Vivani Medical (NASDAQ: VANI) wins HREC nod for SLIM-1 semaglutide implant trial
Rhea-AI Filing Summary
Vivani Medical held its 2026 annual stockholder meeting and approved an amended 2022 Omnibus Incentive Plan that increases the common shares reserved for equity awards by 11,000,000, from 10,033,333 to 21,033,333 shares. Stockholders also re-elected six directors, approved executive compensation on a non-binding advisory basis, and ratified BPM LLP as auditor for the year ending December 31, 2026. The meeting reached a quorum with 62,071,530 of 86,235,104 common shares represented in person or by proxy.
Separately, Vivani received approval from Bellberry, a human research ethics committee in Australia, to initiate SLIM-1, a Phase 1 clinical trial of NPM-139, a semaglutide implant for obesity and chronic weight management. SLIM-1 is designed as an open-label, randomized, active comparator-controlled trial evaluating low-dose NPM-139 versus Wegovy 0.25 mg/week over four weeks in obese or overweight subjects, with 10 participants per group, focusing on safety, tolerability, and pharmacokinetics while also measuring weight loss.
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Insights
Vivani gains early clinical clearance for a GLP-1 implant and expands its equity incentive capacity.
Vivani’s approval from Australia’s Bellberry HREC to start the SLIM-1 Phase 1 trial of NPM-139 advances its GLP-1 implant pipeline into clinical testing for obesity and chronic weight management. The trial compares a low-dose semaglutide implant with Wegovy over four weeks in two 10-patient arms.
The study’s primary focus on safety, tolerability, and pharmacokinetics is typical for early-stage programs and does not provide efficacy proof yet, though weight loss will be tracked. Outcomes from SLIM-1 will likely shape the design and justification of the planned SLIM-2, described as a potential dose-ranging, efficacy-oriented trial, but specific timelines beyond these references are not detailed here.
On the governance side, stockholders backed all director nominees, approved executive compensation on an advisory basis, and ratified BPM LLP as auditor. They also approved increasing shares reserved under the 2022 Amended Plan to 21,033,333, expanding the company’s ability to grant stock-based awards. The overall impact depends on future clinical data and how extensively the enlarged plan is used.
8-K Event Classification
Key Figures
Key Terms
2022 Omnibus Incentive Plan financial
non-binding advisory basis financial
human research ethics committee regulatory
Phase 1 open label, randomized, active comparator-controlled medical
pharmacokinetics medical
GLP-1 based implants medical
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 |
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CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Amended and Restated Vivani Medical, Inc. 2022 Omnibus Incentive Plan
On March 25, 2026, the board of directors (the “Board”), of Vivani Medical, Inc. (“Vivani”), adopted and approved, subject to stockholder approval, an amendment and restatement of the Vivani Medical, Inc. 2022 Omnibus Incentive Plan, (the “2022 Plan”, as so amended and restated, the “2022 Amended Plan”), all as described in Vivani’s definitive proxy statement (the “Proxy Statement”) for its 2026 Annual Meeting of Stockholders (the “Annual Meeting”), as filed with the U.S. Securities and Exchange Commission on April 29, 2026.
The 2022 Amended Plan, which was approved by the Vivani’s stockholders at the Annual Meeting as described under Item 5.07 below, increases the number of shares of Vivani’s common stock reserved under the 2022 Amended Plan by 11,000,000 shares, from 10,033,333 to 21,033,333 shares. No other provisions of the 2022 Plan were amended in the 2022 Amended Plan.
A summary of the principal features of the 2022 Amended Plan is included in the Proxy Statement. The foregoing description is qualified in its entirety by reference to the full text of the 2022 Amended Plan, a copy of which is filed as exhibit 10.1 to this Form 8-K and incorporated herein by reference.
Item 5.07. Submission of Matters to a Vote of Security Holders.
The Annual Meeting was held on June 24, 2026. Holders of 62,071,530 of 86,235,104 shares of Vivani’s common stock were represented at the meeting in person or by proxy, constituting a quorum. The following are the voting results on each matter submitted to the stockholders of Vivani at the Annual Meeting.
Proposal 1: The stockholders elected each of the six director nominees to the Board to serve until Vivani’s 2027 annual meeting of stockholders or until their earlier death, resignation or removal, or until their successors have been duly elected and qualified, as set forth below:
Director Name | Votes For | Votes Withheld | Broker Non-Votes |
Gregg Williams | 47,572,851 | 554,159 | 13,944,519 |
Daniel Bradbury | 47,884,419 | 242,591 | 13,944,519 |
Aaron Mendelsohn | 47,435,960 | 691,050 | 13,944,519 |
Adam Mendelsohn | 47,879,152 | 247,858 | 13,944,519 |
August Moretti | 47,888,337 | 238,673 | 13,944,519 |
Alexandra Popoff | 47,871,817 | 255,193 | 13,944,519 |
Proposal 2: The stockholders approved, on a non-binding advisory basis, the compensation of Vivani’s named executive officers, as set forth below:
Votes For | Votes Abstained | Votes Against | Broker Non-Votes |
47,643,763 | 48,882 | 434,364 | 13,944,519 |
Proposal 3: The stockholders approved the adoption of the 2022 Amended Plan, as set forth below:
Votes For | Votes Abstained | Votes Against | Broker Non-Votes |
47,128,652 | 42,895 | 955,462 | 13,944,519 |
Proposal 4: The stockholders ratified the appointment of BPM LLP by the Audit Committee of the Board to serve as Vivani’s independent registered public accounting firm for the fiscal year ending December 31, 2026, as set forth below:
Votes For | Votes Abstained | Votes Against | Broker Non-Votes |
61,894,328 | 98,793 | 78,409 | 0 |
Item 8.01. Other Events.
On June 25, 2026, Vivani announced that it received regulatory approval from Bellberry, a human research ethics committee in Australia to initiate SLIM-1™, a Phase 1 clinical trial of NPM-139, a semaglutide implant. A copy of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |
10.1# |
| Vivani Medical, Inc. Amended and Restated 2022 Omnibus Incentive Plan, and form award agreements thereunder. |
99.1 |
| Press release issued by Vivani Medical, Inc. on June 25, 2026. |
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104 |
| Cover Page Interactive Data File (embedded within the Inline XBRL document). |
# Indicates a management contract or any compensatory plan, contract or arrangement.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| VIVANI MEDICAL, INC. |
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Date: June 30, 2026 | By: | /s/ Donald Dwyer |
| Name: | Donald Dwyer |
| Title: | Chief Business Officer |
Exhibit 99.1
Vivani Medical Receives Regulatory Approval for the Initiation of SLIM-1, a Phase 1 Clinical Trial of NPM-139 Semaglutide Implant in Obesity and Chronic Weight Management
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: https://vivani.com.
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