On August 8, 2016 FibroGen, Inc. (NASDAQ: FGEN) ("FibroGen"), a research-based biopharmaceutical company, reported financial results for the quarter ended June 30, 2016 (Filing, Q2, FibroGen, 2016, AUG 8, 2016, View Source [SID:1234514414]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We continue to develop our multiple key programs across focused therapeutic areas," said Thomas B. Neff, chief executive officer of FibroGen. "Working jointly with our partners, Astellas and AstraZeneca, we have advanced global clinical development for roxadustat for treatment of anemia in chronic kidney disease patients to Phase 3 in four independent regulatory pathways − the U.S., Europe, China, and Japan − and remain on track to initiate new drug application submissions in 2016 in China, and in 2018 in the U.S. We have completed enrollment in the placebo-controlled portion of our Phase 2 study of FG-3019 (now known as pamrevlumab) for treatment of idiopathic pulmonary fibrosis, and expect to report data from this study in the middle of next year, and our Phase 2 studies in pancreatic cancer and Duchenne muscular dystrophy continue to progress."
Program Updates
Anemia of Chronic Kidney Disease (CKD): roxadustat (FG-4592)
·
China Phase 3 enrollment on track: Completed enrollment in a 300-patient dialysis study, one of two Phase 3 pivotal trials in China; expect to complete enrollment in the second study, a 150-patient non-dialysis study now over 70% enrolled, in Q3 of this year. We expect first reportable data in each of the Phase 3 studies by the end of the year.
·
The independent data safety monitoring board overseeing roxadustat U.S and Europe Phase 3 studies met in July 2016 to review the roxadustat safety data, and confirmed that the trials should proceed with current Phase 3 protocols without modification.
·
Continue to expect to initiate new drug application submissions for roxadustat in 2016 for China and in 2018 for the U.S.
Fibrosis and Other Fibroproliferative Diseases: pamrevlumab (FG-3019)
·
Completed enrollment in the 48-week main study portion of a placebo-controlled Phase 2 trial for treatment of IPF. We plan to report topline data for the entire study in mid-2017, including the six month combination therapy sub-study in which patients will receive pamrevlumab in combination with pirfenidone or nintedanib, which will continue to enroll until the end of the year.
·
Continue to advance our Phase 2 trial in patients with unresectable, locally advanced pancreatic cancer, and anticipate that we will present available findings early next year.
·
Enrollment continues in our open-label Phase 2 study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy (DMD) patients.
Financial Highlights
·
Net income per basic share for the quarter ended June 30, 2016, was $0.39, and $0.35 on a per diluted share basis.
·
At June 30, 2016, FibroGen had $368.6 million of cash, cash equivalents, investments, receivables, and restricted cash.
·
During the quarter ended June 30, 2016, we received a $62.0 million upfront payment under the AstraZeneca Agreement. We also recognized $10.0 million milestone revenue under the Astellas Agreement, which payment was received in early July 2016.