MC1R

New research finds around a quarter of Labrador retriever dogs face a double-whammy of feeling hungry all the time and burning fewer calories due to a genetic mutation. New research finds around a quarter of Labrador retriever dogs face a double-whammy of feeling hungry all the time and burning fewer calories due to a genetic mutation. This obesity-driving combination means that dog owners must be particularly strict with feeding and exercising their Labradors to keep them slim. The mutation is in a gene called POMC, which plays a critical role in hunger and energy use. Around 25% of Labradors and 66% of flatcoated retriever dogs have the POMC mutation, which researchers previously showed causes increased interest in food and risk of obesity. The new study reveals how the mutation profoundly changes the way Labradors and flatcoated retrievers behave around food. It found that although they don't need to eat more to feel full, they are hungrier in between meals. In addition, dogs with the POMC mutation were found to use around 25% less energy at rest than dogs without it, meaning they don't need to consume as many calories to maintain a healthy body weight. "We found that a mutation in the POMC gene seems to make dogs hungrier. Affected dogs tend to overeat because they get hungry between meals more quickly than dogs without the mutation," said Dr Eleanor Raffan, a researcher in the University of Cambridge's Department of Physiology, Development and Neuroscience who led the study. She added: "All owners of Labradors and flatcoated retrievers need to watch what they're feeding these highly food-motivated dogs, to keep them a healthy weight. But dogs with this genetic mutation face a double whammy: they not only want to eat more, but also need fewer calories because they're not burning them off as fast." The POMC mutation was found to alter a pathway in the dogs' brains associated with body weight regulation. The mutation triggers a starvation signal that tells their body to increase food intake and conserve energy, despite this being unnecessary. The results are published today in the journal Science Advances. Raffan said: "People are often rude about the owners of fat dogs, blaming them for not properly managing their dogs' diet and exercise. But we've shown that Labradors with this genetic mutation are looking for food all the time, trying to increase their energy intake. It's very difficult to keep these dogs slim, but it can be done." The researchers say owners can keep their retrievers distracted from this constant hunger by spreading out each daily food ration, for example by using puzzle feeders or scattering the food around the garden so it takes longer to eat. In the study, 87 adult pet Labrador dogs -- all a healthy weight or moderately overweight -- took part in several tests including the 'sausage in a box' test. First, the dogs were given a can of dogfood every 20 minutes until they chose not to eat any more. All ate huge amounts of food, but the dogs with the POMC mutation didn't eat more than those without it. This showed that they all feel full with a similar amount of food. Next, on a different day, the dogs were fed a standard amount of breakfast. Exactly three hours later they were offered a sausage in a box and their behaviour was recorded. The box was made of clear plastic with a perforated lid, so the dogs could see and smell the sausage, but couldn't eat it. The researchers found that dogs with the POMC mutation tried significantly harder to get the sausage from the box than dogs without it, indicating greater hunger. The dogs were then allowed to sleep in a special chamber that measured the gases they breathed out. This revealed that dogs with the POMC mutation burn around 25% fewer calories than dogs without it. The POMC gene and the brain pathway it affects are similar in dogs and humans. The new findings are consistent with reports of extreme hunger in humans with POMC mutations, who tend to become obese at an early age and develop a host of clinical problems as a result. Drugs currently in development for human obesity, underactive sexual desire and certain skin conditions target this brain pathway, so understanding it fully is important. A mutation in the POMC gene in dogs prevents production of two chemical messengers in the dog brain, beta-melanocyte stimulating hormone (β-MSH) and beta-endorphin, but does not affect production of a third, alpha-melanocyte stimulating hormone (α-MSH). Further laboratory studies by the team suggest that β-MSH and beta-endorphin are important in determining hunger and moderating energy use, and their role is independent of the presence of α-MSH. This challenges the previous belief, based on research in rats, that early onset human obesity due to POMC mutations is caused only by a lack of α-MSH. Rats don't produce beta-melanocyte stimulating hormone, but humans and dogs produce both α- and β-MSH.

Palatin's Focus is Solely on the Development of its Melanocortin Receptor (MCR) System Pipeline PL9643 MELODY-1 Pivotal Phase 3 Study in Dry Eye Disease (DED) – Topline Data Expected in February Oral PL8177 Phase 2 Clinical Study in Patients with Ulcerative Colitis – Interim Analysis Expected in 2Q Calendar Year 2024 – Topline Results Expected in 2H Calendar Year 2024 BMT 701 Phase 2 BREAKOUT study in patients with diabetic kidney disease – Topline results expected in the second quarter of calendar year 2024 Obesity: Combination of an MCR4 Agonist + glucagon like peptide-1 (GLP-1) – Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of ED in Patients that do not Respond to PDE5i Monotherapy – Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Vyleesi® Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million – $12 Million Upfront / Up to $159 Million in Sales-Based Milestones Closed on Gross Proceeds of $15 Million in Equity Teleconference and Webcast to be held on February 15, 2024, at 11:00 AM ET CRANBURY, N.J., Feb. 15, 2024 /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 financial results for its fiscal second quarter ended December 31, 2023. "With the planned divestiture of Vyleesi completed, our focus is solely on advancing our robust melanocortin-based development and clinical pipeline," said Carl Spana, Ph.D., President and CEO of Palatin. "We have multiple topline data result readouts in the near future, notably our MELODY-1 pivotal Phase 3 dry eye disease trial, our Phase 2 ulcerative colitis trial and our Phase 2 diabetic kidney disease study. Dr. Spana further commented, "We are also excited to commence two new clinical trials in the first half of calendar year 2024, with topline data readouts in the second half of calendar year 2024. The first is a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients. The second is a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i, for the treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy." Fiscal Second Quarter Ended December 31, 2023 Business Highlights and Recent Updates Anti-Inflammatory / Autoimmune Programs (melanocortin agonists) PL9643 MELODY-1 pivotal Phase 3 study for the treatment of dry eye disease (DED) Database lock completed (575 patients enrolled) Topline data readout expected in February Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT04268069 PL8177 Phase 2 oral formulation for the treatment of ulcerative colitis (UC): Interim assessment expected in the second quarter of calendar year 2024 Topline data readout expected in the second half of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Bremelanotide Phase 2 BREAKOUT study (BMT 701) in patients with diabetic kidney disease: Topline results expected in the second quarter of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Metabolic Program (Obesity): Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy: Phase 2 clinical study targeted to start in the first half of calendar year 2024 Topline data readout expected in the second half calendar year 2024 Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar 2024. Sexual Health Program (Male Sexual Dysfunction) Initiation of clinical program framework for the evaluation of bremelanotide co-formulated with PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Phase 2 clinical study in PDE5i non-responder ED patients expected to commence in the first half of calendar year 2024 Topline data readout expected in the second half of calendar year 2024 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD) Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023 for female HSDD: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications Other: Registered Direct Offering: On January 30, 2024, Palatin entered into a securities purchase agreement with healthcare-focused institutional investors, selling and issuing an aggregate of 1,831,503 shares of Palatin common stock, $0.01 par value per share, at a purchase price of $5.46 per share of common stock. Palatin also agreed to issue in a private placement warrants to purchase up to an aggregate of 1,831,503 shares of Palatin common stock at an exercise price of $5.46 per share. The Offering was completed on February 1, 2024, with the Company receiving gross proceeds of $10 million. The Common Warrants are exercisable beginning six months after the date of issuance and will expire on the date that is four years after the closing date. Registered Direct Offering: On October 23, 2023, Palatin entered into a securities purchase agreement with an institutional investor, selling and issuing an aggregate of 2,358,491 shares of Palatin common stock, $0.01 par value per share, 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 2,358,491 shares of Palatin common stock at an exercise price of $2.12 per share. The Offering was completed on October 24, 2023, with the Company receiving gross proceeds of $5 million. The Common Warrants are exercisable beginning six months after the date of issuance and will expire on the date that is five and a half years after the closing date. Fiscal Second Quarter Ended December 31, 2023 Financial Results Revenue Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals. Vyleesi gross product sales to pharmacy distributors for the quarter ended December 31, 2023 were $4.3 million, with net product revenue of $2.0 million, compared to gross product sales of $2.6 million and net product revenue of $1.0 million for the comparable quarter last year. Gross product sales increased 64% and net product revenue increased 98% over the comparable quarter last year. Operating Expenses Total operating expenses were $0.9 million, net of a $7.8 million gain on the sale of Vyleesi, compared to $6.6 million, net of a $1.0 million 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 of Vyleesi to Cosette Pharmaceuticals. Other Income / (Expense) Total other income / (expense), net, 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 a 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, and 2022, Palatin recorded a fair value adjustment loss of $8.1 million and a gain of $5.2 million, respectively. 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 determined the impact is not material, quantitatively or qualitatively, to any prior period impacted. Accordingly, the Company will adjust prior periods as those financial statements are presented for comparative purposes in future filings. On January 24, 2024, the Company and warrant holders amended the terms of the warrants related to the October 2022 and October 2023 financings. As a result, the $11.9 million of warrant liabilities as of December 31, 2023, are expected to be reclassified to additional paid-in capital upon amendment. Cash Flows Palatin's net cash used in operations was $10.5 million, compared to net cash used in operations of $9.7 million for the same period last year. The increase in net cash used in operations is mainly due to the gain on the sale of Vyleesi of $7.8 million and working capital changes, offset by a loss as the result of the change in fair value of liability classified warrants of $8.1 million for the quarter ended December 31, 2023. Net Loss Palatin's net loss was $7.8 million, or $(0.56) per basic and diluted common share, compared to net income of $2.7 million, or $0.25 per basic and diluted common share for the comparable period last year. The change to net loss over the comparable quarter last year was due to several factors, including an increase in net product revenue of Vyleesi of $1.0 million, a gain on the sale of Vyleesi of $7.8 million and the change in fair value of warrant liabilities of $8.1 million of expense, in 2023, and $5.2 million of income in the change in fair value of warrant liabilities and the recognition of an income tax benefit of $4.7 million, in 2022. Cash Position As of December 31, 2023, Palatin's cash, cash equivalents and marketable securities were $9.5 million plus $2.3 million of accounts receivable, compared to cash, cash equivalents and marketable securities of $5.5 million plus $1.3 million of accounts receivable, as of September 30, 2023, and cash, cash equivalents and marketable securities of $11.0 million plus $2.9 million of accounts receivable, as of June 30, 2023. The $9.5 million of cash, cash equivalents and marketable securities as of December 31, 2023, does not include $9.2 million of net proceeds from the Registered Direct Offering, which closed in February 2024. The Company believes that existing cash, cash equivalents, marketable securities and accounts receivable, will be sufficient to fund currently anticipated operating expenses and disbursements into the second half of calendar year 2024. Conference Call / Webcast Palatin will host a conference call and audio webcast on February 15, 2024, 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 1-888-506-0062 (US) or 1-973-528-0011 (International), conference ID 397299. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at or by clicking here. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 49945. The webcast and telephone replay will be available through February 29, 2024. 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 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 market potential of Vyleesi and other 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 trademarks of Palatin Technologies, Inc. View original content to download multimedia: SOURCE Palatin Technologies, Inc. Company Codes: AMEX:PTN

Dry Eye Disease (DED): PL9643 MELODY-1 Phase 3 Study Data Base Lock 2H January 2024 Topline Data Readout Expected Early 1Q Calendar Year 2024 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Data Readout on Track for 1Q Calendar Year 2024 Topline Results Expected in 2Q Calendar Year 2024 Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like Peptide-1 (GLP-1) Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients that do not Respond to PDE5i Monotherapy Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Vyleesi® Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million $12 Million Upfront Plus Sales-Based Milestones of up to $159 Million CRANBURY, N.J., Jan. 8, 2024 /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 provided a corporate update, highlighted the Company's key calendar year 2023 accomplishments and outlined its anticipated calendar year 2024 clinical development milestones. "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin. "Our internal research and development efforts are focused in areas where we believe we have a high probability of success, product differentiation and the opportunity for a substantial return on our investment. Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024. Our Phase 2 study of oral PL8177 in patients with UC is expected to have an interim analysis data readout in the first quarter and topline trial results in the second quarter of calendar year 2024." Dr. Spana further commented, "We are excited by the significant opportunity of melanocortin-based therapeutics for obesity treatment and believe we are well positioned to deliver selective and efficacious MCR4 long-acting peptides and orally active small molecules. We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024. In addition, following on our significant expertise in product development to treat sexual dysfunction, we expect to commence a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients that do not respond to PDE5i monotherapy in the first quarter of calendar year 2024." The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline. Palatin is now focused on developing novel therapeutics that modulate the melanocortin receptor system. Program Updates and Expected Milestones for 2024 Anti-Inflammatory / Autoimmune Programs PL9643 melanocortin agonist Phase 3 study for the treatment of DED: Patient enrollment completed (n=570) in Phase 3 MELODY-1 study Data base lock second half of January 2024 Topline data readout expected early first quarter of calendar year 2024 Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024 PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC: Interim assessment targeted for the first quarter of calendar year 2024 Topline data readout is expected in the second quarter of calendar year 2024 Bremelanotide BREAKOUT Phase 2 study in patients with diabetic kidney disease: Topline data readout is expected in the second quarter of calendar year 2024 Metabolic Program (Obesity) Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist, plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy: Phase 2 clinical study targeted to start in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar year 2024 Sexual Health Program (Male Sexual Dysfunction) Initiated a clinical development program evaluating bremelanotide co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Phase 2 clinical study in PDE5i non-responder ED patients is expected to commence in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD) Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023 for female HSDD: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Eligible to receive regulatory approval milestones of $10.5 million related to Fosun ($7.5M China) and Kwangdong ($3.0M S. Korea) licenses – Kwangdong completed a required Phase 3 study in HSDD patients and is preparing a regulatory approval submission Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists and Inflammation 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. To learn more about Palatin, please visit us on and follow us on 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 agencies 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. SOURCE Palatin Technologies, Inc.