Q4 2023 Palatin Technologies Inc Earnings Call

Speaker 1: Greetings and welcome to Palatins fourth quarter and fiscal year end 2023 operating results conference

Greetings and welcome to Palatin fourth quarter and fiscal year end 2023 operating results conference call.

Speaker 1: 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 is being recorded.

At this time all participants are in a listen only mode. A question 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.

Speaker 1: Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. 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.

Before we begin our remarks I would like to remind you that statements made by Palatin are not historical facts and maybe forward looking statements. 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.

As discussed in the company's most recent filings with the Securities and Exchange Commission.

Speaker 1: Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's process.

Please consider such risks and uncertainties carefully in evaluating these forward looking statements by Palatin prospects now.

Speaker 1: Now I would like to turn the call over to our host, Dr. Carl Spanner, President and Chief Executive Officer of Palatine. Please go.

Now I would like to turn the call over to our host Dr. Carl <unk>, President and Chief Executive Officer of Palatin. Please go ahead.

Speaker 2: Thank you. Good morning and welcome to the Paladin fourth quarter in fiscal year and 2023 call. I'm Dr. Carl Spanner, CEO and president of Paladin. With me on the call today is Steve Wiltz, Paladin's executive vice president, chief financial officer and chief operating officer.

Thank you good morning, and welcome to the Palatin fourth quarter and fiscal year end 2023 call I'm, Dr. Carl <unk>, 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'll now turn the call over to Steve and he will give financial and operating profit.

Speaker 2: I'll now turn the call over to Steve, and he will give financial and operating.

Speaker 3: Thank you, Carl, and good morning and good afternoon, everyone.

Thank you. Thank you Carl and good morning, and good afternoon, everyone.

Speaker 3: Starting with Vileesi, as a reminder, Vileesi is our FDA-approved commercial product for premenopausal women with Hypoactive Sexual Desire Disorder, or HSDD.

Starting with whereby Lucy.

As a reminder, my D. C is our FDA approved commercial product.

For Paramount a puzzle women with hyperactive <unk> sexual desire disorder for Hs D D.

Speaker 3: The goal of the Vileesi program is to demonstrate commercial product value in the marketplace.

The goals of our leasing program is to demonstrate commercial product value in the marketplace.

With.

Speaker 3: six consecutive quarters of double digit growth that we're going to talk about shortly. I think we're doing that.

Six consecutive quarters of double digit growth that we're going to talk about shortly I think where you're doing that.

But the objective is to re license the U S rights to a committed women's health care company.

Speaker 3: But the objective is to re-license the U.S. rights to a committed women's health care company, and that process is to re-license the U.S. rights to a committed women's health care company,

And that process is advancing.

Speaker 3: When I say nicely, we do expect that there will be a transaction that we will strongly consider later this year. More about that as we move forward.

When I say nicely. We we we do expect that that there will be a transaction that we will strongly consider a later later this year more more about that as we as we move forward.

Speaker 3: Specifically, for the fiscal fourth quarter and the June 30th, 2023.

Specifically for the fiscal fourth quarter ended June 32023.

Speaker 3: Vileesi gross product sales amounted to $4.1 million. This was an increase of 20% over the prior quarter and an increase of 78% over the comparable quarter last year.

Felicia gross product sales amounted to $4 1 million. This was an increase of 20% over the prior quarter and an increase of 78% over the comparable quarter last year.

Speaker 3: Net product revenue of $1.8 million increased 47% over the prior quarter and increased 128% over the comparable quarter last year.

Net product revenue of $1 8 million increased 47% over the prior quarter and increased 128% over the comparable quarter last year.

Speaker 3: Total prescriptions dispensed increased 16% over the prior quarter and increased 92% over the comparable quarter last year.

Total prescriptions dispensed increased 16% over the prior quarter and increased 92% over the comparable quarter last year.

All the all the value metrics.

Speaker 3: All the value metrics are moving in a positive direction. Refill rates, commercial insurance reimbursement, and net revenue per prescription dispense continued with impactful results and trends versus the prior quarter and comparable quarter last year.

Or are moving in a positive direction refill rates commercial insurance reimbursement and net revenue per prescription dispense.

<unk> with impactful results and trends versus the prior quarter and comparable quarter last year.

Speaker 3: Regarding Vileesi licensees outside the US, Fosun Pharma, Palatins licensee of Vileesi in China, reported its first sale in the Hanyin Province of China.

Regarding well at least the licensees outside the U S focused on farmer Pelicans licensee of <unk> in China reported its first sale in the Huntington Province of China.

Speaker 3: Kwandong Pharmaceuticals, Palatins, licensee of Vileesi in South Korea, completed enrollment in its phase three clinical trial, evaluating the efficacy and safety of Vileesi in pre-manopausal women with HSD day.

Quandong pharmaceuticals suitable superlative licensee of <unk> in South Korea completed enrollment in its phase III clinical trial evaluating the efficacy and safety of <unk> in pre menopausal women with H S. D D.

Speaker 3: And data from this trial is currently anticipated by calendar year end with a potential regulatory submission in the first half of calendar year 2024.

And data from this trial is currently anticipated by calendar year end.

With the potential regulatory submission in the first half of calendar year 2024.

Speaker 3: On an additional distribution front, Palatin entered into a strategic partnership with Upscript Health, a leading direct-to-consumer telemedicine company, providing telemedicine services to pharmaceutical and medical technology companies. And we anticipate the reach for Vileesi from an awareness standpoint will be increasing over the coming quarters.

On an additional distribution front palatin entered into a strategic partnership with ups scrap health, a leading direct to consumer telemedicine company, providing telemedicine services to pharmaceutical and medical technology companies and we anticipate the the reach provide easy from an awareness standpoint will be.

Increasing over the over the coming quarters.

Moving over to the financial update.

For the fourth quarter and I will also highlight certain fiscal year ended June 30 of 2023.

Speaker 3: For the 4th quarter, and I will also highlight a certain fiscal year ended June 30th, 2023 results.

Results rigor.

Speaker 3: Regarding revenue, total revenue consists of gross product sales of Vileesi, which is net of expenses, allowances, and accruals in license and contract revenue.

Regarding revenue total revenue consists of gross product sales of ITC, which is net of expenses allowances and accruals and license and contract revenue.

Speaker 3: By leasing gross product sales to pharmacy distributors for the quarter ended June 30, 2023, as I mentioned, was $4.1 million with net product revenue of $1.8 million. And this compared to gross product sales of $2.3 million and net product revenue of $0.8 million for the comparable quarter last year.

Why do you see gross product sales to pharmacy distributors for the quarter ended June 32023, as I mentioned was $4 1 billion with net product revenue of $1 8 million and this compared to gross product sales of $2 3 million and net product revenue of 0.8 million for the comparable quarter last year.

Speaker 3: Gross product sales increased 78%, and net product revenue increased 128% over the compo quarter last year.

Gross product sales increased 78% and net product revenue increased 128% over the comparable quarter last year.

Yeah.

Moving to operating expenses.

Speaker 3: Total operating expenses were $12.6 million for the fourth quarter and the June 30, 2023, compared to $13.9 million for the comparable quarter last year.

Total operating expenses were $12 6 million for the fourth quarter ended June 32023, compared to $13 9 million for the comparable quarter last year.

The decrease in operating expenses was mainly the result of the recognition of expenses during the fiscal year June 30 of 2022 in connection with the sale and issuance issuance of our series B and series C redeemable convertible preferred stock and secondarily to lower spending on our marketing efforts.

Speaker 3: The decrease in operating expenses was mainly the result of the recognition of of expenses during the fiscal year, June 30th, 2022 in connection with the sale and issuance issuance of our series B and series C redeemable convertible preferred stock and secondarily. To lower spending on our marketing efforts by DC during fiscal 2023.

But easy during fiscal 2023.

Speaker 3: I do want to expand a comment in that regarding this 12.6 million.

I do want to expand a comment regarding this $12 6 million.

Speaker 3: again for the fourth quarter of June , fourth quarter ended June 30th, 2023. This 12.6 million of operating expenses, this is actually greater than what we, if you will, had projected internally. And the reason being we advanced our programs primarily our phase three dry eye disease trial, which we did report on recently hit full enrollment. That full enrollment did trigger a milestone, which triggered an expense and a payment. But I do want to note that 12.6 million

Again for the fourth quarter of June 4th quarter ended June 30 of 2023.

This $12 6 million of operating expenses. This is actually greater than what we if you will had projected internally and the reason being we advance our programs primarily our phase III dry eye disease trial, which we did report on recently hit full enrollment that fall enrollment did trigger a milestone which.

Triggered added an expense and a payment.

I do want to note that $12 6 million.

Speaker 3: Expenses operating expenses for the for the June 30th quarter going forward over the next several quarters that that number those operating expenses Will be significantly less than 12.6 million dollars again. We advance the programs we hit some hit some milestones You're going to have some greater expenses. There's always going to be some timing issues in that regard

Expenses operating expenses for the for the June 30 quarter going forward over the next several quarters that that number of those operating expenses will be significantly less than $12 $6 million again, we advanced our programs. We hit some hit some milestones youre going to have some greater expenses, there's always going to be some timing issues in that regard.

Speaker 3: Let me move over to the to the cash flows that cash used in operations for the quarter end of June 30th, 2023 was 9.6Million compared to net cash used in operations of 7.7Million for the same period in 2022. Again, same reason as I just addressed above, we had some greater expenses due to the advancement of the programs, which is a positive thing hitting some milestones that hit in the June 30th quarter.

Let me move over to the to the cash flows.

Relative to net cash used in operations for the quarter ended June 30 of 2023 was $9 6 million compared to net cash used in operations of $7 7 million for the same period. In 2022 again same reason as I just addressed above we had some greater expenses due to the advancement of the programs, which is a positive thing hitting some milestones that hayden.

And then the June <unk> quarter.

Speaker 3: Palatine's net cash used in operations for the fiscal year end June 30th, this is the year for the full fiscal year, was 28.4 million compared to net cash used in operations of 29.9 million for the same period in 2022. The decrease in net cash used in operations, which is not a significant amount, was frankly due to a number of items including

Allison's net cash used in operations for the fiscal year ended June June 30th does for the full fiscal year was $28 4 million compared to net cash used in operations of $29 9 million for the same period in 2022.

The decrease in net cash use in operations are.

Which is not a significant amount was primarily due to a number of items, including.

Speaker 3: different spending levels for Vileesi, but also we did recognize some net operating losses to the state of New Jersey that generated over $4 million of non-dilutive financing.

Different spending levels for <unk>, but also we did recognize.

Some are sell some net operating losses to the state of New Jersey that generated over $4 million of non dilutive financing.

Speaker 3: Finishing up on the financials with the net loss and the cash position, Palatin's net loss for the quarter fiscal year ended June 3rd of 2023 was 10.7M. Again, that was for the quarter and 27.7M.

Finishing up on the financials with the net loss in the cash position Pelicans net loss for the quarter fiscal year ended June 32023 was $10 7 million again that was for the quarter and $27 7 million.

<unk>.

Speaker 3: for the year, respectively, compared to a net loss of $12.8 million and $36.2 million, respectively, for the same periods in 2022.

For the for the year, respectively, compared to a net loss of $12 8 million and $36 2 million.

Respectively for the same periods in 2022.

Regarding our cash position as of June 32023, Palo <unk> cash cash equivalents and marketable securities.

Speaker 3: Regarding our cash position, as of June 30th, 2023, Palatine's cash, cash equivalents, and marketable securities were approximately...

Were approximately $11 million.

Speaker 3: dollars plus 2.9 million of accounts receivable.

Plus two point million $2 9 million of accounts receivable those accounts receivables of 100%. Good all of those funds have been received in the July August timeframe, and this compared to cash and cash equivalents of $19 6 million with $1 7 million of accounts receivables as of March 31 2023.

Speaker 3: Those accounts receivables 100% good. All those funds have been received in the July , August timeframe and this compared to cash and cash equivalents of 19.6M with 1.7M of accounts receivables as of March 31st, 2023.

Speaker 3: Might say, hey, those cash receivables went up a little bit. Well, we're selling more. All good. And based on our current operating plan, we believe that existing cash, cash equivalents and marketable securities and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023.

I'd say, hey, those accounts receivables went up a little bit well, we're selling more all good.

And based on our current operating plan, we believe that existing cash cash equivalents in marketable securities and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023.

Speaker 3: Of note, I do want to highlight that Palatine's audited financial statements for the year ended June 30th, 2023.

Of note I do want to highlight that pallet consolidated financial statements for the year ended June 30 of 2023.

Speaker 3: to be included in the annual report on Form 10-K does include an audit report from our independent registered public accounting firm KPMG that contains a going concern explanatory paragraph which we have had for quite some time.

To be included in the annual report on Form 10-K does include an audit report from our independent registered public accounting firm KPMG that contains a goings on a going concern explanatory paragraph, which we have had for quite some time.

Speaker 3: With that said, I'm going to turn it back over to Karl to talk a bit more granular about our exciting development and commercial programs. Thank you, Steve.

With that said I'm going to turn it back over to Carl to talk a bit more granular about our exciting.

Exciting development and commercial programs Carl Thank you Steve.

Over the course of 2023, we have continued to successfully execute on our strategy to develop novel Therapeutics based on activating them all out of court system.

Speaker 2: Over the course of 2023, we've continued to successfully execute on our strategy to develop novel therapeutics based on activating the melanocortin system. As I stated previously, we are focused on the

As I stated previously we are focused.

Speaker 2: on establishing the melanocortin system as a target for safe and effective medicines to treat inflammatory and autoimmune diseases and to develop a pipeline of highly effective drugs with unparalleled safety.

On establishing the Atlanta Gordon system, as a target for safe and effective medicines to treat inflammatory and autoimmune diseases and to develop a pipeline of highly effective drugs with unparalleled safety.

Speaker 2: An important component of our strategy is to advance our understanding of the role of the melanocortin system in stress responses, inflammation and tissue repair. Our research efforts are being recognized through the numerous peer-reviewed studies and research on the

Warrant component of our strategy is to advance our understanding of the role the Atlanta Gordon system in stress responses inflammation and tissue repair. Our research efforts are being recognized with numerous peer reviewed.

Speaker 2: and scientific presentations by our scientists and academic collaborators. Our research efforts have allowed us to identify opportunities for novel innovative therapeutics to design better clinical trials and our key support for our business development activities.

Scientific presentations by our scientists and academic collaborators. Our research efforts have allowed us to identify opportunities for novel innovative therapeutics to design better clinical trials and are a key support for our business development activities.

Speaker 2: We have three active clinical programs based on melanocort and agonist developed from our research efforts.

We have three active clinical programs based upon a lot of court agonist developed from our research efforts.

Speaker 2: We're very pleased, as Steve mentioned, to have completed patient enrollment in the PL9643 Melody 1, Phase 3 study in dry eye disease and are working to deliver top-line data before calendar year ends.

Very pleased as Steve mentioned to a completed patient enrollment in the PL 9643, <unk> one phase III study in dry eye disease and are working to deliver top line data before calendar year end.

Speaker 2: Our phase two study evaluating oral PL8177, a selective lana-cortin-1 receptor agonist in ulcerative colitis patients, is on track to complete patient enrollment by calendar year end with interim assessment data as early as calendar year end.

Our phase II study evaluating oral <unk> hundred 77, a selective <unk> one receptor agonist and also it's quite as patients is on track to complete patient enrollment by calendar year end with the interim assessment data as early as calendar year end.

Speaker 2: Breakout, our phase two open label study in diabetic patients with kidney disease, is also on track for top line data in the first quarter of 2024.

Breakout our phase two open label study in diabetic patients with kidney disease is also on track for topline data in the first quarter of 2024.

Some of the additional highlights for the fourth quarter and fiscal year end 'twenty three are as follows on the commercial front. We are pleased with VY <unk> quarter over quarter double digit increases across all value metrics, notably net product revenue increased 47% in prescription dispensed increased 16% over the prior quarter.

Speaker 2: Some of the additional highlights for the fourth quarter in fiscal year N23 are as follows. On the commercial front, we are pleased with Vileecy's quarter-over-quarter double-digit increases across all value metrics. Notably net product revenue increased 47% and prescription dispensed increased 16% over the prior quarter.

Speaker 2: We are excited that the Leacy Quarterly Net Product Revenue continues to exceed by Leacy Quarterly operating expenses, i.e. we make some money. As an extension of our commercial efforts in sexual dysfunction, we have developed a co-formulation of our melanocortin receptor 4 agonist, bremelanotide, with a phosphoantisase 5 inhibitor.

We are excited that for at least a quarterly net product revenue continues to exceed by Lisa quarterly operating expenses, while we make some money.

As an extension of our commercial efforts in sexual dysfunction, we have developed a co formulation of <unk> receptor agonists <unk> with a fossil was our series five inhibitor.

Speaker 2: has a treatment for men with erectile dysfunction that have failed current PD-5 inhibitor therapy. Just as an aside, bremelanotide is the active ingredient in Vileci. And phosphodiesterase-5 inhibitors or PD-5 inhibitors are such drugs as Viagra, Cialis, Labecher, and these are the standard of care for men with erectile dysfunction.

As a treatment for men with erectile dysfunction that have failed current PDE five inhibitor therapy, just as an aside <unk> is the active ingredient in <unk>.

POS was actually five inhibitors or PD five inhibitors are such drugs as viagra.

This will feature and these are the standard of care for them with retinal dysfunction.

You may not be aware, but approximately 35% of men with erectile dysfunction fail or have an inadequate response to current treatments and reps.

Speaker 2: You may not be aware, but approximately 35% of men with erectile dysfunction fail or have an inadequate response to current treatments and represent a very large, underserved market. The only treatment options for these patients are highly invasive, such as penile injections or penile implants.

Present, a very large underserved market the only treatment options for these patients are highly invasive such as penile injections or penile implants.

Speaker 2: We have previously conducted clinical trials showing the synergistic effects of combining bromelanotides with the PD-5 inhibitor as a treatment for erectile dysfunction. The large market opportunity and our clinical work support commercial development of this novel formulation, and we are planning to initiate clinical programs as early as the end of this year.

We have previously conducted clinical trials showing the synergistic effects of combining bema latter tied with the PDE five inhibitor as a treatment for erectile dysfunction, the large market opportunity and our clinical work support commercial development of this novel formulation and we are planning to initiate clinical programs as early as the end of this year.

Speaker 2: Our OCCLA programs continue to make impressive advances. As we stated, Melody 1 is fully enrolled, and we expect data by year end.

Our ocular programs continue to make impressive advances as we stated melody one is fully enrolled and we expect data by year end.

We are very excited by the emerging product profile for <unk> four three which is highly differentiated from current treatment for dry eye disease with excellent ocular tolerability broad efficacy that we believe will make PL 9643, the leading treatment for dry eye disease.

Speaker 2: We are very excited by the emerging product profile for PL9643, which is highly differentiated from current treatments for dry eye disease with excellent oxygen tolerability, broad efficacy that we believe will make PL9643 the leading treatment for dry eye disease.

Speaker 2: We presented data from the analysis of the lead in population.

We presented data from the analysis of the lead in population.

Speaker 2: of the MELODY-1 Phase III trial at the annual meeting of the Association for Research and Vision and Ophthalmology, also known as ARVO, where PL963 demonstrated broad efficacy and statistical significance, separation across multiple signs and symptoms of dry eye disease, and excellent ocular tolerability and safety profile with no, I repeat, no ocular adverse event.

The melody one phase II trial at the annual meeting of the Association for research in vision and Ophthalmology also known as ARVO, where <unk> demonstrated broad efficacy.

Significance separation across multiple signs and symptoms of dry eye disease, and excellent ocular tolerability and safety profile with no I repeat no ocular adverse events.

Speaker 2: This analysis was extremely important, allowing us to confidently set the primary sign and symptom endpoints, the hierarchical ordering of secondary endpoints, the analytical methods and sample size for the double-blind segment of melody one.

This analysis was extremely important allowing us to confidently set the primary sign and symptom endpoints are higher ordering a secondary endpoints the analytical methods and sample size the double blind segment of <unk> one.

Speaker 2: We are very excited about the data coming out, and we believe we've done everything we can to reduce the risk of this trial and are anticipating a very positive outcome.

We are very excited about the data coming out and we believe we've done everything we can to reduce the risk of this trial.

Painting, a very positive outcome.

Speaker 2: We also presented data at ARVO on PL9588, a melanocort based treatment for glaucoma.

We also presented data at ARVO appeal, Mifi, eight eight or Milan accord based treatment for glaucoma and preclinical studies PL 9588 show competitive effects on reducing intraocular pressure with a single topical dose with the magnitude of effect similar to the positive controls Latanoprost Timolol, which are some of the current treatments that are used.

Speaker 2: In preclinical studies, PL9588 showed competitive effects on reducing intraocular pressure with a single top.

Speaker 2: with a magnitude of effect similar to the positive controls of Tana, Prox and Timolol, which are some of the current treatments that are used, with effects lasting up to 24 hours. Importantly, we also have shown effects on optic nerve protection, which we think next generation treatments from Lachoma are done in need. So not only do we lower the pressure with this compound, we actually protect the optic nerve.

With effect lasting up to 24 hours importantly, we also except showing effects.

Optic nerve protection, which we think next generation treatment for glaucoma or that need so not only do we lower intraocular pressure with this compound we actually protect the optic nerve.

Speaker 2: As we are preparing to advance this important program, we have already initiated regulatory discussions with the FDA.

As we are preparing to advance this important program, we have already initiated regulatory discussions with the FDA.

Speaker 2: Our research efforts also made significant advances with multiple presentations at scientific meetings, publications, and peer-reviewed journals.

Our research efforts also made significant advances with multiple presentations at scientific meetings publications in peer reviewed journals.

And our expertise in linerboard assistant innovative clinic programs are supporting our business development activities, we have multiple ongoing discussions with potential partners for our programs.

Speaker 2: and our expertise in the Latin accord system and innovative clinic programs are supporting our business development activities. We have multiple ongoing discussions with potential partners for our program.

Speaker 2: And we remain optimistic that we will enter into one or more partnerships to help advance some of these very exciting programs.

And we remain optimistic that we will enter into one or more partnerships to help advance some of these very exciting programs.

Speaker 2: As we look forward to fiscal 2024, we have significant opportunities to drive value. We have data coming from three clinical trials, initiation of two new clinical programs, continued by ILEC growth and partnerships, advances of ILEC by our South Korean and Chinese partners.

As we look forward to fiscal 2024, we have significant opportunities to drive value.

We have data coming from three clinical trials initiation of two new clinical programs continued by leasing growth and partnerships advances of ITC by a south Korean and Chinese partners.

Speaker 2: Steve and I would like to thank you for listening to the Paladin fourth quarter and fiscal year and 2023 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 Vileesi at the vileesi.com website. Thank you. Now open the call to questions.

Stephen I would like to thank you for listening to the pound in the fourth quarter and fiscal year end 2023 conference call. You can find additional information on our science and clinical programs on our website www Palatin dot com and you'll provide additional information on <unk> at <unk> Dot Com website. Thank you we will now open the call to questions.

Operator: Greetings and welcome to Palatin's fourth quarter and fiscal year end 2023 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. As a reminder, this conference call is being recorded.

Thank you very much at this time, we will be conducting a question and answer session. If.

Speaker 1: Thank you very much. At this time we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question key. You may press star 2 if you would like to...

If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question. Keith You May Press Star two if you would like to remove your question from Nicky So any participants using speaker equipment. It may be necessary to pick up your handset before you press the star keys.

Speaker 1: For any participants using speaker equipment, it may be necessary to pick up your handset before you press the star keys.

Operator: Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward looking statements. 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 and risks and uncertainties discussed in the company's most recent filings with the Security and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward looking statements by Palatin's prospects.

Please pose amendment Bowlsby poll for any questions.

Speaker 1: Thank you. Your first question is coming from Joe Pantgenis from H. C. Wainwright. Joe, your line is live.

Thank you. Your first question is coming from Joe Pat Jeanie from H C. Wainwright, Joe Your line is nice.

Hey, guys. Good morning, a couple of questions. If you don't mind, but first you know best of luck with Consummating, a vie Lee C transaction I know, it's a highly anticipated as you continue to show good.

Speaker 4: Good morning. A couple questions if you don't mind, but first, best of luck with the consummating of ILEC transaction. I know it's highly anticipated as you continue to show good traction by not doing that much on your end and having DTC actually show some good results. So best of luck with that. So first, on the 8177 program, wanted to focus a little more on the upcoming data, which is I think anticipated around year end or maybe going into the beginning of the year. What level of data or what do you think you're going to be able to show us for that interim in UC patients?

Good traction by not doing that much on your end and having DTC actually show. Some good results. So best of luck with that so first on the 80 177 program wanted to focus a little more on the upcoming data, which is I think anticipated around year end or maybe going into the beginning of the year what level.

Carl Spana: Now I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead. Thank you. Good morning and welcome to the Palatin fourth quarter in fiscal year end 2023 call. I'm Dr. Carl Spana, CEO and President of Palatin.

Stephen Wills: With me on the call today is Steve Wills, Palatin's Executive Vice President, Chief Financial Officer and Chief Operating Officer. I'm now turning the call over to Steve and he will give financial and operating update. Thank you, Carl and good morning and good afternoon, everyone. Starting with with Valisi, as a reminder, Valisi is our FDA approved commercial product for pre-manopausal women with hydroactive sexual desire disorder for HSD Day. The goal of the Valisi program is to demonstrate commercial product value in the marketplace.

Data or why do you think youre going to be able to show us for that interim in UC patients.

Speaker 2: So, that's the primary endpoint data. So, this is an eight-week treatment study, obviously active versus placebo, and we're looking primarily at a colonoscopy score, so an endoscopic score. So, we're looking for grading, we're looking forward to see endos, lesions, also kind of lesions to decrease and show clear evidence of healing based on male endoscopic sub-score.

So that's the primary endpoint data. So we're this is a eight week treatment study.

Active versus placebo and were looking primarily at <unk>.

Colonoscopy score so endoscopic score.

So we're looking for grading we're looking forward to see.

Lesions also kind of lesions to decrease in show clear evidence of healing based on Mayo endoscopic subsequent.

Speaker 4: Got it, got it. And then obviously, I mean, going back to Vilease a little bit, but more for the combination that you recently announced and gave more details today with the PDE-5 combination. Any more color regarding the design that you're looking at and what kind of enrollment expectations you might have to be able to drive, say, rapid data.

Got it got it and then obviously.

Obviously, I mean going back to buy at least a little bit but more for the combination that you recently announced and gave more details today with the PDE five a combination any more color regarding.

Stephen Wills: With six consecutive quarters of double-digit growth that we're going to talk about shortly, I think we're doing that. But the objective is to relicant the U.S, rights to a committed woman's healthcare company and that process is advancing. When I say nicely, we do expect that there will be a transaction that we will strongly consider later this year. More about that as we move forward. Specifically, for the fiscal fourth quarter ended June 30, 2023, Valisi gross product sales amounted to 4.1 million.

The design that Youre looking at and what kind of enrollment expectations, you might have to be able to drive a rapid the data.

Speaker 2: Sure. So in the study that we're anticipating conducting, the drugs will be given and co-administered, so they won't be the co-formulation. What we're looking for in the study is to determine the right ratio of remelanotide to the PD-5 inhibitor for the failure patient.

Sure a couple things.

No.

So in the.

The first study that we anticipate in conducting the drugs will be given.

Co administered so they won't be won't be the co formulation, where we're looking for in this study is to determine the right ratio of Green Atlanta tied to the PDE five inhibitor for the failure patients.

Speaker 2: The co-formulation would be used in the follow-up study to that, where we can limit the number of combinations that we have to look at.

The co formulation will be used in the second and the follow up study to that.

Stephen Wills: This was an increase of 20% over the prior quarter and an increase of 78% over the comparable quarter last year. Net product revenue of 1.8 increased 47% over the prior quarter and increased 128% over the comparable quarter last year. Told of prescriptions dispensed, increased 16% over the prior quarter and increased 92% over the comparable quarter last year. All the value metrics are moving in a positive direction. Refill rates commercial insurance reimbursement and net revenue per prescription dispensed continued with impactful results and trends versus the prior quarter and comparable quarter last year, in South Korea, regarding Valisi licensees outside the U.S., Phosan Pharma, Palatin's licensee of Valisi in China, reported its first sale in the Hanyan Province of China, Kwan Dong Pharmaceuticals, Pallatin's licensee of Valisi in South Korea, completed involvement in its phased reclinical trial, evaluating the efficacy and safety of Valisi in pre-manipals of women with HSD Day, and data from this trial is currently anticipated by Calendir Ren, with a potential regulatory submission in the first half of Calendir Year 2024.

We can limit the number of combinations that we have to look at.

Speaker 2: So the study, these studies are enrolled very rapidly. We've got, we probably have two clinical sites, actually Philadelphia and New York. We're working with, one of the advantages is we've had obviously a very long history of working sexual dysfunction and NED as well.

So the study these.

These studies enrolled very rapidly we've got we'd probably have two clinical sites are actually Philadelphia, New York, We're working with those.

One of the advantages we've had obviously a very long history in working sexual dysfunction and EDI as well so as we reached back out to some of our key investigators they were quite enthusiastic about conducting this study.

Speaker 2: So as we reached back out to some of our key investigators, they were quite enthusiastic about conducting this study. As they pointed out to us, there hasn't been a new innovation in reptile dysfunction in 30 years, and these guys really don't have an alternative.

As Dave pointed out to US you know there hasn't been a new innovation in retinal dysfunction of 30 years and these guys really don't have an alternative so so I would anticipate the extremely rapid enrollment in the study.

Speaker 2: So I would anticipate extremely rapid enrollment in this study.

Uh huh.

Speaker 4: Okay, good. And then, you know, you know what, I will go back to Vileesi by itself for a second. So look, I believe you guys have the wherewithal to be able to, like I said, consummate transactions, because obviously, you know, you've had the ex-US deals as well, already in place with, you know, upcoming news, as you alluded to, I guess, let me play the opposite side of the argument, nothing in this world is guaranteed until things are signed. So, you know, on the other end of the spectrum, if you do not, say license it in the US, what potential plans or scenarios would you entertain with regard to Vileesi and, you know, what kind of potential investment you might or might not be considering?

Okay. Good and then you know you know what I will go back to finally see by itself for a second so like I I believe you guys have the wherewithal to be able to like I said consummate transactions. Because obviously you know you've had the ex U S deals as well already in place with upcoming news as you alluded to I guess, let me play the opposite.

Side of the argument and nothing in this world is guaranteed until things are signed so you know on the other end of the spectrum. If you do not say.

They license it in the U S what potential plans or scenarios would you.

Entertained with regard to vie Lee C and you know what kind of potential investment you might or might not be considering.

Stephen Wills: On an additional distribution front, Palatin entered into a strategic partnership with Upscript Health, a leading director consumer, telemedicine company, providing telemedicine services to pharmaceutical and medical technology companies, and we anticipate the reach for Valisi from an awareness standpoint will be increasing over the coming quarters.

Speaker 3: Well, it's thanks for that question there, Joe. We internally, we couldn't be more pleased with the results.

Well. Thanks, Thanks for that question there Joe.

Listen we internally, we couldnt be many we couldn't be more pleased with the results of six consecutive quarters of double digit growth and but more importantly.

Speaker 3: six consecutive quarters of double digit growth. But more importantly,

Speaker 3: We're not losing any money. In fact, we're making money on YLISI. We have a very limited infrastructure. Our plan is the targeted profitable growth and we're doing that. I mean, we got 1.8 million of net sales. We anticipate that going up for the third quarter and the fourth quarter and it's, you know, at some point if we don't pull the...

We're not losing any money in fact, we're making money on why we see we have a very limited infrastructure. Our plan is the targeted the targeted profitable growth and we're doing that I mean, your we got $1.8 million of net sales, we anticipate that going up for that for the third quarter and the fourth quarter and it's at.

Stephen Wills: Moving over to the financial update for the fourth quarter, and I will also highlight a certain fiscal year ended June 30, 2023 results. Regarding revenue, total revenue consists of gross product sales of Valisi, which is a license and contract revenue. By these gross product sales to pharmacy distributors for the quarter ended June 30, 2023, as I mentioned, was $4.1 million with that product revenue of $1.8 million, and this compared to gross product sales of $2.3 million and that product revenue of $0.8 million for the comparable quarter last year.

Some point, if we don't pull the trigger.

Speaker 3: And we have options. We 100% have options on pulling a trigger for a transaction for Vileesi. It's always that balance of the value now versus potentially the value later. There's many things that we could do to and we are considering, but we're trying to balance on it. Well, if you do it something here now, how does that affect the potential transaction if it's going to be a quarter or two later? And a lot of that is around

And we have options, we have 100% have options on pulling a trigger for a transaction for <unk>, it's always that balance of of the value now versus potentially the value later.

There are many there's many things that we could do too and we are considering.

But we're trying to balance on that well if you. If you do it something here now how does that affect the potential transaction. If it is going to be a quarter or two later.

Stephen Wills: Gross product sales increased 78%, and net product revenue increased 128% over the comp of quarter last year. Moving to operating expenses, total operating expenses were $12.6 million for the fourth quarter, and the June 30, 2023, compared to $13.9 million for the comparable quarter last year. The decrease in operating expenses was mainly the result of the recognition of expenses during the fiscal year of June 30, 2022, and connection with the sale and issuance issuance of our series being in series CVD, the comparable preferred stock, and secondarily, to lower spending on our marketing efforts by these during fiscal 2023.

And a lot of that is around distribution expansion, we are not considering adding a sales force our feet on the ground, but there is theres many more outlets out there, especially around the tele the telehealth telemedicine I E with ups grips that would like to.

Speaker 3: Distribution expansion we are not considering

Speaker 3: Adding a sales force or feed on the ground, but there's there's there's many more outlets out there, especially around the tele, the telehealth telemedicine with up scripts that would like to. Distribute.

Distribute by leasing so we are advancing those types of discussions those are things that we frankly once we do the deal we're transferring the product over to him for a certain price and they are selling it there. It doesn't it's not just it's not going to disrupt what we're doing.

Speaker 3: So we are advancing those types of discussions. Those are things that we frankly, once we do the deal, we're transferring the product over to them for a certain price and they're selling it there. It doesn't, it's not gonna disrupt what we're doing right now, a lot of those outlets utilize cash only basis, but it's really a market and a patient group that we are currently not able to serve because of the way we're set up for the infrastructure and the spend. So.

Right now a lot of a lot of those those those outlets utilized cash casualty basis, but it's really a a market in a in a patient group that we are currently not able to serve because of the way we're set up for the infrastructure and the spend so.

Stephen Wills: I do want to expand a comment in that regarding this $12.6 million again for the fourth quarter of June, fourth quarter end of June 30, 2023. This $12.6 million of operating expenses, this is actually greater than what we, if you will, had projected internally, and the reason being we advanced our programs, primarily our phase three dry eye disease trial, which we did report on recently hit full enrollment, that full enrollment did trigger a milestone, which triggered an expense and a payment.

Speaker 3: come back around, we have very significant, we have multiple options that could generate significant value and increase revenue, but not one of them is going to result in us spending money where we're not making money with Vileesi. We've been making money on Vileesi for the last several quarters, and anything we do, we'll continue in with that type of strategy.

To come back around.

We have very significant we have we have multiple options that could generate significant value.

Increased revenue, but not not one of them is going to result in us spending money, where we're not making money with Phi leasing we've been making money on VY <unk> for the last several quarters and anything we do will continue and with that with that type of strategy.

Got it appreciate the color guys.

Stephen Wills: But I do want to note that $12.6 million expenses, operating expenses for the June 30 quarter, going forward of the next several quarters, that number of those operating expenses will be significantly less than $12.6 million. Again, we advanced the programs, we hit some milestones, you're going to have some greater expenses, there's always going to be some timing issues in that regard.

Speaker 1: Thank you very much. Your next question is coming from Michael Higgins of Leidenberg-Fahrman. Michael, your line is...

Thank you very much. Your next question is coming from Michael Higgins of Ladenburg Thalmann, Michael Your line is live.

Except for congrats guys. Thanks for taking the question Congrats and continued progress with we're at least seeing the rest of the pipeline just a follow up if I go down the erectile dysfunction program.

Speaker 5: Thanks for taking the question, uh, addressing it and continue progress with the rest of the pipeline just to follow up if I could on the erectile dysfunction program. Joe's asking some smart questions about the, the trial just want to ask 1, but 1 more if I could on design size, that type of thing, what you are able to share at this time, or you plan to wait until you start that program.

Stephen Wills: Let me move over to the cash flows. Palatin's net cash use and operations for the quarter end of June 30, 2023 was 9.6 million compared to net cash use and operations of 7.7 million for the same period in 2022. Again, same reason as I just addressed above, we had some greater expenses due to the advancement of the programs, which is the positive thing, hitting some milestones that hit in the June 30th quarter.

Joe was asking some smart questions about the the trial just wanted to.

Ask one, but one more if I could on design size that type of thing what you are able to share at this time or do you plan to wait.

Until you start that program.

Speaker 2: No, I mean, these are pretty straightforward studies. These are, as I said, these are dosing studies that are designed to find the appropriate ratio in patients that have failed PE5-inhibitive therapy. So you'll be looking at, you know, static dose of the PE5 inhibitor with increasing doses of remelanotide on top of that in patients that have failed PE5-inhibitive therapy. So no real...

So that means that these are pretty straightforward studies. These are as I said. These are dosing studies that are designed to find the appropriate ratio.

Stephen Wills: Palatin's net cash use and operations for the fiscal year end of June 30th, for the full fiscal year, was 28.4 million compared to net cash use and operations of 29.9 million for the same period in 2022. The decrease in that cash use and operations, which is not a significant amount, was frankly due to a number of items, including different spending levels for Valisi, but also we did recognize some sales, some net operating losses to the state of New Jersey that generated over 4 million dollars of non-deluda financing.

In patients that a salesperson five inhibitor therapy, so youre look youll be looking at.

Tadic dose of the PDE five inhibitor with increasing doses of Remonetize on top of that in patients that have failed therapy. So no real.

Speaker 2: There's no trick to these studies. They're pretty straightforward. The way the matrix that we use to measure efficacy are well established.

So no real Theres no trickery studies are pretty straightforward the way.

The matrix that we use to measure efficacy.

Our well established.

Speaker 2: So these studies, as I said, they enrolled very quickly.

So these days as I said, they will very quickly.

Speaker 2: and there's lots of patients out there. Keep in mind, we've also had some discussions with potential third parties around this, and there's a high interest here. There are a lot of companies as you are aware that are distributing PD-5 inhibitors on a cash basis. Many of those companies have now added insurance reimbursement, and they're looking for new products.

And.

There's lots of patients out there we can mind you.

We've also had some discussions with potential third parties around this and there is a high interest here. There are a lot of companies as you are aware that our distributing PDE five inhibitors.

Stephen Wills: Finishing up on the finances with the net loss in the cash position, Palatin's net loss for the quarter fiscal year ended June 30th, 2023 was 10.7 million. Again, that was for the quarter and 27.7 million for the year, respectively, compared to a net loss of 12.8 million and 36.2 million, respectively, for the same period in 2022. Regarding our cash position, as of June 30th, 2023, Palatin's cash, cash equivalents, and marketable securities were approximately 11 million dollars plus 2.9 million of accounts receivables.

On a cash basis many.

Many of those companies have now added reimbursement insurance reimbursement and Theyre looking for.

New products in the <unk> space.

Speaker 2: So this is one where I would expect that we would be able to transact relatively early in its development.

This is one where I would expect that we would be able to transact relatively early.

In its development process.

Yes, Sir we'll take a look at the other phase two that have been done there's been many many years, but will give us some sense for it.

Speaker 5: Yes, sir, we'll take a look at the other phase 2 that have been done. It's been many, many years, but I'll give us some sense for it. It sounds like you've got some from linotide and. Pd by inhibitor combination data if so, what are your plans to share that?

Sounds like you've got some gremlin, Hittite and PDE five inhibitor combination data.

Stephen Wills: Those accounts receivables 100 percent good, all those funds have been received in the July August timeframe, and this compared to cash and cash equivalents of 19.6 million, with 1.7 million of accounts receivables as of March 31st, 2023, might say, hey, those accounts receivables went up a little bit. Well, we're selling more, all good. And based on our current operating plan, we believe that existing cash, cash equivalents and marketable securities and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023.

If so what are your plans to share that.

Speaker 2: Well, those are published. That data is published. It's out in the public domain. You can use it to find it. I see. Right. I have those. I was thinking some additional work. There are additional publications by third-party groups, not in our palatins, that have looked at model therapy, for example, of remelanotide in PD-5-inhibitive failures, showing that a significant percentage, a third of the patients that fail PD-5-inhibitive therapy can be rescued on model therapy alone.

So those are published that data is published it's out in the public domain you can be refined it.

I see right I have those.

Is there are there are.

Additional publications by third party groups not not palatin that have looked at monotherapy for example, with <unk> in PD, one inhibitor failures showing that.

A significant percentage of third of the patients that fail PD, one therapy can be rescued on monotherapy alone.

Speaker 2: So there's a very strong precedent here. And I think this is a program that in our mind represents that has a very low clinical risk. You have FDA-

So there is a very strong precedent here.

Stephen Wills: Of note, I do want to highlight that Palatin's audit and financial statements for the year ended June 30th, 2023, to be included in the annual report on form 10K, does include an audit report from our independent registered public accounting firm KPMJ that contains a going concern, explanatory paragraph, which we have had for quite some time.

And I think this is a program that in our mind represents a very low clinical risk you have FDA approved agents.

Speaker 2: that are with obviously the PD-5 inhibitors work. Obviously, we know they work in men, and we've shown we've treated almost 2,500 men with reptile dysfunction with bromelanotides. So I think there's very strong clinical precedent here.

That's a R.

Obviously, the PDE five inhibitors work, obviously, we know they work in Mandarin we've shown we've treated almost 2500 men with erectile dysfunction with <unk>. So I think the very strong clinical precedent here.

Speaker 2: And more importantly, there's a very high medical need here. I mean, a lot of these, there's a lot of men out there that just don't have other options. So we like it from the standpoint, I think both the commercial side and the development side are relatively low risk.

Carl Spana: With that said, I'm going to turn it back over to Carl to talk a bit more granular about our exciting development and commercial programs. Thank you, Steve. Over the course of 2023, we've continued to successfully execute on our strategy to develop novel therapeutics based on activating the malignant coordinate system. As I stated previously, we are focused on establishing the malignant coordinate system as a target for safe and effective medicine to treat inflammatory and autoimmune diseases and to develop a pipeline of highly effective drugs with unparalleled safety.

And more importantly, there's a very high medical need here I mean, a lot of these there's a lot of it out there that just don't have other options. So we like it from the standpoint, I think both the commercial side and the development side are relatively low risk.

Speaker 5: Yeah, and that that looks great. So we'll, we'll refer to that again in our notes. But another exciting program coming up here might be in obesity, considering it's a lot of court and a target that you're that you have for your pipeline. Any update or feedback for us on interest in the obesity space?

Yeah, and the data looks great. So we'll.

We will refer to that again in our notes, but another exciting program coming up here might be in obesity.

Considering its monarch Horton.

Target that Youre that you have for your pipeline.

Any update or feedback for us on interest in the obesity space.

Carl Spana: The important component of our strategy is to advance our understanding of the role of the malignant coordinate system and stress responses, inflammation and tissue repair. Our research efforts are being recognized for the numerous peer reviewed and scientific presentations by our scientists and academic collaborators. Our research efforts have allowed us to identify opportunities for novel, innovative therapeutics to design better clinical trials and our key support for our business development activities. We have three active clinical programs based on Melania Corden Agnes, developed from our research efforts.

Speaker 2: I'll just say, I'm going to say a few things. Steve's looking at me, he's giving me a glamour. I'm going to say a few things there. Many of you, of course, know we've had a very strong interest in ABC because in part...

I'll just add that as we get to say a few of these guys are looking at me He's giving me a glare when I say a few things there.

Any of you of course know we've had a very strong interest in our BC because in part maybe.

Speaker 2: Many of the people that may be listening to this are a little bit younger, not even around as long as we have. The Malatic-1-4 receptor was probably the first validated target for obesity treatment. And many of the... most of the larger companies did have programs looking for small molecules.

Many of the people who may be listening to this or a little bit younger than our outflows we have the.

Going forward, we said it was probably the first validated target for obesity treatment and many of them. Most of the larger companies did have programs looking for small molecules and unfortunately, it's a very difficult target for small molecules, but a very good one for peptides as I know Michael you are aware you cover central appetite the rhythm product.

Speaker 2: And unfortunately, it's a very difficult target for some molecules, but a very good one for peptides. I know, Michael, you're aware you cover set melanotype in the rhythm product.

Carl Spana: We're very pleased, as Steve mentioned, to have completed patient enrollment in the PL-9643 Melody-1 Phase III study in dry eye disease and are working to deliver top-line data before calendar year-end. Our Phase II study evaluating oral PL-8177, a selective melanocortin-1 receptor agonist and ulceritis patients, is on track to complete patient enrollment by calendar year-end with the interim assessment data as early as calendar year-end. Break out our Phase II Open Label study in diabetic patients with kidney disease is also on track for top-line data in the first quarter of 2024.

Speaker 2: We have published on two studies that we conducted with bremelanotide showing very nice weight loss using bremelanotide in obese patients.

We have published.

On two studies that we conducted with <unk> showing very nice weight loss.

Using pretty more appetite and of these patients.

Speaker 2: We also had a very nice collaboration with AstraZeneca for a number of years. So we have a tremendous experience in...

We also had a very nice collaboration with Astrazeneca for a number of years. So we have a tremendous experience in.

The roles of our important system and regulating food and taken obesity with excellent compounds.

Speaker 2: the role of the live quarantined system in regulating food intake and obesity with excellent compounds, well it is a good insight on how to.

Good insight on how to develop small molecules.

Speaker 2: So we're quite excited about the current growth in that marketplace. And there is a coming attraction. There's an obesity week coming up in a couple of weeks. I'm sure you're well aware of that. So I would just say stay tuned.

So we're quite excited about the current growth in that marketplace and.

Carl Spana: Some of the additional highlights for the fourth quarter in fiscal year and 23 are as follows. On the commercial front, we are pleased with by Lisi's quarter over quarter double digit increases across all value metrics, notably net product revenue increased 47 percent and prescription dispensed, increased 16 percent over the prior quarter. We are excited that by Lisi quarterly net product revenue continues to exceed by Lisi quarterly operating expenses, i.e, we make some money.

There is a coming attraction. There are there is an obesity week coming up in a couple of weeks I'm sure you're well aware of that and so I would just say stay tuned.

Okay.

Speaker 5: Definitely, I'll be down there in Dallas for that. So look forward to that question for you last 1. and I can, I can jump back in the queue or keep going and let me know. But 1 last 1 here for now. Anyways, by Lizzie, listen to your comments on the program and in your, your conversation, Steve with Joe about where to go with this. And.

I'll be down there in Dallas for that so look forward to that.

Question for you last one that I can I can jump back in the queue or keep going here, let me know, but one last one here for now anyway by Leesy listen to your comments on the program in your conversations with Joe about where to go with this.

Carl Spana: As extension of our commercial efforts in sexual dysfunction, we have developed a co-formulation of our melanocortin-receptive four agonist, Bremelanatide, with a phosphatine S3-5 inhibitor. As a treatment for men with rectile dysfunction that has failed current PD-5 inhibitor therapy. To says in the side, Bremelanatide is the active ingredient in by Lisi. And phosphatine S3-5 inhibitors or PD-5 inhibitors are such drugs as Viagra, Cialisle Beacher, and these are the standard of care for men with rectile dysfunction.

Speaker 5: You know, it occurs to me that with successful advancement in erectile dysfunction, you could market this as the only drug for cycle dysfunction in both men and women. That would be unique. That would get a lot of attention. Any thoughts about hanging out on the program a bit longer, at least through some phase two data with a combination study?

Occurs to me that.

With successful advancement in erectile dysfunction, you could market. This is the only drug for sexual dysfunction in both men and women that will be unique.

And get a lot of attention and you talked about hanging onto the program a bit longer at least through some some phase two data with the combination study.

Speaker 2: But since you brought the topic up about drugs for sexual dysfunction, there are also clinicians that are prescribing it for men that have other types of sexual dysfunction. Sexual dysfunction through the SSRI use, low desire to do stress factors and other things. And it works very well in those. And there may be some upcoming data at a meeting about that in the near future. So I personally believe that this could be more treatmentable for male and female sex. It was fun.

Well since you brought the topic up about.

So as I say dysfunction, they're also clinicians that are prescribing it for men that have other types of sexual dysfunction as those functions to fsrus.

Carl Spana: You may not be aware, but approximately 35 percent of men with rectile dysfunction fail or have an inadequate response to current treatments and represent a very large underserved market. The only treatment options for these patients are highly invasive, such as penile injections or penile implants. We have previously conducted clinical trials showing the synergistic effects of combining Bremelanatide with the PD-5 inhibitor as a treatment for rectile dysfunction. The large market opportunity and our clinical work support commercial development of this novel formulation, and we are planning to initiate clinical programs as early as the end of this year.

Low desire stress factors and other things and it works very well in those and there may be some upcoming data at a meeting about that in the near future. So I personally believe that this.

One treatment for both male and female sexual dysfunction.

Speaker 3: So, let me just jump in also Michael in that listen, we, we couldn't be any more excited with the results we've had and some of the things that we're not going to elaborate on today on where we think with the right investment.

So let me let me just jump in also Michael and that listen we couldnt be any more excited with the results we've had and some of the things that were not on elaborate on today on where we think.

With the right investment.

Speaker 3: significant normative value for both patients and different types of patients, albeit the pre, the post, and the mail that you're referencing. So, you know, 100% we're analyzing and assessing that and we have to balance that with, okay, you have a

Very significant normative value for both patients and different types of patients, albeit the pre to post in the mail that youre referencing.

Carl Spana: Our octoprograms continue to make impressive advances. As we stated, melody one is fully enrolled and we expect data by year end. We are very excited by the emerging product profile for PL9643, which is highly differentiated from current treatments for dry eye disease with excellent active tolerability, broad efficacy that we believe will make PL9643 the leading treatment for dry eye disease. We presented data from the analysis of the lead in population of the melody one phase three trial at the annual meeting of the association for research, and vision, and ophthalmology, also known as Arvo, where PL9643 demonstrated broad efficacy and statistical significance separation across multiple signs and symptoms of dry eye disease and excellent ocular tolerability and safety profile with no, I repeat, no, ocular adverse events.

So, 100%, we're analyzing and assessing that and we have to balance that with okay. You have a.

Speaker 3: several potential transactions that you could maybe move forward with and you know, even if you feel that strongly and we do we think there is a lot of value there that the longer we keep we keep Vileesi and we keep having these results the more value you're going to get in the future. We also have to balance it, you know and being realistic, this is a tough landscape, right? We're a small biotech company and

Several potential transactions that you could maybe move forward with and.

Even if you feel that strongly and we do we think there is a lot of value there that the longer we keep we keep <unk> and we keep having these results the more value you are going to get in the future.

Well, we also have to balance it.

Being realistic this is a tough landscape right, where we're a small biotech company and and.

Speaker 3: We're getting into those cash numbers where we may have to do something you know over the next several quarters and and you know the the lude of financing for some deals out there are not pretty and we're not going to do some of those deals that are being done. I'm not trying to throw a dart or judge anybody else. There are different factors that they take into account, but we are not going to be doing that.

We're getting into that.

Cash is cash numbers, where we may have to do something.

Over the next several quarters and the dilutive financing for some deals out there or are not pretty and.

Carl Spana: This analysis was extremely important, allowing us to confidently set the primary sign and symptom endpoints, a hierarchical ordering of secondary endpoints, the analytical methods and sample size of the double blind segment of melody one. We are very excited about the data coming out, and we believe we've done everything we can to reduce the risk of this trial and are anticipating a very positive outcome. We also presented data at Arvo on PL9-588, our Melanacorn-based treatment for glaucoma and preclinical studies, PL9-588 showed competitive effects on reducing inter-ocular pressure with a single topical dose, with the magnitude of effect similar to the positive controls of tanoprosin-timilol, which are some of the current treatments that are used, with effects lasting up to 24 hours.

We're not going to do some of those deals that are that are being done I'm not trying to throw a dart or judge anybody else.

Different factors to take into account, but we are not it's not going to be doing.

Speaker 3: some of those deals that are being done that I don't think a company can recover from. So with that, we have to balance, hey, I have a non-valu to financing, you know, and no matter what, it's going to be a good deal. But timing is a significant factor for us and we do take into account the market landscape regarding raising funds.

Some of those deals that are being done that I don't think the company can can recover from so with that we have to balance hey, I have a non dilutive financing.

No matter, what it's gonna be Oh, it's going to be a good deal.

But timing is the significant factor for us and we do take into account the the market landscape regarding regarding raising funds.

<unk>.

Speaker 3: A quick pause on that after the coconut hot dog, you know, that's not the only potential collaboration that we have. That could happen and I'm not just moving away from Vileecing, which we have a lot of confidence in.

A quick pause on that after the coke in a hot dog.

The only potential collaboration that we have that could happen and I'm not just.

Carl Spana: Importantly, we also have shown effects on optic nerve protection, which we think next generation treatments for glaucoma are done in need, so not only do we lower and allow for the pressure with this compound, we actually protect the optic nerve. As we are preparing to advance this important program, we have already initiated regulatory discussions with the FDA. Our research efforts also made significant advances with multiple presentations at scientific meetings, publications, and peer-reviewed journals, and our expertise in Melanacorn-System and innovative clinical programs are supporting our visit development activities.

Moving away from by leasing, which you have a lot of confidence in dry eye disease. We have obviously the data is coming out we're hoping for that nice Christmas present.

Speaker 3: Obviously the data is coming out. You know, we're hoping for that nice Christmas present and the holidays there But our other program

And the holidays there.

But.

Our other programs have interest and that's also something a lot of times. The word further you take your program as long as everything is working well safety efficacy tolerability those types of things more than likely the greater value you are going to get but you have to balance where your company is in and doing what's right for the shareholders regarding non.

Speaker 3: And that's also something, a lot of times the more, the further you take your program, as long as everything's working well, safety, efficacy, tolerability, those types of things.

Speaker 3: more than likely the greater value you're going to get. But you have to balance where your company is and.

Carl Spana: We have multiple ongoing discussions with potential partners for our programs, and we remain optimistic that we will enter into one or more partnerships to help advance some of these very exciting programs. As we look forward to fiscal 2024, we have significant opportunities to drive value. We have data coming from three clinical trials. Initiation of two new clinical programs, continues by LEC growth and partnerships, advances of LEC by our South Korean and Chinese partners.

Speaker 3: and doing what's right for the shareholders regarding non-dilutive versus dilutive financing. But I want to be clear, we do have other interests. Carl and I try to talk to as many people as we can, where I think it was either you or Joe asked about the 8177 yellow-sieved colitis endpoints. Listen, these endpoints, this is based on a lot of conversation, not just for KOLs, but companies that would be interested. It's a nice way you start with, hey, if we get to first base, we could make a split, we could charge you to their office, and we'll go along to the next one. Thank you. Thank you very much. Any other thoughts? Just a question about the

<unk> versus dilutive financing, but I want to be clear, we do have other other interest you know Carl and I tried to talk to as many people as we can where I think it was either you or Joe asked about the 80 80, 177 Yosef Gladys endpoints listen. These endpoints. This is based on a lot of conversation not just with kols, but companies that would be interested.

It's a nice way to start with Hey, if we get the first phase <unk>.

Carl Spana: Steven, I would like to thank you for listening to the Palladine 4th quarter in fiscal year and 2023 conference call. You can find additional information on our science and clinical programs on our website, www.palladine.com, and you can find additional information on by LEC at the by LEC.com website. Thank you.

<unk> care right and we've changed the protocol based on that type of feedback and that was both with the dry eye disease and also with the ulcer colitis, but to be clear we have multiple shots on goal.

Speaker 3: we've changed the protocol based on that type of feedback and that was both with the dry eye disease and also with the ulcerative colitis, but to be clear we have multiple stops on goals for for cash flow coming in 100% separate than a potential equity raise.

For cash flow coming in.

100% separate than the potential equity raise.

Operator: We will now open the questions. Thank you very much. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question key. You may press star two if you would like to remove your question from the key. For any participants using speaker equipment, it may be necessary to pick up your handset before you press the star keys. Please pause a moment whilst we poll for any questions. Thank you.

Okay, that's great feedback thank you.

Speaker 5: Um, if I may, uh, speaking of the earlier pipeline programs, um, and cash as well, you've talked about 9, 6, 4, 3, starting another indication possibly by year end. Um, it doesn't sound like that's gonna happen. I just wanna bring that 1 up. Is that still? Sure, so, uh, we would in the space, we are following up with a separate compound for glaucoma. That would be the next office program that pending resources. Obviously, we would take forward.

If I may are speaking of the earlier pipeline programs.

And cash as well you've talked about 9643, starting another indication, possibly by year end.

It doesn't feel like that's going to happen, but just wanted to bring that one is that still right.

We were in the ocular space, we are following up with.

With a separate compound for glaucoma.

That would be the next ocular programs pending resources, obviously, we would take forward.

Operator: Your first question is coming from Joe Pantinis from H.C. Joe, your line is live. Hey, guys.

Speaker 2: We've already started outreach to the FDA on what a trial design would look like, some of the preclinical things we would need, and we'll have that feedback before your end. So we would tend to go there.

We've already started outreach to the FDA.

The trial design would look like.

Joseph Pantginis: Good morning. A couple questions, if you don't mind. But first, best of luck with the Confirmating of LEC Transaction. I know it's highly anticipated as you continue to show good traction by not doing that much on your end and having DTC actually show some good results. So best of luck with that.

Some of the preclinical things we would need.

And we'll have that feedback before year end. So we would tend to go there.

Speaker 2: in part because You know our goal at NYSC for three coming out of the melody one would really be look for a partnership

In part because of.

Our goal at 94, three coming out of the metallurgy, one we'd really be look for partnership.

Speaker 2: So obviously in a partnership, we take all of the opportunity for PL9643, we would be taken up by that partnership. So that's why we've held back on some of the things we could do there. And really we're focusing on glaucoma and also back of the eye with 9654, which we didn't talk about, but there's tremendous interest in.

So obviously in a partnership we take all of the opportunity for Pn 943 will be taken up by that partnership. So that's why we've held back on some of the things we could do there.

Carl Spana: So first, on the 8177 program, wanted to focus a little more on the upcoming data which is I think anticipated around year end or maybe going into the beginning of the year. What level of data, what do you think you're going to be able to show us for that interim in UC patients? So, yeah, that's the primary endpoint data. So, this is a eight week treatment study. Obviously, active versus placebo. And we're looking primarily at a colonoscopy score. So an endoscopic score. So we're looking for grading. We're looking forward to see endoscopy lesions also kind of lesions to decrease and show clear evidence of healing based on male endoscopic sub-score. Got it.

Really we're focusing on glaucoma and also back of the eye with nice at slide four which we didn't talk about but there's a tremendous interest in.

Speaker 2: retinal programs, even though they're preclinical, they do represent a novel mechanism and many people don't, many investors don't follow the scientific literature, the posters, and the things we've been presenting there. But the data is quite, really quite exciting on how this monocortin mechanism works to protect the back of the eye from damage.

Our retinal programs, even though their preclinical they do represent a novel mechanism and.

Many people don't many investors don't follow the scientific literature, and the posters and the things <unk> been investing there, but the data is quite really quite exciting on how this mechanism works to protect the back of the eye and.

Damage and that really feeds into both retina and glaucoma. So that's why we're very excited I mean, there is not a product out there for glaucoma for example that can lower intraocular pressure and provide neuro protection, which is really what's needed.

Speaker 2: and that really feeds into both retinal and glaucoma. So that's why we're very excited. I mean, there's not a product out there for glaucoma, for example, that can lower the electric pressure and provide neuroprotection.

Carl Spana: And then obviously, I mean, going back to by lease a little bit, but more for the combination that you recently announced and gave more details today with the PDE 5 combination. Any more color regarding the design that you're looking at and what kind of enrollment expectations you might have to be able to drive say rapid data. So, coming so in the study that we're anticipating conducting, the drugs will be given in the co-administered, so they won't be the co-formulation.

Speaker 2: which is really what's needed. So when we think about how we choose these programs, we do want to make sure these products are well differentiated from what's out there in the marketplace, and they have opportunity to become the leading products in their category.

When we think about how we choose these programs.

We do want to make sure that these products are well differentiated from whats out there in the marketplace and they have opportunity to become the leading products in their category.

Yes, it was very much degree with your back of the eye programs.

Speaker 5: Yeah, I would very much agree with your back of the eye programs. One question we had coming into this, I'll dovetail off of that, is the 9588. I think you're looking to have an IMD cleared by year end, but you're also working with your sub-q formulation. Any update for us on that? And maybe that's bumping into 9654, but. So we go through it. So 9588 for glaucoma is topical administration.

One question, we had coming into this will dovetail off of that as their 95, 8%. I think you were looking to have the 90 cleared by year end, but you're also working with your sub Q formulation any update for us on that and maybe that's bumping into $96 four but.

Carl Spana: What we're looking for in the study is to determine the right ratio of remalana tie to the PDE 5 inhibitor for the failure patients. The co-formulation would be used in the second and the follow-up study to that where we can limit the number of combinations that we have to look at. So the study, these studies are immobile very rapidly. We've got, we probably have two clinical sites, actually Philadelphia and New York.

So because it's so so so 90% 88 for glaucoma is topical administration.

Speaker 2: Again, the progression of these types of programs are purely resource dependent. We have no impediment to moving that product forward. The data is efficient. The activities that we need are beginning to occur. It's a matter of, as Steve was saying, in a tough landscape, we do have to balance out. We balance out. If you like what you've seen, or would like to see more of these modules, see what you

There you will get.

The progression of these types of programs are purely resource dependent there's no. We have no impediment to moving that product forward to data is efficient.

Activity that we need are beginning to occur it's a matter of as Steve was saying it was in a tough landscape, we do have to balance out.

Carl Spana: We're working with, you know, one of the advantages we've had, obviously, a very long history in working sexual dysfunction and ED as well. So as we reach back out to some of our key investigators, they were quite enthusiastic about conducting this study. As they pointed out to us, there hasn't been a new innovation in record of the function in 30 years, and these guys really don't have an alternative. So I would anticipate extremely rapid enrollment in this study. Okay, good.

Al.

Speaker 2: But I think we'll be successful in what we're doing. So I think the cash will take care of itself.

But.

I think we'll be successful in what we're doing so I think the cash would take care of itself.

Sure.

I appreciate all the feedback guys. Thank you.

Thank you very much.

Speaker 1: Thank you very much. We don't appear to have any further questions in the queue. I will now hand back over to you.

It would have any further questions in the key.

I'll now hand back over to Carl for any closing comments.

Joseph Pantginis: And then, you know what, we'll go back to VileyC by itself for a second. So look, I believe you guys have the wherewithal to be able to, like I said, consummate transactions because obviously you've had the XUS deals as well already in place. With, you know, upcoming news as you alluded to.

Speaker 2: I'd like to thank all of you for participating in the Palatine fourth quarter in fiscal year and 2023. I think through our presentation and hopefully eliminating questions from the analysts.

Yes, I'd like to thank all of you for participating in the pallets in the fourth quarter and fiscal year end 2023, I think through our presentation and the I think the hopefully eliminating questions from the analyst I think <unk> gotten.

Speaker 2: I think you've gotten a good flavor of the depth of what Palatine can deliver from a valuation standpoint.

A good flavor of the depth of what pallet and can deliver from a valuation standpoint and.

Carl Spana: I guess let me play the opposite side of the argument. Nothing in this world is guaranteed until things are signed. So, you know, on the other end of the spectrum, if you do not say license it in the US, what potential plans or scenarios would you entertain with regard to VileyC? And, you know, what kind of potential investment you might or might not be considering?

Speaker 2: And, you know, I know there can always be frustration and disconnects between valuation and opportunity, particularly when we deal with microcap companies, but we certainly believe we're undervalued and we certainly are going to be working hard to correct that. And we believe we have all the right things in place to do that. So thank you. Look forward to continuing to update you guys and have a great day. And thank you on behalf of Steve and myself and all the employees at Palit.

I know there can always be frustration and disconnect between valuation and opportunity, particularly deal with microcap companies, but we certainly believe we are undervalued and we certainly are going to be working hard to correct that and we believe we have all the right things in place to do that so thank you look forward to continue update you guys and have a great day and thank you on behalf of <unk>.

Carl Spana: Well, thanks for that question there, Joe. Listen, we internally, we couldn't be more pleased with the results, you know, six and a second of quarters of double digit growth. But more importantly, we're not losing any money. In fact, we're making money on VileyC. We have a very limited infrastructure. Our plan is the targeted profitable growth, and we're doing that. I mean, we got 1.8 million of net sales. We anticipate that going up for the third quarter and the fourth quarter.

Steve myself and all the employees of Palatin.

Thank you very much. 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 1: Thank you very much. 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.

Carl Spana: And it's, you know, at some point, if we don't pull the trigger, and we have options. We 100% have options on pulling a trigger for a transaction for VileyC. It's always that balance of the value now versus potentially the value later. There's many things that we could do to, and we are considering, but we're trying to balance on, well, if you do it, something here now, how does that affect the potential transaction, if it's going to be a quarter or two later?

Carl Spana: And a lot of that is around distribution expansion. We are not considering adding a sales force or feed on the ground. But there's many more outlets out there, especially around the telehealth, telemedicine, i.e, with up scripts that would like to and Distribute Violisi. So we are advancing those types of discussions. Those are things that we, frankly, once we do the deal, we're transferring the product over to them for a certain price, and they're selling it there.

Carl Spana: It doesn't, it's not going to disrupt what we're doing right now. A lot of those outlets utilize cash-only basis, but it's really a market and a patient group that we are currently not able to serve because of the way we're set up for the infrastructure and the spend. So, you know, to come back around, we have very significant, we have multiple options that could generate significant value and increase revenue, but not one of them is going to result in us spending money where we're not making money with Violisi. We've been making money on Violisi for the last several quarters, and anything we do will continue in with that type of strategy.

Joseph Pantginis: Got it.

Joseph Pantginis: Appreciate the color, guys. Thank you very much.

Michael Higgins: Your next question is coming from Michael Higgins of Ladenberg-Fauman. Michael, your line is live. Thanks, Upper. Congrats, guys. Thanks for taking the question. And continue your progress with Violisi in the rest of the pipeline just to follow up if I could on the erectile dysfunction program. Joe's asking some more questions about the trial.

Carl Spana: I just want to ask one more if I could on design size, that type of thing, what you are able to share with the time, or do you plan to wait until you start that program. These are pre-strait forward studies. These are those studies that are designed to find the appropriate ratio in patients that have failed P-5 inhibitor therapy. You'll be looking at you know, static dose of the P-5 inhibitor with increasing doses of remelanetide on top of that in patients that have failed P-5 inhibitor therapy.

Carl Spana: There's no trick to these studies. They're pretty straight forward. The matrices that we use to measure efficacy are well-established. So these studies as I said, they will very quickly, and there are just lots of patients out there. Be keep in mind, we've also had some discussions with potential third parties around this, and there's a high interest here. There are a lot of companies as you are aware that are distributing P-5 inhibitors on a cash basis.

Carl Spana: Many of those companies have now added reimbursement, insurance reimbursement, and they're looking for new product in the ED space. So this is one where I would expect that we would be able to transact relatively early in a development process. That's fair.

Carl Spana: We'll take a look at the other phase two that have been spent many, many years, but look at some sense for it. It sounds like you've got some remelanetide and BDE-5 inhibitor combination data. If so, what are your plans to share that? Well, those are published. That data's published. It's out in the public domain. You can you find it. I see. Right. I have those. I would say that there are additional publications by third party groups, not in Opalipans, that have looked at model therapy, for example, of remelanetides in P-5 inhibitor failures, showing that that significant percentage of third of the patients that fail P-5 inhibitor therapy can be rescued on model therapy alone.

Carl Spana: So there's a very strong precedent here. And I think this is a program that in our mind represents that has a very low clinical risk. You have FDA approved agents that are with with obviously P5 heavies of work, obviously, we know they work in Mendo and we've shown we've treated almost, you know, 2500 men with Rhett Aldousfung should be melanotides. So I did a very strong clinical precedence here. And more importantly, there's a very high medical need here.

Carl Spana: I mean, a lot of these a lot of men out there that just don't have other options. So we like it from the standpoint, I think, both the commercial side and the development side are relatively low risk. Yeah, and that that looks great.

Michael Higgins: So we'll refer to that again in our notes.

Michael Higgins: But another exciting program coming up here might be in obesity, considering it's a lot of court and target that you're that you have for your pipeline. Any update or feedback for us on interest in the obesity space? I'll just say I'm going to say a few of these things.

Carl Spana: Look at me, give me a glance. I want to say a few things there. Many of you, of course, know we've had a very strong interest in obesity because in part, many of the people that may be listening to this are a little bit younger and I'm around as long as we have. The Atlantic one for we said was probably the first validated target for a VC treatment. And many of them, most of the larger companies did have programs looking for small molecules.

Carl Spana: And unfortunately, it's a very difficult target for small molecules, but a very good one for peptides. I know, Michael, you're aware you cover that. We have published on two studies that we conducted with pre-malanetides showing very nice weight loss using pre-malanetide in up these patients. We also had a very nice collaboration with AstraZeneca for a number of years. So we have a tremendous experience in the role of an important system in regulating food and taking obesity with excellent compounds.

Carl Spana: Good insight on how to develop small molecules. So we're quite excited about the current growth in that marketplace. And there is a coming attraction. There are, there's an obesity week coming up in a couple of weeks. I'm sure you're well aware of that. And so I would just say stay tuned. Definitely. I'll be down there and down for that. So look forward to that.

Michael Higgins: Question for you last one. I can jump back in the queue or keep going. You'll let me know. But one last one here for now and away. It's on by Lisi. Listen to your comments on the program and your conversation to you with Joe about where to go with this. And it occurs to me that with successful advancement in erectile dysfunction, you could market this that the only drug for cycle dysfunction in both men and women.

Michael Higgins: That will be unique. That would get a lot of attention. Any thoughts about hanging out of the program a bit longer, at least through some some face to data with the combination study. Since you brought the topic up about. There are also commissions that are describing it for men that have other types of sexual dysfunction. Special dysfunction through the SSRI use. Low desire to do a stress factor and other things. And it works very well in those.

Michael Higgins: And there may be some upcoming data at a meeting about that in the future. So I personally believe this is. One more three. Remember, both male and female sex was fun. So, let me just jump in also Michael in that, listen, we couldn't be any more excited with the results we've had, and some of the things that we're not going to elaborate on today, on where we think with the right investment, very significant normative value for both patients and different types of patients, albeit the pre-the post and the mail that you're referencing.

Michael Higgins: So, 100% we're analyzing and assessing that, and we have to balance that with, okay, you have several potential transactions that you could maybe move forward with, and even if you feel that strongly, and we do, we think there is a lot of value there. The longer we keep Valisi and we keep having these results, the more value you're going to get in the future. But we also have to balance it, you know, in being realistic, this is a tough landscape, right?

Michael Higgins: We're a small biotech company, and we're getting into that for cash numbers where we may have to do something over the next several quarters, and the loot of financing for some deals out there are not pretty, and we're not going to do some of those deals that are being done. I'm not trying to throw a darn or judge anybody else, you know, there are different factors that take into account. But we are not going to be doing some of those deals that are being done that I don't think a company can recover from.

Michael Higgins: So, with that, we have to balance, hey, I have a non-delute of financing, you know, and no matter what, it's going to be a good deal. But timing is a significant factor for us, and we do take into account the market landscape regarding raising funds. A quick pause on that after the Koch and a hot dog, you know, that's not the only potential collaboration that we have that could happen, and I'm not just moving away from by leasing, which we have a lot of confidence in.

Michael Higgins: Dry eye disease, we have, obviously, the data is coming out, you know, we're hoping for that nice Christmas present in the holidays there. But our other programs have interest, and, you know, that's also something, you know, a lot of times, the further you take your program, as long as everything's working well, you know, safety, efficacy, tolerability, those types of things, more than likely, the greater value you're going to get. But you have to balance, you know, where your company is, and doing what's right for the shareholders regarding, you know, non-delute versus delute financing.

Michael Higgins: But I want to be clear, we do have other interests. You know, Carl and I try to talk to as many people as we can, where I think it was either you or Joe asked about, you know, the 80, 81, 77 Yolts of Colitis endpoints. Listen, these endpoints, this is based on a lot of conversation, not just for KOLs, but companies that would be interested, you know, it's a nice way to start with, hey, if we get the first base to care, right?

Michael Higgins: And we've changed the protocol based on that type of feedback, and that was both with the dry eye disease, and also with the Yolts of Colitis. But to be clear, we have multiple stops on goal, for cash flows coming in, 100% separate than the potential equity raise. That's great feedback. Thank you.

Carl Spana: If I may, speaking of the earlier pipeline programs, and cash as well, you've talked about 9643, starting another indication, possibly by year end, it doesn't sound like that's going to happen. You just want to bring that one up if that's still. Sure, so Michael, we were in the ocular space, we were following up with a separate compound full of glaucoma. That would be the next ocular program that, you know, pending resources, obviously, we would take forward.

Carl Spana: You know, we've already started outreach to the FDA, you know, on what a trial design would look like. You know, some of the preclinical things we would need, and we'll have that feedback before your end. So we would tend to go there, and part because, you know, our goal at 9643 coming out of the melody one, we'd really do look for a partnership. So obviously in a partnership, we take all of the opportunity for PL-9-4-3, we will be taken up by that partnership.

Carl Spana: So that's why we've held back on some of the things we could do there. And really we're focusing on Lakoma and also back to the eye with 9-6-5-4, which we didn't talk about, but there's tremendous interest in retinal programs. Even though they're preclinical, they do represent a novel mechanism. And so many people don't, many investors don't follow the scientific literature. They're the posters and they've been mentioning there, but the data is really quite exciting on how this monocortin mechanism works to protect the back of the eye from damage.

Carl Spana: And that really feeds into both retinal and glaucoma. So that's why we're very excited. I mean, there's not a product out there for glaucoma, for example, that can lower the larger pressure and provide neuroprotection, which is really what's needed. So when we think about how we choose these programs, we do want to make sure these products are well-differentiated, but without there in the marketplace. And they have opportunities to become, you know, the leading products in their category.

Carl Spana: Yeah, it's very much agree with your back of the eye programs. The question we had coming into this, I'll tell us about the 9-5-80. I think you're looking to have a 90 cleared by year end, but you're also working with your sub-Q formulation. Any update for us on that? And maybe that's bumping into 9-6-5-4. So we go through it. So 9-5-80 for glaucoma is a topical administration. There again, you know, the progression of these put types of programs are purely resource dependent, right?

Carl Spana: There's no, we have no impediment to moving that product forward. The data is efficient. The activities that we need are beginning to occur. It's a matter of, you know, as Steve was saying, you know, it's in a tough landscape. If we do have to balance out, you know, we'll balance out. But, you know, I think we'll be successful in what we're doing. So I think the cash will take care of itself. I appreciate all the feedback guys. Thank you. Thank you very much.

Carl Spana: We don't appear to have any further questions in the key. I will now hand back over to Carl for any closing comments. Yeah, I'd like to thank all of you for participating in the Palatin Fourth Quarter in fiscal year and 2023. I think through our presentation and I think hopefully eliminating the questions from the analyst, I think you've gotten a good flavor of the depth of what Palatin can deliver from a valuation standpoint.

Carl Spana: And, you know, I know there can always be frustration and disconnects between valuation and opportunity, particularly with microcaps companies. But we certainly believe we're undervalued and we certainly are going to be working hard to correct that. And we believe we have all the right things in place to do that. So thank you. Look forward to continuing you update you guys and have a great day. And thank you on behalf of Steve and myself and all the employees of Palatin. Thank you very much.

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