Palatin Technologies, Inc. (LON:0KF3)
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Earnings Call: Q4 2023

Sep 28, 2023

Operator

Greetings, and welcome to Palatin's Q4 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. 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. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects.

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.

Carl Spana
President and CEO, Palatin

Thank you. Good morning, and welcome to the Palatin Q4 and fiscal year-end 2023 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's 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 update.

Steve Wills
EVP, CFO, and COO, Palatin

Thank you, Carl. Thank you, Carl, and good morning and good afternoon, everyone. Starting with Vyleesi. As a reminder, Vyleesi is our FDA-approved commercial product for premenopausal women with hypoactive sexual desire disorder, or HSDD. The goal of the Vyleesi program is to demonstrate commercial product value in the marketplace. With six consecutive quarters of double-digit growth, that we're gonna talk about shortly, I think we are doing that.

But the objective is to relicense the US rights to a committed women'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 Q4, ended June 30th, 2023, Vyleesi 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. Net product revenue of $1.8 million increased 47% over the prior quarter and increased 128% 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 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. Regarding Vyleesi licensees outside the U.S., Fosun Pharma, Palatin's licensee of Vyleesi in China, reported its first sale in the Hainan Province of China. Kwangdong Pharmaceutical, Palatin's licensee of Vyleesi in South Korea, completed enrollment in its phase III clinical trial, evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD. Data from this trial is currently anticipated by calendar year end, with a potential regulatory submission in the H1 of calendar year 2024.

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. We anticipate the reach for Vyleesi from an awareness standpoint will be increasing over the coming quarters. Moving over to the financial update. For the Q4, and I will also highlight certain fiscal year ended June 30th, 2023 results. Regarding revenue, total revenue consists of gross product sales of Vyleesi, which is net of expenses, allowances, and accruals, and license and contract revenue.

Vyleesi gross product sales to pharmacy distributors for the quarter ended June 30th, 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. Gross product sales increased 78%, and net product revenue increased 128% over the comparable quarter last year. Moving to operating expenses. Total operating expenses were $12.6 million for the Q4, ended June 30th, 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, June 30th, 2022, in connection with the sale and issuance of our Series B and Series C redeemable convertible preferred stock, and secondarily, to lower spending on our marketing efforts of Vyleesi during fiscal 2023. I do want to expand a comment in that regarding this $12.6 million, again, for the Q4 of June, Q4 ended June 30th, 2023, this $12.6 million of operating expenses, this is actually greater than what we, if you will, had projected internally a nd the reason being, we advanced our programs, primarily our phase III 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 expenses, operating expenses for the June 30th quarter, going forward over the next several quarters, that number, 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 gonna be some timing issues in that regard. Let me move over to the cash flows. Palatin's net cash used in operations for the quarter end of June 30th, 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 hit in the June thirtieth quarter. Palatin's net cash used in operations for the fiscal year end of June, 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 different spending levels for Vyleesi, but also we did recognize some a sale some net operating losses to the state of New Jersey that generated over $4 million of non-dilutive financing.

Finishing up on the financials with the net loss and 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 periods in 2022. Regarding our cash position, as of June 30th, 2023, Palatin's cash, cash equivalents, and marketable securities were approximately $11 million, plus $2.9 million of accounts receivable. Those accounts receivable, 100% good. All those funds have been received in the July, August timeframe.

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. B ased 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. Of note, I do want to highlight that Palatin's audited financial statements for the year ended June 30th, 2023, 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.

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. Carl?

Carl Spana
President and CEO, Palatin

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 melanocortin system. As I stated previously, we are focused 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. 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 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 are a key support for our business development activities.

We have three active clinical programs based on melanocortin agonists, developed from our research efforts. 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-one receptor agonist in ulcerative colitis patients, is on track to complete patient enrollment by calendar year end, with the interim assessment data as early as calendar year end. BREAKOUT, our phase II open label study in diabetic patients with kidney disease, is also on track for top-line data in the Q1 of 2024.

Some of the additional highlights for the Q4 and fiscal year in 2023 are as follows: On the commercial front, we are pleased with Vyleesi'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. We are excited that Vyleesi quarterly net product revenue continues to exceed Vyleesi 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 phosphodiesterase 5 inhibitor. As a treatment for men with erectile dysfunction that have failed current PDE5 inhibitor therapy.

Just as an aside, bremelanotide is the active ingredient in Vyleesi, and phosphodiesterase five inhibitors, or PDE5 inhibitors, are such drugs as Viagra, Cialis, or Levitra, and these are the standard of care for men with erectile dysfunction. 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. We have previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5 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. Our ocular programs continue to make impressive advances.

As we stated, MELODY-1 is fully enrolled, and we expect data by year-end. We are very excited by the emerging product profile for PL-9643, which is highly differentiated from current treatments for dry eye disease, with excellent ocular tolerability, broad efficacy that we believe will make PL-9643 the leading treatment for dry eye disease. We presented data from the analysis of the lead-in population of the MELODY-1 phase III trial at the annual meeting of the Association for Research in Vision and Ophthalmology, also known as ARVO, where PL-9643 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.

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-1. 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 PL-9588, our melanocortin-based treatment for glaucoma. In preclinical studies, PL-9588 showed competitive effects on reducing intraocular pressure with a single topical dose, with a magnitude of effect similar to the positive controls of latanoprost 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 for glaucoma are going to need s o not only do we lower intraocular 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. Our expertise in melanocortin system and innovative clinical programs are supporting our business development activities. 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, continued Vyleesi growth and partnerships, advances of Vyleesi by our South Korean and Chinese partners. Steve and I would like to thank you for listening to the Palatin Q4 and fiscal year-end 2023 conference call. You can find additional information on our science and clinical programs on our website, www.palatin.com, and you can find additional information on Vyleesi at the vyleesi.com website. Thank you. We will now open the call to questions.

Operator

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 queue. You may press star two if you would like to remove your question from the queue. 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 while we poll for any questions. Thank you. Your first question is coming from Joe Pantginis from H.C. Wainwright. Joe, your line is live.

Joe Pantginis
Managing Director Equity Research, H.C. Wainwright

Hey, guys. Good morning. A couple questions, if you don't mind, but first, you know, best of luck with the consummating of Vyleesi transaction. I know it's highly anticipated as you continue to show, you know, good traction by not doing that much on your end and having DTC actually show some good results s o best of luck with that. F irst, on the PL-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?

Carl Spana
President and CEO, Palatin

Yeah, 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 s o we're looking for grading, we're looking forward to see endoscopic lesions, also kind of lesions to decrease and show clear evidence of healing, based on the Mayo Endoscopic Sub Score.

Joe Pantginis
Managing Director Equity Research, H.C. Wainwright

Got it. Got it. T hen, obviously, I mean, going back to Vyleesi a little bit, but more for the combination that you recently announced and gave more details today with the PDE5 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, data?

Carl Spana
President and CEO, Palatin

Sure. Couple things. I n the first study that we're anticipating conducting, the drugs will be given co-administered, so it won't be the co-formulation. What we're looking for in this study is to determine the right ratio of bremelanotide to the PDE5 inhibitor for the failure patients. The co-formulation would be used in the second, in the follow-up study to that, where we can limit the number of combinations that we have to look at. T hese studies enroll very rapidly. We probably have two clinical sites, actually, Philadelphia and New York. We're working with, you know, one of the advantages is we've had, obviously, a very long history of working in sexual dysfunction and ED as well.

As we reached back out to some of our key investigators, they were quite enthusiastic about conducting this study. You know, as they pointed out to us, you know, there hasn't been a new innovation in erectile dysfunction in 30 years, and these guys really don't have an alternative s o, I would anticipate extremely rapid enrollment in the study.

Joe Pantginis
Managing Director Equity Research, H.C. Wainwright

Okay, good. T hen, you know what? I will go back to Vyleesi by itself for a second. L ook, 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, 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 U.S., what potential plans or scenarios would you entertain with regard to Vyleesi, and, you know, what kind of potential investment you might or might not be considering?

Carl Spana
President and CEO, Palatin

Well, it's. Thanks for, thanks for that question there, Joe. The, listen, we internally, we couldn't be more pleased with the results. You know, six consecutive quarters of double-digit growth and, but more importantly, you know, we're not losing any money. In fact, we're making money on Vyleesi. 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 Q3 and the Q4 a nd 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 Vyleesi.

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 something here now, how does that affect the potential transaction, if it's gonna be a quarter or two later a nd a lot of that is around distribution expansion. We are not considering adding a sales force or feet on the ground, but there's many more outlets out there, especially around the telehealth, telemedicine, i.e., with UpScript, that would like to distribute Vyleesi s o we are advancing those types of discussions.

Those are things that, you know, 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, 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 Vyleesi.

We've been making money on Vyleesi for the last several quarters, and anything we do, we'll continue in with that, with that type of strategy.

Joe Pantginis
Managing Director Equity Research, H.C. Wainwright

Got it. Appreciate the color, guys.

Operator

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

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

Thanks, Operator. Congrats, guys. Thanks for taking the question. Congrats and continued progress with Vyleesi and the rest of the pipeline. Just to follow up, if I could, on the erectile dysfunction program. Joe was asking some smart questions about the trial. Just wanna ask 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?

Carl Spana
President and CEO, Palatin

No, I mean, listen, 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 PDE5 inhibitor therapy. So, you're looking at, you know, static dose of the PDE5 inhibitor with increasing doses of bremelanotide on top of that, in patients that have failed PDE5 inhibitor therapy s o there's no real trick to these studies. They're pretty straightforward. The way the metrics that we use to measure efficacy, you know, are well established a nd so these studies, as I said, they enroll very quickly, and, you know, there's lots of patients out there.

But keep in mind, you know, 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, you know, PDE5 inhibitors, on a cash basis. Many of those companies have now added, reimbursement, insurance reimbursement, and they're looking for new product in the ED space s o, this is one where I would expect that we would be able to transact relatively early, in this development process.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

That's fair. We'll take a look at the other phase II that have been done. It's been many, many years, but it'll give us some sense for it. It sounds like you've got some bremelanotide and PDE5 inhibitor combination data. If so, what are your plans to share that?

Carl Spana
President and CEO, Palatin

Well, those are published. That data is published. It's out in the public domain. You can find it.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

I see. Right. I have those. I, I was thinking some additional.

Carl Spana
President and CEO, Palatin

If not, there are additional publications by third party groups, not Palatin, that have looked at monotherapy, for example, of bremelanotide in PDE5 inhibitor failure, showing that a significant percentage, a third of the patients that fail PDE5 inhibitor therapy can be rescued on monotherapy alone s o there's a very strong precedent here. You know, and I think this is a program that in our minds represents has a very low clinical risk. You have FDA-approved agents that are, you know, with obviously, the PDE5 inhibitors work. Obviously, we know they work in men, and we've shown we've treated almost, you know, 2,500 men with erectile dysfunction with bremelanotide. I think there's very strong clinical precedence here a nd 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 s o we like it from the standpoint, I think both the commercial side and, and the development side are relatively low risk.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

Yeah, and that, that data looks great. W e'll refer to that again in our notes b ut, another exciting program coming up here, might be in obesity, considering it's melanocortin, a target that you're- that you have for your pipeline. Any update or feedback for us on interest in the obesity space?

Carl Spana
President and CEO, Palatin

Look, I'll just say, I'm gonna say a few of these. Steve's looking at me, he's giving me a glare. I'm gonna 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, not been around as long as we have. The melanocortin-4 receptor was probably the first validated target for obesity treatment, and most of the larger companies did have programs looking for small molecules a nd unfortunately, it's a very difficult target for small molecules, but a very good one for peptides. As I know, Michael, you're aware, you cover setmelanotide, the Rhythm product.

We have published on two studies that we conducted with bremelanotide, showing very nice weight loss using bremelanotide in obese 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 the melanocortin system in regulating food intake and obesity with excellent compounds, good insight on how to develop small molecules. We're quite excited about the current growth in that marketplace a nd 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, and so I would just say stay tuned.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

Definitely. I'll be down there in Dallas for that, so look forward to that. Question for you, last one, and I can jump back in the queue or keep going. You let me know. But, one last one here for now anyway, is on Vyleesi. Listening to your comments on the program and your conversation, Steve, with Joe about where to go with this a nd, you know, it occurs to me that, with successful advancement in erectile dysfunction, you could market this as the only drug for sexual dysfunction in both men and women. That would be unique, and that would get a lot of attention. Any thoughts about hanging out of the program a bit longer, at least through some phase II data with a combination study?

Carl Spana
President and CEO, Palatin

Well, since you brought the topic up about sexual dysfunction, there are also clinicians that are prescribing it for men that have other types of sexual dysfunction. Sexual dysfunction due to SSRI use, low desire due to stress factors and other things, and it works very well in those a nd there may be some upcoming data at a meeting about that in the near future s o I personally believe that this will be the number one treatment for both male and female sexual dysfunction.

Steve Wills
EVP, CFO, and COO, Palatin

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, you know, with the right investment, very significant normative value for both patients and different types of patients, albeit the pre, the post, and the male that you're referencing. Y ou know, 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 a nd, you know, even if you feel that strongly, and we do, we think there is a lot of value there.

The longer we keep Vyleesi, and we keep having these results, the more value you're gonna get in the future b ut we also have to balance it, you know, in being realistic. This is a tough landscape, right? We're a small biotech company, and you know, we're getting into those cash numbers where we may have to do something, you know, over the next several quarters a nd you know, the dilutive financing for some deals out there are not pretty, and we're not gonna do some of those deals that are being done. I'm not trying to throw a dart or judge anybody else.

You know, there are different factors that they take into account, but we are not gonna be doing some of those deals that are being done that I don't think a company can recover from. W ith that, we have to balance, "Hey, I have a non-dilutive financing," you know, and no matter what, it's gonna be a y ou know, it's gonna 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 coke and the hot dog. You know, that's not the only potential collaboration that we have that could happen a nd I'm not just, you know, moving away from Vyleesi, which we have a lot of confidence in.

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 more, 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 gonna get b ut you have to balance, you know, where your company is and, and doing what's right for the shareholders regarding, you know, non-dilutive versus dilutive financing. But I wanna be clear, we do have other interest.

You know, Carl and I try to talk to as many people as we can, where I think it was either you or, or Joe asked about, you know, the PL-8177 ulcerative colitis endpoints. Listen, these endpoints, this is based on a lot of conversation, not just with KOLs, but with companies that would be interested. You know, it's, you know, a nice way you start with, "Hey, if we get the first phase, do you care?" Right? And, and we've, 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 b ut to be clear, we, we have multiple shots on goal for, for cash flow coming in, 100% separate than, than a potential equity raise.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

That's great feedback. Thank you. If I may, speaking of the earlier pipeline programs, and cash as well, you've talked about PL-9643 starting in another indication, possibly by year-end. It doesn't sound like that's gonna happen. Just wanna bring that one up. Is that still.

Carl Spana
President and CEO, Palatin

Sure. Michael, we would. In the ocular space, we are following up with a separate compound for glaucoma. That would be the next ocular program that, you know, pending resources, obviously, we would take forward. You know, we've already started outreach to the FDA 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 year-end s o we would tend to go there, in part because, you know, our goal with PL-9643 coming out of the MELODY-1 would really be to look for a partnership , and obviously in a partnership, we take all of the opportunity for PL-9643 would be taken up by that partnership.

That's why we've held back on some of the things we could do there a nd 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 our 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 have been inventing there b ut the data is quite, really quite exciting on how this molecular mechanism works to protect the back of the eye from damage a nd 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 glaucoma pressure and provide neuroprotection, which is really what's needed.

When we think about how we choose these programs, you know, we do wanna make sure these products are well-differentiated from what's out there in the marketplace, and they have opportunity to become, you know, the leading products in their category.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

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 PL-9588. I think you're looking to have an IND cleared by year-end, but you're also working with your subq formulation. Any update for us on that? M aybe that's bumping into PL-9654, but.

Carl Spana
President and CEO, Palatin

So we go through it. So PL-9588 for glaucoma is topical administration. There, again, you know, the progression of these prototypes of programs are purely resource dependent, right? There's no., w e have no impediment to moving that product forward. The data is sufficient. We, the activities that we need are beginning to occur. It's a matter of, you know, as Steve was saying, you know, in a tough landscape, we do have to balance out, you know, we are, you know, balance out. But, you know, I think, I think we'll be successful in, in, in what we're doing, so I think the cash will take care of itself.

Michael Higgins
Managing Director Equity Research, Ladenburg Thalmann

I appreciate all the feedback, guys. Thank you.

Operator

Thank you very much. We don't appear to have any further questions in the queue. I will now hand back over to Carl for any closing comments.

Carl Spana
President and CEO, Palatin

Yeah, I'd like to thank all of you for participating in the Palatin Q4 and fiscal year end 2023. I think through our presentation and the, I think, the hopefully illuminating questions from the analysts, I think you've gotten a good flavor of the depth of what Palatin can deliver from a valuation standpoint a nd 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 gonna 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 a nd thank you on behalf of Steve and myself, and all the employees at Palatin.

Operator

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.

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