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Iterum Therapeutics Plc (ITRM) is a clinical-stage pharmaceutical company pioneering treatments for multi-drug resistant infections. This page provides investors and industry professionals with verified news and press releases about ITRM's advancements in oral and IV anti-infectives.
Access real-time updates on clinical trials, regulatory milestones like Qualified Infectious Disease Product (QIDP) designations, and strategic partnerships. Our curated repository ensures you stay informed about developments in antibiotic resistance solutions without promotional bias.
Key coverage areas include Phase 3 trial results, FDA communications, financial reporting, and R&D collaborations. All content is sourced directly from Iterum Therapeutics and reputable financial publications to ensure accuracy.
Bookmark this page for streamlined access to ITRM's latest progress in addressing global health challenges through differentiated anti-infective therapies.
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.
Iterum Therapeutics plc (Nasdaq: ITRM) will release its Q3 2021 financial results on November 12, 2021, before U.S. markets open. A conference call will occur at 8:30 a.m. ET to discuss these results and provide a business update. The company focuses on developing antibiotics to combat multi-drug resistant pathogens. Its leading compound, sulopenem, is currently in Phase 3 clinical development, with both oral and IV formulations receiving Fast Track and QIDP designations. For more details, visit iterumtx.com.
Iterum Therapeutics (Nasdaq: ITRM) announced a productive Type A meeting with the FDA regarding the New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). Following a Complete Response Letter (CRL) from the FDA for additional data, the company is exploring options for a new Phase 3 study. As of Q2 2021, Iterum has $91.5 million in cash, sufficient to support operations into H2 2023. The company continues to pursue solutions for addressing multi-drug resistant UTIs through its anti-infective research.