 --Sustained progress across clinical development programs spanning liver, retinal and metabolic diseases and cancer----Aldafermin continues to advance toward late-stage clinical development in non-alcoholic steatohepatitis NASH with ongoing Phase 2b ALPINE 23 and ALPINE 4 clinical studies----Initiated Phase 2 CATALINA study of NGM621, a complement C3 inhibitory antibody to treat patients with geographic atrophy GA----312.1 million in cash, cash equivalents and marketable securities as of June 30, 2020-- SOUTH SAN FRANCISCO, Calif., Aug. 12, 2020 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 June 30, 2020.We continue to progress across our clinical-stage programs spanning liver, retinal and metabolic diseases as well as cancer, despite the ongoing challenges presented by the COVID-19 pandemic, thanks to the dedication and tireless efforts of our team, and the ongoing support and commitment from our clinical collaborators, said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. Were thrilled to have achieved our most recent clinical milestone, the advancement of NGM621 into Phase 2 development for the treatment of patients with GA. GA is a highly prevalent and progressive retinal degenerative disease that can have a devastating, irreversible impact on patients vision and quality of life. Based on NGM621s novel profile as a complement C3 inhibitory monoclonal antibody, we believe it has the potential to be an important treatment option for this significantly underserved patient population. It is gratifying to now have two programs in Phase 2 clinical development in two distinct therapeutic areas, both for the treatment of serious unmet needs.Dr. Woodhouse further commented, Within the diverse NASH development landscape, we are pleased with the impressive and highly consistent clinical performance of aldafermin to date, with robust, placebo-controlled data demonstrating statistically significant dual activity in reversing fibrosis and resolving NASH. Our Phase 2b ALPINE 23 and ALPINE 4 clinical studies remain on track, and we are hard at work on Phase 3 readiness in anticipation of an ALPINE 23 topline data readout in the first half of next year. Key Second Quarter and Recent HighlightsLiver and metabolic disease Continued enrollment in Phase 2b ALPINE 23 study of aldafermin in NASH. NGM has continued enrollment in the Phase 2b ALPINE 23 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 F2-F3 liver fibrosis. The 24-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Enrollment activities have increased since our first quarter update, and we reiterate our expectation of announcing topline data from the study in the first half of 2021. Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM has continued enrollment in the Phase 2b ALPINE 4 study of aldafermin in patients with biopsy-confirmed compensated NASH cirrhosis F4. The 48-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Data from 24-week doubleblind, randomized, placebo-controlled Phase 2 study Cohort 4 of aldafermin in NASH patients published in Gastroenterology. Comprehensive findings and analysis from the 24-week Cohort 4 reported by NGM in February 2020 were published this month in the journal Gastroenterology. The 24-week double-blind, randomized, placebo-controlled Phase 2 clinical study demonstrated statistically significant dual activity in reversing fibrosis and resolving NASH. In the study, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGMs adaptive Phase 2 clinical study of aldafermin in NASH, and the results observed in Cohort 4 were consistent with data from the three previous cohorts. Continued enrollment in Phase 1 study of NGM395 in overweight and obese healthy adults. NGM has continued to enroll patients in a Phase 1 single ascending dose clinical study evaluating the safety, tolerability and pharmacokinetics of NGM395, a long-acting growth differentiation factor 15 GDF15 analog, in overweight and obese but otherwise healthy adults. Completed Phase 1 study of NGM217 in adults with autoimmune diabetes. We recently completed a Phase 1 study of NGM217, an antibody binding an undisclosed target, which assessed the safety, tolerability and pharmacokinetics of NGM217 in adults with autoimmune diabetes. The study demonstrated that NGM217 was well tolerated. However, as NGM continues to advance multiple clinicalstage programs and anticipates advancing earlier-stage discovery programs into clinical development, the company has decided to suspend activities related to NGM217 to concentrate its resources on the development of other product candidates.Retinal disease Initiated Phase 2 CATALINA study of NGM621 in patients with GA. As announced in July 2020, NGM initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal injections IVT of NGM621 in patients with GA secondary to age-related macular degeneration AMD. Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for extended every eight week dosing without PEGylation. Designed as a Phase 3-enabling study, the Phase 2 CATALINA study is expected to enroll 240 patients diagnosed with GA in one or both eyes. NGM also successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting advancement to the Phase 2 CATALINA study. NGM plans to present the data from the Phase 1 study at the American Academy of Ophthalmology AAO 2020 Virtual Annual Meeting from November 13-15, 2020. In addition, NGM presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting, held virtually in June 2020. The presentations are available on NGMs website.Cancer Continued enrollment in Phase 1a1b study of NGM120 in patients with cancer anorexiacachexia syndrome CACS and cancer. NGM continues to enroll patients in a Phase 1a1b clinical study to evaluate NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like GFRAL, and inhibits GDF15 signaling, for the potential treatment of CACS and cancer. CACS is the uncontrolled wasting of both skeletal muscle and fat that is a common co-morbidity of cancer and is associated with shortened survival in cancer patients.Corporate Expanded leadership with key management team and board appointments. NGM announced the appointment of a new executive team member, Siobhan Nolan Mangini, as Chief Financial Officer effective July 13, 2020 and announced the appointment of Carole Ho, M.D. to its Board of Directors. Dr. Ho currently serves as Chief Medical Officer and Head of Development at Denali Therapeutics.Merck CollaborationMerck has a one-time option to license NGM pipeline programs, other than NGMs wholly-owned programs aldafermin and NGM395, following human proof-of-concept trials under the terms of the companies ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license NGM313, also referred to as MK3655. Second Quarter Financial Results For the quarter ended June 30, 2020, NGM reported a net loss of 25.6 million compared to a net loss of 7.7 million for the corresponding period in 2019. Related party revenue from our collaboration with Merck for the quarter ended June 30, 2020 was 19.8 million compared to 25.3 million for the corresponding period in 2019. The decrease in related party revenue was primarily attributable to the completion of all remaining obligations associated with the upfront payment at the conclusion of the initial five-year term of the Merck collaboration. Research and development expenses for the quarter ended June 30, 2020 were 38.5 million compared to 28.8 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in external research and development expenses associated with the advancement of NGMs growing pipeline, primarily expenses related to our aldafermin, NGM621 and NGM395 programs, and personnel-related expenses driven by increased headcount. General and administrative expenses for the quarter ended June 30, 2020 were 6.8 million compared to 6. 