Iterum Therapeutics plc (NASDAQ: ITRM) has announced its Q3 2021 financial results in which net income was $3.7 million relative to a net loss of $12.2 million a year ago.
Iterum has enough cash to run through 2024
The net income increase was a result of non-cash adjustments of derivative liabilities in Q3 2021. The company has a non-GAAP net loss of $5.2 million in Q3 2021 relative to a net loss of $7 million last year. Research and development costs dropped from $3.9 million last year to $1.8 million, attributed to completing phase 3 clinical trials last year.
At the end of the quarter, the company has cash, equivalents, and near-term investments of $85.7 million. The company expects the cash and short-term investments to be enough to fund operations through 2024 based on the present operating plans and depending on the final determination of the design and expected conduct of more non-clinical and clinical development of sulopenem.
Iterum planning Type B meeting with FDA for NDA resubmission
The company held a Type A meeting with the US FDA in the third quarter, and a Type B meeting with the agency has been requested. During the Type A meeting, the company discussed the steps necessary for resubmitting a New Drug Application for oral sulopenem after receiving a Complete Response Letter in July 2021. The Type B meeting with the Agency will discuss the design for a possible new clinical study supporting the potential resubmission.
CEO Corey Fishman said, “We had a productive Type A meeting with the U.S. Food and Drug Administration (FDA) in the third quarter in which various potential paths forward to support potential resubmission of our New Drug Application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) were discussed. We have since requested a Type B meeting with the FDA with the goal of reaching agreement on the design of a Phase 3 trial for oral sulopenem for the treatment of uUTI that, if successful, could lead to a resubmission of our NDA.”
