NGM NGM Biopharmaceuticals Inc

NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that updated preliminary findings from its Phase 1b dose escalation trial of NGM120, a novel GFRAL antagonist antibody drug candidate, in patients with metastatic pancreatic cancer are being presented at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer, on Wednesday, September 14, 2022. These results demonstrate that treatment with the drug was well tolerated to date in the study with no dose-limiting toxicities and provided encouraging signals of anti-cancer activity in patients with metastatic pancreatic cancer.

The presentation titled “Initial Results of a Cohort of Advanced Pancreatic Cancer Patients in a Phase 1b Study of NGM120, a First-in-Class Anti-GDNF Family Receptor Alpha Like (GFRAL) Antibody” is available to conference attendees for the duration of the AACR Special Conference: Pancreatic Cancer and will be archived on the ‘Presentations and Publications’ page of NGM Bio’s website here.

The abstract’s first author, Andrew Hendifar, M.D., Cedars-Sinai, Samuel Oschin Cancer Center, commented, “The preliminary disease control results observed with NGM120 in combination with gemcitabine/Nab-paclitaxel in the Phase 1b cohort merit attention. Historic median progression-free survival in this patient population is approximately 5-7 months. While a small sample size, seeing two patients in this cohort exhibit partial response beyond 17 months is intriguing. I look forward to further clinical study of NGM120.”

“While preliminary, these findings encourage further study of NGM120 for the treatment of patients with advanced pancreatic cancer, a disease for which better therapeutic options are needed for patients,” said Alex DePaoli, M.D., Senior Vice President, Chief Translational Officer at NGM.

In addition to the Phase 1b dose escalation trial of NGM120 in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer, NGM Bio is conducting a Phase 2 randomized, single-blind (investigator-blinded), placebo-controlled, multi-center expansion trial of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer (referred to as the PINNACLES trial), a Phase 1a trial testing NGM120 as a monotherapy for the treatment of patients with solid tumors and a recently initiated Phase 1b trial testing NGM120 in combination with one or more lines of hormone therapies in patients with metastatic castration-resistant prostate cancer (mCRPC).

NGM120 is an antagonist antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling. NGM Bio scientists have made several important discoveries related to GDF15, including identification of its cognate receptor, GFRAL. Evidence has shown that serum levels of GDF15 are elevated in patients with several tumor types, including non-small cell lung cancer, melanoma, pancreatic, prostate, colorectal, gastric, esophageal and ovarian cancer, and are associated with a worse prognosis. For more details on NGM Bio’s oncology portfolio visit NGM Bio’s website at https://www.ngmbio.com/discovery-engine/oncology/.    About NGM Bio

NGM Bio is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. The company’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, NGM Bio aspires to operate one of the most productive research and development engines in the biopharmaceutical industry. All therapeutic candidates in the NGM Bio pipeline have been generated by its in-house discovery engine, always led by biology and motivated by unmet patient need. Today, the company has seven programs in clinical development, including four in Phase 2 or 2b studies, across three therapeutic areas: cancer, retinal diseases and liver and metabolic diseases. Visit us at www.ngmbio.com for more information.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “will,” “look forward,” “potential,” “promising,” “preliminary,” “encouraging,” ”intriguing,” “aspires,” “aims” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: NGM Bio’s product candidates, including the potential of NGM Bio’s oncology product candidate, NGM120 to treat cancer; potential outcomes suggested by preliminary findings regarding NGM120; NGM Bio’s aspiration to operate one of the most productive research and development engines in the biopharmaceutical industry and other statements that are not historical fact. Because such statements deal with future events and are based on NGM Bio’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in ongoing or future trials, that preliminary results will differ from final results and that NGM Bio’s product candidates may otherwise not be tolerable and effective treatments in their planned indications; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, NGM Bio’s business and operations, including NGM Bio’s ability to timely supply, initiate, enroll and complete its ongoing and future clinical trials; the time-consuming and uncertain regulatory approval process; NGM Bio’s reliance on third-party manufacturers for its product candidates and the risks inherent in manufacturing and testing pharmaceutical products; the sufficiency of NGM Bio’s cash resources, including to fund its wholly-owned programs, and NGM Bio’s need for additional capital; and other risks and uncertainties affecting NGM Bio and its development programs, including those discussed in the section titled “Risk Factors” in NGM Bio’s annual report on Form 10-Q for the quarter ended June 30, 2022 filed with the United States Securities and Exchange Commission (SEC) on August 4, 2022 and future filings and reports that NGM Bio makes from time to time with the SEC. Except as required by law, NGM Bio assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Investor Contact:Brian Schoelkopfir@ngmbio.com

Media Contact:media@ngmbio.com