Vivani Medical Provides Business Update Including $10M Equity Financing and Reports Second Quarter 2025 Financial Results
Vivani Medical (NASDAQ: VANI) announced significant developments including a $10M equity financing through a private placement of 7.9M shares at $1.26 per share. The company reported promising results for its semaglutide implant NPM-139, which demonstrated ~20% weight loss maintained over six months in preclinical studies. The financing extends their runway into H2 2026.
Key developments include positive results from the LIBERATE-1 Phase 1 clinical study of NPM-115, plans to initiate NPM-139 clinical trials in 2026, and the upcoming spin-off of Cortigent as an independent public company. Q2 2025 financial results showed a cash balance of $8.1M, with R&D expenses increasing 35% to $4.8M and a net loss of $7.1M.
Vivani Medical (NASDAQ: VANI) ha annunciato sviluppi importanti, incluso un finanziamento azionario da $10M tramite un collocamento privato di 7,9 milioni di azioni a $1,26 ciascuna. L'azienda ha riportato risultati promettenti per il suo impianto di semaglutide NPM-139, che nei studi preclinici ha mostrato una perdita di peso di circa il 20% mantenuta per sei mesi. Il finanziamento estende la sua runway fino al secondo semestre 2026.
Tra gli sviluppi principali: risultati positivi dallo studio clinico di Fase 1 LIBERATE-1 su NPM-115, piani per avviare gli studi clinici su NPM-139 nel 2026 e la prossima scissione di Cortigent come società pubblica indipendente. I risultati finanziari del secondo trimestre 2025 hanno mostrato una liquidità di $8.1M, con spese R&S in aumento del 35% a $4.8M e una perdita netta di $7.1M.
Vivani Medical (NASDAQ: VANI) anunció avances significativos, incluido un financiamiento de capital de $10M mediante una colocación privada de 7.9M de acciones a $1.26 por acción. La compañía reportó resultados prometedores para su implante de semaglutida NPM-139, que mostró aproximadamente un 20% de pérdida de peso mantenida durante seis meses en estudios preclínicos. El financiamiento amplía su runway hasta la segunda mitad de 2026.
Entre los hitos clave: resultados positivos del estudio clínico de Fase 1 LIBERATE-1 de NPM-115, planes para iniciar ensayos clínicos de NPM-139 en 2026 y la próxima escisión de Cortigent como empresa pública independiente. Los resultados financieros del segundo trimestre de 2025 mostraron un saldo de caja de $8.1M, con gastos de I+D aumentando un 35% hasta $4.8M y una pérdida neta de $7.1M.
Vivani Medical (NASDAQ: VANI)는 7.9M주를 주당 $1.26에 사모로 발행하는 $10M 자본 조달 등 주요 진전을 발표했습니다. 회사는 전임상에서 반응성이 좋은 세마글루타이드 이식제 NPM-139가 약 20%의 체중 감소를 6개월 동안 유지하는 유망한 결과를 보고했습니다. 이번 자금 조달로 2026년 하반기까지 운영 자금이 확보됩니다.
주요 내용으로는 LIBERATE-1 1상에서의 긍정적 결과, 2026년 NPM-139 임상시험 개시 계획, Cortigent를 독립 상장사로 분사 예정인 점 등이 포함됩니다. 2025년 2분기 실적은 현금 잔고 $8.1M, 연구개발비가 35% 증가한 $4.8M, 순손실 $7.1M를 기록했습니다.
Vivani Medical (NASDAQ: VANI) a annoncé des avancées importantes, notamment un financement en actions de 10 M$ via un placement privé de 7,9 M d'actions à 1,26 $ par action. La société a publié des résultats prometteurs pour son implant de sémaglutide NPM-139, qui a entraîné une perte de poids d'environ 20% maintenue sur six mois dans des études précliniques. Ce financement prolonge sa visibilité financière jusqu'au second semestre 2026.
Parmi les faits marquants: des résultats positifs de l'étude clinique de Phase 1 LIBERATE-1 sur NPM-115, des plans de lancement des essais cliniques de NPM-139 en 2026, et la prochaine scission de Cortigent en société cotée indépendante. Les résultats du T2 2025 montrent une trésorerie de $8.1M, des dépenses R&D en hausse de 35% à $4.8M et une perte nette de $7.1M.
Vivani Medical (NASDAQ: VANI) gab bedeutende Entwicklungen bekannt, darunter eine $10M Eigenkapitalfinanzierung durch ein Private Placement von 7,9 Mio. Aktien zu je $1,26. Das Unternehmen meldete vielversprechende Ergebnisse für sein Semaglutid-Implantat NPM-139, das in präklinischen Studien einen etwa 20%igen Gewichtsverlust zeigte, der über sechs Monate erhalten blieb. Die Finanzierung verlängert den finanziellen Spielraum bis in die zweite Hälfte 2026.
Zu den wichtigsten Punkten gehören positive Resultate der LIBERATE-1 Phase-1-Studie zu NPM-115, Pläne, 2026 klinische Studien für NPM-139 zu starten, sowie die bevorstehende Ausgliederung von Cortigent als unabhängiges börsennotiertes Unternehmen. Die Finanzergebnisse für Q2 2025 zeigten einen Kassenbestand von $8.1M, einen um 35% gestiegenen F&E-Aufwand von $4.8M und einen Nettoverlust von $7.1M.
- Secured $10M equity financing extending runway into H2 2026
- NPM-139 preclinical data showed ~20% weight loss maintained over 6 months
- Positive safety and tolerability profile from LIBERATE-1 Phase 1 study
- Expanded collaboration with Okava Pharmaceuticals for veterinary applications
- Additional $21.25M committed capital through July 2026
- Net loss increased by $1.8M to $7.1M in Q2 2025
- Cash balance decreased from $19.7M to $8.1M since December 2024
- R&D expenses increased 35% to $4.8M
- G&A expenses rose 25% to $2.7M
Insights
Vivani secures $10M to advance promising semaglutide implant with 20% weight loss data, strengthening financials through 2026.
Vivani Medical's strategic pivot toward its semaglutide implant (NPM-139) represents a significant development in the competitive obesity and diabetes treatment landscape. The company has generated compelling preclinical data showing
The positive results from LIBERATE-1, their first-in-human clinical study for the NanoPortal implant technology with NPM-115, validate their platform's safety and tolerability profile while meeting primary objectives. This de-risks their technology approach considerably and provides a pathway for NPM-139's advancement.
The new
Their quarterly net loss widened to
The planned spin-off of Cortigent (their brain implant division) allows Vivani to concentrate resources on their metabolic disease pipeline while potentially unlocking separate value for shareholders. With clinical development of NPM-139 slated for 2026, Vivani is positioning its implantable technology as a differentiated solution in the high-growth GLP-1 market dominated by pharmaceutical giants.
Vivani's financing and promising NPM-139 data strengthens competitive position in lucrative GLP-1 market despite increasing cash burn.
Vivani's financial maneuvering deserves careful attention. The company has successfully secured
The company's financial position has been significantly stabilized, with committed capital now extending their runway into H2 2026. This financing structure allows them to pursue clinical development of NPM-139 without immediate dilution pressure.
Chairman Gregg Williams' continued investment sends a powerful signal about internal confidence in the company's direction. Williams' participation in this latest round demonstrates alignment between management and shareholders while providing crucial operating capital.
The cash burn requires monitoring, however. Quarterly R&D expenses increased
The strategic decision to spin off Cortigent represents a capital-efficient approach to unlock shareholder value. By creating two focused entities, each can pursue funding and partnerships aligned with their specific therapeutic areas without competing internally for resources.
Vivani's partnership expansion with Okava Pharmaceuticals into veterinary applications provides a complementary revenue opportunity without distracting from their core human therapeutic programs. This diversification into the growing pet health market could provide additional validation for their technology platform.
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
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
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
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
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
Research and development expense: Research and development expense during the three months ended June 30, 2025 was
General and administrative expense: General and administrative expense during the three months ended June 30, 2025 was
Other income, net: Other income, net during the three months ended June 30, 2025 was
Net Loss: The net loss during the three months ended June 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’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
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
info@vivani.com
(415) 506-8462
Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
investors@vivani.com
(415) 506-8462
Media Contact:
Mark Corbae
ICR Healthcare
Mark.Corbae@ICRHealthcare.com
(203) 682-8288
| VIVANI MEDICAL, INC. AND SUBSIDIARIES | ||||||||
| Condensed Consolidated Balance Sheets (unaudited) (in thousands, except per share data) | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,794 | $ | 18,352 | * | |||
| R&D tax credit incentive receivable | 494 | 253 | ||||||
| Prepaid expenses and other current assets | 1,427 | 1,837 | ||||||
| Total current assets | 8,715 | 20,442 | ||||||
| Property and equipment, net | 1,577 | 1,693 | ||||||
| Operating lease right-of-use assets, net | 17,146 | 17,957 | ||||||
| Restricted cash | 1,338 | 1,338 | ||||||
| Other assets | 129 | 131 | ||||||
| Total assets | $ | 28,905 | $ | 41,561 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,762 | $ | 817 | ||||
| Accrued expenses | 1,586 | 1,803 | ||||||
| Litigation accrual | 1,675 | 1,675 | ||||||
| Accrued compensation expense | 356 | 343 | ||||||
| Current operating lease liabilities | 1,337 | 1,348 | ||||||
| Total current liabilities | 6,716 | 5,986 | ||||||
| Long-term operating lease liabilities | 17,279 | 17,965 | ||||||
| Total liabilities | 23,995 | 23,951 | ||||||
| Commitments and contingencies (Note 12) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value | - | - | ||||||
| Common stock, par value | 6 | 6 | ||||||
| Additional paid-in capital | 140,193 | 139,480 | ||||||
| Accumulated other comprehensive income | 81 | 48 | ||||||
| Accumulated deficit | (135,370 | ) | (121,924 | ) | ||||
| Total stockholders’ equity | 4,910 | 17,610 | ||||||
| Total liabilities and stockholders’ equity | $ | 28,905 | $ | 41,561 | ||||
*
| VIVANI MEDICAL, INC. AND SUBSIDIARIES | ||||||||||||||||
| Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net of grants | $ | 4,759 | $ | 3,513 | $ | 8,976 | $ | 7,239 | ||||||||
| General and administrative, net of grants | 2,703 | 2,168 | 5,044 | 4,669 | ||||||||||||
| Total operating expenses | 7,462 | 5,681 | 14,020 | 11,908 | ||||||||||||
| Loss from operations | (7,462 | ) | (5,681 | ) | (14,020 | ) | (11,908 | ) | ||||||||
| Other income, net | 318 | 325 | 574 | 513 | ||||||||||||
| Net loss | $ | (7,144 | ) | $ | (5,356 | ) | $ | (13,446 | ) | $ | (11,395 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.12 | ) | $ | (0.10 | ) | $ | (0.23 | ) | $ | (0.21 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 59,244 | 55,021 | 59,240 | 53,612 | ||||||||||||
FAQ
What are the key findings from Vivani Medical's NPM-139 semaglutide implant trials?
How much funding did Vivani Medical (VANI) secure in their latest equity financing?
What were Vivani Medical's (VANI) Q2 2025 financial results?
When will Vivani Medical spin off Cortigent Inc?
What is the timeline for Vivani Medical's NPM-139 clinical development?
