Primary Graft Dysfunction

WALTHAM, Mass.--( BUSINESS WIRE )-- Paragonix Technologies, Inc. , a pioneer in organ transplant products and services, announces the landmark publication of the first clinical manuscript assessing the use of FDA-cleared advanced organ preservation technology to significantly extend ischemic times, a term referring to the sensitive window of time between organ recovery and transplantation. Prolonged periods of uncontrolled preservation can risk detrimental effects on the viability of the tissue or organ; however, safely extending ischemic times beyond fifteen hours can facilitate potential new avenues that surgeons can harness to significantly enhance access to life-saving transplants for patients. This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation. For example, presenting a means to better accommodate longer transportation times, overnight bridging, or optimizing case scheduling during the day. The retrospective analysis was conducted by three internationally recognized lung transplantation centers, including UZ Leuven Hospital (Belgium), Motol University Hospital (Czech Republic), and Massachusetts General Hospital (United States). During the six-month study period, the LUNGguard® Donor Lung Preservation System was utilized to preserve donor lungs for over 15 hours in 13 separate instances. The standard of care for preserving donor lungs typically utilizes a conventional cooler of ice, with an ischemic time over 6 hours often considered a higher risk factor for transplant outcomes. Longer ischemic times increase the risk of primary graft dysfunction, a serious complication that can occur after lung transplantation. Given the historically acknowledged risks associated with prolonged ischemic times on uncontrolled ice storage, the clinical investigators analyzed the outcomes of the qualified 13 patients to examine the impact of utilizing controlled hypothermic storage. Despite the prolonged preservation times and complex case dynamics including high-risk recipients and extended criteria donors, the study reported 0% instance of PGD-3 at 72 hours. The use of the controlled hypothermic device allowed the teams to remotely monitor the preservation temperature throughout the entire period, reporting an average probe temperature of 7°C across all 13 donor lungs. The device’s proprietary cooling technology and data reporting capabilities allowed full transparency into critical case insights, ensuring a reliable and consistent thermal environment within clinically recommended and FDA-cleared parameters. “The use of controlled hypothermic storage in scenarios that extend beyond fifteen hours has demonstrated significant promise with favorable short-term outcomes,” said Professor Laurens Ceulemans, Assistant Professor of Surgery and Deputy Head of Clinic in the Department of Thoracic Surgery at UZ Leuven. “Through the provision of optimal preservation conditions, we can effectively extend ischemic time, thereby unlocking new possibilities and potentially reaching a broader spectrum of patients.” Disclaimer or Indications of Use for the Paragonix LUNGguard Donor Lung Preservation System The Paragonix LUNGguard® (LUNGguard® ) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard® is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to preservation that represents a significant improvement over the traditional standard of care. Paragonix Advanced Organ Preservation devices combine clinically-proven, stable temperature techniques with digital tracking and monitoring technologies to provide clinicians complete control and oversight throughout the donor organ journey. The clinical impact of Paragonix preservation technology is reinforced by the GUARDIAN clinical registries, the largest database of organ preservation data in the world that analyzes post-transplant outcomes in transplant recipients. For more information, visit www.paragonix.com . Follow us on Twitter: @ParagonixSherpa Connect with us on LinkedIn: Paragonix Technologies Like Us on Facebook: Paragonix SherpaPak References: Ceulemans, et al. Extended Ischemic Time (> 15 Hours) Using Controlled Hypothermic Storage in Lung Transplantation: A Multicenter Experience Running head: Extended Ischemic Time in Lung Transplantation, Journal of Heart and Lung Transplantation, (2024) L-589Ver. 0

Expanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv) Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor activity BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas. “The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment. Data were consistent with previous studies, showing that patients transplanted with omidubicel had rapid hematopoietic recovery and a low rate of serious infections post-transplant.” “The Phase 1 data on our natural killer (NK) cell candidate GDA-201 further support the anti-tumor activity of our NAM-enhanced cellular therapy, and today marked the first presentation of study results using our cryopreserved, readily available formulation,” Simantov added. Reporting on omidubicel’s EAP data, principal investigator Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute, said, “I am highly encouraged by the results in the omidubicel expanded access program. The potential for rapid hematopoietic recovery post-transplant observed with omidubicel could make a meaningful impact on patient health. I am pleased to see that the EAP results are consistent with data from the Phase 3 study.” Additional details on the presentations are as follows: Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)Abstract Number: 313Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer InstituteTime: February 22, 6:45-7:45 p.m. CT Presentation highlights: In this expanded access program (EAP) evaluating outcomes in 29 patients with hematologic malignancies following allogeneic hematopoietic stem cell transplant with omidubicel, outcomes were overall consistent with those from omidubicel’s Phase 3 study. Eligible patients ≥12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Median time to neutrophil and platelet engraftment were 12 and 34 days, respectively. Results were also similar to the Phase 3 study for infection (first grade 2-3 bacterial / invasive fungal infections at 100 days posttransplant: 18%), graft-versus-host-disease (grades 3-4: 19%), disease-free survival (79%) and overall survival (87%). Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which >40% of the study participants were racially or ethnically diverse. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant. Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell LymphomaAbstract Number: 255Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New YorkDate and Time: February 22, 6:45-7:45 p.m. CT Presentation highlights: In this ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma, preliminary data for the first 12 patients were presented. Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant. Patients were treated with doses up to 2x108 cells/kg GDA-201 in combination with rituximab. There were no infusion reactions, dose-limiting toxicities or related serious adverse events. Seven patients exhibited a decrease in tumor burden. Efficacy evaluation using Lugano criteria showed three patients with complete response, two with partial response and two with stable disease. Cytokine release syndrome was reported in two patients (grade 1 and grade 2, respectively). There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Treatment and evaluation of patients in the fourth cohort of the study at the highest dose level of 2x108 cells/kg is ongoing. Full results are expected in Q1 2024. Posters are available at: https://www.gamida-cell.com/our-rd/ About Gamida CellGamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram. About GDA-201GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. NAM-modified NK cells have previously been shown to have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024. GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. Omisirge® (omidubicel-onlv) IndicationOmisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Important Safety Information for Omisirge BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. ContraindicationsOMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and PrecautionsHypersensitivity ReactionsAllergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion ReactionsInfusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Graft-versus-Host DiseaseAcute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment SyndromeEngraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death. Graft FailurePrimary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery. Malignancies of Donor OriginTwo patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478. Transmission of Serious InfectionsTransmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478. Transmission of Rare Genetic DiseasesOMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited. ADVERSE REACTIONSThe most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction. Please see full Prescribing Information, including Boxed Warning. About Gamida CellGamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Facebook, X and Instagram. Cautionary Note Regarding Forward-Looking StatementsThis press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements. Omisirge® is a registered mark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved. Media Contact:  Dan Boyle  Orangefiery  media@orangefiery.com1-818-209-1692  Investor Contact:  Chuck Padala  LifeSci Advisors  Chuck@lifesciadvisors.com1-646-627-8390

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 Santersus' NucleoCapture and HemoNucleoCapture devices. Under the terms of the MTA, Santersus will supply Aethlon with NucleoCapture and HemoNucleoCapture devices, designed to remove Neutrophil Extracellular Traps (NETs), which are toxic to tissues and organs and are implicated in the pathophysiology of cancer, sepsis, autoimmune diseases, such as lupus, and ischemia reperfusion injury in organ transplantation. Aethlon will perform initial pre-clinical studies to examine the NucleoCapture and HemoNucleoCapture devices, alone, and in combination with Aethlon's Hemopurifier® -- a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids -- to assess their ability to remove important targets in samples from cancer patients, as well as from perfusates from kidneys that have undergone machine perfusion as part of the renal transplantation process. "We look forward to initiating pre-clinical studies shortly, to expand upon the data that Santersus has generated in sepsis and liver and lung transplantation, and more importantly, to explore potential synergies with our Hemopurifier, initially in oncology and renal transplantation, as well as other potential indications," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "Our belief is that the NETs removed by the NucleoCapture and HemoNucleoCapture devices, in combination with the clinical mediators removed by our Hemopurifier, could have an additive or synergistic effect in both the cancer and kidney transplant settings. The signing of the MTA represents an important milestone for both companies, as it is the first step toward a potential future collaboration." "Our collaboration with Aethlon has provided us with research and development partners with expertise and capabilities to help advance our NucleoCapture technology platform forward in important fields, such as oncology and kidney transplantation. We are excited to continue building on the progress we've made in Santersus thus far and on taking the next steps forward in executing on our plans to advance NucleoCapture technology," commented Scott Maguire, Chairman of Santersus. "NETs are being increasingly recognized as an important element in cancer progression and metastasis. We believe extracorporeal removal of NETs using NucleoCapture either alone or in combination with Hemopurifier technology might create a transformational treatment option for patients receiving immune checkpoint inhibitors or CAR T cell therapies." About Santersus AG Santersus AG is a clinical stage privately held therapeutic apheresis Anglo-Swiss company. In clinical trials, Santersus' flagship medical device, NucleoCapture, has demonstrated the removal from patient blood of Neutrophil Extracellular Traps (NETs). NETs are fibers of decondensed DNA decorated with cytotoxic proteins that have been released from activated neutrophils. NETs have been recognized as one of the major driving factors in the development of sepsis, cancer, acute organ failure, autoimmune flares, and neurodegeneration, including Alzheimer's disease. NucleoCapture has been granted designation as a Breakthrough Device by the US Food & Drug Administration (FDA). NucleoCapture blood purification technology is based on biocompatible, highly porous polymer beads conjugated with proprietary human recombinant histone H1.3 protein. Histone H1.3 protein was created in nature to act as the ultimate human DNA binding and compacting protein with single digit nanomolar DNA binding constants. As a result, in clinical trials Santersus has demonstrated that a single pass of NETs contaminated blood through the NucleoCapture device results in over 95% removal of NETs. Santersus has developed NucleoCapture for the treatment of sepsis, primary graft dysfunction after lung transplantation, reconditioning of extended criteria donor organs for liver and lung transplantation and Alzheimer's disease. Additional information can be found at 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 raise additional capital and to complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in cancer and infectious diseases; the Company's ability to demonstrate synergies of the Hemopurifier with the NucleoCapture and HemoNucleoCapture devices; the Company's ability to enter into a future collaboration with Santersus; the Company's ability to complete the internal binding study of relevant extracellular vesicles; the Company's ability to commence and manage 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, 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.