangible assets | (1,215 | ) | (1,414 | ) | |
Net cash used in investing activities | (145 | ) | (651 | ) | |
Cash flows from financing activities | |||||
Payments of lease liabilities | (197 | ) | - | ||
Proceeds from lease incentives received | 25 | - | |||
Proceeds from issue of share capital | 125 | 207 | |||
Net cash (used in) from financing activities | (47 | ) | 207 | ||
Net decrease in cash and cash equivalents | (24,025 | ) | (12,668 | ) | |
Cash and cash equivalents at beginning of year | 76,972 | 86,703 | |||
Effect of exchange rate changes on cash and cash equivalents | (985 | ) | 2,937 | ||
Cash and cash equivalents at end of year | 51,962 | 76,972 | |||
For more information, please contact:
Chief Executive Officer
+44 131 357 1111
info@nucana.com
Westwicke, an
+1 339-970-2843
chris.brinzey@westwicke.com
RooneyPartners
+1 212-223-4017
mjanic@rooneyco.com
Source: NuCana plc