Globe Newswire 8-Nov-2018 4:02 PM
—Roxadustat New Drug Applications under Review in China and Japan—
—Phase 3 Clinical Trials in IPF and Pancreatic Cancer to Initiate in First Quarter 2019—
—Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time—
SAN FRANCISCO, Nov. 08, 2018 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today reported financial results for the third quarter of 2018 and provided an update on the company's recent developments.
"With new drug applications for roxadustat in anemia associated with chronic kidney disease supported by positive Phase 3 results and under review in China and Japan, we look forward to the upcoming reporting of topline clinical results, pooled safety data and submitting our U.S. NDA," said Thomas B. Neff, FibroGen's Chief Executive Officer. "For pamrevlumab, our proprietary anti-fibrotic and anti-fibroproliferative therapeutic candidate, we are initiating Phase 3 studies in idiopathic pulmonary fibrosis, and in unresectable locally advanced pancreatic cancer, in the first quarter of 2019."
Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S./EU
Roxadustat for Anemia in CKD in China
Roxadustat for Anemia in CKD in Japan
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Pamrevlumab for Pancreatic Cancer
Corporate and Financial
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, November, 8, 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 third quarter 2018 financial results conference call, and use passcode 47780296. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 4778 0296#.
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.
FibroGen and collaboration partners are pursuing four approval pathways in major jurisdictions to prepare for commercialization worldwide:
FibroGen and its partners have completed 35 Phase 1 and Phase 2 studies. The Phase 2 clinical studies have consistently demonstrated anemia correction and maintenance of hemoglobin levels in multiple subpopulations across a wide spectrum of CKD patients.
Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients to support independent regulatory approvals in the U.S., Europe, Japan, and China. To date, positive topline results have been announced for seven of the Phase 3 studies, with two supporting the China NDA for treatment of anemia in CKD patients on dialysis and not on dialysis, four supporting the Japan NDA for treatment of anemia in CKD patients on dialysis, and one supporting the U.S./EU submissions. The China and Japan NDAs are both under review by the respective regulatory agencies.
Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China.
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, has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People's Republic of China, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company's most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review by the National Medical Products Administration (NMPA) in China. Our partner Astellas submitted a NDA for the treatment of anemia in CKD patients on dialysis in Japan and currently under review by the Pharmaceuticals and Medical Devices Agency (PMDA). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, 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). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development of the company's product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory plans, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Condensed Consolidated Balance Sheets
|September 30, 2018||December 31, 2017 (1)|
|Cash and cash equivalents||$||566,722||$||673,658|
|Prepaid expenses and other current assets||2,865||4,800|
|Total current assets||678,783||748,970|
|Restricted time deposits||5,181||5,181|
|Property and equipment, net||127,908||129,476|
|Liabilities, stockholders' equity and non-controlling interests|
|Total current liabilities||100,426||85,960|
|Long-term portion of lease financing obligations||97,323||97,763|
|Product development obligations||16,948||17,244|
|Deferred revenue, net of current||136,874||138,241|
|Other long-term liabilities||10,291||8,047|
|Total stockholders' equity||471,311||528,467|
|Total liabilities, stockholders' equity and non-controlling interests||$||855,641||$||898,650|
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|2018||2017 (1)||2018||2017 (1)|
|Development and other revenue||29,027||30,617||90,580||90,327|
|Research and development||56,443||50,336||165,555||144,049|
|General and administrative||15,356||12,953||45,961||37,908|
|Total operating expenses||71,799||63,289||211,516||181,957|
|Loss from operations||(42,772||)||(22,739||)||(106,613||)||(81,697||)|
|Interest and other, net:|
|Interest income and other, net||3,079||1,106||7,796||2,783|
|Total interest and other, net||340||(1,663||)||(461||)||(5,118||)|
|Loss before income taxes||(42,432||)||(24,402||)||(107,074||)||(86,815||)|
|Provision for income taxes||124||57||299||166|
|Net loss per share - basic and diluted||$||(0.50||)||$||(0.32||)||$||(1.28||)||$||(1.24||)|
|Weighted average number of common shares used to calculate net loss per share - basic and diluted||84,508||75,891||83,713||69,899|
Karen L. Bergman
Vice President, Investor Relations and Corporate Communications
1 (415) 978-1433
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