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NGMBIO NGM Bio Provides Business Highlights and Reports Third Quarter 2021 Financial Results November 4 , 2021 • Presented preliminary Phase 1a / 1b trial findings at ESMO 2021 for NGM120 , a GFRAL antagonist antibody product candidate , that showed the drug was well tolerated in advanced solid tumors and provided encouraging initial signals of anti - cancer activity in patients with metastatic pancreatic cancer • Initiated Phase 1/2 clinical study of NGM707 , a dual ILT2 / ILT4 antagonist antibody product candidate , as a monotherapy and in combination with KEYTRUDAⓇ ( pembrolizumab ) in patients with advanced solid tumors ; trial designed to enroll approximately 180 patients • Disclosed NGM831 , an ILT3 antagonist antibody product candidate , coinciding with a publication in Cancer Immunology Research revealing the discovery of one of ILT3's functional ligands , fibronectin ; Phase 1 study in cancer patients planned to commence in 1H'22 • Announced completion of enrollment in 320 - patient Phase 2 CATALINA study of NGM621 , an anti - complement C3 antibody product candidate , being studied for the treatment of geographic atrophy ; topline data expected in 2H'22 SOUTH SAN FRANCISCO , Calif . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- NGM Biopharmaceuticals , Inc. ( NGM ) ( Nasdaq : NGM ) , a biotechnology company focused on discovering and developing transformative therapeutics for patients , today provided business highlights and reported financial results for the quarterly period ended September 30 , 2021 . " This quarter we made notable progress advancing NGM's oncology portfolio , now four assets strong , all generated by our in - house discovery engine and wholly owned by NGM , " said David J. Woodhouse , Ph.D. , Chief Executive Officer at NGM . " We reported the first preliminary human data from our NGM120 trial at ESMO 2021 and also unveiled our third myeloid reprogramming program , NGM831 . Over the past 12 months , we have pulled back the curtain on the intensive discovery work in oncology that has been underway at NGM for several years . Leveraging integrated world - class target discovery research and protein engineering , we've created multiple oncology product candidates each with the potential to become next - generation treatment options to help patients mobilize their own immune systems to fight cancer more effectively . We strongly believe myeloid cell reprogramming can be an important additional approach to augment anti - tumor immunity and our portfolio of product candidates provide multiple opportunities to harness that biology . " Key Third Quarter and Recent Highlights Cancer • Presented preliminary findings from ongoing Phase 1a / 1b dose escalation study of NGM120 , a first - in - class anti - GDNF family receptor alpha like ( GFRAL ) antagonist antibody , in patients with advanced solid tumors at the European Society for Medical Oncology ( ESMO ) Virtual Congress . Preliminary results showed that treatment with the drug was well tolerated with no dose - limiting toxicities . All six evaluable metastatic pancreatic cancer patients in the Phase 1b combination cohort ( NGM120 in combination with gemcitabine + Nab - paclitaxel ) demonstrated disease control at 16 weeks , with three partial responses ( PR ) and three stable disease ( SD ) . Four metastatic pancreatic cancer patients in the Phase 1b cohort continued to exhibit PR / SD beyond 36 weeks at the July 26 data cut - off , compared to the historic median progression - free survival in metastatic pancreatic cancer of 22 weeks¹ . As of September 16 , 2021 , three of those four patients remained on drug , with two patients exhibiting PR and one patient exhibiting SD beyond 44 weeks . • Continued enrollment in a Phase 2 placebo - controlled component of the ongoing Phase 1/2 PINNACLES study , with the Phase 2 component testing NGM120 as a first - line treatment in combination with gemcitabine and Nab - paclitaxel in patients with metastatic pancreatic cancer . In March 2021 , NGM initiated a multi - center , randomized , single - blind ( sponsor unblinded ) , placebo - controlled component of NGM120 in combination with gemcitabine and Nab - paclitaxel as a first - line treatment in patients with metastatic pancreatic cancer as part of the ongoing Phase 1/2 trial . The Phase 2 component of the study is designed to enroll approximately 60 patients and will assess the efficacy , safety and tolerability of NGM120 or placebo in combination with gemcitabine and Nab - paclitaxel against both cancer and cancer- related cachexia endpoints . • Initiated the Phase 1 component of a Phase 1/2 Study of NGM707 , a novel dual antagonist antibody that inhibits the Immunoglobulin - like Transcript 2 ( ILT2 ) and Immunoglobulin - like Transcript 4 ( ILT4 ) receptors , for the treatment of patients with advanced solid tumors . The Phase 1 portion ( n = 60 ) of the study includes a monotherapy dose escalation arm ( Part 1a ) and a dose - finding arm in combination with KEYTRUDAⓇ ( pembrolizumab ) ( Part 1b ) . The Phase 2 portion ( n = 120 ) of the study will employ a basket design that will include expansion cohorts of patients treated