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 fourth quarter and year ended December 31, 2020.

“Iterum has made excellent progress in the last few months and we look forward to continuing that momentum throughout 2021. In the fourth quarter of 2020, we submitted a New Drug Application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible organism, which is currently under review by the U.S. Food and Drug Administration (FDA) with a July 25, 2021 Prescription Drug User Fee Act (PDUFA) goal date. We estimate that the market for this indication is approximately 6.5 million uUTIs caused by a quinolone non-susceptible organism annually in the U.S.,” said Corey Fishman, Chief Executive Officer. “Our priorities for the rest of this year are: (1) holding a positive Advisory Committee meeting in June, (2) completion of FDA review of our NDA by the end of July, (3) initiating the commercial launch in the fourth quarter, if approved, and (4) working with the FDA to understand the requirements for potential expansion of our label in uUTI to include all patients, if approved, and to potentially add the complicated urinary tract infection (cUTI) indication. In anticipation of these key milestones, we have raised sufficient capital to support the execution of our strategy as currently planned.”

• NDA accepted for priority review by FDA with PDUFA goal date of July 25, 2021:  In January 2021, the FDA accepted for review our NDA for uUTI in patients with a quinolone non-susceptible organism. The FDA has designated our application as a priority review and consequently assigned a PDUFA goal date for completion of the review of oral sulopenem of July 25, 2021. The FDA currently plans to hold an advisory committee meeting to discuss the NDA on June 2, 2021.
• Extended cash runway  into first half of 2023:  In February 2021, we received total net proceeds of $74.3 million from an underwritten public offering and a registered direct offering which, along with proceeds received from the exercise of certain warrants and existing cash and cash equivalents, has extended our cash runway into the first half of 2023, based on our current operating plan. As of February 28, 2021, we had approximately 176.5 million ordinary shares outstanding.
• Announced collaboration with a third-party provider of commercialization services:  In February 2021, we engaged EVERSANAâ„¢, a leading provider of commercial services to the life science industry, to initiate certain pre-launch activities. We are in the process of finalizing an agreement with EVERSANAâ„¢ to provide commercialization services to launch oral sulopenem, if approved.

Fourth Quarter and Full Year 2020 Financial Results

As of December 31, 2020, Iterum had cash and cash equivalents of $14.5 million. In February 2021, Iterum received total net proceeds of $74.3 million from an underwritten public offering and a registered direct offering. Iterum expects that its current cash and cash equivalents, including the proceeds from these recent financings and proceeds received from the exercise of certain warrants, will be sufficient to fund its operations into the first half of 2023.

Research and development (R&D) expenses for the fourth quarter and full year 2020 were $2.4 million and $21.1 million, respectively, compared to $20.9 million and $90.8 million for the  same periods in 2019. The decreases for both the three-month and twelve-month periods were primarily due to the substantial completion of our three Phase 3 clinical trials in 2019.

General and administrative (G&A) expenses for the fourth quarter and full year 2020 were $2.3 million and $11.1 million, respectively, compared to $2.3 million and $11.3 million for the  same periods in 2019. The slight decrease for the full year was primarily due to lower consulting spend on pre-commercialization activities and lower headcount, partially offset by higher share-based compensation expense.

Interest expense, net for the fourth quarter and full year 2020 was $4.2 million and $15.1 million, respectively, compared to $0.4 million and $0.9 million for the same periods in 2019, primarily due to non-cash interest expense and amortization of debt discounts and deferred financing costs relating to the Company’s Exchangeable Notes and Royalty-Linked Notes issued in 2020.

For the fourth quarter and full year 2020, Iterum reported a net loss of $11.2 million and $52.0 million, respectively, compared to a net loss of $23.6 million and $103.1 million for the same periods in 2019.