Iterum Therapeutics (ITRM) shares gained 3.36% in the morning session on Thursday, May 27, 2021, and closed at $1.23 per share. ITRM continue its momentum in the after-hours and further surged 25.2% to close the trading at $1.54 per share. ITRM shares have declined 71.46% over the last 12 months, and they have moved up 8.85% in the past week. Over the past three months, the stock has lost 25.00%, while over the past six months, it has gained 50.00%.
NDA review update
On May 27, 2021, Iterum Therapeutics participated in a late-cycle meeting with the U.S. Food and Drug Administration (FDA).
FDA discussed the issue related to the company’s new drug application (NDA) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues.
The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021, and at the moment Advisory Committee meeting is not necessary.
Recent financial results
On May 14, 2021, Iterum Therapeutics plc announced its financial results for the first quarter ended March 31, 2021.
Q1 2021 financial highlights
- Research and development expenses were $2.5 million inQ1 2021 compared to $9.7 million for the same period in 2020.
- General and administrative expenses were $3.4 million in Q1 2021 compared to $3.2 million in Q1 2020.
- Iterum suffered from a non-GAAP net loss of $6.1 million in Q1 2021 compared to a non-GAAP net loss of $13.4 million for Q1 2020.
- Iterum reported a net loss of $98.9 million in Q1 2021 compared to a net loss of $16.1 million in Q1 2020.
- Net loss per share attributable to ordinary shareholders, basic and diluted was $0.81 in Q1 2021 compared to $1.08 in Q1 2020.
- Iterum had cash, cash equivalents, and short-term investments of $100.5 million on March 31, 2021.
Participation in the investor and health conferences
Iterum Therapeutics participated in the 20th Annual Needham Virtual Healthcare Conference which held on Thursday, April 15, 2021. The company was presented by Chief Executive Officer, Corey Fishman.
The company took part in HC Wainwright Global Life Sciences Conference which held on March 9, 2021.
The company also participated in SVB Leerink Annual Global Healthcare Conference which held on Thursday, February 25, 2021.
New Board member
On March 16, 2021, Iterum Therapeutics appointed Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron, who left the Board on March 12, 2021. Ms. Hecht will also serve as a member of the Audit Committee and Compensation Committee of the Board.
The recent meeting with the FDA about its NDA could be the reason behind its positive performance on Thursday. it is hard to predict how ITRM stock will end the week.