Vivani Medical Provides Business Update and Reports Third Quarter 2025 Financial Results
Vivani Medical (Nasdaq: VANI) reported third quarter 2025 results and a business update on Nov 13, 2025. The company completed LIBERATE-1, its first human test of the NanoPortal implant, and reported preclinical NPM-139 data showing 20% weight loss sustained for over 7 months. Vivani plans to initiate a Phase 1 semaglutide implant study in the first half of 2026 and is preparing a Phase 2 dose-ranging study pending Phase 1 results and regulatory feedback.
Financings in 3Q and October generated approximately $25.7 million in cash and commitments to support NPM-139 development and, as of Sept 30, 2025, Vivani held $4.0 million in cash. The company expects to complete the spin-off of Cortigent after the SEC resumes operations.
Vivani Medical (Nasdaq: VANI) ha riportato i risultati del terzo trimestre 2025 e un aggiornamento sull'attività il 13 novembre 2025. L'azienda ha completato LIBERATE-1, la sua prima verifica umana dell'impianto NanoPortal, e ha riportato dati preclinici di NPM-139 che mostrano una perdita di peso del 20% mantenuta per oltre 7 mesi. Vivani intende avviare uno studio di fase 1 dell'impianto semaglutide nel primo semestre del 2026 ed è in preparazione di uno studio di dosaggio di fase 2 in attesa dei risultati di fase 1 e del feedback normativo.
I finanziamenti nel 3Q e in ottobre hanno generato circa $25.7 milioni in liquidità e impegni per supportare lo sviluppo di NPM-139 e, al 30 settembre 2025, Vivani deteneva $4.0 milioni in contanti. L'azienda prevede di completare lo spin-off di Cortigent dopo che la SEC riprenderà le operazioni.
Vivani Medical (Nasdaq: VANI) informó los resultados del tercer trimestre de 2025 y una actualización comercial el 13 de noviembre de 2025. La empresa completó LIBERATE-1, su primera prueba en humanos del implante NanoPortal, y reportó datos preclínicos de NPM-139 que muestran una pérdida de peso del 20% sostenida durante más de 7 meses. Vivani planea iniciar un estudio de implante de semaglutida en la fase 1 en la primera mitad de 2026 y está preparando un estudio de dosis de rango de fase 2 a la espera de los resultados de la fase 1 y comentarios regulatorios.
Los financiamientos en el 3Q y en octubre generaron aproximadamente $25.7 millones en efectivo y compromisos para apoyar el desarrollo de NPM-139 y, al 30 de septiembre de 2025, Vivani tenía $4.0 millones en efectivo. La empresa espera completar la escisión de Cortigent después de que la SEC reanude sus operaciones.
Vivani Medical (Nasdaq: VANI)은 2025년 11월 13일 2025년 3분기 실적과 사업 업데이트를 발표했습니다. 회사는 NanoPortal 이식의 첫 인간 시험인 LIBERATE-1를 완료했고, NPM-139의 전임상 데이터에서 7개월 이상 지속된 20% 체중 감소를 보고했습니다. Vivani는 2026년 상반기에 세마글루타이드 이식의 1상 연구를 시작할 계획이며, 1상 결과와 규제 피드백을 기다리며 2상 용량 범위 연구를 준비 중입니다.
3Q와 10월의 파이낸싱으로 NPM-139 개발을 지원하기 위한 현금 약 $25.7백만이 생성되었고, 2025년 9월 30일 기준으로 Vivani는 현금 $4.0백만를 보유하고 있습니다. 이 회사는 SEC가 업무를 재개한 후 Cortigent의 분사를 완료할 것으로 기대합니다.
Vivani Medical (Nasdaq : VANI) a publié les résultats du troisième trimestre 2025 et une mise à jour commerciale le 13 novembre 2025. La société a terminé LIBERATE-1, son premier test chez l'humain de l'implant NanoPortal, et a rapporté des données précliniques de NPM-139 montrant une perte de poids de 20 % maintenue pendant plus de 7 mois. Vivani prévoit d’initier une étude de phase 1 de l’implant à la semaglutide au premier semestre 2026 et prépare une étude de dosage de phase 2 en fonction des résultats de la phase 1 et des retours réglementaires.
Les financements du 3e trimestre et d'octobre ont généré environ $25,7 millions en liquidités et des engagements pour soutenir le développement de NPM-139 et, au 30 septembre 2025, Vivani détenait $4,0 millions en liquidités. L'entreprise prévoit de finaliser la scission de Cortigent après que la SEC reprenne ses opérations.
Vivani Medical (Nasdaq: VANI) berichtete am 13. November 2025 über die Ergebnisse des dritten Quartals 2025 und ein Unternehmensupdate. Das Unternehmen hat LIBERATE-1, seinen ersten Humantest des NanoPortal-Implants, abgeschlossen, und berichtete präklinische NPM-139-Daten, die einen Gewichtsverlust von 20 % bestätigt über mehr als 7 Monate zeigen. Vivani plant, eine Phase-1-Studie zum Semaglutid-Implantat in der ersten Hälfte 2026 zu starten und bereitet eine Phasen-2-Dosierungsstudie vor, die von den Ergebnissen der Phase 1 und dem regulatorischen Feedback abhängt.
Finanzierungen im 3Q und im Oktober haben etwa $25,7 Millionen an Bargeld und Verpflichtungen generiert, um die Entwicklung von NPM-139 zu unterstützen, und zum 30. September 2025 hielt Vivani $4,0 Millionen in bar. Das Unternehmen erwartet, die Spaltung von Cortigent abzuschließen, nachdem die SEC ihre Operationen wieder aufnimmt.
Vivani Medical (Nasdaq: VANI) أعلنت نتائج الربع الثالث من عام 2025 وتحديثاً تجارياً في 13 نوفمبر 2025. أكملت الشركة LIBERATE-1، تجربتها البشرية الأولى لزراعة NanoPortal، وأبلغت عن بيانات مسبقة إكلينيكية لـ NPM-139 تُظهر فقدان وزن يبلغ 20% مع استمرار لأكثر من 7 أشهر. تخطط Vivani لبدء دراسة من المرحلة 1 لزراعة سيميغلوتايد في النصف الأول من 2026 وتستعد لدراسة جرعات من المرحلة 2 بناءً على نتائج المرحلة 1 والتعليقات التنظيمية.
التمويلات في الربع الثالث وفي أكتوبر تولدت حوالي $25.7 مليون نقداً والتزامات لدعم تطوير NPM-139 وبحلول 30 سبتمبر 2025 كانت لدى Vivani $4.0 مليون نقداً. تتوقع الشركة إكمال فصل Cortigent بعد استئناف SEC لعملياتها.
- $25.7M cash and commitments to support NPM-139
- Completed LIBERATE-1 first-in-human NanoPortal study
- 20% weight loss sustained >7 months in preclinical NPM-139
- Plans to start Phase 1 semaglutide implant study in H1 2026
- Cash balance declined to $4.0M as of Sept 30, 2025
- Reported $6.5M net loss in Q3 2025
- Spin-off of Cortigent delayed pending SEC resumption
Insights
Vivani advanced its implant platform clinically and secured financing to fund semaglutide program into 2027.
Vivani reported completion of LIBERATE-1, the first human use of its NanoPortal™ implant, and plans to initiate a Phase 1 study of the semaglutide implant NPM-139 in the first half of
On financing, Vivani disclosed that the
The clinical path depends explicitly on regulatory clearance and favorable Phase 1 results; any delay or negative Phase 1 outcome would halt the planned Phase 2 work. The spin-off of Cortigent remains paused pending SEC resumption, which could affect near-term corporate structure timing. Monitor the timing and content of regulatory feedback, the Phase 1 safety and PK readouts expected after study initiation in
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
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
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
On August 5, 2025, Vivani announced the rapid advancement of NPM-139, a novel semaglutide implant, following data showing
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
Research and development expense: Research and development expense during the three months ended September 30, 2025 was
General and administrative expense: General and administrative expense during the three months ended September 30, 2025 was
Other income, net: Other income, net during the three months ended September 30, 2025 was
Net Loss: The net loss during the three months ended September 30, 2025 was
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
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
info@vivani.com
(415) 506-8462
Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
investors@vivani.com
(415) 506-8462
Media Contact:
Sean Leous
ICR Healthcare
Sean.Leous@ICRHealthcare.com
(646) 866-4012
| VIVANI MEDICAL, INC. AND SUBSIDIARIES | ||||||||
| Condensed Consolidated Balance Sheets (unaudited) (in thousands, except per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,628 | $ | 18,352 | ||||
| R&D tax credit incentive receivable | 664 | 253 | ||||||
| Prepaid expenses and other current assets | 883 | 1,837 | ||||||
| Total current assets | 4,175 | 20,442 | ||||||
| Property and equipment, net | 2,726 | 1,693 | ||||||
| Operating lease right-of-use assets, net | 16,784 | 17,957 | ||||||
| Restricted cash | 1,338 | 1,338 | ||||||
| Other assets | 23 | 131 | ||||||
| Total assets | $ | 25,046 | $ | 41,561 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,434 | $ | 817 | ||||
| Accrued expenses | 1,978 | 1,803 | ||||||
| Litigation accrual | 1,675 | 1,675 | ||||||
| Accrued compensation expense | 357 | 343 | ||||||
| Current operating lease liabilities | 1,386 | 1,348 | ||||||
| Total current liabilities | 6,830 | 5,986 | ||||||
| Long-term operating lease liabilities | 16,907 | 17,965 | ||||||
| Total liabilities | 23,737 | 23,951 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value | - | - | ||||||
| Common stock, par value | 6 | 6 | ||||||
| Additional paid-in capital | 143,062 | 139,480 | ||||||
| Accumulated other comprehensive income | 141 | 48 | ||||||
| Accumulated deficit | (141,900 | ) | (121,924 | ) | ||||
| Total stockholders’ equity | 1,309 | 17,610 | ||||||
| Total liabilities and stockholders’ equity | $ | 25,046 | $ | 41,561 | ||||
| VIVANI MEDICAL, INC. AND SUBSIDIARIES | ||||||||||||||||||
| Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share data) | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development, net of grants | $ | 4,519 | $ | 4,203 | $ | 13,496 | $ | 11,442 | ||||||||||
| General and administrative, net of grants | 2,206 | 2,106 | 7,250 | 6,775 | ||||||||||||||
| Total operating expenses | 6,725 | 6,309 | 20,746 | 18,217 | ||||||||||||||
| Loss from operations | (6,725 | ) | (6,309 | ) | (20,746 | ) | (18,217 | ) | ||||||||||
| Other income, net | 195 | 268 | 770 | 781 | ||||||||||||||
| Net loss | $ | (6,530 | ) | $ | (6,041 | ) | $ | (19,976 | ) | $ | (17,436 | ) | ||||||
| Net loss per common share - basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.34 | ) | $ | (0.32 | ) | ||||||
| Weighted average common shares outstanding - basic and diluted | 59,711 | 55,247 | 59,399 | 54,161 | ||||||||||||||
FAQ
What did Vivani (VANI) report for cash and commitments on Nov 13, 2025?
When will Vivani (VANI) start the Phase 1 semaglutide implant study?
What clinical progress did Vivani (VANI) announce on Nov 13, 2025?
How much cash did Vivani (VANI) have at Sept 30, 2025 and how does it compare to year-end 2024?
What is the status of Vivani's (VANI) planned Cortigent spin-off?
Does Vivani (VANI) have near-term funding commitments to support development into 2027?
