10-K: Vivani Medical Advances GLP-1 Implants, Reports 2025 Losses

Vivani Medical, Inc. reported a net loss of $26.6 million in 2025 while advancing its NanoPortal GLP-1 implant programs and securing significant capital.

Summary

• Vivani Medical, Inc. is a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implant candidates using its proprietary NanoPortal technology.
• The company's lead programs include NPM-139 (semaglutide implant) for chronic weight management, NPM-133 (semaglutide implant) for type-2 diabetes, and NPM-115 (exenatide implant) for chronic weight management.
• Vivani reported a net loss of $26.6 million for the year ended December 31, 2025, an increase from $23.5 million in 2024.
• Research and development expenses increased by 15% to $18.1 million in 2025, reflecting increased clinical trial and development activities.
• General and administrative expenses increased by 6% to $9.4 million in 2025.
• The LIBERATE-1 first-in-human clinical trial for NPM-115 successfully completed in August 2025, demonstrating a positive safety and tolerability profile and encouraging performance data for the NanoPortal technology.
• Positive preclinical data for NPM-139 (semaglutide implant) showed approximately 20% sham-controlled weight loss in rats, maintained for over six months, with potential for annual dosing.
• Vivani plans to prioritize and accelerate NPM-139 into clinical-stage development, with a Phase 1 study expected to initiate in mid-2026.
• The company is exploring both a spin-off and an IPO for its wholly-owned neurostimulation subsidiary, Cortigent, Inc., to unlock shareholder value, though the spin-off record date was withdrawn due to government shutdown delays.
• Vivani secured approximately $23.3 million in net cash from financing activities in 2025 through various private placements and a registered direct offering.
• An amendment to the License and Supply Agreement with Okava Pharmaceuticals, Inc. expanded the OKV-119 program to include dogs, adding $5 million in regulatory milestone payments.
• The company faces ongoing litigation with Pixium Vision SA, with an appeal against a Paris Commercial Court judgment for approximately €1.55 million currently struck out but planned for reinstatement.
• Vivani also faces a breach of contract claim from Oppenheimer & Co. Inc. for no less than $1.625 million, with discovery commencing after partial dismissal of the complaint.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this filing with cautious optimism. While the company's core NanoPortal technology shows promising preclinical and early clinical results in a high-growth market, significant financial losses and ongoing capital needs present substantial risks. The strategic focus on NPM-139 and successful initial human trials are positive, but legal challenges and spin-off delays temper enthusiasm.

Positives

• Successful completion of LIBERATE-1, the first-in-human clinical trial for NPM-115, demonstrating a positive safety and tolerability profile and encouraging performance data for the NanoPortal technology.
• Promising preclinical data for NPM-139 (semaglutide implant) showing approximately 20% sham-controlled weight loss in rats, maintained for over six months, with potential for annual dosing.
• Strategic prioritization and acceleration of NPM-139 into clinical development, with a Phase 1 study anticipated to begin in mid-2026, and parallel preparations for a Phase 2 study.
• FDA clearance of the IND and lifting of the clinical hold for NPM-119 in June 2024, allowing for clinical development.
• Expansion of the collaboration with Okava Pharmaceuticals, Inc. to include dogs in the development of OKV-119, adding $5 million in regulatory milestone payments.
• The NanoPortal technology addresses critical issues in chronic disease treatment: poor medication adherence (50% non-adherence for current GLP-1s) and potential to improve drug tolerability by minimizing fluctuations.
• Market research indicates significant potential adoption, with 56% of GLP-1 patients 'Definitely or Likely' to use an implant and physicians rating NPM-119's profile highly (8.3/10).
• The company's implants offer a unique combination of ultra long-acting dosing (up to six months or longer) and reversibility, differentiating them from other GLP-1 therapies in development.
• Strong intellectual property portfolio with 15 issued U.S. patents and 11 foreign patents, protecting its NanoPortal technology and product candidates until 2034-2041.
• Commitment to environmental sustainability by developing implants that reduce medical waste from single-use injectable pens (estimated 1 billion pens/year by 2030).
• Robust human capital management, including competitive compensation, flexible PTO, annual equity grants, and a diverse workforce (40-50% women in management).

Negatives

• Increased net loss to $26.6 million in 2025 from $23.5 million in 2024, indicating a worsening financial performance.
• Net cash used in operating activities increased to $24.3 million in 2025 from $20.8 million in 2024, reflecting higher cash burn.
• Accumulated deficit reached $148.5 million as of December 31, 2025.
• The company is a clinical-stage company with a limited operating history and no products approved for commercial sale, making its business viability dependent on successful, lengthy, and expensive development processes.
• Requires substantial additional financing to pursue business objectives, with no assurance of availability on acceptable terms, posing a risk of delaying or terminating product development.
• The record date for the Cortigent spin-off was withdrawn due to delays from a U.S. federal government shutdown, creating uncertainty around the transaction.
• Ongoing legal proceedings, including a judgment from the Paris Commercial Court ordering Vivani to pay approximately €1.55 million to Pixium Vision SA, with Vivani's appeal currently struck out.
• A breach of contract lawsuit from Oppenheimer & Co. Inc. seeking no less than $1.625 million in damages, with discovery commencing.
• The potential for the 505(b)(2) regulatory pathway to be deemed unacceptable by the FDA, requiring additional costly and time-consuming clinical studies, including a cardiovascular outcomes study.
• Risk that product candidates may have serious adverse side effects, leading to delays, termination of trials, or limited commercial use.
• The company's ability to utilize its net operating loss (NOL) carry-forwards and other tax attributes may be limited due to ownership changes and changes in tax law (e.g., 80% taxable income offset limitation for post-2017 NOLs).

Risks

• The company is a clinical-stage company with a limited operating history and no products approved for commercial sale, making its business viability uncertain.
• Dependence on the successful design, development, regulatory approval, and commercialization of one or more product candidates, with no assurance of achieving these objectives.
• Final marketing approval of NPM-139, NPM-133, NPM-115, or any other product candidates by the FDA or other regulatory authorities may be delayed, limited, or denied.
• Requires substantial additional financing, which may not be available on acceptable terms or at all, potentially forcing delays, reductions, or termination of product development and commercialization efforts.
• Clinical development is a lengthy and expensive process with uncertain outcomes, potentially incurring additional costs and delays, and may not yield favorable results.
• Commercial success of product candidates, if approved, depends on market acceptance among physicians, patients, healthcare payors, and the medical community.
• Subject to complex manufacturing challenges and risks, including reliance on third parties, which could substantially increase costs and limit supply.
• May not be able to adequately protect its proprietary or licensed technology, or patents may be challenged, narrowed, invalidated, or circumvented.
• May infringe the intellectual property rights of others, preventing or delaying development efforts or increasing commercialization costs.
• May be unable to adequately prevent disclosure of trade secrets and other proprietary information.
• Product candidates may have serious adverse, undesirable, or unacceptable side effects that could delay, pause, or terminate clinical trials, or prevent regulatory approval or commercialization.
• Efforts to identify and develop product candidates beyond the current pipeline may not succeed, and selected candidates may not begin clinical trials.
• Delays in the enrollment of patients in clinical trials would adversely affect the ability to initiate, conduct, and complete such trials on anticipated timelines.
• Difficulty identifying, training, and/or certifying an adequate number of healthcare professionals to properly implant and explant drug implant candidates.
• Competitors' products may be approved faster, marketed more effectively, be better tolerated, have a more favorable safety profile, or be more effective, reducing or eliminating commercial opportunity.
• Approval of generic products competing with any of the company's product candidates could adversely affect sales.
• Failure to obtain and sustain an adequate level of reimbursement by third-party payors for product candidates, if approved, would materially adversely affect future sales.
• Product candidates are subject to extensive regulation and must undergo extensive clinical testing, with no assurance of regulatory approval.
• The 505(b)(2) approval pathway may not be acceptable to the FDA, or approval may be delayed or denied due to patent infringement lawsuits or non-patent exclusivity.
• Additional time may be required to obtain regulatory approval for combination products due to increased complexity.
• Reliance on third-party manufacturers increases the risk of insufficient quantities or unacceptable costs, and manufacturers may not meet regulatory requirements.
• Reliance on third parties to conduct preclinical studies and clinical trials, with risks if they do not perform successfully or meet deadlines.
• Partnerships, collaborations, or other strategic initiatives may not be successful or yield intended benefits.
• Inability to develop its own commercial organization or enter into agreements with third parties to sell and market product candidates, if approved, could prevent significant revenue generation.
• Current and future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers are subject to healthcare regulatory laws, with non-compliance leading to penalties.
• Principal stockholders and management own a significant percentage of stock, potentially entrenching management and discouraging acquisitions.
• The company became a reporting company by means other than a traditional IPO, potentially limiting research analyst coverage and market liquidity.
• No anticipated cash dividends, making capital appreciation the sole source of gain for investors.
• Designation of common stock as 'penny stock' could limit liquidity.
• FINRA sales practice requirements may limit stockholders' ability to buy and sell common stock.
• Market price of common stock may be highly volatile due to numerous factors beyond the company's control.
• Failure to retain current senior management and scientific personnel, or to attract and keep additional key personnel, would impair business operations.
• Need to increase the size of the organization and successfully manage growth, which may be challenging.
• Employees, independent contractors, vendors, principal investigators, CROs, and consultants may engage in misconduct or other improper activities.
• Subject to U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, with serious consequences for violations.
• Failure to maintain proper and effective internal control over financial reporting could impair the ability to produce accurate and timely financial statements.
• Disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
• Incurring increased costs as a public company, with management devoting substantial time to new compliance initiatives.
• Reduced reporting requirements as a smaller reporting company may make common stock less attractive to investors.
• Adverse developments affecting the financial services industry (e.g., liquidity issues, defaults by financial institutions) could adversely affect business operations and financial condition.
• Business, results of operations, and future growth prospects could be materially and adversely affected by global economic and political developments, including inflation, capital market disruption, geopolitical disruptions, and potential global health crises.
• Risks associated with tariffs and other trade restrictions, potentially increasing costs and operational disruptions.
• Rising inflation rates could negatively impact expenses.
• Dependence on sophisticated information technology systems and data processing, with risks of security or data privacy breaches, unauthorized access, or destruction of data.
• Use of new and evolving technologies, such as artificial intelligence, may present risks and challenges, including cybersecurity, data privacy, intellectual property, regulatory, legal, operational, competitive, and reputational risks.
• May not be able to complete the spin-off of Cortigent on the terms anticipated or at all, and the spin-off may not have the anticipated benefits.
• Significant income tax liability if the Cortigent spin-off is determined to be taxable for U.S. federal income tax purposes.

Future Outlook

Vivani plans to rapidly advance NPM-139 (semaglutide implant) into clinical development, with a Phase 1 study expected to initiate in mid-2026, followed by parallel preparations for a Phase 2 study. The company intends to explore the 505(b)(2) regulatory pathway for NPM-139 and NPM-133, potentially reducing the need for extensive clinical trials. Vivani also continues to pursue strategic options, including a spin-off or IPO, for its neurostimulation subsidiary, Cortigent, to unlock shareholder value. The company estimates that currently available cash will provide sufficient funds to meet planned obligations into mid-2027, but acknowledges the need for substantial additional financing to continue operations and pursue business objectives.

Management Comments

• Vivani's main priority is the further development of its miniature, ultra long-acting drug implant candidate programs.
• Vivani's management team remains committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight which are aimed at helping patients recover critical body functions.
• We believe our proprietary NanoPortal implant technology has potential to revolutionize the treatment of chronic diseases by addressing important limitations of oral and injectable therapies, namely, poor real-world medication adherence and persistence, and, in the case of GLP-1 therapy, the potential to improve gastrointestinal tolerability.
• As the only GLP-1 implants in development, to our knowledge, we believe Vivani's product candidates, if approved, could expand the market for GLP-1 drugs by reaching underserved and unaddressed populations of obese and diabetic patients through this differentiated route of administration.
• Vivani believes that a miniature long-term drug implant could have the potential to be an attractive treatment option in MASH because we expect medication adherence will be an even bigger problem in an asymptomatic and slowly progressing indication like MASH than it is other, more symptomatic, indications such as obesity and type 2 diabetes.
• We believe that the continued success of our business will depend, in part, on our ability to attract and retain qualified personnel, and we are committed to developing our people and providing them with opportunities to contribute to our growth and success.
• We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

Industry Context

StockSavvy.ai notes that Vivani Medical operates in the highly competitive and rapidly evolving biopharmaceutical industry, specifically targeting the massive and growing GLP-1 market for chronic weight management and type 2 diabetes. The company's NanoPortal implant technology offers a differentiated approach by addressing medication non-adherence and drug tolerability, which are significant challenges for existing oral and injectable GLP-1 therapies like Novo Nordisk's Wegovy/Ozempic and Lilly's Mounjaro/Zepbound. While the GLP-1 market is projected to reach over $160 billion by 2034, Vivani's unique long-acting, reversible implant strategy positions it to potentially capture underserved market segments. The company's focus on companion animal health with OKV-119 also taps into a growing pet health market, diversifying its portfolio beyond human therapeutics.

Comparison to Industry Standards

• Vivani's NanoPortal implants aim to address the significant issue of medication non-adherence, which affects approximately 50% of patients taking daily oral or weekly injectable medicines. For example, 64% of Wegovy (semaglutide injection) patients discontinue treatment within the first year, rising to 76% by the second year. Vivani's implants are designed to guarantee adherence for six months or longer, offering a potential improvement over current standards.
• The company's preclinical data for NPM-139 (semaglutide implant) showing approximately 20% weight loss maintained for over six months in rats is consistent with weight loss observed with semaglutide injections in similar preclinical models, suggesting comparable efficacy with a longer-acting delivery method.
• Preliminary market research indicates strong patient and physician interest in GLP-1 implants, with 56% of GLP-1 patients 'Definitely or Likely' to use such an implant if approved, and primary care physicians giving an average rating of 8.3 out of 10 for recommending a product with NPM-119's profile. This suggests a potential for significant market penetration compared to existing oral/injectable options.
• Vivani's product candidates are positioned as the only GLP-1 implants in development, differentiating them from over 50 other GLP-1 and dual/triple agonists in clinical development, which are all oral or injectable options. This unique route of administration could allow Vivani to access untapped market segments.
• The reversibility of NanoPortal implants is a key differentiator, especially for situations where GLP-1 use is not recommended (e.g., before certain surgeries, for pregnant women), offering an advantage over other infrequent dosage forms like monthly/quarterly injections or gene therapy approaches.

Management Changes

Corporate Governance

Legal Proceedings

• One opposition filed by Pixium Vision SA in the European Patent Office challenging a Cortigent patent was abandoned by the EPO in February 2025, impacting European patent enforcement for neurostimulation technology but not materially affecting Cortigent's operations.
• Vivani is appealing a Paris Commercial Court judgment from December 8, 2022, which ordered the company to pay Pixium Vision SA approximately €1.55 million (net of €947,780 already paid) after finding Vivani's termination of an MOU invalid. Vivani's appeal was struck out on October 23, 2024, for failure to enforce the decision, but the company plans to reinstate it within two years.
• Oppenheimer & Co. Inc. filed a breach of contract complaint on January 26, 2024, seeking no less than $1.625 million in damages. The Court granted Vivani's motion to dismiss in part on June 12, 2025, dismissing all claims except the breach of contract claim, and discovery is commencing.

Related Party Transactions

• On November 8, 2024, the company sold 3,968,253 shares of common stock to one of its independent directors for $5.0 million.
• During 2025, the company entered into multiple share purchase agreements with an entity affiliated with one of its independent directors, and one share purchase agreement with another investor, for the sale of common stock. As of December 31, 2025, 7,480,158 shares were issued for gross proceeds of $8.6 million, with an additional $12.6 million expected in 2026.
• On October 26, 2025, the company sold 3,703,703 shares of common stock to an entity affiliated with one of its independent directors for gross proceeds of $6.0 million.
• On January 25, 2026 (subsequent event), the company sold 1,351,351 shares of common stock to an entity affiliated with one of its independent directors for gross proceeds of approximately $2.0 million.

Stakeholder Impact

• **Shareholders:** Face dilution from ongoing equity raises but also potential value creation from successful clinical development of NanoPortal implants and the eventual spin-off/IPO of Cortigent. The increased net loss and legal liabilities pose risks to shareholder value.
• **Employees:** Benefit from competitive compensation, flexible work arrangements, and annual equity grants. The company's growth and development efforts provide opportunities, but the need for additional capital and ongoing losses could create uncertainty.
• **Customers/Patients:** Potential for revolutionary treatment options for chronic diseases like obesity and type 2 diabetes through ultra long-acting, reversible GLP-1 implants, addressing medication adherence and tolerability issues. This could lead to better health outcomes.
• **Suppliers/Creditors:** The company's reliance on third-party manufacturers and its need for substantial additional financing introduce risks for suppliers and creditors, although recent capital raises provide some near-term liquidity.
• **Regulatory Bodies:** The company's adherence to FDA and other regulatory requirements, including cGMP and QMSR, is critical for product approval and commercialization. Ongoing dialog with the FDA for 505(b)(2) pathway and new guidance documents is essential.

Next Steps

• Initiate a Phase 1 clinical study for NPM-139 (semaglutide implant) in the first half of 2026, pending regulatory clearance.
• Prepare in parallel to initiate a Phase 2 clinical study of NPM-139, pending enabling results from the Phase 1 study and regulatory feedback.
• Engage further with regulatory authorities on the timing, duration, endpoints, number of enrolled patients, and other aspects of trial design for future clinical trials of NPM-139.
• Continue to pursue a path forward to unlock stockholder value associated with Cortigent, Inc., considering both a spin-off (Form 10) and an IPO (Form S-1).
• Re-instate the appeal against the Paris Commercial Court judgment in the Pixium Vision SA lawsuit within two years, providing evidence of full enforcement or an agreement.
• Commence discovery on the breach of contract claim from Oppenheimer & Co. Inc.
• Issue remaining shares under 2025 Private Sales Transactions in 2026, with expected gross proceeds of approximately $12.6 million.
• Continue to evaluate the impact of new accounting standards (ASU 2025-10 and ASU 2025-11) on consolidated financial statements and related disclosures.
• Continue to monitor any adverse impact from global economic and political developments, including inflation and geopolitical disruptions.

Key Dates

Recommendation

Vivani Medical presents a high-risk, high-reward profile. The NanoPortal technology, with its potential to revolutionize chronic disease treatment by improving medication adherence and tolerability, is a significant long-term positive, especially given the massive and growing GLP-1 market. Successful completion of the first-in-human trial and prioritization of the semaglutide implant (NPM-139) are strong clinical advancements. However, the company's substantial and increasing net losses, significant cash burn, and ongoing need for capital create considerable financial risk. The delays and complexities surrounding the Cortigent spin-off, coupled with ongoing legal liabilities, add further uncertainty. While the technology's potential is compelling, the current financial state and execution risks warrant a 'hold' recommendation for most investors, with a 'speculative buy' for those with a high-risk tolerance and long-term horizon who believe in the technology's transformative potential and the company's ability to secure future funding and navigate regulatory hurdles.

Keywords

GLP-1 implant, semaglutide, exenatide, NanoPortal technology, chronic weight management, type 2 diabetes, obesity, biopharmaceutical, clinical stage, drug delivery, subdermal implant, medication adherence, Nano Precision Medical, Vivani Medical, Cortigent, Okava Pharmaceuticals, SEC filing, 10-K, clinical trials, preclinical data, FDA approval, regulatory milestones, capital raise, corporate governance, risk factors, intellectual property