Palatin Technologies Q4 2026 Earnings Call Transcript

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Provided by Quartr
September 28, 2026

Key Takeaways

  • Palatin is advancing three selective MC4R approaches—non-lipidated peptides, lipidated peptides, and oral small molecules—for rare obesity disorders, with the goal of improving efficacy, gastrointestinal tolerability, and hyperpigmentation versus existing therapies.
  • The company is targeting a Phase I study for its lipidated peptide in the first half of calendar 2027, with data expected in the second half of 2027; the oral program is targeted for clinical entry in the second half of 2027, subject to funding. Preclinical data suggest the lipidated candidate could support once-weekly or potentially less frequent dosing.
  • Fiscal 2026 collaboration and licensing revenue reached $13.2 million, including payments tied to Boehringer Ingelheim and the Altanispac sublicense. Management expects a Boehringer milestone within the next two to three quarters and continues to pursue partnerships for ulcerative colitis, ocular, and other non-core programs.
  • Palatin ended fiscal 2026 with $7.5 million in cash and stated that existing funds are not sufficient to support operations for at least 12 months, creating substantial doubt about its ability to continue as a going concern. Additional equity financing, collaborations, or other capital will be required, and planned milestones depend on securing funding.
  • Management expects operating expenses to increase during the first half of fiscal 2027 as development activities accelerate, while it evaluates the lipidated and non-lipidated peptide programs in parallel before potentially prioritizing one for later-stage development.
AI Generated. May Contain Errors.
Earnings Conference Call
Palatin Technologies Q4 2026
00:00 / 00:00

Transcript Sections

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Operator

Greetings. Welcome to Palatin's fourth quarter and fiscal year-end 2026 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.

Operator

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.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Good morning, everyone, and thank you for joining us. I am Carl Spana, President and Chief Executive Officer of Palatin Technologies. Today, I will discuss our strategic priorities and progress across our development programs. Steve Wills, our Chief Operating Officer and Chief Financial Officer, will then review our fiscal 2026 financial results and liquidity position. We'll then conclude with questions. Our principal strategic focus is the development of next-generation, best-in-class melanocortin-4 receptor, or MC4R, agonists for treating syndromic and rare obesity disorders. We are initially targeting hypothalamic obesity, Prader-Willi syndrome, and Bardet-Biedl syndrome, with potential applicability to other disorders involving the MC4R pathway. MC4R agonism is now clinically and commercially validated in multiple rare and syndromic obesity disorders, establishing a strong foundation for the development of next-generation therapies.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Palatin brings more than 25 years of melanocortin research and drug development experience to this opportunity, including the development of FDA-approved bremelanotide, or Vyleesi. While currently available and emerging therapies have demonstrated meaningful efficacy, gastrointestinal adverse events and hyperpigmentation remain important challenges for patients requiring long-term treatment. Clinical studies of the approved MC4R agonist in the rare obesity space and the next-generation investigational MC4R therapies under development have continued to report high levels of nausea and vomiting, as well as incidents of hyperpigmentation. Our objective is to develop best-in-class melanocortin-4 receptor therapies that deliver comparable or greater efficacy with improved tolerability, little to no hyperpigmentation, and product profiles suitable for lifelong use. We are advancing two complementary peptide series, non-lipidated PL1000 and lipidated PL2000 series. Tested compounds from both series have demonstrated potent MC4R agonism activity without MC1R agonism.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Because MC1R agonism activation contributes to pigmentation, these findings support our strategy to minimize or potentially eliminate hyperpigmentation. Both peptide series contribute to our effort to develop a long-acting, once-weekly subcutaneous therapy. In preclinical studies, compounds from both the PL1000 and PL2000 series have produced significant dose-dependent reductions in body weight and food intake in diet-induced obese mice. For our PL1000 lead development candidate, we have established feasibility of once-weekly subcutaneous dosing and are working to optimize a controlled-release formulation. Our lead MC4R lipidated peptide development candidate has demonstrated significant reductions in food intake and weight loss with once-weekly subcutaneous dosing in a diet-induced obese mouse model. Preclinical pharmacokinetic data supports the potential for longer than once-weekly or less frequent dosing in humans. We are currently conducting the activities required to file an IND and begin human clinical studies. Our oral small molecule MC4R program provides a third treatment approach.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Building on learnings from an earlier drug candidate, PL7737, and utilizing multiple approaches, including artificial intelligence and machine learning tools, we have identified potential drug candidates with improved potency and MC4R selectivity. Our objective is to develop an oral MC4R agonist capable of delivering comparable or greater efficacy than emerging oral MC4R therapies with improved gastrointestinal tolerability. We are also designing our oral candidates to have limited or avoid MCR1-mediated off-target activity to minimize or eliminate hyperpigmentation. Subject to appropriate funding, we are targeting initiation of a phase I single ascending dose and multiple ascending dose studies for our lipidated peptide candidate in the first half of calendar 2027, with data targeted for the second half of 2027.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

We are targeting initiation of the oral phase I single ascending dose and multiple ascending dose studies in the second half of calendar 2027, with initial data expected in the first half of 2028. These studies will evaluate human safety, tolerability, pharmacokinetics, and clinical efficacy. Taken together, our non-lipidated peptide, lipidated peptide, and oral small molecule programs provide three distinct approaches to developing differentiated, selective MC4R agonists for the long-term treatment of patients with syndromic and rare obesity disorders. Each approach is being designed around the same core best-in-class objective: meaningful efficacy, improved tolerability, little to no hyperpigmentation, and a dosing profile suitable for lifelong treatment. Beyond our obesity programs, our broader melanocortin platform has already generated meaningful strategic collaborations. Under our August 2025 retinal disease research collaboration and license agreement, Boehringer Ingelheim paid an aggregate of EUR 7.5 million upfront and initial milestone amounts.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

The agreement provides for up to EUR 280 million in additional success-based milestones and tiered royalties. We continue to perform reimbursed research under the collaboration. We also sub-licensed our PL9643 dry eye program to Altanispac Labs earlier this year. Beyond those partnered assets, our PL8177 ulcerative colitis program has positive phase II proof of principle findings, and our diabetic nephropathy program has encouraging open label phase II data as well. We are pursuing partnerships with these non-core assets so our internal development effort can remain focused on rare obesity MC4R therapies. Our priorities are clear. Advance our complementary non-lipidated and lipidated selective MC4R agonist drug candidates and oral program to a clinical development, translate preclinical differentiating findings into human clinical evidence, and continue creating value through our strategic collaborations and partnerships. Steve will now review our financial results. Steve, over to you.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

Thank you, Carl, and good morning, everyone. I will review our fiscal fourth quarter and full year 2026 results, followed by our cash position and liquidity outlook. Unless otherwise noted, comparisons are with the corresponding fiscal year 2025 periods. For the fourth quarter ended June 30th, 2026, Palatin recognized $300,000 in collaboration and licensed revenue, compared with no revenue in the prior year quarter. For the full fiscal year, collaboration and license revenue totaled $13.2 million, compared with no revenue in fiscal 2025. This included $9.4 million related to our Boehringer Ingelheim collaboration and $3.8 million related to the Altanispac sub-license. The Altanispac revenue was recognized in the form of non-cash debt cancellation. Fourth quarter operating expenses were $4.7 million, compared with $2.3 million in the prior year quarter.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

The prior year quarter included gains associated with Vyleesi and purchase commitments affecting comparability. Research and development expense was $2.0 million in each fourth quarter, while general and administrative expense was $2.7 million as compared with $2.6 million a year earlier. For fiscal 2026, total operating expenses were $21.9 million, compared with $17.5 million in fiscal 2025. Research and development expenses decreased to $12.4 million from $14.9 million, primarily attributable to lower expenses related to the timing of certain activities on our MC4R programs. General and administrative expenses increased to $9.5 million from $7.8 million, primarily due to higher professional fees. Fiscal 2025 operating expenses included a $3.1 million gain on the sale of Vyleesi and a $2.1 million gain on purchase commitments.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

We reported a fourth quarter net loss of $4.4 million, compared with $2.2 million in the prior year quarter. For the full fiscal year, net loss decreased to $8.4 million or a loss of $2.96 per basic and diluted common share, compared with a net loss of $17.3 million or a loss of $32.15 per basic and diluted common share in fiscal 2025. The year-over-year improvement in net loss was primarily attributable to collaboration and license revenue and gains related to Vyleesi and purchase commitments. Net cash used in operating activities was $13.5 million in fiscal 2026, compared with $21.3 million in fiscal 2025.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

Net cash provided by financing activities was $18.5 million, consisting primarily of $16.9 million in net proceeds from common stock and warrant sales and $1.6 million from warrant exercises. Turning to liquidity, we ended June 30th, 2026, with $7.5 million in cash and cash equivalents, compared with $2.6 million at June 30th, 2025. Current liabilities were $1.8 million at fiscal year-end. Based on that cash balance and our current operating and development plans, including our ability to reduce or delay certain expenditures within management's control, we do not expect existing cash to be sufficient to fund operations for at least 12 months following issuance of our financial statements. Accordingly, substantial doubt exists about our ability to continue as a going concern. We will require additional financing to continue advancing our development programs and fund operations.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

We intend to pursue equity financings, collaboration arrangements, and other potential sources of capital, but there can be no assurance that funding will be available when needed or on acceptable terms. The timing of planned development milestones remains subject to appropriate funding. Operationally, we are prioritizing our peptide and oral MC4R obesity programs, executing our collaboration obligations, and pursuing opportunities to realize value from our partnered and partnering assets. That concludes my financial review. Carl, I will turn the call back to you for closing comments and questions.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Thank you, Steve. Our focus is on translating the promising preclinical findings from both non-lipidated and lipidated peptides together with our oral small molecule program into clinical evidence. We are pursuing melanocortin-4 receptor agonist therapies designed for meaningful efficacy, improved tolerability, and little to no hyperpigmentation for patients with rare obesity disorders. Thank you for joining us. We are ready to now take your questions.

Operator

Thank you. Ladies and gentlemen, the floor is now open for questions. If you wish to join the queue to ask a question at this time, please press star one on your telephone keypad. We do ask, if listening on speakerphone this morning, that you pick up your handset while asking your question to provide optimal sound quality. Once again, please press star one 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. Your first question this morning is coming from Scott Henry from AGP. Scott, your line is live. Please go ahead.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Thank you, and good morning. Carl, I will start with you. You mentioned the lipidated and non-lipidated peptide approaches. Could you talk a little bit about the advantages and the differences between those two approaches and eventually, would you narrow it down to one or would you keep both going all the way? Thank you.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Thanks, Scott. The main difference is that in the case of a lipidated peptide, it has an aliphatic part of it that actually binds to a plasma protein. Its longevity is built into the molecule, so you do not have to have a pharma formulation. It is very similar to what you would see with the GLP-1s. When you go to the non-lipidated, that means you are now formulating in erodible polymers that essentially are ejected and then they erode over a certain period of time, and they would slowly release your drug. Both can accomplish long-term delivery. Our preference would be for a lipidated approach in that it gives a little more flexibility. You are not dependent on the release characteristics of the polymer. Essentially, it is a single API that is being made. It is not being formulated. It is not as bulky on the injection side.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

We believe it is also going to give maximum flexibility for dose titration, so you will be able to have multiple doses, or more easily have multiple doses that can be used in a more titrating fashion, very similar to what is done with the GLP-1s today. So it gives the clinician and the patient the most flexibility over the polymer approach. We will run both of those in parallel. Our goal is really to deliver, as we said, a weekly product that has really good efficacy.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

So in other words, high MC4 selectivity and potency and limited to no hyperpigmentation. Our preference, of course, would be to just follow through on the lipidated, and certainly as that goes into the clinic and begins to show efficacy, then we would probably slow down the polymer part. We would not most likely advance both of them all the way through into phase II clinical development. We would make a decision.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. Thank you for that color. I know you have spoken a lot about hyperpigmentation. I did hear a little bit more about improving gastrointestinal tolerability. What are you doing specifically to address that with the MC4R agonist?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. There are two approaches. One, the GI side effects are indeed driven by MC4R agonism. One way of reducing that is to essentially not overdose patients. When you are going with, for example, the lipidated peptide, it is a lot easier to keep the patient in the intended therapeutic range without going over. One of the problems you have with these simpler peptides that are not formulated, is that you are injecting a big bolus dose, right, because it is a short-acting drug.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

You go way above the therapeutic window for the drug, and then you get yourself into higher levels of AE. One approach is simply by flattening out the absorption of the drug and keeping it in the defined therapeutic window. You will limit some of the GI side effects, and you will be left with some of the inherent effects that occur by just activating the receptor.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Second way of doing it, which is a little more complicated, is to try to develop compounds that inherently do not have any ability to cause nausea, emesis. There are structural elements that we are working on that can lead to that, but we are not quite there yet. Right now, the primary way you are going to do it is really by limiting, essentially, that bolus dosing, keeping it in that flat therapeutic window, and that is ideally done with these lipidated peptides.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. A final question for you, Carl. Have you given thought to what rare obesity indication you would likely pursue first?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

I think the first one will be the hypothalamic obesity indication. There are certain advantages there that patients are relatively easy to identify. They have had a type of cancer that causes damage to the hypothalamus when it is treated. They are relatively healthy patients that essentially have had a damage to the hypothalamus that can be corrected with MC4R agonist. That would be the first indication. Prader-Willi syndrome would be also probably done pretty closely, if not in parallel. There, it is a little bit different. You are working on the hyperphagia and trying to reduce some of the obesity as well. Then the third would be the Bardet-Biedl syndrome. Those are the three pretty much in order, but I think the first two, depending on resources, we try to run in parallel, as close to parallel as we can.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. Thank you, Carl. A couple questions for Steve. Steve, how should we think about Collaboration license revenue in fiscal year 2027. Should it be material, significant. Just trying to get a thought relative to what we saw in fiscal 2026.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

Well, thanks, Scott. In our mind, achieving any milestone with these collaborations is significant. Just to back up, we have two ongoing collaborations, one in the ocular with Boehringer Ingelheim, another in the ocular with Altanispac. We anticipate and expect to receive an achieved milestone from Boehringer Ingelheim sometime within the next two to three quarters. Altanispac Labs is a little further out. Also, notwithstanding the existing ongoing collaborations, we do have interest. We have very good interest in some of our other programs, the non-obesity, specifically around our ulcerative colitis, and also some other ocular indications and MCR1 autoimmune and anti-inflammatory. We're not to the point where I could say we expect to get something within the next several quarters, but we wouldn't be surprised if someone does pull the trigger on a research or an early-stage collaboration in that regard.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. Thank you. OpEx trends, certainly lower in Q4. As you prepare to move things along more aggressively, should we expect OpEx to sequentially increase throughout 2027?

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

Well, initially, yes. For the quarter ended June 30th and the same thing with the quarter prior to that, certain activities are done sequential. So based on timing, you're going to fluctuate a bit. But we do anticipate the next several quarters, say the quarter ended December 31 in the first quarter, or frankly, even, excuse me, the first half of 2027, to increase. It's not going to double, if you will. It's going to be more than likely around what we've done in the first few quarters of calendar 2026. But again, we're advancing the program, and I know people are like, "Oh, well, you're spending money." We're investing the money. We couldn't be more pleased with where we are from a differentiating standpoint in the obesity space where we're moving forward with.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. Final question. When we think about the balance sheet in funding development, are we still thinking about those, I believe they were the Series J Warrants that were activated, I believe by an IND acceptance. Is that still part of the financing picture? Thank you.

Steve Wills
Steve Wills
COO and CFO at Palatin Technologies

100%, it is part of the funding picture, and that is why we set it up. The November 2025 financing included a, we call it a short-term warrant. The Series J Warrant is correct. It is triggered on either 18 months, the lesser of 18 months, or the IND filing of one of our internal obesity MCR4 compounds. If that was exercised at 100%, that would yield approximately $18.5 million. So 100%, that is part of the future funding. If we hit that trigger, things are going well.

Scott Henry
Managing Director of Healthcare Analyst at AGP

Okay, great. Thank you for the clarity, and thank you, gentlemen, for taking all the questions.

Operator

Thank you. Your next question is coming from Yale Jen from Laidlaw & Company. Yale, your line is live. Please go ahead.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Good morning, and thanks for taking the questions. My first question is about the PL2000. This is the lipidated one that you anticipate to start trial in first half of next year, calendar next year. What are the remaining IND enabling works remain before you can start the filing and the phase I studies? Then I have a follow-up.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. The main thing remaining is really just getting the initial animal tox work done. We are in scale up now, and those studies are scheduled and getting ready to start. That is really the main largest bulk of what we need to get done. There is always a bunch of other earlier studies or in vitro studies, but a lot of those have been done already. It is really getting the animal work done and the reports in.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Was there any manufacture work that need to be done, or would that be-

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

There is always manufacturing. Once you start designing the compound, manufacturing work never stops. We can manufacture them under cGMP conditions. We will be continuing to work on that, improving efficiencies in scale, formulation, so on and so forth. That never really ever stops. From now on, there is always some type of level of manufacturing work that is going to be ongoing. That is pretty typical for most programs.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Sure. In terms of lipidated versus non-lipidated, lipidated generally will maybe have a longer half-life, maybe a more potent activity, biological activities. When you compare your lipidated versus the earlier non-lipidated, was there any meaningful difference in some of these metrics?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. One of the things that we're seeing is, let me back up and take a second and talk about lipidated peptides, at least when it comes to melanocortins. The ability to get one of these peptides lipidated and maintain good MC4R selectivity and potency was not a trivial undertaking. That took quite a lot of work. You can't just stick any type of aliphatic tail on one of these peptides and expect it to work. That's not the case. Some of that's going to be the nature of patents that have been filed and are continuing to be filed. It took a technological breakthrough to really get good lipidated peptides.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

One of the things that we're seeing is, as we look at the pharmacokinetics across multiple species, both rodent and non-rodent, we're seeing very long half-lives. One of the things that we're optimistic about is that there's a very good probability that these peptides will be less than once a week, meaning that we might be able to dose some things once every two weeks. That's something that we're really excited about, and it's something we didn't expect as we went in. As we're now looking at it and modeling it looks like we're going to have really potential for longer-term dosing windows, which is quite nice.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Okay, great. That's very helpful. Maybe just one question along this line, which is that if you compare your lipidated PL2000 versus, for example, Rhythm's next-gen sort of weekly administrated drug, do you know whether their compound is lipidated or non-lipidated?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

My understanding of what I can tell is that they're using a polymer approach. They have a potent MC4R agonist that they've put in a polymer that erodes over, would indicate that based on what little bit of information that's available, I would presume erodes over about a week and releases the drug. It's a different approach. They're not using the lipidated approach. They're using the polymer approach.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Okay, great. Maybe just two quick questions here. Talk about the oral drugs in terms of, I guess, what lesson you have learned from the prior PL7737, and what sort of improvement you feel that you want to add to it before you feel comfortable to move the program into clinical stage.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. Listen, certainly, we would have preferred that compound move forward. We did pick up a tox issue at the end of the tox studies. We have a good understanding of what that was. We've now taken multiple approaches. We had behind PL7737, we had multiple scaffolds that were moving forward that had better selectivity, really good potency and better selectivity. Those are being optimized now, multiple and parallel. Then with the PL7737 series, understanding what about that was potentially problematic. From a drug standpoint, we've been able to fix that, and those analogs are also now being optimized and will be fully evaluated and go forward.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

On that front, we did learn a lot and understanding what it takes to get one of these things optimized and go forward. We now have multiple scaffolds, including the PL7737 scaffold, to go forward. What we also learned is that these can be quite potent. In multiple animal species, we did see really excellent weight loss. It is nice. It is very clear that if you get it right, you should be able to drive really good efficacy with an MC4R small molecule.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Do you anticipate to get into the IND-enabling study toward end of the year, or that will be in 2027?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

We are pushing real hard to make a selection of the compound by the end of the year and begin the IND-enabling studies. That will put us in the second half of the year in the clinic.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Okay. The last question here is that, just curious, in terms of PWS, there obviously is a drug already approved in current days. Do you feel that ultimately you will use whichever compound you would for the PWS as a monotherapy, or you think that may potentially be a combination because of different mechanism actions? Thanks for taking the questions.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. Yeah, I think ultimately over time, for a lot of these rare syndromic, these TPHO and Prader-Willi, it's likely that you'll find a number of patients who will move on to combination therapy. I don't believe that it necessarily will be with the currently approved drug, VYKAT XR. I mean, that drug, it works and is the first approved, and I'll leave it at that. I think MC4R agonist can provide probably better tolerability, better safety, better efficacy than what's out there today.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

When you combine that with, say, the GLP-1s, there's a potential to drive even better efficacy. I think a combination of polypharmacy for these patients is going to be certainly very dependent on the initial response that the patient has to MC4R agonism and if it's needed to move there. But what's nice is there is an opportunity to continue to push the therapy envelope by including an additional drug.

Yale Jen
Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company

Great, and thanks for the update and best luck forward.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Thank you.

Operator

Thank you. Your next question is coming from Dev Prasad from Lucid Capital Markets. Dev, your line is live. Please go ahead.

Dev Prasad
SVP of Biotech Equity Research Analyst at Lucid Capital Markets

Hi. Congrats on the progress, and thanks for taking our question. Couple of questions. One is, you mentioned that tested compound from both peptide series are not agonist at MC1R. Can you provide a little bit color on quantification MC4R versus MC1R selectivity margin? Compared to previous Palatin compound. The next question is on the clinical trial. How are you planning those trials in terms of design? What do you want to learn from phase I for both peptide and oral? Thank you.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Sure. In general, I'm not going to really enter into ultimately a lot of detail on how we characterize the agonism. In part, this has become a pretty competitive field. There's not just Rhythm and Palatin. There are other companies that are looking at this. One of the reasons why we use 1,000 and 2,000 others is that we're trying to maintain as much competitive advantage for as long as possible, so that people can't just troll through patents and start to immediately see what the lead compound looks like. To answer your question is, we're pretty confident that we know how to characterize an agonist and that these have de minimis MC1R agonism, and that should relate clinically to a good improvement in hyperpigmentation. On the second part, if I remember, you were asking about what clinical trial design?

Dev Prasad
SVP of Biotech Equity Research Analyst at Lucid Capital Markets

Yes. I mean, what are you planning to learn from phase I?

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Obviously in the single ascending dose part of phase I, that is a single dose. Really what you are looking for is there any acute toxicity? And then what your tolerability window is and what your dosing window is. When we move into the multiple ascending dose part, these will now move to what are called healthy obese patients. They will be treated for 28 days, and we intend to learn a tremendous amount from that. We should be able to see efficacy data. We want to see if the compounds can indeed cause reductions in food intake and weight loss. We will be looking for long-term tolerability, longer-term safety signals.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

When we come out of that MAD study, we will have a pretty good idea on how well the compounds are going to work, and when we move into the intended patient population, such as the hypothalamic or Prader-Willi or the ob/ob patients. One thing about the mechanism is it has very, very good translatability across patient populations with regards to efficacy as well as tolerability and safety.

Dev Prasad
SVP of Biotech Equity Research Analyst at Lucid Capital Markets

Great. Thank you so much.

Operator

Thank you. This does conclude today's question and answer session. I would now like to pass the floor back to Dr. Carl Spana for closing remarks.

Carl Spana
Carl Spana
President and CEO at Palatin Technologies

Great. I'd like to thank everyone for your participation in our year-end and first fiscal quarter. We here are extremely excited about the accomplishments that we've had. We've made, I think, some tremendous technical breakthroughs that are leading into some really best-in-class compounds with strong intellectual property supporting them. We're excited about where we are and where we're going. This is really a very exciting time for Palatin, where we've been able to essentially use accumulated experience in this target, really to develop some excellent compounds that we believe are going to be best in class. We look forward to continuing to update you on our progress. Steve and I obviously will talk to some of you guys throughout the quarter. With that being said, enjoy your day, and we look forward to keeping you updated. Thank you.

Operator

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

Executives
    • Carl Spana
      Carl Spana
      President and CEO
    • Steve Wills
      Steve Wills
      COO and CFO
Analysts
    • Scott Henry
      Managing Director of Healthcare Analyst at AGP
    • Yale Jen
      Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company
    • Dev Prasad
      SVP of Biotech Equity Research Analyst at Lucid Capital Markets
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