Q3 2023 Iterum Therapeutics PLC Earnings Call
Speaker 1: Hello, everyone, and welcome to the interim therapeutic third quarter 2023 financial results and business update. My name is Harry and I'll be your operator.
Hello, everyone and welcome to the extreme Therapeutics third quarter 2023 financial results and business update my name is Harry and I'll be your operator today.
Speaker 1: If you'd like to ask a question at Q&A, you may do so by pressing star 1 on your telephone.
If you'd like to ask a question at Q&A you may do so by pressing star one on your telephone keypad.
Speaker 1: And I will now hand the call over to Louise Barrett, Senior Vice President, Legal Affairs to begin. Please go ahead.
And I will now hand, the call over to senior Vice President legal affairs to begin. Please go ahead.
Thank you Harry.
Speaker 2: Thank you, Harry. Good morning and welcome to Interim Therapeutics third quarter 2023 Financial Results and Business Update conference call. A press release with our third quarter results was issued earlier this morning and can be found on our web.
Good morning, and welcome to interim Therapeutics third quarter 2023 financial results and business update conference call a press release with our third quarter results was issued earlier. This morning and can be found on our web site. We are joined this morning by Corey Fishman CEO and Judy Matthews CFO.
Speaker 2: We are joined this morning by Corey Fishman, CEO , and Judy Matthews, CFO .
Speaker 2: Corey will provide some opening remarks, Jidoo will provide details on our financial results and then we'll open the lines for Q&A.
Cory will provide some opening remarks, Judy will provide details on our financial results and then we will open the lines for Q&A.
Speaker 2: In addition, we'll be extending the Q&A portion to answer a few questions we've been routinely receiving from some of our shareholders.
Addiction, we will be extending the Q&A portion to answer a few questions sweeping routinely receiving from some of our shareholders.
Speaker 2: Before we begin, I would like to remind you that some of the information presented on this conference call today will contain forward-looking statements concerning our plans, strategies, and prospects for our business, including the development, therapeutic, and market potential of OZILAPENAM, the timing and results of top-line data from our Reassure Clinical Trial, and the results of the results of the research.
Before we begin I would like to remind you that some of the information presented on this conference call today will contain forward looking statements concerning our plans strategies and prospects for our business, including the development therapeutic and market potential of <unk>, the timing and results of topline data from our reassure clinical trial.
Speaker 2: Our ability to address the deficiency set out in the complete response letter received from the FDA in July 2021.
Our ability to address this deficiency as set out in the complete response letter received from the FDA in July 2021 the.
Speaker 2: The expected timing of resubmission of our NDA and timing of review of the NDA by the FDA. The term and coverage provided by our patent.
We expect the timing of Resubmission of our NDA on timing of review of the NDA by the FDA.
The term and coverage provided by our patents the sufficiency of our cash resources.
Speaker 2: sufficiency of our cash resources and our evaluation of corporate strategic and financing strategies and alternatives to fund future development operations including the issue of new shares.
Evaluation of corporate strategic and financing strategies and alternatives to fund future development operations, including the issue of new shares for cash.
Speaker 2: actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including uncertainties inherent in the design and assiative and conduct of clinical and non-clinical development, availability and timing of data from the REASSURE clinical trial.
Actual results may differ materially from those indicated by these forward looking statements as a result of various factors outside our control, including uncertainties inherent in the design initiation and conduct of clinical and non clinical development availability and timing of data from the reassure clinical trial changes in regulatory requirements are decisions of regulatory authorities.
Speaker 2: changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral cilipenem, changes in public policy or legislation, the accuracy of our expectations regarding how far into the future our cash in hand will fund ongoing operations.
The timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral through the Panama changes in public policy or legislation the accuracy of our expectations regarding how far into the future our cash on hand will fund ongoing operations.
Speaker 2: risk and uncertainties concerning the outcome, impact, effects and results of our evaluation of financing alternatives to fund future development opportunities.
Risks and uncertainties concerning the outcome impact and results of RFID relation of financing alternatives to fund future development Upper <unk>.
Speaker 2: including the terms, timing, structure, value, benefits and costs of any such alternative and our ability to complete one at all. Our ability to maintain our listing on the NASDAQ Capital Market and other factors included and discussed under the caption Risk Factors in our quarterly report and form tank you filed with the SEC today.
Including the terms timing structure value benefits and costs of any such alternatives and our ability to complete one at all our ability to maintain our listing on the NASDAQ capital market and other factors included and discussed under the caption risk factors in our quarterly report on Form 10-Q filed with the SEC today.
In addition, any forward looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date, we specifically disclaim any obligation to update such statements.
Speaker 2: In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disgame any obligation to update such steps.
Speaker 2: We will also be referencing non-GAAP financial measures during the call. We provide a reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning. That said, I'll turn it over to you now, Corey, for your opening remarks.
We will also be referencing non-GAAP financial measures during the call. We have provided a reconciliation of GAAP reported non-GAAP adjusted information in the press release issued this morning.
That said I will turn it over to you know Cory for your opening remarks.
Thanks Louise.
Speaker 3: Welcome and thanks for joining us today. I want to share some exciting highlights about the business and our ongoing activities.
Welcome and thanks for joining us today I want to share some exciting highlights about the business and our ongoing activities.
Speaker 3: Let's begin by talking a bit about our upcoming key milestones and associated timing.
Let's begin by talking a bit about our upcoming key milestones and associated timing.
Speaker 3: Overall, we want to share with you that the timing for these key milestones has been moved forward by an entire quarter versus our previous guidance.
Overall, we want to share with you that the timing for these key milestones has been move forward by an entire quarter versus our previous guidance.
Speaker 3: We are very pleased to report that in October , we completed enrollment in our pivotal phase 3 trial of oral sulapenem for the treatment of uncomplicated urinary tract infections in adult women, our reassured clinical trial.
We are very pleased to report.
Tober, we completed enrollment in our pivotal phase III trial of oral <unk> pattern for the treatment of uncomplicated urinary tract infections and adult women, our reassure clinical trial.
Speaker 3: 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.
Reassured 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 UTI.
Studies.
Speaker 3: With enrollment in the Reassure trial complete, our next key milestone will be reporting top line data, which we now expect will occur early in the first quarter of 2024.
With enrollment in the reassure trop complete our next key milestone will be reporting top line data, which we now expect will occur early in the first quarter of 2024.
Subject to our analysis of the data, we expect to resubmit, our NDA to the FDA in the second quarter of 2024.
Speaker 3: subject to our analysis of the data, we expect to resubmit our NDA to the FDA in the second quarter of 2024.
Provided that our resubmission addressing the deficiencies identified in our complete response letter.
Speaker 3: Provided that our resubmission addresses the deficiencies identified in our complete response letter, we expect the FDA to complete its review and take action six months from the date of resubmission or in the fourth quarter of 2024.
We expect the FDA to complete its review and take action six months from the date of Resubmission or in the fourth quarter of 2024.
Speaker 3: Now I'd like to take a moment and share the results of our interim analysis and the impact on our overall enrollment.
Now I would like to take a moment and share the results of our interim analysis and the impact on our overall enrollment.
Speaker 3: As previously announced, once we achieved our halfway point of enrollment, a blinded interim analysis was conducted by an independent data monitoring committee to determine whether a sample size adjustment was recommended.
As previously announced once we achieved our halfway point of enrollment be blinded interim analysis was conducted by an independent data monitoring committee to determine whether a sample size adjustment was recommended.
Speaker 3: The interim analysis showed that, based on the blinded data review, we were within the 80% to 90% power range outlined in our special protocol assessment agreement with the FDA.
The interim analysis shows that based on the blinded data reviewed we were within the 80% to 90% powder range outlined in our special protocol assessment agreement with the FDA.
Speaker 3: We chose to enroll an additional 263 patients for a total of 2,229 patients in order to finish the study with a power figure towards the top end of that range based on the blinded data.
We chose to enroll an additional 263 patients for a total of 2229 patients in order to finish the study with a power figure towards the top end of that range based on the blinded data.
Importantly, we were able to add these incremental patients and still complete enrollment in the trial a full quarter ahead of our previous guidance.
Speaker 3: Importantly, we were able to add these incremental patients and still complete enrollment in the trial a full quarter ahead of our previous guide.
Speaker 3: 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 cimlopenem in the US and other countries.
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 small pattern in the U S and other countries.
During this quarter, we have been granted a patent in Korea.
Speaker 3: In this quarter, we have been granted a patent in Korea directed to the composition of the bilayer tablet of oral suvapenem.
Directly to the composition of the bilayer tablet of oral Super pattern.
Speaker 3: This patent is scheduled to expire no earlier than 2039.
This patent is scheduled to expire no earlier than 2039.
Speaker 3: Additionally, we were granted a patent in Australia, which is also directed to the composition of the bilayer tablet of oral sulu penim and its related use.
Additionally, we were granted a patent in Australia, which is also direct you to the composition of the bilayer tablet of oral pseudo pattern and its related uses.
Speaker 3: As a reminder, in addition to the newly granted Korean and Australian patents and our in-license patents, Bitterum owns two U.S. patents for oral sousvapenem and a Japanese patent, all expiring in 2039 barring any extension.
As a reminder, in addition to the newly granted Korean and Australian patents and our in license patents interim owns two U S patents for oral Super Panama and the Japanese patents all expiring in 2039 barring any expansions.
Speaker 3: One U.S. patent and the Japanese patent is directed to the composition of the bilayer tablet and its related preparations and or uses. And the other U.S. patent is directed to the method of use of all single patent and treating multiple diseases, including uncomplicated urinary tract infection.
One U S patent and the Japanese patent is directed to the composition of the bilayer tablet and its related preparations <unk> uses.
And the other U S. Patent is directed to the method of use all single pattern treating multiple diseases, including uncomplicated urinary tract infections.
Speaker 3: Additionally, we have a number of pending patent applications in the US and other jurisdictions, including Europe and China.
Additionally, we have a number of pending patent applications in the U S and other jurisdictions, including Europe and China.
As of September 30, we had cash and cash equivalents of $36 million.
Speaker 3: As of September 30th, we had cash and cash equivalents of $36 million.
Based on our current operating plan, we expect that our current cash cash equivalents and short term investments will be able to fund our operations into the third quarter of 2024.
Speaker 3: Based on our current operating plan, we expect that our current cash, cash equivalents, and short-term investments will be able to fund our operations into the third quarter of 2024.
Therefore, given our accelerated timeline, we expect our existing cash to be able to fund operations through the topline data readout as well as a potential NDA resubmission.
Speaker 3: Therefore, given our accelerated timeline, we expect our existing cash to be able to fund operations through the top line data readout, as well as a potential NDA resubmission.
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 timeline I have just laid out for you.
Speaker 3: 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 timeline I have just laid out.
Speaker 3: As mentioned, based on our current projections, we expect to have the cash on hand to fund operations through top line data readout and the potential resubmission of our NDA.
As mentioned based on our current projections, we expect to have the cash on hand to fund operations through top line data readout and the potential resubmission of our NDA.
Speaker 3: We continue to explore opportunities to efficiently and cost effectively raise capital to ensure that we can fund operations into the future.
We continue to explore opportunities to efficiently and cost effectively raise capital to ensure that we can fund operations into the future.
Speaker 3: 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 over 20 years.
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 over 20 years.
Speaker 3: Now I'll turn the call over to Judy for details on our financial results.
Now I'll turn the call over to Judy for details on our financial results.
Speaker 4: Thanks, Corey. Total operating expenses were $16.7 million in the third quarter 2023 compared to $7 million in the third quarter 2022. Operating expenses include research and development expenses and general and administrative expenses.
Thanks Corey.
Total operating expenses were $16 7 million in the third quarter 2023, compared to $7 million in the third quarter 2022 operating expenses include research and development expenses and general and administrative expenses.
Speaker 4: R&D costs were $14.9 million for the third quarter, compared to $4.4 million for the same period in 2022. The primary driver of the increase in R&D expense for the third quarter was cost to support a reassured trial, which began enrollment in October 2022 and completed enrollment last month.
R&D costs were $14 $9 million for the third quarter compared to $4 4 million for the same period in 2022.
The primary driver of the increase in R&D expense for the third quarter with cost to support our reassure trial, which began enrollment in October 2022, and completed enrollment last month.
Speaker 4: GNA costs were $1.8 million for the third quarter of 2023, which is $900,000 lower than GNA costs of $2.7 million in the third quarter of 2022.
G&A costs were $1 $8 million by the third quarter of 2023, which is $900000 lower than G&A costs of $2 $7 million in the third quarter of 2022.
Speaker 4: due primarily to lower share-based compensation expense and a decrease in legal fees incurred in connection with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the case cannot be brought back to court.
Due primarily to lower share based compensation expense and a decrease in legal fees incurred in connection with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the case cannot be brought back to court.
Speaker 4: Our net loss on a US GAAP basis was $3.9 million for the third quarter of 2023 and $29.1 million for the same period in 2022.
Our net loss on a U S. GAAP basis was $3 $9 million for the third quarter of 2023 and $29 1 million.
Same period in 2022.
Speaker 4: On a non-GAAP basis, which excludes certain non-cash 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.
On a non-GAAP basis, which excludes certain non cash 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 2020 to the.
Speaker 4: The $10.4 million increase in our non-GAAP net loss for the third quarter was primarily the results of higher R&D expenses related to our Reassure trial.
The $10 4 million increase in our non-GAAP net loss for the third quarter was primarily a result of higher R&D expenses related to our reassure trial.
Speaker 4: At the end of September , we had cash, cash equivalents and short-term investments of $35.9 million, which based on our current operating plan, will provide a cash runway into the third quarter of 2024.
At the end of September we had cash cash equivalents and short term investments of $35 $9 million, which based on our current operating plan will provide a cash runway into the third quarter of 2024.
Speaker 4: We expect to report top line data early in the 1st quarter of 2024 and if the reassure trial is successful, we expect to submit to the FDA. The NDA for also open them for the treatment of in the 2nd quarter of 2024.
We expect to report top line data early in the first quarter of 2024, and if the reassure trial is successful we expect to resubmit to the FDA. The NDA for also look on them for the treatment of <unk> UTI in the second quarter of 2024.
Speaker 4: Provided that the resubmitted NDA addresses all of the deficiencies identified in the CRL, we expect that the FDA will complete its review and take action 6 months from the date the FDA receives this resubmitted NDA, or during the 4th quarter of 2024.
Provided that the resubmitted NDA addresses all of the deficiencies identified with the <unk>, we expect that the FDA will complete its review and take action on.
The date, the FDA received submitted NDA during the fourth quarter of 2024.
Speaker 4: As of September 30, 2023, we had approximately 13 million ordinary shares outstanding. Also, as of the end of September , we had approximately $12.6 million of exchangeable notes outstanding, which can be exchanged at the option of the note holder for approximately 1.1 million shares.
As of September 32023, we had approximately 13 million ordinary shares outstanding also as at the end of September we had approximately $12 $6 million of exchangeable notes outstanding which can be exchange at the option of the note holder for approximately $1 1 million shares.
Speaker 4: If the notes are not exchanged, we will pay the note holder $12.6 million plus accrued interest in January 2025. fighting within the
The notes are not exchange, we will pay the note holders $12 6 million plus accrued interest in January 2025.
Operator, please open the lines for questions.
Okay.
Speaker 1: Thank you. We will now take questions from the audience. And our first question today is from the line of Ed Arkey of HC Wainwright. Ed, your line is now open.
Thank you we will now take questions from the audience and our first question today is from the line of Ed H.
H C. Wainwright at your line is now open.
Hi, Good morning. This is Thomas Yip, asking a couple of lessons for decades and thats within our questions.
Speaker 5: Hi, good morning. This is Thomas asking a couple of questions for Ed. Thank you so much for the kind of questions.
Speaker 5: So first, perhaps a discussion for the phase three study with over 2200 patients enrolled versus the target of 1966. And also Corey, as you mentioned earlier, one quarter ahead, very impressive. Can you discuss what the main drivers of this over enrollment and also accelerated phase or some initial feedback for the study?
So first perhaps.
A discussion for the phase III study.
With over 200 patients enrolled.
The target of being 66 and also of course as you mentioned earlier one quarter. It had a very impressive.
Discuss what the main drivers of this over enrollment and also accelerated the pace with them in that.
Feedback was steady.
Yeah. Thanks for the question Thomas.
The interim analysis was.
Speaker 3: The interim analysis was
Speaker 3: the real driver in terms of determining power. That's a very complicated, it was blinded of course, and it was a very complicated...
The real driver in terms of determining power. That's a very complicated it was blinded of course and it was a very complicated.
Speaker 3: as all interim analyses are, set of analyses based on a variety of factors including, you know, actual data and understanding where our power calculation was. And what the reason we over-enrolled, as you say, is we wanted to be at the higher end of that power calculation, which was between 80 and 90 percent per our SPA agreement with the FDA.
As all the interim analyses are set of analyses based on a variety of factors, including actual data and understanding where our power calculation was.
The reason we over enrolled as you say as we want it to be at the higher end of that power calculation, which was between 80 and 90%.
Our SBA agreement with the FDA.
Speaker 3: So we were able to do that in a very efficient manner and keep that timeline 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 interim analysis.
So we were able to do that in a very efficient manner and keep that timeline 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.
Got it and then.
Speaker 5: Got it. And then trying to narrow down the early first quarter 2024 readout timeline a little bit. Would this be in kind of January or late January , February timeframe?
Try to narrow down the early first quarter 2024, readout timeline a little bit.
Yes.
And kind of in January or late January February timeframe.
Speaker 3: Yeah, we're obviously still working on that. We don't have any definitive date other than we believe it will be earlier in the quarter versus later in the quarter.
Yeah.
We're obviously still working on that we don't have any definitive date other than we believe it will be earlier in the quarter versus later in the quarter.
Understood understood.
Speaker 5: Understood. Understood. Just one more question from us. We've seen that as you announced multiple new patents issue both in US and ex-US. Can you discuss some options for through a panel for ex-US market?
Just one more question from us.
That's been actually announced multiple new patents issue.
Both in the U S and ex U S did.
Can you discuss worth of options for us to look at them for ex U S markets.
Okay.
Yes, we will we will start looking at those conversations when we have our data in terms of ex U S.
Speaker 3: Yeah, we will start looking at those conversations when we have our data. In terms of XUS, we know that the market is not
We know that the market is very large and we know that the majority of prescribing for oral products is in.
Speaker 3: And we know that the majority of prescribing for oral products is in a handful, just like it is in the US, a handful of therapies. And so what we really have to do is get the data, determine the best route of conversation for potential partnerships outside the US.
A handful just like it is in the U S. A handful of therapies and so what we really have to do is get the data.
<unk> the best route conversation for potential partnerships outside the U S. And then begin those conversations in earnest. The good news is the market is very large.
Speaker 3: and then begin those conversations in earnest. The good news is the market is very large. There's, I don't remember the exact number, but somewhere around 15 or 17 million...
I don't remember, the exact number but somewhere around 15% or $17 million.
Speaker 3: for uncomplicated UTI in what used to be called the big five. And so we know that there's an opportunity there. It's just a question of, you know, having conversations with partners who are appropriate to make sure that, you know, we can optimize what we have outside the US as well.
Infections, or uncomplicated UTI and what used to be called the big five and so we know that there is an opportunity there. Its just a question of.
Having conversations with partners, who are appropriate to make sure that we can optimize what we have outside the U S as well.
And.
Speaker 5: I missed it. Thank you again for the kind of questions, and we look forward to the day of the great open first quarter.
Thank you again for taking my questions and we look forward.
The data readout in first quarter.
Thanks Thomas.
Speaker 1: Thank you, and we have no further questions on the line today, so I'd like to hand back to Louise Barrett to continue.
Thank you and we have no further questions on the lines. Thanks, So I'd like to hand back to do we expect to continue.
Speaker 2: Great, thanks Harry. At this time Corey and Judy will take questions that we've been receiving from some of our shareholders. So Corey, first question for you. When do you expect that oral pseudopanem will be approved?
Great. Thanks Hari.
This time Korean Judy will take questions that we've been receiving from some of our shareholders and with the Macquarie first question for you. When do you expect that oil Pan am will be appraised.
Speaker 3: Thanks, Louise. We expect, as we mentioned, to report top line data in the early part of Q1. And then subject to our analysis of that data, would expect to resubmit the NDA to the FDA in the second quarter of 2024.
Thanks, Louise we expect.
As we mentioned to report topline data in the early part of Q1.
And then subject to our analysis of that data, we would expect to resubmit the NDA to the FDA in the second quarter of 2024.
Speaker 3: provided that our resubmission does address the deficiencies that were identified in our complete response letter, we would expect the timeline the FDA to operate under would be to complete its review and take action six months from the date of that resubmission, and therefore, a potential approval would occur in the fourth quarter of 2024.
Provided that our Resubmission does address the deficiencies that were identified in our complete response letter.
We would expect the timeline with the FDA to operate under would be to complete its review and take action six months from the date of that Resubmission and therefore, a potential approval would occur in the fourth quarter of 2024.
Great Thanks, Corey and.
Speaker 2: Thanks Corey. And one for you Judy, how long can the company operate with its current cash on hand?
One for you Judy and how long can the company operate with its current cash on hand.
Speaker 4: Yeah, thanks Louise. Based on our current projections, our cash on hand is sufficient to allow us to operate into the third quarter of 2024. So, we said that should allow us to fund our operations through the top line data as well as the NDA resubmission. However, additional funds are needed to get to approval in the fourth quarter.
Yeah. Thanks, Yeah based on our current production our cash on hand is sufficient to allow us to operate into the third quarter of 2024.
We said that should allow us to fund our operations through the top line data as well as the NDA resubmission.
However, additional funds are needed to get to approval in the fourth quarter.
Speaker 2: Great, thank you. So, Corey, Judy has talked about cash runway. What about the long-term financing strategy of the company?
Great. Thank you.
Corey Judy has talked about cash runway what about the long term financing strategy of the company.
Speaker 3: talk to us a little bit about that. Sure. And thanks. Thanks for the question. Investors, because this is one we get quite frequently and we want to address this head on.
Talk to us a little bit about that.
Sure and thanks. Thanks for the question investors because this is when we get quite frequently and we want to address it head on.
We're constantly evaluating a variety of financing strategies to ensure that we can continue to fund operations through 'twenty four and over the next few years.
Speaker 3: One such strategy is to take advantage of opportunities to raise capital through share issuances or cash.
One such strategy is to take advantage of opportunities to raise capital through share issuances for cash.
As we've discussed previously.
Irish incorporated company, our shareholders must approve the dis application of statutory preemption rights over the authorized but unissued share capital.
<unk> the additional ordinary shares that were approved at the annual general meeting in May.
And this is otherwise known as the waiver of preemption rights.
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.
Speaker 3: 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 strategy.
Speaker 3: Without this waiver, our ability to raise additional capital for cash is severely limited under our existing authority.
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.
Speaker 3: which does not cover the new shares that were approved at the annual general meeting in May.
As you May know, we did ask shareholders to approve this waiver earlier this year at our annual General meeting.
Speaker 3: As you may know, we did ask shareholders to approve this waiver earlier this year at our annual general meeting and at a subsequent extraordinary meeting in August .
And at a subsequent extraordinary meeting in August and while we received over 60% supportive of both on both occasions, you did not receive the affirmative vote of at least 75% of the votes cast.
Speaker 3: And while we received over 60% support of the vote on both occasions, we did not receive the affirmative votes of at least 75% of the votes cast, as is required under Irish law.
As is required under Irish law.
Speaker 3: Simply stated, without this waiver extending to all authorized and unissued shares, in order to issue shares and raise sufficient capital in the equity markets, we'd be required to either seek a transaction specific waiver from shareholders every time we want to issue shares.
Simply stated without this waiver extending to all authorized an uninsured shares in.
Order to issue shares and raised sufficient capital in the equity markets, we'd be required to either.
Secret transaction specific waiver from shareholders every time, we want to issue shares.
Speaker 3: That would entail a extraordinary general meeting each time and significantly impede the timing of a financing transaction and our likely ability to do a deal efficiently or at all.
That would entail a extraordinary general meeting each time.
And significantly impede the timing of a financing transaction and are likely the ability to do a deal efficiently or at all.
Speaker 3: Alternatively, we can attempt to issue shares through a rights offering by first offering the shares to all existing shareholders for a period of time and then perhaps finding additional investors willing to take any shares that are not subscribed for on the same terms as the right job.
Alternatively, we can attempt to issue shares through a rights offering by first operating ishares to all existing shareholders for a period of time.
And then perhaps finding additional investors willing to take any shares that are not subscribed for.
On the same terms as the rights offering.
Speaker 3: The rights offering is also quite time consuming, costly, and there can be no guarantee that we would raise sufficient capital via this process.
The rights offering is also quite time consuming.
Costly and there can be no guarantee that we would raise sufficient capital via this process.
Speaker 3: 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 sua penem, if approved, to market.
We strongly believe that having the flexibility to quickly take advantage of opportunities to raise capital through share issuances for cash.
Order to fund the continued execution of our business plans and strategies.
Is critical to interim success, and our ability to bring oral suitable Panama if approved to market.
Speaker 3: While we will also continue to pursue other corporate, strategic, financial, and financing alternatives, including partnerships and debt financings, we plan to go back to you, our shareholders, in the near future to seek approval for the waiver of preemption rates over a portion of the authorized but unissued shares.
While we will also continue to pursue other corporate strategic financial and financing alternatives, including partnerships and debt financings.
We plan to go back to you our shareholders in the near future to seek approval for the waiver of preemption rights over a portion of the authorized but unissued shares.
Alright, Thanks Corey.
Speaker 2: That's all the questions for now so I'll pass it back to you Corey just for your closing remarks.
That's all the questions for nice I'll pass it back to you for your closing remarks.
Speaker 3: Great. Thank you, Luis. Thanks for joining us today. We've taken the opportunity to address some of the questions we get most frequently from investors in order to provide as much clarity as we can regarding our upcoming milestones and timelines and to reiterate the importance of obtaining the waiver of preemption rights from shareholders with regard to the long-term financing of the company.
Great. Thank you Louise thanks for joining us today.
Taken the opportunity to address some of the questions. We get most frequently from investors in order to provide as much clarity as we can regarding our upcoming milestones and timelines.
And to reiterate the importance of obtaining a waiver of preemption rights from shareholders with regard to the long term financing of the company.
We continue to remain confident in the value of oral sema, Panama to treat multi drug resistant infections in our community.
Speaker 3: We continue to remain confident in the value of oral cilopenem to treat multidrug-resistant infections in the community. We look forward to our upcoming top-line data readout, and subject to our analysis of the data, resubmitting our NDA to the FDA for this important treatment option for physicians and patients. Thanks again.
We look forward to our upcoming topline data readout and subject to our analysis of the data resubmitting, our NDA to the FDA for this important important treatment option for physicians and patients.
Patients.
Thanks, again for joining us today and have a good day.
Yeah.
Speaker 1: This concludes today's call. Thank you all for joining. You may now disconnect your line.
This concludes today's call. Thank you all for joining you may now disconnect your lines.
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Speaker 6: CLOSING CREDITS
Sure.
Okay.
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