Thank you, Karen. Welcome everyone and thank you for joining us.
Let's start with our anemia program.
We are pleased to report that in our pre-NDA meeting with the FDA regarding roxadustat, we reached an agreement with the agency on the content of the NDA including the cardiovascular safety analysis. This is for both the dialysis and non-dialysis dependent CKD populations. We previously announced that we expected the NDA submission in September or October timeframe with the clarity arising from our meeting with FDA. We and our partner AstraZeneca have refined our timing to target an October submission, with the MAA for Europe to be submitted thereafter.
We recently announced the publication on July 24, two articles in The New England Journal of Medicine of the pivotal studies of roxadustat China Phase 3 program, 1 reporting the results from China Phase 3 dialysis or study 806 and the other reporting the results from China Phase 3 non-dialysis or study 808. We view publication by the New England Journal of these two pivotal studies supporting regulatory approval for roxadustat in China's validation of the scientific and medical importance as well as the quality of clinical research for these studies.
Other updates in China, in December 2018, we announced the approval in China roxadustat for the treatment of CKD anemia and patients receiving dialysis representing the world's first approval for any HIF-PHI.
We expect the non-dialysis dependent or NDD indeed portion of the CKD indication to be approved for roxadustat in the third quarter of 2019.
In a few minutes Dr. Peony Yu will provide further details regarding roxadustat and Ms Chris Chung will provide updates on China program.
Let's turn to Pamrevlumab highlights for the quarter. Starting with Duchenne muscular dystrophy, we presented positive Phase 2 clinical findings from the first year of treatment in our ongoing study 079 at the Parent Project Muscular Dystrophy or PPAMD 2019 AOL conference in June.
Our study suggests pamrevlumab has the potential treatment benefits on heart function, lung function and muscle function in DMD patients. We shall be seeking guidance from the FDA on the design of a Phase 3 program.
For the treatment of idiopathic pulmonary fibrosis or IPF, we initiated patient dosing in the ZEPHYRUS Phase 3 randomized double-blind placebo-controlled study of pamrevlumab with the primary endpoint of change of forced vital capacity or FVC over 52 weeks.
We are enrolling more than 550 patients in this study and we expect to have more than 175 study sites globally.
Turning to pancreatic cancer, this disease is characterized by a high degree of growth of fibrosis characterized as desmoplasia, which is related to extensive CTGF expression.
As an anti-CTGF agent pamrevlumab has the potential to have a meaningful effect on pancreatic cancer.
We are preparing to initiate patient dosing in the LAPC study of Phase 3 randomized double-blind placebo-controlled study of pamrevlumab as a new adjuvant therapy for patients with unresectable locally advanced pancreatic cancer or LAPC.
Later on, this call, Dr. Elias Kouchakji will discuss the DMD data presented at the PPMD conference and our IPF and pancreatic cancer Phase 3 trials in more detail.
I have a few brief corporate and financial updates for the quarter.
Our Chief Financial Officer, Pat Cotroneo provide further detail on finance later on the call.
In the second quarter, we reported $116 million in net income or $1.34 per basic share or $1.26 per diluted share in EPS.
As of June 30, 2019, FibroGen had $686.1 million in cash.
We are privileged to welcome Ms. Suzzane Blaug as a member of FibroGen's Board of Directors. Suzanne is an experienced industry executive and advisor whose deep knowledge and critical commercial marketing and strategic planning experience will be invaluable as we advance through our multiple late stage products.
I would now like to ask Dr. Peony Yu to provide updates on the anemia programs. Peony, please go ahead.