Financial Performance - For the three months ended September 30, 2024, revenue was 1.2million,anincreaseof500.8 million for the same period in 2023[159]. - For the nine months ended September 30, 2024, revenue was 3.1million,asignificantincreaseof121.41.4 million for the same period in 2023[167]. - The company experienced a net loss of approximately 34.0millionandusedapproximately34.3 million of cash in operations during the nine-month period ended September 30, 2024[180]. - As of September 30, 2024, the company had cash on hand of 14.5millionandexpectstocontinueexperiencingrecurringlossesandnegativecashflowfromoperations[180].Expenses−Thecostofrevenueforthesameperiodwasapproximately1.7 million, up from 1.6million,withanetincreaseof0.1 million primarily due to increased third-party professional and IT-related expenses[160]. - Sales and marketing expenses for the three months ended September 30, 2024, were approximately 4.1million,anincreaseof7.93.8 million in the prior year[161]. - General and administrative expenses increased to approximately 5.4millionfrom4.3 million, reflecting a net increase of 1.1millionprimarilyduetogrowthandexpansionofbusinessoperations[161].−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2024,wereapproximately1.7 million, compared to 1.6millionforthesameperiodintheprioryear,indicatingaslightincrease[162].−ThecostofrevenuefortheninemonthsendedSeptember30,2024,wasapproximately5.0 million, up from 4.5million,withanetincreaseof0.5 million attributed to various factors including increased compensation-related costs[168]. - Sales and marketing costs for the nine months ended September 30, 2024, were approximately 12.5million,aslightincreaseof4.212.0 million in the prior year[169]. - General and administrative costs decreased to approximately 14.3millionfrom15.0 million, reflecting a net decrease of 0.7millionprimarilyduetoareductioninstock−basedcompensation[170].−ResearchanddevelopmentcostsfortheninemonthsendedSeptember30,2024,wereapproximately4.5 million, down from 5.3million,indicatingadecreaseof0.8 million[171]. Capital and Financing - The Company increased its authorized shares from 200,000,000 to 300,000,000, approved at the annual stockholders meeting[139]. - The Company plans to redeem the March 2023 Senior Convertible Note and has entered into a securities purchase agreement for 12.0% senior secured convertible notes due 2029[142]. - The company raised 18.16millionthroughtheSeriesBPreferredStockoffering,selling12,495sharesatapurchasepriceof1,000 per share[181]. - The company issued approximately 11,634 shares of Series B-1 Preferred Stock, raising gross proceeds of 11.6million[183].−Thecompanyenteredintoacommittedequityfacilityallowingforthepurchaseofupto50 million of its common stock, with net proceeds of approximately 1.8millionraisedasofSeptember30,2024[190].−ThecompanyissubjecttofinancialcovenantsundertheMarch2023SeniorConvertibleNote,requiringavailablecashtoequalorexceed5.0 million at all times[185]. Product Development and Market Strategy - EsoGuard Esophageal DNA Test demonstrates approximately 90% sensitivity and ~99% negative predictive value for detecting esophageal precancer and cancer[128]. - EsoGuard's recent study showed sensitivity of ~88% and negative predictive value of ~99% for Barrett's Esophagus detection, with specificity at ~81%[132]. - The Company received a Notice of Allowance for a patent covering its method of using methylation of the CCNA1 gene, a key component of EsoGuard[139]. - EsoCheck is an FDA 510(k) and CE Mark cleared device for noninvasive esophageal cell sampling, enhancing the diagnostic process[129]. - The Company has developed proprietary technology for targeted esophageal cell collection, ensuring contamination-free sampling[129]. - The Company is focused on expanding its market presence in cancer prevention diagnostics, particularly for esophageal adenocarcinoma[126]. - The company plans to pursue the development of other products and services as resources permit, focusing on the commercialization of EsoGuard[179]. - The company is actively working to expand insurance reimbursement coverage for its EsoGuard Esophageal DNA Test, which is critical for revenue generation[179]. Compliance and Regulatory - The Company aims to regain compliance with Nasdaq listing standards by addressing the closing bid price issue below 1pershare[138].−TheCompanyhasincreasedthemonthlyfeeinitsmanagementservicesagreementwithPAVmedfrom0.83 million to $1.05 million[133]. - The company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note by the end of the Optional Redemption Notice Period[188].