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Palatin Technologies, Inc. (NYSE American: PTN) is a specialized biopharmaceutical company based in Cranbury, New Jersey. The company focuses on developing first-in-class medicines that target the melanocortin and natriuretic peptide receptor systems. These therapies are aimed at treating a variety of diseases with significant unmet medical needs and commercial potential.
The company's lead product is Vyleesi, a melanocortin receptor agonist for premenopausal women suffering from hypoactive sexual desire disorder (HSDD). Recently, Palatin announced the divestiture of Vyleesi to better focus on its robust development and clinical pipeline.
Palatin is also advancing several promising candidates through clinical trials:
- PL9643: A melanocortin receptor agonist for treating dry eye disease (DED). The company recently reported successful results from its Phase 3 MELODY-1 trial, demonstrating significant efficacy and safety.
- PL8177: This selective melanocortin receptor 1 (MC1R) agonist peptide has completed Phase 1 trials for inflammatory bowel diseases and systemic non-infectious uveitis. It is being further developed for treating COVID-19.
- PL3994: A natriuretic peptide receptor (NPR)-A agonist aimed at treating cardiovascular diseases and other conditions.
Palatin’s strategic focus is on developing targeted, receptor-specific product candidates and forming marketing collaborations with industry leaders to maximize their commercial potential. The company's research and development efforts are guided by a commitment to innovative science and a focus on areas with high probability of success and differentiation.
Financially, Palatin has shown strong operational progress. As of the latest fiscal quarter, the company announced a substantial cash position, ensuring the funding of its ongoing projects into the second half of 2024. The company's leadership believes that their internal research and development efforts, concentrating on melanocortin receptor-based therapies, hold significant promise for the treatment of various conditions, including obesity and erectile dysfunction.
Palatin’s approach to biopharmaceutical development underscores a commitment to addressing significant medical needs through innovative receptor-specific therapies. For more information, visit www.Palatin.com and follow them on Twitter at @PalatinTech.
Palatin Technologies, Inc. (NYSE American: PTN) announced a study published in Frontiers in Immunology, highlighting the therapeutic effects of its oral formulation, PL8177, in preclinical models of inflammatory bowel disease. The study reports that PL8177 remains gut-restricted, showing promising results such as reduced immune cell infiltration and improved colon structure. Pharmacokinetic studies indicated that PL8177 is effective in the colon without systemic absorption. The company is currently enrolling patients in a Phase 2 clinical trial for ulcerative colitis. Initial results from the trial are expected in mid-2023, with final data anticipated later in the year.
On February 28, 2023, Palatin Technologies, Inc. (NYSE American: PTN) announced the issuance of U.S. Patent No. 11,590,209 for the use of bremelanotide in patients with controlled hypertension. This patent strengthens the intellectual property surrounding Vyleesi, its FDA-approved treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. The patent extends to April 29, 2041, enhancing the company's competitive positioning in the market. CEO Carl Spana expressed optimism regarding the patent’s contribution to Palatin's innovation efforts and the expansion of its Vyleesi portfolio, which the company is actively seeking to commercialize further.
Palatin Technologies (PTN) reported financial results for the fiscal second quarter ending December 31, 2022, highlighting a net product revenue of approximately $1 million for Vyleesi®, marking an 18% increase over the previous quarter and a staggering 1,323% increase compared to last year. Operating expenses decreased to $6.6 million from $8.8 million, contributing to a reduced net loss of $1.4 million, down from $8.7 million a year prior. The company closed a $10 million direct offering and received $4.7 million in non-dilutive funding. Key clinical trials, including the Phase 3 study of PL9643 for dry eye disease, are ongoing, with topline results expected in mid-2023.
Palatin Technologies, Inc. (NYSE American: PTN) will announce its second quarter fiscal year 2023 operating results on February 15, 2023, before the U.S. market opens. A conference call and live audio webcast will follow the announcement at 11:00 a.m. ET, featuring insights from the executive management team regarding operating results and developmental updates. The press release for the fiscal results will be available at 7:30 a.m. ET on February 15. Investors can access the audio webcast on Palatin's website, providing crucial information about the company's performance and future strategies.
Palatin Technologies announced the initiation of a Phase 2b clinical trial, known as the BREAKOUT Study, for bremelanotide in treating diabetic kidney disease. This study aims to enroll up to 45 subjects and evaluates the effectiveness of bremelanotide combined with RAAS inhibition therapy. The primary endpoint is a 50% reduction in urine protein/creatinine (UP/Cr) ratio after six months. Patient dosing begins in January 2023, with expected completion of enrollment by Q3 2023 and topline data by Q1 2024. This clinical program marks Palatin’s third clinical initiative utilizing melanocortin agonists, focusing on addressing diabetic nephropathy, a significant cause of renal disease.
Palatin Technologies (PTN) has secured approximately $4.7 million in non-dilutive funding through New Jersey's Net Operating Loss (NOL) Program. This program enables qualified technology companies to convert state operating losses into cash. To date, Palatin has received about $18 million from this program. CFO Stephen T. Wills expressed gratitude for the support from the NJ Economic Development Authority, highlighting the funding's role in advancing drug development efforts. Palatin focuses on creating first-in-class medicines targeting the melanocortin receptor system, aiming to address significant unmet medical needs.
Palatin Technologies (PTN) announced the publication of a study in Frontiers in Immunology highlighting the therapeutic effects of PL-8177 on inflammatory conditions, including arthritis. Conducted with The William Harvey Research Institute and Queen Mary University in London, the study confirmed PL-8177's potential as a melanocortin receptor 1 agonist, demonstrating anti-inflammatory properties in rodent models. The ongoing Phase 2 clinical trial for PL-8177 in ulcerative colitis is set for interim assessment in Q1 2023, with topline data expected by Q2 2023, signifying promising advancements in treating chronic inflammatory diseases.
Palatin Technologies (PTN) disclosed preliminary sales results for Vyleesi® for the fiscal second quarter ended December 31, 2022. The company reported a 15.4% increase in net product revenue, totaling $1.0 million, and a striking 1,290% increase compared to the same quarter in 2021. Gross product sales reached $2.6 million, a 238% increase year-over-year. Additionally, prescriptions dispensed rose by 11.5% quarter-over-quarter, and 134% year-over-year. While management is optimistic about growth, the preliminary nature of the data could lead to significant adjustments.
Palatin Technologies reported positive interim results from its Phase 3 study of PL9643 for dry eye disease, with recommendations to increase patient enrollment to 350. The company also commenced a Phase 2 study for PL8177 in ulcerative colitis, expecting interim results in early 2023. Vyleesi's net revenue climbed 13% with a 17% increase in prescriptions from the previous quarter. Despite a net loss of $8.3 million for the first quarter ended September 30, 2022, cash reserves were $21.2 million, bolstered by a recent $10 million equity offering.
Palatin Technologies, Inc. (NYSE American: PTN) is set to release its first quarter fiscal year 2023 operating results on November 14, 2022, before market open. A conference call will follow at 11:00 a.m. ET for a review of the results and updates on development programs. The press release will be available at 7:30 a.m. ET.
Investors can access the audio webcast through Palatin's website. The company is focused on developing first-in-class medicines for significant unmet medical needs.
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