Aethlon Medical (NASDAQ: AEMD) Research/Media Alert: "Expect Focus on Oncology Studies; Cost Containment Efforts"
December 4, 2023 - Investorideas.com (https://www.investorideas.com) a global investor news source covering biotech and medical technology stocks releases a research/media alert for investors following the sector, featuring medical therapeutic company, Aethlon Medical, Inc. (NASDAQ:AEMD). Zacks small-cap research issued a summary of the report, 'Expect Focus on Oncology Studies; Cost Containment Efforts,' on November 16th.
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By M. Marin
Expect no disruption from management change; increased emphasis on studying Hemopurifier® in oncology likely...
Aethlon Medical (NASDAQ:AEMD) appointed CFO James Frakes as interim CEO. We expect no disruption as a result of the management change - Mr. Frakes has been with Aethlon since 2008 & knows the company well, in our view. Moreover, including Aethlon, he has had 27 years of CFO level financial responsibility with publicly traded companies. We anticipate increased emphasis on studying the Hemopurifier® in the oncology area, as well as potential cost containment measures when possible, are likely.
Mr. Frakes, who was also appointed as a member of the company's board, will continue his responsibilities as CFO. In addition, Guy Cipriani has been named as the company's Chief Operating Officer. He had been Aethlon's Chief Business Officer prior to assuming the COO role. Mr. Cipriani has resigned from the Aethlon board. We do not anticipate major changes as a result of this management shift, although we believe the company is likely to emphasize its clinical efforts in the field of oncology.
... and potential cost containment measures when possible...
Mr. Frakes has been with Aethlon since January 2008 and therefore knows the company well, in our view. Moreover, including his role at Aethlon, he has had 27 years of CFO level financial responsibility with publicly traded companies, as noted. We do not anticipate a major shift in strategy as a result of this management change, as noted, other than likely increased emphasis on studying the Hemopurifier® in the oncology area and potential cost containment efforts when possible.
Expect cash balance, lowering costs where possible, plus accessing ATM funding will enable company to continue moving Hemopurifier forward towards potential regulatory approval, commercialization
We believe lowering costs where possible, plus accessing funding, will enable the company to continue moving the Hemopurifier forward in clinical studies towards potential regulatory approval and commercialization. Under James Frakes' leadership as CFO, the company put in place an ATM (At The Market offering) to enhance its financial flexibility. AEMD believes its cash balance is sufficient to fund operations for at least a year. We believe lowering costs where possible, plus accessing ATM funding, will enable the company to continue moving the Hemopurifier forward in clinical studies towards potential regulatory approval and commercialization. If Aethlon can demonstrate the Hemopurifier's ability to improve outcomes of cancer patients suffering from a variety of different cancer types, we would anticipate strong commercial prospects for the device.
... majority of patients treated with checkpoint inhibitors do not respond; studying whether Hemopurifier with checkpoint inhibitors can improve overall patient outcomes
The company recently received clearance from the Drug Controller General of India (DCGI), which is India's central drug authority, to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda® or Opdivo®. PD-1, or Programmed Cell Death Protein 1, is a protein found on the cell surface that plays a role in inhibiting immune responses. Treatment such as Keytruda®, a type of immunotherapy, helps to block the PD-1 pathway to prevent cancer cells from hiding and, in turn, help the immune system work. While Keytruda® and other anti-PD-1 monotherapy treatments represent a substantial advance in cancer treatment, with certain tumor types it does not work on the majority of cancer patients.
Checkpoint inhibitors such as Keytruda have been used to treat 25+ different types of cancer. By launching a basket oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors, AEMD believes it can generate data to support the Hemopurifier's ability to improve outcomes, when combined with checkpoint inhibitor treatment, in multiple tumor types where cancer associated extracellular vesicles may promote immune suppression and resistance to anti-PD-1 antibodies. Given the Hemopurifier's demonstrated ability to remove exosomes, management believes the device can be used to affect improved outcomes in a number of cancers.
Moreover, by focusing on multiple cancers, the company has also expanded the opportunities for patient enrollment, as well as for building a database to support regulatory approval. By including both Keytruda and Opdivo can also facilitate patient enrollments.
About Aethlon Medical, Inc. (NASDAQ:AEMD)
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 harmful exosomes from blood 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.
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