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Yahoo
15-05-2025
- Business
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Q3 2025 Palatin Technologies Inc Earnings Call
Carl Spana; President, Chief Executive Officer, Director; Palatin Technologies Inc Stephen Wills; Chief Financial Officer, Chief Operating Officer, Executive Vice President, Treasurer, Secretary; Palatin Technologies Inc Scott Henry; Analyst; Alliance Global Partners Operator Greetings. Welcome to Palatin's third-quarter fiscal year 2025 operating results conference call. (Operator Instructions) As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now, I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead. Carl Spana Thank you. Good morning and welcome to the Palatin third-quarter fiscal year 2025 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Chief Financial Officer and Chief Operating Officer. I'll now turn the call over to Steve and he'll give the financial update. Stephen Wills Thank you, Carl. Good morning. Good afternoon, everyone. Regarding non-programmed corporate update, on May 7, 2025, Palatin received notice from NYSE regulation that it had suspended trading of the company's common stock on the NYSE American Stock Exchange and determined to commence proceedings to de-list Palatin's common stock as a result of its determination that the company is no longer suitable for listing pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the company's common stock. Trading of the company's common stock on the NYSE American was suspended on May 7, 2025, and began trading on the OTC Pink Market on May 8, 2025. Palatin exercise our right to review of NYSE regulation's determination to de-list Palatin's common stock. We are disappointed and do not agree with the NYSE's decision and are assessing all available options. Moving over to our fiscal third quarter ending March 31, 2025, financial results. Regarding revenue, pursuant to the completion of the sale of Vyleesi's worldwide rights for female sexual dysfunction to Cosette Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors for the quarter ended March 31, 2025, and March 31, 2024. Regarding operating expenses, total operating expenses were $4.8 million net of $0.4 million gain on a purchase commitment for the quarter ended March 31, 2025, compared to $9.2 million for the comparable quarter last year. The decrease was mainly the result of the decrease lower spending related to our MCR programs for the quarter ended March 31, 2025. Regarding cash flows, Palatin's net cash used in operations for the quarter ended March 31, 2025, was $5.4 million compared to net cash used in operations of $8.6 million for the same period in 2024. The decrease in net cash used in operations is mainly due to the decrease in net loss during the period and, secondarily, to working capital changes. Regarding net loss, Palatin's net loss for the quarter ended March 31, 2025, was $4.8 million compared to a net loss of $8.4 million for the same period in 2024. As referenced above, the decrease in the net loss for the quarter ended March 31, 2025, over the quarter ended March 31, 2024, was driven primarily by the decrease in operating expenses for the quarter ended March 31, 2025. Regarding cash position, as of March 31, 2025, Palatin's cash and cash equivalents were $2.5 million compared to cash and cash equivalents of $9.5 million at June 30, 2024. The $2.5 million of cash and cash equivalents as of March 31, 2025, does not include approximately $3.5 million of net proceeds received in April and May 2025 from Palatin's ATM facility and the recent equity offering. We are actively engaged with multiple potential funding sources, including business development initiatives for future operating cash requirements. Let me turn the call back over to Carl. Carl Spana Thank you, Steve. I'll now go over the operating update for the quarter. Updates for melanocortin 4 receptor VC programs are as follows. For our Phase 2 study, BMT 801, evaluating the safety and efficacy of the co-administration of the melanocortin 4 receptor agonist bremelanotide with tirzepatide GLP-1/GIP dual agonist in patients with generalized obesity, we reported positive top line data for the study. The study successfully answered the research questions, does co-administration result in increased weight loss? And can treatment within melanocortin 4 receptor agonist be used as a treatment for weight loss maintenance by blunting the weight regain seen post-treatment therapy? The primary efficacy end point was weight loss of the combined treatment compared to placebo control at the end of eight weeks of treatment. Patients on the combined therapy had a weight reduction of 4.4% versus 1.6% for the placebo arm. The p-value here was highly significant. Importantly, 19% of patients on the combined treatment had a weight reduction of greater than 7% compared to 0% for patients on placebo and the tirzepatide alone arms. Concerning a weight loss maintenance effect, low dose of bremelanotide prevented the rapid weight regain following tirzepatide treatment. So a very positive study for us. As we move forward, our obesity and weight loss management portfolio includes both novel long-acting melanocortin 4 selective peptide agonist and the orally active melanocortin 4 receptor selective small molecule agonist PL7737. During the quarter, we were notified by the FDA that they granted orphan drug status to PL7737 for treating patients with obesity due to leptin receptor deficiency. Pending financing, PL7737 is on track for an initial new drug application submission in Phase 1 Single Ascending Dose and Multiple Ascending Dose studies in the first quarter of 2026. Our novel next-generation selective melanocortin 4 receptor compounds have reduced activity at melanocortin 1 receptor and, therefore, reduced potential to cause skin darkening. The lack of MCR1 activity, once weekly or oral dosing, represents significant improvements over current FDA approved melanocortin treatments. You can find additional information on our clinical trial at and on our website. During the quarter, we also reported positive top line data for a Phase 2 study evaluating our oral PL8177, a selective melanocortin 1 receptor agonists for treating ulcerative colitis. The study evaluated PL8177 versus placebo for eight weeks in moderate ulcerative colitis patients. Clinical remission was achieved for 33% of PL8177 treated patients versus 0% for placebo. Clinical response was achieved for 78% of PL8177 patients compared to 33% for a placebo, again, highly significant. The systematic remission was achieved for 56% of patients on PL8177 versus 33% for placebo. This exciting data has resulted in a significant increase in business development discussions with potential partners, which is in line with our current strategy to outline this program. During the quarter, we also reported additional data for the PL9643 MELODY-1 Phase 3 study in dry eye disease patients. The data from a responder analysis that compared placebo to PL9643 demonstrated that for 6 of the 13 symptom endpoints, a significantly higher percentage of patients had a complete symptom clearing, i.e., they were cured. This again was highly significant. This level of symptom clearing has not been achieved by any FDA-approved treatment for dry eye disease. Clearing was seen as early as two weeks and continued to improve over the 12 weeks of the study. We are actively engaged in potential corporate partners with this program as one of our earlier ocular programs, and we anticipate one or more transactions closing in the second half of calendar '25. Before moving on to take questions, I would like to comment on our strategy. We are focused on our research and development efforts on our melanocortin 4 receptor obesity assets. We believe the pharmacological treatment of obesity is in the early stages of a multi-year cycle of innovation and will have a market value in excess of $100 billion per year. Melanocortin system plays a critically important role in regulating stored energy and food intake, and we strongly believe that melanocortin 4 receptor agonist will be an important part of the future of obesity treatment and weight loss management. We'll now take the -- thank you for participation and we'll now open the line to questions. Operator (Operator Instructions) Scott Henry, Alliance Global Partners. Scott Henry A couple of questions on the obesity program. First, I know that a low dose of bremelanotide or BMT was used in the study. The question is, do you believe a higher dose would increase the weight loss, putting it in the ranges of Wegovy or Zepbound? Carl Spana Yes, we actually have a publication out on that. We actually looked at higher doses of bremelanotide in an earlier study and where we were looking to optimize -- it's a short acting compound, so they were on multiple doses per day so that patients would be in optimal dose range while they had access to food. And the weight loss there really is comparable to what you would see with the single agent Wegovy. Tirzepatide is a multiple mechanism drug and it's a little bit better than Wegovy. But with regards to these single mechanism drugs like Wegovy, good MC4R agonists like bremelanotide or the ones that we're working on, they will have highly competitive weight loss. Scott Henry Okay, great. Thank you for that color. And then with the GLPs, the rebound weight regain is a common issue. Do you think we may see this idea of weight maintenance in the future, even potentially getting into the label, could that be more of a focus in the next generations? Carl Spana Absolutely. The new compounds coming through are going to be evaluated as weight loss maintenance. There are studies that are going on right now doing that with the GLP-1s, but you're going to need new mechanisms to really address that on a long-term basis. Right now, we don't have any evidence that patients that, once they've lost weight, can effectively come off of treatment and maintain that weight. Right now, the strategies they're going to need to be on long-term weight loss maintenance. How the dosing works out with agents are going to be used, that's going to be worked out in clinical trials. But melanocortin 4 agonists are really ideally suited for that. It's probably dysfunctions in that hypothalamic MCR leptin pathways that actually are leading to that weight regain and this really begins to address that directly. Scott Henry Okay, great. And the final question, just on the next-generation of MC4Rs, if you could just talk about the benefits that will separate them from the first generation. I know pigmentation was an issue. I don't know if that's going to be one of the things that that may be different, but if you could just talk about what your expectations are for that next generation. Thank you. Carl Spana Both bremelanotide, and there's another one, [proselanotide], they're what I would consider first-generation compounds. They are good. They work well. But they are short-term dosing, so you need one or more doses per day. They do have the pigmentation that you pointed out. They're not ideal treatments or as competitive in, say, a general market as current treatments. So what we're looking to do here is really eliminate that MCR1 activity so we don't get the skin darkening. I think we've been able to do that quite successfully. In addition to that, if we're dealing with a peptide which wouldn't be orally active, we certainly want that to be once a week, which is very patient friendly. Or with 7737, which is a small molecule, it's a once a day oral, has a very nice extended half-life so we can really get to steady state. And that's really a goal with these things. Compared to what's out there, on the line of court and side, and when you deal with short acting compounds, it's very hard to maintain a steady state. And in obesity, you really want to get that steady state and we can achieve that with both the long-acting peptide or the oral small molecule that we're bringing forward. So they really are improvements over what's out there today. Scott Henry Okay, thank you for that color and thank you for taking the question. Operator Thank you. This does conclude our question-and-answer session for today. I would now like to pass the floor back to management for closing remarks. Carl Spana Steve and I would like to thank everyone for participating in our third-quarter fiscal year 2025 call. We look forward to keeping you updated on our progress. I think it was, from an operating standpoint, it was a phenomenal quarter for us. We did have a little difficulty with the NYSE, but I think that's going to be transitory. We're going to work to address that as quickly as we can. So thank you and have a great day. Operator Thank you. This does conclude today's conference call. You may disconnect at this time and have a wonderful day. Thank you for your participation. Thank you, Carl, Steve. Have a good day. I'm going to disconnect lines at this time. Sign in to access your portfolio
Yahoo
14-05-2025
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Palatin Reports Fiscal Year 2025 Third Quarter Results and Business Update
Significant Progress in Obesity and Ocular Programs Teleconference and Webcast to be held today - May 14, 2025, at 11:00 AM EST CRANBURY, N.J., May 14, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (OTC PINK: PTNT), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced financial results for its fiscal third quarter ended March 31, 2025. "We had a strong quarter operationally, with significant progress across both our obesity and ocular pipelines," said Carl Spana, Ph.D., President and CEO of Palatin. "Our obesity program Phase 2 study results demonstrated the synergistic potential of melanocortin receptor modulation with GLP-1-based therapies, and our PL9643 Phase 3 dry eye disease program results showed a level of symptom resolution not previously achieved by any approved treatments." Obesity Program Highlights Phase 2 Study Co-administration of Bremelanotide (MC4R agonist) + Tirzepatide (GLP-1/GIP dual agonist): Met primary endpoint in the 8-week treatment study with high statistical significance (p<0.0001). Patients receiving co-administration showed a 4.4% weight reduction, vs. 1.6% for placebo. 19% of patients achieved ≥7% weight loss (p<0.1). Low-dose bremelanotide prevented weight regain typically seen following tirzepatide discontinuation. No added tolerability or safety issues observed with the combination. Next-Generation MC4R Therapeutics: Advancing long-acting peptides and oral small molecules targeting MC4R. IND filings planned for Q1 2026; initial clinical data expected in 1H 2026. Planned Phase 1 SAD/MAD studies will include patients with hypothalamic obesity. Ocular Program Highlights PL9643 – Phase 3 MELODY-1 Study in Dry Eye Disease (DED): Responder analysis revealed: 6 of 13 symptom endpoints showed significantly greater complete symptom resolution with PL9643 vs. placebo (p<0.05). These results represent a level of symptom clearing not achieved by any currently FDA-approved DED treatment. FDA approval guidance (2020) supports the use of responder analysis to demonstrate symptom improvement. PL9643 continues to demonstrate rapid onset, strong efficacy, and excellent tolerability. Corporate Update On May 7, 2025, the Company received notice from NYSE Regulation that it had suspended trading of the Company's common stock on the NYSE American LLC stock exchange ("NYSE American") and determined to commence proceedings to delist the Company's common stock from the NYSE American as a result of its determination that the Company is no longer suitable for listing pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the Company's common stock. Trading of the Company's common stock on the NYSE American was suspended on May 7, 2025 and began trading on the OTC Pink Market on May 8, 2025. The Company has exercised its right to a review of NYSE Regulation's determination to delist the Company's common stock by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange. "We are disappointed by the NYSE decision and assessing all available options," added Dr. Spana. "We remain confident in the value of our programs and are fully committed to executing our strategic plan and enhancing shareholder value." Public Offering On May 8, 2025, Palatin announced the closing of a reduced previously announced public offering consisting of 7,324,119 shares of common stock together with Series F warrants to purchase up to 7,324,119 shares of common stock, Series G warrants to purchase up to 7,324,119 shares of common stock, and Series H warrants to purchase up to 7,324,119 shares of common stock at a combined public offering price of $0.15 per share of common stock and accompanying warrants. Palatin received aggregate gross proceeds of approximately $1.1 million. Fiscal Third Quarter Ended March 31, 2025 Financial Results Revenue Pursuant to the completion of the sale of Vyleesi's worldwide rights for female sexual dysfunction to Cosette Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors, for the third quarter ended March 31, 2025 and March 31, 2024. Operating Expenses Total operating expenses were $4.8 million, net of a $0.4 million gain on purchase commitment for the third quarter ended March 31, 2025, compared to $9.2 million, for the comparable quarter last year. The decrease was mainly the result of the decrease in spending related to our MCR programs for the third quarter ended March 31, 2025. Other (Expense) / Income Total other income / (expense), net, consists mainly of foreign currency transaction gains and (loss) and the change in fair value of warrant liabilities, which Palatin had recorded as a liability on the consolidated financial statements. For the quarter ended March 31, 2024, Palatin recorded a fair value adjustment gain of $0.4 million. Cash Flows Palatin's net cash used in operations for the quarter ended March 31, 2025, was $5.4 million, compared to net cash used in operations of $8.6 million for the same period in 2024. The decrease in net cash used in operations is mainly due to the decrease in net loss during the period and secondarily to working capital changes. Net Loss Palatin's net loss for the quarter ended March 31, 2025, was $4.8 million, or $(0.18) per basic and diluted common share, compared to a net loss of $8.4 million, or $(0.53) per basic and diluted common share, for the same period in 2024. The decrease in net loss for the quarter ended March 31, 2025, over the quarter ended March 31, 2024, was driven primarily by the decrease in operating expenses partially offset by the change in fair values of the warrant liability and the foreign currency transaction gain recorded in the quarter ended March 31, 2024. Cash Position As of March 31, 2025, Palatin's cash and cash equivalents were $2.5 million, compared to cash and cash equivalents of $9.5 million at June 30, 2024. The $2.5 million of cash and cash equivalents as of March 31, 2025, does not include approximately $3.5 million of net proceeds in April and May 2025 from our ATM facility and equity offering. The Company is actively engaged with multiple potential funding sources, including business development initiatives, for future operating cash requirements. Conference Call / Webcast Palatin will host a conference call and audio webcast on May 14, 2025, at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-877-545-0523 (US) or 1-973-528-0016 (International), conference ID 845014. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone reply, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 52446. The webcast and telephone replay will be available through May 28, 2025. About Melanocortin 4 Receptor Agonists Effect on Obesity Genetic analysis has identified the melanocortin 4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MC4R therefore represents an attractive target for potential obesity treatments. About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Χ (formally Twitter) at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Operations (unaudited)Three Months Ended March 31,Nine Months Ended March 31,2025202420252024 REVENUESProduct revenue, net $ -$ -$ -$ 4,140,090 OPERATING EXPENSESCost of products sold ---97,637 Research and development 3,755,1587,159,68612,928,39117,728,516 Selling, general and administrative 1,474,0192,033,4105,176,7948,266,267 Gain on sale of Vyleesi -25,202(2,500,000)(7,798,280) Gain on purchase commitment (416,000)-(416,000)- Total operating expenses 4,813,1779,218,29815,189,18518,294,140 Income (loss) from operations (4,813,177)(9,218,298)(15,189,185)(14,154,050) OTHER INCOME (EXPENSE)Investment income 31,452139,273139,072272,929 Foreign currency transaction gain (loss) (27,900)215,600(15,900)68,653 Interest expense (1,795)(1,254)(11,538)(13,741) Offering expenses ---(696,912) Change in fair value of warrant liabilities -429,029-(6,962,562) Total other income (expense), net 1,757782,648111,634(7,331,633) NET LOSS $ (4,811,420)$ (8,435,650)$ (15,077,551)$ (21,485,683) Basic and diluted net loss per common share $ (0.18)$ (0.53)$ (0.68)$ (1.53) Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share 26,344,58415,792,42122,245,15314,013,848 PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Balance Sheets (unaudited)March 31, 2025June 30, 2024 ASSETSCurrent assets:Cash and cash equivalents $ 2,520,062$ 9,527,396 Other receivables 271,037- Prepaid expenses and other current assets 442,178242,272 Total current assets 3,233,2779,769,668 Property and equipment, net 182,437388,361 Right-of-use assets - operating leases 255,863527,321 Other assets 56,91656,916 Total assets $ 3,728,493$ 10,742,266 LIABILITIES AND STOCKHOLDERS' DEFICIENCYCurrent liabilities:Accounts payable $ 7,770,567$ 4,101,929 Accrued expenses 506,4604,185,046 Short-term operating lease liabilities 194,972380,542 Short-term finance lease liabilities -46,014 Other current liabilities 1,576,350944,150 Total current liabilities 10,048,3499,657,681 Long-term operating lease liabilities 67,248163,782 Other long-term liabilities -1,032,300 Total liabilities 10,115,59710,853,763 Stockholders' deficiency:Preferred stock of $0.01 par value – authorized 10,000,000 shares: shares issued and outstanding designated as follows:Series A Convertible: authorized 4,030 shares as of March 31, 2025: issued and outstanding 4,030 sharesand outstanding 4,030 shares as of March 31, 2025 and June 30, 2024 4040 Common stock of $0.01 par value – authorized 300,000,000 shares:issued and outstanding 28,557,246 shares as of March 31, 2025 and 17,926,640 shares as of June 30, 2024 285,572179,266 Additional paid-in capital 450,171,385441,475,747 Accumulated deficit (456,844,101)(441,766,550) Total stockholders' deficiency (6,387,104)(111,497) Total liabilities and stockholders' deficiency $ 3,728,493$ 10,742,266 View original content to download multimedia: SOURCE Palatin Technologies, Inc. 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08-05-2025
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Palatin Presents Breakthrough Symptom Resolution Data from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease at ARVO 2025
Updated Phase 3 analysis highlights PL9643 as a potential first-in-class treatment achieving full symptom resolution. Responder analyses demonstrate statistically significant symptom resolution across multiple endpoints in PL9643-treated patients compared to placebo. 6 of 13 symptom endpoints reached statistical significance (p<0.05). This level of symptom clearing has not been demonstrated by any currently approved dry eye disease therapy. Symptom resolution was observed as early as two weeks and continued through week 12 without plateau. PL9643 significantly improved clinical signs for staining measures, indicating potential to protect the ocular surface. PL9643 was well tolerated, with adverse event rates comparable to or better than vehicle. CRANBURY, N.J., May 8, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (OTC PINK: PTNT), a biopharmaceutical company advancing innovative treatments targeting the melanocortin receptor system, today presented new data from the Phase 3 MELODY-1 study at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. The updated responder analyses highlight PL9643's rapid onset of action, broad and statistically significant efficacy, and complete symptom resolution across multiple endpoints in patients with dry eye disease (DED). The findings further strengthen PL9643's clinical profile and highlight its potential to address a critical unmet need by achieving levels of symptom relief not observed with existing therapies. The poster, titled "Efficacy and safety of PL9643 in participants with dry eye disease: results from a phase 3, randomized, vehicle-controlled study," was presented by George Ousler, MS, of Ora, Inc. The full poster is available at "This is breakthrough-level data," said Carl Spana, Ph.D., President and CEO of Palatin. "PL9643 is the first investigational therapy to demonstrate complete symptom resolution across multiple endpoints, with rapid onset and excellent tolerability. These results support a highly differentiated profile in the DED treatment landscape." Clinical Data Presented: PL9643 showed statistically significant symptom improvement at week 2, continuing through week 12. 6 of 13 symptom endpoints reached statistical significance for complete resolution. Symptom Composite Score (average of seven VAS metrics) improved significantly at week 2 and continued to improve through week 12. PL9643 improved ocular surface health, including total, inferior, and corneal staining. Safety data showed PL9643 was well tolerated, with a profile similar to or better than vehicle (vehicle similar to artificial tears). "The consistency and strength of these data, including full symptom resolution in a significant portion of patients, underscore PL9643's potential to fill a major therapeutic gap," said Michael Raizman, M.D., Chief Medical Officer of Palatin. "Combined with a robust safety profile, these results position PL9643 as a potential first-in-class DED treatment." Regulatory Relevance:FDA 2020 approval guidance supports the use of responder analyses that demonstrates statistically significant increases in the proportion of patients achieving complete symptom resolution as a basis for approval. PL9643 meets this threshold across multiple endpoints. Phase 3 MELODY-1 PL9643 Design:Palatin successfully completed MELODY-1, its first Phase 3 study, last year. The co-primary symptom endpoint of pain met statistical significance (P<0.025), and 7 secondary symptom endpoints met statistical significance (P<0.05), at the 12-week treatment period. The Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution after treatment for 12 weeks, compared to placebo in patients with moderate-to-severe DED, for multiple sign and symptom analysis from the Phase 3 MELODY-1 trial indicated PL9643 was well-tolerated. Next Steps in the Phase 3 PL9643 Program:The remaining Phase 3 program includes two additional studies, MELODY-2 and MELODY-3, which will evaluate both signs and symptoms of DED. Pending partnership and funding, enrollment could begin in the second half of 2025, with topline data anticipated in the second half of 2026. DED Market Opportunity:DED affects approximately 38 million people in the U.S., but fewer than 10% receive prescription treatment. The market is expected to grow from $6.1 billion in 2024 to $7.5 billion by 2029. About Dry Eye Disease (DED)Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for DED is generally regarded as inadequate by many physicians and patients and often requires months to demonstrate activity. About Melanocortin Receptor SystemThe melanocortin receptor (MCR) system plays a critical role in regulating inflammation, immune response, and tissue repair. MCR agonists have shown promise in restoring tissue homeostasis in ocular, gastrointestinal, and renal diseases. By activating natural resolution pathways, PL9588 and other melanocortin agonists represent a new class of anti-inflammatory, neuroprotective therapeutics. About PalatinPalatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking StatementsStatements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. View original content to download multimedia: SOURCE Palatin Technologies, Inc.
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08-05-2025
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Palatin Announces Breakthrough Symptom Resolution in Updated Analyses from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease
Updated Phase 3 analyses position PL9643 as a potential first-in-class therapy achieving full symptom resolution in dry eye disease. Responder analyses demonstrated statistically significant symptom clearing (resolution) across multiple endpoints in patients treated with PL9643, compared to placebo. Six of 13 symptom endpoints showed a significantly higher percentage of patients in the PL9643 group achieving complete symptom resolution compared to placebo (p<0.05). This level of symptom clearing has not been achieved by any FDA-approved therapy for dry eye disease. Symptom Composite Score (a measure of dry eye symptom improvement) for PL9643-treated patients showed: Statistically significant symptom resolution by week 2. Continued improvement through week 12 with no plateau. In contrast, placebo-treated patients showed minimal improvement that plateaued early. FDA approval guidance (2020) supports the use of responder analysis to demonstrate symptom improvement. This includes showing a statistically significant difference in the percentage of patients achieving complete resolution of a symptom — a threshold PL9643 met across multiple symptom endpoints. CRANBURY, N.J., April 29, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced updated results from responder analyses of its pivotal Phase 3 MELODY-1 clinical trial evaluating the safety and efficacy of PL9643 versus placebo in the treatment of dry eye disease (DED). The updated findings further strengthen PL9643's clinical profile, highlighting its potential to address a critical unmet need in DED by achieving statistically significant complete symptom resolution across multiple symptom endpoints — a level of improvement not seen with any currently approved DED therapies. "Achieving statistically significant symptom resolution across multiple endpoints, a first among dry eye therapies, is a major breakthrough that could transform treatment," said Carl Spana, Ph.D., President and CEO of Palatin Technologies. "These results reinforce PL9643's potential as a best-in-class therapy with a differentiated mechanism of action. Combined with its rapid, sustained efficacy and excellent safety and tolerability profile, PL9643 offers a compelling new option for patients. Critically, these outcomes align with key FDA approval criteria for symptom improvement based on responder analyses." Key Findings:Responder analysis was conducted to evaluate the percentage of patients achieving complete symptom clearing (resolution) across 13 pre-specified symptom endpoints. Separately, the Symptom Composite Score, based on seven Visual Analog Scale (VAS) symptom ratings, was used to quantify overall symptom burden from the patient's perspective. This score averages individual VAS ratings to provide a comprehensive assessment of symptom improvement. The detailed analyses have been accepted for presentation at an upcoming medical conference. Statistically Significant Symptom Clearing (Resolution) After 12 Weeks: In 6 of the 13 symptom endpoints, a significantly higher percentage of patients treated with PL9643 achieved complete symptom resolution compared to placebo (p< 0.05) at 12 weeks. This level of symptom clearing has not been achieved by any FDA-approved dry eye therapies to date. Early and Sustained Symptom Resolution: The Symptom Composite Score for PL9643-treated patients showed statistically significant symptom resolution at two weeks, with continued improvement through 12 weeks and no signs of plateau. In contrast, the placebo group showed minimal improvement that quickly plateaued. Across all 13 symptom endpoints, a greater percentage of patients in the PL9643 group achieved complete symptom resolution compared to those receiving placebo. Symptom clearing with PL9643 was evident as early as two weeks, with an increasing number of symptoms reaching statistical significance from week 4 through week 12 — consistent with the resolution of inflammation, the mechanism of action of melanocortin agonists. Regulatory Relevance: FDA approval guidance for dry eye drug development (2020) supports the use of responder analyses to demonstrate symptom improvement, requiring a statistically significant difference in the proportion of patients achieving complete symptom resolution (complete clearing of a symptom) — a key criterion met by PL9643. "This latest analyses provides critical insights into PL9643's clinical benefit," said Michael Raizman, M.D., Chief Medical Officer of Palatin Technologies. "Demonstrating statistically significant improvement in the Symptom Composite Score — especially as early as week 2 and sustained through week 12 — strongly signals meaningful patient benefit. Coupled with an excellent safety and tolerability profile, PL9643 has the potential to deliver a more consistent and impactful benefit than currently available therapies." Dr. Spana continued, "No currently approved DED treatment offers PL9643's exceptional safety and tolerability profile, rapid onset of efficacy, and statistically significant results across multiple symptom and sign endpoints — including a significantly higher percentage of patients achieving complete symptom resolution, which is a highly differentiating factor from currently approved therapies. These findings position PL9643 as a compelling, potentially best-in-class treatment for dry eye disease. We are actively progressing discussions with potential collaboration partners and aim to finalize a deal in the second half of this year." The remaining Phase 3 clinical program consists of two studies, MELODY-2 and MELODY-3, each evaluating both sign and symptom endpoints. Subject to securing a collaboration and funding, patient enrollment could begin in the second half of this year, with topline data in the second half of next year. Palatin successfully completed MELODY-1, its first Phase 3 study, last year. The co-primary symptom endpoint of pain met statistical significance (P<0.025), and 7 secondary symptom endpoints met statistical significance (P<0.05), at the 12-week treatment period. The Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution after treatment for 12 weeks, compared to placebo in patients with moderate-to-severe DED, for multiple sign and symptom endpoints. Safety analysis from the Phase 3 MELODY-1 trial indicated PL9643 was well-tolerated. PL9643 represents an opportunity to bring relief to the millions of dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment that also has an excellent safety and tolerability profile.1 The dry eye disease market size is estimated at $6.11 billion in 2024, and is expected to reach $7.46 billion by 2029, growing at a CAGR of 4.09% during the forecast period (2024-2029).2 About Dry Eye Disease (DED)Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for DED is generally regarded as inadequate by many physicians and patients and often requires months to demonstrate activity. About Melanocortin Receptor Agonists and InflammationThe melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, like the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About PalatinPalatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking StatementsStatements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. References1. Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.2. Mordor Intelligence – Dry Eye Disease Market Size & Share Analysis – Growth Trends & Forecasts (2024-2029). View original content to download multimedia: SOURCE Palatin Technologies, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
08-05-2025
- Business
- Malaysian Reserve
Palatin Technologies Announces Transition to OTC Pink Following NYSE American Delisting Notice
The Company Intends to Request a Review of the Delisting Determination CRANBURY, N.J., May 7, 2025 /PRNewswire/ — Palatin Technologies, Inc. ('Palatin' or the 'Company'), a biopharmaceutical company developing first-in-class medicines targeting the melanocortin receptor system, today announced that it has received a notice from the NYSE American LLC ('NYSE American') stating that the NYSE Regulation has determined to commence proceedings to delist Palatin's common stock. The notice, issued under Section 1003(f)(v) of the NYSE American Company Guide, cites the low selling price of Palatin's common stock as the basis for delisting. As a result, trading of Palatin's common stock on the NYSE American has been immediately suspended, and the shares will transition to the OTC Pink Market under the ticker symbol 'PTNT' beginning on May 8, 2025. Palatin intends to appeal the delisting decision, although there can be no assurance that any such appeal will be successful. The Company has until May 14, 2025 to appeal the NYSE American's decision. 'We are disappointed with the delisting determination,' said Carl Spana, Ph.D., President and CEO of Palatin Technologies. 'We continue to believe the Company has valuable assets and the actions of NYSE American will in no way deter our commitment to advance our business plan and increase stockholder value.' Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about the transition of the Company's common stock to the OTC Pink Market and the Company's appeal of the NYSE American's delisting determination, are 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. View original content to download multimedia: SOURCE Palatin Technologies, Inc.
