Q3 2024 Palatin Technologies Inc Earnings Call

Operator: Greetings. Welcome to Palatin's third quarter fiscal year 2024 operating results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Greetings and welcome to Palatin third quarter fiscal year, 'twenty 'twenty four operating results conference call.

Speaker Change: At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference call is being recorded.

Operator: As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts. It may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate, and the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission.

Speaker Change: Before we begin our remarks I would like to remind you that statements made by Palatin are not historical facts may be forward looking statements.

Speaker Change: These statements are based on assumptions that may or may not prove to be accurate and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please.

Operator: Please consider such risk and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now, I would like to turn the call over to your host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead.

Speaker Change: Please consider such risks and uncertainties carefully in evaluating these forward looking statements by Palatin prospects now I would like to turn the call over to your host Dr. Carl <unk>, President and Chief Executive Officer of Palatin. Please go ahead.

Carl Spana: Good morning, and welcome to the Palatin third quarter fiscal year 2024 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin Executive Vice President, Chief Financial Officer, and Chief Operating Officer. I'll now turn the call over to Steve, and he will give the financial and operating update.

Thank you good morning, and welcome to the Palatin third quarter fiscal year 2024 call Dr. Carl Spanish CEO and President of Palatin with me on the call today is Steve Wills Pallets as executive Vice President Chief Financial Officer, and Chief Operating Officer, I will now turn the call over to Steve who will give the financial and operating update Steve.

Stephen T. Wills: Thank you, Carl. And hello, everyone.

Steve: Thank you Carl and Hello, everyone propel.

Stephen T. Wills: For Palatin's fiscal third quarter ended March 31st, 2024 financial results. Regarding revenue, total revenue consists of gross product sales of Vylese, net of allowances and accruals. Pursuant to the completion of the sale of Ilesi's worldwide rights for female sexual dysfunction to Costat Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors for the quarter ended March 31, 2024.

Stephen T. Wills: For Palatin fiscal third quarter ended March 31, 2024 financial results.

Stephen T. Wills: Regarding revenue total revenue consists of gross product sales of RAC net of allowances and accruals.

Speaker Change: Pursuant to the completion of the sale of <unk> worldwide twice for female sexual dysfunction, Tucows set pharmaceuticals for up to $171 million in December of 2023, pallets and did not record any product sales to pharmacy distributors for the quarter ended March 31 2024.

Stephen T. Wills: For the quarter ended March 31st, 2023, gross product sales were $3.4 million, with net product revenue of $1.2 million. Regarding operating expenses, total operating expenses were $9.2 million compared to $8.5 million for the comparable quarter last year. The increase was related to greater spending on our melanocortin receptor programs, offset partially by the elimination of selling expenses related to these. Regarding other income and expense, total other income and expense, net, consists mainly of the change in fair value of warrant liabilities, which Palatin had recorded as a liability on the consolidated financial statements, including revisions of certain prior period amounts to correct the misstatement with respect to classifying warrants as equity instead of To be clear, that's all cleaned up. There is no more liability reflection. And as we go forward, again, that item has been cleaned up.

Speaker Change: For the quarter ended March 31, 2023 gross product sales were $3 4 million with net product revenue of $1 2 million.

Speaker Change: Regarding operating expenses total operating expenses were $9 2 million compared to eight 5 million for the comparable quarter of last year. The increase was related to greater spending on a lot of courting receptor programs offset partially by the elimination of selling expenses related to buy D. C.

Speaker Change: Regarding other income and expense total other income and expense net consists mainly of the change in fair value of warrant liabilities, which palatin are recorded as a liability on the consolidated financial statements, including revisions of certain prior period amounts to correct, a misstatement with respect classified warrants as equity instead of lie.

Speaker Change: Ability to be clear, that's all cleaned up there is no more liability reflection.

Speaker Change: And as we go forward.

Speaker Change: That item has been cleaned up.

Stephen T. Wills: The statement of operations was adjusted each quarter to reflect changes in the fair value of these warrants. For the quarters ended March 31, 2024, and 2023. Palatin recorded a fair value adjustment gain of 0.4 million and a loss of 1.5 million, respectively. Regarding cash flows, Palatin's net cash used in operations was $8.6 million, compared to $1.4 million for the same period last year. The increase is mainly due to changes in working capital.

Speaker Change: The statement of operations was adjusted each quarter to reflect changes in the fair value of these warrants for the quarter ended quarter ended March 31, 2024, and 2023 pallets and recorded a fair value adjustment gain of 0.4 million and a loss of $1 5 billion respectfully.

Speaker Change: Regarding cash flows pallet since net cash used in operations was $8 6 million compared to $1 4 million for the same period last year. The increase is mainly due to changes in working capital.

Stephen T. Wills: Regarding net loss, Palatin's net loss was $8.4 million, or $0.53 per common share, compared to a net loss of $8.7 million, or $0.76 per common share, for the comparable period last year. The decrease over the comparable quarter of last year was mainly due to a larger operating loss in fiscal 2024 offset by higher other income, which was primarily from changes in the fair value of the warrant liability. Regarding its cash position, as of March 31, 2024, Palatin's cash, cash equivalents, and marketable securities were $10 million, compared to cash, cash equivalents, and marketable securities of $9.5 million, plus $2.3 million of accounts receivable as of December 31, 2023, and compared to $5.5 million plus 1.3 million of accounts receivable as of September 30, 2023. We believe that existing cash and cash equivalents, and marketable securities will be sufficient to fund currently anticipated operating expenses and disbursements well into the second half of calendar year 2024.

Speaker Change: Regarding that loss palaces net loss was $8 4 million or <unk> 53 per common share compared to a net loss of $8 7 million or <unk> 76 cents per common share for the comparable period last year.

Speaker Change: The decrease over the comparable quarter last year was mainly due to a larger operating loss in fiscal 2024 offset by the higher other income which was primarily from changes in the fair value of the warrant liabilities.

Speaker Change: Regarding cash position as of March 31, 2020 for Palatin cash cash equivalents in marketable securities were $10 million compared to cash cash equivalence and marketable securities of $9 5 million plus.

Speaker Change: Plus $2 $3 million of accounts receivable as of December 31, 2023.

Speaker Change: And compared to $5 5 million plus $1 3 million of accounts receivable as of September 30th 2023.

Speaker Change: We believe that existing cash and cash equivalents marketable securities will be sufficient to fund currently anticipated operating expenses and disbursements well into the second half of calendar year 2024.

Stephen T. Wills: Now, I'd like to turn the call back over to Carl. Carl? Thank you, Steve.

Now I'd like to turn the call back over to Carl.

Carl Spana: Thank you, Steve. As you know, our focus has been on understanding the biology and chemistry of the melanocortin system with the goal of developing selective melanocortin agonists for a variety of indications. These research efforts have resulted in a growing portfolio of melanocortin-based therapeutics. We have three clinical programs based on Melanocortin agonists and are planning to initiate enrollment in two new clinical programs by mid-2024, pending resources, all coming from our highly productive research activities.

Carl: Thank you Steve.

Carl: As you know our focus has been on understanding of the biology and chemistry of the Milan Court system with the goal of developing selective <unk> agonist with a variety of indications.

Carl: Such efforts have resulted in a growing portfolio of Milan. According based therapeutics.

Carl: We have three clinical programs based on our line. According to agonists and are planning to initiate enrollment in two new clinical programs by mid 2024 spending resources, all coming from our highly productive research activities.

Carl Spana: Now, for our PLM 9643 dry eye disease program. We reported positive phase 3 Melody 1 results earlier in the quarter. I'd like to highlight some of the key findings that differentiate PL9643 from current therapies and that have us and potential partners very excited. We see excellent ocular tolerability and safety, essentially similar to a dry artificial tear.

Carl: Now for appeal 94, three dry eye disease program.

We reported positive phase III <unk>, one results earlier in the quarter.

Carl: To highlight some of the key findings that differentiate P. L 94, three concurrent therapies and that have us and potential partners very excited.

Speaker Change: We see excellent ocular tolerability and safety essentially similar to a dry artificial tier I don't think theres any product out there approved or in development that has the tolerability of <unk> 43.

Carl Spana: I don't think there's any product out there, approved or in development, that has the ocular tolerability of PL9643. We see rapid onset of efficacy for both signs and symptoms of dry eye disease, with the primary symptom endpoint of pain and seven of 11 secondary symptom endpoints reaching statistical significance at two weeks, which was the earliest time point that we evaluated. Very importantly, we continue to see improvement of multiple symptom endpoints over the full 12 weeks of treatment.

We see rapid onset of efficacy for both signs and symptoms of dry eye disease with the primary symptom endpoint of pain and seven of 11 secondary symptom endpoints, reaching statistical significance at two weeks, which was the earliest time point that we evaluated.

Speaker Change: Very importantly, we continue to see improvement of multiple set of endpoints or full 12 weeks of treatment we.

Carl Spana: We have not reached maximal efficacy yet, and we believe that as we treat patients longer in the upcoming Phase 3 program, we'll continue to see even more efficacy for PL9643. We are now currently preparing for the remaining clinical studies to support a new drug application submission, which we anticipate will begin in the second half, will be enrollment in the second half of calendar 24, and an upcoming type C meeting with the FDA to discuss the remaining program studies that we have to do.

We have not reached maximal efficacy yet can we believe that as we treat longer in the upcoming phase II program, we will continue to see even more efficacy.

Speaker Change: License for three.

Speaker Change: You are now currently preparing for the remaining clinical studies to support a new drug application submission, which we anticipate will begin in the second half will be enrollment in the second half of calendar 'twenty four and upcoming type C meeting with the FDA to discuss the remaining <unk>.

Speaker Change: Graham studies that we have to do.

Carl Spana: Our phase two study evaluating oral PL-8177, a selective melanocortin-1 receptor agonist, in ulcerative colitis patients is on track for an interim assessment, release of data in mid 2024. Supporting oral-PL-8177 development or preclinical studies demonstrating that treatment with 8177 causes diseased colons to improve toward a healthy state and to resolve inflammation. Dissolving information rather than blocking it provides the possibility of efficacy coupled with significantly differentiating safety in treating ulcerative colitis and other types of inflammatory bowel disease.

Speaker Change: Our phase II study evaluating oral <unk> 177, a selective <unk> one receptor agonist and all subscribed as patients is on track for an interim assessment.

Speaker Change: Release of data in mid 2020 for supporting oral PL 877 development or preclinical studies demonstrating that treatment.

Speaker Change: 877 causes disease cole is to improve toward a healthy state and to resolve inflammation resolving inflammation rather than blocking it provides the possibility of efficacy coupled with significantly differentiating safety and treating ulcerative colitis and other types of inflammatory bowel disease.

Carl Spana: Breakout, our phase two open-label study evaluating melanocort agonist in diabetic patients with kidney disease, is also on track for top-line data release in mid-2024. Additionally, I'd like to take a minute to highlight two new clinical programs that we are planning on starting this year.

Breakout our phase two open label study evaluating a linerboard agonists in diabetic <unk>.

Speaker Change: Patients with kidney disease is also on track for top line data release in mid 2024 as well.

Carl Spana: These two programs leverage our extensive expertise in the chemistry and biology of the monocortin 4-receptor agonist. Both have strong clinical validation, and they address large markets in need of new therapeutic options. The first is a phase two obesity clinical study designed to enroll up to 60 of these patients that are currently using Tuzepatide at 2.5 milligrams weekly. The primary endpoint is to evaluate the safety and increased efficacy of co-administration of bremelanotide with Tuzepatide in reducing weight.

Speaker Change: I'd like to take a minute.

Speaker Change: Alright, two new clinical programs that we're planning on starting this year. These two programs leverage our extensive expertise and the chemistry and biology of Atlanta four receptor agonist, both a strong clinical validation and they address large markets in need of new therapeutic options.

Carl Spana: A secondary endpoint will evaluate the weight loss maintenance effect of bremelanotide in patients that have stopped using Tuzepatide. The initial drug application and the protocol for this study have been reviewed by the FDA, and we are clear to begin enrolling patients. In support of this study and our obesity program in general, we recently hosted a key opinion leader event titled, Beyond GLPs, The Multiple Roles of a Novel Monocortin-4 Receptor Agonist in Treating Obesity and Weight Loss Maintenance.

Speaker Change: The first is a phase II obesity clinical study designed to enroll up to 60 of these patients that are currently using to his appetite at two five milligrams weekly primary endpoint is to evaluate the safety and increased efficacy of co administration of <unk>, which was appetite and reducing weight.

Speaker Change: Secondary endpoint will evaluate the weight loss maintenance effective greenville outside in patients that have stopped using two separate time.

Speaker Change: The initial drug application in the protocol for this study has been reviewed by the FDA and we are cleared to begin enrolling patients.

Speaker Change: Supporting this study and RBC program in General we recently hosted a key opinion leader event.

Speaker Change: Titled Beyond Gop's multiple roles for novel monoclonal <unk> four receptor agonist and treating obesity.

Carl Spana: The speaker was Dr. Jesse Richards from the University of Oklahoma, and he discussed co-administration of linoleic acid receptor agonists, which increase appetite in obese patients, the continued need for novel obesity treatments, and the multiple uses of linoleic acid receptor agonists in treating obesity and weight loss maintenance. You can find the link to the recording of the event on our website.

Speaker Change: And weight loss maintenance.

Speaker Change: The speakers Dr. Jesse Richards from the University of Oklahoma and.

Speaker Change: As he discussed co administration of <unk>, four receptor agonists, which was appetite and obese patients. The continued need for novel obesity treatment and the multiple uses.

Speaker Change: Medical and four receptor agonist in treating obesity and weight loss maintenance.

Speaker Change: By the links.

Speaker Change: <unk> of the event on our website.

Carl Spana: Drug treatment for obesity is now established and growing rapidly. However, we believe multiple drugs with differing mechanisms of action that affect weight loss and, importantly, weight loss maintenance are needed. We strongly believe that drugs targeting the melanocortin receptor system will be an important part of the future of obesity treatment and weight loss maintenance. Our extensive experience in the design and development of melanocortin agonists for treating obesity includes two clinical studies previously completed and published.

Speaker Change: <unk> is now established and growing rapidly we believe multiple drugs with different mechanism of action that affect weight loss and importantly weight loss maintenance are needed. We strongly believe the drug's talking Atlantic Horton receptor system will be an important part of the future of obesity treatment weight loss maintenance.

Speaker Change: Our extensive experience in the design and development of a <unk> agonist for treating obesity include two clinical studies previously completed and published and we are well positioned to be a leader in the development of a liquid based therapeutics for weight loss and weight loss maintenance.

Carl Spana: We are well positioned to be a leader in the development of melanocortis-based therapeutics for weight loss and weight loss maintenance. We are also planning a phase two clinical study evaluating the co-administration of remelanotide with a PD-5 inhibitor for treating erectile dysfunction patients who have failed PD-5 inhibitor monotherapy. This clinical study will support the development of a program for a combination product, which is a co-formulation of bremelanotide with a phosphodiesterase V inhibitor and an extension of our commercial efforts in sexual dysfunction.

Speaker Change: We're also planning a phase II clinical study evaluating the co administration of <unk> with a PDE five inhibitor for treating erectile dysfunction patients at a failed PD one inhibitor monotherapy.

Speaker Change: This clinical study will support the development program for a combination product, which is a co formulation of <unk> with the fossil addresses five inhibitor.

Speaker Change: As an extension of our commercial efforts and sexual dysfunction.

Carl Spana: Approximately 35% of men with erectile dysfunction fail or have an inadequate response to PD-5 inhibitored treatments. These are things like Cialis and Viagra, representing a large underserved market. The only treatment options for these patients are highly invasive, such as direct penile injections or penile implants.

Speaker Change: Approximately 35% of men with retinal dysfunction fail or have an inadequate response to PDE five inhibitor treatments and these are things like cialis and.

Speaker Change: By Agra represent a large underserved market.

Speaker Change: The treatment options for these patients are highly invasive such as direct P&L injections or P&L implants.

Carl Spana: We have previously conducted clinical studies showing the synergistic effects of combining remelanatide with a PD-5 inhibitor as a treatment for rectal dysfunction. I feel well positioned for an efficient and successful development program of the co-formulated product. Key highlights for the third quarter of fiscal year 2024 are as follows.

Speaker Change: Previously conducted clinical studies, showing the synergistic effects of combining a <unk> tied with a PDE five inhibitor as a treatment for erectile dysfunction, we feel well positioned for an efficient successful development program of the co formulated product.

Speaker Change: Do you like highlights for the third quarter and fiscal year 2024 are as follows.

Carl Spana: We reported positive results for PL9643 in a phase 3 Melody 1 dry eye disease clinical study, and PL9643 is emerging as a highly differentiated treatment for dry eye disease with excellent oculotolibility, rapid onset of efficacy, and broad relief from multiple symptoms of dry eye disease. We are planning on initiating two new monocord programs with phase two clinical studies that will have data readouts in 2024. And finally, our clinical programs continue to advance with multiple clinical data milestones from four clinical programs and the initiation of the remaining PL9643 Phase III studies by calendar year end.

The positive results for <unk> license for three phase III <unk> one drive these clinical study NPL 94, three is emerging as a highly differentiated treatment for dry eye disease with excellent ocular tolerability rapid onset of efficacy and broad relief the multiple symptoms of dry eye disease.

Speaker Change: We are planning on initiating two new melodic programs with phase two clinical studies that have data readouts in 2024 and.

Speaker Change: Finally, our clinical programs continue to advance with multiple clinical data milestones for a portion of our programs and the initiation of the remaining <unk> license for three phase III studies by calendar year end.

Carl Spana: Steve and I would like to thank you for listening to the Paladin third quarter fiscal year 2024 conference call. You can find additional information on our science and clinical programs on our website, www.paladin.com, and you can find additional information on Vailisi at the vailisi.com website. We'd like to thank you and now open the call to questions.

Stephen: Stephen I would like to thank you for listening to the <unk> third quarter fiscal year 2024 conference call you can find additional information on our science and clinical programs on our website www dot palette of Dot Com and you can find additional information on <unk> at <unk> Dot Com website.

Stephen: Like to thank you and now open the call to questions.

Operator: Certainly, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. Yes, while posing your question, please pick up your handset if listening on a speakerphone to provide optimum sound quality. Please hold just a moment while we poll for questions. Your first question is coming from Joe Pantginis with H.C. Rainwright. Please pose your question. Your line is live

Speaker Change: Certainly as far as now open for questions. If you have any questions or comments. Please press star one on your phone at this time.

Speaker Change: Yes, all closing your question you. Please pickup your handset and have listing on a speaker phone to provide optimum sound quality. Please hold just a moment, while we poll for questions.

Speaker Change: The first question is coming from Joe <unk> with H C. Wainwright. Please pose your question your line is live.

Joseph Pantginis: Hey guys, good morning, thanks for taking the question. So, Steve and Carl, I wanted to focus on the overall profile for 9643 right now. You know, post-Melody One data, you have an upcoming Type C meeting. What are you looking to clarify or get agreement on with regard to, you know, moving forward? And, you know, before you get that feedback, have any of the learnings from Melody One impacted how you're going to potentially approach Melody Two?

Speaker Change: Hey, guys. Good morning, Thanks for taking the question so.

Speaker Change: Steven Carl I wanted to focus on the overall profile for 90 643, right now you know post the melody one data you have an upcoming type C meeting.

Speaker Change: What are you looking to clarify or get agreement on with regard to you know moving forward and you know before you get that feedback have any of the learnings from melody, one impacted how you're going to potentially approach melody too.

Carl Spana: Sure. Well, let me take that in the reverse order. The answer is yes. I mean, obviously, this Melody-1 was a very large clinical trial. There was a lot of data. And like most dry disease programs, you continue to learn as you do these studies. You don't always get what you want.

Speaker Change: Sure well, let me take that.

Speaker Change: In the reverse order.

Speaker Change: The answer is yes, I mean, obviously this one was a very large clinical trial there was a lot of data.

Speaker Change: Like most drive programs.

Continue to learn as you do these studies.

Speaker Change: You don't always get what you want.

Carl Spana: But the way we're thinking about this is we'd like to do two more studies, Melody 2 and Melody 3, to provide the remaining data that we need. And that way, it will give us three large phase 3 clinical trials to really support the profile of the drug, the safety, and the overall efficacy. And we think that's the most prudent course to go forward. It is very atypical for dry eye disease products to be approved on just two studies.

Speaker Change: When we're thinking about this is we'd like to do two more studies <unk> II <unk> III.

Speaker Change: To provide the remaining data that we need.

Speaker Change: And that way it will give us three large phase III clinical trials to really support the.

Speaker Change: The profile of the drug the safety and the overall efficacy and we think thats. The most prudent course to go forward. It is very atypical for dry eye disease products to be approved on just two studies. They generally most of these programs have 345 phase III studies that support.

Carl Spana: Generally, most of these programs have three, four, five phase 3 studies that support their overall approval. So that's our overall strategy. We've learned, I think, additionally, the end point with regard to symptoms will most likely be ocular pain. But importantly, we really want to continue to highlight the broad efficacy that we're seeing with symptoms. I mean, we're seeing eight symptoms out of the 11 measured, and all reach significance starting at two weeks and then moving forward. There's no product out there that has that type of symptom.

Speaker Change: The overall approval.

Speaker Change: So that's our overall strategy.

Speaker Change: We've learned I think additionally, the endpoint with regards to symptoms.

Speaker Change: We will most likely be the ocular pain.

Speaker Change: But importantly, we really want to continue to highlight the broad efficacy that we're seeing on symptoms.

Speaker Change: We're seeing eight symptoms out of the 11 measured all reach significant starting at two weeks and then moving forward. There's no product out there that has that type of symptom relief.

Carl Spana: So we really want to make sure we get these studies to drive that home. In addition to that, we need to get the sign. The sign is more of a regulatory endpoint. And I think we figured out how to do that, when to measure, and what to measure. It'll be inferior corneal fluorescein staining.

Speaker Change: We really want to make sure we get these studies to drive that home in addition to that.

We need to get the signed design is more of a regulatory endpoint.

Speaker Change: And I think we figured out how to do that.

Speaker Change: When to measure what's measure it'll be inferior corneal fluorescein staining, we'll do it at two weeks.

Carl Spana: We'll do it in two weeks. So it'll be a relatively rapid measurement. And so we think we're now really well positioned to deliver the rest of the program and support an NDA submission. With regard to the first part, there are a number of more technical things there. I don't think there's, I don't think the agency will have, I don't think we're posing any real questions as to the design and overall endpoints that we're using in Melody 2 and 3 and the open label, you know, pain, eye dryness, inferior corneal fluorescein staining, these are all well-known endpoints and well-validated endpoints for use in these trials

Speaker Change: So the relatively rapid measurement and so we think we are now really well positioned to deliver the rest of the program and support an NDA submission with regards to the first part which is the type C meeting.

Speaker Change: There are a number of more technical things there I don't think there is.

Speaker Change: I don't think the agency will have.

Speaker Change: I don't think were posing any real questions as to the design and overall.

Speaker Change: Endpoints that were using <unk> two and three.

Speaker Change: And the open label.

Speaker Change: Pain eye dryness theory, corneal fluorescein staining. These are all well known endpoints and well validated endpoints for use of these trials are the analyses were doing a pretty straightforward throw ITT analyses. So theres no subgroup analysis that we're planning.

Carl Spana: The analyses we're doing are pretty straightforward; they're all ITT analyses, so there's no subgroup analysis that we're planning, so I don't think there's anything there. So none of the questions will be around, you know, just the sufficiency of what we intend to deliver, and I expect that they will agree with that. I think three large, well-controlled studies will be more than sufficient to support an NDA submission and their And in addition, there are a number of questions around manufacturing, etc., that are more things that, you know, we need guidance on what the next steps should be, or, you know, they're more, I would say, you know, you could do either A or B, we just want to make sure that you want A or B.

Speaker Change: So I don't think Theres anything there.

Speaker Change: So none of the questions will be around just.

Just the sufficiency of what we intend to deliver.

Speaker Change: Expect that they will agree with that I think three large well controlled studies will be more than sufficient to support an NDA submission and their evaluation.

Speaker Change: And then in addition, there were a number of.

Speaker Change: It was.

Speaker Change: Questions around manufacturing what have you that are more.

<unk>.

Speaker Change: We need guidance.

Speaker Change: What's the next step should be or.

Speaker Change: They're not they're more I would say.

Speaker Change: You can do either a or b, we just want to make sure which one do you want you want <unk>. So nothing really I think significant just more guidance as to.

Carl Spana: So nothing really, I think, significant, just more guidance as to, you know, what type of data they want there. So overall, I expect a very fruitful meeting on the Type C, and as I said, we're planning now to really move the next set of studies forward, and we're quite excited about the product.

Speaker Change: Which what type of data they want there. So overall I expect a very fruitful meeting on the type C and as I said, we're planning now to really move the next set of studies forward quite a bit and we're quite excited about the product.

Joseph Pantginis: No, I appreciate those comments, and I guess I'll just take it a little further with regard to potential endpoints for the next study. And you brought up, I guess, one of the interesting concepts in dry eye development, where you said, you know, you're looking at eight different signs, and like, would you look to keep the same sign? Because I know you basically have to pick one in a decision with the FDA, so how would you look to address that?

Speaker Change: No I appreciate those comments and I guess I'll just take it a little further with regard to.

Potential end points for the next study and you brought up I guess one of the interesting concepts in a dry eye development and where you said youre looking at a different signs and like would you look to keep the same sign because I know you basically have to pick one in decision with the FDA. So how would you look to address that so on the sign side I'll be inferior corneal fluorescein.

Carl Spana: So on the science side, it'll be inferior corneal fluorescein staining. On the symptom side, we have a lot, we have the flexibility there. You know, Both pain and eye dryness. I think actually eye dryness was reached the highest degree of significance in Melody One. Either one is acceptable.

Speaker Change: Staining.

Speaker Change: On the symptom side.

Speaker Change: We have a lot of flexibility there.

Speaker Change: Both pain and eye dryness, I think actually eye dryness was reached the highest degree of significance.

Melody: And melody one either one is acceptable.

Carl Spana: I mean, one of the questions we will ask the agency is that if we elevate eye dryness as opposed to pain, you know, will that be, and it should be okay. Will they accept that in Melody One as well? As we delivered in Melody Two and Melody Three, will they accept that at the end point in Melody One as well? And I think that they will do that.

Speaker Change: One of the questions. We will ask the agencies is that if we elevate eye dryness as opposed to pain.

Speaker Change: Will that be.

Speaker Change: And it should be okay.

Speaker Change: Except that in <unk>, one as well.

Speaker Change: We delivered a <unk> II <unk> III will they accept that.

Speaker Change: Pete.

Pete: Point, <unk>, one as well and I think that they will.

Carl Spana: But, you know, where you're going is, we will probably have a lot more of the secondary end points be symptom-based. Because, and one of the things we do want to discuss with them is, if we hit all these symptoms again, and as we replicate them, can we get some of these on the label? And can we get some specific symptoms on the label? And I think that would be another differentiating feature.

Speaker Change: Do that but.

Speaker Change: But where you're going is we will probably have a lot more of the secondary endpoints be symptom based because ed one of the things we do want to discuss with them is.

Speaker Change: We hit all the symptoms.

Speaker Change: Again, as we replicate them can we get some of these on the label.

Speaker Change: And can we get some specific symptoms on a label on it.

Speaker Change: That would be another differentiating feature.

Joseph Pantginis: Got it, got it. I appreciate the comments.

Speaker Change: Got it got it appreciate the comments.

Operator: Once again, if you have any remaining questions or comments, please press star one at this time. Please hold a moment while we pull for any additional questions. There are no additional questions in queue. At this time, I would like to turn the floor back over to Dr. Spana for any closing remarks.

Speaker Change: Once again, if you have any remaining questions or comments. Please press star one at this time, please hold the moment, while we poll for any additional questions.

Speaker Change: There are no additional questions in queue at this time I would like to turn the floor back over to Dr. <unk> for any closing remarks.

Carl Spana: Great, thank you. I'd like to thank everyone for participating in the Paladin Technologies third quarter fiscal year 2024 conference call. Have a great day. And Steve and I look forward to updating you on our progress. And we're very excited about where we're going with the company and the milestones that we have coming up throughout the remainder of this year. So have a great day, and thank you.

Dr. <unk>: Great. Thank you I would like to thank everyone for participating on the Palatin technologies third quarter fiscal year 2024.

Dr. <unk>: Conference call have a great day, and Steve and I look forward to updating you on our progress and we're very excited about where we're going with the company and the milestones that we have coming up throughout the remainder of this year. So have a great day and thank you.

Operator: Thank you, everyone. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

Speaker Change: Thank you everyone. This does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.