2024 Q2 Form 10-Q Financial Statement

#000175392624000959 Filed on May 13, 2024

View on sec.gov

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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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

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