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NGM BIOPHARMACEUTICALS, INC.

(NGM)
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NGM Biopharmaceuticals, Inc. Presents Preliminary Findings from Ongoing Phase 1A/1B Dose Escalation Study of NGM120 in Patients with Advanced Solid Tumors at the ESMO Virtual Congress 2021

09/16/2021 | 08:00am EST

NGM Biopharmaceuticals, Inc. announced that preliminary findings from its ongoing, open-label Phase 1a/1b dose escalation study of NGM120, a novel GFRAL antagonist antibody, in patients with advanced solid tumors are being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, being held September 16 - 21. These preliminary results demonstrated that treatment with the drug was well tolerated to date in the study with no dose-limiting toxicities and provided encouraging initial signals of anti-cancer activity in patients with metastatic pancreatic cancer. NGM120 Phase 1a/1b Preliminary Findings: Design, Safety and Tolerability: The primary endpoint of the ongoing Phase 1a/1b multi-site, open-label, dose escalation clinical study is the safety and tolerability of NGM120 30 mg and 100 mg as monotherapy in patients with advanced solid tumors (Phase 1a, n=20) or in combination with gemcitabine + Nab-paclitaxel (Phase 1b, n=8) in patients with metastatic pancreatic cancer. Patients are dosed once every three weeks in the Phase 1a cohort and once every four weeks in the Phase 1b cohort. Secondary endpoints include pharmacokinetics (PK), overall response rate1, progression-free survival (PFS) and changes in lean body mass and body weight. Entry criteria for both cohorts included elevated serum levels of GDF15. Both the Phase 1a and 1b cohorts are fully enrolled. Overall, treatment with NGM120 showed no dose-limiting toxicities in the Phase 1a/1b study data presented at ESMO. The PK exposure of NGM120 in both the Phase 1a and Phase 1b cohorts increased with dose. In the Phase 1a monotherapy cohort, most adverse events were Grade 1-2 with no serious adverse events attributed to NGM120. The Phase 1b combination cohort showed a safety profile consistent with gemcitabine/Nab-paclitaxel treatment, with two patients discontinuing early due to gemcitabine/Nab-paclitaxel toxicity and/or progression of the underlying disease. Phase 1a Cohort Clinical Activity: In the Phase 1a monotherapy cohort, three patients (30%) in the Phase 1a 30 mg arm and two patients (20%) in the Phase 1a 100 mg arm had stable disease1, although no objective response was observed. Four patients experienced increases in lean body mass greater than 3.5% at Week 8. As of the July 26, 2021 data cut-off, one patient in the Phase 1a cohort remained on drug. At the time of this announcement, this patient remains on drug. Phase 1b Cohort Clinical Activity: In the Phase 1b combination cohort, all six evaluable patients with metastatic pancreatic cancer showed disease control at 16 weeks, including three with partial responses (PR) and three with stable disease (SD), with four of those six patients exhibiting PR/SD beyond 36 weeks, as of the July 26, 2021 data cut-off. At the time of this announcement, three of those four patients remain on drug, exhibiting PR (two patients) and SD (one patient) beyond 44 weeks. In addition, all six CT-evaluable patients showed a 4% average maximal increase in lean body mass, and four of the six evaluable patients exhibited greater than 5% maximum body weight gain. NGM plans to report final results from the Phase 1a and Phase 1b cohorts once all patients have completed treatment and follow-up per protocol. Phase 2 PINNACLES Study of NGM120 in Metastatic Pancreatic Cancer: NGM initiated a Phase 2 randomized, single-blind (investigator-blinded), placebo-controlled, multi-center expansion study (PINNACLES) in March 2021 to evaluate NGM120 as a first-line treatment in 60 patients with metastatic pancreatic cancer. In the ongoing study, patients will be randomized to either NGM120 or placebo in combination with gemcitabine/Nab-paclitaxel. The study will evaluate the effects of NGM120 on both cancer and cancer-related cachexia.


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Financials (USD)
Sales 2021 77,6 M - -
Net income 2021 -121 M - -
Net cash 2021 153 M - -
P/E ratio 2021 -11,6x
Yield 2021 -
Capitalization 1 410 M 1 410 M -
EV / Sales 2021 16,2x
EV / Sales 2022 30,1x
Nbr of Employees 210
Free-Float 70,5%
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Number of Analysts 6
Last Close Price 18,15 $
Average target price 35,50 $
Spread / Average Target 95,6%
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Managers and Directors
David J. Woodhouse Chief Executive Officer & Director
Siobhan Nolan Mangini CFO & Principal Accounting Officer
William J. Rieflin Executive Chairman
Hui Tian Vice President-Research
Marc Learned Vice President-Research Operations
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