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AEMD News
AEMD Events
Aethlon Medical Enters Merger Agreement with North Immunology
Aethlon Medical announced that it has entered into a definitive merger agreement for an all-stock transaction with North Immunology, Nighthawk Merger Sub Corp., a wholly owned subsidiary of Aethlon, and Nighthawk Second Merger Sub, a wholly owned subsidiary of Aethlon. The merger and concurrent private placement, which is expected to provide approximately $180M in gross proceeds, are expected to position the combined company to advance the development of NOR-101, a potentially best-in-class half-life extended IL-13 x IL-18 bispecific antibody that is being developed for atopic dermatitis and other immune-mediated diseases. Upon consummation of the transaction contemplated by the Agreement, the combined entity will operate as North Immunology and trade on Nasdaq under a new ticker symbol (NRTX). The private placement is expected to provide North Immunology with approximately $180M in gross proceeds and is expected to fully fund its operations into the second half of 2028. North Immunology's Phase 1a study of NOR-101 is expected to begin in Q1 2027, with interim PK and safety data expected by mid-2027. North Immunology intends to rapidly initiate Phase 1b and Phase 2b studies for NOR-101 in atopic dermatitis in 2027 and deliver topline data for both studies in 2028. Under the terms of the merger agreement, as of the closing of the proposed merger, the pre-merger Aethlon stockholders are expected to own approximately 4.75% of the combined company, and the pre-merger North Immunology stockholders are expected to own approximately 95.25% of the combined company, which is expected to have a pro forma equity value of approximately $346.5M. The percentage of the combined company that Aethlon's stockholders will own as of the closing of the proposed merger is subject to reduction to the extent Aethlon's net cash at closing is less than $0, as further described in the Agreement. In addition, Aethlon stockholders as of immediately prior to the closing will be entitled to receive additional financial consideration through a contingent value right for each share of Aethlon common stock and preferred stock held, entitling the Holders to net proceeds (if any) received following the closing from a sale, license, transfer, divestiture or other monetization transaction with respect to Aethlon's legacy Hemopurifier business, the terms of which will be described in the agreement and/or the Form 8-K to be filed in connection with the proposed transaction. The transaction has received approval by the board of directors of both companies and is expected to close in the first quarter of 2027, subject to certain closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the securities to be issued in connection with the proposed merger, Nasdaq's approval of the initial listing application to be submitted in connection with the proposed merger, and the satisfaction of other customary closing conditions. The combined company plans to operate under the name North Immunology, Inc. and will be led by North Immunology's existing management team. North Immunology's existing board of directors, chaired by Daniel Schneeberger, co-founder of North Immunology and managing partner of ADAR1 Capital Management, will become directors of the combined company, alongside a number of new independent directors.
Aethlon Medical Trading Halted, News Pending
Aethlon Medical trading halted, news pending
Aethlon Medical's Australian Study Shows Biological Changes in Second Patient Cohort
Aethlon Medical announced that patients in the second cohort of its Australian oncology feasibility study demonstrated biological changes consistent with those previously observed in the first cohort following treatment with the investigational Hemopurifier. Replicating these findings in a second group of patients strengthens the scientific rationale for the Company's ongoing clinical program and supports continued enrollment in the third and final cohort before an independent statistical analysis is conducted. "We are encouraged to observe similar directional changes across multiple biomarkers in both the first and second patient cohorts," said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. " Observing these directional changes in a second patient cohort builds upon our initial observations and provides additional data as we advance toward completion of the third cohort. While these are preliminary findings from an early feasibility study, they represent an important milestone as we advance toward completion of the third cohort and an independent statistical analysis to determine whether these observations represent a dose-response to Hemopurifier treatment."
Aethlon Medical Publishes New Research Showing Increased Extracellular Vesicle Levels in Long COVID Patients
Aethlon Medical announced publication of new peer-reviewed research in the International Journal of Molecular Sciences demonstrating that patients with Long COVID exhibit significantly increased levels of mannosylated extracellular vesicles that can be captured using the same Galanthus nivalis agglutinin affinity resin incorporated into the company's Hemopurifier. "The study, conducted in collaboration with investigators from the University of California, San Francisco, provides what we believe is new evidence supporting extracellular vesicles as a potential therapeutic target in Long COVID and helps establish a translational framework for future studies evaluating whether the Hemopurifier can remove disease-associated EVs and their molecular cargo. The publication of this study contributes to the scientific understanding of the biological mechanisms underlying Long COVID while strengthening the rationale for evaluating the Hemopurifier in this significant area of unmet medical need," said Jim Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "While the company's current resources and primary focus remain dedicated to advancing our Australian oncology clinical trial, these findings provide additional translational evidence supporting future preclinical and clinical studies designed to determine whether removal of these circulating extracellular vesicles may benefit patients with Long COVID. More broadly, we believe these findings reinforce the potential of the Hemopurifier as a platform technology with potential applications across multiple disease areas. We believe there exists a 'pipeline within a single device.'"
Aethlon Medical Clinical Trial Safety Review Completed
Aethlon Medical announced that the independent Data Safety Monitoring Board overseeing its ongoing clinical trial AEMD-2022-06 has completed its scheduled safety review of the second cohort participant data and recommended advancing to the third and final cohort. They also stated that "no safety concerns were noted with Hemopurifier device/procedure". The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier's safety, feasibility, and optimal dosing.
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