Royal Adelaide Hospital

Received Two Australian Ethics Committee Approvals for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies; Expects to Open Patient Enrollment in October of 2024 Achieved Significant 24% Reduction in Fiscal First Quarter Operating Expenses Compared to the Same Period in 2023 Conference Call to be Held Today at 4:30 p.m. ET SAN DIEGO, Aug. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal first quarter ended June 30, 2024 and provided an update on recent developments. Company Updates Aethlon Medical is continuing the research and clinical development of its Hemopurifier ®, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology, where cancer associated exosomes may promote immune suppression and metastasis, in life-threatening infectious diseases, and in organ transplantation. As announced on August 12, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia. Earlier, on June 18, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for the same safety, feasibility and dose-finding clinical trial of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia. Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples. "During the fiscal first quarter and subsequent period, we have continued to make significant progress advancing towards our planned oncology trials in Australia and India, punctuated by the recent approval from the Bellberry Human Research Ethics Committee (BHREC), which granted full ethics approval to the Pindara Private Hospital and earlier from the Human Research Ethics Committee at Central Adelaide Local Health Network, in June, for a safety, feasibility and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical." "Going forward, the next steps are to receive approval from the Research Governance Office at each hospital, which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment in the trials may proceed. We expect that we will be open for enrollment in October 2024." Mr. Frakes continued, "We anticipate several upcoming, potential value-creating milestones, including submission to the Ethics Committees at a third site in Australia and one in site in India, with the expectation of possibly receiving approval from one or both of those hospitals in the September or December quarter of 2024. After approval is granted, we expect to be able to enroll patients at those additional sites by the end of 2024." As a reminder, the primary endpoint of the approximate 9 to 18-patient, safety, feasibility and dose-finding trial, is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies. The company continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in capturing viruses such as Zika, Lassa, MERS-CoV, cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, smallpox-related viruses, H1N1 swine flu, H5N1 bird flu, Monkeypox, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in India remains open to accommodate any potential COVID-19 admissions to the intensive care units at the two participating sites, Medanta Medicity Hospital and Maulana Azad Medical College. So far, one patient has been treated. The company is actively evaluating COVID-19 admissions and potential enrollment against the ongoing costs of maintaining the trial. Financial Results for the Fiscal First Quarter Ended June 30, 2024 As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 million. Consolidated operating expenses for the fiscal quarter ended June 30, 2024 were approximately $2.6 million compared to $3.4 million for the fiscal quarter ended June 30, 2023. This decrease of approximately $800,000, or approximately 24%, in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses and a decrease of approximately $300,000 in professional fees partially offset by an increase in payroll and related expenses of approximately $100,000. The $600,000 decrease in general and administrative expenses in the fiscal quarter ended June 30, 2024 was primarily due to a $447,000 decrease in supplies related to the purchase of raw materials for manufacturing of the Hemopurifier and for lab supplies. The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses primarily related to termination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting, and a $78,000 decrease in legal fees relating to general corporate matters. The approximate $100,000 increase in payroll and related was primarily due to an increase in separation expenses of approximately $300,000 related to the termination of an employee. That increase was offset by a decrease of $111,000 in stock-based compensation and an $89,000 decrease in general and administration personnel expense. As a result of the factors noted above, the company's net loss decreased to approximately $2.6 million in the fiscal quarter ended June 30, 2024 from approximately $3.3 million in the fiscal quarter ended June 30, 2023. The consolidated balance sheet for June 30, 2024, and the consolidated statements of operations for the fiscal quarters ended June 30, 2024 and 2023 follow at the end of this release. Conference Call Management will host a conference call today, Wednesday, August 14, 2024, at 4:30 p.m. ET to review the company's financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference by navigating to . Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741 PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through September 14, 2024. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 3788019. About Aethlon and the Hemopurifier® Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies. Additional information can be found at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital on terms favorable to the Company, or at all; the Company's ability to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility and safety of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company's ability to achieve and realize the anticipated benefits from potential milestones; the Company's ability to submit applications to, and obtain approval from, the additional Ethics Committees in Australia and India, including on the timeline expected by the Company; the Company's ability to initiate its planned oncology clinical trials in Australia and India, including on the timeline expected by the Company; the Company's ability to obtain approvals from Research Governance Offices at relevant hospitals and complete site initiation visits in a timely manner; the Company's ability to manage and successfully complete its clinical trials, if initiated; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials; unforeseen changes in regulatory requirements; the Company's ability to maintain its Nasdaq listing; and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances. Company Contact: Jim Frakes Interim Chief Executive Officer and Chief Financial Officer Aethlon Medical, Inc. [email protected] Investor Contact: Susan Noonan S.A. Noonan Communications, LLC [email protected] 917-513-5303 SOURCE Aethlon Medical, Inc.

Second Quarter Revenue Totals $7.5 Million Total Enrollment Exceeds 85% for Burn Center Pivotal U.S. Clinical Trial Q2 2024 Overview Research & Development Revenue of $7.5 MillionCash Position of $6.9 MillionOn Track to Generate First Commercial Revenues in the U.K. Later this YearBurn Pivotal Study Nearing Completion Paving the Way for U.S. FDA Submission in Early 2025Announced Collaboration with PolyNovo Ltd. Providing Introduction to Australian MarketContinued Progress in Handheld Burn Wound Diagnostic TechnologyAdded to Russell Microcap® Index effective July 1, 2024 DALLAS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the second quarter ended June 30, 2024 (“Q2 2024”) and provided an update on its ongoing business activities. “This is one of the most exciting and consequential periods in our history, and I am proud to see the teams advancing our proprietary, AI-driven DeepView™ System for burn indication (“DeepView AI- Burn”) along multiple fronts, including clinical, developmental and commercial,” said Peter M. Carlson, CEO of Spectral AI. “The upcoming completion of enrollment at burn centers for our U.S. Burn Pivotal Study, continued development of both our cart-based device and the handheld diagnostic tool, and anticipation of our first commercial revenues in the U.K. later this year validate our vison and reinforce our strategic imperatives.” CLINCIAL TRIAL UPDATES Patient enrollment for the 2024 U.S. Burn Pivotal Study continues to progress well at burn centers, where total enrollment now exceeds 85%. This pivotal study, which is designed to validate the AI-driven algorithm of DeepView AI-Burn, will be the final clinical trial before the Company seeks regulatory approval in 2025 and is one of the largest burn studies ever conducted in the United States.Building on this momentum, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for DeepView AI-Burn for use in burn centers and expects to submit the request in the second quarter of 2025. A subsequent 510k application will be made for the use of DeepView AI-Burn in emergency departments after receiving approval for use in burn centers.The Company paused patient enrollment for the U.S. DFU Clinical Validation Study at 475 subjects, having achieved sufficient enrollment for development of a robust DFU data set. Management is assessing the insights of this study while focusing on the burn indication, where the opportunity for near-term market penetration is the greatest. SELECT BUSINESS HIGHLIGHTS Product Deployment and Market Development Deployed a total of five DeepView Burn devices at facilities across the U.K. in connection with the February 2024 receipt of UKCA Authorization. These deployments will increase familiarity of the device in advance of commercialization later this year and provide real-word data that enhances the AI-algorithm.Continued to make progress in the development of DeepView SnapShot® M, a handheld diagnostic tool targeted for use in battlefield burn assessment that is based on the DeepView™ System platform. DeepView SnapShot® M is designed to be an integral part of the triage process by providing a quick and accurate wound assessment so that those with more severe burn injuries can be prioritized for treatment and evacuation. A poster presentation highlighting DeepView SnapShot® M is scheduled for the 2024 Military Health System Research Symposium (MHSRS) being held August 26-29, 2024.Signed a Memorandum of Understanding with PolyNovo Limited to support the Company’s application to the Australian Special Access Scheme to allow for the deployment of two DeepView Burn systems at the Royal Adelaide Hospital and The Alfred Hospital in Melbourne. Corporate Received the final $2.5 million principal advance under its existing standby equity purchase agreement.Added to the Russell Microcap® Index effective July 1, 2024.Continued to strengthen and protect its proprietary DeepView™ System wound assessment platform via a 30% increase in the Company’s patent portfolio to 26 granted patents from 20. The Company also announced an additional 38 pending patent applications worldwide. Q2 2024 FINANCIAL RESULTS OVERVIEWAll comparisons are to the second quarter ended June 30, 2023 (“Q2 2023”) unless otherwise stated. Research & Development Revenue 1Research & Development Revenue for Q2 2024 rose 76% to $7.5 million from $4.3 million, primarily reflecting an increased level of activity under the Company’s Project BioShield (PBS) contract with BARDA for the advanced development of the DeepView™ System. Gross Margin Gross margin for Q2 2024 improved to 44.3% from 42.1%, due to a higher reimbursement rate under the BARDA PBS Contract as compared to the rate associated with the now completed BARDA Burn II contract. General & Administrative ExpenseGeneral & administrative expenses in Q2 2024 rose to $5.8 million, or 77% of revenues, from $4.8 million, or 112% of revenues. Operating LossOperating loss narrowed to $(2.4) million from $(3.0) million. Net LossNet loss for Q2 2024 narrowed to $(2.9) million, or $(0.16) per share, as compared to a net loss of $(3.1) million, or $(0.23) per share. Financial Condition As of June 30, 2024, cash was $6.9 million as compared to $4.8 million at December 31, 2023. Cash at June 30, 2024 included $0.9 million in cash in the Company’s newly formed wholly-owned subsidiary Spectral IP, Inc. 2024 Guidance The Company reiterates its revenue guidance of approximately $28.0 million for FY 2024. Financial guidance for FY 2024 does not reflect contributions from the sale of the DeepView™ System for burn in the U.K. that is expected to begin in Q4 2024 or any additional material financial contributions that may result from the commercialization of our DeepView™ System. ________________________1Research and Development Revenue consisted primarily of funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. CONFERENCE CALL The Company will host a conference call today at 5:00 pm Eastern Time to discuss these results. Investors interested in participating in the live call can dial: 833-630-1956 – U.S.412-317-1837 – International A simultaneous webcast of the call may be accessed online from the Events & Presentations section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events. About Spectral AISpectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView™ System. The DeepView™ System is a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, the DeepView™ System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView™ System, visit www.spectral-ai.com. Forward Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Investors: The Equity Group Devin Sullivan Managing Director dsullivan@equityny.com Conor Rodriguez Analyst crodriguez@equityny.com Spectral AI, Inc.Unaudited Condensed Consolidated Balance Sheets(in thousands, except share and per share data) June 30, December 31, 2024 2023 Assets Current assets: Cash $6,877 $4,790 Accounts receivable, net 2,295 2,346 Inventory 267 230 Deferred offering costs - 283 Prepaid expenses 1,249 1,452 Other current assets 973 801 Total current assets 11,661 9,902 Non-current assets: Property and equipment, net 7 12 Right-of-use assets 2,229 778 Total Assets $13,897 $10,692 Commitments and contingencies (Note 8) Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable $2,403 $2,683 Accrued expenses 2,733 4,300 Deferred revenue 1,315 2,311 Lease liabilities, short-term 224 853 Notes payable - 436 Notes payable - at fair value 7,001 - Notes payable - related party 1,000 - Warrant liabilities 1,450 1,818 Total current liabilities 16,126 12,401 Lease liabilities, long-term 2,036 - Total Liabilities 18,162 12,401 Stockholders’ Deficit Preferred stock ($0.0001 par value); 1,000,000 shares authorized; no shares issued and outstanding as of June 30, 2024 and December 31, 2023 - - Common stock ($0.0001 par value); 80,000,000 shares authorized; 17,606,367 and 16,294,935 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 2 2 Additional paid-in capital 34,580 31,065 Accumulated other comprehensive income 10 12 Accumulated deficit (38,857) (32,788)Total Stockholders’ Deficit (4,265) (1,709)Total Liabilities and Stockholders’ Deficit $13,897 $10,692 The accompanying notes are an integral part of these condensed consolidated financial statements Spectral AI, Inc. Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Research and development revenue $7,478 $4,251 $13,804 $9,329 Cost of revenue (4,164) (2,460) (7,545) (5,357)Gross profit 3,314 1,791 6,259 3,972 Operating costs and expenses: General and administrative 5,756 4,782 10,844 9,861 Total operating costs and expenses 5,756 4,782 10,844 9,861 Operating loss (2,442) (2,991) (4,585) (5,889) Other income (expense): Net interest (expense) income (6) 42 8 86 Borrowing related costs (699) - (975) - Change in fair value of warrant liability 348 (81) 368 (65)Change in fair value of notes payable (167) - (101) -Foreign exchange transaction (loss) gain, net (9) - (25) 13 Other income (expenses), including transactions costs 180 - (668) (738)Total other expense, net (353) (39) (1,393) (704) Loss before income taxes (2,795) (3,030) (5,978) (6,593)Income tax provision (69) (40) (91) (86)Net loss $(2,864) $(3,070) $(6,069) $(6,679)Net loss per share of common stock Basic and Diluted $(0.16) $(0.23) $(0.36) $(0.51)Weighted average common shares outstanding Basic and Diluted 17,598,357 13,210,320 17,079,328 13,200,515 Other comprehensive income (loss): Foreign currency translation adjustments $- $2 $(2) $3 Total comprehensive loss $(2,864) $(3,068) $(6,071) $(6,676) The accompanying notes are an integral part of these condensed consolidated financial statements Spectral AI, Inc.Unaudited Condensed Consolidated Statements of Cash Flows(in thousands, except share and per share data) Six Months EndedJune 30, 2024 2023 Cash flows from operating activities: Net loss $(6,069) $(6,679)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 5 5 Stock-based compensation 685 696 Amortization of right-of-use assets 320 350 Change in fair value of warrant liabilities (368) 65 Change in fair value of notes payable 101 - Costs from issuance of common stock 372 - Changes in operating assets and liabilities: Accounts receivable 51 774 Inventory (37) - Unbilled revenue - 527 Prepaid expenses 203 (11)Other assets (172) (322)Accounts payable (206) (752)Accrued expenses (1,567) (405)Deferred revenue (996) 509 Lease liabilities (364) (284)Net cash used in operating activities (8,042) (5,527)Cash flows from financing activities: Proceeds from issuance of common stock 2,667 - Proceeds from notes payable 9,200 - Proceeds from notes payable - related party 1,000 - Payments of deferred offering costs - (306)Payments for notes payable (2,736) (175)Stock option exercises - - Net cash provided by (used in) financing activities 10,131 (481)Effect of exchange rate changes on cash (2) - Net increase (decrease) in cash 2,087 (6,008)Cash, beginning of period 4,790 14,174 Cash, end of period $6,877 $8,166 Supplemental cash flow information: Cash paid for interest $- $(3)Cash paid for taxes $- $- Noncash operating and financing activities disclosure: Recognition of Right-of-use assets and related lease liabilities upon lease amendment $1,771 $483 Unpaid deferred offering costs $- $818 Broker receivable for stock option exercises $- $6

Bellberry Human Research Ethics Committee Granted Full Ethics Approval to the Pindara Private Hospital for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies SAN DIEGO, Aug. 12, 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, on August 6, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia. "We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application. Dr. Matos and his research team have a proven track record of enrollment in device trials in oncology patients that provides momentum to these trials," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "This is the second ethics committee approval we have received for our oncology trial in Australia after receiving approval from the ethics committee for Royal Adelaide Hospital in June." Dr. LaRosa continued, "The next step is to receive approval from the Research Governance Office at each hospital which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment may proceed." Currently, only approximately 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes in cancer patient plasma samples. The primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 therapy will be eligible to enter the Hemopurifier period of the study, where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies. About Aethlon and the Hemopurifier® Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies. Additional information can be found at . Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility and safety of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials; the Company's ability to obtain the approval by the respective Ethics Boards of interested clinical trial sites in India and in Australia; the Company's ability to obtain approvals from Research Governance Offices at relevant hospitals and complete site initiation visits in a timely manner; the Company's ability to recruit patients for and manage its clinical trials and studies; unforeseen changes in regulatory requirements; and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances. Company Contact: Jim Frakes Interim Chief Executive Officer and Chief Financial Officer Aethlon Medical, Inc. [email protected] Investor Contact: Susan Noonan S.A. Noonan Communications, LLC [email protected] 917-513-5303 SOURCE Aethlon Medical, Inc.