On May 9, 2018 FibroGen, Inc. (NASDAQ: FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2018, View Source [SID1234526368]).
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"FibroGen and AstraZeneca are preparing to complete patient enrollment in five Phase 3 roxadustat CKD anemia trials this quarter. We look forward to reporting topline data in the fourth quarter of this year. With our partners, we are continuing to see positive data from our global roxadustat Phase 3 programs, most recently in Japan from Astellas," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "Pamrevlumab continues to reveal its potential in the treatment of fibrotic and fibro-proliferative diseases. We are working towards achieving regulatory alignment with the FDA on pivotal study designs for both IPF and pancreatic cancer. We will be presenting data at the ATS conference in May from our placebo-controlled Phase 2 study in IPF representing the first known significant attenuation of fibrosis progression as measured by quantitative HRCT, and we will report Phase 2 data at ASCO (Free ASCO Whitepaper) in June showing that a majority of unresectable locally advanced pancreatic cancer patients treated with pamrevlumab and chemotherapy were assessed as resectable after six months of treatment. We will also report that there appears to be a survival benefit in this study for patients who have undergone tumor resection. Patients continue to be followed in this study for survival."
Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and ROW
Phase 3 trial enrollment to complete in the second quarter of 2018
Topline Phase 3 clinical studies data expected in the fourth quarter of 2018
In its most recent review in March, the DSMB recommended Phase 3 clinical studies continue under current protocols with no changes
Roxadustat for Anemia in CKD in China
NDA review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA) is ongoing; anticipate regulatory approval by year-end 2018
Roxadustat for Anemia in CKD in Japan
Positive topline data from two Phase 3 studies in dialysis-dependent CKD patients with anemia, a long-term ESA conversion study and an ESA-naïve correction study, were reported in April 2018 by our partner Astellas
Astellas expects to submit a NDA for anemia associated with dialysis-dependent-CKD in Japan in 2018
Astellas expects data readout in one of the Japan Phase 3 studies in non-dialysis-dependent CKD anemia patients in the fourth quarter of 2018
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Multiple abstracts accepted for presentation at the 2018 American Thoracic Society (ATS) Conference in May
Results from our Phase 2 IPF clinical trial
HRCT quantitative imaging of lung fibrosis;
Health-related quality of life assessments; and
PK/PD modeling
Preclinical results from a highly predictive animal model of lung fibrosis
Pamrevlumab for Pancreatic Cancer
Fast Track designation granted by the FDA for the treatment of patients with locally advanced unresectable pancreatic cancer in the first quarter of 2018
Phase 2 clinical trial results have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Pamrevlumab for Duchenne Muscular Dystrophy
Completed clinical trial enrollment in the first quarter of 2018
Corporate and Financial
Net loss for the first quarter was $41.4 million, or ($0.50) per share, compared to $30.6 million, or ($0.48) per share, for the first quarter of 2017, primarily due to ongoing investments in our research and development and general and administrative initiatives
We recast our condensed consolidated statement of operations and condensed balance sheet from the amounts previously reported upon the adoption of the new revenue guidance under Accounting Standards Codification 606 as of January 1, 2018. The impact for the first quarter 2017 was a $2.6 million increase in revenue. The cumulative reduction in revenue of $34.7 million through 2017 for all years impacted on a fully retrospective basis, will be recognized over the future remaining development periods.
At March 31, 2018, FibroGen had $730.4 million of cash, restricted time deposits, cash equivalents, investments, and receivables
The weighted average number of common shares used to calculate net loss per share was 82.9 million shares and 64.0 million shares for the first quarters of 2018 and 2017, respectively, reflecting equity offerings completed in 2017. Total shares outstanding as of March 31, 2018 were 83.4 million shares.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Wednesday, May 9, 2018, at 5:00 p.m. Eastern Time (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 first quarter 2018 financial results conference call, and use passcode 46778299#. 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 46778299#.
About Roxadustat
Roxadustat is a first-in-class oral therapeutic in global Phase 3 clinical development as a treatment for anemia associated with chronic kidney disease (CKD) with the potential to offer a safer and more effective, convenient, and accessible treatment than current therapies. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis, or the production of red blood cells, by increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin, including in the presence of inflammation and without need for supplemental intravenous iron.
The roxadustat Phase 3 program is the largest Phase 3 clinical program in anemia to date, and is supported by extensive Phase 2 results demonstrating correction and maintenance of hemoglobin levels in anemia in multiple subpopulations of CKD dialysis and non-dialysis patients. A New Drug Application (NDA) has been accepted for review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA). In the U.S., data readout for the Phase 3 program is expected in the fourth quarter of 2018. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic syndromes (MDS). For information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has been well tolerated in multiple Phase 2 clinical studies, with a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.