On February 14, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious diseases, reported financial results for its third quarter ended December 31, 2021 and provided an update on recent developments (Press release, Aethlon Medical, FEB 14, 2022, View Source [SID1234608097]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Company Updates
Aethlon Medical is continuing the research and clinical development of the Hemopurifier, our therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.
As disclosed previously, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and, as reported in a peer reviewed publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. That publication also noted that the Hemopurifier has demonstrated the removal of exosomes and exosomal microRNAs associated with coagulopathy and acute lung injury.
We continued to make progress in our Severe COVID trial during the quarter under our open Investigational Device Exemption (IDE) for the Hemopurifier for life threatening viral infections. We now have three hospitals, Hoag Newport Beach, Hoag Irvine, and Loma Linda Medical Center, fully open for patient enrollment and they are actively screening patients for the trial. An additional five centers, including UC Davis, LSU Shreveport, Thomas Jefferson Medical Center, University of Miami and Valley Baptist Medical Center, are expected to be open for enrollment in the near future.
We have also completed all site initiation activities at Medanta Medicity Hospital in India for our planned Severe COVID-19 clinical trial in that country. This site is now open for enrollment and is actively screening patients for the trial.
In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in Head and Neck Cancer. We are looking to expand this trial to one or more additional sites to accelerate patient recruitment and we are also considering initiating additional trials, both domestically and abroad, to investigate the Hemopurifier as a treatment for other forms of cancer.
Financial Results for the Third Quarter Ended December 31, 2021
At December 31, 2021, Aethlon Medical had a cash balance of approximately $20.4 million.
Aethlon recorded approximately $17,000 of revenue related to the cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC." Aethlon recorded the $115,000 invoice submitted under its Phase 2 Melanoma Cancer Contract as deferred revenue, since certain of the milestones for the period were not achieved. As a result, Aethlon recorded total government contract revenue of approximately $17,000 in the three months ended December 31, 2021. Aethlon recorded approximately $625,000 of government contract revenue in the three months ended December 31, 2020.
Consolidated operating expenses for the three months ended December 31, 2021 were approximately $2.55 million, compared to approximately $3.07 million for the three months ended December 31, 2020. This decrease of approximately $520,000, or 17%, in the 2021 period was due to decreases in payroll and related expenses of approximately $520,000 and in professional fees of approximately $190,000, which were partially offset by an increase in general and administrative expenses of approximately $190,000.
The $520,000 decrease in payroll and related expenses was primarily due to the combination of a $440,000 accrual in the December 2020 period related to the separation agreement with our former CEO and $250,000 in bonuses paid in the December 2020 period, with no comparable expenses in the December 2021 period. Additionally, stock-based compensation expense decreased by $180,000 in the December 2021 period, largely due to the separation agreement with our former CEO. Partially offsetting those decreases were $180,000 in relocation-related compensation to two senior executives that relocated to San Diego, California as a condition of their employment, and increases in cash-based compensation of approximately $90,000 and $89,000 in our general and administrative payroll and in our research and development payroll, respectively, due to headcount increases.
The $190,000 decrease in our professional fees was primarily due to a $80,000 decrease in our scientific consulting expenses, a $51,000 decrease in our legal fees, a $37,000 decrease in recruiting fees, a $19,000 decrease in website services, and a $17,000 decrease in our directors’ compensation, which were partially offset by a $17,000 increase in our accounting fees.
The $190,000 increase in general and administrative expenses during the quarter ended December 31, 2021 was primarily due to a $183,000 increase in our clinical trial expenses.
As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $2.5 million for the three months ended December 31, 2021, from approximately $2.4 million for the three months ended December 31, 2020.
The unaudited condensed consolidated balance sheet for December 31, 2021 and the unaudited condensed consolidated statements of operations for the three and nine month periods ended December 31, 2021 and 2020 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Monday, February 14, 2022 at 4:30 p.m. Eastern Time to review 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 View Source
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 March 14, 2022. 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 2728183.