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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 announced the dosing of the first patient in its Phase 3 clinical trial, REASSURE, for oral sulopenem aimed at treating uncomplicated urinary tract infections (uUTI) caused by resistant pathogens. This trial compares oral sulopenem to Augmentin and is being conducted under an FDA Special Protocol Assessment. Successful completion of the trial could lead to a resubmission of the new drug application (NDA) in late 2024. The trial is expected to enroll approximately 1,966 patients.
Iterum Therapeutics plc (Nasdaq: ITRM) announced the presentation of two posters at IDWeek 2022, addressing critical advancements in tackling multi-drug resistant infections. The studies include data on the impact of asymptomatic bacteriuria in UTI treatment, and the efficacy of sulopenem against Bacillus anthracis. The conference runs from October 19-23 in Washington, D.C., with poster presentations scheduled for October 20 and 22. These findings will eventually be accessible on the company's website, emphasizing Iterum's commitment to developing novel antibiotics.
Iterum Therapeutics (Nasdaq: ITRM) received a Notice of Allowance from the U.S. Patent Office for patent application number 16/972,300, enhancing protection for its lead candidate, oral sulopenem. This patent extends protection until at least 2039, crucial for its commercial potential. Oral sulopenem aims to be the first oral penem in the U.S. and the first new treatment for uncomplicated urinary tract infections in over two decades. The company is preparing for a pivotal Phase 3 clinical trial expected to begin soon.
Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company, announced its participation in the H.C. Wainwright 24th Annual Hybrid Global Investment Conference on September 14, 2022, at 12:00 PM (ET). CEO Corey Fishman and CFO Judy Matthews will present a company overview and business update. Investor meetings are scheduled for September 13-14, 2022. The presentation will be accessible for 90 days on the company's website under the 'Investors' section. Iterum focuses on developing innovative antibiotics like sulopenem, which is in Phase 3 clinical development.
Iterum Therapeutics (Nasdaq: ITRM) announced it has regained compliance with Nasdaq's minimum bid price requirement after its shares maintained a closing bid price of over $1.00 for ten consecutive trading days, as of August 31, 2022. Previously, the company faced non-compliance issues that began in September 2021, receiving extensions to meet the requirement. Now, Iterum is in compliance with all listing standards and will continue to trade on the Nasdaq Capital Market.
Iterum Therapeutics plc (Nasdaq: ITRM) announced a 1-for-15 reverse share split effective at 5:00 p.m. ET on August 17, 2022, with trading to commence on August 18. This move follows shareholder approval at the AGM on June 15, 2022, to comply with Nasdaq's minimum $1.00 per share requirement. Post-split, outstanding shares will decrease from approximately 183.3 million to about 12.2 million. The nominal value of shares will adjust from $0.01 to $0.15. The reverse split also affects other equity instruments and does not create fractional shares, offering cash payments instead.
Iterum Therapeutics (ITRM) announced a planned Phase 3 clinical trial for oral sulopenem targeting uncomplicated urinary tract infections (uUTI), set to begin enrollment in Q4 2022. The company secured a Special Protocol Assessment (SPA) agreement with the FDA, which validates the trial design. Financially, Iterum reported a cash position of $68.9 million as of June 30, 2022, sufficient to fund operations into 2024. However, the net loss increased to $6.7 million for Q2 2022, contrasting with a net income of $7.8 million in Q2 2021.
Iterum Therapeutics announced an agreement with the FDA under the Special Protocol Assessment (SPA) for a Phase 3 clinical trial of oral sulopenem in treating uncomplicated urinary tract infections (uUTI). The SPA confirms the trial's design, endpoints, and statistical analysis are sufficient for a potential resubmission of the new drug application (NDA). The study aims to enroll about 1,966 patients and will compare oral sulopenem to Augmentin, with recruitment expected to start in Q4 2022.
Iterum Therapeutics plc (Nasdaq: ITRM) announced the granting of a non-statutory share option to purchase 10,000 ordinary shares to a newly hired employee, effective July 5, 2022. The exercise price is set at $0.22 per share, matching the closing price on the grant date. This 10-year option vests on August 30, 2023, contingent on continued employment. The grant aligns with Nasdaq Listing Rule 5635(c)(4) as part of the new hire's compensation package.
Iterum focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens, with its lead compound sulopenem in Phase 3 development.
Iterum Therapeutics (Nasdaq: ITRM) has granted a non-statutory share option for 35,000 ordinary shares to a newly hired employee as part of their compensation. The option, effective June 13, 2022, has an exercise price of $0.21 per share and a 10-year term, vesting over four years. This grant aligns with Nasdaq's inducement grant exception, aimed at attracting talent. Iterum is advancing sulopenem, a novel anti-infective, through Phase 3 clinical trials, targeting multi-drug resistant pathogens.
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