Iterum Therapeutics Plc Stock Price, News & Analysis

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.

Iterum Therapeutics has entered into agreements for the purchase of 3,372,686 ordinary shares at $1.4825 each in a registered direct offering, totaling approximately $5.0 million. Concurrently, unregistered warrants to purchase up to 1,686,343 ordinary shares will be issued with an exercise price of $1.42 per share. Proceeds will support continued clinical development of sulopenem and general corporate purposes. The offering is set to close around July 2, 2020, pending customary conditions.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the successful passing of all resolutions at its Annual General Meeting on June 10, 2020. A significant resolution allowed Sarissa Capital Management's funds to potentially acquire up to 60% of the company's ordinary shares through the exchange of $15 million of Exchangeable Senior Subordinated Notes. The resolution received 6,808,330 votes in favor and 199,749 against. The Sarissa Notes could result in the issuance of approximately 15 million new shares.

Iterum Therapeutics (Nasdaq: ITRM) announced a registered direct offering to institutional investors, selling 2,971,770 ordinary shares at $1.6825 each. The concurrent private placement includes unregistered warrants for 1,485,885 shares, exercisable at $1.62 per share. Gross proceeds are expected to reach $5 million, which will fund the ongoing Phase 3 trial of sulopenem for uUTI, regulatory filings, and general corporate expenses. The closing date is anticipated around June 5, 2020, subject to customary conditions.

Iterum Therapeutics (Nasdaq: ITRM) announced that its sulopenem did not achieve statistical non-inferiority to ertapenem in the SURE 2 trial for complicated urinary tract infection (cUTI). The trial involved 1,395 patients, and responder rates were 67.8% for sulopenem versus 73.9% for ertapenem, showing a -6.1% difference. Following these disappointing results, the company is evaluating strategic and financial alternatives, including potential asset sales or restructuring. Sulopenem has shown tolerability, with ongoing development in other areas, but the recent trial outcome raises concerns for stakeholders.