Iterum Therapeutics Plc Loss Submission Form

(i) the sulopenem New Drug Application (“NDA”) lacked sufficient data to support approval for the treatment of adult women with urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be nonsusceptible to a quinolone; (ii) accordingly, it was unlikely that the Food and Drug Administration would approve the sulopenem NDA in its current form; (iii) Defendants downplayed the severity of issues and deficiencies associated with the sulopenem NDA; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.