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Nov 27, 2018
Favorable Data Presented at
First Patients Enrolled in Phase Ib Study of NUC-3373 in Advanced Colorectal Cancer
Initiation of Phase III Study of Acelarin in Front-Line Advanced Biliary Tract Cancer and Phase I Study of NUC-7738 Expected by End of 2018
As of
“It has been a productive quarter for
Mr. Griffith continued: “In our ongoing Phase Ib study of patients with advanced biliary tract cancer, Acelarin® combined with cisplatin continued to show an approximate doubling of the response rate compared to the standard of care. Furthermore, some patients showed continued tumor shrinkage over time, which is not typically seen in this setting, and a durable progression free survival. In addition, we presented the latest data for our ongoing Phase I study of NUC-3373, our ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), in patients with advanced solid tumors. NUC-3373 demonstrated single-agent anti-cancer activity in patients who had exhausted all current standards of care, including three patients who achieved Stable Disease with responses lasting more than nine months at the time of data cut-off. In addition, NUC-3373 was well tolerated with no cases of hand-foot syndrome, a common toxicity associated with 5-FU.”
Mr. Griffith added: “We are delighted by the positive data generated with our first two ProTides, and we look forward to initiating a first-in-human Phase I study by the end of the year with NUC-7738, our third ProTide, which is a transformation of a novel nucleoside analog, cordycepin. All of this, plus the recent initiation of a Phase Ib combination study of NUC-3373 in patients with advanced colorectal cancer and the expected launch of a Phase III study of Acelarin plus cisplatin in patients with advanced biliary tract cancer, points to 2019 being a very productive year for NuCana.”
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 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 three clinical studies, including a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with ovarian cancer and a Phase III study for patients with pancreatic cancer. 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 advanced colorectal cancer.
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 September 30, |
For the nine months ended September 30, |
||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||
| (in thousands, except per share data) | |||||||||
| (unaudited) | |||||||||
| £ | £ | £ | £ | ||||||
| Research and development expenses | (3,333 | ) | (10,432 | ) | (12,196 | ) | (14,121 | ) | |
| Administrative expenses | (957 | ) | (3,390 | ) | (3,599 | ) | (4,027 | ) | |
| Initial public offering related expenses | - | (728 | ) | - | (1,794 | ) | |||
| Net foreign exchange gains (losses) | 706 | (74 | ) | 1,765 | (235 | ) | |||
| Operating loss | (3,584 | ) | (14,624 | ) | (14,030 | ) | (20,177 | ) | |
| Finance income | 297 | 34 | 739 | 125 | |||||
| Loss before tax | (3,287 | ) | (14,590 | ) | (13,291 | ) | (20,052 | ) | |
| Income tax credit | 771 | 578 | 3,063 | 1,655 | |||||
| Loss for the period | (2,516 | ) | (14,012 | ) | (10,228 | ) | (18,397 | ) | |
| Basic and diluted loss per share | (0.08 | ) | (0.58 | ) | (0.32 | ) | (0.76 | ) | |
| Unaudited Condensed Consolidated Statements of Financial Position | |||||
| September 30, 2018 |
December 31, 2017 |
||||
| (in thousands) | |||||
| (unaudited) | |||||
| £ | £ | ||||
| Assets | |||||
| Non-current assets | |||||
| Intangible assets | 2,706 | 1,938 | |||
| Property, plant and equipment | 462 | 358 | |||
| Deferred tax asset | 26 | 81 | |||
| 3,194 | 2,377 | ||||
| Current assets | |||||
| Prepayments, accrued income and other receivables | 3,121 | 3,050 | |||
| Current income tax receivable | 5,438 | 4,225 | |||
| Cash and cash equivalents | 78,351 | 86,703 | |||
| 86,910 | 93,978 | ||||
| Total assets | 90,104 | 96,355 | |||
| Equity and liabilities |
|||||
| Capital and reserves | |||||
| Share capital and share premium | 80,690 | 80,508 | |||
| Other reserves | 59,431 | 58,071 | |||
| Accumulated deficit | (55,247 | ) | (45,159 | ) | |
| Total equity attributable to equity holders of the Company | 84,874 | 93,420 | |||
| Non-current liabilities | |||||
| Provisions | 26 | 18 | |||
| Current liabilities | |||||
| Trade payables | 2,537 | 1,120 | |||
| Payroll taxes and social security | 121 | 157 | |||
| Accrued expenditure | 2,546 | 1,640 | |||
| 5,204 | 2,917 | ||||
| Total liabilities | 5,230 | 2,935 | |||
| Total equity and liabilities | 90,104 | 96,355 | |||
| Unaudited Condensed Consolidated Statements of Cash Flows | ||||
| For the nine months ended September 30, |
||||
| 2018 | 2017 | |||
| (in thousands) | ||||
| (unaudited) | ||||
| £ | £ | |||
| Cash flows from operating activities | ||||
| Loss for the period | (10,228 | ) | (18,397 | ) |
| Adjustments for: | ||||
| Income tax credit | (3,063 | ) | (1,655 | ) |
| Amortization and depreciation | 261 | 121 | ||
| Finance income | (739 | ) | (125 | ) |
| Share-based payments | 1,494 | 11,597 | ||
| Initial public offering (IPO) related expenses | - | 1,794 | ||
| Net foreign exchange (gains) losses | (1,808 | ) | 190 | |
| (14,083 | ) | (6,475 | ) | |
| Movements in working capital: | ||||
| Increase in prepayments, accrued income and other receivables | (2 | ) | (134 | ) |
| Increase in trade payables | 1,416 | 301 | ||
| Increase in payroll taxes, social security and accrued expenditure | 878 | 539 | ||
| Movements in working capital | 2,292 | 706 | ||
| Cash used in operations | (11,791 | ) | (5,769 | ) |
| Net income tax credit received | 1,905 | 242 | ||
| Net cash used in operating activities | (9,886 | ) | (5,527 | ) |
| Cash flows from investing activities | ||||
| Interest received | 694 | 140 | ||
| Payments for property, plant and equipment | (205 | ) | (369 | ) |
| Payments for intangible assets | (928 | ) | (559 | ) |
| Net cash used in investing activities | (439 | ) | (788 | ) |
| Cash flows from financing activities | ||||
| IPO related expenses included in statement of operations | - | (1,104 | ) | |
| Proceeds from issue of share capital – exercise of share options | 182 | 120 | ||
| Net cash from (used in) financing activities | 182 | (984 | ) | |
| Net decrease in cash and cash equivalents | (10,143 | ) | (7,299 | ) |
| Cash and cash equivalents at beginning of period | 86,703 | 19,990 | ||
| Foreign currency translation differences | 1,791 | (9 | ) | |
| Cash and cash equivalents at end of period | 78,351 | 12,682 | ||
For more information, please contact:
Chief Executive Officer
+44 131 357 1111
info@nucana.com
+1 339-970-2843
Chris.brinzey@westwicke.com
RooneyPartners
+1 212-223-4017
mjanic@rooneyco.com
Source: NuCana plc