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Aethlon Medical Enters Into Materials Transfer Agreement for Santersus AG's NucleoCapture and HemoNucleoCapture Devices
Prnewswire· 2024-02-21 13:01
Aethlon Medical Will Perform Pre-Clinical Studies to Explore Potential Synergies With its First-in-Class Hemopurifier® Blood Filtration System SAN DIEGO, Feb. 21, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that it entered into a Materials Transfer Agreement (MTA) with Santersus AG, a Zurich-London based, privately held therapeutic medical device company, for ...
Aethlon Medical(AEMD) - 2024 Q3 - Earnings Call Transcript
2024-02-15 02:17
Financial Data and Key Metrics Changes - As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8 million, with an additional $236,000 raised through common stock sales under the at-the-market program [13] - Consolidated operating expenses for the three months ended December 31, 2023, were approximately $3.6 million, an increase of 25.2% from $2.8 million for the same period in 2022 [14] - The company's net loss increased to $3.6 million for the three months ended December 31, 2023, compared to $2.8 million for the same period in 2022 [17] Business Line Data and Key Metrics Changes - The increase in operating expenses was primarily due to a rise in payroll and related expenses, which increased by approximately $871,000, largely attributed to separation expenses for the former CEO [15] - General and administrative expenses decreased by approximately $92,000, mainly due to a reduction in clinical trial expenses [16] Market Data and Key Metrics Changes - The company is conducting a COVID-19 trial in India with one patient treated to date, and the trial remains open for enrollment as new COVID-19 cases arise [8][31] - The oncology program is set to begin trials in India and Australia, with three interested sites in Australia and one in India awaiting approval from ethics committees [10][11] Company Strategy and Development Direction - Aethlon Medical received clearance from the Drug Controller General of India to conduct a Phase I trial of the Hemopurifier in patients with solid tumors [6] - The focus is on oncology and reducing expenses, with plans to publish articles on preclinical organ transplantation data [9] Management's Comments on Operating Environment and Future Outlook - Management noted that the results from the internal data on the Hemopurifier are inconclusive, prompting engagement with third-party laboratories for independent assays [8] - The company is poised for site activation for oncology trials once in vitro studies are completed, indicating readiness to advance research efforts [11] Other Important Information - The company plans to file its quarterly report on Form 10-Q following the call, with the next earnings call scheduled for June 2024 [17] Q&A Session Summary Question: Will an uptick in COVID cases ease patient enrollment in trials in India? - Management indicated that if critically ill patients are admitted to ICUs, enrollment would be possible [19][21] Question: Are there sufficient Hemopurifiers for clinical efforts? - Management confirmed that there are enough Hemopurifiers for planned oncology trials, but a massive outbreak could pose challenges [22][23] Question: Will there be any one-off costs spilling into the fourth quarter? - Management stated that all one-off costs related to the former CEO's separation have been accrued in the December quarter [24][25] Question: How will patients be involved in the oncology trial? - Plasma samples from cancer patients who have consented will be used for preclinical studies [26][27] Question: How many patients are currently enrolled in the COVID study? - One patient has been enrolled to date, with a maximum of 15 patients allowed in the study [30][31] Question: What is the status of the organ transplant progress? - Management confirmed ongoing collaboration with 34 Life and plans to publish findings from organ transplantation studies [39][40]
Aethlon Medical Announces Fiscal Third Quarter Financial Results and Provides Corporate Update
Prnewswire· 2024-02-14 21:15
Core Viewpoint - Aethlon Medical, Inc. reported its financial results for the fiscal third quarter ended December 31, 2023, and provided updates on its ongoing research and clinical development efforts, particularly focusing on its Hemopurifier technology aimed at treating cancer and life-threatening infectious diseases [1][7]. Company Updates - Aethlon Medical is advancing the clinical development of its Hemopurifier, a blood filtration system designed to remove harmful exosomes and viruses, with potential applications in oncology and organ transplantation [2]. - The company received clearance from the Drug Controller General of India to conduct a phase 1 trial of the Hemopurifier in patients with solid tumors undergoing anti-PD-1 therapy [3]. - Aethlon is also maintaining its position in treating life-threatening viral infections through a COVID-19 trial in India, with one patient treated so far [5]. - The interim CEO emphasized a focus on the oncology program and cost reduction, with plans to publish preclinical data related to organ transplantation [6]. Financial Results - As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million [7]. - Consolidated operating expenses for the third quarter were approximately $3.6 million, a 25.2% increase from $2.8 million in the same period in 2022, primarily due to increased payroll expenses [7][8]. - The net loss for the quarter increased to $3.6 million from $2.8 million year-over-year [9]. - The company reported a decrease in general and administrative expenses, but increases in payroll and related expenses, leading to a net loss of $3.6 million for the quarter [8][9].
Aethlon Medical(AEMD) - 2024 Q3 - Quarterly Report
2024-02-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to_____ COMMISSION FILE NUMBER 001-37487 Aethlon Medical, Inc. (Exact name of registrant as specified in its charter) NEVADA 13-3632859 (State or othe ...
Aethlon Medical(AEMD) - 2024 Q2 - Quarterly Report
2023-11-13 16:00
Financial Performance - Consolidated operating expenses for Q3 2023 were $3,175,346, a decrease of 13.4% from $3,665,309 in Q3 2022[95] - Net loss for Q3 2023 decreased to $3,036,891, compared to $3,807,430 in Q3 2022, with a basic and diluted loss per share of ($1.22) versus ($1.84) in the prior year[98] - For the six months ended September 30, 2023, operating expenses were $6,583,506, a slight increase of 0.2% from $6,573,045 in the same period of 2022[101] - The net loss for the six months ended September 30, 2023, was $6,320,064, down from $6,715,166 in the prior year, with a basic and diluted loss per share of ($2.57) compared to ($3.70)[105] Cash and Working Capital - As of September 30, 2023, the company had a cash balance of $10,175,920 and working capital of $8,776,783, down from $14,532,943 and $13,585,477 respectively at March 31, 2023[106] - Net cash used in operating activities was approximately $5,187,000 for the six months ended September 30, 2023, a decrease of $420,000 compared to $5,607,000 for the same period in 2022, primarily due to a decrease in net loss[112] - The company used approximately $237,000 in investing activities during the six months ended September 30, 2023, down from approximately $780,000 in the same period in 2022, reflecting reduced equipment purchases[115] - Net cash provided by financing activities was approximately $1,068,000 for the six months ended September 30, 2023, compared to $8,919,000 for the same period in 2022, indicating a significant decrease in capital raised[116] Clinical Trials and Product Development - The Hemopurifier is designated as a "Breakthrough Device" by the FDA for treating advanced cancer and life-threatening viral infections[80] - A clinical trial for the Hemopurifier in Australia is set to begin, focusing on patients with solid tumors, including head and neck and gastrointestinal cancers[81] - The company has received clearance from the Drug Controller General of India to conduct a Phase 1 trial of the Hemopurifier in patients with solid tumors[88] - The company is investigating the use of the Hemopurifier in organ transplant settings to remove harmful viruses and exosomes from recovered organs[89] - Clinical trial expenses decreased by $537,570 in the six months ended September 30, 2023, but the company expects these expenses to increase in the future as clinical trials expand[117] Future Outlook and Risks - The company is closely monitoring the impact of inflation, recent bank failures, and the war in Ukraine on its business and financial condition[91] - Future capital requirements will depend on various factors, including progress in clinical trials and regulatory approvals, with expectations of continued negative cash flows and net losses[118] Legal and Compliance - There have been no changes in internal control over financial reporting that materially affected the company's financial reporting during the last fiscal quarter[124] - The company is not currently a party to any pending or threatened legal proceedings, which could have a material adverse effect on future operations[126]
Aethlon Medical(AEMD) - 2024 Q1 - Quarterly Report
2023-08-09 16:00
Financial Performance - Total current assets decreased from $15,090,566 as of March 31, 2023, to $13,307,957 as of June 30, 2023, a decline of approximately 11.8%[10] - Total liabilities increased from $2,444,731 as of March 31, 2023, to $2,691,692 as of June 30, 2023, representing an increase of about 10.1%[11] - Operating expenses for the three months ended June 30, 2023, were $3,408,160, up from $2,906,081 for the same period in 2022, reflecting a year-over-year increase of approximately 17.2%[14] - The net loss for the three months ended June 30, 2023, was $3,282,179, compared to a net loss of $2,906,081 for the same period in 2022, indicating an increase in loss of about 12.9%[14] - Basic and diluted net loss per share attributable to common stockholders was $0.14 for the three months ended June 30, 2023, compared to $0.19 for the same period in 2022, showing an improvement of approximately 26.3%[14] - Cash and cash equivalents decreased from $14,532,943 as of March 31, 2023, to $12,897,734 as of June 30, 2023, a reduction of about 11.3%[10] - Total stockholders' equity decreased from $15,064,209 as of March 31, 2023, to $13,108,897 as of June 30, 2023, a decline of approximately 13.0%[12] - The accumulated deficit increased to $(145,640,734) as of June 30, 2023, compared to $(142,358,555) as of March 31, 2023, reflecting an increase of about 2.4%[12] Cash Flow and Financing - Cash used in operating activities for the three months ended June 30, 2023, was $2,482,387, a decrease from $2,728,917 in the same period of 2022, indicating improved cash management[19] - Proceeds from the issuance of common stock, net, amounted to $1,086,119 for the three months ended June 30, 2023, compared to $619,442 in the same period of 2022, reflecting a 75% increase in financing activities[19] - Cash and restricted cash at the end of the period was $12,985,240, down from $15,009,281 at the end of June 30, 2022, indicating a decrease in liquidity[19] - The company raised net proceeds of $1,086,119 from the sale of 1,778,901 shares at an average price of $0.61 per share during the three months ended June 30, 2023[44] - Management expects existing cash as of June 30, 2023, to be sufficient to fund operations for at least twelve months[36] Research and Development - The company is preparing to conduct clinical trials in Australia for the Hemopurifier, which has been designated as a "Breakthrough Device" by the FDA for treating advanced cancer and life-threatening viral infections[21] - Aethlon Medical has received ethics review board approval for a COVID-19 clinical trial in India, with one patient already completing participation[27] - The company is investigating the use of the Hemopurifier in organ transplant settings, aiming to reduce complications post-transplantation[28] - Research and development expenses for the three months ended June 30, 2023, were $678,922, a decrease from $858,347 in the same period of 2022[40] Operational Challenges - The company is experiencing a disruption in Hemopurifier supply due to expired inventory and is awaiting FDA approval for new suppliers, which may impact future operations[26] - The company has classified $87,506 as restricted cash on its balance sheet to comply with lease terms[37] - The company is closely monitoring the impact of inflation, recent bank failures, and geopolitical events on its business and capital access[30] Stock and Compensation - The weighted average number of common shares outstanding increased from 15,486,621 for the three months ended June 30, 2022, to 24,314,759 for the same period in 2023, an increase of about 57.1%[14] - The company recorded stock-based compensation expenses of $250,114 for the three months ended June 30, 2023, compared to $215,437 for the same period in 2022[54] - The basic and diluted loss per common share attributable to stock-based compensation expense was $(0.01) for both the three months ended June 30, 2023 and 2022[54] - The company has approximately $1,719,000 of unrecognized compensation cost related to share-based payments expected to be recognized over a weighted average period of 1.84 years[60] Lease and Rent Expenses - The company reported a right-of-use lease asset of $1,086,108 as of June 30, 2023, down from $1,151,909 as of March 31, 2023[10] - Rent expense for the three-month period ended June 30, 2023, was approximately $105,000, compared to $140,000 for the same period in 2022, indicating a decrease of about 25%[66] - The current monthly base rent under the office and laboratory lease is $13,772, while the manufacturing lease is $12,080[64] Legal and Compliance - The company is not currently involved in any litigation or pending legal proceedings[67]
Aethlon Medical(AEMD) - 2023 Q4 - Annual Report
2023-06-27 16:00
Financial Performance - The company recorded government contract revenue of $574,245 for the fiscal year ended March 31, 2023, compared to $294,165 for the fiscal year ended March 31, 2022, representing an increase of $280,080[301]. - Consolidated operating expenses increased to $12,472,883 for the fiscal year ended March 31, 2023, from $10,715,050 for the fiscal year ended March 31, 2022, an increase of $1,757,833[306]. - The net loss before noncontrolling interests increased to $12,029,786 for the fiscal year ended March 31, 2023, from $10,420,885 for the fiscal year ended March 31, 2022[308]. - The company reported a net cash used in operating activities of approximately $10,505,000 for fiscal 2023, an increase of approximately $738,000 compared to $9,767,000 in fiscal 2022[326]. - The company raised approximately $8,915,000 from financing activities in fiscal 2023, a decrease from $17,368,000 in fiscal 2022[327]. Cash and Capital Management - As of March 31, 2023, the company had a cash balance of $14,532,943 and working capital of $13,585,477, compared to $17,072,419 and $16,332,958, respectively, at March 31, 2022[309]. - The company anticipates continued negative cash flows and net losses for the foreseeable future, necessitating additional capital raises through equity and/or debt financing[320]. - The company expects future capital requirements to depend on various factors, including progress with clinical trials and regulatory approvals[320]. - The company has no obligation to sell any shares under the 2022 ATM Agreement, and sales can be suspended or terminated at any time[317]. - In the fiscal year ended March 31, 2023, the company raised net proceeds of $8,927,211 from the sale of 7,480,836 shares at an average price of $1.19 per share under the 2022 ATM Agreement[313]. - The company raised net proceeds of $1,086,119 from the sale of 1,778,901 shares at an average price of $0.61 per share under the 2022 ATM Agreement[340]. - The company raised approximately $11,659,044 from the sale of 1,380,555 shares at a purchase price of $9.00 per share in a registered direct financing during fiscal 2022[318]. Clinical Trials and Research - The company entered into an agreement with NAMSA to oversee clinical trials for the Hemopurifier in oncology indications, with initial trials anticipated to begin in Australia[289]. - The FDA approved a supplement to the company's open IDE for the Hemopurifier to test it in patients with COVID-19, with a study designed to enroll up to 40 subjects[292]. - The company launched a wholly owned subsidiary in Australia to conduct clinical research and seek regulatory approval for the Hemopurifier[293]. - The company is investigating the use of the Hemopurifier in organ transplant settings to potentially reduce complications following transplantation[295]. - Clinical trial expenses for the preparation of the planned oncology trial in Australia were $103,602 in fiscal 2023, with expectations for continued increases in these expenses[319]. - The company terminated its subaward arrangement with the University of Pittsburgh due to inability to recruit patients for the clinical trial[305]. Operational Challenges - The company is monitoring the impact of inflation, recent bank failures, and the war in Ukraine on its business and capital access[299]. - Rent expense increased by $117,772 in fiscal 2023, with expectations for further increases in the foreseeable future[319]. Director Compensation - In April 2023, three non-employee directors were granted 116,279 RSUs each, priced at $0.43 per share, under the Director Compensation Policy[341]. - The RSUs granted to directors are subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2023, and March 31, 2024[341].
Aethlon Medical(AEMD) - 2023 Q3 - Quarterly Report
2023-02-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to_____ COMMISSION FILE NUMBER 001-37487 AETHLON MEDICAL, INC. (Exact name of registrant as specified in its charter) NEVADA 13-3632859 (State or othe ...
Aethlon Medical(AEMD) - 2023 Q2 - Quarterly Report
2022-11-13 16:00
Financial Performance - Total assets increased to $23.05 million as of September 30, 2022, compared to $19.42 million as of March 31, 2022, representing a growth of approximately 18.5%[6] - Total current assets rose to $20.50 million, up from $18.16 million, marking an increase of about 12.9%[6] - Total liabilities increased to $3.18 million from $2.43 million, reflecting a rise of approximately 31%[7] - Net loss for the three months ended September 30, 2022, was $3.81 million, compared to a net loss of $2.01 million for the same period in 2021, indicating an increase in losses of about 89.1%[10] - Operating expenses for the three months ended September 30, 2022, totaled $3.67 million, up from $2.14 million in the prior year, representing an increase of approximately 71%[10] - Basic loss per share for the three months ended September 30, 2022, was $0.18, compared to $0.13 for the same period in 2021, reflecting a deterioration in per-share performance[10] - Weighted average number of common shares outstanding increased to 20,744,999 for the three months ended September 30, 2022, compared to 15,386,486 in the same period last year, an increase of approximately 35%[10] - For the six months ended September 30, 2022, the net loss was $6,715,166 compared to a net loss of $4,107,242 for the same period in 2021, representing an increase of approximately 63.5%[16] - Cash flows used in operating activities for the six months ended September 30, 2022, totaled $5,607,298, an increase from $3,949,961 in the prior year[16] - The company reported stock-based compensation of $528,975 for the six months ended September 30, 2022, compared to $321,216 in the same period of 2021, reflecting a 64.7% increase[16] Cash and Equity - Cash balance as of September 30, 2022, was $19.60 million, up from $17.07 million as of March 31, 2022, indicating a growth of about 14.8%[6] - Total stockholders' equity increased to $19.87 million as of September 30, 2022, from $16.99 million, representing an increase of approximately 16.5%[8] - The cash and restricted cash at the end of the period was $19,691,531, down from $23,271,651 at the end of the same period in 2021[18] - The company raised net proceeds of $8,927,211 from the sale of 7,480,836 shares at an average price of $1.19 per share under the 2022 ATM Agreement[42] Research and Development - The company is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device for treating cancer and life-threatening viral infections[20] - The Hemopurifier has received FDA designation as a "Breakthrough Device" for treating advanced or metastatic cancer and life-threatening viruses[20] - The company is conducting a clinical trial for the Hemopurifier in patients with advanced and metastatic head and neck cancer, with initial focus on solid tumors[21] - The FDA approved the Investigational Device Exemption for an Early Feasibility Study of the Hemopurifier in combination with pembrolizumab, with a primary endpoint of safety[22] - The study at UPMC Hillman Cancer Center has treated two patients to date, but has been terminated due to lack of further patient enrollment[22] - The Hemopurifier has been used in small-scale human studies to treat infections from HIV, hepatitis-C, and Ebola, and has shown efficacy in capturing various viruses in vitro[23] - The FDA approved a supplement for the Hemopurifier to test its efficacy in COVID-19 patients, with a study designed to enroll up to 40 subjects across 20 centers in the U.S.[24] - A short-term disruption in Hemopurifier supply occurred as the existing supply expired on September 30, 2022, pending FDA approval for a new supplier[26] Operational Costs - Research and development expenses for the three months ended September 30, 2022, were $852,464, compared to $478,201 for the same period in 2021, reflecting a year-over-year increase of 78.2%[37] - Accrued professional fees as of September 30, 2022, were $741,529, indicating ongoing operational costs[48] - The company incurred total rent expense of approximately $309,000 and $167,000 for the six-month periods ended September 30, 2022, and 2021, respectively, reflecting an increase of 84.4%[75] Corporate Developments - The company dissolved its majority-owned subsidiary, Exosome Sciences, Inc., as of September 30, 2022, which had limited activities for over four years[27] - Aethlon Medical launched a wholly-owned subsidiary in Australia in October 2022, focusing initially on the oncology market[79] - The company provided a 30-day termination notice to the CRO in November 2022 due to lack of patient enrollment and delays in FDA approval[78] - Aethlon entered into a CRO Agreement on September 29, 2021, to manage clinical studies for the Hemopurifier, specifically targeting critically ill COVID-19 patients[78] - The CRO Agreement has a five-year term but can be terminated by Aethlon with a 30-day notice due to lack of patient enrollment and FDA approval delays[78] Market and Economic Conditions - The company is monitoring the impact of the COVID-19 pandemic, inflation, and the war in Ukraine on its business and capital access[29]
Aethlon Medical(AEMD) - 2023 Q1 - Quarterly Report
2022-08-08 16:00
Financial Performance - Total current assets decreased from $18,157,007 as of March 31, 2022, to $15,893,911 as of June 30, 2022, representing a decline of approximately 7%[9] - Total liabilities decreased from $2,426,554 as of March 31, 2022, to $2,212,020 as of June 30, 2022, a reduction of about 9%[10] - The company reported no revenue for the three months ended June 30, 2022, compared to $131,966 in government contract revenue for the same period in 2021, indicating a 100% decrease[14] - Total operating expenses increased from $2,230,404 in Q2 2021 to $2,906,081 in Q2 2022, reflecting an increase of approximately 30%[14] - The net loss attributable to Aethlon Medical for the three months ended June 30, 2022, was $2,905,668, compared to a net loss of $2,097,303 for the same period in 2021, representing an increase of about 38%[14] - Basic loss per share for Q2 2022 was $0.19, compared to $0.16 for Q2 2021, indicating a deterioration in earnings per share[14] - Total operating losses for the three months ended June 30, 2022, were $(2,906,081), an increase from $(2,098,438) in the same period of 2021[72] - Net losses before non-controlling interests for the three months ended June 30, 2022, were $(2,906,081), compared to $(2,098,438) for the same period in 2021[72] Cash Flow and Liquidity - Cash flows used in operating activities for the three months ended June 30, 2022, were $2,728,917, compared to $2,071,828 for the same period in 2021, an increase of approximately 32%[20] - The company had cash and cash equivalents of $14,921,775 as of June 30, 2022, down from $17,072,419 as of March 31, 2022, a decrease of about 13%[9] - The company reported a net cash decrease of $2,150,644, resulting in cash and restricted cash at the end of the period totaling $15,009,281[21] - Cash balance as of June 30, 2022, was $14,921,775, down from $17,072,419 at March 31, 2022, indicating a decrease of 12.6%[115] - Cash used in operating activities was approximately $2,729,000 for the three months ended June 30, 2022, compared to $2,072,000 for the same period in 2021, reflecting an increase of $657,000[120] Shareholder Equity and Stock Information - Total stockholders' equity decreased from $16,991,400 as of March 31, 2022, to $14,920,198 as of June 30, 2022, a decline of about 12%[11] - The weighted average number of common shares outstanding increased from 12,828,816 in Q2 2021 to 15,486,621 in Q2 2022, an increase of approximately 21%[14] - The weighted average number of common shares outstanding increased to 15,486,621 for the three months ended June 30, 2022, from 12,828,816 in the prior year[54] - The company raised net proceeds of $619,442 from the sale of 574,560 shares at an average price of $1.08 per share under the 2022 ATM Agreement[45] - The company raised net proceeds of $8,307,769 through the sale of 6,906,276 shares at an average price of $1.20 per share under the 2022 ATM Agreement[85] Research and Development - Research and development expenses for the three months ended June 30, 2022, were $858,347, compared to $587,687 for the same period in 2021, reflecting a 46% increase[41] - The company has initiated a clinical trial for the Hemopurifier in patients with advanced and metastatic head and neck cancer, with a primary endpoint focused on safety[27] - The company is conducting a New Feasibility Study for the Hemopurifier in COVID-19 patients, with a target enrollment of up to 40 subjects across 20 centers in the U.S.[29] - The company has entered into an agreement with PPD, Inc. to oversee U.S. clinical studies for the Hemopurifier in critically ill COVID-19 patients[31] - Clinical trial expenses increased by $161,262 in the three months ended June 30, 2022, and are expected to continue to rise in the foreseeable future[123] Regulatory and Market Challenges - The Hemopurifier has received FDA designation as a "Breakthrough Device" for treating advanced cancer and life-threatening viral infections[25] - The FDA approved a study for the Hemopurifier in COVID-19 patients, with the first patient enrolled in June 2022[94] - The company needs to secure large-scale manufacturing agreements to commercialize its Hemopurifier product, which requires compliance with good manufacturing practice standards[133] - The Hemopurifier product candidate may become unmarketable due to new scientific developments by competitors, which could render the technology obsolete[134] - Extensive government regulations related to development, testing, and commercialization could delay or prevent the commercialization of the Hemopurifier product[134] Future Outlook and Funding Needs - The company expects existing cash to be sufficient to fund operations for at least twelve months from the issuance date of the financial statements[37] - Company expects to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital through equity and/or debt financing[124] - Substantial additional funding will be required to sustain operations, with potential delays or reductions in research and development if capital cannot be raised on favorable terms[133] - Significant expansion of operations will be necessary to implement long-term business plans and growth strategies, which may strain management and resources[136] - Successful commercial development of the Hemopurifier product depends on completing studies and obtaining regulatory approvals, with delays jeopardizing approval[136] Management and Governance - The company is not currently a party to any pending or threatened legal proceedings, but claims could arise in the ordinary course of business[131] - There have been no changes in internal control over financial reporting that materially affect the company's reporting[129] - The company may face challenges in attracting and retaining executive management and directors due to limited financial resources[134]