On February 27, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the fourth quarter and full year 2017 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2335086 [SID1234524229]).
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"In 2017, we continued to make significant progress on key clinical and regulatory milestones. Our first NDA submission for roxadustat was accepted for review by the China Food and Drug Administration. With our partners, we are advancing the roxadustat Phase 3 CKD anemia programs to completion with plans to file for market approvals in the U.S., Europe, and Japan. In our fibrosis program, pamrevlumab has demonstrated tremendous potential in multiple indications. In a randomized double-blind, placebo-controlled Phase 2b study in IPF, pamrevlumab was well-tolerated and achieved statistical significance in the primary endpoint of FVC % predicted, in FVC, and in the secondary endpoints of quantitative changes of lung fibrosis, disease progression, and patient-reported outcomes," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are intensely focused on the execution of critical activities for our CKD anemia, idiopathic pulmonary fibrosis, and pancreatic cancer programs as these approach important new milestones in 2018."
Recent Developments and Highlights
Roxadustat for CKD Anemia in U.S./ROW
With our partner AstraZeneca, we have agreed to a timeline for Phase 3 enrollment completion in the second quarter of 2018 and data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
DSMB recommended Phase 3 clinical studies to continue under current protocols with no changes
Roxadustat for CKD Anemia in China
Positive efficacy and safety results reported from two Phase 3 trials
New Drug Application accepted for filing by the CFDA
Roxadustat for CKD Anemia in Japan
Our partner Astellas has completed three of six Phase 3 trials
Topline positive Phase 3 results reported in peritoneal dialysis study
Roxadustat for MDS Anemia
Enrollment commenced in our first U.S./Europe Phase 3 study for the treatment of anemia in myelodysplastic syndromes (MDS)
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Statistically significant high-resolution computed tomography (HRCT) results achieved in our randomized double-blind, placebo-controlled Phase 2b study
Positive Phase 2b study results presented at European Respiratory Society (ERS) International Congress 2017
Pamrevlumab for Pancreatic Cancer
Reported positive interim Phase 2 open-label results at 2017 ASCO (Free ASCO Whitepaper)-GI conference showing a majority of pamrevlumab-treated patients converted from unresectable to resectable cancer; all resection evaluations complete and results continue to be favorable for pamrevlumab
Corporate and Financial
Net loss for the fourth quarter of 2017 was $22.1 million, or $0.27 per share, compared to $34.0 million, or $0.54 per share one year ago
Net loss for the year ended December 31, 2017, was $126.2 million, or $1.73 per share, compared to $61.7 million, or $0.98 per share one year ago
At December 31, 2017, FibroGen had $762.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables
Received a $15.0 million milestone payment from AstraZeneca in the fourth quarter of 2017 upon roxadustat NDA submission to CFDA
Completed financings in April 2017 and in August 2017 with net proceeds of $115.1 million and $356.2 million, respectively
2018 Outlook
U.S. Phase 3 CKD anemia enrollment completion in the second quarter of 2018
U.S. Phase 3 CKD anemia data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
NDA approval decision expected in China for CKD anemia by the end of 2018
Expect to confirm plans with our partner Astellas for regulatory submissions in Europe and Japan
Anticipate data readout from two Japan Phase 3 hemodialysis studies, a long-term conversion study and a correction (ESA-naïve) study, in the first quarter of 2018
Anticipate initiation of roxadustat Phase 2/3 clinical study in China for anemia associated with MDS in first half of 2018
Expect to present HRCT and health-related quality-of-life results from the IPF Phase 2b trial at an upcoming scientific conference
Design pivotal trials for IPF and locally advanced pancreatic cancer
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, February 27, 2018, at 5:00 p.m. Eastern (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen fourth quarter and full year 2017 financial results conference call, and use passcode 46307822#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46307822#.