Aldafermin

SOUTH SAN FRANCISCO, CA, USA I July 17, 2024 I NGM Biopharmaceuticals, Inc. (NGM Bio), a privately held biotechnology company focused on discovering and developing transformative 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 analog, 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. “At the beginning of this year, we unveiled our strategy to advance clinical development efforts for two serious, rare conditions characterized by significant unmet patient need. This Series A capital strengthens our financial position, enabling us to progress our planned registrational trial of aldafermin in primary sclerosing cholangitis and to 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 bolster our efficiency and flexibility as a company, we’re grateful to TCG and our new investors for their support of these important programs, and we look forward to sharing more details on both trials in the coming months.” “The Column Group has long championed NGM’s mission to turn extraordinary scientific discoveries into meaningful therapeutics. NGM continues to show remarkable resilience and persistence in its pursuit of life-saving medicines while maintaining the highest level of scientific rigor. With this Series A investment, TCG is delighted to extend 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. Aldafermin as a Potential Treatment for PSC PSC is a rare disease that irreparably damages the bile ducts, leading to bile acid dysregulation, which ultimately can result in end-stage liver disease, 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 that supports its differentiated potential to address the bile acid dysregulation underpinning the disease, including NGM Bio’s prior Phase 2 study in PSC. NGM Bio anticipates that the registrational trial for aldafermin in PSC will utilize proposed surrogate endpoints with the goal of obtaining accelerated approval. Learn more about aldafermin as a potential treatment for PSC here . NGM120 as a Potential Treatment for HG HG is characterized by intractable nausea and vomiting (as frequent as 10 to 15 times per day), which results in dehydration, debility, weight loss and malnutrition. HG has a significant physical and psychosocial impact on patients and leads to overall higher rates of fetal loss and termination, preeclampsia, preterm birth, low birth weight, fetal malnutrition, maternal depression, and in some cases, suicidal thoughts. This condition is the second leading cause of hospitalization in pregnancy (second to preterm labor) and typically recurs in subsequent pregnancies. Development of NGM120 as a potential treatment for HG is rooted in NGM Bio’s decade-long efforts to advance the understanding of GDF15 biology and explore its therapeutic application in a number of disease areas. Recent genetic research confirms the link between HG and higher serum levels of GDF15. NGM120 is an antibody designed to block GDF15 signaling through its cognate receptor, GFRAL, in cells at the base of the brain involved in triggering nausea and vomiting and, thereby, may have therapeutic benefit for treating patients suffering from HG. Learn more about NGM120 as a potential treatment for HG here . Aldafermin and NGM120 were both discovered through NGM Bio’s in-house discovery engine. Abbreviations (in alphabetical order) FGF19 = fibroblast growth factor 19; GDF15 = growth differentiation factor 15; GFRAL = glial cell-derived 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 disrupted by disease. NGM Bio’s biology-centric drug discovery approach aims to seamlessly integrate interrogation 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 need. Visit us at http://www.ngmbio.com for more information. SOURCE: NGM Biopharmaceuticals

Part of the funds will go towards a registrational trial of aldafermin in primary sclerosing cholangitis. Three months after The Column Group acquired NGM Bio to take the biotech private, the VC firm has overseen a $122 million fundraise to fuel clinical trials of NGM’s two lead assets. Column swooped in to acquire publicly-listed NGM in February following a 2023 that saw a third of the biotech’s staff laid off and a sliding share price in the wake of a phase 2 trial failure for an age-related macular degeneration asset. Under the ownership of Column, NGM has been a private entity since April. Now, Column wants to inject some cash into NGM’s pipeline. Part of the $122 million series A—which involved “a select group of investors” led by Column—will go towards aldafermin. The engineered FGF19 analog failed in trials for the rare liver disease primary sclerosing cholangitis and for metabolic dysfunction-associated steatohepatitis (MASH). Despite later accruing some better MASH data, NGM is now only pursuing aldafermin for primary sclerosing cholangitis, where it has secured an orphan drug tag from the FDA, and will use part of today’s funds to launch a registrational trial in this indication. The rest of the funds will be used to complete the phase 2 trial of NGM120, a GDF15/GFRAL antagonist that is being evaluated for the treatment of hyperemesis gravidarum, a term for severe vomiting and nausea in pregnancy. Both trials are expected to begin in the fourth quarter of 2024, NGM said in a July 17 release. “Having just completed a take-private transaction in April to bolster our efficiency and flexibility as a company, we’re grateful to [Column] and our new investors for their support of these important programs, and we look forward to sharing more details on both trials in the coming months,” NGM CEO David Woodhouse, Ph.D., said in the release. Although not name-checked in this morning’s release, NGM has another clinical-stage asset in the form of NGM707. In January, the company reported “encouraging responses” from a phase 1 trial of the dual ILT2/ILT4 antagonist in combination with Merck & Co.'s Keytruda in multiple solid tumor indications. Before taking over NGM, Colum already owned almost 27% of the company’s outstanding stock, making it the biotech’s largest shareholder. The same month it announced the acquisition, Column co-launched a $400 million fund described as a “novel venture-biotech model ... to support the advancement of ideas from bench to clinical proof of concept.”