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 March 2020
(Commission File No. 001-38215)
NUCANA PLC
(Translation of registrant’s name into English)
3 Lochside Way
Edinburgh EH12 9DT
United Kingdom
(Address of registrant’s 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 March 10, 2020, NuCana plc (the “Company”) issued two press releases (i) announcing its financial results for the year ended December 31, 2019 and providing an update on its clinical program and (ii) announcing preliminary results from part one of the Phase 2 study of single-agent Acelarin in patients with platinum-resistant ovarian cancer (PRO-105). The press releases are attached as Exhibits 99.1 and 99.2 and are incorporated by reference herein.
The press releases attached as Exhibits 99.1 and 99.2 and incorporated by reference herein are 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 they 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 shall be expressly set forth by specific reference in such a filing.
Exhibits
| Exhibit | Description | |
| 99.1 | Press Release dated March 10, 2020 | |
| 99.2 | Press Release dated March 10, 2020 | |
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: March 10, 2020
Exhibit 99.1
NuCana Reports Preliminary Data from Phase II Study of Single-Agent Acelarin (NUC-1031)
in Patients with Platinum-Resistant Ovarian Cancer
Confirmed Complete Response and Two Partial Responses Achieved
in Heavily Pre-treated Population
Patients had Median of Five Prior Lines of Therapy
Edinburgh, United Kingdom, March 10, 2020 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced preliminary results from part one of the Phase II study of single-agent Acelarin in patients with platinum-resistant ovarian cancer (PRO-105). This part of the study compared a 500mg/m2 dose of Acelarin versus a 750mg/m2 dose of Acelarin in patients who were heavily pre-treated (at least 3 prior lines of chemotherapy). This study is now closed to recruitment and data analysis from part one of the study is ongoing.
Forty-five patients with platinum-resistant ovarian cancer were evaluable for response and all responses had confirmatory scans. Based on an assessment by blinded independent central review, one patient achieved a complete response and two patients achieved partial responses. In addition, 16 patients achieved stable disease.
Patients who entered PRO-105 were heavily pre-treated, having received a median of five prior lines of treatment, and 72% had at least one comorbidity at study entry. Highlighting the fragility of this difficult-to-treat patient population, 45% of patients did not complete the first cycle of treatment with Acelarin despite not having any disease progression or any serious Grade 3 or 4 adverse events. However, for 23 patients in the study who received two or more cycles of Acelarin, the confirmed response rate was 13% and the disease control rate was 83%. These data are still being analyzed and the findings remain preliminary and subject to change.
NuCana’s CEO, Hugh S. Griffith, remarked: “We are pleased with this favorable disease control rate and Acelarin’s ability to achieve confirmed complete and partial responses in this very heavily pre-treated patient population. We are further encouraged by these results in light of the recent CLIO study in less heavily pre-treated patients with platinum-resistant ovarian cancer, where no patients in the chemotherapy group achieved a complete response and only one patient achieved a confirmed partial response which resulted in a confirmed overall response rate of 3%.”
The CLIO study reported on the efficacy of the current chemotherapy standards of care, namely paclitaxel, pegylated liposomal doxorubicin, topotecan and gemcitabine. Thirty-three patients received chemotherapy in the CLIO trial and were significantly less heavily pre-treated than those in the PRO-105 trial, with a median of 3 prior lines of treatment. However, given differences in trial design and statistical analyses, comparisons across studies should be interpreted with caution.
Part two of the PRO-105 study was designed to then investigate the optimal dose identified in part one in an expansion cohort. In December 2019, consistent with NuCana’s previous announcement that it is prioritizing resources on its key programs of Acelarin in biliary tract cancer and NUC-3373 in colorectal cancer, the company determined not to proceed with part two of the PRO-105 study.
Mr. Griffith concluded: “The advent of PARP inhibitors has changed the ovarian cancer treatment landscape markedly in recent years resulting in a more complex regulatory pathway for single-agent therapy. In addition, we have been very encouraged by the synergy we have observed with Acelarin in combination with platinum agents, both in patients with biliary tract cancer and ovarian cancer. As such, any further development of Acelarin in patients with ovarian cancer would likely involve combining it with a platinum agent.”
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 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 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 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 non-clinical 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, 2018 filed with the Securities and Exchange Commission (“SEC”) on March 7, 2019, 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.
For more information, please contact:
NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131 357 1111
info@nucana.com
Westwicke, an ICR Company
Chris Brinzey
+1 339-970-2843
chris.brinzey@westwicke.com
RooneyPartners
Marion Janic
+1 212-223-4017
mjanic@rooneyco.com
Exhibit 99.2
NuCana Reports Fourth Quarter and Year-End 2019 Financial Results
and Provides Business Update
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
Edinburgh, United Kingdom, March 10, 2020 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2019 and provided an update on its broad clinical program with its transformative ProTide therapeutics.
As of December 31, 2019, NuCana had cash and cash equivalents of £52.0 million compared to £58.1 million as of September 30, 2019 and £77.0 million as of December 31, 2018. NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2019, as compared to £3.6 million for the quarter ended December 31, 2018. Net loss for the year ended December 31, 2019 was £21.4 million, compared to a net loss of £13.8 million for the year ended December 31, 2018. Basic and diluted loss per share was £0.24 for the quarter and £0.66 for the year ended December 31, 2019, as compared to £0.11 per share for the comparable quarter and £0.43 for the year ended December 31, 2018.
“It has been a productive year for NuCana in 2019 and we are making excellent progress advancing our pipeline of novel ProTides,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “The year was highlighted by the initiation of our global Phase III NuTide:121 study comparing Acelarin plus cisplatin to gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer. NuTide:121 will enroll up to 828 patients and we have designed the study to potentially support both accelerated as well as full approval filings. We look forward to expediting the recruitment of patients to this study.”
Mr. Griffith added: “We also continue to advance rapidly our other two ProTides in the clinic. For NUC-3373, our ProTide transformation of 5-FU, we recently presented clinical data from part one of NuTide:302, the Phase Ib study of NUC-3373 in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer. We look forward to presenting additional data in 2020 from this study, as well as from the monotherapy Phase I dose-escalation study of NUC-3373 in patients with advanced solid tumors (NuTide:301). Once we have established a dose and schedule for NUC-3373 in combination with other agents, we expect to initiate a registrational program of NUC-3373 in patients with colorectal cancer in 2020. We believe NUC-3373 has significant commercial potential as approximately 500,000 patients in North America alone are estimated to receive 5-FU each year.”
“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:
| • | Continuing to run the Phase III study of Acelarin in combination with cisplatin in patients with biliary tract cancer; |
| • | Initiating a Phase II/III study of NUC-3373 in combination with other agents for patients with colorectal cancer. |
Mr. Griffith concluded: “Overall we are pleased with our progress these past twelve months and feel we are positioned well as we enter 2020. We have continued to validate our ProTide technology’s ability to transform some of the most widely prescribed chemotherapy agents into what we believe will be more efficacious and safer treatments. With multiple milestones expected across our pipeline, we anticipate a busy and productive 2020 for NuCana.”
Anticipated Milestones
| • | Acelarin is NuCana’s ProTide transformation of gemcitabine. In 2020, NuCana expects to: |
| • | Drive enrollment in the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer. |
| • | Report data from the Phase Ib study (ABC-08) of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer. |
| • | NUC-3373 is NuCana’s second ProTide in clinical development, a transformation of the active anti-cancer metabolite of 5-FU. In 2020, NuCana expects to: |
| • | Report data from the ongoing Phase Ib study (NuTide:302) of NUC-3373 in patients with advanced colorectal cancer and establish the recommended Phase II dose of NUC-3373 in combination with other agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan. |
| • | Contingent on regulatory guidance and other factors, initiate a Phase II/III study of NUC-3373 in combination with other agents for patients with colorectal cancer. |
| • | Report data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors. |
| • | NUC-7738 is NuCana’s ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine. In 2020, NuCana expects to: |
| • | Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors. |
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 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 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 amount and sufficiency of the Company’s current cash and cash equivalents to fund its planned operations into the second half of 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; the Company’s goals with respect to the development and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical 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 effects of the COVID-19 outbreak on our business operations and development timelines and 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, 2018 filed with the Securities and Exchange Commission (“SEC”) on March 7, 2019, 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, |
|||||||||||||||
| 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 December 31,
| 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 December 31,
| 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:
NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131 357 1111
info@nucana.com
Westwicke, an ICR Company
Chris Brinzey
+1 339-970-2843
chris.brinzey@westwicke.com
RooneyPartners
Marion Janic
+1 212-223-4017
mjanic@rooneyco.com