管理層發言
Greetings. Welcome to Palatin's Second Quarter Fiscal Year 2026 Operating Results Conference Call. The operator provided instructions on how to ask questions. 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, and good morning, everyone. Earlier today, we reported Palatin's financial results for the second quarter of fiscal year 2026 and provided a corporate update. With me on the call today is Steve Wills, Palatin's Chief Financial Officer. Today, we will highlight our progress advancing our melanocortin-4 receptor based obesity pipeline, review recent strategic and financial milestones and outline our priorities as we move through 2026 before opening the call for questions. First, I will turn the call over to Steve for the financial and operating results. Steve?
Thank you, Carl. Hello, and welcome, everyone. I'll walk through our second quarter fiscal 2026 operations and financial results. Starting with our recent public offering on November 12, 2025, we closed an upsized $18.2 million underwritten public offering, including the full exercise of the overallotment option. The offering consisted of approximately 2.8 million shares of common stock or prefunded warrants in lieu thereof, along with Series J and Series K warrants at a combined public offering price of $6.50 per share and accompanying warrants. Each Series J warrant has an exercise price of $6.50 per share and expires on the earlier of 18 months from issuance or 31 days following FDA acceptance of an IND for an in-house obesity treatment compound. Each Series K warrant has an exercise price of $8.125 per share and a 5-year term, subject to automatic termination if the associated Series J warrants are not exercised within the FDA exercise period. Gross proceeds from the offering were approximately $18.2 million with net proceeds of approximately $16.9 million after underwriting discounts and offering expenses. While the company may receive up to an additional $18.2 million upon the exercise of the Series J warrants, there is no assurance that these warrants will be exercised. The net proceeds from the offering are being used to support the advancement of our obesity programs as well as for working capital and general corporate purposes. As a result of the closing of this financing, Palatin regained compliance with NYSE American continued listing standards, and effective November 12, 2025, our common stock resumed trading on the NYSE American under the symbol PTN. Turning now to the financial results for the second quarter ended December 31, 2025. Revenue for the quarter was $116,000 compared to $0 revenue in the comparable period last year. This revenue relates to cost reimbursements under our collaboration agreement with Boehringer Ingelheim. Total operating expenses were $7.4 million for the quarter compared to $2.6 million in the prior year period. The year-over-year comparison is primarily impacted by the gain on the sale of Vyleesi recorded in the December 31, 2024 quarter, which reduced net operating expenses in that period. In the current quarter, operating expenses increased due to higher investment in our melanocortin-based obesity development programs as well as increased compensation costs and professional fees. Other income, net, was approximately $65,000 for the quarter compared to approximately $169,000 in the prior year period. The decrease reflects lower investment income and foreign currency translation gains, partially offset by lower interest expense. Net cash used in operations was $4.8 million for the quarter, consistent with the same quarter last year. Net loss for the second quarter was $7.3 million or $2.86 per share compared to a net loss of $2.4 million or $5.92 per share in the comparable period last year. This change reflects higher operating expenses associated with advancing our pipeline programs as well as the absence of the Vyleesi divestiture gain recorded in the prior year. Turning to our cash position. As of December 31, 2025, we had $14.5 million in cash and cash equivalents compared to $1.3 million at September 30, 2025, and $2.6 million at June 30, 2025. Based on our current operating plans, we expect our cash runway to extend beyond the quarter ending March 31, 2027. Finally, with respect to our PL9643 sublicensing transaction, in January 2026, we received approximately $3.8 million of upfront consideration in the form of noncash debt cancellation. This amount is reflected in the current liabilities as of December 31, 2025, and will be recognized as license revenue in the quarter ending March 31, 2026. In summary, the successful completion of our public offering significantly strengthened our balance sheet, restored our NYSE American listing and provides the capital needed to advance our obesity pipeline while maintaining operational flexibility. With that, I'll turn the call back to Carl for program updates.
Thank you, Steve. Palatin continues to execute on its strategy to advance differentiated melanocortin-4 receptor based therapeutics with a primary focus on rare syndromic and genetic obesity disorders. During the quarter, we made meaningful progress advancing our lead obesity programs towards the clinic, strengthening our balance sheet and sharpening our strategic focus, as Steve mentioned, through the sublicensing of our dry eye disease clinical candidate, PL9643. Turning to the obesity pipeline. We are advancing a portfolio of proprietary melanocortin-4 receptor agonists initially targeted to rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, areas of significant unmet medical need. Our lead oral small molecule MC4R agonist, PL-7737, continues to progress through IND-enabling toxicology studies, and we remain on track to submit an IND and initiate a Phase I single and multiple ascending dose clinical trial in the first half of calendar year 2026. In parallel, we are advancing our next-generation selective melanocortin-4 receptor peptide agonists which are designed for once-weekly subcutaneous dosing. For this program, we are planning an IND submission in the second half of calendar 2026. As we move these programs forward, our development focus is on delivering differentiated product profiles. Specifically, we are designing our compounds to enhance patient tolerability, including the potential for reduced gastrointestinal side effects while minimizing off-target effects such as hyperpigmentation, factors we believe are important for success in the long-term treatment of chronic obesity indications. Our preclinical data supports the potential of targeting melanocortin-4 receptor across both rare and select broader obesity indications. However, our focus will be on rare neuroendocrine disorders; planned registration clinical studies will enroll patients with hypothalamic obesity and Prader-Willi syndrome. In addition, preclinical and early clinical data support the potential for co-administration of melanocortin-4 receptor agonists with GLP-1-based therapeutics such as tirzepatide, providing optionality as the obesity treatment paradigms continue to evolve. A couple of other things that occurred during the quarter, as Steve had mentioned, in January 2026, we executed the sublicensing of PL9643, a selective melanocortin-1 receptor agonist with positive Phase III clinical data in dry eye disease to Altanispac Labs. This transaction provided approximately $3.8 million in upfront consideration and allows us to sharpen our focus on our core obesity programs while retaining potential future financial participation through milestones and royalties. We also significantly strengthened our balance sheet with the completion of an $18.2 million public offering in November, which included the full exercise of the overallotment. In addition, we successfully regained compliance with the New York Stock Exchange American listing standards and our common stock resumed trading under the symbol PTN, restoring market visibility and liquidity. In summary, Palatin enters 2026 with a strengthened financial position, multiple partnerships with near-term milestones and a focused differentiated obesity pipeline. We believe this positions the company to pursue substantial long-term value creation. With that, I'll turn the call back over to the operator, and we will open the call to questions.
分析師問答
The operator provided instructions on how to ask questions. Your first question for today is from Scott Henry with Alliance Global Partners.
If we could start with PL-7737, as we get ready for the IND, what preclinical or translational signals give you the greatest confidence in differentiation versus current or emerging MC4R agonists, particularly around the tolerability angle?
Scott, the compound is designed — first of all, we'll talk about hyperpigmentation. It's designed to be more selective for the melanocortin-4 receptor than the melanocortin-1 receptor, which should lead to a reduction or substantial reduction in hyperpigmentation. Regarding the GI side effects, we control potential gastrointestinal side effects through a variety of mechanisms, not the least of which is the way the product is administered and absorbed. We slow down the absorption so that we don't get relatively large spikes in exposure, which can lead to an increase or enhanced gastrointestinal side effects.
Okay. Great. And as we get into the Phase I SAD/MAD trial, how are you thinking about patient selection? And what endpoints should we be thinking about as far as what we can get out of the early clinical data? Also, I noticed Prader-Willi is mentioned — is that an increased focus in addition to hypothalamic obesity, or is that just more front and center than in the past?
For the single-ascending dose and the multiple-ascending dose studies, those are primarily safety studies. For the single ascending dose, what we're looking for is to confirm oral bioavailability, that the product is safe and to really define a dosing window for PL-7737; the same will be true for the long-acting peptide when that moves forward. In the multiple ascending dose study, those will be carried out over a longer term and will be in healthy obese patients. Safety is always the paramount primary consideration in these types of studies. That being said, because the MAD part will be in healthy obese patients, we'll be looking for a reduction in their body weight, reductions in hyperphagia and other parameters that relate to the obesity indication. We do expect that we will get at least from the MAD part a pretty clear signal on how well these compounds can work. What's nice is we've seen good translatability from smaller efficacy studies to larger studies with this mechanism. Regarding Prader-Willi syndrome, it has always been in the background. We're looking for indications that meet rare and orphan designation criteria but also have a substantial number of patients. Some of the very small genetically based indications have relatively few patients, which are valid markets but smaller. We are still looking at larger indications like hypothalamic obesity and Prader-Willi where there are substantially more patients.
Okay, great. And then final question on the clinical side: with the oral small molecule and the once-weekly injection, how do you anticipate positioning those two products? Do you view them as complementary? Just trying to get an idea of where we should think about each one of those.
I certainly think they're complementary. Each will have patient populations for which they're better suited. For the weekly injectable peptide, one might expect to see a higher level of efficacy. Generally, we tend to see across the board that we can drive better efficacy with peptides than with small molecules. Final decisions will be predicated on what we see in the early studies, but there will be distinct patient populations for each. In these indications, treatments are long term — unlike generalized obesity where patients might hit a target and move to maintenance, these patients have chronic conditions that require sustained, often aggressive therapy. So you'll need both kinds of options to manage these patients effectively.
Okay. I guess I'll just give Steve a chance to say something. Steve, with regards to OpEx in fiscal Q2, it looks to be about $7.4 million. Was there any kind of one-time noise from the transaction in there? I'm trying to get a sense of how we should think about that OpEx number in the March quarter, the fiscal third quarter.
Thanks, Scott. Yes, the quarter had a number of extraordinary or one-time items, and that amounted to over $2 million that we do not expect going forward. We cleaned up a number of things that we weren't able to clean up prior to the raise. We did mention in the Form 10-Q filed earlier today that there were a number of one-time extraordinary type expenses that we are not going to see going forward. So I would target approximately $2.5 million less in the next comparable quarter versus the quarter that was a little over $7.4 million.
The operator provided instructions on how to ask questions. Your next question for today is from Yale Jen with Laidlaw & Company.
Just going to follow up a little bit on Henry's questions, first on the safety side. As we know, in Prader-Willi syndrome the current approved drug has some issues on the safety side and there has been 15% to 20% discontinuation of patients being treated. How would you assess that issue when you're starting your Phase I study and then further down the pike?
In a Phase I study, we'll get a very good look at the tolerability and safety profile for both approaches. Based on our experience with the melanocortin-4 receptor system, we have a pretty good understanding of what we expect to see. In general, you will see some gastrointestinal side effects, and we think those are controllable through the way these agents can be administered so that rates are lower. We don't generally see high discontinuation rates with this mechanism; they generally tend to be fairly low for GI side effects. In addition, we want to avoid melanocortin-1 receptor activation as much as possible to reduce the potential for hyperpigmentation, which many patients find undesirable. Overall, mechanistically this approach could result in lower discontinuation rates in these patient populations while delivering good efficacy. However, we have to get in the clinic and show that.
Sure. Maybe two quick questions. First, in terms of Prader-Willi, you are looking at hyperphagia. In your Phase I study, and more likely Phase II, how will you assess the two metrics — hyperphagia and weight reduction — in study design to see a clear sign that both are impacted?
When we're dealing with Phase I, we're really talking about the multiple ascending dose study. We're not going to expect to see much from a single dose other than safety. In a 4-week study, such as a 20-day MAD study in healthy obese patients, you're looking for consistent target engagement over the dosing period, consistent pharmacokinetic parameters and consistent exposure. From other studies, we would expect to see a reduction in food intake and a reduction in body mass in these patients. Mechanistically, melanocortin-4 receptor activation downstream can help control hyperphagia. Until you get into PWS patients specifically, you won't know precisely how much you control hyperphagia in that population, but you'll get a very strong signal from Phase I that you're working on target and how much efficacy you can drive. That should translate into a strong signal in PWS patients as well, but you have to test in the intended patient population to know for sure.
Okay. Based on anticipated resources going forward, will PWS be something you contemplate more aggressively later this year or more in the next year?
You're correct that activity on PWS will be more in the next year. I'll let Steve walk through how the cash flow plays out over the next 18 months.
Thanks, Carl. As Carl mentioned, the SAD/MAD Phase I studies are the initial steps, and we have sufficient cash on hand right now to move forward with both the oral small molecule and the long-acting peptide in the Phase I SAD/MAD. That data will read out for the oral small molecule by year-end and in the first half of next year for the long-acting peptide. Thereafter, we'll move forward into what you might call Phase II or Phase II/III specifically in hypothalamic obesity and Prader-Willi syndrome patients for both the oral small molecule and the long-acting peptide, but those studies will not start before mid-2027. Is that helpful?
Yes, absolutely. That's great color. Maybe the last question is on the combination with GLP-1. I understand that's a very competitive space, but you have some positive data. How would you position or anticipate GLP-1 playing a role in your product development or clinical studies going forward?
We've been working on combination of these two mechanisms for some time and have conducted clinical trials specifically looking at the interaction. As more incretin-based therapies enter the marketplace, including oral formulations, clinicians will likely want to combine mechanisms, particularly for patients with severe hyperphagia such as some PWS patients who may need more than one mechanism alone. During clinical development, you'll focus on monotherapy approaches, and some patients entering trials will be on GLP-1s. Longer term, it's likely that you'll see combination therapy, so we're positioning ourselves for lifecycle management and the reality of how these products will be used in the marketplace when approved.
Okay. Great. Again, congrats on having sufficient resources to move forward. This is a great space to be in and congrats on the progress.
We have reached the end of the question-and-answer session. I will now turn the call over to Dr. Carl Spana for closing remarks.
Thank you. I'd like to thank everyone for participating in the Palatin Second Quarter Fiscal 2026 Conference Call. We're excited about what we're doing here. I think we're in a very good place with really good assets, and we'll continue to be excited in moving these products forward and updating you as we continue to make progress in our development. That being said, have a great day, and we look forward to continuing to update you on our progress. Thank you.
This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.