Greetings. Welcome to Palatin’s Second Quarter Fiscal Year 2024 Operating Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [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 our 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 year 2024 call. I’m Dr. Carl Spana, the 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 updates. Steve?

Thank you, Carl. Good morning, good afternoon and good evening everyone. For Palatin's fiscal second quarter ended December 31, 2023, certain business highlights and recent updates follow. Regarding Vyleesi, which is our bremelanotide injection for FDA approved for hypoactive sexual desire disorder or HSDD, we completed an asset sale to Cosette Pharmaceuticals for up to $171 million in December of 2023 for female HSDD. We received $12 million upfront plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million up to $200 million. Importantly, Palatin retained the rights and use of bremelanotide Vyleesi for obesity and male erectile dysfunction indications. Regarding other, we had two equity offerings, a registered direct offering in January 30, 2024, we entered into a securities purchase agreement with healthcare focused institutional investors, selling and issuing an aggregate of approximately 1.8 million shares of Palatin common stock at a purchase price of $5.46 per share of common stock, which was our market price at the time of the transaction. Palatin also agreed to issue in a private placement, warrants to purchase up to an aggregate of approximately 1.8 million shares of Palatin common stock at an exercise price of the same $5.46 per share. The offering was completed on February 1, 2024 with gross proceeds of $10 million. The common warrants are exercisable beginning six months after the date of issuance and will expire on the date that is four years after the closing date. Second equity offering was October 2023 -- October 23, 2023, we entered into a securities purchase agreement with one institutional investor selling and issuing an aggregate of approximately 2.4 million shares of Palatin common stock at a purchase price of $2.12 per share of common stock. Palatin also agreed to issue in a…

Thank you, Steve. Nice lesson in accounting. As you know, our focus has been on understanding the biology and chemistry of the melanocortin system with the goal of developing selective melanocortin agonists for variety of medical indications. Our research efforts have resulted in a growing portfolio of melanocortin based therapeutics. We have three active clinical programs based on melanocortin agonists with multiple new programs ready to advance into clinical development pending resources, all coming from our highly productive research activities. As we have previously reported, we have locked the database and instructed the statistical contract research organization to unblind the data for the PL9643 MELODY-1, Phase 3 study for dry eye disease. We expect to report the top line data this month. Our Phase 2 study evaluating oral PL8177, a selective melanocortin-1 receptor agonist in ulcerative colitis patients is on track for an interim assessment of the clinical data in the first half of 2024. Supporting oral PL8177 development are preclinical studies demonstrating that treatment with oral PL8177 and disease models causes disease colons to improve toward a healthy state and to resolve inflammation. Resolving inflammation rather than blocking it provides possibility of efficacy coupled with significantly differentiating safety in treating colitis and inflammatory bowel disease. Additionally, research work at Palatin has mapped clear mechanisms of action pathways melanocortin agonist in supporting the resolution of inflammation. BREAKOUT, our Phase 2 open label study evaluating melanocortin agonist in diabetic patients with kidney disease is also on track for top line data in the first half of 2024. So clearly, this is a big half for us, three clinical trial readouts. As far as what is on the horizon of Palatin, I would like to take a minute to highlight two new clinical studies that we are anticipating starting in the first…

Thank you. [Operator Instructions]. Your first question for today is coming from Joe Pantginis at H.C. Wainwright.

Hey, guys. Good morning. Thanks for taking the question. A couple of questions first, if you don't mind. Carl, starting at the back end of your comments, I was hoping you could provide… [Technical Issues]

It looks like we've lost the line. Just one moment.

Can you hear me now?

Your line is live.

Okay. No idea what happened there because I don't even have a mute on this phone -- I was not on mute. Anyway, so I was hoping maybe starting at the back end of your comments about providing some level of the mechanistic rationale of combining bremelanotide with GLP-1 agonist or one of those therapies for weight loss right now about -- whether it could be the maintenance setting or why those two drugs can really work together for the broader audience?

Sure. I'll try to do it in a simple way. Well, first and foremost, we've done and have presented data on combining a melanocortin-4 agonist with the GLP-1 agonist, and they work quite nicely together. They work -- I would say they worked quite synergistically. When you think about it, the in part the GLP-1s have probably multiple mechanisms of how they bring about a patient feeling being satiated and changing their energy and us and part of that is actually through the leptin melanocortin system. So these things are working in kind of similar pathways. But when you add the melanocortin-4 agonist on top, you get full activation of the leptin melanocortin pathway and that's a very key pathway in regulating energy homeostasis overall and that actually leads us into why it will be also very useful in weight loss maintenance. There have actually been several studies published -- preclinical studies published on weight loss maintenance using a melanocortin agonist in animals and both of those are actually with palliative compounds and you see very, very nice maintenance of the reduced weight state. And one way to think about this is there are differences in how obese patients respond to various treatments for weight loss. For example, when you're obese, you respond one way when you are losing weight, you respond slightly differently. But importantly, when you get to that weight loss to reduce state, you don't always respond the same way to the GLP-1s as you do when you're obese and you're going to need treatments like -- that affected the leptin melanocortin pathways, things like bremelanotide or some of the new compounds that we are bringing forward to actually maintain that weight and that's really the key here. We can drive a lot of weight loss with the GLPs and the other incretin therapies, but we really need to keep these patients at reduce weight if you want to have a long-term benefit. So if you think that the weight loss market is huge, the weight loss maintenance market probably dwarfs it, because these patients are going to be on treatment for many, many years. So that's why we're very excited about where we stand and really the biology and the science behind targeting the leptin melanocortin pathway for weight loss maintenance is pretty compelling.

That's a helpful summary. I appreciate that. So I have a specific question, which will then segue into sort of a broader strategy question. So when you look at the upcoming 8177 ulcerative colitis data, you have interim data coming up or I'm sorry, an interim analysis coming up, which is part of my question. What is your communication strategy around the interim analysis? Is this a just a continuous plan type of announcement that we hope to see or will you be providing any data?

No, we'll provide We're trying to be transparent, Joe. We'll provide the data that we have and to the best of our ability or how we see it playing out from the interim analysis to the final analysis. The goal here is to we do want this out in public, because one of our key goals is to continue to work with people that are interested in licensing this product. So we want to make sure that it's out there and people understand where we're going in the ulcerative colitis space.

Perfect. And then with us having saying ulcerative colitis, I said going to the broader question and strategy. When you look at the indications that you guys are addressing overall with your different assets, these are very large markets. So I guess, as of today, how do you view your business development strategy because they're very large markets? Are you looking at the potential for global, regional, when you're balancing against your current cash needs.

Well, you've hit on the head, let me backtrack for a second. I'm talking a little bit faster or thinking faster than I'm talking. When it comes to ulcerative colitis or dry eye disease, our goals for those are really to partner those programs. They represent very large markets, but in the case of dry eye disease, we have multiple larger assuming success with 9643, there are still several phase 3 trials that have to be done, plus all the commercial manufacturing. And that really in today's world is a more of a commercial market, right, a consumer market. So we really like to see that product assuming success in the hands of a larger company that's going to eventually market it and has the ability to do the outreach there, and that's not really what Paladin plays. Steve will tell you, he learned a tremendous amount about marketing to consumers through Vyleesi and it's expensive it requires a very consistent effort and that's not kind of where Palatin is set up and certainly not with the resources we currently have. Again, with ulcerative colitis, medical need is extremely high, but again, a competitive marketplace, meaning there are lots of therapies out there competing for patients for the larger trials and then for voice in the commercial sphere, with that being said, the need is very high. So believe it or not, that's one of the programs that even in its early stage, has huge amount of corporate interest already. And then again, when we think about where we want to go with regards to the obesity and erectile dysfunction, the erectile dysfunction one is an area we know extremely well. We've studied thousands of patients there. It's one where a company of our size can probably make good headway, meaning that the we know how to take it, we know how to get into commercialization and there are already distribution channels available and there's high awareness among patients. So that's one where we would probably try to keep longer, because it's one where we can conceptualize thinking about, assuming things go well for us commercializing it. Obesity, the market is hot and I think where we're trying to position ourselves, which in particular is in that weight loss maintenance and then in the supplementation or the adjunct therapy to GLP-1, those are novel spaces where people aren't thinking about them. I think very shortly they will be, and I think we'll be in a great position to monetize our early assets there relatively quickly. And Steve actually -- Steve has a business development people directly reporting to him and is really on top of all the business development activities that we're doing and making sure that they're getting done.

Got it. Appreciate it.

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

Thanks, good morning, guys. Glad you can hear me all right. Congrats on the quarter. Looking forward to seeing MELODY data readout here in February. Wondering ahead of the data here, what you would consider to be a clinically meaningful threshold from this readout, whether it be signs, symptoms or both, what is beyond that say, what you may feel is important for its commercial value?

I think in dry eye disease, the FDA does not require -- they only require statistical significant endpoint. And with regards to the signs, there really aren't -- the only thing the FDA accepts for signs outside of tear production is a complete resolution of the disease, which is unrealistic. Really what we think about it, it's really on the symptom side, which is really more important because that's really what affects the patient. The signs of dry eye disease, the staining result, patients don't understand that, it doesn't really mean anything to them. So on the symptom front, you'd like to see a 10 point change -- 10 point difference between vehicle and active that would be clinically meaningful change. So that's what we -- that would be a really nice response for us. We could talk 10 points on the scale.

We hope to see that too. Thanks for that detail. And ahead of this, we don't want to hold you to it, but just to get your sense for timing for additional data, obviously, you'll have a very busy first half of the year. Is there a chance you can get additional data out at conferences? How do you expect to us a bit more than the topline, we are going see here this month.

Sure. I think there are a lot of ocular meetings throughout the year, and assuming positive data, we'll have presentation at every one of the upcoming ocular meetings. Again, positive data will go through the ARGO, which is in the we've missed the date there, but we'll go for late breaking if it's good. So we'll keep a very good flow out of the data.

That'd be great. Look forward to that. And then switching over to breakout, any feedback you can give us as so what type of data we'll see when you do read it out for?

Yes. I think, Danilo, this is an open label study. It's a single dose It's really a supportive study because people realize this, we haven't had a chance to talk about it, but we're actually in the final stages of selecting actually an orally active small molecule that targets the M01 receptor. So this is really a study that was kind of set up for that. It's an injectable study. But what we expect to see is really a drop in proteinuria and the creatinine protein ratios. These patients don't really -- they don't spontaneously remit. So any change you see, any improvement you see is going to be really due to the drug activity. They don't get better, they just progressively get worse. So one of the reasons why we chose the indication, although the disease progresses relatively slowly, it doesn't have spontaneous remission. So you can do an open label study and if you see effects on kidney function, they'll be most likely really pretty much due to the drug.

Right. Yes, that makes sense. Look forward to seeing that. And then on the obesity and ED programs, have you been able to discuss trial design yet? I'm not clear on that.

For the ED-one, neither have been submitted yet. We haven't opened up INDs. We're going to probably run the ED study as a physician sponsored trial, we have clinicians that were involved in the early days working with us in the early development of bremelanotide that are very -- urologists and they have some large practices that can really get a lot of patients very quickly. So that will be probably run as I said, as physician sponsored I&D. We should be submitting, I think the IND or the pre IND request to the agency by the end of this month for the obesity study.

Interesting. And then a follow-up on the obesity. I believe your phase 2 on this would be with BMT, but your Phase 3 would be kind of a BMT XR version, is that right?

So we have so we've been using the bremelanotide as a test molecule for adding extended release on to our various peptides across the board has been working very, very well, so we can extend green bremelanotide quite nicely. The overall program, although bremelanotide is being used as a proof of concept. We will go forward and we'll be having a little bit more information out on this probably in the second quarter of the year -- of this calendar year. We have novel compounds that really -- are highly selective for the melanocortin-4 receptor. So they have a much cleaner profile than bremelanotide does and they're much more suited for long-term chronic use. And also the receptor profiling for long term obesity treatments, in other words the degree of -- let me not go through that prior to the standpoint, but how you interact with the receptor should maybe be a little bit different than bremelanotide. So one of the things that again -- I'm not going to bore the lay people that are listening is that we have a tremendous understanding of the structural function relationships with regards to all the various melanocortin receptors and their peptide agonists and we're able to dial in a degree of activity that we think It's probably really ideal for obesity treatment and that's what you're going to see going forward into towards the phase 2s and the eventual phase 3 studies.

Yes, these are really exciting programs. So your expertise in this, we're looking forward to seeing in greater detail. So thanks for that. That's it for us for now. Congrats again.

Your next question for today is coming from John Newman with Canaccord.

Hi, guys. Thanks a lot for taking the question. Carl, so I just had a general question about the dry eye program rather than getting into the data details, we've had several dry eye products approved and I know that sometimes the endpoints can be hard to use in order to gauge the effectiveness and success of the product, but I wonder if you could talk more about how you believe 9643 could be differentiated from some of the other products in the market, maybe on the safety side as well.

I think you hit it your last statement kind of hits it. I think at the end of the day, most of the treatments that are in approved for dry eye disease have tolerability issues. Safety in these treatments are pretty good. You're giving a small amount of drug topically, so there's not an overall large concern about systemic effects. So it's really about the patient acceptance and tolerability and long term use, and that's what's really plagued a lot of the drugs that have -- we're in the market for a long period of time and now coming into the marketplace. PL9643 has really excellent ocular tolerability and safety. So that would be a very key differentiating factor, a comfortable installation without itching and tearing and burning or feeling goofiness or off taste, anything of that nature is really key to -- for a product like this, because I said it is very consumer driven. So that's going to be key important factor. I think one of the things I'd like to kind of distinguish is, in the dry eye space, we see different types of products, right. So a product like 9643 really is trying to address the underlying disease. So we're trying to modify the disease condition and through that have an overall effect on the corneal surface health and then how the patient perceives their disease, so their symptoms are improving, that's a little bit of a much more difficult challenge than agents that are, what I would classify just really symptomatic treatment, in other words, i.e. they just drive a tearing of the eye -- short term tearing of the eye that maybe can alleviate symptoms over relatively short period of time, but don't really have long term benefit in treating dry eye disease. So there's another distinct thinking factor there. Again, assuming success, we're really -- we're likely to be having that success because we're really modifying the underlying disease, not just addressing a symptom.

Great. Thank you.

We have reached the end of the question-and-answer session. And I will now turn the call over to Carl for closing remarks.

Thank you. Steve and I would like to thank everyone for participating on the call, and we'd like thank our analysts for the very insightful questions that they ask. It helps us to Steve and I to more or less illuminate what we're doing here. So again, thanks everyone. Big half for us, obviously a big month for us. So we're looking forward to the data and take care and we'll catch up with you soon. Thank you.

Thank you. [Operator Closing Remarks].