NGM Bio Announces $122 Million Series A Financing to Initiate a Registration Study in Primary Sclerosing Cholangitis and Fund a Phase 2 Study in Hyperemesis Gravidarum

• The Column Group (TCG) led the round with the participation of a select group of investors

• Primary sclerosing cholangitis (PSC) is a rare liver disease that causes irreparable damage to the bile ducts, leading to bile acid dysregulation and ultimately severe liver damage.

• Hyperemesis gravidarum (HG) is a rare, debilitating pregnancy condition characterized by persistent nausea and uncontrollable vomiting and frequent, serious complications.

• There are currently no approved therapies for PSC or HG

SOUTH SAN FRANCISCO, Calif., July 17, 2024 (GLOBE NEWSWIRE) — NGM Biopharmaceuticals, Inc. (NGM Bio), a privately held biotechnology company focused on discovering and developing breakthrough therapeutics for patients, today announced a $122 million Series A financing led by TCG with participation from a select group of investors. NGM Bio will use the proceeds from the Series A financing to initiate a planned registrational trial of aldafermin, an engineered FGF19 analogue, for the treatment of PSC and to complete a planned Phase 2 trial of NGM120, a GDF15/GFRAL antagonist, for the treatment of HG. Both trials are expected to begin in the fourth quarter of 2024.

“Earlier this year, we unveiled our strategy to advance clinical development efforts for two serious, rare diseases characterized by significant unmet patient needs. This Series A capital strengthens our financial position and allows us to advance our planned registrational trial of aldafermin in primary sclerosing cholangitis and evaluate NGM120 in a proof-of-concept study for hyperemesis gravidarum,” said David J. Woodhouse, PhD, Chief Executive Officer at NGM Bio. “Having just completed a take-private transaction in April to strengthen our efficiency and flexibility as a company, we are grateful to TCG and our new investors for their support of these important programs and look forward to announcing further details on both studies in the coming months.”

“Column Group has long supported NGM’s mission to translate extraordinary scientific discoveries into meaningful therapies. NGM continues to demonstrate remarkable resilience and perseverance in developing life-saving medicines while maintaining the highest scientific rigor. With this Series A investment, TCG is pleased to expand our investment in NGM and support the compelling opportunities presented by aldafermin and NGM120 as potential treatments for PSC and HG, respectively,” said Peter Svennilson, Founder and Managing Partner of TCG. Concurrent with the Series A financing, Mr. Svennilson joined NGM Bio’s Board of Directors.

The story goes on

Aldafermin as a potential treatment for PSC

PSC is a rare disease that irreparably damages the bile ducts and results in bile acid dysregulation, which can ultimately lead to end-stage liver failure and bile duct cancer. NGM Bio’s advancement of aldafermin as a potential treatment for PSC is based on a large body of clinical data demonstrating its differentiated potential to treat the bile acid dysregulation underlying the disease, including NGM Bio’s prior Phase 2 study in PSC. NGM Bio expects the registration study for aldafermin in PSC will utilize proposed surrogate endpoints to obtain accelerated approval.

Learn more about Aldafermin as a possible treatment for PSC here.

NGM120 as a potential treatment for HG

HG is characterized by intractable nausea and vomiting (up to 10 to 15 times a day), leading to dehydration, weakness, weight loss, and malnutrition. HG has significant physical and psychological impacts on patients, resulting in higher overall miscarriage and abortion rates, preeclampsia, preterm birth, low birth weight, fetal malnutrition, maternal depression, and in some cases, suicidal thoughts. This condition is the second most common reason for hospitalization during pregnancy (after preterm birth) and typically recurs in subsequent pregnancies.

The development of NGM120 as a potential treatment for HG is rooted in NGM Bio’s decades-long efforts to improve understanding of the biology of GDF15 and explore its therapeutic application in a range of disease areas. Recent genetic research confirms the link between HG and higher serum GDF15 levels. NGM120 is an antibody that blocks GDF15 signaling via its cognate receptor GFRAL in cells at the base of the brain that are involved in inducing nausea and vomiting, and therefore may have therapeutic benefit for treating patients with HG.

Learn more about NGM120 as a possible treatment for HG here.

Aldafermin and NGM120 were both discovered by NGM Bio’s internal discovery engine.

Abbreviations (in alphabetical order)

FGF19 = fibroblast growth factor 19; GDF15 = growth differentiation factor 15; GFRAL = glial cell neurotrophic factor receptor alpha-like

About NGM Bio

NGM Biopharmaceuticals, Inc. (NGM Bio), a wholly owned subsidiary of NGM Bio Holdings, Inc., a privately held biotechnology company, is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been compromised by disease. NGM Bio’s biology-centric approach to drug discovery aims to seamlessly integrate the study of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates, enable their rapid advancement into proof-of-concept studies, and address high unmet patient needs. For more information, visit http://www.ngmbio.com.

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