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Vivani Medical and Okava Expand Collaboration to Develop OKV-119 for Dogs, Targeting Metabolic Health and Longevity

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Vivani Medical (NASDAQ: VANI) and Okava Pharmaceuticals have expanded their collaboration to develop OKV-119, a long-acting GLP-1 therapy for dogs, targeting weight management, diabetes, and cardiometabolic conditions. The therapy utilizes Vivani's NanoPortal™ technology to deliver therapeutic molecules over extended periods from a single implant.

The collaboration, initially focused on cats since 2019, now addresses a critical need as over 50% of U.S. dogs are overweight or obese. OKV-119 aims to provide dosing every six months or longer, mimicking the physiological effects of fasting without disrupting feeding routines. Research indicates leaner dogs can live more than two years longer than heavier ones.

The expanded partnership maintains minimal costs and risks for Vivani while offering potential upside through future milestone payments and royalties. The financial terms of the agreement were not disclosed.

Vivani Medical (NASDAQ: VANI) e Okava Pharmaceuticals hanno ampliato la loro collaborazione per sviluppare OKV-119, una terapia GLP-1 a lunga durata d'azione per cani, mirata alla gestione del peso, al diabete e alle condizioni cardiometaboliche. La terapia sfrutta la tecnologia NanoPortal™ di Vivani per rilasciare molecole terapeutiche per lunghi periodi tramite un singolo impianto.

La collaborazione, inizialmente focalizzata sui gatti dal 2019, ora risponde a un bisogno critico poiché oltre il 50% dei cani negli Stati Uniti è sovrappeso o obeso. OKV-119 punta a somministrazioni ogni sei mesi o più, replicando gli effetti fisiologici del digiuno senza interferire con le abitudini alimentari. Le ricerche mostrano che i cani più magri possono vivere più di due anni in più rispetto a quelli con peso eccessivo.

La partnership ampliata mantiene bassi costi e rischi per Vivani, offrendo al contempo potenziali benefici attraverso futuri pagamenti legati a traguardi e royalties. I termini finanziari dell’accordo non sono stati resi noti.

Vivani Medical (NASDAQ: VANI) y Okava Pharmaceuticals han ampliado su colaboración para desarrollar OKV-119, una terapia GLP-1 de acción prolongada para perros, enfocada en el control de peso, la diabetes y las condiciones cardiometabólicas. La terapia utiliza la tecnología NanoPortal™ de Vivani para liberar moléculas terapéuticas durante largos períodos a partir de un solo implante.

La colaboración, inicialmente centrada en gatos desde 2019, ahora responde a una necesidad crítica, ya que más del 50% de los perros en EE. UU. tienen sobrepeso u obesidad. OKV-119 busca ofrecer dosis cada seis meses o más, imitando los efectos fisiológicos del ayuno sin alterar las rutinas de alimentación. Las investigaciones indican que los perros más delgados pueden vivir más de dos años más que los más pesados.

La asociación ampliada mantiene costos y riesgos mínimos para Vivani, al tiempo que ofrece potenciales beneficios a través de futuros pagos por hitos y regalías. No se divulgaron los términos financieros del acuerdo.

Vivani Medical (NASDAQ: VANI)Okava Pharmaceuticals는 개의 체중 관리, 당뇨병 및 심대사 질환을 목표로 하는 장기 작용 GLP-1 치료제 OKV-119 개발을 위해 협력을 확대했습니다. 이 치료제는 Vivani의 NanoPortal™ 기술을 활용하여 단일 이식편에서 장기간 치료 분자를 전달합니다.

2019년부터 고양이를 대상으로 시작된 협력은 미국 개의 50% 이상이 과체중 또는 비만이라는 심각한 문제에 대응하기 위해 확대되었습니다. OKV-119는 6개월 이상 간격의 투여를 목표로 하며, 식사 습관을 방해하지 않으면서 단식의 생리적 효과를 모방합니다. 연구에 따르면, 몸무게가 적당한 개는 무거운 개보다 2년 이상 더 오래 살 수 있습니다.

확대된 파트너십은 Vivani에게 최소한의 비용과 위험만을 부담시키면서 향후 마일스톤 지급 및 로열티를 통한 잠재적 이익을 제공합니다. 계약의 재무 조건은 공개되지 않았습니다.

Vivani Medical (NASDAQ : VANI) et Okava Pharmaceuticals ont élargi leur collaboration pour développer OKV-119, une thérapie GLP-1 à action prolongée pour les chiens, ciblant la gestion du poids, le diabète et les affections cardiométaboliques. Cette thérapie utilise la technologie NanoPortal™ de Vivani pour délivrer des molécules thérapeutiques sur de longues périodes à partir d’un seul implant.

La collaboration, initialement centrée sur les chats depuis 2019, répond désormais à un besoin crucial alors que plus de 50 % des chiens aux États-Unis sont en surpoids ou obèses. OKV-119 vise une administration tous les six mois ou plus, reproduisant les effets physiologiques du jeûne sans perturber les habitudes alimentaires. Les recherches montrent que les chiens plus maigres peuvent vivre plus de deux ans de plus que les plus lourds.

Le partenariat élargi maintient des coûts et risques minimaux pour Vivani tout en offrant un potentiel de gains via des paiements liés à des étapes clés et des redevances futures. Les modalités financières de l’accord n’ont pas été divulguées.

Vivani Medical (NASDAQ: VANI) und Okava Pharmaceuticals haben ihre Zusammenarbeit zur Entwicklung von OKV-119 ausgeweitet, einer langwirksamen GLP-1-Therapie für Hunde, die auf Gewichtsmanagement, Diabetes und kardiometabolische Erkrankungen abzielt. Die Therapie nutzt die NanoPortal™-Technologie von Vivani, um therapeutische Moleküle über längere Zeiträume aus einem einzigen Implantat freizusetzen.

Die Zusammenarbeit, die seit 2019 zunächst auf Katzen ausgerichtet war, reagiert nun auf einen dringenden Bedarf, da über 50 % der Hunde in den USA übergewichtig oder fettleibig sind. OKV-119 soll eine Dosierung alle sechs Monate oder länger ermöglichen und dabei die physiologischen Effekte des Fastens nachahmen, ohne die Fütterungsgewohnheiten zu stören. Studien zeigen, dass schlankere Hunde mehr als zwei Jahre länger leben können als schwerere.

Die erweiterte Partnerschaft hält die Kosten und Risiken für Vivani gering, bietet aber zugleich potenzielle Vorteile durch zukünftige Meilensteinzahlungen und Lizenzgebühren. Die finanziellen Bedingungen der Vereinbarung wurden nicht bekannt gegeben.

Positive
  • Expansion into dog market significantly increases potential market size with over 50% of US dogs being overweight
  • Partnership structure includes milestone payments and royalties with minimal costs and risks
  • Technology provides 6+ month dosing duration, potentially improving treatment compliance
  • Leverages existing NanoPortal technology already in development for human applications
Negative
  • Financial terms of the agreement not disclosed
  • Product still in development phase with no immediate revenue impact

Insights

Vivani's expanded collaboration with Okava to include dogs in OKV-119 development represents a strategic market expansion that potentially increases the addressable market for their NanoPortal™ technology. The pet health market - particularly treatments for obesity and metabolic conditions - presents significant growth potential given that over 50% of US dogs are overweight or obese.

The partnership structure appears favorable for Vivani, as it specifically mentions minimizing costs and risks while maintaining upside through milestone payments and royalties. This capital-efficient approach is particularly important for a clinical-stage company with a $61.6 million market cap that needs to manage cash burn effectively.

The expanded collaboration demonstrates additional validation for Vivani's proprietary drug delivery platform, showing versatility across species while maintaining technological synergy with their human-focused NPM-115 program. The "One-and-Done" dosing approach (6+ month duration) offers a compelling differentiation in veterinary medicine where compliance is challenging.

While financial terms weren't disclosed, this development opens a pathway to potential recurring revenue in the veterinary market without significant additional R&D investment, potentially providing supplementary cash flow to support their primary human therapeutic programs.

Over half of all dogs in the United States today are overweight or obese, placing them at increased risk for chronic diseases, metabolic decline and shortened lifespans

ALAMEDA, Calif. and SAN FRANCISCO, April 15, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, and Okava Pharmaceuticals, Inc. ("Okava"), a clinical-stage company focused on diseases of aging in dogs and cats, today announced an expansion of their collaboration to include dogs in the development of OKV-119, a long-acting GLP-1 therapy for weight management, diabetes and other cardiometabolic conditions. Vivani and Okava initiated their collaboration in 2019, with a focus on developing OKV-119 for cardiometabolic conditions in cats.

OKV-119 leverages Vivani’s proprietary NanoPortal™ technology, which provides smooth and steady delivery of therapeutic molecules, including GLP-1 receptor agonists, over extended periods from a single implant. According to Okava, dosing every six months or longer supports a “One-and-Done” approach between office visits consistent with the product profile of Vivani’s NPM-115, an ultra long-acting GLP-1 implant in clinical stage development to improve medication adherence and tolerability for the treatment of chronic weight management in humans.

"Caloric restriction, or fasting, is one of the most well-established interventions for extending the lifespan and improving metabolic health in dogs," said Okava CEO Michael Klotsman, PhD, MBA. "But it is also one of the hardest to maintain. OKV-119 mimics many of the physiological effects of fasting—improved insulin sensitivity, reduced fat mass and more efficient energy metabolism—without requiring significant changes in feeding routines or disrupting the human-animal bond that often centers around food."

Over half of all dogs in the United States today are overweight or obese, placing them at increased risk for chronic disease, metabolic decline and shortened lifespans. Similar to the changes humans face as they grow older, aging dogs experience declines in metabolic fitness, leading to weight gain, insulin resistance and loss of muscle mass. Research shows that leaner dogs can live more than two years longer than their heavier counterparts. By restoring and maintaining a healthy metabolism through a single, long-acting dose, OKV-119 has the potential to enhance quality of life, promote healthy aging and become the most impactful life-extending therapy available for dogs.

"This collaboration aligns with Vivani’s broader mission to develop innovative medicines that will revolutionize the treatment of chronic diseases by leveraging proprietary drug delivery technologies," said Vivani CEO Adam Mendelsohn, PhD. "This expanded partnership with Okava reflects our shared confidence in the potential of NanoPortal technology to serve a broad array of prospective beneficiaries in the management of metabolic disease. The structure of this expanded partnership minimizes costs and risks for Vivani while integrating upside potential for Vivani shareholders through future milestone payments and royalties. Together with Okava, we are broadening the reach of our technology, meeting unmet needs in veterinary medicine while positioning Vivani to capture future value within an industry segment experiencing continued and unprecedented growth."  

Financial terms of the expanded agreement were not disclosed.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal platform, Vivani develops therapeutic implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani’s lead programs, NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), are miniature, subdermal GLP-1 implants under development for chronic weight management in obese or overweight individuals designed for once or twice-yearly administration. Vivani’s emerging pipeline also includes NPM-119, which refers to the Company’s six-month, subdermal, GLP-1 (exenatide implant) under development for the treatment of type 2 diabetes. Development of a semaglutide implant for the treatment of type 2 diabetes is also under consideration. These NanoPortal implants are designed to provide patients with the opportunity to experience the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of oral and injectable medications.

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. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature, ultra long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit: www.vivani.com.

About Okava Pharmaceuticals, Inc.

OKAVA is a clinical-stage research and development company that develops new treatment options for dogs and cats suffering from chronic diseases of aging. OKAVA is building a portfolio of products to transform and humanize standards of care in veterinary medicine. By harnessing human technologies for the treatment of common diseases in household pets, the company has the potential of increasing the lifespans of dogs and cats by an average of 1 to 3 years. OKAVA is a private company headquartered in San Francisco, California. For more information, see www.okava.com.

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,” “future,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” 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 ongoing clinical trial and reporting of trial results, Vivani’s emerging development plans for its products, Vivani’s collaboration agreement with Okava, and Vivani’s 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; 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; 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 intended spin-off from the Company. 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 SEC 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.

Vivani Contacts:

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

Okava Contacts:

Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
pr@okava.com
(415) 506-8462


FAQ

What is OKV-119 and how does it work for dogs with VANI's technology?

OKV-119 is a long-acting GLP-1 therapy using Vivani's NanoPortal technology to deliver therapeutic molecules through a single implant, lasting 6+ months, to manage weight and metabolic conditions in dogs.

How many dogs could benefit from VANI's OKV-119 treatment in the US?

Over 50% of dogs in the United States are overweight or obese, representing a significant market for OKV-119 treatment.

What is the potential life extension benefit of VANI's OKV-119 for dogs?

Research shows that leaner dogs can live more than two years longer than heavier ones, suggesting significant potential benefits from OKV-119 treatment.

How does the 2025 VANI-Okava expanded collaboration differ from their 2019 partnership?

The 2025 expansion adds dogs to their existing collaboration, which was previously focused only on developing OKV-119 for cats since 2019.
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