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Iterum Therapeutics plc (Nasdaq: ITRM) is an Ireland-based clinical-stage pharmaceutical company committed to developing unique anti-infectives to address the global crisis of multi-drug resistant (MDR) pathogens. The company's flagship product, sulopenem, is a novel penem anti-infective available in both oral and intravenous formulations. Sulopenem has shown potent in-vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.
Currently, Iterum is focused on advancing sulopenem through Phase 3 clinical development. The company recently completed its REASSURE trial—a critical study comparing oral sulopenem to oral Augmentin® in adult women with uncomplicated urinary tract infections (uUTIs). The trial demonstrated that oral sulopenem was non-inferior to Augmentin® for the primary efficacy endpoint, with statistically significant superiority in overall success rates.
Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem in seven indications from the U.S. Food and Drug Administration (FDA). The company recently resubmitted its New Drug Application (NDA) for oral sulopenem, which has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) action date set for October 25, 2024.
Financially, Iterum reported robust research and development (R&D) expenditures, primarily driven by the REASSURE trial. The company’s net loss decreased in 2023 compared to the previous year, reflecting its focused investment in key clinical trials and strategic projects.
Iterum is actively seeking partnerships and strategic options to maximize the value of sulopenem, including potential sales or licensing agreements. The firm's dedicated efforts in combating MDR pathogens aim to significantly improve the lives of people affected by serious and life-threatening diseases.
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.
Iterum Therapeutics (Nasdaq: ITRM) has announced its participation in the ASM Microbe 2024 conference in Atlanta, Georgia, from June 13-17, 2024. The company will present a poster titled 'In Vitro Assessment of Sulopenem against Mycobacterium avium Complex' on June 16, 2024, from 10:00 a.m. to 4:00 p.m. in the Exhibit Hall. The presentation falls under the category of 'New Antimicrobial Agents' and will be delivered by Dr. Steven I. Aronin. The poster will be available on Iterum Therapeutics' website after the conference.
Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to Augmentin® and even demonstrated statistically significant superiority in overall success rate. The FDA's acceptance marks a critical step towards potentially providing a new treatment option for uUTIs, addressing a significant unmet medical need.
Iterum Therapeutics reported its first quarter 2024 financial results, highlighting the resubmission of its NDA for oral sulopenem. The company expects FDA action in early Q4 2024. With cash runway into 2025, Iterum sold 3 million shares for net proceeds of $7.2 million. The company's current cash position is expected to fund operations through 2025.
Iterum Therapeutics plc (Nasdaq: ITRM) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on developing oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens. A conference call will be held to discuss financial results and business updates.
Iterum Therapeutics has resubmitted its New Drug Application for oral sulopenem to the U.S. FDA for the treatment of uncomplicated urinary tract infections. The potential approval of oral sulopenem, the first oral penem in the U.S. and the second new oral treatment for uUTIs in over 25 years, could benefit an estimated 40 million women suffering from uUTIs annually in the U.S. The NDA resubmission includes data from phase 3 clinical trials showing oral sulopenem's efficacy and safety, positioning it as a promising new antibiotic option.
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