UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2018
(Commission File No. 001-38215)
NUCANA PLC
(Translation of registrants name into English)
3 Lochside Way
Edinburgh EH12 9DT
United Kingdom
(Address of registrants principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7): ☐
Other Events
On August 28, 2018, NuCana plc (the Company) issued a press release announcing its second quarter 2018 financial results. The press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein. The Companys unaudited condensed consolidated financial statements as of June 30, 2018 are attached as Exhibit 99.2 and are incorporated by reference herein.
The information in the attached Exhibits 99.1 and 99.2 is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
The information in the attached Exhibit 99.2 shall be deemed to be incorporated by reference into the registration statement on Form S-8 (Registration Number 333-223476), and related Prospectuses, as such Registration Statement and Prospectuses may be amended from time to time, and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibits
99.1 | Press Release dated August 28, 2018 | |
99.2 | Unaudited Condensed Consolidated Financial Statements as of June 30, 2018 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NuCana plc | ||
By: | /s/ Donald Munoz | |
Name: | Donald Munoz | |
Title: | Chief Financial Officer |
Date: August 28, 2018
Exhibit 99.1
NuCana Reports Second Quarter 2018 Financial Results and Provides Business Update
Additional Acelarin and NUC-3373 Data to be Presented at ESMO in October
Edinburgh, United Kingdom, August 28, 2018 (GLOBE NEWSWIRE) NuCana plc (NASDAQ: NCNA) announced financial results for the second quarter ended June 30, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics.
As of June 30, 2018, NuCana had cash and cash equivalents of £81.5 million compared to £81.3 million as of March 31, 2018 and £86.7 million as of December 31, 2017. This increase in cash and cash equivalents during the second quarter of 2018 reflects the weakening of the UK pound sterling relative to the US dollar and the fact that NuCana holds a portion of its cash in US dollars. NuCana reported a loss of £1.3 million for the quarter ended June 30, 2018, compared to £2.7 million for the quarter ended June 30, 2017 as the Company continued to advance its various clinical programs. Basic and diluted loss per share was £0.04 for the quarter ended June 30, 2018, compared to £0.11 per share for the comparable quarter in 2017.
We have made excellent progress with our development programs during the first half of 2018 and look forward to providing additional clinical updates later in the year, said Hugh Griffith, NuCanas Founder and Chief Executive Officer. The high response rates achieved in the first cohort of eight patients with biliary tract cancers, which were reported earlier this year at ASCO GI, has led us to prioritize this indication for rapid development. We are also excited about opening our combination Phase 1b study with NUC-3373 for patients with colorectal cancers and taking our third ProTide, NUC-7738, into the clinic later this year.
Mr. Griffith continued: We are also pleased to announce that we have had three posters accepted for presentation at the European Society for Medical Oncology (ESMO) Congress being held in Munich, Germany on October 19 to 23, 2018. These posters include additional data from the ongoing Phase 1b study of Acelarin® plus cisplatin in front-line advanced biliary tract cancer (the ABC-08 study), additional data from the ongoing Phase 1 study of NUC-3373 in advanced solid tumors (the NuTide:301 study) and a study status update from the ongoing Phase 3 study of Acelarin® compared to gemcitabine in front-line pancreatic cancer patients (the Acelarate study).
Anticipated Second Half 2018 Milestones
| Acelarin® is NuCanas ProTide transformation of gemcitabine. Over the remainder of 2018, NuCana anticipates a number of data read-outs and milestones including: |
| Reporting additional Phase 1b data of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer at ESMO on October 21, 2018 (the ABC-08 study). This will include additional data on the eight patients reported at ASCO-GI in January 2018, data from the six patients in the 725mg/m2 dose cohort, and interim data from the additional six patients in an expansion cohort at the selected 625mg/m2 dose. |
| Initiating a Phase 3 study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer. |
| Continuing to enroll and follow-up with patients in the Phase 2 platinum-resistant ovarian study (the PRO-105 study). |
| Reporting current study status of the ongoing Phase 3 study of Acelarin compared to gemcitabine as a first-line treatment of patients with metastatic pancreatic cancer at ESMO on October 21, 2018 (the Acelarate study). |
| NUC-3373 is NuCanas second ProTide in clinical development, a transformation of 5-fluorouracil (5-FU). In 2018, NuCana expects to: |
| Report additional Phase 1 data in advanced solid tumors at ESMO on October 22, 2018 (the NuTide:301 study). |
| Initiate a Phase 1b study in patients with advanced colorectal cancer in combination with other approved agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan (the NuTide:302 study). |
| NUC-7738 is NuCanas ProTide transformation of cordycepin, a novel nucleoside analog that has shown potent anti-cancer activity in preclinical studies across a range of different human cancer cell lines. NuCana expects to initiate a First-In-Human Phase 1 clinical study of NUC-7738 in patients with solid tumors later in 2018 (the NuTide:701 study). |
About NuCana plc
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 1b study for patients with biliary tract cancer, a Phase 2 study for patients with ovarian cancer and a Phase 3 study for patients with pancreatic cancer. NUC-3373 is currently in a Phase 1 study for the potential treatment of a wide range of advanced solid tumors.
For more information, please visit: www.nucana.com.
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 our results of operations for the second quarter of 2018; our planned and ongoing clinical studies for the Companys 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 Companys 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 our 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 we file with the SEC. Forward-looking statements represent the Companys 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.
Unaudited Condensed Consolidated Statements of Operations
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
£ | £ | £ | £ | |||||||||||||
Research and development expenses |
(5,158 | ) | (2,077 | ) | (8,863 | ) | (3,689 | ) | ||||||||
Administrative expenses |
(1,402 | ) | (313 | ) | (2,642 | ) | (637 | ) | ||||||||
Initial public offering related expenses |
| (1,034 | ) | | (1,066 | ) | ||||||||||
Net foreign exchange gains (losses) |
3,607 | (113 | ) | 1,059 | (161 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating loss |
(2,953 | ) | (3,537 | ) | (10,446 | ) | (5,553 | ) | ||||||||
Finance income |
252 | 44 | 442 | 91 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss before tax |
(2,701 | ) | (3,493 | ) | (10,004 | ) | (5,462 | ) | ||||||||
Income tax credit |
1,383 | 745 | 2,292 | 1,077 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss for the period |
(1,318 | ) | (2,748 | ) | (7,712 | ) | (4,385 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted loss per share |
(0.04 | ) | (0.11 | ) | (0.24 | ) | (0.18 | ) |
Unaudited Condensed Consolidated Statements of Financial Position
June 30, 2018 |
December 31, 2017 |
|||||||
(in thousands) | ||||||||
£ | £ | |||||||
Assets |
||||||||
Non-current assets |
||||||||
Intangible assets |
2,485 | 1,938 | ||||||
Property, plant and equipment |
495 | 358 | ||||||
Deferred tax asset |
32 | 81 | ||||||
|
|
|
|
|||||
3,012 | 2,377 | |||||||
|
|
|
|
|||||
Current assets |
||||||||
Prepayments, accrued income and other receivables |
1,737 | 3,050 | ||||||
Current income tax receivable |
4,660 | 4,225 | ||||||
Cash and cash equivalents |
81,469 | 86,703 | ||||||
|
|
|
|
|||||
87,866 | 93,978 | |||||||
|
|
|
|
|||||
|
|
|
|
|||||
Total assets |
90,878 | 96,355 | ||||||
|
|
|
|
|||||
Equity and liabilities |
||||||||
Capital and reserves |
||||||||
Share capital and share premium |
80,508 | 80,508 | ||||||
Other reserves |
59,072 | 58,071 | ||||||
Accumulated deficit |
(52,871 | ) | (45,159 | ) | ||||
|
|
|
|
|||||
Total equity attributable to equity holders of the Company |
86,709 | 93,420 | ||||||
|
|
|
|
|||||
Non-current liabilities |
||||||||
Provisions |
26 | 18 | ||||||
Current liabilities |
||||||||
Trade payables |
2,123 | 1,120 | ||||||
Payroll taxes and social security |
103 | 157 | ||||||
Accrued expenditure |
1,917 | 1,640 | ||||||
|
|
|
|
|||||
4,143 | 2,917 | |||||||
|
|
|
|
|||||
Total liabilities | 4,169 | 2,935 | ||||||
|
|
|
|
|||||
Total equity and liabilities |
90,878 | 96,355 | ||||||
|
|
|
|
Unaudited Condensed Consolidated Statements of Cash Flows
For the six months ended June 30, | ||||||||
2018 | 2017 | |||||||
(in thousands) | ||||||||
£ | £ | |||||||
Cash flows from operating activities |
||||||||
Loss for the period |
(7,712 | ) | (4,385 | ) | ||||
Adjustments for: |
||||||||
Income tax credit |
(2,292 | ) | (1,077 | ) | ||||
Amortization and depreciation |
164 | 84 | ||||||
Finance income |
(442 | ) | (91 | ) | ||||
Share-based payments |
997 | 532 | ||||||
Initial public offering (IPO) related expenses |
| 1,066 | ||||||
Net foreign exchange (gains) losses |
(1,112 | ) | 142 | |||||
|
|
|
|
|||||
(10,397 | ) | (3,729 | ) | |||||
Movements in working capital: |
||||||||
Decrease in prepayments, accrued income and other receivables |
1,358 | 609 | ||||||
Increase (decrease) in trade payables |
1,003 | (477 | ) | |||||
Increase (decrease) in payroll taxes, social security and accrued expenditure |
231 | (230 | ) | |||||
|
|
|
|
|||||
Movements in working capital |
2,592 | (98 | ) | |||||
|
|
|
|
|||||
Cash used in operations |
(7,805 | ) | (3,827 | ) | ||||
|
|
|
|
|||||
Net income tax credit received |
1,906 | 235 | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
(5,899 | ) | (3,592 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Interest received |
429 | 98 | ||||||
Payments for property, plant and equipment |
(200 | ) | (5 | ) | ||||
Payments for intangible assets |
(648 | ) | (492 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(419 | ) | (399 | ) | ||||
|
|
|
|
|||||
Cash flows from financing activities |
||||||||
IPO related expenses included in statement of operations |
| (73 | ) | |||||
|
|
|
|
|||||
Net cash used in financing activities |
| (73 | ) | |||||
|
|
|
|
|||||
Net decrease in cash and cash equivalents |
(6,318 | ) | (4,064 | ) | ||||
|
|
|
|
|||||
Cash and cash equivalents at beginning of period |
86,703 | 19,990 | ||||||
|
|
|
|
|||||
Foreign currency translation differences |
1,084 | (8 | ) | |||||
|
|
|
|
|||||
Cash and cash equivalents at end of period |
81,469 | 15,918 | ||||||
|
|
|
|
For more information, please contact:
NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131 357 1111
info@nucana.com
Westwicke Partners
Chris Brinzey
+1 339-970-2843
Chris.brinzey@westwicke.com
RooneyPartners
Marion Janic
+1 212-223-4017
mjanic@rooneyco.com
Exhibit 99.2
NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||||||
Notes | 2018 | 2017 | 2018 | 2017 | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
£ | £ | £ | £ | |||||||||||||||||
Research and development expenses |
(5,158 | ) | (2,077 | ) | (8,863 | ) | (3,689 | ) | ||||||||||||
Administrative expenses |
(1,402 | ) | (313 | ) | (2,642 | ) | (637 | ) | ||||||||||||
Initial public offering related expenses |
3 | | (1,034 | ) | | (1,066 | ) | |||||||||||||
Net foreign exchange gains (losses) |
3,607 | (113 | ) | 1,059 | (161 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Operating loss |
(2,953 | ) | (3,537 | ) | (10,446 | ) | (5,553 | ) | ||||||||||||
Finance income |
252 | 44 | 442 | 91 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss before tax |
(2,701 | ) | (3,493 | ) | (10,004 | ) | (5,462 | ) | ||||||||||||
Income tax credit |
4 | 1,383 | 745 | 2,292 | 1,077 | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss for the period |
(1,318 | ) | (2,748 | ) | (7,712 | ) | (4,385 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Basic and diluted loss per share |
5 | (0.04 | ) | (0.11 | ) | (0.24 | ) | (0.18 | ) |
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
1
NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
(in thousands) | ||||||||||||||||
£ | £ | £ | £ | |||||||||||||
Loss for the period |
(1,318 | ) | (2,748 | ) | (7,712 | ) | (4,385 | ) | ||||||||
Other comprehensive expense: |
||||||||||||||||
Items that may be reclassified subsequently to profit or loss: |
||||||||||||||||
Exchange differences on translation of foreign operations |
9 | | 4 | (1 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Other comprehensive income (expense) for the period |
9 | | 4 | (1 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total comprehensive loss for the period |
(1,309 | ) | (2,748 | ) | (7,708 | ) | (4,386 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Attributable to: |
||||||||||||||||
Equity holders of the Company |
(1,309 | ) | (2,748 | ) | (7,708 | ) | (4,386 | ) | ||||||||
|
|
|
|
|
|
|
|
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
2
NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
AS AT
June 30, 2018 |
December 31, 2017 |
|||||||||||
(in thousands) | ||||||||||||
Notes | £ | £ | ||||||||||
Assets |
||||||||||||
Non-current assets |
||||||||||||
Intangible assets |
6 | 2,485 | 1,938 | |||||||||
Property, plant and equipment |
495 | 358 | ||||||||||
Deferred tax asset |
4 | 32 | 81 | |||||||||
|
|
|
|
|||||||||
3,012 | 2,377 | |||||||||||
|
|
|
|
|||||||||
Current assets |
||||||||||||
Prepayments, accrued income and other receivables |
1,737 | 3,050 | ||||||||||
Current income tax receivable |
4 | 4,660 | 4,225 | |||||||||
Cash and cash equivalents |
7 | 81,469 | 86,703 | |||||||||
|
|
|
|
|||||||||
87,866 | 93,978 | |||||||||||
|
|
|
|
|||||||||
Total assets |
90,878 | 96,355 | ||||||||||
|
|
|
|
|||||||||
Equity and liabilities |
||||||||||||
Capital and reserves |
||||||||||||
Share capital and share premium |
9 | 80,508 | 80,508 | |||||||||
Other reserves |
59,072 | 58,071 | ||||||||||
Accumulated deficit |
(52,871 | ) | (45,159 | ) | ||||||||
|
|
|
|
|||||||||
Total equity attributable to equity holders of the Company |
86,709 | 93,420 | ||||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Provisions |
26 | 18 | ||||||||||
Current liabilities |
||||||||||||
Trade payables |
2,123 | 1,120 | ||||||||||
Payroll taxes and social security |
103 | 157 | ||||||||||
Accrued expenditure |
1,917 | 1,640 | ||||||||||
|
|
|
|
|||||||||
4,143 | 2,917 | |||||||||||
Total liabilities |
4,169 | 2,935 | ||||||||||
|
|
|
|
|||||||||
Total equity and liabilities |
90,878 | 96,355 | ||||||||||
|
|
|
|
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
3
NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
For the Six Months Ended June 30, | ||||||||||||||||||||||||||||||||
Share capital |
Share premium |
Own share reserve |
Share option reserve |
Foreign currency translation reserve |
Capital reserve |
Accumulated deficit |
Total equity attributable to equity holders |
|||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||
£ | £ | £ | £ | £ | £ | £ | £ | |||||||||||||||||||||||||
Balance at December 31, 2016 |
663 | 42,770 | (339 | ) | 4,406 | (3 | ) | | (22,256 | ) | 25,241 | |||||||||||||||||||||
Loss for the period |
| | | | | | (4,385 | ) | (4,385 | ) | ||||||||||||||||||||||
Other comprehensive expense for the period |
| | | | (1 | ) | | | (1 | ) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive loss for the period |
| | | | (1 | ) | | (4,385 | ) | (4,386 | ) | |||||||||||||||||||||
Share-based payments |
| | | 532 | | | | 532 | ||||||||||||||||||||||||
Reduction in share premium |
| (42,466 | ) | | | | 42,466 | | | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2017 |
663 | 304 | (339 | ) | 4,938 | (4 | ) | 42,466 | (26,641 | ) | 21,387 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2017 |
1,272 | 79,236 | (339 | ) | 15,955 | (11 | ) | 42,466 | (45,159 | ) | 93,420 | |||||||||||||||||||||
Loss for the period |
| | | | | | (7,712 | ) | (7,712 | ) | ||||||||||||||||||||||
Other comprehensive income for the period |
| | | | 4 | | | 4 | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive loss for the period |
| | | | 4 | | (7,712 | ) | (7,708 | ) | ||||||||||||||||||||||
Share-based payments |
| | | 997 | | | | 997 | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2018 |
1,272 | 79,236 | (339 | ) | 16,952 | (7 | ) | 42,466 | (52,871 | ) | 86,709 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
4
NUCANA PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six months ended June 30, |
||||||||
2018 | 2017 | |||||||
(in thousands) | ||||||||
£ | £ | |||||||
Cash flows from operating activities |
||||||||
Loss for the period |
(7,712 | ) | (4,385 | ) | ||||
Adjustments for: |
||||||||
Income tax credit |
(2,292 | ) | (1,077 | ) | ||||
Amortization and depreciation |
164 | 84 | ||||||
Finance income |
(442 | ) | (91 | ) | ||||
Share-based payments |
997 | 532 | ||||||
Initial public offering (IPO) related expenses |
| 1,066 | ||||||
Net foreign exchange (gains) losses |
(1,112 | ) | 142 | |||||
|
|
|
|
|||||
(10,397 | ) | (3,729 | ) | |||||
Movements in working capital: |
||||||||
Decrease in prepayments, accrued income and other receivables |
1,358 | 609 | ||||||
Increase (decrease) in trade payables |
1,003 | (477 | ) | |||||
Increase (decrease) in payroll taxes, social security and accrued expenditure |
231 | (230 | ) | |||||
|
|
|
|
|||||
Movements in working capital |
2,592 | (98 | ) | |||||
|
|
|
|
|||||
Cash used in operations |
(7,805 | ) | (3,827 | ) | ||||
|
|
|
|
|||||
Net income tax credit received |
1,906 | 235 | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
(5,899 | ) | (3,592 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Interest received |
429 | 98 | ||||||
Payments for property, plant and equipment |
(200 | ) | (5 | ) | ||||
Payments for intangible assets |
(648 | ) | (492 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(419 | ) | (399 | ) | ||||
|
|
|
|
|||||
Cash flows from financing activities |
||||||||
IPO related expenses included in statement of operations |
| (73 | ) | |||||
|
|
|
|
|||||
Net cash used in financing activities |
| (73 | ) | |||||
|
|
|
|
|||||
Net decrease in cash and cash equivalents |
(6,318 | ) | (4,064 | ) | ||||
Cash and cash equivalents at beginning of period |
86,703 | 19,990 | ||||||
|
|
|
|
|||||
Foreign currency translation differences |
1,084 | (8 | ) | |||||
|
|
|
|
|||||
Cash and cash equivalents at end of period |
81,469 | 15,918 | ||||||
|
|
|
|
The accompanying notes form an integral part of these unaudited condensed consolidated financial statements.
5
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. General information
NuCana plc (NuCana or the Company) is a clinical-stage biopharmaceutical company developing a portfolio of new medicines to treat cancer. We are harnessing the power of phosphoramidate chemistry to generate new medicines called ProTides. These compounds have the potential to improve cancer treatment by enhancing the efficacy and safety of several current standards of care.
On August 29, 2017 the Company re-registered as a public limited company and changed its name from NuCana BioMed Limited to NuCana plc.
The Company has had American Depository Receipts (ADRs) registered with the US Securities and Exchange Commission (SEC) and is listed on Nasdaq since October 2, 2017. The Company is incorporated in England and Wales and domiciled in the United Kingdom.
The Company has two wholly owned subsidiaries, NuCana, Inc. and NuCana BioMed Trustee Company Limited (together referred to as the Group).
The comparative figures for the year ended December 31, 2017 are not the Groups statutory accounts for that financial year within the meaning of section 434 of the Companies Act 2006. Those accounts have been reported on by the Companys auditor and delivered to the Registrar of Companies. The report of the auditor was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.
2. Significant accounting policies
Basis of preparation
The unaudited condensed consolidated financial statements (the financial statements) for the three and six months ended June 30, 2018 have been prepared in accordance with International Accounting Standard 34 Interim Financial Reporting (IAS 34). The significant accounting policies and methods of computation applied in the preparation of the financial statements are consistent with those applied in the Companys annual financial statements for the year ended December 31, 2017. No new standards, amendments or interpretations have had an impact on the financial statements for the six months ended June 30, 2018.
The financial statements comprise the financial statements of the Company and its subsidiaries at June 30, 2018. The financial statements are presented in pounds sterling, which is also the Companys functional currency. All values are rounded to the nearest thousand, except where otherwise indicated.
The financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Companys annual financial statements as at December 31, 2017.
The unaudited condensed consolidated statement of cash flows for the six months ended June 30, 2017 has been restated to be consistent with the presentation of foreign exchange differences and IPO related expenses in the annual financial statements for the year ended December 31, 2017.
Going concern
In common with many companies in the biopharmaceutical sector, the Company incurs significant expenditure in its early years as it researches and develops its potential products for market.
The board of directors, having reviewed the operating budgets and development plans, considers that the Company has adequate resources to continue in operation for the foreseeable future. The board of directors is therefore satisfied that it is appropriate to adopt the going concern basis of accounting in preparing the financial statements. The Company believes that its cash and cash equivalents of £81.5 million at June 30, 2018, will be sufficient to fund its current operating plan for at least the next 12 months. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. The Company may never achieve profitability, and unless and until it does, it will continue to need to raise additional capital. There can be no assurances, however, that additional funding will be available on acceptable terms.
Judgements and estimates
The accounting estimates and judgements made by management in applying the Groups accounting policies that have the most significant effect on the amounts included within these financial statements, were the same as those that applied to the annual financial statements for the year ended December 31, 2017.
6
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
3. IPO related expenses
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
(in thousands) | (in thousands) | |||||||||||||||
£ | £ | £ | £ | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
IPO related expenses |
| 1,034 | | 1,066 | ||||||||||||
|
|
|
|
|
|
|
|
IPO related expenses primarily relate to legal, accounting and other advisors fees in relation to the Companys listing on Nasdaq which completed on October 2, 2017.
4. Income tax
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
(in thousands) | (in thousands) | |||||||||||||||
£ | £ | £ | £ | |||||||||||||
Current tax |
1,393 | 745 | 2,341 | 1,077 | ||||||||||||
Deferred tax |
(10 | ) | | (49 | ) | | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax credit |
1,383 | 745 | 2,292 | 1,077 | ||||||||||||
|
|
|
|
|
|
|
|
The income tax credit recognized primarily represents the U.K. research and development tax credit. In the U.K. the Company is able to surrender some of its losses for a cash rebate of up to 33.35% of expenditure related to eligible research and development projects.
June 30, 2018 |
December 31, 2017 |
|||||||
(in thousands) | ||||||||
£ | £ | |||||||
Current income tax receivable |
||||||||
U.K. tax |
4,641 | 4,207 | ||||||
U.S. tax |
19 | 18 | ||||||
|
|
|
|
|||||
4,660 | 4,225 | |||||||
|
|
|
|
|||||
Deferred tax asset |
||||||||
U.S. deferred tax asset |
32 | 81 | ||||||
|
|
|
|
7
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
5. Basic and diluted loss per share
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
£ | £ | £ | £ | |||||||||||||
Loss for the period |
(1,318 | ) | (2,748 | ) | (7,712 | ) | (4,385 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted weighted average number of shares |
31,811 | 24,185 | 31,811 | 24,185 | ||||||||||||
£ | £ | £ | £ | |||||||||||||
Basic and diluted loss per share |
(0.04 | ) | (0.11 | ) | (0.24 | ) | (0.18 | ) | ||||||||
|
|
|
|
|
|
|
|
Basic loss per share is calculated by dividing the loss for the period attributable to the equity holders of the Company by the weighted average number of shares outstanding during the period.
The potential shares issued through equity settled transactions were considered to be anti-dilutive as they would have decreased the loss per share and were therefore excluded from the calculation of diluted loss per share.
8
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
6. Intangible assets
Intangible assets comprise patents with a carrying value of £2.4 million as of June 30, 2018 (as of December 31, 2017: £1.8 million) and computer software with a carrying value of £0.1 million as of June 30, 2018 (as of December 31, 2017: £0.1 million).
During the six months ended June 30, 2018, the Company acquired intangible assets with a cost of £0.6 million in relation to patents (six months ended June 30, 2017: £0.4 million in relation to patents and £0.1 million in relation to computer software).
There were no disposals of intangible assets in the six months ended June 30, 2018 (six months ended June 30, 2017: £nil).
7. Cash and cash equivalents
June 30, 2018 |
December 31, 2017 |
|||||||
(in thousands) | ||||||||
£ | £ | |||||||
Cash and cash equivalents |
81,469 | 86,703 | ||||||
|
|
|
|
Cash and cash equivalents comprise cash at bank with maturities of three months or less and earn interest at fixed or variable rates based on the terms agreed for each account.
9
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
8. Share-based payments
The Company has three share-based payment plans for employees, directors and consultants. The share options granted will be settled in equity.
On April 11, 2018 and May 8, 2018, 79,000 and 62,000 share options respectively were granted under the U.K. share-based payment plans. Options granted under these plans will vest if the option holder remains under respective contract of employment or contract of service for the agreed vesting period. The share options granted under these plans will vest equally over a period of four years, with the exception of options granted to a consultant, which vested immediately.
The fair values of options granted were determined using the Black-Scholes model that takes into account factors specific to the share incentive plan. As NuCana plc listed on October 2, 2017, it is not possible to derive historical volatility from the Companys own share price. The underlying expected volatility was therefore determined by using the historical volatility of similar listed entities as a proxy. The volatility percentage applied to each tranche is the average of the historical volatility of comparable companies to NuCana plc.
The following weighted average principal assumptions were used in calculating the fair values of options granted:
Options granted on | ||||||||||||
Apr 11, 2018 | Apr 11, 2018 | May 8, 2018 | ||||||||||
Vesting dates |
Apr 11, 2019 | Apr 11, 2018 | May 8, 2019 | |||||||||
Apr 11, 2020 | May 8, 2020 | |||||||||||
Apr 11, 2021 | May 8, 2021 | |||||||||||
Apr 11, 2022 | May 8, 2022 | |||||||||||
Volatility |
64.48 | % | 60.06 | % | 65.80 | % | ||||||
Dividend yield |
0 | % | 0 | % | 0 | % | ||||||
Risk-free investment rate |
1.04 | % | 0.83 | % | 1.02 | % | ||||||
Fair value of option at grant date |
£ | 8.97 | £ | 17.35 | £ | 8.63 | ||||||
Fair value of share at grant date |
£ | 17.51 | £ | 17.51 | £ | 16.57 | ||||||
Exercise price at date of grant |
£ | 17.51 | £ | 0.16 | £ | 16.57 | ||||||
Lapse date |
Apr 11, 2028 | Apr 11, 2028 | May 8, 2028 | |||||||||
Expected option life (years) |
4.50 | 2.00 | 4.50 | |||||||||
Number of options granted |
71,500 | 7,500 | 62,000 |
For the six months ended June 30, 2018, the Company has recognized £1.0 million of share-based payment expense in the statement of operations (six months ended June 30, 2017: £0.5 million). For the three months ended June 30, 2018, the Company has recognized £0.6 million of share-based payment expense in the statement of operations (three months ended June 30, 2017: £0.3 million).
10
NUCANA PLC
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
9. Share capital and share premium
June 30, 2018 |
December 31, 2017 |
|||||||
(in thousands) | ||||||||
£ | £ | |||||||
Share capital |
1,272 | 1,272 | ||||||
Share premium |
79,236 | 79,236 | ||||||
|
|
|
|
|||||
80,508 | 80,508 | |||||||
|
|
|
|
|||||
June 30, 2018 |
December 31, 2017 |
|||||||
Number (in thousands) |
||||||||
Issued share capital comprises: |
||||||||
Ordinary shares of £0.04 each |
31,811 | 31,811 | ||||||
|
|
|
|
Number of shares |
Share capital |
Share premium |
||||||||||
(in thousands) | ||||||||||||
Fully paid shares: | £ | £ | ||||||||||
Balance at December 31, 2017 |
31,811 | 1,272 | 79,236 | |||||||||
Balance at June 30, 2018 |
31,811 | 1,272 | 79,236 | |||||||||
|
|
|
|
|
|
10. Contingent liabilities
Under the U.K. share-based payment plan, the Company granted unapproved share options that have fully vested. If and when these share options are exercised, the Company will be liable for the Employer Class 1 National Insurance payable to HMRC in the U.K. This contingent liability will be determined based on the market value of the shares on exercise less the exercise price paid by the option holders, at the prevailing rate of Employer National Insurance (currently 13.8%). Based on the closing share price of ADSs on the Nasdaq Global Select Market on June 29, 2018, the last trading day of the period to which these financial statements relate, and assuming full exercise of all outstanding and vested unapproved share options on that date, the Employer National Insurance contingent liability would have been £4.1 million (December 31, 2017: £2.1 million).
11