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VANI US Equity

Vivani Medical, Inc.Health Care · Electromedical & Electrotherapeutic Apparatus · CIK 1266806 · FY ends Dec 31
$1.39
-0.06 (-4.14%)
USD · as of 2026-08-19 · marketstack

VANI · 10-K · period ended 2022-12-31

← all VANI documents
filed 2023-03-31 · EDGAR original ↗

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Item 7. Management’s Discussion and Analysis of Financial

Condition and Results of Operations

The following discussion

contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those

anticipated in these forward-looking statements as a result of many factors. The consolidated results of operations for the years

ended December 31, 2022 and 2021 are not necessarily indicative of the results that may be expected for any future period. The

following discussion should be read in conjunction with the consolidated financial statements and the notes thereto included in

Part IV, Item 15 of this Form 10-K and in conjunction with the “Risk Factors” included in Part I, Item 1A of this Form

10-K.

Business Overview

Vivani Medical, Inc. (“Vivani,”

the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical

company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortalTM technology to enable long-term,

near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop

and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address

a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately

50% of patients treated for type 2 diabetes are non-adherent to their medicines, which can lead to poor clinical outcomes. We are

developing a portfolio of miniature, sub-dermal drug implant candidates that, unlike most oral and injectable medicines, are designed

with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In

addition, the minimal fluctuations of drug levels dictated by our NanoPortal technology may improve the tolerability profiles for

medicines that produce side effects associated with fluctuating drug levels.

Vivani resulted from the business combination

of Second Sight Medical Products (Second Sight) and Nano Precision Medical (NPM). Since inception, Vivani’s main priority

has been the further development of the company’s lead program, NPM-119, a miniature, 6-month, GLP-1 implant candidate for

the treatment of patients with type 2 diabetes under the company’s Biopharm Division (formerly NPM). In parallel, Vivani’s

new management team remained committed to identifying and exploring strategic options for the Neuromodulation Division (formerly

Second Sight) that will enable further development of its pioneering neurostimulation systems to help patients recover critical

body functions.

In February 2022, we announced the signing

of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.

(“Second Sight”), pursuant to which NPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the two

companies completed the merger, concurrent with which Second Sight changed its name to Vivani Medical, Inc. and now conducts the

present business of the Company. In September 2022, we announced the formation of the Company’s Biopharm Division to advance

the assets of the former NPM which includes the further development of the Company’s lead program, NPM-119, a miniature,

6-month, GLP-1 implant candidate for the treatment of patients with type 2 diabetes. Vivani’s new management team remains

committed to identifying and exploring strategic options for the Neuromodulation Division (formerly Second Sight) that will enable

further development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28,

2022, the assets and liabilities of this segment were contributed to Cortigent, Inc. a newly formed wholly owned subsidiary of

Vivani, in exchange for 20 million shares of common stock of Cortigent.

In March 2023, Vivani announced the filing

of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial

public offering of Cortigent. Vivani, is expected to continue to be majority-owned by Vivani immediately following the initial

public offering.

61

Funding and Liquidity

Capital Funding

From inception, our

operations have been funded primarily through the sales of our common stock and warrants.

Non-Capital Funding

We were awarded a $1.6 million grant (with the intent

to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund

the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018.

Liquidity

We have experienced

recurring operating losses and negative operating cash flows since inception and have financed our working capital requirements

through the recurring sale of our equity securities and receipt of grants.

Our financial statements

have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in

the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to

meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability

to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there

can be no assurances that we will be able to do so.

62

Recently Adopted Accounting Standards

We believe that recently

issued, but not yet effective, authoritative guidance, if currently adopted, would not have a material impact on our financial

statement presentation or disclosures.

Critical Accounting Policies and Estimates

The following discussion

and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been

prepared in conformity with accounting principles generally accepted in the United States of America. Certain accounting policies

and estimates are particularly important to the understanding of our financial position and results of operations and require the

application of significant judgment by our management or can be materially affected by changes from period to period in economic

factors or conditions that are outside of our control. As a result, they are subject to an inherent degree of uncertainty. In applying

these policies, our management uses their judgment to determine the appropriate assumptions to be used in the determination of

certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results,

the terms of existing contracts, our observance of trends in the industry, information provided by our customers and information

available from other outside sources, as appropriate. See Note 2 of notes to our consolidated financial statements for a more complete

description of our significant accounting policies.

Stock-Based Compensation.

Pursuant to Financial Accounting Standards Board ASC 718 Share-Based Payment (“ASC 718”), we record stock-based

compensation expense for all stock-based awards. Under ASC 718, we estimate the fair value of stock options granted using the Black-Scholes

option pricing model. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite

service period of the award, which is generally the option vesting term.

63

Results of Operations

Operating

Expenses. We recognize our operating expenses as incurred in two general operational categories: research and

development, and general and administrative. Our operating expenses also include a non-cash component related to

the amortization of stock-based compensation for research and development, and general and

administrative personnel. From time-to-time we have received grants from institutions or agencies, such as the National

Institutes of Health, to help fund the some of the cost of our development efforts. We have recorded these grants as

reductions to operating expenses.

64

Comparison of the Years Ended December 31, 2022 and 2021

Research

and development expense. Research and development expense increased from $11.0 million in 2021 to $14.2 million in 2022,

an increase of $3.2 million, or 29%. The increase from the prior year was primarily due to increased use of

outside contractors associated with product design, development and manufacturing associated with our products, increased

headcount and professional fees, along with inclusion of new neuromodulation division costs.

65

General

and administrative expense. General and administrative expense increased from $2.3 million in 2021 to $7.1 million in

2022, an increase of $4.8 million, or 205%. The increase is related to a provision for a legal claim of $1.7 million and

increased accounting and legal costs and other expenses related to our merger of approximately $1.5 million and the general

and administrative costs of the neuromodulation division since the merger of $1.1 million.

Net loss. The

net loss was $13.9 million in 2022, as compared to $12.8 million in 2021. The $1.1 million increase in net loss from 2021 to 2022

was primarily attributable to a $7.9 million increase in operating expenses offset by a $6.9 million gain on the bargain purchase

and increased interest income due to rate increases on cash investments.

Liquidity and Capital Resources

We have experienced

recurring operating losses and negative operating cash flows since inception and have financed our working capital requirements

through the recurring sale of our equity securities.

Our financial statements

have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in

the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to

meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability

to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there

can be no assurances that we will be able to do so.

66

Working capital was $40.7 million at December

31, 2022, as compared to $0.4 million at December 31, 2021.

Cash Flows from Operating Activities

During 2022,

we used $18.8 million of cash in operating activities, consisting primarily of a net loss of $13.9 million, offset by $0.4

million from a net change in operating assets and liabilities and non-cash items including $5.3 million for gain on

bargain purchase, depreciation and amortization of property and equipment and stock-based compensation.

During 2021, we used

$11.0 million of cash in operating activities, consisting primarily of a net loss of $12.8 million, offset by a $0.4 million net

change in operating assets and liabilities and non-cash charges of $1.4 million for depreciation and amortization of property and

equipment, stock-based compensation and PPP loan forgiveness.

Cash Flows from Investing Activities

Investing activities

in 2022 and 2021 used $0.3 million and $0.6 million, respectively, of cash for the purchase of equipment.

Cash Flows from Financing Activities

Financing activities

provided $63.4 million of cash in 2022, including $55.4 million from cash acquired in merger for stock consideration and $8.0 million

proceeds from SAFE note.

Financing activities

provided $11.6 million of cash in 2021 from the net proceeds from the issuance of common stock and warrants.

Off-Balance Sheet Arrangements

At December 31, 2022, we did not have any

transactions, obligations or relationships that could be considered off-balance sheet arrangements.

67

Item 7A. Quantitative and Qualitative Disclosures about Market

Risk

Interest Rate Sensitivity

The

primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without

incurring significant risk. We invest cash in excess of our current needs in money market funds. In general, money market

funds are not considered to be subject to interest rate risk because the interest paid on such funds fluctuates with the

prevailing interest rate. As of December 31, 2022 and 2021, our cash equivalents consisted solely of money market funds

deposited at Merrill Lynch and restricted cash as collateral for our lease.

Exchange Rate Sensitivity

In 2022 and 2021,

the majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts

to hedge our operating expense exposure to foreign currencies, but we may do so in the future.

Item 8. Financial Statements and Supplementary Data

Our financial statements

and supplementary data required by this Item are provided in the consolidated financial statements included in this Form 10-K as

listed in Item 15(a) of this Form 10-K.

Item 9. Changes in and Disagreements with Accountants on

Accounting and Financial Disclosure

None.

Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Disclosure controls

and procedures are designed to ensure that information required to be disclosed by us in reports filed or submitted under the Securities

Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time

periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls

and procedures designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act

is accumulated and communicated to management, including our principal executive officer and principal financial officer, or persons

performing similar functions, as appropriate to allow for timely decisions regarding required disclosure. Due to inherent limitations,

internal control over financial reporting may not prevent or detect misstatements. Further, projections of any evaluation of effectiveness

to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree

of compliance with the policies and procedures may deteriorate. Accordingly, even effective disclosure controls and procedures

can only provide reasonable assurance of achieving their control objectives.

As of December 31,

2022, management has concluded that our disclosure controls and procedures were effective based upon testing of our key internal

controls. Our management, including our CEO and CFO, has concluded that the consolidated financial statements included in this

Annual Report on Form 10-K fairly present, in all material respects, our financial position, results of operations and cash flows

for the periods presented in this Annual Report on Form 10-K in conformity with GAAP.

This Annual Report

does not include an attestation report from our independent registered public accounting firm regarding internal control over financial

reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant

to our non-accelerated filer status.

68

Management’s Report on Internal Control over Financial

Reporting

Our management

is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f)

and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance

regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance

with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures

that:

1. Pertain

to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our

assets;

2.

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance

with GAAP, and that our receipts and expenditures are being made only in accordance with the authorization of our management and

directors; and

3.

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets

that could have a material effect on the financial statements.

As of December 31,

2022, based on the criteria established in “Internal Control — Integrated Framework” (2013 Framework) issued

by the Committee of Sponsoring Organizations of the Treadway Commission, management has completed written documentation of its

internal control policies, procedures and controls and has completed its testing of its key controls. Based upon the results of

this testing we have concluded that our internal control over financial reporting was effective as of the end of the period covered

by this Annual Report on Form 10-K.

Changes in Internal Control over Financial Reporting

There has

been no change in our internal control over financial reporting that occurred during or subsequent to our fourth quarter of the

year ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over

financial reporting.

Inherent Limitations on Effectiveness of Controls

The design of any

system of control is based upon certain assumptions about the likelihood of future events. There can be no assurance that any design

will succeed in achieving its stated objectives under all future events, no matter how remote, or that the degree of compliance

with the policies or procedures may not deteriorate. Because of its inherent limitations, disclosure controls and procedures may

not prevent or detect all misstatements. Accordingly, even effective disclosure controls and procedures can provide only reasonable

assurance of achieving their control objectives. In addition, the design of disclosure controls and procedures must reflect the

fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible

controls and procedures relative to their costs. Also, projections of any evaluation of effectiveness to future periods are subject

to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies

and procedures may deteriorate.

Item 9B. Other Information

None.

Item 9C. Disclosure regarding foreign jurisdictions that

prevent inspections

Not Applicable.

69

PART III

Certain

information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated by reference from our

definitive proxy statement relating to our 2023 annual meeting of stockholders, pursuant to Regulation 14A of the Securities

Exchange Act of 1934, as amended, also referred to in this Annual Report on Form 10-K as our 2023 Proxy Statement, which we

will file with the SEC not later than 120 days after the end of the fiscal year covered by this Annual Report on Form

10-K.

Item 10. Directors, Executive Officers and Corporate Governance

Information regarding

our directors, including the audit committee and audit committee financial experts, and executive officers, and compliance with

Section 16(a) of the Exchange Act will be included in an amendment to this Form 10-K or in our 2023 Proxy Statement and is incorporated

herein by reference.

Item 11. Executive Compensation

The information

required by this item regarding executive compensation will be included in an amendment to this Form 10-K or in our 2023 Proxy

Statement and is incorporated herein by reference.

Item 12. Security Ownership of Certain Beneficial Owners

and Management and Related Stockholder Matters

The information required

by this item regarding security ownership of certain beneficial owners and management will be included in an amendment to this

Form 10-K or in our 2023 Proxy Statement and is incorporated herein by reference.

Item 13. Certain Relationships and Related Transactions,

and Director Independence

The information required

by this item regarding certain relationships and related transactions and director independence will be included in an amendment

to this Form 10-K or in our 2023 Proxy Statement and is incorporated herein by reference.

Item 14. Principal Accounting Fees and Services

The information required by this item regarding

principal accounting fees and services will be included in an amendment to this Form 10-K or in our 2023 Proxy Statement and is

incorporated herein by reference.

PART IV

Item 15. Exhibits, Financial Statement Schedules

(a) The following documents are included in this Annual Report on Form 10-K:

70

EXHIBIT INDEX

Exhibit No. Exhibit Description

10.2 Non-Employee Director Compensation Policy*

10.3 Transition funding, support and services agreement dated March 23, 2023

10.4 Employment terms- Cortigent CEO

10.5 New Alameda Lease Agreement

71

23.1* Consent of BPM LLP, Independent Registered Public Accounting Firm

72

24.1 Power of Attorney (included in the signature page to this report)

* Filed or furnished herein, as applicable.

+ Indicates management contract or compensatory plan.

101.INS XBRL Instance Document

101.SCH XBRL Taxonomy Extension Schema Document

101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF XBRL Taxonomy Extension Definition Linkbase Document

101.LAB XBRL Taxonomy Extension Label Linkbase Document

101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

Item 16. Form 10-K

Summary

None.

73

SIGNATURES

Pursuant to the requirements of Section

13 or 15(d) 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.

Dated: March 31, 2023 Vivani Medical, Inc.

/s/ Adam Mendelsohn

Adam Mendelsohn

Chief Executive Officer

POWER OF ATTORNEY AND SIGNATURES

The undersigned officers and directors

of Vivani Medical, Inc., each hereby severally constitutes and appoints Scott Dunbar as his true and lawful attorney-in-fact and

agent, with full power of substitution to sign and execute on behalf of the undersigned any and all amendments to this Annual Report

on Form 10-K, and to perform any acts necessary in order to file the same, with all exhibits thereto and other documents in connection

therewith with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to

do and perform each and every act and thing requested and necessary to be done in connection therewith, as fully to all intents

and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or their

or his or her substitutes, shall do or cause to be done by virtue hereof.

Pursuant to the requirements of

the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and

in the capacities and on the dates indicated.

Name Title Date

/s/ Adam Mendelsohn Chief Executive Officer and Director March 31, 2023

Adam Mendelsohn (Principal Executive Officer)

/s/ Brigid Makes Chief Financial Officer March 31, 2023

Brigid Makes (Principal Financial and Accounting Officer)

* Chairman of the Board March 31, 2023

Gregg Williams

Aaron Mendelsohn

Dean Baker

Alexandra Larson

* By /s/ Scott Dunbar

Scott Dunbar

Attorney-in-fact

74

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Page

Report of Independent Registered Public Accounting Firm (PCAOB ID:207) F-2

Consolidated Balance Sheets as of December 31, 2022 and 2021 F-3

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders

Vivani Medical, Inc. and Subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets

of Vivani Medical, Inc. and Subsidiaries (the “Company”) as of December 31, 2022 and 2021 and the related consolidated

statements of operations, comprehensive loss, stockholders’ equity, and cash flows, for each of the two years in the period

ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company

as of December 31, 2022 and 2021, and the results of their operations and their cash flows for each of the two years in the period

ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility

of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements

based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)

(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities

laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the

PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated

financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor

were we engaged to perform an audit of its internal control over financial reporting. As part of our audit, we are required to

obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness

of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks

of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that

respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in

the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates

made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our

audit provides a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current

period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,

subjective, or complex judgments. We determined that there are no critical audit matters.

/s/ BPM LLP

We have served as the Company’s auditor since 2014.

Walnut Creek, California

March 31, 2023

F-2

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Balance Sheets

(In thousands)

December 31,

ASSETS

Current assets:

Prepaid expenses and other current assets 2,452 291

Restricted cash 1,366 —

Deposits and other assets 275 200

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Litigation accrual 1,675 —

Accrued compensation expense 657 —

Current operating lease liabilities 955 910

Long term operating lease liabilities — 902

Commitments and contingencies (Note 12)

Stockholders’ equity:

Preferred stock, no par value, 10,000 shares authorized; none outstanding — —

Accumulated other comprehensive loss 35 —

Total liabilities and stockholders’ equity $ 51,130 $ 5,453

See accompanying notes to consolidated financial

statements.

F-3

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Operations

(In thousands, except per share data)

Years Ended December 31,

Operating expenses:

Research and development, net of grants $ 14,169 $ 11,002

General and administrative, net of grants 7,072 2,321

Gain on bargain purchase 6,877 —

Net loss per common share – basic and diluted $ (0.36 ) $ (0.39 )

Weighted average shares outstanding – basic and diluted 38,241 33,092

See accompanying notes to consolidated financial

statements.

F-4

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Comprehensive

Loss

(In thousands)

Years Ended December 31,

Other comprehensive income:

Foreign currency translation adjustments 35 —

See accompanying notes to consolidated financial

statements.

F-5

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Condensed Consolidated Statements

of Stockholders’ Equity

(in thousands)

Accumulated

Additional Other Total

Common Stock Paid-in Comprehensive Accumulated Stockholders’

Shares Amount Capital Loss Deficit Equity

Options and warrants exercised, net of partial shares adjustment

Repurchase of common stock (60 ) — — — — —

Shares issued for SSMP net assets

Stock-based compensation expense — — 1,668 — — 1,668

Accumulated

Additional Other Total

Common Stock Paid-in Comprehensive Accumulated Stockholders’

Shares Amount Capital Loss Deficit Equity

Options and warrants exercised, net of partial shares adjustment 797 16 — — — 16

Stock-based compensation expense — — 1,296 — — 1,296

Foreign currency translation adjustment — — — 35 — 35

See accompanying notes to consolidated financial

statements.

F-6

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(In thousands)

Years Ended December 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization of property and equipment 381 345

Gain on bargain purchase (6,877 ) —

PPP loan forgiveness — (641 )

Non-cash lease expense (36 ) 14

Changes in operating assets and liabilities:

Prepaid expenses and other assets (476 ) 102

Accrued compensation expenses 204 —

Net cash used in operating activities (18,787 ) (10,951 )

Cash flows from investing activities:

Purchases of property and equipment (338 ) (572 )

Net cash used in investing activities (338 ) (572 )

Cash flows from financing activities:

Cash acquired in merger for stock consideration 55,374 —

Proceeds from SAFE note 8,000 —

Net cash provided by financing activities 63,390 11,620

Effect of exchange rate changes on cash and cash equivalents (1 ) —

Cash, cash equivalents and restricted cash:

Supplemental disclosure of cash flow information;

Cash paid during the period for:

Income taxes $ — $ 1

Non-cash investing and financing activities:

Cancellation of SAFE indebtedness in merger $ 8,000 $ —

Net liabilities acquired in merger for stock consideration $ 2,112 $ —

See accompanying notes to consolidated financial statements.

F-7

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Notes to Consolidated Financial Statements

1. Organization and Business Operations

Vivani Medical, Inc. (“Vivani,”

the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical

company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortalTM technology to enable long-term,

near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop

and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address

a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately

50% of patients treated for type 2 diabetes are non-adherent to their medicines, which can lead to poor clinical outcomes. We are

developing a portfolio of miniature, sub-dermal drug implant candidates that, unlike most oral and injectable medicines, are designed

with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In

addition, the minimal fluctuations of drug levels dictated by our NanoPortal technology may improve the tolerability profiles for

medicines that produce side effects associated with fluctuating drug levels.

Vivani resulted from the business combination

of Second Sight Medical Products (Second Sight) and Nano Precision Medical (NPM). Since inception, Vivani’s main priority

has been the further development of the company’s lead program, NPM-119, a miniature, 6-month, GLP-1 implant candidate for

the treatment of patients with type 2 diabetes under the company’s Biopharm Division (formerly NPM). In parallel, Vivani’s

new management team remained committed to identifying and exploring strategic options for the Neuromodulation Division (formerly

Second Sight) that will enable further development of its pioneering neurostimulation systems to help patients recover critical

body functions.

In February 2022, we announced the signing

of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.

(“Second Sight”), pursuant to which NPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the two

companies completed the merger, concurrent with which Second Sight changed its name to Vivani Medical, Inc. and now conducts the

present business of the Company. In September 2022, we announced the formation of the Company’s Biopharm Division to advance

the assets of the former NPM which includes the further development of the company’s lead program, NPM-119, a miniature,

6-month, GLP-1 implant candidate for the treatment of patients with type 2 diabetes. Vivani’s new management team remains

committed to identifying and exploring strategic options for the Neuromodulation Division (formerly Second Sight) that will enable

further development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28,

2022, the assets and liabilities of this segment were contributed to Cortigent, Inc. a newly formed wholly owned subsidiary of

Vivani, in exchange for 20 million shares of common stock of Cortigent.

In March 2023, Vivani announced the filing

of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial

public offering of Cortigent. Cortigent is expected to continue to be majority-owned by Vivani immediately following the initial

public offering.

Agreement and Plan of Merger with Nano

Precision Medical, Inc.

On February 4, 2022, Second Sight Medical

Products, Inc. (“Second Sight”) entered into an agreement and plan of merger (the “Merger Agreement”) with

Nano Precision Medical, Inc. (“NPM”). The Merger was approved by the shareholders of Second Sight on July 27, 2022

and closed on August 30, 2022. Upon consummation of the Merger, NPM became a wholly-owned subsidiary of Second Sight. Concurrent

with to the Merger, Second Sight changed its name to Vivani Medical, Inc. and changed its trading symbol from EYES to VANI, and

trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board of directors are also investors

and members of the board of directors of Second Sight.

Under the terms and conditions of the Merger

Agreement, the securities of NPM converted into the right to receive shares of Second Sight’s common stock representing 77.32%

of the total issued and outstanding shares of common stock of Second Sight on a fully converted basis, including, without limitation,

giving effect to the conversion of all options, warrants, and any and all other convertible securities assuming net settlement.

Second Sight filed a Registration Statement on Form S-4 on May 13, 2022 in connection with the Merger to register the merger shares

effective June 24, 2022.

F-8

On February 4, 2022, in connection with

the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight

provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate if the Merger

were to be successfully completed. Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022,

the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the purchase consideration.

The Merger involved a change of control

and was accounted for as a reverse merger in accordance with accounting principles generally accepted in the United States of America

(“GAAP”). Under this method of accounting, Second Sight was treated as the “acquired” company for financial

reporting purposes with NPM as the acquirer. The assets acquired and liabilities assumed by NPM were recorded at fair value under

Accounting Codification Standard (“ASC 805”), Business Combinations. Accordingly, on August 30, 2022 (the “Acquisition

Date”), NPM (a calendar year-end entity) was deemed to have acquired 100% of the outstanding common shares and voting interest

of Second Sight, Medical, Inc. The results of Second Sight’s operations have been included in the consolidated financial

statements since that date.

The acquisition-date fair value of consideration

transferred totaled $54.4 million, which consisted of the fair value of the 13,136 common shares deemed issued to Second Sight

shareholders, was determined based on the per share closing price of the Company’s common shares on the acquisition date

of $4.14.

The following table summarizes the fair

values of the assets acquired and liabilities assumed at the acquisition date (in thousands):

Property and equipment 99

Prepaid expenses 1,657

Right of use assets 140

Other assets 56

Total identifiable assets acquired 57,326

Current liabilities (3,913 )

Right of use liabilities (151 )

Total liabilities assumed 4,064

Net identifiable assets acquired $ 53,262

The SAFE loan of $8.0 million was cancelled

in the Merger which adjusted the fair value of net assets acquired.

The following table summarizes the calculation

of the gain on bargain purchase (in thousands):

Total consideration $ 54,385

SAFE loan forgiven (8,000 )

Less net identifiable assets acquired (53,262 )

Gain on bargain purchase $ 6,877

Because NPM purchased 100% of Second Sight

and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair value of the consideration, we reassessed

the recognition and measurement of identifiable assets acquired and liabilities assumed and concluded that all acquired assets

and assumed liabilities were properly recognized and that the valuation procedures and resulting measures were appropriate. As

a result, we recognized a gain of $6.9 million.

We recognized $0.7 million of acquisition

related costs that were expensed in the twelve months ended December 31, 2022. These costs are included in the consolidated income

statement in the line item entitled “General and administrative costs.”

F-9

Operating expenses of Second

Sight included in the consolidated statements of operations from the acquisition date August 30, 2022 to the period ending

December 30, 2022 were $2.1 million. Pro forma consolidated net loss as if Second Sight had been included in the consolidated

results was $21.7

million for the year ended December 31, 2021, and $28.3

million for the year ended December 31, 2022.

SAFE

On February 4, 2022, in connection with

the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight

provided to NPM an investment advance of $8 million. The agreement provided that the SAFE would terminate if the Merger were to

be successfully completed.

Under the terms of the SAFE, upon successfully

completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a business combination,

the $8.0 million adjusted the purchase consideration.

Liquidity and Capital Resources

From inception, our operations

have been funded primarily through the sales of our common stock as well as from warrants.

F-10

Our financial statements

have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in

the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to

meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability

to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there

can be no assurances that we will be able to do so.

2. Summary of Significant Accounting

Policies Principles of Consolidation

The

accompanying consolidated financial statements have been prepared in accordance with United States generally accepted

Source: SEC EDGAR (public domain) · 10-K for the period ended 2022-12-31, filed 2023-03-31 · accession 0001753926-23-000344

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