NGM Biopharmaceuticals is pushing ahead with two of its 10 clinical-stage programs after the drug developer was taken off the Nasdaq by one of its original investors, The Column Group, back in April.
On Wednesday morning, the Bay Area biotech reemerged with a $122 million Series A, once again led by TCG and an undisclosed “select group of investors.” TCG led the original Series A — of $25.5 million — for the company back in 2008. By 2015, NGM wound up striking a broad collaboration with Merck across obesity, diabetes and NASH, and the companies eventually tacked on ophthalmology as well. NGM then went public in 2019.
But then Merck walked away in 2022 after a mid-stage setback, and NGM struggled to further advance in NASH.
Now, it’s following other once-public biotechs that have landed private megarounds this year, including psychedelic-focused Reunion Neuroscience and retinal gene therapy developer Beacon Therapeutics.
David Woodhouse“When we looked at the requirements for reporting, when we looked at the availability of capital, when we looked at the various factors you look at, the pros started to outweigh the cons in terms of being private again,” CEO David Woodhouse said in an interview. “We think we can be more effective [and] more efficient as a private company.”
NGM Bio continues to “evaluate what’s best, public or private, over time,” he said.
From NASH to PSC
NGM wants to advance its FGF19 analog, which experienced an up-and-down ride in clinical testing for nonalcoholic steatohepatitis, also known as NASH or MASH. Dubbed aldafermin, the asset is slated to enter a registrational trial in the fourth quarter of this year for the rare liver disease known as primary sclerosing cholangitis.
PSC can lead to severe liver damage, and people with the bile duct-damaging disease often have other autoimmune conditions. It impacts about one in 10,000 people, according to PSC Partners Seeking a Cure.
There are no FDA-approved medicines for PSC. CymaBay had tested its drug, seladelpar, in both NASH and PSC but scrapped those ambitions and instead made progress in another liver disease, primary biliary cholangitis. Gilead bought the biotech for $4.3 billion this year, ahead of an FDA decision on Aug. 14. Meanwhile, Ipsen has its recently approved PBC drug elafibranor in Phase 2 for PSC. Other clinical-stage PSC drug developers include HighTide Therapeutics, Mirum Pharmaceuticals and Pliant Therapeutics, which released more Phase 2a data on Tuesday.
NGM plans to look at a biomarker called ELF, or enhanced liver fibrosis, in the registrational study, Woodhouse said. He declined to disclose further details about the trial design, citing the pros of being a private company again.
“When you look at our data, our Phase 2 PSC study and our impact on ELF, it was quite significant in reducing it from baseline and also versus placebo in a relatively small Phase 2 study,” Woodhouse said. “Both ELF and liver stiffness measurement are at the top of the list of what could be active biomarkers to use for accelerated approval.”
Pivoting from cancer to women’s health
Meanwhile, NGM also plans to start a Phase 2 for its GDF15/GFRAL antagonist called NGM120 in the last few months of the year.
The biotech will assess the drug in patients with hyperemesis gravidarum, a rare condition that leads to nausea and vomiting during pregnancy.
“Generally, there’s a big under-investment in women’s health in the industry, and it’s obviously a very sensitive population to look at in pregnancy. So we’re building out our safety database, not only in our existing clinical studies, but in preclinical work to make sure that we’re not putting these patients at risk,” Woodhouse said.
There are no approved medicines for the condition, which Woodhouse described as way more extreme than morning sickness.
“Morning sickness is really just a little rain. We’re talking about Category 5 hurricane here in terms of vomiting 10 to 15 times a day, not being able to leave the house, all those things,” Woodhouse said, noting it impacts about 1% to 3% of pregnancies in the US. “Termination of pregnancy is one of the quote unquote ‘treatments’ that unfortunately these women have to resort to.”
NGM previously tested the drug in patients with various cancers and the wasting syndrome cachexia.
“There are other companies blocking GDF15 directly, so they have an antibody that blocks and binds GDF15 and blocks it that way, and they’re exploring this in oncology. We figure while we’re doing our hyperemesis gravidarum work, we can let their work mature,” He said. “If there’s something there, we can be a fast follower, but that’s not our focus right now.”
One of those biotechs is CatalYm, which disclosed a $150 million round on Tuesday to help it investigate a GDF15 neutralizer in cancer.
For the other eight NGM programs that went from discovery stage to human testing, Woodhouse said the company is in “active BD dialogues” but the company is focusing most of its efforts on the two lead drugs.
“It’s tempting to get distracted with conversations about some of these other assets, so we won’t spend a ton of activity on those areas,” the CEO said, “but they’re certainly available, and we’re having conversations.”