On August 12, 2019 NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported second quarter 2019 financial results for the period ending June 30, 2019 (Press release, NGM Biopharmaceuticals, AUG 12, 2019, View Source [SID1234538637]).
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"Our initiation of a Phase 1 clinical study of NGM621 to treat dry AMD demonstrates our continued progress in executing on our goal to operate one of the industry’s most productive R&D engines," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "We have made important progress advancing NGM282 as a potential treatment for NASH, having advanced this program into Phase 2b clinical development earlier this year. With our R&D roots firmly established and continuing to grow in the metabolic and liver spaces, we are actively building a robust pipeline that also includes novel product candidates for additional therapeutic areas, including oncology and ophthalmic diseases. This strategy positions us to tackle a spectrum of significant unmet needs, leveraging fully our in-house biology and biologics expertise."
Second Quarter 2019 and Recent Highlights
Completed enrollment of Cohort 4 of the Phase 2 clinical study of NGM282 (aldafermin) in non-alcoholic steatohepatitis (NASH) patients with F2-F3 fibrosis. Cohort 4 has enrolled 78 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis and will assess the efficacy, safety and tolerability of aldafermin 1 mg compared to placebo. An interim analysis of the non-invasive measures of efficacy, including liver fat content as measured by MRI-PDFF, liver transaminases and exploratory fibrosis biomarkers, will be conducted in approximately half the subjects after 24 weeks of treatment. NGM expects to report these interim data in the fourth quarter of 2019. Topline results of the full Cohort 4, which will include an assessment of the effect of 24 weeks of treatment on liver histology, are anticipated in early 2020. NGM plans to report preliminary results on ALPINE 2/3, an ongoing Phase 2b study of aldafermin in NASH patients with F2-F3 fibrosis, by the end of 2020.
Dosed first patient in Phase 1 clinical study of NGM621 for the treatment of geographic atrophy, an advanced form of dry AMD. NGM621 is an antibody binding an undisclosed target that has supportive human genetics data to suggest that inhibition of this pathway can effectively slow the progression of vision loss in patients with dry AMD. Currently, there are no approved therapies to treat dry AMD, a disease that is prevalent in approximately one million adults in the United States and progresses to permanent loss of central vision. The primary objective of the Phase 1 clinical study is to evaluate the safety, tolerability and pharmacokinetics of up to two intravitreal doses of NGM621 in patients with geographic atrophy.
Completed Phase 1 clinical study of NGM120. NGM is evaluating the potential of NGM120, an antagonistic antibody binding GFRAL, as a potential treatment of cancer anorexia-cachexia syndrome (CACS). The primary objective of the Phase 1 double blind, placebo-controlled single ascending dose and multiple ascending dose study was to evaluate the safety, tolerability and pharmacokinetics of NGM120 (single doses up to 400 mg and three monthly doses of up to 200 mg) in healthy adult subjects. Preliminary results demonstrate that NGM120 was well-tolerated at all doses studied and the pharmacokinetics support once-monthly dosing. Later this year, NGM plans to initiate a Phase 1a/1b clinical study to further evaluate the safety, tolerability and pharmacokinetics of NGM120, and to gather preliminary evidence of anti-cancer and anti-CACS activity in patients with select solid tumors, including pancreatic cancer.
Second Quarter Financial Results
Related party revenue for the second quarter of 2019 was $25.3 million, compared to $22.1 million for the same period in 2018.
Research and development expenses for the second quarter of 2019 were $28.8 million, compared to $22.8 million for the same period in 2018. The increase in research and development expenses was primarily attributable to increases in unallocated research and development expenses associated with personnel-related expenses, external research and development expenses associated with the advancement of NGM’s growing pipeline and aldafermin program expenses due to ongoing Phase 2 and Phase 2b clinical trials.
General and administrative expenses for the second quarter 2019 were $6.2 million, compared to $3.5 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations as a public company.
For the second quarter of 2019, NGM reported a net loss of $7.7 million, compared to a net loss of $3.2 million for the same period in 2018.
Cash, cash equivalents and short-term marketable securities were $362.2 million as of June 30, 2019, compared to $206.6 million as of December 31, 2018. The increase of $155.6 million was primarily attributable to net cash proceeds of $173.7 million from the Company’s initial public offering and concurrent private placement offset by cash used in operations over the period.