2024 Q2 Form 10-Q Financial Statement
#000175392624000959 Filed on May 13, 2024
Income Statement
Concept | 2024 Q2 | 2024 Q1 | 2023 Q1 |
---|---|---|---|
Revenue | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Cost Of Revenue | |||
YoY Change | |||
Gross Profit | |||
YoY Change | |||
Gross Profit Margin | |||
Selling, General & Admin | $2.168M | $2.501M | $2.650M |
YoY Change | -30.96% | -5.62% | 68.68% |
% of Gross Profit | |||
Research & Development | $3.513M | $3.726M | $3.955M |
YoY Change | -9.08% | -5.79% | 513.18% |
% of Gross Profit | |||
Depreciation & Amortization | $100.0K | $99.00K | $108.0K |
YoY Change | 25.0% | -8.33% | 575.0% |
% of Gross Profit | |||
Operating Expenses | $5.681M | $6.227M | $6.601M |
YoY Change | -18.88% | -5.67% | 197.88% |
Operating Profit | -$5.681M | -$6.227M | -$6.601M |
YoY Change | -18.88% | -5.67% | 197.88% |
Interest Expense | |||
YoY Change | |||
% of Operating Profit | |||
Other Income/Expense, Net | $325.0K | $188.0K | $280.0K |
YoY Change | -32.29% | -32.86% | -1500.0% |
Pretax Income | -$5.356M | -$6.039M | -$6.320M |
YoY Change | -17.98% | -4.45% | 185.71% |
Income Tax | |||
% Of Pretax Income | |||
Net Earnings | -$5.356M | -$6.039M | -$6.318M |
YoY Change | -17.93% | -4.42% | 185.62% |
Net Earnings / Revenue | |||
Basic Earnings Per Share | -$0.10 | $0.12 | -$0.12 |
Diluted Earnings Per Share | -$0.10 | -$0.12 | -$0.12 |
COMMON SHARES | |||
Basic Shares Outstanding | 54.98M shares | 54.98M shares | 50.76M shares |
Diluted Shares Outstanding | 55.02M shares | 50.76K shares |
Balance Sheet
Concept | 2024 Q2 | 2024 Q1 | 2023 Q1 |
---|---|---|---|
SHORT-TERM ASSETS | |||
Cash & Short-Term Investments | $24.92M | $29.65M | $38.07M |
YoY Change | -23.3% | -22.12% | -36.12% |
Cash & Equivalents | $24.92M | $29.65M | $38.07M |
Short-Term Investments | |||
Other Short-Term Assets | $1.418M | $1.854M | $2.610M |
YoY Change | -62.09% | -28.97% | 524.4% |
Inventory | |||
Prepaid Expenses | |||
Receivables | |||
Other Receivables | |||
Total Short-Term Assets | $26.34M | $31.50M | $40.68M |
YoY Change | -27.29% | -22.57% | -32.44% |
LONG-TERM ASSETS | |||
Property, Plant & Equipment | $1.710M | $1.689M | $1.111M |
YoY Change | 59.07% | 52.03% | 266.67% |
Goodwill | |||
YoY Change | |||
Intangibles | |||
YoY Change | |||
Long-Term Investments | $38.00K | $47.00K | $270.0K |
YoY Change | -85.38% | -82.59% | -96.63% |
Other Assets | $1.338M | $1.338M | $1.366M |
YoY Change | -2.05% | -2.05% | |
Total Long-Term Assets | $21.89M | $22.29M | $3.896M |
YoY Change | -6.41% | 472.02% | -53.18% |
TOTAL ASSETS | |||
Total Short-Term Assets | $26.34M | $31.50M | $40.68M |
Total Long-Term Assets | $21.89M | $22.29M | $3.896M |
Total Assets | $48.22M | $53.79M | $44.58M |
YoY Change | -19.1% | 20.66% | -34.96% |
SHORT-TERM LIABILITIES | |||
YoY Change | |||
Accounts Payable | $645.0K | $570.0K | $746.0K |
YoY Change | -67.57% | -23.59% | 0.27% |
Accrued Expenses | $1.660M | $1.953M | $2.114M |
YoY Change | -16.75% | -7.62% | 67.78% |
Deferred Revenue | |||
YoY Change | |||
Short-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Long-Term Debt Due | |||
YoY Change | |||
Total Short-Term Liabilities | $5.784M | $6.138M | $5.863M |
YoY Change | -18.37% | 4.69% | 145.83% |
LONG-TERM LIABILITIES | |||
Long-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Other Long-Term Liabilities | $18.62M | $18.94M | $350.0K |
YoY Change | -7.52% | 5311.43% | |
Total Long-Term Liabilities | $18.62M | $18.94M | $350.0K |
YoY Change | -7.52% | 5311.43% | |
TOTAL LIABILITIES | |||
Total Short-Term Liabilities | $5.784M | $6.138M | $5.863M |
Total Long-Term Liabilities | $18.62M | $18.94M | $350.0K |
Total Liabilities | $24.40M | $25.08M | $6.212M |
YoY Change | -10.34% | 303.7% | 160.46% |
SHAREHOLDERS EQUITY | |||
Retained Earnings | -$109.8M | -$104.5M | -$79.10M |
YoY Change | 28.26% | 32.08% | |
Common Stock | $6.000K | $5.000K | $109.1M |
YoY Change | 20.0% | -100.0% | |
Preferred Stock | |||
YoY Change | |||
Treasury Stock (at cost) | |||
YoY Change | |||
Treasury Stock Shares | |||
Shareholders Equity | $23.82M | $28.71M | $38.37M |
YoY Change | |||
Total Liabilities & Shareholders Equity | $48.22M | $53.79M | $44.58M |
YoY Change | -19.1% | 20.66% | -34.96% |
Cashflow Statement
Concept | 2024 Q2 | 2024 Q1 | 2023 Q1 |
---|---|---|---|
OPERATING ACTIVITIES | |||
Net Income | -$5.356M | -$6.039M | -$6.318M |
YoY Change | -17.93% | -4.42% | 185.62% |
Depreciation, Depletion And Amortization | $100.0K | $99.00K | $108.0K |
YoY Change | 25.0% | -8.33% | 575.0% |
Cash From Operating Activities | -$4.801M | -$4.512M | -$6.966M |
YoY Change | -13.5% | -35.23% | 252.71% |
INVESTING ACTIVITIES | |||
Capital Expenditures | $37.00K | $182.0K | $37.00K |
YoY Change | -7.5% | 391.89% | -305.56% |
Acquisitions | |||
YoY Change | |||
Other Investing Activities | |||
YoY Change | |||
Cash From Investing Activities | -$37.00K | -$182.0K | -$37.00K |
YoY Change | -7.5% | 391.89% | -99.54% |
FINANCING ACTIVITIES | |||
Cash Dividend Paid | |||
YoY Change | |||
Common Stock Issuance & Retirement, Net | |||
YoY Change | |||
Debt Paid & Issued, Net | |||
YoY Change | |||
Cash From Financing Activities | 109.0K | $13.69M | |
YoY Change | 990.0% | ||
NET CHANGE | |||
Cash From Operating Activities | -4.801M | -$4.512M | -$6.966M |
Cash From Investing Activities | -37.00K | -$182.0K | -$37.00K |
Cash From Financing Activities | 109.0K | $13.69M | |
Net Change In Cash | -4.729M | $8.994M | -$7.003M |
YoY Change | -15.25% | -228.43% | |
FREE CASH FLOW | |||
Cash From Operating Activities | -$4.801M | -$4.512M | -$6.966M |
Capital Expenditures | $37.00K | $182.0K | $37.00K |
Free Cash Flow | -$4.838M | -$4.694M | -$7.003M |
YoY Change | -13.45% | -32.97% | 257.84% |
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20761000 | usd |
CY2024Q1 | us-gaap |
Stock Issued During Period Value Issued For Services
StockIssuedDuringPeriodValueIssuedForServices
|
13687000 | usd |
CY2024Q1 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
353000 | usd |
CY2024Q1 | us-gaap |
Other Comprehensive Income Foreign Currency Transaction And Translation Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeForeignCurrencyTransactionAndTranslationAdjustmentNetOfTaxPortionAttributableToParent
|
-52000 | usd |
CY2024Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6039000 | usd |
CY2024Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
28710000 | usd |
CY2024Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6039000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6318000 | usd |
CY2024Q1 | us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
99000 | usd |
CY2023Q1 | us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
108000 | usd |
CY2024Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
353000 | usd |
CY2023Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
369000 | usd |
CY2024Q1 | us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
-82000 | usd |
CY2023Q1 | us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
62000 | usd |
CY2024Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-556000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
153000 | usd |
CY2024Q1 | us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
27000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
-429000 | usd |
CY2024Q1 | us-gaap |
Increase Decrease In Employee Related Liabilities
IncreaseDecreaseInEmployeeRelatedLiabilities
|
110000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Employee Related Liabilities
IncreaseDecreaseInEmployeeRelatedLiabilities
|
-243000 | usd |
CY2024Q1 | us-gaap |
Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
|
300000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
|
-238000 | usd |
CY2024Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-4512000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-6966000 | usd |
CY2024Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
182000 | usd |
CY2023Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
37000 | usd |
CY2024Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-182000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-37000 | usd |
CY2024Q1 | vani |
Proceeds From Issuance Of Common Stock And Option
ProceedsFromIssuanceOfCommonStockAndOption
|
3000 | usd |
CY2024Q1 | vani |
Issuance Of Common Stock And Warrants In Connection With Securities Purchase Agreement Net Of Issuance Costs
IssuanceOfCommonStockAndWarrantsInConnectionWithSecuritiesPurchaseAgreementNetOfIssuanceCosts
|
13687000 | usd |
CY2024Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
13690000 | usd |
CY2024Q1 | us-gaap |
Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
EffectOfExchangeRateOnCashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
-2000 | usd |
CY2024Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
8994000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
-7003000 | usd |
CY2023Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
21992000 | usd |
CY2022Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
46442000 | usd |
CY2024Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
30986000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
39439000 | usd |
CY2024Q1 | us-gaap |
Income Taxes Paid Net
IncomeTaxesPaidNet
|
2000 | usd |
CY2023Q1 | us-gaap |
Income Taxes Paid Net
IncomeTaxesPaidNet
|
1000 | usd |
CY2023Q1 | vani |
Establishment Of Operating Rightofuse Assets Through Operating Lease Obligations
EstablishmentOfOperatingRightofuseAssetsThroughOperatingLeaseObligations
|
668000 | usd |
CY2024Q1 | vani |
Receivables For Cash Intransit On Exercise Of Common Stock Under Equity Incentive Plan
ReceivablesForCashIntransitOnExerciseOfCommonStockUnderEquityIncentivePlan
|
-3000 | usd |
CY2024Q1 | vani |
Purchase Of Property And Equipment In Accrued Expenses
PurchaseOfPropertyAndEquipmentInAccruedExpenses
|
-123000 | usd |
CY2024Q1 | us-gaap |
Nature Of Operations
NatureOfOperations
|
<p id="xdx_801_eus-gaap--NatureOfOperations_zXGGpdvGBTN2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 1. <span id="xdx_822_z1mSQBG9QXk3">Organization and Business Operations</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 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 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. According to the U.S. Centers for Disease Control and Prevention, adherence is defined as the extent to which an individual’s behavior, including taking medications, corresponds to recommendations from a health care provider. For example, a recent retrospective cohort study of approved obesity drugs found that only 40% of patients remained persistent on semaglutide therapy after one year of treatment indicating significant opportunity for improvement. 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 medication adherence by delivering therapeutic drug levels for up to 6 months or longer. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of our NanoPortal technology, which may improve the tolerability profiles for medicines that produce side effects associated with fluctuating drug levels in the blood.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM closed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of the company’s lead program NPM-115, a miniature, 6-month, GLP-1 implant candidate for chronic weight management in obese or overweight patients with one or more risk factors and further development of the balance of company’s miniature, long-term drug implant portfolio. In parallel, Vivani’s management team remained committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight aimed at helping patients recover critical body functions.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In December 2022, we contributed our neurostimulation assets and certain liabilities to Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of Vivani. Cortigent has 5,000,000 shares of common stock outstanding, all owned by Vivani. Cortigent is advancing the Company’s pioneering neurostimulation technology. 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. The Registration Statement on Form S-1 was recently amended and filed with the SEC in February 2024 to refresh the financial information and provide minor updates to the business.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On July 6, 2023, Vivani changed its state of incorporation from the State of California to the State of Delaware by means of a plan of conversion, effective July 5, 2023. The reincorporation, including the principal terms of the plan of conversion, was submitted to a vote of, and approved by, Vivani’s stockholders at its 2023 Annual Meeting of Stockholders held on June 15, 2023. As part of this change of incorporation the Company established a par value of $0.0001 per share and all periods have been retroactively adjusted to reflect this change.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">An Investigational New Drug Application (“IND”) for NPM-119 (GLP-1 implant for the treatment of type 2 diabetes) was filed with the U.S. Food and Drug Administration (“FDA”) on July 14, 2023, to support the initiation of the first-in-human study of NPM-119 in patients with type 2 diabetes, also named LIBERATE-1™. On August 18, 2023, FDA provided written notification that the LIBERATE-1 study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects. Vivani remains on track to provide the FDA with the requested CMC information associated with the current Clinical Hold on NPM-119 during the first half of 2024.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On August 25, 2023, the Company and Cortigent 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, Vivani 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, 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 $<span id="xdx_905_eus-gaap--RepaymentOfNotesReceivableFromRelatedParties_c20230823__20230825_zkfPShV2zXHi" title="Cortigent has agreed to repay">1,500,000</span> to Vivani at the conclusion of the Funding Support Term. In addition, at the conclusion of the Funding Support Term, Cortigent will enter into a <span id="xdx_900_ecustom--PromissoryFundingSupportTerm_dxL_c20230823__20230825_z8yMdeG8qR9k" title="Funding support term::XDX::P5Y"><span style="-sec-ix-hidden: xdx2ixbrl0371">five</span></span>-year promissory note at <span id="xdx_90B_eus-gaap--DerivativeAverageVariableInterestRate_iI_pid_dp_uPure_c20230825_z09IHGp2Nvu" title="Interest rate">5</span>% interest for $<span id="xdx_909_eus-gaap--OriginationOfNotesReceivableFromRelatedParties_c20230823__20230825_zPIr8WKASfvg" title="Cortigent enter into a promissory note">2,000,000</span> in favor of Vivani. Consequently, Vivani will forgive any remaining amounts due by Cortigent to the Company under the TFSSA. In October 2023, Vivani implemented a reduction-in-force to conserve cash that decreased Cortigent’s employees from 14 to 7 while continuing the ongoing Orion® clinical study and basic operations.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In the fourth quarter of 2023, Vivani Medical Australia Pty Ltd., a wholly owned subsidiary in Australia was established to support studies of our product candidates.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In February 2024, Vivani announced positive NPM-115 preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic®/Wegovy®, and disclosed NPM-139 as a semaglutide implant as our strategy shifted to prioritize our obesity portfolio. In a study of high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic®/Wegovy®) in the same study. The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 1, 2024, <span id="xdx_904_eus-gaap--SecuritiesPurchasedUnderAgreementsToResellMeasurementDifferenceDescription_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_zHWhXZV0qGf6" title="Description of purchase agreement">the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with an institutional investor to purchase <span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_pid_uShares_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_zFtyJdx15LT" title="Number of share purchase">3,947,368</span> shares of common stock, par value $<span id="xdx_901_eus-gaap--AcceleratedShareRepurchasesInitialPricePaidPerShare_pid_uUSDPShares_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_zLBk5faWS8M8" title="Number of share purchase, per share">0.0001</span> per share (the “Common Stock”) and warrants to purchase up to an aggregate of <span id="xdx_903_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_pid_uShares_c20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_zpaXM0HSV9kl" title="Aggregate of share of common stock">3,947,368</span> shares of common stock at a purchase price of $<span id="xdx_905_eus-gaap--CommonStockNoParValue_iI_pid_uUSDPShares_c20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_z56BhmBILNh" title="Common stock, purchase price, per share">3.80</span> per share and accompanying warrant in a registered direct offering (the “Offering”). The warrants have an exercise price of $<span id="xdx_902_eus-gaap--WarrantExercisePriceIncrease_pid_uUSDPShares_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_z8K0uTcWLFYg" title="Warrant exercise price, per share">3.80</span> per share, are exercisable immediately upon issuance, and will expire <span id="xdx_90A_eus-gaap--WarrantsAndRightsOutstandingTerm_iI_dxL_c20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember_zEXz2tMiktz4" title="Warrant term::XDX::P3Y"><span style="-sec-ix-hidden: xdx2ixbrl0389">three</span></span> years following the date of issuance.</span></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Liquidity and Capital Resources</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">From inception, our operations have been funded primarily through the sales of our common stock and warrants.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 are subject to the risks and uncertainties associated with a business with no revenue that is developing novel medical devices, including limitations on our operating capital resources. 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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 1, 2024, <span id="xdx_90B_eus-gaap--SecuritiesPurchasedUnderAgreementsToResellMeasurementDifferenceDescription_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__srt--ProductOrServiceAxis__custom--LiquidityAndCapitalResourcesMember_zP6GhOH5lHGf" title="Description of purchase agreement">the Company entered into a securities purchase agreement with an institutional investor (the “Securities Purchase Agreement”) relating to the issuance of 3,947,368 shares of the Common Stock and warrants to purchase up to an aggregate of 3,947,368 shares of Common Stock (the “Warrants”), to such investor at a purchase price of $3.80 per share and accompanying warrants in the Offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance.</span> Simultaneously, the Company also entered into a placement agency agreement with Maxim Group LLC (“Maxim” and such agreement, the “Placement Agency Agreement,” and together with the Securities Purchase Agreement, the “Agreements”), who acted as the sole placement agent for the Offering. The gross proceeds of $<span id="xdx_905_eus-gaap--ProceedsFromIssuanceOfDebt_pn5n6_c20240228__20240301__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__srt--ProductOrServiceAxis__custom--LiquidityAndCapitalResourcesMember_zEEyiIqr9L7" title="Gross proceeds">15</span>.0 million from the Offering, before paying the placement agent fees and other offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million, during the three months ended March 31, 2024. For additional information, refer to Note 6. Equity Securities of the Notes to Condensed Consolidated Financial Statements.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.3in"><span style="font: 10pt Times New Roman, Times, Serif"></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.3in"><span style="font: 10pt Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into the second half of 2025. 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.</span></p> | |
CY2023Q3 | us-gaap |
Repayment Of Notes Receivable From Related Parties
RepaymentOfNotesReceivableFromRelatedParties
|
1500000 | usd |
CY2023Q3 | us-gaap |
Derivative Average Variable Interest Rate
DerivativeAverageVariableInterestRate
|
0.05 | pure |
CY2023Q3 | us-gaap |
Origination Of Notes Receivable From Related Parties
OriginationOfNotesReceivableFromRelatedParties
|
2000000 | usd |
CY2024Q1 | us-gaap |
Use Of Estimates
UseOfEstimates
|
<p id="xdx_842_eus-gaap--UseOfEstimates_zbNGHDBldQx4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_869_z870kQtQA6Bc">Use of estimates</span></i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the <span style="background-color: white">reporting </span>periods. On an ongoing basis, management evaluates its estimates, including, but not limited to, those related to useful lives of long-lived assets, stock-based compensation and evaluation of going concern. Management bases its estimates on historical experience and on various assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates.</span></p> | |
CY2024Q1 | us-gaap |
Cash And Cash Equivalents Fair Value Disclosure
CashAndCashEquivalentsFairValueDisclosure
|
22869000 | usd |
CY2023Q4 | us-gaap |
Cash And Cash Equivalents Fair Value Disclosure
CashAndCashEquivalentsFairValueDisclosure
|
18629000 | usd |
CY2024Q1 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
4231000 | usd |
CY2023Q4 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
4171000 | usd |
CY2024Q1 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
2542000 | usd |
CY2023Q4 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
2442000 | usd |
CY2024Q1 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
1689000 | usd |
CY2023Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
1729000 | usd |
CY2024Q1 | us-gaap |
Class Of Warrant Or Right Exercise Price Of Warrants Or Rights1
ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1
|
3.15 | |
CY2024Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
|
3387345 | shares |
CY2024Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
|
200000 | usd |
CY2024Q1 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
353000 | usd |
CY2023Q1 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
369000 | usd |
CY2024Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Maximum Number Of Shares Per Employee
ShareBasedCompensationArrangementByShareBasedPaymentAwardMaximumNumberOfSharesPerEmployee
|
59014 | shares |
CY2024Q1 | us-gaap |
Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Exercise Price Beginning Balance1
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1
|
1.90 | |
CY2024Q1 | vani |
Share Based Compensation1
ShareBasedCompensation1
|
100000 | usd |
CY2023Q1 | vani |
Share Based Compensation1
ShareBasedCompensation1
|
900000 | usd |
CY2024Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
|
0 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
|
0 | pure |
CY2024Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
|
1 | pure |
CY2023Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
|
1 | pure |
CY2024Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6039000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6318000 | usd |
CY2024Q1 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
52202000 | shares |
CY2023Q1 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
50755000 | shares |
CY2024Q1 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
0.12 | |
CY2023Q1 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
0.12 | |
CY2024Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
17244000 | shares |
CY2023Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
16366000 | shares |
CY2023Q1 | us-gaap |
Lessor Operating Lease Description
LessorOperatingLeaseDescription
|
lease 14,823 square feet of office space at 27200 Tourney Road, Valencia, California 91355. | |
CY2023Q1 | us-gaap |
Lessee Finance Sublease Option To Extend
LesseeFinanceSubleaseOptionToExtend
|
The sublease has a term of two years and two months. We also entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two years and one month. | |
CY2024Q1 | us-gaap |
Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
|
19212000 | usd |
CY2023Q4 | us-gaap |
Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
|
19616000 | usd |
CY2024Q1 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
1434000 | usd |
CY2023Q4 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
1383000 | usd |
CY2024Q1 | us-gaap |
Liabilities Other Than Longterm Debt Noncurrent
LiabilitiesOtherThanLongtermDebtNoncurrent
|
18940000 | usd |
CY2023Q4 | us-gaap |
Liabilities Other Than Longterm Debt Noncurrent
LiabilitiesOtherThanLongtermDebtNoncurrent
|
19313000 | usd |
CY2024Q1 | us-gaap |
Operating Lease Cost
OperatingLeaseCost
|
800000 | usd |
CY2023Q1 | us-gaap |
Operating Lease Cost
OperatingLeaseCost
|
300000 | usd |
CY2024Q1 | us-gaap |
Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
|
100000 | usd |
CY2023Q1 | us-gaap |
Utilities Operating Expense Maintenance
UtilitiesOperatingExpenseMaintenance
|
100000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Three
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearThree
|
2314000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Four
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearFour
|
2914000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Five
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearFive
|
2889000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Six
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearSix
|
2976000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Seven
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearSeven
|
3065000 | usd |
CY2024Q1 | vani |
Lessee Discounted Operating Lease Liability Payments Due Year Eight
LesseeDiscountedOperatingLeaseLiabilityPaymentsDueYearEight
|
15861000 | usd |
CY2024Q1 | us-gaap |
Operating Lease Payments
OperatingLeasePayments
|
30019000 | usd |
CY2024Q1 | us-gaap |
Finance Lease Interest Expense
FinanceLeaseInterestExpense
|
9645000 | usd |
CY2024Q1 | us-gaap |
Lease Cost
LeaseCost
|
20374000 | usd |
CY2024Q1 | us-gaap |
Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
|
0.0841 | pure |
CY2024Q1 | vani |
Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
|
756000 | usd |
CY2023Q1 | vani |
Cash Paid For Operating Lease Liabilities
CashPaidForOperatingLeaseLiabilities
|
377000 | usd |
CY2024Q1 | vani |
Clinical And Regulatory Expense
ClinicalAndRegulatoryExpense
|
6000 | usd |
CY2023Q1 | vani |
Clinical And Regulatory Expense
ClinicalAndRegulatoryExpense
|
26000 | usd |
CY2021Q2 | vani |
Liquidated Damages Paid Value
LiquidatedDamagesPaidValue
|
1000000 | usd |
CY2024Q1 | us-gaap |
Contract Termination Claims Description
ContractTerminationClaimsDescription
|
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 $5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000. | |
CY2021Q2 | us-gaap |
Loss Contingency Damages Paid Value
LossContingencyDamagesPaidValue
|
1000000 | usd |
CY2021Q2 | us-gaap |
Loss Contingency Damages Sought Value
LossContingencyDamagesSoughtValue
|
5600000 | usd |
CY2022Q4 | us-gaap |
Loss Contingency Settlement Agreement Court
LossContingencySettlementAgreementCourt
|
On December 8, 2022, the Company received notice that the Paris Commercial Court has rendered its judgment, including finding that the Company’s termination of the MOU was not valid. In the judgment, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. On May 24, 2023, the Company filed an appeal against the judgment from the Paris Commercial Court except in so far as such prior judgment dismissed (i) Pixium’s claim for the Company to pay it a sum of €480,693 relating to the alleged time spent by its teams, (ii) Pixium’s application to order the Company to pay it a sum of €1,500,000 in respect to alleged loss of opportunity and (iii) deducted the sum of $1,000,000 that we already paid Pixium and which Pixium retained converted into euros at the date of the judgment. Thereafter Pixium filed its brief with Paris Court of Appeal and filed a cross-appeal on January 18, 2024. Meanwhile, the Company received notice that the Paris Commercial Court had opened safeguard proceedings against Pixium by judgment dated October 9, 2023, then in its judgment dated November 13, 2023, converted safeguard proceedings into receivership, and in its judgment dated January 31, 2024, converted Pixium’s receivership proceedings to liquidation proceedings, the transfer plan being rejected. As a result, Pixium’s liquidator intervened on behalf Pixium in the pending proceedings before the Paris Court of Appeal and filed its brief on March 21, 2024. The Company filed its brief in reply with the Paris Court of Appeal on April 17, 2024. Proceedings before the Paris Court of Appeal are pending. In parallel, since the Company has failed to enforce the judgment, Pixium has requested the pre-trial judge to strike out the Company's appeal for failure to enforce the judgment. The hearing is scheduled to be in June 2024. The Company recorded a charge of $1,675,000 for the year ended December 31, 2022, related to this matter but plans to continue its appeal against the preliminary judgment. | |
CY2023Q1 | vani |
Loss Contingency Settlement Agreement Court1
LossContingencySettlementAgreementCourt1
|
1675000 | usd |