Aethlon Medical, Inc. (AEMD) - Q1 2026 10-Q Summary
Business Context and Reporting Period
This Quarterly Report on Form 10-Q covers the three-month period ended June 30, 2025. Aethlon Medical, Inc. is a clinical-stage medical therapeutic company developing the Hemopurifier® (HP), an immunotherapeutic device designated as a "Breakthrough Device" by the FDA for cancer and life-threatening viral infections. The company operates as a single segment focused on advancing clinical trials and pre-clinical research.
Key Financial Metrics
| Metric | Q1 2026 (Ended June 30, 2025) | Q1 2025 (Ended June 30, 2024) |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(1,761,858) | $(2,571,440) |
| Operating Expenses | $1,792,390 | $2,620,858 |
| Cash and Cash Equivalents | $3,765,154 | $9,072,379 |
| Working Capital | $2,423,421 | $4,050,514 |
| Net Cash Used in Operating Activities | $(1,714,937) | $(1,747,537) |
| Loss Per Share (Basic & Diluted) | $(0.85) | $(2.76) |
Material Changes vs. Prior Period
- Expense Reduction: Total operating expenses decreased by approximately 31.6% ($828,468) compared to the prior year. This was primarily driven by a $673,802 reduction in payroll and related expenses, largely due to the absence of a $320,604 severance accrual recorded in the prior year and a reduction in headcount.
- Professional Fees: Decreased by $138,050, attributed to lower legal fees following a firm transition and reduced scientific consulting costs.
- Reverse Stock Split: On June 9, 2025, the company effected a 1-for-8 reverse stock split. All share and per-share data in this report have been retroactively adjusted to reflect this split.
- Cash Position: Cash and cash equivalents declined by approximately $1.7 million during the quarter, reflecting continued operating losses and no significant financing inflows.
Guidance, Outlook, and Risks
- Liquidity and Going Concern: Management has expressed substantial doubt about the company's ability to continue as a going concern. Existing cash as of June 30, 2025, is not expected to fund operations for at least twelve months. The company is actively evaluating financing options, including equity offerings, but there is no assurance of availability.
- Clinical Trial Progress:
- Australia: The Phase 1 oncology trial is ongoing at three sites. Cohort 1 (3 participants) was completed with no safety concerns reported by the Data Safety Monitoring Board (DSMB). Cohort 2 enrollment is open.
- India: Despite receiving regulatory approval in July 2025, the company decided to cancel the planned Indian trial to conserve resources and focus on the Australian trial due to extended timelines and costs.
- Pre-Clinical Research: Published results in bioRxiv demonstrated >98% removal of platelet-derived extracellular vesicles (EVs) in an ex-vivo study, supporting potential applications in cancer and autoimmune diseases.
- Risks: Key risks include the inability to raise additional capital, delays in clinical trials, regulatory hurdles, and the potential expiration of patents before product approval.
Investor Verification Checklist
- Verify the timeline and terms of any upcoming equity financing required to extend the cash runway beyond 12 months.
- Monitor the enrollment rates and safety data for Cohort 2 of the Australian oncology trial.
- Review the status of the FDA supplement approval for the additional supplier of a key Hemopurifier component.
- Assess the impact of the 1-for-8 reverse stock split on market liquidity and share price volatility.
- Confirm the company's ability to maintain Nasdaq Capital Market listing requirements given current financial metrics.