UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

For the quarterly period ended June 30, 2022March 31, 2023

OR

For the transition period from ________ to ________

Commission File Number 001-36747

Second SightVivani Medical, Products, Inc.

(Exact name of Registrant as specified in its charter)

13170 Telfair Avenue5858 Horton Street, SylmarSuite 280Emeryville, CA 9134294608 

(Address of principal executive offices, including zip code)

((818)415) 833-5000506-8462

(Registrant’s telephone number, including area code)

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes ☒  No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes ☒  No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐  No ☒

As of August 8, 2022,May 10, 2023, the registrant had 39,409,17650,793,799 shares of common stock, no par value per share and 7,680,938 warrants, outstanding.

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

FORM 10-Q

TABLE OF CONTENTS

Part PART I. Financial StatementsFINANCIAL STATEMENTS

Item 1. Financial Statements

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Balance Sheets (unaudited)

(in thousands)

SeeThe accompanying notes.notes are an integral part of these condensed consolidated financial statements.

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Statements of Operations (unaudited)

(in thousands, except per share data)

The accompanying notes are an integral part of these condensed consolidated financial statements.

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

(in thousands)

SeeThe accompanying notes to theare an integral part of these condensed consolidated financial statements.

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity (Deficit) (unaudited)

(in thousands)

Litigation, Claims and Assessments

Three oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned by us. The outcomes of the challenges are not certain, however, if successful, they may affect our ability to block competitors from utilizing our patented technology. We do not believe a successful challenge will not have a material effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.

As described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium. In response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021, and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claimsclaim damages of approximately €5.1 million or about $5.25.6 million at current exchange rates.million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000 and thus$1,000,000.On December 9, 2022, the Company doesreceived notice that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU was not believe any further loss accrual is necessary.

valid. In November 2020, we andthe judgement, the Company was ordered to pay to Pixium retained Oppenheimer & Co. Inc. as placement agentthe amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a proposed private placementnet amount payable of securities in connection withapproximately €1,552,220. The Company may appeal the Business Combination. On April 1, 2021, we received an invoicedecision within three months from Oppenheimerthe date of service which was February 28, 2023. The Company recorded a charge of $1,675,000 for more than $1.86 millionthe year ended December 31, 2022, related to this matter but plans to raise any and all legal challenges to this preliminary judgement. This amount includes a requested commission of 6.5% on $27.9 million raised in the private placement. We believe that claims for payment presented by this invoice are without merit.

We are party to litigation arising in the ordinary course of business. It is our opinion that the outcome of such matters will not have a material effect on our results of operations, however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

10. Subsequent Events

The 2022 Annual Meeting of Shareholders of Second Sight Medical Products Inc. was held on July 27, 2022. Holders of 27,621,649 shares of Second Sight’s common stock were represented at the meeting in person or by proxy, constituting a quorum. A proposal to approve the transactions contemplated by the Agreement and Plan of Merger, dated February 4, 2022, by and between the Company and Nano Precision Medical, Inc., a California corporation (“NPM”), pursuant to which NPM will merge with and into NPM Acquisition Corp., a California corporation and a wholly-owned subsidiary of the Company, with NPM surviving as a wholly-owned subsidiary of the Company was approved.

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited 2021 financial statements and related notes included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (“SEC”) on March 29, 2022.10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect toourproducts,plansand strategy for our business and related financing, contains forward-looking statements that involve risks and uncertainties, including statements regarding our expected financial results in future periods. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “projects,” “will,” “would,” “strategy” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, liquidity, cash flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals, insurance reimbursements and product launches, our financing plans and future capital requirements, and statements regarding the anticipated or projected impact of our merger with NPM (as defined below), if and when occurs, on our business, results of operations, financial condition or prospects, the materially adverse impact of the recent COVID-19 coronavirus pandemic and related public health measures on our business. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We assume no obligations to update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report or to reflect actual outcomes.

Overview

Second SightVivani Medical, Products, Inc. (“Second Sight,Vivani,” the “Company,” “we,” “us,” “our” or similar terms) has developed, manufacturedis a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ 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 marketed implantable visual prosthetics thatpotentially 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 intendednon-adherent to deliver useful artificial visiontheir medicines which can lead to blind individuals.poor clinical outcomes. We are developing a recognized global leader in neuromodulation devicesportfolio 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 blindness and are committedup to developing new technologies to treat6 months or the broadest population of sight-impaired individuals.

Leveraging our 20 years of experience in neuromodulation for vision, we are developing the Orion^® Visual Cortical Prosthesis System (“Orion”), an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surfacelife of the brain’s visual cortex, where it is intended to provideimplant. In addition, by leveraging our proprietary NanoPortal implant technology we can design implants that deliver minimally fluctuating drug levels that may improve the perception of patterns of light. Wetolerability profiles for certain medicines for which side effects are conducting an Early Feasibility Study of the Orion device at the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and Baylor College of Medicine in Houston (“Baylor”). Regularly scheduled visits at both sites were paused in mid-March 2020 due to the coronavirus outbreak, however visits at UCLA resumed mid-September 2020 and Baylor resumed in December 2020. Our 36-month results, all of which were measured after the study resumed, indicate to us that:

No peer-reviewed data is available yet for the Orion system. We are currently negotiating the clinical and regulatory pathway to commercializationassociated with the FDAfluctuating drug levels such as part of the Breakthrough Devices Program.GLP-1 receptor agonists (GLP-1s).

In November 2017,February 2022, we announced the FDA granted Breakthrough Devices Program designationsigning 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 merger closed and the combined company of Nano Precision Medical (“NPM” and Second Sight Medical Products (“SSMP)” was renamed Vivani Medical, Inc,

While the primary focus of Vivani is to develop and ultimately commercialize the drug implant business from legacy company NPM, Vivani’s new management team remains committed to identifying and exploring strategic options for the Orion. This designation is given to a few select medical devices in order to provide more effective treatmentfurther advancement of life-threatening or irreversibly debilitating diseases or conditions. This program is intendedthe neuromodulation business of former legacy company Second Sight which includes development of its pioneering neurostimulation systems to help patients have more timely accessrecover critical body functions. On December 28, 2022, the neuromodulation assets and certain of its liabilities were contributed to these medical devicesCortigent, 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 expediting their development, assessment, and review.Vivani immediately following the initial public offering.

On February 26, 2021,Subject to completion of Cortigent’s initial public offering, Vivani intends to focus exclusively on further development of the U.S.drug implant business. Vivani plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) approvedto support a first in human (FIH) study with lead asset NPM-119 (GLP-1 implant). Following an acceptable IND submission, Vivani plans to initiate the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development. In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.

Market Development Plans

Orion. By further developing our visual cortical prosthesis, Orion, we believe we may be able to significantly expand our market to include nearly all profoundly blind individuals. The only notable exceptions for potential use of the Orion are those who are blind due to otherwise currently treatable diseases, individuals who are born blind, or blindness due to direct damage of the visual cortex,FIH study, named LIBERATE-1, which is rare. However,a randomized, Phase 2, 12-week investigation of the estimated 36 million blind people worldwide, there are approximately 5.8 million people who are legally blind due to causes that are not otherwise treatable. We continue to develop and refine our estimates of the potential addressable market size as we evaluate the commercial prospects for Orion using a combination of published sources, third party market research, and physician feedback. We currently estimate over 500,000 individualsNPM-119 in the US are legally blind due to retinitis pigmentosa, glaucoma, diabetic retinopathy, optic nerve disease and eye injury. Of this population, we estimate the potential US addressable market is between 50,000 and 100,000 individualspatients with bi-lateral blindness at the light-perception level or worse. Our marketing approvals by the FDA and other regulatory agencies will ultimately determine the subset of these patients who are eligible for the Orion based on our clinical trialstype 2 diabetes. The IND filing and the associated results.

Our objective in designing and developing the Orion visual prosthesis system isinitiation of LIBERATE-1 remain on track to bypass the optic nerve and directly stimulate the part of the brain responsible for human vision. An Early Feasibility Study of the Orion device is currently underway at UCLA and Baylor College of Medicine. Regularly scheduled visits at both sites were placed on hold in mid-March due to Covid-19, however visits at UCLA resumed mid-September 2020 and Baylor resumed in December 2020. Our 36 month results indicate a good safety profile with encouraging efficacy data and benefits in helping subjects perform their daily living tasks. We believe these data are encouraging and support advancement of Orion into a larger clinical study. Early promising results are not necessarily indicative of results which may be obtained in large clinical trials. No assurance can be given that we will achieve similar results in our larger Orion clinical trials. No peer-reviewed data is available yet for the Orion system.

occur mid-2023.

Liquidity

From inception, our operations have been funded primarily through the sales of our common stock and warrants, as well as from the issuance of convertible debt, research and clinical grants, and limited product revenue generated from the salewarrants. The completion of our Argus II product. We have funded our business since 2020 primarily through the following transactions:reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million in cash.

We wereSecond Sight was awarded a $1.6$6.4 million NIH five-year grant (with the intent to fund $6.4 million over five years subject to annual review and approval)reviews) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second. The fifth and final year grant of $1.4$1.0 million was approved on April 6, 2021, our third year grant of $1.4 million was approved on May 12, 2021 and our fourth year grant of $1.1 million was approved on July 18, 2022.in March 2023.

We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device.devices candidates. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. We expect our operating expenses to increase significantly as we continue our business operations, particularly as we prepare to and initiate our planned clinical trial of NPM-119 and conduct our other research and development activities. Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. To finance our operations, we will need to raise additional capital, which cannot be assured. Our operating plan may change as a result of many factors currently unknown to us, and we will need to seek additional funds through public or private equity offerings or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs, or we may be unable to expand or maintain our operations, maintain our current organization and employee base or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations. 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.

Merger Agreement

As discussed in the Notes to Condensed Consolidated Financial Statements of the Company, on February 4, 2022, the Company entered the Merger Agreement. On May 13, 2022, the Company filed a Registration Statement on Form S-4 (the “Registration Statement”) with the SEC in connection with the contemplated Merger, which is currently effective. Shareholders of the Company approved the Merger on July 27, 2022, and the merger is anticipated to bewas completed in August 2022. We encourage you to review the final proxy statement/prospectus filed with the SEC on June 24, 2022 for more information about the contemplated Merger.

Safe Agreement

On February 4, 2022, and in connection with the Merger, discussed in Note 1,Second Sight and NPM and SSMPalso entered into an agreementa Simple Agreement for Future Equity (“SAFE”) whereby SSMP would provideSecond Sight provided to NPM pending closing of the Merger an investment advance of $8 million, which effective upon the termination date ofmillion. If the Merger Agreementwere to be terminated without completion, of the Merger, will result in NPM’s issuingNPM would issue to SSMPSecond Sight that number of shares of NPM Capital Stock which following that issuance willcommon stock equal to not less than 2.133% of the issued and outstanding shares of NPM capitalcommon stock assuming exercise or conversion of all outstanding vested and unvested options, warrants, and convertible securities.

In The agreement provided that the event NPM completes an equity financing within one year from the date of termination of the merger at a lower valuation, SSMP may be eligible to receive additional shares of NPM capital stock as set forth in the SAFE. IfSAFE would terminate if the Merger is completed,were to be successfully completed.

Under the SAFE will terminate. The SAFE is classified as a marked-to-market asset pursuant to ASC 480, Distinguishing Liabilities from Equity, due to the potential variability at the time of share settlement. The carrying valueterms of the SAFE, asupon successfully completion of Junethe Merger on August 30, 2022, the investment advance was determined to approximate fair value due to proximity toeliminated. Under the issuance date and current probability ofaccounting for a successful merger.business combination, the $8 million adjusted the purchase consideration.

Critical Accounting Policies and Estimates

The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States (“GAAP”) and the requirements of the United States Securities and Exchange Commission require management to make estimates, assumptions and judgments that affect the amounts, liabilities, revenue and expenses reported in the financial statements and the notes to the financial statements. On an ongoing basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2021.

There have been no other material changes to our critical accounting policies during the sixthree months ended June 30, 2022.March 31, 2023.

Results of Operations

Operating Expenses. We generally recognize our operating expenses as incurred in threetwo general operational categories: research and development clinical and regulatory 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 clinical and regulatory and general and administrative personnel. 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 the amount of funding received from these grants as reductions to operating expenses.

Comparison of the Three Months Ended June 30,March 31, 2023 and 2022 and 2021

Research and development expense. Research and development expense increased by $0.1$1.3 million, or 21%48%, to $0.8$4.0 million in the secondfirst quarter of 20222023 from $0.7$2.7 million in the secondfirst quarter of 2021.2022. The costs increased due to costs of our acquired company Second Sight being included from the merger acquisition date of August 30, 2022. This inclusion increased usethese costs for the quarter by $0.6 million. The remainder of outside services and additional salaries as we restart our curtailed activity.the increase was primarily due to subdermal drug implants development costs.

Clinical and regulatory expense. Clinical and regulatory expense decreased $0.1 million, or 39%, to $0.2 million in the second quarter of 2022 from $0.3 million in the second quarter of 2021. This decrease is attributable to decreased costs associated with outside services primarily from patient studies.

General and administrative expense. General and administrative expense increased $0.8$1.4 million, or 59%115%, to $2.1$2.6 million in the secondfirst quarter of 20222023 from $1.3$1.2 million in the same period of 2021.2022. This increase is primarily attributable to increased legal costs associated with the current merger agreement.

Comparisoninclusion of the Six Months Ended June 30, 2022 and 2021

Research and development expense. Research and development expense increased by $0.5 million, or 45%, to $1.5our acquired company Second Sight which totaled $1.1 million in the first sixquarter of 2023. Approximately $0.1 million of costs were incurred related to the Cortigent IPO in the quarter.

Other income. Other income was impacted by the merger acquisition of cash which increased our interest income for the three months of 2022 from $1.0 million inended March 31, 2023 as compared to the same period of 2021. The costs increased due to increased use of outside services and increased salaries as we restart our curtailed activity.in 2022 before the merger.

Clinical and regulatory expense. Clinical and regulatory expense decreased $34,000, or 11%, to $266,000 in the first six months of 2022 from $300,000 in the same period of 2021. This decrease is attributable to decreased costs associated with outside services primarily from patient studies.

General and administrative expense. General and administrative expense decreased $0.2 million, or 6%, to $3.6 million in the first six months of 2022 from $3.8 million in the same period of 2021. This decrease is attributable to the termination fee associated with our termination of the MOU which occurred in the first six months of 2021 partially offset by increased legal costs associated with the current merger agreement.

Liquidity and Capital Resources

Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future.

Conducting clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for Orion.our products. We expect expenses to increase in connection with our ongoing activities, particularly as we continueinitiate clinical trials, of Orion, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. In particular, we expect to incur increased expenses as we initiate our planned Phase 2 clinical trial of NPM-119, for which we plan to file an IND with the FDA. In addition, if we obtain marketing approval for Orion, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

Until such time, if ever, we can generate substantial product revenues, we anticipate that we will seek to fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity, convertible debt or other equity-linked securities, the ownership interests of some or all of our common stockholders will be diluted, the holders of new equity securities may have priority rights over our existing stockholders and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If adequate funds are not available, we may be required to further curtail operations significantly or to obtain funds by entering into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. Our inability to raise capital could have a material adverse effect on our business, financial condition and results of operations.

Cash, and cash equivalents and restricted cash decreased by $13.2$7.0 million from $69.6$46.4 million as of December 31, 20212022 to $56.4$39.4 million as of June 30, 2022.March 31, 2023. Working capital was $54.8$34.9 million as of June 30, 2022, asMarch 31, 2023 compared to $68.0$40.7 million as of December 31, 2021,2022, a decrease of $13.2 million primarily as a result of the funding of the SAFE agreement and the current period operating loss.$5.8 million. We use our cash and cash equivalents and working capital to fund our operating activities.

Material Cash Requirements for Known Contractual and Other Obligations

The Merger Agreement as amended provides for the aggregate amount of cash, cash equivalents, and marketable securities of the Company being not less than $63 million less the amount of any advances made to NPM for working capital, in order to consummate the Merger. To date, the Company made an investment advance to NPM in the amount of $8 million under the SAFE, thereby having decreased the available cash requirement of the Merger Agreement to $55 million. The Company currently anticipates that it will be able to satisfy the available cash requirement of the Merger Agreement. 

Cash Flows from Operating Activities

During the first sixthree months of 2022,ended March 31, 2023, we used $5.2$7.0 million of cash in operating activities, consisting primarily of a net loss of $5.3$6.3 million offset byand a net changeincrease in net operating assets and liabilities of $0.1 million. During the first six months of 2021, we used $4.9$1.1 million, of cash in operating activities, consisting primarily of a net loss of $5.1 million,partially offset by non-cash charges which provided cash of $0.1$0.4 million for depreciation and amortization of property and equipment, stock-based compensation and change in right of use assetsassets. During the three months ended March 31, 2022, we used $3.2 million of cash in operating activities, consisting primarily of a net loss of $3.9 million, offset by non-cash charges which provided cash of $0.4 million for depreciation and amortization of property and equipment, stock-based compensation, change in right of use and partially offset by a net changedecrease in net operating assets and liabilities of $0.1$0.3 million.

Cash Flows from Investing Activities

Cash used for investing activities in the first sixthree months ofended March 31, 2023 and 2022 was $8,018,000 and was zero in the first six months of 2021. The $18,000minimal for both periods. In 2023 $37,000 was used for the purchase of property and equipment and $8.0 millionequipment. In 2022, $30,000 was used for our SAFE agreement.the purchase of property and equipment.

Cash Flows from Financing Activities

Financing activities was zero in the three months ended March 31, 2023. Financing activities provided zero cash in the first six months of 2022. Financing activities provided $75.6$8.0 million of cash in the first sixthree months of 2021 $77.8 millionended March 31, 2022 from the salefunding of common stock offset by $2.2 million for repayment of debt.the SAFE agreement.

Off-Balance Sheet Arrangements

At June 30, 2022,As of March 31, 2023, we did not have any transactions, obligations or relationships that constitute off-balance sheet arrangements.

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. As of June 30, 2022,March 31, 2023, our investments consisted solely of money market funds.

Exchange Rate Sensitivity

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.

Evaluation of Disclosure Controls and Procedures

Our management, including our Acting Chief Executive Officer (“CEO”) and our Acting Chief AccountingFinancial Officer (“CAO”CFO”), evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under 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 by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. As of June 30, 2022,March 31, 2023, based on the evaluation of these disclosure controls and procedures, our CEO and CAOCFO have concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during the six monthsquarter ended June 30, 2022,March 31, 2023, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are updating our internal control environment to address changes in our risks in financial reporting to accommodate our reductions in operating activities, reductions in staffing levels, and segregation of duties. Such changes may result in new or reduced controls.

Inherent Limitations on Effectiveness of Controls

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II-OTHER INFORMATION

Three oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned by us.Second Sight. The outcomes of the challenges are not certain, however, if successful, they may affect our ability to block competitors from utilizing our patented technology. We believe a successful challenge will not have a material effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.

As described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium.Pixium Vision SA (“Pixium”). In response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately €5.1 million or about $5.2 million at current exchange rates.$5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000 and thus$1,000,000. On December 9, 2022, the Company doesreceived notice that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU was not believe any further loss accrual is necessary.

valid. In November 2020, we andthe judgement, the Company was ordered to pay to Pixium retained Oppenheimer & Co. Inc. as placement agentthe amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a proposed private placementnet amount payable of securities in connection withapproximately €1,552,220. The Company may appeal the Business Combination. On April 1, 2021, we received an invoicedecision within three months from Oppenheimerthe date of service which was February 28, 2023. The Company recorded a charge of $1,675,000 for more than $1.86 million. This amount includes a requested commission of 6.5% on $27.9 million raised in the private placement. We believe that claims for payment presented byyear ended December 31, 2022 related to this invoice are without merit.matter but plans to raise any and all legal challenges to this preliminary judgement.

From time to time, we may be involved in a variety of legal proceedings and claims relating to securities laws, product liability, patent infringement, contract disputes, employment matters and other matters relating to various claims that arise in the normal course of our business in addition to governmental and other regulatory investigations and proceedings. It is our opinion that the outcome of such matters will not have a material adverse effect on our results of operations, however, the results of litigation, proceedings, disputes and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Our business is subject to numerous material and other risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Form 10-Q, including our consolidated financial statements and the related notes, and in our other filings with the SEC. If any of the stated risks actually occur, our business, prospects, operating results, and financial condition could suffer materially. In such event, the trading price of our common stock could decline and you might lose all or part of your investment. The material risks associated with our business were most recently discussed in our Form 10-K that we filed on March 31, 2023. There have been no material changes from the risk factors previously disclosed in the Company’s 2021 Annual Report on Form 10-K, filed with the SEC on March 29, 2022. For risk factors concomitant to the Merger, please review the Registration Statement. such filing.

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