The lead underwriters on the deal were Leerink Partners and RBC Capital Markets. Shares are set to open for trading later this morning on the Nasdaq.
ITRM is a pharmaceutical company dedicated to developing and commercializing sulopenem to be potentially the first and only oral and intravenous (IV) branded penem available globally. Penems, including thiopenems and carbapenems, belong to a class of antibiotics more broadly defined as ß-lactam antibiotics, the original example of which was penicillin, but which now also includes cephalosporins.
The company licensed Sulopenem from Pfizer in November 2015. The drug is a potent, thiopenem antibiotic delivered intravenously which is active against gram-negative bacteria that cause urinary tract and intra-abdominal infections. Pfizer also developed an oral prodrug, sulopenem etzadroxil, which it further enhanced with the addition of probenecid and combined into a single bilayer tablet, which ITRM refers to as oral sulopenem.
ITRM plans to initiate a Phase 3 clinical program in 2H18 for the treatment of adults in three indications. One of these will be treatment ofuUTIs, complicated urinary tract infections, and complicated intra-abdominal infections. Furthermore, it expects to complete enrollment and produce top-line data for all three clinical trials in 2H19 and to submit its new drug applications to the FDA by the end of 2019.
If the FDA approves oral sulopenem and sulopenem, it plans to build a targeted commercial infrastructure to launch both product candidates in the United States. Outside of the United States, ITRM is evaluating its options to maximize the value of its sulopenem program.
Finally, the company plans to employ a dual sourcing strategy for critical elements of its sulopenem supply chain. ITRM expects to register two suppliers and validate at least one supplier for the manufacture of the active pharmaceutical ingredient at the time of our planned regulatory filings in the United States by the end of 2019.
As a clinical stage pharmaceutical company, there is little in the way of financials at this point. For the three months ended March 31, 2018, it generated $191K in revenue and had an operating loss of ($12.2) mln As of March 31, 2018, it has pro forma cash on hand of $74.8 mln and an outstanding $15 mln credit facility.