Central Adelaide Local Health Network, Inc.

Conference Call to be Held Today at 4:30 p.m. ET SAN DIEGO, June 27, 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 year ended March 31, 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, and in life-threatening infectious diseases. Aethlon is also investigating the use of the Hemopurifier in the organ transplant setting, initially focusing on the potential removal of viruses and exosomes with harmful cargo from recovered kidneys. As announced on June 18, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's 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 exosomes from the plasma of cancer patient samples. "During the fourth quarter and subsequent period, we have continued to make significant progress advancing towards our planned, safety, feasibility and dose finding oncology trials in Australia and India, punctuated by the recent approval from the Human Research Ethics Committee at Central Adelaide Local Health Network," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "Upon submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit, we expect that we will be able to enroll and treat the first patient either in the September quarter or in the December quarter. "It is also worth noting that in April 2024, the U.S. Food and Drug Administration (FDA) approved our internal manufacturing facility." Mr. Frakes continued, "We anticipate several upcoming, potential value-creating milestones, including submission to the Ethics Committees at two additional sites in Australia and one in India, with the expectation of possibly receiving approval from one or more of those three hospitals in the September quarter of 2024, after which, 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 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 is also maintaining a position in the use of its Hemopurifier as a treatment against life-threatening viral infections through its COVID-19 trial in India. There are two participating sites for this trial -- the Medanta Medicity Hospital and Maulana Azad Medical College (MAMC). One patient has been treated thus far. However, the company has been informed by its contract research organization that a new COVID-19 subvariant was recently detected in India. The COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care units at the two participating sites. The company has also received multiple inquiries regarding the current, multi-state outbreak of H5N1 Avian Influenza (H5N1 HPAI) virus in dairy cattle. While the Hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in invitro experiments, the company has not tested the Hemopurifier against the current strain nor have there been many cases of the current strain infecting humans. The company will continue to monitor the situation and provide any potential updates, as needed. Financial Results for the Fiscal Year Ended March 31, 2024 As of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million and as of June 25, 2024, had a cash balance of approximately $9.1 million. Consolidated operating expenses for the fiscal year ended March 31, 2024 were approximately $12.6 million, compared to approximately $12.5 million for the fiscal year ended March 31, 2023, an increase of approximately $164,000. This increase in the fiscal year ended March 31, 2024 was due to an increase in payroll and related expenses of approximately $763,000, partially offset by decreases in general and administrative expenses of approximately $578,000 and in professional fees of approximately $21,000. The approximate $763,000 increase in payroll and related expenses was primarily due to separation expenses for the company's former chief executive officer of $862,000 and an increase of $127,000 associated with an increase in average headcount, partially offset by a decrease in stock-based compensation of $226,000. The approximate $578,000 decrease in general and administrative expenses was primarily driven by the following: a decrease of $819,000 in clinical trial expenses related to the closed U.S. COVID-19 clinical trial, a decrease of $280,000 in subcontract expense related to contracts and grants with the National Institutes of Health, a $99,000 decrease in rent expense associated with a mobile clean room leased in the prior year, a decrease of $30,000 in travel related expenses associated with a former remote employee and a decrease of $22,000 in expenses related to various other general office operating expenses. These decreases were partially offset by an increase of $405,000 in manufacturing and research and development supplies related to the manufacturing of the company's Hemopurifier device and various research and development activities. Other increases included $118,000 in depreciation expense and amortization expense related to leasehold improvements to manufacturing space, a $70,000 increase in insurance expenses to include medical, D&O and liability, and an increase of $82,000 primarily related to the company's manufacturing facility, encompassing equipment maintenance, utilities, and outside services. The approximate $21,000 decrease in professional fees was primarily due to a decrease in outside scientific, product research and regulatory services of $303,000, a decrease of $60,000 in recruiting fees and a $33,000 decrease in legal fees. These decreases were partially offset by increases in investor relations of $151,000, accounting fees of $137,000, board of director fees of $34,000 and outside operational and administration expenses of $53,000. As a result of the factors noted above, the company's net loss increased to $12.2 million for the fiscal year ended March 31, 2024, from $12.0 million for the fiscal year ended March 31, 2023. The consolidated balance sheet for March 31, 2024, and the consolidated statements of operations for the fiscal years ended March 31, 2024 and 2023 follow at the end of this release. Conference Call Management will host a conference call today, Thursday, June 27, 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 who are 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 July 27, 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 6876352. 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 and to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility 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 timing expected by the Company; the Company's ability to initiate its planned oncology clinical trials in Australia and India, including on the timing expected by the Company; the Company's ability to manage and successfully complete its clinical trials, if initiated; the potential impact of Hemopurifier on the H5N1 Avian Influenza (H5N1 HPAI) virus in dairy cattle; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials, 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.

SA Health and the Commission on Excellence and Innovation in Health (CEIH) recently announced the first go-live of the South Australia Statewide Patient Reported Measures (PRMs) Program. Introduced in 2021, the PRM Program encourages patients to report on their health outcomes and experiences, which clinicians can tap into to make better decisions on their patients' health. It leverages New Zealand-based The Clinician's ZEDOC solution for the near-real-time collection and reporting of PRMs. ZEDOC is currently being integrated into the Sunrise EMR , which is also being rolled out across SA. In December, the program went live at the South Australian Medical Imaging (SAMI) Nuclear Medicine Theranostics Service of The Queen Elizabeth Hospital (TQEH) in Adelaide. CEIH PRM Program director Megan Scott gave Healthcare IT News a walkthrough of their experience in this first implementation, highlighting a key success factor in raising clinicians' uptake of new digital solutions. She also detailed how they are maintaining cybersecurity for both patients and clinicians amid growing threats. Q: Can you walk us through the implementation of the PRMs at TQEH's SAMI Scott: Clinicians at the Theranostics Service have been using a digital electronic medical record for nearly 10 years, in addition to multiple other digital solutions. They were exceptionally keen to be early adopters of the ZEDOC solution and had a great level of comfort with the implementation process given their prior experience in implementing digital solutions. As a result, the implementation went very well with the service completing a full outpatient clinic on implementation day and both patients and clinicians using the ZEDOC solution. The PRM Program team worked with the Theranostics service team to customise their survey project build in the solution specific to their requirements. The process of service discovery, requirements gathering, configuration, testing, training and workflow planning was conducted over approximately 12 weeks in late 2023, with the implementation date occurring in mid-December. Key priorities for the team were understanding their requirements, enabling the visualisation of longitudinal PRM data through dashboards, and supporting new clinical workflows using real-time information as reported by patients. The service's previous digital survey solution relied on patients to complete the survey while in the clinic waiting room using a hospital-supplied device. With the new ZEDOC solution, survey invitations are sent to patients some days ahead of their clinical encounters, thus enabling the patient to complete the survey in their own time. Evidence indicates that this method reduces pressure for patients and results in better symptom recall by the patient. The ZEDOC solution also allows for near real-time review of the recent survey results and historical responses presented in a longitudinal format, the presence of which enhances partnership and shared decision-making between patients and clinicians during clinical consultations. Early reports from both clinicians and patients at TQEH SAMI note that the ZEDOC solution is a significant improvement from their previous solution and approach as it provides an excellent user experience for both patients and clinicians and a more streamlined process for collecting and reviewing the data from patients . As the collection of PROMs (patient-reported outcome measures ) forms part of the patient care continuum, they are considered part of the medical record with the relevant South Australian legislative and policy requirements for the handling of medical records in place in the ZEDOC solution. The usage of PREMs (patient-reported experience measures ) is considered a quality improvement activity, with survey results being de- identified and used at an aggregate level for the improvement of health services. Patients may opt out of receiving or responding to survey invitations or the program entirely if they so choose. This process is managed locally by each implementing service as well as by patients within the patient-facing elements of the solution. Q: After TQEH, which services are also slated under the Stage 1 implementation? What do you expect the implementation to look like at those services? Scott : While some components for ZEDOC are similar across the board, each clinical service has the opportunity to tailor the solution to meet their requirements. In our experience, offering a degree of customisation enhances clinical adoption and long-term acceptance of the solution . Customising survey messaging and enabling service-designed patient resources within the solution also enhances patient response rates. Once the PRM instrument has been chosen by the service, the PRM team then work to configure the survey project in ZEDOC based on the requirements. This work includes adding hospital/service logos and branding to the survey, developing patient resources for the ZEDOC FAQ, designing the survey invitation messages, applying the survey milestone configuration (such as when surveys are collected and when invitations are sent), and configuring alerts and response dashboards, as well as broader reporting requirements. The remainder of our Stage 1 implementations are scheduled to occur during February and March 2024, with our next service (Radiation Oncology at the Royal Adelaide Hospital) having already gone live on 31 January 2024. The remaining Stage 1 implementation also includes: select Central Adelaide Local Health Network Rheumatology services; Southern Adelaide Local Health Network Plastic and Reconstructive Surgery services, including the Hand Surgery Service, Breast Reconstruction Service, and Facial Skin Cancer Surgery Service; select Southern Adelaide Local Health Network Rehabilitation services; and Women’s and Children’s Health Network . An additional two implementation stages are planned for 2024, with scope negotiations currently underway with SA Health Local Health Networks. Additional stages are anticipated during 2025. Q: Not long ago local SA Health networks reported a cyber incident affecting their digital patient pathways. With the digital collection of PRMs underway across SA, how do you intend to protect PPIs and other sensitive patient information amid rising cyber threats? How is the PRM Program designed to deal with cyber threats and intrusions? Scott: The PRM Program has undertaken a significant review of operational, policy, and legislative requirements in relation to the handling of personal information. The ZEDOC solution underwent rigorous security assessments during both procurement and configuration phases and is compliant with SA Health requirements in this regard. Controls are in place to minimise the risk of unauthorised access to the system. Core technical assets are allocated exclusively to SA Health and the solution, providing greater visibility and control of what happens inside them. Meanwhile, the vendor maintains an internationally recognised security certification to ensure operational security competency. _ The interviewee's res ponses have been edited for brevity and clarity.

Data breach affected 121 SA Health patients SA Health has recently disclosed a cyber incident that affected Personify Care, the third-party provider of digital patient pathways for its local health networks. On 16 October, Personify Care detected a breach on its platform used at Central Adelaide Local Health Network and Southern Adelaide Local Health Network, which led to a folder containing the health information of 121 patients getting deleted. The affected folder also included the name and phone number of 12,624 patients used to invite them onto the Personify Care platform. "No evidence has been found that affected documents were copied or downloaded, but the incident resulted in an unauthorised party deleting the contents of a folder used to store some information uploaded by patients and staff using Digital Patient Pathways," SA Health reported. "The incident did not affect the use of the platform at any other SA Health Local Health Networks," it added. SA Health further emphasised that "the incident occurred outside the SA Health network within a specific part of the infrastructure used by Personify Care." In a separate media statement, Personify Care chief executive Ken Saman clarified: "The security of all other patient information entered into the system, including user credentials, have not been compromised." "We have also confirmed the situation has been resolved, and the risk to patient information has been mitigated." As for the reason why the apparent hackers deleted the said folder of patient information, Saman shared that "the forensic analysis could not confirm the identity or motivation of the third party." Te Whatu Ora expands PowerHealth's costing solution implementation across South Island Te Whatu Ora has recently signed a deal to expand further the implementation of a clinical costing solution by PowerHealth across the South Island. Based on a media release, the expanded implementation of the web-based PowerPerformance Manager (PPM) aims to consolidate the region's health costing systems by standardising costing configurations in line with the New Zealand Common Costing Standards. It also seeks to "improve operational decision-making within health services and hospitals, [provide] better data for health service benchmarking and a sound basis for Inter-District Flow pricing by creating consistency in costing and cost allocation within the health service sector and [lift] the quality of cost reporting." The agreement began as a costing tender from the then-Southern District Health Board in 2021. When the New Zealand health system was reformed last year, it adopted a whole-of-country approach to planning and delivery services, hence the decision to expand the adoption of PPM island-wide. PPM, which calculates hospital service delivery costs and delivers comprehensive performance reports, has been used by Te Whatu Ora Canterbury and West Coast since 2003. NSW Health builds new digital register of life-saving drugs NSW Health has established a new Life-Saving Drugs Register to streamline the tracking of vital stock for time-critical emergencies. The digital register, according to a media release, updates daily and pinpoints the exact location of life-saving drugs to specific NSW public hospital departments. These medicines include those used to treat paracetamol overdose, snake and spider bites, and poisoning from heavy metals, including 31 antidotes and 10 antivenoms. The new register, which is accessible via mobile devices, replaces a web-based Excel spreadsheet that is updated every six months. It was also given the ability to link to evidence-based guidelines to provide frontline health workers with directions for the appropriate use of such medications. Healthscope rolls out Genie Solutions' latest e-booking solution Healthscope, the only national private hospital operation and healthcare provider in Australia, has rolled out an electronic booking solution across its network of 38 hospitals. The FHIR-based electronic booking solution by Genie Solutions streamlines the information flow between specialists and hospitals. As the solution allows all procedure and patient information to be securely shared from Genie or Gentu directly to the hospital's booking system, all essential information is provided before planned procedures. It also enables Healthscope hospitals to see theatre bookings instantly.