Palatin Technologies Inc (PTN) Q3 2026 Earnings Call Transcript

Hello, everyone. Welcome to Palatine's third quarter fiscal year 2026 operating results conference call. At this time, all participants are on 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 the 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 risk and uncertainties discussed in the company's recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatine prospects. Now, I would like to turn the call over to your host, Dr. Carl Spana, President and Chief Executive Officer of Palatine. Please go ahead.

Good morning, and welcome to the Palatine Third Quarter Fiscal Year 2026 call. I'm Dr. Carl Spana, CEO and President of Palatine. With me on the call today is Steve Wills, Palatins' Chief Financial Officer and Chief Operating Officer. Earlier today, we issued a press release reporting Palatins' financial results for the third quarter of fiscal year 2026 and are now providing a corporate update. Today, we will highlight our progress advancing our LATICOTIN-4 receptor-based obesity pipeline, review recent strategic and financial milestones, and outline our priorities as we move through 2026, followed by a question-and-answer session. First, I will turn the call over to Steve for the financial and operating results.

Thank you, Carl, and hello, everyone. I will briefly review our financial results that the fiscal third quarter ended March 31, 2026, beginning with revenue. For the third quarter, we recognized $3.9 million in collaboration and license revenue compared to no revenue in the prior year period. The increase was primarily related to the revenue recognition of the upfront consideration under the Altanaspac agreement. Turning to operating expenses, total operating expenses for the quarter were $5.5 million compared to $4.8 million in the prior year period, which included a $0.4 million gain on purchase commitment. The increase was primarily attributable to higher compensation costs and professional fees. Net cash used in operations for the quarter was $4.4 million compared to $5.4 million in the prior year period. The reduction in cash used and operations was primarily driven by collaboration and license revenue recognized during the quarter. Net loss for the third quarter of fiscal 2026 was $1.4 million, or $0.37 per basic and diluted common share, compared to a net loss of $4.8 million, or $9.13 per basic and diluted common share for the prior year period. The improvement in net loss was primarily related to collaboration and license revenue recognized during the quarter. Turning to our balance sheet and liquidity position, as of March 31st, 2026, Paliton had cash and cash equivalents of $10.2 million, in addition to approximately $2.2 million of other receivables, which are expected to be collected during the quarter ending June 30, 2026. Based on our current operating and development plans and our ability to manage the timing of certain operating expenses, we believe our existing cash resources and expected receivables will be sufficient to fund operations through June 30, 2027. With that, I will turn the call back to Carl. Carl?

Thank you, Steve. This quarter, Palatin continued to execute on its strategy of advancing our melanocortin-4 receptor agonist therapies for rare obesity disorders with a focus on improving tolerability, usability, and long-term outcomes in chronic treatment settings. The melanocortin-4 receptor pathway is a clinically and commercially validated target. We strongly believe the next phase of innovation will be defined not just by efficacy, but by improvements in overall treatment profile, particularly tolerability and patient-friendly delivery to support long-term patient adherence. In this context, our goal is very straightforward. This is developed best-in-class monoclonal receptor agonists for the treatment of rare syndromic and genetic obesity disorders. We are uniquely positioned to achieve this with our extensive experience in the design of monoclonal receptor-selective agonists, along with our recent advancements in the understanding of receptor-ligand interactions. In rare obesity disorders such as hypothalamic obesity, Prader-Willi syndrome, and Bardet-Bidal syndrome, patients face severe hypophagia, rapid weight gain, and significant metabolic complications. These are chronic conditions that require lifelong treatment, and current therapeutic options often present challenges for long-term use. As a result, improving tolerability and usability is critical to achieving meaningful, sustained outcomes for patients. Updating our obesity pipeline. Our melanocoin-4 receptor agonist peptide program is designed to achieve sustained efficacy with a treatment profile optimized for high selectivity for the melanocortin-4 receptor in once-weekly delivery. Our once-weekly melanocortin-4 receptor-selective peptide agonist remains on track for an initial new drug application submission in the fourth quarter of calendar 2026 and represents our lead clinical asset. In our oral small molecule program, we are advancing next-generation oral melanocortin-4 receptor-selective agonist candidates based on data and learnings from earlier compounds, including PL7737. Recent data from our research work in medicinal chemistry and our advancements in understanding detailed receptor ligand interactions. In internal preclinical studies, our candidates demonstrate significantly improved melanocortin-4 receptor selectivity with minimal melanocortin-1 receptor activity and increased potency of melanocortin-4 receptor compared to earlier compounds. We believe this improved selectivity and potency will result in lower dosing requirements and a meaningful reduction in the potential elimination of hyperpigmentation. I want to emphasize the importance of the last point. Hyperpigmentation is a known class effect associated with melanocortin-1 receptor activity and remains a limitation of current therapies. Our approach is specifically designed to minimize melanocortin-1 receptor off-target interactions, and the selectivity data we have supports this conclusion. Our goal is to develop best-in-class therapies with superior efficacy and long-term patient compliance. In addition to advancing our ABC programs, we continue to leverage the broader potential of our melanocortin receptor platform through strategic partnerships and business development activities. Our partnership with Borgel Ingelheim for retinal diseases continues to provide non-dilutive capital, milestone opportunities, and potential long-term royalty participation. During the second half of calendar 2025, we received upfront and milestone payments totaling 7.5 million euros, or approximately 8.8 million dollars. We also completed the sub-licensing of PL-9643 for dry eye disease to Altanaspac Labs in January of 2026, receiving 3.8 million in upfront consideration while retaining the potential for future payments and royalties. In addition, our PL8177 ulcerative colitis program remains positioned for potential partnering following positive phase two proof of concept results. These transactions reflect our strategy of leveraging the breadth of our melanocortment receptor platform to generate non-dilutive capital and support our pipeline advancements and create multiple potential long-term value drivers for shareholders. In summary, our peptide program remains on track for an IND submission in the fourth quarter of calendar 2026. Our oral small molecule program is advancing next-generation candidates with improved selectivity and potency toward an IND in the first half of calendar 2027. We have developed new intellectual property around melanocotin-4 receptor selectivity, and we are continuing to leverage both our vast experience and new data to design melanocotin-4 receptor therapies with improved selectivity and overall better treatment profiles. We believe the strategy positions Palatin deliver differentiated best-in-class line of 1 and 4 receptor agonist therapies for patients with significant unmet medical need. With that, we will now open the call to questions.

Certainly. The floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on a speakerphone to provide optimum sound quality. Please hold for just a few moments while we pull for questions. Your first question is coming from Scott Henry with AGP. Please pose your question. Your line is live.

Thank you, and good morning. Just recapping on PL7737, is that molecule now discontinued? And if so, was it due to an issue with PL7737, or did some of the backup compounds present a better profile to take going forward?

Thanks for the question, Scott. You know, we're not going to be first to market in this space, so we really want to make sure we have best-in-class compounds. So our selectivity, our parameters for selecting a compound or continuing a compound to go through development into the clinic is pretty stringent. So it's kind of when the decision was really multifactorial. As we were running through the PL7737 development, we came to a point where we felt that the selectivity and the dosing that we wanted to achieve to be best in class, we didn't necessarily think that the compound would meet that. And in addition to that, we were seeing, since we were funded in November of last year, we were able to really push some of these backup compounds forward, and we started to see compounds that really are verging on almost the elimination of M01 activity. So their profiles are just coming out just better than where 7737 is. And so we had to make the decision on, do we continue to put resources into a compound that may not be best in class, or do we divert those to the peptide, which is, you know, really highly selective and, you know, once a week and has a really excellent profile, and then bring along a second generation compound that really has got a much better profile. So it was a combination of a number of factors that went in. And we also have to consider that, you know, this is a target that is, you know, growing in interest and there's potential competition. So, you know, when we are making final decisions to go in the clinic and start spending lots of investor money, we really want to make sure that it's a very stringent decision and that the compounds that we take forward really meet a high degree of selectivity for MCR-4, have excellent drug-like characteristics, are easier for the patients to use, whether it be oral or once weekly. And so there were a lot of factors that went into it, into the decision. And 7737 is still extremely valuable to the company. We've learned a tremendous amount from it. We're still evaluating it, and we'll continue to be supportive of everything that we're doing.

Okay. In the next generation oral small molecule compound, would you expect to have a similar clinical game plan as you did for PL7737 as far as looking at hypothalamic obesity patients as well as Prader-Willi?

Absolutely. that'll follow a similar path. I think that the peptides and the oral cell molecules will each have their place in treating these patients based on patient preferences, efficacy, side effect profiles. But the next generation compounds really we're seeing, I expect that these compounds really won't have any M-01 activity at all. They're going to be quite clean. And I think that's going to be a major advancement. And we have to keep in mind that this is going to be competitive field, and we really want to make sure we're bringing, you know, the best that we can deliver, you know, based on the experience that we have.

Okay, and when you think about the differentiation of your pipeline with compounds on the market and under development, what do you think are the key attributes that separate your pipeline? I mean, obviously, you've mentioned selectivity, and hyperpigmentation. Are there any other aspects that you would highlight?

Sure. I mean, that's a key aspect. I think the technologies that we use for potentially delivering once a week injections for peptides can be differentiating as well. I think the understanding that the PK parameters, these compounds, have to put them in a range where We don't need to go to, you know, levels of drug exposure that exceed the therapeutic window so that we can eliminate or drastically reduce the potential side effects that you can see outside of hyperpigmentation. In addition to that, in the small molecule program, you know, we're looking for compounds that really limit the brain penetrance so that they don't get into the CNS. So there are a number of things that are built into these things that overall will make them better drugs. And this is not atypical. As indications move from first approved drugs, it's generally when you get to that second or third one where you get the better compounds coming through, better drug-like characteristics, better PK parameters, more usability for the patient, and that's what we're aiming for.

Okay, great. And kind of the final question, obviously your game plan has followed a lot of what we've seen with Rhythm and what they've done. How would you compare your products to those of Rhythm, and how far behind do you consider yourself at this point?

You know, so currently, from an improved standpoint, is that melanotide or Increvia's product, and they've done a tremendous job, you know, bringing that product forward, expanding its indications, and beginning to build new markets, you know, for MCL-4 agonists. That's a first-generation peptide that's got limitations with regards to MCL-1 activity, and it's a daily injectable. I know that they have a weekly injectable that's coming behind that. There's very little data. I can't comment on that. There's no data available. I think there will be data later in the quarter, but I can't comment on that. They have a small molecule in Bevamellagon. Again, it's a first-generation compound. Again, we see hyperpigmentation in the clinic, and it's going through some reformulation work, and I don't know where that's going to lead. They're going to hopefully get that back in the clinic later in the year. So I think, you know, from my perspective, I think that we're going to deliver better compounds.

I think they're going to be cleaner.

I think they're going to have better drug-like characteristics, going to have better decay parameters, and, you know, and a chance to be highly competitive and expand and take market share. And that's the goal in bringing investing class forward, right, is to have the better compounds. From how far behind are you? So, you know, depending on the indication, obviously, you know, set melanotide is approved. It's approved for HO. It's approved for a number of indications. So you can look at our plan to get there. You know, in that case, we're several years behind. With regards to compounds coming through, I don't know, is it a year, year and a half? I mean, I'm not clear. I know it's a question that investors always ask, and there's relative there. we're not all that far behind and you're trying to come in with a better candidate and a better product. And I think that's the more important part. Who's going to have the compounds that really help to solve this issue with better patient compliance and better patient usability, maintaining good efficacy? And that's really what you're trying to drive forward. And that's really, at the end of the day, what's going to probably determine this market.

Okay, great. Thank you for taking the questions.

Your next question is coming from Yale Jen with Laidlaw & Company. Please put your question. Your mind is live.

Good morning, and thanks for taking the question. Your oral compound now is pushed out probably roughly a year compared to 7737. My question to you is that do you see any challenges to have that become R&D ready? next year. So, any specific you can mention without, you know, reveal too much on the competitive side?

Sure. I mean, look, you know, whenever you're dealing with orally active small molecules, you know, we run, as we did with 7.737, we run a tremendous amount of preclinical studies on these compounds to evaluate, you know, not only their efficacy and their selectivity, but really their drug ability side effect profiles metabolism all sorts of other things at any point you know the predictability even though we use state of the art and what have you to help predict and obviously wet chemistry to go through all this stuff until you get into animals until you get through that process you're not going to really know what you have and how high you can dose, and so on and so forth. So I would characterize it as we have a very good handle on what's required. I think we understand the pharmacophores that we're dealing with very well. They are very druggable with regards to their interactions with SIPs and their metabolism and so on and so forth. So we have a high degree of confidence that we can deliver a compound. But until we get through the work, I can't tell you what the actual outcome was going to be. So, I mean, I'm confident that we will do the work, we will get the candidate forward, we'll go through the process with the candidate, and I'm confident that it will pass and we'll have a great profile, but until it's done, I can't comment, I don't know.

Fair enough, that's very helpful. So without revealing too much, should I think about this as heading to animal study or it's already in, you know, animal study?

It depends on the candidate. I mean, we haven't made a final selection, so it depends on the candidate. Some are in animal studies. Some are a little further back. We'll make a little bit later in the year, we'll make a final selection on the actual candidate that we want to go forward with. So it varies depending on the candidate.

Okay, so still, okay, great. Maybe your last question here is that for the sub-Q weekly peptides, that you are slightly ahead. I mean, I thought the last time we thought that you may start it in the third quarter, but I guess it's slightly more push out to a four. Was there any issues that you want to resolve, like you said, would be the new product going forward?

There's no issues.

I mean, listen, we're not manufacturing screws here. We're doing very complex things. And we want to make sure, again, that we have the right compound. One of the things that we're seeing is with the ability, with the funding that we did in the third or fourth quarter of last year, that really allowed us to really accelerate a lot of the work we were doing on the medicinal chemistry side with both the peptides and the small molecules. So what we're trying to make sure is, particularly on the peptide side, in the candidate we selected, we want to make sure it was the best we have, not something that's really good, but when we find out a month later, we've got something better. So it's really an issue of making sure we've got the right candidate. But in a nice way, we are very productive in our understanding of this and of the receptor and the receptor-like interactions. And we've been really pushing the boundaries and understanding how to eliminate the MCER1 activity and building that into these compounds. So we really want to make sure we pick the best one. So I don't really see much difference. That peptide program, to me, is moving along quite nicely. I think we have an excellent candidate. And we'll be running through – I mean, we're actually now entering in the IND-enabling studies, so I see that moving along and staying on track quite nicely.

Okay, great. Maybe the last question to squeeze in, which is that you mentioned about also you're contemplating the PWC, Pratt-Wooley syndromes. At this point, would that be a second priority to HO, or you feel that you may jump the gun into the PwC even faster or earlier?

Again, Janet, everything is based on resources. I think that they're equal. I mean, they're both excellent commercial activities. They're both ones where there's an extremely high medical need for innovative treatments. So, given resources, we'd like to move them in parallel.

Okay, great. Thanks a lot, and good luck for everything. Thank you.

Your next question is coming from Dev Prasad with Loop Capital. Please pose your question. Your line is live.

Hi, team. Thanks for taking our question. I have a few. One is, is the goal with the new oral compound, is the goal is to eliminate hyperpigmentation entirely or you're trying to reduce the frequency and severity? And a follow-up is that what preclinical species or model is the most predictive for these MC1R-mediated hyperpigmentation? And then on what's weekly injectable, just wondering what are the key IND-enabling studies still remaining before the plan for Q IND submission? Thank you.

All right. A lot there, so let's go through. For the small molecule, what we're seeing is the potential to eliminate activity. um that doesn't mean that when you go in and you start treating chronically that you won't see some small amount but that's really what the goal is and that's what we're seeing pre-clinically really a very significant separation between one and four uh and um but until you know you get into the clinic you're not going to know you're not going to not going to know the animal models that we use. So, you know, animals, if you look at a rat, a dog, or mouse, their skin is not really pigmented. So, you have to look at fur. You look at fur darkening, and there are a number of models that you can use for that. When you're seeing, you know, if your compounds have good MC01 activity and they work in these models, you're going to see that translate to humans. So, we think there's a high degree of predictability and if you're showing, you know, lack of efficacy or very large separations between where you see weight loss and then where you see potential for even a small change in pigmentation, that that's going to translate to the human condition as well. So with regards to where we are in development, you know, there's – right now we're beginning the IND enabling studies, that's going to include a whole bunch of in vitro assays that we're required to do with regards to sip binding, metabolism, and so on and so forth, as well as getting into the animal work that will start as well. So we have everything moving and coming together so that we will have the documentation we need to file with the FDA and open up an IND in the fourth quarter of the year.

Great, thank you.

There are no more questions in queue at this time. I would now like to turn the call back over to Carl Spana for any closing remarks.

So I'd like to thank everyone for your participation on the call. You know, there's an opportunity for us to give you updates, and we're quite excited about where we are, where we're going. I thank the analysts for their questions that allow us opportunities to maybe speak a little beyond what we have in the script and maybe give a little more color and context to what we're doing. I think that the advances that we're making are quite significant. We're generating some very good IP that I think is going to not only support the work that we're doing, but make it a little more difficult for those that are following behind as well. So I think we're very well positioned and feel pretty confident about what we're doing and going forward that we're going to deliver some really phenomenal compounds into the clinic. So with that, thank you guys. Have a great day, and we look forward to keeping everybody updated as we continue to make progress on our programs.

Steve. Thanks also. Have a great rest of the day. Take care.

Thank you, everyone. 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.