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| Statement |
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| On the patent front, we are happy to inform you that we continue to enhance our patent estate, which provides a substantial runway to protect the value of oral sulopenem in the U.S |
| We continue to remain confident in the value of oral sulopenem to treat multidrug-resistant infections in the community |
| This waiver provides us with the ability to more efficiently and cost-effectively access the capital necessary to continue to execute on our business plans and strategies |
| And also, Corey, as you mentioned earlier, one quarter ahead, very impressive |
| Importantly, we were able to add these incremental patients and still complete enrollment in the trial, a full quarter ahead of our previous guidance |
| Lastly, we remain excited about potentially bringing the first new oral treatment for uncomplicated urinary tract infections to the market in the U.S |
| In summary, we are very pleased to have completed enrollment well ahead of our previous guidance and are looking forward to our upcoming milestones on the accelerated time line I have just laid out for you |
| The REASSURE trial completed enrollment in just 12 months, which is quite remarkable given how long it takes uncomplicated urinary tract infection studies to complete enrollment from our experience and based on other recent uUTI studies |
| So we were able to do that in a very efficient manner and keep that time line to basically one year for full enrollment, but we took that opportunity to increase the power or the expected power of the study based on the data from the interim analysis |
| The good news is the market is very large |
| We are very pleased to report that in October, we completed enrollment in our pivotal Phase 3 trial of oral sulopenem, for the treatment of uncomplicated urinary tract infections in adult women, our REASSURE clinical trial |
| I want to share some exciting highlights about the business and our ongoing activities |
| We strongly believe that having the flexibility to quickly take advantage of opportunities to raise capital through share issuances for cash in order to fund the continued execution of our business plans and strategies is critical to interim success and our ability to bring oral sulopenem, if approved, to market |
| We continue to explore opportunities to efficiently and cost effectively raise capital to ensure that we can fund operations into the future |
| Thanks again for joining us today, and have a good day |
| And so we know that there’s an opportunity there |
| Welcome, and thanks for joining us today |
| The $10.4 million increase and our non-GAAP net loss for the third quarter was primarily a result of higher R&D expenses related to our REASSURE trial |
| Thank you all for joining |
| Statement |
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| Our net loss on a U.S |
| Without this waiver, our ability to raise additional capital for cash is severely limited under our existing authority, which does not cover the new shares that were approved at the Annual General Meeting in May |
| On a non-GAAP basis, which excludes certain noncash adjustments, our net loss of $15.7 million in the third quarter of 2023 compared to our non-GAAP net loss of $5.3 million in the third quarter of 2022 |
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