Exenatide

ALAMEDA, Calif., June 25, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that it has received approval from Bellberry, a human research ethics committee (HREC) in Australia to initiate SLIM-1™, a Phase 1 clinical trial of NPM-139, a semaglutide implant. Vivani CEO Adam Mendelsohn, Ph.D., stated, “HREC approval to initiate SLIM-1 in Australia marks an important moment for our Company, clearing the way for near-term, mid-2026, initiation. We are eager to conduct this Phase 1 clinical trial of NPM-139, a semaglutide implant, building on the success of the Phase 1 clinical trial with NPM-119 (exenatide implant) we conducted in Australia in 2025.” Dr. Mendelsohn continued: “In parallel with the execution of SLIM-1, our team is preparing diligently for SLIM-2 which, pending successful results from SLIM-1, we anticipate will be a dose-ranging efficacy-oriented trial of NPM-139 with the aim of accelerating the development of NPM-139’s clinical program. We believe that the market demand for a miniature, reversible GLP-1 implant technology will be strong, and we are fully committed to bringing this important technology to patients. We are grateful for the regulatory approval to initiate SLIM-1 and we look forward to providing further SLIM-1 updates as we proceed.” About SLIM-1 SLIM-1 (Semaglutide ultra Long-acting IMplant in obesity) is a Phase 1 open label, randomized, active comparator-controlled clinical trial evaluating a low-dose NPM-139 (semaglutide NanoPortal implant) and Wegovy (0.25 mg/week) over a four-week duration in obese or overweight subjects (n=10 per group). The trial will primarily assess the safety, tolerability, and pharmacokinetics of NPM-139. Weight loss will be measured. 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. 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 50%, including those taking daily pills. For more information, please visit: 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 express or implied statements regarding the SLIM-1 trial, including initiation, enrollment and read out dates; Vivani’s business, products in development, including the therapeutic potential thereof, the planned development thereof, 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, the risks associated with developing biopharmaceutical implants and conducting clinical trials; the risk that observations in preclinical studies will not be replicated in human trials; risks associated with obtaining regulatory approvals; 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. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Vivani’s expectations in any forward-looking statement. There may be additional risks that Vivani considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in Vivani’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 13, 2026, as may be supplemented by additional filings with the SEC. Any forward-looking statement made by Vivani in this press release is based only on information currently available and speak only as of the date on which it is made. Vivani 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 and Media Relations Contact: Jami Taylor Investor and Media Relations Advisor investors@vivani.com (415) 506-8462

BOSTON--(BUSINESS WIRE)--Ontada®, a McKesson business dedicated to real-world oncology data and insights, will present a real-world observational research study in an oral presentation at the American Society of Oncology (ASCO) Annual Meeting examining GLP-1 receptor agonist (RA) utilization and overall survival outcomes among patients treated in U.S. community oncology practices. The study, titled, “GLP 1 receptor agonist utilization and survival outcomes in a large U.S. community oncology cohort,” analyzed patients diagnosed with cancer between January 2021 and October 2024, with follow-up through October 2025. Investigators identified 418 patients treated with a GLP-1 receptor agonist and 3,476 non-users, with matching by cancer type and diagnosis year to evaluate overall survival (OS) outcomes. Key Data Findings Propensity-score adjusted Cox proportional hazards models evaluated the association between GLP1 RA use and overall survival among patients diagnosed with breast, prostate, colorectal, lung, hepatocellular or renal cancer. After adjustment for confounders including age, BMI, cancer stage and type, GLP‑1 receptor agonist use was significantly associated with improved overall survival (hazard ratio 0.66; 95% CI 0.45–0.97; p = 0.0031). “While GLP-1 therapies are well established for metabolic disease, emerging preclinical and observational data suggest potential anticancer effects, yet large-scale studies investigating this association have been limited,” said Jess Paulus, ScD, vice president of Real-World Research at Ontada and presenting author of the study. “As use of these therapies continues to expand, high-quality real-world data are essential to understanding their broader impact. Our findings demonstrate the value of real-world evidence in identifying anticancer signals and helping efficiently guide future research and prioritization of prospective studies.” Study Methodology This retrospective analysis used data collected between January 2021 and October 2024, with follow‑up through October 2025, and evaluated GLP‑1 receptor agonist use, including dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide. Overall survival was measured from initial cancer diagnosis to death from any cause, with methods applied to address immortal time bias. Among patients who received a GLP‑1 receptor agonist, median age was 63 years, 58% were White, and 57% had a body mass index (BMI) ≥30 kg/m². Semaglutide accounted for the majority of prescriptions (55%). By comparison, non‑users had a median age of 68 years, 58% were White, and 28% had BMI ≥30 kg/m². Most GLP‑1 users (74%) initiated therapy after initial cancer diagnosis, of whom 7% initiated after a metastatic diagnosis, with breast (27%) and prostate (13%) cancers representing the most common malignancies among this group. “At Ontada, our focus is on advancing cancer care by transforming real-world data into meaningful insights,” said Christine Davis, president, Ontada. “This research reflects Ontada’s commitment to generating high-quality, real-world evidence that helps advance how cancer is understood and treated. By studying emerging therapies within community oncology settings, we can help surface insights that inform future research and ultimately support better outcomes for patients.” Other Research & Activities at ASCO 2026 Ontada is a part of McKesson, which has a broad portfolio of oncology and multispecialty solutions and partners that provide research, insights, technologies and services that help to address barriers and improve cancer and multispecialty care. At ASCO, McKesson-supported businesses including The US Oncology Network, Ontada, and Sarah Cannon Research Institute (SCRI), are part of approximately 171 accepted abstracts and presentations. These are inclusive of oral and poster presentations, educational sessions, late-breaking studies and early-phase studies. For a comprehensive list of Ontada’s 14 accepted abstracts, visit Ontada’s ASCO 2026 site. Additionally, visit the Ontada Booth (#30123) at the McCormick Place Convention Center from May 29 – June 2 to explore the data presented at ASCO and discuss Ontada’s solutions. Expert Panel on Community Oncology During ASCO 2026 Additionally, McKesson will be participating in a thought leadership panel hosted by Endpoints News on June 3, 2026, at 12 p.m. ET, titled, “Delivering Excellence, Close to Home.” Panelists include Jason Hammonds, president of Oncology & Multispecialty for McKesson, John Schuler MD, medical director and radiation oncologist with Compass Oncology, and Dr. Patt. Register and join the panelists as they share their insights and perspectives on what is working today—and what needs to evolve—to support and strengthen community oncology as a foundational component of the cancer care ecosystem. About Ontada® Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the belief that precise insights—delivered exactly at the point of need—can save more patients’ lives. Ontada connects the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by leading life sciences companies. For more information, visit ontada.com. About McKesson Oncology & Multispecialty Our Oncology & Multispecialty segment delivers a portfolio of integrated solutions that support patient care by accelerating drug development, expanding access to high-quality care close to home and ensuring life-saving therapies reach the patients who need them most. We provide practice management, technology solutions, specialty drug distribution, clinical trial and group purchasing services, along with pharmacy solutions for community-based oncology practices and multispecialty providers in retina and ophthalmology. We partner behind the scenes with healthcare providers in local communities, supporting their operations so that they can stay focused on who matters most – patients.