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NGMBIO NGM Bio Provides Business Highlights and Reports First Quarter 2021 Financial Results May 6 , 2021 • Expect to report topline data from Phase 2b ALPINE 2/3 clinical trial of aldafermin in patients with NASH with F2 and F3 liver fibrosis in the second quarter • Continued enrollment in Phase 2 CATALINA study of NGM621 in patients with geographic atrophy and expect to complete enrollment by mid - year • Achieved key milestone in oncology portfolio with initiation in January of a Phase 2 placebo - controlled component of ongoing Phase 1/2 clinical trial of NGM120 , testing NGM120 in combination in patients with metastatic pancreatic cancer • Strengthened capital position with completion of public offering of NGM common stock in January , raising net proceeds of $ 134.6 million • $ 412.7 million in cash , cash equivalents and marketable securities as of March 31 , 2021 SOUTH SAN FRANCISCO , Calif . , May 06 , 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 period ending March 31 , 2021 . " In the first quarter of 2021 , we achieved a key milestone in our oncology portfolio with the initiation of the randomized , placebo - controlled component of our NGM120 study in patients with metastatic pancreatic cancer , " said David J. Woodhouse , Ph.D. , Chief Executive Officer at NGM . " We also continued to make progress across our four other ongoing Phase 2 and Phase 2b programs . We remain on track to report topline data from our Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with NASH in the second quarter and we expect to complete enrollment in our Phase 2 CATALINA clinical study of NGM621 in patients with geographic atrophy by mid - year . Our team continues to work diligently to advance our two lead immuno - oncology product candidates into the clinic later this year . " Dr. Woodhouse continued , " We demonstrated strong pipeline and corporate execution despite the continued challenges presented by the COVID - 19 pandemic and continue to focus on our mission to translate powerful biology with urgency and rigor to deliver life - changing medicines . " Key First Quarter and Recent Highlights Liver and metabolic diseases • Anticipate reporting topline data from the Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH with liver fibrosis stage 2 or 3 ( F2 - F3 ) in the second quarter . ALPINE 2/3 is a Phase 2b clinical study of aldafermin in patients with biopsy - confirmed NASH and liver fibrosis F2 or F3 . The 24 - week study will assess the efficacy , safety and tolerability of 0.3 mg , 1 mg and 3 mg doses of aldafermin compared to placebo . The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24 . • Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with NASH with liver fibrosis stage 4 ( F4 ) and compensated cirrhosis . NGM continued enrollment in the Phase 2b ALPINE 4 clinical study of aldafermin in patients with biopsy - confirmed NASH with F4 liver fibrosis and compensated cirrhosis . The 48 - week study is designed to enroll approximately 160 patients and will assess the efficacy , safety and tolerability of 0.3 mg , 1 mg and 3 mg doses of aldafermin compared to placebo . The primary objective of ALPINE 4 is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 48 . • Merck continued the Phase 2b study of MK - 3655 in patients with NASH with F2 - F3 liver fibrosis . In November 2020 , Merck initiated a global Phase 2b multicenter study of MK - 3655 for the treatment of F2 - F3 NASH . The 52 - week randomized , double - blind study is designed to enroll approximately 320 patients and will assess the efficacy , safety and tolerability of 50 mg , 100 mg and 300 mg doses of MK - 3655 compared to placebo . The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks . Merck licensed MK - 3655 following NGM's completion of a proof - of - concept study . NGM retains an option , at the initiation of the first Phase 3 clinical trial for MK - 3655 , to either receive milestone and royalty payments or to co - fund development and participate in a global cost and revenue sharing arrangement of up to 50 % for MK - 3655 . Retinal diseases • Expect to complete enrollment in the Phase 2 CATALINA study of NGM621 in patients with GA by mid - year . NGM