Latest news with #NanoPortal
Yahoo
13-05-2025
- Business
- Yahoo
Vivani Medical Provides Business Update Including $3M Equity Financing and Reports First Quarter 2025 Financial Results
ALAMEDA, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ('Vivani' or the 'Company'), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, today reported financial results for the first quarter ended March 31, 2025, and provided a business update including a $3M equity financing. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, 'Our ongoing first-in-human study, LIBERATE-1, remains on track to deliver key data in mid-2025 with the aim of validating our proprietary NanoPortal™ implant technology and enabling us to advance our portfolio of exenatide and semaglutide based drug implants in clinical development. The study enrolled ahead of schedule, and all NPM-115 (exenatide implant) insertions were successful.' Dr. Mendelsohn added, 'While the GLP-1 market continues to grow and mature, it is clear that meaningful differentiation will be required for commercial success of new market entrants, in part because of the significant clinical benefits delivered by the currently available GLP-1 therapies. We remain confident that our emerging portfolio of convenient, miniature, subdermal drug implants with once- or twice-yearly dosing will stand out as a highly differentiated and sought-after alternative GLP-1 treatment option for patients and providers, with the potential to substantially improve patient outcomes by addressing poor medication adherence and patient tolerability.' Recent Business Highlights On May 12, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 2,912,621 shares, each at a price of $1.03 per share, expected to result in gross proceeds of approximately $3.0 million in a private placement. On April 15, 2025, Vivani and Okava Pharmaceuticals, Inc. ('Okava'), a clinical-stage company focused on the treatment of age-related diseases in dogs and cats, announced an expansion of their collaboration focused on cats that was initiated in 2019, to now include dogs in the development of OKV-119, a long-acting GLP-1 therapy that leverages Vivani's NanoPortal technology for weight management, diabetes and other cardiometabolic conditions On March 27, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 7,366,071 shares, each at a price of $1.12 per share, expected to result in gross proceeds of approximately $8.25 million in a private placement. On March 26, 2025, Vivani announced promising preclinical data for NPM-139, its subdermal semaglutide implant under development for chronic weight management in obese and overweight individuals. These results reinforce the Company's commitment to addressing chronic weight management and other chronic diseases by leveraging its NanoPortal implant technology designed to enable smooth and steady delivery of therapeutic molecules, including GLP-1 therapy. On March 13, 2025, Vivani announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marked a critical step toward addressing one of healthcare's most pressing challenges: medication adherence in the treatment of metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal exenatide implant and reaffirming previous estimates that top-line results should be available in mid-2025. On March 12, 2025, Vivani announced that it intends to spin off Cortigent, Inc., a division of the Company that develops brain implant devices to help patients recover critical body functions, as an independent publicly traded company. The strategic goal of this transaction intends to create two companies that are focused and dedicated to driving current and future value in their respective therapeutic areas of expertise. Upcoming Anticipated Milestones Vivani anticipates top-line data from the LIBERATE-1 study in mid-2025. LIBERATE-1 is a Phase 1 study of a miniature, ultra long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability and full pharmacokinetic profile in obese or overweight subjects. Vivani plans to participate in the BIO International Convention hosted in Boston, MA from June 16 to 19, 2025. Dr. Mendelson will provide a Company presentation during the Convention, in addition to participating in partnering activities with potential investors and strategic partners alongside Vivani Chief Business Officer Don Dwyer. First Quarter 2025 Financial Results Cash balance: As of March 31, 2025, Vivani had cash, cash equivalents and restricted cash totaling $14.3 million, compared to $19.7 million as of December 31, 2024. The decrease of $5.4 million is attributed to a net loss of $6.3 million, partially offset by a $0.6 million net change to operating assets and liabilities, and non-cash items totaling $0.5 million for depreciation and amortization of property and equipment, stock-based compensation and lease expenses. Research and development expense: Research and development expense during the three months ended March 31, 2025 was $4.2 million, compared to $3.7 million during the three months ended March 31, 2024. The increase of $0.5 million, or 13%, was primarily attributable to increased research and development expenses from our Biopharma division. General and administrative expense: General and administrative expense during the three months ended March 31, 2025 was $2.3 million, compared to $2.5 million during the three months ended March 31, 2024. The decrease of $0.2 million, or 6%, was attributable to reduced professional services and personnel expenses from our Biopharma division. Other income, net: Other income, net during the three months ended March 31, 2025 was $0.3 million, compared to $0.2 million during the three months ended March 31, 2024. The change was not significant. Net Loss: The net loss during the three months ended March 31, 2025 was $6.3 million, compared to $6.0 million during the three months ended March 31, 2024. The increase in net loss of $0.3 million was primarily attributable to an increase in operating expenses of $0.3 million. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical 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 program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight subjects. Vivani's emerging pipeline also includes NPM-139 (semaglutide implant), which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly dosing. NPM-119 refers to the Company's type 2 diabetes development program utilizing a six-month, subdermal exenatide implant. Both the NPM-115 and NPM-119 programs utilize exenatide, based products with a higher-dose associated with the NPM-115 program for chronic weight management in obese or overweight patients. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. 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 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 long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. About Cortigent, Inc. Vivani's wholly owned subsidiary, Cortigent, Inc. ('Cortigent'), is developing precision neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion®, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. Cortigent has developed, manufactured, and marketed an implantable visual prosthetic device, Argus II®, that delivered meaningful visual perception to blind individuals. Vivani continues to assess strategic options for advancing Cortigent's pioneering technology. 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 initiation of the LIBERATE-1 trial and reporting of trial results, Vivani's emerging development plans for NPM-115, NPM-139, or Vivani's plans with respect to Cortigent and its proposed initial public offering, 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 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, including Vivani's ability to commence clinical development of NPM-119; 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 initial public offering. 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 866-4012VIVANI MEDICAL, SUBSIDIARIES Condensed Consolidated Balance Sheets (unaudited)(in thousands, except per share data) March 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 13,008 $ 18,352 R&D tax credit incentive receivable 175 253 Prepaid expenses and other current assets 1,667 1,837 Total current assets 14,850 20,442 Property and equipment, net 1,609 1,693 Operating lease right-of-use assets, net 17,523 17,957 Restricted cash 1,338 1,338 Other assets 132 131 Total assets $ 35,452 $ 41,561 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,004 $ 817 Accrued expenses 1,859 1,803 Litigation accrual 1,675 1,675 Accrued compensation expense 350 343 Current operating lease liabilities 1,311 1,348 Total current liabilities 6,199 5,986 Long-term operating lease liabilities 17,629 17,965 Total liabilities 23,828 23,951 Commitments and contingencies (Note 12) Stockholders' equity: Preferred stock, par value $0.0001 per share; 10,000 shares authorized; none outstanding - - Common stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 59,244 and 59,235 at March 31, 2025 and December 31, 2024, respectively 6 6 Additional paid-in capital 139,802 139,480 Accumulated other comprehensive income 42 48 Accumulated deficit (128,226 ) (121,924 ) Total stockholders' equity 11,624 17,610 Total liabilities and stockholders' equity $ 35,452 $ 41,561 VIVANI MEDICAL, SUBSIDIARIES Condensed Consolidated Statements of Operations (unaudited)(in thousands, except per share data) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development, net of grants $ 4,217 $ 3,726 General and administrative, net of grants 2,340 2,501 Total operating expenses 6,557 6,227 Loss from operations (6,557 ) (6,227 ) Other income, net 255 188 Net loss $ (6,302 ) $ (6,039 ) Net loss per common share - basic and diluted $ (0.11 ) $ (0.12 ) Weighted average common shares outstanding - basic and diluted 59,236 52,202 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
Yahoo
13-05-2025
- Business
- Yahoo
Vivani Medical Provides Business Update Including $3M Equity Financing and Reports First Quarter 2025 Financial Results
ALAMEDA, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ('Vivani' or the 'Company'), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, today reported financial results for the first quarter ended March 31, 2025, and provided a business update including a $3M equity financing. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, 'Our ongoing first-in-human study, LIBERATE-1, remains on track to deliver key data in mid-2025 with the aim of validating our proprietary NanoPortal™ implant technology and enabling us to advance our portfolio of exenatide and semaglutide based drug implants in clinical development. The study enrolled ahead of schedule, and all NPM-115 (exenatide implant) insertions were successful.' Dr. Mendelsohn added, 'While the GLP-1 market continues to grow and mature, it is clear that meaningful differentiation will be required for commercial success of new market entrants, in part because of the significant clinical benefits delivered by the currently available GLP-1 therapies. We remain confident that our emerging portfolio of convenient, miniature, subdermal drug implants with once- or twice-yearly dosing will stand out as a highly differentiated and sought-after alternative GLP-1 treatment option for patients and providers, with the potential to substantially improve patient outcomes by addressing poor medication adherence and patient tolerability.' Recent Business Highlights On May 12, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 2,912,621 shares, each at a price of $1.03 per share, expected to result in gross proceeds of approximately $3.0 million in a private placement. On April 15, 2025, Vivani and Okava Pharmaceuticals, Inc. ('Okava'), a clinical-stage company focused on the treatment of age-related diseases in dogs and cats, announced an expansion of their collaboration focused on cats that was initiated in 2019, to now include dogs in the development of OKV-119, a long-acting GLP-1 therapy that leverages Vivani's NanoPortal technology for weight management, diabetes and other cardiometabolic conditions On March 27, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 7,366,071 shares, each at a price of $1.12 per share, expected to result in gross proceeds of approximately $8.25 million in a private placement. On March 26, 2025, Vivani announced promising preclinical data for NPM-139, its subdermal semaglutide implant under development for chronic weight management in obese and overweight individuals. These results reinforce the Company's commitment to addressing chronic weight management and other chronic diseases by leveraging its NanoPortal implant technology designed to enable smooth and steady delivery of therapeutic molecules, including GLP-1 therapy. On March 13, 2025, Vivani announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marked a critical step toward addressing one of healthcare's most pressing challenges: medication adherence in the treatment of metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal exenatide implant and reaffirming previous estimates that top-line results should be available in mid-2025. On March 12, 2025, Vivani announced that it intends to spin off Cortigent, Inc., a division of the Company that develops brain implant devices to help patients recover critical body functions, as an independent publicly traded company. The strategic goal of this transaction intends to create two companies that are focused and dedicated to driving current and future value in their respective therapeutic areas of expertise. Upcoming Anticipated Milestones Vivani anticipates top-line data from the LIBERATE-1 study in mid-2025. LIBERATE-1 is a Phase 1 study of a miniature, ultra long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability and full pharmacokinetic profile in obese or overweight subjects. Vivani plans to participate in the BIO International Convention hosted in Boston, MA from June 16 to 19, 2025. Dr. Mendelson will provide a Company presentation during the Convention, in addition to participating in partnering activities with potential investors and strategic partners alongside Vivani Chief Business Officer Don Dwyer. First Quarter 2025 Financial Results Cash balance: As of March 31, 2025, Vivani had cash, cash equivalents and restricted cash totaling $14.3 million, compared to $19.7 million as of December 31, 2024. The decrease of $5.4 million is attributed to a net loss of $6.3 million, partially offset by a $0.6 million net change to operating assets and liabilities, and non-cash items totaling $0.5 million for depreciation and amortization of property and equipment, stock-based compensation and lease expenses. Research and development expense: Research and development expense during the three months ended March 31, 2025 was $4.2 million, compared to $3.7 million during the three months ended March 31, 2024. The increase of $0.5 million, or 13%, was primarily attributable to increased research and development expenses from our Biopharma division. General and administrative expense: General and administrative expense during the three months ended March 31, 2025 was $2.3 million, compared to $2.5 million during the three months ended March 31, 2024. The decrease of $0.2 million, or 6%, was attributable to reduced professional services and personnel expenses from our Biopharma division. Other income, net: Other income, net during the three months ended March 31, 2025 was $0.3 million, compared to $0.2 million during the three months ended March 31, 2024. The change was not significant. Net Loss: The net loss during the three months ended March 31, 2025 was $6.3 million, compared to $6.0 million during the three months ended March 31, 2024. The increase in net loss of $0.3 million was primarily attributable to an increase in operating expenses of $0.3 million. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical 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 program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight subjects. Vivani's emerging pipeline also includes NPM-139 (semaglutide implant), which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly dosing. NPM-119 refers to the Company's type 2 diabetes development program utilizing a six-month, subdermal exenatide implant. Both the NPM-115 and NPM-119 programs utilize exenatide, based products with a higher-dose associated with the NPM-115 program for chronic weight management in obese or overweight patients. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. 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 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 long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. About Cortigent, Inc. Vivani's wholly owned subsidiary, Cortigent, Inc. ('Cortigent'), is developing precision neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion®, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. Cortigent has developed, manufactured, and marketed an implantable visual prosthetic device, Argus II®, that delivered meaningful visual perception to blind individuals. Vivani continues to assess strategic options for advancing Cortigent's pioneering technology. 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 initiation of the LIBERATE-1 trial and reporting of trial results, Vivani's emerging development plans for NPM-115, NPM-139, or Vivani's plans with respect to Cortigent and its proposed initial public offering, 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 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, including Vivani's ability to commence clinical development of NPM-119; 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 initial public offering. 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 866-4012VIVANI MEDICAL, SUBSIDIARIES Condensed Consolidated Balance Sheets (unaudited)(in thousands, except per share data) March 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 13,008 $ 18,352 R&D tax credit incentive receivable 175 253 Prepaid expenses and other current assets 1,667 1,837 Total current assets 14,850 20,442 Property and equipment, net 1,609 1,693 Operating lease right-of-use assets, net 17,523 17,957 Restricted cash 1,338 1,338 Other assets 132 131 Total assets $ 35,452 $ 41,561 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,004 $ 817 Accrued expenses 1,859 1,803 Litigation accrual 1,675 1,675 Accrued compensation expense 350 343 Current operating lease liabilities 1,311 1,348 Total current liabilities 6,199 5,986 Long-term operating lease liabilities 17,629 17,965 Total liabilities 23,828 23,951 Commitments and contingencies (Note 12) Stockholders' equity: Preferred stock, par value $0.0001 per share; 10,000 shares authorized; none outstanding - - Common stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 59,244 and 59,235 at March 31, 2025 and December 31, 2024, respectively 6 6 Additional paid-in capital 139,802 139,480 Accumulated other comprehensive income 42 48 Accumulated deficit (128,226 ) (121,924 ) Total stockholders' equity 11,624 17,610 Total liabilities and stockholders' equity $ 35,452 $ 41,561 VIVANI MEDICAL, SUBSIDIARIES Condensed Consolidated Statements of Operations (unaudited)(in thousands, except per share data) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development, net of grants $ 4,217 $ 3,726 General and administrative, net of grants 2,340 2,501 Total operating expenses 6,557 6,227 Loss from operations (6,557 ) (6,227 ) Other income, net 255 188 Net loss $ (6,302 ) $ (6,039 ) Net loss per common share - basic and diluted $ (0.11 ) $ (0.12 ) Weighted average common shares outstanding - basic and diluted 59,236 52,202 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
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
15-04-2025
- Health
- Yahoo
Vivani Medical and Okava Expand Collaboration to Develop OKV-119 for Dogs, Targeting Metabolic Health and Longevity
Over half of all dogs in the United States today are overweight or obese, placing them at increased risk for chronic diseases, metabolic decline and shortened lifespans ALAMEDA, Calif. and SAN FRANCISCO, April 15, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, and Okava Pharmaceuticals, Inc. ("Okava"), a clinical-stage company focused on diseases of aging in dogs and cats, today announced an expansion of their collaboration to include dogs in the development of OKV-119, a long-acting GLP-1 therapy for weight management, diabetes and other cardiometabolic conditions. Vivani and Okava initiated their collaboration in 2019, with a focus on developing OKV-119 for cardiometabolic conditions in cats. OKV-119 leverages Vivani's proprietary NanoPortal™ technology, which provides smooth and steady delivery of therapeutic molecules, including GLP-1 receptor agonists, over extended periods from a single implant. According to Okava, dosing every six months or longer supports a 'One-and-Done' approach between office visits consistent with the product profile of Vivani's NPM-115, an ultra long-acting GLP-1 implant in clinical stage development to improve medication adherence and tolerability for the treatment of chronic weight management in humans. "Caloric restriction, or fasting, is one of the most well-established interventions for extending the lifespan and improving metabolic health in dogs," said Okava CEO Michael Klotsman, PhD, MBA. "But it is also one of the hardest to maintain. OKV-119 mimics many of the physiological effects of fasting—improved insulin sensitivity, reduced fat mass and more efficient energy metabolism—without requiring significant changes in feeding routines or disrupting the human-animal bond that often centers around food." Over half of all dogs in the United States today are overweight or obese, placing them at increased risk for chronic disease, metabolic decline and shortened lifespans. Similar to the changes humans face as they grow older, aging dogs experience declines in metabolic fitness, leading to weight gain, insulin resistance and loss of muscle mass. Research shows that leaner dogs can live more than two years longer than their heavier counterparts. By restoring and maintaining a healthy metabolism through a single, long-acting dose, OKV-119 has the potential to enhance quality of life, promote healthy aging and become the most impactful life-extending therapy available for dogs. "This collaboration aligns with Vivani's broader mission to develop innovative medicines that will revolutionize the treatment of chronic diseases by leveraging proprietary drug delivery technologies," said Vivani CEO Adam Mendelsohn, PhD. "This expanded partnership with Okava reflects our shared confidence in the potential of NanoPortal technology to serve a broad array of prospective beneficiaries in the management of metabolic disease. The structure of this expanded partnership minimizes costs and risks for Vivani while integrating upside potential for Vivani shareholders through future milestone payments and royalties. Together with Okava, we are broadening the reach of our technology, meeting unmet needs in veterinary medicine while positioning Vivani to capture future value within an industry segment experiencing continued and unprecedented growth." Financial terms of the expanded agreement were not disclosed. 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: About Okava Pharmaceuticals, Inc. OKAVA is a clinical-stage research and development company that develops new treatment options for dogs and cats suffering from chronic diseases of aging. OKAVA is building a portfolio of products to transform and humanize standards of care in veterinary medicine. By harnessing human technologies for the treatment of common diseases in household pets, the company has the potential of increasing the lifespans of dogs and cats by an average of 1 to 3 years. OKAVA is a private company headquartered in San Francisco, California. For more information, see 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,' 'future,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 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 ongoing clinical trial and reporting of trial results, Vivani's emerging development plans for its products, Vivani's collaboration agreement with Okava, 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; 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 SEC 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. Vivani Contacts: Company Contact:Donald DwyerChief Business Officerinfo@ 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@ 506-8462 Media Contact:Sean LeousICR 866-4012 Okava Contacts: Investor Relations Contact:Jami TaylorInvestor Relations Advisorpr@ 506-8462
