Exchange: NASDAQ | Sector: Healthcare | Industry: Medical Devices
Q3 2025
Published: Feb 12, 2025
Earnings Highlights
EPS of $-0.13 increased by 90.6% from previous year
Net income of -1.76M
""As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million. Our consolidated operating expenses for the fiscal quarter ended December 31, 2024 decreased by approximately $1.8 million or approximately 50% to $1.8 million compared to $3.6 million for the fiscal quarter ended December 31, 2023."" - Jim Frakes
Aethlon Medical Inc (AEMD) QQ3 2025 Earnings Analysis: Cost Discipline Supports Narrowing Losses as Australia/India Oncology Trials Advance
Executive Summary
- QQ3 2025 (quarter ended December 31, 2024) shows no consolidated revenue yet for Aethlon, with a net loss of approximately $1.755 million and basic earnings per share of $-0.13. Management attributes a meaningful improvement in spend discipline, noting operating expenses declined roughly 50% year-over-year to about $1.815 million, aided by ~$1.3 million reductions in payroll/related costs and reductions in professional fees and G&A. The company ended the quarter with ~ $4.8 million in cash, signaling improved liquidity but still a tight runway absent material near-term revenue.
Key Performance Indicators
Operating Income
-1.82M
QoQ: 37.46% | YoY:49.12%
Net Income
-1.76M
QoQ: 37.48% | YoY:49.37%
EPS
-0.13
QoQ: 35.00% | YoY:90.58%
Revenue Trend
Margin Analysis
Key Insights
Profitability: net loss of $1.755 million; EPS -$0.13 for QQ3 2025. YoY and QoQ improvements in operating income and net income are implied by the earnings metrics provided, with YoY operating income up ~49.1% and YoY net income up ~49.4% (per the earnings metrics section, noting negative base effects).
Cash flow and liquidity: net cash used in operating activities of $2.010 million; free cash flow of $-2.012 million; cash at end of period approximately $4.912 million; operating cash flow was negative at $-2.011 million for the quarter.
Balance sheet health: total assets $6.526 million; total liabilities $2.191 million; total stockholders’ equity $4.334 million; cash and cash equivalents ~$4.825 million; net debt around $(4.101) million (i.e., net cash position when including debt).
Leverage and efficiency: current ratio 2.77; debt-to-equity 0.167; price-to-book ~0.0028; equity base significantly depressed by accumulated deficit, but tangible liquidity supports near-term operations.
Working programs: no revenue recognition yet; ongoing Australian oncology trial with three enrolled patients; third site expected to initiate enrollment in Sydney in February 2025, with India trials under consideration/approval process. Management emphasizes cost discipline and strategic trial focus as the path to longer-term value.
Financial Highlights
- Profitability: net loss of $1.755 million; EPS -$0.13 for QQ3 2025. YoY and QoQ improvements in operating income and net income are implied by the earnings metrics provided, with YoY operating income up ~49.1% and YoY net income up ~49.4% (per the earnings metrics section, noting negative base effects).
- Cash flow and liquidity: net cash used in operating activities of $2.010 million; free cash flow of $-2.012 million; cash at end of period approximately $4.912 million; operating cash flow was negative at $-2.011 million for the quarter.
- Balance sheet health: total assets $6.526 million; total liabilities $2.191 million; total stockholders’ equity $4.334 million; cash and cash equivalents ~$4.825 million; net debt around $(4.101) million (i.e., net cash position when including debt).
- Leverage and efficiency: current ratio 2.77; debt-to-equity 0.167; price-to-book ~0.0028; equity base significantly depressed by accumulated deficit, but tangible liquidity supports near-term operations.
- Working programs: no revenue recognition yet; ongoing Australian oncology trial with three enrolled patients; third site expected to initiate enrollment in Sydney in February 2025, with India trials under consideration/approval process. Management emphasizes cost discipline and strategic trial focus as the path to longer-term value.
Income Statement
Metric
Value
YoY Change
QoQ Change
Operating Income
-1.82M
49.12%
37.46%
Net Income
-1.76M
49.37%
37.48%
EPS
-0.13
90.58%
35.00%
Key Financial Ratios
currentRatio
2.77
returnOnAssets
-26.9%
returnOnEquity
-0.04%
debtEquityRatio
0.17
operatingCashFlowPerShare
$-0.14
freeCashFlowPerShare
$-0.14
priceToBookRatio
0
priceEarningsRatio
-1.71
Net Income vs. Revenue
Expense Breakdown
Management Commentary
- Strategy and cost discipline: Management reiterated a sharp focus on oncology programs and operating expense reductions as a path to profitability. Jim Frakes highlighted strategic cost-cutting to optimize resources and a shift toward oncology trials in Australia and India.
- Trial progress and protocol changes: Dr. Steven LaRosa described steady progress in the Australian solid-tumor oncology trial, with 3 patients enrolled and a protocol amendment to remove the two-month anti-PD-1 run-in in favor of enrolling only responders/non-responders, aiming to shorten time-to-treatment and data. This amendment, approved by HREC/RGO, is planned to be extended to India when feasible.
- Near-term enrollment and site activation: A third site (Royal North Shore Hospital in Sydney) is expected to become fully active within days, which management believes should accelerate enrollment alongside existing sites. Jim Frakes noted the potential for a few patients to be enrolled in the coming months, though no firm timing was provided.
- Market and external risk context: The call covered broader regulatory and infectious-disease considerations (bird flu, Marburg/Ebola) and the role of Hemopurifier in extracellular vesicle removal as a potential differentiator, while emphasizing that bird flu remains outside of first-line therapy today. Management underscored ongoing data collection (EVs, T-cell changes) to inform future PMA studies and regulatory expectations.
"As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million. Our consolidated operating expenses for the fiscal quarter ended December 31, 2024 decreased by approximately $1.8 million or approximately 50% to $1.8 million compared to $3.6 million for the fiscal quarter ended December 31, 2023."
— Jim Frakes
"We will do the – what’s called the site initiation visit on our Thursday, which is Friday in Australia. So it’s dated the 14. Within a day to two days, they will be fully active to enroll patients, recruit and enroll."
— Steven LaRosa
Forward Guidance
- Near-term trajectory: The company intends to accelerate enrollment across the three sites (two active and one soon-to-be-activated in Sydney) for the Hemopurifier safety/feasibility cohorts in solid tumors, with the objective of achieving 9-18 Hemopurifier-treated patients in the Australian/India programs. The amended protocol is designed to shorten enrollment timelines and data availability, potentially enabling earlier discussions on future efficacy studies.
- Financial trajectory: With a roughly 50% YoY QoQ reduction in quarterly OpEx to $1.8 million and an ~ $4.8 million cash balance, management aims to extend the company’s liquidity runway while prioritizing oncology programs. The anticipated 43% cash tax rebate on Australian clinical-trial expenses provides a meaningful cash inflow to offset a portion of ongoing spend.
- Risks to watch: The primary revenue and clinical milestone risks remain (no product revenue yet, reliance on successful safety/feasibility results to move to PMA-like studies). Regulatory approvals, enrollment speed, and data readouts are pivotal. The pace of India trial approvals and site activations could materially affect the timeline. Investors should monitor: (i) enrollment rates, (ii) safety/feasibility readouts for extracellular vesicle removal and anti-tumor T-cell dynamics, (iii) progress toward PMA study prerequisites, and (iv) any incremental expenses as trials scale.
- Guiding principle: The investment thesis hinges on a positive safety/feasibility signal and eventual regulatory clearance for PMA-like studies, coupled with meaningful cost discipline to preserve liquidity during a prolonged pre-revenue phase.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
AEMD Focus
0.00%
0.00%
-0.04%
-1.71%
TIVC
34.90%
-11.36%
-50.50%
-8.99%
TLIS
92.10%
-223.30%
-19.20%
-16.70%
BJDX
0.00%
0.00%
-20.70%
-17.20%
HSCS
0.00%
0.00%
-1.42%
-0.03%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Aethlon Medical operates in a high-risk, pre-revenue space with a potentially outsized payoff if the Hemopurifier can demonstrate safety/feasibility in solid tumors and progress toward PMA. The QQ3 2025 results illustrate meaningful cost discipline and progressing oncology trials, supported by a near-term catalyst in site activations (Sydney) and protocol enhancements designed to shorten time-to-data. The key drivers are (1) enrollment velocity across Australia and India, (2) safety/feasibility readouts on EV removal and anti-tumor T-cell dynamics, and (3) regulatory progress toward PMA-style approvals. The cash runway, while improved, remains thin, making additional financing or licensing partnerships a potential outcome to sustain trial momentum. Given these dynamics, the stock represents a high-risk, high-variance opportunity with potential upside on successful trial readouts and eventual regulatory milestones, but substantial downside risk if safety signals fail to emerge or enrollment slows.
Key Investment Factors
Growth Potential
- Long-run upside centers on Hemopurifier-enabled modulation of extracellular vesicles and immune response in solid tumors, with potential expansion into India and other markets if safety and feasibility data are favorable. The expected PMA study framework could unlock FDA/regulatory pathways if clinical data support efficacy signals. The Australia/India trials are a critical proof-of-concept that could catalyze broader adoption if successful.
Profitability Risk
- Stage-35 biotech/medical device risk: no revenue and negative cash flow; dependence on successful progression through safety/feasibility cohorts to reach efficacy milestones; regulatory risk for PMA/approval; enrollment risk and potential delays from site activation or regulatory queries; competitive landscape in cancer immunotherapy devices; reliance on external incentives (Australian R&D tax rebate) that could vary by policy changes.
Financial Position
- Near-term liquidity anchored by a ~$4.8 million cash balance and a quarterly OpEx run-rate of ~ $1.8 million, implying a finite runway absent any material revenue or additional financing. Net loss in QQ3 2025 was ~$1.76 million with negative free cash flow; accumulated deficit remains large, though cash burn has moderated due to cost discipline.
SWOT Analysis
Strengths
Distinctive Hemopurifier technology targeting extracellular vesicles (EVs) and PD-1 resistance pathways in solid tumors
Active oncology program with Australian and India trials; first-mover potential in EV-removal immunotherapy
Clear cost-cutting actions improving quarterly burn and liquidity; 50% OpEx reduction in QQ3 2025
Potential 43% cash rebate on Australian R&D expenditures (cash-collar benefit)
Experienced leadership focusing on cost discipline and trial progress
Weaknesses
No revenue from operations; dependence on successful feasibility results to move toward PMA/regulatory milestones
Smaller clinical footprint with limited patient data to date (3 patients enrolled in Australia; 1 treated in cohort)
Significant accumulated deficit and tight liquidity runway without confirmatory efficacy data
Reliance on multiple regulatory/ethics approvals (Australia and India) for trial expansion
Opportunities
Potential PMA study pathway if safety/feasibility signals prove robust; potential expansion into India with clarified protocol
Regulatory incentives (43% rebate) to offset R&D costs in Australia; potential for faster enrollment through new Sydney site
Long-term demand for novel immunotherapy devices in oncology where resistance to PD-1 inhibitors remains an unmet need
Threats
Regulatory hurdles for PMA and acceptance of device-based immunotherapies in solid tumors; potential delays or failures in enrollment
Competitive landscape with established oncology modalities and other device-based approaches
Macro risks: clinical trial failures, negative safety readouts, or slower-than-expected data readouts