CO-1686 NDA submission expected by mid-2015
CO-1686 Breakthrough Therapy designation granted during Q2
Proposed INN rociletinib assigned to CO-1686
Rociletinib and rucaparib data updates to be presented at medical
conferences in Fall 2014
“This is a very busy and exciting time at our Company,” said Patrick J. Mahaffy, President and CEO of
Q2 2014 Financial Results and Financial Outlook
Clovis reported a net loss for the second quarter of 2014 of
Research and development expenses totaled
General and administrative expenses totaled
Operating expenses for the second quarter of 2014 totaled
Net cash burn for the second quarter of 2014 totaled
Progress Toward 2014 Key Milestones and Objectives
The Company has substantive clinical, regulatory and development objectives for 2014 for each of its products; highlights of recent progress and planned objectives follow.
An update of clinical data from the rociletinib Phase 1/2 study were presented in early June in an oral session at the
Rociletinib is the only EGFR-directed therapy to spare wild-type EGFR in clinical studies, which the Company believes represents a significant point of differentiation from approved EGFR inhibitors and those currently in clinical development.
The next update of CO-1686 clinical data is expected to take place at the 26th EORTC-AACR-NCI Symposium on Molecular Targets and Cancer Therapeutics in
The Company is currently enrolling two Phase 2 expansion cohorts of its Phase 1/2 study in EGFR mutant patients with the T790M mutation; the first includes approximately 150 to 200 T790M positive patients directly after progression on their first and only TKI therapy, comparable to the TIGER2 registration study patient population. The second cohort includes approximately 150 to 200 later-line T790M positive patients after progression on their second or later TKI therapy or subsequent chemotherapy. Both cohorts are exploring doses of 500mg, 625mg and 750mg BID. The TIGER2 study, in T790M positive patients directly after progression on their first and only TKI therapy, began enrolling patients earlier in the second quarter at a dose of 625mg BID.
Data from the expansion cohorts, combined with data from TIGER2, are expected to serve as the basis of an NDA submission for rociletinib by mid-2015.
In May, the U.S.
Clovis expects to initiate two more studies in the TIGER program during 2014. The TIGER1 study, a randomized Phase 2/3 registration study of rociletinib versus erlotinib in newly-diagnosed EGFR mutant patients is expected to begin shortly. The TIGER3 study, a randomized, comparative study of rociletinib versus chemotherapy in patients with EGFR-mutant NSCLC and acquired TKI resistance, is expected to begin during the second half of 2014. In addition, the Company initiated its Phase 1 study of rociletinib in
Rucaparib is an oral, potent small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of ovarian cancer in patients with BRCA mutations (genes that are linked to hereditary breast and ovarian cancers) and other DNA repair deficiencies. Rucaparib is also being explored in patients with BRCA-mutant pancreatic cancer.
Data from the Phase 1/2 monotherapy study in ovarian cancer and other currently enrolling rucaparib trials were presented at the 2014 ASCO Annual Meeting in early June. Durable responses were observed in ovarian cancer patients, and rucaparib was shown to be well-tolerated with a manageable side effect profile. In addition, a durable response was observed in a pancreatic cancer patient with a BRCA2 mutation following failed first-line therapy, with treatment well-tolerated and no significant toxicity.
The next update of rucaparib clinical data is expected to take place at the ESMO 2014
Enrollment is underway for both studies in the ARIEL program. The global ARIEL2 study, a single-arm, open-label, Phase 2 study designed to identify molecular features that predict sensitivity to rucaparib, using DNA sequencing to evaluate each patient’s tumor, initiated in Q4 2013 and has enrolled quickly, with enrollment expected to complete early next year. In this study, rucaparib efficacy is assessed and correlated with the genotype and phenotype of each patient’s tumor, and these data will inform the final definition of homologous recombination deficiency (HRD) for the ARIEL3 registration study efficacy analysis.
The Company has initiated its pivotal study, ARIEL3, a randomized, double-blind, Phase 3 study that compares the effects of rucaparib versus placebo. The study will evaluate whether maintenance rucaparib in platinum-sensitive, high-grade ovarian cancer patients can extend the period of time for which the disease is controlled after successful chemotherapy. The study will utilize pre-specified step-down efficacy analyses: first in tissue BRCA-mutant patients; then in patients with DNA repair deficiencies, defined using data from the ARIEL2 study; and lastly, in all-comers.
During the second quarter, the first patient was enrolled in the RUCAPANC study, a Phase 2, open-label study exploring rucaparib monotherapy in patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation (germline or somatic) who have progressed on one to two prior therapies.
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR1-2), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFRa-ß). Clovis, which holds exclusive U.S. and Japanese rights, is collaborating with its development partner
A broad Phase 2 program is underway to explore lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced squamous NSCLC with FGFR1 amplification. In parallel with these Clovis-sponsored studies initiating shortly, a
Conference Call Details
Clovis will hold a conference call to discuss second quarter 2014 results this afternoon,
To the extent that statements contained in this press release are not descriptions of historical facts regarding
CONSOLIDATED FINANCIAL RESULTS
(in thousands, except per share amounts)
|Three Months Ended ||Six Months Ended |
|License and milestone revenue||$||-||$||-||$||13,625||$||-|
|Research and development||28,440||15,816||52,591||27,938|
|General and administrative||5,265||3,492||10,585||6,710|
|Acquired in-process research and development||400||-||8,806||250|
|Amortization of intangible asset||-||-||3,409||-|
|Accretion of contingent purchase consideration||861||-||1,683||-|
|Other income (expense), net||270||(33||)||164||(111||)|
|Loss before income taxes||(34,696||)||(19,341||)||(63,285||)||(35,009||)|
|Basic and diluted net loss per common share||$||(1.03||)||$||(0.72||)||$||(1.93||)||$||(1.33||)|
|Basic and diluted weighted average common shares outstanding||33,872||26,717||33,846||26,377|
|CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||273,232||$||323,228|
|Common stock and additional paid-in capital||773,240||762,204|
|Total stockholders' equity||441,606||497,886|