Palatin Technologies, Inc.

First, welcome to Haliton's third quarter fiscal year 2025 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.

Thank you. Good morning, and welcome to the Palatin third quarter fiscal year 2025 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Chief Financial Officer and Chief Operating Officer. I'll now turn the call over to Steve, and he'll give the financial update.

Thank you, Carl. Good morning, good afternoon, everyone. Regarding non-program corporate update, on May 7th, 2025, Palatin received notice from NYSE regulation that it had suspended trading of the company's common stock on the NYSE American Stock Exchange and determined to commence proceedings to delist Palatin's common stock as a result of its termination. that the company is no longer suitable for listing pursuant to Section 1003F5 of the NYSE American Company Guide due to the low selling price of the company's common stock. Trading of the company's common stock on the NYSE American was suspended on May 7, 2025, and began trading on the OTC Pink market on May 8, 2025. Palatin exercised our right to review of NYSE regulations determination to delist Palatant's common stock. We are disappointed and do not agree with the NYSE's decision and are assessing all available options. Moving over to our fiscal third quarter, ended March 31st, 2025 financial results regarding revenue. Pursuant to the completion of the sale of Ilesi's worldwide rights for female sexual dysfunction to Cassette Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors for the quarter ended March 31, 2025 and March 31, 2024. Regarding operating expenses, Total operating expenses were $4.8 million, net of $0.4 million gain on a purchase commitment for the quarter ended March 31st, 2025, compared to $9.2 million for the comparable quarter last year. The decrease was mainly the result of the decrease lower spending related to our MCR programs for the quarter ended March 31st, 2025. Regarding cash flows, Palleton's net cash used in operations for the quarter ended March 31st, 2025 was 5.4 million compared to net cash used in operations of 8.6 million for the same period in 2024. The decrease in net cash used in operations is mainly due to the decrease in net loss during the period and secondarily to working capital changes. Regarding net loss, Palatine's net loss for the quarter ended March 31st, 2025 was 4.8 million compared to a net loss of 8.4 million for the same period in 2024. As referenced above, the decrease in the net loss for the quarter ended March 31st, 2025 over the quarter ended March 31st, 2024 was driven primarily by the decrease in operating expenses for the quarter ended March 31st, 2025. Regarding cash position, as of March 31st, 2025, Palatine's cash and cash equivalents were 2.5 million compared to cash and cash equivalents of 9.5 million at June 30th, 2024. The $2.5 million of cash and cash equivalents as of March 31st, 2025 does not include approximately $3.5 million of net proceeds received in April and May 2025 from Palatine's ATM facility and the recent equity offering. We are actively engaged with multiple potential funding sources, including business development initiatives for future operating cash requirements. Let me turn the call back over to Carl.

Thank you, Steve. I'll now go over the operating update for the quarter. Updates for melanocortin-4 receptor obesity programs are as follows. For our Phase II study, BMT-801, evaluating the safety and efficacy of the co-administration of the melanocortin-4 receptor agonist remelanotide with terceptotide HLP1-GIP dual agonist in patients with generalized obesity, we reported positive top-line data for the study. The study successfully answered the research questions, does co-administration result in increased weight loss, and can treatment with an Atlanticortin-4 receptor agonist be used as a treatment for weight loss maintenance by blending the weight regain seen post-increased therapy. The primary efficacy endpoint was weight loss of the combined treatment compared to placebo control at the end of eight weeks of treatment. Patients on the combined therapy had a weight reduction of 4.4% versus 1.6% for the placebo arm. The p-value here was highly significant. Importantly, 19% of patients on the combined treatment had a weight reduction of greater than 7% compared to 0% for patients on placebo and the trisepatide alone arms. Concerning a weight loss maintenance effect, low dose of remolanotide prevented the rapid weight regain following trisepatide treatment. So a very positive study for us. As we move forward, our obesity and weight loss management portfolio includes both novel long-acting melanocortin-4-receptive peptide agonist and the orally active melanocortin-4-receptor-selective small molecule agonist PL7737. During the quarter, we were notified by the FDA that they granted orphan drug status to PL7737 for treating patients with obesity due to leptin receptor deficiency. Pending financing, PL7737 is on track for... An initial new drug application submission in phase one, single ascending dose and multiple ascending dose studies in the first quarter of 2026. Our novel next generation selective melanocortin-4 receptor compounds have reduced activity at the melanocortin-1 receptor and therefore reduced potential to cause skin darkening. The lack of MCR-1 activity, the once weekly or oral dosing represents significant improvements over current FDA-approved melanocortin treatments. You can find additional information on our clinical trial at clinicaltrials.gov and on our website. During the quarter, we also reported positive top-line data for our Phase II study evaluating our oral PL8177, a selective melanocortin-1 receptor agonist for treating ulcerative colitis. The study evaluated PL8177 versus placebo for eight weeks in moderate ulcerative colitis patients. Clinical remission was achieved for 33% of PL8177-treated patients versus 0% for placebo. Clinical response was achieved for 78% of PL8177 patients compared to 33% for placebo, again, highly significant. The symptomatic remission was achieved for 56% of patients on PL8177 versus 33% for placebo. This exciting data has resulted in a significant increase in business development discussions with potential partners, which is in line with our current strategy to out-license this program. During the quarter, we also reported additional data for the PL8177 9643, Melody 1, Phase III study in dry eye disease patients. The data from a responder analysis that compared placebo to PL9643 demonstrated that for six of the 13 symptom endpoints, a significantly higher percentage of patients had a complete symptom clearing, i.e., they were cured. This, again, was highly significant. This level of symptom clearing has not been achieved by any FDA-approved treatment for dry eye disease. Clearing was seen as early as two weeks and continued to improve over the 12 weeks of the study. We are actively engaged in potential corporate partners for this program as one of our earlier OCCLA programs, and we anticipate one or more transactions closing in the second half of calendar 25. Before moving on to take questions, I would like to comment on our strategy. We are focused on our research and development efforts on our melanocortin-4 receptor obesity assets. We believe the pharmacological treatment of obesity is in the early stages of a multi-year cycle of innovation and will have a market value at excess of $100 billion per year. The melanocortin system plays a critically important role in regulating stored energy and food intake, and we strongly believe that melanocortin-4 receptor agonists will be an important part of the future of obesity treatment and weight loss management. Thank you for participation, and we'll now open the line to questions.

Thank you. The floor is now open for questions. If you wish to join the queue to ask a question at this time, please press star 1 on your telephone keypad. We do ask if listening on speakerphone today that you pick up your handset while asking your question to provide optimal sound quality. Once again, you may press star 1 on your telephone keypad at this time if you wish to join queue to ask a question. Please hold a moment while we poll for questions. And we have a question from Scott Henry from Alliance Global Partners. Scott, your line is live. Please go ahead.

Thank you, and good morning. A couple questions on the obesity program. First, I know that a low dose of remolamotide or BMT was used in this study. The question is, do you believe a higher dose would increase the weight loss, putting it in the ranges of Wagovi or Zepfam?

Sure. Thanks, Scott, for the question. Yes, we actually have a publication out on that. We actually looked at higher doses of remelanotide in an earlier study. and where we were, you know, looking to optimize. It's a short-acting compound, so they were on multiple doses per day so that patients would be in optimal dose range, you know, while they had access to food. And the weight loss there really is comparable to what you would see with the single agent Wigovi. Tazepatide is a multiple mechanism drug, and it's a little bit better than Wigovi. But with regards to, you know, these single mechanism drugs like Wigovi, a good MTR4 agonist like Bremelanotide are the ones that we're working on. They will have highly competitive weight loss.

Okay, great. Thank you for that color. And then with the GLPs, the rebound weight regain is kind of a common issue. Do you think we may see this idea of weight maintenance in the future, even potentially getting into the label? Could that be more of a focus in these next generations?

Absolutely. New compounds coming through are going to be evaluated as weight loss maintenance. There are studies that are going on right now doing that with the GLP-1s. But you're going to need newer mechanisms to really address that on a long-term basis. Right now, we don't have any evidence that patients that once they've lost weight can effectively come off of treatment and maintain that weight. Right now, the strategies are going to need to be on long-term weight loss maintenance you know, how the dosing works out, what agents are going to be used, you know, that's going to be worked out in clinical trials. But, you know, monoclonal agonists are really ideally suited for that. It's probably dysfunctions in the hypothalamic MCR leptin pathways that actually are leading to that weight regain, and this really begins to address that directly.

Okay, great. And the final question, just on the next generation of MC4Rs, if you could just talk about the benefits that will separate them from the first generation. I know pigmentation was an issue. I don't know if that's going to be one of the things that may be different, but if you could just talk about what, you know, what your expectations are for that next generation. Thank you.

Sure. Thanks. You know, both remelanotide, and there's another one that proves remelanotide, they're what I would consider first-generation compounds. They are good. They work well. But, you know, they are – They are short-term dosing, so you need one or more doses per day. They do have the pigmentation that you pointed out, and they're not ideal treatments or as competitive in, say, a general market as current treatments. So what we're looking to do here is really eliminate that MCR1 activity so we don't get the skin darkening. I think we've been able to do that quite successfully. In addition to that, if we're dealing with a peptide which wouldn't be orally active, we certainly want that to be once a week. which is very patient-friendly, or with 7737, which is a small molecule, it's a once-a-day oral, has a very nice extended half-life, so we can really get to steady state. And that's really a goal with these things. Compared to what's out there on the melanocortin side, when you deal with short-acting compounds, it's very hard to maintain a steady state. And in obesity, you really want to get that steady state, and we can achieve that with both the long-acting peptide or the oral small molecule that we're bringing forward. So there really are improvements over what's out there today.

Okay, thank you for that caller, and thank you for taking the question.

Thank you, Scott.

Thank you. This does conclude our question and answer session for today. I would now like to pass the floor back to management for closing remarks.

Steve and I would like to thank everyone for participating in our third quarter Fiscal Year 2025 call. We look forward to keeping you updated on our progress. I think it was, you know, from an operating standpoint, it was a phenomenal quarter for us. You know, we did have a little difficulty with the NYSC, but I think that's going to be transitory. We're going to work to address that as quickly as we can. So thank you and have a great day.

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