Gilead Sciences and Goldfinch Bio Announce Strategic Collaboration to Develop Novel Therapies for Kidney Disease

May 8, 2019 Off By BusinessWire

— Companies to Pursue a Human Genetics Approach to Drug Discovery
and Development —

FOSTER CITY, Calif. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Goldfinch Bio, Inc., a
biotechnology company focused on developing precision therapies for
patients with kidney diseases, today announced a strategic collaboration
to discover, develop and commercialize a pipeline of innovative
therapeutics for diabetic kidney disease (DKD) and certain orphan kidney
diseases.


Under the multi-year collaboration, Gilead has exclusive options to
license worldwide rights to certain products directed toward targets
emerging from Goldfinch’s proprietary Kidney Genome Atlas™ (KGA), a
comprehensive registry of patients with kidney diseases integrating
genomic, transcriptomic and proteomic data with patient clinical
profiles. In addition, Goldfinch will apply its biology platform of
human induced pluripotent stem cell-derived kidney cells and kidney
organoids to validate targets and support discovery and development of
products to which Gilead will have exclusive option rights.

Through sequencing the DNA of a large cohort of diabetic patients with
and without kidney disease, Goldfinch will expand the scope of the KGA
beyond orphan kidney diseases to include DKD. In addition to target
identification and validation, Goldfinch will lead discovery and
development activities prior to exercise of exclusive option rights by
Gilead, at which time Gilead will be responsible for the development and
commercialization of optioned products. Goldfinch retains the option to
lead development and co-promote optioned products directed to specific
kidney disease targets. The collaboration does not include Goldfinch’s
existing programs, GFB-887 and GFB-024, for which Goldfinch will retain
all rights.

“We are excited to partner with Gilead Sciences, a biopharmaceutical
company known for its science-driven innovation and productivity,”
said Tony Johnson, MD, Goldfinch’s President and Chief Executive
Officer. “There is significant unmet need to improve health outcomes for
patients with kidney diseases. This partnership will leverage
Goldfinch’s KGA platform to identify new therapeutic targets
and Gilead’s proven track record of efficiently advancing life-saving
therapies for patients.”

“Goldfinch has established unique genetic and biology platforms that
will allow for the identification and validation of novel targets for
kidney disease and for the discovery and development of novel
compounds,” said John McHutchison, AO, MD, Chief Scientific Officer and
Head of Research and Development at Gilead Sciences. “We look forward to
partnering with our research collaborators at Goldfinch, as we seek to
advance novel treatment options for people living with DKD and other
serious kidney diseases.”

Under the terms of the agreement, Goldfinch will receive $55 million in
upfront payments, which includes a $5 million equity investment, and an
additional $54 million to support the development of the KGA platform
for DKD. Goldfinch is also eligible to receive up to $1.95 billion in
potential payments for the first five collaboration programs based on
the successful achievement of research, development, regulatory and
commercial milestones, and tiered royalties on sales of potential
products originating from the collaboration. Additionally, Goldfinch
retains the option to equally share in U.S. profits for certain optioned
products in certain pre-defined kidney indications. Development costs
for profit share products will be shared among the two parties in a
manner commensurate with product rights.

About Diabetic Kidney Disease

Diabetic kidney disease (DKD) develops in approximately 30-40 percent of
patients who have diabetes and is a leading cause of end-stage kidney
disease, cardiovascular disease and early mortality worldwide. Despite
current therapies, the number of people with DKD continues to increase,
highlighting the need for additional treatments that preserve kidney
function.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com.

About Goldfinch Bio

Goldfinch Bio is a biotechnology company that is singularly focused on
discovering and developing precision therapies for patients with kidney
diseases. Just as the goldfinch has long been a symbol of healing and
renewal and was a prominent figure of the Renaissance, Goldfinch Bio is
leading a new age of therapeutic discovery to transform the treatment
paradigm for patients with kidney diseases. Goldfinch was launched in
2016 by Third Rock Ventures, and is headquartered in Cambridge, Mass.
For more information, please visit www.goldfinchbio.com.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that the parties may not realize the potential benefits of this
collaboration, and Gilead may fail to discover, develop and
commercialize any product candidates for the treatment of diabetic
kidney disease and other kidney diseases. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These risks, uncertainties and other factors
could cause actual results to differ materially from those referred to
in the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are described
in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended March 31, 2019, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.

Contacts

Gilead Contacts:

Sung Lee, Investors
(650) 524-7792

Nathan Kaiser, Media
(650) 522-1853

Goldfinch Contacts:

Michael Broxson, Investors
617-337-4200
[email protected]

Gina Nugent, Media
617-460-3579
[email protected]