Financial Condition and Profitability - The company has a history of losses and may not achieve or maintain profitability in the future[76] - The company does not have adequate cash resources to fund operations through December 2025 and will require additional capital to grow its business[76] - The company has incurred net losses of 13.5millionand29.8 million for the years ended December 31, 2024 and 2023, respectively[98] - As of December 31, 2024, the company had a working capital deficit of 29.8million[98]−ThecompanyexpectstorequiresignificantcapitaltogrowitsbusinessandwillneedadditionalfinancingtofundoperationsthroughDecember2025andbeyond[100]−Thecompanyhasasubstantialamountofintangibleassetsandmayberequiredtowritedowntheirvalueduetoimpairment,whichcouldadverselyaffectfinancialcondition[109]−Thecompanyhasasignificantamountofindebtedness,withthemajorityofitsdebtinstrumentsinpaymentdefault,whichmaylimitoperationalflexibility[121]−Thecompanyhasnotbeenprofitablesinceitsinceptionin2019andmaycontinuetoincursignificantlossesinthefuture[99]RegulatoryandComplianceRisks−Thecompanyissubjecttoextensivefederalandstatelawsandregulationsrelatedtothesubmissionofclaimsforpayment,whichcanresultinsignificantmonetarydamagesandpenaltiesfornon−compliance[137]−Thecompanyfacespotentialclaimsforprofessionalliability,whichmaynotbefullycoveredbyinsurance,potentiallyimpactingfinancialcondition[139]−CompliancewithHIPAAandrelatedlawsiscritical,asfailuretomaintainsecurityofpatient−relatedinformationcouldleadtosubstantialcostsandreputationaldamage[151]−Thecompanymayneedtochangeoperationsinresponsetoregulatoryinterpretations,whichcouldharmbusinessrelationshipsandfinancialresults[132]−Legislativechangesmayresultinlimitationsonpaymentandreimbursementforhospitalprocedures,impactingrevenue[143]−Thecompanyissubjecttopotentialscrutinyfromregulatorsregardingcompliancewithhealthcarelaws,whichcouldleadtolegalremediesorpenalties[131]−TheCompanyissubjecttoHIPAAprivacyandsecurityregulations,whichmayincreaseoperationalcostsduetocompliancerequirements[154]−TheCompanyexpectscontinuedpressurefromgovernmentandprivatepayerstoreducereimbursementrates,whichcouldadverselyimpactnetrevenuesandprofitability[159]−ChangesinhealthcarereformandreimbursementsystemscouldmateriallyimpacttheCompany′scashflowandoverallfinancialcondition[156]MarketandCompetitiveRisks−Thecompanyfacessubstantialcompetitioninthepersonalhealthandwellnesstestingmarket,whichmaythreatenitsbusinesssuccess[81]−Increasedcompetitioninthehealthcaresector,includingpricecompetition,couldadverselyaffectthecompany′snetrevenuesandprofitability[148]−ThehealthcareoperationsareconcentratedinTennessee,makingtheCompanysensitivetolocaleconomicconditionsandregulatorychanges[165]−IncreasedcompetitioninthepersonalhealthandwellnesstestingmarketmaythreatentheCompany′smarketshareandgrowthpotential[171]OperationalRisks−Thecompanyreliesonalimitednumberofcriticalthird−partysuppliersforitsepigenetictestingservices,andanyinabilitytoprocuretheirmaterialscouldadverselyimpactoperations[81]−Thecompanyhasexperiencedchangesinseniormanagement,whichmaycreatecontinuityrisksandchallengesinexecutingitsbusinessplan[111]−Thecompanyisimplementingsystemsandprocessingchangestoimprovebillingproceduresandcollectionresults,butcannotassurethatadditionalprovisionswillnotbeneeded[146]−Thehealthcareindustryisexperiencingashortageofqualifiedhealthcareprofessionals,whichcouldweakenthecompany′sabilitytodeliverservices[140]IntellectualPropertyRisks−Thecompanyreliesonproprietarytechnologyandintellectualpropertyforitscompetitiveedge,withpotentialrisksifpatentprotectionsareinadequateoriftradesecretsaredisclosed[200]−Theuncertaintysurroundingpatentandtrademarklawsmaydiminishthevalueofthecompany′sintellectualproperty,affectingitsabilitytoprotectproductsandservices[205]−Changesinpatentlaw,suchasthetransitiontoafirstinventortofilesystem,couldcomplicatethepatentapplicationprocessandincreasecompetitionforpatentrights[206]−RecentU.S.SupremeCourtrulingshavenarrowedpatentprotection,creatinguncertaintyregardingtheabilitytoobtainandenforcepatents[207]−Thecompanymayfaceclaimsregardingthewrongfuluseofconfidentialinformationbyemployeesorcontractors,whichcouldleadtocostlylitigationandlossofintellectualpropertyrights[208]−Trademarkregistrationandenforcementmayfacechallenges,potentiallycomplicatingtheabilitytoprotectbrandidentityandmarketposition[209]−Thecompanymaybecomeinvolvedinlitigationrelatedtopatentrights,whichcouldincursubstantialcostsanddivertresourcesfrombusinessdevelopment[212]−Asthecompanyexpandsintonewmarkets,itmayencounterpatentassertionsfromincumbents,whichcouldhindermarketentryandleadtosignificantlicensingcosts[215]StockandMarketRisks−TheClassACommonStockhastradedaslowas0.09 per share since the business combination, indicating significant volatility in the market[223] - Future issuances of Class A Common Stock may dilute existing stockholders' ownership and voting power, potentially reducing the market price of outstanding shares[224] - The company is subject to continued listing standards of the NYSE American, and failure to meet these criteria may result in delisting, which could classify the stock as a "penny stock" if the price falls below 5.00[225]−Thepublicmarketforthecompany′ssecuritiesisvolatile,influencedbytechnologydevelopmentprogressandbroadermarketfluctuations[223]DataPrivacyandSecurityRisks−Noncompliancewithdataprivacylaws,suchastheCaliforniaConsumerPrivacyAct(CCPA),couldresultinfinesofupto7,500 per violation[191] - The company may face significant penalties for noncompliance with the EU's General Data Protection Regulation (GDPR), which can trigger fines of up to €20 million or 4% of global annual revenues[192] - The company may incur substantial costs to comply with evolving data security and privacy regulations, which could adversely affect its financial condition[192] - The potential for data misappropriation by third parties could harm the company's reputation and business operations[195] Technology and Development Risks - The company believes its bioinformatics and analytic activities are not subject to CLIA regulations, but future changes could adversely impact its business[180] - The company’s products and services may be subject to FDA regulations, which could require premarket review and authorization, potentially halting sales or requiring modifications[181] - The FDA has historically exercised enforcement discretion regarding laboratory developed tests (LDTs), but this could change with new legislative proposals[182] - The company’s proprietary bioinformatics and machine learning technology is believed to be exempt from FDA regulation, but this position is not guaranteed[184] - The use of saliva-based epigenetic biomarkers in life insurance underwriting is permissible, but future regulatory changes could impact operations[186] - Open-source software usage poses risks, including potential legal claims and requirements to release proprietary source code under unfavorable terms[220] - The company may incur significant costs defending or indemnifying third parties involved in infringement claims, impacting financial results[219] - The company may face claims related to open-source software compliance, which could lead to significant legal costs and operational disruptions[221] - The company may encounter delays in product introductions while developing alternatives to avoid infringing third-party patents[216]