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| We have previously conducted clinical trial showing the synergistic effects of combining bremelanotide with a PD-5 inhibitor and a treatment for erectile dysfunction and feel well positioned for an efficient and successful development program of this co formulated product |
| PL9643 has really excellent ocular tolerability and safety |
| Gross product sales for this period December 31, 2023 quarter increased 64% and net product revenue increased 98% over the comparable quarter last year |
| So that's what we -- that would be a really nice response for us |
| 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 into commercialization and there are already distribution channels available and there's high awareness among patients |
| So that's why we're very excited about where we stand and really the biology and the science behind targeting the leptin melanocortin pathway for weight loss maintenance is pretty compelling |
| The emerging product profile for PL9643 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 clinical programs also continue to make good advancements for our PL9643 MELODY-1, Phase 3 dry eye disease study, we should report top line data this month |
| Through our extensive experience in the design and development of melanocortin agonist for treating obesity, including two 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 |
| Safety in these treatments are pretty good |
| Resolving inflammation rather than blocking it provides possibility of efficacy coupled with significantly differentiating safety in treating colitis and inflammatory bowel disease |
| So one of the things that again -- I'm not going to bore the lay people that are listening is that we have a tremendous understanding of the structural function relationships with regards to all the various melanocortin receptors and their peptide agonists and we're able to dial in a degree of activity that we think It's probably really ideal for obesity treatment and that's what you're going to see going forward into towards the phase 2s and the eventual phase 3 studies |
| 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 |
| Nice lesson in accounting |
| So we'll keep a very good flow out of the data |
| 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 |
| Again, assuming success, we're really -- we're likely to be having that success because we're really modifying the underlying disease, not just addressing a symptom |
| 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 |
| So they have a much cleaner profile than bremelanotide does and they're much more suited for long-term chronic use |
| So specifically, we had an increase in net product revenue of Vyleesi of $1 million compared to the prior quarter of last year |
| It helps us to Steve and I to more or less illuminate what we're doing here |
| 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? Carl Spana So we have so we've been using the bremelanotide as a test molecule for adding extended release on to our various peptides across the board has been working very, very well, so we can extend green bremelanotide quite nicely |
| Steve and I would like to thank everyone for participating on the call, and we'd like thank our analysts for the very insightful questions that they ask |
| 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 |
| Good morning, good afternoon and good evening everyone |
| So again, thanks everyone |
| They work -- I would say they worked quite synergistically |
| Again, positive data will go through the ARGO, which is in the we've missed the date there, but we'll go for late breaking if it's good |
| So that would be a very key differentiating factor, a comfortable installation without itching and tearing and burning or feeling goofiness or off taste, anything of that nature is really key to -- for a product like this, because I said it is very consumer driven |
| BREAKOUT, our Phase 2 open label study evaluating melanocortin agonist in diabetic patients with kidney disease is also on track for top line data in the first half of 2024 |
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| 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 -- we're in the market for a long period of time and now coming into the marketplace |
| But what we expect to see is really a drop in proteinuria and the creatinine protein ratios |
| They don't get better, they just progressively get worse |
| I think at the end of the day, most of the treatments that are in approved for dry eye disease have tolerability issues |
| Regarding Palatin's net loss for the quarter ended December 31, 2023 was $7.8 million or $0.56 per basic and diluted common share compared to income of $2.7 million or $0.25 per basic and diluted common share for the comparable period last year |
| 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 |
| Carl, starting at the back end of your comments, I was hoping you could provide… [Technical Issues] Operator It looks like we've lost the line |
| The change in net loss of the comparable quarter last year was due to several factors |
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