Iterum Therapeutics plc (ITRM), a clinical-stage pharmaceutical company, has seen an increase of 21.65% in the premarket trading session. As a result, ITRM stock was trading at $0.67 when last checked. The reason for this gain appears to be the update by the company regarding a meeting with FDA about Oral Sulopenem. On Tuesday, ITRM stock closed the day at $0.55 after gaining a 0.49% increase in regular trading hours.
ITRM meeting with FDA
In the late hours of Tuesday, ITRM announced that the company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the third quarter of fiscal 2021. The meeting was held to discuss the steps for potential resubmission of a New Drug Application (NDA) about sulopenem etzadroxil/probenecid (oral sulopenem). Sulopenem etzadroxil is used to treat uncomplicated urinary tract infections. In July, ITRM announced that it had received a Complete Response Letter (CRL) from FDA. The CRL requested Iterum to provide additional data, which would have ultimately supported the approval of oral sulopenem for the treatment of adult women with Urinary Tract Infections. The company said that at the end of the second quarter, it had cash and cash equivalents of $91.5 million. Based on that, the company hoped that it is well-positioned to fund its operations in future quarters. Corey Fishman, Chief Executive Officer of Iterum said that the company had a successful meeting with FDA and hopes that it would generate positive outcomes for it.
Q2 2021 financial results
On 13th August, ITRM reported the quarterly results for the second quarter of the fiscal year 2021, which ended on 30th June. According to the details, the company had cash and cash equivalents of $36.57 million on 30th June. The total assets stood at $106.04 million while total liabilities at the end of the quarter were $58.85 million. The operating expenses bore by the company during the quarter stood at $6.98 million, as compared to $8.25 million for an equivalent period of 2020. The operating loss for the period stood at $6.98 million, while during the equivalent period of 2020, the operating loss was $8.25 million. The net income attributable to common shareholders stood at $7.79 million. Comparative to that, the net loss attributable to common shareholders for the equivalent period of 2020 stood at $12.52 million. The net income per basic and diluted share for the period stood at $0.04. For an equivalent period of 2020, the net loss per basic and diluted share stood at $0.80.
What’s ahead for ITRM?
The 52 weeks high of ITRM stock has been $2.99, while 562 week low stands at $0.45. According to analyst estimates, the EPS of ITRM stock is expected to rise by 69% during the current fiscal year. Based on these stats, ITRM stock could enjoy positive times in the near future.
