Full Year 2023 Inhibikase Therapeutics Inc Earnings Call

Operator: Ladies and gentlemen, thank you for standing by. Greetings and welcome to Inhibikase Therapeutics' fourth quarter and full year 2023 financial results. This time, all participants will be in listen-only mode.

Okay.

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Operator: The question and answer session will follow the formal presentation. Please note that today's conference is being recorded, and if you should require operator assistance, you may press star zero from your telephone keypad. I'll now turn the call over to Alex Lobo, Stern Investor Relations. Alex, you may now begin.

Alex Lobo: Thank you, Operator. Good morning and welcome to Inhibikase Therapeutics' fourth quarter and full year 2023 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Garth Lees-Ross, Chief Financial Officer.

Alex Lobo: On March 27th, Inhibikase issued a press release announcing financial results for the fourth quarter and full year ended December 31st, 2020. We encourage everybody to read yesterday's press release as well as Inhibikase's annual report on Form 10, which is being filed. The company's press release and annual report are also available on its website at inhibikase.com.

None: Ladies and gentlemen, thank you were standing by greetings and welcome to inhibit cases therapeutics fourth quarter and full year 2023 financial results.

Alex Lobo: In addition, this conference call is being webcast through the investor relations section of the company's website and will be archived there. Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1998. Participants are cautioned that this conference call contains time-sensitive information and is accurate only as of the date of this live broadcast, March 28. However, actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the content.

None: All participants will be in listen only mode.

None: A question and answer session will follow the formal presentation.

None: Please note that today's conference is being recorded and if you should require operator assistance you May press star zero from your telephone keypad.

None: Now I'll turn the call over to Alex Global.

Alex Lobo: Stern Investor Relations, Alex you May now begin.

Alex Lobo: Thank you operator good morning.

Alex Lobo: And welcome to Endeavour drinks therapeutics fourth quarter and full year of 2023 financial results conference call and audio webcast.

Alex Lobo: With me today is Dr. Melton, Weiner, Chief Executive Officer, and Barclays Ross.

Barclays Ross: Chief Financial Officer.

Milton H. Werner: Information on potential risks and uncertainties is set forth in our most recent public filing, at sec.gov. The company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date, except as may be required by law. With that said, I would now like to turn the call over to Dr. Thank you, Alex. And thank you, everybody, for joining the call today. Before I begin, I just want to give a round of applause to our outgoing Chief Financial Officer, Joe Frattaroli, who is on the call. Tomorrow will be his last day with the company, and we are very grateful for the six years of work that he and I have done together to bring Inhibikase where we are.

Barclays Ross: On March 27th and have a case issued a press release announcing financial results for the fourth quarter and full year ended December 31 2023.

Barclays Ross: We encourage everybody to read yesterday's press release as well it didn't have the case its annual report on Form 10-K, which is being filed with the SEC.

Barclays Ross: The company's press release and annual report are also available I didn't have cases website I didn't have a case dot com.

Barclays Ross: In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.

Barclays Ross: Please note that certain information discussed on today's call is covered under the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Barclays Ross: Participants are cautioned that this conference call contains time sensitive information and is accurate only as of the date of this live broadcast March 'twenty eight 'twenty 'twenty four.

Milton H. Werner: Also, to introduce you to our new Chief Financial Officer, who will begin on Monday, formally in the job, Garth Lees-Rolfe, who will be discussing our financial returns. And so with that, really, we appreciate everybody joining the call for our discussion of our fourth quarter and full year 2023 financial results and recent clinical and business updates. 2023 was really a year of execution as we made significant advancements across our clinical pipeline, culminating in a recent pre-MDA meeting with the FDA for IKT01 Pro and the rapid enrollment of Parkinson's patients in our 201 trial for Risvodetumib, or RISVO, as we'll refer to it throughout this presentation. We are also evaluating new second-generation molecules arising from our internal medicinal chemistry and external collaboration While we have much work to do in 2024, we believe that we are well positioned for success and will continue to build value for our shareholders.

Barclays Ross: Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

Barclays Ross: Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Gov.

Barclays Ross: The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this webcast, except as may be required by applicable securities law.

Barclays Ross: With that said I would now like to turn the call over to Dr. Melton, we're not nothing.

Milton H. Werner: Thank you Alex and thank you everybody for joining the call today before I begin I just wanted to give a round of applause to our outgoing.

Milton H. Werner: Chief Financial Officer, Joe Friday, Rolley, who is on the call Tomorrow will be his last day with the company and we are very grateful for the six years of work that he and I have done together to bring in any case, where we are.

Milton H. Werner: Also to introduce you to our new Chief Financial Officer, who will begin on Monday formally in the jobs have gotten resolved, we'll be discussing our financial results.

Milton H. Werner: And so what that really we appreciate everybody joining the call for a discussion of our fourth quarter and full year 2023 financial results and recent clinical and business updates.

Milton H. Werner: Let's now take a deeper dive into each of our programs, starting with Risk of Death Enabled or RISD. As you may recall, Rizzo is a potent, selective inhibitor of C-ABL that is administered once daily and that we believe may slow or halt the progression of Parkinson's disease. Our 201 trial is a two-phase trial with an ongoing 12-week double-bonded study across three doses that we believe should be therapeutic, plus a fourth group that is taking a placebo. The trial is approximately 61% enrolled, as of March 22nd, with 73 participants, 20 prospective participants in medical screening, and an additional 48 potential participants being evaluated for suitability to initiate medical screening. Additionally, 34 participants have completed the full 12-week dosing period. To date, 15 mild and two moderate adverse events have been observed that may be related to visual therapy.

2023 was really a year of execution as we made significant advancements across our clinical pipeline, culminating in a recent pre NDA meeting with the FDA for Ikea T O one pro and the rapid enrollment of part of Parkinson's patients and our tier one trailer originally definitely aboard Russo as we will refer to it throughout this presentation.

Milton H. Werner: We are also evaluating new second generation molecules arising from our internal medicinal chemistry and external collaborations to further expand our pipeline and enhanced suppression of nerve regeneration or address other diseases that can be benefiting from able kinase inhibition.

Milton H. Werner: While we have much work to do in 2024, we believe that we are well positioned for success and continue to build value for shareholders.

Milton H. Werner: Now I'll take a deeper dive into each of our programs starting with <unk> conducted neighborhoods, though.

Milton H. Werner: Two people elected to withdraw from the trial despite having only one or two moderate adverse events. We believe the last patient will be enrolled during the summer of 2024. To date, trial improvement has been successful in our review, generating broad interest within the Parkinson's patient community nationwide, allowing for hundreds of unique individuals to be screened by an outside medical staff and referred to our clinical sites prior to entering a medical record review process in advance of the initiation of formal medical screening. We plan to report top-line results from this study in the second half of this year. The 2-1 trial plans to enroll everyone who continues to meet the eligibility criteria in a 12-month extension.

Milton H. Werner: As you May remember Rizzo is a potent selective inhibitor of see Abel that is administered once daily and that we believe may slow or halt the progression of Parkinson's disease.

Milton H. Werner: Our 201 trial is a two phase trial with an ongoing 12 week double blind study across three doses that we believe should be therapeutic plus a fourth group.

None: Taking a placebo.

None: The trial is approximately 61% enrolled as of March 22nd with 73 participants 20, prospective participants and medical screening and an additional 48 potential participants being evaluated for suitability to initiate medical screening.

None: Additionally, 34 participants have completed the full 12 week dosing period.

None: 815 mild to moderate adverse events have been observed that may be related to those old treatment.

None: Two people elected to withdraw from the trial, despite having only one or two moderate adverse events.

Milton H. Werner: Although we have completed several of the infrastructure builds to execute this trial, we are still in need of additional funding to begin enrolling participants into the extension study at our clinical site. As we have previously disclosed, the extension study will transition participants from the blinded phase, who will still meet enrollment criteria, to an additional 12 months of treatment, which will also serve the purpose of evaluating our novel commercial tablet formulation for RISDRO that we announced last year. As we continue to establish the potential of RISDO and Parkinson's disease, we believe it is important to communicate the progress to key stakeholders in the medical and scientific communities. In January, we published the Phase I-Ib data evaluating RISDO in healthy volunteers and patients treated with anti-Parkinson's medication. That report appeared in the peer-reviewed journal, Journal of Parkinson's Disease.

None: We believe the last patient will be role during the summer of 2024 to date trial recruitment has been successful and I review generating brought interest within the pet Parkinson's patient community nationwide, allowing for hundreds of unique individuals to be screened by an outside medical staff and referred into our clinical sites prior to entering a medical record review process.

None: Advancing the initiation of a formal medical screening.

None: Plan to report top line results from this study in the second half of this year.

None: Q1 trial plans football everyone, who continues to meet the eligibility criteria into a 12 month extension study.

None: Although we have completed several of the infrastructure builds to execute this trial, we are still in need of additional financing to begin enrolling participants into the extension study at our clinical sites as.

None: As we've previously disclosed the extension study will transition participants from the blinded phase who will still need the enrollment criteria to an additional 12 months of treatment, which will also serve the purpose of evaluating our novel commercial tablet formulation for as well that we announced last year.

None: As we continue to establish the potential originally in Parkinson's disease. We believe it is important to communicate the progress with key stakeholders in the medical and scientific community in January we published the phase <unk> data evaluating original in healthy volunteers and patients treated badly Parkinson medications that report appeared in the peer reviewed journal journal of Parkinson's disease.

Milton H. Werner: The publication highlighted the safety, the tolerability, and the pharmacokinetics of RISDO across 94 healthy volunteers and 14 participants with Parkinson's disease in both single, ascending dose, and multiple ascending dose studies. We found that RISD demonstrated a favorable safety and tolerability profile for all trial participants with 12 potentially treatment-related adverse events observed, none of clinical significance, single-dose pharmacokinetics for approximately the year between 12 and a half and 200 milligrams for both CMAX and the area under the curve or AUC measurement with no pharmacokinetic difference between healthy volunteers and participants with Parkinson's disease. Exposures of e-tose were high relative to other drugs in the same class, same kind of inhibitor class, and of note, we used voluntary lumbar puncture to measure the concentration of RISVO in cerebral spinal fluid in six participants with or without PDE, which indicated that RISVO crossed the blood-brain barrier and was persistently present in the central nervous system.

None: Publication highlighted the safety Tolerability and pharmacokinetics of Israel across 94 in healthy volunteers and 14 participants with Parkinson disease in both single ascending dose and multiple ascending dose studies.

None: We found that reason with demonstrated a favorable safety and Tolerability profile for all trial participants with 12 potentially treatment related adverse events observed none of clinical significance.

None: All those pharmacokinetics for approximately anywhere between 12, and a half and 200 milligrams for both C. Max and the area under the curve or AUC measurement with no pharmacokinetic difference between healthy volunteers and participants with Parkinson's disease.

None: Exposures are details were high relative to other drugs in the same class same kind of inhibitor class and of note. We use the voluntary lumbar puncture to measure the concentration of Israel and cerebral spinal fluid and six participants with or without PD, which indicated that original cross the blood brain barrier and whats persistently prism central nervous system.

Milton H. Werner: While this is a limited data set, we find these results encouraging. Overall, we believe that the totality of the data we've generated to date continues to support the development of RISDO, and we look forward to providing updates on the progress of the 2-1 trial throughout the year. Moving now to IKT-01-PRO, which is a pro-drug formulation of imatinib mesylate that has been designed to improve the safety profile of imatinib. We had a pre-MDA meeting on January 19th of this year with the FDA to discuss the requirements for potential approval of IKT-01-PRO under the 505B2 statute. We are pleased with the discussion we had with the agency as we began the process of building our first MDA package, and we plan to seek all 11 blood and stomach cancer indications for which imatinomacillate has been approved.

None: Well this is a limited dataset we find these results encouraging overall, we believe the totality of the data we've generated to date continues to support the development of Batesville and we look forward to providing updates on our progress with two one trial throughout the year.

None: Moving now to I K T O and pro which is a prodrug formulation of Imatinib Mesylate that has been designed to improve on the safety profile of Imatinib. We had a pre NDA meeting on January 19th of this year with the FDA to discuss the requirements for potential approval of <unk> pro under the <unk> statute.

None: We were pleased with the discussion we have with the agency as we begin the process of building our first NDA package and we plan to seek all 11 blood and stomach cancer indications for which American that's the way it has been approved.

Milton H. Werner: The FDA review team from the Division of Hematologic Malignancies determined through a review of our clinical data that 600mg and 800mg IKT-01 Pro provided similar exposures to 400mg and 600mg Imat and Methylate, respectively. The review team advised that if we want to seek all the indications for which imatinib has previously been approved, we should measure the safety, tolerability, and problem-proof kinetics of IKT-01-PRO which would deliver up to 800 mg, the highest approved dose of imatinib messenger. We plan to evaluate IKT-OMPRO at a 1200 mg dose, which we believe will lead to exposures to imatinib that are similar to 800 mg imatinib mesylate. Further, the review team asks that we evaluate whether O1-pro and imatinib are absorbed differently from the gut.

None: The FDA review team from the division of the hematologic malignancies determined through a review of our clinical data that 600 milligram and 800 milligram I K T. O M probe provided similar exposures to 400 milligram and 60 milligram amount unless weight respectively.

None: I'm advised that if you want to see all the indications for which a magnum has previously been approved we should measure the safety Tolerability and pharmacokinetics of Ik T. O. One pro that will deliver up to 800 milligrams the highest approved dose of that domestically we.

None: Plan to evaluate I K T O and pro at a 1200 milligram dose, which we believe will lead to exposures to Matt and they've got a similar to 800 milligrams of mountain Messily.

None: Further review team as we evaluate whether one pro and imatinib or absorbed differently from a debt. So we are initiating a standard preclinical test to further evaluate I K T O and pro and our man they've got absorption, which is a test performed in cell culture.

Milton H. Werner: So we are initiating a standard preclinical test to further evaluate IKT-O1-pro and imatinib gut absorption, which is a test performed in silicone. As we continue to advance the elements of the NDA package, we will seek milestone meetings with the FDA to ensure we are meeting manufacturing, scientific, and quality control requirements for approval. Now, before I turn the call over to our incoming Chief Financial Officer, Garth Lees-Roth, to review our financial results for the quarter, I'd like again to extend our deepest gratitude from both the Board of Directors and our entire team to Joe Frattaroli for his years of service as Chief Financial Officer, and we all wish him best in his retirement. With that said, I'll turn the call over to Garth to review our financial results Thank you, Milton. Now, let me review our financial results for the year and quarter ended December 31, 2023. The net loss for the year ended December 31, 2023 was $19.0 million or $3.57 per share, compared to a net loss of $18.1 million or $4.28 per share for the year ended December 31, 2022.

None: As we continue to advance the elements of the NDA package, we will seek milestone meetings with the FDA to ensure we are meeting manufacturing scientific and quality control requirements for approval.

None: Now before I turn the call over to our incoming Chief Financial Officer Barclays wealth to review our financial results for the quarter I'd like to again extend our deepest gratitude from both the board of directors and our entire team Joe for out of Raleigh for his years of service as Chief Financial Officer, and we all wish investments retirement, but that said I will turn the cartilage Garth to review our financial results.

Garth: Thank you Nelson.

Garth: With you our financial results for the year and Kona ended December 31 2023.

Garth: Net loss for year ended December 31, 2023 was.

Garth: It was $19 7 million or $3.57 per share compared to a net loss of $18 1 million or $4 28 per share for the year.

Garth: And at December 31, 2022.

Garth Lees-Ross: Research and development expenses for the full year ended December 31, 2023 were $13.6 million compared to $12.0 million for the full year 2022. The increase was primarily due to a $1.5 million increase for IKT-001 Pro and a decrease of $0.6 million in expenses for RISVO and a net increase of $0.7 million for all other R&D activities. Selling general and administrative expenses for the full year 2023 were $6.7 million, compared to $6.2 million for the same period in 2020.

Garth: Research and development expenses for the full year ended December 31, 2023, with $13 6 million compared to 12.0 million for the full year 2022.

Garth: The increase was primarily due to a one 5 million increased.

Garth: For <unk> one.

Garth: One price and a decrease of $7 6 million in expenses for research and a net increase of <unk> 7 million for at our R&D activities.

Garth: Selling general and administrative expenses for the full year 2023, with $6 7 million compared to $6 2 million for the same period in 2012.

Garth: Is there a <unk> 5 million increase was primarily the result of an increase in investor relation costs of $1 7 million an increase in employee costs of $7 3 million and were partly.

Garth Lees-Ross: The $0.5 million increase was primarily the result of an increase in investor relations costs of $1.0 million, an increase in employee costs of $0.3 million that were partly offset by a decrease in D&O insurance of $0.6 million, a decrease in legal and consulting fees of $0.4 million, and a net increase of $0.2 million in all other selling, general, and administrative. As of December 31, 2023, we had $13.3 million in cash, cash equivalents, We expect that our existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2025. They are complete with financial statements.

Garth: Partly offset by a decrease in D&O insurance <unk>.

Garth: <unk> 6 million a decrease in legal and consulting fees of $7 4 million and a net increase of $7 2 million.

Garth: Selling general and administrative.

Garth: Yeah.

Garth: As of December 31, 2023, we had $13 3 million in cash cash equivalence and marketable securities. We expect that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2025.

Garth: Yeah.

Garth: Our financial statements I'd like to hand, the call back over to Milton for closing remarks.

Milton H. Werner: I'd like to hand the call back over to Milton for his closing remarks. Thank you, Garth. As we look ahead to 2024, we will continue to take advantage of the recent momentum we've experienced to continue to create value for our shareholders. We believe that the recent feedback from our pre-MBA meeting was constructive as we plan to conduct additional tests and studies to begin to build our first MBA submission package. In addition, we will continue to enroll patients into our 2-in-1 trial and expect to provide top-line data from this study in the second half of the year. Our recent publication of early clinical data for RISDO and Adrenal Parkinson's Disease reinforces our belief that RISDO could be a transformative treatment for patients with Parkinson's disease and related disorders.

Milton: Thank you Gary as we look ahead to 2024, we will continue to take advantage of the recent momentum we've experienced to continue to create value for our shareholders. We believe that the recent feedback from our pre NDA meeting was constructive as we plan to conduct additional tests and studies to begin to build our first NDA submission package. In addition, we will continue to enroll patients in.

Milton: Our tier one trial and expect to provide top line data from this study in the second half of the year.

Milton: A recent publication of early clinical data for rhythm and a durable parkinson disease reinforces our belief that <unk> could be a transformative treatment for patients with Parkinson's disease and related disorders. We look forward to continuing to establish ourselves as the leader in the development of treatments for each of these.

Milton H. Werner: We look forward to continuing to establish ourselves as a leader in the development of treatments for neurodegenerative disease, and we want to thank all our shareholders and trial participants for their continued support as we advance new medicines for patients with high-end methamphetamine. I would now like to open the call to questions. Operator?

Milton: I want to thank all our shareholders and trial participants for their continued support as we advance new medicines for patients with high unmet needs.

None: I'd now like to open the call to questions operator.

None: Thank you well now be conducting a question and answer session.

Operator: Thank you. If you'd like to ask a question at this time, please press star 1 on your telephone keypad and a confirmation tone to indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

None: If you'd like to ask a question at this time. Please press star one from your telephone keypad and a confirmation tone will indicate your line is the question queue.

None: You May press Star two if you like to remove your question from the queue.

None: Sorry, the speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please, while we poll for questions. Thank you. Thank you. Our first question is from the line of Ed White with HC Wainwright. Please proceed with your question. Good morning, this is Steve Unser with Ed White.

None: One moment please poll for questions. Thank you.

None: Thank you. Our first question is from the line of Ed White with H C. Wainwright. Please proceed with your questions.

None: Good morning. This is Steve on for Ed White, So assuming positive data.

Milton H. Werner: So, assuming positive data... Parkinson's in the second half. What are the next steps towards approval and timing? Well, approval is a little bit hard to gauge. We've been fortunate to be able to enroll the 201 trial, at least for this patient population, at a faster rate than other studies of its kind in the last three years since COVID emerged. The phase three trial or trials would be run again in untreated Parkinson's patients on a larger scale. We'll need to assess the degree of benefit, if any, at all three doses of varicepidecinib and decide whether we're going to have a one or two trial, a one or two dose trial, for registration purposes. We also think that based on the outcomes of biomarker analysis, and we don't know those outcomes today, but if biomarkers support what we've seen in the preclinical animal models, there are opportunities to seek accelerated approval designations that could assist and accelerate those phase three, one or two trials that would be necessary for registration. I would guess it's probably a two- to three-year process overall.

Parking signs in the second half what are the next steps towards approval and timing.

Steve: Well approval of a little bit hard to gauge, where we've been fortunate to be able to enroll the 201 trial.

Steve: At least for this patient population and a faster rate than other studies of its kind in the last three years since COVID-19 emerged.

Steve: <unk> III trial or trials would be run again in untreated parkinson patients on a larger scale.

Steve: To assess the degree of benefit if observed at all three doses. If there is a Dutch name and to decide whether we're going to have a one or two trial, one or two dose trial.

Steve: For Registrational purposes.

Steve: We also think that based on the outcomes of biomarker analysis, and we don't know that that comes today.

Steve: If biomarkers support what we've seen in the preclinical animal models there are opportunities to seek.

Steve: Accelerated approval designations that could assist and accelerate those phase III, one or two trials that would be necessary for registration.

Steve: I would guess, it's probably a two to three year process overall.

Milton H. Werner: We would plan, depending on the outcome of the trial that we see this year, to schedule a meeting with the FDA to discuss the parameters of the Phase III program. On the manufacturing side, we're well ahead of the game. We are already producing rizvodexamide on the order of a commercial scale. We have a commercial tablet formulation we'll be testing in the extension trial. And assuming that there are no issues that arise from that tablet formulation, we'll be in a very strong position to complete the other requirements of clinical development and enter into an NDA process. All right, thank you.

Steve: Would plan depending on the outcome of the trial that we see this year to schedule a meeting with the FDA to discuss the parameters of the phase III program.

Steve: On the manufacturing side, we're well ahead of the game, we are really producing a risk reduction it on the on the order of commercial scale, we have a commercial tablet formulation will be testing.

Steve: In the extension trial and assuming that there are no issues that arise from that tablet formulation will be in a very strong position to complete the other requirements of clinical development and enter into an NDA process.

None: Alright, Thank you and for <unk> and <unk> trials can you just comment on the big picture strategy.

Milton H. Werner: And for IKT001Pro, can you just comment on the big picture strategy and then any comments on potential partnering? So, you know, we have O1 pro is a bit of an unusual molecule for us. It's technically a novel chemical entity. We have compositions of matter protection.

None: And then any comments on potential partnering.

None: So we know we have you know.

None: <unk> pro is a bit of unusual.

None: Molecule for us.

None: It's technically a novel chemical entity, we have composition of matter protection.

Milton H. Werner: We evaluated it originally to determine whether the technology ideas that we built into that molecule could improve a well-established, well-tolerated drug substance. And we see hints of that coming through in the clinical work that we've done to date. We also seem to have reasonable support at the FDA that could lead to approval through the 505A2 statute. So along that path, the one qualification is that O1 Pro would be a kind of, in quotations, branded generic. Its earning potential is unknown at the moment, but it's much more modest given that the front-line drug, imatinib mesylate, is now generic. And there are 15 generic suppliers in the U.S. for that medication.

None: We evaluated it originally to determine whether technology ideas that we built into that molecule could improve on our well established well tolerated drug substance and we see hints of that coming through the clinical work that we've done to date. We also seem to have reasonable supported the FTAA that could lead to approval through the five to $5 two stats.

None: So along that path. The one qualification is that all one pro would be a kind of quotations branded generic.

None: It's earning potential would be.

None: Unknown at the moment, but it's a much more modest given that the frontline drug Amanda Mesler is now generic.

None: And there are 15 generic suppliers in the U S.

None: For that medication.

Milton H. Werner: So it depends on how this evolves moving forward. We would be seeking a partner to assist in the cost of a non-inferiority or superiority trial to further augment safety knowledge. That trial does not have to be part of any approval process, but we would like to initiate it in the near future because it would be done in the target patient population who have blood or stomach cancer. Separately from that, as we've disclosed previously, we have an interest in evaluating O1Pro as a potential branded product in non-oncology indications, and we'll be providing a further update on that underlying strategy in the coming days because we have an upcoming meeting with the FDA on that subject at the end of next week.

None: So it depends on what how this evolves moving forward, we would be seeking a partner to assist in the cost of a non inferiority or superiority trial to further augment the safety knowledge that trial does not have to be part of any approval process, but we would like to initiate it in the near future because it would be done in the target patient.

Population of have bladder stomach cancers.

None: Separately from that as we've disclosed previously we have an interest in evaluating <unk> pro.

None: The potential branded products and non oncology indications and will be providing a further update on that underlying strategy in the coming days, because we have an upcoming meeting with the FDA on that subject at the end of next week at all I don't want to preempt that announcements, but we'll be saying a little bit more about that in a couple of days.

Milton H. Werner: And I don't want to preempt that announcement, but we'll be saying a little bit more about that in the coming days. All right, thank you. I was going to ask about that meeting. That's all our questions.

None: Alright. Thank you yeah, I was going to ask you about that meeting that's all our questions Max.

Operator: Thanks. Thank you. Seeing no additional questions at this time, this will also conclude today's teleconference. You may now disconnect your lines. We thank you for your participation, and have a wonderful day.

Thank you.

None: Seeing no additional questions at this time. This will also conclude today's teleconference. You may now disconnect. Your lines at this time, we thank you for your participation.

And have a wonderful day.