Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (ITRM) reported Q4 and full-year 2020 financial results, highlighting notable progress on its NDA for oral sulopenem intended for urinary tract infections. The FDA's PDUFA goal date is set for July 25, 2021. The company has extended its cash runway into the first half of 2023 due to proceeds of $74.3 million from recent offerings. R&D expenses decreased significantly to $21.1 million from $90.8 million a year earlier. Iterum's net loss for 2020 narrowed to $52.0 million from $103.1 million in 2019. A conference call is scheduled for today at 8:30 am ET.

Iterum Therapeutics (Nasdaq: ITRM) is set to announce its fourth quarter and full year 2020 financial results on March 12, 2021, before the U.S. market opens. A conference call will follow at 8:30 a.m. ET for management to discuss the outcomes. Iterum is focused on developing antibiotics like sulopenem, which is in Phase 3 trials to combat multi-drug resistant pathogens. The company has received QIDP and Fast Track designations for sulopenem's formulations across seven indications.

Iterum Therapeutics, a clinical-stage pharmaceutical company, announced that CEO Corey Fishman will present at key investor conferences, including the SVB Leerink Annual Global Healthcare Conference on February 25, 2021, and the HC Wainwright Global Life Sciences Conference starting March 9, 2021. The company is focusing on its lead compound, sulopenem, in Phase 3 clinical trials for treating infections caused by multi-drug resistant pathogens. Sulopenem has received Fast Track and Qualified Infectious Disease Product designations for various indications.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the successful closure of its public offering of ordinary shares, with the underwriter fully exercising its option to purchase an additional 5,217,391 shares. This brings the total shares sold to 40,000,000, generating net proceeds of approximately $42.1 million. The funds are projected to sustain operations through mid-2023, covering expenses until the PDUFA goal date of July 25, 2021, for the FDA's review of sulopenem. The offering is registered under Form S-3 with the SEC and includes forward-looking statements about the company's financial outlook.

Iterum Therapeutics plc (Nasdaq: ITRM) announced a definitive agreement to sell 17,500,000 ordinary shares at $2.00 each in a registered direct offering, expected to close by February 12, 2021. The offering is projected to generate approximately $35.0 million in gross proceeds. The funds will be allocated for ongoing NDA review for oral sulopenem, pre-commercialization activities, continued clinical development, and general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for this transaction.

Iterum Therapeutics plc (Nasdaq: ITRM) has announced an increase in its public offering to 34,782,609 ordinary shares at $1.15 each, aiming to raise approximately $40 million. The funds will support the New Drug Application review for oral sulopenem, pre-commercialization, and operational expenses. The offering closes around February 8, 2021, pending customary conditions. With this offering, Iterum anticipates its funds will last into Q3 2022, covering expenses until the FDA's review completion date of July 25, 2021.

Iterum Therapeutics plc (Nasdaq: ITRM) announced an underwriting agreement with H.C. Wainwright & Co. to sell 8,695,653 ordinary shares at $1.15 each, potentially raising approximately $10 million. An additional 1,304,347 shares may be purchased by the underwriter. Proceeds will primarily support the review of its New Drug Application for oral sulopenem, pre-commercialization activities, and working capital. The offering is expected to close around February 8, 2021. The company anticipates sufficient funds to support operations into Q1 2022, but warns of inherent risks to projections.

Iterum Therapeutics (Nasdaq: ITRM) announced a partnership with EVERSANA™ to initiate pre-launch activities for its oral sulopenem, targeting uncomplicated urinary tract infections (uUTIs). The FDA accepted the New Drug Application (NDA) for sulopenem, with a priority review and a PDUFA date set for July 25, 2021. The collaboration aims to enhance market access, strategic marketing, and medical education, preparing for a potential late 2021 launch. The CEO expressed confidence in EVERSANA's capabilities to support an effective launch of this antibiotic aimed at combating multi-drug resistant pathogens.

Iterum Therapeutics announced that the FDA accepted its New Drug Application for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs). This application has been designated for priority review, with a PDUFA goal date of July 25, 2021. If approved, sulopenem would be the first oral penem in the U.S. and the first new treatment for uUTIs in over 20 years, addressing the issue of quinolone resistance in millions of U.S. cases annually. The NDA includes positive data from Phase 3 clinical trials demonstrating superior efficacy compared to ciprofloxacin.