'We recently achieved 50% patient enrollment and expect to complete the planned enrollment of 1,966 patients in our REASSURE trial in the first quarter of next year. We have over 140 clinical trial sites currently open to enrollment in the
Highlights and Recent Events
Enrollment in REASSURE Clinical Trial Ongoing: Iterum began enrollment in its pivotal Phase 3 clinical trial, REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales), for the treatment of uncomplicated urinary tract infections (uUTI) in adult women in
New Japanese Patent Issued: The Japanese Patent Office has issued a Certificate of Patent for Japanese Patent Registration No. 7295964 entitled 'Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof' directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (oral sulopenem) and its preparation. This patent is scheduled to expire no earlier than 2039. In addition to in-licensed patents, Iterum also owns two
Second Quarter 2023 Financial Results
Cash, cash equivalents and short-term investments were
Research and development (R&D) expenses for the second quarter 2023 were
General and administrative (G&A) expenses for the second quarter 2023 were
Net loss for the second quarter 2023 was
About
Sulopenem also has an IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Non-GAAP Financial Measures
To supplement Iterum's financial results presented in accordance with
Iterum believes that the presentation of non-GAAP net loss and non-GAAP net loss per share, when viewed with its results under GAAP and the accompanying reconciliation, provides useful supplementary information to, and facilitates additional analysis by, investors, analysts, and Iterum's management in assessing Iterum's performance and results from period to period. These non-GAAP financial measures closely align with the way management measures and evaluates Iterum's performance. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net loss or other financial measures calculated in accordance with GAAP. Non-GAAP net loss and non-GAAP net loss per share are not based on any standardized methodology prescribed by GAAP and represents GAAP net loss, which is the most directly comparable GAAP measure, adjusted to exclude intangible asset amortization; share-based compensation expense; the interest expense associated with accrued interest on the Exchangeable Notes payable in cash, shares or a combination of both upon exchange, redemption or at the Maturity Date, whichever is earlier; the non-cash amortization of the Exchangeable Notes and the non-cash adjustments to the fair value of derivatives and Royalty-Linked Notes for the three and six months ended
Special Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding Iterum's plans, strategies and prospects for its business, including the development, therapeutic and market potential of sulopenem, the timing, conduct, progress and results of Iterum's ongoing REASSURE clinical trial, including the ability to complete planned enrollment within the projected timeframe and the timing of top-line results, the expected timing of resubmission of the NDA, the term and coverage provided by Iterum's patents, and the sufficiency of Iterum's cash resources. In some cases, forward-looking statements can be identified by words such as 'may,' 'believes,' 'intends,' 'seeks,' 'anticipates,' 'plans,' 'estimates,' 'expects,' 'should,' 'assumes,' 'continues,' 'could,' 'would,' 'will,' 'future,' 'potential' or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum's control, including uncertainties inherent in the design, initiation and conduct of clinical and non-clinical development, including the REASSURE clinical trial, availability and timing of data from the REASSURE clinical trial, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of the NDA for oral sulopenem, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum's expectations regarding how far into the future Iterum's cash on hand will fund Iterum's ongoing operations, Iterum's ability to maintain its listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of Iterum's evaluation of corporate, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic, financial or financing alternative and Iterum's ability to complete one at all and other factors discussed under the caption 'Risk Factors' in its Quarterly Report on Form 10-Q filed with the
Contact:
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Email: IR@iterumtx.com
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