- Iterum Therapeutics plc is a small late-clinical-stage pharmaceutical company developing Sulopenem, their lead and sole therapeutic for urinary tract and intra-abdominal infections.
- Iterum has tested their sole candidate Sulopenem in 3 simultaneous Phase 3 trials, but none met their primary endpoints, except for a subpopulation of uUTI patients with a quinolone non-susceptible pathogen.
- Iterum is in a strong financial position with cash of $17M and an additional +$74.3M from Feb. 2021 financings albeit with no revenues and total debt of $48M.
- Iterum's next catalyst that is life or death for this biotech is the NDA approval meeting by the FDA (advisory-committee delayed in April 2021) for Sulopenem expected in Q3 2021.
- In summary, the author projects Iterum Therapeutics plc as a risky "hold" and if successful with Sulopenem's NDA, a 1-year conservative price target of $2.00 (+61% upside).
For further details see:
Iterum Therapeutics: Delayed Review Of Its NDA For Sulopenem, But Upside Still Exists