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VANI

Vivani MedicalF
Nasdaq / Health Care Equipment & Services
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2026-08-13
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Investor releaseQuarter not tagged2026-08-13

Vivani Medical: Q2 Earnings Snapshot

Associated Press

ALAMEDA, Calif. (AP) — ALAMEDA, Calif. (AP) — Vivani Medical, Inc. (VANI) on Thursday reported a loss of $6.4 million in its second quarter. The Alameda, California-based company said it had a loss of 7 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VANI at https://www.zacks.com/ap/VANI

Investor releaseQuarter not tagged2026-08-13

Vivani Medical Reports Second Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
All participants successfully dosed in SLIM-1™, the Company's first-in-human Phase 1 trial of NPM-139, a miniature, ultra long-acting semaglutide implant for chronic weight management; top-line data expected in November 2026 Company entered into non-exclusive agreement with Novo Nordisk to evaluate NPM-139 and Vivani's proprietary NanoPortal™ technology Completion of the Cortigent-ClearOne merger into Cortigent Holdings and initiation of trading on the Nasdaq exchange under ticker symbol CRGT anticipated in the third quarter of 2026 ALAMEDA, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants utilizing its proprietary NanoPortal™ technology, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress. "I am very pleased with the progress and achievements that Vivani made in all aspects of our business during the second quarter of 2026. We accelerated clinical development of lead asset NPM-139 (semaglutide implant), entered into a non-exclusive agreement with Novo Nordisk enabling them to evaluate NPM-139, and signed a merger agreement with Nasdaq-listed ClearOne which, upon successful closing, would finance and establish our neurostimulation subsidiary Cortigent as a stand-alone publicly traded company," said Adam Mendelsohn, Ph.D., CEO of Vivani Medical. "We enrolled and dosed all 20 SLIM-1 participants ahead of schedule, with every insertion procedure completed successfully. We expect to be able to share top-line data in November, an exciting milestone that we anticipate will support advancing NPM-139 into a Phase 2 dose-ranging trial in 2027. Combined with the agreement with Novo Nordisk announced in July, these positive developments further strengthen our conviction in the potential of our pipeline to transform chronic disease management for the roughly half of patients who struggle with medication adherence. Today, Vivani remains the only developer of convenient, ultra-long-acting and reversible GLP-1 candidates with the potential for administration once or twice yearly during a routine primary care office visit." Vivani’s NanoPortal implant technology has the potential to enable patients to maintain continuous and therapeutic drug exposure levels…Read full document

All participants successfully dosed in SLIM-1™, the Company's first-in-human Phase 1 trial of NPM-139, a miniature, ultra long-acting semaglutide implant for chronic weight management; top-line data expected in November 2026 Company entered into non-exclusive agreement with Novo Nordisk to evaluate NPM-139 and Vivani's proprietary NanoPortal™ technology Completion of the Cortigent-ClearOne merger into Cortigent Holdings and initiation of trading on the Nasdaq exchange under ticker symbol CRGT anticipated in the third quarter of 2026 ALAMEDA, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants utilizing its proprietary NanoPortal™ technology, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress. "I am very pleased with the progress and achievements that Vivani made in all aspects of our business during the second quarter of 2026. We accelerated clinical development of lead asset NPM-139 (semaglutide implant), entered into a non-exclusive agreement with Novo Nordisk enabling them to evaluate NPM-139, and signed a merger agreement with Nasdaq-listed ClearOne which, upon successful closing, would finance and establish our neurostimulation subsidiary Cortigent as a stand-alone publicly traded company," said Adam Mendelsohn, Ph.D., CEO of Vivani Medical. "We enrolled and dosed all 20 SLIM-1 participants ahead of schedule, with every insertion procedure completed successfully. We expect to be able to share top-line data in November, an exciting milestone that we anticipate will support advancing NPM-139 into a Phase 2 dose-ranging trial in 2027. Combined with the agreement with Novo Nordisk announced in July, these positive developments further strengthen our conviction in the potential of our pipeline to transform chronic disease management for the roughly half of patients who struggle with medication adherence. Today, Vivani remains the only developer of convenient, ultra-long-acting and reversible GLP-1 candidates with the potential for administration once or twice yearly during a routine primary care office visit." Vivani’s NanoPortal implant technology has the potential to enable patients to maintain continuous and therapeutic drug exposure levels with convenient once- or twice-yearly administration while still enabling the ability to rapidly reverse GLP-1 drug exposure in patients when cessation of therapy is needed or desired. Reversibility can be an important clinical consideration in certain situations including when a woman becomes pregnant or when patients undergoing surgery have an increased aspiration risk. Recent Business Highlights On August 6, 2026, Vivani announced full enrollment and successful initial dosing of all participants in its SLIM-1™ Phase 1 trial for NPM-139, a miniature, subdermal semaglutide implant designed to provide six- to twelve-months of continuous drug delivery utilizing its proprietary NanoPortal™ technology. The trial of 20 GLP-1 naïve participants in Australia includes low-doses of NPM-139 and Wegovy® to assess safety, tolerability, and pharmacokinetics. Changes in weight will be measured. Top-line data from SLIM-1 are expected in November 2026, which the Company anticipates will pave the way for initiation of a Phase 2 dose-ranging trial in 2027. On July 7, 2026, the Company announced the signing of an agreement with Novo Nordisk to enable Novo Nordisk to evaluate NPM-139, the Company’s semaglutide drug implant. NPM-139, which utilizes Vivani’s NanoPortal™ platform technology, is under development for chronic weight management. There are no exclusivity provisions for NPM-139 or Vivani’s proprietary NanoPortal technology associated with this agreement. Also in July 2026, Vivani announced that its wholly owned subsidiary Cortigent, Inc., a developer of brain-computer interface devices based on precision neurostimulation technology, entered into a definitive merger agreement with Nasdaq-listed ClearOne, Inc. The transaction, which is expected to close in the third quarter of 2026 subject to customary closing conditions, is designed to establish Cortigent as a separately listed public company, reduce Vivani's direct expenditures related to Cortigent, and enable the Vivani team to focus fully on advancing its portfolio of miniature, ultra long-acting drug implants. On June 26, 2026, the Company announced the appointment of August J. Moretti to its board of directors. Mr. Moretti joins the board with extensive operating and financial executive experience spanning all phases of company growth. Mr. Moretti served as CFO of 4D Molecular Therapeutics from 2019 until his retirement. Prior to this he held CFO positions at Assertio Therapeutics until its acquisition by Zydus Lifesciences; Alexza Pharmaceuticals until its acquisition by Ferrer Pharmaceuticals; and Alavita, Inc. Mr. Moretti holds a B.A. in Economics from Princeton University and a J.D. from Harvard Law School. On June 25, 2026, Vivani announced that it had received approval from Bellberry, a human research ethics committee (HREC) in Australia to initiate SLIM-1™, a Phase 1 clinical trial of NPM-139, a semaglutide implant. Upcoming Anticipated Milestones Completion of SLIM-1, the on-going Phase 1 study of low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, and anticipated reporting of top-line results in November 2026. Preparation, and submission of an Investigational New Drug (“IND”) Application for NPM-139 to support initiation of a proposed Phase 2 dose-ranging study of this semaglutide implant planned for 2027. Transition of Cortigent into an independent, publicly traded company following completion of all customary closing and related financing activities. We anticipate establishment of the post-merger company, renamed Cortigent Holdings (d/b/a Cortigent), to be traded on the Nasdaq exchange under the ticker (CRGT) in the third quarter of 2026. Second Quarter 2026 Financial Results Cash: As of June 30, 2026, Vivani had cash, cash equivalents and restricted cash totaling $20.8 million, compared to $17.6 million as of December 31, 2025. The increase of $3.2 million is primarily attributed to tranche closings associated with share purchase agreements entered into in 2025 with an entity affiliated with one of our independent directors and a private placement and registered direct offering completed in January, 2026, offset by net loss for the six months ending June 30, 2026, of $13.2 million. Research and development expense, net of grants: Research and development expense, net of grants, during the three months ended June 30, 2026 was $4.5 million, compared to $4.8 million during the three months ended June 30, 2025. The decrease of $0.3 million, or 6%, was primarily attributable to the decrease in both the clinical trial related expense and development expense from our Biopharm Division. General and administrative expense, net of grants: General and administrative expense, net of grants, during the three months ended June 30, 2026 was $2.4 million, compared to $2.7 million during the three months ended June 30, 2025. The decrease of $0.3 million, or 11%, was primarily attributable to the decrease in the professional services from our Neurostimulation Division and our Biopharm Division. Other income, net: Other income, net during the three months ended June 30, 2026 was $0.5 million, compared to $0.3 million during the three months ended June 30, 2025. The increase of $0.2 million was primarily attributable to the derecognition of a contract liability previously held by the Neurostimulation Division, offset by lower interest income earned during the period. Net loss: For the foregoing reasons, we had a net loss of $6.4 million during the three months ended June 30, 2026 compared to $7.1 million during the three months ended June 30, 2025. About SLIM-1™ TrialSLIM-1 is an open-label, active-controlled trial evaluating a low-dose NPM-139 (semaglutide implant) given to 10 participants, and the starting dose of Wegovy (0.25mg/week semaglutide injection) is also given to 10 participants, over a four-week duration. The trial is designed to evaluate the safety, tolerability and pharmacokinetic profile in overweight or obese participants who are otherwise healthy. Top-line results from SLIM-1 are expected to be available in November. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops miniature, biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed for once- or twice-yearly administration to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. For more information, please visit: www.vivani.com. About Cortigent, Inc. Cortigent, Inc., a wholly owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Its patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Vivani’s predecessor, Second Sight Medical Products, previously marketed Argus® II, the first and only medical device to obtain FDA approval to treat a rare form of blindness. This innovative device has helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com. 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,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential or the planned development thereof, and its 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, 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. 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. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Vivani’s expectations in any forward-looking statement. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (the “SEC”) including the factors described in Vivani’s most recent Quarterly Report on Form 10-Q filed with the SEC on May 13, 2026, as updated by future filings with the SEC. 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 of this press release. 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 [email protected](415) 506-8462 Investor and Media Relations Contact:Jami TaylorInvestor and Media Relations [email protected](415) 506-8462

Investor releaseQuarter not tagged2026-05-13

Vivani Medical Reports First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Initiation of SLIM-1™ clinical trial, a Phase 1 study of NPM-139, a semaglutide implant under development for chronic weight management, on track for mid-year 2026 $28 million in cash, cash equivalents, restricted cash and capital commitments expected to fund current operating plan through the first half of 2027 ALAMEDA, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implants utilizing its proprietary NanoPortal™ technology, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “I’m very pleased with the progress our team made in the first quarter. We are on track to initiate the first study in our SLIM™ Clinical Program (Semaglutide ultra Long-acting IMplant in obesity). Our Phase 1 study of NPM-139, also known as SLIM-1, will be conducted in Australia and is anticipated to start mid-year 2026. Based on our prior experience with the execution of our first-in-human LIBERATE-1 clinical trial in 2025, we anticipate top-line SLIM-1 results by the end of this year. In parallel, we continue to make good progress on our next generation NPM-139 implant configuration, which is designed to accommodate larger doses of semaglutide in-line with Wegovy® dosing. Pending positive SLIM-1 clinical results, a pre-IND meeting with the U.S. FDA and filing of an Investigational New Drug Application, we aim to launch our Phase 2 study in the SLIM program in 2027. Our strong financial position, with a cash runway through the first half of 2027, underscores our ability to deliver on these milestones and drive meaningful progress in addressing critical healthcare needs." Dr. Mendelsohn continued: “As the obesity treatment landscape continues to evolve, challenges associated with medication adherence have emerged as a clear and undeniable barrier to the full realization of health outcomes otherwise possible with GLP-1 therapies. These challenges affect patients on injectable and oral GLP-1 options alike. With the potential to provide steady and continuous GLP-1 delivery over periods of 6 months, 12 months, or more, our NanoPortal™ technology is uniquely designed to solve for these challenges while still allowing f…Read full document

Initiation of SLIM-1™ clinical trial, a Phase 1 study of NPM-139, a semaglutide implant under development for chronic weight management, on track for mid-year 2026 $28 million in cash, cash equivalents, restricted cash and capital commitments expected to fund current operating plan through the first half of 2027 ALAMEDA, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implants utilizing its proprietary NanoPortal™ technology, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “I’m very pleased with the progress our team made in the first quarter. We are on track to initiate the first study in our SLIM™ Clinical Program (Semaglutide ultra Long-acting IMplant in obesity). Our Phase 1 study of NPM-139, also known as SLIM-1, will be conducted in Australia and is anticipated to start mid-year 2026. Based on our prior experience with the execution of our first-in-human LIBERATE-1 clinical trial in 2025, we anticipate top-line SLIM-1 results by the end of this year. In parallel, we continue to make good progress on our next generation NPM-139 implant configuration, which is designed to accommodate larger doses of semaglutide in-line with Wegovy® dosing. Pending positive SLIM-1 clinical results, a pre-IND meeting with the U.S. FDA and filing of an Investigational New Drug Application, we aim to launch our Phase 2 study in the SLIM program in 2027. Our strong financial position, with a cash runway through the first half of 2027, underscores our ability to deliver on these milestones and drive meaningful progress in addressing critical healthcare needs." Dr. Mendelsohn continued: “As the obesity treatment landscape continues to evolve, challenges associated with medication adherence have emerged as a clear and undeniable barrier to the full realization of health outcomes otherwise possible with GLP-1 therapies. These challenges affect patients on injectable and oral GLP-1 options alike. With the potential to provide steady and continuous GLP-1 delivery over periods of 6 months, 12 months, or more, our NanoPortal™ technology is uniquely designed to solve for these challenges while still allowing for patients to stop exposure to the drug on a timeline similar to the current weekly injectables. We’re confident that its distinct advantages will become increasingly apparent as adherence-related data for the GLP-1 class continues to accumulate, and as adherence-related costs for patients, payors, and health systems continue to mount.” Recent Business Highlights The Company plans to continue exploring opportunities for Vivani’s stockholders to potentially realize value in its neuromodulation assets. Cortigent Inc. (“Cortigent”), a wholly owned subsidiary of the Company, filed its most recent amendment to its registration statement on Form S-1 on May 13, 2026. Including multiple share purchase agreements and registered direct offerings entered into in the last 12 months, Vivani has raised $30.2 million in gross proceeds. Current cash, cash equivalents and capital commitments as of March 31, 2026, are expected to fund operations through the first half of 2027. Upcoming Anticipated Milestones Initiation of SLIM-1, a Phase 1 study of low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, anticipated mid-2026 and top-line results are projected by the end of 2026. Investigational New Drug (“IND”) Application for NPM-139 to support initiation of the proposed Phase 2 dose-ranging study of this semaglutide implant planned for 2027. Transition of Cortigent into an independent, publicly traded company. Currently, multiple approaches, including a spin-off to be registered on a Form 10 and an IPO to be registered on a Form S-1 are under consideration. First Quarter 2026 Financial Results Cash: During the three months ended March 31, 2026, Vivani used $6.2 million of cash in operating activities, consisting primarily of a net loss of $6.8 million, partially offset by $0.1 million from a net change in operating assets and liabilities, and non-cash items totaling $0.5 million for stock-based compensation, lease expense, and depreciation of property and equipment. Cash used for investing activities during the three months ended March 31, 2026 was $3,000 for the purchase of property and equipment. Cash provided by financing activities was $9.7 million during the three months ended March 31, 2026, primarily attributable to $2.2 million in net proceeds from a registered direct offering with a placement agent and $7.6 million in net proceeds from other securities purchase agreements with an affiliate of one of its independent directors and another investor. Research and development expense, net of grants. Research and development expense, net of grants, during the three months ended March 31, 2026 was $4.4 million, compared to $4.2 million during the three months ended March 31, 2025. The increase of $0.2 million, or 4%, was primarily attributable to the increase in both the clinical trial related expense and development expense. General and administrative expense, net of grants. General and administrative expense, net of grants, during the three months ended March 31, 2026 was $2.4 million, compared to $2.3 million during the three months ended March 31, 2025. The increase of $0.1 million, or 4%, was primarily attributable to an increase in professional services fees. Other income, net. Other income, net during the three months ended March 31, 2026 was insignificant, compared to $0.3 million during the three months ended March 31, 2025. The decrease of $0.3 million was primarily attributable to lower interest income being earned on deposits and the write-off of the accumulated other comprehensive income related to foreign currency translation balance of the Neurostimulation Division’s Switzerland subsidiary effectively closed in 2025, partially offset by an increase in research and development rebates earned. Net loss. For the foregoing reasons, Vivani had a net loss of $6.8 million during the three months ended March 31, 2026 compared to $6.3 million during the three months ended March 31, 2025. About Vivani Medical, Inc. Vivani is a clinical stage biopharmaceutical company that develops miniature, ultra long-acting subdermal drug implant candidates utilizing its proprietary NanoPortal™ technology, which is designed to enable reversible, ultra long-acting, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani is leveraging its proprietary NanoPortal™ platform, to develop biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. For more information, please visit: www.vivani.com. About Cortigent, Inc. Cortigent, Inc., a wholly owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Its patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Vivani’s predecessor, Second Sight Medical Products, previously marketed Argus® II, the first and only medical device to obtain FDA approval to treat a rare form of blindness. This innovative device has helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com. 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,” “positioned,” “future,” and other similar expressions that are used in this press release, including express or implied statements regarding Vivani’s business, products in development, including the therapeutic potential and planned development thereof (including, for example, initiation of Phase 1 study of NPM-139, announcement of topline results, and launch of Phase 2 study in the SLIM clinical program), Vivani’s plans with respect to Cortigent and its ability to spin-out Cortigent, as well as statements regarding Vivani’s technology, strategy, cash position and financial runway, among others. 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks related to developing subdermal implants and conducting clinical trials; risks related to the biopharmaceutical industry generally; risks related to the Cortigent spin-off, including that it will not be completed in a timely manner or at all, that conditions to spin-out will not be satisfied, risks related to the tax treatment of the spin-off, and uncertainty of whether the anticipated benefits of the spin-off can be achieved; as well as more general risks of unexpected costs or delays in conducting its business; 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; among others. There may be additional risks that the Company or 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 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on May 13, 2026, as updated by the future filings with the SEC. 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. Any forward-looking statement made by Vivani in this press release is based only on information currently available and speak only as of the date of this press release. Vivani 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 Contacts: Company Contact:Donald DwyerChief Business [email protected](415) 506-8462 Investor and Media Relations Contact:Jami TaylorInvestor and Media Relations [email protected](415) 506-8462

Investor releaseQuarter not tagged2026-05-13

Vivani Medical: Q1 Earnings Snapshot

Associated Press

ALAMEDA, Calif. (AP) — ALAMEDA, Calif. (AP) — Vivani Medical, Inc. (VANI) on Wednesday reported a loss of $6.8 million in its first quarter. The Alameda, California-based company said it had a loss of 8 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VANI at https://www.zacks.com/ap/VANI

Investor releaseQuarter not tagged2026-03-27

Vivani Medical: Q4 Earnings Snapshot

Associated Press Finance

ALAMEDA, Calif. (AP) — ALAMEDA, Calif. (AP) — Vivani Medical, Inc. (VANI) on Thursday reported a loss of $6.6 million in its fourth quarter. On a per-share basis, the Alameda, California-based company said it had a loss of 9 cents. For the year, the company reported a loss of $26.6 million, or 43 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VANI at https://www.zacks.com/ap/VANI

Investor releaseQuarter not tagged2026-03-27

Vivani Medical Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

GlobeNewswire
Successful completion of first-in-human study LIBERATE-1 paired with preclinical proof of concept data for a semaglutide implant advance NPM-139, miniature, ultra long-acting semaglutide implant under development for chronic weight management toward a Phase 1 clinical study with results anticipated by the end of 2026. Single preclinical administration of semaglutide implant configuration demonstrates continued semaglutide exposure and >20% sham-adjusted weight loss for a full year. Solid cash position from multiple recent financings will support operations into mid-2027 and enable the projected completion of key milestones including the Phase 1 study of NPM-139. ALAMEDA, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implant candidates utilizing its proprietary NanoPortal™ technology, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “2025 was a pivotal year for Vivani. We successfully completed our first-in-human study, LIBERATE-1; we demonstrated feasibility of our technology with semaglutide, the active ingredient in Wegovy® and Ozempic®; and we made progress against strategic decisions that favorably position the Company in the GLP-1 marketplace,” said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. “The decision to focus on semaglutide was made based on the combination of promising initial preclinical semaglutide implant feasibility data and encouraging results from LIBERATE-1, the first-in-human application of our proprietary NanoPortal implant technology with exenatide. Our encouragement was reinforced after having recently demonstrated sustained preclinical semaglutide exposures and >20% sham-adjusted weight loss for a full year with a single implant administration. Our GLP-1 implant candidates are unique because of their potential for both once- or twice-yearly administration and the ability to quickly eliminate GLP-1 levels between scheduled administrations if that became necessary. Because GLP-1 based medicines are contraindicated for prevalent conditions such as pregnancy, and because GLP-1 discontinuation is recommended before certain procedures such as surgeries with high aspiration risk, the ability to qui…Read full document

Successful completion of first-in-human study LIBERATE-1 paired with preclinical proof of concept data for a semaglutide implant advance NPM-139, miniature, ultra long-acting semaglutide implant under development for chronic weight management toward a Phase 1 clinical study with results anticipated by the end of 2026. Single preclinical administration of semaglutide implant configuration demonstrates continued semaglutide exposure and >20% sham-adjusted weight loss for a full year. Solid cash position from multiple recent financings will support operations into mid-2027 and enable the projected completion of key milestones including the Phase 1 study of NPM-139. ALAMEDA, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implant candidates utilizing its proprietary NanoPortal™ technology, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “2025 was a pivotal year for Vivani. We successfully completed our first-in-human study, LIBERATE-1; we demonstrated feasibility of our technology with semaglutide, the active ingredient in Wegovy® and Ozempic®; and we made progress against strategic decisions that favorably position the Company in the GLP-1 marketplace,” said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. “The decision to focus on semaglutide was made based on the combination of promising initial preclinical semaglutide implant feasibility data and encouraging results from LIBERATE-1, the first-in-human application of our proprietary NanoPortal implant technology with exenatide. Our encouragement was reinforced after having recently demonstrated sustained preclinical semaglutide exposures and >20% sham-adjusted weight loss for a full year with a single implant administration. Our GLP-1 implant candidates are unique because of their potential for both once- or twice-yearly administration and the ability to quickly eliminate GLP-1 levels between scheduled administrations if that became necessary. Because GLP-1 based medicines are contraindicated for prevalent conditions such as pregnancy, and because GLP-1 discontinuation is recommended before certain procedures such as surgeries with high aspiration risk, the ability to quickly cease treatment will be a critical feature in any GLP-1 based product that provides sustained delivery for many months at a time.” Dr. Mendelsohn continued: “In addition, we have made significant progress in advancing our manufacturing capabilities through thoughtful capital equipment purchases and facilities upgrades as part of our efforts to begin preparing for commercial-scale manufacturing. Having also achieved significant clinical operations progress, we project the initiation of our Phase 1 feasibility for NPM-139 (semaglutide implant) for chronic weight management in mid-2026 with data potentially available by the end of this year. This initial Phase 1 study will be conducted in Australia, allowing us to leverage our recent success with LIBERATE-1 and take advantage of the attractive tax incentives provided by the Australian government.” Recent Business Highlights On August 5, 2025, Vivani announced plans to support the rapid advancement of NPM-139, a novel semaglutide implant, based on promising results from the LIBERATE-1 clinical study and additional positive data from a preclinical study with a semaglutide implant. LIBERATE-1, the first-in-human application of Vivani’s proprietary NanoPortal implant technology, demonstrated a positive safety and tolerability profile and encouraging performance data. Vivani also announced new NPM-139 (semaglutide implant) preclinical feasibility data that demonstrated approximately 20% sham-adjusted weight loss with a single implant, which had been maintained for more than six months at the time of the announcement. Since the announcement, this feasibility study has now demonstrated sustained sham-adjusted weight loss >20% as well as sustained drug exposure for an entire year. These semaglutide data support the potential for a semaglutide implant with annual dosing. Based on the LIBERATE-1 data supporting the clinical application of the NanoPortal platform technology, and the preclinical weight loss data with a semaglutide implant configuration, Vivani announced plans to prioritize advancement of NPM-139, with clinical development expected to begin in 2026. In September 2025, Vivani announced plans to initiate a Phase 1 clinical study for the NPM-139 semaglutide implant program, pending regulatory clearance, along with high-level details of the anticipated study design. The Company also announced parallel preparations to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. The Company anticipates initiating the Phase 1 study in mid-2026. The Company plans to continue exploring opportunities for Vivani’s stockholders to potentially realize value in its neuromodulation assets. Cortigent Inc. (“Cortigent”), a wholly owned subsidiary of the Company, filed amendments to its registration statement on Form S-1 with the most recent amendments occurring on March 3 and March 17, 2026. Including multiple share purchase agreements and registered direct offerings it entered into in 2025 and in 2026 year-to-date, the Company raised $41.5M in gross proceeds. Current cash, equivalents and commitments as of December 31, 2025, are expected to fund operations into mid-2027. Upcoming Anticipated Milestones Phase 1 study results for low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, by the end of 2026. Investigational New Drug Application for NPM-139 to support the proposed Phase 2 dose-ranging study of this semaglutide implant. Transition of Cortigent into an independent, publicly traded company. Currently exploring both a spin-off to be registered on a Form 10 and an IPO to be registered on a Form S-1 registration statement. Fourth Quarter 2025 Financial Results Note: Vivani (or the “Company”) refers to the consolidated company including the Biopharm Division and Cortigent. The Biopharm Division refers to the drug implant business, the main focus of the consolidated company. Cash Balance: As of December 31, 2025, Vivani had cash and cash equivalents totaling $16.2 million, compared to $18.4 million as of December 31, 2024. The decrease of $2.2 million is primarily attributed to a net loss of $26.6 million, and $1.2 million related to purchase of equipment, which was mostly offset by net proceeds of $23.3 million provided by the financing activities, non-cash items totaling $3.5 million which include stock-based compensation, depreciation and amortization of property and equipment, and lease expense. Research and development expenses: Research and development expenses during the fourth quarter of 2025 were $4.6 million, compared to $4.3 million during the fourth quarter of 2024. The increase of $0.3 million, or 7%, was primarily attributable to staffing reduction and reduced use of outside services. General and administrative expenses: General and administrative expenses during the fourth quarter of 2025 were $2.2 million, compared to $2.1 million during the fourth quarter of 2024. Other income (expense): Other income (expense), net during the fourth quarter of 2025 was $0.2 million, compared to $0.4 million during the fourth quarter of 2024. The decrease of $0.2 million, or 50%, was primarily attributable to lower interest income being earned on deposits from the Biopharm Division and the write off of the accumulated other comprehensive income related to foreign currency translation balance of the Neurostimulation Division’s Switzerland subsidiary which effectively closed in 2025, partially offset by an increase R&D rebates earned. Net Loss: The net loss during the fourth quarter of 2025 was $6.6 million, compared to $6.1 million during the fourth quarter of 2024. The increase of $0.5 million, or 8%, was primarily attributable to the increase in the clinical trial related expense and development expense from our Biopharm Division, the increase in professional services and the decrease in other income from our Neurostimulation Division and our Biopharm Division. Full Year 2025 Financial Results Research and development expense. Research and development expense during the year ended December 31, 2025 was $18.1 million, compared to $15.7 million during the year ended December 31, 2024. The increase of $2.4 million, or 15%, was primarily attributable to the increase in both the clinical trial related expense and development expense from our Biopharm Division. General and administrative expense. General and administrative expense during the year ended December 31, 2025 was $9.4 million, compared to $8.9 million during the year ended December 31, 2024. The increase of $0.5 million, or 6%, was primarily attributable to the increase in the professional services of our Neurostimulation Division and our Biopharm Division. Other income, net. Other income, net during the year ended December 31, 2025 was $0.9 million, compared to $1.2 million during the year ended December 31, 2024. The decrease of $0.3 million was primarily attributable to lower interest income being earned on deposits from our Biopharm Division and the write off of the accumulated other comprehensive income related to foreign currency translation balance of our Neurostimulation Division’s Switzerland subsidiary effectively closed in 2025, partially offset by an increase R&D rebates earned. Net loss. The net loss during the year ended December 31, 2025 was $26.6 million, compared to $23.5 million during the year ended December 31, 2024. The increase in net loss of $3.1 million was primarily attributable to the increase in the clinical trial related expense and development expense from our Biopharm Division, the increase in professional services and the decrease in other income from our Neurostimulation Division and our Biopharm Division. 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 improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. For more information, please visit: www.vivani.com. About Cortigent, Inc. Cortigent, Inc., a wholly owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Our patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Our predecessor, Second Sight Medical Products, previously marketed Argus® II, the first and only medical device to obtain FDA approval to treat a rare form of blindness. This innovative device has helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com. 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,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development thereof, Vivani’s plans with respect to Cortigent and its 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. 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 nonrecognition 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. 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 market conditions and the ability of Cortigent to complete its spin-off, Cortigent’s history of losses and its ability to access additional capital or otherwise fund its business and advance its product candidates and preclinical 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 or 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 the U.S. Securities and Exchange Commission on March 26, 2026, 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 Contacts: Company Contact: Donald Dwyer Chief Business Officer [email protected] (415) 506-8462 Investor and Media Relations Contact: Jami Taylor Investor and Media Relations Advisor [email protected] (415) 506-8462

Investor releaseQuarter not tagged2026-01-29

Vivani Subsidiary Cortigent Presents Promising 6-Year Early Feasibility Study Results for the Orion System at NANS 2026

GlobeNewswire
Cortigent is a leading developer of brain implant devices based on precision neurostimulation technology Cortigent is the only company to have obtained FDA approval of a device providing artificial vision for the profoundly blind The Company is also developing a new medical device aimed at improving recovery of arm and hand motion in patients with paralysis due to stroke ALAMEDA, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that Cortigent, Inc. (“Cortigent”), its wholly-owned subsidiary developing brain implant devices, presented the results of a 6-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System under development to deliver meaningful visual perception to blind persons at the North American Neuromodulation Society (“NANS”) annual meeting. NANS took place in Las Vegas, NV on January 22-25, 2026. The Orion system incorporates advanced neurostimulation technology and features a wirelessly powered and controlled implantable pulse generator connected to an array of 60 micro-electrodes designed for implantation on the surface of the brain involved in vision (the visual cortex) in blind patients. The system features a small processing unit worn on the belt that converts a real-time video stream captured by a camera embedded in specialized glasses into wireless commands to precisely stimulate neuron populations and elicit spots of light called phosphenes that provide visual perception. The study results were presented by Principal Investigator Nader Pouratian, MD, PhD from the University of Texas Southwestern Medical Center. Cortigent’s lead neuroscientist, Uday Patel, PhD, commented: “We are encouraged by the positive clinical study results that demonstrate the Orion cortical stimulation system’s safety and reliability over 6 years and ability to deliver meaningful visual perception. Our next step will be to plan a larger pivotal clinical trial intended to seek marketing approval, subject to discussions with the U.S. Food and Drug Administration.” Results Summary Six subjects were implanted between January 2018 and January 2019. The study concluded in March 2025. After training and experience using the Orion system, all subjects demonstrated improvement with the s…Read full document

Cortigent is a leading developer of brain implant devices based on precision neurostimulation technology Cortigent is the only company to have obtained FDA approval of a device providing artificial vision for the profoundly blind The Company is also developing a new medical device aimed at improving recovery of arm and hand motion in patients with paralysis due to stroke ALAMEDA, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that Cortigent, Inc. (“Cortigent”), its wholly-owned subsidiary developing brain implant devices, presented the results of a 6-year Early Feasibility Study of the Orion® Visual Cortical Prosthesis System under development to deliver meaningful visual perception to blind persons at the North American Neuromodulation Society (“NANS”) annual meeting. NANS took place in Las Vegas, NV on January 22-25, 2026. The Orion system incorporates advanced neurostimulation technology and features a wirelessly powered and controlled implantable pulse generator connected to an array of 60 micro-electrodes designed for implantation on the surface of the brain involved in vision (the visual cortex) in blind patients. The system features a small processing unit worn on the belt that converts a real-time video stream captured by a camera embedded in specialized glasses into wireless commands to precisely stimulate neuron populations and elicit spots of light called phosphenes that provide visual perception. The study results were presented by Principal Investigator Nader Pouratian, MD, PhD from the University of Texas Southwestern Medical Center. Cortigent’s lead neuroscientist, Uday Patel, PhD, commented: “We are encouraged by the positive clinical study results that demonstrate the Orion cortical stimulation system’s safety and reliability over 6 years and ability to deliver meaningful visual perception. Our next step will be to plan a larger pivotal clinical trial intended to seek marketing approval, subject to discussions with the U.S. Food and Drug Administration.” Results Summary Six subjects were implanted between January 2018 and January 2019. The study concluded in March 2025. After training and experience using the Orion system, all subjects demonstrated improvement with the system turned on versus off in visual function tests to detect a small square on a computer screen and detect movement across the visual field. All subjects had either a positive or mild positive score on their final Functional Low-vision Observer Rated Assessment (“FLORA”), a tool used to measure the impact of the Orion system on subjects’ well-being and functional vision. All devices remained functional throughout the study with a loss of functionality on fewer than 4% of electrodes. Three subjects had their devices safely explanted after their respective 3-year visits and 1 subject had his device safely explanted at the conclusion of the study. One serious adverse event, a seizure, occurred early in the study. With stimulation patterns adjusted, no further seizures or serious adverse events were observed in any subjects. “We are very grateful to Dr. Pouratian and his fellow investigators and medical institutions that conducted this important clinical trial,” commented Cortigent CEO Jonathan Adams. “We look forward to advancing the Orion cortical stimulation system in 2026 and working with world-leading experts and the FDA to eventually commence a larger pivotal trial.” About Cortigent, Inc. Cortigent, Inc., a wholly-owned subsidiary of Vivani, is developing brain implant devices to help patients recover critical body functions. Our patent-protected precision neurostimulation technology platform leverages neuroscience and proprietary microelectronics to create advanced medical devices. Our predecessor, Second Sight Medical Products, previously marketed the Argus® II, the first and only medical device to obtain FDA approval to treat a rare form of blindness called retinitis pigmentosa. This innovative device helped hundreds of profoundly blind patients to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion® cortical stimulation system, has been designed to treat blindness caused by common conditions including glaucoma and diabetic retinopathy. Orion has an FDA Breakthrough Device designation, completed a 6-year Early Feasibility Study in 2025 with promising safety and efficacy results and is covered by an extensive intellectual property estate. Cortigent is also applying its core technology to improving recovery of arm and hand motion in patients with paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com. 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 improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. For more information, please visit: www.vivani.com. 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,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development thereof, Vivani’s plans with respect to Cortigent and its 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, 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. 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 Cortigent’s history of losses and its ability to access additional capital or otherwise fund its 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 or 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 the U.S. Securities and Exchange Commission 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 [email protected] (415) 506-8462 Investor Relations Contact: Jami Taylor Investor Relations Advisor [email protected] (415) 506-8462 Media Contact: Sean Leous ICR Healthcare [email protected] (646) 866-4012

Investor releaseQuarter not tagged2025-11-13

Vivani Medical Provides Business Update and Reports Third Quarter 2025 Financial Results

GlobeNewswire
Company plans to initiate Phase 1 clinical study of semaglutide implant for chronic weight management in the first half of 2026 and parallel investments in studies to enable rapid initiation of Phase 2 dose-ranging study, pending Phase 1 results and regulatory feedback 3Q 2025 private placement, together with October financings, generated approximately $25.7M in cash and cash commitments to support accelerated development of NPM-139 while securing financial position into 2027 ALAMEDA, Calif., Nov. 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 third quarter ended September 30, 2025, and provided a business update. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “Vivani achieved significant progress during the third quarter of 2025 including the successful completion of LIBERATE-1, marking the first clinical application of the Company’s proprietary platform technology, NanoPortal™. This study paves the way for continued development of our growing pipeline of ultra long-acting miniature drug implants, including NPM-139 and NPM-133, our semaglutide-based implants in development for chronic weight management and treatment of type 2 diabetes, respectively. Our initial focus is on the Phase 1 study, which we anticipate will generate clinical data supporting both semaglutide development programs.” Dr. Mendelsohn added, “Vivani remains the only company developing ultra long-acting miniature GLP-1 implants designed for once- or twice-yearly dosing. Our NanoPortal drug delivery platform is uniquely differentiated from a competitive landscape that includes over 50 injectable and oral candidates in development for chronic weight management by offering both infrequent administration and peace of mind that, if necessary, treatment can be discontinued at any time. NanoPortal GLP-1 implants promise to address two of the main challenges in obesity treatment today that contribute to suboptimal patient outcomes: poor medication adherence and poor tolerability. We are excited to be positioned to initiate clinical development of the semaglutide implant program in the first half of 2026.” Recent Business Highlights On October 28, 2025, Vivani closed its previously announced best efforts registe…Read full document

Company plans to initiate Phase 1 clinical study of semaglutide implant for chronic weight management in the first half of 2026 and parallel investments in studies to enable rapid initiation of Phase 2 dose-ranging study, pending Phase 1 results and regulatory feedback 3Q 2025 private placement, together with October financings, generated approximately $25.7M in cash and cash commitments to support accelerated development of NPM-139 while securing financial position into 2027 ALAMEDA, Calif., Nov. 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 third quarter ended September 30, 2025, and provided a business update. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “Vivani achieved significant progress during the third quarter of 2025 including the successful completion of LIBERATE-1, marking the first clinical application of the Company’s proprietary platform technology, NanoPortal™. This study paves the way for continued development of our growing pipeline of ultra long-acting miniature drug implants, including NPM-139 and NPM-133, our semaglutide-based implants in development for chronic weight management and treatment of type 2 diabetes, respectively. Our initial focus is on the Phase 1 study, which we anticipate will generate clinical data supporting both semaglutide development programs.” Dr. Mendelsohn added, “Vivani remains the only company developing ultra long-acting miniature GLP-1 implants designed for once- or twice-yearly dosing. Our NanoPortal drug delivery platform is uniquely differentiated from a competitive landscape that includes over 50 injectable and oral candidates in development for chronic weight management by offering both infrequent administration and peace of mind that, if necessary, treatment can be discontinued at any time. NanoPortal GLP-1 implants promise to address two of the main challenges in obesity treatment today that contribute to suboptimal patient outcomes: poor medication adherence and poor tolerability. We are excited to be positioned to initiate clinical development of the semaglutide implant program in the first half of 2026.” Recent Business Highlights On October 28, 2025, Vivani closed its previously announced best efforts registered direct offering of 6,000,000 shares of its common stock at an offering price of $1.62 per share, which was the closing market price on Friday, October 26, 2025, along with the closing of a concurrent private placement of 3,703,703 shares of its common stock at the same offering price of $1.62 per share purchased by an entity affiliated with Gregg Williams, the Chairman of the Company’s board of directors. Gross proceeds from the two transactions were approximately $15.7 million, before deducting fees and offering expenses. On October 3, 2025, Vivani announced that it will temporarily withdraw the previously announced record date for the planned spin-off of Cortigent, Inc. (“Cortigent”), its wholly owned subsidiary developing brain implant devices with cutting-edge neuromodulation technology, due to circumstances surrounding the current shutdown of the U.S. federal government. Vivani expects to establish a new record date shortly after the U.S. Securities and Exchange Commission (“SEC”) resumes normal operations. This followed Vivani’s earlier announcement on September 17, 2025, indicating that its board of directors had set the record date for the approved spin-off of Cortigent. On September 4, 2025, Vivani announced plans to initiate a Phase 1 clinical study in the NPM-139 semaglutide implant program in the first half of 2026, pending regulatory clearance. The Company is also preparing to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. The NPM-139 clinical program will evaluate the Company’s investigational semaglutide implant for chronic weight management in patients who are either obese or overweight with a related comorbidity. On August 11, 2025, Vivani entered into a share purchase agreement to issue and sell an aggregate of 7,936,507 shares of common stock, priced at $1.26 per share, the closing market price on August 11, 2025, in a private placement with two investors including an entity beneficially owned by Gregg Williams. This private sale transaction is expected to result in gross proceeds of approximately $10.0 million and supports the prioritization and accelerated development of NPM-139 into clinical-stage development with initiation anticipated in 2026. On August 5, 2025, Vivani announced the rapid advancement of NPM-139, a novel semaglutide implant, following data showing 20% weight loss sustained over more than 7 months, from an ongoing preclinical study of NPM-139 and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115. LIBERATE-1 represented the first-in-human test of the Company’s proprietary NanoPortal implant technology. Upcoming Anticipated Milestones Vivani anticipates initiating clinical development of a semaglutide implant, NPM-139, in obesity and chronic weight management in 2026. Vivani anticipates completing the spin-off of Cortigent, a subsidiary of the Company that develops brain implant devices to help patients recover critical body functions, as an independent publicly traded company shortly after the SEC resumes operations. Third Quarter 2025 Financial Results Cash balance: As of September 30, 2025, Vivani had cash, cash equivalents and restricted cash totaling $4.0 million, compared to $19.7 million as of December 31, 2024. The decrease of $15.7 million is primarily attributed to a net loss of $20.0 million, partially offset by a $0.9 million net change to operating assets and liabilities, and non-cash items totaling $1.5 million for depreciation and amortization of property and equipment, stock-based compensation and lease expenses. Including three equity purchase agreements entered into in March 2025, May 2025 and August 2025, an additional $18.6 million of committed capital will be contributed through July 2026. Research and development expense: Research and development expense during the three months ended September 30, 2025 was $4.5 million, compared to $4.2 million during the three months ended September 30, 2024. The increase of $0.3 million was primarily attributable to increased research and development expenses. General and administrative expense: General and administrative expense during the three months ended September 30, 2025 was $2.2 million, compared to $2.1 million during the three months ended September 30, 2024. The increase of $0.1 million was primarily attributable to increased professional services. Other income, net: Other income, net during the three months ended September 30, 2025 was $0.2 million, compared to $0.3 million during the three months ended September 30, 2024. The decrease of $0.1 million was due to lower interest income. Net Loss: The net loss during the three months ended September 30, 2025 was $6.5 million, compared to $6.0 million during the three months ended September 30, 2024. The increase in net loss of $0.5 million was primarily attributable to an increase in operating expenses of $0.4 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 improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type-2 diabetes. The Company is also considering another semaglutide implant 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. About Cortigent, Inc. Vivani’s wholly owned subsidiary, 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 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,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development thereof, the completion of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for its product candidates, Vivani’s plans with respect to Cortigent and its 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, 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, including Vivani’s ability to commence clinical development of Vivani’s product candidates or successful completion of ongoing clinical trials for product candidates; 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; risks that the Cortigent 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. 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 market conditions and the ability of Cortigent to complete its spin-off, Cortigent’s history of losses and its ability to access additional capital or otherwise fund its 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 or 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 the U.S. Securities and Exchange Commission 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 [email protected] (415) 506-8462 Investor Relations Contact: Jami Taylor Investor Relations Advisor [email protected] (415) 506-8462 Media Contact: Sean Leous ICR Healthcare [email protected] (646) 866-4012

Investor releaseQuarter not tagged2025-11-13

Vivani Medical: Q3 Earnings Snapshot

Associated Press Finance

ALAMEDA, Calif. (AP) — ALAMEDA, Calif. (AP) — Vivani Medical, Inc. (VANI) on Thursday reported a loss of $6.5 million in its third quarter. On a per-share basis, the Alameda, California-based company said it had a loss of 11 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VANI at https://www.zacks.com/ap/VANI

Investor releaseQuarter not tagged2025-08-14

Vivani Medical: Q2 Earnings Snapshot

Associated Press Finance

ALAMEDA, Calif. (AP) — ALAMEDA, Calif. (AP) — Vivani Medical, Inc. (VANI) on Wednesday reported a loss of $7.1 million in its second quarter. The Alameda, California-based company said it had a loss of 12 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VANI at https://www.zacks.com/ap/VANI

Investor releaseQuarter not tagged2025-08-14

Vivani Medical Provides Business Update Including $10M Equity Financing and Reports Second Quarter 2025 Financial Results

GlobeNewswire
Company plans rapid advancement of semaglutide implant NPM-139, following positive weight loss data from an ongoing preclinical study of NPM-139 and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115 New $10M equity financing to enable accelerated development of NPM-139 while securing financial position into the second half of 2026 Vivani 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 ALAMEDA, Calif., Aug. 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 second quarter ended June 30, 2025, and provided a business update, including a new $10M equity financing. Vivani Chairman of the Board Gregg Williams, stated, “Today’s financing announcement reinforces my enthusiasm about the recent progress and future prospects of NanoPortal™ drug implants as well as my confidence in the management team to successfully develop and deliver transformational therapeutic options for the treatment of chronic diseases, starting with obesity and type 2 diabetes. I remain committed to supporting the Company’s efforts to continue advancing development of its pipeline based on the recent, very positive developments.” Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “Our strategic prioritization of the semaglutide implant NPM-139 provides Vivani with significantly improved prospects regarding both technical success and commercial potential considering the clinical evidence, broad adoption, and continued growth of semaglutide-based products into the foreseeable future. Our rapid advancement of NPM-139 toward clinical-stage development is supported by two recent achievements within our R&D programs, namely, the success of LIBERATE-1™ and the positive preclinical weight loss data generated with NPM-139.” Dr. Mendelsohn added, “As the first-in-human application of Vivani’s NanoPortal™ implant technology, it was important that LIBERATE-1 showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives. Concurrently, newly generated NPM-139 preclinical feasibility data showed…Read full document

Company plans rapid advancement of semaglutide implant NPM-139, following positive weight loss data from an ongoing preclinical study of NPM-139 and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115 New $10M equity financing to enable accelerated development of NPM-139 while securing financial position into the second half of 2026 Vivani 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 ALAMEDA, Calif., Aug. 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 second quarter ended June 30, 2025, and provided a business update, including a new $10M equity financing. Vivani Chairman of the Board Gregg Williams, stated, “Today’s financing announcement reinforces my enthusiasm about the recent progress and future prospects of NanoPortal™ drug implants as well as my confidence in the management team to successfully develop and deliver transformational therapeutic options for the treatment of chronic diseases, starting with obesity and type 2 diabetes. I remain committed to supporting the Company’s efforts to continue advancing development of its pipeline based on the recent, very positive developments.” Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “Our strategic prioritization of the semaglutide implant NPM-139 provides Vivani with significantly improved prospects regarding both technical success and commercial potential considering the clinical evidence, broad adoption, and continued growth of semaglutide-based products into the foreseeable future. Our rapid advancement of NPM-139 toward clinical-stage development is supported by two recent achievements within our R&D programs, namely, the success of LIBERATE-1™ and the positive preclinical weight loss data generated with NPM-139.” Dr. Mendelsohn added, “As the first-in-human application of Vivani’s NanoPortal™ implant technology, it was important that LIBERATE-1 showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives. Concurrently, newly generated NPM-139 preclinical feasibility data showed approximately 20% weight loss was maintained longer than six months with a single implant in an ongoing study, continuing to support the potential for annual dosing. We anticipate initiating the NPM-139 clinical program in 2026.” Recent Business Highlights On August 11, 2025, Vivani entered into a share purchase agreement to issue and sell an aggregate of 7,936,507 shares of common stock, priced at $1.26 per share, the closing market price on August 11, 2025, in a private placement with two investors including an entity beneficially owned by Gregg Williams. The private sale transaction is expected to result in gross proceeds of approximately $10.0 million which secures Vivani’s financial position into the second half of 2026 and supports the prioritization and accelerated development of NPM-139 into clinical-stage development with initiation anticipated in 2026. On August 8, 2025, Vivani announced advancement of NPM-139, a novel semaglutide implant, based on encouraging weight loss data for over six months from a single implant from an ongoing preclinical study of NPM-139 and results from the LIBERATE-1 Phase 1 clinical study of NPM-115. On June 11, 2025, the Company announced the appointment of Anthony Baldor as Chief Financial Officer. Baldor succeeds Brigid A. Makes, who decided to retire from Vivani to focus on her board appointments and personal projects after a distinguished career and significant contributions to the Company. Baldor brings more than 20 years of financial management experience in the biotechnology sector, with a proven record in fundraising, business development and corporate strategy. On May 12, 2025, Vivani announced that it had 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., a clinical-stage company focused on the treatment of age-related diseases in dogs and cats, announced an expansion of their 2019 collaboration, initially focused on cats, 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. Upcoming Anticipated Milestones Vivani anticipates providing a more detailed NPM-139 program update later this year, which will include the proposed design of the NPM-139 clinical program through a dose-ranging weight maintenance study outcome. Vivani anticipates initiating clinical development of NPM-139 in 2026. Vivani anticipates completing the spin-off of 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 in the third quarter or fourth quarter of 2025. Second Quarter 2025 Financial Results Cash balance: As of June 30, 2025, Vivani had cash, cash equivalents and restricted cash totaling $8.1 million, compared to $19.7 million as of December 31, 2024. The decrease of $11.6 million is primarily attributed to a net loss of $13.4 million, partially offset by a $1.1 million net change to operating assets and liabilities, and non-cash items totaling $1.1 million for depreciation and amortization of property and equipment, stock-based compensation and lease expenses. Including three equity purchase agreements entered into in March 2025, May 2025 and August 2025, an additional $21.25 million of committed capital will be contributed through July 2026. Research and development expense: Research and development expense during the three months ended June 30, 2025 was $4.8 million, compared to $3.5 million during the three months ended June 30, 2024. The increase of $1.2 million, or 35%, was primarily attributable to increased research and development expenses from the Company's Biopharma division. General and administrative expense: General and administrative expense during the three months ended June 30, 2025 was $2.7 million, compared to $2.2 million during the three months ended June 30, 2024. The increase of $0.5 million, or 25%, was primarily attributable to increased professional services from the Company's Biopharma division. Other income, net: Other income, net during the three months ended June 30, 2025 was $0.3 million, compared to $0.3 million during the three months ended June 30, 2024. The change was not significant. Net Loss: The net loss during the three months ended June 30, 2025 was $7.1 million, compared to $5.3 million during the three months ended June 30, 2024. The increase in net loss of $1.8 million was primarily attributable to an increase in operating expenses of $1.8 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 improving patient tolerance to their medication. Vivani’s priority product candidate, NPM-139, is a miniature, six-month, subdermal, GLP-1 (semaglutide) implant under development for chronic weight management in obese or overweight subjects. NPM-139 has the added potential for once-yearly dosing. Vivani’s emerging pipeline also includes NPM-115 (exenatide implant) for chronic weight management in obese and overweight individuals, and NPM-119, an exenatide implant program for the treatment of type-2 diabetes. The Company is also considering another semaglutide implant 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. About Cortigent, Inc. Vivani’s wholly owned subsidiary, 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 completion of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-139, NPM-115, or Vivani’s plans with respect to Cortigent and its proposed spin-out, 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-139 and NPM-115; 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-139; 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 proposed spin-out. 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 [email protected] (415) 506-8462 Investor Relations Contact: Jami Taylor Investor Relations Advisor [email protected] (415) 506-8462 Media Contact: Mark Corbae ICR Healthcare [email protected] (203) 682-8288 *$6.794 million in cash and cash equivalents held on June 30, 2025 does not include three equity purchase agreements entered into in March 2025, May 2025 and August 2025, which will bring an additional $21.25 million of committed capital into the Company through July 2026.

Investor releaseQuarter not tagged2025-08-05

Vivani Medical Announces Rapid Advancement of NPM-139, a Novel Semaglutide Implant, Following Positive Weight Loss Data from an Ongoing Preclinical Study of NPM-139 and Promising Results from the LIBERATE-1 Phase 1 Clinical Study of NPM-115

GlobeNewswire
LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual dosing Based on these data, Vivani prioritizes the advancement of NPM-139, with clinical development expected to begin in 2026, pending regulatory clearance ALAMEDA, Calif., Aug. 05, 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 reported results from the LIBERATE-1 clinical study, the Phase 1 study of the exenatide GLP-1 implant NPM-115 representing the first-in-human test of the Company’s proprietary NanoPortal™ implant technology. The Company also reported new feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study, supporting prioritization of the semaglutide implant in the Company’s pipeline and clinical development strategy. Semaglutide is the active ingredient in blockbuster drug products Ozempic®, Wegovy®, and Rybelsus®. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. stated, “We are very pleased to report that LIBERATE-1, our Phase 1 study in obese and overweight subjects and the first clinical application of NanoPortal technology, achieved its primary objectives. The results support the general safety and tolerability profile of the device and continued development with higher dose configurations, which we expect to produce clinically relevant weight management effects.” “In addition to the LIBERATE-1 results, we are very excited to report new preclinical feasibility data with our semaglutide implant candidate NPM-139, under development for chronic weight management which have shown approximately 20% weight loss with a single administration for over 6 months and continue to show potential for annual dosing. When we couple the successful completion of the LIBERATE-1 study with the new feasibility data for our semaglutide implant, it is an easy decision to focus our resources and prioritize efforts to accelerate NPM-139 into clinical-stage develo…Read full document

LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual dosing Based on these data, Vivani prioritizes the advancement of NPM-139, with clinical development expected to begin in 2026, pending regulatory clearance ALAMEDA, Calif., Aug. 05, 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 reported results from the LIBERATE-1 clinical study, the Phase 1 study of the exenatide GLP-1 implant NPM-115 representing the first-in-human test of the Company’s proprietary NanoPortal™ implant technology. The Company also reported new feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study, supporting prioritization of the semaglutide implant in the Company’s pipeline and clinical development strategy. Semaglutide is the active ingredient in blockbuster drug products Ozempic®, Wegovy®, and Rybelsus®. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. stated, “We are very pleased to report that LIBERATE-1, our Phase 1 study in obese and overweight subjects and the first clinical application of NanoPortal technology, achieved its primary objectives. The results support the general safety and tolerability profile of the device and continued development with higher dose configurations, which we expect to produce clinically relevant weight management effects.” “In addition to the LIBERATE-1 results, we are very excited to report new preclinical feasibility data with our semaglutide implant candidate NPM-139, under development for chronic weight management which have shown approximately 20% weight loss with a single administration for over 6 months and continue to show potential for annual dosing. When we couple the successful completion of the LIBERATE-1 study with the new feasibility data for our semaglutide implant, it is an easy decision to focus our resources and prioritize efforts to accelerate NPM-139 into clinical-stage development.” The decision to prioritize NPM-139 is supported by several factors. These include the Company’s belief that the development timelines for the NPM-115 and NPM-139 programs are comparable, the increased confidence in NPM-139 due to the fact that semaglutide products have already established compelling weight loss data in humans, and the strong commercial performance of semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, which have generated over $29B in sales in 2024 and are expected to have continued growth into the foreseeable future. LIBERATE-1 Study Results The LIBERATE-1 Phase 1 study successfully met its primary objectives, which were to evaluate the NPM-115 implant’s safety and tolerability profile and to characterize the pharmacokinetic (PK) profile of the implant over a 9-week duration. Throughout the study, the implant was generally well tolerated, and drug release from the implant without any clinically meaningful burst was supported by PK analysis and by the absence of gastrointestinal adverse events in subjects with the implant. No serious adverse events were observed in the study. The release profile observed from the implants over 9 weeks provides encouragement regarding the potential for this technology to provide durable delivery over the 6-month duration that has already been established in preclinical studies of both NPM-115 and NPM-139. This study paves the way for future clinical development of the implant technology not just for exenatide (NPM-115 and NPM-119) but also for semaglutide (NPM-139) and any other application of NanoPortal technology that Vivani may pursue in the future. Semaglutide Implant Preclinical Feasibility Data In an ongoing preclinical study, substantial progress in the development of a miniature, ultra long-acting, semaglutide implant, NPM-139 has been established by showing weight loss from a single administration for over 231 days. NPM-139 (Semaglutide Implant) Weight difference versus control group in healthy Sprague-Dawley rats. The percentage weight change from baseline for NPM-139 (semaglutide implant) corrected to control (sham implant). Implants from 4 animals were removed on each of Day 21, Day 84, and Day 168 for characterization. Values are mean ± standard error. While the emerging preclinical data on the Company’s semaglutide implant currently supports the initial target profile of bi-annual dosing, the Company continues to anticipate that a semaglutide implant candidate may be able to support annual dosing in the future. Vivani’s near-term efforts are focused on completion of PK optimization activities and preparation of data to enable the submission of an Investigational New Drug application for NPM-139. 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 improving patient tolerance to their medication. Vivani’s priority product candidate, NPM-139, is a miniature, six-month, subdermal, GLP-1 (semaglutide) implant under development for chronic weight management in obese or overweight subjects. NPM-139 has the added potential for once-yearly dosing. Vivani’s emerging pipeline also includes NPM-115 (exenatide implant) for chronic weight management in obese and overweight individuals, and NPM-119, an exenatide implant program for the treatment of type-2 diabetes. The Company is also considering another semaglutide implant 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 numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. 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 Phase 1 study and reporting of study results, Vivani’s emerging development plans for NPM-139, NPM-115, NPM-119 or Vivani’s plans with respect its 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-139, 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-139; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical studies and the results therefrom; or Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business. 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 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 [email protected] (415) 506-8462 Investor Relations Contact: Jami Taylor Investor Relations Advisor [email protected] (415) 506-8462 Media Contact: Mark Corbae ICR Healthcare [email protected] (203) 682-8288 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a049bc2-9622-4156-b325-dc73a1f1b9d1.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook