Latest news with #NPM-139
Yahoo
07-05-2025
- Business
- Yahoo
Vivani Medical to Present at the American Association of Pharmaceutical Scientists' 'Beyond GLP1s: Where the Science will Take Business Next' Virtual Workshop
Leveraging its proprietary NanoPortal platform, Vivani develops therapeutic implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani's lead programs, NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), are miniature, subdermal GLP-1 implants under development for chronic weight management in obese or overweight individuals designed for once or twice-yearly administration. Vivani's emerging pipeline also includes NPM-119, which refers to the Company's six-month, subdermal, GLP-1 (exenatide implant) under development for the treatment of type 2 diabetes. Development of a semaglutide implant for the treatment of type 2 diabetes is also under consideration. These NanoPortal implants are designed to provide patients with the opportunity to experience the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of oral and injectable medications. Story Continues Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature, ultra long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit: Forward-Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that in this press release, including statements regarding Vivani's business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 trial and reporting of trial results, Vivani's emerging development plans for NPM-115, NPM-139, NPM-119, and Vivani's technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani's current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani's control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani's products, including NPM-115, NPM-139, and NPM-119; delays and changes in the development of Vivani's products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani's development activities; risks related to the initiation, enrollment and conduct of Vivani's planned clinical trials and the results therefrom; Vivani's history of losses and Vivani's ability to access additional capital or otherwise fund Vivani's business; market conditions and the ability of Cortigent to complete its intended spin-off from the Company. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission filed on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact: Donald Dwyer Chief Business Officer info@ (415) 506-8462 Investor Relations Contact: Jami Taylor Investor Relations Advisor investors@ (415) 506-8462 Media Contact: Sean Leous ICR Healthcare (646) 866-4012
Yahoo
16-04-2025
- Business
- Yahoo
Vivani Medical to Participate in Virtual Fireside Chat Hosted by H.C. Wainwright & Company
ALAMEDA, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) ('Vivani' or the 'Company'), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced its participation in a virtual fireside chat hosted by Yi Chen, Ph.D., CFA, Managing Director of Equity Research at H.C. Wainwright & Company. As part of the presentation, Vivani CEO Adam Mendelsohn, Ph.D. and CMO Lisa Porter, M.D., will discuss Vivani's LIBERATE-1 clinical trial. LIBERATE-1 is a first-in-human study of NPM-115, the Company's miniature, twice-yearly GLP-1 (exenatide) implant under development for chronic weight management. Vivani anticipates topline data for LIBERATE-1 in mid-year 2025. Details for viewing the fireside chat are as follows: Date: Thursday, April 24, 2025 Time: 10 a.m. Eastern Time Weblink: About Vivani Medical, Inc. Leveraging its proprietary NanoPortal platform, Vivani develops therapeutic implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani's lead programs, NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), are miniature, subdermal GLP-1 implants under development for chronic weight management in obese or overweight individuals designed for once or twice-yearly administration. Vivani's emerging pipeline also includes NPM-119, which refers to the Company's six-month, subdermal, GLP-1 (exenatide implant) under development for the treatment of type 2 diabetes. Development of a semaglutide implant for the treatment of type 2 diabetes is also under consideration. These NanoPortal implants are designed to provide patients with the opportunity to experience the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of oral and injectable medications. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature, ultra long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit: Forward-Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that in this press release, including statements regarding Vivani's business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 trial and reporting of trial results, Vivani's emerging development plans for NPM-115, NPM-139, NPM-119, and Vivani's technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani's current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani's control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani's products, including NPM-115, NPM-139, and NPM-119; delays and changes in the development of Vivani's products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani's development activities; risks related to the initiation, enrollment and conduct of Vivani's planned clinical trials and the results therefrom; Vivani's history of losses and Vivani's ability to access additional capital or otherwise fund Vivani's business; market conditions and the ability of Cortigent to complete its intended spin-off from the Company. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission filed on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@ 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@ 506-8462 Media Contact:Sean LeousICR 866-4012Sign in to access your portfolio
Yahoo
03-04-2025
- Health
- Yahoo
Weight loss implants to increase compliance and cut admin burden for patients
Obesity is a chronic metabolic disease characterised by excess body weight and comorbidities that can become life-threatening. The obesity treatment landscape has immensely improved in the past few years, but compliance remains a problem for patients. According to GlobalData, the next generation of obesity therapies will see candidates improving patients' experience, from higher tolerability profiles to lower dosage frequency and better routes of administration. Vivani Medical, an emerging biopharmaceutical company in the metabolic diseases space, is developing subdermal implants that are changed once or twice per year, delivering GLP-1R agonist with no need for a weekly injection. Thanks to their NanoPortal implant technology, NPM-115 and NPM-139 will soon be able to deliver exenatide and semaglutide respectively in patients with obesity. The company has recently completed enrolment for its first-in-human trial, LIBERATE-1, investigating NPM-115. A trial of NPM-139 is expected to follow in due course. In late March 2025, results from NPM-139's preclinical study were announced. It confirmed that the treatment resulted in close-to-20% placebo-adjusted weight loss from a single administration and that this semaglutide implant could be eligible for once-yearly administration. Key opinion leaders (KOLs) interviewed by GlobalData have stated that a twice-yearly or once-yearly therapy administration would be a great improvement from the current once-weekly administration. While a once-monthly injection is not seen as a major difference, experts seem enthusiastic about longer interval options. The self-administering nature of injection pens is not ideal, according to KOLs, as dosing errors can occur and patients can forget about them. Instead, a once or twice-yearly injection could be performed by a doctor or in a hospital setting, reducing patient responsibility and risk of error. The application of the implant will likely be different to a small subcutaneous injection, so patients' perspectives on the implant administration experience will be crucial for treatment uptake and the perception of these candidates. Reduced frequency of administration is very encouraging for patient compliance, and if the implant delivery is smooth and safe, it could secure a large number of patients who are adverse to weekly injections and self-administration. This is especially beneficial as they are likely to need lifelong treatment. "Weight loss implants to increase compliance and cut admin burden for patients" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
