Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral antibiotics for multi-drug resistant pathogens in community settings, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Corey Fishman will engage in a Fireside Chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, on October 16, 2024, at 10:00 a.m. ET.

The summit is scheduled from October 15 – 17, 2024, and will be live-streamed on M-Vest. Interested parties can register and access the fireside chat through the provided link: https://m-vest.com/events/healthcare-10152024.

Iterum Therapeutics (Nasdaq: ITRM) provided an update on the FDA Advisory Committee discussion of oral sulopenem for treating uncomplicated urinary tract infections (uUTI) in adult women. The Antimicrobial Drugs Advisory Committee (AMDAC) met on September 9, 2024, to discuss the benefits, risks, and appropriate use of sulopenem etzadroxil/probenecid. The committee acknowledged oral sulopenem as an important treatment option for certain uUTI patients. Iterum presented data from the REASSURE and SURE-1 Phase 3 clinical trials. The FDA's decision on approval is expected by the PDUFA goal date of October 25, 2024. If approved, oral sulopenem could become the first oral penem approved in the U.S., potentially offering a new treatment for multi-drug resistant pathogens in community settings.

Iterum Therapeutics (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral antibiotics, will participate in the 26th Annual H.C. Wainwright Global Investment Conference from September 9-11, 2024, in New York City. CEO Corey Fishman will present on September 10 at 8:30 AM ET and host investor meetings.

The conference, held at the Lotte New York Palace Hotel, is open to qualified investors. Iterum's management will be available for one-on-one meetings on September 10. A replay of the webcast presentation will be accessible on Iterum's website in the Events & Presentations section after the event.

Iterum Therapeutics (NASDAQ: ITRM) reported Q2 2024 financial results and provided updates on its oral sulopenem NDA for uUTI treatment. Key highlights:

- FDA PDUFA action date set for October 25, 2024
- Advisory Committee meeting scheduled for September 9, 2024
- Completed rights offering, raising $7.4 million gross proceeds
- Cash runway extended into 2025
- Q2 2024 R&D expenses decreased to $2.1 million from $9.0 million in Q2 2023
- Q2 2024 net loss reduced to $5.0 million from $12.2 million in Q2 2023
- Cash position of $11.7 million as of June 30, 2024

The company continues to work with the FDA during the NDA review process and is preparing for the upcoming Advisory Committee meeting.

Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing next-generation oral and IV antibiotics, has announced its plans to release second quarter 2024 financial results on August 14, 2024, before the U.S. financial markets open. The company will host a conference call at 8:30 a.m. ET on the same day to discuss the results and provide a business update.

Investors and interested parties can access the call by dialing 833-470-1428 (domestic) or 404-975-4839 (international) and using the Access Code 775539. A pre-registration option is available. The audio webcast will be accessible under the "Financials & Filings" section of Iterum's website at www.iterumtx.com following the call.

Iterum Therapeutics plc (Nasdaq: ITRM) announced the expiration and results of its rights offering on August 6, 2024. The company distributed 17,007,601 non-transferable subscription rights to purchase 8,503,800 units at $1.21 per unit. Each unit consisted of one ordinary share and warrants. 6,121,965 units were validly subscribed for during the offering, with an additional 5,091,550 units exercised through over-subscription privileges. Iterum expects to receive gross proceeds of approximately $7.4 million, with estimated expenses of $1.1 million. The company plans to deliver the ordinary shares and warrants to rights holders and the warrant agent, respectively, on or about August 9, 2024.

Iterum Therapeutics (Nasdaq: ITRM) has strengthened its patent portfolio for oral sulopenem with new patents in the US and Canada. The USPTO has issued notices of allowance for two US patents: one covering the use of sulopenem etzadroxil and probenecid in treating uncomplicated urinary tract infections (expiring April 1, 2039), and another for the combination of sulopenem etzadroxil, probenecid, and valproic acid in treating specified infections (expiring March 11, 2041). Additionally, the Canadian Intellectual Property Office has issued a patent for a bilayer tablet comprising sulopenem etzadroxil and probenecid, its preparation methods, and use in treating specified diseases (expiring December 23, 2039). Iterum also has pending patent applications in other jurisdictions, including Europe and China.

Iterum Therapeutics (Nasdaq: ITRM) has commenced its previously announced rights offering. The company is distributing non-transferable subscription rights to eligible shareholders and warrant holders to purchase up to 8,503,800 units at $1.21 per unit. Each unit consists of one ordinary share, a 1-year warrant, and a 5-year warrant. The subscription period runs from July 22 to August 6, 2024. If fully subscribed, the offering could result in the issuance of 8,503,800 ordinary shares and warrants to purchase up to 12,755,700 additional shares. The company has engaged Maxim Group as the dealer-manager for the offering.

Iterum Therapeutics announced that the FDA has scheduled an Advisory Committee meeting on September 9, 2024, to discuss the NDA for oral sulopenem for treating uncomplicated urinary tract infections (uUTIs) in adult women. The discussion will address antimicrobial stewardship and the target patient population for this first-of-its-kind oral penem in the U.S. In April 2024, Iterum resubmitted the NDA, which the FDA accepted in May 2024, classifying it as a Class II complete response with a review period of six months. The FDA has set a PDUFA action date of October 25, 2024.