Iterum Therapeutics plc (ITRM) shares plunged 39.74% in after-hours on Thursday, July 1, 2021, and closed the day at $1.38 per share. earlier in the morning session, ITRM’s stock lost 0.87% to close Thursday’s normal session at $2.29 per share. ITRM shares have risen 92.44% over the last 12 months, and they have moved up 12.81% in the past week. Over the past three months, the stock has gained 56.85%, while over the past six months, it has declined 140.55%.

Let’s have a look at ITRM recent developments.

Recent Regulatory Update about sulopenemetzadroxil/probenecid

On July 01, 2021, Iterum Therapeutics plc received a letter from the U.S. Food and Drug Administration (FDA) stating that as part of their ongoing review of the Company’s New Drug Application (NDA) for sulopenemetzadroxil/probenecid.

The FDA identified deficiencies that prevent the continuation of the discussion of labeling and post-marketing requirements. The notification does not reflect a final decision on the information under review and FDA has set July 25, 2021, for completion of its review of the NDA.

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.

Conclusion

The recent letter from the FDA identifying the deficiencies in its NDA for sulopenemetzadroxil was the reason behind its poor performance on Thursday. ITRM can face more headwinds on Friday as well.