Iterum Therapeutics plc Ordinary Share - ITRM STOCK NEWS

Iterum Therapeutics plc (Nasdaq: ITRM) announced a meeting with the FDA on May 5, 2022, regarding plans for an additional Phase 3 trial of oral sulopenem aimed at treating uncomplicated urinary tract infections (uUTI). The company reported reaching alignment with the FDA on trial design, which will compare oral sulopenem with Augmentin® in adult women. Iterum plans to seek a Special Protocol Assessment (SPA) agreement from the FDA and aims to start patient enrollment in the second half of 2022. The outcome of the SPA agreement is crucial but does not guarantee FDA approval.

Iterum Therapeutics plc (Nasdaq: ITRM) presented two posters at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held in Lisbon from April 23-26, 2022. The presentations highlighted the in vitro activity of its antibiotic, Sulopenem, against anaerobic bacteria and the efficacy of IV to oral Sulopenem in treating complicated intra-abdominal infections compared to standard treatments. The company continues to advance Sulopenem, which has received Fast Track and Qualified Infectious Disease Product designations for seven indications.

Iterum Therapeutics (ITRM) reported its fourth quarter and full year 2021 financial results, emphasizing progress in its NDA resubmission for oral sulopenem. The firm plans to start a Phase 3 trial for uUTI in H2 2022, aided by a 180-day Nasdaq compliance extension granted on March 9, 2022. Iterum's cash reserves total $81.3 million, sufficient to fund operations into 2024. The net loss narrowed to $4.2 million for Q4 2021, with a full-year loss of $91.6 million. R&D expenses rose to $10.7 million, while G&A expenses reached $13.8 million, reflecting increased pre-commercial activities.

Iterum Therapeutics plc (Nasdaq: ITRM) will announce its Q4 and full year 2021 financial results on March 28, 2022, before U.S. markets open. A conference call is scheduled for 8:30 a.m. ET the same day to discuss these results and provide a business update. The company focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens, with its lead product, sulopenem, in Phase 3 clinical development. It has received QIDP and Fast Track designations for multiple indications.

Iterum Therapeutics (Nasdaq: ITRM) has been granted a 180-day extension by Nasdaq to regain compliance with its minimum bid price requirement, now due by September 5, 2022. The company must close at $1.00 or higher for 10 consecutive business days to meet the Bid Price Rule. If compliance is not achieved, Nasdaq may delist the company's ordinary shares, although an appeal is possible. The extension has no immediate effect on trading. Iterum aims to combat multi-drug resistant pathogens, advancing its compound sulopenem in Phase 3 clinical development.

Iterum Therapeutics plc (Nasdaq: ITRM) announced on February 8, 2022, the granting of a non-statutory share option to a new employee, comprising 50,000 ordinary shares. The share option has an exercise price of $0.41, equal to the closing price on the grant date, and a 10-year term, vesting over four years. This incentive aligns with Nasdaq regulations and forms part of the new hire's compensation package. Iterum is focused on developing advanced antibiotics, particularly sulopenem, which is in Phase 3 clinical development.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the granting of a share option for 1,800,000 ordinary shares and 500,000 restricted share units to its new Chief Medical Officer, Dr. Sailija Puttagunta. Effective December 10, 2021, the share option has an exercise price of $0.48 and vests over four years. This grant is part of Dr. Puttagunta’s employment compensation and complies with Nasdaq's inducement grant exception. Iterum Therapeutics focuses on developing antibiotics to combat multi-drug resistant pathogens and is advancing its lead compound, sulopenem, in Phase 3 clinical development.

Iterum Therapeutics (Nasdaq: ITRM) announced the appointment of Dr. Sailaja Puttagunta as Chief Medical Officer, effective immediately. Dr. Puttagunta, who has over 20 years of experience in infectious diseases, will oversee global clinical development and regulatory initiatives as the company advances its antibiotic candidate, sulopenem, which is currently in Phase 3 trials. The leadership change is expected to enhance Iterum's strategies for clinical development, particularly against multi-drug resistant infections.

Iterum Therapeutics reported a productive Type A meeting with the FDA regarding the potential resubmission of its NDA for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTI). A Type B meeting has been requested to finalize the design for an additional Phase 3 trial. Financially, the company has $85.7 million in cash, sufficient to fund operations into 2024. The third-quarter net income was $3.7 million compared to a net loss of $12.2 million in 2020, supported by a significant non-cash adjustment in derivative liabilities.