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Yahoo
14-05-2025
- Business
- Yahoo
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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Perth Now
12-05-2025
- Health
- Perth Now
Weight-loss jabs could prevent obesity-related cancers
Weight-loss jabs could cut the risk of obesity-related cancers. Experts in Israel analysed data from 6,356 people - with around half of the volunteers having had bariatric surgery, which modifies the digestive system to lower food intake, and the rest took slimming jabs - and after an average follow-up of 7.5 years, 298 patients were found to have had obesity-related cancers. Weight-loss jabs, or GLP-1-based medicines, such as tirzepatide - act like the glucose hormone GLP-1 by decreasing appetite and increasing feelings of fullness. And researchers, who presented the findings - which are in the journal eClinicalMedicine - at the European Congress on Obesity in Malaga, Spain, said "new generation, highly potent GLP1-RAs with higher efficacy in weight reduction" such as Wegovy, can produce could result in an "even greater advantage" of reducing obesity-related cancers. Study co-lead and author Professor Dror Dicker, from Rabin Medical Center in Israel, said: "New generation, highly potent GLP1-RAs with higher efficacy in weight reduction may convey an even greater advantage in reducing the risk of obesity-related cancers."
Miami Herald
08-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review
With valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing. MIAMI, FLORIDA / ACCESS Newswire / May 8, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, Inc. (the "Merger"), following the completion of independent valuation reports on both companies. The Merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting ("Moore") assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5 million, based on a risk-adjusted net present value (rNPV) of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30 million, further validating the strength and synergy of the combined pipeline. As outlined in the previously announced binding letter of intent for the merger between MIRA and SKNY-1, upon the closing, SKNY must hold at least $5 million in cash or other assets, to be transferred at closing, and the Company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. As MIRA advances this merger, the combined enterprise value (based on Moore's valuations) of over $60 million represents a strong platform for expansion into high-value therapeutic markets. According to MIRA CEO Erez Aminov, the acquisition "brings together two pipelines, two market opportunities, and one unified strategy, developing targeted, first-in-class therapies for urgent public health needs." Targeting Major Markets with a Differentiated Mechanism SKNY-1 is being developed as a next-generation oral therapeutic designed to modulate CB1 and CB2 cannabinoid receptors, as well as monoamine oxidase B (MAO-B)-an enzyme involved in dopamine metabolism and addiction regulation. This multi-target mechanism is being evaluated for its potential to address both metabolic dysfunction and nicotine dependence, providing a differentiated therapeutic alternative in two of the most urgent health markets globally. The global weight loss drug market is projected to surpass $150 billion by 2030, driven by growing demand for safer and more tolerable alternatives to GLP-1-based injectables (Source: Reuters).The U.S. smoking cessation market is projected to grow from $28.11 billion in 2024 to $50.90 billion by 2030, at a CAGR of 10.4% (Source: Grand View Research). These are large, underserved markets with limited innovation, and MIRA's leadership believes the addition of SKNY-1 to the Company's pipeline enhances its ability to compete in both. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, noted that SKNY-1's pharmacological profile, particularly its combined activity on both MAO-B and cannabinoid receptors, makes it a unique and promising candidate for craving, addiction and metabolic conditions with a sound neurochemical basis. "From a scientific perspective, this is a rationally designed molecule that addresses the biological complexity of both obesity and addiction," said Dr. Angel. "The early data are promising, and I'm looking forward to advancing its development." Strategic Value for the Future With both companies independently valued by Moore at approximately $30 million, MIRA believes this transaction creates a platform with scale, differentiated science, and a pipeline built to target urgent unmet needs. The Company views this merger as a foundation for long-term growth and innovation. Additional information about MIRA Pharmaceuticals is available at Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
CairoScene
17-04-2025
- Health
- CairoScene
Saudi-Born Startup Kilow Launches Arabic-Language Weight Loss App
Saudi-Born Startup Kilow Launches Arabic-Language Weight Loss App Saudi health tech startup Kilow has officially launched its Arabic-language platform, offering a personalised, all-in-one digital weight loss solution tailored to local lifestyles. The app, now available across Saudi Arabia, merges smart health tracking, expert-led lifestyle coaching, and access to licensed medical care—including GLP-1-based weight loss medication, when appropriate. Kilow was founded by Fahed Al Essa, a four-time startup founder and digital health expert whose background spans biotech, public health, and clinical operations. Developed entirely in Saudi Arabia, the app is designed to reflect the specific habits, food cultures, and behavioural patterns of users in the Kingdom. 'This isn't just another weight loss app,' says Al Essa. 'It's built by people who understand the Saudi lifestyle and the health challenges we face. For me, Kilow is deeply personal—after years of struggling with my weight, I finally feel like I've found a solution that works, and I wanted to share that with others.' Users begin with a brief onboarding process and receive a free medical consultation. Approved participants can select flexible plans ranging from one to six months, with options that include home-delivered medication, lab testing kits, and ongoing tracking of nutrition, movement, and sleep. Beyond standard diet coaching, Kilow is grounded in science-backed, culturally relevant interventions. 'If you tell someone in the GCC to stop eating rice, they probably won't. But if you teach them how to eat rice better, that's where we specialize,' Al Essa adds. 'We don't want to overhaul your life. We give you small, practical tools—like having vinegar before your rice meal to reduce blood sugar spikes. Tiny changes. Big effect.' The launch comes at a time when Saudi Arabia is increasingly prioritising wellness and preventative care as part of Vision 2030. Kilow plans to expand regionally and is preparing to raise its first funding round in the coming weeks. Future features include AI-powered meal feedback, wearable integrations, and adaptive coaching tools based on biometric data. The company is also working on precision health modules that will incorporate genetic testing, hormonal profiling, and predictive health scoring to flag plateau phases before they occur.
Yahoo
07-04-2025
- Health
- Yahoo
Ypsomed and Sidekick Health launch a collaborative digital health solution for obesity management
NEW YORK, April 7, 2025 /PRNewswire/ -- Ypsomed and Sidekick Health are launching an integrated digital health solution to better support people with obesity. Ypsomed's autoinjectors seamlessly integrate into Sidekick's digital health and chronic condition support app to help patients using GLP-1-based injectable therapies manage their treatment more effectively. In this digital health solution the SmartPilot, an intelligent add-on for YpsoMate autoinjectors, is paired with the Sidekick app. This allows users, medical professionals, and pharma companies to see real-time injection data on time and date, duration, and correctness of administration, while simultaneously supporting users with wrap-around disease education and selfcare support. The challenge of obesity: support for a complex chronic conditionObesity is a complex, multifaceted chronic condition that demands holistic care and affects hundreds of millions of people worldwide. Despite the transformative potential of GLP-1 therapies, many patients struggle with selfcare-management. They face challenges such as managing side effects, understanding their condition, and adhering to medication titration schedules. As a result, many fail to reach their therapeutic potential, which limits the effectiveness of GLP-1 therapies. A tailored digital solution for obesity management By improving adherence and persistence, this integrated solution aims to unlock the full health potential of GLP-1 therapies, including sustained weight loss, and reductions in cardiovascular and metabolic risks. Key features include: Patient education: Resources to help patients better understand obesity as a condition, manage medication titration, and set realistic expectations for treatment outcomes. Lifestyle and behavioral support: Personalised, engaging content based on behavioral health principles to empower patients throughout their treatment journey, including symptom tracking, nutritional guidance, physical activity coaching, and tools to enhance sleep, and manage stress. Injection support: A dedicated injection guide designed to simplify and optimise the injection process, including a reminder function, step-by-step instructions, feedback on whether the injection has been conducted correctly, and addressing needle-related concerns. The solution offers a robust technical platform for pharmaceutical companies to deliver an enhanced patient experience by integrating therapy and injection procedures while supporting patient behavior tracking. Ypsomed's smart devices collect real-time adherence data, generating high-quality real-world data to optimise therapy. "This collaboration with Sidekick Health enables us to empower patients with knowledge, real-time insights and smarter therapy management, improving long-term health outcomes. By connecting our smart injection devices, real-time data can be collected to track therapy. This allows our pharma customers to continually improve the treatment of obesity," said Ulrike Bauer, Chief Business Officer of Ypsomed Delivery Systems. "This partnership exemplifies our commitment to leveraging technology to address critical gaps in chronic condition management. Our partnership with Ypsomed underscores our shared commitment to transforming the treatment journey for people with obesity and enhancing patient outcomes," said Dr. Tryggvi Thorgeirsson, CEO of Sidekick Health. For more details on this collaboration and how digital health enhances the management of chronic conditions, visit ContactManda Bertrand, Sidekick Health+1 212 930 8555press@ Sidekick HealthSidekick Health is a digital health and therapeutics innovator founded by two passionate medical doctors on a mission to improve the health of humanity. Sidekick provides a uniquely wide range of digital health programs (including oncology, cardiovascular, metabolic, inflammatory, and other chronic conditions), engaging and empowering people to make positive changes, and improve their health outcomes and quality of life. Sidekick works with health insurers, including leading national US health plans, and pharmaceutical companies, including half of the 10 leading Life Sciences companies, to improve patient outcomes, drive clinical efficiency, and lower the cost of care. To learn more, visit View original content to download multimedia: SOURCE Sidekick Health Sign in to access your portfolio
