Latest news with #Vivani
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29-05-2025
- Business
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Vivani Medical Announces Filing of Form 10 Registration Statement for Planned Spin-Off of Cortigent Neurostimulation Business to Vivani Shareholders
Transaction is anticipated to be completed in third quarter 2025 Planned Cortigent Nasdaq listing intended to drive value for Vivani and Cortigent stockholders Cortigent is developing the Orion® Visual Cortical Prosthesis System to provide meaningful visual perception to people who are blind Cortigent is developing the Stroke Recovery System to improve the recovery of arm and hand movement in people who have suffered paralysis due to stroke Spin-off will allow Vivani to focus on its continued development of miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with annual or bi-annual dosing ALAMEDA, Calif., May 29, 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 that Cortigent, Inc. ('Cortigent'), a wholly owned subsidiary of the Company that develops brain implant devices to help patients recover critical body functions, has filed a Form 10 registration statement with the U.S. Securities and Exchange Commission ('SEC') to spin off Cortigent as an independent, publicly traded Nasdaq company in third quarter 2025. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. 'Filing the Form 10 registration statement is an important milestone in our journey to establish Cortigent as an independent, publicly traded company dedicated to advancing its pioneering neurostimulation technology,' said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. 'Elon Musk's Neuralink Corp. has brought renewed excitement to the brain implant field, having commenced a six-year Early Feasibility Study of its brain computer interface device in paralyzed patients last year, which study is expected to be complete in 2031. The Orion Visual Cortical Prosthesis System has a U.S. Food and Drug Administration ('FDA') Breakthrough Device designation and completed a six-year Early Feasibility Study in March 2025, with promising safety and efficacy results. Cortigent's proven technology platform also achieved the first and only FDA authorization (under a Humanitarian Device Exemption) for an artificial vision device. This remarkable device, called the Argus II®, was marketed for a rare form of blindness and implanted in hundreds of patients. Establishing Cortigent as an independent public company on Nasdaq will allow Vivani to be fully focused on leveraging our proprietary NanoPortal™ drug implant technology and advance the development of our portfolio of miniature, subdermal GLP-1 implants with annual or bi-annual dosing for chronic weight management, type 2 diabetes, and other chronic diseases.' 'Our plan for Cortigent to trade as an independent public company on Nasdaq will best position Cortigent to accelerate development of the Orion Visual Cortical Prosthesis System and the Stroke Recovery System,' said Cortigent Chief Executive Officer Jonathan Adams, MBA. 'After successfully completing an Early Feasibility Study of Orion in 2025, which is our latest brain implant device for artificial vision, Cortigent is preparing for a pivotal trial of this breakthrough technology. We will advance clinical evaluation of Orion for commercialization and study applying our precision neurostimulation technology to a device for the recovery of arm and hand movement after paralysis due to stroke. We are confident that the important proprietary technology that underpins our platform will also allow us to address other critical unmet medical needs.' Adams has served as Cortigent's CEO since 2023, and prior to joining Cortigent, he founded and was CEO of BioVie Inc., a Nasdaq-listed biopharmaceutical company. He has 35 years of experience in the biopharmaceutical field and with medical devices including technology commercialization, financial management, operations, marketing and sales, and has assisted in the launch of dozens of new drugs and medical devices. Cortigent will continue to be headquartered in the Los Angeles area. Vivani previously announced the submission of a Form S-1 registration statement to support an Initial Public Offering of Cortigent and revised its strategy to file a Form 10 registration statement with the SEC, enabling the spin-off of Cortigent into a separate, publicly traded Nasdaq company subject to listing and regulatory requirements. This approach will allow Vivani stockholders to directly participate in Cortigent's future and enable Vivani to focus exclusively on the development of NanoPortal drug implants. Vivani believes the spin-off of Cortigent will result in two distinct companies that will: focus on and pursue strategic priorities specific to their core commercial therapies and pipeline assets; benefit from separate capital structures and capital allocation strategies; achieve additional operating efficiencies consistent with their respective long-term strategic objectives; and respond more quickly to the rapidly changing developments and global opportunities in their respective patient markets. The spin-off of Cortigent is expected to provide investors with greater visibility into the financial and operational structures of Vivani and Cortigent and a clearer understanding of their respective strategies and risks. Vivani believes creating two stand-alone companies, with dedicated and talented management teams, will provide the necessary foundation for long term value creation for each business. Vivani's board of directors has authorized management to proceed with a plan to spin off its Cortigent neuromodulation business. The spin-off is planned to be completed during third quarter 2025 or otherwise in 2025, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani's board of directors, receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss, as a result of receipt of Cortigent shares, for U.S. Federal Income Tax purposes, and SEC and Nasdaq approval. The spin-off is expected to be accomplished by distributing the requisite number of shares of Cortigent to Vivani stockholders. ThinkEquity is acting as the exclusive financial advisor to Cortigent, Inc. with respect to the spin-off transaction. For more information, please visit: About Cortigent, Inc. Cortigent, Inc., formerly Second Sight Medical Products and a wholly owned subsidiary of Vivani, is developing brain implant devices to help people recover critical body functions. Cortigent is a global leader in precision neurostimulation technology that provides meaningful visual perception ('artificial vision') for blind people. Cortigent previously marketed the Argus II, the first and only artificial vision device approved by the FDA, to treat a rare form of blindness. The Argus II has helped hundreds of profoundly blind people to achieve meaningful visual perception. Cortigent's next generation investigational system, the Orion Visual Cortical Prosthesis System, has been designed to treat blindness due to glaucoma, diabetic retinopathy, and other common causes. Orion has an FDA Breakthrough Device designation and completed a six-year Early Feasibility Study in 2025 with encouraging safety and efficacy results. Cortigent's platform technology combines advanced neuroscience with proprietary microelectronics, software, and data processing capabilities to create medical devices for alleviating serious medical conditions that cannot be treated with drugs. It is protected by an extensive intellectual property estate. Cortigent is also applying its core precision neurostimulation technology to the recovery of arm and hand motion in paralysis due to stroke by its Stroke Recovery System. For more information and patient videos, please visit: 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, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani's emerging pipeline includes NPM-139 (semaglutide implant), which is also under development for chronic weight management. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company's six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. 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 is 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. 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 U.S. 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,' 'planned,' 'positioned,' 'potential,' 'future,' 'allow,' 'intended' and other similar expressions that are 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 development plans for Vivani's products, including NPM-115, NPM-139, NPM-119 or Vivani's plans with respect to Cortigent and its proposed spin-off, 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks that the spin-off will not be completed in a timely manner or at all; risks of failure to satisfy any conditions to the spin-off; risks of failure of the spin-off to qualify for non-recognition of gain or loss for U.S. federal income tax purposes; uncertainty of whether the anticipated benefits of the spin-off can be achieved; risks of unexpected costs or delays; and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Because forward-looking statements relate to the future, they are subject to additional 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, 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 spin-off, Cortigent's history of losses and Cortigent's ability to access additional capital or otherwise fund Cortigent's business and advance its product candidates and pre-clinical programs. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. There may be additional risks that the Company and Cortigent consider 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 SEC on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q and in other reports that the Company has filed with the SEC. Any forward-looking statements made by Vivani or Cortigent in this press release are based only on information currently available to the Company and Cortigent and assumptions that Vivani and Cortigent believe to be reasonable. Any forward-looking statement speaks only as of the date on which it is made. Neither the Company nor Cortigent undertake any 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 866-4012Error in retrieving data Sign in to access your portfolio 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
13-05-2025
- Business
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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
