Financial Performance - For the three months ended September 30, 2024, net revenue was 3.1million,adecreasefrom8.4 million for the same period in 2023, primarily due to a 2.5milliondecreaseindiagnosticservicesanda2.7 million decrease in consumer products[152]. - For the nine months ended September 30, 2024, net revenue was 9.3million,downfrom40.9 million for the same period in 2023, with a 24.8milliondecreaseindiagnosticservicesrevenue[161].−NetlossforthethreemonthsendedSeptember30,2024,was6.6 million, or (0.35)pershare,comparedtoanetlossof5.1 million, or (0.30)pershare,forthesameperiodin2023[161].−NetlossfortheninemonthsendedSeptember30,2024,was19.0 million, or (1.02)pershare,comparedtoanetlossof8.0 million, or (0.47)pershare,forthesameperiodin2023[170].DiagnosticServices−Overalldiagnostictestingvolumedecreasedfrom13,000testsinthethreemonthsendedSeptember30,2023,tozerotestsinthesameperiodin2024[152].−Overalldiagnostictestingvolumedecreasedfrom259,000testsintheninemonthsendedSeptember30,2023,tozerotestsinthesameperiodin2024[161].−DiagnosticservicescostsfortheninemonthsendedSeptember30,2024,werezero,downfrom1.9 million in the same period in 2023, due to decreased COVID-19 testing volumes[164]. - There were no diagnostic services revenue generated from the HRSA funding program for the three months ended September 30, 2024, and 2023[194]. - The expiration of the federal Public Health Emergency on May 11, 2023, led to a significant decrease in demand for COVID-19 testing services[195]. Expenses - General and administration expenses for the three months ended September 30, 2024, were 7.7million,adecreasefrom8.2 million in the same period in 2023[157]. - General and administration expenses decreased by 4.0millionto22.5 million for the nine months ended September 30, 2024, compared to 26.5millionforthesameperiodin2023[165].−ResearchanddevelopmentcostsforthethreemonthsendedSeptember30,2024,were122,000, down from 428,000forthesameperiodin2023[158].−Researchanddevelopmentcostsdecreasedto533,000 for the nine months ended September 30, 2024, down from 1.144millioninthesameperiodin2023,primarilyduetoreducedproductresearchactivities[167].−InterestexpenseforthethreemonthsendedSeptember30,2024,was1.2 million, compared to 275,000forthesameperiodin2023,reflectingahigherbalanceofoutstandingdebt[160].−Interestexpenseincreasedto2.3 million for the nine months ended September 30, 2024, compared to 781,000forthesameperiodin2023,duetoahigherbalanceofoutstandingdebt[169].CashFlowandCapital−Cashandcashequivalentsdecreasedto1.1 million as of September 30, 2024, down from 2.1millionatDecember31,2023,primarilydueto14.0 million used in operating activities[178]. - The company anticipates continued losses and will require additional capital to fund operations, which may be raised through public or private equity or debt financings[181]. - The company sold 1,033,500 shares of common stock, generating cash proceeds of 4.6millionduringtheninemonthsendedSeptember30,2024[199].AcquisitionsandAgreements−Thecompanycontinuestoactivelypursueacquisitionopportunitiesforothercompanies,technologies,andproductswithinandoutsidetheconsumerproductsindustry[151].−ThecompanyenteredintoamanufacturingagreementwithVespyrBrands,Inc.fortheproductionofcertainproducts,whichiscurrentlyundernegotiationforrenewal[182].−ThecompanypurchasedassetsrelatedtotheBE−SmartEsophagealPre−Cancerdiagnosticscreeningtestfor3.5 million in cash and 100,000 shares of common stock[186]. - The company issued an unsecured promissory note for an aggregate principal amount of 7.6million,accruinginterestatarateof1010.0 million, with an interest rate raised to 15% per annum and a new maturity date of August 15, 2027[192]. Internal Controls and Compliance - A material weakness in internal control over financial reporting was identified, affecting the accuracy of account reconciliations and revenue recognition[218][220]. - The company is currently evaluating material weaknesses in internal controls and has hired a third-party accounting consultant to assist in remediation efforts[222]. - As of December 31, 2023, the company's internal controls over financial reporting were deemed ineffective due to several identified deficiencies[218]. - There were misstatements in accounts receivable, deferred revenue, and revenue for multiple subsidiaries due to inadequate controls and reliance on manual input processes[220]. - The evaluation of disclosure controls and procedures concluded that they were effective at the reasonable assurance level as of September 30, 2024[217]. - No material changes in internal control over financial reporting occurred during the most recent quarter that would likely affect internal controls[223]. Market Conditions - The company anticipates that increased costs for contract manufacturing and retail operations will be passed on to customers, while costs related to diagnostic services will be absorbed by the company[200]. - The company is subject to normal inflationary trends, which could materially affect its business in the future[200]. - Current economic conditions may adversely affect the company's business and financial performance, including the collection of accounts receivables and realization of inventory[214]. - There have been no material changes to market risk exposures since December 31, 2023[215]. - The company does not expect material losses related to its investment portfolio or excessive exposure to market risks associated with interest rates[213].