The clinical-stage pharmaceutical company Iterum Therapeutics plc (NASDAQ: ITRM) recently reported its Q1-2021 financial results. The shares of ITRM were up 17.89% on Monday, anticipating its new drug application with the FDA for a potential treatment for UTI.
Pitching oral sulopenem for UTI treatment
Sulopenem etzadroxil/probenecid is pitched for uncomplicated UTI or urinary tract infections in patients suffering from quinolone non-susceptible pathogen. While the NDA status is still under review, investors are diving into ITRM on high hopes. Additionally, the company has also reported that the final status review of this drug is July 25, 2021.
ITRM’s plans for oral sulopenem seem to be in line with its goals, pushing the price movement in the market. In February 2021, Iterum Therapeutics engaged a leading commercial services provider, EVERSANA™, to its life science industry. The company has kicked off pre-launch activities, even as it is in the final leg of getting the oral drug approved by the FDA. The agreement finalization stage with EVERSANA™ is also in place, and the commercial services provider will officially and commercially launch the FDA-approval waiting drug, oral sulopenem.
Q1-2021 financial report
With the completion of Phase 3 clinical trials of sulopenem etzadroxil/probenecid, the company reported lesser R&D expense. In Q1 2021, the research and development expenses came in at $2.5 million against $9.7 million in Q1-2020.
In Q1-2021, ITRM incurred a $98.9 million net loss, comparable with $16.1 million for the same period in a year prior. The present net loss is largely attributed to non-cash adjustments applicable on derivative liabilities regarding the company’s Royalty-Linked Notes and Exchangeable Notes. Additionally, the cash on hand, short-term investments, and cash equivalents as of March 31, 2021, were reported at $100.5 million. Depending upon its present operational status, the company is hoping for sufficient funds to power through H1-2023.
ITRM’s late-cycle meeting with FDA has also concluded, and the NDA status is still under review. Once approved, the new drug will generate revenue for the company, from where the investors are hoping to mint money.