On August 28, 2018 NuCana plc (NASDAQ: NCNA) reported that its financial results for the second quarter ended June 30, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 28, 2018, View Source [SID1234529093]).
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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, NuCana’s 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 (Free ASCO Whitepaper) 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) (Free ESMO Whitepaper) 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 NuCana’s 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 (Free ESMO Whitepaper) on October 21, 2018 (the ABC-08 study). This will include additional data on the eight patients reported at ASCO (Free ASCO Whitepaper)-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 (Free ESMO Whitepaper) on October 21, 2018 (the Acelarate study).
NUC-3373 is NuCana’s 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 (Free ESMO Whitepaper) 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 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. 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).