NGM secures $122M, unveils new look post-privatization

NGM Bio recently delisted and transitioned to private ownership through a take-private deal with The Column Group (TCG), following some clinical setbacks. Despite this, the biotech company is poised for a new phase of growth, driven by a refined focus on orphan diseases and bolstered by a $122 million infusion from TCG. CEO David Woodhouse emphasizes that this move does not signal a retreat: “We’re firing away here on all cylinders.” He notes that being private allows NGM to expedite its development programs by avoiding the burdensome regulatory and financial requirements associated with being publicly traded.

NGM's streamlined pipeline is designed to concentrate resources more effectively. This strategic shift aims to advance two lead programs, with new studies set to commence in the fourth quarter. These include a potentially registrational trial of aldafermin, an engineered FGF19 analogue, for primary sclerosing cholangitis (PSC), and a Phase II study of NGM120, a GDF15/GFRAL antagonist for treating hyperemesis gravidarum (HG).

Woodhouse, who has been with NGM for nearly ten years and CEO since 2018, explained that the company's previous pipeline was broad, targeting large-scale diseases like type two diabetes, geographic atrophy, and colorectal cancer. The new focus narrows down to diseases with significant unmet medical needs and fewer treatment options, thereby allowing NGM to make a more substantial impact.

PSC is one such disease with no existing treatments. It is a progressive liver disease akin to primary biliary cholangitis (PBC), which recently gained attention when Ipsen’s oral PPAR agonist Iqirvo (elafibranor) received accelerated FDA approval. This marked the first new medicine for PBC in the U.S. in nearly a decade. Gilead Sciences also entered the liver disease space by acquiring CymaBay for $4.3 billion. Unlike PBC, PSC has lacked a clear regulatory approval pathway, which had previously hindered NGM's progress with aldafermin, despite promising Phase II results. Following renewed discussions with the FDA, NGM is now ready to push forward with aldafermin for PSC.

The second key program, NGM120, addresses a severe form of morning sickness known as hyperemesis gravidarum (HG). This condition causes extreme nausea and vomiting during pregnancy, far surpassing typical morning sickness in severity. Woodhouse underscores the severity by comparing it to a hurricane rather than a mere drizzle. HG leads to approximately 400,000 emergency room visits annually due to dehydration and can cause esophageal tears from excessive vomiting, underscoring the urgent need for an effective treatment.

Conducting trials in pregnant women is challenging, but Woodhouse believes the significant unmet need justifies the effort. The focus on these specific indications exemplifies NGM's strategy of concentrating on areas with substantial medical needs that are not being met by current treatments.

In summary, NGM Bio is gearing up for a significant new phase, driven by a targeted approach to orphan diseases and financial backing from TCG. By narrowing its focus and leveraging its resources, the company aims to make meaningful advancements in the treatment of PSC and HG, conditions that currently have no available treatments.