Inmune Bio, Inc. (INMB)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 was defined by XPro’s Phase 2 MINDFuL readout (primary EMACC endpoint missed in mITT), but management highlighted consistent cognitive/behavioral/biomarker signals in a pre-defined “enriched” subgroup (Aβ+ and ≥2 inflammation biomarkers) with no ARIA and a favorable safety profile; the company will seek Breakthrough Therapy, publish the full dataset, and hold an end-of-Phase 2 FDA meeting in Q4 2025 .
• Financially, INmune recorded a $24.5M net loss in Q2 (vs. $9.7M LY), driven by a $16.5M impairment of in-process R&D intangible assets tied to XPro; operating spend trended down sequentially (R&D $5.8M vs. $7.6M in Q1) as the Alzheimer’s trial concluded .
• Balance sheet strengthened: $19M registered direct financing closed June 30, lifting cash to $33.4M at quarter-end; management now sees cash runway into 2026 (vs. prior through Q3’25) .
• Pipeline momentum: CORDStrom advanced toward BLA/MAA (target mid-2026) with manufacturing partnership and positive clinical signals (itch reduction, safety) in RDEB; INKmune CaRe PC met primary and secondary biomarker endpoints and was closed to further enrollment to complete follow-up .
• Leadership transition: Co-founder RJ Tesi retired; David Moss became President/CEO; Board Chair appointed; interim CFO named—management reiterated focus on partnering XPro (timing likely post-FDA EOP2) and capital-efficient execution .

What Went Well and What Went Wrong

• What Went Well

  • No ARIA and favorable safety in MINDFuL despite inclusion of high-risk patients (APOE4 carriers, microbleeds, antithrombotic use) .
  • Enriched subgroup showed consistent effect sizes favoring XPro across EMACC, NPI and pTau217 with supportive biomarker trends; management plans Breakthrough and EOP2 in Q4 .
  • CORDStrom advancing: RPDD/ODD secured; external manufacturing scale-up with CGT Catapult; intent to file BLA/MAA by mid‑2026; qualitative and quantitative itch improvements observed in MissionEB .

• What Went Wrong

  • MINDFuL primary endpoint (EMACC) not met in the overall mITT population (n=200) as placebo did not decline over 24 weeks in that cohort .
  • Accounting impact: $16.5M impairment of in-process R&D intangible assets associated with XPro following decision to halt immediate self-funded AD development pending partnership, driving wider net loss .
  • Trial scope adjustments and closure of INKmune CaRe PC to further recruitment prioritize follow-up over expansion, which may defer certain efficacy readouts to later periods .

Financial Results

• Cash and Liquidity

  • Cash & cash equivalents: $33.4M at 6/30/25 ($19.3M at 3/31/25; $31.1M at 6/30/24) .
  • Financing: $19M registered direct closed June 30 (gross), supporting runway into 2026 (management commentary) .

• Qualitative drivers

  • YoY net loss widened due to the $16.5M non-cash impairment tied to XPro intangible assets; operating expenses otherwise declined YoY and sequentially as the AD Phase 2 trial completed .

Estimates comparison: S&P Global quarterly consensus for Q2 2025 was not available; the company is pre‑revenue and small-cap coverage is limited. Values retrieved from S&P Global.*

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Our immediate next steps for XPro and AD include publishing the trial results… and preparing a briefing book for [an] end of phase two meeting with the FDA, which we expect to occur before year's end.” — David Moss, CEO .
• “In this [enriched] subgroup we observed an effect size of 0.27 on the primary endpoint EMACC and 0.23 on… the neuropsychiatric inventory… comparable to or even exceed those achieved by currently approved [AD] therapies… with an exceptional safety profile (no ARIA).” — Dr. C.J. Barnum .
• “INKmune was safe and effective at activating NK cells… we did see, in some patients, individual tumor lesions either reducing in size or completely disappearing during treatment.” — Dr. Mark Lowdell .
• “Following the release of phase two MINDFuL data, the company has… halt[ed] immediate plans to further develop [XPro in AD] at this time given the cost of a phase three program as it seeks partnerships… [we] wrote off the value of [XPro’s] intangible asset value.” — David Moss .

Q&A Highlights

• Partnership timing: management expects any XPro partnership only after the end‑of‑Phase 2 FDA meeting and publication of the dataset; negotiations could extend into 2026 if pursued .
• EMACC/regulatory: FDA will opine after seeing data; company followed the “playbook” for validation; scientific community feedback at AAIC was constructive on EMACC and NPI findings .
• CORDStrom regulatory package: management believes MissionEB randomized crossover data are adequate for BLA/MAA; independent statistical re‑analysis underway to strengthen the package; open‑label to follow submissions .
• Cash runway: with June financing and spend trajectory, management projects runway into 2026 .

Estimates Context

• S&P Global consensus for Q2 2025 revenue/EPS was unavailable; INMB is pre‑revenue with limited quarterly coverage. Future-quarter consensus implies ongoing quarterly losses as the company advances programs toward regulatory events. Values retrieved from S&P Global.*

*Values retrieved from S&P Global.

Key Takeaways for Investors

• The MINDFuL primary miss caps near‑term approval odds, but the enriched subgroup signal (EMACC/NPI/pTau217), clean safety (no ARIA), and EOP2 meeting set a credible registrational path if a partner funds a focused Phase 3 .
• Non‑cash impairment resets the XPro intangible asset while reducing future amortization burden; core operating spend is trending lower post‑trial with R&D down sequentially to $5.8M .
• The balance sheet improved: $19M raise plus $33.4M quarter‑end cash extends runway into 2026, reducing financing overhang near term as partnership and regulatory catalysts play out .
• CORDStrom is an underappreciated asset with RPDD/ODD, a plausible mid‑2026 BLA/MAA timeline, and supportive clinical signals (itch reduction, safety); a PRV if approved could be monetized .
• INKmune’s biomarker success and safety support moving into earlier‑stage disease settings where immunotherapy benefits may be greater; design work can proceed while completing current follow‑up .
• Near‑term stock catalysts: MINDFuL publication, EOP2 FDA outcome, additional CORDStrom data in Q4, and clarity on partnering. Execution against these milestones will likely drive estimate revisions and sentiment.

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Sources: SEC filings, press releases, and earnings call transcripts:

• Q2 2025 8-K/press release and exhibits
• Q2 2025 10-Q (financial statements, impairment, liquidity)
• Q2 2025 earnings call transcript (management commentary)
• Q1 2025 8-K/press release and call (trend)
• FY 2024 8-K and Q4 2024 call (trend, runway)
• MINDFuL topline 8-K (June 30) and AAIC updates
• June financing 8-Ks
• TBI program 8-K (context)