FGEN FibroGen Inc

FibroGen, Inc. (NASDAQ: FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here.

The event will feature Rahul Aggarwal, M.D. (University of California San Francisco), who will discuss the unmet need and evolving treatment landscape for prostate cancer, as well as the clinical development program for FG-3246* (also known as FOR46), a CD46 targeting antibody-drug conjugate (ADC) with first-in-class potential for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The initiation of a Phase 2 monotherapy trial in mCRPC is expected in the second half of 2024.

The event will additionally review data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide in mCRPC presented at the 2024 American Society of Clinical Oncology (ASCO) meeting.

A live question and answer session will follow the formal presentation.

This series is intended for investor audiences only.

About Rahul Aggarwal, MDRahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research in the UCSF Helen Diller Family Comprehensive Cancer Center and the Program Leader for the Genitourinary Oncology program. He specializes in translational and clinical research in prostate cancer, with a particular emphasis on the development of novel therapeutic and imaging modalities for men with advanced prostate cancer. He has led numerous phase 1, 2, and 3 clinical trials in prostate cancer across a number of treatment modalities including small molecule targeted therapies, radioligand therapies, antibody-drug conjugates, and bi-specific T cell engagers.

About FG-3246FG-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 initiation of the Phase 2 monotherapy trial in metastatic castration-resistant prostate cancer is anticipated in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.

Forward-Looking StatementsThis release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs for FG-3246. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives 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. FibroGen’s 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 its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent quarterly and annual reports on Form 10-Q and Form 10-K, respectively, as 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 FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

*FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

For Investor Inquiries:David DeLucia, CFAVice President, Head of Investor Relations and Corporate FP&Air@fibrogen.com

For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com