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AETHLON MEDICAL INC (AEMD)·Q1 2026 Earnings Summary

Executive Summary

  • Fiscal Q1 2026 delivered a narrower loss year over year as operating expenses fell 31.6% to $1.79M; EPS was ($0.85), better than consensus ($0.86) and prior year ($2.76) . EPS beat by $0.01 versus Wall Street, while revenue remained $0, consistent with development-stage status * .
  • Clinical catalyst: DSMB confirmed safety in first oncology cohort and recommended advancing to two Hemopurifier treatments per week in Cohort 2, with sites actively screening under an amended protocol to broaden eligibility .
  • Strategic focus sharpened: management cancelled the India oncology trial to conserve $0.5–$1.0M and avoid timeline risk, concentrating resources on faster-moving Australian sites .
  • R&D narrative strengthening: preclinical data showed 98.5% removal of platelet-derived EVs; Long COVID poster presented at Keystone Symposium, underpinning platform optionality .
  • Balance sheet: cash declined to $3.77M at quarter-end with going concern disclosure; equity financing and/or partnerships remain near-term needs .

What Went Well and What Went Wrong

What Went Well

  • DSMB safety validation and progression to Cohort 2: “Following a closed-session deliberation, the DSMB provided … a recommendation to advance to our second treatment cohort where patients will receive two Hemopurifier treatments during a one-week period” .
  • Cost discipline: operating expenses down 31.6% YoY, primarily from payroll/related savings and lower legal/consulting fees, reducing operating loss to $1.79M from $2.62M .
  • Platform validation: “removed 98.5% of platelet-derived extracellular vesicles … at a time point equivalent to a 4-hour treatment,” supporting oncology and broader applications .

What Went Wrong

  • Capital needs and runway: management disclosed “substantial doubt” about going concern; additional capital will be required to fund operations and clinical trials .
  • Clinical pace and enrollment: need for added sites and recruitment initiatives (trial liaisons, social media) to accelerate screening/enrollment, indicating execution risk on timelines .
  • India trial abandoned: while strategic, cancellation underscores regulatory/logistical challenges and removes a potential source of incremental patient throughput .

Financial Results

MetricQ3 2025Q1 2025Q1 2026
Operating Expenses ($USD)$1,814,747 $2,620,858 $1,792,390
Operating Loss ($USD)$(1,814,747) $(2,620,858) $(1,792,390)
Net Loss ($USD)$(1,754,783) $(2,571,440) $(1,761,858)
Basic & Diluted EPS ($USD)$(0.13) $(2.76) $(0.85)

Notes:

  • Revenue not reported for Q3 2025 or Q1 2025 in the cited releases; Q1 2026 had no revenue recognized .

KPIs

KPIQ4 2025 (Mar 31, 2025)Q1 2026 (Jun 30, 2025)
Cash & Cash Equivalents ($USD)$5,501,261 $3,765,154
Working Capital ($USD)$4,050,514 $2,423,421
Weighted Avg Shares (Basic & Diluted)1,560,839 (FY) 2,076,416 (Q)

Estimates vs Actual (Q1 2026)

MetricConsensusActual
Revenue ($USD)$0.00*$0.00
Primary EPS ($USD)$(0.86)*$(0.85)

Values marked with * were retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/QuarterNone providedNone providedMaintained (no guidance)
Operating ExpensesFY/QuarterNone providedOpex optimization ongoing; R&D expected to fluctuate with trial activityMaintained (qualitative)
Clinical TimelineAustralia OncologyFirst cohort safety read; DSMB meeting pending (Q4 FY2025)Advance to Cohort 2 (two treatments/week); central lab observations expected Sept 2025Raised (operational progress)
India OncologyTrial initiationCDSCO approval achieved (June 2025)Cancelled to avoid delay and conserve $0.5–$1.0MLowered (terminated)
Tax rebateAustralia R&DApprox. 43% cash rebateApprox. 43% cash rebate unchangedMaintained

Earnings Call Themes & Trends

TopicQ3 2025 (Dec 2024)Q4 2025 (Mar 2025)Q1 2026 (Jun 2025)Trend
Oncology trial progressFirst patient treated; protocol amendment to speed enrollment Three patients treated; DSMB meeting planned DSMB recommended advancing to Cohort 2; sites screening under amended protocol Advancing
India trialAwaiting CDSCO approval; plan to mirror AU trial CDSCO approval received (June 19) Trial cancelled to focus AU and avoid delays; $0.5–$1.0M savings Refocus on AU
Long COVID R&DUCSF samples; planned data sharing Poster accepted for Keystone Symposium Poster presented; EV binding data supportive Maturing
Preclinical EV data98.5% removal in ex vivo study submitted 98.5% removal highlighted 98.5% removal reiterated Consistent validation
Cost structureOpex down ~50% YoY in Q3 Annual opex down ~26% Opex down 31.6% YoY; lower operating loss Sustained discipline
Financing/runwayExpect G&A to rise with trial progress; may add headcount Equity raises and grants contemplated Going concern; exploring equity/strategic options Capital need persists
Australia R&D cash rebate~43% rebate highlighted ~43% rebate confirmed Stable support

Management Commentary

  • “In the first quarter, we advanced our lead oncology program, delivered preclinical results supporting broader applications including Long COVID — all while significantly reducing operating expenses.” — James Frakes, CEO/CFO .
  • “We remain committed to driving the Hemopurifier toward regulatory approval and unlocking its potential across multiple disease areas.” — James Frakes .
  • “We expect to conserve $500,000 to $1,000,000 by this decision [cancelling India], … focusing our resources in Australia, which keeps us on the fastest track toward our next milestone.” — James Frakes .
  • “All three participants completed the entire four hour Hemopurifier treatment without any device deficiencies and no immediate complications … none … experienced a dose limiting toxicity or a device related serious adverse event.” — Steven LaRosa, CMO .

Q&A Highlights

  • Safety endpoint trajectory: Analysts confirmed understanding that primary endpoint is safety; management noted DSMB sign-off to proceed to Cohort 2 — reinforcing clinical momentum .
  • Expense and capital: Discussion focused on the depth of cost reductions, the strategic nature of the India cancellation, and timing/likelihood of future capital raises or strategic partnerships .
  • Enrollment acceleration: Management outlined prescreening logs, two additional sites recruitment, trial liaisons, and social media to hasten enrollment; early data readouts expected September 2025 from central lab .
  • Australia R&D rebate: Confirmed ~43% cash rebate remains in place, supporting economics of AU trial execution .

Estimates Context

  • Q1 2026 EPS of ($0.85) modestly beat the consensus ($0.86) by $0.01; revenue matched consensus at $0, consistent with development-stage status. Three estimates underpin consensus for EPS and revenue, indicating limited but present coverage. Values retrieved from S&P Global.*
  • Near-term EPS consensus points to continued losses with narrowing over time (e.g., forward quarters), but magnitude remains sensitive to opex cadence and trial-related spend.*

Key Takeaways for Investors

  • Clinical advancement is the core catalyst: DSMB’s Cohort 2 greenlight and broadened eligibility should increase data velocity; early central lab observations in September 2025 may influence sentiment .
  • Expense discipline is real: sustained reductions lowered operating loss; however, going concern disclosure and cash decline necessitate timely financing or partnerships .
  • Strategic focus should reduce execution risk: cancelling India avoids regulatory delays and aligns resources with AU trial throughput; savings of $0.5–$1.0M help bridge to next milestones .
  • Platform optionality (oncology + infectious disease/Long COVID) is building via EV data and academic collaborations; external validation could open non-dilutive funding pathways .
  • Trading implications: the September 2025 lab observations and Cohort 2 enrollment pace are likely near-term stock catalysts; financing announcements (equity/partner) will be pivotal given going concern .
  • Medium-term thesis: if AU safety/feasibility demonstrates EV reduction and improved T-cell activity, PMA-enabling efficacy design could emerge; execution on manufacturing component qualification remains a dependency .
  • Risk management: monitor cash runway, listing requirements, and enrollment trends; Australian R&D cash rebate (~43%) provides structural cost relief but does not replace external capital .