On March 1, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the full year and fourth quarter ending December 31, 2021 (Press release, NGM Biopharmaceuticals, MAR 1, 2022, View Source [SID1234609278]).

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"2021 was a meaningful year for NGM Bio. We made significant progress advancing our pipeline, which now includes five programs in the clinic, with four programs in Phase 2 trials," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "2022 is poised to be one of the most eventful years in NGM Bio’s history with multiple milestones expected, including clinical data readouts from three of our programs, continued development across our pipeline and steady output from our research and discovery engine."

Key Fourth Quarter and Recent Highlights

Oncology

Progressed the Phase 1/2 trial of NGM707, an ILT2/ITL4 dual antagonist antibody product candidate, in patients with advanced solid tumors through multiple dose cohorts in the Phase 1a monotherapy dose escalation. Initial data readout from the Phase 1a portion of the trial is expected in the second half of 2022.
Continued to progress the Phase 1 portion of the PINNACLES trial of NGM120, an antagonist antibody product candidate that binds GFRAL and is designed to inhibit GDF15 signaling. The PINNACLES trial is evaluating NGM120 as a monotherapy in patients with advanced solid tumors and in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer. Additional clinical data from the Phase 1a and Phase 1b cohorts is expected in the second half of 2022.
Continued enrollment in the placebo-controlled Phase 2 portion of the PINNACLES trial, evaluating NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer.
Retinal disease

Continued to advance the fully enrolled Phase 2 CATALINA trial of NGM621 in patients with GA. Topline data readout is expected in the fourth quarter of this year.
The FDA granted Fast Track designation to NGM621 for the treatment of patients with GA secondary to age-related macular degeneration in February 2022.
Liver and metabolic diseases

Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin in patients with compensated NASH cirrhosis (F4 NASH), in January 2022. Topline data readout is expected in the first half of 2023.
Updated the design of the ALPINE 4 trial, elevating the Enhanced Liver Fibrosis (ELF) test, a reproducible, quantitative non-invasive liver prognostic test that evaluates liver fibrosis and correlates to liver-related outcomes to be the primary endpoint for the trial. The ELF test is a composite blood test measuring the presence of three biomarkers associated with liver matrix metabolism. Liver biopsy data will also be measured and reported as a secondary endpoint upon completion of the trial.
Merck, known as MSD outside of the United States and Canada, continued to progress enrollment in a global Phase 2b trial of MK-3655 for the treatment of non-cirrhotic (F2/F3) NASH. MK-3655 is an agonistic antibody product candidate binding to fibroblast growth factor receptor 1c-beta-klotho that Merck licensed from NGM Bio.
Corporate Highlights

Entered into a clinical trial collaboration and supply agreement with Merck related to NGM Bio’s ongoing Phase 1/2 trial of NGM707 in combination with Merck’s KEYTRUDA (pembrolizumab) in December 2021.
Fourth Quarter and Full Year 2021 Financial Results

NGM Bio reported a net loss of $27.2 million and $120.3 million for the quarter and year ended December 31, 2021, respectively, compared to a net loss of $28.0 million and $102.5 million for the same periods in 2020.
Related party revenue from our collaboration with Merck was $21.0 million and $77.9 million for the quarter and year ended December 31, 2021, respectively, compared to $19.8 million and $87.4 million for the same periods in 2020. Related party revenue decreased $9.5 million in 2021 as compared to 2020 primarily due to the effects of amending and restating our collaboration agreement with Merck in June 2021.
Research and development (R&D) expenses were $38.7 million and $161.7 million for the quarter and year ended December 31, 2021, respectively, compared to $40.1 million and $164.0 million for the same periods in 2020. R&D expenses decreased $1.3 million in the quarter as compared to the prior year period primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin. R&D expenses decreased $2.3 million in 2021 as compared to 2020 primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin partially offset by increases in personnel-related expenses and external expenses driven by our ongoing clinical trials of NGM621, NGM120 and NGM707 and our preclinical studies of NGM438 and NGM831.
General and administrative expenses were $9.5 million and $36.9 million for the quarter and year ended December 31, 2021, respectively, compared to $7.4 million and $27.2 million for the same periods in 2020. The $9.6 million increase in general and administrative expenses in 2021 was primarily attributable to increases in compensation-related expenses driven by higher headcount and an increase in expenses associated with being a public company.
Cash, cash equivalents and short-term marketable securities were $366.3 million as of December 31, 2021, compared to $295.2 million as of December 31, 2020. NGM Bio believes its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the first half of 2024.