NGM Biopharma to Release Mid-Stage NASH Data Monday: What to Expect?

NGM Biopharmaceuticals, Inc. NGM is a clinical-stage biopharma developing liver and metabolic disorders therapies. Its stock is down just 6.2% year-to-date despite the broader market turbulence.

NGM's NASH Data Due:  NGM has scheduled conference calls on Monday at 8:30 am to announce topline results from the 24-week Phase 2b study, dubbed ALPINE, that is evaluating three doses of its investigational asset, aldafermin (0.3mg, 1mg, and 3mg) in patients with non-alcoholic steatohepatitis (NASH), with stage 2 or 3 liver fibrosis.

Aldafermin is NGM's lead drug and wholly-owned candidate evaluated in two mid-stage studies for NASH, with stage 2 or 3 liver fibrosis, and NASH, with stage 4 liver fibrosis.

The primary endpoint of the ALPINE 2/3 study is to evaluate a dose-response showing an improvement in liver fibrosis by one or more stages, with no worsening of steatohepatitis at week 24.

Aldafermin is an engineered version of the human hormone FGF19 that demonstrated the ability to rapidly improve NASH and reverse liver fibrosis in clinical and preclinical studies.

In August, NGM presented final data from the 24-week, Phase 2 study, with a new analysis of Cohort 4 data showing 1mg aldafermin has a potent anti-fibrotic effect in patients with more advanced disease.

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NASH- A Virgin Opportunity: NASH is a severe form of non-alcoholic fatty liver disease usually associated with a triple combination of obesity, pre-diabetes, and diabetes. The symptoms of NASH are often not evident until the liver is damaged beyond repair. 

When untreated, NASH can progress to more severe disease stages such as fibrosis, cirrhosis, liver failure, or liver cancer. Fibrosis is the formation of an abnormally large amount of scar tissue in the liver, impacting its functioning.

There is no FDA-approved treatment for NASH currently, and liver transplantation is the only way out for patients. Several companies have jumped into the fray to find a curative option for this metabolic disorder but have not seen much success.

Intercept Pharmaceuticals, Inc.'s ICPT regulatory application for its obeticholic acid for the treatment of fibrosis due to NASH was shot down by the FDA last year, and it is working on resubmitting the application.

Others companies that have a NASH drug in their pipeline include Madrigal Pharmaceuticals, Inc. MDGL, Gilead Sciences, Inc. GILD, and Genfit SA GNFT.

NGM Targets Pivotal Trial:  NGM had said in its 10-Q filing for the first quarter that it is leveraging the results of its completed clinical trials of aldafermin, as well as guidance from the FDA, to support the design of a pivotal clinical trial program to enable a potential biologics license application submission.

Following the release of NGM's first-quarter results, Chardan analyst, Michael Morabito, said he sees substantial upside for the shares following Imminent ALPINE 2/3 Data.

"With the upcoming NASH readout in ALPINE 2/3 and ongoing pipeline expansion throughout the year, we expect NGM to remain an attractive investment," the analyst wrote in the note.

NGM's Pipeline:  The company has another proprietary Phase 2 compound, codenamed NGM313 or MK3655, a monoclonal agonistic antibody, which could potentially be used as a once-month injectable insulin sensitizer for the treatment of Type 2 diabetes as well as NASH. The compound has been licensed to Merck & Co., Inc. MRK.

NGM has a mid-stage investigational asset named NGM621, being evaluated for a retinal disorder called geographic atrophy.

The company's oncology portfolio consists of NGM120, being evaluated in two Phase 1 studies for metastatic pancreatic cancer, and cancer anorexia-cachexia syndrome, or CACS.

Chardan has a Buy rating and a $44 price target for NGM stock. Positive results from the study could send the stock skyrocketing toward a near-term resistance around a little over $30. At the same time, a clinical trial disappointment could knock the shares down to support around the $25 region.

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