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    Earnings call· Jun 2026(Q2 FY26)

    Inmune Bio Q2 FY26 earnings call INMB

    Aug 6, 2026 Source

    Executive summary

    INmune Bio Inc. Q2 FY26 — Regulatory Progress for Ebstracell and Positive EXPRO Phase 2 Data

    INmune Bio Inc. advanced its late-stage platforms, Ebstracell and EXPRO, with significant regulatory and clinical milestones. Ebstracell is on track for UK MAA submission by end of Q3 or early Q4 2026, supported by manufacturing readiness and supply chain agreements. EXPRO's Phase 2 data and FDA Fast-Track designation strengthen its path forward, while the company focuses on disciplined execution and capital preservation to reach potential commercialization.

    Highlights

    4

    • Ebstracell secured formal MHRA alignment and pediatric investigation plan approval, materially reducing regulatory risk for UK MAA submission by end Q3/early Q4 2026.

    • EXPRO received FDA Fast-Track designation for early Alzheimer's disease and showed a statistically significant treatment effect (p=0.0028) on white matter myelin MRI biomarkers in the Phase 2 MINDFUL study.

    • The company strengthened its long-term supply chain for Ebstracell through an expanded Anthony Nolan Agreement and successful commercial manufacturing milestones.

    • Cash and cash equivalents of approximately $18.4 million as of June 30, 2026, supplemented by a $4.2 million Australian R&D tax rebate, extend the cash runway into Q2 2027.

    Concerns

    2

    • Net loss attributable to common stockholders was approximately $1.3 million for Q2 FY26, compared to $24.5 million in Q2 FY25 (which included a $16.5 million impairment charge).

    • The company's current share price is seen as undervalued by management and investors despite recent positive developments.

    Guidance & targets

    12
    CategoryTargetConfidence
    Ebstracell MAA submission to MHRA (UK)
    by the end of Q3 or early Q4 26
    high materiality
    High
    Ebstracell MAA submission to EMA (EU)
    early 27
    medium materiality
    High
    Ebstracell BLA submission to US FDA
    first quarter of 27
    high materiality
    High
    Cash runway
    into the second quarter of 2027
    high materiality
    High
    Ebstracell UK approval timeline
    sometime, I think, I'm going to say early Q2 next year, but let's just say Q2 the following year
    high materiality
    Medium
    Ebstracell UK patient enrollment
    around 100 patients or so
    medium materiality
    High
    Ebstracell Phase 3 confirmatory trial enrollment
    40 to 45 patients
    medium materiality
    High
    Ebstracell Phase 3 confirmatory trial enrollment pace
    one to two patients
    low materiality
    Medium
    Ebstracell Phase 3 confirmatory trial duration
    18 months
    medium materiality
    High
    Ebstracell Phase 3 confirmatory trial data readout
    around the middle of 28
    medium materiality
    High
    Priority Review Voucher (PRV) value
    $100 million to $200 million
    high materiality
    High
    Capital raising strategy
    raise money through the end of next year
    medium materiality
    High

    Operational metrics

    10
    Net loss attributable to common stockholders
    $1.3 millioncompared to approximately $24.5 million for the quarter ended June 30th, 2025
    Q2 FY26

    The prior period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets.

    Research and development expenses
    $0.8 million benefitcompared to approximately $5.8 million of expense for the quarter end of June 30, 2025
    Q2 FY26

    The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development rebate.

    Cash and cash equivalents
    $18.4 million
    as of June 30, 2026

    Subsequent to June 30, 2026, we received approximately $4.2 million in Australian research and development tax rebate, providing non-dilutive capital to support our development programs.

    Australian research and development tax rebate
    $4.2 million
    subsequent to June 30, 2026

    providing non-dilutive capital to support our development programs.

    Shares of common stock outstanding
    27.8 million
    as of August 6, 2026
    Cash burn rate
    $1 million to $1.5 million
    per month

    It's a little bit unusual what we had in the last six months because we took a lot of R&D rebates in, which is great, but we're not expecting R&D rebates in that amount on a go-forward basis, at least over the next 12 months or so.

    R-DEB patient population
    2,000 to 3,000
    current

    10 to 15% of those suffer from the more severe form of R-DEP.

    R-DEB patient population
    2,000 to 3,000
    current

    very similar to those numbers

    R-DEB patient population
    800
    current

    somewhere around 800 or so patients in total. Now, about 60% of those numbers represent children and the rest represent adults.

    Ebstracell expected pricing
    £400,000 to £500,000
    per year

    We expect it's somewhere around 400,000 to 500,000 pounds per year per child. We will start our pricing negotiations right after we file the MAA will be the timeline for that.

    Industry KPIs

    3
    MetricValueDetails
    Pipeline read out calendarMultiple milestones
    Regulatory approvals filingsMultiple filings planned
    Clinical trial efficacy safety dataP.0028

    Deals & partnerships

    2
    Anthony Nolan Core Blood BankExpanded agreement for long-term access to qualified umbilical cord tissue.long-term

    Secures long-term access to qualified umbilical cord tissue for the Cordstrom platform for use in the UK, EU, and US, supporting scalable supply.

    N/AEvaluation of strategic partnership opportunities for EXPRO.

    The company continues to evaluate strategic partnership opportunities that could accelerate the EXPRO program while preserving meaningful value for immune shareholders.

    Risks & headwinds

    5
    Regulatory risk for Ebstracell MAA submissionAhead of planned UK MAA submission (end Q3/early Q4 26)

    materially reduced

    Mitigation: Formal MHRA alignment across CMC, non-clinical, and clinical packages; PIP approval; commercial manufacturing milestone; strengthened long-term supply chain.

    Operational risk for Ebstracell supply chainAhead of planned UK MAA submission and future commercial supply

    materially reduced

    Mitigation: Successful processing of commercial-ready umbilical cord tissue; transfer of MSC isolation stage to commercial facility; expanded Anthony Nolan Agreement.

    Share price undervaluationCurrent

    undervalued

    Mitigation: Focus on execution, achieving MAA approval, judicious capital management, highlighting potential PRV value.

    Dilution for shareholdersOngoing

    Not quantified

    Mitigation: Management (founders) are large shareholders and highly sensitive to dilution, aiming for small, judicious capital raises and careful spending.

    Cash burn rate and runwayNext 12 months

    Burn rate of $1M-$1.5M per month; cash runway into Q2 2027

    Mitigation: Judicious spending, R&D rebates, small capital raises through ATM.

    What to watch in Q3 FY26

    5

    Ebstracell UK MAA Submission

    End of Q3 or early Q4 2026
    CurrentMHRA alignment secured, PIP approved, manufacturing milestones met.
    TargetSubmission of Marketing Authorization Application to MHRA.

    Why it matters

    This is the critical first regulatory filing for Ebstracell, potentially leading to conditional marketing authorization and revenue generation.

    We now expect to submit EBSTRASELL MAA to the MHRA by the end of Q3 or early Q4 26.

    Q&A highlights

    6

    Clarification on whether the open-label Phase III trial is the previously discussed 12-month safety trial and its design.

    The open-label Phase III confirmatory trial is the same one previously discussed, focusing on safety and confirmation. It will enroll 40-45 patients (33 already lined up), enrolling 1-2 patients per month, and run for 18 months, with data expected around mid-2028.

    “Yes, so we expect it to be somewhere around 40 to 45 patients. We already have about 33 lined up, ready to go. Most of those are the patients that were on the original, almost all of those actually are the patients that were on the original trial that want to stay on Cordstrom. We expect to enroll about one to two patients... And it'll run a total of 18 months... And we'll have the data right around the middle of 28.”

    asked by James Molloy · answered by Unknown Speaker

    2 min read5 chapters

    Detailed Narrative

    01

    Ebstracell Regulatory and Manufacturing Progress

    INmune Bio secured formal MHRA alignment for Ebstracell, covering CMC, non-clinical, and clinical evidence, providing a defined path for conditional marketing authorization in R-DEB. The MHRA also approved the pediatric investigation plan and recognized Mission EB data for clinically meaningful symptomatic benefits, particularly in pain and pruritus. Manufacturing readiness advanced with successful processing of commercial-ready umbilical cord tissue and transfer of MSC isolation to the commercial facility, supported by an expanded Anthony Nolan Agreement for scalable supply.

    02

    EXPRO Clinical Development and Strategic Focus

    EXPRO received FDA Fast-Track designation for early Alzheimer's disease. The Phase 2 MINDFUL study demonstrated a statistically significant treatment effect (p=0.0028) on white matter myelin MRI biomarkers, with a Cohen's effect size of 0.46 (0.59 in the biomarker-enriched population). These data, along with successful end-of-Phase II alignment with the FDA and publication in NPJ Dementia, strengthen the clinical and regulatory foundation for a Phase 2b3 program. While Alzheimer's remains the clinical priority, the company evaluates strategic partnership opportunities for EXPRO.

    03

    Cordstrom Platform Expansion

    The Cordstrom platform patent application entered the US national phase, potentially providing broad protection into at least 2045. A newly formed scientific advisory board (SAB) will strengthen Ebstracell's late-stage development and prioritize additional disease-specific applications of the platform, focusing on phase three design, translational biomarker identification, potency assays, and indication selection.

    04

    Financial Overview and Capital Strategy

    The company reported a net loss of $1.3 million for Q2 FY26, significantly lower than the prior year due to an R&D benefit. Cash and cash equivalents stood at $18.4 million as of June 30, 2026, supplemented by a $4.2 million Australian R&D tax rebate. Existing cash resources are believed to fund operations into Q2 2027. Management emphasized a cautious approach to capital, aiming to fund operations through small, judicious raises, leveraging an ATM, and being sensitive to dilution given their significant founder ownership.

    05

    R-DEB Market Opportunity and Pricing

    The R-DEB patient population is estimated at 2,000-3,000 in the US, similar in Europe, and around 800 in the UK, with approximately 60% being children. The company expects Ebstracell pricing in the UK to be around £400,000-£500,000 per year per child, with pricing negotiations beginning after MAA filing. Hospitals in the UK have mechanisms to fund medication before final reimbursement negotiations.

    AI-generated summary of the company’s earnings call. Not investment advice.