On November 10, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2025 and provided an update on the company’s recent developments.

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"With the completion of the transformative sale of our FibroGen China operations, we have significantly simplified our capital structure and extended our cash runway into 2028. Notably, we initiated the Phase 2 monotherapy trial of FG-3246 and its companion diagnostic FG-3180, with an interim analysis anticipated in the second half of 2026," said Thane Wettig, Chief Executive Officer, FibroGen. "We remain on track to submit the Phase 3 protocol for roxadustat in LR-MDS in the fourth quarter of 2025 and continue to assess its development options. We are excited to continue building on the strong momentum we have gained throughout this year."

Recent Developments and Key Highlights of Third Quarter 2025:

Completed the sale of FibroGen China to AstraZeneca for a total consideration of approximately $220 million, consisting of $85 million in enterprise value and approximately $135 million in net cash held in China.
Successfully repaid term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure
FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas.
Initiated the Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC. The trial will also evaluate FG-3180 as a companion PET imaging agent and a potential predictive patient selection biomarker.
Reached agreement with the FDA on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden. FibroGen continues to assess both internal development or partnership opportunities for this program.
Upcoming Milestones:

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC are expected to be presented at a medical conference in the first quarter of 2026.
Interim results from the Phase 2 monotherapy trial are expected in the second half of 2026. The trial will also assess the diagnostic performance of FG-3180 to determine the potential correlation between CD46 expression and response to FG-3246.
Roxadustat

FibroGen remains on track to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in the fourth quarter of 2025.
Financial:

Total revenue from continuing operations for the third quarter of 2025 was $1.1 million, as compared to $0.1 million for the third quarter of 2024.
Net loss from continuing operations for the third quarter of 2025 was $13.1 million, or $3.25 loss per basic and diluted share, compared to a loss of $48.3 million, or $12.01 loss per basic and diluted share, one year ago.
On September 30, 2025, FibroGen reported cash, cash equivalents, accounts receivable, and investments of $121.1 million.
The Company expects its cash, cash equivalents, accounts receivable, and investments to be sufficient to fund operating plans into 2028.
Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer has been initiated. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, FibroGen, NOV 10, 2025, View Source [SID1234659712])