VANI Announces Clinical Development Plans for Semaglutide Implant NPM-139

Rhea-AI Filing Summary

Vivani Medical, Inc. announced on September 4, 2025 that it has outlined clinical development plans for NPM-139, its investigational semaglutide implant intended for chronic weight management in patients who are obese or overweight with a related comorbidity. The disclosure is furnished as an exhibit (Press Release, Exhibit 99.1) to this Current Report and does not include financial metrics, timelines, enrollment targets, regulatory milestones, or expected costs. The filing is signed by Donald Dwyer, Chief Business Officer.

Positive

• Program advancement: Company publicly announced clinical development plans for NPM-139, indicating progression of its pipeline
• Targeted indication clarity: NPM-139 is aimed at chronic weight management in patients who are obese or overweight with a related comorbidity
• Regulatory transparency: The announcement was furnished as Exhibit 99.1 in a Form 8-K, complying with disclosure processes

Negative

• Insufficient operational detail: The filing does not provide study design, phase, endpoints, enrollment targets, or timeline
• No financial metrics disclosed: There is no information on expected costs, funding, or impact to revenues or cash runway
• No regulatory or partnership details: The press release content furnished does not state regulatory interactions, collaborations, or manufacturing plans

Insights

Clinical Development Strategist

TL;DR: Announcing clinical development plans for an investigational semaglutide implant signals program progression but the filing lacks operational and timeline detail.

The company has publicly committed to advancing NPM-139 into a clinical development phase for chronic weight management in specified patient populations. This is a program-level disclosure that may matter to stakeholders tracking product pipelines. However, the filing provides no specifics on study design, phases, endpoints, patient populations beyond broad eligibility, regulatory interactions, or projected timelines and costs. Without those details, assessing clinical or commercial probability of success is not possible from this document alone.

Securities/Corporate Filings Analyst

TL;DR: The Form 8-K furnishes a press release about NPM-139 development plans but contains limited material detail for valuation or near-term impact.

This Form 8-K properly furnishes Exhibit 99.1, a press release announcing clinical development plans. The disclosure meets filing requirements for furnishing material announcements, yet it omits quantitative disclosure: no projected expenses, milestones, partnerships, or timelines. For investors, the item is notable as a program update but is informational rather than a detailed material update that changes financial outlooks based on the content provided.

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 UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 4, 2025

Vivani Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-36747		02-0692322
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1350 S. Loop Road

Alameda, California 94502

(Address of principal executive offices, including zip code)

(415) 506-8462

(Telephone number, including area code, of agent for service)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐		Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐		Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐		Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐		Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		VANI		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

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 8.01 Other Events.

On September 4, 2025, Vivani Medical, Inc. (the “Company”) announced clinical development plans for NPM-139, the Company’s investigational semaglutide implant for chronic weight management in patients who are either obese and overweight with a related comorbidity. A copy of the press release issued in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press release issued by Vivani Medical, Inc. on September 4, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 thereunto duly authorized.

		VIVANI MEDICAL, INC.
Date: September 4, 2025	By:	/s/ Donald Dwyer
	Name:	Donald Dwyer
	Title:	Chief Business Officer

FAQ

What did Vivani Medical (VANI) announce in this Form 8-K?

The company announced clinical development plans for NPM-139, a semaglutide implant for chronic weight management in patients who are obese or overweight with a related comorbidity, and furnished a press release as Exhibit 99.1.

Does the filing include timelines or study phase details for NPM-139?

No. The Form 8-K states the company announced clinical development plans but does not provide timelines, study phase, or enrollment targets.

Are there any financial impacts or costs disclosed for NPM-139 in this filing?

No. The filing does not include financial metrics, projected costs, or statements about funding related to NPM-139.

Where can I find the press release mentioned in the 8-K?

The press release is furnished as Exhibit 99.1 to this Current Report, as stated in the filing.

Who signed the Form 8-K for Vivani Medical?

The filing is signed by Donald Dwyer, Chief Business Officer.