NGM Biopharmaceuticals, Inc. announced encouraging new data from an ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA®? (pembrolizumab). There are currently no FDA-approved therapies for PSC.

NGM Bio recently met with the FDA regarding the design of a potential registrational trial, including the utilization of proposed surrogate primary endpoints. NGM Bio plans to continue working with the FDA to reach agreement on a trial design in the coming months, with the goal of initiating trial enrollment by the end of 2024, contingent upon reaching agreement with the FDA on trial design and additional capital availability. Continue discussions with the FDA on the design of aldafermin for the treatment of PSC and provide an update in the first half of 2024; plan to initiate enrollment by the end of 2024.

Plan to initiate a reproductive toxicology study of NGM120 for the treatment of hyperemesis in 2024, subject to ongoing discussions with the FDA on an acceptable toxicology package; the therapeutic potential of, potential indications for and/or planned and continued development of the product candidates in NGM Bio's pipeline, including NGM707, aldafermin, NGM120, NGM831 and NGM438; the planned timing of initiation, enrollment, data readouts and results of NGM Bio's clinical trials; These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with: the shift in NGM Bio's strategy and investor perception thereof; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; 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 future trials and that interim topline and preliminary results of clinical trials may change as more participant data becomes available and are subject to audit and verification procedures, which could result in material changes in the final data and such interim topline and preliminary Results may not be predictive of final results or results obtained in future trials; the lack of regulatory clarity regarding acceptable surrogate endpoints for PSC and related development uncertainty.