NuCana Reports Third Quarter 2018 Financial Results and Provides Business Update
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
“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.”
- Acelarin® is NuCana’s ProTide transformation of gemcitabine. Over the remainder of 2018 and in 2019,
NuCanaanticipates a number of data read-outs and milestones including:
° Contingent on regulatory guidance and other factors, initiate a Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer by the end of 2018.
° Report interim data in 2019 from our ongoing Phase II study (PRO-105) of Acelarin for patients with platinum-resistant ovarian cancer.
° Contingent on regulatory guidance and other factors, evaluate the initiation in 2019 of a Phase II/III study of Acelarin in combination with a platinum agent for patients with ovarian cancer.
° Continue enrollment in the Phase III study (Acelarate) of Acelarin as a first-line treatment compared to gemcitabine for patients with metastatic pancreatic cancer. In
October 2018, we reported that 152 patients had been enrolled in this study.
- NUC-3373 is NuCana’s second ProTide in clinical development, a transformation of 5-fluorouracil (5-FU). In 2019,
° Report initial data from the ongoing Phase Ib study (NuTide:302) of NUC-3373 in patients with advanced colorectal cancer in combination with other approved agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan.
° Report additional data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
° Contingent on regulatory guidance and other factors, initiate a Phase II/III study of NUC-3373 in combination with other agents for patients with advanced colorectal cancer.
- NUC-7738 is NuCana’s 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. Over the remainder of 2018 and in 2019,
° Contingent on regulatory guidance and other factors, initiate a first-in-human Phase I clinical study (NuTide:701) of NUC-7738 for patients with solid tumors or lymphoma in 2018.
° Report initial data from the NuTide:701 study in 2019.
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.
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
|For the nine months ended
|(in thousands, except per share data)|
|Research and development expenses||(3,333||)||(10,432||)||(12,196||)||(14,121||)|
|Initial public offering related expenses||-||(728||)||-||(1,794||)|
|Net foreign exchange gains (losses)||706||(74||)||1,765||(235||)|
|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|
|Property, plant and equipment||462||358|
|Deferred tax asset||26||81|
|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|
Equity and liabilities
|Capital and reserves|
|Share capital and share premium||80,690||80,508|
|Total equity attributable to equity holders of the Company||84,874||93,420|
|Payroll taxes and social security||121||157|
|Total equity and liabilities||90,104||96,355|
|Unaudited Condensed Consolidated Statements of Cash Flows|
|For the nine months ended
|Cash flows from operating activities|
|Loss for the period||(10,228||)||(18,397||)|
|Income tax credit||(3,063||)||(1,655||)|
|Amortization and depreciation||261||121|
|Initial public offering (IPO) related expenses||-||1,794|
|Net foreign exchange (gains) losses||(1,808||)||190|
|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|
|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
Source: NuCana plc