Exchange: NASDAQ | Sector: Healthcare | Industry: Medical Devices
Q4 2025
Published: Jun 26, 2025
Earnings Highlights
EPS of $-4.01 decreased by 335.9% from previous year
Net income of -6.25M
"Our focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial." - James B. Frakes
Aethlon Medical Inc (AEMD) Q4 2025 Results Analysis โ Oncology Focus with Multi-Geography Trials (Australia, India), Long COVID Collaboration, and Cash Flow Outlook
Executive Summary
Aethlon Medical reported a Q4 FY2025 period dominated by clinical progress rather than revenue generation. The company advanced its Hemopurifier program in oncology with the first three Australian patients completing treatment in a safety/feasibility dose-finding study, triggering the DSMB review for the next cohort. India received CDSCO approval to initiate a parallel oncology study at Medanta Medicity Hospital, broadening global trial footprint. Management emphasized that oncology remains the primary focus, while also pursuing exploratory long COVID research in collaboration with UCSF, leveraging existing relationships and low incremental cost to obtain samples and data. Operating costs were materially reduced year-over-year, contributing to an improved operating expense trajectory that, combined with a noncash warrant inducement charge, left net income negative for the quarter but with meaningful clinical progress and a cash balance around $5.5โ$5.6 million at quarter-end. Near-term catalysts include the DSMB meeting in July for Australia Cohort 2, data on EV/T cell dynamics from the Australian sites, and the start of the Indian trial. The company recognizes the need to raise additional capital to sustain ongoing clinical development and potentially pursue grants or partnerships. Investors should weigh the potential upside of a progressing oncology program and potential nondilutive funding against substantial execution risk and a continuing burn profile with no revenue visibility in the near term.
Key Performance Indicators
Operating Income
7.34M
QoQ: 504.30% | YoY:395.17%
Net Income
-6.25M
QoQ: -256.40% | YoY:-157.93%
EPS
-4.01
QoQ: -2 984.62% | YoY:-335.87%
Revenue Trend
Margin Analysis
Key Insights
Revenue: Not reported in Q4 2025 (No product revenue yet).
Operating income: $7,338,000 for Q4 2025 (positive due to operating activities in a low-revenue period; note that this is offset by a large net expense line and one-off items in the quarter).
Net income: -$6,254,893 for Q4 2025 (YoY -157.9%; QoQ -256.4%).
EPS (diluted): -$4.01 per share for Q4 2025 (YoY -335.9%; QoQ -2,984.6%).
EBITDA: $7,421,864 for Q4 2025 (positive, aided by non-operational items in the period).
Financial Highlights
Summary of key quarterly metrics (USD, unless noted otherwise):
- Revenue: Not reported in Q4 2025 (No product revenue yet).
- Operating income: $7,338,000 for Q4 2025 (positive due to operating activities in a low-revenue period; note that this is offset by a large net expense line and one-off items in the quarter).
- Net income: -$6,254,893 for Q4 2025 (YoY -157.9%; QoQ -256.4%).
- EPS (diluted): -$4.01 per share for Q4 2025 (YoY -335.9%; QoQ -2,984.6%).
- EBITDA: $7,421,864 for Q4 2025 (positive, aided by non-operational items in the period).
- Cash, end of period: $5,599,074 (approx. $5.6 million).
- Cash burn from operating activities: -$1,672,649 in Q4 2025.
- Net cash provided by/used in financing activities: +$2,359,060.
- Change in cash: +$686,181.
- Weighted average shares outstanding: 1,561,000; Diluted: 1,561,000.
- G&A expenses (quarterly): approximately $4.0965 million; Selling & Marketing: $1.3639 million; Combined SG&A: ~$5.4599 million for the period (subject to rounding and line-item presentation).
- R&D: not disclosed as a separate line in the quarter (management notes emphasis on oncology; annual R&D spend disclosed in annual filings).
Notes: Revenue and some expense line items in the data set show signs of potential rounding or formatting inconsistencies (e.g., G&A line items that seem high given the companyโs revenue profile). Management commentary in the earnings call corroborates a significant operating expense reduction for the year (approx. 26% year-over-year) with a $4.6 million noncash warrant inducement charge. The reported Q4 EBITDA and operating income illustrate the impact of one-time items and the timing of cash flows in a pre-revenue clinical-stage company.
Income Statement
Metric
Value
YoY Change
QoQ Change
Operating Income
7.34M
395.17%
504.30%
Net Income
-6.25M
-157.93%
-256.40%
EPS
-4.01
-335.87%
-2 984.62%
Key Financial Ratios
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Key insights from management on the earnings call, grouped by themes:
- Strategy and clinical focus
- Oncological program is the core focus; India trial is running in parallel with the Australian program. Quote: โOur focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial.โ (James B. Frakes)
- Long COVID collaboration with UCSF is exploratory and cost-efficient, aimed at data collection and potential grant opportunities, with a Keystone Symposium poster planned for August.
- Clear emphasis on advancing in-clinic data and preparing for a potential premarket strategy depending on DSMB outcomes.
- Clinical progression and governance
- Australia: first three patients completed a single 4-hour Hemopurifier treatment with no device deficiencies; DSMB meeting anticipated in July to authorize the next cohort (2 treatments over one week). Data on EV/T cell modulation expected later in summer.
- India: CDSCO approval received; Medanta Medicity Hospital site initiation pending, reflecting a near-term international expansion plan.
- Preclinical PD-EV removal results reported (98.5% PD-EV removal in ex vivo study); supports the mechanistic rationale for the oncology program and potential new therapeutic applications.
- Operations and financials
- Management highlighted a substantial reduction in operating expenses for the year (approx. 26% year-over-year) and a focus on cost discipline to preserve cash while pursuing clinical milestones.
- A warrant inducement in March 2025 generated roughly $2.3 million in cash but included a $4.6 million noncash accounting charge; management notes this did not impact net worth on the balance sheet.
- Additional income in the quarter from CARES Act employee retention credits (~$324k) and IRS interest (~$36k); some of these items were recorded as receivables in current assets.
- Financial outlook and fundraising
- Management reiterated the need to continue fundraising given the absence of revenue; potential for nondilutive government grants or research contracts, but acknowledged that such opportunities depend on alignment with corporate goals and regulatory pathways.
- They expect ongoing equity financing and possibly government grants to support expansion and operation of multi-site clinical trials.
- Management tone and cadence
- Jim Frakes emphasized progress in the clinic and lab as the most meaningful advancement in the period, a departure from prior quarters, and indicated a favorable trajectory for data readouts in the coming months.
Our focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial.
โ James B. Frakes
We significantly reduced our operating expenses through streamlined operations.
โ James B. Frakes
Forward Guidance
Catalysts and near-term roadmap:
- DSMB review for Australia Cohort 2: The next cohort comprises two Hemopurifier treatments within a one-week period. A DSMB decision is anticipated in July 2025 to authorize progression. Data readouts will focus on EV levels and T-cell activity, with laboratory analyses conducted by the University of Sydney. Management expects preliminary data from the first cohort within approximately 3 months of treatment completion (summer 2025).
- India oncology trial: CDSCO approval already granted; site initiation with Qualtran to occur after a site initiation visit. Monotherapy protocol currently approved; potential for faster enrollment given India's large patient pool. The timing for completion of India data will hinge on enrollment pace and regulatory processes but could extend into late 2025 or 2026 depending on catchment and site performance.
- Long COVID and other exploratory work: UCSF collaboration to be presented at Keystone Symposium in August 2025; potential for nondilutive funding if grant opportunities align with government priorities.
- Financial runway and capital needs: The company reiterates dependence on equity financing to sustain ongoing clinical work; potential for government grants or contracts as a non-dilutive option, but funding is contingent on alignment with program goals and regulatory pathways. The balance sheet shows approximately $5.5โ$5.6 million in cash as of March 31, 2025, with an operating expense base that implies a continued cash burn absent new revenue or partnering arrangements.
- Market/operational watchpoints: Watch for DSMB outcomes that influence trial design (e.g., transition to higher-frequency treatment cohorts), recruitment efficiency in Australia (potential faster enrollment in Cohorts 2 and 3), and any signs of collaboration or licensing interest from larger pharma players depending on emerging safety and efficacy signals.
Assessment: The near-term guidance is qualitative and primarily milestone-driven. The main foreseeable catalysts are clinical data readouts from Australia, the progression of the India site, and potential nondilutive funding. Given the current lack of revenue, the investment thesis hinges on successful clinical readouts, the ability to de-risk the Hemopurifier program, and the company's ability to secure external financing or partnerships to scale development.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
TIVC
-1.33%
-8.57%
-58.30%
-9.55%
TLIS
-3.12%
-96.03%
-19.50%
-25.20%
BJDX
50.00%
-6.87%
-25.00%
-13.60%
HSCS
0.00%
0.00%
-25.20%
-84.70%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Aethlon Medical presents a high-risk, potentially high-reward setup anchored on a novel Hemopurifier device with a plausible mechanism to enhance cancer immunotherapy through EV removal. Near-term catalysts are largely clinical and regulatory: DSMB review for Australia Cohort 2 in July 2025, subsequent readouts on EV/T-cell dynamics, and the India trial initiation. The absence of revenue and the need for ongoing fundraising imply a fragile financial runway unless data readouts translate into a timely partnering or grant opportunity. The companyโs strategic focus on oncology, coupled with exploratory long COVID work, creates optionality but also adds execution risk. An investment thesis would consider allocating only to higher-risk biotech portfolios with line-of-sight to translational readouts, potential strategic partnerships, and significant upside if oncology data demonstrate meaningful EV-related efficacy signals. Key monitoring items include readouts from the Australian cohort, enrollment pace and regulatory updates in India, any signs of non-dilutive funding, and the pace of cash burn versus availability of new capital.
Key Investment Factors
Growth Potential
High long-term upside anchored on the Hemopurifier's mechanismโremoving tumor-derived extracellular vesicles and other circulating factors to potentially augment anti-PD-1 therapies. Positive early ex vivo data (98.5% PD-EV removal) supports expansion into oncology and potential application in other diseases where EVs contribute to pathogenesis (e.g., autoimmune and infectious diseases). Parallel long COVID collaboration potentially broadens the device's therapeutic narrative and may unlock additional funding avenues if clinical signals emerge.
Profitability Risk
Significant execution and financing risk with no current revenue. Clinical trial readouts are early and small in scale; DSMB outcomes could impact trial progression. Dependence on fundraising exposes the company to equity market volatility. Regulatory and cross-border site initiation risks (Australia, India) could delay timelines. Competitive landscape in cancer immunotherapy and device-based therapies remains intense, with larger biopharma entities as potential partnering targets. Data quality and consistency concerns given the large formatting variances in the disclosed numbers.
Financial Position
Cash runway limited to roughly 6โ12 months given cash balance of about $5.5โ$5.6 million and ongoing cash burn from G&A and R&D. The year-over-year operating expense reduction (~26%) improves runway but does not eliminate the need for additional capital. Noncash warrant inducement provided a short-term cash influx (~$2.3 million) but introduced accounting charges and potential future dilution. The balance sheet shows modest cash and working capital, with ongoing need for external funding or partnering to sustain multi-site oncology trials.
SWOT Analysis
Strengths
Progress in clinical oncology program with first three patients treated in Australia; DSMB review expected to authorize next cohort.
Global trial footprint expansion planned with India CDSCO approval, potentially accelerating enrollment due to large population base.
Ex vivo PD-EV removal data (98.5%) supports biological rationale and potential for improved responses to anti-PD-1 therapies.
Cost discipline yielding a 26% year-over-year reduction in operating expenses; focus on deploying resources where clinical/regulatory impact is greatest.
Ongoing collaboration with UCSF for long COVID research, providing cost-efficient data gathering and potential nondilutive funding avenues.
Weaknesses
No product revenue and high reliance on equity raises; cash runway is tight without additional funding.
Small patient cohorts; early-stage data may not be predictive of broader population outcomes.
Complex regulatory processes across geographies may introduce execution risk and delays.