Welcome to Palatin Second Quarter Fiscal Year 2023 Operating Results Conference Call. [Operator Instructions] As a reminder, this conference 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 your host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead.

Thank you. Good morning, and welcome to the Palatin Second Quarter Fiscal 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 the financial and operating updates. Steve?

Thank you, Carl, and good morning, everyone. Carl will provide detail on our development programs a bit later on. Starting with Vyleesi, which is our commercial product approved for hypoactive sexual desire disorder in premenopausal women. The goal of the Vyleesi program is to demonstrate commercial product value in the marketplace, which we are doing with an objective of relicensing the U.S. rights to a committed women's health care company. For the fiscal second quarter ended December 31, 2022, gross product sales were $2.6 million, an increase of 14% over the prior quarter and an increase of 238% over the comparable quarter last year. Net product revenue of $1 million increased 18% over the prior quarter and increased 1,323% over the comparable quarter last year. We are pleased -- actually very pleased that net product revenue exceeded Vyleesi operating expenses for the quarter. Total prescriptions dispensed increased 12% over the prior quarter and increased 134% over the comparable quarter last year. Refill rates, commercial insurance reimbursement and net revenue per prescription dispensed increased over the prior quarter and comparable quarter last year. Regarding our recent registered direct offering. On October 31, 2022, Palatin entered into a securities purchase agreement with an institutional investor, selling and issuing an aggregate of approximately 1 million shares of Palatin common stock, prefunded warrants to purchase approximately 0.8 million shares of Palatin common stock and common warrants to purchase up to approximately 1.8 million shares of Palatin common stock. Each share of common stock and prefunded warrant was offered with 1 accompanying common warrant for a combined offering price of approximately $5.50. The common warrants have an exercise price of $5.83 per share and will expire five and one-half years from the date of issuance. The offering was completed on November 2, 2022, with Palatin…

Thank you, Steve. As I stated on previous calls, our major objectives are to establish the melanocortin system as a target for safe and effective medicines to treat inflammatory autoimmune diseases and to develop a pipeline of innovative drugs. There are 2 key part to achieving our objectives. The first is to advance our understanding of how the melanocortin system works by defining the molecular mechanisms and key signaling pathways that determine physiological effects. To accomplish this through research in Palatin's laboratory and multiple collaborations with academic researchers. In calendar 2023, we already have multiple abstracts accepted for presentations at scientific and medical meetings. In addition, we have managed [indiscernible] that have undergone peer review and that have been accepted for publication. Our research efforts are helping us to design better clinical trials and to support our business development activities. The second part is the translation of the science of the clinical results and openly therapeutics that address unmet medical needs. We are now enrolling patients in 3 studies, MELODY-1, a Phase III study in dry eye disease. A Phase II study evaluating oral PL-8177, a selective melanocortin-1 receptor agonist in patients with ulcerative colitis. And our third is called Breakout, a Phase II study in diabetic patients with kidney disease. We anticipate all 3 clinical studies will have data readouts in calendar '23. In addition, all 3 clinical studies are evaluating compounds that work by modulating the ability of the melanocortin system to resolve pathological inflammation and promote tissue repair. Summarizing our second quarter fiscal 2023 results and looking forward to calendar '23. As Steve told you, Vyleesi continues to show impressive quarter-over-quarter growth in all key metrics, and we anticipate this growth will continue. We continue to make significant progress in establishing the melanocortin system as an innovative target for therapeutics to treat a variety of inflammatory diseases. We are enrolling patients in 3 clinical studies that are evaluating the efficacy and safety of our melanocortin target therapeutics and all 3 have planned data readouts in 2023. Our research efforts continue to expand our understanding of the melanocortin system and are being recognized by the broader scientific and biotechnology and pharmaceutical communities. If successful, our efforts will support the continued advancement of our innovative therapeutics and our efforts to attract partnerships with larger biotechnology and pharmaceutical companies helped advance our programs. Thank you for listening to the Palatin Second Quarter Fiscal 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. I'd thank you all, and we will now open the call for questions.

[Operator Instructions] Your first question is coming from Joe Pantginis with H.C. Wainwright.

A couple, if you don't mind. So just focusing on Vyleesi for the moment. So Steve, I was hoping you could provide some more color regarding the current refill rates that you're seeing. Let's start with that.

The -- yes, thanks for the question there, Joe. The way we respond to the refill rate, there's 2 metrics you look at. One is the percentage of the TRx, the total prescriptions dispense that you have, how much of that is -- are from refills. And we've been increasing that every month and definitely quarter-over-quarter. And that's not because the TRx is going down, it's because -- it's actually even stronger than that because our TRx is actually going up, greater. The second metric is indigenous to the patient in a nice way, if there were just 10 women getting a prescription [ stash ] dispensed, how many of them are getting back in line. And that's also a very significant metric. And we have seen that number also increase every month, quarter-over-quarter. And we're now in excess of 40% of any woman that's taken the first prescription dispensed has gotten back in line for a renewed script.

That's helpful. And nice to hear. So I guess this is more of a scenario question. So obviously, you guys are real busy in the background regarding the potential U.S. licensing of Vyleesi. So I guess -- let me ask this scenario, excluding a U.S. licensee, what are you guys prepared to do internally with Vyleesi?

We're -- as I mentioned, the objective of Carl, Steve and the Board is to find a home for Vyleesi that's -- in a nice way, with a company that has a reasonably significant female health care franchise. This is not our primary focus going forward. We have made what we believe are measured informed investments. When we first got the product back, we're actually losing significant money, multiple 7 digits on a quarterly basis. We now -- we had a little greater than breakeven for the quarter, which is great. What we're still concentrating on is showing that these metrics, you can extrapolate, you can see that you can scale it up. And in the right organization, in the right hands, this product can do so much more than it's doing with us. So we're in a better position for these discussions. We're not going to rush into anything. We think Vyleesi has significant value. So it's not costing us anything, if you will. Carl says, he doesn't care if I have to work extra nights and weekends, I'm on a fixed salary. So that's okay. But we absolutely have interest. And we do believe that at some point, when it's right, we will be handing off the baton to a new partner. And that's on the U.S. front.

Got it. And then with that's -- talking about geography, I guess, we haven't had a lot of visibility and hopefully, you could share any expectations coming out of your current ex-U.S. licensees in both China and South Korea.

All right. So with -- Fosun is in the latter stage of their, let's just call it somewhat smaller -- much smaller Phase III trial for regulatory approval. And that should finish up by midyear, and then they will be filing their -- if everything goes as planned, filing for regulatory approval, and that would not -- the first commercial sale, we don't anticipate until we -- let's just say, mid-'20, maybe second half of calendar '24, I think, would be the best that they would be in a position. And this is, of course, Kwangdong in South Korea. With Fosun, I think we're going to hold off a little bit on some coming attractions. We're making some good progress with the Fosun partner, and they're exploring several avenues to accelerate the revenue -- the regulatory approval. So I'd rather -- Carl and I would rather just hold off on that until we get a little bit more granularity, but they are 100% committed to moving the program forward and to commencing sales of Vyleesi in China as soon as possible.

Your next question is coming from Michael Higgins with Ladenburg Thalmann.

This is Farhana on behalf of Michael. We have 3 questions first on the breakout trial. So the first one is that clinicaltrials.gov currently shows that 5 sites are recruiting, is that accurate? And when do you expect all the 7 sites to be enrolling? The second question is, why not have an arm for the RAAS therapy alone? And the third question is, when will you decide to advance this program considering that there is a renal biopsy in these patients after 12 months?

Okay. So let's take them in order. So part of the reason we're doing this study is that we're really collaborating with a group of nephrologists, a nephrology group that has lots of patients. So we actually think the study will pretty much do complete enrollment probably by the middle or the end of the second quarter. So we have 5 sites up now. The other 7 should come on pretty quickly. We actually are enrolling patients quite readily in that study, and we actually already have started dosing patients. So that study is going to -- I expect that study will go very, very quickly because of the group that we're working with. They're very motivated. They've actually been looking for a melanocortin-based therapeutic to actually evaluate in patients with -- kidney patients -- diabetic patients with kidney disease. So the other question is why do we not have a straight control arm? That was really due to, I'll tell you, this is -- was designed -- firstly, these patients don't spontaneously revert. This is not a type of inflammatory condition or immune condition where these patients -- [indiscernible] immune condition was more inflammatory where these patients actually wax and wane, they will continue to steadily progress, so that's one reason. And then the second reason is because this is -- really was designed to be a first look to really gather how well can it [ work ] really work in this patient population. So that's really, really the reasoning there. And also, it's an issue of cost because this is -- we'll be able to do 40 patients pretty quickly. We'll get a really good look at the 6-month time point, and then we'll go from there. And then I'm forgetting what was in your third point.

Yes. The third point was when will you decide to advance the program given that there is a renal biopsy in these patients after 12 months?

So again, we'll have -- being an open-label study, obviously, data will continue to roll in. So we'll see -- as each patient's data comes in, we'll see it. I mean obviously, we'll get a look from there. We have to make some decisions post the data coming in and then to be prepared to go forward. So even though the last patient out, it's still 6 months further until you get their final data. I think we'll know if the study works, and we'll be able to make some decisions in that intervening period. And quite frankly, in today's world, turning around clinical trial times, getting clinical trial sites, materials and so on and so forth will take longer than from last patient leaving until their last data point comes in.

Your next question is coming from John Newman with Canaccord.

The question is just on the regulatory filing strategy for the dry eye indication. Just if you could just remind us what you think you'll need just in terms of the number of clinical studies? And then also just kind of your thinking on the endpoint that you'll look to take forward to the agency there?

So John -- thank you. So there are -- in dry eye there are -- obviously, there are multiple strategies that one can employ. The most efficient, of course, would be -- to be -- to have 2 clinical -- Phase III clinical trials that replicate, and in which both the sign and a symptom met significant -- statistical significance in both studies, obviously, the same signs and symptoms in both studies. And then in addition to that, you would need your open-label safety. So it's technically 3 studies, depending on how you do it. And that's really what we're really shooting for here, right? That's the most efficient way to do it. And that's one of the reasons why we built in an interim assessment in the first study is really to make sure that we can take a look, make sure that we were on track, make sure we have the right size, right symptoms as we go forward. And you have a successful Phase -- first Phase III trial, which is where we get a sign and a symptom. And then that would have to replicate in a second study. If one was only to hit, say, for example, a sign and -- but -- and had a very good idea of how you might reach the symptom or vice versa, then you could take an alternative strategy, which would be to do 2 -- 4 Phase III studies, they can be smaller, of course, in size where you would look for hitting the sign in [ 2 ] and then the symptom in the second. So that's a longer-term strategy, obviously, a more expensive strategy. So our overall objective is really to nail the sign and the symptom in both MELODY-1 and then a subsequent MELODY-2, then MELODY-3 would be an open-label safety study. That will be the most cost-effective and efficient way to go forward. With regards to signs and symptoms, we have some that are predefined. But of course, based on the interim assessment, we have some flexibility there. And I think I would rather wait until the second quarter, try to give a little more detail on that. We have an abstract that has been on the first 120 patients that's been accepted for presentation. So I don't want to front run that. But there will be some nice coming attractions in late April at the ARVO meeting, which is a meeting on vision in research and ophthalmology, which is occurring, as I said, in April, down in New Orleans. And we have a nice presentation going on there on those first 120 patients and really have a lot more clarity on how we expect the first Phase III study to read out.

We have reached the end of our question-and-answer session, and I will now turn the call back over to Carl Spana for any closing remarks.

Great. Steve and I would like to thank you all for participating in the Palatin's Second Quarter Fiscal 2023 Conference Call. As you can see, I mean, we're really shaking a move in here. I mean, Vyleesi is doing great under Steve's leadership. The research and development activities, I mean we now have 3 clinical trials that are enrolling patients, lots of data readouts this year. It's a big year for us. Steve and I are very excited about what we're going to deliver. So stay tuned. There's a lot coming. So again, Steve and I thank you all. Have a great day, and we look forward to updating you next quarter. Thanks.

This does conclude today's conference, and you may disconnect your lines at this time. Thank you for your participation.