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Aethlon Medical(AEMD) - 2026 Q3 - Earnings Call Transcript
2026-02-12 22:32
Financial Data and Key Metrics Changes - As of December 31, 2025, the company had a cash balance of approximately $7 million [13] - Consolidated operating expenses for Q3 2026 were approximately $2.06 million, an increase of $250,000 or 13.6% compared to the same period last year [13] - Operating loss for the quarter increased to $2.06 million compared to $1.81 million in the prior year period [13] - For the nine-month period, operating expenses decreased significantly to $5.36 million, down $1.98 million or 27% from $7.34 million last year [15] Business Line Data and Key Metrics Changes - The company is advancing its Hemopurifier platform while maintaining disciplined cost control [5] - Continued enrollment and treatment progress in the Australian oncology trial, with two patients treated in the second cohort [7][29] - The R&D team is exploring the Hemopurifier's compatibility with a simplified blood treatment system, which could enhance clinical and commercial flexibility [10] Market Data and Key Metrics Changes - There has been an uptick in the number of interested potential participants in the Australian oncology trial since contracting with Trialfacts and Dedicated [8] - The trial is designed to examine the number of Hemopurifier treatments needed to decrease extracellular vesicle concentrations and improve the body's ability to attack tumor cells [9] Company Strategy and Development Direction - The company aims to advance the Hemopurifier platform while managing costs effectively [5] - The focus remains on the Australian oncology trial, with no plans to expand to other markets like India at this time [75][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing progress in the oncology trial and the potential for the Hemopurifier to serve multiple indications [11][29] - The company is committed to maintaining cost containment while advancing its research and development efforts [27] Other Important Information - The scientific rationale and full design of the Australian oncology trial have been published in a peer-reviewed journal [10] - The next earnings call for fiscal Q4, ending March 31, 2026, will coincide with the filing of the annual report in June 2026 [16] Q&A Session Summary Question: Clarification on Cohort 2 treatment duration - The follow-up period remains the same, but participants in Cohort 2 will receive two Hemopurifier treatments instead of one [18][19] Question: Impact of SLAMB system on treatment administration - The SLAMB system would allow for a less invasive treatment method, making it easier for both hospital staff and patients [20][23] Question: Cost-effective approach in R&D - The company is focused on keeping costs down while advancing research, utilizing in-house resources as much as possible [26][27] Question: Timeline for Data Safety Monitoring Board's decision - The board is expected to provide a decision on advancing to the third cohort on the same day or the next business day after their meeting [36] Question: Need for Cohort 3 - Management believes it is essential to investigate Cohort 3 to determine if three treatments could yield better results than two [62] Question: Regulatory hurdles for SLAMB system integration - The SLAMB system is not yet approved, and the company would need to conduct safety tests before integration [46][47] Question: Future trials in India - The company is currently focused on the Australian trial and does not plan to return to India for additional trials [75][81]
Aethlon Medical(AEMD) - 2026 Q3 - Earnings Call Transcript
2026-02-12 22:32
Financial Data and Key Metrics Changes - As of December 31, 2025, the company had a cash balance of approximately $7 million [13] - Consolidated operating expenses for the three months ended December 31, 2025, were approximately $2.06 million, an increase of $250,000 or 13.6% compared to the same period last year [13] - The operating loss for the quarter increased to $2.06 million compared to $1.81 million in the prior year period [13] - For the nine-month period, operating expenses decreased significantly to $5.36 million, down $1.98 million or 27% from $7.34 million last year [15] Business Line Data and Key Metrics Changes - The company is advancing its Hemopurifier platform while maintaining disciplined cost control [5] - Continued enrollment and treatment progress in the Australian oncology trial, with two Hemopurifier treatments completed in the second cohort [7][9] - The R&D team is exploring the compatibility of the Hemopurifier with a simplified blood treatment system, which could enhance clinical and commercial flexibility [10] Market Data and Key Metrics Changes - There has been an uptick in the number of interested potential participants in the Australian oncology trial since contracting with TrialFax and Dedicated for advertising and pre-screening [8] - The study is designed to examine the number of Hemopurifier treatments needed to decrease extracellular vesicle concentrations and improve the body's ability to attack tumor cells [9] Company Strategy and Development Direction - The company is focused on advancing the Hemopurifier platform and exploring its potential as a multi-indication therapeutic [5] - The integration of the Hemopurifier with the SLAMB system could facilitate its use in oncology units and infusion centers, reducing invasiveness for patients [23][24] - The company aims to build on preclinical data in Long COVID and explore other indications related to extracellular vesicles [11][12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of cost containment while advancing clinical trials and R&D efforts [27] - The company is currently focused on completing the Australian trial and is not planning to expand to other regions like India at this time [75][78] Other Important Information - The next earnings call for the fiscal fourth quarter, ending March 31, 2026, will coincide with the filing of the annual report in June 2026 [16] Q&A Session Summary Question: Clarification on Cohort 2 treatment duration - The follow-up period remains the same, but participants in Cohort 2 will receive two Hemopurifier treatments instead of one [19] Question: Impact of SLAMB system on treatment administration - The SLAMB system would allow for a less invasive catheter insertion, making it easier for patients and hospital staff to administer treatments [24] Question: Cost-effective approach in R&D - The company is trying to keep costs down by conducting work in-house and limiting outside lab involvement while still advancing research [27] Question: Timeline for Data Safety Monitoring Board's decision - The board is expected to provide a decision on advancing to the third cohort on the same day or the next business day after their meeting [36] Question: Need for Cohort 3 - Management believes it is important to investigate the third cohort to assess the potential benefits of three treatments compared to two [62] Question: Regulatory hurdles for SLAMB system integration - The SLAMB system is not yet approved, and the company would need to conduct safety tests before using it with the Hemopurifier [47]
Aethlon Medical(AEMD) - 2026 Q3 - Earnings Call Transcript
2026-02-12 22:30
Financial Data and Key Metrics Changes - As of December 31, 2025, the company had a cash balance of approximately $7 million [13] - Consolidated operating expenses for Q3 2026 were approximately $2.06 million, an increase of $250,000 or 13.6% compared to the same period last year [13] - The operating loss for the quarter increased to $2.06 million compared to $1.81 million in the prior year period [13] - For the nine-month period, operating expenses decreased significantly to $5.36 million, down $1.98 million or 27% from $7.34 million last year [14] Business Line Data and Key Metrics Changes - The company is advancing its Hemopurifier platform while maintaining disciplined cost control, with ongoing enrollment in the Australian oncology trial [5] - The second cohort of the oncology trial has seen two patients treated with Hemopurifier, with a third patient expected to be treated by the end of February [6][7] Market Data and Key Metrics Changes - There has been an uptick in the number of interested potential participants in the Australian oncology trial since contracting with TrialFax and Dedicated for recruitment [8] - The trial is designed to examine the number of Hemopurifier treatments needed to decrease extracellular vesicle concentrations and improve immune response against tumor cells [9] Company Strategy and Development Direction - The company is focused on advancing the Hemopurifier platform and exploring its compatibility with a simplified blood treatment system, which could enhance clinical and commercial flexibility [5][10] - Aethlon Medical is also exploring the potential of the Hemopurifier in treating conditions beyond oncology, including Long COVID and other diseases associated with extracellular vesicles [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing progress in the Australian oncology trial and the potential for the Hemopurifier to be integrated into oncology units and infusion centers, reducing invasiveness for patients [22][24] - The company is committed to cost containment while advancing its research and development efforts, particularly in the context of Long COVID [26] Other Important Information - The scientific rationale and full design of the Australian oncology trial have been published in a peer-reviewed journal, indicating the company's commitment to transparency and scientific rigor [10] - The next earnings call for the fiscal fourth quarter is scheduled to coincide with the filing of the annual report in June 2026 [16] Q&A Session Summary Question: Clarification on Cohort 2 treatment duration - Management confirmed that participants in Cohort 2 will receive two Hemopurifier treatments, maintaining the same follow-up period as Cohort 1 [19] Question: Impact of SLAMB system on treatment administration - The SLAMB system is expected to simplify the administration of Hemopurifier treatments, making it less invasive for patients and easier for hospital staff [22][24] Question: Cost-effective approach in R&D - Management emphasized the importance of cost containment while advancing research, focusing on in-house work and limiting external lab involvement [26] Question: Timeline for Data Safety Monitoring Board's decision - Management anticipates a decision from the Data Safety Monitoring Board on whether to advance to the third cohort on the same day or the next business day after the meeting [34] Question: Need for Cohort 3 - Management believes it is essential to conduct Cohort 3 to fully assess the efficacy of three treatments, based on historical data suggesting that more treatments may yield better results [60] Question: Regulatory hurdles for SLAMB system integration - The SLAMB system is not yet approved, and the company will need to conduct safety tests and treatments before integration with the Hemopurifier [45]
Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 12, 2026
Prnewswire· 2026-02-04 13:01
Core Viewpoint - Aethlon Medical, Inc. is set to release its financial results for the fiscal third quarter ending December 31, 2025, on February 12, 2026, at 4:15 p.m. ET [1] Group 1: Financial Results Announcement - The financial results will be discussed in a conference call on February 12, 2026, at 4:30 p.m. ET, which will include a question and answer session [2] - Interested parties can register for the conference call online, and registered participants will receive a dial-in number [2] Group 2: Conference Call Access - For those without internet access, a toll-free number is available for participation in the conference call [3] - A replay of the call will be accessible approximately one hour after the call ends and will be available until March 12, 2026 [4] Group 3: Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an immunotherapeutic device aimed at treating cancer and life-threatening viral infections [5] - The Hemopurifier has shown promise in human studies for removing life-threatening viruses and harmful exosomes, which may have applications in cancer treatment [5] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses not addressed by approved therapies [5]
Aethlon Medical(AEMD) - Prospectus
2026-01-07 21:15
As filed with the Securities and Exchange Commission on January 7, 2026. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 AETHLON MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 3826 13-3632859 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 11555 Sorr ...
Aethlon Medical Announces Pricing of a Private Placement and Warrant Inducement, Priced At-The-Market for Aggregate Gross Proceeds of $3.3 Million
Prnewswire· 2025-12-05 14:15
Core Viewpoint - Aethlon Medical, Inc. has entered into a securities purchase agreement for a private placement to raise approximately $3.3 million through the sale of common stock and warrants, aimed at supporting its development of medical products for cancer and infectious diseases [1][3]. Group 1: Securities Purchase Agreement - The company will sell 595,897 shares of common stock and warrants to purchase up to 1,042,820 additional shares, with a combined effective offering price of $4.03 per share [1]. - The warrants will have an exercise price of $4.03 and will be exercisable upon shareholder approval, expiring five and a half years after such approval [1]. Group 2: Warrant Inducement Agreement - Aethlon has entered into a warrant inducement agreement to allow the investor to exercise certain outstanding warrants at a reduced price of $4.03, which includes 155,000 shares from March 2025 Warrants and 55,555 shares from September 2025 Warrants [2]. - In exchange for the immediate exercise of these warrants, the company will issue new unregistered warrants for an additional 368,471 shares, also at an exercise price of $4.03 [2]. Group 3: Financial Details - The gross proceeds from the private placement and warrant inducement are estimated to be around $3.3 million before deducting fees and expenses [3]. - The offering is expected to close on or about December 8, 2025, pending customary closing conditions [3]. Group 4: Company Overview - Aethlon Medical, Inc. is a clinical-stage medical device company based in San Diego, California, focused on developing the Hemopurifier to address unmet needs in oncology and infectious diseases [6].
Aethlon Medical Announces Publication of Preclinical Data Showing That the GNA Affinity Resin in the Hemopurifier® Binds to Extracellular Vesicles in Long COVID patient samples and Decreases Inflammatory microRNAs
Prnewswire· 2025-12-02 13:01
Core Insights - Aethlon Medical, Inc. announced a pre-clinical study indicating the potential of the Hemopurifier device in treating Long COVID by targeting extracellular vesicles (EVs) [1][6][4] Company Overview - Aethlon Medical is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device aimed at treating cancer and life-threatening viral infections [7][8] - The Hemopurifier has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [8] Long COVID Context - Long COVID affects an estimated 44 to 48 million people in the U.S., with a projected economic burden of $2 billion for those experiencing symptoms for a year [2] - Symptoms include fatigue, shortness of breath, and cognitive difficulties, persisting for weeks or months after initial COVID-19 infection [2] Research Findings - The study published on November 20, 2025, demonstrated that the Hemopurifier can remove harmful EVs from the blood, which are implicated in Long COVID [1][5] - Elevated levels of both large and small EVs were found in the plasma of Long COVID patients compared to recovered controls, indicating a potential therapeutic target [5][6] - The GNA affinity resin in the Hemopurifier was shown to deplete specific microRNAs associated with inflammatory pathways, suggesting a mechanism for reducing inflammation in Long COVID [5][6] Future Directions - Aethlon Medical plans to further investigate whether the removal of EVs can decrease SARS-CoV-2 viral particles, which may contribute to Long COVID pathogenesis [6]
Aethlon Medical to Release Fiscal Second Quarter Financial Results and Host Conference Call on November 12, 2025
Prnewswire· 2025-11-07 13:01
Core Insights - Aethlon Medical, Inc. will release its financial results for the fiscal second quarter ended September 30, 2025, on November 12, 2025, at 4:15 p.m. ET [1] - A conference call will be held on the same day at 4:30 p.m. ET to discuss the financial results and recent corporate developments [2] - The Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation [4] Company Overview - Aethlon Medical, Inc. is a clinical-stage medical device company based in San Diego, California, focusing on oncology and infectious diseases [6] - The Hemopurifier has received U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [5] Conference Call Details - Interested parties can register for the conference call online, and those without internet access can dial in using provided toll-free numbers [2][3] - A replay of the call will be available approximately one hour after the call ends, accessible through the company's website or via specific phone numbers [4]
Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News
Investorideas.com· 2025-10-08 13:41
Core Insights - The article highlights significant advancements in clinical trials for biotech and medical tech companies, particularly focusing on Aethlon Medical, Envoy Medical, Soligenix, and MBX Biosciences, showcasing their recent progress and milestones in the sector [3][4]. Aethlon Medical, Inc. - Aethlon Medical is conducting an ongoing oncology clinical trial in Australia, evaluating the Hemopurifier in cancer patients unresponsive to anti-PD-1 therapy, with preliminary observations showing encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after treatment [5][7]. - In the initial cohort of three patients, decreases in seven out of ten examined microRNAs were noted, indicating potential effects on cancer growth and metastasis [6][8]. - The study's small sample size limits the ability to draw definitive conclusions about clinical efficacy or dose response, with further data needed from subsequent cohorts [11][12]. Envoy Medical, Inc. - Envoy Medical received FDA approval to expand its pivotal clinical trial for the Acclaim® cochlear implant, based on promising data from the first ten patients, allowing for a shortened timeline to commercialization by three to six months [13][14]. - The initial trial phase showed no serious adverse events, and the data indicated that the Acclaim® cochlear implant can achieve effectiveness for its intended use [16]. Soligenix, Inc. - Soligenix's confirmatory Phase 3 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) has concluded its first Data Monitoring Committee meeting, confirming no safety concerns and an acceptable safety profile consistent with prior studies [17][18]. - The company anticipates providing updates on enrollment progress and response rates before year-end, with topline results expected in the second half of 2026 [19]. MBX Biosciences, Inc. - MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint with statistical significance in its Phase 2 Avail™ trial for chronic hypoparathyroidism, with 63% of treated patients meeting the primary composite endpoint [21][22]. - The company plans to initiate a Phase 3 clinical trial in 2026, building on the positive results from the Phase 2 trial, which demonstrated the potential for canvuparatide to become a best-in-class treatment for hypoparathyroidism [23][24].
Aethlon Medical's Hemopurifier® shows Changes in Extracellular Vesicles, Extracellular MicroRNAs, and T Cell Numbers in Australian Oncology Clinical Trial
Prnewswire· 2025-10-07 12:01
Core Insights - Aethlon Medical, Inc. is conducting an ongoing oncology clinical trial in Australia to evaluate the safety, feasibility, and dose-finding of its Hemopurifier device in cancer patients unresponsive to anti-PD-1 therapy [1][2] Summary by Categories Clinical Trial Observations - Preliminary results from the first patient cohort indicate encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single Hemopurifier treatment [2][3] - In the initial three patients, two showed decreases in large EVs, which are implicated in cancer metastasis and immune evasion [7] - All three participants exhibited decreases in large EVs carrying PD-L1, which is associated with resistance to anti-PD-1 therapies [7] - Seven out of ten microRNAs examined showed decreases in two of the three participants following treatment, indicating potential effects on cancer growth and metastasis [7] - Improvements in laboratory ratios related to immunotherapy responses were observed in at least two participants after treatment [7] Device Information - The Aethlon Hemopurifier® is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment [9] - The device operates extracorporeally and utilizes a combination of plasma separation, size exclusion, and affinity binding [9] - It holds a U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [10] Limitations and Future Directions - The small sample size limits the ability to draw definitive conclusions about the efficacy and dose response of the Hemopurifier [3][8] - Further data from subsequent cohorts will be necessary to determine the reproducibility of the observed changes and the potential for dose-dependent effects [3] - The current observations are part of an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters [8]