On November 3, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended September 30, 2022 (Press release, NGM Biopharmaceuticals, NOV 3, 2022, View Source [SID1234622975]).

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"We are disappointed that the CATALINA trial did not meet its primary endpoint and we continue to evaluate the study results to gain a better understanding of that outcome," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "We remain committed to advancing our portfolio of clinical-stage oncology programs in a capital efficient manner to generate proof-of-concept data and look forward to sharing initial clinical data from the Phase 1a NGM707 trial in the fourth quarter of this year."

Key Third Quarter and Recent Highlights

Oncology

Presented updated preliminary findings from Phase 1a and Phase 1b cohorts evaluating NGM120, an antagonist antibody that binds GFRAL and inhibits GDF15 signaling, for the treatment of cancer at the ESMO (Free ESMO Whitepaper) Annual Congress and at the AACR (Free AACR Whitepaper) Special Conference: Pancreatic Cancer.
Initiated a Phase 1b cohort of the ongoing Phase 1/1b trial evaluating NGM120 in combination with one or more lines of hormone therapies in patients with metastatic castration-resistant prostate cancer (mCRPC.)
Initiated a Phase 1b cohort of the Phase 1/1b trial evaluating NGM831, an ILT3 antagonist antibody product candidate, in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with advanced solid tumors.
Continued enrollment in the Phase 1b cohort of the Phase 1/2 trial evaluating NGM707, an ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with advanced solid tumors.
Continued enrollment in the Phase 1a cohort of the Phase 1/1b trial evaluating NGM438, a LAIR1 antagonist antibody product candidate, for the treatment of patients with advanced solid tumors.
Retinal Disease

Announced that the Phase 2 CATALINA trial evaluating NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy, in patients with geographic atrophy (GA) secondary to age-related macular degeneration did not meet its primary endpoint of statistically significant rate of change in GA lesion area using slope analysis over 52 weeks for NGM621 versus sham.
Liver and Metabolic Diseases

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.
Remained on track for topline data readout of ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH) in the first half of 2023.
Third Quarter 2022 Financial Results

NGM Bio reported a net loss of $47.3 million for the quarter ended September 30, 2022, compared to a net loss of $28.9 million for the same period in 2021.
Related party revenue from our collaboration with Merck Sharp & Dohme LLC, or Merck, was $7.9 million for the quarter ended September 30, 2022, compared to $18.6 million for the same period in 2021. In 2021, we entered into an amended and restated research collaboration, product development and license agreement with Merck, or the Amended Collaboration Agreement. Under the narrowed scope of the Amended Collaboration Agreement, our related party revenue from Merck has decreased substantially and is expected to continue to remain at a significantly lower level through March 31, 2024.
R&D expenses were $46.1 million for the quarter ended September 30, 2022, compared to $38.7 million for the same period in 2021. R&D expenses increased $7.4 million in the third quarter as compared to the same period in 2021, primarily due to costs related to our ongoing clinical trials of NGM707, NGM438, NGM831 and NGM120, our completed Phase 2 trial of NGM621, and personnel-related expenses, partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $10.1 million for the quarter ended September 30, 2022, compared to $8.9 million for the same period in 2021.
Cash, cash equivalents and short-term marketable securities were $300.2 million as of September 30, 2022, compared to $366.3 million as of December 31, 2021. NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the fourth quarter of 2024.