ITRMF — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2025-11-14

• ORLYNVAH™ was commercially launched in the United States in August 2025. Our launch strategy involves direct sales force outreach to high-volume prescribers of uUTI antibiotics in a limited geographic area. We expect modest sales of ORLYNVAH™ in 2025 during the early stages of our commercialization …

• ORLYNVAH™ was launched in the United States in August 2025, with our commercialization partner, EVERSANA. We have incurred and expect to continue to incur significant expenses relating to the commercialization of ORLYNVAH™. We may also incur expenses in connection with the further clinical developme…

• Revenues from product sales are recorded at the time of sale at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from distribution service fees, prompt pay discounts, chargebacks, rebates, co-payment assis…

• liability (if a payment is required of us). Our estimates take into consideration current contractual and statutory requirements. Actual amounts of consideration ultimately received or paid may differ from our estimates.

• Our revenue recognition is based on unit shipments from our third-party logistics warehouse to our customers. We have recognized limited net product sales in the United States since the commercial launch of ORLYNVAH™ in August 2025. As discussed in Note 3 – Revenue, gross revenues are adjusted for v…

Text removed vs the prior filing · source: 10-Q · 2025-08-05

• Following receipt of FDA approval for ORLYNVAH™ in October 2024, we focused our efforts on a strategic process to sell, license, or otherwise dispose of our rights to sulopenem, and since the first quarter of 2025, we concurrently began pre-commercialization activities in preparation for the commerc…

• As our strategic process to sell, license, or otherwise dispose of our rights to sulopenem did not result in any type of transaction acceptable to our board of directors, and while we are continuing to engage in business development discussions with other companies regarding the potential sale, lice…

• Cost of sales consists primarily of amortization related to the finite-lived intangible asset recognized in relation to the regulatory milestone payment payable to Pfizer Inc. (Pfizer) upon approval of ORLYNVAH™ by the FDA.

• Interest expense, net consists of interest accrued and amortization of debt costs with respect to the 6.500% Exchangeable Senior Subordinated Notes, which were repaid in full on maturity on January 31, 2025 (Exchangeable Notes), interest accrued with respect to the promissory note issued by Iterum T…

• Derivative liabilities, which consist of the Limited Recourse Royalty-Linked Subordinated Notes (RLNs) issued in 2020 are revalued at each balance sheet date and the change in fair value during the reporting period is recorded in the condensed consolidated statements of operations as adjustments to …

Text added vs the prior filing · source: 10-Q · 2025-11-14

• In August 2025, we commercially launched ORLYNVAH™ and in conjunction with beginning product sales we began recording product revenue and cost of goods sold. We enhanced our internal control over financial reporting by adding new processes and controls in these areas. We did not identify any materia…

• There have been no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended September 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal c…

Text removed vs the prior filing · source: 10-Q · 2025-08-05

• No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial report…

Text added vs the prior filing · source: 10-Q · 2025-11-14

• We currently have limited authorized share capital and authority to issue additional ordinary shares to raise capital.

• We will need substantial additional funding to continue fund our operations, including the ongoing commercialization of

• ORLYNVAH™, which we may attempt to raise through public or private equity offerings, debt financings, and collaborative and licensing arrangements. We currently have limited ordinary shares available and authorized for issuance. Investors in prior transactions have purchased convertible notes and wa…

• If we are unable to increase our authorized shares available for issuance, we will be limited in our efforts to raise the additional capital needed to continue to fund our ongoing operations, including the commercialization of ORLYNVAH™ in the United States. This may have a negative effect on our fi…

• We have incurred net losses in each year since our inception and anticipate that we will continue to incur significant losses unless the continued commercialization of ORLYNVAH™ is successful.

Text removed vs the prior filing · source: 10-Q · 2025-08-05

• Based on our available cash resources we do not believe that our existing cash and cash equivalents, including amounts raised under the Sales Agreement with HC Wainwright, will enable us to fund our operating expenses for the next 12 months from the date of filing this Quarterly Report on Form 10-Q.

• We have incurred net losses in each year since our inception and anticipate that we will continue to incur significant losses unless we successfully commercialize our sulopenem program.

• We have a limited operating history, have not generated any product revenue and have incurred net losses in each year since our inception in 2015. As of June 30, 2025, we had an accumulated deficit of $497.5 million cash and cash equivalents of $13.0 million. On October 25, 2024, we received approva…

• We have financed our operations to date primarily with the issuance of ordinary shares, nominal value $0.01 per ordinary share (the ordinary shares), and convertible preferred shares, pre-funded warrants and warrants, debt raised under a financing arrangement with Silicon Valley Bank (SVB), a sub-aw…

• ordinary shares for aggregate gross proceeds to us of $5.0 million and net proceeds of $4.3 million after deducting fees payable to the placement agent and other offering expenses payable by us. In late June 2020, we issued and sold, in a registered direct offering (June 30, 2020 Offering), ordinary…