Palatin Technologies Q2 2024 Earnings Call Transcript

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Provided by Quartr
February 15, 2024

There are 6 speakers on the call.

Operator

Greetings. Welcome to Palatin's Second Quarter Fiscal Year 20 24 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. As a reminder, this conference call is being recorded.

Operator

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, Doctor. Carl Spana, President and Chief Executive Officer of Palatin.

Operator

Please go ahead.

Speaker 1

Thank you. Good morning, and welcome to the Palatin Second Quarter Fiscal Year 2024 Call. I'm Doctor. Carl Spana, the CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Executive Vice President, Chief Financial Officer and Chief Operating Officer.

Speaker 1

I'll turn the call over to Steve and he will give and operating update. Steve?

Speaker 2

Thank you, Carl. Good morning, good afternoon, good evening everyone. For Palatin's fiscal Q2 ended December 31, 2023, certain business highlights and recent updates follow. Regarding Vyleesi, which is Our bremelanotide injection for approved FDA approved for hyperactive sexual desire disorder or HSDD. We completed an asset sale to COSAT Pharmaceuticals for up to $171,000,000 in December of 2023 for female HSDD.

Speaker 2

We received $12,000,000 upfront plus potential sales based milestones of up to $159,000,000 based on annual net sales ranging from 15,000,000 up to $200,000,000 Importantly, Palatin retained the rights and use of Bremelanotide Vyleesi for obesity and male erectile dysfunction indications. Regarding other, we had 2 equity offerings, A registered direct offering in January 30, 2024, we entered into a securities purchase agreement with healthcare focused institutional investors, Selling and issuing an aggregate of approximately 1,800,000 shares of Palatin common stock at a purchase price of $5.46 per share of common stock, which was our market price at the time of the transaction. Powhatan also agreed to issue In a private placement, warrants to purchase up to an aggregate of approximately 1,800,000 shares of Palatin common stock at an exercise price of the same $5.46 per share. The offering was completed on February 1, 2024 with gross proceeds of $10,000,000 The common warrants are exercisable beginning 6 months after the date of issuance and will expire on the date that is 4 years after the closing date. 2nd equity offering was October 23, 2023.

Speaker 2

We entered into a securities purchase agreement with 1 institutional investor selling and issuing an aggregate of approximately 2,400,000 shares of Palatin common stock at a purchase price of $2.12 per share of common stock. Palatin also agreed to issue in a private placement warrants to purchase up to an aggregate of approximately 2,400,000 shares of Palatin common stock at the exercise price of $2.12 per share. This offering was completed on October 24, 2023 with gross proceeds of $5,000,000 The common warrants Our exercise will beginning 6 months after the date of issuance and will expire on the date that is 5.5 years after the closing date. Moving over to our fiscal Q2 ended December 31, 2023 financial results. Regarding revenue, Total revenue consists of gross product sales of Vyleesi net of allowances and accruals.

Speaker 2

Vyleesi gross product sales to pharmacy distributors the quarter ended December 31, 2023 were $4,300,000 with net product revenue of approximately 2,000,000 This compared to gross product sales of $2,600,000 and net products revenue of $1,000,000 for the comparable quarter last year. Gross product sales for this period December 31, 2023 quarter increased 64% and net product revenue increased 98% over the comparable quarter last year. Regarding operating expenses, total operating expenses were $900,000 Net of a $7,800,000 gain on the sale of Vyleesi compared to $6,600,000 net of a $1,000,000 gain on Vyleesi purchase commitments for the comparable quarter last year. The decrease in operating expenses was mainly the result of the gain recognized on the sale by LISI to COSAT Pharmaceuticals. Moving over to other incomeexpense.

Speaker 2

This net figure consists mainly of the change in fair value of warrant liabilities, which Palatin has recorded as a liability on the consolidated financial statements, including the revisions of certain prior period amounts to correct the misstatement with respect to classifying warrants as equity instead of a liability. The statement of operations is adjusted each quarter to reflect changes in the fair value of these warrants. For the quarters Ended December 31, 2023 2022, Palatin recorded a fair value adjustment loss of $8,100,000 and a gain of $5,200,000 respectively. Regarding warrant liabilities, Palatin has assessed the impact of improperly classifying the warrants related to the October 2022 financing within equity rather than as a warrant liability that is adjusted through charges or credits to the statement of operations to reflect changes in the fair value of the warrants. And we've determined that the impact is not material to any prior period impacted.

Speaker 2

Accordingly, Palatin will adjust prior periods only as those financial statements are presented for comparative purposes in future filings. On January 24, 2024, Palatin and the warrant holders amended the terms of the warrants related to the October 22 and October 2023 financings. As a result, the $11,900,000 of warrant liabilities as of December 31, 2023 will be reclassified to additional paid in capital upon amendment. So let me give you the concise version. No harm, no foul.

Speaker 2

There'll be no future adjustments to the statement of operations regarding the liability regarding the warrants Starting with the Q1 of 2024 filing and the liability that's on the balance sheet As of December 31, 2023, we'll be reallocated to equity. We amended the warrants to characterize it as equity versus the liability treatment. Regarding Palatin's net loss for the quarter ended December 31, 2023 was $7,800,000 or 0.56 dollars per basic and diluted common share compared to income of $2,700,000 or $0.25 per basic and diluted common share for the comparable period last year. The change in net loss of the comparable quarter last year was due to several factors. Since the derivative liability accounting took place in the Q4, we have several and also the sale of Vyleesi.

Speaker 2

So specifically, we had an increase in net product revenue of Vyleesi of $1,000,000 compared to the prior quarter of last year. We had a gain on the sale of Vyleesi of $7,800,000 And we had a change in fair value of warrant liabilities of $8,100,000 of expense in 2023. For 2022, we had $5,200,000 of income related to the change in fair value of warrant liabilities and we had the recognition of an income tax benefit of 4 $7,000,000 during the 2022 period. The income tax benefit is related to that very nice program they have in the state of New Jersey for net operating losses. Moving over to cash position.

Speaker 2

As of December 31, 2023, Palatin's cash, cash equivalents and marketable securities were $9,500,000 Plus we had $2,300,000 of accounts receivable compared to cash, cash equivalents and marketable securities of $5,500,000 plus $1,300,000 of accounts receivable as of September 30, 2023. The $9,500,000 of cash, cash equivalents and marketable securities as of December 31, 2023 does not include the $9,200,000 of net proceeds from the registered direct equity offering, which closed in February of 2024. So pro form a as of December 31, January 1, 2024, We have approximately $18,700,000 of cash, cash equivalents and marketable securities. We believe that existing Cash, cash equivalents and marketable securities and accounts receivable will be sufficient to fund currently anticipated operating expenses and disbursements into the second half of calendar year twenty twenty four. Now I'll turn the call back over to Carl.

Speaker 2

Carl?

Speaker 1

Thank you, Steve. Nice lesson in accounting. As you know, our focus has been on understanding the biology and chemistry of the melanocort system with the goal of developing selective melanocortin agonists for a variety of medical indications. Our research efforts have resulted in a growing portfolio of We have 3 active clinical programs based on melanocore antagonist with multiple new programs ready to advance into clinical development pending resources all coming from our highly productive research activities. As we have previously reported, we have locked the database and instructed the statistical contract research organization to unblind the data for the PL-nine thousand six hundred and forty three MELODY-one Phase 3 study in dry eye disease.

Speaker 1

We expect to report the top line data this month. Our Phase 2 study evaluating oral PL-eight thousand one hundred and seventy seven, A selective melanocortin receptor 1 agonist in ulcerative colitis patients is on track for an interim assessment of the clinical data in the first half of twenty twenty four. Supporting oral PL-eight thousand one hundred and seventy seven development are preclinical studies demonstrating that treatment with oral PL-eight thousand one hundred and seventy seven And disease models causes disease colons to improve toward a healthy state and to resolve inflammation. Resolving inflammation rather than blocking it provides the possibility of efficacy coupled with significantly differentiating safety in treating colitis and inflammatory bowel disease. Additionally, Research work at Palatin has mapped clear mechanisms of action pathways, melanocort and agnis in supporting the resolution of inflammation.

Speaker 1

Breakout, our Phase 2 open label study evaluating the melanocortin agonist in diabetic patients with kidney disease is also on track for top line data in the first half of twenty twenty four. So clearly, this is a big half for us, three clinical trial readouts. As far as what is on the horizon at Palatin, I would like to take a minute to highlight 2 new clinical studies that we are anticipating starting in the first half of calendar twenty twenty four. The first is a Phase 2 study evaluating co administration of bremelanotide, a melanocortin agonist with a phosphodiesterase 5 inhibitor. Those are just Viagra, Cialis.

Speaker 1

So those are the drugs that are currently used to treat erectile dysfunction. This would be an erectile dysfunction patients that have not responded current therapy. So these are guys that are failing Cialis, Viagra and so on. This clinical study will support the development program of a combination product, which is the co formulation of our MCR4 agonist bremelanotide with a phosphodiesterase Sp5 inhibitor. Just as a reminder, bromelanotide is the active agent in Vyleesi, our approved product for female sexual dysfunction.

Speaker 1

All of this work is an extension of our commercial efforts in sexual dysfunction. Just to note, approximately 35% of men with erectile dysfunction fail or have an inadequate response to current therapy represent a large underserved market. The only treatment options for these Failure patients are highly invasive such as direct penile injections or penile implants. We have previously conducted clinical trials showing the synergistic effects of combining with a PD-five inhibitor as a treatment for rectal dysfunction and feel well positioned for an efficient and successful development program of this co formulated product. 2nd planned study will evaluate a melanocortin 4 receptor agonist in obese patients, taking a glucagon like peptide 1 or the GLP-one and you know those as Manjaro or Gobi.

Speaker 1

These are over the range now. These are the current treatments that are being used for obesity. Since drug treatment for obesity is now established and growing rapidly, we believe the treatment goal will switch from driving down weight loss to overall weight management. This will require a variety of drugs with different mechanisms of action that affect weight loss and very importantly weight loss maintenance. We strongly believe that drugs targeting the melanocortin system will be an important part of future obesity Treatment and weight loss management.

Speaker 1

With our extensive experience in the design and development of melanocortin agonists for treating obesity including 2 clinical studies Completed and published, we are well positioned to be a leader in the development of melanocortin based therapeutics for weight loss and importantly weight loss maintenance. The operating highlights for the Q2 of fiscal year 2024 as follows. As Steve noted, we completed the asset sale of Eyleesi to COSEP Pharmaceuticals for up to 100 $71,000,000 with $12,000,000 received upon as an upfront payment. We are planning on initiating 2 new melanocortin programs with Phase 2 clinical study starting in the first half of calendar twenty twenty four with readout later in the calendar year. And as we noted, these studies are: 1, evaluate the co formulation of bremelanotide with a PD-five inhibitor in ED patients that have failed first line therapy.

Speaker 1

And the second, as we also noted, we'll evaluate the addition of elanocortin 4 receptor agonist, meaning green melanocyte to these patients taking a CLP-one agonist. Our clinical programs also continue to make good advancements for our PL-nine thousand six hundred and forty three MELODY-one Phase 3 dry eye disease study. We should report top line data this month. The emerging product profile for PL-nine thousand six hundred and forty three is highly differentiated from current treatments with excellent ocular tolerability and broad efficacy that we believe will make it a leading treatment for dry eye disease. Our oral PL-eight thousand one hundred and seventy seven clinical trial in ulcerative colitis We'll have the interim analysis in the first half of this year as will our breakout open label Phase 2 study evaluating melanocortin agonist in diabetic kidney disease.

Speaker 1

I'd like to thank you for listening to the Palazant Second Quarter Fiscal Year 20 24 Conference Call. You can find additional information on our science and clinical programs on our website, www.palizant.com and you can find additional information on Vyleesi@vyleesi.com website. Steve and I would like to thank you all for participating on the conference call. We will now open the call to questions.

Operator

Certainly. At this time, we will be conducting a question and answer session. Your first question for today is coming from Joe Pantginis at H. C. Wainwright.

Speaker 3

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

Speaker 1

Okay. Hello.

Speaker 3

Can you hear me now?

Speaker 1

We can,

Operator

Jeff. Your line is live.

Speaker 3

Okay. No idea what happened there because I don't even have a mute on this phone. I was not on mute. Anyway, of combining bromelanotide with GLP-one agonist or one of those therapies for weight loss right now about whether it could be the maintenance setting or why those two drugs can really work together for the broader audience?

Speaker 1

Sure. I'll try to do it in a simple way. Well, 1st foremost, we've done and have presented data on combining agonist with a GLP-1 agonist, and they work quite nicely together. They work, I wouldn't say they work quite synergistically. When you think about it, the in part the GLP-1s have probably multiple mechanisms of how they bring about a patient feeling being satiated and changing their energy use and part of that is actually through the left imilacortin system.

Speaker 1

So these things are working in kind of similar pathways. But when you add the melanocortin 4 agonist on top, you get full activation of the leptin melanocortin pathway and that's a very key pathway in regulating energy homeostasis overall. And that actually leads us into why it will be also very useful in weight loss maintenance. There have actually been several studies published, preclinical studies published on weight loss maintenance using a melanocortin agonist in animals And both of those are actually with palliative compounds and you see very, very nice maintenance of the reduced weight state. And one way to think about this is there are differences in how obese patients respond to various treatments for weight loss.

Speaker 1

For example, when you're obese, You respond one way when you are losing weight, you respond slightly differently. But importantly, when you get to that weight loss reduced state, You don't always respond the same way to the CLP-1s as you do when you're obese. And you're going to need treatments like that affect the left and myocardial things like bromelainotide or some of the new compounds that we are bringing forward to actually maintain that weight. And that's really the key here. We can drive a lot of weight loss with the GLPs and the other incretin therapies, but we really need to keep these patients at a reduced weight if you want to have a long term benefits.

Speaker 1

So if you think that the weight loss market is huge, the weight loss maintenance market is probably dwarfs it because these patients are going to be on treatment for many, many years. So that's why we're very excited about where we stand and really the biology and the science behind targeting the left imilacordin pathway for weight loss maintenance is pretty compelling.

Speaker 3

That's a helpful summary. I appreciate that. So, I have a specific question, which then segue into sort of a broader strategy question. So when you look at the upcoming, 8,177 ulcerative colitis data, You have interim data coming up or I'm sorry an interim analysis coming up which is part of my question. What is your communication strategy around the interim analysis?

Speaker 3

Is this a just a continuous plan type of announcement that we hope to see? Or will you be providing any data?

Speaker 1

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

Speaker 3

No, perfect. And then with us having saying ulcerative colitis, I said going to the broader question and strategy. When you look at the indications that you guys are addressing overall with your different assets, these are very large markets. So I guess as of today, How do you view your business development strategy because they're very large markets? Are you looking at the potential for global, regional?

Speaker 3

When you're balancing against your current cash needs?

Speaker 1

Well, you've hit on the head. Let me backtrack for a second. I'm talking a little bit faster or thinking faster than I'm talking. When it comes to ulcerative colitis or dry eye disease, Our goals of those are really to partner those programs. They represent very large markets, but in the case of dry eye disease, we have Most of them are larger, assuming success with 9,643, there are still several Phase 3 trials that have to be done plus all the commercial manufacturing.

Speaker 1

And that really in today's world is a more of a commercial market, right, a consumer market. So we really like to see that product, Assuming success in the hands of a larger company that's going to eventually market it and has the ability to do the outreach there. And that's not really what Paladin plays. Steve will tell you he learned a tremendous amount about marketing to consumers through Vyleesi and it's expensive and it requires a very consistent effort and that's not kind of where how Powhatan is set up and certainly not with the resources we currently have. Again, when ulcerative colitis, Medical need is extremely high, but again a competitive marketplace, meaning there are lots of therapies out there competing for patients for the larger trials And then for voice in the commercial sphere, with that being said, the need is very high.

Speaker 1

So believe it or not, that's one of the programs that even in its early stage has huge amount of corporate interest already. And then again, when we think about where we want to go with regards to the obesity and erectile dysfunction. The erectile dysfunction one is an area we know extremely well. We've studied thousands of patients there. It's one where a company of our size can probably make good headway, meaning that the we know how to take it, we know how to get it into commercialization And there are already distribution channels available and there's high awareness among patients.

Speaker 1

So that's one where we would probably try to keep longer, because it's one where we can conceptualize thinking about assuming things go well for us commercializing it. Obesity, market is hot and I think we're trying to position ourselves, which in particular is in that weight loss maintenance and then in the supplementation or the adjunct therapy to GLP-1s, those are novel spaces where people aren't thinking about them. I think very shortly they will be and I think we'll be in a great position to monetize our early assets there relatively quickly. Got it. Appreciate it.

Speaker 1

We're saying it. Sorry. And Steve actually Steve has a business development people directly reporting to him and is really on top of all the business development activities that we're doing and making sure that they're getting done.

Speaker 3

Got it. Appreciate it, Minh.

Operator

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

Speaker 4

Thanks, Jeffrey. Good morning, guys. How are you?

Speaker 1

Hello, Michael. Hi, Mike.

Speaker 4

You can hear me all right. Congrats on the quarter. Looking forward to seeing Melodi data readout here in February. Wondering ahead of the data here, what you

Speaker 1

would consider to be a clinically meaningful threshold,

Speaker 4

from this readout? To be a clinically meaningful threshold from this readout, whether it be signs, symptoms or both, what is beyond that segue you may feel is important for its commercial value?

Speaker 1

I think the in tri eye disease, the FDA does not require They only require just a significant endpoint. And with regards to the signs, there really aren't the only in the FDA except for signs outside of tier production is a complete resolution of the disease, which is unrealistic. Really what we think about it's really on the symptom side, which is really more important because that's really what affects the patient. The sign of dry eye disease, the Staining results, patients don't understand that it doesn't really mean anything to them. So on the symptom front, you'd like to see a 10 point change, 10 point difference between vehicle and active that would be clinically of the clinical change.

Speaker 1

So that's what we that would be a really nice response for us. So we could top 10% 10 points on the scale.

Speaker 4

We hope to see that too. Thanks for that detail. And ahead of this, we don't want to hold you to it, but just to get your sense for timing for data. Obviously, you'll have a very busy first half of the year. Is there a chance you can get additional data out at conferences?

Speaker 4

How do you expect to give us a bit more

Speaker 1

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

Speaker 5

That'd be great. Look forward to that.

Speaker 4

And then switching over to breakout, any You can give us as to what type of data we'll see when you do read it out for?

Speaker 1

Yes, I think Dan, this is an open label study. It's a single dose study, it's really

Speaker 4

a

Speaker 1

supportive study because people Realize as we haven't had a chance to talk about it, but we're actually in the final stages of selecting actually an orally active small molecule that targets the MCR1 receptor. So this is really a study that was kind of set up for that. It's an injectable study. But what we'd expect to see is really a drop in proteinuria and the change. These patients don't really they don't spontaneously remit.

Speaker 1

So any change you see, any improvement you see is going to be really due the drug activity. They don't get better, they just progressively get worse. So one of the reasons why we chose the indication, although the disease progresses relatively slowly, it doesn't have spontaneous remission. So you can do an open label study and if you see effects on your kidney function, they'll be most likely really pretty much due to the drug.

Speaker 4

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

Speaker 1

For the ED-one, neither have been submitted yet. We haven't opened up INDs. We're going to probably run the ED study for expediency as a physician sponsored trial. We have clinicians that were involved in the early days working with us in the early development of remelanotide that are very urologists and they have some large practices that can really get us a lot of patients very quickly. So that will be probably run as I said, a Cision sponsored IND.

Speaker 1

We should be submitting I think the IND or the pre IND request to the agency by the end of this month for the obesity study.

Speaker 4

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

Speaker 1

So we've been Using the bremelanotide as a test molecule for adding extended release onto our various peptides across the board It's been working very, very well, but we can extend green linacide quite nicely. The overall program although it is really green linacide is being used As a proof of concept, we will go forward and we'll be having a little bit more information out on this probably in the Q2 of the year of this calendar year, we have novel compounds that really are highly selective for melanocortin-four receptor. So they have a much cleaner profile than bremelanotide does and they're much more suited for long term chronic use. And also the receptor filing for long term obesity treatments, in other words, the degree of let me not go through that part of the standpoint, But how you interact with the receptor should maybe be a little bit different every melanocyte. So one of the things that again, Not to bore the way people that are listening is that we have a tremendous understanding of the structural function relationships with regards to all the various receptors and their peptide agonist and we're able to dial in a degree of activity that we think is probably really ideal for an obesity treatment.

Speaker 1

That's what you're going to see going forward into towards the Phase IIs and the Phase III studies.

Speaker 4

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

Speaker 4

Thanks, Ken.

Speaker 1

Thanks, Mike.

Operator

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

Speaker 1

Hi, guys.

Speaker 5

Thanks a lot for taking the question.

Speaker 4

Carl, so I just had

Speaker 5

a general question about the dry eye program rather than Getting into the data details, we've had several dry eye products approved and I know that sometimes the endpoints can be Hard to use in order to gauge the effectiveness and success of the product, but I wonder if you could talk more about how You believe 9,643 could be differentiated from some of the other products in the market, maybe on the safety side as well as Thanks.

Speaker 1

Well, Joe, I think you hit it your last data kind of hits it. I think at the end of the day, most of the treatments that are in approved for dry eye disease have Tolerability issues. Safety in these treatments are pretty good. You're giving a small amount of drug topically. So there's not an overall Large concern about systemic effects.

Speaker 1

So it's really about the patient acceptance and tolerability and long term use and that's what's really plagued a lot of the drugs that have were in the market for a long period of time and they're coming into the marketplace. The PL-nine thousand six hundred and forty three has really ocular tolerability and safety. So that would be a very key differentiating factor, a comfortable installation without Itching and tearing and burning or feeling goofiness or off taste and things of that nature is really key to for a product like this because I said it is very consumer driven. So that's going to be key important factor. I think one of the things I'd like to kind of distinguish is in the dry eye space, we see Different types of products, right?

Speaker 1

So a product like 9,643 really is trying to rest the underlying disease. So we're trying to modify the disease condition and through that have an overall effect on the Corneal surface health and then how the patient perceives their disease, so either symptoms improving, that's a little bit of a much more difficult challenge Then agents that are what I would classify just really symptomatic treatment. In other words, I. E. They just drive a tearing of the eye, Short term tearing of the eye that maybe can alleviate symptoms over relatively short period of time, but don't really have long term benefit in treating dry eye disease.

Speaker 1

So there's another distinct factor there. Again, assuming succession, we're really We're likely to be having that success because we're really modifying the underlying disease, not just addressing a symptom.

Speaker 5

Great. Thank you.

Operator

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

Speaker 1

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

Speaker 1

So we're looking forward to the data and Take care and we'll catch up with you soon. Thank you.

Operator

This concludes today's conference

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Key Takeaways

  • In December 2023 Palatin sold Vyleesi rights for female HSDD to Cosat for up to $171 million, retaining obesity and male erectile dysfunction indications.
  • For Q2 FY2024, Vyleesi gross product sales rose 64% year-over-year to $4.3 million and net revenue increased 98% to $2 million, while net loss was $7.8 million due to a $7.8 million gain on the Vyleesi sale offset by an $8.1 million fair-value loss on warrant liabilities.
  • At December 31, 2023 Palatin held $9.5 million in cash equivalents and marketable securities plus $2.3 million in receivables, pro forma to $18.7 million after subsequent equity financing, funding operations into H2 2024.
  • Palatin expects three clinical readouts in H1 2024: top-line data from the Phase 3 MELODY-1 dry eye study (PL-9643) and interim results for Phase 2 trials in ulcerative colitis (PL-8177) and diabetic kidney disease.
  • Two new Phase 2 trials are slated to begin in H1 2024: co-formulation of bremelanotide with a PDE-5 inhibitor for ED patients unresponsive to first-line therapy, and an MC4 agonist add-on to GLP-1 therapy for obesity and weight-loss maintenance.
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Earnings Conference Call
Palatin Technologies Q2 2024
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