Exchange: NASDAQ | Sector: Healthcare | Industry: Medical Devices
Q1 2025
Published: Aug 14, 2024
Earnings Highlights
EPS of $-0.34 increased by 75.7% from previous year
Net income of -2.57M
""We are starting to achieve the two goals that I stated were our objectives when I was appointed as Interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses."" - James Frakes
Aethlon Medical Inc (AEMD) QQ1 2025 Results Analysis: Oncology Strategy Advancing with Cost Discipline Amid Early Clinical Trials in Australia; Strong Liquidity Supports Near-Term Runway
Executive Summary
Aethlon Medical reported a non-revenue QQ1 2025 quarter (period ended June 30, 2024) with a net loss of approximately $2.57 million and negative EBITDA of about $2.53 million. The quarter reflects meaningful ongoing cost containment and a path toward clinical activity in Australia, where ethics approvals were secured for Hemopurifier trials in solid tumors under anti-PD-1 therapy. Management described progress toward two core objectives: advancing the oncology indication and reducing operating expenses. The company ended the quarter with roughly $9.1 million of cash and equivalents, net of financing activity generating approximately $5.38 million in the quarter, providing a liquidity runway into the Australian trial ramp expected in late 2024. The key near-term catalysts are site readiness and enrollment in Australia, the potential activation of a third site, and continuing work toward a PMA pathway informed by safety and exploratory analyses. While the absence of revenue and a substantial cost base remain material overhangs, the company’s stated focus on containment, and its early-stage oncology/EV (extracellular vesicle) program, could unlock value if clinical milestones materialize and regulatory interactions progress as planned. Investors should monitor trial initiation progress, governance approvals, ENP (external vesicle) biology outcomes, and the pace of expenses as activity potentially picks up in Australia.
Key Performance Indicators
Operating Income
-2.62M
QoQ: -5.43% | YoY:23.09%
Net Income
-2.57M
QoQ: -6.02% | YoY:21.66%
EPS
-0.34
QoQ: 63.04% | YoY:75.71%
Revenue Trend
Margin Analysis
Key Insights
Revenue: N/A (non-revenue QQ1 2025 quarter)
Net income: -$2.571 million in QQ1 2025 (YoY improvement from -$3.27 million in QQ1 2024, per management commentary). EPS: -$0.34
EBITDA: -$2.534 million
Operating income: -$2.621 million
R&D expenses: $0.415 million
Financial Highlights
Snapshot of quarter-to-quarter and year-over-year metrics (USD, unless noted):
- Revenue: N/A (non-revenue QQ1 2025 quarter)
- Net income: -$2.571 million in QQ1 2025 (YoY improvement from -$3.27 million in QQ1 2024, per management commentary). EPS: -$0.34
- EBITDA: -$2.534 million
- Operating income: -$2.621 million
- R&D expenses: $0.415 million
- General & Administrative (G&A) expenses: data inconsistencies in the reported line items; company notes indicate substantial expense rationalization; press release states total operating expenses around $2.6 million for the quarter
- Cash, equivalents, and investments: $9.07–$9.16 million cash balance at quarter end; net cash provided by financing activities: +$5.379 million; net cash used by operating activities: -$1.748 million; free cash flow: -$1.748 million
- Liquidity/ratios: Current ratio 4.49; Quick ratio 4.49; Cash ratio 4.26; Total assets ~$11.41 million; Total liabilities ~$2.70 million; Total stockholders’ equity ~$8.71 million; Net debt ≈ -$8.20 million (net cash position)
- Valuation signals: Price-to-book ~0.39x; Enterprise value multiple ~1.95x; Earnings per share negative; No revenue generated in the period.
Notes: The company’s 10-Q-style disclosures show inconsistent line-item details for SG&A components (some entries show very large negative/positive values). The narrative commentary confirms the reported quarterly operating expense level (~$2.6 million) and a $2.6 million net loss, aligning with the cash-flow and earnings metrics described above.
Income Statement
Metric
Value
YoY Change
QoQ Change
Operating Income
-2.62M
23.09%
-5.43%
Net Income
-2.57M
21.66%
-6.02%
EPS
-0.34
75.71%
63.04%
Key Financial Ratios
currentRatio
4.49
returnOnAssets
-22.5%
returnOnEquity
-29.5%
debtEquityRatio
0.1
operatingCashFlowPerShare
$-0.23
freeCashFlowPerShare
$-0.23
priceToBookRatio
0.39
priceEarningsRatio
-0.33
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Key management takeaways and quotes from the QQ1 2025 earnings call:
- Strategy and cost discipline: "We are starting to achieve the two goals that I stated were our objectives when I was appointed as Interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses." — James Frakes
- Clinical development progress and expected cadence: "We expect that we will be open for enrollment in mid to late September 2024" and related remarks about site governance and initiation steps reflect the planned ramp in Australia and the ongoing collaboration with ReSQ. — Steven LaRosa
"We are starting to achieve the two goals that I stated were our objectives when I was appointed as Interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses."
— James Frakes
"We expect that we will be open for enrollment in mid to late September 2024."
— Steven LaRosa
Forward Guidance
Outlook and catalysts based on QQ1 2025 results and management commentary:
- Near-term catalysts: Enrollment initiation in Australian sites (Pindara and CALHN Royal Adelaide sites) anticipated in September 2024, with a potential third site under governance review. The company expects to train site personnel via site initiation visits and an investigator meeting, enabling enrollment. These steps could begin to translate into trial activity in late 2024.
- Regulatory and PMA pathway: Exploratory central analyses are intended to inform subsequent efficacy and safety trials and the PMA study framework required by FDA/regulators. Progress on EV burden reduction and safety endpoints will be critical for PMA discussions.
- Expense trajectory: The leadership has signaled sustained cost discipline and anticipated reductions in professional fees as contracts are renegotiated or terminated with CROs/m suppliers. However, clinical trial activity will introduce higher, potentially offsetting, costs as enrollment ramps in Australia.
- Risks and uncertainties: Key uncertainties include governance approvals timing, site initiation success, patient enrollment pace, regulatory feedback on PMA design, and ongoing funding sufficiency to support trial activities until potential regulatory milestones. Investors should monitor site activation progress, enrollment rates, and any updated clinical milestones.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
AEMD Focus
0.00%
0.00%
-29.50%
-32.60%
TIVC
50.00%
-4.43%
-68.80%
-30.20%
TLIS
-2.67%
-125.29%
-23.00%
-29.70%
BJDX
0.00%
0.00%
-69.20%
-4.92%
HSCS
0.00%
0.00%
-34.60%
-36.50%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Aethlon Medical remains a high-risk, high-reward speculative name anchored in early-stage clinical development of the Hemopurifier for oncology and infectious diseases. The QQ1 2025 results confirm a non-revenue quarter with a net loss of approximately $2.57 million but show tangible progress toward a clinical African ramp in Australia and substantial cost-control efforts. The near-term catalysts are site initiation, patient enrollment, and the generation of safety/feasibility data that could inform an FDA PMA strategy. However, the company faces execution risk around enrollment pace, governance milestones, and the ultimate transition to revenue generation. Given the current liquidity, management expectations around sequencing of clinical milestones and cost reductions will be critical to monitor. An investment thesis would hinge on successful site activations, robust safety signals, and a clear PMA development plan that could attract partnerships or licensing opportunities, offsetting future dilution risks. Until there is visible revenue potential and clearer regulatory milestones, the stock should be viewed as a speculative, early-stage healthcare micro-cap with limited downside protection but potential upside tied to landmark trial outcomes.
Key Investment Factors
Growth Potential
High-uncertainty, high-upside potential tied to Hemopurifier oncology indication and extracellular vesicle biology. Positive catalysts include successful site initiation and enrollment in Australia, followed by safety, feasibility, and dose-finding signals that could inform longer-term efficacy studies and PMA pathways. If clinical milestones align with FDA/regulatory expectations, AEMD could transition from a development-stage device company to a payable PMA trajectory with potential partnerships or licensing in oncology and infectious disease applications.
Profitability Risk
Absolute lack of revenue in QQ1 2025; ongoing operating losses; dependence on successful clinical trial progression; regulatory and governance delays; dependence on third-party CROs and site initiation; dilution risk if additional financing is required; relatively fragile liquidity given cash burn (~$1.75M operating cash burn in the quarter) despite a cash runway into 2024–2025 depending on trial cadence.
Financial Position
Solid short-term liquidity with roughly $9.1 million of cash as of June 30, 2024, and a net cash position after financing of about $8.2 million. The balance sheet shows modest total assets (~$11.4M) and stockholders’ equity around $8.7M, with relatively low debt (~$0.87M). Retained earnings are deeply negative, reflecting cumulative losses. The company carries a strong current and quick ratio (~4.49x), but the lack of revenue combined with ongoing clinical investments implies a fragile near-term earnings profile.
SWOT Analysis
Strengths
Strategic focus on Hemopurifier oncology indication with potential to integrate with anti-PD-1 therapies (Keytruda, Opdivo).
Regulatory momentum in Australia, with ethics approvals already granted for multi-site trials in solid tumors.
Ongoing exploration of Hemopurifier’s ability to reduce extracellular vesicle levels and potentially enhance immunotherapy effectiveness.
Strong short-term liquidity position with cash and equivalents supporting a testing-and-building phase into late 2024.
Weaknesses
No revenue in QQ1 2025 and meaningful operating losses persist; business model dependent on successful clinical development and regulatory milestones.
Data integrity concerns in reported line items (large outliers in SG&A components); reliance on press release narratives for expense trajectory.
Significant dependence on successful enrollment and governance approvals to unlock near-term value.
Opportunities
Potential PMA pathway leveraging safety and dose-finding data to support broader efficacy trials.
Expansion of Australian sites and potential new international collaborations (e.g., India) to accelerate enrollment and data generation.
Broad applicability to oncology and infectious disease (including viruses) with Hemopurifier technology.
Threats
Clinical trial enrollment rate uncertainty and potential regulatory delays could extend the burn period.
Competition in the medical-device and immunotherapy-support ecosystem; potential valuation downside if milestones slip.
Funding risk if financing markets tighten or trial costs exceed projections.