8-K

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): August 25, 2023

VIVANI MEDICAL, INC.

(Exact name of registrant as specified in its charter)

California	001-36747	02-0692322
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

5858 Horton Street, Suite 280 Emeryville, California	94608
(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	VANI	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 1.01 Entry into a Material Definitive Agreement.

On August 25, 2023, the Company and Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of the Company entered into an Amendment 1 (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, the Company has agreed to advance funds and provide or cause to be provided to Cortigent the services and funding intended to cover salaries and related costs, rent and other overhead in order to permit Cortigent to operate in substantially the same manner in which business operations of Cortigent were previously operated by Second Sight Medical Products, Inc., prior to the formation of Cortigent, which obligations will continue, in the case of the funding obligations, until the earlier of December 31, 2024 or the closing of an initial public offering of Cortigent (the "Funding Support Term"). Under the Amendment, Cortigent has agreed to repay $1,500,000 to the Company at the conclusion of the Funding Support Term. In addition, at the conclusion of the Funding Support Term, Cortigent will enter into a five-year promissory note at 5% interest for $2,000,000 in favor of the Company. The Company will forgive any remaining amounts due by Cortigent to the Company under the TFSSA.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which is being filed as Exhibit 10.1 hereto and is incorporated by reference into this Item 1.01. 

Item 7.01. Regulation FD Disclosure

Vivani Medical, Inc. (the “Company”) from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. These slides are attached to this Current Report on Form 8-K as Exhibit 99.1 and are incorporated by reference herein. The Company is also posting to the “Investors” portion of its website a copy of its current corporate slide presentation. The slides speak as of the date of this Current Report on Form 8-K. This updated slide deck provides updated financial information for 2Q2023 as well as an update on the regulatory status of NPM-119 (GLP-1 implant) currently under development for the treatment of patients with type 2 diabetes. As previously reported the original Investigational New Drug Application (“IND”) for NPM-119 was filed with the U.S. Food and Drug Administration (“FDA”) on July 14, 2023, to support the initiation of the Phase 2a, first in human study of NPM-119 in patients with type 2 diabetes, also named LIBERATE-1. On August 11, 2023, FDA provided verbal notice that the LIBERATE-1 study was placed on Clinical Hold pending the resolution of certain deficiencies regarding Chemistry, Manufacturing and Controls (“CMC”) information. On August 18, 2023, FDA provided the formal Full Clinical Hold correspondence which stated that there was insufficient CMC information to assess risks to human subjects.  The requested information was related to the assessment of device risks and device performance. On August 25, 2023, Vivani provided a Complete Response (“CR”) including additional information and commitments to obtain supplemental information in parallel with the conduct of LIBERATE-1. Per guidelines, FDA has 30 days after the submission date to respond. Vivani will continue to work with FDA to address all outstanding deficiencies to enable lifting of the Clinical Hold and initiation of the proposed LIBERATE-1 study as soon as possible. Regarding guidance, if the CR is adequate and the Clinical Hold is lifted, Vivani anticipates commencing LIBERATE-1 in October of 2023, interim results (full 12-week data from the first ~12 patients) in 1H2024, and full top-line results in 2H2024. If the CR is deemed inadequate, Vivani anticipates that additional in vitro data may enable IND clearance and cause a delay to our timeline guidance by approximately one quarter. While the Company may elect to update the slides in the future or reflect events and circumstances occurring or existing after the date of this Current Report on Form 8-K, the Company specifically disclaims any obligation to do so. 

The information contained in this Item 7.01 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, 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
10.1	Amendment 1 to the Transition Funding, Support and Services Agreement dated August 25, 2023.
99.1	Corporate Slides, dated August 28, 2023.
104	The cover page of this Current Report on Form 8-K, formatted in Inline XBRL.

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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.

	VIVANI MEDICAL, INC.
Date: August 28, 2023	By:	/s/ Donald Dwyer
		Donald Dwyer
		Chief Business Officer

EX-10.1

Exhibit 10.1

FIRST AMENDMENT TO

TRANSITION FUNDING, SUPPORT AND SERVICES AGREEMENT

This First Amendment To Transition Funding, Support and Services Agreement (this “First Amendment”) is made and entered into as of August 25, 2023 (the “First Amendment Effective Date”), between Vivani Medical, Inc., a Delaware corporation (“Parent”), and Cortigent, Inc., a Delaware corporation (“Cortigent”). Parent and Cortigent are sometimes referred to individually as a “Party” and collectively as the “Parties.” Capitalized terms used herein but not defined herein shall have the same meaning as set forth in the Agreement (as defined below).

WHEREAS, Parent and Cortigent are parties to that certain Transition Funding, Support and Services Agreement, dated as of March 19, 2023 (the “Agreement”); and

WHEREAS, pursuant to Section 9.9 of the Agreement, the Parties wish to amend the Agreement as set forth herein.

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby acknowledged, the Parties do hereby agree and amend the Agreement as follows:

1.Amendment.

a. Schedule 1.3 to the Agreement is hereby deleted in its entirety.

b. Section 1.3 of the Agreement is hereby deleted and replaced in its entirety as follows:

“Payment of Funding Support Payments; Invoices. After the Effective Date and during the Funding Support Term, upon request by Cortigent for Funding Support Payments necessary to support Cortigent’s activities, Parent shall promptly pay to Cortigent the applicable Funding Support Payment by electronic funds transmission in U.S. dollars to the account designated by Cortigent. Promptly, but no later than ten (10) business days following the Effective Date, Parent shall submit an invoice to Cortigent detailing all Funding Support Payments made by Parent to or on behalf of Cortigent from the period commencing on January 1, 2023 until the Effective Date.

c. Schedule 1.4 attached hereto is hereby added to the Agreement as Schedule 1.4.

d. Section 1.4 of the Agreement is hereby deleted and replaced in its entirety as follows:

“Repayment of Funding Support Payments. Within ten (10) business days following expiration of the Funding Support Term, Cortigent shall pay to Parent an amount equal to One Million Five Hundred Thousand Dollars ($1,500,000) by electronic funds transmission in U.S. dollars to the account designated by Parent. Upon the expiration of the Funding Support Term, Cortigent shall issue to Parent a Promissory Note in the form attached hereto as Schedule 1.4 (the “Promissory Note”), providing for, among other things, the repayment of certain principal and interest payments by Cortigent to Parent on the terms and conditions set forth therein. “Cumulative Repayment Amount” means the total amount payable to Parent by Cortigent under this Section 1.4 and as set forth in the Promissory Note. For the avoidance of doubt, Cortigent shall not be obligated to repay Parent for any Funding Support Payments that exceed the Cumulative Repayment Amount.”

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2.No Other Amendments. Except as amended hereby, the Agreement shall remain in full force and effect as originally written.

3.Governing Law; Jurisdiction. Section 9.8 of the Agreement shall apply to this Amendment mutatis mutandis.

4.Execution in Counterparts. This Amendment may be executed in one or more identical counterparts, each of which shall be deemed to be an original, and which collectively shall be deemed to be one and the same instrument. In addition, signatures may be exchanged by PDF.

IN WITNESS WHEREOF, the Parties have caused this First Amendment to be executed as of the First Amendment Effective Date by their respective duly authorized representatives as set forth below.

VIVANI MEDICAL, INC.
By:	/s/ Adam Mendelsohn
Title	CEO
CORTIGENT, INC.
By:	/s/ Jonathan Adams
Title	CEO

2

Schedule 1.4

PROMISSORY NOTE

This Promissory Note (this “Promissory Note”) is made and entered into pursuant to that certain Transition Funding, Support and Services Agreement dated as of March 19, 2023 as amended by that certain First Amendment To Transition Funding, Support and Services Agreement dated August [•], 2023 (the “Agreement”) between Vivani Medical, Inc., a Delaware corporation (“Parent”), and Cortigent, Inc., a Delaware corporation (“Cortigent”), and this Promissory Note shall be considered an essential part of the Agreement. The date of issuance of this Promissory Note is [Date of end of Funding Support Term] (the “Issuance Date”). Capitalized terms used herein but not defined herein shall have the same meaning as set forth in the Agreement.

For value received, Cortigent hereby promises to pay to the order of Parent the principal amount of Two Million Dollars ($2,000,000.00) together with interest accruing on the outstanding amount at a rate of five percent (5%) per annum (or such maximum interest permitted by applicable Law, if less), such interest to commence accruing on the Issuance Date. The balance of principal and accrued interest shall be fully paid on or before 5:00 p.m. Pacific Time on the fifth (5^th) anniversary of the Issuance Date.

All payments by Cortigent hereunder shall be (a) made in lawful money of the United States of America without set off, deduction or counterclaim of any kind whatsoever, (b) credited first to amounts for Parent’s costs of enforcing this Promissory Note, if any, second to any accrued interest under this Promissory Note and finally to the principal balance under this Promissory Note, and (c) deemed paid by Cortigent upon their actual receipt by Parent. This Promissory Note may be prepaid at any time without penalty, premium or discount.

This Promissory Note shall be considered as having been entered into by Parent and Cortigent in the State of California and shall be construed and enforced in accordance with the internal laws of the State of California. Except as set forth herein, Section 9.8 of the Agreement shall apply to this Promissory Note mutatis mutandis.

No delay or failure on the part of Parent to exercise any remedy or right shall operate as a waiver and these rights and remedies shall be deemed continuous, nor shall any single or partial exercise of any right or remedy preclude any other or further exercise thereof or of any other right or remedy, and no right or remedy of Parent shall be deemed abridged, waived or modified by any course of conduct.

Cortigent waives presentment, protest, demand, notice of dishonor and all other notices that may be lawfully waived. Each party to this Promissory Note shall execute and deliver all instruments and documents and take all actions as may be reasonably required or appropriate to carry out the purposes of this Promissory Note. Each provision of this Promissory Note is valid and enforceable to the fullest extent permitted by applicable Law. If any provision of this Promissory Note (or the application of such provision to any person or circumstance) is or becomes invalid or unenforceable, the remainder of this Promissory Note, and the application of such provision to persons or circumstances other than those as to which it is held invalid or unenforceable, are not affected by such invalidity or unenforceability.

[Signatures Follow]

3

IN WITNESS WHEREOF, the Parties have caused this Promissory Note to be executed by their duly authorized representatives.

Dated ____________

	Cortigent, Inc.
	By
		[OFFICER NAME AND TITLE]
Dated ____________
	Vivani Medical, Inc.
	By:
		[OFFICER NAME AND TITLE]

4

EX-99.1

Exhibit 99.1

Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI August 28, 2023 www.vivani.com

Disclaimers The following slides and any accompanying oral presentation contain forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the "s afe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These sta tements may be identified by words such as "estimates," "anticipates," "projects," "plans" or "planned," "strategy," “goal," "seeks," "may," "will," "expe cts ," "intends," "believes," "should," and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that ad dress operating performance or events or developments that Vivani Medical, Inc. ("Vivani", the "Company", "we" or "us) expects or anticipates will occur in the future, such as stated objectives or goals, our products and their therapeutic potential and planned development, the indications that we intend to target, our te chnology, our business and strategy, milestones, addressable markets, or that are not otherwise historical facts, are forward - looking statements. While man agement has based any forward - looking statements included in this presentation on its current expectations, the information on which such expectations were based may change. Forward - looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from t hose in the forward - looking statements as a result of various factors. These risks and uncertainties include, but are not limited to, that we may fail to complete any required pre - clinical activities for NPM - 119 or otherwise commence our planned Phase 2 trial for this product under development; conduct any pre - clini cal activities of our other products; our products may not demonstrate safety or efficacy in clinical trials; we may fail to secure marketing approvals f or our products; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable m ark ets of our products may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing t rea tment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract a nd retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third - pa rties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks and uncertainties are described in ou r Annual Report on Form 10 - K filed on March 31, 2023, and our subsequent filings with the SEC. We urge you to consider those risks and uncertainties in ev alu ating our forward - looking statements. We caution readers not to place undue reliance upon any such forward - looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any fo rward - looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in eve nts , conditions, or circumstances on which any such statement is based. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third party sources and the Company’s own internal estimates and research. While we believe these third - party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, a ccu racy or completeness of, any information obtained from third - party sources. Finally, while we believe our own internal research is reliable, such research ha s not been verified by any independent source. All of our therapies are still investigational and have not been approved by any regulatory authority for an y use. 2

Vivani Executive Leadership Team • Co - founder/Co - inventor of Nano Precision Medical technology • PhD Bioengineering (UCSF/UC Berkeley) • Management of Technology Certificate at Haas School of Business • Research focused on diabetes treatment • Formerly at Boston Scientific and Minimed Adam Mendelsohn PhD – CEO/Director • Numerous COO and Executive Positions at Device and Drug - Device Companies, including: • COO at Dance Biopharm , COO at Avid Bio • Exec VP at Prima Biomed, Sr. VP at Nektar Therapeutics (responsible for Exubera approval), and Worldwide VP at Johnson & Johnson Truc Le, MBA – Chief Operations Officer • Former Chief Medical Officer for Eiger BioPharmaceuticals and Dance BioPharm • Former VP of Medical Development for Amylin • Former Director at GSK, Global Head of Clinical Strategy for Avandia • Former Board member of ViaCyte , Inc. Lisa Porter, MD – Chief Medical Officer • Former Sr. VP and CFO Miramar Labs • Former Sr. VP and CFO AGA Medical • Former CFO Nektar Therapeutics, OraVax and Haemonetics • Current Board director: Quantum - Si and Aziyo Biologics • Involved in/Directed 2 IPOs, 2 reverse mergers and 1 SPAC Brigid A. Makes, MBA – Chief Financial Officer • Former Executive Director at AstraZeneca with leadership roles in drug development, commercial and business development • Former Nano Precision Medical Board observer for AZ • Former PhaseBio Board observer for AZ (prior to IPO) • Former Director at Cephalon and Rhone Poulenc Rorer Donald Dwyer, MBA – Chief Business Officer 3

Vivani Medical, Inc. Lead program NPM - 119 is a miniature, 6 - month, GLP - 1 implant under development for the treatment of patients with type 2 diabetes (T2D) and obesity. Vivani’s First In Human Phase 2 clinical study of NPM - 119 in T2D patients, named LIBERATE - 1, was placed on Clinical Hold prior to initiating the study. A Complete Response to the Clinical Hold was submitted on August 25, 2023. In March, we announced the proposed initial public offering of our Neuromodulation Division, renamed Cortigent, Inc. This allows Vivani to focus on our drug implant business. An innovative, biopharmaceutical company developing a portfolio of miniature, long - term, drug implants to treat chronic disease. Our NanoPortal Ƞ platform technology enables the design of implants aimed at improving medication non - adherence and tolerability. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 and our emerging pipeline of innovative therapeutic implants. 4

Company Pipeline If Approved, Vivani Candidates will Compete in Markets with Large Potential * Estimated Market Sizes where Vivani candidates would compete, if approved; Does not represent future sales or revenue estim ate s of Vivani candidates ** In Partnership with Okava Pharmaceuticals, Inc. *** Feasibility in progress with a non - exenatide compound in collaboration with an undisclosed major pharma company Indication Feasibility Pre - Clinical Clinical Market Size* Human Type II Diabetes and Obesity Feline Pre - Diabetes & Diabetes NASH (Non - Alcoholic Steatohepatitis) Human Obesity NPM - 119 exenatide >$20B >$500M >$18B >$19B NPM - 159*** proprietary compound NPM - 139*** proprietary compound Vivani OKV - 119** exenatide 5

Drug Implants Proprietary Platform Technology

Potential application with many molecular types Designed to Assure Adherence Minimally - fluctuating and tunable delivery profiles NanoPortal: Innovative Delivery Technology Drug Reservoir Nanotube Membrane 7

By precisely adjusting nanotubes to molecule size, interactions between drug and nanotube walls can result in desirable release profiles over time, including near constant release NanoPortal : How it Works... Pore too small: No release Pore target size: Near constant release Pore too large: Burst release 8

0 20 40 60 80 100 120 98.0 98.5 99.0 99.5 100.0 In Vitro Release - Rate (ug/Day)* Time (days) Minimal Fluctuations with 2.5 - hour interval sampling Near - Constant and Minimally - Fluctuating Release *Release - rates include exenatide and related substances. Day 1 timepoint includes cumulative release over the first day including a separately measured 1 st hour of release, which was ~7 µg for the high - dose and ~4 µg for the low - dose. Fluctuations during each 2.5 - hour interval are within measurement error 2.5 - hour interval 0 20 40 60 80 100 120 0 30 60 90 120 150 In Vitro Release - Rate ( µ g/day)* Time (days) High-Dose (n=6) Low-Dose (n=6) 9

Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile NanoPortal TM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants 10

Targeting the Rapidly Growing GLP - 1 RA Market >$20B in 2022 & >$35B Expected in 2028 Vivani’s Lead Program NPM - 119

1 Guo 2016 2 Carls et al., 2017 3 IMS 2013 Report • Non - adherence is the primary reason for low, real - world effectiveness 1,2 • Guaranteed adherence will produce significant healthcare cost savings 3 • FDA indicated 505(b)(2) streamlined approval pathway may be available • ~$54M raised pre - merger from investors including AstraZeneca 6 - Month Exenatide (Glucagon - like Peptide 1 Receptor Agonist) Implant for Type 2 Diabetes and Obesity Lead Product (NPM - 119): 12

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 40 20 15 10 5 0 Expected 2028 ~$37B The GLP - 1 Market is Very Large and Growing Rapidly World - wide Sales ($Billions)* * Adopted from Evaluate Pharma 13 35 30 25

Januvia Trulicity Invokana NPM - 119* 100% 75% 50% 25% 0% DPP - 4 inhibitors, daily pills Polonsky et al.,2016 GLP - 1 weekly injections Modyet al., 2018 SGLT - 2 daily pills Cai et al., 2017 GLP - 1 implant every 6 months • Orals and injectables do not guarantee adherence • Approximately 50% of patients do not meet glycemic targets primarily due to adherence NPM - 119 Designed to Enable 100% Adherence through Implant Duration Dual Incentive to Adopt Technology that Improves Adherence • Pharmaceutical revenue is increased • Healthcare costs are decreased Current Drug Adherence Challenge " Drugs don't work in people that don't take them" Real - world Adherence * NPM - 119 – under development, not approved in any market * NPM - 119 designed to enable 100% adherence. Real - World Adherence of Select Drugs 14

• Varying levels of adherence are associated with different health outcomes • Different health outcomes may not be attributable to drug substance alone • The American Diabetes Association (ADA) Standard of Care guidelines encourage treatment options that address adherence Guaranteed adherence is expected to deliver improved health outcomes Drug Substance + Administration = Drug Product NPM - 119* Drug Substance Drug Product Administration Weekly Injection 6 - Month Implant Weekly Injection Weekly Injection Daily Pill exenatide (GLP - 1 Receptor Agonist) dulaglutide (GLP - 1 Receptor Agonist) semaglutide (GLP - 1 Receptor Agonist) exenatide (GLP - 1 Receptor Agonist) * NPM - 119 – under development, not approved in any market 15

Intarcia’s ITCA 650 (6 - month exenatide implant) may be a relevant value analog for NPM - 119 2014 – Intarcia signed ITCA 650 deal with Servier (excluding US + Japan) $171M up - front, $880M milestones, and double - digit royalties – Financings valued Intarcia as high as $4.0B (2017); Intarcia’s lead program was ITCA 650 2016 – Intarcia filed initial ITCA 650 New Drug Application (NDA) 2017 – FDA issued the first ITCA 650 CRL* (cited manufacturing concerns) 2019 – Intarcia re - submitted ITCA 650 NDA 2020 – FDA issued second ITCA 650 CRL (cited clinical safety and device constituent concerns) 2022 – After dispute resolutions, FDA’s CDER proposes to deny Intarcia’s public hearing request 2023 – FDA Advisory Board to discuss ITCA - 650 scheduled for September 21, 2023 Value of long - term GLP - 1 (exenatide) implant externally validated previously * CRL: Complete Response Letter – issued by FDA to identify NDA deficiencies 16

(Intarcia) • FDA alleges that daily variations in drug release may be responsible for clinical safety signals • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating drug release profile observed in pre - clinical studies • Smaller Device (2.2mm x 21.5mm) • Insertion using smaller 11 - gauge needle NPM - 119 well - positioned to avoid Intarcia’s device technology challenges NanoPortal TM Osmotic Pump (NPM) 17

NPM - 119 Clinical and Regulatory Pathway

Proposed First in Human Trial: LIBERATE - 1 Primary Objectives: Safety/tolerability assessment and full PK characterization Secondary Objective: Evaluate change from baseline in glycemic control (HbA1c) Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c ≥6.5% and <10.0% • On non - exenatide GLP - 1 therapy (discontinued upon enrollment) • May be taking their GLP - 1 in combination with up to 2 of the following: metformin, TZD, SGLT - 2 inhibitor, or DPP - 4 inhibitor • Excluded: SU, insulin NPM - 119 (N=32, total) Sentinel Dosing Cohort (N=8)* Bydureon BCise 2mg/week (N=16, total) Sentinel Dosing Cohort (N=4)* T2DM: Type 2 Diabetes Mellitus; TZD: Thiazolidinedione; SGLT - 2: Sodium - glucose cotransporter - 2; DPP - 4: Dipeptidyl peptidase 4; S U: Sulfonylurea 19 Preliminary Data Interim Data Top - Line Data - First 4 weeks of sentinel dosing cohort (n=12), reviewed by FDA before enrollment continues - Full 12 weeks of sentinel dosing cohort (n=12) - Full 12 weeks for all patients (n=32)DD0

NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2023 IND filed to support Ph 2a (LIBERATE - 1) clinical study July 14, 2023 2023 FDA provided Clinical Hold letter and CMC deficiencies August 18, 2023 2023 Vivani submitted Complete Response to Clinical Hold August 25, 2023 August 11, 2023 – FDA provided verbal notification that NPM - 119 IND was on Full Clinical Hold. August 18, 2023 – FDA letter stated that there was insufficient CMC information to assess risks to human subjects. The requeste d information was related to the assessment of device risks and device performance. August 25, 2023 – Vivani provided a Complete Response (CR) including additional information and commitments to obtain supplement al information in parallel with the conduct of LIBERATE - 1. Per guidelines, FDA has 30 days after the submission date to respond. • If the CR is adequate and the Clinical Hold is lifted, Vivani anticipates commencing LIBERATE - 1 in October of 2023, preliminary results in 1Q2024, interim results in 1H2024, and top - line results 2H2024. • If the CR is deemed inadequate, Vivani anticipates that additional in vitro data may enable IND clearance and cause a delay to our timeline guidance by approximately one quarter. 20

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 0 5 10 15 20 25 0 30 60 90 120 Expected Exenatide Plasma Concentration in 85 kg Human (ng/mL) Exenatide Plasma Concentration Normalized to 250g Rats (ng/mL) Time from initial initiation (days) 12 - Week NPM - 119 PK in Rats (n=8) * Exenatide antibody - positive animals are not included in this data set. Explant at 12 weeks 21 EC 50 Maximally effective concentration

0 100 200 300 400 500 600 700 0 2 4 6 8 10 12 14 16 0 30 60 90 120 150 Expected Exenatide Plasma Concentration in 85 kg Human ( pg /mL) Exenatide Plasma Concentration Normalized to 250g Rats (ng/mL) Time from initial initiation (days) 6-Month NPM-119 Prototype (n=6) 6 - Month NPM - 119 Preclinical Proof - of - Concept Achieved EC 50 * Exenatide antibody - positive animals are not included in this data set. **2 of 6 implants are responsible for higher Day 1 exenatide concentrations. Additional optimization ongoing to yield consis ten t gradual initial PK profiles. Implants removed. ** 22

Vivani Medical, Inc. Financial Information

Vivani Medical, Inc. Q2 2023: P&L Statement 24 In Thousands, except Share Data Jun. 30, 2023 Jun. 30, 2022 Jun. 30, 2023 Jun. 30, 2022 Operating expenses: Research and development, net of grants 3,864 3,203 7,819 5,883 General and administrative 3,139 884 5,785 2,112 Total operating expenses 7,003 4,087 13,604 7,995 Loss from operations (7,003) (4,087) (13,604) (7,995) Other income (expense), net 477 (16) 760 (33) Net income/(loss) (6,526)$ (4,103)$ (12,844)$ (8,028)$ Net income/(loss) per common share – basic (0.13)$ (0.11)$ (0.25)$ (0.22)$ Weighted average common shares outstanding – basic 50,795 36,880 50,748 36,819 3 Months Ended 6 Months Ended Condensed Consolidated Statements of Operations (unaudited)

Vivani Medical, Inc. Vivani Medical, Inc. Q2 2023: Balance Sheet 25 In Thousands Jun. 30, 2023 Dec. 31, 2022 ASSETS Current assets: Cash and cash equivalents 32,486$ 45,076$ Prepaid expenses and other current assets 3,669 2,452 Total current assets 36,155 47,528 Property and equipment, net 1,142 1,182 Right-of-use assets 20,684 779 Restricted cash 1,366 1,366 Deposits and other assets 260 275 Total assets 59,607$ 51,130$ LIABILITIE S AND STOCKHOLDERS’ EQUITY Current liabilities 7,086$ 6,822$ Long term operating lease liabilities 20,127 — Total liabilities 27,213 6,822 Stockholders’ equity: Total Common Stock, APIC & Other Comp Loss 118,024 117,094 Accumulated deficit (85,630) (72,786) Total liabilities and stockholders’ equity 59,607$ 51,130$ Statement - Condensed Consolidated Balance Sheets (unaudited)

Vivani Medical, Inc. Q2 2023: Cap Table 26 As June 30, 2023 Equity WAEP* Number of Shares Common Stock 50,798,799 Stock Options $2.79 6,139,233 RSUs $3.15 402,500 Warrants ** $11.13 10,310,543 Fully Diluted Shares 67,651,075 *Weighted Average Exercise Price **Actual warrants total 15,437,918 including 7,684,313 for Second Sight which when exercised 3 for 1, convert to 2,563,688 co mmo n shares

Vivani Medical, Inc. Lead program NPM - 119 is a miniature, 6 - month, GLP - 1 implant under development for the treatment of patients with type 2 diabetes (T2D) and obesity. Vivani’s First In Human Phase 2 clinical study of NPM - 119 in T2D patients, named LIBERATE - 1, was placed on Clinical Hold prior to initiating the study. A Complete Response to the Clinical Hold was submitted on August 25, 2023. In March, we announced the proposed initial public offering of our Neuromodulation Division, renamed Cortigent, Inc. This allows Vivani to focus on our drug implant business. An innovative, biopharmaceutical company developing a portfolio of miniature, long - term, drug implants to treat chronic disease. Our NanoPortal Ƞ platform technology enables the design of implants aimed at improving medication non - adherence and tolerability. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 and our emerging pipeline of innovative therapeutic implants. 27

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Document Period End Date	Aug. 25, 2023
Entity File Number	001-36747
Entity Registrant Name	VIVANI MEDICAL, INC.
Entity Central Index Key	0001266806
Entity Tax Identification Number	02-0692322
Entity Incorporation, State or Country Code	CA
Entity Address, Address Line One	5858 Horton Street
Entity Address, Address Line Two	Suite 280
Entity Address, City or Town	Emeryville
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94608
City Area Code	(415)
Local Phone Number	506-8462
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	VANI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false