Form 8-K - Groowe Newsroom

8-K — Vivani Medical, Inc.

Accession: 0001753926-26-000550

Filed: 2026-03-26

Period: 2026-03-26

CIK: 0001266806

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — vani-20260326.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ex991_1.htm)

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0001266806

Vivani Medical, Inc.

00012668062026-03-262026-03-26

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): March 26, 2026

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)

(Zip

Code)

Registrant’s

telephone number, including area code: (415) 506-8462

(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

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 ☐

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 2.02

Results of Operations and Financial Condition.

March 26, 2026, Vivani Medical, Inc. (the “Company”) issued a press release entitled “Vivani

Medical Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update”, which is attached to this

Current Report as Exhibit 99.1.

The

information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of

the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the

Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set

forth by reference in such a filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit No.

Description

99.1

Press Release dated March 26, 2026 entitled “Vivani Medical Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update”.

104

The cover

page of this Current Report on Form 8-K, formatted in Inline XBRL.

SIGNATURE

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.

VIVANI

MEDICAL, INC.

Date: March 26, 2026

By:

/s/ Donald Dwyer

Donald Dwyer

Chief Business Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ex991_1.htm · Sequence: 7

Exhibit 99.1

Vivani Medical Reports Fourth Quarter and Full Year 2025

Financial Results and Provides Business Update

Successful completion of first-in-human study LIBERATE-1

paired with preclinical proof of concept data for a semaglutide implant advance

NPM-139, miniature, ultra long-acting semaglutide implant under development for

chronic weight management toward a Phase 1 clinical study with results

anticipated by the end of 2026.

Single preclinical administration of semaglutide implant configuration

demonstrates continued semaglutide exposure and >20% sham-adjusted weight

loss for a full year.

Solid cash position from multiple recent financings will support

operations into mid-2027 and enable the projected completion of key milestones

including the Phase 1 study of NPM-139.

Alameda, CA --

(GLOBE NEWSWIRE) -- March 26, 2026 – Vivani Medical, Inc. (Nasdaq: VANI)

(“Vivani” or the “Company”), a clinical-stage biopharmaceutical company

developing miniature, ultra long-acting subdermal drug implant candidates

utilizing its proprietary NanoPortal™ technology, today reported financial

results for the fourth quarter and full year ended December 31, 2025, and

provided a business update.

“2025 was a pivotal

year for Vivani. We successfully completed our first-in-human study,

LIBERATE-1; we demonstrated feasibility of our technology with semaglutide, the

active ingredient in Wegovy® and Ozempic®; and we made progress

against strategic decisions that favorably position the Company in the GLP-1

marketplace,” said Vivani

Chief Executive Officer Adam Mendelsohn, Ph.D. “The decision to

focus on semaglutide was made based on the combination of promising initial preclinical

semaglutide implant feasibility data and encouraging results from LIBERATE-1,

the first-in-human application of our proprietary NanoPortal implant technology

with exenatide. Our encouragement was reinforced after having recently

demonstrated sustained preclinical semaglutide exposures and >20% sham-adjusted

weight loss for a full year with a single implant administration. Our GLP-1

implant candidates are unique because of their potential for both once- or

twice-yearly administration and the ability to quickly eliminate GLP-1 levels

between scheduled administrations if that became necessary. Because GLP-1 based

medicines are contraindicated for prevalent conditions such as pregnancy, and because

GLP-1 discontinuation is recommended before certain procedures such as

surgeries with high aspiration risk, the ability to quickly cease treatment

will be a critical feature in any GLP-1 based product that provides sustained

delivery for many months at a time.”

Dr. Mendelsohn continued:

“In addition, we have made significant progress in advancing our manufacturing

capabilities through thoughtful capital equipment purchases and facilities

upgrades as part of our efforts to begin preparing for commercial-scale

manufacturing. Having also achieved significant clinical operations progress,

we project the initiation of our Phase 1 feasibility for NPM-139 (semaglutide implant)

for chronic weight management in mid-2026 with data potentially available by the

end of this year. This initial Phase 1 study will be conducted in Australia,

allowing us to leverage our recent success with LIBERATE-1 and take advantage

of the attractive tax incentives provided by the Australian government.”

Recent Business

Highlights

On August 5, 2025, Vivani announced plans to

support the rapid advancement of NPM-139, a novel semaglutide implant, based on

promising results from the LIBERATE-1 clinical study and additional positive

data from a preclinical study with a semaglutide implant. LIBERATE-1,

the first-in-human application of Vivani’s proprietary NanoPortal implant

technology, demonstrated a positive safety and tolerability profile and

encouraging performance data. Vivani also announced new NPM-139

(semaglutide implant) preclinical feasibility data that demonstrated approximately

20% sham-adjusted weight loss with a single implant, which had been

maintained for more than six months at the time of the announcement. Since the

announcement, this feasibility study has now demonstrated sustained sham-adjusted

weight loss >20% as well as sustained drug exposure for an entire year. These

semaglutide data support the potential for a semaglutide implant

with annual dosing. Based on the LIBERATE-1 data supporting the clinical

application of the NanoPortal platform technology, and the

preclinical weight loss data with a semaglutide implant

configuration, Vivani announced plans to prioritize advancement of NPM-139,

with clinical development expected to begin in 2026.

In September 2025,

Vivani announced plans to initiate a Phase 1 clinical study for the

NPM-139 semaglutide implant program, pending regulatory clearance, along with

high-level details of the anticipated study design. The Company also

announced parallel preparations to initiate a Phase 2 clinical study of NPM-139

pending enabling results from the Phase 1 study and regulatory feedback. The

Company anticipates initiating the Phase 1 study

in mid-2026.

The Company plans to continue

exploring opportunities for Vivani’s stockholders to potentially realize value

in its neuromodulation assets. Cortigent Inc. (“Cortigent”), a wholly owned

subsidiary of the Company, filed amendments to its registration statement

on Form S-1 with the most recent amendments occurring on March 3 and March 17,

2026.

Including multiple share purchase

agreements and registered direct offerings it entered into in 2025 and in 2026

year-to-date, the Company raised $41.5M in gross proceeds. Current cash,

equivalents and commitments as of December 31, 2025, are expected to fund

operations into mid-2027.

Upcoming Anticipated

Milestones

Phase 1 study results for low-dose NPM-139, Vivani’s miniature,

ultra long-acting semaglutide implant under development for chronic weight

management, by the end of 2026.

Investigational New Drug Application for NPM-139 to support

the proposed Phase 2 dose-ranging study of this semaglutide implant.

Transition of Cortigent into an independent, publicly

traded company. Currently exploring both a spin-off to be registered on a Form

10 and an IPO to be registered on a Form S-1 registration statement.

Fourth Quarter 2025

Financial Results

Note: Vivani (or the “Company”)

refers to the consolidated company including the Biopharm Division and

Cortigent. The Biopharm Division refers to the drug implant business, the main

focus of the consolidated company.

Cash Balance: As of December

31, 2025, Vivani had cash and cash equivalents totaling $16.2 million, compared

to $18.4 million as of December 31, 2024. The decrease of $2.2 million is

primarily attributed to a net loss of $26.6 million, and $1.2 million related

to purchase of equipment, which was mostly offset by net proceeds of $23.3

million provided by the financing activities, non-cash items totaling $3.5

million which include stock-based compensation, depreciation

and amortization of property and equipment, and lease expense.

Research and

development expenses: Research and development expenses during the fourth quarter of 2025 were

$4.6 million, compared to $4.3 million during the fourth quarter of 2024. The increase

of $0.3 million, or 7%, was primarily attributable to staffing

reduction and reduced use of outside services.

General and

administrative expenses: General and administrative expenses during the fourth

quarter of 2025 were $2.2 million, compared to $2.1 million during the

fourth quarter of 2024.

Other income (expense): Other income

(expense), net during the fourth quarter of 2025 was $0.2 million,

compared to $0.4 million during the fourth quarter of 2024. The decrease of

$0.2 million, or 50%, was

primarily attributable to lower interest income being earned on

deposits from the Biopharm Division and the write off of the accumulated

other comprehensive income related to foreign currency translation balance of the

Neurostimulation Division’s Switzerland subsidiary which effectively

closed in 2025, partially offset by an increase R&D rebates earned.

Net Loss: The net loss during

the fourth quarter of 2025 was $6.6 million, compared to $6.1 million

during the fourth quarter of 2024. The increase of $0.5 million, or 8%, was primarily attributable

to the increase in the clinical trial related expense and development expense

from our Biopharm Division, the increase in professional services and the decrease in other income from our

Neurostimulation Division and our Biopharm Division.

Full Year 2025 Financial

Results

Research and development expense. Research and

development expense during the year ended December 31, 2025 was $18.1 million,

compared to $15.7 million during the year ended December 31, 2024. The increase

of $2.4 million, or 15%, was primarily attributable

to the increase in both the clinical trial related expense and

development expense from our Biopharm Division.

General and administrative expense. General and

administrative expense during the year ended December 31, 2025 was $9.4

million, compared to $8.9 million during the year ended December 31, 2024. The

increase of $0.5 million, or 6%, was primarily

attributable to the increase in the professional services of

our Neurostimulation Division and our Biopharm Division.

Other income, net. Other income,

net during the year ended December 31, 2025 was $0.9 million, compared to $1.2

million during the year ended December 31, 2024. The decrease of $0.3 million

was primarily attributable to lower interest income being earned on

deposits from our Biopharm Division and the write off of the accumulated

other comprehensive income related to foreign currency translation balance of

our Neurostimulation Division’s Switzerland subsidiary effectively closed

in 2025, partially offset by an increase R&D rebates earned.

Net loss. The net loss

during the year ended December 31, 2025 was $26.6 million, compared to $23.5

million during the year ended December 31, 2024. The increase in net loss of $3.1

million was primarily attributable to the increase in the clinical trial

related expense and development expense from our Biopharm Division, the

increase in professional services and the decrease

in other income from our Neurostimulation Division and our Biopharm

Division.

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: www.vivani.com.

About Cortigent,

Inc.

Cortigent,

Inc., a wholly owned subsidiary of Vivani, is developing brain implant devices

to help patients recover critical body functions. Our patent-protected

precision neurostimulation technology platform leverages neuroscience and

proprietary microelectronics to create advanced medical devices. Our

predecessor, Second Sight Medical Products, previously marketed Argus® II, the

first and only medical device to obtain FDA approval to treat a rare form of

blindness. This innovative device has helped hundreds of profoundly blind

patients to achieve meaningful visual perception. Cortigent’s next generation

investigational system, the Orion® cortical stimulation system, has been

designed to treat blindness caused by common conditions including glaucoma and

diabetic retinopathy. Orion has an FDA Breakthrough Device designation,

completed a 6-year Early Feasibility Study in 2025 with promising safety and

efficacy results and is covered by an extensive intellectual property estate.

Cortigent is also applying its core technology to improving recovery of arm and

hand motion in patients with paralysis due to stroke. For more information and

patient videos, please visit: www.cortigent.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 statements regarding Vivani’s business, products

in development, including the therapeutic potential thereof, the planned

development thereof, Vivani’s plans with respect to Cortigent and its

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. These

statements involve risks and uncertainties that could cause actual results to

differ materially from those reflected in such statements, including, without

limitation, risks that the spin-off will not be completed in a timely manner or

at all; risks of failure to satisfy any conditions to the spin-off; risks of

failure of the spin-off to qualify for nonrecognition of gain or loss for U.S. federal

income tax purposes; uncertainty of whether the anticipated benefits of the

spin-off can be achieved; 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. 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 market conditions and the ability of Cortigent to complete its spin-off,

Cortigent’s history of losses and its ability to access additional capital or

otherwise fund its business and advance its product candidates and preclinical

programs. The foregoing sets forth many, but not all, of the factors that could

cause actual results to differ from our expectations in any forward-looking

statement. There may be additional risks that the Company or Cortigent consider

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 on March 26, 2026,

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

Contacts:

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

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Balance Sheets

(In thousands, except per share data)

December 31,

2025

2024

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

16,232

18,352

R&D tax credit incentive receivable

654

253

Prepaid expenses and other current assets

1,012

1,837

Total current assets

17,898

20,442

Property and equipment, net

2,879

1,693

Operating lease right-of-use assets, net

17,230

17,957

Restricted cash

1,338

Deposits and other assets

131

TOTAL ASSETS

39,393

41,561

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable

1,032

817

Accrued expenses

1,736

1,803

Litigation accrual

1,675

Accrued compensation expense

365

343

Lease liability, current portion

1,794

1,348

Total current liabilities

6,602

5,986

Lease liability, noncurrent portion

17,061

17,965

TOTAL LIABILITIES

23,663

23,951

Commitments and contingencies (Note 13)

STOCKHOLDERS' EQUITY:

Preferred stock, par value $0.0001 per share; 10,000 shares authorized; none outstanding

—

Common stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 76,428 and 59,235 as of December 31, 2025 and 2024, respectively

Additional paid-in capital

164,225

139,480

Accumulated other comprehensive income

Accumulated deficit

(148,533

)

(121,924

)

TOTAL STOCKHOLDERS' EQUITY

15,730

17,610

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

39,393

41,561

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Operations

(In thousands, except per share data)

Year Ended December 31,

2025

2024

Operating expenses:

Research and development, net of grants

18,126

15,745

General and administrative, net of grants

9,430

8,932

Total operating expenses

27,556

24,677

Loss from operations

(27,556

)

(24,677

)

Other income (expense), net

947

1,191

Net loss

(26,609

)

(23,486

)

Net loss per common share - basic and diluted

(0.43

)

(0.43

)

Weighted average shares outstanding - basic and diluted

62,389

54,981

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

duration