Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (Nasdaq: ITRM) announced a public offering of 26,923,076 ordinary shares at $0.65 per share, alongside warrants for 20,192,307 shares. The offering, expected to close on October 27, 2020, aims to raise approximately $17.5 million for its clinical initiatives, including the New Drug Application for oral sulopenem targeting urinary tract infections linked to quinolone-resistant pathogens. H.C. Wainwright & Co. acts as the exclusive placement agent. The offering is registered under Form S-1 with the SEC, effective October 22, 2020.

Iterum Therapeutics announced two data presentations at the IDSA IDWeek™ 2020 from October 21-25, covering results from the SURE-1 and SURE-2 trials for urinary tract infections. The SURE-1 trial demonstrated that oral sulopenem was statistically superior to oral ciprofloxacin in treating uncomplicated urinary tract infections (uUTI). Results from both trials will be presented by Michael Dunne, showing the comparative efficacy and safety of sulopenem against existing treatments for complicated and uncomplicated infections.

Iterum Therapeutics announced two upcoming data presentations at the IDWeek™ 2020, set for October 21-25, 2020. This includes findings from the SURE-1 trial demonstrating oral sulopenem's effectiveness against uncomplicated urinary tract infections (uUTI) compared to oral ciprofloxacin, deemed statistically superior. Additionally, results from the SURE-2 trial on complicated urinary tract infections (cUTI) will be shared. The company is progressing with sulopenem as a novel anti-infective aimed at combating antibiotic resistance.

Iterum Therapeutics has announced plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, a treatment for uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a positive pre-NDA meeting with the FDA, the company has received confidence regarding the submission's requirements. Over 6 million quinolone-resistant urinary tract infections occur annually in the U.S., and sulopenem has shown effectiveness exceeding ciprofloxacin. The company has been granted Fast Track and Qualified Infectious Disease Product designations for sulopenem.

Iterum Therapeutics (Nasdaq: ITRM) plans to submit a New Drug Application (NDA) for sulopenem etzadroxil/probenecid, aimed at treating uncomplicated urinary tract infections caused by quinolone-resistant pathogens. Following a pre-NDA meeting with the FDA, Iterum is confident about its submission strategy. Each year, over 6 million quinolone-resistant UTIs occur in the U.S. The NDA follows sulopenem's proven superiority over ciprofloxacin in clinical settings. The company’s innovative approach addresses the growing crisis of multi-drug resistant infections.

Iterum Therapeutics announced its participation in the 22^nd Annual H.C. Wainwright Global Investment Conference, taking place virtually from September 14 – 16, 2020. CEO Corey Fishman will present an overview of the company on September 16, 2020, at 10:00 a.m. ET. The company is dedicated to developing antibiotics to combat multi-drug resistant pathogens, focusing on its lead compound, sulopenem, currently in Phase 3 clinical development. Iterum has received QIDP and Fast Track designations for sulopenem in seven indications.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the expiration of its rights offering subscription period on August 31, 2020. The offering allowed rights holders to purchase units consisting of Exchangeable Senior Subordinated Notes and Limited Recourse Royalty-Linked Subordinated Notes. The company reported preliminary results with 6,374 units subscribed, estimating gross proceeds of approximately $6.37 million, excluding estimated expenses of $1.5 million. Settlement is expected around September 8, 2020. The offering was linked to a prior private placement involving new securities.

Iterum Therapeutics plc (Nasdaq: ITRM) reported its Q2 2020 financial results, highlighting a net loss of $12.5 million, a significant improvement from the $27.6 million loss in Q2 2019. Cash and cash equivalents stood at $12.3 million, supplemented by $4.4 million from a registered direct offering in July 2020. The company achieved one primary endpoint in its uUTI trial but failed in its cUTI trial. A meeting with the FDA is scheduled for Q3 2020 to discuss regulatory options for sulopenem. Overall R&D expenses dropped to $5.0 million, reflecting reduced clinical trial activities.

Iterum Therapeutics plc (Nasdaq: ITRM) announced a planned rights offering to raise up to $8.4 million, following a private placement of senior subordinated notes. The record date for the rights offering is set for August 5, 2020. Each eligible shareholder will receive one non-transferable subscription right per ordinary share owned, allowing them to purchase up to 8,400 units at a subscription price of $1,000 per unit. The subscription period is expected to start on August 11, 2020, lasting at least 20 days. Details will follow after the SEC registration statement becomes effective.