Iterum Therapeutics plc (NASDAQ:ITRM) Reports A Loss Of $98.9 Million In Q1 2021: FDA Reviews Oral Sulopenem To Treat uUTI In Patients With Quinolone Non-susceptible Organism

Iterum Therapeutics plc (NASDAQ:ITRM) widened its loss to $98.91 Million in Q1 2021. It is mainly because of non-cash adjustments. 

The company maintains short-term investments, CE (Cash Equivalents), and a cash balance of $100.5 million in Q1 2021. It can use these funds to support its operations until Q1 2023. 

A significant drop in R&D spending

Iterum reduced its R&D spending by 74.22% YoY to $2.5 million in Q1 2021 because it already concluded Phase 3 clinical studies in 2020.

The company’s G&A expenses are almost flat at $3.4 million. It is on the backdrop of increased spending on consultation fees for its G&A activities and pre-commercialization support. 

Sulopenem under review by the FDA

CEO of Iterum, Corey Fishman, said the company would hold a conference with FDA. Meanwhile, FDA is reviewing its NDA (new drug application) for oral sulopenem to cure uUTI (uncomplicated urinary tract infections) in females with a QNO (quinolone non-susceptible organism). 

The company expects the decision of the FDA for oral sulopenem in H2 2021. It expects to unveil oral sulopenem in Q4 2021 into the community on receiving FDA approval.

Raises $74.3 million

Iterum raised $74.3 million through registered direct offering and underwritten public offering in February 2021. The company maintains ordinary outstanding shares of 179.1 million in Q1 2021.

The company would sign an agreement with a third-party commercialization services provider – EVERSANA, in January 2021 to commercialize its oral sulopenem. It commenced pre-launch activities.

Replaces Patrick Heron with Beth P. Hecht

Iterum replaced Patrick Heron with Beth P. Hecht on March 12, 2021, on the board. 

The company inducted Beth to the board because Heron said he would relinquish his post. In addition to acting as a board member, Beth would also work as a member of the Compensation Committee of the Board and audit committee.

Fishman expressed pleasure at the leadership of Patrick since the company’s inception in 2015. Patrick’s experiences and experience helped the company to build a solid foundation. 

Fishman welcomed Beth as she came at the right time and would contribute in-depth knowledge in commercial operations, extensive experience in various industries, and exemplary expertise in legal, regulatory, and compliance matters.