10-Q: Vivani Medical Q3 Loss Widens, Secures Capital, Advances GLP-1

Vivani Medical reported increased net losses and significant cash burn in Q3 2025, while securing new capital and advancing its lead GLP-1 implant program, NPM-139, towards clinical trials in 2026.

Summary

• Net loss for the nine months ended September 30, 2025, increased to $19.976 million from $17.436 million in the prior year period.
• Cash and cash equivalents significantly decreased to $2.628 million as of September 30, 2025, from $18.352 million at December 31, 2024.
• Working capital deteriorated from $14.5 million at December 31, 2024, to a negative $2.7 million at September 30, 2025.
• Research and development expenses increased by 18% to $13.496 million for the nine months ended September 30, 2025, primarily due to the Biopharma division.
• General and administrative expenses increased by 7% to $7.250 million for the nine months ended September 30, 2025.
• The LIBERATE-1 clinical study for NPM-115 (exenatide implant) demonstrated a positive safety and tolerability profile and encouraging performance data.
• Vivani plans to prioritize and advance NPM-139 (semaglutide implant), with Phase 1 clinical study expected to begin in the first half of 2026, pending regulatory clearance.
• The planned spin-off of Cortigent, Inc. was delayed due to the U.S. federal government shutdown, with the record date withdrawn on October 3, 2025.
• Subsequent to the quarter, Vivani secured approximately $15.7 million in gross proceeds from a private placement and a registered direct offering in October 2025.
• The company estimates that currently available cash will provide sufficient funds to meet planned obligations into 2027.

Sentiment

Score: 4

Explanation: While there are significant positive developments in clinical trials and substantial capital raises, the company's financial health shows considerable deterioration with widening losses, negative working capital, and increased cash burn. The delay in the Cortigent spin-off and ongoing legal challenges add to the uncertainty. The capital raises are critical for continued operations but highlight the persistent need for funding for a clinical-stage company with no revenue.

Positives

• LIBERATE-1 clinical study for NPM-115 (exenatide implant) met primary objectives, demonstrating positive safety, tolerability, and encouraging performance data.
• Preclinical feasibility data for NPM-139 (semaglutide implant) showed approximately 20% weight loss maintained for over six months with a single implant, supporting potential for annual dosing.
• FDA cleared the IND and lifted the clinical hold for NPM-119 (exenatide implant) in June 2024, allowing for clinical development.
• Expanded collaboration with Okava Pharmaceuticals to include dogs in the development of OKV-119, a GLP-1 therapy for companion animals.
• Successfully raised approximately $15.7 million in gross proceeds through a private placement and a registered direct offering in October 2025, post-quarter end.
• Management estimates that currently available cash will provide sufficient funds to meet planned obligations into 2027.

Negatives

• Net loss for the nine months ended September 30, 2025, increased to $19.976 million, compared to $17.436 million for the same period in 2024.
• Cash and cash equivalents decreased significantly to $2.628 million at September 30, 2025, from $18.352 million at December 31, 2024.
• Working capital declined from a positive $14.5 million at December 31, 2024, to a negative $2.7 million at September 30, 2025.
• Net cash used in operating activities increased to $17.601 million for the nine months ended September 30, 2025, from $14.974 million in the prior year, indicating higher cash burn.
• The company continues to incur recurring operating losses and negative operating cash flows since inception.
• The record date for the Cortigent spin-off was withdrawn due to delays from the U.S. federal government shutdown, creating uncertainty around the transaction timeline.

Risks

• Requires substantial additional financing to pursue business objectives, which may not be available on acceptable terms or at all, potentially forcing delays or termination of product development.
• Developing pharmaceutical products, including clinical trials, is a time-consuming, expensive, and uncertain process.
• Global economic and political developments, including inflation, capital market disruption, geopolitical conflicts, and potential global health crises, could materially and adversely affect business.
• Exposure to tariffs and other trade restrictions, including potential new tariffs on pharmaceutical raw materials and APIs, could increase costs and disrupt operations.
• Disruptions at the FDA, SEC, and other government agencies due to staffing reductions, funding shortages, or government shutdowns could hinder regulatory approvals and business functions.
• The impact of recent healthcare reform legislation, such as the Medicare Drug Price Negotiation Program and changes to Medicaid, could adversely affect revenue prospects and commercial success.
• Ongoing litigation with Pixium Vision SA, where the Paris Commercial Court ordered payment of approximately €1.55 million, and an appeal was struck out for failure to enforce the judgment.
• Litigation with Oppenheimer & Co. Inc. asserting breach of contract and seeking no less than $1,625,000 in damages, with the outcome uncertain.

Future Outlook

Vivani plans to prioritize the advancement of NPM-139 (semaglutide implant), with clinical development expected to begin in 2026, including a Phase 1 study in the first half of 2026, pending regulatory clearance, and parallel preparations for a Phase 2 study. The company expects to reestablish a new record date for the Cortigent spin-off as soon as possible following delays from the U.S. federal government shutdown. Vivani anticipates continued significant expenses and operating losses as it initiates additional clinical trials and conducts research and development activities, and expects to fund operations through public or private equity or debt financings, grants, collaborations, or strategic partnerships.

Management Comments

• Our NanoPortal implant technology has the potential to reduce dosing administration frequency to 6 months or longer and allows for treatment to be discontinued at any time if necessary.
• We aim to minimize fluctuations in patients drug levels which may improve the tolerability of medicines, including GLP-1 receptor agonists which produce side effects that are associated with fluctuating drug levels in the blood.
• Our emerging portfolio of miniature, ultra long-acting drug implants have the potential to revolutionize the treatment of chronic diseases by directly addressing poor medication adherence and improving drug tolerability in patients, both of which have the potential to translate into better health outcomes for patients in the real-world setting.
• Vivani's main priority is the further development of its miniature, ultra long-acting drug implant 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.
• We believe this six-month administration profile is important commercially in the veterinary setting due to the infrequent cadence of veterinary visits.
• The strategic goal of the Cortigent spin-off is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.
• We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into 2027.

Industry Context

Vivani Medical operates in the highly competitive biopharmaceutical sector, specifically targeting chronic diseases with its novel NanoPortal technology for long-acting subdermal drug implants. The focus on GLP-1 agonists (semaglutide, exenatide) places it directly in the rapidly growing and lucrative market for weight management and type 2 diabetes, currently dominated by injectable and oral medications like Ozempic and Wegovy. Vivani's approach aims to address a critical industry challenge: medication non-adherence, which affects approximately 50% of patients. By offering ultra long-acting implants (6 months to yearly dosing), Vivani seeks to differentiate itself by improving adherence and potentially drug tolerability due to minimized drug level fluctuations. The expansion into veterinary applications with Okava Pharmaceuticals also taps into a growing market for companion animal health. The planned spin-off of its neurostimulation division (Cortigent) reflects a strategic move to streamline focus on its core biopharm pipeline, a common practice in the industry to unlock value and attract specialized investment.

Comparison to Industry Standards

• NPM-115 (exenatide implant) preclinical weight loss data of approximately 20% in obese mice was comparable to semaglutide injections (active ingredient in Ozempic and Wegovy) in the same study, suggesting competitive efficacy.
• NPM-139 (semaglutide implant) preclinical data demonstrated approximately 20% weight loss maintained for over six months, supporting the potential for once-yearly dosing, which would be a significant improvement over weekly injectable GLP-1s like Wegovy, where 64% of patients discontinue treatment within the first year.
• The GLP-1 (exenatide) implant produced sham-implant adjusted liver fat reduction of 82% in an obese mouse model, consistent with published results from similar investigations with semaglutide, indicating comparable therapeutic effects on liver health.
• The company's NanoPortal technology aims to address the 50% medication non-adherence rate for chronic diseases, a significant improvement over current daily oral or weekly injectable medicines like Wegovy, which sees 64% discontinuation within the first year and 76% by the second year.

Corporate Governance

Legal Proceedings

• Paris Commercial Court ordered Vivani to pay Pixium Vision SA approximately €1.55 million (net of €1 million 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 judgment, requiring reinstatement within two years by enforcing the judgment or reaching an agreement.
• Oppenheimer & Co. Inc. filed a complaint asserting breach of contract against Vivani, seeking no less than $1,625,000 in damages. The court dismissed all claims except the breach of contract claim, and discovery is commencing. Both parties have filed notices of appeal.

Related Party Transactions

• On March 26, 2025, Vivani entered into a share purchase agreement with an entity affiliated with one of its directors to sell 7,366,071 shares for approximately $8.25 million.
• On May 12, 2025, Vivani entered into a share purchase agreement with an entity affiliated with one of its directors to sell 2,912,621 shares for approximately $3.0 million.
• On August 11, 2025, Vivani entered into a share purchase agreement with an entity affiliated with one of its directors and another investor to sell 7,936,507 shares for approximately $10.0 million.
• Subsequent to the quarter, on October 26, 2025, Vivani entered into a private placement with an entity affiliated with one of its board of directors for the purchase of 3,703,703 shares for approximately $6.0 million.

Stakeholder Impact

• Shareholders: Dilution from ongoing equity raises, potential for value creation from successful clinical development of GLP-1 implants, but also risk from widening losses and legal liabilities. The Cortigent spin-off, if successful, could unlock value.
• Employees: Continued investment in R&D and operations, but ongoing financial losses and need for capital raise could create uncertainty.
• Customers (future): Potential for revolutionary long-acting drug implants to improve medication adherence and tolerability for chronic diseases like obesity and type 2 diabetes.
• Creditors: Increased current liabilities and negative working capital indicate higher short-term financial risk, though recent capital raises provide some liquidity.
• Regulatory Authorities: Continued engagement with FDA for INDs and clinical trials, and SEC for filings and spin-off approvals.

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.
• Reestablish a new record date for the Cortigent, Inc. spin-off as soon as possible.
• Continue to seek additional funds through public or private equity offerings, debt financings, grants, collaborations, strategic partnerships, or other sources.
• Commence discovery on the breach of contract claim with Oppenheimer & Co. Inc. and defend vigorously.
• Request reinstatement of the appeal in the Pixium litigation within two years by enforcing the judgment or reaching an agreement.

Key Dates

Recommendation

Vivani Medical presents a mixed bag for investors. On one hand, the company is making significant progress in its core biopharmaceutical pipeline, particularly with the promising preclinical and early clinical data for its GLP-1 implants (NPM-139 and NPM-115). The NanoPortal technology addresses a critical market need for medication adherence in chronic diseases, and the potential for once-yearly dosing is a strong differentiator against existing therapies. The recent capital raises, totaling approximately $15.7 million post-quarter, provide crucial liquidity and extend the cash runway into 2027, mitigating immediate going concern risks. The planned spin-off of Cortigent could also unlock value by allowing each segment to focus on its respective therapeutic area. However, the financial performance remains challenging, with widening net losses, a substantial decrease in cash and working capital, and increased cash burn. The delay in the Cortigent spin-off due to external factors introduces uncertainty, and ongoing legal proceedings carry financial liabilities. Given the high-risk, high-reward nature of clinical-stage biopharma, coupled with the current financial strain and operational progress, a 'hold' recommendation is appropriate. Investors should monitor the progress of NPM-139's clinical trials, the successful execution of the Cortigent spin-off, and the company's ability to secure further non-dilutive funding or partnerships to improve its financial position.

Keywords

GLP-1, semaglutide implant, exenatide implant, NanoPortal technology, chronic weight management, type 2 diabetes, biopharmaceutical, clinical stage, subdermal drug implants, Cortigent spin-off, obesity treatment, medication adherence, animal health, capital raise, SEC filing, 10-Q