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AETHLON MEDICAL INC (AEMD)·Q4 2025 Earnings Summary
Executive Summary
- Fiscal Q4 2025 centered on clinical execution: three oncology patients completed single 4‑hour Hemopurifier treatments with no device deficiencies; DSMB review is imminent to advance to two‑treatment cohort .
- Operating discipline continued: FY25 operating expenses fell ~26% to ~$9.3M vs ~$12.6M in FY24; cash was ~$5.5M at Mar 31, 2025 .
- EPS missed Wall Street in Q4: S&P Global consensus EPS was -$10.90 vs actual about -$37.00; prior quarter (Q3) was a beat (-$16.27 est. vs -$10.40 actual) (values with asterisk from S&P Global).
- Near‑term catalysts: DSMB decision in July and preliminary EV/T‑cell data from the first cohort expected ~three months post‑third patient; India regulator (CDSCO) approved similar oncology study at Medanta, positioning for faster enrollment .
What Went Well and What Went Wrong
What Went Well
- Treated first three oncology patients in Australia; all tolerated single 4‑hour Hemopurifier sessions “without device deficiencies or immediate complications,” triggering DSMB review to advance cohorts .
- Protocol expanded to include combination therapy with pembrolizumab/nivolumab to align with standard of care, broadening the eligible patient pool .
- Preclinical data showed 98.5% removal of platelet‑derived EVs in an ex vivo 4‑hour session, reinforcing mechanism and multi‑indication potential; management cited this as “the most forward progress in the clinic and in the lab since I joined the company” .
What Went Wrong
- Q4 EPS sharply missed consensus due to non‑cash warrant inducement charge (~$4.6M) and development‑stage losses; management highlighted the one‑time nature of executive separation/severance costs winding down (values with asterisk from S&P Global; warrant commentary cited) .
- Enrollment pace has been deliberate; DSMB must meet between cohorts, potentially gating speed; management expects cohort‑to‑cohort DSMB reviews before advancing to 2‑ and 3‑treatment weeks .
- Ongoing need for external funding until grants/partnering are achieved; management explicitly noted additional equity financing may be required absent non‑dilutive awards .
Financial Results
Quarterly P&L and Cash (oldest → newest)
Values with asterisk retrieved from S&P Global.
Estimates vs. Actuals (S&P Global; oldest → newest)
Values retrieved from S&P Global.
Note: Company is pre‑revenue; quarterly revenue not disclosed in the cited materials.
KPIs and Operating Highlights (Q4 FY25)
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We treated the first three patients in our oncology trial… each participant received a single four‑hour Hemopurifier treatment without device deficiencies or immediate complications” .
- “We expanded our trial protocol to allow enrollment of patients receiving combination therapies with either pembrolizumab… or nivolumab… should help us reach a broader patient pool” .
- “On May 12th, we showed that the Hemopurifier… removed 98.5% of platelet‑derived extracellular vesicles” .
- “I’ve never seen this much forward progress in the clinic and in the lab since I joined the company” .
- “We raised approximately $2.3 million in cash through this warrant inducement offer… Because it was a non‑cash charge, it did not impact the net worth on our balance sheet” .
Q&A Highlights
- Focus prioritization: Oncology remains “almost entirely” the focus; Long COVID collaboration is opportunistic and could be pursued if non‑dilutive funding emerges .
- Cohort cadence and DSMB gates: DSMB to meet between each cohort; management expects faster recruitment with three hospitals and larger Sydney catchment; aiming to line up patients pre‑approval .
- India protocol: Initially monotherapy per original approval; hospital is capable and familiar with device; potential to consider amendments later -.
- Timeline: Australia could complete remaining ~6 patients at ~1/month with write‑up in 9–12 months; India timing TBD as site ramps .
- Funding outlook: Likely need additional equity until grants/partnering; management experienced with prior DARPA/HHS contracts but will align future grants with core goals -.
Estimates Context
- Q4 EPS materially missed consensus: estimate -$10.90 vs actual about -$37.00; management cited a ~$4.6M non‑cash inducement expense that impacted reported results .
- Q3 EPS was a notable beat: estimate -$16.27 vs actual about -$10.40 (values with asterisk from S&P Global).
- Revenue was expected at $0.0 across recent quarters; company is pre‑revenue (values retrieved from S&P Global; revenue not disclosed in cited documents).
- Investor implication: Models should incorporate DSMB‑gated cadence, potential India contribution, and ongoing OpEx restraint; Q4 miss is largely non‑cash/one‑time driven, but development costs persist.
Values retrieved from S&P Global.
Key Takeaways for Investors
- Clinical momentum: Three treated patients and DSMB review in July position the program to accelerate into two‑ and three‑treatment cohorts; preliminary EV/T‑cell data in ~3 months could be a narrative catalyst .
- Broadened eligibility: Inclusion of combo PD‑1 regimens should improve enrollment velocity, especially in Sydney’s larger catchment area .
- Funding plan: Expect continued need for external capital until grants/partnering emerge; monitor dilution risk vs. clinical data milestones -.
- Non‑cash distortion: Q4 EPS miss reflects a one‑time ~$4.6M inducement charge; strip this to assess normalized OpEx trajectory .
- Optionality: Long COVID poster acceptance and EV biology deepen optionality; treat as upside skew rather than base case near‑term driver .
- Near‑term trading lens: Headlines around DSMB “go” and EV/T‑cell preliminary readouts likely move the stock; position sizing should reflect binary‑like data risk windows .
- Medium‑term thesis: If EV reduction and T‑cell activity translate into efficacy signals, partnering odds rise; India ramp could validate scalability and recruitment speed .
Appendix: Source Documents
- Q4 FY25 press release and financials .
- Q4 FY25 8‑K referencing press release -.
- Q4 FY25 earnings call transcript (full, including Q&A) -.
- Prior quarters press releases and 8‑Ks: Q3 FY25 - -; Q2 FY25 - -.