Iterum Therapeutics Files for a $92 Million IPO to Advance Antibiotics

Published: May 02, 2018 By

IPO

Iterum Therapeutics, with headquarters in Dublin, Ireland and locations in Chicago and Old Saybrook, Connecticut, filed with the U.S. Securities and Exchange Commission (SEC) to initiate an initial public offering (IPO). The company hopes to raise $92 million.

Iterum is a clinical-stage drug company focused on developing anti-infectives for multi-drug resistant (MDR) pathogens.

The company recently gave a presentation and published two posters at the European Congress of Clinical Microbiology held in Madrid, Spain, April 21 to 24. The oral presentation of ePoster 0736 was, “Impact of Initial Inappropriate Antibiotic Therapy on Outcome for Uncomplicated Urinary Tract Infection Due to Antibiotic Non-Susceptible Enterobacteriaceae.” The study reviewed the records of 3,792 patients given oral antibiotics for urinary tract infections and concluded that more than 20 percent of patients with an outpatient UTI were given an antibiotic to bacteria that were resistant.

The posters were “Antimicrobial Activity of Sulopenem in the Urine of Healthy Volunteers” and “Impact of ESBL-Positivity and Quinolone Non-Susceptibility on Outcome for Inpatients with Complicated Urinary Tract Infections: A Multicenter Evaluation in the US.”

Sulopenem is the company’s lead compound, a novel penem anti-infective with oral and IV formulations. It has shown in vitro activity against a wide range of gram-negative, gram-positive and anaerobic bacteria that are resistant to other antibiotics. The compound has been designated a Qualified Infectious Disease Product (QIDP) under the U.S. Food and Drug Administration (FDA)’s Generating Antibiotics Incentives Now (GAIN) Act.

Iterum was founded in 2015 and brought in around $0.5 million in revenue in 2017. It expects to list on the Nasdaq under the symbol ITRM. Leerink Partners and RBC Capital Markets are the joint bookrunners on the IPO.

The funds will be used to advance the Phase III clinical trials of both oral and IV formulations of sulopenem.

Iterum acquired sulopenem, which is in the same class of antibiotics as penicillin, from Pfizer in 2015. Pfizer received an upfront payment, a stake in Iterum, and a shot at additional equity, milestones and royalties in the future.

Pfizer published information about the synthesis of sulopenem in the early 1990s and eventually evaluated it in a Phase II clinical trial. It presented results in 2010, showing cure rates of 90 percent and 88 percent in patients with community-acquired peneumonia requiring hospitalization. This compared to patients receiving ceftriaxone followed by an amoxicillin-clavulanate suspension, who had a cure rate of 63 percent.

The trial only had 33 patients, smaller than planned, and 10 didn’t complete the trial. The patients who dropped out came from both trial arms. The control arm had more side effects-related dropouts, and as many serious side effects as the sulopenem arms combined.

Technically, the data failed to show a statistically significant difference between the sulopenem and control arms, but it showed promise. The trial size wasn’t large enough to support definitive conclusions. But Pfizer apparently lost interest and didn’t prioritize the drug until Corey Fishman and Michael Dunne, who were part of the management team of Durata Therapeutics. Durata received approval for Dalvance, an antibiotic, which was then acquired by Actavis for $675 million in 2014. Durata bought its antibiotic from Pfizer as well.

Fishman is Iterum’s chief executive officer. At Durata, he was chief financial and chief operating officer. Dunne is Iterum’s chief scientific officer. He was Durata’s chief medical officer.

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