Financial Performance - Consolidated operating expenses for Q2 2024 were 2,620,858,adecreaseof787,302 or 23.1% compared to 3,408,716inQ22023[107].−NetlossforQ22024decreasedto2,571,440 from 3,282,179inQ22023,withbasicanddilutedlosspershareimprovingto(0.34) from (1.35)[111].−Asignificantdecreaseingeneralandadministrativeexpensesof556,309 was attributed to reduced supply costs and other operational efficiencies[107]. - For the three months ended June 30, 2024, expenses decreased by approximately 787,000comparedtothesameperiodin2023,withcashusedinoperatingandinvestingactivitiesdecreasingbyapproximately964,000[114]. - Net cash used in operating activities was approximately 1,748,000forthethreemonthsendedJune30,2024,adecreaseof734,000 from 2,482,000inthesameperiodin2023[129].−Thecompanyanticipatescontinuingtoincurincreasingnegativecashflowsandnetlossesfortheforeseeablefuture,necessitatingadditionalcapitalraises[132].LiquidityandCapitalRaising−CashbalanceasofJune30,2024,was9,072,379, up from 5,441,978atMarch31,2024,indicatingimprovedliquidity[112].−ThecompanyclosedapublicofferingonMay17,2024,raisingapproximately4.7 million in gross proceeds, with net proceeds around 3.5millionafterexpenses[113].−AsofJune30,2024,thecompanyraised5,379,229 net through equity offerings and warrant exercises, alleviating substantial doubt about its ability to continue as a going concern[114]. - The company raised approximately 5,384,000fromfinancingactivitiesduringthethreemonthsendedJune30,2024,primarilyfromthesaleandissuanceofcommonstockandwarrants[130].−ThegrossproceedsfromtheMay2024publicofferingwereapproximately4.7 million, with net proceeds of approximately 3.5millionafterdeductingfeesandexpenses[125].−AsofJune30,2024,5,302,617 of 2022 ATM Shares remained available for sale under the 2022 ATM Agreement[118]. - The Class A and Class B warrants from the May 2024 offering have an exercise price of $0.58 per share and are immediately exercisable[123]. Clinical Development - The Hemopurifier has received FDA designation as a "Breakthrough Device" for treating advanced cancer and life-threatening viral infections[90]. - Clinical trials for the Hemopurifier are planned in Australia and India, with ethics approvals obtained for trials involving solid tumors[93][101]. - The company is investigating the use of the Hemopurifier in organ transplant settings to reduce complications from viral infections[103]. - The company is working with NAMSA to manage clinical trials for the Hemopurifier in oncology indications in the U.S. and Australia[92]. - The Hemopurifier has shown potential in capturing various viruses in vitro, including HIV, Ebola, and Zika virus, indicating broad therapeutic applications[96]. - The company expects clinical trial expenses for planned oncology trials in Australia and India to increase for the foreseeable future[131]. Legal and Compliance Risks - The company has identified a material weakness in internal control over financial reporting and is actively implementing measures to remediate it[140]. - The company is not currently involved in any pending or threatened legal proceedings[143]. - Claims made against the company in the ordinary course of business may lead to litigation[143]. - Unfavorable outcomes from litigation could result in monetary damages, fines, or penalties[143]. - The occurrence of adverse outcomes could materially affect the company's operational results[143]. - The company acknowledges the inherent uncertainties associated with litigation[143]. - Potential injunctions could prohibit the company from selling certain products or engaging in specific activities[143]. - The impact of legal proceedings may affect future periods' results of operations[143]. - The company is monitoring claims and litigation risks as part of its business strategy[143]. - Legal proceedings are considered a normal risk in the company's business operations[143]. - The company remains vigilant in managing potential legal challenges[143].