Full Press Release Details
NuCana Reports Fourth Quarter and Year-End 2018 Financial Results and Provides Business Update
Numerous Clinical Data Announcements and Study Initiations Expected in 2019
Current Cash Balance Expected to Fund the Company Into 2021
Edinburgh, United Kingdom, March 7, 2019 (GLOBE NEWSWIRE) NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year
ended December 31, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics.
December 31, 2018, NuCana had cash and cash equivalents of 77.0 million compared to 78.4 million as of September 30, 2018 and 86.7 million as of December 31, 2017. NuCana reported a loss of
3.6 million for the quarter ended December 31, 2018, compared to 5.0 million for the quarter ended December 31, 2017 as the Company continued to advance its various clinical programs. Net loss for the year ended
December 31, 2018 was 13.8 million, compared to a net loss of 23.1 million for the year ended December 31, 2017. Basic and diluted loss per share was 0.11 for the quarter and 0.43 for the year ended
December 31, 2018, compared to 0.16 per share for the comparable quarter and 0.89 on a year-over-year basis in 2017.
its current cash and cash equivalents will be sufficient to fund operations into 2021. In addition to continuing or completing the ongoing clinical studies, NuCana s current cash and cash equivalents will enable the following:
2018 has been another very productive year for NuCana highlighted by several
encouraging clinical data presentations for Acelarin and NUC-3373, said Hugh S. Griffith, NuCana s Founder and Chief Executive Officer. We began the year by announcing interim data at ASCO-GI from the ongoing Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer, which showed a 50% response rate, approximately doubling the response rate seen with the standard
of care, gemcitabine plus cisplatin, in this patient population. At the European Society for Medical Oncology (ESMO) 2018 Congress in October, we announced that the second cohort from this study maintained a 50% response rate. In addition, results
showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time.
Mr. Griffith continued: Additionally, in October we announced at ESMO interim data from an ongoing Phase I study of our second ProTide, NUC-3373, a transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), in patients with advanced solid tumors who
had exhausted all current standards of care. Notably, three patients achieved stable disease lasting more than nine months at the time of data cutoff and, importantly, no patients developed hand-foot syndrome, which is a debilitating side effect
associated with fluoropyrimidine therapy.
Mr. Griffith added: In addition to the clinical successes of our first two ProTides, we expect to
enroll the first patients with advanced solid tumors in the Phase I clinical study of our third ProTide, NUC-7738, which is based on a novel nucleoside analog, 3 -deoxyadenosine, and which has shown
potent anti-cancer activity in preclinical studies.
Mr Griffith concluded: We are very pleased with the progress NuCana made in 2018. We have
continued to validate our ProTide technology s ability to transform some of the most widely prescribed chemotherapy agents into more efficacious and safer treatments. With plans to open a Phase III study of Acelarin plus cisplatin in patients
with advanced biliary tract cancer and additional data from the two ongoing studies with NUC-3373, as a single agent in patients with advanced solid tumors as well as in combination with other agents typically
combined with 5-FU in patients with advanced colorectal cancer, we anticipate 2019 being another important year for NuCana.
Anticipated Milestones
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 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 results of operations for
the fourth quarter and year ended December 31, 2018; the amount and sufficiency of the Company s cash and cash equivalents to fund its operations into 2021; the Company s planned and ongoing clinical studies for the Company s
product candidates and the potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress,
release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. 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, 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, 2017 filed with the Securities and Exchange Commission ( SEC ) on March 22, 2018, 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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Research and development expenses | (4,650 | ) | (3,807 | ) | (16,846 | ) | (17,673 | ) | ||||||||
| Administrative expenses | (1,585 | ) | (645 | ) | (5,184 | ) | (4,573 | ) | ||||||||
| Initial public offering related expenses | (1,794 | ) | ||||||||||||||
| Net foreign exchange gains (losses) | 1,137 | (1,419 | ) | 2,902 | (1,654 | ) | ||||||||||
| Operating loss | (5,098 | ) | (5,871 | ) | (19,128 | ) | (25,694 | ) | ||||||||
| Finance income | 326 | 83 | 1,065 | 208 | ||||||||||||
| Loss before tax | (4,772 | ) | (5,788 | ) | (18,063 | ) | (25,486 | ) | ||||||||
| Income tax credit | 1,160 | 746 | 4,223 | 2,401 | ||||||||||||
| Loss for the year | (3,612 | ) | (5,042 | ) | (13,840 | ) | (23,085 | ) | ||||||||
| Basic and diluted loss per share | (0.11 | ) | (0.16 | ) | (0.43 | ) | (0.89 | ) |
Condensed Consolidated Statements of Financial Position
| 2018 | 2017 | |||||||
| (in thousands) | ||||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 3,122 | 1,938 | ||||||
| Property, plant and equipment | 427 | 358 | ||||||
| Deferred tax asset | 47 | 81 | ||||||
| 3,596 | 2,377 | |||||||
| Current assets | ||||||||
| Prepayments, accrued income and other receivables | 2,354 | 3,050 | ||||||
| Current income tax receivable | 4,263 | 4,225 | ||||||
| Cash and cash equivalents | 76,972 | 86,703 | ||||||
| 83,589 | 93,978 | |||||||
| Total assets | 87,185 | 96,355 | ||||||
| Equity and liabilities | ||||||||
| Capital and reserves | ||||||||
| Share capital and share premium | 80,715 | 80,508 | ||||||
| Other reserves | 59,692 | 58,071 | ||||||
| Accumulated deficit | (58,813 | ) | (45,159 | ) | ||||
| Total equity attributable to equity holders of the Company | 81,594 | 93,420 | ||||||
| Non-current liabilities | ||||||||
| Provisions | 26 | 18 | ||||||
| Current liabilities | ||||||||
| Trade payables | 2,455 | 1,120 | ||||||
| Payroll taxes and social security | 127 | 157 | ||||||
| Accrued expenditure | 2,983 | 1,640 | ||||||
| 5,565 | 2,917 | |||||||
| Total liabilities | 5,591 | 2,935 | ||||||
| Total equity and liabilities | 87,185 | 96,355 |
Condensed Consolidated Statements of Cash Flows
for the year ended December 31,
| 2018 | 2017 | |||||||
| (in thousands) | ||||||||
| Cash flows from operating activities | ||||||||
| Loss for the year | (13,840 | ) | (23,085 | ) | ||||
| Adjustments for: | ||||||||
| Income tax credit | (4,223 | ) | (2,401 | ) | ||||
| Amortization and depreciation | 371 | 194 | ||||||
| Finance income | (1,065 | ) | (208 | ) | ||||
| Share-based payments | 1,795 | 11,731 | ||||||
| Initial public offering (IPO) related expenses | 1,794 | |||||||
| Net foreign exchange (gains) losses | (2,959 | ) | 1,584 | |||||
| (19,921 | ) | (10,391 | ) | |||||
| Movements in working capital: | ||||||||
| Decrease in prepayments, accrued income and other receivables | 817 | 458 | ||||||
| Increase in trade payables | 1,335 | 392 | ||||||
| Increase in payroll taxes, social security and accrued expenditure | 1,321 | 551 | ||||||
| Movements in working capital | 3,473 | 1,401 | ||||||
| Cash used in operations | (16,448 | ) | (8,990 | ) | ||||
| Net income tax credit received | 4,224 | 282 | ||||||
| Net cash used in operating activities | (12,224 | ) | (8,708 | ) | ||||
| Cash flows from investing activities | ||||||||
| Interest received | 973 | 162 | ||||||
| Payments for property, plant and equipment | (210 | ) | (370 | ) | ||||
| Payments for intangible assets | (1,414 | ) | (725 | ) | ||||
| Net cash used in investing activities | (651 | ) | (933 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issue of share capital | 79,834 | |||||||
| IPO related expenses from issue of share capital included in share premium | (413 | ) | ||||||
| IPO related expenses included in statement of operations | (1,794 | ) | ||||||
| Proceeds from issue of share capital - exercise of share options | 207 | 120 | ||||||
| Net cash from financing activities | 207 | 77,747 | ||||||
| Net (decrease) increase in cash and cash equivalents | (12,668 | ) | 68,106 | |||||
| Cash and cash equivalents at beginning of year | 86,703 | 19,990 | ||||||
| Foreign currency translation differences | 2,937 | (1,393 | ) | |||||
| Cash and cash equivalents at end of year | 76,972 | 86,703 |
For more information, please contact:
Chief Executive Officer
Westwicke, an ICR Company