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Goldfinch Bio Announces Upcoming Presentation of Phase 1 Clinical Data for Lead Precision Kidney Therapeutic Candidate, GFB-887, and Expansion of Scientific Leadership Team

CAMBRIDGE, Mass.–()–Goldfinch Bio, a clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today announced that it will present clinical data from a Phase 1 study of its lead precision kidney therapeutic candidate, GFB-887, at the American Society of Nephrology (ASN) Kidney Week 2020 Annual Meeting, taking place virtually October 22-25, 2020. Goldfinch is developing GFB-887, a first-in-class, highly potent and selective inhibitor of Transient Receptor Potential Canonical Channel 5 (TRPC5), as a precision medicine for patients with kidney diseases characterized by overactivation of the TRPC5-Rac1 pathway.

The Phase 1 safety, tolerability and TRPC5-Rac1-pathway target engagement data to be presented support the advancement of its Phase 2 study of GFB-887 (TRACTION-2), which is now underway. Goldfinch Bio will present additional posters at Kidney Week 2020 showcasing GFB-887’s novel urinary Rac1 predictive biomarker strategy as well as the company’s proprietary platform.

“We are excited to share the final results from our Phase 1 clinical trial of GFB-887, as well as new preclinical data demonstrating urinary Rac1 as a novel predictive biomarker of response in focal segmental glomerulosclerosis (FSGS) and diabetic nephropathy (DN). Together, these data informed the design of TRACTION-2, our ongoing Phase 2 clinical trial,” said Anthony Johnson, M.D., President and Chief Executive Officer at Goldfinch Bio.

Coinciding with the continued advancement of its pipeline of precision kidney therapeutics, Goldfinch Bio also today announced the appointment of Thomas (Gus) Gustafson, Ph.D., to the newly-created role of Senior Vice President, Discovery and Translational Biology. In this role, Dr. Gustafson will bring his deep expertise in kidney therapeutics research and development to his new role. Specifically, Dr. Gustafson will be responsible for leading the discovery and validation of new targets using Goldfinch Bio’s Kidney Genome Atlas (KGA™) and Human Biology Platform. He will also be responsible for the discovery and development of biomarkers to support Goldfinch Bio’s precision medicine approach to the treatment of kidney disease.

“We are thrilled to welcome Dr. Gustafson to Goldfinch Bio. Gus has devoted his career, with notable success, to delivering transformative new treatments for cardio-metabolic diseases, and shares our foundational commitment to bring new hope to people with kidney diseases through therapeutic innovation that sheds the inevitability of dialysis and transplant,” said Dr. Johnson.

Dr. Gustafson commented, “I’m delighted to join Goldfinch Bio at this exciting time for the company. I believe Goldfinch Bio is leading an important revolution in the treatment of kidney disease, which has been mischaracterized and treated for too long as a homogenous condition. I look forward to continuing to cull through our proprietary platform to deliver novel medicines to defined patient subsets, with the goal of radically transforming the treatment paradigm for people living with severe and debilitating kidney diseases.”

ASN Presentations

The abstracts for Goldfinch Bio’s presentations at ASN are now available online at www.asn-online.org. The poster presentations will be available for on-demand viewing on the ASN website beginning Thursday, October 22, 2020 at 10:00 a.m. ET. Details are as follows:

Presentation Title: GFB-887, a TRPC5 inhibitor, is safe, well tolerated and engages the TRPC5 target leading to reductions in urinary Rac1 in healthy subjects

Session Title: Glomerular Diseases: Clinical, Outcomes, and Trials – 2

ePoster #: PO1886

Presentation Title: Safety and Efficacy Evaluation of GFB-887, a TRPC5 Channel Inhibitor, in Patients with DN, FSGS, or TR-MCD: Phase 2 Study Design (TRACTION Program)

Session Title: Informational Posters

ePoster #: INFO22

Presentation Title: Urinary Rac1, a Novel Predictive Biomarker, is Elevated in FSGS and DN Patients and Reduced by TRPC5 Inhibition with GFB-887 in a Rat FSGS Model

Session Title: Podocyte Biology

ePoster #: PO1965

Presentation Title: Generation of collecting duct kidney organoids from hiPSC

Session Title: Cystic Kidney Diseases: Emerging Concepts, Biomarkers, and Clinical Trials

ePoster #: PO1546

Thomas (Gus) Gustafson, Ph.D., Senior Vice President, Discovery and Translational Biology

Dr. Gustafson brings 30 years of experience to Goldfinch Bio., including extensive research and development experience across chronic kidney disease, acute kidney injury, Type 1 and 2 Diabetes, obesity, nonalcoholic steatohepatitis and heart failure. Most recently, he served as Vice President, Cardiovascular & Metabolic (CVM) Scientific Innovation at Janssen Pharmaceuticals, Johnson & Johnson CA Innovation Center, where he was responsible for identifying scientific and business opportunities in cardiovascular and metabolism and related areas. Earlier, Dr. Gustafson served as Site Lead – Diabetes at Merck & Co., where he led Diabetes discovery efforts, Vice President at Pfizer, where he led the Cardiovascular, Metabolic and Endocrine Diseases (CVMED) Target Exploratory Unit and Chief Scientific Officer – Diabetes Discovery at Eli Lilly & Co., where he led the Diabetes “Drug Hunting Team.” Dr. Gustafson started his career as an Associate Professor in the University of Maryland School of Medicine’s Department of Physiology. Dr. Gustafson holds a Ph.D. in Pharmacology and Toxicology from the University of Arizona, Tucson and a B.S. in Biology from the University of Wisconsin, Stevens Point, and completed his postdoctoral work at Stanford University and the University of California, San Francisco. His work has been published in more than 50 peer-reviewed publications.

About Goldfinch Bio

Goldfinch Bio, Inc. is a clinical stage biotechnology company that leverages a genomics-based, precision medicine approach to discovering and developing kidney disease treatments. Its Kidney Genome Atlas (KGA™) is a proprietary biology platform that drives candidate discovery, biomarker development and patient selection. The Company’s lead candidate, GFB-887, is a TRPC5 ion channel inhibitor, in Phase 2 development for the treatment of kidney diseases. Goldfinch Bio is also developing GFB-024, a peripherally-restricted cannabinoid receptor 1 (CB1) inverse agonist monoclonal antibody, for the treatment of rare and metabolic kidney diseases and expects to submit an investigational new drug (IND) application in 2021. Goldfinch Bio, headquartered in Cambridge, Massachusetts, was launched in 2016 by Third Rock Ventures and named in 2020 as one of FierceBiotech’s “Fierce 15.” Goldfinch Bio has an established strategic collaboration with Gilead Sciences, Inc. For more information, visit www.goldfinchbio.com.

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