EXHIBIT 99.1

 

 

 

 

FOR IMMEDIATE RELEASE

 

Iterum Therapeutics Reports Third Quarter 2020 Financial Results

 

--NDA Filing Expected Q4 2020--

 

DUBLIN, Ireland and CHICAGO, November 16, 2020

-- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter ended September 30, 2020.

 

“Following the positive feedback we received from the FDA at our pre-NDA meeting in September, we have been diligently preparing our new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) due to quinolone-resistant pathogens for submission in the coming weeks, and are making preparations for a potential commercial launch of oral sulopenem in the U.S.,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “With potential approval anticipated within the next three quarters, we are pleased to be the first oral penem to market in the U.S., and the first approved product in uUTI in over 20 years, where quinolone-resistant pathogens now cause as many as one third of the 22 million uUTIs annually.”

 

Q3 2020 Highlights and Recent Events

 

Positive meeting with the FDA resulting in continued preparation for submission of the NDA filing in the near-term:  Based on discussions with the FDA at a pre-NDA meeting in September 2020 and previous correspondence with the FDA, the Company plans to proceed with an NDA submission for oral sulopenem (sulopenem etzadroxil/probenecid) for the treatment of uUTIs in patients with a quinolone non-susceptible pathogen in the fourth quarter of 2020.  In June 2020, as previously disclosed, the Company announced topline data from the SURE-1 clinical trial demonstrating that oral sulopenem was statistically superior to ciprofloxacin in the treatment of patients with uUTI caused by a quinolone non-susceptible pathogen.

Extended cash runway:  In October 2020, the Company raised approximately $17.4 million gross proceeds (approximately $15.3 million net proceeds) in a registered public offering of ordinary shares, pre-funded warrants exercisable for ordinary shares and warrants exercisable for ordinary shares, which extended the Company’s expected cash runway into the third quarter of 2021.

Presented results from two Phase 3 studies at the Infectious Disease Society of America (IDSA) IDWeek™ 2020 (IDWeek):  In October 2020, the Company presented results from two of its Phase 3 clinical trials at IDWeek.  The two data presentations included a poster presentation of the results of the SURE-2 clinical trial in complicated urinary tract


The following information was filed by Iterum Therapeutics Plc (ITRM) on Monday, November 16, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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